REGISTRATION REPORT Part a Risk Management

REGISTRATION REPORT Part A Risk Management

Product code: FBR-1 Product name(s): FBR-C Chemical active substance: Active substance 1, Potassium phosphonate 726 g/L

Central Zone Zonal Rapporteur Member State: Germany

NATIONAL ASSESSMENT Germany (authorization)

Applicant: Fitosanitarios Bajo Riesgo AIE Submission date: 29/07/2016 MS Finalisation date: 20.04.2020 FBR-1 / FBR-C ZV1 008838-00/00 Page 2 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Version history

When What

2016-07-29 Submission date 2017-10 Update to the dRR Part A to: -revise the GAP tables to include the EPPO codes for pest organisms and crops -revise the “List of fata submitted by applicant and relied on” -revise the List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review” 2017-12 Update of the dRR Part A to revise the GAP 20-04-2020 Draft registration report provided for commenting. DD/MM/YYYY Registration Report: zRMS assessment

FBR-1 / FBR-C ZV1 008838-00/00 Page 3 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Table of Contents

1 Details of the application ...... 5 1.1 Application background ...... 5 1.2 Letters of Access ...... 5 1.3 Justification for submission of tests and studies ...... 6 1.4 Data protection claims ...... 6

2 Details of the authorization decision ...... 6 2.1 Product identity ...... 6 2.2 Conclusion ...... 7 2.3 Substances of concern for national monitoring ...... 7 2.4 Classification and labelling ...... 7 2.4.1 Classification and labelling under Regulation (EC) No 1272/2008 ...... 7 2.4.2 Standard phrases under Regulation (EU) No 547/2011 ...... 8 2.4.3 Other phrases (according to Article 65 (3) of the Regulation (EU) No 1107/2009) ...... 8 2.5 Risk management ...... 8 2.5.1 Restrictions linked to the PPP ...... 8 2.5.2 Specific restrictions linked to the intended uses ...... 9 2.6 Intended uses (only NATIONAL GAP) ...... 10

3 Background of authorization decision and risk management ...... 12 3.1 Physical and chemical properties (Part B, Section 2) ...... 12 3.2 Efficacy (Part B, Section 3) ...... 12 3.3 Efficacy data ...... 12 3.3.1 Information on the occurrence or possible occurrence of the development of resistance ...... 13 3.3.2 Adverse effects on treated crops ...... 13 3.3.3 Observations on other undesirable or unintended side-effects ...... 13 3.4 Methods of analysis (Part B, Section 5) ...... 13 3.4.1 Analytical method for the formulation ...... 13 3.4.2 Analytical methods for residues ...... 13 3.5 Mammalian toxicology (Part B, Section 6) ...... 14 3.5.1 Acute toxicity ...... 14 3.5.2 Operator exposure ...... 14 3.5.3 Worker exposure ...... 14 3.5.4 Bystander and resident exposure ...... 14 3.6 Residues and consumer exposure (Part B, Section 7) ...... 14 3.6.1 Residues ...... 14 3.6.2 Consumer exposure ...... 15 3.7 Environmental fate and behaviour (Part B, Section 8) ...... 15 3.7.1 Predicted environmental concentrations in soil (PECsoil) ...... 15 3.7.2 Predicted environmental concentrations in groundwater (PECgw) ...... 15 3.7.3 Predicted environmental concentrations in surface water (PECsw)...... 16 3.7.4 Predicted environmental concentrations in air (PECair) ...... 16 3.8 Ecotoxicology (Part B, Section 9) ...... 16 FBR-1 / FBR-C ZV1 008838-00/00 Page 4 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

3.8.1 Effects on terrestrial vertebrates ...... 16 3.8.2 Effects on aquatic species ...... 17 3.8.3 Effects on bees ...... 18 3.8.4 Effects on other arthropod species other than bees ...... 18 3.8.5 Effects on soil organisms ...... 19 3.8.6 Effects on non-target terrestrial plants ...... 19 3.8.7 Effects on other terrestrial organisms (Flora and Fauna) ...... 19 3.9 Relevance of metabolites (Part B, Section 10) ...... 19

4 Conclusion of the national comparative assessment (Art. 50 of Regulation (EC) No 1107/2009) ...... 20

5 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorization ...... 20

Appendix 1 Copy of the product authorization (see Appendix 5) ...... 21

Appendix 2 Copy of the product label ...... 22

Appendix 3 Letter of Access ...... 23

Appendix 4 Lists of data considered for national authorization ...... 24

Appendix 5 Copy of the product authorization ...... 52

FBR-1 / FBR-C ZV1 008838-00/00 Page 5 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

PART A RISK MANAGEMENT

1 Details of the application

1.1 Application background

This application was submitted by Fitosanitarios Bajo Riesgo AIE on 29.07.2016 in order to allow the - registration (Art. 29) of this product in Germany according to Regulation (EC) No 1107/2009.

Germany is the zRMS for the evaluation of the core assessment and the cMS is only Hungary. The application is for registration of FBR-C (FBR-1) containing 726 g/L potassium phosphonates. The product is intended to be used as fungicide to control Plasmospora viticola in grapevine. It is a SL formulation. The risk assessment conclusions are based on the information, data and assessments provided in the Reg- istration Report, Part B Sections 0-9 and Part C and where appropriate the addendum for Germany. The information, data and assessments provided in Registration Report, Parts B includes assessment of further data or information as required at national registration by the EU review. It also includes assessment of data and information relating to FBR-1 where that data have not been considered in the EU review. Oth- erwise assessments for the safe use of FBR-1 have been made using endpoints agreed in the EU review of potassium phosphonates.

This document describes the specific conditions of use and labelling required for the German registration of FBR-C.

Appendix 1 should include the authorisation of the final product in Germany. Due to technical reasons, the authorisation of the final product in Germany is inserted under Appendix 5.

Appendix 2: The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions made by the competent authority. The final version of the German label has to fulfil the requirements according to Article 31 of Regulation (EC) No 1107/2009 and PflSchG § 31.

Appendix 3: Letters of access are classified as confidential and, thus, are not attached to this document.

Appendix 4 of this document contains the lists of data considered for national authorisation.

Appendix 5 of this document provides a copy of the final product authorisation in Germany.

1.2 Letters of Access

The applicant demonstrated access to a.i. data by means of a matching table. The remaining data require-

FBR-1 / FBR-C ZV1 008838-00/00 Page 6 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020 ments were fulfilled by studies for which the applicant demonstrated (co)ownership.

1.3 Justification for submission of tests and studies

To obtain approval the product FBR-A must meet the conditions of Commission implementing Regula- tion (EU) 369/2013 of 22 April 2013 approving the active substance potassium phosphonates and be supported by dossiers satisfying the requirements of Commission regulation (EU) No 284/2013, with an assessment to Uniform Principles, using agreed end-points.

This application was submitted in order to allow the registration of this product in Germany in accordance with the above.

The reference list included in Part A Appendix 4 defines the list of studies and reports, submitted by the applicant and relied on as well as a list of studies submitted by the applicant but not relied on for the authorisation. Furthermore, Appendix 4 includes studies already evaluated at EU peer review and studies necessary but not submitted.

1.4 Data protection claims

Data protection is claimed in accordance with Article 59 of Regulation (EC) No. 1107/2009 as provided for in the list of references in Appendix 4.

2 Details of the authorization decision

2.1 Product identity

Product code FBR-1 Product name in MS FBR-C Authorization number 008632-00/00 Function Fungicide Applicant Fitosanitarios Bajo Riesgo AIE Active substance(s) Potassium phosphonates; 726 g/L (incl. content) Formulation type Soluble concentrate [Code: SL] Packaging professional user: 60 mL - 1 L bottle HDPE 5 L - 25 L jerry can HDPE 200 L - 220 L barrel HDPE 1000 L tank HDPE 1000 L IBC HDPE Coformulants of concern for Not acpplicable national authorizations Restrictions related to identiy None Mandatory tank mixtures None Recommended tank mixtures None

FBR-1 / FBR-C ZV1 008838-00/00 Page 7 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

2.2 Conclusion

With respect to identity, physical, chemical and technical properties, further information and analytical methods for the formulation an authorisation can be granted.

With respect to analytical methods for residues, an authorisation can be granted.

With respect to toxicology, residues and consumer protection an authorisation can be granted.

With respect to fate and ecotoxicology assessment, an authorisation can be granted. Considering an application of the product in accordance with the intended and evaluated use pattern and good agricultural practice as well as compliance with imposed risk mitigation measures no harmful effects on groundwater or unacceptable effects on non-target organisms are to be expected. However, an authorisation is possible only in combination with the mandatory condition of use “Provision of a field monitoring study with phosphonates on earthworm populations”.

With respect to efficacy and sustainable use/IPM an authorisation can be granted.

The evaluation of the application for FBR-C resulted in the decision to grant the authorization.

2.3 Substances of concern for national monitoring

None.

2.4 Classification and labelling

2.4.1 Classification and labelling under Regulation (EC) No 1272/2008

The following classification is proposed in accordance with Regulation (EC) No 1272/2008:

Hazard class(es), categories: None

The following labelling information is derived from the classification and to be mentioned in the safety data sheet.

Hazard pictograms: None Signal word: None Hazard statement(s): None Precautionary statement(s): None Additional labelling phrases: To avoid risks to man and the environment, comply with the instructions for use.

FBR-1 / FBR-C ZV1 008838-00/00 Page 8 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

[EUH401]

Special rule for labelling of plant protection product (PPP): EUH401 To avoid risks to man and the environment, comply with the instructions for use. Further labelling statements under Regulation (EC) No 1272/2008: None

2.4.2 Standard phrases under Regulation (EU) No 547/2011

SP 1 Do not contaminate water with the product or its container (Do not clean application equipment near surface water/Avoid contamination via drains from farmyards and roads).

2.4.3 Other phrases (according to Article 65 (3) of the Regulation (EU) No 1107/2009)

None

2.5 Risk management

2.5.1 Restrictions linked to the PPP

The authorization of the PPP is linked to the following conditions (mandatory labelling):

Operator protection: SB001 Avoid any unnecessary contact with the product. Misuse can lead to health damage. SB005 If medical advice is needed, have product container or label at hand. SB010 Keep out of the reach of children. SB111 Concerning the requirements for personal protective gear for handling the plant protection product the material safety data sheet and the instructions for use of the plant protection product as well as the guideline "Personal protective gear for handling plant protection prod-ucts" of the Federal Office of Consumer Protection and Food Safety (www.bvl.bund.de) must be observed. SB166 Do not eat, drink or smoke when using this product. SS206 Working clothes (if no specific protective suit is required) and sturdy footwear (e.g. rubber boots) must be worn when applying/handling plant protection products. Worker protection: SF245-02 It must be ensured that treated areas/crops may not be entered until the film of the plant protection product has dried. SF275-4WE During the first 4 days after application in viticulture, it must be ensured that long-sleeved working clothes and sturdy footwear are worn during successive work/inspections with direct contact with the treated crops/areas. Integrated pest management (IPM)/sustainable use:

FBR-1 / FBR-C ZV1 008838-00/00 Page 9 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

WMFP7 Mode of action (FRAC-Group): P7 (for phosphonates) Environmental protection NW470 Fluids left over from application and their remains, products and their remains, empty containers and packaging, and cleansing and rinsing fluids must not be dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and to rain- water and sewage canals. Other specific restrictions none

The authorization of the PPP is linked to the following conditions (voluntary labelling):

Integrated pest management (IPM)/sustainable use: NN1001 The product is classified as non-harmful for populations of relevant beneficial insects. NN1002 The product is classified as non-harmful for populations of relevant beneficial predatory mites and spiders. NB6641 The product is classified as non-hazardous to bees, even when the maximum application rate, or concentration if no application rate is stipulated, as stated for authorisation is applied. (B4)

2.5.2 Specific restrictions linked to the intended uses

Some of the authorised uses are linked to the following conditions in addition to those listed under point 2.5.1 (mandatory labelling):

Integrated pest management (IPM)/sustainable use: Relevant for use no. WG734 Use of the product for spontaneous fermentation can lead to a Uses 001 and 002 delay in fermentation. WW750 The maximum number of applications is limited due to active Uses 001 and 002 substance-specific reasons. Sufficient control is therefore not expected in all cases. If necessary, use products containing other active substances afterwards or alternately. Environmental protection: Relevant for use no. NW642-1 The product may not be applied in or in the immediate vicinity of for all uses surface or coastal waters. Irrespective of this, the minimum buffer zone from surface waters stipulated by state law must be observed. Violations may be punished by fines of up to 50 000 EUR NG402 Between treated areas with an incline of more than 2% and surface for all uses water - except only occasionally but including periodically water- bearing surface water - there must be a border under complete plant cover. The border's protective function must not be impaired by the use of implements. It must be at least 10 m wide. This border is not necessary if: - sufficient catching systems are available for the water and soil transported by run-off, which do not flow into surface water or are not connected with the urban drainage system or - the product is used for mulch or direct drilling methods. Other specific restrictions: Relevant for use no. none

FBR-1 / FBR-C ZV1 008838-00/00 Page 10 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

2.6 Intended uses (only NATIONAL GAP)

The following table is supposed to be a subset of the uses listed in the GAP table of Appendix 1 in Part B Section 0. Guidance for completing the GAP table is an- nexed to that table.

GAP rev. 1, date: 2018-03-28 PPP (product name/code): FBR-C Formulation type: SL (a, b) Active substance 1: Potassium phosphonate Conc. of as 1: 726.00 g/L (c) Applicant: Fitosanitarios Bajo Riesgo AIE Professional use: Zone(s): central (d) Non professional use: Verified by MS: yes/no Field of use: Fungicide

1 2 3 4 5 6 7 8 9 10 11 12 13 14 Use- Member Crop and/ F, Pests or Group of pests Application Application rate PHI Remarks: No. (e) state(s) or situation Fn, controlled (days) Fpn Method / Timing / Growth Max. number Min. interval kg or L product g or kg as/ha Water L/ha e.g. g safener/synergist (crop destination / G, (additionally: develop- Kind stage of crop & a) per use between / ha per ha (f) purpose of crop) Gn, mental stages of the pest season b) per crop/ applications a) max. rate per a) max. rate per min / max Gpn or pest group) season (days) appl. appl. or b) max. total b) max. total I rate per rate per crop/season crop/season

Zonal uses (field or outdoor uses, certain types of protected crops) 001 DE grape vine F downy mildew of grape- spraying from BBCH 15 a) 6 10 to 14 a) basic appli- 0.726 kg as/ha max. 400 14 Notes on dose rate: VITVI vine or fine days cation rate: L/ha naximum application Plasmopara viticola spraying in case of dan- 1 L/ha rate 18 L/ha PLASVI (low ger of infection use as table and volume and/or after a) BBCH 61: 1.452 kg as/ha max. 800 wine grape spraying) warning service 2 L/ha L/ha appeal a) BBCH 71: 2.178 kg as/ha max 1200 3 L/ha L/ha

a) BBCH 75: 2.904 kg as/ha max 1600 4 L/ha L/ha

b) 18 L/ha 13.068 kg/ b) 6 asha 002 DE grape vine F downy mildew of grape- spraying from BBCH 15 a) 5 20 to 28 a) basic appli- 0.726 kg as/ha max 400 14 notes on dose rate:

10 FBR-1 / FBR-C ZV1 008838-00/00 Page 11 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

VITVI vine or fine days cation rate: L/ha maximum application Plasmopara viticola spraying in case of dan- 1 L/ha rate 18 L/ha PLASVI (low ger of infection use as table and volume and/or after a) BBCH 61: 1.452 kg as/ha max 800 wine grape spraying) warning service 2 L/ha L/ha appeal a) BBCH 71: 2.178 kg as/ha max 1200 3 L/ha L/ha

a) BBCH 75: 2.904 kg sa/ha max 1600 4 L/ha L/ha

b) 6 b) 18 L/ha 13.068 kg sa/ha

Remarks (a) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (d) Select relevant table (b) Catalogue of pesticide formulation types and international coding system CropLife (e) Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be heading: International Technical Monograph n°2, 6th Edition Revised May 2008 given in column 1 (c) g/kg or g/l (f) No authorization possible for uses where the line is highlighted in grey, Use should be crossed out when the notifier no longer supports this use.

Remarks 1 Numeration necessary to allow references 7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, columns: 2 Use official codes/nomenclatures of EU Member States Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of ap- 3 For crops, the EU and Codex classifications (both) should be used; when relevant, the use plication situation should be described (e.g. fumigation of a structure) 8 The maximum number of application possible under practical conditions of use must be provided. 4 F: professional field use, Fn: non-professional field use, Fpn: professional and non- 9 Minimum interval (in days) between applications of the same product professional field use, G: professional greenhouse use, Gn: non-professional greenhouse 10 For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty use, Gpn: professional and non-professional greenhouse use, I: indoor application rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products. 5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when relevant, the 11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g, common names of the pest groups (e.g. biting and sucking insects, soil born insects, foliar kg or L product / ha). fungi, weeds) and the developmental stages of the pests and pest groups at the moment of 12 If water volume range depends on application equipments (e.g. ULVA or LVA) it should be application must be named. mentioned under “application: method/kind”. 6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench 13 PHI - minimum pre-harvest interval Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - 14 Remarks may include: Extent of use/economic importance/restrictions type of equipment used must be indicated.

11 FBR-1 / FBR-C ZV1 008838-00/00 Page 12 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

3 Background of authorization decision and risk management

3.1 Physical and chemical properties (Part B, Section 2)

All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. The appearance of the product is that of a colourless liquid with a characteristic odour. It is not explosive, has no oxidising properties. The product is not flammable. It has a self-ignition temperature of 590 °C. In aqueous solution, it has a pH value around 5.7 whereas the neat test item has a pH around 5.8. There is no effect of low and high temperature on the stability of the formulation, since after 7 days at 0 °C and 14 days at 54 °C, neither the active ingredient content nor the technical properties were changed. The shelf-life study at ambient temperature is available and acceptable. The technical characteristics of FBR-1 are acceptable for a soluble concentrate formulation.

In use concentration: 0.03 % - 2.00 %.

The plant protection product has been analysed by the authority. Results of the analytics are shown in Appendix 3.

Justified Proposals for Classification and Labelling (KCP 12) for physical chemical part only According to the physical, chemical and technical properties of the product FBR-1, no classification is required.

Notifier Proposals for Risk and Safety Phrases (KCP 12) None required.

Compliance with FAO specifications: The product FBR-1 complies with FAO specifications.

Formulation used for tests The product used in the tests has the same composition as the one cited in Part C. Batch n°2015-10-07, containing 31.6% phosphonates ions and 17.8% potassium ion.

3.2 Efficacy (Part B, Section 3)

The plant protection product FBR-C, a soluble concentrate product containing 726 g/l of Potassium phosphonates against Downy mildew (Plasmapora viticola) on grapevine, is sufficiently effective and has no adverse effects.

3.3 Efficacy data

Preliminary tests or minimum effective dose tests were not submitted but the available information is considered sufficient. The active substance is well-known. The applicant submitted sufficient valid trials to support the claim in the maritime EPPO zone. Efficacy was adequate and comparable to reference products.

FBR-1 / FBR-C ZV1 008838-00/00 Page 13 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

3.3.1 Information on the occurrence or possible occurrence of the development of resistance

Phosphonates are listed under FRAC code P07. Only a few resistance cases have been reported for some pathogens. The development of resistance is unlikely, further mitigation measures are not necessary.

3.3.2 Adverse effects on treated crops

Phytotoxic symptoms were not observed in any of the available trials. Effects on transformation processes were not evaluated, no specific trials were submitted. Undesirable effects cannot be excluded entirely. A label warning is added. No additional data was provided to exclude a negative impact on treated plants or plant products to be used for propagation. The information is not considered relevant.

3.3.3 Observations on other undesirable or unintended side-effects

No additional data was provided to exclude a negative impact on succeeding plants. The target crop is a perennial crop. Information regarding a negative impact on other plants including adjacent crops is not considered relevant. No undesirable effects on beneficial and other non-target organisms were observed. Further risk mitigation is not required.

3.4 Methods of analysis (Part B, Section 5)

3.4.1 Analytical method for the formulation

The method for determination of the potassium and the phosphonate content were successfully validated according to SANCO/3030/99 rev.4. All relevant chromatograms are available. Raw data of the validation measurement is not available.

3.4.2 Analytical methods for residues

Analytical methods for the determination of residues of potassium phosphonates were provided and evaluated in the EU review. They were considered adequate for food of plant origin. Methods for soil and water provided in the EU review involved the use of diazomethane, which is considered to be an unacceptable derivatisation agent. However, analytical methods are available in the DAR for fosetyl-Al, which are also adequate for the determination of the components of the residue definition of potassium phosphonates in soil and water. These studies are not protected anymore. As the applicant does not have access to the EU dossier, own studies for the determination of potassium phosphonates residues in plants, soil, water and air have been submitted. These studies are considered acceptably validated.

Taking the data requirements of Reg. (EU) No. 284/2013 into account, the following data gaps exist:  An independent laboratory validation (ILV) of the method of Perboni (2018) for the determination of residues of potassium phosphonate (phosphonic acid and its salts, expressed as phosphonic acid) in drinking water is missing.  A sufficiently validated analytical method (primary and confirmatory method) for the determination of residues of potassium phosphonate (phosphonic acid and its salts, expressed as phosphonic acid) in body fluids and tissues is missing.

However, potassium phosphonate is not classified as toxic (T / T+) nor as Xi or Xn nor is it classified according to GHS as follows: Acute toxicity (cat. 1 -3), CMR (cat. 1) or STOT (cat. 1).

FBR-1 / FBR-C ZV1 008838-00/00 Page 14 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Furthermore, the following minor data gaps have been noted:

 A sufficiently validated analytical method (primary and confirmatory method) for the determination of residues of potassium phosphonate (phosphonic acid and its salts, expressed as phosphonic acid) in plant matrices (high water content and high fat content) is missing.  An independent laboratory validation (ILV) of a method for the determination of residues of potassium phosphonate (phosphonic acid and its salts, expressed as phosphonic acid) in plant matrices (high water content, high fat content and dry commodities) is missing.  A statement on the extraction efficiency of the methods used for the determination of residues of potassium phosphonate (phosphonic acid and its salts, expressed as phosphonic acid) in plant matrices is missing.

3.5 Mammalian toxicology (Part B, Section 6)

3.5.1 Acute toxicity

FBR-C, containing 726 g/L potassium phosphonate has a low toxicity in respect to oral, dermal and acute inhalation toxicity. It has no sensitizing properties. It is not irritating to skin and to eyes.

3.5.2 Operator exposure

Operator exposure was assessed against the AOEL agreed in the EU review (potassium phosphonates 5.0 mg/kg bw/d). Dermal absorption data of studies conducted with an identical formulation has been used. The detailed evaluation is provided in Part B. According to the model calculations, it can be concluded that the risk for the operator using FBR-C in grape vine is acceptable with the use of work wear.

3.5.3 Worker exposure

The worker exposure was estimated using the EFSA model. For a period of 3 days after the last application of the plant protection product, workers must wear working clothes when working in treated crops to ensure that the AOEL is not exceeded.

3.5.4 Bystander and resident exposure

The bystander and/or resident exposure estimations indicated that the acceptable operator exposure level (AOEL) for potassium phosphonates will not be exceeded under conditions of intended uses.

3.6 Residues and consumer exposure (Part B, Section 7)

3.6.1 Residues

Fundamental residue data on potassium phophonate are already evaluated previously and is described in detail in the respective DARs. The data available are considered sufficient for risk assessment. An exceedance of the current MRL of 100 mg/kg for grapes as laid down in Reg. (EU) 396/2005 is not expected.

FBR-1 / FBR-C ZV1 008838-00/00 Page 15 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

3.6.2 Consumer exposure

An estimation of dietary intake using EFSA PRIMo results in a maximum consumption of the respective ADI/ARfD below 100 %.

ADI/ARfD Con- Substance ADI/ARfD Model / Diet sumption

Phosphonic acid ADI: 2.25 mg/kg bw/d IEDI, EFSA PRIMo rev.3, 52 % NL toddler

ARfD: not applicable - -

The chronic and the short-term intake of potassium phosphonate residues are unlikely to present a public health concern.

3.7 Environmental fate and behaviour (Part B, Section 8)

3.7.1 Predicted environmental concentrations in soil (PECsoil)

PECsoil was calculated for the active substance phosphonic acid considering a soil depth of 1 cm. Due to the slow degradation of the active substance phosphonic acid in soil the accumulation potential of phosphonic acid was not considered. Therefore, PECsoil used for risk assessment comprises background concentration in soil (PECaccu) considering a tillage depth of 5 cm (permanent crops) and the maximum annual soil concentration PECact.

The PECsoil values for the active substance were used in the eco-toxicological risk assessment for the intended uses of the plant protection product FBR-1 in Germany.

3.7.2 Predicted environmental concentrations in groundwater (PECgw)

Direct leaching into groundwater Results of modelling with FOCUS PELMO 5.53 show that the active substance Phosphonic acid is not expected to penetrate into groundwater at concentrations of ≥ 0.1µg/L in the intended uses of FBR-1 in Germany according to use No 001 & 002.

Groundwater contamination by bank filtration due to surface water exposure via runoff and drainage According modelling with EXPOSIT 3, groundwater contamination at concentrations ≥ 0.1 µg/L by the active substance phosphonic acid due to surface runoff and drainage into the adjacent ditch with subsequent bank filtration can be excluded in case risk mitigation measures (vegetated buffer strip of 10 m) are applied.

Consequences for authorization: The authorization of the plant protection product FBR-1 is linked with following labelling:

Use No. 001 & 002 NG402

FBR-1 / FBR-C ZV1 008838-00/00 Page 16 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

3.7.3 Predicted environmental concentrations in surface water (PECsw)

Risk mitigation measures for the intended uses of plant protection products in Germany due to exposure of surface water consider two routes of entry (i) spray drift and volatilization with subsequent deposition and (ii) runoff, drainage separately. Surface water exposure including effects of risk mitigation via spray drift and volatilization with subsequent deposition was estimated with the model EVA 3 using drift data by Rautmann and Ganzelmeier. Surface water exposure including effects of risk mitigation via surface runoff and drainage was estimated using the model EXPOSIT 3. The results of the specific national exposure assessment for the active substance were used in the eco- toxicological risk assessment.

3.7.4 Predicted environmental concentrations in air (PECair)

The vapour pressure at 20 °C of the active substance phosphonic acid is not known. As worst case a default vapour pressure of < 10-5 Pa was assumed. Hence the active substance phosphonic acid is assumed to be volatile (volatilisation from soil and plant surfaces). Therefore, exposure of adjacent surface waters and terrestrial ecosystems by the active substance Potassium phosphonates due to volatilization with subsequent deposition was considered.

3.8 Ecotoxicology (Part B, Section 9)

3.8.1 Effects on terrestrial vertebrates

Birds

Based on tier 1 assessment step, the calculated TER values for the acute risk resulting from an exposure of birds to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 achieve the acceptability criteria TER ≥ 10, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute effects. Based on tier 1 assessment step, the calculated TER values for the long-term risk resulting from an exposure of birds to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 do achieve the acceptability criteria TER ≥ 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for chronic effects. The results of the assessment indicate an acceptable acute and long-term risk for birds due to the intended use of FBR-1 in in vines according to the label.

Based on the assessment of the risk arising from the uptake of Potassium Phosphonates via drinking water, a TER calculation is not necessary. A low risk can be concluded since. The ratios of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) for birds were calculated, taking into account the relevant toxicity data for Potassium Phosphonates and calculated exposure levels for exposure via drinking water, according to the intended uses of the product FBR-1 in vines. The calculated ratios do not exceed 3000, which is the trigger in the case of more sorptive substances (Koc ≥ 500 L/kg). The results of the assessment indicate an acceptable risk for birds due to the intended use of FBR-1 in vines according to the label.

FBR-1 / FBR-C ZV1 008838-00/00 Page 17 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Terrestrial vertebrates other than birds

Based on screening assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of mammals to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 indicated a risk for herbivorous mammals. A first tier assessment has been performed based on the focal species bank vole. The calculated TER values for the acute and long-term risk resulting from an exposure of mammals to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 do achieve the refined acceptability criteria TER ≥ 5 resp. TER ≥ 2, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute and chronic effects, respectively. The results of the assessment indicate an acceptable acute and long-term risk for mammals due to the intended use of FBR-1 in vines according to the label.

Based on the assessment of the risk arising from the uptake of Potassium Phosphonates via drinking water, a TER calculation is not necessary. A low risk can be concluded since. The ratios of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) for mammals were calculated, taking into account the relevant toxicity data for Potassium Phosphonates and calculated exposure levels for exposure via drinking water, according to the intended uses of the product FBR-1 in vines. The calculated ratios do not exceed 3000, which is the trigger in the case of more sorptive substances (Koc ≥ 500 L/kg). The results of the assessment indicate an acceptable risk for mammals due to the intended use of FBR-1 in vines according to the label.

3.8.2 Effects on aquatic species

For authorization in Germany, exposure assessment of surface water considers the two routes of entry (i) spraydrift and volatilization with subsequent deposition and (ii) run-off, drainage separately in order to allow risk mitigation measures separately for each entry route.

In agreement with the German modelling scheme TER values are calculated for all relevant exposure routes; i.e. spray drift, run-off and drainage entry. The calculation is based on the following relevant endpoint: LC50 = 118 mg a.s./L (O.mykiss).

Based on the calculated concentrations of Potassium Phosphonates in surface water (EVA 3, EXPOSIT 3.0.1), the calculated TER values for the acute and long-term risk resulting from an exposure of aquatic organisms to Potassium Phosphonates according to the GAP of the formulation FBR-1indicate an acceptable risk for aquatic organisms due to the intended use of FBR-1 in vines according to the label. However, the application of PPP in the immediate vicinity of surface or coastal waters is not permitted in Germany, minimum buffer zones stipulated by state law must be observed. According to the water framework directive (2000/60/EC) and its implementation law in Germany, the regulation for the protection of surface waters (Oberflächengewässerverordnung), the environmental quality standard representing a good ecological status of surface water bodies is 20 µg ortho-Phosphates/L or 50 µg total P/L. Moreover, the inclusion directive for Potassium Phosphonates states that member states shall pay particular attention to the risk of eutriphication of surface water. Since no definition for an acceptable limit of eutrophication exists, the environmental quality standard representing a good ecological status of surface water bodies for ortho-phosphates, which is 20 µg/L, is taken as limit value for setting risk mitigation measures.

Based on the EXPOSIT 3.0.1 calculations this limit is exceeded only in case of an application on drained areas between 1 November and 15 March. Since the plant protection product FBR-1 will not be used between 1 November and 15 March the limit will not be exceeded due to the intended use of FBR-1 in vines

FBR-1 / FBR-C ZV1 008838-00/00 Page 18 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020 according to the label. However, no additional entries as those according to the evaluated use pattern and good agricultural practice are acceptable. Therefore, additional labelling with risk phrases (NW264-1) and safety phrases (NW470) is assigned, particularly to enforce prevention of any point source entry into surface waters; see also chapter 2.2.

Consequences for authorization: For the authorization of the plant protection product FBR-1 the following labelling and conditions of use are mandatory: Safety precautions / Conditions of use All uses NW470 NW642-1

3.8.3 Effects on bees

Effects on bees for FBR-C were not evaluated as part of the EU review of potassium phosphonate. Risk assessments for FBR-C with the proposed use pattern were provided and are considered adequate.

The risks of FBR-C to honey-bees were assessed from hazard quotients between toxicity endpoints, estimated from acute oral and contact studies with the formulated product, and the maximum single application rate of 1882 g /ha.

Table 3.8.3-1: First-tier assessment of the risk for bees due to the use of FBR-1 in Grapevine

Intended use Grapevine Active substance Potassium phosphonates Application rate (g/ha) Phosphonic acid equivalent: 1882

Test design LD50 (lab.) Single application rate QHO, QHC (µg/bee) (g/ha) criterion: QH ≤ 50 Oral toxicity 50.34 37.4 1882 Contact toxicity 71.87 26.2

QHO, QHC: Hazard quotients for oral and contact exposure. QH values shown in bold breach the relevant trigger.

All the hazard quotients are considerably less than 50, indicating that the application of FBR-C according to the recommended use pattern poses a low risk towards bees.

3.8.4 Effects on other arthropod species other than bees

Based on the calculated rates of Potassium Phosphonates/ FBR-1 in off-field areas, the calculated TER values describing the risk resulting from an exposure of non-target arthropods to Potassium Phosphonates / FBR-1 according to the GAP of the formulation FBR-1 achieve the acceptability criteria of TER ≥ 10 (Tier 1), according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Spe- cific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for non-target arthropods due to the intended use of FBR-1 in vines according to the label.

FBR-1 / FBR-C ZV1 008838-00/00 Page 19 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

3.8.5 Effects on soil organisms

Based on the chemical composition of the products Stamina (ZA 7207 Veriphos), Alginure Bio Schutz (ZA 7839), FBR-1 (ZA 8837, ZA 8838, ZA 8632), it can be expected that the chronic studies on earthworms represent the toxicity of the active ingredient Potassium Phosphonates, or rather phosphonic acid. The studies with Potassium Phosphonates conducted with Alginure Bio Schutz and FBR-1, however, indicate an acceptable risk for soil organisms. The study conducted with Stamina (Veriphos) indicates an unacceptable risk for soil organisms. Overall, it can be concluded that the risk is acceptable in the intended use grape vine if the remaining uncertainty is addressed in a field test with phosphonates on earthworm populations. The submission of the study is mandatory within 3 years after authorisation of the product in the intended uses.

Consequences for authorization: Authorisation possible only in combination with the mandatory condition of use “provision of a field test with phosphonates on earthworm populations”

Based on the predicted concentrations of Potassium Phosphonates in soils, the risk to soil microbial processes following exposure to Potassium Phosphonates / FBR-1 according to the GAP of the formulation FBR-1 is considered to be acceptable according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2.

3.8.6 Effects on non-target terrestrial plants

The rates tested with the formulation exceed the predicted field rates of Potassium Phosphonates following exposure to Potassium Phosphonates / FBR-1 according to the GAP of the formulation FBR-1. The results of the assessment indicate an acceptable risk for non-target terrestrial plants due to the intended use of FBR-1 in vines according to the label.

3.8.7 Effects on other terrestrial organisms (Flora and Fauna)

No data submitted, not required.

3.9 Relevance of metabolites (Part B, Section 10)

No metabolites are predicted above 0.1 µg/L in the groundwater.

FBR-1 / FBR-C ZV1 008838-00/00 Page 20 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

4 Conclusion of the national comparative assessment (Art. 50 of Regulation (EC) No 1107/2009)

The active substance potassium phosphonate is not approved as a candidate of substitution there-fore a comparative assessment is not foreseen.

5 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorization

AnnexIII point Data

KCP 10.4.1.2 Submission of the results of a field monitoring study with phosphonates on earthworm populations. The data has to be submitted according to § 36 paragraph 5 PflSchG within 3 years after the authorization. The concept has to be developed together with the authorization agencies.

FBR-1 / FBR-C ZV1 008838-00/00 Page 21 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Appendix 1 Copy of the product authorization (see Appendix 5)

FBR-1 / FBR-C ZV1 008838-00/00 Page 22 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Appendix 2 Copy of the product label

The submitted draft product label has been checked by the competent authority. The final version of the label is not displayed in the RR, because the label is the sole responsibility of the applicant and is therefore not finally checked by the competent authority. The applicant is requested to gen-erate the product label in accordance with the authorisation granted by the competent authority.

FBR-1 / FBR-C ZV1 008838-00/00 Page 23 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Appendix 3 Letter of Access

Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.

FBR-1 / FBR-C ZV1 008838-00/00 Page 24 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Appendix 4 Lists of data considered for national authorization

List of data submitted by the applicant and relied on Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not Section B.1, B.2, B.4 Identity, Physical and chemical properties, Further information KCP 2.1 Simona Nichetti 2016 Potassium phosphonate liquid and crystal: Determination of N Y Study report never submitted before Fitosanitarios the colour, odour and physical state to Germany Bajo Riesgo AIE ChemService S.r.l., Report No. CH-728/2015 GLP Unpublished 3328460 KCP 2.2 Antonella Mazzei 2016 Explosive properties and oxidizing properties on the sample N Y Study report never submitted before Fitosanitarios Potassium Phosphonate Liquid to Germany Bajo Riesgo AIE Innovhub, Report No. 201504699 GLP Unpublished 3328461 KCP 2.3 Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the flash N Y Study report never submitted before Fitosanitarios point to Germany Bajo Riesgo AIE ChemService S.r.l., Report No. CH-736/2015 GLP Unpublished 3328462 KCP 2.3 Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the auto N Y Study report never submitted before Fitosanitarios ignition temperature to Germany Bajo Riesgo AIE ChemService S.r.l., Report No. CH-735/2015 GLP Unpublished 3328463 KCP 2.4 Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the accel- N Y Study report never submitted before Fitosanitarios erated storage stability and corrosion characteristics to Germany Bajo Riesgo AIE

24 FBR-1 / FBR-C ZV1 008838-00/00 Page 25 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not ChemService S.r.l., Report No. CH-741/2015 GLP Unpublished 3328455 KCP 2.5 Simona Nichetti 2016 Potassium phosphonate liquid: Determination of viscosity N Y Study report never submitted before Fitosanitarios ChemService S.r.l., Report No. CH-733/2015 to Germany Bajo Riesgo AIE GLP Unpublished 3328456 KCP 2.5 Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the surface N Y Study report never submitted before Fitosanitarios tension to Germany Bajo Riesgo AIE ChemService S.r.l., Report No. CH-732/2015 GLP Unpublished 3328467 KCP 2.6 Simona Nichetti 2015 Potassium phosphonate liquid: Determination of the relative N Y Study report never submitted before Fitosanitarios density to Germany Bajo Riesgo AIE ChemService S.r.l., Report No. CH-729/2015 GLP Unpublished 3328457 KCP 2.7 Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the accel- N Y Study report never submitted before Fitosanitarios erated storage stability and corrosion characteristics to Germany Bajo Riesgo AIE ChemService S.r.l., Report No. CH-741/2015 GLP Unpublished 3328466 KCP 2.7 Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the low N Y Study report never submitted before Fitosanitarios temperature stability to Germany Bajo Riesgo AIE ChemService S.r.l., Report No. CH-734/2015 GLP Unpublished 3328458 KCP 2.7 Simona Nichetti 2016 Study plan: Potassium phosphonate liquid: Two year stor- N Y Study report never submitted before Fitosanitarios

25 FBR-1 / FBR-C ZV1 008838-00/00 Page 26 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not age stability and corrosion characteristics to Germany Bajo Riesgo AIE ChemService S.r.l., Study plan No. CH-742/2015 GLP Unpublished 3328459 KCP 2.7 Simona Nichetti 2018 Potassium phosphonate liquid: Two years storage stability N Y Study report never submitted before Fitosanitarios and corrosion characteristics to Germany Bajo Riesgo AIE ChemService S.r.l., GLP Study No. CH-742/2015 GLP Unpublished 4051290 KCP Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the accel- N Y Study report never submitted before Fitosanitarios 2.8.2 erated storage stability and corrosion characteristics to Germany Bajo Riesgo AIE ChemService S.r.l., Report No. CH-741/2015 GLP Unpublished 3328465 KCP Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the accel- N Y Study report never submitted before Fitosanitarios 2.8.4 erated storage stability and corrosion characteristics to Germany Bajo Riesgo AIE ChemService S.r.l., Report No. CH-741/2015 GLP Unpublished 3328464 Section B.3 Efficacy Data and Information KCP 3.8 Anonymous 2016 Entwurf der Gebrauchsanleitung (Word) N Y Study report never submitted Fitosanitarios before to Germany Bajo Riesgo AIE

KCP 3.8 Anonymous 2016 Entwurf der Gebrauchsanleitung (PDF) N Y Study report never submitted Fitosanitarios before to Germany Bajo Riesgo AIE

KCP 3.8 Anonymous 2016 Entwurf der Gebrauchsanleitung überarbeitet N Y Study report never submitted Fitosanitarios before to Germany Bajo Riesgo AIE

KCP 3.8 Anonymous 2016 Entwurf der Gebrauchsanleitung überarbeitet (PDF) N Y Study report never submitted Fitosanitarios

26 FBR-1 / FBR-C ZV1 008838-00/00 Page 27 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Section B.5 Analytical Methods KCP Simona Nichetti 2014 Potassium phosphonate: Validation of the analytical method N Y Study report never submitted before Fitosanitarios 5.1.1-01 for the determination of the potassium content to Germany Bajo Riesgo AIE ChemService S.r.l., Report No.: CH-288/2014 GLP Unpublished 3328468 KCP Simona Nichetti 2014 Potassium phosphonate: Validation of the analytical method N Y Study report never submitted before Fitosanitarios 5.1.1-02 for the determination of the phosphonate content to Germany Bajo Riesgo AIE ChemService S.r.l., Report No.: CH-289/2014 GLP Unpublished 3328469 KCP Schneider, E. 2016 Validation of the analytical method for the determination N Y Study report never submitted Fitosanitarios 5.1.2 of Potassium Phosphonate in Grapes whole fruits and before to Germany Bajo Riesgo AIE processed fractions (wine, wet pomace, dry pomace, juice and dried raisins) B5174 GLP: Y Published: N 3345671 KCP Egron, C. 2019 Validation of the analytical method for the determination of N Y Study report never submitted Fitosanitarios 5.1.2 phosphonic acid in the compartments of an before to Germany Bajo Riesgo in-vitro human skin absorption study AIE Study plan No. S19-04939 Eurofins Agroscience Services GLP Unpublished KCP 5.2- Eric Schneider 2016 Validation of the analytical method for the determination of N Y Study report never submitted before Fitosanitarios 01 Potassium Phosphonate in Grapes whole fruits and to Germany Bajo Riesgo AIE processed fractions (wine, wet pomace, dry pomace, juice and dried raisins)

27 FBR-1 / FBR-C ZV1 008838-00/00 Page 28 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not ANADIAG, Report No. B5174 GLP Unpublished 3336112 KCP 5.2- Adelaide Perboni 2016 Validation of the analytical method to determine Potassium N Y Study report never submitted before Fitosanitarios 02 phosphonate residue in soil (sandy loam) to Germany Bajo Riesgo AIE Research Center BioSphereS, Report No RAU-051-15 GLP Unpublished 3336115 KCP 5.2- Adelaide Perboni 2016 Validation of the analytical method to determine Potassium N Y Study report never submitted before Fitosanitarios 03 phosphonate residue in surface water Research Center to Germany Bajo Riesgo AIE BioSphereS, Report No RAU-052-15 GLP Unpublished 3336116 KCP 5.2- Adelaide Perboni 2016 Validation of the analytical method to determine Potassium N Y Study report never submitted before Fitosanitarios 04 phosphonate residue in air to Germany Bajo Riesgo AIE Research Center BioSphereS, Report No RAU-053-15 GLP Unpublished 3336117 KCP 5.2 Perboni, A. 2018 Validation of the analytical method to determine Potassium N Y Fitosanitarios Bajo phosphonate in drinking water RAU-069-18 GLP: Y/GEP: O Published: N 3841772 KCP 5.2 Signore, E. 2018 Independent Laboratory Validation of analytical method for the N Y Fitosanitarios Bajo determination of Potassium Phosphonates in Grapes, validated in the Study "Validation of the analytical method for the determination of Potassium Phosphonate in Grapes whole fruits and ... RAU-071-18 GLP: Y/GEP: O Published: N

28 FBR-1 / FBR-C ZV1 008838-00/00 Page 29 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not 3841774 Section B.6 Mammalian Toxicology KCP Bernal, C. 2020 Final Report: In-vitro human skin penetration of phosphonic acid N Y Fitosanitarios 7.2.3.1 inpotassium phosphonates FBR-1 test item Bajo Riesgo Study Code S19-22158 AIE Eurofins Agroscience Services GLP Unpublished KCP 7.3 Egron, C. 2019 Validation of the analytical method for the determination of phos- N Y Study report never submitted before Fitosanitarios phonic acid in the compartments of an in-vitro human skin absorp- to Germany Bajo Riesgo tion study AIE Study plan No. S19-04939 Eurofins Agroscience Services GLP Unpublished KCP Guest, D. and 1990 The complex action of phosphonates as antifungal agents N Y Study report never submitted Fitosanitarios Section Grant, B. Biol. Rev., 66, 159-187 before to Germany Bajo Riesgo AIE 6/01 Non GEP Published KCP Coffet, M.D. and 1988 Nitrogen, Phosphorous and Sulphur Utilization by Fungi N Y Study report never submitted Fitosanitarios Section Ouimette, D.G. (Phosphonates: antifungal compounds against oomycetes), before to Germany Bajo Riesgo AIE 6/02 April 1988, Cambridge University Press, 316, 106-128 Non GEP Published KCP Fenn, M.E. and 1983 Studies on the in vitro and in vivo antifungal activity of N Y Study report never submitted Fitosanitarios Section Coffey, M.D. Fosetyl-Al and Phosphorous acid before to Germany Bajo Riesgo AIE 6/03 Phytopathology, 74, 606-611 Non GEP Published KCP Fenn, M.E. and 1985 Further evidance for the direct mode of action of Fosetyl-Al N Y Study report never submitted Fitosanitarios Section Coffey, M.D. and phosphorous acid before to Germany Bajo Riesgo AIE 6/04 Phytopathology, 75, 1064-1068 Non GEP Published KCP Dolan, T.E. and 1988 Correlative in vitro and in vivo behavior of mutant strains N Y Study report never submitted Fitosanitarios

29 FBR-1 / FBR-C ZV1 008838-00/00 Page 30 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not Section Coffey, M.D. of Phytophthora palmivora expressing different resistances before to Germany Bajo Riesgo AIE 6/05 to phosphorous acid and Fosetyl-Al Phytopathology, 78, 974-978 Non GEP Published KCP Fenn, M.E. and 1989 Quantification of phosphonate and ethyl phosphonate in N Y Study report never submitted Fitosanitarios Section Coffey, M.D tobacco and tomato tissues and significance for the mode of before to Germany Bajo Riesgo AIE 6/06 action of two phosphonate fungicides Phytopathology, 79, 76-82 Non GEP Published KCP Ouimette, D.G. and 1989 Phosphonate levels in avocado (Persea americana) seedling N Y Study report never submitted Fitosanitarios Section Coffey, M.D. and soil following treatment with Fosetyl-Al or potassium before to Germany Bajo Riesgo AIE 6/07 phosphonate Plant Disease, 73, 212-215 Non GEP Published KCP Saindrenan, P. 1988 Effects of phosphite on phytoalexin accumulation in leaves N Y Study report never submitted Fitosanitarios Section Barchietto, T. of cowpea infected with Phytophthora cryptogea before to Germany Bajo Riesgo AIE 6/08 Avelino, J. and Physiological and Molecular Plant Pathology, 32, 425-435 Bompeix, G. Non GEP Published KCP Anonymous 2017 Efficacy Data and Information - Detailed summary – BAD N Y Study report never submitted Fitosanitarios Section 6 No GLP before to Germany Bajo Riesgo AIE Unpublished KCP Anonymous 2017 Efficacy Data and Information - Detailed summary – BAD N Y Study report never submitted Fitosanitarios Section 6 No GLP before to Germany Bajo Riesgo AIE Unpublished KCP 6.2- Perrin, E and Nora 2016 Evaluated the efficacy of different treatments against mil- N Y Study report never submitted Fitosanitarios 01 P.D. dew on grapevine in Germany 2015 before to Germany Bajo Riesgo AIE SGS AGRI MIN, Report 15-00609-01 GEP Not published KCP 6.2- Perrin, E and Nora 2016 Evaluated the efficacy of different treatments against mil- N Y Study report never submitted Fitosanitarios

30 FBR-1 / FBR-C ZV1 008838-00/00 Page 31 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not 02 P.D. dew on grapevine in Germany. 2015 before to Germany Bajo Riesgo AIE SGS AGRI MIN, Report 15-00609-02 GEP Not published KCP 6.2- Perrin, E and Nora 2016 Evaluated the efficacy of different treatments against mil- N Y Study report never submitted Fitosanitarios 03 P.D. dew on grapevine in Hungary in 2015 before to Germany Bajo Riesgo AIE SGS AGRI MIN, Report 15-00506-01 GEP Not published KCP 6.2- Perrin, E and Nora 2016 Evaluated the efficacy of different treatments against mil- N Y Study report never submitted Fitosanitarios 04 P.D. dew on grapevine in Hungary in 2015 before to Germany Bajo Riesgo AIE SGS AGRI MIN, Report 15-00506-02 GEP Not published KCP 6.2- Novoa, D. 2014 Eurion trial experimental fungicide ECX against downy N Y Study report never submitted Fitosanitarios 05 mildew (Plasmoparaviticola). before to Germany Bajo Riesgo AIE NOVEX, Report dn14-36-Eur-M-VdM3 GEP Not published KCP 6.2- Dghim, A. A. 2014 Efficacy of FBR-1 against downy mildew (plasmapora N Y Study report never submitted Fitosanitarios 06 viticola) on grapevine in France in 2014 before to Germany Bajo Riesgo AIE University of Sciences, Report Vigne-Fr-01 No GEP Not published KCP 6.2- Dghim, A. A. 2015 Efficacy of FBR-1 against downy mildew (plasmapora N Y Study report never submitted Fitosanitarios 07 viticola) on grapevine in France in 2015. before to Germany Bajo Riesgo AIE University of Sciences, Report Vigne-Fr-02 No GEP Not published KCP 6.2- Perrin, E and Nora 2016 Evaluated the efficacy of different treatments against mil- N Y Study report never submitted Fitosanitarios 08 P.D. dew on grapevine in France in 2015 before to Germany Bajo Riesgo AIE SGS AGRI MIN, Report 15-00560-02 GEP Not published

31 FBR-1 / FBR-C ZV1 008838-00/00 Page 32 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not KCP 6.2- Perrin, E and Nora 2016 Evaluated the efficacy of different treatments against mil- N Y Study report never submitted Fitosanitarios 09 P.D. dew on grapevine in France in 2015 before to Germany Bajo Riesgo AIE SGS AGRI MIN, Report 15-00560-03 GEP Not published KCP 6.2- Perrin, E and Nora 2016 Evaluated the efficacy of different treatments against mil- N Y Study report never submitted Fitosanitarios 10 P.D. dew on grapevine in France in 2015. before to Germany Bajo Riesgo AIE SGS AGRI MIN, Report 15-00560-04 GEP Not published KCP 6.2- García, J.A.M. 2017 Evaluation of efficacy of product coded FBR-1 alone or in N Y Study report never submitted Fitosanitarios 11 association on fungicide program against downy mildew before to Germany Bajo Riesgo AIE (Plasmopara viticola) on grapevine, in France, in 2016. SGS AGRI MIN, Report 16-00676-03 GEP Not published KCP 6.2- García, J.A.M. 2017 Determination of efficacy of FBR-1 against downy mildew N Y Study report never submitted Fitosanitarios 12 (Plamopara viticola) in grapevine 2016 before to Germany Bajo Riesgo AIE Trialcamp S.L.U., Report EUR16V02-07F GEP Not published KCP 6.2- García, J.A.M. 2017 Determination of efficacy of FBR-1 against downy mildew N Y Study report never submitted Fitosanitarios 13 (Plamopara viticola) in grapevine 2016 before to Germany Bajo Riesgo AIE Trialcamp S.L.U., Report EUR16V02-08F GEP Not published KCP 6.2- Paugaud, A. 2017 Determination of efficacy of FBR-1 against downy mildew N Y Study report never submitted Fitosanitarios 14 (Plamopara viticola) in grapevine 2016 before to Germany Bajo Riesgo AIE Trialcamp S.L.U., Report EUR16V02-09F GEP Not published KCP 6.2- Paugaud, A. 2017 Evaluation of efficacy of product coded FBR-1 alone or in N Y Study report never submitted Fitosanitarios 15 association on fungicide program against downy mildew before to Germany Bajo Riesgo AIE (Plasmopara viticola) on grapevine, in Germany, in 2016.

32 FBR-1 / FBR-C ZV1 008838-00/00 Page 33 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not SGS AGRI MIN, Report 16-00711-01 GEP Not published KCP 6.2- Paugaud, A. 2017 Evaluation of efficacy of product coded FBR-1 alone or in N Y Study report never submitted Fitosanitarios 16 association on fungicide program against downy mildew before to Germany Bajo Riesgo AIE (Plasmopara viticola) on grapevine, in Germany, in 2016. SGS AGRI MIN, Report 16-00711-02 GEP Not published KCP 6.2- García, J.A.M. 2017 Determination of efficacy of FBR-1 against downy mildew N Y Study report never submitted Fitosanitarios 17 (Plamopara viticola) in grapevine 2016 before to Germany Bajo Riesgo AIE Trialcamp S.L.U., Report EUR16V02-10F GEP Not published KCP 6.2- García, J.A.M. 2017 Determination of efficacy of FBR-1 against downy mildew N Y Study report never submitted Fitosanitarios 18 (Plamopara viticola) in grapevine 2016 before to Germany Bajo Riesgo AIE Trialcamp S.L.U., Report EUR16V02-11F GEP Not published KCP 6.2- García, J.A.M. 2017 Determination of efficacy of FBR-1 against downy mildew N Y Study report never submitted Fitosanitarios 19 (Plamopara viticola) in grapevine 2016 before to Germany Bajo Riesgo AIE Trialcamp S.L.U., Report EUR16V02-12F GEP Not published KCP 6.2- Paugaud, A. 2017 Evaluation of efficacy of product coded FBR-1 alone or in N Y Study report never submitted Fitosanitarios 20 association on fungicide program against downy mildew before to Germany Bajo Riesgo AIE (Plasmopara viticola) on grapevine, in Hungary, in 2016. SGS AGRI MIN, Report 16-00677-01 GEP Not published KCP 6.2- García, J.A.M. 2017 Evaluation of efficacy of product coded FBR-1 alone or in N Y Study report never submitted Fitosanitarios 21 association on fungicide program against downy mildew before to Germany Bajo Riesgo AIE (Plasmopara viticola) on grapevine, in France, in 2016. SGS AGRI MIN, Report 16-00676-03

33 FBR-1 / FBR-C ZV1 008838-00/00 Page 34 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not GEP Not published KCP 6.2- Lorenz, B. 2019 Interim Report: Efficacy and Selectivity evaluation of FBR- N Y Data/study report never submit- Fitosanitarios 22 1 for the control of downy mildew in grape; Germany; ted before to Germany Bajo Riesgo AIE MAR; 2019 BioChem agar GmbH, Report OUT19-004-931FE GEP Not published KCP 6.2- Lorenz, B. 2019 Interim Report: Efficacy and Selectivity evaluation of FBR- N Y Data/study report never submit- Fitosanitarios 23 1 for the control of downy mildew in grape; Germany; ted before to Germany Bajo Riesgo AIE MAR; 2019 BioChem agar GmbH, Report OUT19-005-931FE GEP Not published KCP 6.2- Lorenz, B. 2019 Interim Report: Efficacy and Selectivity evaluation of FBR- N Y Data/study report never submit- Fitosanitarios 24 1 for the control of downy mildew in grape; Germany; ted before to Germany Bajo Riesgo AIE MAR; 2019 BioChem agar GmbH, Report OUT19-006-931FE GEP Not published KCP 6.2- Viglione, P. 2019 Efficacy and Selectivity evaluation of FBR-1 for the control N Y Data/study report never submit- Fitosanitarios 25 of Downy mildew in grapevine – Bulgaria 2019 ted before to Germany Bajo Riesgo AIE SAGEA ood, Report OUT19-001-931FE GEP Not published KCP 6.2- Viglione, P. 2019 Efficacy and Selectivity evaluation of FBR-1 for the control N Y Data/study report never submit- Fitosanitarios 26 of Downy mildew in grapevine – Bulgaria 2019 ted before to Germany Bajo Riesgo AIE SAGEA ood, Report OUT19-002-931FE GEP Not published KCP 6.2- Viglione, P. 2019 Efficacy and Selectivity evaluation of FBR-1 for the control N Y Data/study report never submit- Fitosanitarios 27 of Downy mildew in grapevine – Bulgaria 2019 ted before to Germany Bajo Riesgo AIE SAGEA ood, Report OUT19-003-931FE GEP

34 FBR-1 / FBR-C ZV1 008838-00/00 Page 35 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not Not published KCP 6.3- Perrin, E and Nora 2016 Evaluated the efficacy of different treatments against mil- N Y Study report never submitted Fitosanitarios 01 P.D. dew on grapevine in Germany 2015 before to Germany Bajo Riesgo AIE SGS AGRI MIN, Report 15-00609-01 GEP Not published KCP 6.3- Perrin, E and Nora 2016 Evaluated the efficacy of different treatments against mil- N Y Study report never submitted Fitosanitarios 02 P.D. dew on grapevine in Germany. 2015 before to Germany Bajo Riesgo AIE SGS AGRI MIN, Report 15-00609-02 GEP Not published KCP 6.3- Perrin, E and Nora 2016 Evaluated the efficacy of different treatments against mil- N Y Study report never submitted Fitosanitarios 03 P.D. dew on grapevine in Hungary in 2015 before to Germany Bajo Riesgo AIE SGS AGRI MIN, Report 15-00506-01 GEP Not published KCP 6.3- Perrin, E and Nora 2016 Evaluated the efficacy of different treatments against mil- N Y Study report never submitted Fitosanitarios 04 P.D. dew on grapevine in Hungary in 2015 before to Germany Bajo Riesgo AIE SGS AGRI MIN, Report 15-00506-02 GEP Not published KCP 6.3- Novoa, D. 2014 Eurion trial experimental fungicide ECX against downy N Y Study report never submitted Fitosanitarios 05 mildew (Plasmoparaviticola). before to Germany Bajo Riesgo AIE NOVEX, Report dn14-36-Eur-M-VdM3 GEP Not published KCP 6.3- Dghim, A. A. 2014 Efficacy of FBR-1 against downy mildew (plasmapora N Y Study report never submitted Fitosanitarios 06 viticola) on grapevine in France in 2014 before to Germany Bajo Riesgo AIE University of Sciences, Report Vigne-Fr-01 No GEP Not published KCP 6.3- Dghim, A. A. 2015 Efficacy of FBR-1 against downy mildew (plasmapora N Y Study report never submitted Fitosanitarios 07 viticola) on grapevine in France in 2015. before to Germany Bajo Riesgo AIE University of Sciences, Report Vigne-Fr-02

35 FBR-1 / FBR-C ZV1 008838-00/00 Page 36 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not No GEP Not published KCP 6.3- Perrin, E and Nora 2016 Evaluated the efficacy of different treatments against mil- N Y Study report never submitted Fitosanitarios 08 P.D. dew on grapevine in France in 2015 before to Germany Bajo Riesgo AIE SGS AGRI MIN, Report 15-00560-02 GEP Not published KCP 6.3- Perrin, E and Nora 2016 Evaluated the efficacy of different treatments against mil- N Y Study report never submitted Fitosanitarios 09 P.D. dew on grapevine in France in 2015 before to Germany Bajo Riesgo AIE SGS AGRI MIN, Report 15-00560-03 GEP Not published KCP 6.3- Perrin, E and Nora 2016 Evaluated the efficacy of different treatments against mil- N Y Study report never submitted Fitosanitarios 10 P.D. dew on grapevine in France in 2015. before to Germany Bajo Riesgo AIE SGS AGRI MIN, Report 15-00560-04 GEP Not published KCP 6.3- García, J.A.M. 2017 Evaluation of efficacy of product coded FBR-1 alone or in N Y Study report never submitted Fitosanitarios 11 association on fungicide program against downy mildew before to Germany Bajo Riesgo AIE (Plasmopara viticola) on grapevine, in France, in 2016. SGS AGRI MIN, Report 16-00676-03 GEP Not published KCP 6.3- García, J.A.M. 2017 Determination of efficacy of FBR-1 against downy mildew N Y Study report never submitted Fitosanitarios 12 (Plamopara viticola) in grapevine 2016 before to Germany Bajo Riesgo AIE Trialcamp S.L.U., Report EUR16V02-07F GEP Not published KCP 6.3- García, J.A.M. 2017 Determination of efficacy of FBR-1 against downy mildew N Y Study report never submitted Fitosanitarios 13 (Plamopara viticola) in grapevine 2016 before to Germany Bajo Riesgo AIE Trialcamp S.L.U., Report EUR16V02-08F GEP Not published KCP 6.3- Paugaud, A. 2017 Determination of efficacy of FBR-1 against downy mildew N Y Study report never submitted Fitosanitarios

36 FBR-1 / FBR-C ZV1 008838-00/00 Page 37 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not 14 (Plamopara viticola) in grapevine 2016 before to Germany Bajo Riesgo AIE Trialcamp S.L.U., Report EUR16V02-09F GEP Not published KCP 6.3- Paugaud, A. 2017 Evaluation of efficacy of product coded FBR-1 alone or in N Y Study report never submitted Fitosanitarios 15 association on fungicide program against downy mildew before to Germany Bajo Riesgo AIE (Plasmopara viticola) on grapevine, in Germany, in 2016. SGS AGRI MIN, Report 16-00711-01 GEP Not published KCP 6.3- Paugaud, A. 2017 Evaluation of efficacy of product coded FBR-1 alone or in N Y Study report never submitted Fitosanitarios 16 association on fungicide program against downy mildew before to Germany Bajo Riesgo AIE (Plasmopara viticola) on grapevine, in Germany, in 2016. SGS AGRI MIN, Report 16-00711-02 GEP Not published KCP 6.3- García, J.A.M. 2017 Determination of efficacy of FBR-1 against downy mildew N Y Study report never submitted Fitosanitarios 17 (Plamopara viticola) in grapevine 2016 before to Germany Bajo Riesgo AIE Trialcamp S.L.U., Report EUR16V02-10F GEP Not published KCP 6.3- García, J.A.M. 2017 Determination of efficacy of FBR-1 against downy mildew N Y Study report never submitted Fitosanitarios 18 (Plamopara viticola) in grapevine 2016 before to Germany Bajo Riesgo AIE Trialcamp S.L.U., Report EUR16V02-11F GEP Not published KCP 6.3- García, J.A.M. 2017 Determination of efficacy of FBR-1 against downy mildew N Y Study report never submitted Fitosanitarios 19 (Plamopara viticola) in grapevine 2016 before to Germany Bajo Riesgo AIE Trialcamp S.L.U., Report EUR16V02-12F GEP Not published KCP 6.3- Paugaud, A. 2017 Evaluation of efficacy of product coded FBR-1 alone or in N Y Study report never submitted Fitosanitarios 20 association on fungicide program against downy mildew before to Germany Bajo Riesgo AIE (Plasmopara viticola) on grapevine, in Hungary, in 2016.

37 FBR-1 / FBR-C ZV1 008838-00/00 Page 38 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not SGS AGRI MIN, Report 16-00677-01 GEP Not published KCP 6.3- Paugaud, A. 2017 Evaluation of efficacy of product coded FBR-1 alone or in N Y Study report never submitted Fitosanitarios 21 association on fungicide program against downy mildew before to Germany Bajo Riesgo AIE (Plasmopara viticola) on grapevine, in Hungary, in 2016. SGS AGRI MIN, Report 16-00677-02 GEP Not published KCP 6.3- Lorenz, B. 2019 Interim Report: Efficacy and Selectivity evaluation of FBR- N Y Data/study report never submit- Fitosanitarios 22 1 for the control of downy mildew in grape; Germany; ted before to Germany Bajo Riesgo AIE MAR; 2019 BioChem agar GmbH, Report OUT19-004-931FE GEP Not published KCP 6.3- Lorenz, B. 2019 Interim Report: Efficacy and Selectivity evaluation of FBR- N Y Data/study report never submit- Fitosanitarios 23 1 for the control of downy mildew in grape; Germany; ted before to Germany Bajo Riesgo AIE MAR; 2019 BioChem agar GmbH, Report OUT19-005-931FE GEP Not published KCP 6.3- Lorenz, B. 2019 Interim Report: Efficacy and Selectivity evaluation of FBR- N Y Data/study report never submit- Fitosanitarios 24 1 for the control of downy mildew in grape; Germany; ted before to Germany Bajo Riesgo AIE MAR; 2019 BioChem agar GmbH, Report OUT19-006-931FE GEP Not published KCP 6.3- Viglione, P. 2019 Efficacy and Selectivity evaluation of FBR-1 for the control N Y Data/study report never submit- Fitosanitarios 25 of Downy mildew in grapevine – Bulgaria 2019 ted before to Germany Bajo Riesgo AIE SAGEA ood, Report OUT19-001-931FE GEP Not published KCP 6.3- Viglione, P. 2019 Efficacy and Selectivity evaluation of FBR-1 for the control N Y Data/study report never submit- Fitosanitarios 26 of Downy mildew in grapevine – Bulgaria 2019 ted before to Germany Bajo Riesgo AIE

38 FBR-1 / FBR-C ZV1 008838-00/00 Page 39 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not SAGEA ood, Report OUT19-002-931FE GEP Not published KCP 6.3- Viglione, P. 2019 Efficacy and Selectivity evaluation of FBR-1 for the control N Y Data/study report never submit- Fitosanitarios 27 of Downy mildew in grapevine – Bulgaria 2019 ted before to Germany Bajo Riesgo AIE SAGEA ood, Report OUT19-003-931FE GEP Not published KCP Barnabè, D. 2019 Study plan: Study of unintentional effects of FBR-1 on N Y Data/study report never submit- Fitosanitarios 6.4.4-01 fermentation processes and characteristics of wine; Germa- ted before to Germany Bajo Riesgo AIE ny 2019 (2 trials – 1 on white wine and 1 on red wine) Agri2000 GEP Not published KCP Barnabè, D. 2019 Study plan: Study of unintentional effects of FBR-1 on N Y Data/study report never submit- Fitosanitarios 6.4.4-02 fermentation processes and characteristics of wine; Bulgary ted before to Germany Bajo Riesgo AIE 2019 (2 trials – 1 on white wine and 1 on red wine) Agri2000 GEP Not published Section B.7 Metabolites and Residues KCA Perny, A. 2016 Frozen storage stability of residues of Potassium N Y Study report never submitted Fitosanitarios 6.1-01 phosphonate in Grapes Whole Fruits and in processed frac- before to Germany Bajo Riesgo AIE tions (wine, wet pomace, dry pomace, juice and dried raisins) ANADIAG, Study plan No. B5175 GLP Unpublished 3334864 KCA Schneider, E. 2016 Validation of the analytical method for the determination of N Y Study report never submitted Fitosanitarios 6.1-02 Potassium Phosphonate in Grapes whole fruits and pro- before to Germany Bajo Riesgo AIE cessed fractions (wine, wet pomace, dry pomace, juice and

39 FBR-1 / FBR-C ZV1 008838-00/00 Page 40 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not dried raisins) ANADIAG, Report No. B5174 GLP Unpublished 3334862 KCA Schneider, E. 2016 Determination of Potassium phosphonate Residues in RAC N Y Study report never submitted Fitosanitarios 6.3-01 Grapes and processed commodities Following foliar before to Germany Bajo Riesgo AIE 6.5.2-01 application with FBR-1 under Field Conditions in Northern 6.5.3-01 and Southern Europe in 2015 ANADIAG, Report No B5143 GLP Unpublished 3334863 3343190 3343195 KCA Perny, A. 2017 Determination of Potassium phosphonate Residues in RAC N Y Study report never submitted Fitosanitarios 6.3-02 Grapes Following foliar application with FBR-1 under before Bajo Riesgo AIE 6.5.2-02 Field Conditions in Northern in 2016 to Germany 6.5.3-02 ANADIAG, Report No B6156 GLP Unpublished 3406560 Section B.8 Environmental Fate

Section B.9 Ecotoxicology KCP Monica Colli 2015 Chronic oral effects of FBR-01 to adult worker honeybees N Y Study report never submitted Fitosanitarios 10.3.1.2 Apis mellifera L. Laboratory test before to Germany Bajo Riesgo AIE Biotecnologie BT S.r.l, Report No BT151/15 GLP Unpublished 3352754 KCP Monica Colli 2016 Effects of FBR-01 to honeybees (Apis mellifera L.) Larval N Y Study report never submitted Fitosanitarios 10.3.1.3 toxicity test, repeated exposure. before to Germany Bajo Riesgo AIE

40 FBR-1 / FBR-C ZV1 008838-00/00 Page 41 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not Biotecnologie BT S.r.l, Report No BT152/15 GLP Unpublished 3352756 KCP Monica Colli 2016 Effects of FBR-01 on the aphid parasitoid Aphidius N Y Study report never submitted Fitosanitarios 10.3.2.1 rhopalosiphi de Stefani Perez (Hymenoptera: Braconidae) before to Germany Bajo Riesgo AIE under laboratory conditions Biotecnologie BT S.r.l, Report No BT149/15 GLP Unpublished 3352760 KCP Simone Venturi 2016 Effects of FBR-01 on the predatory mite Typhlodromus N Y Study report never submitted before Fitosanitarios Bajo 10.3.2.2 pyri Scheuten (Acari: Phytoseiidae) under extended to Germany Riesgo AIE laboratory conditions Biotecnologie BT S.r.l, Report No BT148/15 GLP Unpublished 3352767 KCP Francesco Pecorari 2016 Effects of the product FBR-01 on reproduction and growth N Y Study report never submitted before Fitosanitarios Bajo 10.4.1.1 of the earthworm Eisenia andrei in artificial soil to Germany Riesgo AIE Biotecnologie BT S.r.l, Report No BT129/15 GLP Unpublished 3352768 KCP Pecorari, F., Federici, 2019 Effects of the product FBR-01 on reproduction and growth N O Fitosanitarios Bajo 10.4.1.1 A. of the earthworm Eisenia andrei in artificial soil - Amendment No.1 BT129/15 GLP: N/GEP: N Published: N KCP Monica Colli 2016 Effects of FBR-1 on terrestrial plants vegetative vigour N Y Study report never submitted before Fitosanitarios Bajo 10.6.2 limit test to Germany Riesgo AIE Biotecnologie BT S.r.l, Report No BT150/15 GLP

41 FBR-1 / FBR-C ZV1 008838-00/00 Page 42 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review Data point Author(s) Year Title Verte- Data pro- Justification if data protection is Owner Company Report No. brate tection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not Section B.1, B.2, B.4 Identity, Physical and chemical properties, Further information

Section B.3 Efficacy Data and Information

Section B.5 Analytical Methods 5.2.2 Kieken, J.L., 1999 Fosetyl-Al and its metabolite (phosphorous acid). N N Aventis (KCP Analytical method for the determination of residues in soil Cropscience 5.1.2) Method AR 214-99 5.3.2.4 Report No. R011736 (KCP Source: Aventis Cropscience 5.2) non GLP Unpublished 5.2.2 Barbier G., 2004 Confirmatory method for the determination of fosetyl-Al N N Bayer (KCP and its metabolite phosphorous acid in soil Cropscience 5.1.2) Report No. C044380 5.3.2.4 Source: Bayer Cropscience (KCP GLP 5.2) Unpublished 5.2.2 Kieken, J.L., 2000 Fosetyl-Al and its metabolite (phosphorous acid). N N Aventis (KCP Analytical method for the determination of residues in Cropscience

42 FBR-1 / FBR-C ZV1 008838-00/00 Page 43 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data pro- Justification if data protection is Owner Company Report No. brate tection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not 5.1.2) drinking water and surface water 5.3.2.5 Method AR 231-99 (KCP Report No. R011736 5.2) Source: Aventis Cropscience non GLP Unpublished 5.2.2 Diot, R et al. 2001 Phosphorous acid. Evaluation of the HPLC/ICP/MS N N Bayer (KCP technique for the determination of residue in drinking Cropscience 5.1.2) water and surface water 5.3.2.5 Report No. C013051 (KCP Source: Aventis Cropscience 5.2) non GLP Unpublished Section B.6 Mammalian Toxicology KCP Bernal, J. 2020 In-vitro human skin penetration of Phosphonic acid in N J Fitosanitario 7.2.3 & potassium phosphonates s 7.3 FBR-1 test item Bajo S19-22158 GLP: Yes Published: No

Section B.7 Metabolites and Residues KIIA 6.2.1 Whiley, A.W., Pegg, 1987N INFLUENCE OF PHYTOPHTHORA ROOT ROT ON MIN- N N LIT K.G., Saranah, J.B., ERAL NUTRIENT CONCENTRATIONS IN AVOCADO Langdon, P.W. LEAVES

Australian Journal of Experimental Agriculture, 27(1), 173-177 GLP: N/GEP: N Published: Y 2100307 KCA Garrec, J.P.; Barrois, A 1992 Caractéristiques de la fixation et de la pénétration corticale. N N LIT 6.2.1-02 Passage du phosphite dipotassique et de l’eau au travers d’écorces isolées. Sorption and permeation characteristics of bark. Penetration of k2hpo3 and water through isolated bark. Environmental and Experimental Botany 32 (1): pp. 11-23 Not GLP, published KCA 6.2.1- Whiley, A.W.; Pegg, 1995 Changing sink strengths influence translocation of phosphonate N N Aventis

43 FBR-1 / FBR-C ZV1 008838-00/00 Page 44 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data pro- Justification if data protection is Owner Company Report No. brate tection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not 03 K.G.; Saranah, J.B.; in avocado (persea americana mill.) trees. CropScience Langdorn, P.W. Australian Journal of Agricultural Research 45 (5): pp. 1079- 1090 Not GLP, published KCA Ouimette, D.G. & 1989a Phosphonate levels in Avocado (Persea americana) Seedlings and N N LIT 6.2.1-04 Coffey, M.D. soil following treatment with Fosetyl-Al or potassium phosphonate. Plant Disease 73(3): 212-215 Not GLP, published KCA Ouimette, D.G. & 1990 Symplastic entry and phloem translocation of phosphonate. Pes- N N LIT 6.2.1-05 Coffey, M.D. ticide Biochemistry and Physiology. 38: 18-25 Not GLP, published KCA Schutte, G.C.; Be- 1991 Timing of application of phosphonate fungicides using different N N LIT 6.2.1-06 zuidenbout, J.J; Kotze, application methods as determined by means of gas-liquid chro- J.M matography for phytophthora root rot control of citrus. Phytophylactica 23 (1): pp. 69-72 Not GLP, published KCA Carswell, C.; Grant, 1996 The fungicide phosphonate disrupts the phosphatestarvation N N LIT 6.2.1-08 B.R.; Thoedorou, M.E; response in brassica nigra seedlings. Harris, J.; Niere, J.O.; Plant Physiology, Vol. 110: pp. 110-115 Plaxton, W.C. Not GLP, published KCA Förster, H.; 1998 Effect of phosphite on tomato and pepper plant and susceptibility N N LIT 6.2.1-09 Adaskaveg, J.E.; Kim, of pepper to phytophthora root crown rot hydroponic culture. D.H.; Stanghellini, Plant Disease, Vol. 32 (10): pp. 1165-1170 M.E. Not GLP, published KCA 6.5.1 Avril Crowe 2001 Fosetyl-Aluminium and phosphorous acid: Hydrolysis under N N Aventis simulated processing conditions CropScience Report No. C013568 GLP Unpublished

Section B.8 Environmental Fate KCP Adams & Conrad 1953 ransition of phosphite to phosphate in soils. Soil Science, 75, N NA 9.1.1.1 361-372. Published. KCP Lowden & Oddy 1999 Aerobic metabolism of [33P]-Phosphorous acid in two soils N ACS 9.1.1.1 Aventis CropScience, Report R011658 Unpublished

44 FBR-1 / FBR-C ZV1 008838-00/00 Page 45 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data pro- Justification if data protection is Owner Company Report No. brate tection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not KCP Völkel 2006 Adsorption/desorption of LBG-01F34 on soils. RCC Ltd, Itingen, N LGB 9.1.2.1 Switzerland, Study Report n° 30306, Unpublished Section B.9 Ecotoxicology

Section B.10 Assessment of the relevance of metabolites in groundwater

The following tables are to be completed by MS

List of data submitted by the applicant and not relied on

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not Section B.1, B.2, B.4 Identity, Physical and chemical properties, Further information KCA 2.1 Nichetti, S. 2016 Potassium phosphonate liquid: Determination of the freezing point N Y Fitosanitarios CH-730/2015 Bajo GLP: Y/GEP: O Published: N 3331443 KCA 2.1 Nichetti, S. 2016 Potassium phosphonate crystal: Determination of the boiling point N Y Fitosanitarios CH-731/2015 Bajo GLP: Y/GEP: O Published: N 3331444 KCA 2.1 Stecher, P.G.; 1968 The Merck Index - An encyclopedia of chemicals and drugs (8th N N LIT Windholz, M.; Leahy, edition) D.S. Merck & Co. Inc, Rahway, N.Y. USA GLP: N/GEP: N Published: Y 3335096 KCA 2.1 van Wazer, J.R. 1958 Phosphorus and its compounds N N LIT

45 FBR-1 / FBR-C ZV1 008838-00/00 Page 46 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not Interscience Publishers, Inc. New York, Volume I: Chemistry GLP: N/GEP: N Published: Y 3335117 KCA 2.10 Nichetti, S. 2016 Potassium phosphonate liquid: Determination of the flash point N Y Fitosanitarios CH-736/2015 Bajo GLP: Y/GEP: O Published: N 3331440 KCA 2.11 Mazzei, A. 2016 Explosive properties and oxidizing properties on the sample N Y Fitosanitarios Potassium Phosphonate Liquid Bajo 201504699 GLP: Y/GEP: O Published: N 3331441 KCA 2.12 Nichetti, S. 2016 Potassium phosphonate liquid: Determination of the surface N Y Fitosanitarios tension Bajo CH-732/2015 GLP: Y/GEP: O Published: N 3331442 KCA 2.13 Mazzei, A. 2016 Explosive properties and oxidizing properties on the sample N Y Fitosanitarios Potassium Phosphonate Liquid Bajo 201504699 GLP: Y/GEP: O Published: N 3335040 KCA 2.14 Nichetti, S. 2015 Potassium phosphonate liquid: Determination of the relative N Y Fitosanitarios density Bajo CH-729/2015 GLP: Y/GEP: O Published: N 3331445 KCA 2.14 van Wazer, J.R. 1958 Phosphorus and its compounds N N LIT Interscience Publishers, Inc. New York, Volume I: Chemistry GLP: N/GEP: N Published: Y 3335134

46 FBR-1 / FBR-C ZV1 008838-00/00 Page 47 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not KCA 2.14 Holleman, A. F.; 1971 Lehrbuch der anorganischen Chemie - Phosphorige Säure (P N N LIT Wiberg, E. Lehrbuch der anorganischen Chemie GLP: N/GEP: N Published: Y 3335261 KCA 2.14 Ohashi, S. 1964 Lower oxo acids of phosphorus and their salt N N LIT Topics in Phosphorous Chemistry, Vol. 1 GLP: N/GEP: N Published: Y 3335262 KCA 2.3 Nichetti, S. 2016 Potassium phosphonate liquid and crystal: Determination of the N Y Fitosanitarios colour, odour and physical state Bajo CH-728/2015 GLP: Y/GEP: O Published: N 3331446 KCA 2.3 van Wazer, J.R. 1958 Phosphorus and its compounds N N LIT Interscience Publishers, Inc. New York, Volume I: Chemistry GLP: N/GEP: N Published: Y 3335131 KCA 2.4 Nichetti, S. 2016 Potassium phosphonate crystal: UV/VIS, IR, MS and NRM N Y Fitosanitarios spectra Bajo CH-740/2015 GLP: Y/GEP: O Published: N 3331436 KCA 2.4 van Wazer, J.R. 1958 Phosphorus and its compounds N N LIT Interscience Publishers, Inc. New York, Volume I: Chemistry GLP: N/GEP: N Published: Y 3335133 KCA 2.4 Corbridge, D. E. C.; 1954 The infra-red spectra of some inorganic phosphorus compounds N O LIT Lowe, E. J. Journal of the Chemical Society GLP: O/GEP: O Published: N 3335257 KCA 2.4 Callis, C. F.; van 1956 Analysis of phosphorus compounds - Use of nuclear magnetic N N LIT

47 FBR-1 / FBR-C ZV1 008838-00/00 Page 48 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not Wazer, J. R.; resonance spectra in differential determination of the oxyacids of Shoolery, J. N. phosphorus Analytical Chemistry, Volume 28 GLP: N/GEP: N Published: Y 3335258 KCA 2.5 Nichetti, S. 2016 Potassium phosphonate crystal: Determination of the water N Y Fitosanitarios solubility Bajo CH-737/2015 GLP: Y/GEP: O Published: N 3331437 KCA 2.5 Frazier, A. W.; 1992 Crystallography and equilibrium solubility for ammonium and N N LIT Waerstad, K. R. potassium orthophosphites and hypophosphites Fertilizer Research, Volume 32 GLP: N/GEP: N Published: Y 3335259 KCA 2.5 Weast, R. C. 1972 Handbook of Chemistry and Physics - A Ready-Reference Book N Y LIT of Chemical and Physical Data The Chemical Rubber Co., Cleveland, Ohio, USA GLP: N/GEP: N Published: Y 3335260 KCA 2.6 Nichetti, S. 2016 Potassium phosphonate crystal: Determination of the solubility in N Y Fitosanitarios organic solvents Bajo CH-738/2015 GLP: Y/GEP: O Published: N 3331438 KCA 2.9 Nichetti, S. 2016 Potassium phosphonate liquid: Determination of the auto ignition N Y Fitosanitarios temperature Bajo CH-735/2015 GLP: Y/GEP: O Published: N 3331439 Section B.3 Efficacy Data and Information

48 FBR-1 / FBR-C ZV1 008838-00/00 Page 49 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Section B.5 Analytical Methods

Section B.6 Mammalian Toxicology

Section B.7 Metabolites and Residues KCA Robertson, H.E.; Boy- 1956b Orthophosphite as a buffer for biological studies. N N Aventis Crop- 6.2.1-01 er, P.D. Arch Biochem Biophys, 62: pp. 396-401 Science Not GLP, published KCA Whiley, A.W.; Pegg, 1995 Changing sink strengths influence translocation of phosphonate N N Aventis Crop- 6.2.1-03 K.G.; Saranah, J.B.; in avocado (persea americana mill.) trees. Science Langdorn, P.W. Australian Journal of Agricultural Research 45 (5): pp. 1079- 1090 Not GLP, published KCA Kast, W.K. 2000 Salicylic and phosphorous acid-possible alternative to copper? N N Aventis Crop- 6.2.1-07 Report No. 20011174/R1-FPVI Science Not GLP, unpublished

KCA Macintire, W.H.; 1950 Evaluation of certain phosphorus, phosphorous and phosphoric N N Aventis Crop- 6.2.1-10 Winterberg, S.H.; material by means of pot cultures. Science Hardin, L.J.; Sterges, Agronomy Journal, Vol. 42: pp. 543-549 A.J., Clements, L.B. Not GLP, published KCA XXXXX 1987a Metabolism of 14C-fosetyl-Al in lactating dairy goats. Y N Aventis Crop- 6.2.3-01 Report No. R001413 Science GLP, unpublished KCA XXXXX 1987b Metabolism of 14C-fosetyl-Al in lactating dairy goats (supple- Y N Aventis Crop- 6.2.3-02 ment). Science Report No. R003993 GLP, unpublished KCA XXXXX 1987 Characterisation of 14C-fosetyl-Al metabolites in goat milk. Y N Aventis Crop- 6.2.3-03 Report No. R003992 Science GLP, unpublished KCA XXXXX 1992 Metabolism of 14C-fosetyl-Al in lactating goats. Report No. Y N 6.2.3-04 C012432 GLP, unpublished

49 FBR-1 / FBR-C ZV1 008838-00/00 Page 50 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protection claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not KCA XXXXX 2000 Fosetyl-Al: ruminant feeding study residues of fesetyl-Al and the Y N Aventis Crop- 6.4.2-01 metabolite phosphorous acid in milk and edible tissues of cattle. Science Report No. C010251 GLP, unpublished KCA XXXXX 1984 Analysis of tissues and milk from treated dairy cows ded Y N Aventis Crop- 6.4.2-02 Fosetyl-Al – Aluminium Tris (O-ethyl phosphonate). Science Report No. R011762 GLP, unpublished KCA XXXXX 1984 Fosetyl-Al tissue and milk residue study in dairy cows. Y N Aventis Crop- 6.4.2-03 Report No. R0117637 Science Not GLP, unpublished KCA XXXXX 1987 Characterisation of 14C-fosetyl-Al metabolites in goat milk. Y N Aventis 6.2.3-03 Report No. R003992 CropScience GLP, unpublished KCA XXXXX 1992 Metabolism of 14C-fosetyl-Al in lactating goats. Report No. Y N 6.2.3-04 C012432 GLP, unpublished

Section B.8 Environmental Fate KCP 9.1.2 Goller S. 2013 Potassium Phosphonate KH2PO3/K2HPO3. Adsorption / Desorp- N Y Study report never submitted before SILC FERTI- tion using a batch equilibrium method Dr. U. Noack-Laboratorien, to Germany LIZZANTI s.r.l Report No. CAD15405 Source GLP Unpublished 3337991

Section B.9 Ecotoxicology

Section B.10 Assessment of the relevance of metabolites in groundwater

50 FBR-1 / FBR-C ZV1 008838-00/00 Page 51 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

List of data relied on and not submitted by the applicant but necessary for evaluation

Section B.3 Efficacy Data and Information

Section B.5 Analytical Methods

Section B.6 Mammalian Toxicology

Section B.7 Metabolites and Residues

Section B.8 Environmental Fate KCP Völkel 2008 Na2HPO3 liquid solution. Degradation rate in three soils incubated N ISK 9.1.1.1 under aerobic conditions, RCC Ltd, report n° B30690 KCP Völkel 2008 Na2HPO3 liquid solution. Adsorption /desorption on soil, RCC Ltd, N ISK 9.1.2.1 report n°B30701 Section B.9 Ecotoxicology

Section B.10 Assessment of the relevance of metabolites in groundwater

51 FBR-1 / FBR-C ZV1 008838-00/00 Page 52 /52 Part A - National Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE/ German version MS finalisation date: 20.04.2020

Appendix 5 Copy of the product authorization

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dr. Claudia Bock Dienstsitz Braunschweig • Postfach 15 64 • 38005 Braunschweig Referentin

TELEFON +49 (0)531 299-3471 Fitosanitarios Bajo Riesgo AIE TELEFAX +49 (0)531 299-3002 San Miguel De La Balenya-Seva E-MAIL [email protected] Serrat de la Creu 15 IHR ZEICHEN 08554 Barcelona IHRE NACHRICHT VOM SPANIEN AKTENZEICHEN 200.22100.008632-00/00.156729 (bitte bei Antwort angeben)

DATUM 31. August 2020

ZV1 008632-00/00 FBR-C Zulassungsverfahren für Pflanzenschutzmittel Bescheid

Das oben genannte Pflanzenschutzmittel

mit dem Wirkstoff: 726 g/l Kaliumphosphonat (Kaliumphosphit)

Zulassungsnummer: 008632-00

Versuchsbezeichnungen: FIT-00001-F-0-SL

Antrag vom: 29. Juli 2016

wird auf der Grundlage von Art. 29 der Verordnung (EG) Nr. 1107/2009 des Europäischen Parlaments und des Rates vom 21. Oktober 2009 über das Inverkehrbringen von Pflanzen- schutzmitteln und zur Aufhebung der Richtlinien 79/117/EWG und 91/414/EWG des Rates (ABl. L 309 vom 24.11.2009, S. 1), wie folgt zugelassen:

Zulassungsende

Die Zulassung endet am 30. September 2024.

Festgesetzte Anwendungsgebiete bzw. Anwendungen

Es werden folgende Anwendungsgebiete bzw. Anwendungen festgesetzt (siehe Anlage 1): BVL_FO_05_2437_200_V1.9

Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet: www.bvl.bund.de SEITE 2 VON 12

Anwendungs- Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck nummer Zweckbestimmung Objekte 008632-00/00-001, Falscher Mehltau Weinrebe Nutzung als Tafel- und 008632-00/00-002 (Plasmopara viticola) Keltertraube

Festgesetzte Anwendungsbestimmungen

Es werden folgende Anwendungsbestimmungen gemäß § 36 Abs. 1 S. 1 des Gesetzes zum Schutz der Kulturpflanzen (Pflanzenschutzgesetz - PflSchG) vom 6. Februar 2012 (BGBl. I S. 148, 1281), zuletzt geändert durch Artikel 4 Absatz 84 des Gesetzes vom 18. Juli 2016 (BGBl. I S. 1666), festgesetzt: (NW470) Etwaige Anwendungsflüssigkeiten, Granulate und deren Reste sowie Reinigungs- und Spül- flüssigkeiten nicht in Gewässer gelangen lassen. Dies gilt auch für indirekte Einträge über die Kanalisation, Hof- und Straßenabläufe sowie Regen- und Abwasserkanäle. Begründung: Aufgrund der Tatsache, dass eine Förderung der Gewässereutrophierung nach Anwendung des o.g Kaliumphosphit haltigen Pflanzenschutzmittels nicht ausgeschlossen werden kann (siehe EFSA Conclusion, EFSA Journal 2012;10(12):2963), besitzt das o.g. Pflanzenschutz- mittel einen den Naturhaushalt schädigenden Charakter, so dass jeder weitergehende, d.h. den als Folge der sachgerechten und bestimmungsgemäßen Anwendung des o.g. Pflanzen- schutzmittels übersteigende Eintrag von Rückständen in Gewässer zu einer erheblichen Gefährdung des Naturhaushaltes führen würde. Da ein erheblicher Anteil der in Oberflächen- gewässern nachzuweisenden Pflanzenschutzmittelfrachten auf Einträge aus kommunalen Kläranlagen zurückzuführen ist, muss dieser Gefährdung durch die bußgeldbewehrte Anwendungsbestimmung durchsetzbar begegnet werden.

(SF275-4WE) Es ist sicherzustellen, dass bei Nachfolgearbeiten/Inspektionen mit direktem Kontakt zu den behandelten Pflanzen/Flächen innerhalb von 4 Tagen nach der Anwendung in Weinbau lange Arbeitskleidung und festes Schuhwerk getragen werden. Begründung: Im Ergebnis der Expositionsbewertung für Arbeiter bei Nachfolgearbeiten/Inspektionen ist die Anwendungsbestimmung erforderlich, um den Referenzwert bei bestimmungsgemäßer Anwendung nicht zu überschreiten. Nur in Verbindung mit der Verwendung der zusätzlichen Maßnahmen wird das Risiko als vertretbar beurteilt.

Siehe anwendungsbezogene Anwendungsbestimmungen in Anlage 1, jeweils unter Nr. 3. BVL_FO_05_2437_200_V1.9 SEITE 3 VON 12

Verpackungen

Gemäß § 36 Abs. 1 S. 2 Nr. 1 PflSchG sind für das Pflanzenschutzmittel die nachfolgend näher beschriebenen Verpackungen für den beruflichen Anwender zugelassen:

Verpackungs- Verpackungs- Anzahl Inhalt art material von bis von bis Einheit Flasche HDPE 1 16 60,00 1000,00 ml IBC HDPE 1 2 1000,00 l Kanister HDPE 1 23 5,00 25,00 l Tank HDPE 1 3 1000,00 l Trommel, Fass, HDPE 1 5 200,00 220,00 l Tonne

Die Verpackungen für den beruflichen Anwender sind wie folgt zu kennzeichnen: Anwendung nur durch berufliche Anwender zulässig.

Auflagen

Die Zulassung wird mit folgenden Auflagen gemäß § 36 Abs. 3 S. 1 PflSchG verbunden: Kennzeichnungsauflagen: (EB001-2) SP 1: Mittel und/oder dessen Behälter nicht in Gewässer gelangen lassen. (Ausbringungsge- räte nicht in unmittelbarer Nähe von Oberflächengewässern reinigen./Indirekte Einträge über Hof- und Straßenabläufe verhindern.)

(SB001) Jeden unnötigen Kontakt mit dem Mittel vermeiden. Missbrauch kann zu Gesundheitsschä- den führen.

(SB005) Ist ärztlicher Rat erforderlich, Verpackung oder Etikett des Produktes bereithalten.

(SB010) Für Kinder unzugänglich aufbewahren.

(SB111) Für die Anforderungen an die persönliche Schutzausrüstung beim Umgang mit dem Pflan- zenschutzmittel sind die Angaben im Sicherheitsdatenblatt und in der Gebrauchsanweisung des Pflanzenschutzmittels sowie die BVL-Richtlinie "Persönliche Schutzausrüstung beim BVL_FO_05_2437_200_V1.9 SEITE 4 VON 12

Umgang mit Pflanzenschutzmitteln" des Bundesamtes für Verbraucherschutz und Lebens- mittelsicherheit (www.bvl.bund.de) zu beachten.

(SB166) Beim Umgang mit dem Produkt nicht essen, trinken oder rauchen.

(SF245-02) Es ist sicherzustellen, dass behandelte Flächen/Kulturen erst nach dem Abtrocknen des Pflanzenschutzmittelbelages wieder betreten werden.

(SS206) Arbeitskleidung (wenn keine spezifische Schutzkleidung erforderlich ist) und festes Schuh- werk (z.B. Gummistiefel) tragen bei der Ausbringung/Handhabung von Pflanzenschutzmit- teln.

(WMFP7) Wirkungsmechanismus (FRAC-Gruppe): P7

Siehe anwendungsbezogene Kennzeichnungsauflagen in Anlage 1, jeweils unter Nr. 2.

Sonstige Auflagen: (WH952) Auf der Verpackung und in der Gebrauchsanleitung ist die Angabe zur Kennzeichnung des Wirkungsmechanismus als zusätzliche Information direkt jedem entsprechenden Wirkstoffna- men zuzuordnen.

Die Zulassung wird mit folgenden Auflagen gemäß § 36 Abs. 5 PflSchG verbunden:

Dem Bundesamt für Verbraucherschutz und Lebensmittelsicherheit sind Unterlagen zu den nachfolgend aufgeführten Punkten und den dabei jeweils genannten Terminen vorzulegen: Antragspunkt: KCP 10.4.1.2 Termin: 31. Dezember 2023 Forderung: Zulassungsbegleitendes Freilandmonitoring zur Wiederbesiedlung und/ oder Erholung der Regenwurmpopulationen nach der basierend auf den Laborergebnissen zu erwartenden Auswirkung des Wirkstoffes Kaliumphosphonat auf Regenwürmer. BVL_FO_05_2437_200_V1.9 SEITE 5 VON 12

Begründung Aufgrund der chemischen Zusammensetzung ist davon auszugehen, dass folgende Mono- formulierungen mit dem Wirkstoff Kaliumphosphonat hinsichtlich ihrer ökotoxikologischen Wirkung auf Regenwürmer vergleichbar sind: EU- Beispiel-Formulierung Stamina (ZA 7207 Veriphos), Alginure Bio Schutz (ZA 7839), FBR-1 (ZA 8837, ZA 8838, ZA 8632), BFA 1-14 (ZA 8104) und Soriale (ZA 8650). Zu zwei Pflanzenschutzmitteln liegen chronische Studien an Eisenia fetida fetida vor: zu der EU-Formulierung Stamina mit einer NOEC = 62,5 mg/kg Boden; EC10 = 52,1 mg/kg Boden (Kölzer, U., 2006, 20051318/01-NREf) und zu Alginure Bio Schutz mit einer NOEC = 128 mg/kg Boden (Wagenhoff, E., 2012, S12-02325). Weiter- hin liegt zu dem Pflanzenschutzmittel "FBR-1" ein Effektwert zu der Spezies Eisenia fetida andrei mit einer NOEC = 146.2 mg/kg Boden (Pecorari, 2016, BT129/15) vor. Es ergibt sich auf Grundlage des niedrigsten verfügbaren Endpunktes mit dem Pflanzenschutzmittel "Sta- mina" ein unakzeptables Risiko für Regenwürmer durch die Anwendung in den beantragten Anwendungen 00-001 und 00-002. Auf Grundlage des höchsten verfügbaren Endpunktes auf Basis des Tests mit dem Pflanzenschutzmittel " FBR-1" dagegen ergibt sich ein vertretbares Risiko für diese Anwendungen (s. Nationales Addendum Sektion 9.8). Im Ergebnis ergibt die Risikobewertung TER-Werte unterhalb und oberhalb des Akzeptabili- tätskriteriums von 5. Da die chemische Zusammensetzung der Pflanzenschutzmittel sehr ähnlich ist und eine Wirkung der Beistoffe ausgeschlossen werden kann, wird eine Zulas- sung des Pflanzenschutzmittels "FBR-1" in den hier beantragten Anwendungen in der Gesamtschau der Effektwerte als vorläufig vertretbar erachtet. Aufgrund der verbleibenden Unsicherheiten in den betreffenden Anwendungen (TER = 3,6 auf Basis der EC10 = 52,1 mg/kg Boden), wird in Bezugnahme auf § 36 (5) PflSchG zulassungsbegleitend eine Frei- landstudie an Regenwurmpopulationen mit geeigneter Analytik gefordert. Wir regen an, eine gemeinsame Studie der Antragssteller zum Wirkstoff Kaliumphosphonat und ggf. Dinatriumphosphonat in Betracht zu ziehen (Task force) und das Studiendesign vorab mit dem Umweltbundesamt abzustimmen.

Unter Berücksichtigung der für die Erarbeitung dieser Unterlagen sowie ihrer Prüfung erfor- derlichen Zeitdauer sind die Studien zu den oben genannten Terminen vorzulegen. Ich weise darauf hin, dass mir § 36 Abs. 5 S. 3 PflSchG für den Fall der nicht fristgerechten Erfüllung dieser Auflage die Möglichkeit eröffnet, das Ruhen der Zulassung anzuordnen. Ferner eröff- net mir in diesem Fall § 49 Abs. 2 Nr. 2 VwVfG auch die Möglichkeit des Widerrufs der Zulas- sung.

Vorbehalt

Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder Ergänzung von Anwendungsbestimmungen und Auflagen verbunden. BVL_FO_05_2437_200_V1.9 SEITE 6 VON 12

Angaben zur Einstufung und Kennzeichnung gemäß Verordnung (EG) Nr. 1272/2008

Signalwort: - keine -

Gefahrenpiktogramme: - keine -

Gefahrenhinweise (H-Sätze): (EUH 401) Zur Vermeidung von Risiken für Mensch und Umwelt die Gebrauchsanleitung einhalten.

Sicherheitshinweise (P-Sätze): - keine -

Abgelehnte Anwendungsgebiete bzw. Anwendungen

Für folgende Anwendungsgebiete bzw. Anwendungen lehne ich Ihren Antrag ab (siehe Anlage 2): - keine -

Hinweise

Auf dem Etikett und in der Gebrauchsanleitung kann angegeben werden: (NB6641) Das Mittel wird bis zu der höchsten durch die Zulassung festgelegten Aufwandmenge oder Anwendungskonzentration, falls eine Aufwandmenge nicht vorgesehen ist, als nicht bienen- gefährlich eingestuft (B4).

(NN1001) Das Mittel wird als nicht schädigend für Populationen relevanter Nutzinsekten eingestuft.

(NN1002) Das Mittel wird als nicht schädigend für Populationen relevanter Raubmilben und Spinnen eingestuft.

Weitere Hinweise und Bemerkungen Zu KCP 5.2: - Die Analysenmethode von Perboni (2018) zur Bestimmung von Kaliumphosphonat (Phos-

BVL_FO_05_2437_200_V1.9 phonsäure und ihre Salze, ausgedrückt als Phosphonsäure) in Trinkwasser ist durch ein SEITE 7 VON 12

unabhängiges Labor zu validieren (ILV). Begründung: Um sicher zu stellen, dass sich vorgeschlagene Analysenverfahren allgemein eignen, ist gemäß der Verordnung (EU) Nr. 284/2013 eine unabhängige Validierung erforderlich.

- Ein validiertes Analysenverfahren (Primärmethode) zur Bestimmung von Kaliumphosphonat (Phosphonsäure und ihre Salze, ausgedrückt als Phosphonsäure) in Körperflüssigkeiten und Körpergeweben ist vorzulegen. Begründung: Zum Nachweis bzw. zum Ausschluss von Vergiftungen durch Pflanzenschutzmittel werden gemäß der Verordnung (EU) Nr. 284/2013 sowie der Leitlinie SANCO/825/00 rev. 8.1 Analy- senverfahren für Körperflüssigkeiten und Körpergewebe benötigt.

- Ein validiertes Absicherungsverfahren (Absicherung) zur Bestimmung von Kaliumphospho- nat (Phosphonsäure und ihre Salze, ausgedrückt als Phosphonsäure) in Körperflüssigkeiten und Körpergeweben ist vorzulegen. Begründung: Um falsch positive Ergebnisse beim Nachweis von Vergiftungen zu vermeiden, ist gemäß Leitlinie SANCO/825/00 ein validiertes Absicherungsverfahren erforderlich. Die Anforderun- gen hinsichtlich des Umfangs der Validierung von Absicherungsverfahren sind in der Leitlinie SANCO/825/00 rev. 8.1 präzisiert worden.

Vorsorglich weise ich darauf hin, dass bisher mitgeteilte Forderungen bestehen bleiben, soweit sie noch nicht erfüllt sind.

Unterbleibt eine Beanstandung der vorgelegten Gebrauchsanleitung, so ist daraus nicht zu schließen, dass sie als ordnungsgemäß angesehen wird. Die Verantwortung des Zulas- sungsinhabers für die Übereinstimmung mit dem Zulassungsbescheid bleibt bestehen.

Hinsichtlich der Gebühren erhalten Sie einen gesonderten Bescheid. BVL_FO_05_2437_200_V1.9 SEITE 8 VON 12

Rechtsbehelfsbelehrung

Gegen diesen Bescheid kann innerhalb eines Monats nach Bekanntgabe Widerspruch erhoben werden. Der Widerspruch ist beim Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Braunschweig einzulegen.

Mit freundlichen Grüßen im Auftrag

gez. Dr. Martin Streloke Abteilungsleiter

Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig.

Anlage BVL_FO_05_2437_200_V1.9 SEITE 9 VON 12

Anlage 1 zugelassene Anwendung: 008632-00/00-001 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Falscher Mehltau (Plasmopara viticola) Pflanzen/-erzeugnisse/Objekte: Weinrebe Verwendungszweck: Nutzung als Tafel- und Keltertraube

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

Einsatzgebiet: Weinbau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Anwenderkategorie: Beruflich Stadium der Kultur: 15 bis 89 Anwendungszeitpunkt: Bei Infektionsgefahr bzw. ab Warndiensthinweis Maximale Zahl der Behandlungen - in dieser Anwendung: 6 - für die Kultur bzw. je Jahr: 6 - Abstand: 10 bis 14 Tage Anwendungstechnik: spritzen oder sprühen Aufwand: - Basisaufwand: 1 l/ha in maximal 400 l Wasser/ha

- ES 61: 2 l/ha in maximal 800 l Wasser/ha

- ES 71: 3 l/ha in maximal 1200 l Wasser/ha

- ES 75: 4 l/ha in maximal 1600 l Wasser/ha

- Erläuterungen: maximaler Mittelaufwand 18 l/ha

2.2 Sonstige Kennzeichnungsauflagen (NW642-1) Die Anwendung des Mittels in oder unmittelbar an oberirdischen Gewässern oder Küstenge- wässern ist nicht zulässig. Unabhängig davon ist der gemäß Länderrecht verbindlich vorge- gebene Mindestabstand zu Oberflächengewässern einzuhalten. Zuwiderhandlungen können mit einem Bußgeld bis zu einer Höhe von 50.000 Euro geahndet werden.

(WG734) Die Anwendung des Mittels kann bei Spontangärung zu Gärverzögerungen führen.

(WW750) Die maximale Anzahl der Anwendungen ist aus wirkstoffspezifischen Gründen eingeschränkt. BVL_FO_05_2437_200_V1.9 SEITE 10 VON 12

Ausreichende Bekämpfung ist damit nicht in allen Fällen zu erwarten. Gegebenenfalls des- halb anschließend oder im Wechsel Mittel mit anderen Wirkstoffen verwenden.

2.3 Wartezeiten 14 Tage Freiland: Weinrebe (Tafel- und Keltertrauben)

3 Anwendungsbezogene Anwendungsbestimmungen (NG402) Zwischen behandelten Flächen mit einer Hangneigung von über 2 % und Oberflächenge- wässern - ausgenommen nur gelegentlich wasserführender, aber einschließlich periodisch wasserführender - muss ein mit einer geschlossenen Pflanzendecke bewachsener Rand- streifen vorhanden sein. Dessen Schutzfunktion darf durch den Einsatz von Arbeitsgeräten nicht beeinträchtigt werden. Er muss eine Mindestbreite von 10 m haben. Dieser Randstrei- fen ist nicht erforderlich, wenn: - ausreichende Auffangsysteme für das abgeschwemmte Wasser bzw. den abgeschwemmten Boden vorhanden sind, die nicht in ein Oberflächenge- wässer münden, bzw. mit der Kanalisation verbunden sind oder - die Anwendung im Mulch- oder Direktsaatverfahren erfolgt. Begründung: Der im o.g. Pflanzenschutzmittel enthaltene Wirkstoff Kaliumphosphonat weist ein hohes Potenzial für Einträge in das Grundwasser über den Pfad Drainage mit anschließender Ufer- filtration auf. Ausgehend von einem Datensatz expositionsbestimmender Eigenschaften des Wirkstoffs (Wasserlöslichkeit = 1 875 000 mg/L mg/L; DT50 Boden = 267 d; KOC = 721) und einer Berechnung der zu erwartenden Einträge mit dem Modell Exposit 3.02 ist die Anwen- dungsbestimmung NG402 erforderlich, um einen ausreichenden Schutz des Grundwassers vor Rückständen des Wirkstoffs Kaliumphosphonat (Konzentration im Grundwasser < 0,1 µg/L) zu gewährleisten. Weitere Informationen hierzu sind dem Draft Registration Report, Part B nationales Adden- dum zu entnehmen (Sektion 8, Kapitel 8.8). BVL_FO_05_2437_200_V1.9 SEITE 11 VON 12

Anlage 1 zugelassene Anwendung: 008632-00/00-002 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Falscher Mehltau (Plasmopara viticola) Pflanzen/-erzeugnisse/Objekte: Weinrebe Verwendungszweck: Nutzung als Tafel- und Keltertraube

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

Einsatzgebiet: Weinbau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Anwenderkategorie: Beruflich Stadium der Kultur: 15 bis 89 Anwendungszeitpunkt: Bei Infektionsgefahr bzw. ab Warndiensthinweis Maximale Zahl der Behandlungen - in dieser Anwendung: 5 - für die Kultur bzw. je Jahr: 6 - Abstand: 20 bis 28 Tage Anwendungstechnik: spritzen oder sprühen Aufwand: - Basisaufwand: 1 l/ha in maximal 400 l Wasser/ha

- ES 61: 2 l/ha in maximal 800 l Wasser/ha

- ES 71: 3 l/ha in maximal 1200 l Wasser/ha

- ES 75: 4 l/ha in maximal 1600 l Wasser/ha

- Erläuterungen: maximaler Mittelaufwand 18 l/ha

(WG734) Die Anwendung des Mittels kann bei Spontangärung zu Gärverzögerungen führen.

(WW750) Die maximale Anzahl der Anwendungen ist aus wirkstoffspezifischen Gründen eingeschränkt. BVL_FO_05_2437_200_V1.9 SEITE 12 VON 12

Ausreichende Bekämpfung ist damit nicht in allen Fällen zu erwarten. Gegebenenfalls des- halb anschließend oder im Wechsel Mittel mit anderen Wirkstoffen verwenden.

2.3 Wartezeiten 14 Tage Freiland: Weinrebe (Tafel- und Keltertrauben)

Product code: FBR-1 Product name(s): FBR-C Chemical active substance: Potassium phosphonates 726 g/L

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: Fitosanitarios Bajo Riesgo AIE Submission date: 29/07/2016 MS Finalisation date: July 2020 Product code: FBR-1/ Product name: FBR-C Page 2 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Version history

When What

November 2019 dRR zRMS version 07/2020 zRMS final RR

Product code: FBR-1/ Product name: FBR-C Page 3 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Table of Contents

1 Section 1: Identity of the plant protection product ...... 4 1.1 Applicant (KCP 1.1) ...... 4 1.2 Producer of the plant protection product and of the active substances (KCP 1.2) ...... 4 1.2.1 Producer(s) of the preparation ...... 4 1.2.2 Producer(s) of the active substance(s) ...... 4 1.2.3 Statement of purity (and detailed information on impurities) of the active substance(s) ...... 4 1.2.3.1 Potassium phosphonates ...... 4 1.3 Trade names and producer’s development code numbers for the preparation (KCP 1.3) ...... 4 1.4 Detailed quantitative and qualitative information on the composition of the preparation (KCP 1.4) ...... 5 1.4.1 Composition of the plant protection product (KCP 1.4.1) ...... 5 1.4.2 Information on the active substance(s) (KCP 1.4.2) ...... 5 1.4.3 Information on safeners, synergists and co-formulants (KCP 1.4.3) ...... 5 1.5 Type and code of the plant protection product (KCP 1.5) ...... 5 1.6 Function (KCP 1.6) ...... 5

2 Section 2: Physical, chemical and technical properties of the plant protection product ...... 6

3 Section 3 is presented as a separate document ...... 12

4 Section 4: Further information on the plant protection product ...... 13 4.1 Packaging and Compatibility with the Preparation (KCP 4.4) ...... 13

Appendix 1 Lists of data considered in support of the evaluation ...... 25

Appendix 2 Additional data on the physical, chemical and technical properties of the active substance ...... 29 A 2.1 Potassium phosphonates ...... 29

Product code: FBR-1/ Product name: FBR-C Page 4 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Sufficient data on identity, physical and chemical properties and other information are available for the plant protection product and the contained technical active substance(s).

Identified data gap: Study on effectivity of tank cleaning procedure has not been submitted.

1 Section 1: Identity of the plant protection product

1.1 Applicant (KCP 1.1)

Name: Fitosanitarios Bajo Riesgo AIE Address: Serrat de la Creu, 15 08554 San Miguel De La Balenya-Seva (Barcelona) SPAIN

1.2 Producer of the plant protection product and of the active substances (KCP 1.2)

1.2.1 Producer(s) of the preparation

Confidential information or data are provided separately (Part C).

1.2.2 Producer(s) of the active substance(s)

Confidential information or data are provided separately (Part C).

1.2.3 Statement of purity (and detailed information on impurities) of the active substance(s)

1.2.3.1 Potassium phosphonates

Potassium phosphonates min. 990 g/kg on dry weight basis (TC)

Technical concentrate (TK): 31.6 % - 32.6 % phosphonate ions (sum of hydrogen phosphonate and phosphonate ions) 17.8 % - 20.0 % potassium ions

Further information is provided in Part C.

1.3 Trade names and producer’s development code numbers for the preparation (KCP 1.3)

Trade name: FBR-C Company code number: FBR-1 Product code: FBR-1/ Product name: FBR-C Page 5 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

1.4 Detailed quantitative and qualitative information on the composition of the preparation (KCP 1.4)

1.4.1 Composition of the plant protection product (KCP 1.4.1)

FBR-1 was not the representative formulation during Annex I inclusion of potassium phosphonates.

Table 1.4-1: Active substance(s) and variant(s) of the active substance(s)

Active substance / Declared content of FAO Limits Technical content Technical content variant the pure active sub- (min – max) (g/L or g/kg) (%w/w) stance / variant (g/L or g/kg)

Potassium phospho- 726 g/L 701 – 751 g/L N/A* N/A* nates (± 25 g/L) * Not applicable for this active substance. Please refer to Part C

1.4.2 Information on the active substance(s) (KCP 1.4.2)

Table 1.4-2: Information on Potassium phosphonates

Type Name/Code Number

ISO common name Potassium phosphonates Potassium phosphite (former name) CAS No. 13977-65-6 for potassium hydrogen phosphonate 13492-26-7 for dipotassium phosphonate EC No. not allocated CIPAC No. 756 (for potassium phosphonates)

1.4.3 Information on safeners, synergists and co-formulants (KCP 1.4.3)

CONFIDENTIAL information is provided separately (Part C).

1.5 Type and code of the plant protection product (KCP 1.5)

Type: Soluble concentrate [Code: SL]

1.6 Function (KCP 1.6)

FBR-1 is a fungicide. Product code: FBR-1/ Product name: FBR-C Page 6 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

2 Section 2: Physical, chemical and technical properties of the plant protection product

In use concentration: 0.03 % - 2.00 %.

The plant protection product has been analysed by the authority. Results of the analytics are shown in Appendix 3.

Notifier Proposals for Risk and Safety Phrases (KCP 12) None required.

Compliance with FAO specifications: The product FBR-1 complies with FAO specifications.

Formulation used for tests The product used in the tests has the same composition as the one cited in Part C. Batch n°2015-10-07, containing 31.6% phosphonates ions and 17.8% potassium ion

Product code: FBR-1/ Product name: FBR-C Page 7 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Table 2-1: Physical, chemical and technical properties of the plant protection product

Annex point Method used Test Findings GLP Reference Acceptability / / deviations material Y/N comments

Colour and Visual as- Batch colourless liquid Y Nichetti, S., Acceptable. physical state sessment and n°2015- characteristic odour 2016, (KCP 2.1) organoleptic 10-07 CH-728/2015 determination Explosive properties EC A.14 Batch The product is not considered to present a danger of explosion. Y Mazzei, A., Acceptable. (KCP 2.2) n°2015- 2016, 10-07 201504699 Oxidizing properties EC A.21 Batch The preparation has no oxidising properties. Y Mazzei, A., Acceptable. (KCP 2.2) n°2015- 2016, 10-07 201504699 Flash point ISO 3680 Batch The preparation has no flash point up to 130 °C. Y Nichetti, S., Acceptable. (KCP 2.3) method n°2015- 2016, 10-07 CH-736/2015 Flammability Not required for a SL formulation. Acceptable. (KCP 2.3) Self-heating EC A.15 Batch Auto-ignition at 590 °C. Y Nichetti, S., Acceptable. (KCP 2.3) n°2015- 2016, 10-07 CH-735/2015 Acidity or alkalinity Not applicable, as pH is >4 and <10. Acceptable. and pH (KCP 2.4) pH of a 1% aqueous CIPAC MT Batch 1 %, deionised water, 20 °C: 5.7 Y Nichetti, S., Acceptable. dilution, emulsion or 75.3 n°2015- Neat formulation, 20 °C: 5.8 2015, dispersion 10-07 CH-741/2015 (KCP 2.4) Viscosity OECD 114 Batch Kinematic viscosity: Y Nichetti, S., Acceptable. (KCP 2.5) n°2015- - 20°C: 4.87 mm²/s 2016, Product code: FBR-1/ Product name: FBR-C Page 8 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

10-07 - 40°C: 3.44 mm²/s CH-733/2015

Dynamic viscosity: - 20°C: 6.86 mPa*s - 40°C: 4.84 mPa*s

Test item can be considered as a Newtonian liquid. Surface tension OECD 115 Batch 0.03 %, distilled water, 20 °C: 69.7 mN/m Y Nichetti, S., Acceptable. (KCP 2.5 n°2015- 2.00 %, distilled water, 20 °C: 67.5 mN/m 2016, 10-07 neat, 20 °C: 69.8 mN/m CH-732/2015

20 Relative density OECD 109 Batch d4 = 1.4079 Y Nichetti, S., Acceptable. (KCP 2.6) n°2015- 2015, 10-07 CH-729/2015 Bulk density Not required for a SL formulation. Acceptable. (KCP 2.6) Storage Stability after CIPAC MT Batch Storage: 14 days, at 54°C. Y Nichetti, S., Acceptable. 14 days at 54º C 46.3 n°2015- Commercial pack, HDPE 2015, (KCP 2.7) (MT 47.1, 10-07 CH-741/2015 o MT 75.3, Test T0 T14 Days at 54 C MT 41) Physical state, Colourless liquid with Colourless liquid with character- Colour characteristic odour istic odour Active content Potassium: 18.4% w/w Potassium: 18.2% w/w Phosphonates: 32.2% w/w (-1.23 %) Phosphonates: 30.9% w/w (-3.92 %) Weight variation HDPE bottle A: 1504.8 g A: 1500.9 g (-0.26%) HDPE bottle B: 1516.6 g B: 1512.5 g (-0.27%) pH of a 1% 5.7 5.8 dilution pH (neat test 5.8 5.8 item) Persistent After 1 min: After 1 min: foaming - 0.03% v/v: 0mL - 0.03% v/v: 0mL - 2.00% v/v: 0mL - 2.00% v/v: 0mL Dilution stability No visual separation of No visual separation of solid or (0.03% v/v and solid or liquid material liquid material after 18 hours at 2.00% v/v) after 18 hours at 20°C 20°C

Product code: FBR-1/ Product name: FBR-C Page 9 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

No change in the sample appearance, colour or odour was found in the formulation and no deformation in the container, no loss of sample or evident corrosion phenomena was found. Moreover, no significant changes in physical properties nor in the active substance contents were found comparing to the initial characterisation (the active ingredient content do not decline to less than 95% of the initial content measured). Therefore from the obtained results, it can be concluded that the sample of the formulation is stable in its commercial packaging (HDPE) under the tested accelerated storage conditions. Stability after storage Not required. for other periods and/or temperatures (KCP 2.7) Minimum content Not required. after heat stability testing (KCP 2.7) Effect of low temper- CIPAC MT Batch Initially, the test item is a clear colourless liquid. Y Nichetti, S., Acceptable. atures on stability 39.3 n°2015- After 7 days at 0°C the sample, did not show separation of solid or liquid ma- 2016, (KCP 2.7) 10-07 terial, nor changes in its physical state. CH-734/2015 Ambient temperature Visual exami- Batch Test After 6 months After 12 After 24 Y Nichetti, S., Acceptable. shelf life nation of both n°2015- storage months months 2018, (KCP 2.7) external and 10- storage storage CH-742/2015 internal pack- Packaging HDPE bottle “C” HDPE bottle “D” HDPE bottles “E” aging and “F” By technical Weight variation C: 0.00% D: - 0.01% E: - 0.60%; balance (%) F: - 0.62% No. 288/2014 Potassium cationic 18.2 ± 0.4 % w/w 18.3 ± 0.4 % w/w 17.6 ± 0.4 % w/w No. 289/2014 part of the active ingredient content OPPTS Potassium anionic 32.0 ± 0.5 % w/w 32.1 ± 0.5 % w/w 31.4 ± 0.5 % w/w 830.6302, part of the active OPPTS ingredient con- 830.6303, tent OPPTS Appearance Colourless liquid Colourless liquid Colourless liquid 830.6304 (Colour, odour with characteristic with characteris- with characteris- CIPAC MT and physical state) odour tic odour tic odour Product code: FBR-1/ Product name: FBR-C Page 10 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

75.3 Compatibility The container The container The container CIPAC MT (resistance) of the didn’t present any didn’t present any didn’t present any 47.1 packaging materi- deformation in deformation in deformation in and MT 18 al both bottom and both bottom and both bottom and (using Stand- lateral layers, or lateral layers, or lateral layers, or loss of sample and loss of sample and loss of sample and ard evident corrosion evident corrosion evident corrosion Water D) phenomena phenomena phenomena CIPAC MT pH value 6.0 5.7 5.7 41 (neat test item) and MT 18 pH value (1% 5.7 5.7 5.6 (using Stand- aqueous dilution) ard Persistent Foam- Foam after 1 Foam after 1 Foam after 1 Water D) ing minute: minute: minute: 0.03 % v/v = 0 mL 0.03 % v/v = 0 mL 0.03 % v/v = 0 mL 2.00 % v/v = 0 m 2.00 % v/v = 0 mL 2.00 % v/v = 0 mL Dilution Stability After 18 hours After 18 hours After 18 hours at 20 ± 2°C: at 20 ± 2°C: at 20 ± 2°C: no visual separa- no visual separa- no visual separation of solid or tion of solid or tion of solid or liquid material liquid material liquid material for both dilution for both dilution for both dilution rates rates rates

Shelf life in months Not required. Acceptable. (if less than 2 years) (KCP 2.7) Wettability Not required for a SL formulation. Acceptable. (KCP 2.8.1) Persistence of foam- CIPAC MT Batch 0.03 % v/v and 2.00 % v/v in CIPAC water D: Y Nichetti, S., Acceptable. ing 47.2 n°2015- after 1 min 0 mL 2015, (KCP 2.8.2) 10-07 CH-741/2015

Suspensibility Not required for a SL formulation. Acceptable. (KCP 2.8.3) Spontaneity of dis- Not required for a SL formulation. Acceptable. persion (KCP 2.8.3) Product code: FBR-1/ Product name: FBR-C Page 11 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Dispersion stability Not required for a SL formulation. Acceptable. (KCP 2.8.3) Degree of dissolution CIPAC MT Batch After 18 hours at 20 °C: no visual separation of solid or liquid material was Y Nichetti, S., Acceptable. and dilution stability 41 n°2015- observed. 2015, (KCP 2.8.4) CIPAC MT 10-07 CH-741/2015 18

Particle size distribu- Not required for a SL formulation. Acceptable. tion / nominal size range of granules (KCP 2.8.5.1) Wet sieve test Not required for a SL formulation. Acceptable. (KCP 2.8.5.1) Dust content Not required for a SL formulation. Acceptable. (KCP 2.8.5.2) Particle size of dust Not required for a SL formulation. Acceptable. (KCP 2.8.5.2) Attrition Not required for a SL formulation. Acceptable. (KCP 2.8.5.3) Hardness and integri- Not required for a SL formulation. Acceptable. ty (KCP 2.8.5.4) Emulsifiability Not required for a SL formulation. Acceptable. (KCP 2.8.6) Emulsion stability Not required for a SL formulation. Acceptable. (KCP 2.8.6) Re-emulsifiability Not required for a SL formulation. Acceptable. (KCP 2.8.6) Flowability Not required for a SL formulation. Acceptable. (KCP 2.8.7) Pourability Not required for a SL formulation. Acceptable. (KCP 2.8.7) Product code: FBR-1/ Product name: FBR-C Page 12 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Dustability following Not required for a SL formulation. Acceptable. accelerated storage (KCP 2.8.7) Physical compatibil- Not required as the product is not intended for tank mixes. Acceptable. ity of tank mixes (KCP 2.9) Chemical compatibil- Not required as the product is not intended for tank mixes. Acceptable. ity of tank mixes (KCP 2.9) Adhesion to seeds Not required for a SL formulation. Acceptable. (KCP 2.10) Distribution to seed Not required for a SL formulation. Acceptable. (KCP 2.10) Other/special studies None. Study on effectivity of (KCP 2.11) tank cleaning procedure has not been submitted.

3 Section 3 is presented as a separate document

Please refer to the separate file “dRR Part B3”.

Product code: FBR-1/ Product name: FBR-C Page 13 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

4 Section 4: Further information on the plant protection product

4.1 Packaging and Compatibility with the Preparation (KCP 4.4)

It should be noted that resistance of the commercial packaging (HDPE) has been tested during the accelerated storage stability study at 54º C for 14 days and is currently tested in the 2-year shelf life study. Please refer to point 2.7.1 and 2.7.5.

Table 4.1-1: Packaging information for 60 mL bottles

Type Description Material: HDPE Shape/size: cylindrical / approx. 37.2 mm diameter x 102.9 mm Opening: 20.2 mm inner diameter Closure: screw cap Seal: Screwed, no thermal sealing Manner of construction Extrusion blow molding UN/ADR -

Table 4.1-2: Packaging information for 120 mL bottles

Type Description Material: HDPE Shape/size: cylindrical / approx. 41.3 mm diameter x 131.8mm Opening: 20.2 mm inner diameter Closure: screw cap Seal: Screwed, no thermal sealing Manner of construction Extrusion blow molding UN/ADR -

Table 4.1-3: Packaging information for 250 mL bottles

Type Description Material: HDPE Shape/size: cylindrical / approx. 63 mm diameter x 133 mm Opening: 41 mm inner diameter Closure: screw cap Seal: Screwed, no thermal sealing Manner of construction Extrusion blow molding UN/ADR Yes, N° B-1308 Product code: FBR-1/ Product name: FBR-C Page 14 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Type Description

Material: HDPE Shape/size: cylindrical / approx. 63 mm diameter x 133 mm Opening: 50 mm inner diameter Closure: Threaded cap Seal: Threaded cap Manner of construction Injection and blown plastic UN/ADR No

Table 4.1-4: Packaging information for 500 mL bottles

Type Description Material: HDPE Shape/size: cylindrical / approx. 79 mm diameter x 165 mm Opening: 41 mm inner diameter Closure: screw cap Seal: Screwed, no thermal sealing Manner of construction Extrusion blow molding UN/ADR Yes, N° B-1309

Material: HDPE Shape/size: cylindrical / approx. 79 mm diameter x 165 mm Opening: 50 mm inner diameter Closure: Threaded cap Seal: Threaded cap Manner of construction Injection and blown plastic UN/ADR No

Product code: FBR-1/ Product name: FBR-C Page 15 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Table 4.1-5: Packaging information for 1 liter bottles

Type Description Material: HDPE Shape/size: cylindrical / approx. 88 mm diameter x 248 mm Opening: 41 mm inner diameter Closure: Tamper proof screw cap Seal: Molded-in sealing cap Manner of construction Extrusion UN/ADR Not applicable

Material: HDPE Shape/size: cylindrical / approx. 88 mm diameter x 244 mm Opening: 50 mm inner diameter Closure: Threaded cap Seal: Threaded cap Manner of construction Injection and blown plastic UN/ADR No

Material: HDPE Shape/size: cylindrical / approx. 88 mm diameter x 240 mm Opening: 40 mm inner diameter Closure/seal: Thread with security strap Manner of construction Blow molding UN/ADR Compliant (UN: 1H1/Y1,3/150/XX E/02 B-737-11/AA3)

Material: HDPE Shape/size: cylindrical / approx. 87 mm diameter x 239 mm Opening: 40 mm inner diameter Closure: - Seal: - Manner of construction - UN/ADR Compliant (UN: 4G/Y18/S)

Material: HDPE Shape/size: cylindrical / approx. 89 mm diameter x 240 mm Opening: 41.8 mm inner diameter Closure: Thermal induction cap Seal: Ferrule Product code: FBR-1/ Product name: FBR-C Page 16 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Type Description Manner of construction Extrusion blow molding UN/ADR Compliant (UN: 1H1/Y1.8/130)

Material: HDPE Shape/size: cylindrical / approx. 88.5 mm diameter x 240 mm Opening: 42 mm inner diameter Closure: Ø56 HDPE cap Seal: Duplex disk Manner of construction - UN/ADR Compliant (UN: 1H1/Y1,3/150/XX E/02 B-737-11/AA3)

Material: HDPE Shape/size: cylindrical / approx. 88 mm diameter x 248 mm Opening: 41 mm inner diameter Closure: screw cap Seal: Screwed, no thermal sealing Manner of construction Extrusion blow molding UN/ADR Yes, N° J-304

Material: HDPE Shape/size: cylindrical / approx. 88.5 mm diameter x 240 mm Opening: 40 mm inner diameter Closure: Cap Seal: - Manner of construction blow UN/ADR Compliant (UN: 1H1/Y1,3/150/XX E/ B-1279/ALCION)

Material: HMW-HDPE Shape/size: cylindrical / 88 mm diameter x 248 mm Opening: 40 mm inner diameter Closure: screw cap with security seal Seal: security seal Manner of construction blown UN/ADR Yes, N° J-304

Material: HDPE Shape/size: cylindrical / approx. 88.5 mm diameter x 233 mm Opening: 54.4 mm inner diameter Product code: FBR-1/ Product name: FBR-C Page 17 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Type Description Closure: Ø63 HDPE cap Seal: Duplex disk Manner of construction - UN/ADR Compliant (UN: 1H1/Y1,3/150/XX E/02 B-781-11/AA3)

Table 4.1-6: Packaging information for 5 liter Jerry cans

Type Description Material: HDPE Shape/size: Top Handle Jerry Can rectangular / approx. 192 mm Length x 136 mm Width x 285 mm Height Opening: 52 mm inner diameter Closure: Tamper proof screw cap Seal: Molded-in sealing cap Manner of construction Extrusion UN/ADR Not applicable

Material: HDPE Shape/size: rectangular / approx. 187 mm Length x 132 mm Width x 288 mm Height Opening: 40 mm inner diameter Closure/seal: Thread with security strap Manner of construction Blow molding UN/ADR Compliant (UN: 3H1/Y1,3/150/XX E/02 J-499-11/AA3)

Material: HDPE Shape/size: rectangular / approx. 187 mm Length x 132 mm Width x 288 mm Height Opening: 50 mm inner diameter Closure: Threaded cap Seal: Threaded cap Manner of construction Injection and blown plastic UN/ADR No

Material: HDPE Shape/size: rectangular / approx. 192 mm Length x 136 mm Width x 285 mm Height Opening: 60 mm inner diameter Closure: - Seal: - Manner of construction - Product code: FBR-1/ Product name: FBR-C Page 18 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Type Description UN/ADR Compliant (UN: 3H1/Y1,3/150)

Material: HDPE Shape/size: Tank: 190 mm Length x 140 mm Width x 306 mm Height Opening: 54 mm inner diameter Closure: Screwed cap Seal: Seal Manner of construction Blow molding UN/ADR Compliant (UN: 3H1/Y1,8/150)

Material: HDPE Shape/size: rectangular / approx. 188 mm Length x 135 mm Width x 285 mm Height Opening: 42 mm inner diameter Closure: Ø56 HDPE cap Seal: Duplex disk Manner of construction - UN/ADR Compliant (UN: 3H1/Y1,3/150/XX E/02 J499-11/AA3)

Material: HDPE Shape/size: rectangular / approx. 187 mm Length x 132 mm Width x 288 mm Height Opening: 41 mm inner diameter Closure: screw cap Seal: Screwed, no thermal sealing Manner of construction Extrusion blow molding UN/ADR Yes, N° J-1157

Material: HDPE Shape/size: rectangular / approx. 187 mm Length x 132 mm Width x 288 mm Height Opening: 40 mm inner diameter Closure: PP cap Seal: Thread with security seal Manner of construction Blow UN/ADR Compliant (ADR n° J-1157 type X-1.2)

Material: HMW-HDPE Shape/size: rectangular 187 mm Length x 132 mm Width x 288 mm Height Opening: 40 mm inner diameter Closure: screw cap with security seal Product code: FBR-1/ Product name: FBR-C Page 19 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Type Description Seal: security seal Manner of construction blown UN/ADR Yes, N° J-1157

Material: HDPE Shape/size: rectangular / approx. 191 mm Length x 136 mm Width x 285 mm Height Opening: 54.4 mm inner diameter Closure: Ø63 HDPE cap Seal: Duplex disk Manner of construction - UN/ADR Compliant (UN: 3H1/Y1,3/150/XX E/02 J501-11/AA3)

Table 4.1-7: Packaging information for 10 liter Jerry cans

Type Description Material: HDPE Shape/size: Stackable Top Handle Jerry Can rectangular / approx. 230 mm Length x 192 mm Width x 310 mm Height Opening: 39 mm inner diameter Closure: Tamper proof screw cap Seal: Molded-in sealing cap Manner of construction Extrusion UN/ADR Not applicable

Material: HDPE Shape/size: rectangular / approx. 232 mm Length x 190 mm Width x 310 mm Height Opening: 50 mm inner diameter Closure: Tamper proof screw cap Seal: Molded-in sealing cap Manner of construction Extrusion UN/ADR Not applicable

Material: HDPE Shape/size: Tank: 238 mm Length x 195 mm Width x 300 mm Height Opening: 44.5 mm inner diameter Closure: Screwed cap Seal: Seal Manner of construction Blow type “BB 82” UN/ADR Compliant (UN: 3H1/Y1,5/120) Product code: FBR-1/ Product name: FBR-C Page 20 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Type Description

Material: HDPE Shape/size: rectangular / approx. 231 mm Length x 192 mm Width x 310 mm Height Opening: 40 mm inner diameter Closure: PP cap Seal: Thread with security seal Manner of construction Blow UN/ADR Compliant (ADR n° J-401 type Y-1.3)

Material: HMW-HDPE Shape/size: rectangular / approx. 231 mm Length x 192 mm Width x 310 mm Height Opening: 40 mm inner diameter Closure: Tamper-evident screw cap Seal: - Manner of construction Blow molded UN/ADR Compliant (ADR: J-401 Y-1.3)

Table 4.1-8: Packaging information for 20 liter Jerry cans

Type Description Material: HDPE Shape/size: Stackable Top Handle Jerry Can rectangular / approx. 290 mm Length x 240 mm Width x 387 mm Height Opening: 47 mm inner diameter Closure: Tamper proof screw cap Seal: Molded-in sealing cap Manner of construction Extrusion UN/ADR Not applicable

Material: HDPE Shape/size: rectangular / approx. 295 mm Length x 245 mm Width x 387 mm Height Opening: 50 mm inner diameter Closure: Threaded cap Seal: Threaded cap Manner of construction Injection and blown plastic UN/ADR No

Material: HDPE Shape/size: Tank: 300 mm Length x 250 mm Width x 390 mm Height Product code: FBR-1/ Product name: FBR-C Page 21 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Type Description Opening: 44.5 mm inner diameter Closure: Cap HDPE Seal: Seal Manner of construction Blow type “BB 82” UN/ADR Compliant (UN: 3H1/Y1,75/120)

Material: HDPE Shape/size: rectangular / approx. 285 mm Length x 240 mm Width x 387.5 mm Height Opening: 47 mm inner diameter Closure: K 60 HDPE cap Seal: Ring foamed PE Manner of construction - UN/ADR Compliant (UN: 3H1/Y1,9/180/XX E/02-J-506-11/AA-3)

Material: HDPE Shape/size: rectangular / approx. 295 mm Length x 245 mm Width x 387 mm Height Opening: 50 mm inner diameter Closure: screw cap Seal: Screwed, no thermal sealing Manner of construction Extrusion blow molding UN/ADR Yes, N° J-1029

Material: HDPE Shape/size: rectangular / approx. 295 mm Length x 245 mm Width x 387 mm Height Opening: 61 mm inner diameter Closure: PP cap Seal: Thread with security seal Manner of construction Blow UN/ADR Compliant (ADR n° J-1029 type X-1.2)

Product code: FBR-1/ Product name: FBR-C Page 22 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Table 4.1-9: Packaging information for 25 liter Jerry cans

Type Description Material: HDPE Shape/size: rectangular / approx. 295 mm Length x 245 mm Width x 455 mm Height Opening: 60 mm inner diameter Closure/seal: Thread with security strap Manner of construction Blow molding UN/ADR Compliant (UN: 3H1/X1,5-Y1,9/250/XX E/02 J-431-11/AA3)

Table 4.1-10: Packaging information for 200 liter containers

Type Description Material: HDPE Shape/size: Cylindrical drum: 585 mm diameter x 930 mm Opening: 51 mm inner diameter OR 57 mm inner diameter Closure: 2 x screw plugs with tamper proof tear-off caps covering the plugs Seal: O-ring sealing plug Manner of construction Extrusion UN/ADR Not applicable

Material: HDPE Shape/size: Cylindrical drum: 581 mm diameter x 945 mm Opening: 56 mm (female thread S56x4) Closure: screwed Seal: No seal Manner of construction - UN/ADR Compliant (UN: 1H1)

Table 4.1-11: Packaging information for 220 liter containers

Material: HDPE Shape/size: Cylindrical drum: 581 mm diameter x 940 mm Opening: 55 mm inner diameter Closure: Sheet metal Seal: Sheet metal Manner of construction Blown plastic UN/ADR No

Material: HDPE Shape/size: Cylindrical drum: 581 mm diameter x 935 mm Product code: FBR-1/ Product name: FBR-C Page 23 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Opening: 52.5 mm Closure: cap Seal: gasket PE HD HMW Manner of construction Extrusion blow molding UN/ADR Compliant (UN: 1H1/Y1,9/200)

Material: HDPE Shape/size: Cylindrical drum: 581 mm diameter x 940 mm Opening: 52.5 mm Closure: 2” BCS56x4 bung Seal: gasket PE Manner of construction - UN/ADR Compliant (UN: 1H1/Y1,5/200/XX E/B 332/AA3)

Table 4.1-12: Packaging information for 1000 liter containers

Type Description Material: HDPE Shape/size: Composite IBC (Intermediate Bulk Container) with plastics inner receptacle and a steel outer packaging rectangular / approx. 1200 mm Length x 1000 mm Width x 1160 mm Height Opening: 142 mm inner diameter (top opening) 46 mm inner diameter (bottom opening) Closure: Screw caps with plastic security pull-up seals Seal: O-ring and molded-in sealing caps Manner of construction Extrusion UN/ADR Not applicable

Material: HDPE Shape/size: IBC (Intermediate Bulk Container): approx. 1200 mm Length x 1000 mm Width x 1160 mm Height Opening: 140 mm inner diameter Closure: Threaded cap Seal: Threaded cap Manner of construction Blown plastic UN/ADR No

Material: HMW HDPE Shape/size: GIR: 1200 mm Length x 1000 mm Width x 1165 mm Height Opening: 150 mm Closure: cap Product code: FBR-1/ Product name: FBR-C Page 24 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Type Description Seal: Seal SBR Manner of construction Extrusion blow molding UN/ADR Compliant (UN: 31 HA1/Y/D)

Material: HDPE tank - Metallic cage - Metal/plastic/wood base Shape/size: Cubic shape: 1200 mm Length x 1000 mm Width x 1180 mm Height Opening: Top opening: 140 mm inner diameter (filling) Lower opening: 38.1 mm inner diameter (emptying) Closure: screwed cap, both top and bottom Seal: top: plastic tag fastener seal bottom: thermal seal Manner of construction Extrusion blow molding UN/ADR Compliant (n° varies)

Material: HDPE Shape/size: rectangular / approx. 1200 mm Length x 1000 mm Width x 1160 mm Height (with pallet) Opening: Filling opening: 150 mm Fork opening: 95 mm Closure: HDPE DN150 screw cap Seal: TPE O-ring gasket Manner of construction Blow molded UN/ADR Compliant (UN: 31 HA1) Product code: FBR-1/ Product name: FBR-C Page 25 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Appendix 1 Lists of data considered in support of the evaluation

List of data submitted by the applicant and relied on

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 2.1 Simona Nichetti 2016 Potassium phosphonate liquid and crystal: Determination of the colour, odour and physical state N Fitosanitarios ChemService S.r.l., Report No. CH-728/2015 Bajo Riesgo GLP AIE Unpublished 3322616 KCP 2.2 Antonella Mazzei 2016 Explosive properties and oxidizing properties on the sample Potassium Phosphonate Liquid N Fitosanitarios Innovhub, Report No. 201504699 Bajo Riesgo GLP AIE Unpublished 3322617 KCP 2.3 Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the flash point N Fitosanitarios ChemService S.r.l., Report No. CH-736/2015 Bajo Riesgo GLP AIE Unpublished 3322618 KCP 2.3 Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the auto ignition temperature N Fitosanitarios ChemService S.r.l., Report No. CH-735/2015 Bajo Riesgo GLP AIE Unpublished 3322619 KCP 2.4 Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the accelerated storage stability and corrosion N Fitosanitarios characteristics Bajo Riesgo ChemService S.r.l., Report No. CH-741/2015 AIE GLP Unpublished Product code: FBR-1/ Product name: FBR-C Page 26 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

3322610 KCP 2.5 Simona Nichetti 2016 Potassium phosphonate liquid: Determination of viscosity N Fitosanitarios ChemService S.r.l., Report No. CH-733/2015 Bajo Riesgo GLP AIE Unpublished 3322611 KCP 2.5 Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the surface tension N Fitosanitarios ChemService S.r.l., Report No. CH-732/2015 Bajo Riesgo GLP AIE Unpublished 3327078 KCP 2.6 Simona Nichetti 2015 Potassium phosphonate liquid: Determination of the relative density N Fitosanitarios ChemService S.r.l., Report No. CH-729/2015 Bajo Riesgo GLP AIE Unpublished 3322613 KCP 2.7 Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the accelerated storage stability and corrosion N Fitosanitarios characteristics Bajo Riesgo ChemService S.r.l., Report No. CH-741/2015 AIE GLP Unpublished 3324195 KCP 2.7 Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the low temperature stability N Fitosanitarios ChemService S.r.l., Report No. CH-734/2015 Bajo Riesgo GLP AIE Unpublished 3322614 KCP 2.7 Simona Nichetti 2016 Study plan: Potassium phosphonate liquid: Two year storage stability and corrosion characteristics N Fitosanitarios ChemService S.r.l., Study plan No. CH-742/2015 Bajo Riesgo Product code: FBR-1/ Product name: FBR-C Page 27 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

GLP AIE Unpublished 3322615 KCP 2.7 Simona Nichetti 2018 Potassium phosphonate liquid: Two years storage stability and corrosion characteristics N Fitosanitarios ChemService S.r.l., GLP Study No. CH-742/2015 Bajo Riesgo GLP AIE Unpublished 4051290 KCP Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the accelerated storage stability and corrosion N Fitosanitarios 2.8.2 characteristics Bajo Riesgo ChemService S.r.l., Report No. CH-741/2015 AIE GLP Unpublished 3324194 KCP Simona Nichetti 2016 Potassium phosphonate liquid: Determination of the accelerated storage stability and corrosion N Fitosanitarios 2.8.4 characteristics Bajo Riesgo ChemService S.r.l., Report No. CH-741/2015 AIE GLP Unpublished 3324193

List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review None.

List of data submitted by the applicant and not relied on None. Product code: FBR-1/ Product name: FBR-C Page 28 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

List of data relied on and not submitted by the applicant but necessary for evaluation None.

Product code: FBR-1/ Product name: FBR-C Page 29 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Appendix 2 Additional data on the physical, chemical and technical properties of the active substance

A 2.1 Potassium phosphonates

New studies, not evaluated in the EU peer review, on physical and chemical data on the active substance are submitted to demonstrate the access to a complete active substance dossier. A summary of the new data submitted are provided in the table below. They are considered as acceptable for data matching.

Test or Study Guideline Test material Findings Acceptability / GLP Reference & and method purity and comments Annex point specification Y/N Melting point, EC A1 Liquid: Batch No phenomena of crystallization not relevant for TK Y Nichetti freezing point method n°2015-10-07, were noted until -50°C (2016) or CIPAC MT1 containing However, the DSC Report No. solidification 31.6% phos- analysis (Report CH-730/2015 point phonates ions No. CH-731/2015) (IIA 2.1.1) and 17.8% showed an endo- potassium ion thermic transition at 212 °C which can be attributed to melting. Boiling point EC A2 Crystal: Batch No boiling point was observed acceptable Y Nichetti (IIA 2.1.2) method n°20161204, until 300°C. (2016) OECD 103 with a purity Report No. of 99.08% From the DSC analysis, conducted CH-731/2015 not in compliance with GLP regu- lations, it can be concluded that Potassium Phosphonate Crystal presents a decomposition phenom- enon occurred in the range from about 226°C – 350°C but no boiling transition was observed. Vapour EEC A.4, Crystal: Batch From the experimental data ob- acceptable Y Nichetti pressure and OECD 104 n°20161204, tained, it can be concluded that the (2016) volatility with a purity vapour pressure of Potassium Report No. (IIA 2.3.1) of 99.08% Phosphonate Crystal is lower than CH-739/2015 10-10 Pa in the range of temperature from about 40°C to about 85°C, the extrapolation at 20°C or 25°C would lead to an even lower value.

Physical state OPPTS Crystal: Batch The “Potassium Phosphonate acceptable Y Nichetti and colour 830.6302 n°20161204, Crystal” has the appearance of (2016) (IIA 2.4.1) 830.6303 with a purity white solid crystals. Report No. of 99.08% CH-728/2015 Odour OPPTS Crystal: Batch The “Potassium Phosphonate not relevant Y Nichetti (IIA 2.4.2) 830.6304 n°20161204, Crystal” has a characteristic odour. (2016) with a purity Report No. of 99.08% CH-728/2015 UV/VIS, IR, OECD No. Crystal: Batch IR spectrum: acceptable Y Nichetti NMR, MS 101 n°20161204, Wavelength (2016) Assignments spectra (a.s.) with a purity (cm-1) Report No. (IIA 2.5.1) of 99.08% O = P - O - H CH-740/2015 2688 stretching 2382 P - H stretching Product code: FBR-1/ Product name: FBR-C Page 30 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Test or Study Guideline Test material Findings Acceptability / GLP Reference & and method purity and comments Annex point specification Y/N

1216 - 1172 P = O stretching

1051 - 1007 P - O -H bending

UV/Vis Spectra: The UV/Vis Spectra of three potassium phosphonate solutions (in water, in HCl 1N and in NaOH 1N) were obtained. No molar absorption coefficient ε for the Potassium Phosphonate Crystal was obtained due to the absence of absorption of the molecule.

ICP-OES Spectra: The determination of the potassium and phosphorus was performed by the analysis with an Inductively Coupled Plasma equipped with an Optical Emission Spectroscopy detector.

NMR Spectra: 31P-NMR spectrum was recorded using a Bruker spectrometer with a probe temperature controlled at 315 K. One peak was found.

All spectroscopic characterisations were consistent with the structure of potassium phosphonates. Solubility in OECD 105 Crystal: Batch From the obtained experimental acceptable Y Nichetti water CIPAC MT n°20161204, data, it can be concluded that the (2016) (IIA 2.6) 157 with a purity water solubility of potassium Report No. of 99.08% phosphonate crystal sample is CH-737/2015 higher than 1 kg/L at room temperature (about 20°C). Solubility in EC A6 Crystal: Batch From the obtained experimental acceptable Y Nichetti organic method, n°20161204, data, it can be concluded that the (2016) solvents OECD 105 with a purity solubility of Potassium Phospho- Report No. (IIA 2.7) CIPAC MT of 99.08% nate Crystal sample in six organic CH-738/2015 181 solvents at 20°C is the following:

Methanol: 12.8 g/L

n-Heptane, toluene, dichloro- methane, acetone, ethyl acetate: all < 0.80 mg/L (< LOD) Auto- EC A15 Liquid: Batch no auto-ignition up to 590 °C acceptable Y Nichetti flammability n°2015-10-07, (not necessary for (2016) (IIA 2.11.2) containing this aqueous TK) Report No. 31.6% phos- CH-735/2015 phonates ions and 17.8% potassium ion Flash point EC A9 Liquid: Batch not flammable acceptable Y Nichetti (IIA 2.12) n°2015-10-07, (not necessary for (2016) containing this aqueous TK) Report No. 31.6% phos- CH-736/2015 phonates ions and 17.8% potassium ion Product code: FBR-1/ Product name: FBR-C Page 31 /31 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2020

Test or Study Guideline Test material Findings Acceptability / GLP Reference & and method purity and comments Annex point specification Y/N Explosive EC A14 Liquid: Batch not explosive acceptable Y Mazzei (2016) properties n°2015-10-07, (not necessary for Report No. (IIA 2.13) containing this aqueous TK) 201504699 31.6% phosphonates ions and 17.8% potassium ion Surface EC A5 Liquid: Batch 69.8 mN/m (undiluted) acceptable Y Nichetti tension n°2015-10-07, 69.7 mN/m (2016) (IIA 2.14) containing (0.03 % v/v aqueous solution) Report No. 31.6% phos- 67.5 mN/m CH-732/2015 phonates ions (2 % v/v aqueous solution) and 17.8% all 20 °C potassium ion Oxidising EC A21 Liquid: Batch not oxidising acceptable Y Mazzei (2016) properties n°2015-10-07, (not necessary for Report No. (IIA 2.15) containing this aqueous TK) 201504699 31.6% phosphonates ions and 17.8% potassium ion

Appendix 3: Experimental testing of the product's physico-chemical and technical characteristics: The following physical, chemical and technical properties of the plant protection product were experi- mentally tested: density, colour, pH, surface tension, storage stability at high temperatures (14 d at 54 °C), low temperature stability (7 d at 0 °C), persistent foaming. No significant deviations from the data submitted by the applicant were detected. The formulation complies with the chemical, physical and technical criteria which are stated for this type of formulation in the FAO/WHO manual (2016).

DRAFT REGISTRATION REPORT Part B Section 3 Efficacy Data and Information Concise summary

Product code: FBR-1 Product name(s): FBR-C Chemical active substance: Potassium phosphonates 726 g/L

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: Fitosanitarios Bajo Riesgo AIE Submission date: 31/05/2016 MS Finalisation date: 2309/0703/08/2020 FBR-1 / FBR-C Page 2 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Version history

When What

06.10.2017 Adding of the new efficacy trials (2016 campaign) 12.07.2019 New trials requested by BVL 02.10.2019 DE evaluation of dRR with additional information, green boxes have been added at the end of each chapter, additional information has been considered in the green boxes, highlighting of additional information in dRR has been removed 2309.0703.08.2020 Final RR of DE, comments received from applicant and cMSs concerning the DE evaluation have been considered and the green boxes have been amended accordingly

FBR-1 / FBR-C Page 3 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Table of Contents

3 Efficacy Data and Information (including Value Data) on the Plant Protection Product (KCP 6) ...... 4 3.1 Summary and conclusions of zRMS on Section 3: Efficacy (KCP 6) ...... 4 3.2 Efficacy data (KCP 6) ...... 107 3.2.1 Preliminary tests (KCP 6.1) ...... 129 3.2.2 Minimum effective dose tests (KCP 6.2) ...... 1310 3.2.3 Efficacy tests (KCP 6.2) ...... 1814 3.2.3.1 Efficacy trials performed on grapevine against downy mildew ...... 1814 3.2.3.2 Conclusions of the efficacy trials performed on grapevine against downy mildew ...... 3733 3.3 Information on the occurrence or possible occurrence of the development of resistance (KCP 6.3) ...... 3834 3.4 Adverse effects on treated crops (KCP 6.4) ...... 3934 3.4.1 Phytotoxicity to host crop (KCP 6.4.1) ...... 3935 3.4.2 Effect on the yield of treated plants or plant product (KCP 6.4.2) ...... 4035 3.4.3 Effects on the quality of plants or plant products (KCP 6.4.3) ...... 4035 3.4.4 Effects on transformation processes (KCP 6.4.4) ...... 4035 3.4.5 Impact on treated plants or plant products to be used for propagation (KCP 6.4.5) ...... 4136 3.5 Observations on other undesirable or unintended side-effects (KCP 6.5) 4136 3.5.1 Impact on succeeding crops (KCP 6.5.1) ...... 4136 3.5.2 Impact on other plants including adjacent crops (KCP 6.5.2) ...... 4136 3.5.3 Effects on beneficial and other non-target organisms (KCP 6.5.3) ...... 4136 3.6 Other/special studies ...... 4336 3.7 List of test facilities including the corresponding certificates ...... 4336

Appendix 1 Lists of data considered in support of the evaluation ...... 4437

FBR-1 / FBR-C Page 4 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

3 Efficacy Data and Information (including Value Data) on the Plant Protection Product (KCP 6)

Transformation of the dRR (applicant version) into the RR (zRMS version)

The process chosen by the zRMS to transform the dRR into a RR should be explained. Options are to rewrite the document (with track change or not) or to use commenting boxes such as the following:

Comments of zRMS: The commenting boxes are filled-in by the zRMS. They are usually placed at the end of each chapter. Commenting boxes should be understandable alone and refer very precisely to the text commented. The main advantage of their use is to distin- guish easily between the applicant and the zRMS text.

3.1 Summary and conclusions of zRMS on Section 3: Efficacy (KCP 6)

Abstract zRMS to provide main conclusions on each use. Indicate whether the overall assessment was performed according to the uniform principles. Overall summaries are not necessary here, as they will be provided at the end of each chapter of the dRR. The text of the abstract should complete the table below, by briefly explaining the reasons of the conclusions proposed (data missing, restrictions proposed, warnings...). For uses for which the proposed conclusion is “acceptable”, the text can be “zRMS considers that the data provided support the following uses: ...

The following data and information were mainly provided by the applicant submitted as dRR and BAD.

Additional comments and the final evaluation by the zRMS in this Registration Report are marked by green boxes.

Germany is the only involved European Member state in this registration process. No other European countries are named as cMS for registration.

Abstract

This document summarizes the information related to the efficacy of the new plant protection product FBR-1, a soluble concentrate product containing 726 g/l of Potassium phosphonates against Downy mildew (Plasmapora viticola) on grapevine.

No preliminary tests were performed, but the active substance included in the intended product is well-known and sufficient data are available.

Also, no minimum effective dose tests were performed. However, new efficacy trials have been started in 2019 (3 in the Maritime EPPO zone and 3 in the South-East EPPO zone) in order to complete the efficacy data package and the modality with a lower dose of FBR-1 has been added too, for the confirmation of the minimum effective dose. The final results are not yet FBR-1 / FBR-C Page 5 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016 available. Interim results show also a good control of the target organism with the lower dose.

Overall 16 valid efficacy trials are available at this time. For 6 additional trials interim results are available. 6 valid trials exists for maritime Eppo climatic zone, 4 valid trials for south-eastern zone and 6 for Mediterranean zone. Exclusive the ongoing trials, a sufficient number of valid trials is available for maritime and mediterranean EPPO zone. When the pathogen pressure is very high, treatments with FBR-1 used in program allow a better efficacy on grapevine compared to consecutives applications of FBR-1.

Efficacy could be considered as sufficient and was comparable to reference products.

FBR-1 / FBR-C Page 6 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Table 3.1-1: Acceptability of intended uses (and respective fall-back GAPs, if applicable)

1 2 3 4 5 6 7 8 9 10 11 12 13 14 Use- Member Crop and/ F, Pests or Group of pests Application Application rate PHI Remarks: No. (e) state(s) or situation Fn, controlled (days) Fpn Method / Timing / Max. Min. inter- L product / ha kg as/ha Water L/ha e.g. g safener/synergist per ha (crop destination / G, (additionally: developmen- Kind Growth number val between a) max. rate (f) purpose of crop) Gn, tal stages of the pest or stage of a) per use applications per appl. a) max. rate min / max Gpn pest group) crop & b) per crop/ (days) b) max. total per appl. or season season rate per b) max. I crop/season total rate per crop/season

Zonal uses (field or outdoor uses, certain types of protected crops) 1 Hungary Grapevine (VITVI) F Mildew (PLASVI) Foliar From 6 10 a) 4 a) 2.904 200-1000 14 6 consecutive applications from Vitis vinifera Plasmopara viticola spray BBCH 15 b) 24 b) 17.424 BBCH 15, follow by treatments with to BBCH products used traditionally at the end 89 of a program against mildew 2 Hungary Grapevine (VITVI) F Mildew (PLASVI) Foliar From 5 20 a) 4 a) 2.904 200-1000 14 Program consists in alternation Vitis vinifera Plasmopara viticola spray BBCH 15 b) 20 b) 14.520 between the product FBR-1 and other to BBCH products used traditionally in pro- 89 gram against mildew 3 Germany Grapevine (VITVI) F Mildew (PLASVI) Foliar From 6 10 a) a) 1st: 400 14 6 consecutive applications from Vitis vinifera Plasmopara viticola spray BBCH 15 1st: 1 1st: 0.726 2nd: 800 BBCH 15, follow by treatments with to BBCH 2nd: 2 2nd: 1.452 3rd: 1200 products used traditionally at the end 89 3rd: 3 3rd: 2.178 4th: 1600 of a program against mildew 4th: 4 4th: 2.904 5th: 1600 5th: 4 5th: 2.904 6th: 1600 6th: 4 6th: 2.904

b)18 b)13.068 4 Germany Grapevine (VITVI) F Mildew (PLASVI) Foliar From 5 20 a) a) 1st: 400 14 Program consists in alternation Vitis vinifera Plasmopara viticola spray BBCH 15 1st: 1 1st: 0.726 2nd: 800 between the product FBR-1 and other to BBCH 2nd: 2 2nd: 1.452 3rd: 1200 products used traditionally in pro- 89 3rd: 3 3rd: 2.178 4th: 1600 gram against mildew 4th: 4 4th: 2.904 5th: 1600 5th: 4 5th: 2.904

b)14 b)10.164 * Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1. ** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional FBR-1 / FBR-C Page 7 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

and non-professional greenhouse use, I: indoor application

Column 15: zRMS conclusion. A Acceptable R Acceptable with further restriction C To be confirmed by cMS N Not acceptable / evaluation not possible n.r. Not relevant for section 3

Reg.-No. 008632-00/00 GAP rev.1, date: 2018-03-28 PPP (product name/code): FBR-C Formulation type: SL (a, b) Active substance 1: Kaliumphosphonat (Kaliumphosphit) Conc. of as 1: 726.00 g/L (c) Active substance 2: Conc. of as 2: 0 (c) Active substance 3: Conc. of as 3: 0 (c) Active substance 4: Conc. of as 4: 0 (c) Active substance 5: Conc. of as 5: 0 (c) Applicant: Fitosanitarios Bajo Riesgo AIE Professional use: Yes Zone(s): central/interzonal (d) Non professional use: No Verified by MS: Yes Field of use: Fungicide

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Use- Member Crop and/ F, Pests or Group of Application Application rate PHI Remarks: Conclusion No. state(s) or situation Fn, pests controlled (days) (efficacy) (e) Fpn Method / Timing / Max. Min. interval kg or L prod- g or kg as/ha Water e.g. g safen- (crop destina- G, (additionally: develop- Kind Growth number between uct / ha L/ha er/synergist per tion / purpose Gn, mental stages of the stage of a) per applications a) max. rate a) max. rate ha of crop) Gpn pest or pest group) crop & use (days) per appl. per appl. min / max (f) or season b) per b) max. total b) max. total I crop/ rate per rate per season crop/season crop/season 001 DE grape vine F downy mildew of grape- spraying In case of a) 6 10 to 14 a) basic ap- a) 0.726 basic - A (VITVI) vine (Plasmopara vitico- or fine danger of b) 6 days plication rate: kg/ha application Notes on dose use as table la) (PLASVI) spraying infection 1 L/ha rate: - rate: maximum and wine grape (low vol- and/or /400 application rate ume after L/ha 18 L/ha spraying) warning service appeal 15 to 89 a) BBCH 61: 1.452 kg/ha BBCH 61: - 2 L/ha -/800 L/ha a) BBCH 71: 2.178 kg/ha BBCH 71: - 3 L/ha -/1200 L/ha FBR-1 / FBR-C Page 8 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

a) BBCH 75: 2.904 kg/ha BBCH 75: - 4 L/ha -/1600 L/ha 002 DE grape vine F downy mildew of grape- spraying In case of a) 5 20 to 28 a) basic ap- a) 0.726 basic - A (VITVI) vine (Plasmopara vitico- or fine danger of b) 6 days plication rate: kg/ha application Notes on dose use as table la) (PLASVI) spraying infection 1 L/ha rate: - rate: maximum and wine grape (low vol- and/or /400 application rate ume after L/ha 18 L/ha spraying) warning service appeal 15 to 89 a) BBCH 61: 1.452 kg/ha BBCH 61: - 2 L/ha -/800 L/ha a) BBCH 71: 2.178 kg/ha BBCH 71: - 3 L/ha -/1200 L/ha a) BBCH 75: 2.904 kg/ha BBCH 75: - 4 L/ha -/1600 L/ha

Remarks (a) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (d) Select relevant table (b) Catalogue of pesticide formulation types and international coding system Crop (e) Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be heading: Life International Technical Monograph n°2, 6th Edition Revised May 2008 given in column 1 (c) g/kg or g/l (f) No authorization possible for uses where the line is highlighted in grey, Use should be crossed out when the notifier no longer supports this use.

Remarks 1 Numeration necessary to allow references 8 The maximum number of application possible under practical conditions of use must be pro- columns: vided. 2 Use official codes/nomenclatures of EU Member States 9 Minimum interval (in days) between applications of the same product 3 For crops, the EU and Codex classifications (both) should be used; when rele- 10 For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of vant, the use situation should be described (e.g. fumigation of a structure) empty rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products. 4 F: professional field use, Fn: non-professional field use, Fpn: professional and 11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usu- non-professional field use, G: professional greenhouse use, Gn: non- ally g, kg or L product / ha). professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application 5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when 12 If water volume range depends on application equipment (e.g. ULVA or LVA) it should be relevant, the common names of the pest groups (e.g. biting and sucking in- mentioned under “application: method/kind”. sects, soil born insects, foliar fungi, weeds) and the developmental stages of 13 PHI - minimum pre-harvest interval the pests and pest groups at the moment of application must be named. 14 Remarks may include: Extent of use/economic importance/restrictions 6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, 15 A: Acceptable drench R: Acceptable with further restriction Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between C: To be confirmed by cMS the plants - type of equipment used must be indicated. N: Not acceptable / evaluation not possible FBR-1 / FBR-C Page 9 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of n.r.: Not relevant for section 3 Plants, 1997, Blackwell, ISBN 38263-3152-4), including where relevant, information on season at time of application

FBR-1 / FBR-C Page 10 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

3.2 Efficacy data (KCP 6)

Introduction This document summarizes the information related to the efficacy of the new plant protection product FBR-1, a soluble concentrate product containing 726 g/l of Potassium phosphonates. This active substance was included in the Annex to Commission Implementing Regulation (EU) No 540/2011 amended by the Commission Implementing Regulation (EU) No 369/2013 of 22 April 2013.

The purpose of this dossier is to provide the efficacy data to support the registration of this new product FBR-1 according to the intended uses (please refer to the Table 3.1-1).

Germany is the zRMS of this registration dossier. Hungary is cMS.

Description of active substances FBR-1 contains a new active substance: 726 g/l of Potassium phosphonates.

Mode of action (DAR of Potassium phosphonates – B.3.1.5 – IIA 3.4) The mode of action of phosphite based compounds has remained unclear for several years, however, two ways of action were identified:  Direct inhibition of pathogens such as downy mildew  Indirect action through enhancement of the plant natural defence system (Guest et al., 1991)

The first commercial product presenting an anti-oomycete activity through induction of plant defence mechanisms was fosetyl-Al, however, the product displayed little direct antifungal activity (Coffet et. al., 1988). Some years later, it was established that fosetyl-Al degraded in plant to form phosphorous / phosphonic acids showing the fungicidal activity.

Direct antifungal activity: 2- Fenn et. al. (1984) established the activity of the anion phosphite HPO3 through in vitro studies with a direct inhibition of mycelial growth of some Phytophthora species during application with phosphorous acid aqueous solution. The direct mode of action was proved by Fenn et. al. (1985) using tomato leaflets inoculated by Phytophthora capsici. Other authors went to the same conclusions like Dolan et. al. (1988), Fenn et. al. (1989) and Ouimette et. al. (1989).

Indirect mode of action: Numerous studies were undertaken to prove the induction of enhancement of plant defence mechanisms by phosphonate / phosphite; for instance, the levels of phosphite detected in organs of certain protected plants (tobacco, cowpeas) were well below the levels required for in vitro inhibition of the pathogen. Fol- lowing authors contributed to these studies: Guest et. al. (1991) and Saindrenan et. al. (1988). Some searchers concluded that phosphite treatments enhanced the rate and magnitude of phytoalexins accumulation in the necrotic cells of the lesions (Saindrenan et. al., 1988).

Table 3.2-1: Details of the active substances

Active substance Potassium phosphonates

Concentration 726 g/L (Unit: g/kg or g/L...) FBR-1 / FBR-C Page 11 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Active substance Potassium phosphonates

Chemical group Phosphonate (FRAC, 2016) Mode of action Unknown (FRAC, 2016) Biological action Fungicide

Description of the plant protection product FBR-1 is a soluble concentrate product containing 726 g/l of Potassium phosphonates.

Table 3.2-2: Simplified table of currently registered uses and requested uses for the product code.

Uses Comments / Other Member Currently registered Requested relevant details on State rate(s) rate(s) Crop(s) Target(s) GAPs

Grapevine Downy DE, HU - 4 l/ha - Mildew Further details are in the table “All intended uses” in Part B - Section 0.

Description of the target pests

Table 3.2-3: Glossary of pests mentioned in the dossier.

EPPO code Scientific name Common name

PLASVI Plasmopara viticola Downy mildew of grap

Downy mildew (Plasmapora viticola) is one of the endemic cryptogrammic oomycete of Europe and the most common cause of economic losses in vineyard industry worldwide. Downy mildew attacks and affect almost all of the grapevine (Vitis vinifera) organs which cause not only a productivity loss but also alter both taste and texture of fruits. Given the climatic conditions of southern Europe, it occurs yearly without exception, forcing heavy treatments during the grapevine growth cycles and the fruit development. Without treatment and in the presence of favourable climate conditions, mildew can destroy up to 75 % of the grape harvest.

Table 3.2-4: Major / minor status of intended uses (for all cMS and zRMS).

Crop status Pest status Crop and/or situa- Pests or group of pests tion controlled Major minor Major minor

Grapevine DE, HU - Downy Mildew DE, HU -

Compliance with the Uniform Principles The overall, trials were performed according to the Uniform Principles with the same standards for all countries. FBR-1 / FBR-C Page 12 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Information on trials submitted (3.1 Efficacy data)

Table 3.2-5: Presentation of trials

Number of trials GEP, Comments Type (number of valid trials) non- (any other Crop(s) Target(s) Country Years of GEP, relevant trial Maritime South- Mediterranean official information) zone east zone zone

Grapevine Plasmopara France 2014 E - - 2 (2) GEP - viticola (1) Non- GEP (1) 2015 E - - 4 (4) GEP - (3) Non- GEP (1) 2016 E 1 (1) - - GEP On-going - Germany 2015 E 2 (0) - - GEP - 2016 E 5 (5) - - GEP On-going - 2019 E 3 - - GEP - Hungary 2015 E - 2 (0) - GEP - 2016 E - 5 (4) - GEP On-going - 2019 E - 3 - GEP - TOTAL - 2014- - 6 8 (6) 5 7 (4) 6 (6) - - 2017 +3 +3 ongoing ongoing

3.2.1 Preliminary tests (KCP 6.1)

No preliminary test was performed, due to the knowledge on the products containing Potassium phosphonates already registered in Europe since several years.

Furthermore, as the zRMS (BVL) explained it in the letter requested additional data/information (15.01.2019), this information is required when the active substance and associated formulations are not known in Europe and/or in the concerned countries. This is not the case of Potassium Phosphate and associated formulation which are known and authorized in Europe as well as in Germany. Indeed, in Ger- many 4 products are authorized: Alginure Bio Schutz (007839-00), Frutogard (007839-60), LBG-01F34 (027207-60) and Veriphos (027207-00). Furthermore, it can be noted that LBG-01F34 (027207-60) and Veriphos (027207-00) are products equivalent to FBR-1: same formulation type and same composition (SL - 100% of Potassium Phosphonate), same use, same number of application and dose. In this context, preliminary range finding test are not necessary as efficacy of Potassium Phosphate is already known in Europe and Germany.

FBR-1 / FBR-C Page 13 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Preliminary tests No preliminary tests were performed, but the active substance included in the intended product is well-known and sufficient data are available.

3.2.2 Minimum effective dose tests (KCP 6.2)

No minimum effective dose test was performed, due to the knowledge on the products containing Potas- sium phosphonates already registered in Europe since several years.

Furthermore, as the zRMS (BVL) explained it in the letter requested additional data/information (15.01.2019), this information is required when the active substance and associated formulations are not known in Europe and/or in the concerned countries. This is not the case of Potassium Phosphate and associated formulation which are known and authorized in Europe as well as in Germany. Indeed, in Ger- many 4 products are authorized: Alginure Bio Schutz (007839-00), Frutogard (007839-60), LBG-01F34 (027207-60) and Veriphos (027207-00). Furthermore, it can be noted that LBG-01F34 (027207-60) and Veriphos (027207-00) are products equivalent to FBR-1: same formulation type and same composition (SL - 100% of Potassium Phosphonate), same use, same number of application and dose. In this context, minimum effective dose test is not required as efficacy of Potassium Phosphate is already known in Eu- rope and Germany.

However, new efficacy trials have been started in 2019 (3 in the Maritime EPPO zone and 3 in the South- East EPPO zone) in order to complete the efficacy data package as requested by the zRMS (BVL), and the modality with a lower dose of FBR-1 has been added too, for the confirmation of the minimum effective dose.

Considering the application timing of the product FBR-1, the final reports will be available in October 2019. In this context, meantime, interim results are provided. The final reports will be provided as soon as all the final reports will be available.

Details about the trials modalities are summarized in the Table 3.2.2-1, and global results of the trials are presented in the Table 3.2.2-2 to Table 3.2.2-3.

Minimum effective dose tests

No minimum effective dose tests were performed, but the active substance included in the intended product is well-known and sufficient data are available.

However, new efficacy trials have been started in 2019 (3 in the Maritime EPPO zone and 3 in the South-East EPPO zone) in order to complete the efficacy data package and the modality with a lower dose of FBR-1 has been added too, for the confirmation of the minimum effective dose. The final results are not yet available. Interim results show also a good control of the target organism with the lower dose.

FBR-1 / FBR-C Page 14 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

FBR-1 / FBR-C Page 15 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Table 3.2.2-16: Details on the tested modalities Modalities Trial code FBR-1 – claimed dose FBR-1 – lower dose (EPPO zone) Untreated Reference In program In program FBR-1 Reference FBR-1 Reference OUT19-004- - ABCD ACEGI BDFHJ (Folpan ACEGI BDFHJ 931FE (Folpan 500 SC – (1 l/ha) 500 SC – 0.6-2.4 (0.6 l/ha) (Folpan 500 (Maritime) - 0.6-2.4 l/ha) (2 l/ha – l/ha) (1.25 l/ha – SC – 0.6-2.4 2019 EFGHIJ ES 61) ES 61) l/ha) (Cuprozin pro- (3 l/ha – (1.8 l/ha – gress 0.4-1.6 l/ha) ES71) ES71) (4 l/ha – (2.44 l/ha – ES 75) ES 75) OUT19-005- - ABCD ACEGI BDFHJ (Folpan ACEGI BDFHJ 931FE (Folpan 500 SC – (1 l/ha) 500 SC – 0.6-2.4 (0.6 l/ha) (Folpan 500 (Maritime) - 0.6-2.4 l/ha) (2 l/ha – l/ha) (1.25 l/ha – SC – 0.6-2.4 2019 EFGHIJ ES 61) ES 61) l/ha) (Cuprozin pro- (3 l/ha – (1.8 l/ha – gress 0.4-1.6 l/ha) ES71) ES71) (4 l/ha – (2.44 l/ha – ES 75) ES 75) OUT19-006- - ABCD ACEGI BDFHJ (Folpan ACEGI BDFHJ 931FE (Folpan 500 SC – (1 l/ha) 500 SC – 0.6-2.4 (0.6 l/ha) (Folpan 500 (Maritime) - 0.6-2.4 l/ha) (2 l/ha – l/ha) (1.25 l/ha – SC – 0.6-2.4 2019 EFGHIJ ES 61) ES 61) l/ha) (Cuprozin pro- (3 l/ha – (1.8 l/ha – gress 0.4-1.6 l/ha) ES71) ES71) (4 l/ha – (2.44 l/ha – ES 75) ES 75) OUT19-001- - ACEGI ACEGI BDFHJ ACEGI BDFHJ 931FE (Solofol 1.8 4 l/ha (Acrobat Plus 2 2.5 l/ha (Acrobat Plus (South-east) - kg/ha) kg/ha) 2 kg/ha) 2019 BDFHJ (Kocide 2000 WG 1.2 kg/ha) OUT19-002- - ACEGI ACEGI BDFHJ ACEGI BDFHJ 931FE (Solofol 1.8 4 l/ha (Acrobat Plus 2 2.5 l/ha (Acrobat Plus (South-east) - kg/ha) kg/ha) 2 kg/ha) 2019 BDFHJ (Kocide 2000 WG 1.2 kg/ha) OUT19-003- - ACEGI ACEGI BDFHJ ACEGI BDFHJ 931FE (Solofol 1.8 4 l/ha (Acrobat Plus 2 2.5 l/ha (Acrobat Plus (South-east) - kg/ha) kg/ha) 2 kg/ha) 2019 BDFHJ (Kocide 2000 WG 1.2 kg/ha)

FBR-1 / FBR-C Page 16 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Table 3.2.2-2: Summary of pest incidence and pest severity on leaves

FBR-1 FBR-1 Trial code Assessment Untreated in program Target Rating type Reference in program (EPPO zone) date control At the claimed At a lower dose dose OUT19-004- Plasmopara Pest incidence 13 DAC 12.3 a 0.0 b/100% 0.0 b/100% 0.0 b/100% 931FE viticola (%)/ Efficacy (Maritime) - Pest severity (%)/ 2019 13 DAC 0.8 a 0.0 b/100% 0.0 b/100% 0.0 b/100% Efficacy OUT19-005- Plasmopara Pest incidence 11 DAC 11.0 a 0.0 b/100% 0.0 b/100% 0.0 b/100% 931FE viticola (%)/ Efficacy (Maritime) - Pest severity (%)/ 2019 11 DAC 0.9 a 0.0 b/100% 0.0 b/100% 0.0 b/100% Efficacy OUT19-006- Plasmopara Pest incidence 10 DAC 0.0 a 0.0 a 0.0 a 0.0 a 931FE viticola (%)/ Efficacy (Maritime) - Pest severity (%)/ 2019 10 DAC 0.0 a 0.0 a 0.0 a 0.0 a Efficacy OUT19-001- Plasmopara Pest incidence 14 DAB 6.8 a 0.0b/100% 0.0b/100% 0.0b/100% 931FE viticola (%)/ Efficacy* (South-east) - Pest severity (%)/ 2019 14 DAB 0.6 a 0.0b/100% 0.0b/100% 0.0b/100% Efficacy OUT19-002- Plasmopara Pest incidence 14 DAB 11.8 a 0.5b/95.76% 0.0b/100% 0.0b/100% 931FE viticola (%)/ Efficacy* (South-east) - Pest severity (%)/ 2019 14 DAB 0.9 a 0.0b/100% 0.0b/100% 0.0b/100% Efficacy OUT19-003- Plasmopara Pest incidence 15 DAB 8.8 a 0.3b/96.59% 0.0b/100% 0.0b/100% 931FE viticola (%)/ Efficacy* (South-east) - Pest severity (%)/ 2019 15 DAB 0.4 a 0.0b/100% 0.0b/100% 0.0b/100% Efficacy *Efficacy (%) calculated according to Abbott’s formula FBR-1 / FBR-C Page 17 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Table 3.2.2-1: Summary of pest incidence and pest severity on bunches

FBR-1 FBR-1 Assessment Untreated in program Trial code Target Rating type Reference in program date control At the claimed At a lower dose dose OUT19-004- Plasmopara Pest incidence 13 DAC 0.0a 0.0a 0.0a 0.0a 931FE viticola (%)/ Efficacy (Maritime) - Pest severity (%)/ 2019 13 DAC 0.0a 0.0a 0.0a 0.0a Efficacy OUT19-005- Plasmopara Pest incidence 11 DAC 0.0a 0.0a 0.0a 0.0a 931FE viticola (%)/ Efficacy (Maritime) - Pest severity (%)/ 2019 11 DAC 0.0a 0.0a 0.0a 0.0a Efficacy OUT19-006- Plasmopara Pest incidence 10 DAC 17.5a 0.0b/100% 0.0b/100% 0.0b/100% 931FE viticola (%)/ Efficacy (Maritime) - Pest severity (%)/ 2019 10 DAC 0.5a 0.0b/100% 0.0b/100% 0.0b/100% Efficacy OUT19-001- Plasmopara Pest incidence 14 DAB 0.0a 0.0a 0.0a 0.0a 931FE viticola (%)/ Efficacy (South-East) - Pest severity (%)/ 2019 14 DAB 0.0a 0.0a 0.0a 0.0a Efficacy OUT19-002- Plasmopara Pest incidence 14 DAB 0.0a 0.0a 0.0a 0.0a 931FE viticola (%)/ Efficacy (South-East) - Pest severity (%)/ 2019 14 DAB 0.0a 0.0a 0.0a 0.0a Efficacy OUT19-003- Plasmopara Pest incidence 15 DAB - - - - 931FE viticola (%)/ Efficacy (South-East) - Pest severity (%)/ 2019 15 DAB 0.0a 0.0a 0.0a 0.0a Efficacy

FBR-1 / FBR-C Page 18 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

3.2.3 Efficacy tests (KCP 6.2)

3.2.3.1 Efficacy trials performed on grapevine against downy mildew

A total of 4 trials were carried out in 2015 in Germany (2) and in Hungary (2), to evaluate the efficacy of FBR-1 against downy mildew (Plasmopara viticola) on grapevine. However, due to the extreme weather conditions, the Plasmopara viticola contamination did not occurred on grapevine (leaves and bunches). Therefore, no results can be presented. In this context, 10 trials (5 in Germany and 5 in Hungary) were started in 2016. The results and corresponding final reports will be provided as soon as available.

Meantime, the trials performed in France to sustain the dossier in the southern zone (zRMS France) are provided and are presented in this dossier. A total of 6 efficacy trials were carried out, under GEP (4) and non-GEP (2) conditions, to evaluate the efficacy of FBR-1 against downy mildew (Plasmopara viticola) on grapevine. These trials were conducted in 2014 and in 2015 in France. During these trials, 6 to 10 applications of FBR-1 were tested at the dose of 4 l/ha, alone or including in a program.

Furthermore, 11 trials (5 in Germany, 1 in France and 5 in Hungary) were carried out in 2016. However, for 1 trial performed in Hungary (EURV02-12F), due to the extreme weather conditions, the Plasmopara viticola contamination did not occurred on grapevine (leaves and bunches), therefore, no results can be presented for this trial.

In addition, 6 trials (3 in Germany and 3 in Bulgaria) where carried out in 2019. However, considering the application timing of the product FBR-1, the final reports will be available in October 2019. In this context, meantime, interim results are provided. The final reports will be provided as soon as all the final reports will be available.

Details about the trials program are summarized in the Table 3.2-7. More details about the trials method- ology and global results of the trials are presented in the BAD dossier. FBR-1 / FBR-C Page 19 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Table 3.2-7: Details on the tested modalities – French trials Modalities FBR-1 – 4 l/ha Blank program Trial code In program In mixture (EPPO zone) Untreated Reference Alone With Folpan FBR-1 Reference 1.25 kg/ha dn14-36-Eur-M- - ABCDEF ABCDEF ACE BDF ABCDEF BDF VdM3 (Mikal Flash 4 kg/ha) (Folpan 1.9 kg/ha) (Folpan 1.9 kg/ha) (Mediterranean) Vigne-Fr-01 - ABCDEFGHI ABCDEFGHI ACEG BDFHI ABCDEFGHI BDFHI (Mediterranean) (Mikal Flash 4 kg/ha) (Folpan 1.9 kg/ha) (Folpan 1.9 kg/ha) Vigne-Fr-02 - ABCDEFGHI ABCDEFGHI ACEG BDFHI ABCDEFGHI BDFHI (Mediterranean) (Mikal Flash 4 kg/ha) (Folpan 1.9 kg/ha) (Folpan 1.9 kg/ha) 15-00560-02 - ABCDEFGHIJ ABCDEFGHIJ ACEGI BDFHJ - ABCDEFGHIJ (Mediterranean) (Mikal Flash 4 kg/ha) (Foltane FL 3 l/ha) (Foltane FL 3 l/ha) 15-00560-03 - ABCDEFGHIJ ABCDEFGHIJ ACEGI BDFHJ - BCDEFGHIJ (Mediterranean) (Mikal Flash 4 kg/ha) (Foltane FL 3 l/ha) (Foltane FL 3 l/ha) 15-00560-04 - ABCDEFGH ABCDEFGH ACEG BDFH - BCDEFGH (Mediterranean) (Mikal Flash 4 kg/ha) (Foltane FL 3 l/ha) (Foltane FL 3 l/ha) 16-00676-03 - ABCDEFGH ABCDEFGH ACEG BDFH - - (Maritime) (Mikal Flash 4 kg/ha) (Mikal Flash 4 kg/ha) EUR16V02-07F - A ABCDEF ACEG BDF - - (Maritime) (Cuprozin Progress 100 (1 l/ha) (1 l/ha) (Folpan 80 WG 100 l/ha) (2 l/ha – ES 61) (2 l/ha – g/hl) BCDEF (3 l/ha – ES71) ES 61) (Folpan 80 WG 100 (4 l/ha – ES 75) (3 l/ha – g/hl) ES71) (4 l/ha – ES 75) EUR16V02-08F - A ABCDEF* ACEGI BDFH - - (Maritime) (Cuprozin Progress 100 (1 l/ha) (1 l/ha) (Folpan 80 WG 100 l/ha) (2 l/ha – ES 61) (2 l/ha – g/hl) BCDEFGHI (3 l/ha – ES71) ES 61) (Folpan 80 WG 100 (4 l/ha – ES 75) (3 l/ha – g/hl) ES71) (4 l/ha – ES 75) FBR-1 / FBR-C Page 20 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Modalities FBR-1 – 4 l/ha Blank program Trial code In program In mixture (EPPO zone) Untreated Reference Alone With Folpan FBR-1 Reference 1.25 kg/ha EUR16V02-09F - A ABCDEF* ACEGI BDFH - - (Maritime) (Cuprozin Progress 100 (1 l/ha) (1 l/ha) (Folpan 80 WG 100 l/ha) (2 l/ha – ES 61) (2 l/ha – g/hl) BCDEFGHI (3 l/ha – ES71) ES 61) (Folpan 80 WG 100 (4 l/ha – ES 75) (3 l/ha – g/hl) ES71) (4 l/ha – ES 75) 16-00711-01 - Folpan 80 WDG ABCDEFGHI ACEGI B - - (Maritime) 0,8 kg/ha A (1 l/ha) (1 l/ha) (Folpan 80 WG 1 1 kg/ha B (2 l/ha – ES 61) (2 l/ha – kg/ha) Mildicut 2,5 l/ha C (3 l/ha – ES71) ES 61) D Forum Gold (4 l/ha – ES 75) (3 l/ha – (Forum Gold 1,46 kg/ha D ES71) 1.46kg/ha) 1,7 kg/ha E (4 l/ha – Mildicut 4,0 l/ha FG ES 75) Forum Gold 1,92 kg/ha H Folpan 80 WDG 1.6 kg/ha I 16-00711-02 - Folpan 80 WDG ABCDEFGHI ACEGI B - - (Maritime) 0,8 kg/ha A (1 l/ha) (1 l/ha) (Folpan 80 WG 1 1 kg/ha B (2 l/ha – ES 61) (2 l/ha – kg/ha) Mildicut 2,5 l/ha C (3 l/ha – ES71) ES 61) D Forum Gold (4 l/ha – ES 75) (3 l/ha – (Forum Gold 1,46 kg/ha D ES71) 1.46kg/ha) 1,7 kg/ha E (4 l/ha – Mildicut 4 l/ha FG ES 75) Forum Gold 1.92 kg/ha H Folpan 80 WDG I 1.6 kg/ha FBR-1 / FBR-C Page 21 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Modalities FBR-1 – 4 l/ha Blank program Trial code In program In mixture (EPPO zone) Untreated Reference Alone With Folpan FBR-1 Reference 1.25 kg/ha OUT19-004-931FE - ABCD - ACEGI BDFHJ (Folpan 500 - - (Maritime) - 2019 (Folpan 500 SC – 0.6- (1 l/ha) SC – 0.6-2.4 l/ha) 2.4 l/ha) (2 l/ha – EFGHIJ ES 61) (Cuprozin progress 0.4- (3 l/ha – 1.6 l/ha) ES71) (4 l/ha – ES 75) OUT19-005-931FE - ABCD - ACEGI BDFHJ (Folpan 500 - - (Maritime) - 2019 (Folpan 500 SC – 0.6- (1 l/ha) SC – 0.6-2.4 l/ha) 2.4 l/ha) (2 l/ha – EFGHIJ ES 61) (Cuprozin progress 0.4- (3 l/ha – 1.6 l/ha) ES71) (4 l/ha – ES 75) OUT19-006-931FE - ABCD - ACEGI BDFHJ (Folpan 500 - - (Maritime) - 2019 (Folpan 500 SC – 0.6- (1 l/ha) SC – 0.6-2.4 l/ha) 2.4 l/ha) (2 l/ha – EFGHIJ ES 61) (Cuprozin progress 0.4- (3 l/ha – 1.6 l/ha) ES71) (4 l/ha – ES 75) EUR16V02-10F - ABGHI ABCDEF* ACEGI BDFH - - (South-east) (Champion WG 3 (Folpan 80 WG 1.25 kg/ha) kg/ha) CDEF (Folpan 80 WG 1.25 kg/ha) FBR-1 / FBR-C Page 22 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Modalities FBR-1 – 4 l/ha Blank program Trial code In program In mixture (EPPO zone) Untreated Reference Alone With Folpan FBR-1 Reference 1.25 kg/ha EUR16V02-11F - ABGHI ABCDEF* ACEGI BDFH - - (South-east) (Champion WG 3 (Folpan 80 WG 1.25 kg/ha) kg/ha) CDEF (Folpan 80 WG 1.25 kg/ha) EUR16V02-12F - ABGHI ABCDEF* ACEGI BDFH - - (South-east) (Champion WG 3 (Folpan 80 WG 1.25 kg/ha) kg/ha) CDEF (Folpan 80 WG 1.25 kg/ha) 16-00677-01 - ABCDEFGHIJ ABCDEF* ACEGI BDFHJ (ACROBAT - - (South-east) (ACROBAT MZ WG MZ WG 2.5 kg/ha) 2.5 kg/ha) 16-00677-02 - ABCDEFGHIJ ABCDEF* ACEGI BDFHJ (ACROBAT - - (South-east) (ACROBAT MZ WG MZ WG 2.5 kg/ha) 2.5 kg/ha) OUT19-001-931FE - ACEGI - ACEGI BDFHJ - - (South-east) - 2019 (Solofol 1.8 kg/ha) (Acrobat Plus 2 kg/ha) BDFHJ (Kocide 2000 WG 1.2 kg/ha) OUT19-002-931FE - ACEGI - ACEGI BDFHJ - - (South-east) - 2019 (Solofol 1.8 kg/ha) (Acrobat Plus 2 kg/ha) BDFHJ (Kocide 2000 WG 1.2 kg/ha) OUT19-003-931FE - ACEGI - ACEGI BDFHJ - - (South-east) - 2019 (Solofol 1.8 kg/ha) (Acrobat Plus 2 kg/ha) BDFHJ (Kocide 2000 WG 1.2 kg/ha) FBR-1 / FBR-C Page 23 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

*FBR-1 treatments followed by 3 treatments with products used traditionally at the end of a program against Plasmopara viticola

Table 3.2-8: Summary of pest incidence and pest severity on leaves

Trial code Assessment Untreated FBR-1 FBR-1 FBR-1 Target Rating type Reference Blank program (EPPO zone) date control alone in program in mixture

Pest incidence dn14-36-Eur- 8 DAD 86a 15.00b/ 82.56% 14.00b/ 83.72% 24.00b/ 72.09% 22.00b/ 74.42% 34.00b/ 60.47% M-VdM3 Plasmopara (%) / Efficacy (Mediter- viticola Pest severity (%) 8 DAD 41.20a 2.20b/ 94.66% 2.60b/ 93.69% 2.55b/ 93.81% 2.05b/ 95.02% 7.55b/ 81.67% ranean) / Efficacy Vigne-Fr-01 Plasmopara 6 DAD 87.00a 12.00b/ 86.21% 12.00b/ 86.21% 11.00b/ 87.36% 11.00b/ 87.04% 20.00c/ 77.01% (Mediterrane- viticola Pest incidence 11 DAF 72.00a 14.00b/ 80.56% 12.00b/ 83.33% 9.00b/ 87.50% 11.00b/ 84.72% 24.00c/ 66.67% an) (%)/ Efficacy 10 DAI 76.00a 10.00b/ 86.84% 11.00b/ 85.53% 9.00b/ 88.16% 10.00b/ 86.84% 11.00b/ 84.75% 6 DAD 50.00a 1.45b/ 97.10% 3.10b/ 93.80% 1.45b/ 97.10% 2.00b/ 90.77% 7.25c/ 85.50% Pest severity (%) 11 DAF 62.50a 1.35b/ 91.36% 2.15b/ 96.56% 1.60b/ 97.44% 1.85b/ 97.04% 10.07c/ 83.89% / Efficacy 10 DAI 67.00a 3.45b/ 94.85% 4.87b/ 92.69% 1.82b/ 97.28% 1.87b/ 97.21% 2.70b/ 95.97%

Vigne-Fr-02 Plasmopara Pest incidence 12 DAF 70.00a 14.00b/ 80.00% 11.00b/ 84.29% 11.00b/ 84.29% 13.00b/ 81.43 15.00c/ 78.57% (Mediterrane- viticola (%)/ Efficacy 13 DAH 31.00a 9.00b/ 70.97% 6.00b/ 80.65% 6.00b/ 80.65% 9.00b/ 70.97% 21.00ac/ 32.26% an) Pest severity (%) 12 DAF 26.25a 1.45b/ 94.48% 1.15b/ 95.62% 1.60b/ 93.90% 1.77b/ 93.24% 1.70b/ 93.52% / Efficacy 13 DAH 21.25a 1.75b/ 91.76% 2.12b/ 90.00% 0.85b/ 96.00% 1.95b/ 90.82% 7.37b/ 65.29%

15-00560-02 Plasmopara Pest incidence 7 DAD 72.3a 0.4c/ 99.45% 2.6c/ 96.40% 2.9c/ 95.99% - 21.6b/ 70.12% (Mediterrane- viticola (%)/ Efficacy* 2 DAJ 91.6a 76.3b/ 16.70% 28.9d/ 68.45% 45.0c/ 50.87 - 42.1c/ 54.04 an) Pest severity (%) 7 DAD 13.7a 0.0b/ 100% 0.2b/ 98.54% 0.2b/ 98.54% - 1.7b/ 87.59% / Efficacy* 2 DAJ 44.2a 33.4b/ 24.43% 9.6c/ 78.28% 16.1c/ 63.57% - 15.3c/ 65.38%

15-00560-03 Plasmopara Pest incidence 10 DAD 100.0b 0.0a/ 100% 0.0a/ 100% 0.0a/ 100% - 0.0a/ 100% (Mediterrane- viticola (%)/ Efficacy* 10 DAE 100.0b 0.0a/ 100% 0.0a/ 100% 0.0a/ 100% - 0.0a/ 100% FBR-1 / FBR-C Page 24 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Trial code Assessment Untreated FBR-1 FBR-1 FBR-1 Target Rating type Reference Blank program (EPPO zone) date control alone in program in mixture an) Pest severity (%) 10 DAD 32.5b 0.0a/ 100% 0.0a/ 100% 0.0a/ 100% - 0.0a/ 100% / Efficacy* 10 DAE 12.5b 0.0a/ 100% 0.0a/ 100% 0.0a/ 100% - 0.0a/ 100%

15-00560-04 Plasmopara Pest incidence 9 DAE 83.4a 4.9c/ 94.12% 1.2d/ 98.56% 1.8d/ 97.84% - 12.1b/ 85.49% (Mediterrane- viticola (%)/ Efficacy* 14 DAF 99.5a 27.1b/ 72.76% 12.0c/ 87.94% 13.0c/ 86.93% - 32.5b/ 67.34% an) Pest severity (%) 9 DAE 26.5a 0.4b/ 98.49% 0.1b/ 99.62% 0.1b/ 99.62% - 1.1b/ 95.85% / Efficacy* 14 DAF 34.9a 1.1b/ 96.85% 0.4c/ 98.85% 1.6b/ 95.42% - 1.6b/ 95.42% 16-00676-03 Plasmopara 9 DAE 59.5a 4.8b/91.9% 6.8b/88.6% 3.0b/94.9% - - (Maritime) viticola Pest incidence 9 DAF 62.8a 22.5b/64.2% 12.5b/80.1% 10.8b/82.8% - - (%)/ Efficacy* 4 DAH 66.0a 24.8b/62.4% 15.0b/77.3% 12.3b/81.4% - - 9 DAE 11.8a 0.3b/97.6% 0.5b/95.6% 0.2b/98.5% - - Pest severity (%)/ 9 DAF 15.4a 2.0b/87.0% 1.3b/91.4% 0.9b/93.9% - - Efficacy 4 DAH 17.4a 2.4b/86.4% 1.7b/90.3% 1.3b/92.6% - - EUR16V02- Plasmopara 7 DAB 82.23a 63.46b/22.8% 69.81b/15.1% 63.46b/22.8% - - 07F viticola 10 DAC 96.60a 84.60b/12.4% 87.20b/9.7% 87.40b/9.5% - - (Maritime) Pest incidence 11 DAD 96.40a 83.00a/13.9% 90.99a/5.6% 83.20a/13.7% - - (%)/ Efficacy 11 DAE 93.40a 79.60b/14.8% 86.40b/7.5% 80.37b/13.9% - - 11 DAF 97.20a 82.20b/12.4% 84.60b/15.4% 81.20b/16.5% - - 7 DAB 7.73a 3.99b/48.3% 4.53b/41.5% 3.58b/53.8% - - 10 DAC 23.06a 7.16b/69.0% 10.60b/54.0% 7.78b/66.2% - - Pest severity (%)/ 11 DAD 26.35a 7.52c/71.5% 11.61b/55.9% 7.32c/72.2% - - Efficacy 11 DAE 26.46a 6.73c/74.6% 10.37b/60.8% 6.05c/77.1% - - 11 DAF 34.02a 9.04b/73.4% 11.05b/67.5% 6.61b/80.6% - - EUR16V02- Plasmopara Pest incidence 10 DAB 15.60a 8.60b/44.9% 10.00b/35.9% 10.80b/30.8% - - FBR-1 / FBR-C Page 25 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Trial code Assessment Untreated FBR-1 FBR-1 FBR-1 Target Rating type Reference Blank program (EPPO zone) date control alone in program in mixture

08F viticola (%)/ Efficacy 9 DAC 47.80a 29.40b/38.5% 15.00c/68.6% 19.00b/18.6% - - (Maritime) 9 DAD 53.20a 31.80b/40.2% 17.20c/67.7% 21.20c/60.2% - - 11 DAE 54.20a 32.80b/39.5% 17.80c/67.2% 18.80c/65.3% - - 10 DAF 62.60a 39.6b/36.7% 21.20c/66.1% 23.40c/62.6% - - 9 DAG 76.40a 46.8b/38.7% 24.40c/68.1% 25.80c/66.2% - - 10 DAH 81.40a 51.60b/36.6% 26.00c/68.1% 28.00c/65.6% - - 18 DAI 91.80a 65.40b/28.8% 30.60d/66.7% 40.00c/56.4% - - 10 DAB 1.71a 0.73b/57.4% 0.77b/54.8% 0.98b/42.9% - - 9 DAC 5.57a 1.64b/70.5% 0.30b/94.6% 0.53b/90.5% - - 9 DAD 17.18a 8.25b/52.0% 3.07c/82.1% 4.19c/75.6% - -

Pest severity (%)/ 11 DAE 25.86a 10.76b/58.4% 3.95c/84.7% 4.70c/81.8% - - Efficacy 10 DAF 33.76a 12.85b/61.9% 5.29c/84.3% 6.32c/81.3% - - 9 DAG 45.74a 17.35b/62.1% 6.65c/85.5% 7.85c/82.8% - - 10 DAH 52.16a 19.82b/62.0% 7.56c/85.5% 8.94c/82.9% - - 18 DAI 57.14a 26.18b/54.2% 9.96c/82.6% 13.13c/77.0% - - EUR16V02- Plasmopara 8 DAB 7.20a 3.40b/52.8% 2.80b/61.1% 3.00b/58.3% - - 09F viticola 8 DAC 33.00a 13.80b/58.2% 11.60b/64.8% 11.40b/65.5% - - (Maritime) 8 DAD 45.00a 19.20b/57.3% 17.20b/61.8% 17.80b/60.4% - -

Pest incidence 10 DAE 50.40a 27.40b/45.6% 19.00b/62.3% 21.20b/57.9% - - (%)/ Efficacy 10 DAF 64.80a 42.20b/34.9% 26.60c/59.0% 29.80c/54.0% - - 9 DAG 72.40a 50.40b/30.4% 31.80c/56.1% 34.60c/52.2% - - 11 DAH 85.00a 65.60b/22.8% 38.40c/54.8% 39.60c/53.4% - - 16 DAI 95.40a 73.40b/23.1% 43.20c/54.7% 45.40c/52.4% - - FBR-1 / FBR-C Page 26 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Trial code Assessment Untreated FBR-1 FBR-1 FBR-1 Target Rating type Reference Blank program (EPPO zone) date control alone in program in mixture

8 DAB 0.75a 0.26b/65.1% 0.23b/69.9% 0.24b/68.5% - - 8 DAC 6.79a 2.61b/61.6% 2.36b/65.2% 1.76b/74.1% - - 8 DAD 14.02a 3.60b/74.3% 3.52b/74.9% 3.13b/77.6% - -

Pest severity (%)/ 10 DAE 15.56a 6.09b/60.9% 4.10b/73.7% 5.45b/65.0% - - Efficacy 10 DAF 23.13a 10.49b/54.6% 5.78c/75.0% 7.73bc/66.6% - - 9 DAG 23.64a 7.70b/67.4% 2.39c/89.9% 3.48c/85.3% - - 11 DAH 37.26a 20.16b/45.9% 10.36c/72.2% 13.46c/63.9% - - 16 DAI 49.18a 29.94b/39.1% 13.96c/71.6% 16.55c/66.3% - - 16-00711-01 Plasmopara Pest incidence 8 DAB 40.0a 33.0a/15.5% 18.0a/55.0% 23.0a/42.5% - - (Maritime) viticola (%)/ Efficacy Pest severity (%)/ 8 DAB 5.3a 3.7a/30.2% 1.3a/71.9% 3.0a/48.5% - - Efficacy 16-00711-02 Plasmopara Pest incidence 8 DAB 29.0a 12.0b/58.6% 4.0c/81.2% 2.0c/93.1% - - (Maritime) viticola (%)/ Efficacy Pest severity (%)/ 8 DAB 3.8a 0.9b/76.4% 0.3b/91.5% 0.1b/97.0% - - Efficacy OUT19-004- Plasmopara Pest incidence 13 DAC 12.3 a - 0.0 b/100% 0.0 b/100% - - 931FE viticola (%)/ Efficacy (Maritime) - Pest severity (%)/ 2019 13 DAC 0.8 a - 0.0 b/100% 0.0 b/100% - - Efficacy OUT19-005- Plasmopara Pest incidence 11 DAC 11.0 a - 0.0 b/100% 0.0 b/100% - - 931FE viticola (%)/ Efficacy (Maritime) - Pest severity (%)/ 2019 11 DAC 0.9 a - 0.0 b/100% 0.0 b/100% - - Efficacy OUT19-006- Plasmopara Pest incidence 10 DAC 0.0 a - 0.0 a 0.0 a - - 931FE viticola (%)/ Efficacy FBR-1 / FBR-C Page 27 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Trial code Assessment Untreated FBR-1 FBR-1 FBR-1 Target Rating type Reference Blank program (EPPO zone) date control alone in program in mixture

(Maritime) - Pest severity (%)/ 10 DAC 0.0 a - 0.0 a 0.0 a - - 2019 Efficacy EUR16V02- Plasmopara 11 DAC 18.00a 0.00b/100% 0.00b/100% 0.00b/100% - - 10F viticola 10 DAD 58.80a 0.00c/100% 36.40b/38.1% 4.60c/92.2% - - (South-east) 11 DAE 68.60a 3.20d/95.3% 43.60b/36.4% 10.0c/85.4% - -

Pest incidence 10 DAF 89.55a 16.96c/81.1% 36.74b/59.0% 17.90c/80.0% - - (%)/ Efficacy 11 DAG 96.40a 34.80b/63.9% 36.80b/61.8% 28.40b/70.5% - - 10 DAH 99.46a 35.67b/64.1% 35.05b/64.8% 29.32b/70.5% - - 11 DAI 100.0a 47.20b/52.9% 56.65b/43.4% 48.60b/51.4% - - 21 DAI 100.0a 64.60c/35.4% 77.80b/22.2% 66.60c/33.4% - - 11 DAC 1.04a 0.00b/100% 0.00b/100% 0.00b/100% - - 10 DAD 1.91a 0.00c/100% 0.44b/77.0% 0.00c/100% - - 11 DAE 10.96a 0.08c/99.3% 2.46b/77.6% 0.32c/97.1% - -

Pest severity (%)/ 10 DAF 20.63a 0.71b/96.6% 2.83b/86.3% 0.84b/95.9% - - Efficacy 11 DAG 38.45a 2.96b/92.3% 4.44b/88.4% 2.29b/94.0% - - 10 DAH 47.58a 1.66b/96.5% 1.89b/96.0% 0.88c/98.2% - - 11 DAI 62.06a 8.24b/86.7% 9.81b/84.2% 5.76b/90.7% - - 21 DAI 73.89a 12.66b/82.9% 13.39b/81.9% 9.64b/87.0% - - EUR16V02- Plasmopara 10 DAB 66.80a 0.00b/100% 0.00b/100% 0.00b/100% - - 11F viticola 10 DAC 88.00a 32.60c/63.0% 0.00d/100% 47.00b/46.6% - - (South-east) Pest incidence 11 DAD 99.00a 79.92c/19.3% 14.56d/85.3% 89.70b/9.4% - - (%)/ Efficacy 10 DAE 100.0a 99.09a/0.9% 40.20b/59.8% 99.46a/0.5% - - 11 DAF 100.0a 98.60a/1.4% 61.40b/38.6% 97.80a/2.2% - - FBR-1 / FBR-C Page 28 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Trial code Assessment Untreated FBR-1 FBR-1 FBR-1 Target Rating type Reference Blank program (EPPO zone) date control alone in program in mixture

10 DAG 100.0a 99.96a/0.0% 81.86b/18.1% 97.67a/0.3% - - 11 DAH 100.0a 100.0a/0.0% 94.40b/5.6% 99.40a/0.6% - - 10 DAI 100.0a 99.92a/0.1% 95.98b/4.0% 99.84a/0.2% - - 21 DAI 100.0a 99.60a/0.4% 99.00a/1.0% 99.80a/0.2% - - 10 DAB 4.10a 0.00b/100% 0.00b/100% 0.00b/100% - - 10 DAC 9.05a 0.83c/90.9% 0.00d/100% 1.61b/82.2% - - 11 DAD 17.52a 7.07b/59.7% 0.66c/96.3% 8.84b/49.6% - - 10 DAE 24.46a 11.27b/53.9% 1.40c/94.3% 12.46b/49.1% - - Pest severity (%)/ 11 DAF 32.37a 16.12b/50.2% 6.66c/79.4% 17.56b/45.8% - - Efficacy 10 DAG 41.49a 22.02b/46.9% 10.40c/74.9% 22.31b/46.2% - - 11 DAH 50.92a 26.71b/47.5% 16.74c/67.1% 27.91b/45.2% - - 10 DAI 62.11a 34.89b/43.8% 21.23c/65.8% 34.00b/45.3% - - 21 DAI 73.17a 46.83b/36.0% 25.81d/64.7% 40.67c/44.4% - - 16-00677-01 Plasmopara 14 DAB 23.3a 4.0b/82.8% 1.8b/92.3% 1.8b/92.3% - - (South-east) viticola Pest incidence 14 DAD 38.8a 11.5b/70.3% 5.3c/86.5% 5.0c/87.1% - - (%)/ Efficacy* 10 DAE 48.8a 17.5b/64.1% 8.0c/83.6% 8.0c/83.6% - - 7 DAJ 99.8a 54.8b/45.1% 29.3c/70.7% 23.0c/76.9% - - 14 DAB 0.9a 0.1b/86.7% 0.0b/100.0% 0.0b/100.0% - -

Pest severity (%)/ 14 DAD 6.4a 0.4b/94.1% 0.1b/98.1% 0.1b/98.1% - - Efficacy 10 DAE 8.7a 0.7b/91.5% 0.2b/97.6% 0.2b/97.2% - - 7 DAJ 56.2a 11.6b/79.3% 2.5c/95.5% 1.7c/97.0% - -

16-00677-02 Plasmopara Pest incidence 14 DAB 24.8a 0.0b/100% 1.5b/93.9% 0.0b/100% - - (South-east) viticola (%)/ Efficacy* 14 DAD 82.5a 22.3b/73.0% 9.3b/88.8% 5.0b/93.9% - - FBR-1 / FBR-C Page 29 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Trial code Assessment Untreated FBR-1 FBR-1 FBR-1 Target Rating type Reference Blank program (EPPO zone) date control alone in program in mixture

10 DAE 91.3a 27.8b/69.6% 19.5b/78.6% 14.8b/83.8% - - 7 DAJ 100.0a 77.0b/23.0% 31.5c/68.5% 23.3c/76.8% - - 14 DAB 3.2a 0.0b/100% 0.1b/97.7% 0.0b/100% - -

Pest severity (%)/ 14 DAD 16.6a 3.2b/80.6% 1.3b/92.0% 0.5b/96.8% - - Efficacy 10 DAE 18.4a 4.5b/75.8% 2.2c/88.0% 1.4c/92.1% - - 7 DAJ 73.9a 34.7b/53.1% 13.1c/82.3% 7.0d/90.6% - - OUT19-001- Plasmopara Pest incidence 14 DAB 6.8 a - 0.0b/100% 0.0b/100% - - 931FE viticola (%)/ Efficacy* (South-east) - Pest severity (%)/ 2019 14 DAB 0.6 a - 0.0b/100% 0.0b/100% - - Efficacy OUT19-002- Plasmopara Pest incidence 14 DAB 11.8 a - 0.5b/95.76% 0.0b/100% - - 931FE viticola (%)/ Efficacy* (South-east) - Pest severity (%)/ 2019 14 DAB 0.9 a - 0.0b/100% 0.0b/100% - - Efficacy OUT19-003- Plasmopara Pest incidence 15 DAB 8.8 a - 0.3b/96.59% 0.0b/100% - - 931FE viticola (%)/ Efficacy* (South-east) - Pest severity (%)/ 2019 15 DAB 0.4 a - 0.0b/100% 0.0b/100% - - Efficacy *Efficacy (%) calculated according to Abbott’s formula

FBR-1 / FBR-C Page 30 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Table 3.2-9: Summary of pest incidence and pest severity on bunches

Assessment Untreated FBR-1 FBR-1 FBR-1 Trial code Target Rating type Reference Blank program date control alone in program in mixture

Pest incidence 4 DAE 97.00a 46.00b/ 52.58% 4.00c/ 95.88% 24.00bc/ 75.26% 22.00bc/ 77.32% 21.00bc/ 78.35% dn14-36-Eur- (%) / Efficacy M-VdM3 Plasmopara 16 DAF 94.00a 66.00b/ 29.79% 11.00c/ 88.30% 38.00bc/ 59.57% 21.00bc/ 77.66% 30.00bc/ 68.09% (Mediter- viticola Pest severity (%) 4 DAE 44.85a 8.90b/ 80.16% 0.50b/ 98.89% 3.45b/ 92.31% 2.35b/ 94.76% 2.25b/ 94.98% ranean) / Efficacy 16 DAF 49.40a 12.10b/ 75.51% 1.90b/ 96.15% 5.85b/ 88.16% 3.15b/ 93.62% 3.95b/ 92.00% Vigne-Fr-01 Plasmopara 6 DAD 54.00a 7.00b/ 87.04% 2.00b/ 96.30% 2.00b/ 96.30% 4.00b/ 92.59% 5.00b/ 90.74% (Mediterrane- viticola Pest incidence 11 DAF 59.00a 6.00b/ 89.83% 5.00b/ 91.53% 7.00b/ 88.14% 5.00b/ 91.53% 6.00b/ 89.83% an) (%) / Efficacy 10 DAI 59.00a 9.00b/ 84.75% 9.00b/ 84.75% 8.00b/ 86.44% 9.00b/ 84.75% 7.00b/ 88.14% 6 DAD 35.75a 3.30b/ 90.70% 2.50b/ 93.00% 2.62b/ 92.70% 2.45b/ 93.10% 1.80b/ 94.90% Pest severity (%) 11 DAF 57.50a 4.75b/ 91.74% 4.30b/ 92.52% 4.60b/ 92.00% 2.50b/ 95.65% 4.25b/ 92.61% / Efficacy 10 DAI 65.00a 5.60b/ 91.38% 5.85b/ 91.00% 5.37b/ 91.7% 5.30b/ 91.85% 5.15b/ 92.08%

Vigne-Fr-02 Plasmopara Pest incidence 12 DA-F 20.00a 5.00b/ 75.00 2.00b/ 90.00 4.00b/ 80.00 6.00b/ 70.00 6.00b/ 70.00 (Mediterrane- viticola (%) / Efficacy 13 DA-H 23.00a 3.00b/ 86.96 2.00b/ 91.30 2.00b/ 91.30 2.00b/ 91.30 1.00b/ 95.65 an) Pest severity (%) 12 DA-F 20.00a 0.95b/ 95.25 0.92b/ 95.38 1.32b/ 93.38 1.3b/ 93.50 0.77b/ 96.13 / Efficacy 13 DA-H 13.75a 1.25b/ 90.91 0.5b/ 96.36 2.5b/ 81.82 1.25b/ 91.82 1.25b/ 90.91 15-00560-02 Plasmopara Pest incidence 14 DAF 48.4a 16.4b/ 66.12% 10.6b/ 78.10% 12.1b/ 75.00% - 6.7b/ 86.16% (Mediterrane- viticola (%) / Efficacy an) Pest severity (%) 14 DAF 10.5 1.0a/ 90.48% 0.3a/ 97.14% 0.8a/ 92.38% - 0.5a/ 95.24 / Efficacy

15-00560-03 Plasmopara Pest incidence 11 DAE 75.0b 0.0a/ 100% 0.0a/ 100% 0.0a/ 100% - 0.0a/ 100% (Mediterrane- viticola (%)/ Efficacy 4 DAH 88.0b 2.1a/ 97.61% 0.6a/ 99.32% 0.5a/ 99.43% - 1.6a/ 98.18% an) Pest severity (%) 11 DAE 12.5b 0.0a/ 100% 0.0a/ 100% 0.0a/ 100% - 0.0a/ 100% / Efficacy 4 DAH 15.5b 0.4a/ 97.42% 0.1a/ 99.35% 0.1a/ 99.35% - 0.3a/ 98.06% FBR-1 / FBR-C Page 31 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Assessment Untreated FBR-1 FBR-1 FBR-1 Trial code Target Rating type Reference Blank program date control alone in program in mixture

15-00560-04 Plasmopara Pest incidence 14 DAF 65.0a 76.0a/ 0% 19.0b/ 70.77% 60.0a/ 7.69% - 3.4a/ 94.77% (Mediterrane- viticola (%) / Efficacy an) Pest severity (%) 14 DAF 7.1a 5.0a/ 29.58% 0.4b/ 94.37% 2.8a/ 60.56% - 66.0a/ 0% / Efficacy 16-00676-03 Plasmopara 9 DAE 32.5a 1.5b/95.4% 0.5b/98.5% 0.5b/98.5% - - (Maritime) viticola Pest incidence 9 DAF 68.5a 12.0b/82.5% 5.5b/92.0% 5.5b/92.0% - - (%)/ Efficacy* 4 DAH 76.5a 14.5b/81.0% 7.5b/90.2% 7.0b/90.9% - - 9 DAE 5.9a 0.4b/94.1% 0.1b/99.2% 0.0b/100% - - Pest severity (%)/ 9 DAF 22.2a 1.1b/94.9% 0.4b/98.4% 0.3b/98.5% - - Efficacy 4 DAH 24.2a 1.5b/93.9% 0.5b/97.8% 0.5b/97.9% - - EUR16V02- Plasmopara 7 DAB 82.80a 77.20a/6.8% 75.20a/9.2% 68.80a/16.9% - - 07F viticola 10 DAC 99.64a 99.00a/0.6% 95.21a/4.4% 98.91a/0.7% - - (Maritime) Pest incidence 11 DAD 100.00a 99.96a/0.0% 97.82a/2.2% 99.63a/0.4% - - (%) / Efficacy 11 DAE 100.00a 99.96a/0.0% 98.62a/1.4% 99.44a/0.6% - - 11 DAF 100.00a 100.0a/0.0% 96.6a/3.4% 99.40a/0.6% - - 7 DAB 9.09a 7.32a/19.4% 6.51a/28.4% 5.40a/40.6% - - 10 DAC 59.32a 38.81b/34.6% 25.38b/57.2% 28.60b/51.8% - - Pest severity (%) 11 DAD 94.68a 81.95ab/13.4% 44.41c/53.1% 60.61bc/36.0% - - / Efficacy 11 DAE 97.50a 90.82a/6.9% 55.58c/43.0% 70.52b/27.7% - - 11 DAF 98.48a 96.80a/0.0% 54.79c/44.4% 70.63b/28.3% - - EUR16V02- Plasmopara 10 DAB 22.80a 12.80b/43.9% 14.40b/36.8% 13.60b/40.4% - - 08F viticola Pest incidence 9 DAC 69.20a 43.60b/37.0% 19.20c/72.3% 20.00c/71.1% - - (Maritime) (%) / Efficacy 9 DAD 76.80a 54.40b/29.2% 18.80c/75.5% 20.80c/72.9% - - FBR-1 / FBR-C Page 32 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Assessment Untreated FBR-1 FBR-1 FBR-1 Trial code Target Rating type Reference Blank program date control alone in program in mixture

11 DAE 86.40a 65.60b/24.1% 15.60c/81.9% 19.60c/77.3% - - 10 DAF 92.40a 75.60b/18.2% 20.00c/78.4% 26.00c/71.9% - - 9 DAG 96.80a 79.20b/18.2% 24.80c/74.4% 27.20c/71.9% - - 10 DAH 99.20a 82.00b/17.3% 27.20c/72.6% 30.80c/69.0% - - 18 DAI 100.0a 91.20a/8.8% 38.80c/61.2% 51.60b/48.4% - - 10 DAB 1.30a 0.52b/59.7% 0.59b/54.8% 0.80b/38.2% - - 9 DAC 14.00a 7.08b/49.4% 1.40b/90.0% 2.80b/80.0% - - 9 DAD 22.88a 14.16b/38.1% 2.02c/91.2% 3.94c/82.8% - -

Pest severity (%) 11 DAE 52.72a 29.06b/44.9% 2.80c/94.7% 5.42c/89.7% - - / Efficacy 10 DAF 61.16a 36.40b/40.5% 3.62c/94.1% 6.92c/88.7% - - 9 DAG 67.76a 42.90b/36.7% 5.26c/92.2% 7.72c/88.6% - - 10 DAH 70.24a 46.00b/34.5% 6.68c/90.5% 8.96c/87.2% - - 18 DAI 80.44a 55.92b/30.5% 11.60c/85.6% 15.52c/80.7% - - EUR16V02- Plasmopara 8 DAC 18.00a 9.80b/45.6% 7.40b/58.9% 5.00b/72.2% - - 09F viticola 8 DAD 61.80a 43.80b/29.1% 15.00d/75.7% 28.00c/54.7% - - (Maritime) 10 DAE 69.40a 50.40b/27.4% 18.40d/73.5% 30.80c/55.6% - - Pest incidence 10 DAF 79.60a 57.80b/27.4% 25.40d/68.1% 36.60c/54.0% - - (%) / Efficacy 9 DAG 85.40a 66.00b/22.7% 30.60d/64.2% 40.20c/52.9% - - 11 DAH 91.00a 72.20b/20.7% 32.80d/64.0% 41.40c/54.5% - - 16 DAI 95.40a 73.60b/22.9% 36.60d/61.6% 45.80c/52.0% - -

Pest severity (%) 8 DAC 3.34a 1.94ab/41.9% 0.89b/73.4% 0.88b/73.6% - - / Efficacy 8 DAD 31.64a 22.10b/30.2% 5.96c/81.2% 12.18c/61.5% - - FBR-1 / FBR-C Page 33 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Assessment Untreated FBR-1 FBR-1 FBR-1 Trial code Target Rating type Reference Blank program date control alone in program in mixture

10 DAE 34.99a 22.72b/35.1% 6.68d/80.9% 13.26c/62.1% - - 10 DAF 42.32a 26.77b/36.7% 7.99d/81.1% 14.70c/65.3% - - 9 DAG 49.57a 29.48b/40.5% 9.65d/80.5% 16.25c/67.2% - - 11 DAH 53.79a 34.72b/35.5% 10.69d/80.1% 17.50c/67.5% - - 16 DAI 59.68a 38.46b/35.6% 13.88d/76.7% 19.42c/67.5% - -

16-00711-01 Plasmopara Pest incidence 7 DAD 72.0a 64.0a/11.1% 39.0a/45.8% 37.0a/48.6% - - (Maritime) viticola (%)/ Efficacy 25 DAI 80.0a 70.0a/12.5% 80.0a/0.0% 46.0a/42.5% - -

Pest severity (%)/ 7 DAD 34.7a 27.4a/30.0% 16.5a/49.7% 14.6a/51.2% - - Efficacy 25 DAI 37.7a 34.0a/21.9% 29.1a/23.9% 20.0a/43.4% - -

16-00711-02 Plasmopara Pest incidence 7 DAD 67.0a 57.0a/14.9% 13.0b/80.6% 11.0b/83.6% - - (Maritime) viticola (%)/ Efficacy 25 DAI 77.0a 61.0a/20.8% 25.0b/67.5% 16.0b/79.2% - -

Pest severity (%)/ 7 DAD 42.2a 37.3a/21.6% 6.50b/84.3% 6.40b/85.3% - - Efficacy 25 DAI 51.50a 38.90a/22.4% 11.70b/76.7% 8.90b/83.2% - - OUT19-004- Plasmopara Pest incidence 13 DAC 0.0a - 0.0a 0.0a - - 931FE viticola (%)/ Efficacy (Maritime) - Pest severity (%)/ 2019 13 DAC 0.0a - 0.0a 0.0a - - Efficacy OUT19-005- Plasmopara Pest incidence 11 DAC 0.0a - 0.0a 0.0a - - 931FE viticola (%)/ Efficacy (Maritime) - Pest severity (%)/ 2019 11 DAC 0.0a - 0.0a 0.0a - - Efficacy OUT19-006- Plasmopara Pest incidence 10 DAC 17.5a - 0.0b/100% 0.0b/100% - - 931FE viticola (%)/ Efficacy FBR-1 / FBR-C Page 34 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Assessment Untreated FBR-1 FBR-1 FBR-1 Trial code Target Rating type Reference Blank program date control alone in program in mixture

(Maritime) - Pest severity (%)/ 10 DAC 0.5a - 0.0b/100% 0.0b/100% - - 2019 Efficacy EUR16V02- Plasmopara 11 DAC 16.00a 0.00b/100% 0.00b/100% 0.00b/100% - - 10F viticola 10 DAD 27.20a 0.00c/100% 6.40b/76.5% 2.00c/92.6% - - (South-east) 11 DAE 41.60a 9.20b/77.9% 11.60b/72.1% 9.20b/77.9% - -

Pest incidence 10 DAF 81.20a 48.80b/39.9% 44.00b/45.8% 41.60b/48.8% - - (%) / Efficacy 11 DAG 96.00a 60.80b/36.7% 52.40b/45.4% 58.00b/39.6% - - 10 DAH 100.0a 69.60b/30.4% 53.60c/46.4% 58.80c/41.2% - - 11 DAI 100.0a 81.60b/18.4% 66.40c/33.6% 72.80bc/27.2% - - 21 DAI 100.0a 89.20b/10.8% 76.00c/24.0% 84.80b/15.2% - - 11 DAC 1.12a 0.00b/100% 0.00b/100% 0.00b/100% - - 10 DAD 2.70a 0.00b/100% 0.43b/84.0% 0.14b/94.7% - - 11 DAE 10.16a 0.35b/96.5% 1.56b/84.7% 0.63b/93.8% - -

Pest severity (%) 10 DAF 15.12a 1.14b/92.5% 1.55b/89.7% 1.05b/93.0% - - / Efficacy 11 DAG 34.52a 5.03b/85.4% 3.20b/90.7% 3.43b/90.1% - - 10 DAH 42.14a 7.10b/83.1% 3.91b/90.7% 4.53b/89.2% - - 11 DAI 44.24a 9.60b/78.3% 5.76b/87.0% 6.84b/84.5% - - 21 DAI 50.94a 19.68b/61.4% 14.52b/71.5% 15.78b/69.0% - - EUR16V02- Plasmopara 10 DAB 13.20a 0.00b/100% 0.00b/100% 0.00b/100% - - 11F viticola 10 DAC 68.40a 0.00b/100% 4.00b/94.2% 0.00b/100% - - (South-east) Pest incidence 11 DAD 90.00a 32.80b/63.6% 22.40b/75.1% 26.00b/71.1% - - (%) / Efficacy 10 DAE 96.80a 73.20b/24.4% 60.80b/37.2% 57.20b/40.9% - - 11 DAF 99.76a 85.18b/14.6% 78.00b/21.8% 85.78b/14.0% - - FBR-1 / FBR-C Page 35 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Assessment Untreated FBR-1 FBR-1 FBR-1 Trial code Target Rating type Reference Blank program date control alone in program in mixture

10 DAG 100.0a 93.20a/6.8% 91.20a/8.8% 90.80a/9.2% - - 11 DAH 100.0a 92.80a/7.2% 90.40a/9.6% 92.40a/7.6% - - 10 DAI 100.0a 96.80a/3.2% 94.00a/6.0% 93.20a/6.8% - - 21 DAI 100.0a 99.60a/0.4% 100.0a/0.0% 99.20a/0.8% - - 10 DAB 0.47a 0.00a/100% 0.00a/100% 0.00a/100% - - 10 DAC 2.19a 0.00b/100% 0.00b/100% 0.00b/100% - - 11 DAD 7.59a 1.30b/82.9% 0.93b/87.8% 1.04b/86.2% - - 10 DAE 14.64a 6.32b/56.8% 4.95b/66.2% 4.66b/68.2% - - Pest severity (%) 11 DAF 21.48a 12.76b/40.6% 9.70b/54.8% 11.16b/48.0% - - / Efficacy 10 DAG 36.64a 19.38b/47.1% 18.32b/50.0% 18.52b/49.5% - - 11 DAH 55.72a 27.66b/50.4% 28.06b/49.6% 24.84b/55.4% - - 10 DAI 65.76a 33.12b/49.6% 33.90b/48.4% 29.10b/55.7% - - 21 DAI 72.50a 39.00b/46.2% 39.27b/45.8% 33.15b/54.3% - - 16-00677-01 Plasmopara 14 DAB 11.0a 2.0b/81.8% 1.0b/90.9% 0.0b/100% - - (South-east) viticola Pest incidence 14 DAD 58.0a 24.0b/58.6% 10.0c/82.8% 11.0c/81.0% - - (%)/ Efficacy* 10 DAE 69.0a 31.0b/55.1% 17.0c/75.4% 13.0c/81.2% - - 7 DAJ 100.0a 48.0b/52.0% 28.0c/72.0% 22.0c/78.0% - - 14 DAB 0.3a 0.0b/100.0% 0.0b/100.0% 0.0b/100.0% - -

Pest severity (%)/ 14 DAD 8.2a 0.7b/91.4% 0.1b/98.3% 0.2b/98.2% - - Efficacy 10 DAE 11.4a 0.9b/91.8% 0.4b/96.2% 0.3b/97.0% - - 7 DAJ 36.4a 2.2b/94.0% 1.0b/97.3% 0.6b/98.2% - - 16-00677-02 Plasmopara Pest incidence 14 DAB 20.0a 10.0b/50.0% 8.0b/60.0% 9.0b/55.0% - - FBR-1 / FBR-C Page 36 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Assessment Untreated FBR-1 FBR-1 FBR-1 Trial code Target Rating type Reference Blank program date control alone in program in mixture

(South-east) viticola (%)/ Efficacy* 14 DAD 35.0a 23.0b/34.3% 17.0b/51.4% 18.0b/48.6% - - 10 DAE 65.4a 42.0b/36.1% 25.0b/62.0% 25.0b/61.8% - - 7 DAJ 100.0a 51.0b/49.% 33.0c/67.0% 40.0c/60.0% - - 14 DAB 1.4a 0.6b/57.1% 0.5b/67.9% 0.5b/64.3% - -

Pest severity (%)/ 14 DAD 4.8a 1.6b/67.7% 1.3b/74.0% 1.2b/75.0% - - Efficacy 10 DAE 9.2a 2.7b/70.1% 1.7b/81.6% 1.4b/84.3% - - 7 DAJ 81.6a 6.3b/92.3% 2.2b/97.3% 2.3b/97.1% - - OUT19-001- Plasmopara Pest incidence 14 DAB 0.0a - 0.0a 0.0a - - 931FE viticola (%)/ Efficacy (South-East) - Pest severity (%)/ 2019 14 DAB 0.0a - 0.0a 0.0a - - Efficacy OUT19-002- Plasmopara Pest incidence 14 DAB 0.0a - 0.0a 0.0a - - 931FE viticola (%)/ Efficacy (South-East) - Pest severity (%)/ 2019 14 DAB 0.0a - 0.0a 0.0a - - Efficacy OUT19-003- Plasmopara Pest incidence 15 DAB ------931FE viticola (%)/ Efficacy (South-East) - Pest severity (%)/ 2019 15 DAB 0.0a - 0.0a 0.0a - - Efficacy *Efficacy (%) calculated according to Abbott’s formula

FBR-1 / FBR-C Page 37 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

3.2.3.2 Conclusions of the efficacy trials performed on grapevine against downy mildew

A total of 4 trials were carried out in 2015 in Germany (2) and in Hungary (2), to evaluate the efficacy of FBR-1 against downy mildew (Plasmopara viticola) on grapevine. However, due to the extreme weather conditions, the Plasmopara viticola contamination did not occurred on grapevine (leaves and bunches). Therefore, 10 trials (5 in Germany and 5 in Hungary) were started in 2016. The results and corresponding final reports will be provided as soon as available.

Meantime, the trials performed in France to sustain the dossier in the southern zone (zRMS France) are provided and are presented in this dossier. For the southern zone dossier, a total of 6 efficacy trials were carried out, under GEP (4) and non-GEP (2) conditions, to evaluate the efficacy of FBR-1 against downy mildew (Plasmopara viticola) on grapevine. These trials were conducted in 2014 and in 2015 in France.

During these trials, 3 fungicide treatments were compared:  6 to 10 applications of FBR-1 (4 l/ha) alone  3 to 5 applications of FBR-1 (4 l/ha) including in a program treatment  Reference product or reference program treatment

During these trials performed in 2019, 2 fungicide treatments were compared:  5 applications of FBR-1 including in a program treatment  Reference program treatment

Conclusions for Germany:

At the dose of 1 to 4 l/ha, 6 consecutives applications of FBR-1 (followed by 3 treatments with products used traditionally at the end of a program against Plasmopara viticola) and 5 applications of FBR-1 applied in program are able to control Plasmopara viticola on grapevine (leaves and bunches). Furthermore, results obtained with FBR-1 are statistically equivalent to those of the reference program treatment.

However, when the pathogen pressure is very high (on leaves and bunches), treatments with FBR-1 used in program allow a better efficacy on grapevine compared to 6 consecutives applications of FBR-1 (followed by 3 treatments with products used traditionally at the end of a program against Plasmopara viticola).

Conclusions for Hungary:

At the dose rate of 4 l/ha, 6 consecutives applications of FBR-1 (followed by 3 treatments with products used traditionally at the end of a program against Plasmopara viticola) and 5 applications of FBR-1 applied in program are able to control Plasmopara viticola on grapevine (leaves and bunches). Furthermore, the treatments with FBR-1 are statistically equivalent to the reference pro- FBR-1 / FBR-C Page 38 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016 gram treatment.

However, when the pathogen pressure is very high on leaves (only), 5 applications of FBR-1 applied in a program treatment allow a better efficacy compared to 6 consecutives applications of FBR-1 (followed by 3 treatments with products used traditionally at the end of a program against Plasmo- para viticola).

Efficacy tests

4 trials were carried out in 2015 in Germany (2) and in Hungary (2), to evaluate the efficacy of FBR-1 against downy mildew (Plasmopara viticola) on grapevine. However, due to the extreme weather conditions, no infestation did occurred on grapevine. Therefore, no results can be presented.

6 trials performed in France to sustain the dossier in the southern zone (zRMS France) are provided and are presented in this dossier. These trials were conducted in 2014 and in 2015 in France. During these trials, 6 to 10 applications of FBR-1 were tested at the dose of 4 l/ha, alone or including in a program.

Further trials were carried out in 2016 (5 in Germany, 1 in France and 5 in Hungary) and 2019 (3 in Germany and 3 in Bulgaria). However the final reports for the 2019 trials are not yet available. Interim results were provided.

Overall 16 valid trials are available at this time. For 6 additional trials interim results are available. 6 valid trials exists for maritime Eppo climatic zone, 4 valid trials for south-eastern zone and 6 for Mediterranean zone. Exclusive the ongoing trials, a sufficient number of valid trials is available for maritime and mediterranean EPPO zone. When the pathogen pressure is very high, treatments with FBR-1 used in program allow a better efficacy on grapevine compared to consecutives applications of FBR-1. Efficacy could be considered as sufficient and was comparable to reference products.

3.3 Information on the occurrence or possible occurrence of the development of resistance (KCP 6.3)

The extensive use of phosphonate products as disease control agents, fertilizers, and/or during periods of environmental stress to improve crops quality, has led scientist and agricultural practitioner to development concerns about the occurrence of pathogen resistance. To date, although phosphonate-resistant oomycete mutants in Pythium aphanidermatum have been induced, there are no confirmed reports of pathogen resistance to phosphonate fungicides in Grapevine. This is probably due to two major factors. The first risk-minimizing factor is the fungicide mode of action of phosphonates, which may involve several sites. The second parameter may involvement the stimulation of the host defences mechanisms. Both of these factors are very strong barriers for pathogens to overcome through resistance.

Development of resistance

Phosphonates are listed under FRAC code P07 with few resistance cases reported in few pathogens and low risk. The development of resistance is not expected.

FBR-1 / FBR-C Page 39 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

3.4 Adverse effects on treated crops (KCP 6.4)

Adverse effects on treated crops (phytotoxicity symptoms) were observed during all the trials performed and presented on point 3.2.3 (Efficacy tests).

Table 3.4-1: Presentation of trials (same as table 3.2-5)

3.4.1 Phytotoxicity to host crop (KCP 6.4.1)

A total of 10 21 efficacy trials were carried out, under GEP (8 19) and non-GEP (2) conditions, to evaluate the efficacy of FBR-1 against downy mildew (Plasmopara viticola) on grapevine. These trials were conducted in 2014 and in 2015 and in 2016 in France, Germany and Hungary:  France: 2 trials in 2014 and 4 trials in 2015 and 1 trial in 2016  Germany: 2 trials in 2015 and 5 trials in 2016  Hungary: 2 trials in 2015 and 5 trials in 2016

During these trials, 5 to 12 applications of FBR-1 were tested at the dose of 1 to 4 l/ha, at 10 days interval, alone or including in a program treatment. No phytotoxicity symptom caused by FBR-1 at the proposed and tested dose rate was recorded in all the trials.

In addition, 6 trials (3 in Germany and 3 in Bulgaria) where carried out in 2019. These trials are still ongoing, however, no phytotoxicity symptom caused by FBR-1 at the proposed and tested dose rate has been recorded for the first available assessments.

FBR-1 / FBR-C Page 40 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Phytotoxicity

During the efficacy trials phytotoxicity were evaluated. 5 to 12 applications of FBR-1 were tested at the dose of 1 to 4 l/ha, at 10 days interval, alone or including in a program treatment. No phytotoxicity symptom caused by FBR-1 at the proposed and tested dose rate was recorded in all the trials.

3.4.2 Effect on the yield of treated plants or plant product (KCP 6.4.2)

Not relevant. No additional data was provided.

3.4.3 Effects on the quality of plants or plant products (KCP 6.4.3)

Not relevant. No additional data was provided.

3.4.4 Effects on transformation processes (KCP 6.4.4)

According to the EPPO standard 293, trials on wine making process are required for products containing active substance(s) (or metabolite(s)) known to have caused unintentional effects on fermentation processes and characteristics of wine or effect on yeasts; or for product which unintentional effects cannot be excluded. Furthermore, according to the EPPO standard 293, these trials should be necessary as a last resort only. The residue definition in plant is the same for Potassium phosphonate and Fosetyl-Al: “Sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl (Regulation (EU) 2018/832)”. In this context, the residues in grapes treated by these products will be the same, and therefore, it can be reasonably concluded that the impact on fermentation processes and characteristics of wine of these products should be equivalent and similar. It can be noted that Potassium phosphonate, Phosphonates/Phosphites, as well as Fosetyl-Al, and their associated formulations, are well-known in Europe. Indeed, products containing Fosetyl-Al, Potassium Phosphonate, Disodium phosphonate and Phosphonates/Phosphites are authorized and used as PPPs and fertilizers in Europe since several years. In the international bibliography / national papers and documents of the “wine industry”, none of them show or identify a possible or known negative impact/effect of Po- tassium Phosphonate, Disodium phosphonate, Phosphonates/Phosphites or Fosetyl-Al products on the wine making process and wine characteristics. Despite this intensive use of these products on grapevine since several years, negative effects on wine making process and on characteristics of wine has never been shown nor suspected.

In Germany 4 products containing potassium phosphonates are authorized: Alginure Bio Schutz (007839- 00), Frutogard (007839-60), LBG-01F34 (027207-60) and Veriphos (027207-00). It can be noted that following their renewal authorization, the product LBG-01F34 (027207-60) and Veriphos (027207-00) are now classified in Germany “WG734: The use of the product may lead to delayed fermentation”, which is not the case of the 2 other authorized products Alginure Bio Schutz (007839-00), Frutogard (007839- 60).

In this context, new trials in fields have been started in 2019 (4 trials – 2 with red wine and 2 with white wine) in order to demonstrate no effect in real (field) conditions. Nevertheless, considering the application timing of the product FBR-1, the final reports will be available in May 2020. In this context, meantime, study plans are provided and a summary is detailed below (Tables 3.4-7 to 3.4-).

The final reports will be provided as soon as all the final reports will be available. Furthermore, as agreed according to the EPPO guideline 268, additional trials will be conducted in 2020 (second year of trials).

FBR-1 / FBR-C Page 41 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Effects on transformation processes

To date no trials on transformation process or taint tests are presented. 4 trials have been started in 2019, the final reports will be available in May 2020.

Potassium phosphonate/Phosphonates/Phosphites are well-known substances in Europe. In Germany 4 products containing potassium phosphonates are authorized: Alginure Bio Schutz, Frutogard, LBG-01F34 and Veriphos. Two products are classified with restriction-no WG734 (The use of the product may lead to de-layed fermentation). cMS should decide if this declara- tion should be made for this product in their countries.

3.4.5 Impact on treated plants or plant products to be used for propagation (KCP 6.4.5)

Not relevant. No additional data was provided.

3.5 Observations on other undesirable or unintended side-effects (KCP 6.5)

3.5.1 Impact on succeeding crops (KCP 6.5.1)

No additional data was provided as all the intended crops are perennial (grapevine).

3.5.2 Impact on other plants including adjacent crops (KCP 6.5.2)

Not relevant. No additional data was provided.

3.5.3 Effects on beneficial and other non-target organisms (KCP 6.5.3)

Detailed studies on the possible adverse effects to beneficial organisms are submitted and summarised in Part B, Section 9 (Ecotoxicology).

The fungicide FBR-C / FBR-1 (726 g/L potassium phosphonate) has been proposed for application in grapevine at a total maximum application rate of 24 L/ha and year (6 applications, max. rate per application: 4 L product/ha).Taking into account the potential disappearance of the active ingredient between the applications (using the maximum default value MAF of 3.2), this corresponds to 9.29 kg active substance/ha and year. Throughout the field trials on effectiveness and selectivity there have been no reports or observations to suggest a detrimental impact of FBR-C / FBR-1 on beneficial or non-target organisms. Appropriate studies on the potential adverse effects on beneficial arthropods were available from Registration Report Part B, Section 9, Annex Point A2.3.2 KCP 10.3.2 9.7(Effects on arthropods other than bees), Core Assessment.

The toxicity of FBR-C / FBR-1 have been tested by carrying out

- laboratory tests on Aphidius rhopalosiphi. - extended laboratory tests on Typhlodromus pyri.

When laboratory tests and higher tier tests were available for the same species, only the results FBR-1 / FBR-C Page 42 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016 from the higher tier test are being used for the assessment. These results are presented in Ta- ble 3.5.3-1.

Table 3.5.3-1: Effects of FBR-1 on beneficial arthropods in laboratory tests and extended laboratory tests. Species Substrate Rate Corrected Sublethal Reference (Exposed Stage) active Mortality Effect ingredient [%] [%] [g/ha] Aphidius glass BT149/15 11568 16.3 -4.1 rhopalosiphi (A) Colli, 2016 Typhlodromus Bean leave BT148/15 11568 9.5 7.5 pyri (PN) disc Venturi, 2016 A = adults, PN = protonymphs

On the basis of the presented results no effects > 30% for populations of Aphidius rhopalosiphi and no effects > 25% for populations of Typhlodromus pyri are expected when FBR-C / FBR-1 is applied according to the recommended use pattern. However, Aphidius rhopalosiphi is not a relevant antagonist in the proposed crops. The results indicate that the recommended application of FBR-C Input Plus has no effects > 30% on populations of relevant beneficial insects when applied in the proposed crops.

Classification scheme of the effects:

Laboratory tests on artificial substrates (glass, quartz sand) < 30% = not harmful 30 – 80% = slightly harmful > 80% = harmful Extended laboratory tests on natural substrates, semi-field and field tests < 25% = not harmful 25 – 50% = slightly harmful > 50% = harmful

Proposal for classification:

FBR-C / FBR-1 is classified as: - not harmful for the predatory mite Typhlodromus pyri. - not harmful for populations of relevant beneficial insectsthe parasitoid wasp Aphidius rhopalosiphi.

Summary and conclusion on other undesirable or unintended side-effects

Adverse effects on beneficial organisms (other than bees)

Concerning the toxicity to relevant beneficial organisms, FBR-C is classified as not harmful for the predatory mite Typhlodromus pyri and as not harmful for populations of relevant beneficial insects.

Adverse effects on soil quality indicators (e. g. microorganisms, earthworms) are considered in Section 9 Ecotoxicological Studies in the Registration Report.

FBR-1 / FBR-C Page 43 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

3.6 Other/special studies

Not relevant. No additional data was provided.

3.7 List of test facilities including the corresponding certificates

Please refer to the BAD dossier.

FBR-1 / FBR-C Page 44 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Appendix 1 Lists of data considered in support of the evaluation

Tables considered not relevant can be deleted as appropriate. MS to blacken authors of vertebrate studies in the version made available to third parties/public.

List of data submitted by the applicant and relied on

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 6-01 David Guest and 1991 The complex action of phosphonates as antifungal agents. N Literature Bruce Grant Biol. Rev., 66, 159-187 Non GEP Published KCP 6-02 M.D. Coffet and D.G. 1988 Phosphonates: antifungal compounds against oomycetes. N Literature Ouimette Nitrogen, Phosphorous and Sulphur Utilization by Fungi. Symposium of the British Mycological Society, April 1988, Cambridge University Press, 316, 106-128 Non GEP Published KCP 6-03 M.E. Fenn and M.D. 1984 Studies on the in vitro and in vivo antifungal activity of Fosetyl-Al and Phosphorous acid. N Literature Coffey Phytopathology, 74, 606-611 Non GEP Published KCP 6-04 M.E. Fenn and M.D. 1985 Further evidance for the direct mode of action of Fosetyl-Al and phosphorous acid. N Literature Coffey Phytopathology, 75, 1064-1068 Non GEP Published FBR-1 / FBR-C Page 45 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 6-05 T.E. Dolan and M.D. 1988 Correlative in vitro and in vivo behavior of mutant strains of Phytophthora palmivora expressing different N Literature Coffey resistances to phosphorous acid and Fosetyl-Al. Phytopathology, 78, 974-978 Non GEP Published KCP 6-06 M.E. Fenn and M.D. 1989 Quantification of phosphonate and ethyl phosphonate in tobacco and tomato tissues and significance for N Literature Coffey the mode of action of two phosphonate fungicides. Phytopathology, 79, 76-82 Non GEP Published KCP 6-07 D.G. Ouimette and 1989 Phosphonate levels in avocado (Persea americana) seedling and soil following treatment with Fosetyl-Al N Literature M.D. Coffey or potassium phosphonate. Plant Disease, 73, 212-215 Non GEP Published KCP 6-08 P. Saindrenan, T. 1988 Effects of phosphite on phytoalexin accumulation in leaves of cowpea infected with Phytophthora N Literature Barchietto, J. Avelino cryptogea. and G. Bompeix Physiological and Molecular Plant Pathology, 32, 425-435 Non GEP Published KCP 6.2- Estelle Perrin 2016 Evaluated the efficacy of different treatments against mildew on grapevine in Germany. 2015. N Fitosanitarios 01 SGS AGRI MIN, Report 15-00609-01 Bajo Riesgo KCP 6.3- GEP AIE 01 Not published KCP 6.2- Estelle Perrin 2016 Evaluated the efficacy of different treatments against mildew on grapevine in Germany. 2015. N Fitosanitarios 02 SGS AGRI MIN, Report 15-00609-02 Bajo Riesgo KCP 6.3- GEP AIE 02 Not published FBR-1 / FBR-C Page 46 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 6.2- Estelle Perrin 2016 Evaluated the efficacy of different treatments against mildew on grapevine in Hungary in 2015. N Fitosanitarios 03 SGS AGRI MIN, Report 15-00506-01 Bajo Riesgo KCP 6.3- GEP AIE 03 Not published KCP 6.2- Estelle Perrin 2016 Evaluated the efficacy of different treatments against mildew on grapevine in Hungary in 2015. N Fitosanitarios 04 SGS AGRI MIN, Report 15-00506-02 Bajo Riesgo KCP 6.3- GEP AIE 04 Not published KCP 6.2- Daniel Novoa 2014 Eurion trial experimental fungicide ECX against downy mildew (Plasmoparaviticola). N Fitosanitarios 05 NOVEX, Report dn14-36-Eur-M-VdM3 Bajo Riesgo KCP 6.3- GEP AIE 05 Not published KCP 6.2- Ata Dghim 2014 Efficacy of FBR-1 against downy mildew (plasmapora viticola) on grapevine in France in 2014. N Fitosanitarios 06 University of Sciences, Report Vigne-Fr-01 Bajo Riesgo KCP 6.3- No GEP AIE 06 Not published KCP 6.2- Ata Dghim 2015 Efficacy of FBR-1 against downy mildew (plasmapora viticola) on grapevine in France in 2015. N Fitosanitarios 07 University of Sciences, Report Vigne-Fr-02 Bajo Riesgo KCP 6.3- No GEP AIE 07 Not published KCP 6.2- Estelle Perrin 2016 Evaluated the efficacy of different treatments against mildew on grapevine in France in 2015. N Fitosanitarios 08 SGS AGRI MIN, Report 15-00560-02 Bajo Riesgo KCP 6.3- GEP AIE 08 Not published KCP 6.2- Estelle Perrin 2016 Evaluated the efficacy of different treatments against mildew on grapevine in France in 2015. N Fitosanitarios 09 SGS AGRI MIN, Report 15-00560-03 Bajo Riesgo KCP 6.3- GEP AIE 09 Not published FBR-1 / FBR-C Page 47 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 6.2- Estelle Perrin 2016 Evaluated the efficacy of different treatments against mildew on grapevine in France in 2015. N Fitosanitarios 10 SGS AGRI MIN, Report 15-00560-04 Bajo Riesgo KCP 6.3- GEP AIE 10 Not published KCP 6.2- Audrey PAUGAUD 2017 Evaluation of efficacy of product coded FBR-1 alone or in association on fungicide program against N Fitosanitarios 11 downy mildew (Plasmopara viticola) on grapevine, in France, in 2016. Bajo Riesgo KCP 6.3- SGS AGRI MIN, Report 16-00676-03 AIE 11 GEP Not published KCP 6.2- José Antonio 2017 Determination of efficacy of FBR-1 against downy mildew (Plamopara viticola) in grapevine 2016 N Fitosanitarios 12 Martinez garcia Trialcamp S.L.U., Report EUR16V02-07F Bajo Riesgo KCP 6.3- GEP AIE 12 Not published KCP 6.2- José Antonio 2017 Determination of efficacy of FBR-1 against downy mildew (Plamopara viticola) in grapevine 2016 N Fitosanitarios 13 Martinez garcia Trialcamp S.L.U., Report EUR16V02-08F Bajo Riesgo KCP 6.3- GEP AIE 13 Not published KCP 6.2- José Antonio 2017 Determination of efficacy of FBR-1 against downy mildew (Plamopara viticola) in grapevine 2016 N Fitosanitarios 14 Martinez garcia Trialcamp S.L.U., Report EUR16V02-09F Bajo Riesgo KCP 6.3- GEP AIE 14 Not published KCP 6.2- Audrey PAUGAUD 2017 Evaluation of efficacy of product coded FBR-1 alone or in association on fungicide program against N Fitosanitarios 15 downy mildew (Plasmopara viticola) on grapevine, in Germany, in 2016. Bajo Riesgo KCP 6.3- SGS AGRI MIN, Report 16-00711-01 AIE 15 GEP Not published FBR-1 / FBR-C Page 48 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 6.2- Audrey PAUGAUD 2017 Evaluation of efficacy of product coded FBR-1 alone or in association on fungicide program against N Fitosanitarios 16 downy mildew (Plasmopara viticola) on grapevine, in Germany, in 2016. Bajo Riesgo KCP 6.3- SGS AGRI MIN, Report 16-00711-02 AIE 16 GEP Not published KCP 6.2- José Antonio 2017 Determination of efficacy of FBR-1 against downy mildew (Plamopara viticola) in grapevine 2016 N Fitosanitarios 17 Martinez garcia Trialcamp S.L.U., Report EUR16V02-10F Bajo Riesgo KCP 6.3- GEP AIE 17 Not published KCP 6.2- José Antonio 2017 Determination of efficacy of FBR-1 against downy mildew (Plamopara viticola) in grapevine 2016 N Fitosanitarios 18 Martinez garcia Trialcamp S.L.U., Report EUR16V02-11F Bajo Riesgo KCP 6.3- GEP AIE 18 Not published KCP 6.2- José Antonio 2017 Determination of efficacy of FBR-1 against downy mildew (Plamopara viticola) in grapevine 2016 N Fitosanitarios 19 Martinez garcia Trialcamp S.L.U., Report EUR16V02-12F Bajo Riesgo KCP 6.3- GEP AIE 19 Not published KCP 6.2- Audrey PAUGAUD 2017 Evaluation of efficacy of product coded FBR-1 alone or in association on fungicide program against N Fitosanitarios 20 downy mildew (Plasmopara viticola) on grapevine, in Hungary, in 2016. Bajo Riesgo KCP 6.3- SGS AGRI MIN, Report 16-00677-01 AIE 20 GEP Not published KCP 6.2- Audrey PAUGAUD 2017 Evaluation of efficacy of product coded FBR-1 alone or in association on fungicide program against N Fitosanitarios 21 downy mildew (Plasmopara viticola) on grapevine, in Hungary, in 2016. Bajo Riesgo KCP 6.3- SGS AGRI MIN, Report 16-00677-02 AIE 21 GEP Not published FBR-1 / FBR-C Page 49 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 6.2- Bastian Lorenz 2019 Interim Report: Efficacy and Selectivity evaluation of FBR-1 for the control of downy mildew in grape; N Fitosanitarios 22 Germany; MAR; 2019 Bajo Riesgo KCP 6.3- BioChem agar GmbH, Report OUT19-004-931FE AIE 22 GEP Not published KCP 6.2- Bastian Lorenz 2019 Interim Report: Efficacy and Selectivity evaluation of FBR-1 for the control of downy mildew in grape; N Fitosanitarios 23 Germany; MAR; 2019 Bajo Riesgo KCP 6.3- BioChem agar GmbH, Report OUT19-005-931FE AIE 23 GEP Not published KCP 6.2- Bastian Lorenz 2019 Interim Report: Efficacy and Selectivity evaluation of FBR-1 for the control of downy mildew in grape; N Fitosanitarios 24 Germany; MAR; 2019 Bajo Riesgo KCP 6.3- BioChem agar GmbH, Report OUT19-006-931FE AIE 24 GEP Not published KCP 6.2- Paolo Viglione 2019 Efficacy and Selectivity evaluation of FBR-1 for the control of Downy mildew in grapevine – Bulgaria N Fitosanitarios 25 2019 Bajo Riesgo KCP 6.3- SAGEA ood, Report OUT19-001-931FE AIE 25 GEP Not published KCP 6.2- Paolo Viglione 2019 Efficacy and Selectivity evaluation of FBR-1 for the control of Downy mildew in grapevine – Bulgaria N Fitosanitarios 26 2019 Bajo Riesgo KCP 6.3- SAGEA ood, Report OUT19-002-931FE AIE 26 GEP Not published KCP 6.2- Paolo Viglione 2019 Efficacy and Selectivity evaluation of FBR-1 for the control of Downy mildew in grapevine – Bulgaria N Fitosanitarios 27 2019 Bajo Riesgo KCP 6.3- SAGEA ood, Report OUT19-003-931FE AIE 27 GEP Not published FBR-1 / FBR-C Page 50 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 6.4.4- - 2019 Study plan: Study of unintentional effects of FBR-1 on fermentation processes and characteristics of N Fitosanitarios 01 wine; Germany 2019 Bajo Riesgo (2 trials – 1 on whiote wine and 1 on red wine) AIE Agri2000 GEP Not published KCP 6.4.4- - 2019 Study plan: Study of unintentional effects of FBR-1 on fermentation processes and characteristics of N Fitosanitarios 02 wine; Bulgary 2019 Bajo Riesgo (2 trials – 1 on whiote wine and 1 on red wine) AIE Agri2000 GEP Not published MCP Fitosanitarios Bajo 2016 dRR - B10 - core - DE - 008632-00/00 - FBR-C N Fitosanitarios Section 10 Riesgo Bajo

O/O N 3315378/520672 MCP Fitosanitarios Bajo 2016 dRR - B10 - core - DE - 008632-00/00 - FBR-C N Fitosanitarios Section 10 Riesgo Bajo

O/O N 3315380/520673 FBR-1 / FBR-C Page 51 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

MCP Fitosanitarios Bajo 2016 dRR - B3 - core - DE - 008632-00/00 - FBR-C N Fitosanitarios Section 3 Riesgo Bajo

O/O N 3315386/520676 MCP Fitosanitarios Bajo 2016 dRR - B3 - core - DE - 008632-00/00 - FBR-C N Fitosanitarios Section 3 Riesgo Bajo

O/O N 3315387/520677 MCP Fitosanitarios Bajo 2016 dRR - B3 - core - DE - 008632-00/00 - FBR-C N Fitosanitarios Section 3 Riesgo Bajo

O/O N 3315390/520678 MCP Fitosanitarios Bajo 2016 dRR - B3 - core - DE - 008632-00/00 - FBR-C N Fitosanitarios Section 3 Riesgo Bajo

O/O N 3315391/520679 FBR-1 / FBR-C Page 52 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

MCP Fitosanitarios Bajo 2016 dRR - B1-B2-B4 - core - DE - 008632-00/00 - FBR-C N Fitosanitarios Section 1 Riesgo Bajo

O/O N 3315727/520680 MCP Fitosanitarios Bajo 2016 dRR - B1-B2-B4 - core - DE - 008632-00/00 - FBR-C N Fitosanitarios Section 1 Riesgo Bajo

O/O N 3315728/520681 MCP Fitosanitarios Bajo 2017 dRR - B9 - core - DE - 008632-00/00 - FBR-C N Fitosanitarios Section 9 Riesgo Bajo

O/O N 3315769/520682 MCP Fitosanitarios Bajo 2017 dRR - B9 - core - DE - 008632-00/00 - FBR-C N Fitosanitarios Section 9 Riesgo Bajo

O/O N 3315771/520683 FBR-1 / FBR-C Page 53 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

MCP Fitosanitarios Bajo 2017 dRR - B9 - nat. - DE - 008632-00/00 - FBR-C N Fitosanitarios Section 9 Riesgo Bajo

O/O N 3315772/520684 MCP Fitosanitarios Bajo 2017 dRR - B9 - nat. - DE - 008632-00/00 - FBR-C N Fitosanitarios Section 9 Riesgo Bajo

O/O N 3315773/520685 MCP Fitosanitarios Bajo 2016 dRR - B6 - core - DE - 008632-00/00 - FBR-C N Fitosanitarios Section 6 Riesgo Bajo

O/O N 3316879/520690 MCP Fitosanitarios Bajo 2016 dRR - B6 - core - DE - 008632-00/00 - FBR-C N Fitosanitarios Section 6 Riesgo Bajo

O/O N 3316881/520691 FBR-1 / FBR-C Page 54 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 6.2 Novoa, D. 2014 Eurion trial experimental fungicide ECX against downy mildew(Plasmoparaviticola) N EURION Consulting dn14-36-Eur-M-VdM3!FFIT14969

O/J N 3338357/520708 KCP 6.2 Dghim, A. A. 2014 Efficacy of FBR-1 against downy mildew (Plasmapora viticola) ongrapevine in France in 2014 N EURION Consulting Vigne-Fr-01

O/N N 3338359/520709 KCP 6.2 Dghim, A. A. 2015 Efficacy of FBR-1 against downy mildew (Plasmapora viticola) ongrapevine in France in 2015 N EURION Consulting Vigne-Fr-02

O/N N 3338361/520710 KCP 3.8 Anonymous 2016 Entwurf der Gebrauchsanleitung (Word) N Fitosanitarios Bajo

O/N N 3338392/520711 FBR-1 / FBR-C Page 55 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 3.8 Anonymous 2016 Entwurf der Gebrauchsanleitung (PDF) N Fitosanitarios Bajo

O/N N 3338394/520712 MCP Fitosanitarios Bajo 2016 dRR - B3 - core - DE - 008838-00/00 - FBR-A N Fitosanitarios Section 3 (pdf) Bajo

O/O N 3406878/520718 MCP Fitosanitarios Bajo 2016 dRR - B3 - core - DE - 008838-00/00 - FBR-A N Fitosanitarios Section 3 Bajo

O/O N 3406880/520719 FBR-1 / FBR-C Page 56 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 6.3 Perrin, E and Nora 2016 SGS AGRI MIN GEP Trial Report: Evaluate the efficacy of different treatments against mildew N EURION P.D. on grapevine in France in 2015 Consulting 15-00560-02

O/J N 3408462/520722 KCP 6.3 Perrin, E and Nora 2016 SGS AGRI MIN GEP Trial Report: Evaluate the efficacy of different treatments against mildew N EURION P.D. on grapevine in France in 2015 Consulting 15-00560-03

O/J N 3408464/520723 KCP 6.3 Perrin, E and Nora 2016 SGS AGRI MIN GEP Trial Report: Evaluate the efficacy of different treatments against mildew N EURION P.D. on grapevinein France in 2015 Consulting 15-00560-04

O/J N 3408466/520724 FBR-1 / FBR-C Page 57 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 6.3 Perrin, E and Nora 2016 SGS AGRI MIN GEP Trial Report; Evaluate the efficacy of different treatments against mildew N EURION P.D. on grapevine in Germany 2015 Consulting 15-00609-01

O/J N 3408468/520725 KCP 6.3 Perrin, E and Nora 2016 SGS AGRI MIN GEP Trial Report: Evaluate the efficacy of different treatments against mildew N EURION P.D. on grapevine in Germany 2015 Consulting 15-00609-02

O/J N 3408470/520726 KCP 6.3 Perrin, E and Nora 2016 SGS AGRI MIN GEP Trial Report: Evaluate the efficacy of different treatments against mildew N EURION P.D. on grapevine in Hungary in 2015 Consulting 15-00560-01

O/J N 3408472/520727 FBR-1 / FBR-C Page 58 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 6.3 Perrin, E and Nora 2016 SGS AGRI MIN GEP Trial Report: Evaluate the efficacy of different treatments against mildew N EURION P.D. on grapevine in Hungary in 2015 Consulting 15-00560-02

O/J N 3408474/520728 KCP 6.3 Novoa, D. 2014 Eurion trial experimental fungicide ECX against downy mildew(Plasmoparaviticola) N EURION Consulting dn14-36-Eur-M-VdM3!FFIT14969

O/J N 3408476/520729 KCP 6.3 Dghim, A. A. 2014 Efficacy of FBR-1 against downy mildew (Plasmapora viticola) ongrapevine in France in 2014 N EURION Consulting Vigne-Fr-01

O/N N 3408478/520730 FBR-1 / FBR-C Page 59 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 6.3 Dghim, A. A. 2015 Efficacy of FBR-1 against downy mildew (Plasmapora viticola) ongrapevine in France in 2015 N EURION Consulting Vigne-Fr-02

O/N N 3408480/520731 KCP 3.8 Anonyomous 2017 Entwurf der Gebrauchsanleitung überarbeitet N Fitosanitarios Bajo

O/O N 3409196/520754 KCP 3.8 Anonymous 2017 Entwurf der Gebrauchsanleitung überarbeitet (PDF) N Fitosanitarios Bajo

O/O N 3409198/520755 KCP Anonymous 2017 Efficacy Data and Information - Detailed summary - BAD N Fitosanitarios Section 6 Bajo

N/N N 3409211/520756 FBR-1 / FBR-C Page 60 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP Anonymous 2017 Efficacy Data and Information - Detailed summary - BAD N Fitosanitarios Section 6 Bajo

N/N N 3409213/520757 Document Fitosanitarios Bajo 2017 dRR - B0 - core - DE - 008632-00/00 - FBR-C N Fitosanitarios N Riesgo Bajo

O/O N 3449025/520758 Document Fitosanitarios Bajo 2017 dRR - A - DE - 008632-00/00 - FBR-C N Fitosanitarios N Riesgo Bajo

O/O N 3449026/520759 Document Fitosanitarios Bajo 2017 dRR - A - DE - 008632-00/00 - FBR-C N Fitosanitarios N Riesgo (pdf) Bajo

O/O N 3450030/520760 FBR-1 / FBR-C Page 61 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

Document Fitosanitarios Bajo 2017 dRR - B0 - core - DE - 008632-00/00 - FBR-C N Fitosanitarios N Riesgo (pdf) Bajo

O/O N 3450032/520761 Document Fitosanitarios Bajo 2019 COMPLEMENTARY INFORMATION CONCERNING THE REGISTRATION OF THE N Fitosanitarios N Riesgo AIE PLANT PROTECTION PRODUCT FBR-C Bajo

N/N N 3841775/594602 Document Fitosanitarios Bajo 2019 dRR - B0 - core - DE - 008632-00/00 FBR-C (word) N Fitosanitarios N Riesgo AIE Bajo

N/N N 3841787/594611 FBR-1 / FBR-C Page 62 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

Document Fitosanitarios Bajo 2019 dRR - B0 - core - DE - 008632-00/00 FBR-C (pdf) N Fitosanitarios N Riesgo AIE Bajo

N/N N 3841788/594612 MCP Fitosanitarios Bajo 2019 dRR - B6 - core - DE - 008632-00/00 FBR-C (word) N Fitosanitarios Section 6 Riesgo AIE Bajo

N/N N 3841789/594613 MCP Fitosanitarios Bajo 2019 dRR - B6 - core - DE - 008632-00/00 FBR-C (pdf) N Fitosanitarios Section 6 Riesgo AIE Bajo

N/N N 3841790/594614 MCP Fitosanitarios Bajo 2019 dRR - B9 - core - DE - 008632-00/00 FBR-C (word) N Fitosanitarios Section 9 Riesgo AIE Bajo

N/N N 3841791/594615 FBR-1 / FBR-C Page 63 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

MCP Fitosanitarios Bajo 2019 dRR - B9 - core - DE - 008632-00/00 FBR-C (pdf) N Fitosanitarios Section 9 Riesgo AIE Bajo

N/N N 3841792/594616 MCP Fitosanitarios Bajo 2019 dRR - B3 - core - DE - 008632-00/00 FBR-C (word) N Fitosanitarios Section 3 Riesgo AIE Bajo

N/N N 3841793/594617 MCP Fitosanitarios Bajo 2019 dRR - B3 - core - DE - 008632-00/00 FBR-C (pdf) N Fitosanitarios Section 3 Riesgo AIE Bajo

N/N N 3841794/594618 MCP Fitosanitarios Bajo 2019 BAD!!!! dRR - B3 - core - DE - 008632-00/00 FBR-C (word) N Fitosanitarios Section 3 Riesgo AIE Bajo

N/N N 3841795/594619 FBR-1 / FBR-C Page 64 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

MCP Fitosanitarios Bajo 2019 BAD!!!! dRR - B3 - core - DE - 008632-00/00 FBR-C (pdf) N Fitosanitarios Section 3 Riesgo AIE Bajo

N/N N 3841796/594621 Document Fitosanitarios Bajo 2019 dRR - A - DE - 008632-00/00 FBR-C (word) N Fitosanitarios N Riesgo AIE Bajo

N/N N 3841797/594622 Document Fitosanitarios Bajo 2019 dRR - A - DE - 008632-00/00 FBR-C (PDF) N Fitosanitarios N Riesgo AIE Bajo

N/N N 3841798/594623

The following tables are to be completed by MS FBR-1 / FBR-C Page 65 /65 Part B – Section 3 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version JulyAug.May 202016

List of data submitted by the applicant and not relied on

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP XX Author YYYY Title Y/N Owner Company Report N Source GLP/non GLP/GEP/non GEP Published/Unpublished

List of data relied on not submitted by the applicant but necessary for evaluation

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP XX Author YYYY Title Y/N Owner Company Report N Source GLP/non GLP/GEP/non GEP Published/Unpublished

DRAFT REGISTRATION REPORT Part B Section 5 Analytical Methods Detailed summary of the risk assessment

Product code: FBR-1 Product name(s): FBR-C Chemical active substance: Potassium phosphonates 726 g/L

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: Fitosanitarios Bajo Riesgo AIE Submission date: 29/07/2016 Finalisation date: July 2020 Product code: FBR-1/ Product name: FBR-C Page 2 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Version history

When What March 2020 dRR zRMS version 07/2020 Final RR zRMS version

Product code: FBR-1/ Product name: FBR-C Page 3 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Table of Contents

5 Analytical methods ...... 4 5.1 Conclusion and summary of assessment ...... 4 5.2 Methods used for the generation of pre-authorization data (KCP 5.1) ...... 5 5.2.1 Analysis of the plant protection product (KCP 5.1.1) ...... 5 5.2.1.1 Determination of active substance and/or variant in the plant protection product (KCP 5.1.1) ...... 5 5.2.1.2 Description of analytical methods for the determination of relevant impurities (KCP 5.1.1) ...... 7 5.2.1.3 Description of analytical methods for the determination of formulants (KCP 5.1.1) ...... 7 5.2.1.4 Applicability of existing CIPAC methods (KCP 5.1.1) ...... 7 5.2.2 Methods for the determination of residues (KCP 5.1.2) ...... 8 5.3 Methods for post-authorization control and monitoring purposes (KCP 5.2) ...... 9 5.3.1 Analysis of the plant protection product (KCP 5.2) ...... 9 5.3.2 Description of analytical methods for the determination of residues of potassium phosphonate (KCP 5.2) ...... 9 5.3.2.1 Overview of residue definitions and levels for which compliance is required ...... 9 5.3.2.2 Description of analytical methods for the determination of residues in plant matrices (KCP 5.2) ...... 10 5.3.2.3 Description of analytical methods for the determination of residues in animal matrices (KCP 5.2) ...... 11 5.3.2.4 Description of methods for the analysis of soil (KCP 5.2) ...... 11 5.3.2.5 Description of methods for the analysis of water (KCP 5.2) ...... 12 5.3.2.6 Description of methods for the analysis of air (KCP 5.2) ...... 12 5.3.2.7 Description of methods for the analysis of body fluids and tissues (KCP 5.2) ...... 13 5.3.2.8 Other studies/ information ...... 13

Appendix 1 Lists of data considered in support of the evaluation ...... 14

Appendix 2 Detailed evaluation of submitted analytical methods ...... 18 A 2.1 Analytical methods for potassium phosphonate ...... 18 A 2.1.1 Methods used for the generation of pre-authorization data (KCP 5.1) ...... 18 A 2.1.2 Methods for post-authorization control and monitoring purposes (KCP 5.2) ...... 18

Product code: FBR-1/ Product name: FBR-C Page 4 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

General comment of zRMS Germany as zRMS has written this section of the dRR/RR as part of the evaluation of the application for authorisation of the present product in accordance with article 33 of Regulation (EC) No 1107/2009. Thus, the document represents completely the results of the assessment conducted by the zRMS regarding the present product in the intended uses according to the application submitted by the applicant, unless stated otherwise.

Commenting boxes were used by zRMS for the detailed evaluation of studies in the dRR/RR. The description of the studies is based on the dRR originally submitted by the applicant. Some text passages therefore may be taken from the applicant´s dRR, however, the text will be adapted such that it in the end reflects the assessment of the zRMS based on the original studies.

5 Analytical methods

5.1 Conclusion and summary of assessment

Sufficiently sensitive and selective analytical methods are available for the active substance(s) and relevant impurities in the plant protection product.

Sufficiently sensitive and selective analytical methods are not available for all analytes included in the residue definitions.

Noticed data gaps are:  A sufficiently validated analytical method (primary and confirmatory method) for the determination of residues of potassium phosphonate (phosphonic acid and its salts, expressed as phosphonic acid) in plant matrices (high water content and high fat content) is missing.  An independent laboratory validation (ILV) of a method for the determination of residues of potassium phosphonate (phosphonic acid and its salts, expressed as phosphonic acid) in plant matrices (high water content, high fat content and dry commodities) is missing.  A statement on the extraction efficiency of the methods used for the determination of residues of potassium phosphonate (phosphonic acid and its salts, expressed as phosphonic acid) in plant matrices is missing.  An independent laboratory validation (ILV) of the method of Perboni (2018) for the determination of residues of potassium phosphonate (phosphonic acid and its salts, expressed as phosphonic acid) in drinking water is missing.  A sufficiently validated analytical method (primary and confirmatory method) for the determination of residues of potassium phosphonate (phosphonic acid and its salts, expressed as phosphonic acid) in body fluids and tissues is missing.

Commodity/crop Supported/ Not supported Grapes Supported

Product code: FBR-1/ Product name: FBR-C Page 5 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

5.2 Methods used for the generation of pre-authorization data (KCP 5.1)

5.2.1 Analysis of the plant protection product (KCP 5.1.1)

5.2.1.1 Determination of active substance and/or variant in the plant protection product (KCP 5.1.1)

An overview on the acceptable methods and possible data gaps for analysis of potassium phosphonate in plant protection product is provided as follows:

The following analytical methods for the determination of the potassium and the phosphonate in the active substance as manufactured have been developed and have not been previously evaluated at EU level.

 Analytical method for determination of the Potassium content

Comments of zRMS: The method for determination of the substance phosphonate was successfully validated according to SANCO/3030/99 rev.4. All relevant chromatograms are available. Raw data of the validation measurement is not available.

Reference: KCP 5.1.1-01 Report Potassium phosphonate: Validation of the analytical method for the determination of the potassium content, Simona Nichetti (2014), Report No.: CH-288/2014 Guideline(s): SANCO/3030/99 rev.4, 11/07/00 Deviations: Yes 1/ Test facility logo has been renewed thus header and footer in the report are different from Study plan 2/ The chemical nature of the Potassium, cationic substance, and the analytical conditions adjusted for this study, anion exchange column with me- hanesulfonic acid eluent, are not compatible with the mass detector. Moreo- ver, the very low and unspecific UV absorption of the active ingredient exclude also to use a diode array (DAD) detector. For these reasons it was not possible to conduct a confirmatory test, but just the specificity of this method and the coherence of the retention times among reference material and test item injected solutions leaves no doubt about the identity pf the analyte.

The study director declares that these deviations do not affect the outcome of the study. GLP: Yes Acceptability: Yes

Principle of method The determination of the Potassium content is performed by IC using an external standard and conductimetric detector.

Product code: FBR-1/ Product name: FBR-C Page 6 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Table 5.2-1: Methods suitable for the determination of potassium in plant protection product FBR-1

Potassium

Author(s), year Simona Nichetti, 2014 Principle of method IC using an external standard and conductimetric detector Linearity Concentration of the a.i.: 5.00 - 20.01 µg/mL (linear between mg/L / % range of the de- y = 0.0843*x -0.0308 clared content) r = 0.99929 (correlation coefficient, expressed as r) Precision – Repeatability RSD: 1.46 % Mean RSDr: 1.73 n = 6 Concentration of a.i: 18.3% w/w (mean value) (%RSD) Accuracy 98 - 102% n = 6 (spiking test at three levels, additon of 3.5 %, 8.8 % and 12.3 % of the nominal (% Recovery) concentration of a.i.) Interference/ Specificity A comparison of the chromatograms of the solvent wash (water), Potassium reference material and test item solution, shows that Potassium peak is well separated and there is no evidence of interferences with the technical sample. Comment -

Conclusion of the zRMS The method for determination of the substance potassium was successfully validated according to SAN- CO/3030/99 rev.4. All relevant chromatograms are available. Raw data of the validation measurement is not available.

 Analytical method for determination of the Phosphonate content

Reference: KCP 5.1.1-02 Report Potassium phosphonate: Validation of the analytical method for the determination of the phosphonate content, Simona Nichetti (2014), Report No.: CH-289/2014 Guideline(s): SANCO/3030/99 rev.4, 11/07/00 Deviations: Yes 1/ Test facility logo has been renewed thus header and footer in the report are different from Study plan 2/ The chemical nature of the Potassium, cationic substance, and the analytical conditions adjusted for this study, anion exchange column with me- hanesulfonic acid eluent, are not compatible with the mass detector. Moreo- ver, the very low and unspecific UV absorption of the active ingredient exclude also to use a diode array (DAD) detector. Product code: FBR-1/ Product name: FBR-C Page 7 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

For these reasons it was not possible to conduct a confirmatory test, but just the specificity of this method and the coherence of the retention times among reference material and test item injected solutions leaves no doubt about the identity pf the analyte.

The study director declares that these deviations do not affect the outcome of the study. GLP: Yes Acceptability: Yes

Table 5.2-2: Methods suitable for the determination of phosphonate in plant protection product FBR-1

Phosphonate

Author(s), year Simona Nichetti, 2014 Principle of method IC using an external standard and conductimetric detector Linearity Concentration of the a.i.: 4.90 - 19.58 µg/mL (linear between mg/L / % range of the de- y = 0.0728*x + 0.0116 clared content) r = 0.99 (correlation coefficient, expressed as r) Precision – Repeatability RSD: 0.78 % Mean RSDr: 1.59 n = 6 Concentration of the a.i.: 32.2% w/w (mean value). (%RSD) Accuracy 98 - 102% n = 6 (% Recovery) Interference/ Specificity A comparison of the chromatograms of the solvent wash (water), Phosphonate reference material and test item solution, shows that Phosphonate peak is well separated and there is no evidence of interferences with the technical sample. Comment -

5.2.1.2 Description of analytical methods for the determination of relevant impurities (KCP 5.1.1)

Not relevant as there is no relevant impurity in the product FBR-1

5.2.1.3 Description of analytical methods for the determination of formulants (KCP 5.1.1)

Not relevant.

5.2.1.4 Applicability of existing CIPAC methods (KCP 5.1.1)

No existing CIPAC method for analysis of the active substance.

Product code: FBR-1/ Product name: FBR-C Page 8 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

5.2.2 Methods for the determination of residues (KCP 5.1.2)

An overview on the acceptable methods for analysis of residues of potassium phosphonate for the generation of pre-authorization data is given in the following table. For the detailed evaluation of new/additional studies it is referred to Appendix 2.

Table 5.2-3: Validated methods for the generation of pre-authorization data

Component of residue definition: phosphonic acid and its salts, expressed as phosphonic acid

Author(s), year / missing / EU Matrix type Method type Method LOQ Principle of method agreed

Grapes, wine, wet Primary & 0.5 mg/kg LC-MS/MS, Schneider E., 2016 pomace, dry confirmatory Hypercarb column, Report B5274 pomace, juice, ESI-, m/z 81→79, ASB2018-928 raisins 81→63 see Appendix 2 (Residues) Soil Primary & 0.05 mg/kg LC-MS/MS, C18 Perboni A., 2016 (Environmental confirmatory column1, ESI-, m/z Report RAU-051-15 fate) 81→79, 81→63 ASB2018-931 see Appendix 2 Soil Primary 0.1 mg/kg GC-FPD, wax Kieken J.L., 1999 (Environmental column Report 99-135 (AR 214-99) fate) MET2003-89 EU agreed Soil Primary 0.1 mg/kg GC-TSD, wax Barbier G., 2004 (Environmental column Report 04-20 fate) ASB2008-4657 EU agreed Drinking water Primary 2 µg/L GC-FPD, wax Kieken J.L., 2000 (Environmental column Report 99-211 (AR 231-99) fate) MET2003-90 EU agreed Drinking water Primary 2 µg/L HPLC-ICP-MS, Ion Diot R., Guyot C., Kieken J.L., (Environmental Pak column 2001 fate) Report R&D/CRLD/AN/0015845 MET2003-91 EU agreed Surface water Primary & 0.2 µg/L LC-MS/MS, C18 Perboni A., 2016 (Environmental confirmatory column1, ESI-, m/z Report RAU-052-15 fate) 81→79, 81→63 ASB2018-932 see Appendix 2 Surface water Primary 4 µg/L GC-FPD, wax Kieken J.L., 2000 (Environmental column Report 99-211 (AR 231-99) fate) MET2003-90 EU agreed Air Primary & 10 µg/m3 LC-MS/MS, C18 Perboni A., 2016 (Environmental confirmatory column1, ESI-, m/z Report RAU-053-15 fate) 81→79, 81→63 ASB2018-933 see Appendix 2 Tape strips, Primary & con- 0.05 LC-MS/MS, Hyper- Egron, C.; 2019 cotton buds, skin, firmatory µg/specimen carb column, ESI-, Report S19-04939 receptor fluid (tape strips, skin) m/z 81→79, 81→63 ASB2020-2706 (Exposure: dermal 5 µg/specimen see Appendix 2 Product code: FBR-1/ Product name: FBR-C Page 9 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Component of residue definition: phosphonic acid and its salts, expressed as phosphonic acid

Author(s), year / missing / EU Matrix type Method type Method LOQ Principle of method agreed adsorption) (cotton buds) 8 µg/L (receptor fluid) 1 The use of a reversed phase column for a highly polar analyte is questionable.

5.3 Methods for post-authorization control and monitoring purposes (KCP 5.2)

5.3.1 Analysis of the plant protection product (KCP 5.2)

Analytical methods for the determination of the active substance and relevant impurities in the plant protection product shall be submitted, unless the applicant shows that these methods already submitted in accordance with the requirements set out in point 5.2.1 can be applied.

5.3.2 Description of analytical methods for the determination of residues of potassium phosphonate (KCP 5.2)

5.3.2.1 Overview of residue definitions and levels for which compliance is required

Compared to the residue definition proposed in the Draft Assessment Report (incl. its addenda) the current legal residue definition is not identical. While the current legal residue definition according to Regu- lation (EU) No 2019/552 is “fosetyl-Al (sum fosetyl, phosphonic acid and their salts, expressed as fosetyl)”, in the Conclusion on the peer review of the pesticide risk assessment of the active substance potassium phosphonate (EFSA Journal 2012;10(12):2963, ASB2012-16090) “phosphonic acid and its salts, expressed as phosphonic acid” is defined as the relevant residue for monitoring. The EU agreed residue definition was used for the present assessment.

Table 5.3-1: Relevant residue definitions for monitoring/enforcement and levels for which compliance is required

Matrix Residue definition MRL / limit Reference for MRL/level Remarks

Plant, high water content Phosphonic acid and its 2 mg/kg 1 EFSA conclusion, EFSA salts, expressed as Journal 2012;10(12):2963, phosphonic acid ASB2012-16090 Plant, high acid content 2 mg/kg 1 EFSA conclusion, EFSA Journal 2012;10(12):2963, ASB2012-16090 Plant, high protein/high 2 mg/kg 1 EFSA conclusion, EFSA starch content (dry Journal 2012;10(12):2963, commodities) ASB2012-16090 Plant, high oil content 2 mg/kg 1 EFSA conclusion, EFSA Journal 2012;10(12):2963, ASB2012-16090 Muscle Not required Not required EFSA conclusion, EFSA Product code: FBR-1/ Product name: FBR-C Page 10 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Matrix Residue definition MRL / limit Reference for MRL/level Remarks

Journal 2012;10(12):2963, ASB2012-16090 Milk Not required EFSA conclusion, EFSA Journal 2012;10(12):2963, ASB2012-16090 Eggs Not required EFSA conclusion, EFSA Journal 2012;10(12):2963, ASB2012-16090 Fat Not required EFSA conclusion, EFSA Journal 2012;10(12):2963, ASB2012-16090 Liver, kidney Not required EFSA conclusion, EFSA Journal 2012;10(12):2963, ASB2012-16090 Soil Phosphonic acid and its 0.05 mg/kg common limit (Ecotoxicology) salts, expressed as phosphonic acid Drinking water Phosphonic acid and its 0.1 µg/L general limit for drinking (Human toxicology) salts, expressed as water phosphonic acid

Surface water Phosphonic acid and its > 11800 µg/L LC50 O. mykiss (96h) (Ecotoxicology) salts, expressed as EC50 Daphnia magna (48h) phosphonic acid EFSA conclusion, EFSA Journal 2012;10(12):2963, ASB2012-16090 Air Phosphonic acid and its 1500 µg/m3 AOEL: 5 mg/kg bw/d salts, expressed as EFSA conclusion, EFSA phosphonic acid Journal 2012;10(12):2963, ASB2012-16090 Tissue (meat or liver) Phosphonic acid and its 0.1 mg/kg SANCO/825/00 rev. 8.1 salts, expressed as Body fluids 0.05 mg/L SANCO/825/00 rev. 8.1 phosphonic acid 1 MRL for Fosetyl-Al according to Regulation (EU) No 2019/552.

5.3.2.2 Description of analytical methods for the determination of residues in plant matrices (KCP 5.2)

An overview on the acceptable methods and possible data gaps for analysis of potassium phosphonate in plant matrices is given in the following table. For the detailed evaluation of new studies it is referred to Appendix 2.

Table 5.3-2: Validated methods for food and feed of plant origin

Component of residue definition: phosphonic acid and its salts, expressed as phosphonic acid

Author(s), year / missing / EU Matrix type Method type Method LOQ Principle of method agreed

High water Primary Missing Product code: FBR-1/ Product name: FBR-C Page 11 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Component of residue definition: phosphonic acid and its salts, expressed as phosphonic acid

Author(s), year / missing / EU Matrix type Method type Method LOQ Principle of method agreed content ILV Missing Confirmatory Missing (if required) High acid Primary & 0.5 mg/kg LC-MS/MS, Schneider E., 2016 content confirmatory Hypercarb column, Report B5274 ESI-, m/z 81→79, ASB2018-928 81→63 see Appendix 2 ILV 0.5 mg/kg LC-MS/MS, Signore E., 2016 Hypercarb column, Report RAU-071-18 ESI-, m/z 81→79, ASB2019-13929 81→63 see Appendix 2 High oil content Primary Missing ILV Missing Confirmatory Missing (if required) High Primary & 0.5 mg/kg LC-MS/MS, Schneider E., 2016 protein/high confirmatory Hypercarb column, Report B5274 starch content ESI-, m/z 81→79, ASB2018-928 (dry) 81→63 see Appendix 2 ILV Missing

For any special comments or remarkable points concerning the analytical methods for the determination of residues in plant matrices, please refer to Appendix 2.

Table 5.3-3: Statement on extraction efficiency

Method for products of plant origin

Required, available from: Missing

5.3.2.3 Description of analytical methods for the determination of residues in animal matrices (KCP 5.2)

Analytical methods for the determination of residues of potassium phosphonate in animal matrices are not required.

5.3.2.4 Description of methods for the analysis of soil (KCP 5.2)

An overview on the acceptable methods for analysis of potassium phosphonate in soil is given in the following table. For the detailed evaluation of new studies it is referred to Appendix 2. Product code: FBR-1/ Product name: FBR-C Page 12 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Table 5.3-4: Validated methods for soil

Component of residue definition: phosphonic acid and its salts, expressed as phosphonic acid

Method type Method LOQ Principle of method Author(s), year / missing

Primary & confirmatory 0.05 mg/kg LC-MS/MS, C18 column1, Perboni A., 2016 ESI-, m/z 81→79, 81→63 Report RAU-051-15 ASB2018-931 see Appendix 2 1 The use of a reversed phase column for a highly polar analyte is questionable.

For any special comments or remarkable points concerning the analytical methods for soil please refer to Appendix 2.

5.3.2.5 Description of methods for the analysis of water (KCP 5.2)

An overview on the acceptable methods and possible data gaps for analysis of potassium phosphonate in surface and drinking water is given in the following table. For the detailed valuation of new studies it is referred to Appendix 2.

Table 5.3-5: Validated methods for water

Component of residue definition: phosphonic acid and its salts, expressed as phosphonic acid Matrix type Method type Method LOQ Principle of method Author(s), year / missing Drinking water Primary & 0.1 µg/L LC-MS/MS, Hypercarb Perboni A., 2018 confirmatory column, ESI-, m/z Report RAU-069-18 81→79, 81→63 ASB2019-13930 see Appendix 2 ILV Missing Surface water Primary & 0.2 µg/L LC-MS/MS, C18 Perboni A., 2016 confirmatory column1, ESI-, m/z Report RAU-052-15 81→79, 81→63 ASB2018-932 see Appendix 2 1 The use of a reversed phase column for a highly polar analyte is questionable.

For any special comments or remarkable points concerning the analytical methods for water please refer to Appendix 2.

5.3.2.6 Description of methods for the analysis of air (KCP 5.2)

An overview on the acceptable methods for analysis of potassium phosphonate in air is given in the following table. For the detailed evaluation of new studies please refer to Appendix 2.

Table 5.3-6: Validated methods for air

Component of residue definition: phosphonic acid and its salts, expressed as phosphonic acid

Method type Method LOQ Principle of method Author(s), year / missing

Primary & confirmatory 10 µg/m3 LC-MS/MS, C18 column1, Perboni A., 2016 ESI-, m/z 81→79, 81→63 Report RAU-053-15 ASB2018-933 see Appendix 2 Product code: FBR-1/ Product name: FBR-C Page 13 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

1 The use of a reversed phase column for a highly polar analyte is questionable.

For any special comments or remarkable points concerning the analytical methods for air it is referred to Appendix 2.

5.3.2.7 Description of methods for the analysis of body fluids and tissues (KCP 5.2)

An overview on the acceptable methods and possible data gaps for analysis of potassium phosphonate in body fluids and tissues is given in the following table.

Table 5.3-7: Methods for body fluids and tissues

Component of residue definition: phosphonic acid and its salts, expressed as phosphonic acid

Matrix type Method type Method LOQ Principle of method Author(s), year / missing Body fluids Primary Missing Confirmatory Missing (if required) Body tissues Primary Missing Confirmatory Missing (if required)

5.3.2.8 Other studies/ information

None

Product code: FBR-1/ Product name: FBR-C Page 14 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Appendix 1 Lists of data considered in support of the evaluation

References

Title Company Report No. Author(s) Year Source (where different from company) GLP or GEP status Published or not

EFSA 2013 Conclusion on the peer review of the pesticide risk assessment of the active substance Potassium phosphonates EFSA Journal 2012;10(12):2963 ASB2012-16090

List of data submitted by the applicant and relied on

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP Simona Nichetti 2014 Potassium phosphonate: Validation of the analytical method for the determination of the potassium N Fitosanitarios 5.1.1/01 content de Bajo ChemService S.r.l., Report No.: CH-288/2014 Riesgo AIE GLP Unpublished 3322673 KCP Simona Nichetti 2014 Potassium phosphonate: Validation of the analytical method for the determination of the phosphonate N Fitosanitarios 5.1.1/02 content de Bajo ChemService S.r.l., Report No.: CH-289/2014 Riesgo AIE GLP Unpublished 3322674 Product code: FBR-1/ Product name: FBR-C Page 15 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 5.1.2 Egron, C. 2019 Validation of the analytical method for the determination of Phosphonic acid in the compartments of an N Fitosanitarios in-vitro human skin absorption study de Bajo S19-04939 Riesgo GLP: Yes Published: No ASB2020-2706 KCA 6.1, Schneider, E. 2016 Validation of the analytical method for the determination of Potassium Phosphonate in grapes whole fruits N Fitosanitarios KCP 5.1.2, and processed fractions (wine, wet pomace, dry pomace, juice and dried raisins) - final report - original 1 de Bajo KCP 5.2 of 2 Riesgo B5174 GLP: Yes Published: No ASB2018-928 KCP 5.1.2, Perboni, A. 2016 Validation of the analytical method to determine Potassium phosphonate residue in soil (sandy loam) N Fitosanitarios KCP 5.2 RAU-051-15 de Bajo GLP: Yes Published: No Riesgo ASB2018-931 KCP 5.1.2, Perboni, A. 2016 Validation of the analytical method to determine Potassium phosphonate residue in surface water N Fitosanitarios KCP 5.2 RAU-052-15 de Bajo GLP: Yes Published: No Riesgo ASB2018-932 KCP 5.1.2, Perboni, A. 2017 Validation of the analytical method to determine Potassium phosphonate residue in air N Fitosanitarios KCP 5.2 RAU-053-15 de Bajo GLP: Yes Published: No Riesgo ASB2018-933 KCP 5.2 Perboni, A. 2018 Validation of the analytical method to determine Potassium phosphonate in drinking water N Fitosanitarios RAU-069-18 de Bajo GLP: Yes Published: No Riesgo ASB2019-13930 KCP 5.2 Signore, E. 2018 Independent laboratory validation of analytical method for the determination of Potassium phosphonates N Fitosanitarios in grapes, validated in the study "Validation of the analytical method for the determination of Potassium de Bajo Product code: FBR-1/ Product name: FBR-C Page 16 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

phosphonate in grapes whole fruits and processed fractions (wine, wet pomace, dry pomace, juice and Riesgo dried raisins) - Report No. B5174 by ANADIAG RAU-071-18 GLP: Yes Published: No ASB2019-13929

List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 5.1.2, Barbier, G. 2004 Fosetyl: Confirmatory method for the determination of fosetyl-Al and its metabolite phosphorous acid in N Bayer KCP 5.2 soil CropScience 04-20 GLP: Open Published: Open ASB2008-4657 KCP 5.1.2, Diot, R.; Guyot, C. 2001 Phosphorous acid: Evaluation of the HPLC/ICP/MS technique for the determination of residues in N Bayer KCP 5.2 ; Kieken, J. L. drinking water and surface water CropScience R&D/CRLD/AN/0015845 GLP: Open Published: Open MET2003-91 KCP 5.1.2, Kieken, J. L. 1999 Fosetyl-AI and its metabolite (phosphorous acid): Analytical method for the determination of residues in N Aventis KCP 5.2 soils CropScience 99-135 (AR 214-99) GLP: Open Published: Open MET2003-89 Product code: FBR-1/ Product name: FBR-C Page 17 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 5.1.2, Kieken, J. L. 2000 Fosetyl-AI and its metabolite (phosphorous acid): Analytical method for the determination of residues in N Aventis KCP 5.2 drinking water and surface water CropScience 99-211 (AR 231-99) GLP: Open Published: Open MET2003-90

List of data submitted by the applicant and not relied on

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

– – – – – –

List of data relied on not submitted by the applicant but necessary for evaluation

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

– – – – – –

Product code: FBR-1/ Product name: FBR-C Page 18 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Appendix 2 Detailed evaluation of submitted analytical methods

A 2.1 Analytical methods for potassium phosphonate

A 2.1.1 Methods used for the generation of pre-authorization data (KCP 5.1)

A new validation of the analytical method for the determination of phosphonic acid in the compartments of an in-vitro human skin absorption study was submitted by the applicant. This study has not previously evaluated within a peer reviewed process at EU level and is therefore briefly described in A 2.1.1.1.

All other methods submitted for the generation of pre-authorization data are also methods for post- authorization control and monitoring purposes. For detailed evaluation, please refer to A 2.1.2.

A 2.1.1.1 Analytical method for a dermal adsorption study

Comments of zRMS: Acceptable according to SANCO/3029/99 rev.4

Reference: KCP 5.1.2 Report Validation of the analytical method for the determination of Phosphonic acid in the compartments of an in-vitro human skin absorption study; Egron, C.; 2019, Study code S19-04939, ASB2020-2706 Guideline(s): SANCO/825/00 rev. 8.1 Deviations: No GLP: Yes Acceptability: Yes

Conclusion by the zRMS: In brief, samples of tape strips and washing (cotton-buds) were extracted with MeOH LC/MS grade + 1% formic acid. Samples of skin were extracted with water LC/MS grade + 1% formic acid. Receptor fluid was diluted. All the samples were shaken for 30 min on a multi-vortex. All extracts were analyed by LC- MS/MS in ESI- mode, using a Hypercarb column and monitoring the ion ransitions m/z 81→79 and 81→63.

The method is sufficiently validated according to the number of fortifications levels (2) and the number of fortified samples per level (5), the recovery, the repeatability, the selectivity (blank value) and the calibration. Validated LOQs are 0.05 µg/specimen for tape strips and skin; 5 µg/specimen for cotton buds and 8 µg/L for the receptor fluid.

A 2.1.2 Methods for post-authorization control and monitoring purposes (KCP 5.2)

A 2.1.2.1 Description of analytical methods for the determination of residues in plant matrices (KCP 5.2) Product code: FBR-1/ Product name: FBR-C Page 19 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

A 2.1.2.1.1 Analytical method 1

A 2.1.2.1.1.1 Method validation

Comments of zRMS: Acceptable according to SANCO/825/00 rev. 8.1.

Reference: KCP 5.2-01 Report Validation of the analytical method for the determination of Potassium Phosphonate in grapes whole fruits and processed fractions (wine, wet pomace, dry pomace, juice and dried raisins) - final report - original 1 of 2; Schneider E.; 2016, Report R B5174, Study B5174; ASB2018-928 Guideline(s): SANCO/825/00 rev. 8.1 SANCO/3029/99 rev. 4 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods Residues of phosphonic acid are extracted from samples of grapes, wine, wet pomace, dry pomace, juice and dried raisins by shaking with methanol. After centrifugation or filtration (for pomace), the extracts of all matrices are cleaned-up on an active carbon cartridge. Final determination is performed by LC-MS/MS using a Thermo Hypercarb column with electrospray ionisation in negative mode (m/z 81→79, 81→63). Quantification is performed by calibration with external standards in solvent or matrix matched standards (dry pomace).

Results and discussions

Table A 1: Recovery results from method validation of phosphonic acid using the analytical method

Fortification Mean Matrix Analyte level (mg/kg) RSD (%) Comments recovery (%) (n = x) Grapes Phosphonic acid 0.5 (5) 109 4.1 m/z 81→79 5 (5) 90 1.9 Wine Phosphonic acid 0.5 (5) 110 1.2 m/z 81→79 5 (5) 93 0.9 Wet pomace Phosphonic acid 0.5 (5) 91 5.1 m/z 81→79 5 (5) 82 4.1 Dry pomace Phosphonic acid 0.5 (5) 81 3.6 m/z 81→79 5 (5) 88 2.5 Juice Phosphonic acid 0.5 (5) 105 1.9 m/z 81→79 5 (5) 91 2.1 Dried raisins Phosphonic acid 0.5 (5) 98 3.2 m/z 81→79 5 (5) 74 1.8 Grapes Phosphonic acid 0.5 (5) 110 1.8 m/z 81→63 Wine Phosphonic acid 0.5 (5) 109 1.1 Product code: FBR-1/ Product name: FBR-C Page 20 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Fortification Mean Matrix Analyte level (mg/kg) RSD (%) Comments recovery (%) (n = x) m/z 81→63 Wet pomace Phosphonic acid 0.5 (5) 75 4.9 m/z 81→63 Dry pomace Phosphonic acid 0.5 (5) 93 2.8 m/z 81→63 Juice Phosphonic acid 0.5 (5) 110 2.8 m/z 81→63 Dried raisins Phosphonic acid 0.5 (5) 92 3.6 m/z 81→63

Table A 2: Characteristics for the analytical method used for validation of phosphonic acid residues in several matrices

Phosphonic acid Phosphonic acid

m/z 81→79 m/z 81→63 Specificity mass spectrum is provided mass spectrum is provided blank value < 30% of LOQ blank value < 30% of LOQ Calibration (type, number of data points) individual calibration data individual calibration data presented| presented| calibration line equation calibration line equation presented presented number of data points: 7 number of data points: 7 (pomace), 6 (others) (pomace), 6 (others) Calibration range Accepted calibration range in Accepted calibration range in concentration units: concentration units: 15-600 ng/mL (pomace) 15-600 ng/mL (pomace) 30-1200 ng/mL (others) 30-1200 ng/mL (others) Corresponding calibration Corresponding calibration range in mass ratio units for range in mass ratio units for the sample: the sample: 0.15-6 mg/kg 0.15-6 mg/kg Assessment of matrix effects is presented yes yes Limit of determination/quantification 0.5 mg/kg 0.5 mg/kg

A 2.1.2.1.1.2 Independent laboratory validation

Comments of zRMS: Acceptable according to SANCO/825/00 rev. 8.1.

Reference: KCP 5.2 Report Independent laboratory validation of analytical method for the determination of Potassium phosphonates in grapes, validated in the study "Validation Product code: FBR-1/ Product name: FBR-C Page 21 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

of the analytical method for the determination of Potassium phosphonate in grapes whole fruits and processed fractions (wine, wet pomace, dry pomace, juice and dried raisins) - Report No. B5174 by ANADIAG; Signore E.; 2018; Report RAU-071-18, Study RAU-071-18; ASB2019-13929 Guideline(s): SANCO/825/00 rev. 8.1 SANCO/3029/99 rev. 4 OECD ENV/JM/MONO(2007)17 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods Residues of phosphonic acid are extracted from grape samples by shaking with methanol. After centrifugation, the extract is cleaned-up on an active carbon cartridge. Final determination is performed by LC-MS/MS using a Thermo Hypercarb column with electrospray ionisation in negative mode (m/z 81→79, 81→63). Quantification is performed by calibration with matrix matched external standards.

Results and discussions

Table A 3: Recovery results from method validation of phosphonic acid using the analytical method

Fortification Mean Matrix Analyte level (mg/kg) RSD (%) Comments recovery (%) (n = x) Grapes Phosphonic acid 0.5 (5) 92 7.6 m/z 81→79 5 (5) 87 4.4 Grapes Phosphonic acid 0.5 (5) 93 7.3 m/z 81→63 5 (5) 76 4.8

Table A 4: Characteristics for the analytical method used for validation of phosphonic acid residues in grapes

Phosphonic acid Phosphonic acid

m/z 81→79 m/z 81→63 Specificity mass spectrum is provided mass spectrum is provided blank value < 30% of LOQ blank value < 30% of LOQ Calibration (type, number of data points) individual calibration data individual calibration data presented| presented| calibration line equation calibration line equation presented presented number of data points: 5 number of data points: 5 Calibration range Accepted calibration range in Accepted calibration range in concentration units: concentration units: 30-2000 ng/mL 30-2000 ng/mL Corresponding calibration Corresponding calibration range in mass ratio units for range in mass ratio units for the sample: the sample: 0.15-10 mg/kg 0.15-10 mg/kg Assessment of matrix effects is presented yes yes Product code: FBR-1/ Product name: FBR-C Page 22 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Phosphonic acid Phosphonic acid

m/z 81→79 m/z 81→63 Limit of determination/quantification 0.5 mg/kg 0.5 mg/kg

Conclusion by the zRMS The method is sufficiently validated according to SANCO/825/00 rev. 8.1 for the determination of residues of potassium phosphonate (phosphonic acid and its salts, expressed as phosphonic acid) in acidic commodities of plant origin with a limit of quantification of 0.5 mg/kg. The method of Schneider (2016) is independently validated by the present method.

A 2.1.2.2 Description of analytical methods for the determination of residues in animal matrices (KCP 5.2)

No new or additional studies have been submitted

A 2.1.2.3 Description of Methods for the Analysis of Soil (KCP 5.2)

A 2.1.2.3.1 Analytical method 1

A 2.1.2.3.1.1 Method validation

Comments of zRMS: Acceptable according to SANCO/825/00 rev. 8.1. The use of a reversed phase column for a highly polar analyte is questionable.

Reference: KCP 5.2-02 Report Validation of the analytical method to determine Potassium phosphonate residue in soil (sandy loam); Perboni A.; 2016; Report RAU-051-15, Study RAU-051-15; ASB2018-931 Guideline(s): SANCO/825/00 rev. 8.1 SANCO/3029/99 rev. 4 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods Residues of phosphonic acid are extracted from soil samples by shaking with water, followed by centrifugation. Final determination is performed by LC-MS/MS using a Phenomenex Gemini-NX 5 µm C18 column with electrospray ionisation in negative mode (m/z 81→79, 81→63). Quantification is performed by calibration with matrix matched external standards. Product code: FBR-1/ Product name: FBR-C Page 23 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Results and discussions

Table A 5: Recovery results from method validation of phosphonic acid using the analytical method

Fortification Mean Matrix Analyte level (mg/kg) RSD (%) Comments recovery (%) (n = x) Sandy loam Phosphonic acid 0.5 (5) 76 2.8 m/z 81→79 5 (5) 75 3.4 Sandy loam Phosphonic acid 0.5 (5) 76 6.0 m/z 81→63

Table A 6: Characteristics for the analytical method used for validation of phosphonic acid residues in soil

Phosphonic acid Phosphonic acid

m/z 81→79 m/z 81→63 Specificity blank value < 30% of LOQ blank value < 30% of LOQ Calibration (type, number of data points) individual calibration data individual calibration data presented| presented| calibration line equation calibration line equation presented presented number of data points: 5 number of data points: 5 Calibration range Accepted calibration range in Accepted calibration range in concentration units: concentration units: 7.5-500 ng/mL 7.5-500 ng/mL Corresponding calibration Corresponding calibration range in mass ratio units for range in mass ratio units for the sample: the sample: 0.015-1.0 mg/kg 0.015-1.0 mg/kg Assessment of matrix effects is presented no, but matrix matched no, but matrix matched standards used for standards used for quantification quantification Limit of determination/quantification 0.05 mg/kg 0.05 mg/kg

Conclusion by the zRMS The method is sufficiently validated according to SANCO/825/00 rev. 8.1 for the determination of residues of potassium phosphonate (phosphonic acid and its salts, expressed as phosphonic acid) in soil with a limit of quantification of 0.05 mg/kg. As two mass transitions are monitored, the method also meets confirmatory purposes. However, the use of a reversed phase column for a highly polar analyte does not seem feasible.

A 2.1.2.4 Description of Methods for the Analysis of Water (KCP 5.2)

A 2.1.2.4.1 Analytical method 1

A 2.1.2.4.1.1 Method validation

Comments of zRMS: Acceptable according to SANCO/825/00 rev. 8.1. Product code: FBR-1/ Product name: FBR-C Page 24 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Reference: KCP 5.2 Report Validation of the analytical method to determine Potassium phosphonate in drinking water; Perboni A.; 2018; Report RAU-069-18, Study RAU-069- 18; ASB2019-13930 Guideline(s): SANCO/825/00 rev. 8.1 SANCO/3029/99 rev. 4 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods Residues of phosphonic acid in drinking water samples are concentrated by rotary evaporation. Final determination is performed by LC-MS/MS using a Thermo Hypercarb column with electrospray ionisation in negative mode (m/z 81→63, 81→79). Quantification is performed by calibration with external standards in solvent.

Results and discussions

Table A 7: Recovery results from method validation of phosphonic acid using the analytical method

Fortification Mean Matrix Analyte level (µg/L) RSD (%) Comments recovery (%) (n = x) Drinking Phosphonic acid 0.1 (5) 95 3.9 water m/z 81→63 0.2 (5) 72 8.7 2 (5) 80 20 Drinking Phosphonic acid 0.1 (5) 94 8.8 water m/z 81→79

Table A 8: Characteristics for the analytical method used for validation of phosphonic acid residues in drinking water

Phosphonic acid Phosphonic acid

m/z 81→63 m/z 81→79 Specificity blank value < 30% of LOQ blank value < 30% of LOQ Calibration (type, number of data points) individual calibration data individual calibration data presented| presented| calibration line equation calibration line equation presented presented number of data points: 4-5 number of data points: 4-5 Calibration range Accepted calibration range in Accepted calibration range in concentration units: concentration units: 0.3-20 ng/mL 0.3-20 ng/mL Corresponding calibration Corresponding calibration range in mass ratio units for range in mass ratio units for the sample: the sample: 0.03-2.0 µg/L 0.03-2.0 µg/L Assessment of matrix effects is presented no no Product code: FBR-1/ Product name: FBR-C Page 25 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Phosphonic acid Phosphonic acid

m/z 81→63 m/z 81→79 Limit of determination/quantification 0.1 µg/L 0.1 µg/L

A 2.1.2.4.2 Analytical method 2

A 2.1.2.4.2.1 Method validation

Comments of zRMS: Acceptable according to SANCO/825/00 rev. 8.1. The use of a reversed phase column for a highly polar analyte is questionable.

Reference: KCP 5.2-03 Report Validation of the analytical method to determine Potassium phosphonate residue in surface water; Perboni A.; 2016; Report RAU-052-15, Study RAU-052-15; ASB2018-932 Guideline(s): SANCO/825/00 rev. 8.1 SANCO/3029/99 rev. 4 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods Residues of phosphonic acid in surface water samples are concentrated by rotary evaporation. Final determination is performed by LC-MS/MS using a Phenomenex Gemini-NX 5 µm C18 column with electrospray ionisation in negative mode (m/z 81→63, 81→79). Quantification is performed by calibration with matrix matched external standards.

Results and discussions

Table A 9: Recovery results from method validation of phosphonic acid using the analytical method

Fortification Mean Matrix Analyte level (µg/L) RSD (%) Comments recovery (%) (n = x) Surface water Phosphonic acid 0.2 (5) 97 5.6 m/z 81→63 2 (5) 96 3.0 Surface water Phosphonic acid 0.2 (5) 97 6.2 m/z 81→79 Product code: FBR-1/ Product name: FBR-C Page 26 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Table A 10: Characteristics for the analytical method used for validation of phosphonic acid residues in surface water

Phosphonic acid Phosphonic acid

m/z 81→63 m/z 81→79 Specificity blank value < 30% of LOQ blank value < 30% of LOQ Calibration (type, number of data points) individual calibration data individual calibration data presented| presented| calibration line equation calibration line equation presented presented number of data points: 5 number of data points: 5 Calibration range Accepted calibration range in Accepted calibration range in concentration units: concentration units: 0.6-41 ng/mL 0.6-41 ng/mL Corresponding calibration Corresponding calibration range in mass ratio units for range in mass ratio units for the sample: the sample: 0.06-4.1 µg/L 0.06-4.1 µg/L Assessment of matrix effects is presented no, but matrix matched no, but matrix matched standards used for standards used for quantification quantification Limit of determination/quantification 0.2 µg/L 0.2 µg/L

Conclusion by the zRMS The method is sufficiently validated according to SANCO/825/00 rev. 8.1 for the determination of residues of potassium phosphonate (phosphonic acid and its salts, expressed as phosphonic acid) in surface water with a limit of quantification of 0.2 µg/L. As two mass transitions are monitored, the method also meets confirmatory purposes. However, the use of a reversed phase column for a highly polar analyte does not seem feasible.

A 2.1.2.5 Description of Methods for the Analysis of Air (KCP 5.2)

A 2.1.2.5.1 Analytical method 1

A 2.1.2.5.1.1 Method validation

Comments of zRMS: Acceptable according to SANCO/825/00 rev. 8.1. The use of a reversed phase column for a highly polar analyte is questionable.

Reference: KCP 5.2-04 Report Validation of the analytical method to determine Potassium phosphonate residue in air; Perboni A.; 2017; Report RAU-053-15, Study RAU-053-15; ASB2018-933 Guideline(s): SANCO/825/00 rev. 8.1 SANCO/3029/99 rev. 4 Deviations: No GLP: Yes Product code: FBR-1/ Product name: FBR-C Page 27 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

Acceptability: Yes

Materials and methods Residues of phosphonic acid are extracted from warm, humid (35°C, 80% r.h.) air samples by sampling of on a SKC silica gel cartridge for 6 h at a flow rate of 0.3 L/min (total air volume: 0.108 m³). The trapped phosphonic acid was extracted by shaking and sonication with water. Final determination is performed by LC-MS/MS using a Phenomenex Gemini-NX 5 µm C18 column with electrospray ionisation in negative mode (m/z 81→79, 81→63). Quantification is performed by calibration with external standards in solvent.

Results and discussions

Table A 11: Recovery results from method validation of phosphonic acid using the analytical method

Fortification Mean Matrix Analyte level (µg/m3) RSD (%) Comments recovery (%) (n = x) Air Phosphonic acid 10 (5) 85 17 m/z 81→79 100 (5) 88 10 Air Phosphonic acid 10 (5) 84 19 m/z 81→63

Table A 12: Characteristics for the analytical method used for validation of phosphonic acid residues in air

Phosphonic acid Phosphonic acid

m/z 81→79 m/z 81→63 Specificity blank value < 30% of LOQ blank value < 30% of LOQ Calibration (type, number of data points) individual calibration data individual calibration data presented| presented| calibration line equation calibration line equation presented presented number of data points: 5 number of data points: 5 Calibration range Accepted calibration range in Accepted calibration range in concentration units: concentration units: 60-4000 ng/mL (others) 60-4000 ng/mL (others) Corresponding calibration Corresponding calibration range in mass ratio units for range in mass ratio units for the sample: the sample: 3-180 µg/m3 3-180 µg/m3 Assessment of matrix effects is presented no no Limit of determination/quantification 10 µg/m3 10 µg/m3

Conclusion by the zRMS The method is sufficiently validated according to SANCO/825/00 rev. 8.1 for the determination of residues of potassium phosphonate (phosphonic acid and its salts, expressed as phosphonic acid) in air with a limit of quantification of 10 µg/m3. As two mass transitions are monitored, the method also meets confirmatory purposes. However, the use of a reversed phase column for a highly polar analyte does not seem feasible. Product code: FBR-1/ Product name: FBR-C Page 28 /28 Part B – Section 5 - Core Assessment Template for chemical PPP Fitosanitarios Bajo Riesgo AIE / Germany version Version March 2020

A 2.1.2.6 Description of Methods for the Analysis of Body Fluids and Tissues (KCP 5.2)

No new or additional studies have been submitted.

A 2.1.2.7 Other Studies/ Information

No new or additional studies have been submitted. FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

REGISTRATION REPORT Part B

Section 6: Mammalian Toxicology Detailed summary of the risk assessment

Product name: FBR-C Active Substance: Potassium Phosphonates (726 g/L)

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: FIT - Fitosanitarios Bajo Riesgo AIE Date: July 2020

Page 1 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

Version history

When What

March 2020 Draft Registration Report: zRMS assessment

July 2020 Registration Report: finalization of the assessment by zRMS considering the comments of applicant/cMS

Changes are marked in yellow. Revision is only necessary for: - a footnote was added to Table 6.1-3 to clarify the allocation of use restrictions - minor edits (e.g., replace “dRR” by “RR”)

Page 2 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

Table of Contents

6 Mammalian Toxicology (KCP 7) ...... 5 6.1 Summary ...... 5 6.2 Toxicological Information on active substance(s) ...... 7 6.3 Toxicological Evaluation of Plant Protection Product ...... 7 6.4 Toxicological Evaluation of Groundwater Metabolites ...... 8 6.5 Dermal Absorption (KCP 7.3) ...... 8 6.5.1 Justification for proposed values – Potassium phosphonates ...... 8 6.6 Exposure Assessment of Plant Protection Product (KCP 7.2) ...... 9 6.6.1 Selection of critical use(s) and justification ...... 10 6.6.2 Operator exposure (KCP 7.2.1) ...... 10 6.6.2.1 Estimation of operator exposure ...... 10 6.6.2.2 Measurement of operator exposure ...... 11 6.6.3 Worker exposure (KCP 7.2.3) ...... 11 6.6.3.1 Estimation of worker exposure ...... 11 6.6.3.2 Refinement of generic DFR value (KCP 7.2) ...... 11 6.6.3.3 Measurement of worker exposure ...... 12 6.6.4 Resident and bystander exposure (KCP 7.2.2) ...... 12 6.6.4.1 Estimation of resident and bystander exposure ...... 12 6.6.4.2 Measurement of resident and/or bystander exposure ...... 13 6.6.5 Combined exposure ...... 13

Appendix 1 Lists of data considered in support of the evaluation ...... 14

Appendix 2 Detailed evaluation of the studies relied upon ...... 16 A 2.1 Statement on bridging possibilities ...... 16 A 2.2 Acute oral toxicity (KCP 7.1.1) ...... 16 A 2.3 Acute percutaneous (dermal) toxicity (KCP 7.1.2) ...... 16 A 2.4 Acute inhalation toxicity (KCP 7.1.3) ...... 16 A 2.5 Skin irritation (KCP 7.1.4) ...... 17 A 2.6 Eye irritation (KCP 7.1.5) ...... 17 A 2.7 Skin sensitisation (KCP 7.1.6) ...... 17 A 2.8 Supplementary studies for combinations of plant protection products (KCP 7.1.7) ...... 17 A 2.9 Data on co-formulants (KCP 7.4) ...... 17 A 2.9.1 Material safety data sheet for each co-formulant ...... 17 A 2.9.2 Available toxicological data for each co-formulant ...... 17 A 2.10 Studies on dermal absorption (KCP 7.3) ...... 17 A 2.10.1 Study 1 – Potassium phosphonates in FBR-C ...... 18

Appendix 3 Exposure calculations ...... 21 A 3.1 Operator exposure calculations (KCP 7.2.1.1) ...... 21 A 3.1.1 Calculations for Potassium phosphonates ...... 21 A 3.2 Worker exposure calculations (KCP 7.2.3.1) ...... 23 A 3.2.1 Calculations for Potassium phosphonates ...... 23

Page 3 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

A 3.3 Resident and bystander exposure calculations (KCP 7.2.2.1) ...... 24 A 3.3.1 Calculations for Potassium phosphonates ...... 24 A 3.4 Combined exposure calculations ...... 26

Appendix 4 Detailed evaluation of exposure and/or DFR studies relied upon (KCP 7.2, KCP 7.2.1.1, KCP 7.2.2.1, KCP 7.2.3.1) ...... 27

Page 4 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

General comment of zRMS Germany as zRMS has written this section of the dRR/RR as part of the evaluation of the application for authorisation of the present product in accordance with article 33 of Regulation (EC) No 1107/2009. Thus, the document represents completely the results of the exposure and risk assessment conducted by the zRMS regarding the present product in the intended uses according to the application submitted by the applicant, unless stated otherwise.

Commenting boxes were used by zRMS only for the detailed evaluation of studies in Appendix 2 of the dRR. The description of the studies in Appendix 2 is based on the dRR originally submitted by the applicant. Some text passages therefore may be taken from the applicant´s dRR, however, the text will be adapted such that it in the end reflects the assessment of the zRMS based on the original studies.

6 Mammalian Toxicology (KCP 7)

6.1 Summary

Table 6.1-1: Information on FBR-C*

Product name (and code) FBR-C (FBR-1; BVL-Code: FIT-00001-F-0-SL) Formulation type Soluble concentrate (SL) Active substance(s) (incl. content) Potassium phosphonates (726 g/l) Function Fungicide Product already evaluated as the ‘representative No formulation’ during the approval of the active substance(s) Product previously evaluated in another MS according No to Uniform Principles * Information on the detailed composition of FBR-C can be found in the confidential dRR Part C

Justified proposals for classification and labelling

According to the criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, the following classification and labelling with regard to toxicological data is proposed for the preparation:

Table 6.1-2: Justified proposals for classification and labelling for FBR-C according to Regulation (EC) No 1272/2008 Hazard class(es), categories None Hazard pictograms or Code(s) for hazard pictogram(s) None Signal word None Hazard statement(s) None Precautionary statement(s) None Additional labelling phrases To avoid risks to man and the environment, comply with the instructions for use. [EUH401]

Page 5 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

Table 6.1-3: Summary of risk assessment for operators, workers, residents and bystanders for FBR-C Result PPE / Risk mitigation measures Operators Acceptable - Avoid any unnecessary contact with the product. Misuse can lead to health damage. [SB001] - If medical advice is needed, have product container or label at hand. [SB005] - Keep out of children's reach. [SB010] - Concerning the requirements for personal protective gear for handling the plant protection product the material safety data sheet and the instructions for use of the plant protection product as well as the guideline "Personal protective gear for handling plant protection products" of the Federal Office of Consumer Protection and Food Safety (www.bvl.bund.de) must be observed. [SB111] - Do not eat, drink or smoke when using this product. [SB166] - Working clothes (if no specific protective suit is required) and sturdy footwear (e.g. rubber boots) must be worn when applying/handling plant protection products. [SS206]

Workers Acceptable - It must be ensured that treated areas/crops may not be entered until the film of the plant protection product has dried. [SF245-02] - During the first 4 days after application in viticulture, it must be ensured that long-sleeved working clothes and sturdy footwear are worn during successive work/inspections with direct contact with the treated crops/areas. [SF275-4WE] * Residents and Acceptable None Bystanders * It is noted that the number of days in this table is not identical to the time period revealed in the exposure assessment for workers. The presented use restriction follows the practice of allocation of risk mitigation measures in Germany. If appropriate, cMS may adjust the wording to their country-specific practice and regulatory requirements, but must ensure that work wear is worn at least for 3 days after the last application of the plant protection product.

No unacceptable risk for operators, workers, residents and bystanders was identified when the product is used as intended and provided that the PPE/ risk mitigation measures stated in Table 6.1-3 are applied.

A summary of the critical uses and the overall conclusion regarding exposure for operators, workers and residents / bystanders is presented in the following table.

Table 6.1-4 Critical uses and overall conclusion of exposure assessment

1 2 3 4 5 6 7 8 9 10

Use- Crops and F, Application Application rate PHI Remarks: Acceptability of No.* situation Fn, (d) (e.g. exposure (e.g. growth Fpn safener/synergist assessment stage of crop) G, [L/ha]) Gn, Method / Max. number Max. Water Gpn, Kind (min. interval application critical gap for I, In, between rate min – operator, worker, (incl. applications) max Ipn** application bystander or per application resident exposure technique a) per use / per crop and [L/ha] b) per crop/ based on season [Exposure model] season [kg a.s./ha] Operator Worker Residents Bystander 1 Grapes F Upward a) 6 a) 2.904 200-1000 N/A EFSA Journal A R A A (BBCH 15-89) spraying b) 6 b) 17.424 2014;12(10):3874 vehicle- (10) mounted or manual-hand held * Use number(s) in accordance with the list of all intended GAPs in Part B (Section 0) should be given in column 1

Page 6 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application, In: non-professional indoor use; Ipn: professional and non-professional indoor use

Explanation for column 10 “Acceptability of exposure assessment” A Exposure acceptable without PPE / risk mitigation measures R Further refinement and/or risk mitigation measures required N Exposure not acceptable/ Evaluation not possible

Data gaps Noticed data gaps are:  None

6.2 Toxicological Information on active substance(s)

The active substance was evaluated under directive No 94/414/EEC (as amended) or regulation (EC) No 1107/2009 (as amended). Information regarding classification of the active substance and on EU endpoints identified during the EU review is given in the following table(s). Further information on active substance is included in the reports on the results of the peer review process and in the respective background documents.

Table 6.2-1: Information on active substance(s)

Potassium Phosphonates Potassium hydrogen phosphonate (CAS-No. 13977-65-6) Dipotassium phosphonate (CAS-No. 13492-26-7) Classification and labelling With regard to toxicological Hazard classes, categories: None endpoints (according to the Codes for hazard pictograms: None criteria in Regulation (EC) No Signal word: None 1272/2008, as amended) Hazard statement: None Proposals for additional None classification and labelling Agreed EU endpoints AOEL systemic 5.0 mg/kg bw/d (Oral absorption: 100%) Reference EFSA Journal 2012; 10(12):2963; (ASB2012-16090)

6.3 Toxicological Evaluation of Plant Protection Product

A summary of the toxicological evaluation for FBR-C is given in the following table. No toxicological studies on the formulation FBR-C were performed since it is possible to extrapolate from active substance data due to the composition of the formulation (please refer to Part C). The calculation method outlined in Regulation (EC) No. 1272/2008 was used to assess the toxicological properties of FBR-C. Thus, no further study is required.

Page 7 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

Table 6.3-1: Summary of evaluation of the studies on acute toxicity including irritancy and skin sensitisation for FBR-C

Classification and Type of test, species, model Result labelling Acceptability Reference system (Guideline) (acc. to the criteria in Reg. 1272/2008) Acute Oral Toxicity > 2000 mg/kg bw Yes None Acute Dermal Toxicity > 2000 mg/kg bw Yes None Calculation method Acute Inhalation Toxicity > 5 mg/L air Yes None according to Skin irritation Non-irritant Yes None Regulation (EC) No. Eye irritation Non-irritant Yes None 1272/2008 Skin sensitisation Non-sensitizing Yes None Supplementary studies for No data – not N/A N/A N/A combinations of plant required/not protection products relevant

Additional toxicological information relevant for classification/labelling of FBR-C: None

6.4 Toxicological Evaluation of Groundwater Metabolites

For the applied uses the predicted groundwater concentrations of phosphonic acid (to which potassium phosphonates dissociates in water) are <0.1 µg/L. No toxicological evaluation of groundwater metabolites is required.

6.5 Dermal Absorption (KCP 7.3)

A summary of the dermal absorption rates used in the exposure assessment of the present application are presented in the following table. Data presented the final report of the study on dermal absorption was analysed as stipulated in the “Guidance on Dermal Absorption” (EFSA Journal 2017; 15(6):4873).

Table 6.5-1: Dermal absorption rates for potassium phosphonates in FBR-C

Potassium Phosphonates

Value Reference

Concentrate 1.4% Bernal, J. (2020); ASB2020-2707 Dilution 2.6% Bernal, J. (2020); ASB2020-2707 (1:250) Dilution 4.2% pro rata corrected value for spray dilution (1:400) according to Guidance on Dermal Absorption (EFSA Journal 2017; 15(6):4873; ASB2017-9503)

6.5.1 Justification for proposed values – Potassium phosphonates

Proposed dermal absorption rates for Potassium phosphonates are based on dermal absorption studies on a

Page 8 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version formulation identical to FBR-C. The study results are summarized in the following table. Since the study has not been evaluated within an EU peer review process yet, a full summary of the study on the dermal absorption of potassium phosphonates formulated as FBR-1 (FBR-C) is provided in Appendix 2.

Table 6.5-2: Summary of the results of submitted dermal absorption studies

Test Concen- Spray dilution Formula- Accepta- Justification Acceptability Reference trate tion in bility of provided on of study study representativity justification of study formulation for current product

in vitro 1.4% 2.6% FBR-1 Yes used formulation Yes Bernal, J., 2020; (human (726 g/L) (2.9 g/L) (company identical to ASB2020-2707 skin) code) product

Intended dilutions for the application of the plant protection product range from 8.52 g/L to 1.813 g/L (1:50- 1:400). This range is not fully covered by the concentrations used in the study on dermal absorption. Therefore, a pro rata correction is necessary. A dermal absorption of 4.2% was used for the spray dilution in the exposure assessment. The corrected value was calculated as follows:

= ∗

2.9 = ∗ 2.6% = 4.1589% ≈ 4.2% 1.813

6.6 Exposure Assessment of Plant Protection Product (KCP 7.2)

Table 6.6-1: Product information and toxicological reference values used for exposure assessment

Product name and code FBR-C (FIT-00001-F-0-SL) Formulation type Soluble concentrate (SL) Category Fungicide

Container size(s), short description 60 - 1000 mL HDPE bottle, 5 - 25 L HDPE jerrican, 200 - 220 L HDPE drum/barrel, 1000 L HDPE tank or IBC container, Active substance (incl. content) Potassium Phosphonates, 726 g/L AOEL systemic 5.0 mg/kg bw/d Inhalation absorption 100% Oral absorption Oral absorption: 100% Dermal absorption Concentrate: 1.4% Dilution: 2.6% (2.9 g/L) Dilution: 4.2% (1.813 g/L)

Page 9 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

6.6.1 Selection of critical use(s) and justification

The critical GAP used for the exposure assessment of the plant protection product is shown in Table 6.1 4.

6.6.2 Operator exposure (KCP 7.2.1)

6.6.2.1 Estimation of operator exposure

A summary of the exposure models used for estimation of operator exposure to the active substances during application of FBR-C according to the critical use(s) is presented in Table 6.6-2. The outcome of the estimation is presented in Table 6.6-3 and Table 6.6-4 (longer term exposure). Detailed calculations are in Appendix 3.

Table 6.6-2: Exposure models for intended uses

Critical use(s) Grapes (max. 4 L product/ha), tractor-mounted and hand-held application Model(s) Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products; EFSA Journal 2014; 12(10):3874. Calculator version: 30/03/2015

Table 6.6-3: Estimated operator exposure (longer term exposure), tractor mounted application

Potassium phosphonates

Model data Level of PPE Total absorbed % of systemic dose AOEL (mg/kg/day)

Grapes / Outdoor / Upward spraying / Vehicle-mounted / 50 ha/d Application rate: 2.9 kg a.s./ha Spray Potential exposure 0.269 5.4 application (AOEM; 75th Work wear M/L and A 0.084 1.7 percentile) (arms, body and legs covered) Body weight: 60 kg

Table 6.6-4: Estimated operator exposure (longer term exposure), hand held application

Potassium phosphonates

Model data Level of PPE Total absorbed % of systemic dose AOEL (mg/kg/day)

Grapes / Outdoor / Upward spraying / Manual, hand-held / 4 ha/d Application rate: 2.9 kg a.s./ha Spray Potential exposure 0.101 2.02 application (AOEM; 75th Work wear M/L and A 0.034 0.68 percentile) (arms, body and legs covered) Body weight: 60 kg

Page 10 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

6.6.2.2 Measurement of operator exposure

Since the operator exposure estimations carried out indicated that the acceptable operator exposure level (AOEL) will not be exceeded under conditions of intended uses, a study to provide measurements of operator exposure was not necessary and was therefore not performed.

6.6.3 Worker exposure (KCP 7.2.3)

6.6.3.1 Estimation of worker exposure

Table 6.6-5 shows the exposure model(s) used for estimation of worker exposure after entry into a previously treated area or handling a crop treated with FBR-C according to the critical use(s). Outcome of the estimation is presented in Table 6.6-6 (longer term exposure). Detailed calculations are in Appendix 3.

For a period of 3 days after the last application of the plant protection product, workers must wear working clothes when working in treated crops to ensure that the AOEL is not exceeded.

Table 6.6-5: Exposure models for intended uses

Critical use(s) Grapes (max. 6 x 4 L product/ha) Model Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products; EFSA Journal 2014; 12(10):3874. Calculator version: 30/03/2015

Table 6.6-6: Estimated worker exposure (longer term exposure)

Potassium phosphonates

Model data Level of PPE Total absorbed % of systemic dose (mg/kg AOEL bw/day)

Hand harvesting / Outdoor / Work rate: 8 hours/day 2 DT50: 30 days / DFR: 3.0 µg/cm /kg a.s./ha Interval between treatments: 10 days / MAF: 3.6 Number of applications and application rate: 6 x 2.9 kg a.s./ha Re-entry after spray has dried Body weight: Potential 5.32 106.4 60 kg TC: 30000 cm2/person/h Work wear (arms, body and legs covered) 1.79 35.8 TC: 10100 cm2/person/h Re-entry 3 days after last application Body weight: Potential 4.96 99.3 60 kg TC: 30000 cm2/person/h

6.6.3.2 Refinement of generic DFR value (KCP 7.2)

Not required.

Page 11 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

6.6.3.3 Measurement of worker exposure

Since the worker exposure estimations carried out indicated that the acceptable operator exposure level (AOEL) will not be exceeded under conditions of intended uses and considering above mentioned PPE, a study to provide measurements of worker exposure was not necessary and was therefore not performed.

6.6.4 Resident and bystander exposure (KCP 7.2.2)

6.6.4.1 Estimation of resident and bystander exposure

No bystander risk assessment is required for PPPs that do not have significant acute toxicity or the potential to exert toxic effects after a single exposure. Exposure in this case will be determined by average exposure over a longer duration, and higher exposures on one day will tend to be offset by lower exposures on other days. Therefore, exposure assessment for residents also covers bystander exposure.

Table 6.6-7 shows the exposure model(s) used for estimation of resident exposure to Potassium phosphonates. The outcome of the estimation is presented in Table 6.6-8 (longer term resident exposure). Detailed calculations are in Appendix 3.

Table 6.6-7: Exposure models for intended uses

Table 6.6-8: Estimated resident and bystander exposure

Potassium phosphonates

Model data Total absorbed dose % of systemic AOEL (mg/kg bw/day)

Grapes / Outdoor / Upward spraying / Vehicle-mounted Buffer zone: 5.0 m Drift reduction technology: No 2 DT50: 30 days / DFR: 3.0 µg/cm /kg a.s./ha Interval between treatments: 10 days / MAF: 3.6 Minimum volume of water (liquids): 200 L Number of applications and application rate: 6 x 2.9 kg a.s./ha Resident child Drift (75th perc.) 0.0868 1.74 Body weight: 10 kg Vapour 0.0011 0.02 Deposits (75th perc.) 0.0082 0.16 Re-entry (75th perc.) 0.075 1.50 Sum (mean) 0.124 2.49 Resident adult Drift (75th perc.) 0.0474 0.95 Body weight: 60 kg Vapour 0.00023 0.01 Deposits (75th perc.) 0.0017 0.03 Re-entry (75th perc.) 0.0416 0.83 Sum (mean) 0.0657 1.31

Page 12 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

6.6.4.2 Measurement of resident and/or bystander exposure

Since the resident and/or bystander exposure estimations carried out indicated that the acceptable operator exposure level (AOEL) for Potassium phosphonates will not be exceeded under conditions of intended uses and considering above mentioned risk mitigation measures, a study to provide measurements of resident / bystander exposure was not necessary and was therefore not performed.

6.6.5 Combined exposure

Not relevant. The product contains only one active substance.

Page 13 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

Appendix 1 Lists of data considered in support of the evaluation

References

Title Company Report No. Author(s) Year Source (where different from company) GLP or GEP status Published or not

EFSA 2012 Conclusion on the peer review of the pesticide risk assessment of the active substance potassium phosphonates EFSA Journal 2012; 10(12):2963 ASB2012-16090

List of data submitted by the applicant and relied on

Title Company Report No. Vertebrate Data Author(s) Year Source (where different from company) study Owner point GLP or GEP status Y/N Published or not

KCP Bernal, J. 2020 In-vitro human skin penetration of Phosphonic acid in potassium phosphonates N Fitosanitarios 7.2.3 FBR-1 test item Bajo & 7.3 S19-22158 GLP: Yes Published: No BVL-3941497, ASB2020-2707

List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review

Title Company Report No. Vertebrate Data Author(s) Year Source (where different from company) study Owner point GLP or GEP status Y/N Published or not

------

List of data submitted by the applicant and not relied on

Title Company Report No. Vertebrate Data Author(s) Year Source (where different from company) study Owner point GLP or GEP status Y/N Published or not

------

Page 14 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

List of data relied on not submitted by the applicant but necessary for evaluation

Title Company Report No. Vertebrate Data Author(s) Year Source (where different from company) study Owner point GLP or GEP status Y/N Published or not

------

Page 15 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

Appendix 2 Detailed evaluation of the studies relied upon

Comments of zRMS: The applicant did not provide toxicological studies for the plant protection product. Considering the composition of the plant protection product, as outlined in Part C of this dRR, it can be concluded that its toxicological properties are solely determined by the toxicological properties of the active substance potassium phosphonates. Therefore, and in order to avoid unnecessary animal testing as mandated by Regulation (EC) No. 1107/2009, waiving these studies is acceptable.

The calculation method outlined in Regulation (EC) No. 1272/2008 was used to substitute for data from animal testing.

A 2.1 Statement on bridging possibilities

Comments of zRMS: The study on dermal absorption was executed with a formulation identical to FBR- C, thus bridging is not required. No further studies were submitted by the applicant.

A 2.2 Acute oral toxicity (KCP 7.1.1)

Comments of zRMS: As stated above, no experimental data was available. However, the calculation method outlined in Regulation (EC) No. 1272/2008 was used to substitute for data from animal testing. The plant protection product does not contain ingredients which are classified for acute toxicity. Consequently, the calculated value is above the threshold for classification. Thus, no classification for oral toxicity is required.

A 2.3 Acute percutaneous (dermal) toxicity (KCP 7.1.2)

A 2.4 Acute inhalation toxicity (KCP 7.1.3)

Page 16 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

A 2.5 Skin irritation (KCP 7.1.4)

Comments of zRMS: As stated above, no experimental data was available. However, the calculation method outlined in Regulation (EC) No. 1272/2008 was used to substitute for data from animal testing. The plant protection product does not contain ingredients which are classified for skin irritation. Consequently, the calculated value is below the threshold for classification. Thus, no classification for skin irritation is required.

A 2.6 Eye irritation (KCP 7.1.5)

Comments of zRMS: As stated above, no experimental data was available. However, the calculation method outlined in Regulation (EC) No. 1272/2008 was used to substitute for data from animal testing. The plant protection product does not contain ingredients which are classified for eye irritation. Consequently, the calculated value is below the threshold for classification. Thus, no classification for eye irritation is required.

A 2.7 Skin sensitisation (KCP 7.1.6)

Comments of zRMS: As stated above, no experimental data was available. However, the calculation method outlined in Regulation (EC) No. 1272/2008 was used to substitute for data from animal testing. The plant protection product does not contain ingredients which are classified for skin sensitisation. Thus, no classification for skin sensitisation is required.

A 2.8 Supplementary studies for combinations of plant protection products (KCP 7.1.7)

No additional studies required.

A 2.9 Data on co-formulants (KCP 7.4)

A 2.9.1 Material safety data sheet for each co-formulant

Information regarding material safety data sheets of the co-formulants can be found in the confidential dossier of this submission (Registration Report - Part C).

A 2.9.2 Available toxicological data for each co-formulant

Available toxicological data for each co-formulant can be found in the confidential dossier of this submission (Registration Report - Part C).

A 2.10 Studies on dermal absorption (KCP 7.3)

The study on dermal absorption by Bernal (2020) has not been evaluated in a peer review EU process yet. Therefore results of the data analysis are presented below.

Page 17 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

A 2.10.1 Study 1 – Potassium phosphonates in FBR-C

Dermal absorption, in vitro using human skin

Comments of zRMS: Study is acceptable and meets recent requirements of relevant guidelines. Used formulation FBR-1 is identical to FBR-C.

Data analysis was done in accordance with the “Guidance on dermal absorption” (EFSA Journal 2017;15(6):4873). A pro rata correction was required since the tested concentrations did not cover the minimum concentration from the intended uses presented in the GAP table (see Part A). Derived values for dermal absorption were used for the risk assessment.

Reference: KCP 7.3 Report In-vitro human skin penetration of Phosphonic acid in potassium phosphonates FBR-1 test item, Bernal, J., 2020, S19-22158, BVL-3941519, ASB2020-2707 Guideline(s): Yes (OECD guideline for the testing of chemicals: Test No. 428: Skin Absorption: in vitro Method (13 April 2004); OECD Guidance notes on dermal absorption, 18 August 2011 (ENV/JM/MONO(2011) 36); Guidance on Dermal Absorption, EFSA Journal 2017; 15(6): 4873) Deviations: No GLP: Yes Acceptability: Yes

Materials and methods Test material Name (Lot/Batch No.) Potassium phosphonate (not labelled; see product for details) Test preparation see Product Radiochemical purity N/A Product Name (Lot/Batch No.) FBR-1 potassium phosphonates (Batch 2642019) Company code FBR-1 Concentration a.s. 726.0 g/L Formulation type SL Blank product Name (Lot/Batch No.) N/A Concentration a.s. N/A g/L or g/kg Formulation type N/A

Test system Diffusion cell Type of diffusion cell Static (if dynamic) Flow rate N/A Exposed skin area 2.0 cm² Cover No Membrane Skin type dermatomed skin Skin thickness range 302-400 µm Skin donors age 37-62 years Skin donors sex female Site abdomen Source ex vivo (surgery) Integrity test Transepidermal Water Loss (TEWL ≤ 5 g/m2/h)

Page 18 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

Receptor Receptor medium 0.9 % NaCl Solubility in receptor medium Tested in separate study (Egron 2019, Study No. S19-04939; Study not available) Sampling Exposure time 8 h Observation time 24 h Sample intervals 6 sampling times: 1h, 2h, 4h, 8h, 12h, 24h Skin wash/Swabbing 3 half cotton-swabs soaked with Sanex® 10 + 2 dry half cottonswabs Final Procedure Tape stripping Yes Type of tape strips used Scotch Tape Crystal ® TS1-2 analysed separately Yes Remark: Radiolabelling of potassium phosphonate was not possible. Analysis was done by following the accumulation of phosphonic acid (dissociation equilibrium) using LC-MS/MS.

Tested doses Concentrate Dilution 1 Target concentration [mg/mL] 726 2.9 Area dose [µg/cm²] 7260 29 Specific activity [kBq/mL] N/A N/A No. of donors 4 4 No. of cells used/valid cells* 8/8 8/8 * Justification for excluded cells, if applicable

Results and discussions

Table A 1: In-vitro dermal penetration of Potassium phosphonates formulated as FBR-1 through human skin - Recovery data Concentrate Dilution 1 Dose group (1:250) Target concentration [mg/mL] 726.0 2.9 Target dose [µg/cm²] 7260 29.0 Mean actual applied dose [µg/cm²] Recovery [%] Recovery [%] Mean SD Mean SD Dislodgeable dose Skin wash after x hours 90.5 7.66 103.0 9.6 Donor chamber wash 0.74 0.64 1.13 0.66 Dose associated to skin Tape strips: 1st sample, strips 1 + 2 0.21 0.14 0.64 0.35 Tape strips: 2nd sample; strips 3 - n 0.26 0.13 0.84 0.77 Skin preparation 0.56 0.44 1.04 0.67 Absorbed dose Receptor fluid 0.047 0.071 0.35 0.36 Receptor chamber wash 0.001 N/A N/A N/A Total recovery1 92.3 7.58 106.26 8.84 Lower limit of confidence of T1/2 39.2 22.5 36.12 38.88 Absorption essentially complete at end of study No No (>75% absorption within half the study duration) If no: 0.87 0.53 1.93 0.83 Absorption estimates = absorbed dose + skin preparation + tape strips sample 2)2

Page 19 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

If yes: N/A N/A N/A N/A Absorption estimates = absorbed dose + skin preparation Absorption estimate normalised3 0.93 0.55 1.93 0.83 Relevant absorption estimate4 1.39 2.626 Absorption estimates used for risk assessment5 1.4 2.6 1 Values may not calculate exactly due to rounding of figures 2 In accordance with the EFSA Guidance on Dermal Absorption (EFSA Journal 2017;15(6):4873) the radioactivity in the second tape-strip pool (3rd to nth tape strip) is considered potentially absorbable if less than 75% of the absorption occurred in the first half of the study. Finally, the skin preparation is also considered potentially absorbable. 3 According to the EFSA Guidance on Dermal Absorption, cells with insufficient recovery (< 95%) can be corrected by normalisation of absorption estimate to 100% recovery; explanation should be included. 4. In accordance with the EFSA Guidance on Dermal Absorption, a multiple of the standard deviation was added to the mean% dermal penetration to account for the 95th percent confidence interval. 5 Relevant absorption estimate was rounded to the required number of significant figures. N/A: not applicable

Remarks

Two cells for the dilution exhibited amounts of phosphonic acid below the LOQ at all time points. In general, the majority of phosphonic acid in the experiment with the diluted product was detected in skin preparation and tape strips for 7 out of 8 cells.

The following adjustments of the calculation in the spreadsheet were made:

- Concentrate: Adding the missing proportion of the test item to correct for low recovery of cells A, D, E, G, and H is not required, because these cells showed similar absorption rates as cells with acceptable recovery. Thus, it can be concluded that the missing proportion is non-absorbable and is not relevant for the absorption rate. However, values were normalized to 100% recovery.

- Dilution: The determination of the proportion absorbed at t0.5 required adjustments. Two cells (K&L) showed no absorption (below LOQ) at t0.5 and t1, hence the absorption was considered as "complete" at t0.5 and the corresponding value was set to 100%. For cells I&J the absorption was below LOQ at t0.5, but a value was obtained at t1. The resulting “0%” absorption was not considered for calculation by the calculation spreadsheet, thus the spreadsheet was adjusted to ensure that the 0% were included when calculating the mean absorption at t0.5.

Conclusion by the zRMS The dermal penetration of potassium phosphonates formulated as FBR-1/FBR-C through human dermatomed skin was determined in vitro. Based on the EFSA guidance criteria, the amount of applied dose penetrating within 24 hours was determined to be 1.39% (0.93% ± 0.55) for the formulation, and 2.63% (1.93% ± 0.83) for the (1:250) spray dilution. The dermal penetration estimates to be used for risk assessment were set at 1.4% for the formulation concentrate, and 4.2% for the (1:400) spray dilution (pro rata correction using the value of 2.6% obtained from the 1:250 dilution).

Page 20 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

Appendix 3 Exposure calculations

A 3.1 Operator exposure calculations (KCP 7.2.1.1)

A 3.1.1 Calculations for Potassium phosphonates

Table A 2: Input parameters considered for the estimation of operator exposure for tractor mounted applictation

Formulation type Soluble concentrates, Crop type Grapes emulsifiable concentrate, etc. Application rate (AR) 2.9 kg a.s./ha Application method Upward spraying Area treated per day (A) 10 ha Application equipment Vehicle-mounted Dermal absorption (DA) 1.4 % (concentr.) Indoor/outdoor Outdoor 4.2 % (dilution) Closed cabin Not relevant Inhalation absorption (IA) 100 % Drift reduction No Body weight (BW) 60 kg/person Cultivation Not relevant AOEL 5.0 mg/kg bw/d Water soluble bag No

Table A 3: Estimation of longer term operator exposure towards potassium phosphonates according to EFSA guidance (tractor mounted application)

Potential With work wear Mixing and loading Hands None Specific exposure value 909.4 µg/person 909.4 µg/person Systemic exposure 15.2 µg/kg bw/d 15.2 µg/kg bw/d Body Work wear Specific exposure value 533.1 µg/person 6.59 µg/person Systemic exposure 8.89 µg/kg bw/d 0.11 µg/kg bw/d Head None Specific exposure value 21.1 µg/person 21.1 µg/person Systemic exposure 0.35 µg/kg bw/d 0.35 µg/kg bw/d Inhalation None Specific exposure value 10.1 µg/person 10.1 µg/person Systemic exposure 0.17 µg/kg bw/d 0.17 µg/kg bw/d Application Hands None Specific exposure value 2101.7 µg/person 2101.7 µg/person Systemic exposure 35.0 µg/kg bw/d 35.0 µg/kg bw/d Body Work wear Specific exposure value 10747.5 µg/person 140.2 µg/person Systemic exposure 179.1 µg/kg bw/d 2.34 µg/kg bw/d Head None

Page 21 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

Specific exposure value 1412.4 µg/person 1412.4 µg/person Systemic exposure 23.5 µg/kg bw/d 23.5 µg/kg bw/d Inhalation None Specific exposure value 428.2 µg/person 428.2 µg/person Systemic exposure 7.14 µg/kg bw/d 7.14 µg/kg bw/d

Total Total systemic exposure 0.269 mg/kg bw/d 0.084 mg/kg bw/d % of AOEL 5.39 % 1.68 %

Table A 4: Input parameters considered for the estimation of operator exposure for hand- held application

Formulation type Soluble concentrates, Crop type Grapes emulsifiable concentrate, etc. Application rate (AR) 2.9 kg a.s./ha Application method Upward spraying Area treated per day (A) 4 ha Application equipment Manual-Hand held Dermal absorption (DA) 1.4 % (concentr.) Indoor/outdoor Outdoor 4.2 % (dilution) Closed cabin Not relevant Inhalation absorption (IA) 100 % Drift reduction No Body weight (BW) 60 kg/person Cultivation Not relevant AOEL 5.0 mg/kg bw/d Water soluble bag No

Table A 5: Estimation of longer term operator exposure towards potassium phosphonate according to EFSA guidance (hand-held application)

Potential With work wear Mixing and loading Hands None Specific exposure value 449.2 µg/person 449.2 µg/person Systemic exposure 7.49 µg/kg bw/d 7.49 µg/kg bw/d Body Work wear Specific exposure value 280.0 µg/person 2.93 µg/person Systemic exposure 4.67 µg/kg bw/d 0.049 µg/kg bw/d Head None Specific exposure value 8.44 µg/person 8.44 µg/person Systemic exposure 0.14 µg/kg bw/d 0.14 µg/kg bw/d Inhalation None Specific exposure value 7.68 µg/person 7.68 µg/person Systemic exposure 0.13 µg/kg bw/d 0.13 µg/kg bw/d Application Hands None Specific exposure value 888.4 µg/person 888.4 µg/person Systemic exposure 14.8 µg/kg bw/d 14.8 µg/kg bw/d Body Work wear

Page 22 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

Specific exposure value 3789.3 µg/person 43.4 µg/person Systemic exposure 63.2 µg/kg bw/d 0.72 µg/kg bw/d Head None Specific exposure value 14.1 µg/person 14.1 µg/person Systemic exposure 0.23 µg/kg bw/d 0.23 µg/kg bw/d Inhalation None Specific exposure value 618.8 µg/person 618.8 µg/person Systemic exposure 10.3 µg/kg bw/d 10.3 µg/kg bw/d

Total Total systemic exposure 0.101 mg/kg bw/d 0.034 mg/kg bw/d % of AOEL 2.02 % 0.68 %

A 3.2 Worker exposure calculations (KCP 7.2.3.1)

A 3.2.1 Calculations for Potassium phosphonates

Table A 6: Input parameters considered for the estimation of worker exposure

Intended use(s) Grapes Dislodgeable foliar residue 3 µg/cm2/kg a.s./ha Hand harvesting (DFR) Outdoor Application rate (AR) 2.9 kg a.s./ha Dermal absorption (DA) 4.2 % (worst case) Number of applications (NA) 6 Inhalation absorption (IA) 100 % Interval between applications 10 days Work rate per day (WR) 8 h/d Half-life of active substance 30 days TC dermal (potential) 30000 cm2/h Multiple application factor (MAF) 3.64 TC dermal (work wear) 10100 cm2/h Body weight (BW) 60 kg/person TC dermal (work wear, no TC available for cm2/h gloves) this assessment AOEL 5.0 mg/kg bw/d Task specific factor N/A ha/h x 10-3 (automated appl) AAOEL N/A mg/kg bw/d Task specific factor N/A (cutting ornamentals) Task specific factor N/A (sorting, bundling)

Table A 7: Estimation of longer term worker exposure towards potassium phosphonates according to EFSA guidance (re-entry after the spray has dried)

Potential With work wear Worker (re-entry): Dermal exposure after application (DFR x TC x WR x AR x MAF x DA) / BW Systemic exposure 5.32 mg/kg bw/d 1.79 mg/kg bw/d Worker (re-entry): Total Systemic exposure 5.32 mg/kg bw/d 1.79 mg/kg bw/d % of AOEL 106.4 % 35.8 %

Page 23 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

Table A 8: Estimation of longer term worker exposure towards potassium phosphonates according to EFSA guidance (re-entry 3 days after last application)

Potential With work wear Worker (re-entry): Dermal exposure after application (DFR x TC x WR x AR x MAF x DA) / BW Systemic exposure 4.96 mg/kg bw/d 1.67 mg/kg bw/d Worker (re-entry): Total Systemic exposure 4.96 mg/kg bw/d 1.67 mg/kg bw/d % of AOEL 99.3 % 33.4 %

A 3.3 Resident and bystander exposure calculations (KCP 7.2.2.1)

A 3.3.1 Calculations for Potassium phosphonates

Table A 9: Input parameters considered for the estimation of longer term resident exposure

Intended use(s) Grapes, Upward spraying Drift reduction (DR) No N/A Application rate (AR) 2.9 kg a.s./ha Transfer coefficient surface 7300 cm2/h (adult) deposits (TC) 2600 cm2/h (child) Minimum water volume 200 L/ha Drift on surface (D) - 75th perc. 3.07 % (V) Buffer strip 5 m Drift on surface (D) - mean 2.32 % Number of applications 6 Turf Transferable Residues 5 % (NA) (TTR)

Interval between 10 days Exposure duration dermal (HD) 2 h applications

Half-life of active 30 days Exposure duration inhal. (HI) 24 h substance Multiple application 3.64 Exposure duration entry into 0.25 h factor (MAF) treated crops (HE) Body weight (BW) 60 kg/person (adult) Airborne concentration of vapour 0.001 mg/m3 (VC) 10 kg/person (child) Dermal absorption (DA) 4.2 % (worst case) Dislodgeable foliar residue 3.0 µg/cm2/kg a.s. (DFR) Inhalation absorption 100 % Light clothing adjustment factor 18 % (IA) (CF) Oral absorption (OA) 100 % Saliva extraction factor (SE) 50 % AOEL 5.0 mg/kg bw/d Surface area of hands (SA) 20 cm2 Spray drift dermal (SD) - 5.63 mL spray dilution Frequency of hand to mouth 20 events/h 75th perc. (adult) (Freq) 1.69 mL spray dilution (child) Spray drift inhal. (SI) - 0.0021 mL spray dilution Dislodgeable residues object to 20 % th 75 perc. (adult) mouth (DROM)

Page 24 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

0.0016 mL spray dilution (child) Spray drift dermal (SD) - 3.68 mL spray dilution Ingestion rate for mouthing of 25 cm2/d mean (adult) grass (IgR) 1.11 mL spray dilution (child) Spray drift inhal. (SD) - 0.0017 mL spray dilution TC entry into treated crops - 75th 7500 cm2/h (adult) mean (adult) perc. 0.0013 mL spray dilution 2250 cm2/h (child) (child) Inhalation rate (IR) 16.57 m3/d (adult) TC entry into treated crops - 5980 cm2/h (adult) mean 8.31 m3/d (child) 1794 cm2/h (child)

Table A 10: Estimation of longer term resident exposure towards Potassium phosphonates according to EFSA guidance

Adult Child Spray drift (75th perc.) (SD x DA x (1- CF) + SI) x AR x MAF x V x DR/ BW Systemic exposure 0.047 mg/kg bw/d Systemic exposure 0.0868 mg/kg bw/d % of AOEL 0.95 % % of AOEL 1.74 % Vapour (VC x IR x IA) / BW Systemic exposure 0.00023 mg/kg bw/d Systemic exposure 0.0011 mg/kg bw/d % of AOEL 0.01 % % of AOEL 0.02 % Surface deposits (75th perc.) Dermal

AR x MAF x D x TTR x TC x HD x DA / BW Systemic exposure 0.002 mg/kg bw/d Systemic exposure 0.0035 mg/kg bw/d Hand to mouth

AR x MAF x D x TTR x SE x SA x Freq x HD x OA / BW NA Systemic exposure 0.0031 mg/kg bw/d Object to mouth

AR x MAF x D x DROM x IgR x OA / BW NA Systemic exposure 0.0016 mg/kg bw/d Total surface deposits Systemic exposure 0.002 mg/kg bw/d Systemic exposure 0.0082 mg/kg bw/d % of AOEL 0.03 % % of AOEL 0.16 % Entry into treated crops (75th perc.) Dermal

AR x MAF x TC x HD x DFR x DA / BW Systemic exposure 0.042 mg/kg bw/d Systemic exposure 0.075 mg/kg bw/d Hand to mouth

AR x MAF x 100 % x TTR x x SE x SA x Freq x HD x OA / BW

Page 25 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

NA Systemic exposure mg/kg bw/d Object to mouth

AR x MAF x 100% x DROM x IgR x OA / BW NA Systemic exposure mg/kg bw/d Total exposure - entry into treated crops Systemic exposure 0.042 mg/kg bw/d Systemic exposure 0.075 mg/kg bw/d % of AOEL 0.83 % % of AOEL 1.50 % All pathways (mean) Systemic exposure 0.066 mg/kg bw/d Systemic exposure 0.12 mg/kg bw/d % of AOEL 1.31 % % of AOEL 2.49 %

A 3.4 Combined exposure calculations

Not relevant, because plant protection product contains only a single active substance.

Page 26 / 27 FBR-C – ZV1 008632-00/00 Part B – Section 6 - Core Assessment zRMS version

Appendix 4 Detailed evaluation of exposure and/or DFR studies relied upon (KCP 7.2, KCP 7.2.1.1, KCP 7.2.2.1, KCP 7.2.3.1)

No additional studies submitted.

Page 27 / 27 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

REGISTRATION REPORT Part B

Section 7: Metabolism and Residues Detailed summary of the risk assessment

Product name: FBR-C Active Substance: Potassium phosphonates (726 g/L)

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: FIT - Filosanitarios Bajo Riesgo AIE Date: March 2020 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Version history

When What

March 2020 Draft Registration Report: zRMS assessment

FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Table of Contents

7 Metabolism and residue data (KCA section 6) ...... 5 7.1 Summary and zRMS Conclusion ...... 5 7.1.1 Critical GAP(s) and overall conclusion ...... 5 7.1.2 Summary of the evaluation ...... 7 7.1.2.1 Summary for Potassium phosphonates ...... 8 7.1.2.2 Summary for Summary for FBR-C ...... 8 7.2 Potassium phosphonates ...... 9 7.2.1 Stability of Residues (KCA 6.1) ...... 9 7.2.1.1 Stability of residues during storage of samples ...... 9 7.2.1.2 Stability of residues in sample extracts ...... 10 7.2.2 Nature of residues in plants, livestock and processed commodities ...... 10 7.2.2.1 Nature of residue in primary crops (KCA 6.2.1) ...... 10 7.2.2.2 Nature of residue in rotational crops (KCA 6.6.1) ...... 10 7.2.2.3 Nature of residues in processed commodities (KCA 6.5.1) ...... 10 7.2.2.4 Conclusion on the nature of residues in commodities of plant origin (KCA 6.7.1) ...... 11 7.2.2.5 Nature of residues in livestock (KCA 6.2.2-6.2.5) ...... 12 7.2.2.6 Conclusion on the nature of residues in commodities of animal origin (KCA 6.7.1) ...... 12 7.2.3 Magnitude of residues in plants (KCA 6.3) ...... 13 7.2.4 Magnitude of residues in livestock ...... 14 7.2.4.1 Dietary burden calculation ...... 14 7.2.5 Magnitude of residues in processed commodities (Industrial Processing and/or Household Preparation) (KCA 6.5.2-6.5.3) ...... 14 7.2.6 Magnitude of residues in representative succeeding crops ...... 14 7.2.7 Other / special studies (KCA6.10, 6.10.1) ...... 14 7.2.8 Estimation of exposure through diet and other means (KCA 6.9) ...... 14 7.2.8.1 Input values for the consumer risk assessment ...... 15 7.2.8.2 Conclusion on consumer risk assessment ...... 15 7.3 Combined exposure and risk assessment ...... 16 7.4 References ...... 17

Appendix 1 Lists of data considered in support of the evaluation ...... 18

Appendix 2 Detailed evaluation of the additional studies relied upon ...... 23 A 2.1 Stability of residues ...... 23 A 2.1.1 Storage stability of residues in plant products ...... 23 A 2.1.2 Storage stability of residues in animal products ...... 25 A 2.2 Nature of residue in plants ...... 25 A 2.3 Nature of residues in livestock ...... 25 A 2.4 Magnitude of residues in plants ...... 25 A 2.4.1 Wine grapes ...... 25 A 2.5 Livestock feeding studies ...... 32 A 2.6 Magnitude of residues in processed commodities (Industrial Processing and/or Household Preparation) ...... 32 A 2.7 Magnitude of residues in representative succeeding crops ...... 32

Page 3 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

A 2.8 Other/Special Studies ...... 32

Appendix 3 Pesticide Residue Intake Model (PRIMo) ...... 33 A 3.1 TMDI calculations ...... 33 A 3.2 IEDI calculations ...... 33

Page 4 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Commenting boxes were used by zRMS only for the detailed evaluation of studies in Appendix 2 of the dRR/RR. The description of the studies in Appendix 2 is based on the dRR originally submitted by the applicant. Some text passages therefore may be taken from the applicant´s dRR, however, the text will be adapted such that it in the end reflects the assessment of the zRMS based on the original studies.

7 Metabolism and residue data (KCA section 6)

7.1 Summary and zRMS Conclusion

7.1.1 Critical GAP(s) and overall conclusion

Selection of critical uses and justification The critical GAPs with respect to consumer intake and risk assessment for the preparation FBR-C are presented in Table 7.1-1. They have been selected from the individual GAPs in the central zone for wine grapes. A list of all intended uses within the central zone is given in Part B, Section 0.

Overall conclusion The data available are considered sufficient for risk assessment. An exceedance of the current MRL of 100 mg/kg as laid down in Reg. (EU) 396/2005 is not expected. The chronic and the short-term intakes of potassium phosphonate residues are unlikely to present a public health concern. As far as consumer health protection is concerned, BfR/Germany agrees with the authorization of the intended uses.

Data gaps

 None.

Page 5 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Table 7.1-1: Acceptability of critical GAPs (and respective fall-back GAPs, if applicable)

1 2 3 4 5 6 7 8 9 10 11 12 13 14 Use- Member Crop and/ F, Pests or Group of Application Application rate PHI Conclusion / No. state(s) or situation Fn, pests controlled (days) Fpn Method Timing / Growth Max. Min. interval L product / ha kg as/ha Water Remarks: (crop destination G, (additionally: / Kind stage of crop & number between a) max. rate per appl. L/ha e.g. g safener/synergist / purpose of Gn, developmental stages season a) per use applications b) max. total rate per a) max. rate per appl. per ha crop) Gpn of the pest or pest b) per crop/ (days) crop/season b) max. total rate per min / or group) season crop/season max I Zonal uses (field or outdoor uses, certain types of protected crops) EU: 1 HU Grapes F downy mildew of foliar BBCH 15 - 89, a) 6 10 Potassium phosphonates: Potassium phosphonates: 14 grapevine spray in case of danger b) 6 a) 4.0 a) 2.9 200- use as table and (Plasmopara viticola) of infection and/or b) 24.0 b) 17.4 1000 A wine grape after warning

service appeal (0151000)

EU: 2 HU Grapes F downy mildew of foliar BBCH 15 - 89, a) 5 20 Potassium phosphonates: Potassium phosphonates: 14 grapevine spray in case of danger b) 6 a) 4.0 a) 2.9 200- use as table and (Plasmopara viticola) of infection and/or b) 20.0 b) 14.5 1000 A wine grape after warning service appeal (0151000) EU: 3 DE Grapes F downy mildew of spraying BBCH 15 - 89, a) 6 10-14 Potassium phosphonates: Potassium phosphonates: 14 grapevine or low in case of danger c) 6 a) basis application: 1.0 a) basis application: 0.726 400 use as table and (Plasmopara viticola) volume of infection and/or BBCH 61: 2.0 BBCH 61: 1.45 800 wine grape spraying after warning BBCH 71: 3.0 BBCH 71: 2.18 1200 A DE: service appeal BBCH 75: 4.0 BBCH 75: 2.9 1600 001 (0151000)

18.0 13.1 EU: 4 DE Grapes F downy mildew of spraying BBCH 15 - 89, a) 5 20-28 Potassium phosphonates: Potassium phosphonates: 14 grapevine or low in case of danger d) 6 a) basis application: 1.0 a) basis application: 0.726 400 use as table and (Plasmopara viticola) volume of infection and/or BBCH 61: 2.0 BBCH 61: 1.45 800 wine grape spraying after warning BBCH 71: 3.0 BBCH 71: 2.18 1200 A DE: service appeal BBCH 75: 4.0 BBCH 75: 2.9 1600 002 (0151000)

18.0 13.1

Explanation for Column 14 “Conclusion” A Sufficient data available, exposure acceptable, safe use R Data gap N Exposure not acceptable, no safe use

Page 6 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

7.1.2 Summary of the evaluation

The preparation FBR-C is composed of Potassium phosphonates. Potassium phosphonate (formerly named potassium phosphite) dissociates to phosphonic acid. Information on phosphonate residues can also be extracted from studies with Fosetyl-Al, since phosphonate, the biologically active substance in potassium phosphonate is also the main metabolite of Fosetyl-Al, and is the relevant residue in both cases. It is noted that the plant residue definition currently established for enforcement of potassium phosphonate is combined with that of fosetyl, reading as follows: ´sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl´ (Reg. (EU) 2019/552).

Table 7.1-2: Toxicological reference values for the dietary risk assessment of Potassium phosphonates

Reference Safety Source Year Value Study relied upon value factor Fosetyl-Al (sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl) ADI EFSA Conclusion on 2013 2.25 mg/kg bw/d 2-year rat; with hydrated 100 potassium phosphonate monosodium phosphonate, ASB2012-16090 expressed as phosphonic acid EFSA, Peer Review on 2019 1 mg/kg bw/d developmental study, rabbit, 100 Fosetyl expressed as fosetyl equivalents, ASB2019-4285 the reference values of the parent are applied to phosphonic acid ARfD EFSA Conclusion on 2013 Not applicable potassium phosphonate ASB2012-16090 EFSA, Peer Review on 2018 1 mg/kg bw maternal decreased body weight 100 fosetyl gain observed in rabbit ASB2018-7723 developmental study EFSA, Peer Review on 2019 Not applicable Fosetyl (update) ASB2019-4285

It is highlighted that an ADI has recently been proposed at 1 mg/kg in the EFSA conclusion on the peer review of the pesticide risk assessment of fosetyl (EFSA, 2019, ASB2019-4285) but this value has not yet been agreed upon. Since phosphonic acid is a major metabolite in rat, its toxicity is considered covered by the studies performed with fosetyl-Al. Similarly an ARfD was proposed at 1 mg/kg bw (EFSA, 2018, ASB2018-7723) but this proposal has been revoked in the meantime (EFSA, 2019, ASB2019-4285).

Page 7 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

7.1.2.1 Summary for Potassium phosphonates

Table 7.1-3: Summary for Potassium phosphonates

Sample storage Chronic Acute risk Plant Sufficient PHI Use- covered MRL risk for for Crop metabolism residue sufficiently No.* by compliance consumers consumers covered? trials? supported? stability identified? identified? data?

EU: Grapes Yes Yes (9) Yes Yes Yes No No 1-4 * Use number(s) in accordance with the list of all intended GAPs in Part A / Part B, Section 0 should be given in column 1

Crops under evaluation are not expected to be grown in rotation. Further investigation of residues in rotational crops is therefore not required.

Residues of potassium phosphonate in commodities of animal origin were not assessed, since potassium phosphonate is intended to be applied to grapes only, which are not relevant for livestock feeding.

7.1.2.2 Summary for Summary for FBR-C

Table 7.1-4: Information on FBR-C (KCA 6.8)

PHI for FBR- PHI for FBR- zRMS Comments C PHI sufficiently supported for C Crop (if different PHI proposed by Potassium phosphonates proposed by proposed) applicant zRMS

Grapes 14 days Yes 14 --

Page 8 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Assessment

7.2 Potassium phosphonates

General data on potassium phosphonates are summarized in the table below (last updated 2020/02/26)

Table 7.2-1: General information on Potassium phosphonates

Active substance (ISO Common Name) potassium phosphonate IUPAC potassium hydrogen phosphonate and dipotassium phosphonate Chemical structure

Molecular formula KH2PO3 [ HPO(OH)(O-K+) ] and K2HPO3 [HPO(O-K+)2] Molar mass monopotassium phosphonate: 120.1 g/mol and dipotassium phosphonate: 158.2 g/mol Chemical group inorganic phosphonate Mode of action (if available) Potassium phosphonate acts by two ways, first within the fungus inhibiting fungus growth, and second by changing the nature of the fungal cell walls by activating the plants own immune defense mechanisms. Systemic Yes Company (ies) Luxembourg Industries (Pamol) Ltd. * Rapporteur Member State (RMS) France Approval status Approved (Commission Implementing Regulation (EU) No 369/2013 of 22 April 2013) Restriction Restricted to uses as a fungicide. Review Report SANCO/10416/2013 rev 2 of 15 March 2013

Current MRL regulation Commission Regulation (EU) No. 2019/552 Peer review of MRLs according to Article 12 of Reg. No (EC) No 396/2005 performed EFSA Journal : Conclusion on the peer review Yes (EFSA, 2013, ASB2012-16090) Current MRL applications on intended uses -- * Notifier in the EU process to whom the a.s. belong(s)

7.2.1 Stability of Residues (KCA 6.1)

7.2.1.1 Stability of residues during storage of samples

Available data A brief summary of the storage stability data on potassium phosphonate is given in the following table. For the detailed evaluation of new/additional storage stability studies it is referred to Appendix 2.

Page 9 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Table 7.2-2: Summary of stability data achieved at ≤ - 18°C (unless stated otherwise)

Characteristics of the Acceptable Maximum Matrix Reference matrix Storage duration New data Plant products Grapes High acid content 7 months (phosphonic acid) Perny, 2016, ASB2018-941 Perny, 2017, ASB2019- 13950

Conclusion on stability of residues during storage Residues of phosphonic acid are stable in grapes and processed grape commodities (wine, wet pomace, dry pomace, juice, raisins) under deep freezer conditions for at least 7 months.

7.2.1.2 Stability of residues in sample extracts

Available data The stability of extracts during frozen storage was investigated during the validation of the analytical methods (ASB2018-928). It could be demonstrated that phosphonic acid residues are stable in samples extracts for all grape matrices when stored at < -18°C for a period of 15/16 days.

7.2.2 Nature of residues in plants, livestock and processed commodities

7.2.2.1 Nature of residue in primary crops (KCA 6.2.1)

The behaviour (uptake and distribution) of phosphonate was described in several studies in open literature. In its Conclusion on the peer review (ASB2012-16090) EFSA concluded that phosphonate is translocated through the entire plant after soil or foliar application and that phosphonate is not significantly oxidised to phosphate in plants. Only transformation of the potassium phosphonate salts into phosphonic acid is expected in plants.

7.2.2.2 Nature of residue in rotational crops (KCA 6.6.1)

Not required as grapes are perennial crops.

7.2.2.3 Nature of residues in processed commodities (KCA 6.5.1)

Not required. The chemistry of phosphorous acid is well understood. Apart from acid-base conversion, no further modification of the residue has to be expected. Still, hydrolytic stability was assessed and Fosetyl -Al and phosphonic acid were considered to be hydrolytically stable under conditions representative of pasteurisation, baking, brewing, boiling and sterilisation (RIP2003-409). This was also concluded by EFSA (ASB2019-4285).

Page 10 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

7.2.2.4 Conclusion on the nature of residues in commodities of plant origin (KCA 6.7.1)

Table 7.2-3: Summary of the nature of residues in commodities of plant origin Endpoints Plant groups covered The behaviour of potassium phosphonate was described in several studies in open literature. The major conclusions drawn from these studies were:  Potassium phosphonate readily penetrates both bark and cuticle of Betula pendula trees (ASB2010- 1158).  Following trunk injection, phosphonate is bipetally translocated in phloem and in xylem (ASB2010- 1157).  Following foliar application, phosphonate is detected in the plant roots, confirming its mobility in the plant phloem (ASB2009-4287, ASB2009-4288).  Distribution of phosphonate to both roots and leaves is more rapid after foliar application than after trunk injection (ASB2010-1156).  Phosphonate can be actively taken up into the symplast of castor bean plants and sugar beet leaves, and transported through the phloem. The involvement of an active transport system is evidenced by the effect of metabolic inhibitors (ASB2009-4288). Information on phosphonate residues can also be extracted from studies with Fosetyl-Al, since phosphonate, the biologically active substance in potassium phosphonate is also the main metabolite and the biologically active substance of Fosetyl-Al, and the relevant residue in both cases. The major conclusions from these studies are as follows:  Levels of phosphonate residues are related to the total dose applied, and to the route of application (ASB2009-4287).  In aerial plant parts, residue levels increase rapidly after foliar application but decline within 4-6 weeks after treatment (ASB2009-4287). Phosphonate is not readily oxidised in the plant to phosphate, evidenced by the fact that phosphate levels in plant tissues are not raised upon phosphonate applications, but sometimes even reduced (ASB2009-4284, ASB2010-1163). Thus, phosphonate bound phosphorus does not serve as an immediate P source in plants. Rotational crops covered Not required in this case. Metabolism in rotational crops similar to metabolism NA in primary crops? Processed commodities Not required. The chemistry of phosphonic acid is well understood. Apart from acid-base conversion, no further modification of the residue has to be expected. Residue pattern in processed commodities similar to Not applicable pattern in raw commodities? Plant residue definition for monitoring Potassium phosphonate forms phosphonic acid. Thus it is covered by the already existing residue definition “Fosetyl-Al (sum fosetyl + phosphonic acid and their salts, expressed as

Page 11 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

fosetyl)” which is established in Reg. (EC) No 396/2005.

Note: Currently discussions are ongoing if separate MRLs should be set for fosetyl-Al and for phosphonic acid and its salts. For the time being the current residue definition is kept. Plant residue definition for risk assessment Phosphonic acid and its salts, expressed as phosphonic acid (EFSA, 2013, ASB2012-16090) Conversion factor from enforcement to RA none

7.2.2.5 Nature of residues in livestock (KCA 6.2.2-6.2.5)

The metabolism of potassium phosphonate in livestock was not investigated. Data is not required for the time being. This was confirmed by EFSA in its Conclusion on the peer review of the pesticide risk assessment of the active substance potassium phosphonate (ASB2012-16090).

7.2.2.6 Conclusion on the nature of residues in commodities of animal origin (KCA 6.7.1)

Table 7.2-4: Summary on the nature of residues in commodities of animal origin

Endpoints

Animals covered No toxicologically significant residues of phosphorous (=phosphonic) acid and its salts are anticipated in livestock feed and therefore studies with livestock were not performed (in compliance also with the Animal Protection Act). Time needed to reach a plateau Not applicable concentration

Animal residue definition for monitoring Not required Animal residue definition for risk Not required assessment

Conversion factor Not applicable Metabolism in rat and ruminant similar Not applicable

Fat soluble residue No

Page 12 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

7.2.3 Magnitude of residues in plants (KCA 6.3)

Available data A summary of the magnitude of residues of Potassium phosphonates is given in the following table. For the detailed evaluation of new/additional studies on the magnitude of residues it is referred to Appendix 2. The residue definitions for risk assessment and enforcement are different. The current residue definition for enforcement is the one set for fosetyl (covering also phosphonates): sum of fosetyl, phosphonic acid and their salts expressed as fosetyl while the residue definition for risk assessment is defined as the sum of phosphonic acid and its salts expressed as phosphonic acid. To express residues of phosphonic acid as fosetyl, a molecular weight conversion factor of 1.34 was applied.

Table 7.2-5: Summary of EU reported and new data supporting the intended uses of FBR-C and conformity to existing MRL

Residue Evaluation Unrounded zone (N- Current GAP OECD MRL EU, S- STMR HR EU MRL Commodity Source Residue levels (mg/kg) calculator compliance EU, EU, (mg/kg) (mg/kg) (mg/kg) E = according to enforcement residue definition MRL outside RA = according to risk assessment residue definition (mg/kg) * EU)

Grapes New trials N-EU Trials GAP: 6-10 x ~3 kg as/ha, PHI 14 d, outdoor N/A ASB2018-945 E: 7.1, 24.9, 2 x 29.1, 39.1, 54.1, 66.6, 73.4, 92.9 ASB2018-925 RA: 5.3, 18.6, 2 x 21.7, 29.2, 40.4, 49.7, 54.8, 69.3

Overall N-EU E: 7.1, 24.9, 2 x 29.1, 39.1, 54.1, 66.6, 73.4, 92.9 E: 39.1 E: 92.9 -- 100 Yes supporting RA: 5.3, 18.6, 2 x 21.7, 29.2, 40.4, 49.7, 54.8, 69.3 RA: 29.2 RA: 69.3 data for cGAP * Source of EU MRL: Reg. (EU) 2019/552

Page 13 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Conclusion on the magnitude of residues in plants A total of twelve trials were submitted, out of which nine were considered as acceptable. The maximum storage period of deep-frozen samples in the supervised residue trials is covered by the storage stability studies.

According to the available data, the intended uses on grapes are considered acceptable.

The data submitted show that no exceedance of the MRL will occur. The uses are considered acceptable.

7.2.4 Magnitude of residues in livestock

7.2.4.1 Dietary burden calculation

Residues of potassium phosphonate in commodities of animal origin were not assessed, since potassium phosphonate is intended to be applied to grapes, which are not relevant for livestock feeding.

Livestock feeding studies are not required and no residues are expected to occur in food commodities of animal origin.

7.2.5 Magnitude of residues in processed commodities (Industrial Processing and/or Household Preparation) (KCA 6.5.2-6.5.3)

A new study was submitted along with the current application. For the detailed evaluation of these studies on the magnitude of residues it is referred to Appendix 2.

The following median processing factors were derived: - Juice: 1.0, 1.0 (Mean = 1.0) - Wine: 1.1, 1.3 (Mean = 1.2) - Raisins: 2.5, 1.6 (Mean = 2.1)

7.2.6 Magnitude of residues in representative succeeding crops

Crops under evaluation are not expected to be grown in rotation. Further investigation of residues in rotational crops is therefore not required.

7.2.7 Other / special studies (KCA6.10, 6.10.1)

The available data for the potassium phosphonates sufficiently address aspects of the residue situation that might arise from the use of FBR-C. Therefore, other special studies are not needed.

7.2.8 Estimation of exposure through diet and other means (KCA 6.9)

Toxicological reference values relevant for dietary risk assessment are reported in the summary of the evaluation (see 7.1.2). As ARfD was not deemed necessary, acute risk assessment is not relevant.

Page 14 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

7.2.8.1 Input values for the consumer risk assessment

A summary of the toxicological reference values relevant for dietary risk assessment are reported in the summary of the evaluation (see 7.1.2). As ARfD was not deemed necessary, acute risk assessment is not relevant. For the chronic risk assessment, STMR values derived in previous EFSA assessments (expressed as phosphonic acid) and the MRLs established for fosetyl-Al in Regulation (EC) No 2019/552, recalculated to phosphonic acid, were used as input values. Crops with MRLs set at the LOQ were disregarded. The molecular weight CF of 0.75 was used to express residue levels as phosphonic acid.

Table 7.2-6: Input values for the consumer risk assessment

Chronic risk assessment Acute risk assessment Commodity Input value Input value Comment Comment (mg/kg) (mg/kg)

Risk assessment residue definition: phosphonic acid and its salts, expressed as phosphonic acid Blackberries, 58.2 Median residue Not worked out as no ARfD is raspberries (EFSA, 2018 / ASB2018-10457) currently allocated. Blueberries, currants, 18.4 Median residue gooseberries, (EFSA, 2018 / ASB2018-10457) elderberries Tree nuts (except 64.5 Median residue coconuts) (EFSA, 2018 / ASB2018-10457) Pome fruit 23.2 Median residue (EFSA, 2018 / ASB2018-10457) Peaches 12.5 Median residue (EFSA, 2018 / ASB2018-10457) Potatoes 6.0 Median residue (EFSA, 2018 / ASB2018-10457) Celeriacs 0.21 Median residue (EFSA, 2018 / ASB2018-10457) Kiwi fruits 23.5 Median residue (EFSA, 2018 / ASB2018-10457) Spices 74 Median residue (EFSA, 2018 / ASB2018-10457) Other commodities of MRL MRL (Reg. (EU) 2019/552) plant and animal origin

7.2.8.2 Conclusion on consumer risk assessment

Extensive calculation sheets are presented in Appendix 3.

Table 7.2-7: Consumer risk assessment

TMDI (% ADI) according to EFSA PRIMo Not calculated since the RDMO ≠RDRA IEDI (% ADI) according to EFSA PRIMo Based on legally established toxicological reference value of 2.25 mg/kg bw/d: 52% (based on NL toddler, mean body

Page 15 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

weight) IESTI (% ARfD) according to EFSA PRIMo Not applicable as no ARfD is allocated

NTMDI (% ADI) according to German NVS II Not calculated since the RDMO ≠RDRA NEDI (% ADI) according to German NVS II Based on legally established toxicological reference value of 2.25 mg/kg bw/d: 45% (based on DE children,2-4 years, individual consumption/body weight ratio) NESTI (% ARfD) according to German NVS II Not applicable as no ARfD is allocated

The proposed uses of potassium phosphonates in the formulation FBR-C do not represent unacceptable acute and chronic risks for the consumer.

7.3 Combined exposure and risk assessment

Not relevant. The product contains only one active substance.

Page 16 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

7.4 References

EFSA (European Food Safety Authority), 2013. Conclusion on the peer review of the pesticide risk assessment of the active substance potassium phosphonate; EFSA Journal 2012;10(12):2963; doi: 10.2903/j.efsa.2012.2963; ASB2012-16090. EFSA (European Food Safety Authority), 2018. Reasoned opinion on the modification of the existing maximum residue levels for potassium phosphonate in certain berries and small fruits. EFSA Journal 2018; 16(9):5411, 26 pp. https://doi.org/10.2903/j.efsa.2018.5411; ASB2018-10457. EFSA (European Food Safety Authority), 2018b. Conclusion on pesticides peer review; Peer review of the pesticide risk assessment of the active substance fosetyl; EFSA Journal 2018;16(7):5307; https://doi.org10.2903/j.efsa.2018.5307 ; ASB2018-7723. EFSA (European Food Safety Authority), 2019. Conclusion on pesticides peer review of the pesticide risk assessment of the active substance fosetyl. EFSA Journal 2018;16(7):5307, 25 pp. https://doi.org10.2903/j.efsa.2018.5307; ASB2019-4285. France, 2012. Potassium phosphonate: Final addendum to the Draft Assessment Report; ASB2012-13621.

Page 17 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Appendix 1 Lists of data considered in support of the evaluation

List of data submitted by the applicant and relied on

Title Company Report No. Vertebrate Data Author(s) Year Source (where different from company) study Owner point GLP or GEP status Y/N Published or not

KCP 6.1 Perny, A. 2016 Frozen storage stability of residues of Potassium phosphonate in grapes whole fruits and in processed N Fitosanitarios fractions (wine, wet pomace, dry pomace, juice and dried raisins) – STUDY PLAN Bajo Riesgo B5175 AIE GLP: Open Published: Open BVL-3334864, ASB2018-941 KCP 6.1 Schneider, E. 2016 Validation of the analytical method for the determination of Potassium Phosphonate in grapes whole N Fitosanitarios fruits and processed fractions (wine, wet pomace, dry pomace, juice and dried raisins) - final report - Bajo original 1 of 2 Fitosanitarios B5174 Bajo Riesgo GLP: Open (1) Yes (2) Published: No (2) Open (1) AIE BVL-3334862, BVL-3336016, BVL-3345267, ASB2018-928 KCP 6.1 Schutte, G. C.; 1991 Timing of application of Phosphonate fungicides using different application methods as determined by N LIT Bezuidenbout, J. J.; means of gas-liquid chromatography for phytophrhora root rot control of citrus Kotze, J. M. A2AS04P0601_04 ! pages 69-71 GLP: Open Published: Open BVL-3339153, ASB2010-1156 KCP 6.2 Ouimette, D. G.; 1988 Phosphonate levels in avocado (Persea americana) seedlings and soil following treatment with Fosetyl-Al N LIT Coffey, M. D. or Potassium phosphonate page 212-215 GLP: Open Published: Open BVL-3338458, ASB2009-4287 KCP 6.2 Ouimette, D. G.; 1990 Symplastic entry and phloem translocation of Phosphonate N LIT Coffey, M. D. 0048-3575/90 ! pages 18-25 GLP: Open Published: Open

Page 18 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Title Company Report No. Vertebrate Data Author(s) Year Source (where different from company) study Owner point GLP or GEP status Y/N Published or not

BVL-3338656, ASB2009-4288 KCP 6.2 Förster, H.; 1998 Effect of Phosphite on tomato and pepper plants and susceptibility of pepper to Phytophthora root and N LIT Adaskaveg, J. E.; crown rot in hydroponic culture Kim, D. H.; A2AS04P0601_14 ! pages 1165-1170 Stanghellini, M. E. GLP: Open Published: Open BVL-3339159, ASB2010-1163 KCP 6.2 Garrec, J. P.; 1991 Caracteristiques de la fixation et de la penetration corticale. Passage du phosphite dipotassique et de l?eau N LIT Barrois, A. au travers d?ecorces isolees A2AS04P0601_06 ! pages 11-23 GLP: Open Published: Open BVL-3339133, ASB2010-1158 KCP 6.2 Carswell, C.; Grant, 1995 The fungicide Phosphonate disrupts the Phosphatestarvation response in Brassica nigra seedlings N LIT B. R.; Theodorou, pages 105-110 M. E.; Harris, J.; GLP: Open Published: Open Niere, J. O.; Plaxton, BVL-3339156, ASB2009-4284 W. C KCP 6.2 Whiley, A. W.; 1986 Influence of Phytophthora root rot on mineral nutrient concentrations in avocado leaves N LIT Pegg, K. G.; A2AS04P0601_05 Saranah, J. B.; GLP: No (2) Open (2) Published: Open (2) Yes (2) Langdon, P. W. BVL-2100307, BVL-2100307, BVL-2100650, BVL-2100650, ASB2010-1157 KCP 6.3 Perny, A. 2017 Determination of Potassium phosphonate residues in RAC grapes following foliar application with FBR-1 N Fitosanitarios under field conditions in Northern in 2016 - Final report Bajo B6156 Fitosanitarios GLP: Open Published: Open Bajo Riesgo BVL-3406560, BVL-3406560, BVL-3406560, ASB2018-945 AIE KCP 6.3 Schneider, E. 2016 Determination of Potassium phosphonate residues in RAC grapes and processed commodities following N Fitosanitarios foliar application with FBR-1 under field conditions in Northern and Southern Europe in 2015 - final Bajo report - original 1 of 2 Fitosanitarios B5143 Bajo Riesgo

Page 19 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Title Company Report No. Vertebrate Data Author(s) Year Source (where different from company) study Owner point GLP or GEP status Y/N Published or not

GLP: Open Published: Open AIE BVL-3343190, BVL-3343195, BVL-3343195, ASB2018-925

List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review

Title Company Report No. Vertebrate Data Author(s) Year Source (where different from company) study Owner point GLP or GEP status Y/N Published or not

KCP 6.5 Crowe, A. 2001 Fosetyl-al and phosphorous acid: hydrolysis under simulated processing conditions N Aventis AES 043/012745 ! C013568 ! M-203002-02-1 CropScience GLP: Open Published: Open BVL-2110391, RIP2003-409

List of data submitted by the applicant and not relied on

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 6.2.1 Kast, W. K. 2000 Salicylic and Phosphorous acid - possible alternative to Copper? N LIT A2AS04P0601_08 GLP: Open Published: Open BVL-3339102, ASB2010-1159 KCP 6.2.1 MacIntire, W. H.; 1950 Fertilizer evluation for certain Phosphorus, Phosphorous and Phosphoric material by means of pot cultures N LIT Winterberg, S. H.; A2AS04P0601_11 ! page 543-549

Page 20 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

Hardin, L. J.; Sterges, GLP: Open Published: Open A. J.; Clements, L. B. BVL-3339162, ASB2010-1128 KCP 6.2.1 Robertson, H. E.; 1955 Di-Sodium Phosphonate: Orthophosphite as a buffer for biological studies N LIT Boyer, P. D. page 396-401 GLP: Open Published: Open BVL-3338455, ASB2009-4289 KCP 6.2.1 Whiley, A. W.; Pegg, 1995 Changing sink strengths influence translocation of Phosphonate in avocado (Persea americana Mill.) trees N LIT K. G.; Saranah, J. B.; A2AS04P0601_01 ! pages 1079-1090 Langdorn, P. W. GLP: Open Published: Open BVL-3339152, ASB2010-1154 KCP 6.2.3 XXXXX 1992 Metabolism of 14C-Fosetyl-Al metabolites in lactating goats Y Aventis C012432 ! 1219 ! 430619 ! M-202696-01-1 CropScience GLP: Open Published: Open BVL-2110362, RIP2003-388 KCP 6.2.3 XXXXX 1987 Characterisation of 14C-Fosetyl-Al metabolites in goat milk Y Aventis 33115 ! R003992 ! M-165774-01-1 CropScience GLP: Open Published: Open BVL-2110361, RIP2003-387 KCP 6.2.3 XXXXX 1987 Metabolism of 14C-Fosetyl-Al in lactating dairy goats Y Aventis ABC 32637 ! R001413 ! M-160479-01-1 ! 423855 CropScience GLP: Open Published: Open BVL-2110359, RIP2003-385 KCP 6.2.3 XXXXX 1987 Metabolism of 14C-Fosetyl-Al in lactating dairy goats - Supplement Y Aventis ABC 32637 ! R003993 ! M-165777-01-1 CropScience GLP: Open Published: Open BVL-2110360, RIP2003-386 KCP 6.4 XXXXX 1984 Fosetyl-al tissue and milk residue study in dairy cows Y Aventis 4608 ! R011763 ! M-184519-01-1 CropScience GLP: Open Published: Open

Page 21 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

BVL-2110390, RIP2003-408 KCP 6.4 XXXXX 1984 Analysis of tissues and milk from treated dairy cows fed Fosetyl-Al - Aluminium tris (O-ethyl Y Aventis phosphonate) CropScience ASD 84/084 ! R011762 ! 447435 ! M-184515-01-1 GLP: Open Published: Open BVL-2110389, RIP2003-407 KCP 6.4 XXXXX 2000 Forsetyl-AL: Ruminant feeding study residues of Fosetyl-Al and the metabolite Phosphorous acid in milk Y Aventis and edible tissues of cattle CropScience 709571 ! C010251 ! M-198684-01-1 GLP: Open Published: Open BVL-2110388, RIP2003-406

List of data relied on and not submitted by the applicant but necessary for evaluation

Title Company Report No. Vertebrate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Y/N Published or not

KCP 6.1 Perny, A. 2017 Frozen storage stability of residues of Potassium phosphonate in grapes whole fruits and in processed N Fitosanitarios fractions (wine, wet pomace, dry pomace, juice and dried raisins) - Final report Bajo B5175 GLP: Yes Published: No BVL-3879636, ASB2019-13950

Page 22 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Appendix 2 Detailed evaluation of the additional studies relied upon

A 2.1 Stability of residues

A 2.1.1 Storage stability of residues in plant products

Comments of zRMS: Acceptable.

Reference: 6.1 Report Frozen storage stability of residues of Potassium phosphonate in grapes whole fruits and in processed fractions (wine, wet pomace, dry pomace, juice and dried raisins) - Final report, Perny, A., 2017, B5175, ASB2019-13950 Guideline(s): Yes (OECD 506 Stability of Pesticide residues in stored commodities, SANCO/825/00 rev. 8.1, 16 November 2010, SANCO/3029/99 rev. 4, 11 July 2000) Deviations: No GLP: Yes Acceptability: Yes

Materials and methods (text passages were taken from the applicant´s dRR) Grapes whole fruits, wine, wet pomace, dry pomace, juice and dried raisins supplemented with phosphorous acid were analysed after 0, 60 ( 3) and 210 ( 5) days of frozen storage at temperatures below -18 °C.

The validation of this method was performed under the ANADIAG study No. B5174: Validation of the analytical method for the determination of Potassium Phosphonate in Grapes whole fruits and processed fractions (wine, wet pomace, dry pomace, juice and dried raisins). Residues in homogenized crop sample are extracted by manual or mechanical agitation with methanol. The extract is centrifuged and filtered on glass wool. An aliquot of 50% is purified on a charcoal cartridge. The residues are filtered through CE filter and analyzed by LC/MS/MS.

Results and discussions Procedural recoveries were acceptable. No residues were detected in the corresponding control samples. Concurrent recoveries are presented in Table A 1. The results of the storage stability recoveries for the matrices investigated are also summarized in Table A 2. No degradation was observed during the full study time of 7 months for any of grape matrices tested.

Table A 1: Summary of concurrent recoveries of phosphorous acid

Spike level (mg/kg) Storage Interval Sample size (n) Individual Mean ± std dev (days) procedural recoveries (%) Grape whole fruits 5 0, 60 4 79, 87, 76, 71 78± 6.7 5 207 2 77, 82 80

Page 23 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Spike level (mg/kg) Storage Interval Sample size (n) Individual Mean ± std dev (days) procedural recoveries (%) Wine 5 0, 60 4 83, 75, 73, 79 77± 4.0 5 207 2 99, 96 97 Dry pomace 5 0, 60 4 71, 81, 82, 75 77± 5.1 5 207 2 80, 74 77 Wet pomace 5 0, 60 4 76, 70, 78, 72 74± 3.4 5 207 2 84, 86 85 Juice 5 0, 60 4 95, 99, 92, 92 95± 3.0 5 207 2 84, 90 87 Raisins 5 0, 60 4 86, 95, 85, 92 90± 4.7 5 207 2 109. 109 109

Table A 2: Stability of phosphorous acid residues in grape matrices following storage at - 18C

Matrix Spike level Storage Individual Individual (mg/kg) interval recovered residues recoveries (days) (mg/kg) (%) Grapes 5 0 3.932, 4.352, 3.814, 3.548 79, 87, 76, 71 61 3.929, 3.750 75, 71 207 3.887, 3.828 74, 73 Wine 5 0 4.126, 3.769, 3.668, 3.927 83, 75, 73, 79 61 3.600, 3.991 68, 76 208 4.770, 4.733 91, 90 Wet pomace 5 0 3.860, 3.579, 3.970, 3.683 76, 70, 78, 72 61 4.098, 3.880 78, 74 207 4.770, 4743 91, 90 Dry pomace 5 0 3.612, 4.109, 4.179, 3.852 71, 81, 82, 75 61 4.328, 3.915 82, 74 207 3.844, 3.693 73, 70 Juice 5 0 4.742, 4.930, 4.623, 4.609 95, 99, 92, 92 61 4.228, 4.711 80, 89 208 4.778, 4.736 91, 90 Raisins 5 0 4.299, 4.736, 4.258, 4.616 86, 95, 85, 92 61 4.784, 4.627 91, 88

Page 24 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Matrix Spike level Storage Individual Individual (mg/kg) interval recovered residues recoveries (days) (mg/kg) (%) 207 3.773, 3.653 72, 69

Conclusion of zRMS Residues of phosphonic acid are stable in grapes and processed grape commodities (wine, wet pomace, dry pomace, juice, raisins) under deep freezer conditions for at least 7 months.

A 2.1.2 Storage stability of residues in animal products

No new study submitted/required.

A 2.2 Nature of residue in plants

No new study submitted/required.

A 2.3 Nature of residues in livestock

No new study submitted/required.

A 2.4 Magnitude of residues in plants

A 2.4.1 Wine grapes

Table A 3: Comparison of intended and critical EU GAPs

Type of GAP Number of Application rate Interval Growth stage at PHI (days) applications per treatment between last application (precise unit) application

Intended cGAP (#3) 6 2.9 kg as/ha 10-14 BBCH 15 – 89 14 * Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0

Page 25 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Reference: OECD KIIA 6.3 Report see authority registration numbers cited in the remarks columns of the tables below (and study identification as laid down in the reference list) Guideline(s): in accordance with agreed guidance unless stated otherwise in the commenting box Deviations: no relevant deviations unless stated otherwise in the commenting box GLP: see reference list Acceptability: acceptable unless stated otherwise in the commenting box

Table A 4: Summary of residue trials with Potassium phosphonates RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Potassium phosphonates (Application on agricultural and horticultural crops) Crop / crop group : wine grapes Crop Code : VITVI Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2018-01-09

Content of a.i. (g/kg or g/l) : 726 g/L Indoors / Outdoors : Outdoors (Northern and Central Europe) Formulation (e.g. WP) : SL (soluble concentrate) Other a.i. in formulation Commercial product (name) : FBR-C (content and common name) : Applicant : Fitosanitarios Bajo Riesgo AIE Residues calculated as : phosphonic acid

79189 3) 2015-10-01 3.1 530 0.58 2015-08-204) 625 (HPLC-MS/MS), 4) bunch of grapes, 39.4 20 Biengen, Bad- - 2015-10-05 2.9 500 0.58 2015-09-11 RAC 39.5 20 LOQ(s): 0.5 mg/kg Krözingen, Baden- max. sample storage time in month(s): 7 juice 39.5 20 Württemberg pomace, wet 51.1 20 ASB2018-925 2016-05-30 pomace, dried 33.3 20

wine 43.3 20

raisin 99.0 20

Page 26 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) study B5143, Sauvignon 1) 2007 2.8 780 0.36 2015-05-274) BBCH 79 bunch of grapes 46.4 0 4) spraying trial B5143 CZ1 (white variety) (planting) 2.9 790 0.37 2015-06-174) 38.1 7 2) 2015-05-30 2.9 790 0.37 2015-07-074) 53.9 13 analytical method: SOP MP 517 + SOP MA Czech Republic - 2015-06-10 2.9 790 0.37 2015-07-284) 54.8 21 625 (HPLC-MS/MS), 69301 Horni 3) 2015-09-25 2.9 800 0.36 2015-08-174) LOQ(s): 0.5 mg/kg Bojanovice, South - 2015-09-30 2.9 800 0.36 2015-09-074) max. sample storage time in month(s): 6 Moarvian ASB2018-925 2016-05-30 study B5143, Pinot Noir 1) 2007-02 3.0 520 0.57 2015-05-124) BBCH 85 bunch of grapes 51.5 0 4) spraying trial B5143 GE2 (red variety) (planting) 3.1 530 0.59 2015-05-224) 59.2 7 2) 2015-05-28 2.8 480 0.58 2015-06-044) 49.6 14 analytical method: SOP MP 517 + SOP MA Germany (DE) - 2015-06-07 2.9 500 0.59 2015-06-164) 49.7 21 625 (HPLC-MS/MS), 79235 Oberrotweil, 3) 2015-09-10 2.9 510 0.57 2015-06-264) 30.3 28 LOQ(s): 0.5 mg/kg Baden-Württemberg 3.0 510 0.58 2015-07-094) max. sample storage time in month(s): 7 3.1 530 0.58 2015-07-214) 2016-05-30 3.0 510 0.58 2015-07-314) ASB2018-925 3.0 520 0.58 2015-08-134) 3.1 530 0.58 2015-08-254) study B5143, Pinot Noir 1) 1995 3.1 530 0.59 2015-05-214) BBCH 85 bunch of grapes 54.5 0 4) spraying trial B5143 MA1 (red variety) (planting) 3.0 510 0.59 2015-06-014) 58.6 8 2) 2015-05-30 3.0 520 0.58 2015-06-124) 69.3 15 replicate RAC-field sample(s), France (FR) - 2015-06-12 3.0 520 0.58 2015-06-244) 66.6 22 analytical method: 57630 3) 2015-09-25 3.0 530 0.56 2015-07-044) 64.7 28 SOP MP 517 + SOP MA 625 (HPLC- 4) Marsal, Lorraine 3.0 510 0.59 2015-07-15 bunch of grapes, 69.8 28 MS/MS), 2.9 510 0.57 2015-07-274) LOQ(s): 0.5 mg/kg RAC 69.7 28 2016-05-30 2.9 490 0.59 2015-08-064) max. sample storage time in month(s): 7 2.9 500 0.58 2015-08-174) juice 68.2 28 4) 2.9 500 0.58 2015-08-27 pomace, wet 102 28 ASB2018-925

pomace, dried 27.8 28

wine 87.3 28

raisin 110 28

Comments of zRMS: Although some of the trials were conducted with 10 instead of 6 applications, no residue levels above the current MRL occurred. Therefore, all trials were considered for the assessment. Storage stability of the main transformation product of potassium phosphonate, phosphonic acid, was demonstrated in grape

Page 27 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

matrices under frozen conditions (-18°C) for up to 7 months. With storage intervals between sampling and analysis of up to 7 months integrity of the samples can be assumed. It is concluded that the residue data are valid with regard to storage stability. The analytical method applied to determine phosphonic acid residues is deemed adequately validated and fit for purpose.

Page 28 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Potassium phosphonates (Application on agricultural and horticultural crops) Crop / crop group : wine grapes Crop Code : VITVI Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2018-01-09

Content of a.i. (g/kg or g/l) : 726 g/L Indoors / Outdoors : Outdoors (Northern and Central Europe) Formulation (e.g. WP) : SL (soluble concentrate) Other a.i. in formulation Commercial product (name) : FBR-A (content and common name) : Applicant : Fitosanitarios Bajo Riesgo AIE Residues calculated as : phosphonic acid

2017-10-06 ASB2018-945 study B6156, Gewürztraminer 1) 1996 2.8 480 0.58 2016-05-204) BBCH bunch of grapes 21.7 13 4) spraying trial B6156 GE1 (white variety) (planting) 3.1 540 0.58 2016-06-094) 83-85 2) 2016-06-23 3.1 540 0.58 2016-07-054) analytical method: SOP MP 517 + SOP MA France (FR) - 2016-07-07 3.0 520 0.57 2016-07-284) 625 (HPLC-MS/MS), 68920 3) 2016-10-03 3.0 520 0.57 2016-08-194) LOQ(s): 0.5 mg/kg Wettolsheim - 2016-10-07 2.8 480 0.58 2016-09-134) max. sample storage time in month(s): 5

2017-10-06 ASB2018-945

Page 29 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

1 2 3 4 5 6 7 8 9 10 Report-No. Commodity/ Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) study B6156, Chardonnay 1) 1990 3.0 520 0.58 2016-05-264) BBCH 85 bunch of grapes 21.7 13 4) spraying trial B6156 BM1 (white variety) (planting) 3.0 520 0.58 2016-06-184) 2) 2016-06-16 2.8 490 0.57 2016-07-084) analytical method: SOP MP 517 + SOP MA France (FR) - 2016-06-25 2.9 500 0.58 2016-07-284) 625 (HPLC-MS/MS), 49540 3) 2016-09-19 2.8 480 0.58 2016-08-174) LOQ(s): 0.5 mg/kg Martigné-Briand, 3.0 520 0.58 2016-09-064) max. sample storage time in month(s): 5 Pays de la Loire ASB2018-945 2017-10-06 study B6156, Müller Thurgau 1) 1990 3.0 520 0.58 2016-05-274) BBCH 77 bunch of grapes 14.5 0 4) spraying trial B6156 MA1, (white variety) (planting) 2.9 500 0.59 2016-06-164) 20.4 25 plot 3 2) 2016-06-05 3.0 510 0.59 2016-06-244) 22.8 47 analytical method: SOP MP 517 + SOP MA - 2016-06-15 3.0 520 0.58 2016-07-084) 625 (HPLC-MS/MS), France (FR) 3) 2016-09-30 3.0 520 0.58 2016-07-224) LOQ(s): 0.5 mg/kg 57630 Marsal, 3.0 520 0.58 2016-08-054) max. sample storage time in month(s): 6 Lorraine ASB2018-945 2017-10-06 study B6156, Pinot Noir 1) 1986 2.9 510 0.57 2016-06-094) BBCH bunch of grapes 10.9 21 4) spraying trial B6156 GE2, (red variety) (planting) 3.0 520 0.58 2016-06-294) 83-85 plot 2 2) 2016-06-12 2.9 500 0.58 2016-07-194) analytical method: SOP MP 517 + SOP MA - 2016-06-28 2.9 510 0.57 2016-08-104) 625 (HPLC-MS/MS), Germany (DE) 3) 2016-10-05 2.9 500 0.58 2016-08-314) LOQ(s): 0.5 mg/kg 79235 Vogstburg - 2016-10-12 max. sample storage time in month(s): 5

2017-10-06 ASB2018-945 study B6156, Pinot Noir 1) 1986 2.8 480 0.59 2016-06-094) BBCH bunch of grapes 5.6 51 4) spraying trial B6156 GE2, (red variety) (planting) 2.8 490 0.58 2016-06-194) 77-79 plot 3 2) 2016-06-12 3.0 520 0.58 2016-06-294) analytical method: SOP MP 517 + SOP MA - 2016-06-28 2.8 490 0.58 2016-07-094) 625 (HPLC-MS/MS), Germany (DE) 3) 2016-10-05 3.1 530 0.58 2016-07-194) LOQ(s): 0.5 mg/kg 79235 Vogstburg - 2016-10-12 2.6 450 0.58 2016-08-014) max. sample storage time in month(s): 5

2017-10-06 ASB2018-945

Page 30 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

(a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included

Comments of zRMS: Only trials with samples taken at PHI of 14 days were considered for the assessment. Storage stability of the main transformation product of potassium phosphonate, phosphonic acid, was demonstrated in grape matrices under frozen conditions (-18°C) for up to 7 months. With storage intervals between sampling and analysis of up to 5 months integrity of the samples can be assumed. It is concluded that the residue data are valid with regard to storage stability. The analytical method applied to determine phosphonic acid residues is deemed adequately validated and fit for purpose.

Page 31 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

A 2.5 Livestock feeding studies

No new study submitted/required.

A 2.6 Magnitude of residues in processed commodities (Industrial Processing and/or Household Preparation) see A 2.4.

A 2.7 Magnitude of residues in representative succeeding crops

No new study submitted/required.

A 2.8 Other/Special Studies

No new study submitted/required.

Page 32 / 33 FBR-C / ZV1 008632-00/00 Part B – Section 7 - Core Assessment zRMS version

Appendix 3 Pesticide Residue Intake Model (PRIMo)

A 3.1 TMDI calculations

Not calculated.

A 3.2 IEDI calculations

Page 33 / 33

DRAFT REGISTRATION REPORT Part B Section 8 Environmental Fate Detailed summary of the risk assessment

Product code: ZV1 008632-00/00 Product name(s): FBR-1 (= FBR-C) Chemical active substance: potassium phosphonate 726 g/L (470.2 g/L phosphonic acid equivalents)

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT(authorization)

Applicant: Fitosanitarios Bajo Riesgo AIE Submission date: 29.07.2016 MS Finalisation date: 07.11.2019 ZV1 008632-00/00 / FBR-1 Page 2 / 28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Version history

When What

Dezember 2018 First Draft RR by UBA November 2019 Revised Draft RR by UBA

ZV1 008632-00/00 / FBR-1 Page 3 / 28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Table of Contents

8 Fate and behaviour in the environment (KCP 9) ...... 5 8.1 Critical GAP and overall conclusions ...... 6 8.1.1 Table of critical GAPs ...... 6 8.1.2 Overall conclusion ...... 8 8.1.3 Grouping of intended uses for risk assessment ...... 8 8.2 Metabolites considered in the assessment ...... 10 8.3 Rate of degradation in soil (KCP 9.1.1) ...... 11 8.3.1 Aerobic degradation in soil (KCP 9.1.1.1) ...... 11 8.3.1.1 Phosphonic acid ...... 11 8.3.2 Anaerobic degradation in soil (KCP 9.1.1.1) ...... 12 8.4 Field studies (KCP 9.1.1.2) ...... 12 8.4.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1) . 12 8.4.1.1 Phosphonic acid ...... 12 8.4.2 Soil accumulation testing (KCP 9.1.1.2.2) ...... 12 8.5 Mobility in soil (KCP 9.1.2) ...... 12 8.5.1 Adsorption and desorption in soil (KCP 9.1.2.1) ...... 12 8.5.1.1 Phosphonic acid ...... 12 8.5.2 Column leaching (KCP 9.1.2.1) ...... 13 8.5.3 Lysimeter studies (KCP 9.1.2.2) ...... 13 8.5.4 Field leaching studies (KCP 9.1.2.3) ...... 14 8.6 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1, KCP 9.2.2, KCP 9.2.3) ...... 15 8.6.1 Water/sediment study (KCP 9.2.2) ...... 15 8.6.1.1 Phosphonic acid ...... 15 8.7 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3) ...... 15 8.7.1 Justification of new endpoints ...... 15 8.7.2 Active substance and relevant metabolite(s) ...... 15 8.7.2.1 PECsoil ...... 16 8.8 Predicted Environmental Concentrations in groundwater (PECgw) (KCP 9.2.4.1) ...... 17 8.8.1 Justification of new endpoints ...... 17 8.8.2 Active substance and relevant metabolite(s) (KCP 9.2.4.1) ...... 17 8.8.2.1 Phosphonic acid ...... 18 8.8.3 Additional field test (KCP 9.2.4.2) ...... 19 8.8.4 Summary of the risk assessment for groundwater ...... 19 8.9 Predicted Environmental Concentrations in surface water (PECsw) (KCP 9.2.5) ...... 20 8.9.1 Justification of new endpoints ...... 20 8.9.2 Active substance, relevant metabolite(s) and the formulation (KCP 9.2.5) 20 8.9.2.1 Phosphonic acid and its metabolite phosphate ions ...... 21 8.9.2.2 PECsw/sed of formulation ...... 23 8.10 Fate and behaviour in air (KCP 9.3, KCP 9.3.1) ...... 23

Appendix 1 Lists of data considered in support of the evaluation ...... 24

Appendix 2 Summaries of the new Annex II studies ...... 26 ZV1 008632-00/00 / FBR-1 Page 4 / 28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

A 2.1 Goller, 2013 ...... 26

Appendix 3 Additional information provided by the applicant (e.g. detailed modelling data) ...... 26

ZV1 008632-00/00 / FBR-1 Page 5 / 28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8 Fate and behaviour in the environment (KCP 9)

ZV1 008632-00/00 / FBR-1 Page 6 / 28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.1 Critical GAP and overall conclusions

8.1.1 Table of critical GAPs

Table 8.1-1: Critical use pattern of the formulated product

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Use- Member Crop and/or situ- F, Fn, Pests or Group of pests Application Application rate PHI Remarks: Conclusion No. state(s) ation Fpn controlled (days) e.g. g saf- * (crop destination G, (additionally: develop- Method / Kind Timing / Max. number Min. interval kg or L kg as/ha Water L/ha ener/ syner- Groundwater / purpose of Gn, mental stages of the Growth a) per use between ap- product/ha min/max gist per ha crop) Gpn pest or pest group) stage of crop b) per crop/ plications a) max. rate a) max. rate or & season season (days) per appl. per appl. I ** b) max. total b) max. total rate per rate per crop/season crop/season Zonal uses (field or outdoor uses, certain types of protected crops)

1 Hungary Grapevine F Mildew - Plasmopara Foliar spray BBCH 15- 6 10 a) 4 a) 2.904 200-1000 14 6 consecu- (VITVI) viticola 89 b) 24 b) 17.424 tive applica- (PLASVI) tions from BBCH 15- 18, follow by treatments with products used traditionally at the end of a program against mildew

2 Hungary Grapevine F Mildew - Plasmopara Foliar spray BBCH 15- 5 20 a) 4 a) 2.904 200-1000 14 Program (VITVI) viticola 89 b) 20 b) 14.520 consists in (PLASVI) alternation between the product FBR-1 and other products used traditionally ZV1 008632-00/00 / FBR-1 Page 7 / 28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

in program against mildew

st 3 Germany Grapevine F Mildew - Plasmopara Foliar spray BBCH 15- 6 10 a) a) 1 : 400 14 6 consecu- R st st nd (VITVI) viticola 89 1 : 1 1 : 0.726 2 : 800 tive applica- nd nd rd (PLASVI) 2 : 2 2 : 1.452 3 : 1200 rd rd th tions from 3 : 3 3 : 2.178 4 : 1600 BBCH 15- th th th 4 : 4 4 : 2.904 5 : 1600 18, follow 5th: 4 5th: 2.904 6th: 1600 th th by treat- 6 : 4 6 : 2.904 ments with products b)18 b)13.068 used traditionally at the end of a program against mildew

4 Germany Grapevine F Mildew - Plasmopara Foliar spray BBCH 15- 5 20 a) a) 1st: 400 14 Program R viticola 89 1st: 1 1st: 0.726 2nd: 800 consists in (PLASVI) 2nd: 2 2nd: 1.452 3rd: 1200 alternation 3rd: 3 3rd: 2.178 4th: 1600 between the 4th: 4 4th: 2.904 5th: 1600 product 5th: 4 5th: 2.904 FBR-1 and other prod- b)14 b)10.164 ucts used traditionally in program against mildew * Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 ** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application

Explanation for column 15 “Conclusion” A Safe use R Further refinement and/or risk mitigation measures required C To be confirmed by cMS N No safe use

ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 8 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.1.2 Overall conclusion

Results of FOCUS groundwater modelling show that phosphonic acid is expected to penetrate into groundwater at concentrations of ≥ 0.1 µg/L in the intended uses of FBR-1 in 6 out of 7 FOCUS groundwater scenarios. However, in concordance with the EFSA conclusions (EFSA Journal 2012; 10(12): 2963) on Potassium phosphonates, the predicted groundwater concentrations are far below the health based drinking water limit of 3 mg/L for phosphonic acid that was calculated following the WHO 20091 guideline. Further refinement /risk mitigation might be required on Member State level.

8.1.3 Grouping of intended uses for risk assessment

The following table documents the intended uses according to their relevant applitcation rate to support application of the risk envelope approach (according to SANCO/11244/2011).

Table 8.1-2: Critical use pattern of FBR-1 grouped according to soil

Grouping according to soil

Intended uses Application rate (g/ha) Soil-relevant effective applic. interception, % rate, cumulative (g/ha) 1 6 x 2904 g/ha potassium phosphonate (6 x 1881 6 x 752.32 g/ha phosphonic acid g/ha phosphonic acid) = 4514 g/ha phosphonic acid 60 % 2 5 x 2904 g/ha potassium phosphonate (4 x 1881 5 x 752.32 g/ha phosphonic acid g/ha phosphonic acid) = 3762 g/ha phosphonic acid 60 % 3 1 x 726 g/ha potassium phosphonate (1 x 470 g/ha 188.08 g/ha + 376.16 g/ha + phosphonic acid) 564.24 g/ha + 3 x 752.32 g/ha 1 x 1452 g/ha potassium phosphonate (1 x 940 g/ha phosphonic acid phosphonic acid) = 3385 g/ha phosphonic acid 1 x 2178 g/ha potassium phosphonate (1 x 1411 g/ha phosphonic acid) 3 x 2904 g/ha potassium phosphonate (3 x 1881 g/ha phosphonic acid) 4 1 x 726 g/ha potassium phosphonate (1 x 470 g/ha 188.08 g/ha + 376.16 g/ha + phosphonic acid) 564.24 g/ha + 2 x 752.32 g/ha 1 x 1452 g/ha potassium phosphonate (1 x 940 g/ha phosphonic acid phosphonic acid) = 2633 g/ha phosphonic acid 1 x 2178 g/ha potassium phosphonate (1 x 1411 g/ha phosphonic acid) 2 x 2904 g/ha potassium phosphonate (2 x 1881 g/ha phosphonic acid)

1 WHO (World Health Organization), 2009. WHO Guidelines for Drinking-water Quality, Policies and Procedures used in updating the WHO Guidelines for Drinking-water Quality, 33 pp. ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 9 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Table 8.1-3: Critical use pattern of FBR-1 grouped according to spray drift

Grouping according to spray drift

Intended uses Application rate (g/ha) (interval, d) Drift scenario 1 6 x 2904 g/ha potassium phosphonate (6 x 1881 g/ha phosphonic acid) 60 % 2 5 x 2904 g/ha potassium phosphonate (5 x 1881 g/ha phosphonic acid) 60 % 3 1 x 726 g/ha potassium phosphonate (1 x 470 g/ha phosphonic acid) 1 x 1452 g/ha potassium phosphonate (1 x 940 g/ha phosphonic acid) 1 x 2178 g/ha potassium phosphonate (1 x 1411 vines g/ha phosphonic acid) 3 x 2904 g/ha potassium phosphonate (3 x 1881 g/ha phosphonic acid) 4 1 x 726 g/ha potassium phosphonate (1 x 470 g/ha phosphonic acid) 1 x 1452 g/ha potassium phosphonate (1 x 940 g/ha phosphonic acid) 1 x 2178 g/ha potassium phosphonate (1 x 1411 g/ha phosphonic acid) 2 x 2904 g/ha potassium phosphonate (2 x 1881 g/ha phosphonic acid)

ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 10 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.2 Metabolites considered in the assessment

Metabolites of potassium phosphonate Phosphate is the only relevant metabolite of potassium phosphonates (technical active substance) and phosphonic acid (actual active substance) in soil, surface water and sediment. Based on the criteria laid down in the EFSA guidance document Sanco/221/200-rev.10-final (2003)2, phosphate is a metabolite of no concern for the groundwater. However, PECsw and PECsed values of phosphate ions were calculated for risk assessment of aquatic organisms.

+ 2- - + 3- + K + HPO3 /H2PO3 + H2O  K + PO4 + H3O

2 Guidance Document on the assessment of the relevance of metabolites in groundwater of substances regulated under council directive 91/414/EEC (SANCO/221/2000 –rev.10- final - 25 February 2003)

ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 11 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.3 Rate of degradation in soil (KCP 9.1.1)

Studies on degradation in soil with the formulation were not performed, since it is possible to extrapolate from data obtained with the active substance.

8.3.1 Aerobic degradation in soil (KCP 9.1.1.1)

8.3.1.1 Phosphonic acid

No new studies have been submitted regarding route and rate of degradation in soil of potassium phosphonates by the applicant. The EU agreed DT50 values of phosphonic acid based on published and unprotected laboratory studies. The available DT50 values are considered sufficient by the zRMS for environmental exposure and risk assessment of FBR-1 in its intended use in vines. However, a new GLP study (Völkel, 2008) on the degradation of phosphonic acid was submitted for EU approval of the active substance Disodium phosphonate which also forms phosphonic acid as actual active substance. The study was evaluated for EU approval of Disodium phosphonate (see EFSA Journal 2013;11(5):3213). In order to base the evaluation of phosphonic acid on more available data, the DT50 values of the new study will be used together with the EU approved DT50 values submitted for potassium phosphonates for environmental exposure and risk assessment of FBR-1.

The available DT50 values of phosphonic acid used for environmental exposure and risk assessment of potassium phosphonates are summarized in Table 8.3-1

Table 8.3-1: Summary of aerobic degradation rates for phosphonic acid - laboratory studies

Soil type pH T Moisture DT50 DT90 DT50 (d) Kinetic, Fit Reference (oC) (d) (d) 20 C pF2/10kPa San Joaquin clay Not 28 Field 96 319 196 1st order, r2: Adams & loam soil stated capacity 0.96 Conrad (1953) – see EFSA Journal 2012;10(12):29 63 US sandy loam 5.0 20 75% of 133 442 88 1st order, r2: Lowden & 33kPa 0.68 Oddy (1999) – see EFSA Journal 2012;10(12):29 63 Hagenthal, clay 7.5 20 pF 2.0 – 179 750 - DFOP, chi2: Völkel (2008) loam 2.5 1.86 – see EFSA k1: 15.50854 Journal k2: 0.00282 2013;11(5):321 g: 0.1714 3 246 - 246 DFOP, slow phase ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 12 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Stolpe, Sandy 6.3 20 pF 2.0 – 191 843 - DFOP, chi2: Loam 2.5 6.76 k1: 0.07544 k2: 0.00247 g: 0.2011 281 - 281 DFOP, slow phase

Vouvry II, silt 7.7 20 pF 2.0 – 29.65 98.50 29.7 SFO, chi2: loam 2.5 16.7%

Geometric mean (n = 5) 128.8

pH dependency No

8.3.2 Anaerobic degradation in soil (KCP 9.1.1.1)

Not relevant for assessment.

8.4 Field studies (KCP 9.1.1.2)

8.4.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1)

8.4.1.1 Phosphonic acid

No field studies with potassium phosphonates or phosphonic acid are available or required.

8.4.2 Soil accumulation testing (KCP 9.1.1.2.2)

No data with potassium phosphonates or phosphonic acid are available or required.

8.5 Mobility in soil (KCP 9.1.2)

Studies on mobility in soil with the formulation were not performed, since it is possible to extrapolate from data obtained with the active substance.

8.5.1 Adsorption and desorption in soil (KCP 9.1.2.1)

8.5.1.1 Phosphonic acid

No new studies have been submitted regarding adsorption/desorption in soil of potassium phosphonates. The EU Kdoc values of phosphonic acid based on a GLP study (Völkel, 2006) are considered sufficient by ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 13 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015 the zRMS for environmental exposure and risk assessment of FBR-1 in its intended use in Vines. However, an additional GLP study (Völkel, 2008) was evaluated for EU approval of the active substance disodium phosphonate which also forms phosphonic acid as actual active substance (see EFSA Journal 2013;11(5):3213). Furthermore a new adsorption study Goller (2013) with potassium phosphonate was submitted by the applicant. In the study Kd values of phosphonic acid were determined in 5 soils. The determined Kd values were in the same range or higher than the values determined in the studies agreed upon for EU approval. The study is summarized in Appendix 2 of this assessment but was not evaluated in detail by the zRMS and was not used for risk assessment. In order to base the evaluation of phosphonic acid on more available data, the adsorption parameter of the new study will be used together with the EU approved Kdoc values submitted for potassium phosphonates for environmental exposure and risk assessment of FBR-1.

Table 8.5-1: Summary of soil adsorption/desorption for potassium phosphonate

OC pH Kf Kfoc 1/n Soil/ Soil Type -1 -1 Reference (%) H2O (mL g ) (mL g ) (-) Mechthildshausen/ Loam 1.36 6.8 3.10+ 228+ - Völkel (2006) – see EFSA Journal Mussig/ Clay Loam 4.13 7.6 10.37+ 251+ - 2012;10(12):2963

Uffholtz/ Silty Clay Loam 2.67 5.0 15.67+ 587+ -

Speyer 2.2/ Sandy Loam 2.3 5.6 5.30+ 230+ -

Bretagne/ Silt Loam 1.95 5.5 18.96+ 972+ -

Vouvry II/ Silt Loam 1.7 7.7 4.177 246 0.88 Völkel (2008) – see EFSA Journal Hagenthal/ Clay Loam 1.18 7.5 12.82 1086 0.74 2013;11(5):3213

Stolpe/ Sand 1.08 6.4 32.81 3038 (0.66)*

Fislis/ Silt Loam 2.6 7.2 5.01 193 0.78

Mechtildshausen/ Loam 1.46 7.6 4.85 332 0.92

Arithmetic mean (n=10) 11.31 716.3 0.844

Geometric mean (n=10) 8.58 456.3

pH dependency No + adsorption values based on the lowest test concentration only (85 mg/L) * 1/n values < 0.9 are considered as measurement artifact by the zRMS, thus the default value of 0.9 is used here

8.5.2 Column leaching (KCP 9.1.2.1)

No data, not required for assessment.

8.5.3 Lysimeter studies (KCP 9.1.2.2)

No data, not required for assessment.

ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 14 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.5.4 Field leaching studies (KCP 9.1.2.3)

No data, not required for assessment. ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 15 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.6 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1, KCP 9.2.2, KCP 9.2.3)

Studies on degradation in water/sediment systems with the formulation were not performed, since it is possible to extrapolate from data obtained with the active substance.

8.6.1 Water/sediment study (KCP 9.2.2)

8.6.1.1 Phosphonic acid

No water/sediment study with potassium phosphonates was submitted for EU approval. According to the RMS, it is expected that phosphorous acid is rapidly adsorbed to the sediment where it could slowly be oxidized to phosphate.

8.7 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3)

8.7.1 Justification of new endpoints

Not applicable as no new endpoints were used.

8.7.2 Active substance and relevant metabolite(s)

PECsoil calculations are based on the recommendations of the FOCUS workgroup on degradation kinetics. A soil bulk density of 1.5 g/cm3, a soil depth of 5 cm and a tillage depth of 20 cm (arable crop)/5 cm (permanent crops) were assumed. The PECsoil calculations were performed by the zRMS for use no 001 and 002 with Excel based on the input parameters as presented in the tables below. PECsoil calculations for use no 003 and 004 can be found in section 8.7 of the national addendum for Germany.

Table 8.7-1: Input parameters related to application for PECsoil calculations

Use No 001 and 002 Crop vine Application rate (g as/ha) 4 l/ha x 1407.9 g/L = 5631.6 g/ha FBR-1 1881 g/ha phosphonic acid Number of applications/interval Use no 001 : 6/ 10 Use no 002: 5/ 20 Crop interception (%) 60% Density of formulation (g/L) 1407.9 Depth of soil layer (relevant for plateau concentra- 5 (no tillage) tion) (cm)

ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 16 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Table 8.7-2: Input parameter for active substance and relevant metabolite(s) for PECsoil calculation

Compound Molecular weight Max. occurrence DT50 (g/mol) (%) (days) EU endpoint

phosphonic acid Not required - 196 (SFO)

Due to the slow degradation of phosphonic acid in soil (DT90 > 365 d, laboratory data) the accumulation potential of phosphonic acid needs to be considered. Therefore an accumulated soil concentration (PECaccu) is used for risk assessment that comprises background concentration in soil (PECbkgd) and the maximum annual soil concentration PECact.

8.7.2.1 PECsoil

Table 8.7-3: PECsoil for FBR-1 in vines according to use No 001

Active Soil relevant PECact PECtwa21 d Tillage depth PECsoil,plateau PECaccu = PE- substance/ application (mg/kg) (mg/kg) (cm) (mg/kg) Cact + formulation rate (g/ha) PECsoil,plateau (mg/kg)

phosphonic 6 x 752.32 5.52 5.32 5 2.10 7.62 acid FBR-1 13516 18.02 - - - -

Table 8.7-4: PECsoil for FBR-1 in vines according to use No 002

Active Soil relevant PECact PECtwa21 d Tillage depth PECsoil,plateau PECaccu = PE- substance/ application (mg/kg) (mg/kg) (cm) (mg/kg) Cact + formulation rate (g/ha) PECsoil,plateau (mg/kg)

phosphonic 5 x 752.32 4.68 4.51 5 1.78 6.56 acid FBR-1 11263 15.02 - - - -

ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 17 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.8 Predicted Environmental Concentrations in groundwater (PECgw) (KCP 9.2.4.1)

Groundwater contamination by direct leaching of the active substance and its metabolites, degradation or reaction products through soil is generally assessed by groundwater model calculations.

8.8.1 Justification of new endpoints

Not applicable as no new endpoints were used.

8.8.2 Active substance and relevant metabolite(s) (KCP 9.2.4.1)

The PECs of active substance and its metabolites in groundwater have been assessed with standard FOCUS scenarios to obtain outputs from the FOCUS models. The FOCUS calculation was performed by the applicant. It was evaluated by the zRMS using the EU agreed endpoints (except the molecurlar weight of phosphonic acid) and following the approach chosen for EU approval. The molecular weight used by the applicant differed from the molecular weight used for EU approval, However no major changes in the modelled groundwater concentrations are expected from this. Besides an interception of 40% was assumed for groundwater modelling, while in the opinion of the zRMS, already an interception of 60% would have been already sufficient. Generally using absolute application times are considered more correct than relative application dates, however again no major changes in groundwater risk assessment are expected from this. However, it should be noted that groundwater modelling would result in smaller concentrations of phosphonic acid in groundwater possibly also < 0.1 μg/L when also considering the endpoints of disodium phosphonate listed in Table 8.3-1 and Table 8.5-1.

Table 8.8-1: Input parameters related to application of FBR-1 for PECgw calculations

Use No. 001 & 002 Crop vines Application rate (g as/ha) 1881 phosphonic acid Number of applications/interval (d) use no 001: 6/ 10 Relative application date Early applications: 1° appln: 0 days after emergence 2° appln: 10 days after emergence 3° appln: 20 days after emergence 4° appln: 30 days after emergence 5° appln: 40 days after emergence 6° appln: 50 days after emergence

Late applications: 1° appln: 64 days before harvest 2° appln: 54 days before harvest 3° appln: 44 days before harvest 4° appln: 34 days before harvest 5° appln: 24 days before harvest 6° appln: 14 days before harvest Crop interception (%) 40% Frequency of application annual Models used for calculation FOCUS PEARL v4.4.4

In adapting the risk envelope approach PECgw for use no 002 is covered by PECgw for use No 002. ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 18 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.8.2.1 Phosphonic acid

Table 8.8-2: Input parameters related to active substance phosphonic acid for PECgw calculations Parameter Value Remarks Not according to LoEP (see EFSA Journal Molecular weight [g mol-1] 82 2012; 10(12): 2963), where a value of 80.5 for a partly dissociated compound was used LoEP (see EFSA Journal 2012; 10(12): Water solubility [mg L-1] 1,875,000 (20°C) 2963) Default worst case value, see EFSA Journal Vapour pressure [Pa] 0 (20°C) 2012; 10(12): 2963 LoEP (see EFSA Journal 2012; 10(12): DT50 soil [d] 196 2963), laboratory, maximum, n=2, 20°C, pF2, SFO LoEP (see EFSA Journal 2012; 10(12): Kf [mL g-1] 10.7 2963), arithmetic mean distribution coefficient Kd, n=5 LoEP (see EFSA Journal 2012; 10(12): Freundlich exponent 1/n [-] 0.9 2963) LoEP (see EFSA Journal 2012; 10(12): Crop uptake factor [-] 0.5 2963)

As soil adsorption of phosphonic acid is not expected to be well correlated with organic carbon content down the soil profile, the parameterisation for adsorption was modified. Adsorption in the top soil layer was implemented based on the Kd determined for the lowest concentration tested in the soil adsorption studies. Factors for adsorption down the soil profile were reduced using the same reduction factors as implemented in the scenarios for reducing substance transformation rates with increasing soil depth.

The factor was 1 for up to 30 cm depth, 0.5 for the layer just below the plough layer (generally ca. 30 cm - 60 cm), 0.3 for the subsequent layer (generally 60 cm to 1 m) and 0.0 below 1 m depth. For each soil profile and horizon, the “Non Default Factors for Depth Effect” for sorption (FacZSor) were set accordingly. The factors for the effect of depth on transformation (FacZTra) remained unchanged for each soil horizon.

Table 8.8-3 Factors for adsorption down the soil profile of each crop-relevant FOCUS groundwater scenario in FOCUS PEARL 4.4.3 FacZSor Horizon Châ- Hamburg Kremsmünster Piacenza Porto Sevilla Thiva teaudun 1 1 1 1 1 1 1 1 2 0.5 0.5 0.5 0.5 0.5 1 0.5 3 0.5 0.3 0.5 0.5 0.3 0.5 0.5 4 0.3 0.3 0.3 0.3 0 0.3 0.3 5 0 0.3 0 0.3 - 0 0.3 6 0 0 - 0 - 0 0

ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 19 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

PECgw of phosphonic acid

Table 8.8-4: PECgw for phosphonic-acid for the application of FBR-1 in vines

80th Percentile PECgw at 1 m Soil Depth (g/L) Crop Scenario Phosphonic acid

Grapevines Châteaudun 4.364 (early Hamburg 4.927 applications) Kremsmünster 9.012 Piacenza 1.902 Porto 5.369 Sevilla 0.502 Thiva 0.010 Grapevines Châteaudun 4.527 (late Hamburg 5.359 applications) Kremsmünster 9.447 Piacenza 2.057 Porto 6.303 Sevilla 0.532 Thiva 0.012

Following the simulations with the conservative parameterisation and considering the application rates according to GAP, a maximum PECGW value of 9.447 µg/L Phosphonic acid was simulated for the Krems- münster scenario following late applications. In the case of early applications, the highest PECGW concentration was also predicted for Kremsmünster (9.012 µg/L). For all other scenarios and both application timings, PECGW values range between < 0.010 and 6.303 µg/L Phosphonic acid. In concordance with the EFSA conclusions on Potassium Phosphonates, these predicted groundwater concentrations are far below a health based drinking water limit calculated at 3 mg/L following the WHO 20093 guideline.

8.8.3 Additional field test (KCP 9.2.4.2)

No additional data were available.

8.8.4 Summary of the risk assessment for groundwater

Results of modelling with FOCUS PEARL 4.4.4 a groundwater contamination of the active substance phosphonic acid at a concentration of ≥ 0.1 µg/L cannot be excluded for all FOCUS groundwater scenarios except Thiva. Maximum simulated concentrations of phosphonic acid are 9.447 µ g/L at scenario Krems- münster. In concordance with the EFSA conclusions (EFSA Journal 2012; 10(12): 2963) on Potassium phosphonates, these predicted groundwater concentrations are far below a health based drinking water limit of 3 mg/L for phosphonic acid that was calculated following the WHO 20094 guideline.

3 WHO (World Health Organization), 2009. WHO Guidelines for Drinking-water Quality, Policies and Pro- cedures used in updating the WHO Guidelines for Drinking-water Quality, 33 pp.

ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 20 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.9 Predicted Environmental Concentrations in surface water (PECsw) (KCP 9.2.5)

PECsw and PECsed calculations are provided according to the recommendations of the FOCUS working group on surface water scenarios in a stepwise approach considering the pathways spray drift, drainage and run-off. The results of the FOCUSsw modelling provided below were calculated by the applicant in his dossier. The zRMS Germany has reviewed the input parameters of the PECsw/sed modelling and the PEC calculations. The molecular weight used by the applicant for phosphonic acid differs from the value used in EFSA Jour- nal 2012; 10(12): 2963 and the applied crop growth stage used in FOCUS SW Step 2 was not stated. How- ever, PECsw and PECsed in the same range were obtained when using the molecular weight listed in EFSA Journal 2012; 10(12): 2963 and assuming minimal crop cover for step 2 calculations. For phosphate ions the zRMS repeated the FOCUS SW calculations estimating the application rate of phosphate ions using the molecular weight of 80.5 g/mol used in EFSA Journal 2012; 10(12): 2963 instead.

8.9.1 Justification of new endpoints

Not applicable as no new endpoints used.

8.9.2 Active substance, relevant metabolite(s) and the formulation (KCP 9.2.5)

To achieve a concise exposure assessment, the risk envelope approach is applied. Here, the assessment for the use no 001 also covers the exposure from all other intended uses of use no 002 (see 8.1.3). PECsw values for use no 003 and 004 are provided in section 8.9 of the National Addendum for Germany.

Table 8.9-1: Input parameters related to application for PECsw/sed calculations

Use No 001 Crop vines Application rate (kg as/ha) Product*: 5632

Phosphonic acid equivalent**: 1882

Phosphate ions***: 2219 Number of applications/interval (d) 6/10 Season of application (step 2) March-May (early) June-Sept (late) Crop interception (step 2) Not stated Models used for calculation FOCUS STEPS 1-2 v3.2 * Taking into account a density value of 1.4079 ** Please refer to Part C for detailed calculation *** Corrected taking into account the molecular factor (94.9/80.5)

ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 21 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.9.2.1 Phosphonic acid and its metabolite phosphate ions

Table 8.9-2: Input parameters related to active substance phosphonic acid for PECsw/sed calculations

Compound Value Remarks

Molecular weight (g/mol) 82 Not according to LoEP (see EFSA Journal 2012; 10(12): 2963), where a value of 80.5 for a partly dissociated compound was used Water solubility (mg/L) 1875000 (20°C) according to see EFSA Journal 2012; 10(12): 2963, at 20°C

KFoc (mL/g) 10.7 LoEP (see EFSA Journal 2012; 10(12): 2963) (values for two sets of simulations) 10000 LoEP (see EFSA Journal 2012; 10(12): 2963) DT (d) LoEP, laboratory, maximum, n=2, 20°C, pF2, 50,soil 196 SFO (see EFSA Journal 2012; 10(12): 2963) DT (d) LoEP, conservative default value (see EFSA 50,water 1000 Journal 2012; 10(12): 2963) DT (d) LoEP, conservative default value (see EFSA 50,sed 1000 Journal 2012; 10(12): 2963) DT (d) LoEP, conservative default value (see EFSA 50,whole system 1000 Journal 2012; 10(12): 2963)

PECsw/sed-FOCUS SW Step 1, 2

Table 8.9-3: FOCUS Step 1,2 PECsw and PECsed for Phosphonic acid following single/ multiple application(s) of FBR-1 to Grapevines for Koc = 10.7

Scenario Period (Step 2) Max PECsw Max PECsed FOCUS Waterbody (Step 3) (μg/L)* (μg/kg)*

Step 1 --- 4010 428.66 March-May 488.02 52.14 Step 2 Northern Europe June-Sept 570.57 60.89 * single applications should be marked (bold)

Table 8.9-4: FOCUS Step 1,2 PECsw and PECsed for Phosphonic acid following single/ multiple application(s) of FBR-1 to Grapevines for Koc = 10.7

Scenario Period (Step 2) Max PECsw Max PECsed (μg/kg)* Waterbody (Step 3) (μg/L)* FOCUS

Step 1 --- 564.78 28300 March-May 37.33 3450 Step 2 Northern Europe June-Sept 60.32 4030 * single applications should be marked (bold)

ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 22 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Table 8.9-5: Input parameters related to phosphate ions used for PECsw/sed calculations

Parameter Value Remarks

Molecular weight [g mol-1] 94.9 LoEP (see EFSA Journal 2012; 10(12): 2963) LoEP, in modelling the max. possible value Water solubility [mg L-1] 1875000 (20°C) 1,000,000 was used (see EFSA Journal 2012; 10(12): 2963)

DT50 soil [d] LoEP, conservative default value (see EFSA 1000 (Step 2) Journal 2012; 10(12): 2963)

-1 10 LoEP (see EFSA Journal 2012; 10(12): 2963) KOC [mL g ] (values for two sets of simulations) 10000 LoEP (see EFSA Journal 2012; 10(12): 2963) LoEP, conservative default value (see EFSA DT total system [d] 1000 50 Journal 2012; 10(12): 2963) LoEP, conservative default value (see EFSA DT water [d] 1000 50 Journal 2012; 10(12): 2963) LoEP, conservative default value (see EFSA DT sediment [d] 1000 50 Journal 2012; 10(12): 2963)

Table 8.9-6: FOCUS Step 1,2 PECsw and PECsed for Phosphate ions following single/ multiple application(s) of FBR-1 to Grapevines for Koc = 10

Scenario Period (Step 2) Max PECsw Max PECsed (μg/kg)* Waterbody (Step 3) (μg/L)* FOCUS

Step 1 --- 4500 437.96 March-May 615.85 61.50 Step 2 Northern Europe June-Sept 615.85 61.50 * single applications should be marked (bold)

Table 8.9-7: FOCUS Step 1,2 PECsw and PECsed for Phosphate ions following single/ multiple application(s) of FBR-1 to Grapevines for Koc = 10000

Scenario Period (Step 2) Max PECsw Max PECsed (μg/kg)* Waterbody (Step 3) (μg/L)* FOCUS

Step 1 --- 2020 19000 March-Ma 277.52 2670 Step 2 Northern Europe June-Sept 277.52 2670 * single applications should be marked (bold)

The derived PECsw and PECsed were used for aquatic risk assessment of FBR-1 in its intended uses (Please refer to the core assessment, section 9.5). Besides, also the risk of eutrophication by phosphate ions entering the surface water bodies is discussed in more detail in the core assessment, section 9.5.

ZV1 008632-00/00 / FBR-1 (= FBR-C) Page 23 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.9.2.2 PECsw/sed of formulation

Not relevant.

8.10 Fate and behaviour in air (KCP 9.3, KCP 9.3.1)

Table 8.10-1 Summary of atmospheric degradation and behaviour for potassium phosphonate

Compound phosphonic acid Direct photolysis in air No data, It is not expected that phosphorous acid is absorbing light at more than 290 nm and thus photodegradation is not expected Quantum yield of direct phototransformation - Photochemical oxidative degradation in air no data available for potassium phosphonate Volatilisation no data available, but vapour pressure (Pa) and the Henry's Law Constant (Pa.m3/mol) can be considered as low

No vapour pressure at 20 °C of the active substance phosphonic acid is available. As a worst case, a vapour pressure of > 10-5 Pa is therefore assumed. Hence the active substance phosphonic acid is regarded as volatile (volatilisation from soil and plant surfaces). Therefore exposure of adjacent surface waters and terrestrial ecosystems by the active substance phosphonic acid due to volatilization with subsequent deposition should be considered.

ZV1 008632-00/00 / FBR-1 Page 24 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Appendix 1 Lists of data considered in support of the evaluation

List of data submitted by the applicant and relied on None

List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review

Title Verte- Company Report No. Data brate Author(s) Year Source (where different from company) Owner point study GLP or GEP status Published or not Y/N

KCP Adams & Conrad 1953 ransition of phosphite to phosphate in soils. Soil Science, 75, 361-372. Published. N NA 9.1.1.1 KCP Lowden & Oddy 1999 Aerobic metabolism of [33P]-Phosphorous acid in two soils N ACS 9.1.1.1 Aventis CropScience, Report R011658 unpublished KCP Völkel 2006 Adsorption/desorption of LBG-01F34 on soils. RCC Ltd, Itingen, Switzerland, Study Report n° 30306, N LGB 9.1.2.1 Unpublished

List of data submitted by the applicant and not relied on

Title Verte- Company Report No. Data brate Author(s) Year Source (where different from company) Owner point study GLP or GEP status Published or not Y/N

KCP Goller 2013 Potassium Phosphonate KH2PO3/K2HPO3. Adsorption / Desorption using a batch equilibrium method N SILC 9.1.2.1 Dr. U. Noack-Laboratorien, Report No. CAD15405 FERTILIZZANTI Source s.r.l ZV1 008632-00/00 / FBR-1 Page 25 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Title Verte- Company Report No. Data brate Author(s) Year Source (where different from company) Owner point study GLP or GEP status Published or not Y/N

GLP Unpublished

List of data relied on not submitted by the applicant but necessary for evaluation

Title Verte- Company Report No. Data brate Author(s) Year Source (where different from company) Owner point study GLP or GEP status Published or not Y/N

KCP Völkel 2008 Na2HPO3 liquid solution. Degradation rate in three soils incubated under aerobic conditions, RCC Ltd, N ISK 9.1.1.1 report n° B30690

KCP Völkel 2008 Na2HPO3 liquid solution. Adsorption /desorption on soil, RCC Ltd, report n°B30701 N ISK 9.1.2.1

ZV1 008632-00/00 / FBR-1 Page 26 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Appendix 2 Summaries of the new Annex II studies

A 2.1 Goller, 2013

Comments of zRMS: The study Goller, 2013 was not evaluated by the zRMS in detail and was not used for risk or exposure assessment of FBR-1

Reference: KCA 7.1.3.1.1 Author Goller, S. Report Adsorption / Desorption using a Batch Equilibrium Method Report number CAD15405 Guideline(s): OECD No 106 Deviations: 1/ Based on the physico-chemical properties of the test item adaptations were necessary. Demineralised water was used as aqueous phase instead of 0.01 mol/L CaCl2 to avoid precipitation of the test item as calcium salt during conduction of the experiments 2/ Five instead of three replicates were used for the lower fortification level of the method validation in eurosoils 2-4. This fact had no nega-tive impact on the integrity and quality of the obtained data. GLP: Yes Acceptability: Not evaluated in detail

Materials and methods The aim of this study was the determination of the adsorption behavior of Potassium Phosphonate KH2PO3/K2HPO3 (batch No. 20130102-018) on soils. Adsorption kinetics and equilibrium adsorption coefficients KD with a single concentration (40 mg/L) on five soils were determined as function of soil characteristics (Table A 1).

Table A 1: Relevant soil characteristics of Eurosoils for adsorption Eurosoils 1 2 3 4 5 FOA soil unit1) Vertic Cam- Rendzina Dystric Cam- Orthic Lu- Orthic Pod- biol bisol vizol zol pH1) 6.2 8.1 6.2 7.5 4.1 Total Carbon [%]1) 3.39 10.81 3.25 1.45 6.43 Organic carbon [%]1) 3.27 3.72 3.01 1.31 5.96 Clay (<0.002 mm) [%]2) 75.0 22.6 17.0 20.3 6.0 Silt (0.002-0.063 mm) [%]2) 21.9 64.1 36.8 75.7 12.5 Sand (0.063-2 mm) [%]2) 3.3 13.4 46.4 4.1 81.6 1) Gawik and Muntau, Eurosoils II laboratory and reference materials for soil-related studies environment institute 1999 2) Kuhnt and Muntau, EURO-soils: Indentification, collection, treatment, characterization, ISPRA 1994

Additionally equilibrium adsorption coefficients KD were determined on a second concentration level (100 mg/L) in all soils to investigate the concentration dependency of adsorption. Furthermore the reversibility of adsorption (desorption behaviour) was investigated on these two concentration levels in all soils after reaching adsorption equilibrium. Therefore, the supernatant was replaced by fresh demineralised water and agitated as long as it had been necessary to reach equilibrium before. The amount adsorbed / desorbed on / from soil was calculated by the difference between initial and actual concentration in the aqueous phase at any time. ZV1 008632-00/00 / FBR-1 Page 27 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Results and discussions Adsorption kinetic in Eurosoils Table A 2 shows the results obtained for the determination of distribution coefficients KD in eurosoils 1 to 5. Adorption experiments lasted 48h.

Table A 2 Distribution coefficients KD for Potassium Phosphonate in Eurosoils Eurosoils 1 2 3 4 5 KD [mg/L] 50 15 14 19 3 Adsorption equilibrium [%] 92 79 78 82 39 T(eq) [h] 48 48 48 30 48

The results demonstrate under consideration of soil parameters that there is a positive correlation between the degree of adsorption at equilibrium and the proportion of the clay fraction in the soils. The highest KD of 50 mL/g was obtained in eurosoil 1, characterised by high clay content of 75%. Silt and sand are minor constituents of this soil at 22 and 3% w/w respectively. Distribution coefficients KD ranging from 15 to 19 mg/L were obtained for the test item in eurosoil 2, 3and 4 which are comparable regarding the amount of clay (approx.. 20%) but differ in their amount of silt and sand. The lowest distribution coefficients KD of 3 mg/L was determined in eurosoil 5 which has the lowest amount of clay and silt (19% in sum) but has the highest amounts of sand (82%) and organic carbon (6%). This result indicates that the sand fraction is of low importance for the adsorption behaviour of the test item. In addition, as expected for an inorganic compound, the amount of organic carbon in the soil does not influence the adsorption behaviour. Therefore, no organic carbon normalised distribution coefficients KOC were calculated. In summary, the results indicate that adsorption of Potassium Phosphonate is significant on all soils.

Adsorption isotherms in Eurosoils Table A 3 shows the result for the concentration dependency of adsorption. The degree of adsorption as mass adsorbed on soil was determined after 48h and compared with the values obtained in the lower application concentration (40mg/L).

Table A 3 Adsorbed mass in soil in dependence on test item concentration Test item con- Eurosoils centration Replicate 1 2 3 4 5 [mg/L] Msoil [mg] 1 1.479 1.244 1.269 1.311 0.638 40 2 1.468 1.259 1.225 1.311 0.590 1 3.731 2.849 2.935 0.866 1.998 100 2 3.769 2.778 2.935 0.822 1.951

Except for eurosoil 4, the adsorbed amount on soil increased with the higher loading level of test item. The relative increase in the adsorbed amount was similar to the relative increase in the loading level in aqueous phase.

Eurosoils - Desorption Table A 4 and Table A 5 show the results of the desorption experiments which were performed after an adsorption period of 48h and lasted 48h.

Table A 4 % of desorption for 40mg/L Potassium Phosphonate in Eurosoils Eurosoils Replicate 1 2 3 4 5 % of desorption 1 8 16 16 28 55 2 10 16 17 31 53

ZV1 008632-00/00 / FBR-1 Page 28 /28 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

The data indicate that adsorption is partially reversible. % of desorption was between 7 and 10% in eurosoil 1 independent on the applied concentration level. % of adsorption was between 16 and 17% for the lower concentration level in eurosoils 2 and 3 but decreased to 5-6% in the higher concentration level. Desorption is more significant in eurosoil 4 and 5. Up to 31% of the adsorbed amount was desorbed in the lower application level and complete reversibility of adsorption was observed in the higher application level for eurosoil 4. % of desorption was between 46 and 55% for the test item in eurosoil 5.

Table A 5 % of desorption for 100mg/L Potassium Phosphonate in Eurosoils Eurosoils Replicate 1 2 3 4 5 % of desorption 1 7 5 5 110 46 2 8 6 6 117 51

Conclusion The highest degree of adsorption for Potassium Phosphonate was obtained in the soil with the highest amount of clay. The organic carbon content does not influence the adsorption behaviour as expected for an inorganic compound. Nevertheless, the results indicate that adsorption of the test item is significant on all soils. The adsorbed mass on soil increased with a higher loading level of the test item in the aqueous phase. Only the results for the corresponding experiments in eurosoil 4 do not follow this behaviour. Based on the given soil data there is no explanation for this difference. For example, there is no significant difference between eurosoil 2 and 4 when considering the proportion of clay, silt and sand. Only more significant differences are visible for the proportion of organic carbon. But, these experiments indicated that his parameter has no relevance. Probably other soil parameters, which were not taken into account in this study, are responsible for this behaviour. Adsorption is at least partially reversible in all eurosoils. The most significant desorption behaviour was observed in eurosoil 4 and 5.

DRAFT REGISTRATION REPORT Part B Section 8 Environmental Fate Detailed summary of the risk assessment

Product code: ZV1 008632-00/00 Product name(s): FBR-1 (=FBR-C) Chemical active substance: Potassium phosphonate 726 g/L (470.2 g/L phosphonic acid)

Central Zone Zonal Rapporteur Member State: Germany

NATIONAL ADDENDUM – GERMANY (authorisation)

Applicant: Fitosanitarios Bajo Riesgo AIE Submission date: 29.07.2016 MS Finalisation date: 07/11/2019

ZV1 008632-00/00 / FBR-1 Page 2 / 24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

Version history

When What

Dezember 2018 First Draft RR by UBA November 2019 Revised Draft RR by UBA

ZV1 008632-00/00 / FBR-1 Page 3 / 24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

Table of Contents

8 Fate and behaviour in the environment (KCP 9) ...... 5 8.1 Critical GAP and overall conclusions ...... 6 8.1.1 Table of critical GAPs ...... 6 8.1.2 Overall conclusion ...... 8 8.1.2.1 Predicted environmental concentrations in soil (PECsoil) ...... 8 8.1.2.2 Predicted environmental concentrations in groundwater (PECgw) ...... 8 8.1.2.3 Predicted environmental concentrations in surface water (PECsw)...... 8 8.1.2.4 Fate and behaviour in air ...... 9 8.1.3 Grouping of intended uses for risk assessment ...... 9 8.2 Metabolites considered in the assessment ...... 9 8.3 Rate of degradation in soil (KCP 9.1.1) ...... 10 8.3.1 Aerobic degradation in soil (KCP 9.1.1.1) ...... 10 8.3.2 Anaerobic degradation in soil (KCP 9.1.1.1) ...... 10 8.4 Field studies (KCP 9.1.1.2) ...... 10 8.4.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1) . 10 8.4.2 Soil accumulation testing (KCP 9.1.1.2.2) ...... 10 8.5 Mobility in soil (KCP 9.1.2) ...... 10 8.5.1 Adsorption and desorption in soil (KCP 9.1.2.1) ...... 10 8.5.2 Column leaching (KCP 9.1.2.1) ...... 10 8.5.3 Lysimeter studies (KCP 9.1.2.2) ...... 10 8.5.4 Field leaching studies (KCP 9.1.2.3) ...... 10 8.6 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1, KCP 9.2.2, KCP 9.2.3) ...... 10 8.6.1 Water/sediment study (KCP 9.2.2) ...... 11 8.7 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3) ...... 12 8.7.1 Justification of new endpoints ...... 12 8.7.2 Active substance and relevant metabolite(s) ...... 12 8.7.2.1 PECsoil ...... 12 8.8 Predicted Environmental Concentrations in groundwater (PECgw) (KCP 9.2.4) ...... 15 8.8.1 Justification of new endpoints ...... 15 8.8.2 Active substance and relevant metabolite(s) (KCP 9.2.4.1) Direct Leaching into groundwater ...... 15 8.8.2.1 Phosphonic acid ...... 15 8.8.3 Summary on estimation of PECgw after direct leaching ...... 17 8.8.4 Groundwater contamination by bank filtration due to surface water exposure via runoff and drainage ...... 17 8.8.4.1 Phosphonic acid and its metabolites ...... 17 8.9 Predicted Environmental Concentrations in surface water (PECsw) (KCP 9.2.5) ...... 19 8.9.1 Justification of new endpoints ...... 19 8.9.2 PECsw after exposure by spray drift and volatilization with subsequent deposition ...... 19 8.9.2.1 Phosphonic acid and its metabolites ...... 19 8.9.3 PECsw after exposure by surface runoff and drainage ...... 20 8.10 Fate and behaviour in air (KCP 9.3, KCP 9.3.1) ...... 22 ZV1 008632-00/00 / FBR-1 Page 4 / 24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

8.11 Classification and labelling ...... 22 8.11.1 GHS Classification and labelling ...... 22 8.11.2 National labelling and conditions of use ...... 22

Appendix 1 Lists of data considered in support of the evaluation ...... 23

ZV1 008632-00/00 / FBR-1 Page 5 / 24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

8 Fate and behaviour in the environment (KCP 9)

The exposure assessment of the plant protection product FBR-1 in its intended uses in vines is documented in detail in the core assessment of the plant protection product FBR-1 dated from Dezember 2018 performed by Germany. This national addendum has been produced to support a national decision on the authorisation of the product FBR-1 in Germany for the uses listed below. It reflects the impact of specific German environmental or agricultural circumstances on the exposure and risk assessment for FBR-1 including risk mitigation measures.

ZV1 008632-00/00 / FBR-1 Page 6 / 24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

8.1 Critical GAP and overall conclusions

8.1.1 Table of critical GAPs

Table 8.1-1: Critical use pattern of the formulated product

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Use- Member Crop and/or situ- F, Fn, Pests or Group of pests Application Application rate PHI Remarks: Conclusion No. state(s) ation Fpn controlled (days) e.g. g saf- * (crop destination G, (additionally: develop- Method / Timing / Max. number Min. interval L kg as/ha Water L/ha ener/ syner- Groundwater / purpose of Gn, mental stages of the Kind Growth stage a) per use between ap- product/ha min/max gist per ha crop) Gpn pest or pest group) of crop & sea- b) per crop/ plications a) max. rate a) max. rate or son season (days) per appl. per appl. I ** b) max. total b) max. total rate per rate per crop/season crop/season Intended for uses in Germany

001 Germany grape vine F downy mildew of spraying or BBCH 15-89 a) 6 10 - 14 a) a) basic appli- XF This DE-use R Vitis vinifera L. grapevine fine spraying basic applica- basic applica- cation rate: corresponds ssp. vinifera Plasmopara viticola (low volume in case of dan- b) 6 tion rate: tion rate: 400 to or is part VITVI PLASVI spraying) ger of infec- 1.0 L/ha 0.73 kg as/ha BBCH 61: of tion and/or af- BBCH 61: BBCH 61: 800 EU/ZONAL (use as table and ter warning 2.0 L/ha 1.45 kg as/ha BBCH71: -use no. 003 wine grape) service appeal BBCH71: BBCH71: 1200 3.0 L/ha 2.19 kg as/ha BBCH 75: maximum BBCH 75: BBCH 75: 1600 application rate 18 L/ha 4.0 L/ha 2.90 kg as/ha

b) b) 18.0 L/ha 13.07 kg as/ha

002 Germany grape vine F downy mildew of spraying or BBCH 15-89 a) 5 20 - 28 a) a) basic appli- XF This DE-use R Vitis vinifera L. grapevine basic applica- basic applica- cation rate: fine spraying corre-sponds ssp. vinifera Plasmopara viticola (low volume b) 6 tion rate: tion rate: 400 to or is part VITVI PLASVI spraying) in case of dan- 1.0 L/ha 0.73 kg as/ha BBCH 61: of ger of infec- BBCH 61: BBCH 61: 800 EU/ZONAL (use as table and tion and/or af- 2.0 L/ha 1.45 kg as/ha BBCH71: -use no. 004 wine grape) ter warning BBCH71: BBCH71: 1200 service appeal 3.0 L/ha 2.19 kg as/ha BBCH 75: BBCH 75: BBCH 75: 1600 ZV1 008632-00/00 / FBR-1 Page 7 / 24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

4.0 L/ha 2.90 kg as/ha maximum application b) b) rate 18 L/ha 18.0 L/ha 13.07 kg as/ha * Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 ** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application

Explanation for column 15 “Conclusion” A Safe use R Further refinement and/or risk mitigation measures required N No safe use ZV1 008632-00/00 / FBR-1 (=FBR-C) Page 8 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

8.1.2 Overall conclusion

8.1.2.1 Predicted environmental concentrations in soil (PECsoil)

PECsoil was calculated for the active substance phosphonic acid considering a soil depth of 1 cm. Due to the slow degradation of the active substance phosphonic acid in soil the accumulation potential of phosphonic acid was not considered. Therefore PECsoil used for risk assessment comprises background concentration in soil (PECaccu) considering a tillage depth of 5 cm (permanent crops) and the maximum annual soil concentration PECact.

The PECsoil values for the active substance were used in the eco-toxicological risk assessment for the intended uses of the plant protection product FBR-1 in Germany.

8.1.2.2 Predicted environmental concentrations in groundwater (PECgw)

Consequences for authorization: None.

Groundwater contamination by bank filtration due to surface water exposure via runoff and drainage According modelling with EXPOSIT 3, groundwater contamination at concentrations ≥ 0.1 µg/L by the active substance phosphonic acid due to surface runoff and drainage into the adjacent ditch with subsequent bank filtration can be excluded in case risk mitigation measures (vegetated buffer strip of 10 m) are applied.

Consequences for authorization: The authorization of the plant protection product FBR-1 is linked with following labelling:

Use No. 001 & 002 NG 402

8.1.2.3 Predicted environmental concentrations in surface water (PECsw)

Risk mitigation measures for the intended uses of plant protection products in Germany due to exposure of surface water consider two routes of entry (i) spray drift and volatilization with subsequent deposition and (ii) runoff, drainage separately. Surface water exposure including effects of risk mitigation via spray drift and volatilization with subsequent deposition was estimated with the model EVA 3 using drift data by Rautmann and Ganzelmeier. Surface water exposure including effects of risk mitigation via surface runoff and drainage was estimated using the model EXPOSIT 3. The results of the specific national exposure assessment for the active substance were used in the eco- toxicological risk assessment. ZV1 008632-00/00 / FBR-1 (=FBR-C) Page 9 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

8.1.2.4 Fate and behaviour in air

The vapour pressure at 20 °C of the active substance phosphonic acid is is not known. As worst case default a vapour pressure of < 10-5 Pa was assumed. Hence the active substance phosphonic acid is assumed to be volatile (volatilisation from soil and plant surfaces). Therefore exposure of adjacent surface waters and terrestrial ecosystems by the active substance Potassium phosphonates due to volatilization with subsequent deposition was considered.

8.1.3 Grouping of intended uses for risk assessment

The following table documents lists the intended uses in Germany to support application of the risk envelope approach (according to SANCO/11244/2011).

Table 8.1-2: Critical use pattern of FBR-1 grouped according to soil

Grouping according to soil

Intended uses Application rate (g/ha) (inter- Soil-relevant effective applic. ception, %) rate, cumulative (g/ha) 001 1 x 470 g/ha phosphonic acid, 188.08 g/ha + 376.16 g/ha + 60% 352.65 g/ha + 3 x 470.2 g/ha 1 x 940 g/ha phosphonic acid, phosphonic acid 60% = 2327 g/ha phosphonic acid 1 x 1411 g/ha phosphonic acid, 75% 3 x 1881 g/ha phosphonic acid, 75% 002 1 x 940 g/ha phosphonic acid, 376.16 g/ha + 4 x 470.2 g/ha 60% phosphonic acid 4 x 1881 g/ha phosphonic acid, = 2257 g/ha phosphonic acid 75%

Table 8.1-3: Critical use pattern of FBR-1 grouped according to spray drift

Grouping according to spray drift

Intended uses Application rate (g/ha) (inter- Drift scenario val, d) 001 1 x 470 g/ha phosphonic acid vines 1 x 940 g/ha phosphonic acid 1 x 1411 g/ha phosphonic acid 3 x 1881 g/ha phosphonic acid 002 1 x 940 g/ha phosphonic acid 4 x 1881 g/ha phosphonic acid

8.2 Metabolites considered in the assessment

Please refer to the core assessment. ZV1 008632-00/00 / FBR-1 (=FBR-C) Page 10 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

8.3 Rate of degradation in soil (KCP 9.1.1)

Studies on degradation in soil with the formulation were not performed, since it is possible to extrapolate from data obtained with the active substance.

8.3.1 Aerobic degradation in soil (KCP 9.1.1.1)

Please refer to the core assessment.

8.3.2 Anaerobic degradation in soil (KCP 9.1.1.1)

Not relevant for assessment.

8.4 Field studies (KCP 9.1.1.2)

8.4.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1)

Please refer to the core assessment.

8.4.2 Soil accumulation testing (KCP 9.1.1.2.2)

Please refer to the core assessment.

8.5 Mobility in soil (KCP 9.1.2)

Studies on mobility in soil with the formulation were not performed, since it is possible to extrapolate from data obtained with the active substance.

8.5.1 Adsorption and desorption in soil (KCP 9.1.2.1)

Please refer to the core assessment.

8.5.2 Column leaching (KCP 9.1.2.1)

Please refer to the core assessment.

8.5.3 Lysimeter studies (KCP 9.1.2.2)

Please refer to the core assessment.

8.5.4 Field leaching studies (KCP 9.1.2.3)

Please refer to the core assessment.

8.6 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1, KCP 9.2.2, ZV1 008632-00/00 / FBR-1 (=FBR-C) Page 11 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

KCP 9.2.3)

Studies on degradation in water/sediment systems with the formulation were not performed, since it is possible to extrapolate from data obtained with the active substance.

8.6.1 Water/sediment study (KCP 9.2.2)

Please refer to the core assessment

ZV1 008632-00/00 / FBR-1 (=FBR-C) Page 12 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

8.7 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3)

Results of PECsoil calculation for FBR-1 in its intended uses in vine according to EU assessment considering 5 cm soil depth are given in the core assessment, part B, section 8, chapter 8.7.In the German exposure assessment, the considered soil layer depth is based on experimental data.1 Generally, a soil layer depth of 2.5 cm is applied in the calculation for active substances with a KFoc <500, whereas a soil layer depth of 1 cm is applied for active substances with a KFoc >500. A soil bulk density of 1.5 g/cm³ is assumed as in the core assessment.

8.7.1 Justification of new endpoints

For national assessment the combined endpoints available data for phosphonic acid (EFSA Journal 2012;10(12):2963) from potassium phosphonate (see EFSA Journal 2013;11(5):3213) and disodium phosphonate were considered.

8.7.2 Active substance and relevant metabolite(s)

The PECsoil calculations were performed with ESCAPE 2.0 based on the input parameters as presented in the tables below.

Table 8.7-1: Input parameters for active substance and relevant metabolite(s) for PECsoil calculation

Compound DT50 DT50 (days) (days) EU endpoint updated endpoint

phosphonic acid DT50, fast= 9.19 No (additional DT50 values DT50, slow = 280.6 available) g= 0.2011 DFOP, Maximum, Laboratory data,

Due to the slow degradation of Phosphonic acid in soil (DT90 > 365 d, laboratory data) the accumulation potential of Phosphonic acid needs to be considered. Therefore an accumulated soil concentration (PECaccu) is used for risk assessment that comprises background concentration in soil (PECbkgd) and the maximum annual soil concentration PECact.

8.7.2.1 PECsoil

The calculated PECsoil used for German risk assessment for phosphonic acid as well as for the formulation FBR-1 are summarised in Table 8.7-2.

1 Fent, Löffler, Kubiak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirkstoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ 360 03 018, UBA, Berlin 1999 ZV1 008632-00/00 / FBR-1 (=FBR-C) Page 13 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

Table 8.7-2: Results of PECsoil calculation for the intended use 003 in vine used for German risk assessment

Plant protection product: FBR-1 Use: 001 Density of formulation (g/L) 1407.9 Number of applications/interval: 6/10 Application rate (g/ha): 1 x 1 L/ha x 1407.9 g/L = 1407.9 g/ha FBR-1 1 x 2 L/ha x 1407.9 g/L = 2815.8 g/ha FBR-1 1 x 3 L/ha x 1407.9 g/L = 4223.7 g/ha FBR-1 3 x 4 L/ha x 1407.9 g/L = 3 x 5631.6 g/ha FBR-1

1 x 470 g/ha phosphonic acid 1 x 940 g/ha phosphonic acid 1 x 1411 g/ha phosphonic acid 3 x 1881 g/ha phosphonic acid Crop interception (%): 60 for application 1 to 2, 75% for application 3 to 6

Active substance/ Soil relevant ap- Soil depthact PECact Tillage PECbkgd PECaccu = formulation plication rate (cm) (mg/kg) depth (cm) (mg/kg) PECact + (g/ha) PECbkgd (mg/kg) FBR-1 1 x 563.2 g/ha 1 38.69 - - - 1 x 1126.3 g/ha 1 x 1055.9 g/ha 3 x 1407.9 g/ha phosphonic acid 1 x 188.1 g/ha 1 12.92 5 1.61 14.53 1 x 376.2 g/ha 1 x 352.7 g/ha 3 x 470.2 g/ha

Table 8.7-3: Results of PECsoil calculation for the intended use 004 in vine used for German risk assessment

Plant protection product: FBR-1 Use: 002 Density of formulation (g/L) 1407.9 Number of applications/interval: 5/between application 1 and 2: 34 d, between application 2 to 5: 20 d Application rate (g/ha): 1 x 2 L/ha x 1407.9 g/L = 2815.8 g/ha FBR-1 4 x 4 L/ha x 1407.9 g/L = 2 x 5631.6 g/ha FBR-1

1 x 940 g/ha phosphonic acid 4 x 1881 g/ha phosphonic acid Crop interception (%): 60% for application 1, 75% for application 2-5

Active substance/ Soil relevant ap- Soil depthact PECact Tillage PECbkgd PECaccu = formulation plication rate (cm) (mg/kg) depth (cm) (mg/kg) PECact + (g/ha) PECbkgd (mg/kg) FBR-1 1 x 1126.3 g/ha 1 35.07 - - - 4 x 1407.9 g/ha phosphonic acid 1 x 188.1 g/ha 1 11.71 5 1.49 13.20 ZV1 008632-00/00 / FBR-1 (=FBR-C) Page 14 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

1 x 376.2 g/ha 1 x 564 g/ha 2 x 752 g/ha

ZV1 008632-00/00 / FBR-1 (=FBR-C) Page 15 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

8.8 Predicted Environmental Concentrations in groundwater (PECgw) (KCP 9.2.4)

Results of the PECgw calculation of phosphonic acid for the intended uses of FBR-1 in vine according to EU assessment using FOCUS PEARL are given in the core assessment, part B, section 8, chapter 8.8.

Risk assessment for groundwater for authorisation of plant protection products in Germany considers two pathways, (i) direct leaching of the active substance into the groundwater after soil passage and (ii) surface runoff and drainage of the active substance into an adjacent ditch with subsequent bank filtration into the groundwater. The latter pathway was not addressed neither by core assessment nor for EU assessment of the active substances. The risk assessment for groundwater of the pathway direct leaching after soil passage follows the recom- mendation of the Ground Water Work Group of FOCUS as provided by the Commission Services (Sanco/13144/2010, version 3, 10 October 2014) as also done by the zRMS in the core assessment.

Risk assessment for groundwater for the pathway surface runoff and drainage into an adjacent ditch with subsequent bank filtration into the groundwater are estimated using the model EXPOSIT 3 stipulating also risk mitigation measures, if applicable.

8.8.1 Justification of new endpoints

8.8.2 Active substance and relevant metabolite(s) (KCP 9.2.4.1) Direct Leaching into groundwater

8.8.2.1 Phosphonic acid

Table 8.8-1: Input parameters related to application of FBR-1 for PECgw calculations

Use No. 001 Crop vines Application rate 1 x 0.470 kg/ha phosphonic acid 1 x 0.940 kg/ha phosphonic acid 1 x 1.411 kg/ha phosphonic acid 3 x 1.881 kg/ha phosphonic acid interval (d) 10 FOCUS scenario Hamburg Application date 10.07. 17.07. 10.08. 20.08. 30.08. 10.09. Crop interception (%) 60% for application 1 to 2, 75% for application 2 to 6 ZV1 008632-00/00 / FBR-1 (=FBR-C) Page 16 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

1 x 0.188 kg/ha phosphonic acid 1 x 0.376 kg/ha phosphonic acid Soil relevant application rate 1 x 0.353 kg/ha phosphonic acid 3 x 0.470 kg/ha phosphonic acid Frequency of application annual

Application method Foliar spray (soil application assumed in the model) Models used for calculation FOCUS PELMO 5.5.3

Table 8.8-2: Input parameters related to active substance phosponic acid for PECgw calculations

Parent Phosphonic acid Remarks/Reference to core assessment, part B, section 8

Molecular weight (g/mol) 80.5 Not applicable

DT50 in soil (d)* 128.8 Geometric mean of study datasets from LoEP and Disodium phosphonate LoEP, n=5, see Table 8.3.1 of core assessment

KFoc (mL/g) Arithmetic mean Kf/Kd of adsorption study datasets from LoEP and Diso- dium phosphonate LoEP, n=10; used 11.31 for soil horizon 1-3 of scenario Hamburg, see Table 8.5.1 of core assessment Default, used for soil horizon 0-6 of 0 scenario Hamburg 1/n 0.844 Arithmetic mean of adsorption study datasets from LoEP and Disodium phosphonate LoEP, n=5 Plant uptake factor 0 Worst case default

In adapting the risk envelope approach PECgw for use no 002 is covered by PECgw for use No 001 due to the lower intended application rate and the longer interval between applications..

PECgw of potassium phosphonate and its metabolites due to direct leaching

Table 8.8-3: PECgw for potassium phosphonate and its metabolite(s) for the application of BFA 1-14 in vine considered relevant for German exposure assessment

th -1 use No. Scenario 80 percentile PECgw at 1 m soil depth (g L ) groundwater model: FOCUS PELMO 5.5.3

potassium phosphonate

001 Hamburg <0.001 ZV1 008632-00/00 / FBR-1 (=FBR-C) Page 17 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

8.8.3 Summary on estimation of PECgw after direct leaching

Results of modelling with FOCUS PELMO show that the active substance phosphonic acid is not expected to penetrate into groundwater at concentrations of ≥ 0.1µg/L in the intended uses of FBR-1 in vine according to use No 001 and 002.

Consequences for authorization: None

8.8.4 Groundwater contamination by bank filtration due to surface water exposure via runoff and drainage

Surface runoff and drainage into an adjacent ditch with subsequent bank filtration into the groundwater are estimated using the model EXPOSIT 3.

Table 8.8-4: Input parameters related to application of FBR-1 for PECgw calculations with EXPOSIT 3

Use No. 001 Crop vine Application rate (g as/ha) 1 x 470 g/ha phosphonic acid 1 x 940 g/ha phosphonic acid 1 x 1411 g/ha phosphonic acid 3 x 1881 g/ha phosphonic acid Number of applications/interval (d) 6/10 Crop interception (%) 60% for application 1 &2, 75% for application 3 to 6 Use No. 002 Crop vine Application rate (g as/ha) 1 x 940 g/ha phosphonic acid 4 x 1881 g/ha phosphonic acid

1 x 1109 g/ha phosphate ions* 4 x 2217 g/ha g/ha phosphate ions* Number of applications/interval (d) 5/20 Crop interception (%) 60% for application 1, 75% for application 2 to 5

8.8.4.1 Phosphonic acid and its metabolites

Table 8.8-5: Input parameters for phosphonic acid used for PECgw calculations with EX- POSIT 3 Parameter Phosphonic acid Reference Molecular weight (g/mol) 80.5

KFoc 721 arithm. mean th DT50 soil (d) 267 90 percentile, SFO, lab data at 20°C and pF2 ZV1 008632-00/00 / FBR-1 (=FBR-C) Page 18 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

Solubility in water (mg/L) 1875000 Mobility class 3 Reduction by bank filtration 90%

PECgw of phosphonic acid and its metabolites due to bank filtration

Table 8.8-6: PECgw for phosphonic acid after surface runoff and drainage with subsequent bank filtration (modelled with EXPOSIT 3)

Use No. PECgw due to Runoff Drainage Vegetated buffer Bank filtrate Time of applica- Bank filtrate strip (µg/L) tion (µg/L) (m) 001 0 0.124 spring/summer 0.080 5 0.107 10 0.092 autumn/winter/ 0.246 20 0.064 early spring Required labelling NG 402

Table 8.8-7: PECgw for phosphonic acid after surface runoff and drainage with subsequent bank filtration (modelled with EXPOSIT 3)

Use No. PECgw due to Runoff Drainage Vegetated buffer Bank filtrate Time of applica- Bank filtrate strip (µg/L) tion (µg/L) (m) 002 0 0.115 spring/summer 0.051 5 0.100 10 0.085 autumn/winter/ 0.156 20 0.060 early spring Required labelling NG 402

According modelling with EXPOSIT 3, groundwater contamination at concentrations ≥ 0.1 µg/L by the active substance phosphonic acid due to surface runoff and drainage into the adjacent ditch with subsequent bank filtration can be excluded in case risk mitigation measures (vegetated buffer strip of 10 m) are applied.

Consequences for authorization: The authorization of the plant protection product FBR-1 is linked with following labeling:

Use No. 001 & 002 NG 402

ZV1 008632-00/00 / FBR-1 (=FBR-C) Page 19 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

8.9 Predicted Environmental Concentrations in surface water (PECsw) (KCP 9.2.5)

Risk mitigation measures for the intended uses of plant protection products in Germany due to exposure of surface water consider the two routes of entry (i) spray drift and volatilization with subsequent deposition and (ii) runoff, drainage separately. Surface water exposure including effects of risk mitigation via spray drift and volatilization with subsequent deposition is estimated with the model EVA. Surface water exposure including effects of risk mitigation via surface runoff and drainage is estimated using the model EXPOSIT.

8.9.1 Justification of new endpoints

Not applicable as no new endpoints used.

8.9.2 PECsw after exposure by spray drift and volatilization with subsequent deposition

The calculation of PECsw after exposure via spray drift and volatilization with subsequent deposition is performed using the model EVA 3. For a single application, the exposure assessment via spray drift is based on the application rate in conjunction with the 90th percentile of the drift values. For multiple applications, lower percentiles of the drift values for each application are applied, resulting in an overall 90th percentile of drift probabilities. Only one volatilization event following the last use of pesticide is generally considered.

Table 8.9-1: Input parameters for FBR-1 related to the application used for PECsw calculations with EVA 3

Use No.: 001 002 Number of applica- 6/10 5/20 tions/ interval: Application rate 1 x 470 g/ha phosphonic acid 1 x 940 g/ha phosphonic acid (g a.s./ha) 1 x 940 g/ha phosphonic acid 4 x 1881 g/ha phosphonic acid 1 x 1411 g/ha phosphonic acid 3 x 1881 g/ha phosphonic acid

8.9.2.1 Phosphonic acid and its metabolites

The calculation of concentrations in surface water is based on spray drift data by Rautmann and Ganzel- meier. The vapour pressure at 20 °C of the active substance Phosphonic acid is assumed to be < 10-5 Pa (worst case default). Hence for exposure assessment, the active substance Phosphonic acid is regarded as volatile (volatilization from soil and plant surfaces). Therefore exposure of surface water by the active substance Potassium phosphonates due to volatilization with subsequent deposition needs to be considered.

The input parameters used for modelling of surface water exposure via spray drift and volatilization with subsequent deposition with EVA 3 are summarised below.

ZV1 008632-00/00 / FBR-1 (=FBR-C) Page 20 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

Table 8.9-2: Input parameters for phosphonic acid used for the PECsw calculations with EVA 3 Parameter phosphonic acid Reference Vapour pressure at 20°C (Pa) 1 x 10-02 worst case default value Solubility in water at 20°C (mg/L) 1875000 EU agreed endpoint, default value

DissT50 water (d) 1000 default value

DegT50 water/sediment study, total 1000 default value system (d)

For PECsw/sed due to spray drift and volatilization with subsequent deposition for phosphonic acid please refer to national Addendum Germany, Part B, Section 9, chapter 9.5.

8.9.3 PECsw after exposure by surface runoff and drainage

The concentration of the active substance phosphonic acid and its metabolite phosphate in adjacent ditch due to surface runoff and drainage is calculated using the model EXPOSIT 3. The input parameters for FBR-1 related to the application used for PECsw calculations with Exposit 3 are summerised in Table 8.9-4Table 8.8-4.

Table 8.9-3: Input parameters related to application of FBR-1 for PECsw calculations with EXPOSIT 3

Use No. 001 Crop vine Application rate (g as/ha) 1 x 470 g/ha phosphonic acid 1 x 940 g/ha phosphonic acid 1 x 1411 g/ha phosphonic acid 3 x 1881 g/ha phosphonic acid

1 x 554 g/ha phosphate ions* 1 x 1109 g/ha phosphate ions* 1 x 1663 g/ha phosphate ions* 3 x 2217 g/ha g/ha phosphate ions* Number of applications/interval (d) 6/10 Crop interception (%) 60% for application 1 &2, 75% for application 3 to 6 Use No. 002 Crop vine Application rate (g as/ha) 1 x 940 g/ha phosphonic acid 4 x 1881 g/ha phosphonic acid

1 x 1109 g/ha phosphate ions* 4 x 2217 g/ha g/ha phosphate ions* Number of applications/interval (d) 5/20 Crop interception (%) 60% for application 1, 75% for application 2 to 5 * corrected with the molecular weight correction factor (80.5/94.9)

The substance specific input parameters used for modelling surface water exposure via runoff and drainage in an adjacent ditch with EXPOSIT 3 are summarised in chapter 8.8.4 of this document.

ZV1 008632-00/00 / FBR-1 (=FBR-C) Page 21 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

The parameters for phosphate ions used for modelling surface water exposure via run-off and drainage in an adjacent ditch with EXPOSIT 3.01 are summarized in Table 8.9-4.

Table 8.9-4 Input parameters for phosphate ions used for PECSW calculations with EX- POSIT 3.01 Parameter Phosphate ions Reference

K foc, Runoff 10 worst case default value

Kfoc, mobility class 10 worst case default value

DT50 soil (d) 1000 worst case default value Solubility in water (mg/L) 1875000 water solubility of phosphonic acid

For PECsw/sed due to surface runoff and drainage please refer to national Addendum Germany, Part B, Sec- tion 9, chapter 9.5. ZV1 008632-00/00 / FBR-1 (=FBR-C) Page 22 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

8.10 Fate and behaviour in air (KCP 9.3, KCP 9.3.1)

Please refer to chapter 8.9.2.

8.11 Classification and labelling

8.11.1 GHS Classification and labelling

Please refer to the core assessment Part B Section 9.

8.11.2 National labelling and conditions of use

Table 8.11-1 Mandatory conditions of use according to § 36 (1) PflSchG

use No Conditions of use 001 & 002 NG 402 ZV1 008632-00/00 / FBR-1 Page 23 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

Appendix 1 Lists of data considered in support of the evaluation

No additional data not listed in the core assessment were used for national assessment ZV1 008632-00/00 / FBR-1 Page 24 /24 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

DRAFT REGISTRATION REPORT Part B Section 9 Ecotoxicology Detailed summary of the risk assessment

Product code: ZV1 008632-00/00 Product name(s): FBR-C; FBR-1 Chemical active substance: potassium phosphonate 726 g/L (470.2 g/L phosphonic acid equivalents)

Central Zone Zonal Rapporteur Member State: DE

Core Assessment zRMS version (authorisation)

Applicant: Fitosanitarios Bajo Riesgo AIE Submission date: 29.07.2016 MS Finalisation date: November 2019 Page 2 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Version history

When What

December 2018 First draft by zRMS November 2019 Revised draft RR by UBA

Page 3 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Table of Contents

9 Ecotoxicology (KCP 10) ...... 6 9.1 Critical GAP and overall conclusions ...... 6 9.1.1 Overall conclusions ...... 9 9.1.1.1 Effects on birds (KCP 10.1.1), Effects on terrestrial vertebrates other than birds (KCP 10.1.2), Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3) ...... 9 9.1.1.2 Effects on aquatic organisms (KCP 10.2) ...... 10 9.1.1.3 Effects on bees (KCP 10.3.1) ...... 11 9.1.1.4 Effects on arthropods other than bees (KCP 10.3.2) ...... 11 9.1.1.5 Effects on non-target soil meso- and macrofauna (KCP 10.4), Effects on soil microbial activity (KCP 10.5) ...... 11 9.1.1.6 Effects on non-target terrestrial plants (KCP 10.6) ...... 12 9.1.1.7 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ...... 12 9.1.2 Grouping of intended uses for risk assessment ...... 12 9.1.3 Consideration of metabolites ...... 13 9.2 Effects on birds (KCP 10.1.1) ...... 13 9.2.1 Toxicity data ...... 13 9.2.1.1 Justification for new endpoints ...... 14 9.2.2 Risk assessment for spray applications ...... 14 9.2.2.1 First-tier assessment (screening/generic focal species) ...... 14 9.2.2.2 Higher-tier risk assessment ...... 15 9.2.2.3 Drinking water exposure ...... 16 9.2.2.4 Effects of secondary poisoning ...... 17 9.2.2.5 Biomagnification in terrestrial food chains ...... 17 9.2.3 Risk assessment for baits, pellets, granules, prills or treated seed ...... 17 9.2.4 Overall conclusions ...... 17 9.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2) ...... 18 9.3.1 Toxicity data ...... 18 9.3.1.1 Justification for new endpoints ...... 18 9.3.2 Risk assessment for spray applications ...... 18 9.3.2.1 First-tier assessment (screening/generic focal species) ...... 19 9.3.2.2 Drinking water exposure ...... 23 9.3.2.3 Effects of secondary poisoning ...... 23 9.3.2.4 Biomagnification in terrestrial food chains ...... 24 9.3.3 Risk assessment for baits, pellets, granules, prills or treated seed ...... 24 9.3.4 Overall conclusions ...... 24 9.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3) ...... 25 9.5 Effects on aquatic organisms (KCP 10.2) ...... 25 9.5.1 Toxicity data ...... 25 9.5.1.1 Justification for new endpoints ...... 26 9.5.2 Risk assessment ...... 26 9.5.3 Overall conclusions ...... 29 9.6 Effects on bees (KCP 10.3.1) ...... 29 9.6.1 Toxicity data ...... 29 Page 4 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

9.6.1.1 Justification for new endpoints ...... 30 9.6.2 Risk assessment ...... 30 9.6.2.1 Hazard quotients for bess ...... 31 9.6.2.2 Higher-tier risk assessment for bees (tunnel test, field studies) ...... 31 9.6.3 Effects on bumble bees ...... 31 9.6.4 Effects on solitary bees ...... 31 9.6.5 Overall conclusions ...... 32 9.7 Effects on arthropods other than bees (KCP 10.3.2) ...... 32 9.7.1 Toxicity data ...... 32 9.7.1.1 Justification for new endpoints ...... 33 9.7.2 Risk assessment ...... 33 9.7.2.1 Risk assessment for in-field exposure ...... 33 9.7.2.2 Risk assessment for off-field exposure ...... 34 9.7.2.3 Additional higher-tier risk assessment ...... 34 9.7.2.4 Risk mitigation measures ...... 34 9.7.3 Overall conclusions ...... 34 9.8 Effects on non-target soil meso- and macrofauna (KCP 10.4) ...... 35 9.8.1 Toxicity data ...... 35 9.8.1.1 Justification for new endpoints ...... 36 9.8.2 Risk assessment ...... 37 9.8.2.1 First-tier risk assessment ...... 37 9.8.2.2 Higher-tier risk assessment ...... 37 9.8.3 Overall conclusions ...... 37 9.9 Effects on soil microbial activity (KCP 10.5) ...... 38 9.9.1 Toxicity data ...... 38 9.9.1.1 Justification for new endpoints ...... 38 9.9.2 Risk assessment ...... 38 9.9.3 Overall conclusions ...... 39 9.10 Effects on non-target terrestrial plants (KCP 10.6) ...... 39 9.10.1 Toxicity data ...... 39 9.10.1.1 Justification for new endpoints ...... 40 9.10.2 Risk assessment ...... 40 9.10.2.1 Tier-1 risk assessment (based screening data) ...... 40 9.10.2.2 Tier-2 risk assessment (based on dose-response data) ...... 40 9.10.2.3 Higher-tier risk assessment ...... 41 9.10.2.4 Risk mitigation measures ...... 41 9.10.3 Overall conclusions ...... 41 9.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ...... 41 9.12 Monitoring data (KCP 10.8) ...... 41 9.13 Classification and Labelling ...... 41

Appendix 1 Lists of data considered in support of the evaluation ...... 42

Appendix 2 Detailed evaluation of the new studies ...... 44 A 2.1 KCP 10.1 Effects on birds and other terrestrial vertebrates ...... 44 A 2.1.1 KCP 10.1.1 Effects on birds ...... 44 A 2.1.2 KCP 10.1.2 Effects on terrestrial vertebrates other than birds ...... 44 Page 5 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

A 2.1.3 KCP 10.1.3 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) ...... 44 A 2.2 KCP 10.2 Effects on aquatic organisms ...... 44 A 2.2.1 KCP 10.2.1 Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes ...... 44 A 2.2.2 KCP 10.2.2 Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms ...... 44 A 2.2.3 KCP 10.2.3 Further testing on aquatic organisms ...... 44 A 2.3 KCP 10.3 Effects on arthropods ...... 44 A 2.3.1 KCP 10.3.1 Effects on bees ...... 44 A 2.3.2 KCP 10.3.2 Effects on non-target arthropods other than bees ...... 49 A 2.4 KCP 10.4 Effects on non-target soil meso- and macrofauna ...... 53 A 2.4.1 KCP 10.4.1 Earthworms ...... 53 A 2.4.2 KCP 10.4.2 Effects on non-target soil meso- and macrofauna (other than earthworms) ...... 55 A 2.5 KCP 10.5 Effects on soil nitrogen transformation ...... 55 A 2.6 KCP 10.6 Effects on terrestrial non-target higher plants ...... 55 A 2.6.1 KCP 10.6.1 Summary of screening data ...... 56 A 2.6.2 KCP 10.6.2 Testing on non-target plants ...... 58 A 2.6.3 KCP 10.6.3 Extended laboratory studies on non-target plants ...... 58 A 2.6.4 KCP 10.6.4 Semi-field and field tests on non-target plants ...... 58 A 2.7 KCP 10.7 Effects on other terrestrial organisms (flora and fauna) ...... 58 A 2.8 KCP 10.8 Monitoring data ...... 58

Page 6 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

9 Ecotoxicology (KCP 10)

9.1 Critical GAP and overall conclusions

Table 9.1-1: Table of critical GAPs

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Use- Member Crop and/or situ- F, Pests or Group of pests Application Application rate PHI Remarks: Conclusion No. state(s) ation Fn, controlled (days) e.g. g saf- * (crop destination Fpn (additionally: develop- Method / Timing / Max. num- Min. inter- kg or L g or kg as/ha Water L/ha ener/ syner-

/ purpose of G, mental stages of the Kind Growth ber val between product/ha min/max gist per ha crop) Gn, pest or pest group) stage of crop a) per use applications a) max. rate a) max. rate Gpn & season b) per crop/ (days) per appl. per appl. season b) max. total b) max. total

I ** rate per rate per arthro- -target plants -target

crop/season crop/season Mammals Birds organisms Aquatic Bees organisms Soil Non pods Non Zonal uses (field or outdoor uses, certain types of protected crops) 1 Hungary Grapevine F Mildew - Plasmopara Foliar spray BBCH 15- 6 10 a) 4 a) 2.904 200-1000 14 6 consecu- R (VITVI) viticola 89 b) 24 b) 17.424 tive appli- (PLASVI) cations from BBCH 15- 89, follow by treatments with products used traditionally at the end of a program against mildew 2 Hungary Grapevine F Mildew - Plasmopara Foliar spray BBCH 15- 5 20 a) 4 a) 2.904 200-1000 14 Program (VITVI) viticola 89 b) 20 b) 14.520 consists in (PLASVI) alternation between the Page 7 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 product FBR-1 and other products used traditionally in program against mildew 3 Germany Grapevine F Mildew - Plasmopara Foliar spray BBCH 15- 6 10 a) a) 1st: 400 14 6 consecu- R (VITVI) viticola 89 1st: 1 1st: 0.726 2nd: 800 tive appli- (PLASVI) 2nd: 2 2nd: 1.452 3rd: 1200 cations 3rd: 3 3rd: 2.178 4th: 1600 from 4th: 4 4th: 2.904 5th: 1600 BBCH 15- 5th: 4 5th: 2.904 6th: 1600 89, follow 6th: 4 6th: 2.904 by treatments with b)18 b)13.068 products used traditionally at the end of a program against mildew 4 Germany Grapevine F Mildew - Plasmopara Foliar spray BBCH 15- 5 20 a) a) 1st: 400 14 Program viticola 89 1st: 1 1st: 0.726 2nd: 800 consists in (PLASVI) 2nd: 2 2nd: 1.452 3rd: 1200 alternation 3rd: 3 3rd: 2.178 4th: 1600 between the 4th: 4 4th: 2.904 5th: 1600 product 5th: 4 5th: 2.904 FBR-1 and other prod- b)14 b)10.164 ucts used traditionally in program against mildew * Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 ** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application

Page 8 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Explanation for column 15 – 21 “Conclusion” A Acceptable, Safe use R Further refinement and/or risk mitigation measures required C To be confirmed by cMS N No safe use

R1: Further risk refinement on member state level is necessary

Remarks (1) Numeration necessary to allow references (7) Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Black- table: (2) Use official codes/nomenclatures of EU well, ISBN 3-8263-3152-4), including where relevant, information on season at time of application (3) For crops, the EU and Codex classifications (both) should be used; where relevant, the use (8) The maximum number of application possible under practical conditions of use must be provided situation should be described (e.g. fumigation of a structure) (9) Minimum interval (in days) between applications of the same product. (4) F: professional field use, Fn: non-professional field use, Fpn: professional and non-profes- (10) For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty sional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products professional and non-professional greenhouse use, I: indoor application (11) The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g, (5) Scientific names and EPPO-Codes of target pests/diseases/ weeds or when relevant the com- kg or L product / ha). mon names of the pest groups (e.g. biting and sucking insects, soil born insects, foliar fungi, (12) If water volume range depends on application equipments (e.g. ULVA or LVA) it should be men- weeds) and the developmental stages of the pests and pest groups at the moment of applica- tioned under “application: method/kind”. tion must be named (13) PHI - minimum pre-harvest interval (6) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (14) Remarks may include: Extent of use/economic importance/restrictions Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated

Page 9 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

9.1.1 Overall conclusionsPhosphate is the only relevant metabolite of potassium phosphonates (technical active substance) and phosphonic acid (actual active substance) in soil, surface water and sediment. PECsw and PECsed values of phosphate ions were calculated for risk assessment of aquatic organisms.

9.1.1.1

9.1.1.2 K+ + HPO32-/H2PO3- + H2O  K+ + PO43- + H3O+

9.1.1.3 Effects on birds (KCP 10.1.1), Effects on terrestrial vertebrates other than birds (KCP 10.1.2), Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3)

Birds

Dietary risk assessment

Based on tier 1 assessment step, the calculated TER values for the acute risk resulting from an exposure of birds to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 achieve the acceptability criteria TER ≥ 10, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute effects. Based on tier 1 assessment step, the calculated TER values for the long-term risk resulting from an exposure of birds to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 do achieve the acceptability criteria TER ≥ 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for chronic effects. The results of the assessment indicate an acceptable acute and long-term risk for birds due to the intended use of FBR-1 in in grapevines according to the label.

Risk assessment for exposure via drinking water

Based on the assessment of the risk arising from the uptake of Potassium Phosphonates via drinking water, a TER calculation is not necessary. A low risk can be concluded since. The ratios of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) for birds and mammals were calculated, taking into account the relevant toxicity data for Potassium Phosphonates and calculated exposure levels for exposure via drinking water, according to the intended uses of the product FBR-1 in grapevines. The calculated ratios do not exceed 3000, which is the trigger in the case of more sorptive substances (Koc ≥ 500 L/kg). The results of the assessment indicate an acceptable risk for birds due to the intended use of FBR-1 in grapevines according to the label.

Effects on terrestrial vertebrates other than birds

Dietary risk assessment

TER ≥ 10 resp. TER ≥ 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute and chronic effects, for scenarios application crop directed BBCH 10 – 19 and application crop directed BBCH 20 - 39 for small herbivorous mammal "vole”. The results of the assessment indicate an unacceptable acute and long-term risk for mammals due to the intended uses 001 and 003 of FBR-1 in grapevines according to the label. The refinement presented in the core assessment by the applicant could only be used for national legislation in Germany. Therefore, further refinement should be performed on member state level.

Based on tier 1 assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of mammals to Potassium Phosphonates (oral exposure) according to use 002 and 004 of the GAP of the formulation FBR-1 indicated no risk for herbivorous mammals. The calculated TER values for the acute and long-term risk resulting from an exposure of mammals to Potassium Phosphonates (oral exposure) according to use 002 of the GAP of the formulation FBR-1 do achieve the acceptability criteria TER ≥ 10 resp. TER ≥ 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute and chronic effects, respectively. The results of the assessment indicate an acceptable acute and long-term risk for mammals due to the intended use 002 and 004 of FBR-1 in grapevines according to the label.

Risk assessment for exposure via drinking water

Based on the assessment of the risk arising from the uptake of Potassium Phosphonates via drinking water, a TER calculation is not necessary. A low risk can be concluded since. The ratios of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) for mammals were calculated, taking into account the relevant toxicity data for Potassium Phosphonates and calculated exposure levels for exposure via drinking water, according to the intended uses of the product FBR-1 in grapevines. The calculated ratios do not exceed 3000, which is the trigger in the case of more sorptive substances (Koc ≥ 500 L/kg). The results of the assessment indicate an acceptable risk for mammals due to the intended use of FBR-1 in grapevines according to the label.

9.1.1.4 Effects on aquatic organisms (KCP 10.2)

Risk ratios of predicted environmental versus regulatory acceptable concentrations (PEC/RAC) for aquatic organisms were calculated. Calculated exposure concentrations in surface water bodies, according to the intended uses of the product FBR-1 in grapevines were considered in the exposure term. The calculated risk ratios do achieve the acceptability criterion PEC/RAC ≤ 1 for aquatic organisms, as derived from the prescriptions in Commission Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.2. The results of the assessment indicate an acceptable risk for aquatic organisms due to the intended use of FBR-1 in grapevines according to the label.

According to the water framework directive (2000/60/EC) and the implementation law in Germany, the regulation for the protection of surface waters (Oberflächengewässerverordnung), the environmental quality standard representing a good ecological status of surface water bodies is 20 µg ortho-Phosphates/L or 50 µg total P/L. Based on the FOCUS Step 1 and 2 calculations these limits are exceeded for Phosphonates and Phosphate Ions (see Sec. 8.9 CA). These concentrations indicate a potential risk of eutrophication in some European surface water bodies. The national approval for FBR-1 in Germany will address this potential risk with risk mitigation measures like drift reduction techniques and buffer strips. For details see national addendum Section 9 Germany. Since no definition for an acceptable limit of eutrophication exists, other member states may decide differently. Page 11 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

9.1.1.5 Effects on bees (KCP 10.3.1)

Based on the first-tier assessments conducted for bees exposed to phosphonic acid, it is concluded that there is no unacceptable risk to bees from exposure to FBR-1 following applications according to the proposed intended uses. zRMS comments Due to the results of laboratory tests, FBR-1 is considered to be non-toxic to to 9.1.1.3 bees. All hazard quotients are below the trigger of 50, indicating that the intended use poses a low risk to bees in the field.

Therefore, it is concluded that FBR-1 will not adversely affect bees or bee colonies when used as recommended.

9.1.1.6 Effects on arthropods other than bees (KCP 10.3.2)

In-field

Based on the calculated rates of Potassium Phosphonates in in-field areas, the calculated HQ and TER values describing the risk resulting from an exposure of non-target arthropods to Potassium Phosphonates / FBR-1 according to the GAP of the formulation FBR-1 achieve the acceptability criteria HQ  2 (Tier 1) and of TER ≥ 10 (Tier 1), according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for non-target arthropods due to the intended use of FBR-1 in grapevines according to the label.

Off-field

Based on the calculated rates of Potassium Phosphonates/ FBR-1 in off-field areas, the calculated HQ and TER values describing the risk resulting from an exposure of non-target arthropods to Potassium Phospho- nates / FBR-1 according to the GAP of the formulation FBR-1 achieve the acceptability criteria HQ  2 (Tier 1) and of TER ≥ 10 (Tier 1), according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for non-target arthropods due to the intended use of FBR-1 in grapevines according to the label.

9.1.1.7 Effects on non-target soil meso- and macrofauna (KCP 10.4), Effects on soil microbial activity (KCP 10.5)

Based on the predicted concentrations of Potassium Phosphonates/ FBR-1 in soils, the TER values describing the acute and long-term risk for earthworms and other non-target soil organisms following exposure to Potassium Phosphonates / FBR-1 according to the GAP of the formulation FBR-1 achieve the acceptability criteria TER ≥ 10 resp. TER ≥ 5 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for soil organisms due to the intended use of FBR-1in grapevines according to the label.

9.1.1.8 Effects on non-target terrestrial plants (KCP 10.6)

The rates tested with the formulation exceed the predicted field rates of Potassium Phosphonates following exposure to Potassium Phosphonates / FBR-1 according to the GAP of the formulation FBR-1. The results of the assessment indicate an acceptable risk for non-target terrestrial plants due to the intended use of FBR- 1 in grapevines according to the label.

9.1.1.9 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)

No data submitted.

9.1.2 Grouping of intended uses for risk assessment

The following table documents the grouping of the intended uses to support application of the risk envelope approach (according to SANCO/11244/2011).

Table 9.1-2: Critical use pattern of FBR-1 grouped according to soil

Grouping according to soil

Intended uses Application rate (g/ha) Soil-relevant effective applic. interception, % rate, cumulative (g/ha) 1 6 x 2904 g/ha potassium phosphonate (6 x 1881 6 x 752.32 g/ha phosphonic acid g/ha phosphonic acid) = 4514 g/ha phosphonic acid 60 % 2 5 x 2904 g/ha potassium phosphonate (5 x 1881 5 x 752.32 g/ha phosphonic acid g/ha phosphonic acid) = 3762 g/ha phosphonic acid 60 % 3 1 x 726 g/ha potassium phosphonate (1 x 470 g/ha 188.08 g/ha + 376.16 g/ha + phosphonic acid) 564.24 g/ha + 3 x 752.32 g/ha 1 x 1452 g/ha potassium phosphonate (1 x 940 g/ha phosphonic acid phosphonic acid) = 3385 g/ha phosphonic acid 1 x 2178 g/ha potassium phosphonate (1 x 1411 g/ha phosphonic acid) 3 x 2904 g/ha potassium phosphonate (3 x 1881 g/ha phosphonic acid) 4 1 x 726 g/ha potassium phosphonate (1 x 470 g/ha 188.08 g/ha + 376.16 g/ha + phosphonic acid) 564.24 g/ha + 2 x 752.32 g/ha 1 x 1452 g/ha potassium phosphonate (1 x 940 g/ha phosphonic acid phosphonic acid) = 2633 g/ha phosphonic acid 1 x 2178 g/ha potassium phosphonate (1 x 1411 g/ha phosphonic acid) 2 x 2904 g/ha potassium phosphonate (2 x 1881 g/ha phosphonic acid)

Page 13 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Table 9.1-3: Critical use pattern of FBR-1 grouped according to spray drift

Grouping according to spray drift

Intended uses Application rate (g/ha) (interval, d) Drift scenario 1 6 x 2904 g/ha potassium phosphonate (6 x 1881 g/ha phosphonic acid) 60 % 2 5 x 2904 g/ha potassium phosphonate (4 x 1881 g/ha phosphonic acid) 60 % 3 1 x 726 g/ha potassium phosphonate (1 x 470 g/ha phosphonic acid) 1 x 1452 g/ha potassium phosphonate (1 x 940 g/ha phosphonic acid) 1 x 2178 g/ha potassium phosphonate (1 x 1411 vines g/ha phosphonic acid) 3 x 2904 g/ha potassium phosphonate (3 x 1881 g/ha phosphonic acid) 4 1 x 726 g/ha potassium phosphonate (1 x 470 g/ha phosphonic acid) 1 x 1452 g/ha potassium phosphonate (1 x 940 g/ha phosphonic acid) 1 x 2178 g/ha potassium phosphonate (1 x 1411 g/ha phosphonic acid) 2 x 2904 g/ha potassium phosphonate (2 x 1881 g/ha phosphonic acid)

9.1.3 Consideration of metabolites

Phosphate is the only relevant metabolite of potassium phosphonates (technical active substance) and phosphonic acid (actual active substance) in soil, surface water and sediment. PECsw and PECsed values of phosphate ions were calculated for risk assessment of aquatic organisms.

+ 2- - + 3- + K + HPO3 /H2PO3 + H2O  K + PO4 + H3O

9.2 Effects on birds (KCP 10.1.1)

9.2.1 Toxicity data

An avian acute oral study has been carried out with Potassium Phosphonates and a long-term reproduction study was listed in the EU-LoEP as bridging data from Fosetyl-Al. Full details of avian toxicity studies are provided in the respective EU DAR. The studies with the relevant acute and long-term endpoints were agreed during EU review process and are used for the risk assessment.

Effects on birds of FBR-1 were not evaluated as part of the EU assessment of Potassium Phosphonates. However, the provision of further data on the formulation FBR-1 is not considered essential, as the available data on Potassium Phosphonates are deemed to be sufficient to assess the risk of birds exposed to FBR-1.

The selection of studies and endpoints for the risk assessment is in line with the results of the EU review Page 14 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version process.

Table 9.2-1: Endpoints and effect values relevant for the risk assessment for birds

Species Substance Exposure Results Reference System

Colinus virgianus Potassium Acute LD50 > 2250 mg EFSA Journal Phosphonates a.s./kg bw; 2012;10(12):2963 phosphonic acid xxxxxx 20.12.1999 286-113 Colinus virgianus Fosetyl-Al Long-term NOEC = 216 mg /kg EFSA Journal [EU-LoEP: bridging bw 2012;10(12):2963 data from fosetyl-Al] equivalent to 149.04 xxxxxx mg phosphonic acid/ 07.07.1999 kg bw 171-183

9.2.1.1 Justification for new endpoints

Not necessary.

9.2.2 Risk assessment for spray applications

The risk assessment is based on the methods presented in the Guidance Document on Risk Assessment for Birds and Mammals on request from EFSA (EFSA Journal 2009; 7(12): 1438; hereafter referred to as EFSA/2009/1438). To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use 1 also covers the risk for birds from all other intended uses 2-4 (see 9.1.2).

9.2.2.1 First-tier assessment (screening/generic focal species)

The results of the acute and reproductive first-tier risk assessments are summarised in the following tables.

Table 9.2-2: First-tier assessment of the acute and long-term/reproductive risk for birds due to the use of FBR-1 in grapevines (use 1 covering uses 1-4)

Intended use use 1 covering uses 1-4 Active substance/product potassium phosphonates Application rate (g/ha) 6 x 2904 g/ha potassium phosphonate (6 x 1881 g/ha phosphonic acid)

Acute toxicity (mg/kg bw) LD50 > 2250 mg a.s./kg bw phosphonic acid; equivalent to > 6505 mg potassium phosphonates / kg bw TER criterion 10

Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Vineyard Small omnivorous bird 95.3 1.6 287 7.8 Page 15 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Reprod. toxicity (mg/kg bw/d) NOEC = 216 mg /kg bw equivalent to 149.04 mg phosphonic acid/ kg bw TER criterion 5

Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Vineyard Small herbivorous mammal 38.9 2.0 x 0.53 77.6 1.9 SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.

9.2.2.2 Higher-tier risk assessment

Table 9.2-3: Higher-tier assessment of the acute and long-term/reproductive risk for birds due to the use of FBR-1 in grapevines (use 001)

Intended use Grapevine

Active substance/product Potassium phosphonates/FBR-1 Application rate (g/ha) 6 × 1882 (phosphonic acid equivalent*) Acute toxicity (mg/kg bw) 2250 (Phosphonic acid) TER criterion 10

Crop scenario Generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Vineyard BBCH ≥ Small insectivorous species 25.7 1.6 77.4 29.1 20 “Redstart” Vineyard BBCH ≥ Small granivorous bird “Finch” 7.4 1.6 22.3 101.0 40 Vineyard BBCH ≥ Small omnivorous bird “lark” 7.2 1.6 21.7 103.8 40 Vineyard BBCH 10- Small granivorous bird “Finch” 14.8 1.6 44.6 50.5 19 Vineyard BBCH 10- Small insectivorous species 27.4 1.6 82.5 27.3 19 “Redstart” Vineyard BBCH 10- Small omnivorous bird “lark” 14.4 1.6 43.4 51.9 19 Vineyard BBCH 20- Small granivorous bird “Finch” 12.4 1.6 37.3 60.3 39 Vineyard BBCH 20- Small omnivorous bird “lark” 12.0 1.6 36.1 62.3 39 Vineyard ripening Frugivorous bird 28.9 1.6 87.0 25.9 “Trush/starling” Reprod. toxicity (mg/kg bw/d) 149.04 (Phosphonic acid) TER criterion 5

Crop scenario Generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Vineyard BBCH ≥ Small insectivorous species 9.9 2 x 0.53 19.7 7.5 Page 16 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

20 “Redstart” Vineyard BBCH ≥ Small granivorous bird “Finch” 3.4 2 x 0.53 6.8 22.0 40 Vineyard BBCH ≥ Small omnivorous bird “lark” 3.3 2 x 0.53 6.6 22.6 40 Vineyard BBCH 10- Small granivorous bird “Finch” 6.9 2 x 0.53 13.8 10.8 19 Vineyard BBCH 10- Small insectivorous species 11.5 2 x 0.53 22.9 6.5 19 “Redstart” Vineyard BBCH 10- Small omnivorous bird “lark” 6.5 2 x 0.53 13.0 11.5 19 Vineyard BBCH 20- Small granivorous bird “Finch” 5.7 2 x 0.53 11.4 13.1 39 Vineyard BBCH 20- Small omnivorous bird “lark” 5.4 2 x 0.53 10.8 13.8 39 Vineyard ripening Frugivorous bird 14.4 2 x 0.53 28.7 5.2 “Trush/starling” SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger. * Please refer to Part C for detailed calculation on phosphonic acid equivalent

9.2.2.3 Drinking water exposure

When necessary, the assessment of the risk for birds due to uptake of contaminated drinking water is conducted for a small granivorous bird with a body weight of 15.3 g (Carduelis cannabina) and a drinking water uptake rate of 0.46 L/kg bw/d (cf. Appendix K of EFSA/2009/1438).

Leaf scenario Since FBR-1 is not not intended to be applied on leafy vegetables forming heads or crop plants with comparable water collecting structures at principal growth stage 4 or later, the leaf scenario does not have to be considered.

Puddle scenario Due to the characteristics of the exposure scenario in connection with the standard assumptions for water uptake by animals, no specific calculations of exposure and TER are necessary when the ratio of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) does not exceed 50 in the case of less sorptive substances (Koc < 500 L/kg) or 3000 in the case of more sorptive substances (Koc ≥ 500 L/kg).

With a K(f)oc of 721, Potassium Phosphonates belong to the group of more sorptive substances. In cases of multiple applications a MAF (Multiple Application Factor) has to be applied based on the DT50 in soil to achieve the effective application rate. MAFm = 5.5 (based on a DT50 of 196 days, 6 applications and 10 days interval in grapevines).

Here, the assessment for the use 1 also covers the risk for birds from all other intended uses 2-4 (see 9.1.2).

Effective application rate (g/ha) = 4140 Page 17 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Acute toxicity (mg/kg bw) = 2250 quotient = 1.84 Reprod. toxicity (mg/kg bw/d) = 149.04 quotient = 27.8

9.2.2.4 Effects of secondary poisoning

The log Pow of Potassium Phosphonates / Phosphonic acid is very low (-0.7699; pH = 7) and thus does not exceed the trigger value of 3. A risk assessment for effects due to secondary poisoning is not required.

Risk assessment for earthworm-eating birds via secondary poisoning Not required.

Risk assessment for fish-eating birds via secondary poisoning Not required.

9.2.2.5 Biomagnification in terrestrial food chains

Not relevant.

9.2.3 Risk assessment for baits, pellets, granules, prills or treated seed

Not relevant.

9.2.4 Overall conclusions

Dietary risk assessment

Based on higher tier assessment step, the calculated TER values for the acute risk resulting from an exposure of birds to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 achieve the acceptability criteria TER ≥ 10, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute effects. Based on higher tier assessment step, the calculated TER values for the long-term risk resulting from an exposure of birds to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 do achieve the acceptability criteria TER ≥ 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for chronic effects. The results of the assessment indicate an acceptable acute and long-term risk for birds due to the intended use of FBR-1 in in grapevines according to the label.

Risk assessment for exposure via drinking water

Based on the assessment of the risk arising from the uptake of Potassium Phosphonates via drinking water, a TER calculation is not necessary. A low risk can be concluded since. The ratios of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) for birds were calculated, taking into account the relevant toxicity data for Potassium Phosphonates and calculated exposure levels for exposure via drinking water, according to the intended uses of the product FBR-1 in grapevines. The calculated ratios do not exceed 3000, which is the trigger in the case of more sorptive substances (Koc ≥ 500 L/kg). The results of the assessment indicate an acceptable risk for birds due to the intended use of FBR-1 in grapevines according to the label.

Page 18 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Risk assessment for exposure via secondary poisoning

Not required.

9.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2)

9.3.1 Toxicity data

Mammalian toxicity studies have been carried out with Potassium Phosphonates. Full details of these studies are provided in the respective EU DAR and related.

Effects on mammals of FBR-1 were not evaluated as part of the EU assessment of Potassium Phosphonates. Since the formulation FBR-1 is an aqueous solution of Potassium Phosphonates salts with the addition of a small amount of colouring agent (because it is possible to extrapolate from active substance data due to the composition of the formulation FBR-1 (please refer to Part C)), the data on the active substance, derived from testing of the technical product is deemed adequate to conduct a risk assessment for the intended use of the formulation FBR-1.

Table 9.3-1: Endpoints and effect values relevant for the risk assessment for mammals

Species Substance Exposure Results Reference System

Rat Potassium Acute oral toxicity LD50 > 5000 mg/kg EFSA Journal Phosphonates bw (equivalent to 2012;10(12):2963 1736 mg phosphonic xxxxxx acid/kg bw) 02.05.2000 1263/013 Rat Fosetyl-Al Long-term NOEL = 439 mg/kg EFSA Journal [EU-LoEP: bridging bw 2012;10(12):2963 data from fosetyl-Al] (equivalent to 302.9 N.N. mg phosphonic acid/kg bw))

9.3.1.1 Justification for new endpoints

Not necessary. No new studies have been submitted.

9.3.2 Risk assessment for spray applications

The risk assessment is based on the methods presented in the Guidance Document on Risk Assessment for Mammals and Mammals on request from EFSA (EFSA Journal 2009; 7(12): 1438; hereafter referred to as EFSA/2009/1438). To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use 1also covers the risk for mammals from all other intended uses in 2-4 (see 9.1.2). Page 19 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

9.3.2.1 First-tier assessment (screening/generic focal species)

The results of the acute and reproductive first-tier risk assessments are summarised in the following tables.

Table 9.3-2: First-tier assessment of the acute and long-term/reproductive risk for mammals due to the use of FBR-1 in grapevines (use 1 covering uses 1-4)

Intended use use 1 covering uses 1-4 Active substance/product potassium phosphonate Application rate (g/ha) 6 x 2904 g/ha potassium phosphonate (6 x 1881 g/ha phosphonic acid)

Acute toxicity (mg/kg bw) LD50 > 5000 mg/kg bw (equivalent to 1736 mg phosphonic acid/kg bw) TER criterion 10

Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Vineyard Small herbivorous mammal 136.4 1.6 411 4.2 Reprod. toxicity (mg/kg bw/d) NOEL = 439 mg/kg bw (equivalent to 302.9 mg phosphonic acid/kg bw) TER criterion 5

Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Vineyard Small herbivorous mammal 72.3 2.0 x 0.53 144 2.1 SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.

In order to refine the different uses separately, the use n°1 and n° 2 have been considered in the risk assessment, covering the use n°3 and n°4, respectively.

Table 9.3-3: First-tier assessment of the acute and long-term/reproductive risk for mammals due to the use of FBR-1 in Vineyard – Use n°1

Intended use Grapevine – use n°1

Active substance/product Potassium phosphonates/FBR-1 Application rate (g/ha) 6 × 1882 (phosphonic acid equivalent*) Acute toxicity (mg/kg bw) 1736 (Phosphonic acid) TER criterion 10

Crop scenario Generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Application crop directed Small herbivorous mammal "vole” 40.9 1.6 123.2 14.1 BBCH ≥ 40 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” 5.2 1.6 15.7 110.9 BBCH ≥ 40 Combination (invertebrates without interception) 25% weeds 50% weed seeds 25% ground arthropods Application crop directed Small herbivorous mammal "vole” 81.9 1.6 246.6 7.0 BBCH 10 - 19 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” 10.3 1.6 31.0 56.0 Page 20 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

BBCH 10 - 19 Combination (invertebrates without interception) 25% weeds 50% weed seeds 25% ground arthropods Application crop directed Small herbivorous mammal "vole” 68.2 1.6 205.4 8.5 BBCH 20 - 39 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” 8.6 1.6 25.9 67.0 BBCH 20 - 39 Combination (invertebrates without interception) 25% weeds 50% weed seeds 25% ground arthropods BBCH ≥ 20 Small insectivorous mammal “shrew” 5.4 1.6 16.3 106.8 ground dwelling invertebrates with interception 100% ground arthropods BBCH ≥ 40 Large herbivorous mammal 8.1 1.6 24.4 71.2 “lagomorph” Non-grass herbs 100% Plant matter BBCH 10 - 19 Small insectivorous mammal “shrew” 7.6 1.6 22.9 75.9 ground dwelling invertebrates without interception 100% ground arthropods BBCH 10 - 19 Large herbivorous mammal 16.3 1.6 49.1 35.4 “lagomorph” Non-grass herbs 100% Plant matter BBCH 20 - 39 Large herbivorous mammal 13.6 1.6 41.0 42.4 “lagomorph” Non-grass herbs 100% Plant matter Reprod. toxicity (mg/kg bw/d) 302.9 (Phosphonic acid) TER criterion 5

Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Application crop directed Small herbivorous mammal "vole” 21.7 2.0 x 0.53 43.3 7.0 BBCH ≥ 40 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” 2.3 2.0 x 0.53 4.6 66.0 BBCH ≥ 40 Combination (invertebrates without interception) 25% weeds 50% weed seeds 25% ground arthropods Application crop directed Small herbivorous mammal "vole” 43.4 2.0 x 0.53 86.6 3.5 BBCH 10 - 19 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” 4.7 2.0 x 0.53 9.4 32.3 BBCH 10 - 19 Combination (invertebrates without interception) 25% weeds 50% weed seeds 25% ground arthropods Application crop directed Small herbivorous mammal "vole” 36.1 2.0 x 0.53 72.0 4.2 BBCH 20 - 39 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” 3.9 2.0 x 0.53 7.8 38.9 BBCH 20 - 39 Combination (invertebrates without interception) 25% weeds 50% weed seeds 25% ground arthropods BBCH ≥ 20 Small insectivorous mammal “shrew” 1.9 2.0 x 0.53 3.8 79.9 ground dwelling invertebrates with Page 21 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

interception 100% ground arthropods BBCH ≥ 40 Large herbivorous mammal 3.3 2.0 x 0.53 6.6 46.0 “lagomorph” Non-grass herbs 100% Plant matter BBCH 10 - 19 Small insectivorous mammal “shrew” 4.2 2.0 x 0.53 8.4 36.2 ground dwelling invertebrates without interception 100% ground arthropods BBCH 10 - 19 Large herbivorous mammal 6.7 2.0 x 0.53 13.4 22.7 “lagomorph” Non-grass herbs 100% Plant matter BBCH 20 - 39 Large herbivorous mammal 5.5 2.0 x 0.53 11.0 27.6 “lagomorph” Non-grass herbs 100% Plant matter SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger. * Please refer to Part C for detailed calculation on phosphonic acid equivalent

TERa values are greater than the Annex VI trigger of 10 except for the species “vole”, indicating a potential unacceptable acute risk to mammals. TERlt values are greater than the trigger of 5 except for the species “vole” indicating a potential unacceptable long-term risk to mammals. The refinement submitted by the applicant is considered unacceptable as the specified refinement steps are only applicable for the national authorisation in Germany. For zonal application further refinement should be conducted on member state level.

Table 9.3-4: First-tier assessment of the acute and long-term/reproductive risk for mammals due to the use of FBR-1 in Vineyard – Use n°2

Intended use Grapevine – use n°2

Active substance/product Potassium phosphonates/FBR-1 Application rate (g/ha) 5 × 1882 (phosphonic acid equivalent*) with 20 days interval Acute toxicity (mg/kg bw) 1736 (Phosphonic acid) TER criterion 10

Crop scenario Generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Application crop directed Small herbivorous mammal "vole” 40.9 1.17 90.4 19.2 BBCH ≥ 40 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” BBCH ≥ 40 Combination (invertebrates without 5.2 1.17 11.5 151 interception) 25% weeds 50% weed seeds 25% ground arthropods Application crop directed Small herbivorous mammal "vole” 81.9 1.17 181 9.6 BBCH 10 - 19 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” BBCH 10 - 19 Combination (invertebrates without 10.3 1.17 22.8 73.3 interception) 25% weeds 50% weed seeds 25% ground arthropods Application crop directed Small herbivorous mammal "vole” 68.2 1.17 150.7 11.5 Page 22 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

BBCH 20 - 39 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” BBCH 20 - 39 Combination (invertebrates without 8.6 1.17 19 91.4 interception) 25% weeds 50% weed seeds 25% ground arthropods BBCH ≥ 20 Small insectivorous mammal “shrew” ground dwelling invertebrates with 5.4 1.17 11.9 145.5 interception 100% ground arthropods BBCH ≥ 40 Large herbivorous mammal “lagomorph” Non-grass herbs 100% 8.1 1.17 17.9 97 Plant matter BBCH 10 - 19 Small insectivorous mammal “shrew” ground dwelling invertebrates without 7.6 1.17 16.8 103.4 interception 100% ground arthropods BBCH 10 - 19 Large herbivorous mammal “lagomorph” Non-grass herbs 100% 16.3 1.17 36 48.2 Plant matter BBCH 20 - 39 Large herbivorous mammal “lagomorph” Non-grass herbs 100% 13.6 1.17 30.1 57.8 Plant matter Reprod. toxicity (mg/kg bw/d) 302.9 (Phosphonic acid) TER criterion 5

Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Application crop directed Small herbivorous mammal "vole” 21.7 1.3 x 0.53 28.1 10.8 BBCH ≥ 40 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” BBCH ≥ 40 Combination (invertebrates without 2.3 1.3 x 0.53 3.0 101.6 interception) 25% weeds 50% weed seeds 25% ground arthropods Application crop directed Small herbivorous mammal "vole” 43.4 1.3 x 0.53 56.3 5.4 BBCH 10 - 19 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” BBCH 10 - 19 Combination (invertebrates without 4.7 1.3 x 0.53 6.1 49.7 interception) 25% weeds 50% weed seeds 25% ground arthropods Application crop directed Small herbivorous mammal "vole” 36.1 1.3 x 0.53 46.8 6.5 BBCH 20 - 39 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” BBCH 20 - 39 Combination (invertebrates without 3.9 1.3 x 0.53 5.1 59.9 interception) 25% weeds 50% weed seeds 25% ground arthropods BBCH ≥ 20 Small insectivorous mammal “shrew” ground dwelling invertebrates with 1.9 1.3 x 0.53 2.5 122.9 interception 100% ground arthropods BBCH ≥ 40 Large herbivorous mammal “lagomorph” Non-grass herbs 100% 3.3 1.3 x 0.53 4.3 70.8 Plant matter Page 23 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

BBCH 10 - 19 Small insectivorous mammal “shrew” ground dwelling invertebrates without 4.2 1.3 x 0.53 5.4 55.6 interception 100% ground arthropods BBCH 10 - 19 Large herbivorous mammal “lagomorph” Non-grass herbs 100% 6.7 1.3 x 0.53 8.7 34.9 Plant matter BBCH 20 - 39 Large herbivorous mammal “lagomorph” Non-grass herbs 100% 5.5 1.3 x 0.53 7.1 42.5 Plant matter SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger. * Please refer to Part C for detailed calculation on phosphonic acid equivalent

TERa values are greater than the Annex VI trigger of 10 except for the species “vole” for the scenario application crop directed BBCH 10 – 19, indicating a potential unacceptable acute risk to mammals. As the LD50 used in the acute risk assessment is from a limit test conducted at a dose of 5000 mg/kg potassium phosphonate (equivalent to 1736 mg/kg phosphonic acid) and for which no mortalities were observed and the calculated TER of 9.6 is near the requested trigger of 10 it is assumed that the acute risk to mammals is acceptable for use 002

9.3.2.2 Drinking water exposure

When necessary, the assessment of the risk for mammals due to uptake of contaminated drinking water is conducted for a small omnivorous mammal with a body weight of 21.7 g (Apodemus sylvaticus) and a drinking water uptake rate of 0.24 L/kg bw/d (cf. Appendix K of EFSA/2009/1438).

To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use 1 also covers the risk for mammals from all other intended uses 2-4 (see 9.1.2).

Effective application rate (g/ha) = 4140 Acute toxicity (mg/kg bw) = 1736 quotient = 2.4 Reprod. toxicity (mg/kg bw/d) = 302.9 quotient = 13.7

9.3.2.3 Effects of secondary poisoning

The log Pow of Potassium Phosphonates/Phosphonic acid is very low (-0.7699; pH = 7), and thus does not exceed the trigger value of 3. A risk assessment for effects due to secondary poisoning is not required. Page 24 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Risk assessment for earthworm-eating mammals via secondary poisoning Not required.

Risk assessment for fish-eating mammals via secondary poisoning Not required.

9.3.2.4 Biomagnification in terrestrial food chains

Not relevant.

9.3.3 Risk assessment for baits, pellets, granules, prills or treated seed

Not relevant.

9.3.4 Overall conclusions

Dietary risk assessment

Based on tier 1 assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of mammals to Potassium Phosphonates (oral exposure) according to use 001 of the GAP of the formulation FBR-1 indicated a risk for herbivorous mammals. The calculated TER values for the acute and long-term risk resulting from an exposure of mammals to Potassium Phosphonates (oral exposure) according to use 001 of the GAP of the formulation FBR-1 do not achieve the acceptability criteria TER ≥ 10 resp. TER ≥ 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute and chronic effects, for scenarios application crop directed BBCH 10 – 19 and application crop directed BBCH 20 - 39 for small herbivorous mammal "vole”. The results of the assessment indicate an unacceptable acute and long-term risk for mammals due to the intended use of FBR-1 in grapevines according to the label. The refinement presented in the core assessment by the applicant could only be used for national legislation in Germany. Therefore, further refinement should be performed on member state level.

Based on tier 1 assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of mammals to Potassium Phosphonates (oral exposure) according to use 00-002 and 00-004 of the GAP of the formulation FBR-1 indicated no risk for herbivorous mammals. The calculated TER values for the acute and long-term risk resulting from an exposure of mammals to Potassium Phosphonates (oral exposure) according to use 002 of the GAP of the formulation FBR-1 do achieve the acceptability criteria TER ≥ 10 resp. TER ≥ 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute and chronic effects, respectively. The results of the assessment indicate an acceptable acute and long-term risk for mammals due to the intended use 00- 002 and 00-004 of FBR-1 in grapevines according to the label.

Risk assessment for exposure via drinking water

Based on the assessment of the risk arising from the uptake of Potassium Phosphonates via drinking water, a TER calculation is not necessary. A low risk can be concluded since. The ratios of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) for mammals were calculated, taking into account the relevant toxicity data for Potassium Phosphonates and calculated exposure levels for exposure via drinking water, according to the intended uses of the product FBR-1 in grapevines. The calculated ratios do not Page 25 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version exceed 3000, which is the trigger in the case of more sorptive substances (Koc ≥ 500 L/kg). The results of the assessment indicate an acceptable risk for mammals due to the intended use of FBR-1 in grapevines according to the label.

Risk assessment for exposure via secondary poisoning

Not required.

9.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3)

Not yet considered.

9.5 Effects on aquatic organisms (KCP 10.2)

9.5.1 Toxicity data

Studies on the toxicity to aquatic organisms have been carried out with Potassium Phosphonates. Full details of these studies are provided in the respective EU DAR and related documents.

Effects on aquatic organisms of FBR-1 were not evaluated as part of the EU assessment of Potassium Phosphonates. However, the provision of further data on the formulation FBR-1 is not considered essential because it is possible to extrapolate from active substance data due to the composition of the formulation FBR-1 (please refer to Part C).

The selection of studies and endpoints for the risk assessment is in line with the results of the EU review process.

Table 9.5-1: Endpoints and effect values relevant for the risk assessment for aquatic organisms – Potassium Phosphonates (indicated as phosphonic acid equivalents)

Species Substance Exposure Results Reference System

O.mykiss Potassium 96 h, flow-through LC50 > 118 mg a.s./L EFSA Journal Phosphonates (mm) 2012;10(12):2963 xxxxxx 03.12.1999 286A-108 O.mykiss STAMINA 21 d; Juvenile NOEC = 300 mg/L EFSA Journal (= LBG-01F34) Growth Test, flow- (nom); equivalent to 2012;10(12):2963 through 100 mg a.s./L (nom.) xxxxxx 12.12.2008 GAB-019/4-63 Page 26 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Species Substance Exposure Results Reference System

Daphnia magna Potassium 48 h, flow-through EC50 > 118 mg a.s./L EFSA Journal Phosphonates (m.m.) 2012;10(12):2963 Sutherland, C.A., Kendall, T.Z., Krueger, H.O. 03.12.1999 286A-109 Daphnia magna STAMINA 23 d, semi-static NOEC = 292 mg/L EFSA Journal (= LBG-01F34) (nom); equivalent to 2012;10(12):2963 100 mg a.s./L (nom.) Stäbler, D. 26.07.2006 20051318/01-ARDm Chironomus riparius STAMINA 28 d, s NOEC = 100 EFSA Journal (= LBG-01F34) mg phosphonic 2012;10(12):2963 acid/L nom

Desmodesmus STAMINA 72 h, static EbC50 = 452.2 mg/L EFSA Journal Subspicatus (= LBG-01F34) (nom); equivalent to 2012;10(12):2963 (formerly 146.7 mg a.s./L Dengler, D. Scenedesmus (nom.) 15.11.2001 subspicatus) ErC50 = 6779.8 mg/L 20001344/01-AADs (nom); equivalent to 2305.1 mg a.i./L*

Lemna gibba Fosetyl-Al 14 d, ss LC50 = 79.67 Fosetyl- EFSA Scientific Al mg/L equivalent Report (2005) 54, 1- to 55.36 mg 79 phosphonic acid/L s: static; ss: semi-static; f: flow-through; nom: based on nominal concentrations; mm: based on mean measured concentrations; im: based on initial measured concentrations * Transformations of values to H3PO3 (phosphorous acid)

9.5.1.1 Justification for new endpoints

As there is no existing endpoint for the species Lemna gibba with the potassium phosphonates in the LoEP for potassium phosphonates, reference to the EU agreed endpoints of the active substance Fosetyl-Al is made here, in addition to the EU agreed endpoints of the active substance potassium phosphonates, in order to cover this species. Please note that according to the Draft Assessment Report (DAR – April 2005) of Potassium phosphonates, it was concluded that information generated on Fosetyl-Al is regarded applicable to the technical substance Potassium Phosphite and that studies with Fosetyl-Al can be used for risk assessment of Potassium Phos- phite (former name of Potassium phosphonates).

9.5.2 Risk assessment

The evaluation of the risk for aquatic and sediment-dwelling organisms was performed in accordance with the recommendations of the “Guidance document on tiered risk assessment for plant protection products for aquatic organisms in edge-of-field surface waters in the context of Regulation (EC) No 1107/2009”, as provided by the Commission Services (SANTE-2015-00080, 15 January 2015). The relevant global maximum FOCUS Step 1, 2 and 3 PECSW for risk assessments covering the proposed Page 27 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version use pattern and the resulting PEC/RAC ratios are presented in the table below.

To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use 1 also covers the risk for aquatic organisms from all other intended uses 2-4 (see 9.1.2). Page 28 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

In the following table, the ratios between predicted environmental concentrations in surface water bodies (PECSW, PECSED) and regulatory acceptable concentrations (RAC) for aquatic organisms are given per intended use for each FOCUS scenario and each organism group.

Table 9.5-2: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for Potassium Phosphonates for each organism group based on FOCUS Steps 1 and 2 calculations for the use of FBR-1 in grapevines (use 1 covering uses 1-4)

Inverteb. Inverteb. pro- Sed. dwell. pro- Group Fish acute Fish prolonged Algae Aquatic macrophytes acute longed longed Oncorhynchus Oncorhynchus Daphnia Daphnia magna D. subspicatus Chironomus ri- Test species Lemna gibba mykiss mykiss magna parius

Endpoint LC50 NOEC EC50 NOEC EbC50 NOEC LC50 (µg/L) > 118000 100000 > 118000 100000 146700 100 000 55 360 AF 100 10 100 10 10 10 10 RAC (µg/L) > 1180 10000 > 1180 10000 14670 10 000 5 536

PEC gl-max FOCUS Scenario (µg/L) Step 1 4650 0.25 2.15 0.25 2.15 3.15 2.15 1.19 Step 2 N-Europe, March-May 604.47 2.0 -- 2.0 ------N-Europe, June-Sept 693.50 1.7 -- 1.7 ------AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

Page 29 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

9.5.3 Overall conclusions

9.6 Effects on bees (KCP 10.3.1)

zRMS comments The Applicant (Fitosanitarios Bajo Riesgo AIE) has prepared the current report in the dRR format.

The zRMS comments, evaluations and conclusions are introduced in grey commenting boxes. Minor corrections are directly introduced in the text and highlighted in grey. Unaccepted information are struck through.

9.6.1 Toxicity data

Studies on the toxicity to bees have been carried out with Potassium phosphonates. Full details of these studies are provided in the respective EU DAR and related documents as well as in the compensation dossier (document MII-08) of the active substance potassium phosphonates provided along with this dRR dossier to demonstrate the access to a complete Annex II dossier.

Effects on bees of the formulation FBR-1 were not evaluated as part of the EU assessment of Potassium phosphonates. New data submitted with this application are listed in Appendix 1 and summarised in Ap- pendix 2.

The selection of studies and endpoints for the risk assessment is in line with the results of the EU review process

Table 9.6-1: Endpoints and effect values relevant for the risk assessment for bees

Species Substance Exposure Results Reference System

Apis mellifera Potassium Oral LD50 = 145 µg/bee EFSA Journal Page 30 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Species Substance Exposure Results Reference System

phosphonates 2012;10(12):2963

Apis mellifera Potassium Contact LD50 = 207µg/bee EFSA Journal phosphonates 2012;10(12):2963

Apis mellifera Phosphonic acid Oral LD50 = 50.34 µg/bee EFSA Journal 2012;10(12):2963

Apis mellifera Phosphonic acid Contact LD50 = 71.87 µg/bee EFSA Journal 2012;10(12):2963

Apis mellifera FBR-1 Chronic oral effects LDD50 = 165.56 µg KCP 10.3.1.2-01 prod./bee/day NOEDD = 58.61 µg/prod./bee/day

Apis mellifera FBR-1 Larval toxicity test, LD50 = 307.68 µg KCP 10.3.1.3-01 repeated exposure prod./larva NOED = 60 µg/prod./ larva Higher-tier studies (tunnel test, field studies) No data

9.6.1.1 Justification for new endpoints

New endpoints are available from chronic toxicity and larval toxicity studies on bees performed with the formulation FBR-1 in order to comply with the new requirements of regulation (EU) N° 284/2013.

zRMS comments The formulated product FBR-1 (726 g a.s./L) is almost identical to potassium phos- to 9.6.1 phonates. Therefore, the submitted studies for the EU review, which performed with the active substance potassium phosphonates, cover the potential toxicity of FBR-1 and could be used in the risk assessment. Moreover, laboratory studies regarding adult and larval chronic toxicity of the product FBR-1 are submitted to fulfil the new Annex III data requirements of EU-regulation (284/2013). Accepted end- LD50 (Phosphonic acid) Oral: 50.34 µg/bee points: Contact: 71.87 µg/bee 9.6.1 LDD50 (FBR-1) Adults: 165.56 µg prod./bee/day NOEDD(FBR-1) Adults: 58.61 µg prod./bee/day LD50 (FBR-1) Larvae: 307.68 µg prod./bee/day

9.6.2 Risk assessment

The evaluation of the risk for bees was performed in accordance with the recommendations of the “Guid- ance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services (SANCO/10329/2002 rev.2 (final), October 17, 2002).

To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use group grapevine taking into account the maximum application rate also covers the risk for bees from all other intended uses in group grapevine (see 9.1.2). Page 31 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

9.6.2.1 Hazard quotients for bess

Table 9.6-2: First-tier assessment of the risk for bees due to the use of FBR-1 in Grapevine

Intended use Grapevine Active substance Potassium phosphonates Application rate (g/ha) Phosphonic acid equivalent: 1882

Test design LD50 (lab.) Single application rate QHO, QHC (µg/bee) (g/ha) criterion: QH ≤ 50 Oral toxicity 50.34 37.4 1882 Contact toxicity 71.87 26.2

QHO, QHC: Hazard quotients for oral and contact exposure. QH values shown in bold breach the relevant trigger.

Conclusion First-tier assessments indicate that there is no risk for bees exposed to the product FBR-1 in Grapevine. Therefore, it can be concluded that no risk for bees exposed to the product FBR-1 is expected according to the proposed intended uses.

zRMS comments Effects on bees of FBR-1 have not been evaluated as part of the EU review of the to EU assessment of Potassium phosphonates. 9.6.2 Due to the results of laboratory tests with the Potassium phosphonates and Phos- phoric acid, FBR-1 could consider as slightly toxic to bees. All hazard quotients are below the trigger of 50, indicating that the intended use would pose a low risk to honey bees in the field.

It is concluded that FBR-1 will not adversely affect bees or bee colonies when used as recommended. Accepted end- LD50 (Phosphonic acid) Oral: 50.34 µg/bee points: Contact: 71.87 µg/bee 9.6.2 LDD50 (FBR-1) Adults: 165.56 µg prod./bee/day NOEDD (FBR-1) Adults: 58.61 µg prod./bee/day LD50 (FBR-1) Larvae: 307.68 µg prod./bee/day

9.6.2.2 Higher-tier risk assessment for bees (tunnel test, field studies)

Not required.

9.6.3 Effects on bumble bees

No data available.

zRMS comments At the time of submission, no validated guidance for testing the acute toxicity to to 9.6.3 bumble bees was available. Therefore, no acute toxicity data to bumble bees is required.

9.6.4 Effects on solitary bees

No data available. Page 32 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

zRMS comments At the time of submission, no validated guidance for testing the acute toxicity to to 9.6.4 solitary bees was available. Therefore, no acute toxicity data to solitary bees is required.

9.6.5 Overall conclusions

zRMS comments RMS concludes that that FBR-1 will not adversely affect bees or bee colonies when to 9.6.5 used as recommended. Accepted end- Due to fulfilment of the data requirement, the risk assessment of FBR-1 on honey point/s 9.6.5 bees could be finalized.

9.7 Effects on arthropods other than bees (KCP 10.3.2)

9.7.1 Toxicity data

Studies on the toxicity to non-target arthropods have been carried out with Potassium phosphonates. Full details of these studies are provided in the respective EU DAR and related documents.

Effects on non-target arthropods of FBR-1 were not evaluated as part of the EU assessment of Potassium phosphonates. New data submitted with this application are listed in Appendix 1 and summarised in Ap- pendix 2.

The selection of studies and endpoints for the risk assessment deviates from the results of the EU review process. Justifications are provided below.

Table 9.7-1: Endpoints and effect values relevant for the risk assessment for non-target arthropods

Species Substance Exposure Results Reference System

Aphidius STAMINA (= 2 d LR50 > 40 L/ha EFSA Journal rhopalosiphi LBG-01F34) glass plate equivalent to 2012;10(12):2963 LR50 > 20.2 kg Schuld, M. phosphonic acid/ha 22.05.2001 Effect: 20001344/01-NLAp Mortality: 12.8% Reproduction: 0%

Typhlodromus pyri STAMINA (= 7 d, extend. lab, LR50 > 16 L/ha EFSA Journal LBG-01F34) apple leaves, equivalent to 2012;10(12):2963 mortality and LR50 > 8.1 kg Adelberger, I. reproduction phosphonic 22.05.2001 acid./ha 20001344/01-NETp Effect: Mortality: 10.8% Reproduction: 17% Page 33 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Species Substance Exposure Results Reference System

Typhlodromus pyri Formulation FBR-1 Laboratory test LR50 > 36 608 g/ha KCP 10.3.2.1-01 (protonymphs) glass plates (3D) ER50 > 36 608 g/ha Monica Colli (corresponding to 2016 11568.13 g BT149/15 Phosphonate/ha and 6516.22 g Potassium/ha)

Aphidius Formulation FBR-1 Extended LR50 > 36 608 g/ha KCP 10.3.2.2-01 rhopalosiphi laboratory test (2D) ER50 > 36 608 g/ha Simone Venturi (adults) (corresponding to 2016 11568.13 g BT148/15 Phosphonate/ha and 6516.22 g Potassium/ha)

9.7.1.1 Justification for new endpoints

Previous endpoints for laboratory and extended tests were realised with the reference formulation STAM- INA. The applicant additionally performed tests conducted with the formulation FBR-1.

9.7.2 Risk assessment

The evaluation of the risk for non-target arthropods was performed in accordance with the recommendations of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services (SANCO/10329/2002 rev.2 (final), October 17, 2002), and in consideration of the recommendations of the guidance document ESCORT 2.

9.7.2.1 Risk assessment for in-field exposure

To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use 1 also covers the risk for non-target arthropods from all other intended uses 2-4 (see 9.1.2).

Table 9.7-2: First- and higher-tier assessment of the in-field risk for non-target arthropods due to the use of FBR-1 in grapevines (use 1 covering uses 1-4)

Intended use use 1 covering uses 1-4 Active substance/product FBR-1 Application rate (g/ha) 6 x 5 632** MAF 3.2 (leaves); 4.6 (soil)

Test species LR50 (lab.) PERin-field HQin-field Tier I (g/ha) (g/ha) criterion: HQ ≤ 2 Typhlodromus pyri 36 608 0.7 25907 Aphidius rhopalosiphi 36 608 0.7 MAF: Multiple application factor; PER: Predicted environmental rate; HQ: Hazard quotient; DALT: Days after last treatment. Criteria values shown in bold breach the relevant trigger. Page 34 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

* If an LR50 or ER50 from a relevant extended laboratory test is available, it should be considered in place of the rate with ≤ 50 % effect. ** taking into account a density value of 1.4079

9.7.2.2 Risk assessment for off-field exposure

Table 9.7-3: First- and higher-tier assessment of the off-field risk for non-target arthropods due to the use of FBR-1 in grapevines (use 1 covering uses 1-4)

Intended use Use 1 covering uses 1-4 Active substance/product potassium phosphonate /FBR-1 Application rate (g/ha) 6 x 2904 g/ha potassium phosphonate (6 x 1881 g/ha phosphonic acid) MAF 3.2 (leaves); 4.6 (soil) vdf 10 (Tier 1, 2D); 1 (3D)

Test species LR50 (lab.) Drift rate PERoff-field CF HQoff-field Tier I (g/ha) (g/ha) criterion: HQ ≤ 2

Typhlodromus pyri 36 608 165.4** 0.45 6.41 10 Aphidius rhopalosiphi 36 608 1654 0.045 MAF: Multiple application factor; vdf: Vegetation distribution factor; (corr.) PER: (corrected) Predicted environmental rate; CF: Correction factor; HQ: Hazard quotient. Criteria values shown in bold breach the relevant trigger. * If an LR50 or ER50 from a relevant extended laboratory test is available, it should be considered in place of the rate with ≤ 50 % effect. ** 3 D

9.7.2.3 Additional higher-tier risk assessment

Not relevant.

9.7.2.4 Risk mitigation measures

No risk mitigation needed.

9.7.3 Overall conclusions

In-field

Off-field

9.8 Effects on non-target soil meso- and macrofauna (KCP 10.4)

9.8.1 Toxicity data

Studies on the toxicity to earthworms and other non-target soil organisms (meso- and macrofauna) have been carried out with Potassium Phosphonates. Full details of these studies are provided in the respective EU DAR and related documents.

Effects on earthworms and other non-target soil organisms (meso- and macrofauna) of FBR-1 were not evaluated as part of the EU assessment of Potassium Phosphonates. New data submitted with this application are listed in Appendix 1 and summarised in Appendix 2.

The selection of studies and endpoints for the risk assessment deviates from the results of the EU review process. Justifications are provided below.

Table 9.8-1: Endpoints and effect values relevant for the risk assessment for earthworms and other non-target soil organisms (meso- and macrofauna)

Species Substance Exposure Results Reference System

Eisenia fetida STAMINA Acute LC50 = 2920 mg EFSA Conclusion or (= LBG-01F34) 14 d LBG-0134F /kg soil Review Report dw (equivalent to Kölzer, U. 1000 mg a.i. /kg soil 19.04.2006 dw) 20051318/01-NLEf Mortality Page 36 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Species Substance Exposure Results Reference System

Eisenia fetida STAMINA chronic NOEC = 182.5 mg EFSA Conclusion or (= LBG-01F34) 56 d LBG-0134F /kg soil Review Report dw (equivalent to Kölzer, U. 62.5 mg a.i.) 10.07.2006 Reproduction * 20051318/01-NREf

EC10 =149.1 mg LBG-0134F/kg soil (95%CI: 94.6-204.1) bzw. EC10= 52.1 mg phosphonic acid equivalent/kg soil (95%CI: 35.8-68.7) EC20= 91.8 mg phosphonic acid equivalent/kg soil (95%CI: 69.5-113) # Eisenia andrei FBR-1 Mixed into substrate NOEC = 437.5 mg KCP 10.4.1.1-01 56 d, chronic FBR-1/kg dw Francesco Pecorari 10 % peat content (146.2 mg 2016 phosphonic acid BT129/15 equivalent*) EC10 = 790.83 mg FBR-1/kg dw (95%CI: 227.72 – 2746.43) EC20 = 1397.63 mg FBR-1/kg dw (95%CI: 393.01 – 4979.69) * LoEP 8/2012 # ER10 calculated by RMS (final addendum to the DAR, September 2012).

9.8.1.1 Justification for new endpoints

New endpoint is available from a reproductive toxicity study on earthworms performed with the formulation FBR-1 in order to comply with the requirements of Regulation (EU) N° 284/2013. The new study has been conducted with the formulation FBR-1 which is considered relevant for the active substance as manufactured due to the composition the formulation (please refer to Part C). The applicant claims the new study to be more relevant for risk assessment since the study evaluated in the DAR was performed with the product LBG-01F34 containing 34.3% w/w phosphorous acid equivalent which is higher than the specification limit defined for the TK in the EFSA Journal 2012;10(12):2963 (in terms of phosphorous acid equivalent). RMS does not see a product-related effect due to the composition the formulation (please refer to Part C). It can therefore be assumed that both studies are representative for the active substance. One study is conducted with the soecies Eisenia fetida, and the other with Eisenia andrei. For risk assessment, the lower of these endpoints is considered relevant for the active substance and has therefore been used for the risk assessment presented below. Page 37 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

9.8.2 Risk assessment

The evaluation of the risk for earthworms and other non-target soil organisms (meso- and macrofauna) was performed in accordance with the recommendations of the “Guidance Document on Terrestrial Ecotoxicol- ogy”, as provided by the Commission Services (SANCO/10329/2002 rev 2 (final), October 17, 2002).

9.8.2.1 First-tier risk assessment

The relevant PECsoil for risk assessments covering the proposed use pattern are taken from Section 8 (En- vironmental Fate), Chapter 8.7.2, Table 8.7-3. According to the assessment of environmental-fate data, multi-annual accumulation in soil is considered for Potassium Phosphonates.

To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use 1 also covers the risk for earthworms and other non-target soil organisms (meso- and macrofauna) from all other intended uses in 2-4 (see 9.1.2).

Table 9.8-2: First-tier assessment of the acute and chronic risk for earthworms and other non-target soil organisms (meso- and macrofauna) due to the use of FBR-1 in grapevines (use1 covering uses 1-4)

Intended use use1 covering uses 1-4 Acute effects on earthworms

Product/active substance LC50 PECsoil TERa (mg/kg dw) (mg/kg dw) (criterion TER ≥ 10) Potassium Phosphonates 1000 7.62 131 Chronic effects on earthworms

Product/active substance NOEC PECsoil TERlt (mg/kg dw) (mg/kg dw) (criterion TER ≥ 5) Potassium Phosphonates 62.5 7.62 8.2 52.1 6.8 Formulation FBR-1 437.5 18.2 24 TER values shown in bold fall below the relevant trigger.

9.8.2.2 Higher-tier risk assessment

Not relevant.

9.8.3 Overall conclusions

Based on the predicted concentrations of Potassium Phosphonates/ FBR-1 in soils, the TER values describing the acute and long-term risk for earthworms and other non-target soil organisms following exposure to Potassium Phosphonates / FBR-1 according to the GAP of the formulation FBR-1 achieve the acceptability criteria TER ≥ 10 resp. TER ≥ 5 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for soil organisms due to the intended use of FBR-1in grapevines according to the label. Page 38 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

9.9 Effects on soil microbial activity (KCP 10.5)

9.9.1 Toxicity data

Studies on effects soil microorganisms have been carried out with Potassium Phosphonates. Full details of these studies are provided in the respective EU DAR and related documents.

Effects on soil microorganisms of FBR-1 were not evaluated as part of the EU assessment of Potassium Phosphonates. However, the provision of further data on the formulation FBR-1 is not considered essential, because it is deemed possible to extrapolate from active substance data due to the composition of the formulation FBR-1 (please refer to Part C).

The selection of studies and endpoints for the risk assessment is in line with the results of the EU review process.

Table 9.9-1: Endpoints and effect values relevant for the risk assessment for soil microorganisms

Endpoint Substance Exposure Results Reference System

N-mineralisation STAMINA 28 d, aerobic Nitrate formation rate EFSA Conclusion or (= LBG-01F34) soil type 28 days at 7.87 and Review Report 78.67 mg LBG- Kölzer, U. 0134F /kg soil 19.06.2006 (= 2.70 and 26.99 mg 20051318/01-ABMF phosphonic acid equivalent/kg soil) Deviation < 25

C-mineralisation STAMINA 28 d, aerobic CO2 formation EFSA Conclusion or (= LBG-01F34) soil type 28 days at 7.87 and Review Report 78.67 mg LBG- Kölzer, U. 0134F /kg soil 19.06.2006 (= 2.70 and 26.99 mg 20051318/01-ABMF phosphonic acid equivalent/kg soil) Deviation < 25%

9.9.1.1 Justification for new endpoints

Not necessary.

9.9.2 Risk assessment

The evaluation of the risk for soil microorganisms was performed in accordance with the recommendations of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services (SANCO/10329/2002 rev 2 (final), October 17, 2002). The relevant PECsoil for risk assessments covering the proposed use pattern are taken from Section 8 (En- vironmental Fate), Chapter 8.7.2, Table 8.7-3 and were already used in the risk assessment for earthworms and other non-target soil organisms (meso- and macrofauna) (see 9.8). Page 39 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use 1 also covers the risk for the soil microorganisms from all other intended uses 2-4 (see 9.1.2).

Table 9.9-2: Assessment of the risk for effects on soil micro-organisms due to the use of FBR-1 in grapevines (use1 covering uses 1-4)

Intended use Use 1 covering uses 1-4 (grapevines) N-mineralisation

Product/active substance Max. conc. with effects PECsoil Risk acceptable? ≤ 25 % (mg/kg dw) (mg/kg dw) Potassium Phosphonates 26.99 (at 28 d) 7.62 yes C-mineralisation

Product/active substance Max. conc. with effects PECsoil Risk acceptable? ≤ 25 % (mg/kg dw) (mg/kg dw) Potassium Phosphonates 26.99 (at 28 d) 7.62 yes

9.9.3 Overall conclusions

9.10 Effects on non-target terrestrial plants (KCP 10.6)

9.10.1 Toxicity data

Studies on the toxicity to non-target terrestrial plants have been carried out with Potassium Phosphonates. Full details of these studies are provided in the respective EU DAR and related documents.

Effects on non-target terrestrial plants of FBR-1 were not evaluated as part of the EU assessment of Potas- sium Phosphonates. New data submitted with this application are listed in Appendix 1 summarised in Ap- pendix 2.

The selection of studies and endpoints for the risk assessment deviates from the results of the EU review process. Justifications are provided below. Page 40 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Table 9.10-1: Endpoints and effect values relevant for the risk assessment for non-target terrestrial plants

Species Substance Exposure Results Reference System

Allium cepa. m STAMINA 21 d EC50 > 20.0 L EFSA Journal Avena sativa. m (LBG-01F34) Vegetative vigour STAMINA/ha 2012;10(12):2963 Beta vulgaris. d equivalent to Porch, J.R., Krueger, Brassica napus. d > 10.1 kg phosphonic H.O., Martin, K.H. Daucus carota. d acid/ha 16.12.2008 Glycine max. d 286-114

Allium cepa, m FBR-1 21 d ER50 > 43 kg FBR- KCP 10.6.2-01 Brassica napus, d Vegetative vigour 1/ha Monica Colli Cucumis sativus, d equivalent to > 14.4 2016 Helianthus annuus, d kg phosphonic BT150/15 Pisum sativum, d acid/ha Zea mais, m NOER = 43 kg FBR- 1/ha equivalent to 14.4 kg phosphonic acid/ha m: monocotyledonous; d: dicotyledonous

9.10.1.1 Justification for new endpoints

New endpoint is available from a vegetative vigour study on terrestrial plants performed with the formulation FBR-1 in order to comply with the requirements of Regulation (EU) N° 284/2013. Previous endpoints were obtained in a study preformed with the reference formulation STAMINA. In addition, it should be noted that the dose rate of the new study is higher and has been chosen to cover the critical GAPs of the formulation FBR-1 which are more critical than the EU GAP. Therefore, it is considered justified to use here the new endpoints for the risk assessment.

9.10.2 Risk assessment

9.10.2.1 Tier-1 risk assessment (based screening data)

Limit tests at rates up to 43 kg FBR-1/ha equivalent to 14.4 kg phosphonic acid/ha were conducted with FBR-1 and effects were below the critical threshold as defined by the “Guidance Document on Terrestrial Ecotoxicology”, (SANCO/10329/2002 rev.2 final, 2002). The limit test rates exceeds the highest field application rate of 5.362 kg product/ha, including when taking into account the MAF value (3.2), for all the intended uses and is thus considered an indicator for an acceptable risk.

9.10.2.2 Tier-2 risk assessment (based on dose-response data)

Not required since the Tier-1 risk is acceptable. Page 41 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

9.10.2.3 Higher-tier risk assessment

Not relevant.

9.10.2.4 Risk mitigation measures

No risk mitigation needed.

9.10.3 Overall conclusions

9.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)

No data available.

9.12 Monitoring data (KCP 10.8)

No data available.

9.13 Classification and Labelling

Table 9.13-1 Classification and labelling of FBR-1 Relevant toxicity/basis for Active substance: Potassium Phosphonates (content 63.4 %) classification EbC50 = 19.4 mg/L (Desmodesmus subspicatus) Phosphonic acid is an inorganic compound, thus the criteria of ready biodegradability is not appropriate. The log POW = - 0.7699, thus not bioaccumulating The chronic aquatic toxicity of phosphonic acid is not < 1 mg/L. Classification and labelling according to Regulation 1272/2008 Hazard symbol none Signal word none Hazard statement none

Page 42 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Appendix 1 Lists of data considered in support of the evaluation

List of data submitted by the applicant and relied on

Title Verte- Company Report No. brate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Published or not Y/N

KCP Monica Colli 2015 Chronic oral effects of FBR-01 to adult worker honeybees Apis mellifera L. Laboratory test N Fitosanitarios 10.3.1.2 Biotecnologie BT S.r.l, Report No BT151/15 Bajo Riesgo GLP AIE Unpublished KCP Monica Colli 2016 Effects of FBR-01 to honeybees (Apis mellifera L.) Larval toxicity test, repeated exposure. N Fitosanitarios 10.3.1.3 Biotecnologie BT S.r.l, Report No BT152/15 Bajo Riesgo GLP AIE Unpublished KCP Monica Colli 2016 Effects of FBR-01 on the aphid parasitoid Aphidius rhopalosiphi de Stefani Perez (Hymenoptera: N Fitosanitarios 10.3.2.1 Braconidae) under laboratory conditions Bajo Riesgo Biotecnologie BT S.r.l, Report No BT149/15 AIE GLP Unpublished KCP Simone Venturi 2016 Effects of FBR-01 on the predatory mite Typhlodromus pyri Scheuten (Acari: Phytoseiidae) under N Fitosanitarios 10.3.2.2 extended laboratory conditions Bajo Riesgo Biotecnologie BT S.r.l, Report No BT148/15 AIE GLP Unpublished Page 43 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Title Verte- Company Report No. brate Data point Author(s) Year Source (where different from company) study Owner GLP or GEP status Published or not Y/N

KCP Francesco Pecorari 2016 Effects of the product FBR-01 on reproduction and growth of the earthworm Eisenia andrei in artificial N Fitosanitarios 10.4.1.1 soil Bajo Riesgo Biotecnologie BT S.r.l, Report No BT129/15 AIE GLP Unpublished KCP Monica Colli 2016 Effects of FBR-1 on terrestrial plants vegetative vigour limit test N Fitosanitarios 10.6.2 Biotecnologie BT S.r.l, Report No BT150/15 Bajo Riesgo GLP AIE Unpublished

List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review None.

Page 44 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Appendix 2 Detailed evaluation of the new studies

A 2.1 KCP 10.1 Effects on birds and other terrestrial vertebrates

A 2.1.1 KCP 10.1.1 Effects on birds

A 2.1.1.1 KCP 10.1.1.1 Acute oral toxicity

A 2.1.1.2 KCP 10.1.1.2 Higher tier data on birds

A 2.1.2 KCP 10.1.2 Effects on terrestrial vertebrates other than birds

A 2.1.2.1 KCP 10.1.2.1 Acute oral toxicity to mammals

A 2.1.2.2 KCP 10.1.2.2 Higher tier data on mammals

A 2.1.3 KCP 10.1.3 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)

A 2.2 KCP 10.2 Effects on aquatic organisms

A 2.2.1 KCP 10.2.1 Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes

A 2.2.2 KCP 10.2.2 Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms

A 2.2.3 KCP 10.2.3 Further testing on aquatic organisms

A 2.3 KCP 10.3 Effects on arthropods

A 2.3.1 KCP 10.3.1 Effects on bees

New studies are available with the formulation FBR-1 in order to comply with the new requirements of regulation (EU) N° 284/2013 and are summarized below. Page 45 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

A 2.3.1.1 KCP 10.3.1.1 Acute toxicity to bees

No new study available. Not required since it is possible to extrapolate from active substance data due to the composition of the formulation FBR-1 (please refer to Part C). Please refer to the compensation dossier (document MII-08) of the active substance potassium phosphonates provided along with this dRR dossier to demonstrate the access to a complete Annex II dossier.

zRMS comments Effects on bees of FBR-1 have not been evaluated as part of the EU review of the to 10.3.1.1 EU assessment of Potassium phosphonates. However, the formulated product FBR-1 (726 g a.s./L) is almost identical to potassium phosphonates. Therefore, the submitted studies for the EU review, which performed with the active substance potassium phosphonates, cover the potential toxicity of FBR-1 and could be used in the risk assessment. Due to the results of laboratory tests with the Potassium phosphonates, FBR-1 could consider slightly toxic to bees. Accepted end- LD50 (Phosphonic acid) Oral: 50.34 µg/bee point/s Contact: 71.87 µg/bee 10.3.1.1/01

A 2.3.1.1.1 KCP 10.3.1.1.1 Acute oral toxicity to bees

Not required. Please see point 2.3.1.1

A 2.3.1.1.2 KCP 10.3.1.1.2 Acute contact toxicity to bees

Not required. Please see point 2.3.1.1

A 2.3.1.2 KCP 10.3.1.2. Chronic toxicity to bees

Reference: KCP 10.3.1.2-01 Report Chronic oral effects of FBR-01 to adult worker honeybees Apis mellifera L. Laboratory test, Monica Colli (2015), Report No. BT151/15 Guideline(s): - Method No. 230: Commission des Essais Biologiques Method for the Eval- uation of Plant protection Products on Honey Bees Apis mellifera L. (2003); - EFSA Guidance Document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees) (2013) revised on July 2014; - Current recommendations of the ring test group (2014) for a proposal for a new OECD Guideline for 10 day chronic adult honey bee toxicity test. Deviations: No GLP: Yes Acceptability: Yes Duplication Not relevant (if vertebrate study) Page 46 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Materials and methods The effects of the test item FBR-01 (Batch N° 2015-0404) containing on adult worker honeybees (Apis mellifera L.) were tested under laboratory conditions over a period of 10 days. The test item was dissolved in water each day for 10 days, in order to get a stock solution and subsequent dilutions. The final feeding solutions were prepared freshly every day from the stock solutions with 50% (w/v) aqueous sucrose solution. The chronic effects of the test item were evaluated by comparing the results of the test item groups to those of the control group. Five treatments of the test items at doses of 750, 1500, 3000, 6000 and 12 000 mg product/kg diet were tested. In addition, the reference item Rogor L20 (Dimethoate) was also tested at 0.60 mg a.s/kg (corresponding to 3.35 mg reference item/kg diet) in order to verify that the responses of the system was within the normal level.

Results and discussions

Table 2.3.1.2-1 Food uptaken Mean uptaken feeding solution Mean uptaken product Treatments mg product/kg diet mg feeding solution/bee/day µg product/bee/day at test end Control 0.00 36.74 0.00 Test item – T1 750.00 37.09 27.82 Test item – T1 1500.00 39.07 58.61 Test item – T1 3000.00 38.67 116.01 Test item – T1 6000.00 32.06 192.36 Test item – T1 12000.00 39.68 476.19 Reference item 3.35 37.86 0.13

Table 2.3.1.2-2 Mortality Mortality mg product/kg µg prod- Treatments ± SD Mean corrected diet uct/bee/day Mean % % mortality % Control 0.00 0.00 3.3 5.8 --- Test item – T1 750.00 27.82 10.0 10.0 6.9 Test item – T1 1500.00 58.61 10.0 10.0 6.9 Test item – T1 3000.00 116.01 26.7* 5.8 24.1 Test item – T1 6000.00 192.36 53.3* 11.5 51.7 Test item – T1 12000.00 476.19 96.7* 5.8 96.6 Reference item 3.35 0.13 96.7 5.8 96.6 * The mean was significant (Cochran Armitage test procedure – alpha 0.05)

The available data showed that the test item FBR-01 had significant effects on the honeybee mortality starting from the dose of 116.01 µg prod./bee/day (based on the mean food consumption/bee/day) corresponding to an administration of 3000 mg product/kg diet.

Validity criteria The test was considered valid because the following criteria were satisfied:  The average mortality for the control did not exceed 15% at the end of the test (exact value: 3.3%)  The average mortality in the reference item treatment was ≥50% at the end of the test (exact value: 96.7%). Page 47 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Conclusion The effects of FBR-01 to adult worker honeybees (Apis mellifera L.) were assessed in a 10-day oral chronic toxicity test. In terms of dose (related to the mean food consumption), the LDD50 had been calculated to be 168.56 μg prod./bee/day. The NOEDD was determined as 58.61 μg prod./bee/day (based on the mean food consumption/bee/day) corresponding to an administration of 1500.00 mg/kg diet.

zRMS comments The study was conducted in compliance with the OECD 245 guidelines for 10 days to 10.3.1.2/01 chronic feeding test and considered to be valid. This study is acceptable and usable to evaluate the risk of product FBR-C on bees. The toxicity data indicates that the product is practically non-toxic to bees. Accepted end- LDD50 (FBR-1) 168.56 µg prod./bee/day point/s NOEDD (FBR-1) 58.61 μg prod./bee/day 10.3.1.2/01

A 2.3.1.3 KCP 10.3.1.3 Effects on honey bee development and other honey bee life stages

Reference: KCP 10.3.1.3-01 Report Effects of FBR-01 to honeybees (Apis mellifera L.) Larval toxicity test, repeated exposure, Monica Colli (2016), Report No. BT152/15 Guideline(s): - OECD, Draft Guidance Document: “Honeybees (Apis mellifera) larval toxicity test, repeated exposure”, revised on April 2015. - EFSA Guidance Document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees) (2013) revised on July 2014; Deviations: No GLP: Yes Acceptability: Yes Duplication Not relevant (if vertebrate study)

Materials and methods The effects on honeybees’ larvae of repeated exposure to the test item FBR-01 (Batch N° 2015-0404) containing were tested in a laboratory study. The test item was mixed to the diet in a range of five increasing concentrations (15, 30, 60, 120 and 240 µg product/larva), and administered daily to the larvae at a constant concentration, from day 3 (D3) to 6 (D6) of the test. Three replicates of 12 larvae were prepared for each experimental group. The reference item Dimethoate was dissolved in deionized water and simultaneously tested at a single dose (equivalent to 7.08 µg a.s./larva).

Results and discussions The following tables show the mean mortalities, the pupae mortality and the effects on adult emergence.

Table 2.3.1.3-1 Mortality (M%) and Corrected Mortality (CM%) on D8, D15 and D22 Treatments Doses D8 D15 D22 Page 48 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

µg/larva M% SD% CM% M% SD% CM% M% SD% CM% Control 0.00 0.00 0.00 --- 0.00 0.00 --- 2.78 4.81 --- Test item – 15.00 0.00 0.00 0.00 0.00 0.00 0.00 2.78 4.81 0.00 T1 Test item – 30.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 T1 Test item – 60.00 0.00 0.00 0.00 0.00 0.00 0.00 2.78 4.81 0.00 T1 Test item – 120.00 2.78 4.81 2.78 8.33* 0.00 8.33 13.89* 4.81 0.00 T1 Test item – 240.00 11.11* 4.81 11.11 11.11* 4.81 11.11 36.11* 19.25 34.29 T1 Reference 7.12 97.22 4.81 97.22 100.00 0.00 100.00 100.00 0.00 100.00 item * The mean was significant (Chi² 2x2 Table test with Bonferroni correction for D8 and D15 and Step down Cochran-Armitage test for D22 – alpha = 0.05)

Table 2.3.1.3-2 Pupal mortality (M%) and corrected mortality (CM%) from D8 to D22 Doses D8 – D22 Treatments µg/larva M% SD% CM% Control 0.00 2.78 4.81 --- Test item – T1 15.00 2.78 4.81 0.00 Test item – T1 30.00 0.00 0.00 0.00 Test item – T1 60.00 2.78 4.81 0.00 Test item – T1 120.00 14.39 14.39 11.95 Test item – T1 240.00 27.58 27.58 25.51

Table 2.3.1.3-3 Adults’ emergence (D22) Doses D22 Treatments µg/larva Mean% SD % Reduction Rate % Control 0.00 97.22 4.81 --- Test item – T1 15.00 97.22 4.81 0.00 Test item – T1 30.00 100.00 0.00 2.78 Test item – T1 60.00 97.22 4.81 0.00 Test item – T1 120.00 86.11 4.81 -11.11 Test item – T1 240.00 63.89 19.25 -33.33

Validity criteria According to the OECD Draft Guidance Document “Honeybees Larval Toxicity Test, Repeated Exposure” (2015) the test was considered valid because: a) in the control plate the cumulative larval mortality from D4 to D8 was ≤ 15% across replicates (exact value 0.00%); b) in the control plate the adult emergence rate was ≥ 70% on D22 (exact value: 97.22%); c) in the reference item group larval mortality (after adjustment) was ≥ 50% at D8 (exact value: 97.22%).

Conclusion The results demonstrate that the test item FBR-01 caused statistically significant adverse effects to the development of Apis mellifera L. when administered to larvae at concentrations > 60.0 μg prod./larva. The NOED on D8 was evaluated to be 120.0 μg prod./larva. On D15 and D22 the NOED resulted in 60.0 μg prod./larva. The LD50 value calculated on D22 is 307.68 μg prod./larva. Page 49 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

zRMS comments The study was conducted in compliance with the OECD 239 guidelines for larval to 10.3.1.3/01 toxicity test and considered to be valid. This study is acceptable and usable to evaluate the risk of product FBR-1 on bees. The toxicity data indicates that the product is practically non-toxic to bees. Accepted end- LD50 (FBR-1) 307.68 μg prod./larva point/s NOED (FBR-1) 60.00 μg prod./larva 10.3.1.3/01

A 2.3.1.4 KCP 10.3.1.4 Sub-lethal effects

No data available. Not required.

A 2.3.1.5 KCP 10.3.1.5 Cage and tunnel tests

No data available. Not required.

A 2.3.1.6 KCP 10.3.1.6 Field tests with honeybees

No data available. Not required.

A 2.3.2 KCP 10.3.2 Effects on non-target arthropods other than bees

A 2.3.2.1 KCP 10.3.2.1 Standard laboratory testing for non-target arthropods

A 2.3.2.2 KCP 10.3.2.2 Extended laboratory testing, aged residue studies with non-target arthropods

Comments of zRMS: The study is acceptable. Laboratory test (2D) Typhlodromus pyri: ER50 and LR50 >36608 g FBR-01/ha.

Reference: KCP 10.3.2.1-01 Report Effects of FBR-01 on the aphid parasitoid Aphidius rhopalosiphi de Stefani Perez (Hymenoptera: Braconidae) under laboratory conditions, Monica Colli (2016), Report No. BT149/15 Guideline(s): - ESCORT I Guidance Document (Barret K.L. et al., eds. 1994) - ESCORT II Guidance Document (Candolfi et al., eds. 2001) - IOBC/WPRS Guidelines (Mead-Briggs et al., 2000) - Guideline of the ring-testing group (Mead-Briggs et al., 2009). Deviations: The spray equipment was not calibrated before using due to a problem with the pressurized air pump that did not allow the calibration. This has no impact on the study because each plate was weighed before and after treatment and Page 50 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

only the plates treated with the correct amount of solution were used for as- sembling the test units. GLP: Yes Acceptability: Yes Duplication Not relevant (if vertebrate study)

Materials and methods The effects of the test item FBR-01 (Batch N° 2015-0404) containing on the aphid parasitoid Aphidius rhopalosiphi were evaluated after 48 hours of exposure under laboratory conditions. The test item was sprayed on glass plates with a spray equipment at a single application rate of 36 608 g product/ha, chosen according to the results of a range finding test. The treated plates were allowed to dry for about 1 hour, then the test cages were assembled and ten adults per cage were introduced. After 48 hours of exposure to the treated plates, the surviving parasitoids were removed from the exposure cages and the parasitic capacity per female was evaluated in the fecundity test. The formulation Rogor L40 (containing 404.96 g Dimethoate/L) was used as reference item, whereas deionised water was used as control. Five replicates per treatment groups were tested, each containing ten wasps.

Results and discussions Behaviour data: The test item had no effects on the behaviour of the survival parasitoids as demonstrated by the lack of changes in the normal behaviour. The survival parasitoids showed no signs of reduced coordination and no differences in the general activity respect to the wasps of the control group.

Mortality:

Table 2.3.2.1-1 Mortality of the wasps after 48 hours of exposure % Mean mortal- % Mean corrected Treatments g prod./ha Sig. ity mortality Control 0.00 2.00 ------Test Item – T1 36 608.00 18.00 16.33 + Reference item 0.472 (Dimethoate 0.18) 100.00 100.00 ---

A statistically significant (Fisher exact binomial test, alpha = 0.05) mortality was found between the control and treated group, however this mortality was lower than 50%.

Reproduction performance:

Table 2.3.2.1-2 Reproduction performance of the treated group Treatments g prod./ha Mean No. of mummies/female ± SD % R Sig. Control 0.00 34.40 12.26 ------Test item – T1 36 608.00 35.80 14.53 -4.07 -

No statistically significant difference was found in reproduction performance between control and treated group (Student T-test for Homogeneous variances, alpha = 0.05) Page 51 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Validity criteria The test was considered valid because the following criteria were satisfied:  The mean mortality in the control group was ≤ 10.00 % (exact value: 2.00%) after 48 hours;  The mean mortality caused by the reference item was ≥ 50% (exact value: 100.00%) after 48 hours;  The mean parasitization rate of the control group was ≥ 5 aphid mummies per surviving female (exact value: 34.4)  No female failed to produce mummies in the control group (maximum allowed: two females).

Conclusion The effects of FBR-01 to adult Aphidius rhopalosiphi were assessed in a laboratory limit test. The results obtained showed that the test item FBR-1 caused significant mortality when applied on glass plates at the worst case application rate of 36608 g product/ha. However the corrected mortality caused by the test item was lower than 50%. The LR50 value after 48 hours of exposure was greater than 36608 g product/ha.

The results of the reproduction phase did not show adverse effects of the test item at the worst case application rate of 36608.00 g product/ha. No significant reduction in mummies production was observed, so the ER50 was greater than 36608 g product/ha.

A 2.3.2.3 KCP 10.3.2.2. Extended laboratory testing, aged residue studies with non-target arthropods

Comments of zRMS: The study is acceptable. extended laboratory Typhlodromus pyri: ER50 and LR50 >36608 g FBR-01/ha.

Reference: KCP 10.3.2.2-01 Report Effects of FBR-01 on the predatory mite Typhlodromus pyri Scheuten (Acari: Phytoseiidae) under extended laboratory conditions, Simone Venturi (2016), Report No. BT148/15 Guideline(s): - ESCORT I Guidance Document (Barret K.L. et al., eds. 1994) - ESCORT II Guidance Document (Candolfi et al., eds. 2001) - IOBC/WPRS Guidelines (Blumel S. et al., 2000) Deviations: None GLP: Yes Acceptability: Yes Duplication Not relevant (if vertebrate study)

Materials and methods The effects of the test item FBR-01 (Batch N° 2015-0404) on the survival and the reproduction of the predatory mite Typhlodromus pyri were evaluated under extended laboratory conditions. The protonymphs were exposed to dried spray deposits of the test item on leaf discs detached from treated plants, in order to evaluate the effects on mortality. The test item was applied to potted beans plants at a Page 52 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version single application rate of 36 608 g product/ha, determined following a range finding test, using a spraying equipment, calibrated to deliver spray at a volume rate of 400L/ha. The control group and the reference item group were prepared spraying deionised water and a Dimethoate formulation, respectively. After spraying, the plants were left to dry for 1 hour, then the leaves were col- lected in order to make the test units. Five replicates per experimental group were prepared, each containing 20 predatory mites.

Results and discussions Mortality: Table 2.3.2.2-1 Mortality at 7 days after exposure Groups g prod./ha % Mean mortality % Mean corrected mortality Control 0.00 16.00 --- Test Item – T1 36 608.00 24.00 9.52 Reference item 23.65 (Dimethoate 9.0) 64.00 57.14

The Chi² 2x2 Table test revealed no statistically difference between the control and the treated group.

Reproduction: Table 2.3.2.2-2 Reproduction capacity at 14 days after exposure Groups g prod./ha Mean No. of eggs/female ± SD % R Control 0.00 9.28 0.80 --- Test item – T1 36 608.00 8.58 1.84 7.49

The STUDENT-t test for Homogeneous Variances revealed no statistically differences between the control and the treated group.

Validity criteria The test was considered valid because the following criteria were satisfied:  The arithmetic mean mortality of the control group (dead and escaped) is ≤ 20 % on day 7 AT (exact value: 16.00%);  The cumulative mean number of eggs per female of the control group (from day 7 to day 14) is ≥ 4 eggs/female (exact value: 9.28);  The cumulative mean mortality of the reference item group (control corrected) of protonymphs on day 7, at the application rate proposed, is in the range between 50% and 100% (exact value: 57.14%).

Conclusion The results showed that the test item FBR-1 did not cause statistically significant mortality on T. pyri when applied on natural substrate. The LR50 value after 7 days of exposure was greater than 36608 g product/ha. The NOEAR for mortality endpoint was 36608 g product/ha.

The female exposed to the test item and survived to the first phase of the trial did not show statistically significant reduction in reproductive capacity respect to the reproductive capacity of the surviving females of the control group. The ER50 was greater than 36608 g product/ha. The NOEAR for the reproduction was 36608 g product/ha. Page 53 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

A 2.3.2.4 KCP 10.3.2.3 Semi-field studies with non-target arthropods

A 2.3.2.5 KCP 10.3.2.4 Field studies with non-target arthropods

A 2.3.2.6 KCP 10.3.2.5 Other routes of exposure for non-target arthropods

A 2.4 KCP 10.4 Effects on non-target soil meso- and macrofauna

A 2.4.1 KCP 10.4.1 Earthworms

A 2.4.1.1 KCP 10.4.1.1 Earthworms - sub-lethal effects

Comments of zRMS: The study is acceptable. NOEC (Eisenia andrei)= 437.5 mg/kg dw ER10 = 790.83 mg/kg dw ER20 = 1397.63 mg/kg dw

Reference: KCP 10.4.1.1-01 Report Effects of the product FBR-01 on reproduction and growth of the earthworm Eisenia andrei in artificial soil, Francesco Pecorari (2016), Report No. BT129/15 Guideline(s): - OECD Guideline for the testing of chemicals N°222: “Earthworm, Repro- duction test (Eisenia foetida/Eisenia andrei)” adopted on 13 April 2004. - International Standard ISO 11268-2 "Soil quality - Effects of pollutants on earthworms - Part 2: Determination of effects on reproduction to Eisenia fetida/Eisenia andrei " (2012). Deviations: No GLP: Yes Acceptability: Yes Duplication Not relevant (if vertebrate study)

Materials and methods The effects of the test item FBR-01 (Batch N° 2015-0404) on reproduction of the earthworm Eisenia andrei were tested. The test item was applied into the soil at five concentrations (218.75, 437.50, 875.00, 1750.00 and 3500.00 mg of test item/kg of dry soil). Four replicates per treatment groups, each containing 10 earthworms, were tested. For the control group, there were eight replicates. After 4 weeks of exposure to the treated soil, the surviving earthworms were removed from the exposure cages, and weighed. 8 weeks after the treatments the reproduction performance was evaluated by the assessment of the number of juveniles produced.

Results and discussions

Page 54 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Behaviour data

The test item did not have effects on the behaviour of the exposed earthworms as demonstrated by the lack of changes in the normal behaviour.

Mortality data

Four week after treatment, the average adult mortality (%) per treatment group was evaluated. The results are summarized in the following table.

Table 2.4.1.1-1 Mortality of the earthworms after 4 weeks of exposure mg of test item/kg dry % Mean mortal- % Corrected mor- Treatments artificial soil ity tality Control 0.00 0.00 --- Test item – T1 218.75 0.00 0.00 Test item – T1 437.50 0.00 0.00 Test item – T1 875.00 0.00 0.00 Test item – T1 1750.00 0.00 0.00 Test item – T1 3500.00 0.00 0.00

The results showed that there was not mortality of the test system after exposure to artificial soil treated with the test item.

Biomass data

Four weeks after treatment, the average biomass change (%) per treatment group was evaluated by comparing the initial and the final weight of the adult earthworms. The results are summarized in the following table.

Table 2.4.1.1-2 % Mean increase in biomass of the exposed adults mg of test item/kg dry ar- % Mean increase Treatments ±SD Sig.* tificial soil in weight Control 0.00 5.89 4.77 Test item – T1 218.75 9.62 6.63 - Test item – T1 437.50 13.37 5.35 - Test item – T1 875.00 18.76 3.91 - Test item – T1 1750.00 15.54 3.81 - Test item – T1 3500.00 22.51 4.17 - * + : significant; - : non-significant (Williams Multiple Sequential t-test Procedure, ToxRat Pro 3.2.1)

The exposed earthworms showed a biomass increase if compared to the earthworms of the control group.

Reproductive output

At the end of the test (eight weeks after treatment), the average number of cocoons and/or juveniles per treatment group was calculated and the reduction in reproduction (in terms of % of the average number of the juveniles for each treatment group) was evaluated. The results are summarized in the following table.

Table 2.4.1.1-3 Reproduction performance mg of test Mean number Mean num- % reduction Treatments item/kg dry ar- of unhatched ber of juve- in reproduc- ±SD CV Sig.* tificial soil cocoon niles tion Page 55 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Control 0.00 0.00 98.38 --- 21.67 22.03 Test item – T1 218.75 0.00 95.25 3.18 13.72 14.40 - Test item – T1 437.50 0.00 110.75 -12.57 9.60 8.67 - Test item – T1 875.00 0.00 73.75 25.04 10.08 13.67 + Test item – T1 1750.00 0.00 80.75 17.92 15.71 19.46 + Test item – T1 3500.00 0.00 54.00 45.11 7.16 13.26 + * + : significant; - : non-significant (Williams Multiple Sequential t-test Procedure, ToxRat Pro 3.2.1)

At the end of the study, no cocoons unhatched were found in all the treatment groups. The reproductive capacity of the earthworms exposed to the test item treatments resulted statistically reduced at the higher concentrations (T3 – T4 and T5), if compared with the reproductive capacity of the earthworms of the control group.

Validity criteria According to the OECD Guideline N° 222, the test is valid because the following criteria were met in the control group:  Each replicate (containing 10 adults) had produced ≥ 30 juveniles by the end of the test (being 132, 112, 97, 80, 72, 116, 104 and 74 for the replicates a, b, c, d, e, f, g and h);  The coefficient of variation (% RSD or CV) of reproduction was ≤ 30% (being 22.03 %);  Adult mortality over the initial 4 weeks of the test was ≤ 10% (being 0 %).

Conclusion The results obtained in the trial showed that the test item FBR-01 did not cause, up to and including the concentration of 437.50 mg of test item./kg dry artificial soil, adverse effects to the treated earthworms.

Regarding the survival and the weight change of the adults, no adverse effects were found at the end of the test, so the LC50 and EC50 values are greater than 3500.00 mg of test item/kg of dry artificial soil. The NOEC value for the weight change endpoint is then 3500.00 mg of test item/kg of dry artificial soil.

Regarding the reproduction endpoint, a NOEC of 437.50 mg test item/kg dry artificial soil is derived from the results.

A 2.4.1.2 KCP 10.4.1.2 Earthworms - field studies

A 2.4.2 KCP 10.4.2 Effects on non-target soil meso- and macrofauna (other than earthworms)

A 2.4.2.1 KCP 10.4.2.1 Species level testing

A 2.4.2.2 KCP 10.4.2.2 Higher tier testing

A 2.5 KCP 10.5 Effects on soil nitrogen transformation

A 2.6 KCP 10.6 Effects on terrestrial non-target higher plants Page 56 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

A 2.6.1 KCP 10.6.1 Summary of screening data

Comments of zRMS: The study is acceptable. ER50/LR50 > 43000 g prod./ha

Reference: KCP 10.6.1-01 Report Effects of FBR-1 on terrestrial plants vegetative vigour limit test, Monica Colli (2016), Report No. BT150/15 Guideline(s): - OECD Guideline N°227. - EPPO Standard 2014 guideline PP1/135(4) - SANCO/10329/2002 rev. 2 guidance document Deviations: None GLP: Yes Acceptability: Yes Duplication Not relevant (if vertebrate study)

Materials and methods The potential adverse effects of the test item FBR-01 (Batch N° 2015-0404) on plants following deposition on the leaves and above-ground portions of plants was assessed. Following a range finding test, plants of six different species (four dicotyledonous and two monocotyledonous) were treated with a single application rate of 43 000 g product/ha. Plants were grown from seeds until 2-4 true leaves stage and the test item was sprayed on the plants and leave surface using a spray equipment calibrated to deliver an output of 400 L/ha (± 10%). Deionised water was used as control. The pots were then placed on a bench top in the greenhouse. The conditions of the test plants were assessed weekly after the application and, at the end of the test, 21 days after the treatment, the fresh shoot weight was measured. The EC50 on seedling emergence of the reference item Boric Acid is determined at least once a year in order to provide assurance that the test conditions are adequate and to verity that the responses of the test system does not statistically change over time.

Results and discussions

Mortality data

Table 2.6.2-1 Dicotyledonous mortality: % at the end of the test Treatment g prod./ha % Mortality Helianthus an- Cucumis sa- Brassica napus Pisum sativum nuus tivus Control 0.00 0.00 0.00 0.00 0.00 Test item – T1 43 000.00 0.00 0.00 0.00 0.00

No significant mortality was recorded during the test for each dicotyledonous species tested.

Table 2.6.2-2 Monocotyledonous mortality: % at the end of the test Treatment g prod./ha % Mortality Zea mais Allium cepa Control 0.00 0.00 0.00 Page 57 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Test item – T1 43 000.00 0.00 0.00

No significant mortality was recorded during the test for each monocotyledonous species tested.

Visual phytotoxicity

The phytotoxic effects (deformations, modifications in colour and necrosis) are reported in the following tables. The percentage of effects reflects the surface area affected.

Table 2.6.2-3 Dicotyledonous: % of phytotoxic effects % modifications in col- Species % necrosis % deformations our Brassica napus 0.00 0.00 0.00 Helianthus annuus 0.00 0.00 0.00 Cucumis sativus 0.00 0.00 0.00 Pisum sativum 0.00 0.00 0.00

Table 2.6.2-4 Monocotyledonous: % of phytotoxic effects % modifications in col- Species % necrosis % deformations our Zea mais 0.00 0.00 0.00 Allium cepa 0.00 0.00 0.00

No phytotoxic effects as deformations, necrosis or modification in colour were recorded during the test.

Final biomass

Table 2.6.2-5 Dicotyledonous: Effects on fresh shoot weight Helianthus an- Brassica napus Cucumis sativus Pisum sativum nuus Treatment g prod./ha Mean Mean Mean Mean weight % R weight % R weight % R weight % R g/pot g/pot g/pot g/pot Control 0.00 11.88 --- 23.29 --- 15.67 --- 7.25 --- Test item – 43 000.00 12.65 -6.51 23.06 1.00 15.22 2.87 7.23 0.36 T1 R= reduction in fresh shoot weight respect to the control

No statistically significant reduction in shoot fresh weight was observed at the end of the test for the dicotyledonous species.

Table 2.6.2-6 Monocotyledonous: Effects on fresh shoot weight Zea mais Allium cepa Mean Mean Treatment g prod./ha weight % R weight % R g/pot g/pot Control 0.00 19.65 --- 4.88 --- Test item – T1 43 000.00 20.66 -5.13 4.65 4.65

No statistically significant reduction in shoot fresh weight was observed at the end of the test for the monocotyledonous species. Page 58 /58 Template for chemical PPP Version April 2015 ZV1 008632-00/00 / FBR-1 Part B – Section 9 - Core Assessment zRMS version

Validity criteria According to the OECD Guideline N° 227, the test is valid because the following criteria were met:  The seedling emergence was at least 70% in control and treated groups

Table 2.6.2-7: % seedlings emergence before the start of the test Species N° sown seeds N° emerged plants % seedlings emergence Brassica napus 96 90 93.75 Helianthus annuus 96 94 97.92 Cucumis sativus 96 94 97.92 Pisum sativum 96 91 94.79 Zea mais 96 95 98.96 Allium cepa 96 91 94.79

 The plants did not exhibit visible phytotoxic effects (e.g. modification in colour, necrosis, leaf and stem deformations) and the plants exhibited only normal variation in growth and morphology for that particular species;  The mean plant survival was at least 90% at the end of the test (exact value 100% for each species);  Environmental conditions for particular species were identical and growing media contained the same amount of soil matrix, support media or substrate from the same source.

Conclusion The effects of FBR-1 on the vegetative vigour of terrestrial plants were assessed in a greenhouse test. Regarding the Dicotyledonous species, none of the treated species showed adverse effects on survival and on biomass (as fresh shoot weight): for all the Dicotyledonous species, the ER50/LR50 values were greater than 43000.00 g prod./ha and the NOER was 43000.00 g prod./ha. No phytotoxic effects as deformations, necrosis or modification in colour were recorded during the test. Regarding the Monocotyledonous species, none of the treated species showed adverse effects on survival and on biomass (as fresh shoot weight): for all the monocotyledonous species, the ER50/LR50 values were greater than 43000.00 g prod./ha and the NOER was 43000.00 g prod./ha. No phytotoxic effects as deformations, necrosis or modification in colour were recorded during the test.

A 2.6.2 KCP 10.6.2 Testing on non-target plants

A 2.6.3 KCP 10.6.3 Extended laboratory studies on non-target plants

A 2.6.4 KCP 10.6.4 Semi-field and field tests on non-target plants

A 2.7 KCP 10.7 Effects on other terrestrial organisms (flora and fauna)

A 2.8 KCP 10.8 Monitoring data REGISTRATION REPORT Part B Section 9 Ecotoxicology Detailed summary of the risk assessment

Product code: ZV1 008632-00/00 Product name: FBR-C; FBR-1 Chemical active substance: Potassium phosphonate 726 g/L (470.2 g/L phosphonic acid)

Central Zone Zonal Rapporteur Member State: Germany

National Addendum Germany (authorisation)

Applicant: Fitosanitarios Bajo Riesgo AIE Submission date: 29.07.2016 MS Finalisation date: November 2019 Page 2 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

Version history

When What

December 2018 First Draft RR by UBA November 2019 Revised draft RR by UBA

Page 3 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

Table of Contents

9 Ecotoxicology (KCP 10) ...... 5 9.1 Critical GAP and overall conclusions ...... 5 9.1.1 Overall conclusions ...... 8 9.1.1.1 Effects on birds (KCP 10.1.1), Effects on terrestrial vertebrates other than birds (KCP 10.1.2), Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3) ...... 8 9.1.1.2 Effects on aquatic organisms (KCP 10.2)Fehler! Textmarke nicht definiert. 9.1.1.3 Effects on bees (KCP 10.3.1) ...... 9 9.1.1.4 Effects on arthropods other than bees (KCP 10.3.2) ...... 9 9.1.1.5 Effects on non-target soil meso- and macrofauna (KCP 10.4), Effects on soil microbial activity (KCP 10.5) ...... 9 9.1.1.6 Effects on non-target terrestrial plants (KCP 10.6) ...... 10 9.1.1.7 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ...... 10 9.1.2 Grouping of intended uses for risk assessment ...... 10 9.1.3 Consideration of metabolites ...... 10 9.2 Effects on birds (KCP 10.1.1) ...... 10 9.2.1 Toxicity data ...... 10 9.2.2 Risk assessment for spray applications ...... 10 9.2.2.1 First-tier assessment (screening/generic focal species) ...... 10 9.2.2.2 Higher-tier risk assessment ...... 10 9.2.2.3 Drinking water exposure ...... 11 9.2.2.4 Effects of secondary poisoning ...... 11 9.2.2.5 Biomagnification in terrestrial food chains ...... 11 9.2.2.6 Birds - Indirect effects via trophic interactions ...... 11 9.2.3 Risk assessment for baits, pellets, granules, prills or treated seed ...... 12 9.2.4 Overall conclusions ...... 12 9.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2) ...... 13 9.3.1 Toxicity data ...... 13 9.3.2 Risk assessment for spray applications ...... 13 9.3.2.1 First-tier assessment (screening/generic focal species) ...... 13 9.3.2.2 Higher-tier risk assessment ...... 15 9.3.2.3 Drinking water exposure ...... 15 9.3.2.4 Effects of secondary poisoning ...... 15 9.3.2.5 Biomagnification in terrestrial food chains ...... 15 9.3.3 Risk assessment for baits, pellets, granules, prills or treated seed ...... 15 9.3.4 Overall conclusions ...... 15 9.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3) ...... 16 9.5 Effects on aquatic organisms (KCP 10.2) ...... 16 9.5.1 Toxicity data ...... 16 9.5.2 Risk assessment ...... 16 9.5.3 Overall conclusions ...... 18 9.6 Effects on bees (KCP 10.3.1) ...... 19 9.7 Effects on arthropods other than bees (KCP 10.3.2) ...... 19 9.7.1 Toxicity data ...... 19 9.7.2 Risk assessment ...... 19 9.7.2.1 Risk assessment for off-field exposure ...... 19 Page 4 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

9.7.2.2 Additional higher-tier risk assessment ...... 20 9.7.2.3 Risk mitigation measures ...... 20 9.7.3 Overall conclusions ...... 20 9.8 Effects on non-target soil meso- and macrofauna (KCP 10.4) ...... 21 9.8.1 Toxicity data ...... 21 9.8.2 Risk assessment ...... 21 9.8.2.1 First-tier risk assessment ...... 21 9.8.2.2 Higher-tier risk assessment ...... 22 9.8.3 Overall conclusions ...... 22 9.9 Effects on soil microbial activity (KCP 10.5) ...... 22 9.9.1 Toxicity data ...... 22 9.9.2 Risk assessment ...... 23 9.9.3 Overall conclusions ...... 23 9.10 Effects on non-target terrestrial plants (KCP 10.6) ...... 23 9.10.1 Toxicity data ...... 23 9.10.2 Risk assessment ...... 23 9.10.3 Overall conclusions ...... 23 9.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ...... 24 9.12 Monitoring data (KCP 10.8) ...... 24 9.13 Classification and Labelling ...... 24 9.13.1 GHS Classification and Labelling ...... 24 9.13.2 National labelling and conditions of use ...... 24

Appendix 1 Lists of data considered in support of the evaluation ...... 26

Appendix 2 Detailed evaluation of the new studies ...... 26

Page 5 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

9 Ecotoxicology (KCP 10)

9.1 Critical GAP and overall conclusions

Table 9.1-1: Table of critical GAPs

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 In- Member Crop and/or sit- F, Pests or Group of Application Application rate PHI Remarks: Conclusion

tended state(s) uation Fn, pests controlled (days) e.g. g saf- for (crop destination Fpn (additionally: develop- Method / Timing / Max. num- Min. inter- kg or L g or kg Water ener/ syner- uses / purpose of G, mental stages of the Kind Growth ber val between product/ha as/ha L/ha gist per ha

in crop) Gn, pest or pest group) stage of a) per use applications a) max. rate min/max Ger- Gpn crop & sea- b) per crop/ (days) per appl. a) max. rate many or son season b) max. total per appl. rate per b) max. total

I ** crop/season rate per arthropods -target plants -target

crop/season Mammals Birds organisms Aquatic Bees organisms Soil Non Non Intended for uses in Germany Page 6 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21

001 Germany grape vine F downy mildew of spraying or BBCH 15- a) 6 10 - 14 a) a) basic ap- XF This DE-use R1 Vitis vinifera L. grapevine fine 89 basic appli- basic appli- plication corresponds ssp. vinifera Plasmopara viticola spraying b) 6 cation rate: cation rate: rate: to or is part VITVI PLASVI (low volume in case of 1.0 L/ha 0.73 kg 400 of spraying) danger of BBCH 61: as/ha BBCH 61: EU/ZONAL- (use as table and infection 2.0 L/ha BBCH 61: 800 use no. 003 wine grape) and/or after BBCH71: 1.45 kg BBCH71: maximum warning 3.0 L/ha as/ha 1200 application service BBCH 75: BBCH71: BBCH 75: rate 18 L/ha appeal 4.0 L/ha 2.19 kg 1600 as/ha b) BBCH 75: 18.0 L/ha 2.90 kg as/ha

b) 13.07 kg as/ha

002 Germany grape vine F downy mildew of spraying or BBCH 15- a) 5 20 - 28 a) a) basic ap- XF This DE-use R1 Vitis vinifera L. grapevine fine spray- 89 basic appli- basic appli- plication corre-sponds ssp. vinifera Plasmopara viticola ing (low b) 6 cation rate: cation rate: rate: to or is part VITVI PLASVI volume 1.0 L/ha 0.73 kg 400 of in case of spraying) BBCH 61: as/ha BBCH 61: EU/ZONAL- danger of (use as table and 2.0 L/ha BBCH 61: 800 use no. 004 wine grape) infection BBCH71: 1.45 kg BBCH71: and/or after 3.0 L/ha as/ha 1200 warning ser- BBCH 75: BBCH71: BBCH 75: maximum vice appeal 4.0 L/ha 2.19 kg 1600 application as/ha rate 18 L/ha b) BBCH 75: 18.0 L/ha 2.90 kg as/ha

b) 13.07 kg as/ha

* Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 ** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application

Explanation for column 15 – 21 “Conclusion” A Acceptable, Safe use Page 7 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

R Further refinement and/or risk mitigation measures required C To be confirmed by cMS N No safe use

R1: Authorisation possible only in combination with the mandatory condition of use “provision of a field test with phosphonates on earthworm populations

Page 8 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

9.1.1 Overall conclusions

9.1.1.1 Effects on birds (KCP 10.1.1), Effects on terrestrial vertebrates other than birds (KCP 10.1.2), Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3)

Birds

Based on tier 1 assessment step, the calculated TER values for the acute risk resulting from an exposure of birds to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 achieve the acceptability criteria TER ≥ 10, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute effects. Based on tier 1 assessment step, the calculated TER values for the long-term risk resulting from an exposure of birds to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 do achieve the acceptability criteria TER ≥ 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for chronic effects. The results of the assessment indicate an acceptable acute and long-term risk for birds due to the intended use of FBR-1 in in vines according to the label.

Based on the assessment of the risk arising from the uptake of Potassium Phosphonates via drinking water, a TER calculation is not necessary. A low risk can be concluded since. The ratios of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) for birds were calculated, taking into account the relevant toxicity data for Potassium Phosphonates and calculated exposure levels for exposure via drinking water, according to the intended uses of the product FBR-1 in vines. The calculated ratios do not exceed 3000, which is the trigger in the case of more sorptive substances (Koc ≥ 500 L/kg). The results of the assessment indicate an acceptable risk for birds due to the intended use of FBR-1 in vines according to the label.

Terrestrial vertebrates other than birds

Based on screening assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of mammals to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 indicated a risk for herbivorous mammals. A first tier assessment has been performed based on the focal species bank vole. The calculated TER values for the acute and long-term risk resulting from an exposure of mammals to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 do achieve the refined acceptability criteria TER ≥ 5 resp. TER ≥ 2, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute and chronic effects, respectively. The results of the assessment indicate an acceptable acute and long-term risk for mammals due to the intended use of FBR-1 in vines according to the label.

Based on the assessment of the risk arising from the uptake of Potassium Phosphonates via drinking water, a TER calculation is not necessary. A low risk can be concluded since. The ratios of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) for mammals were calculated, taking into account the relevant toxicity data for Potassium Phosphonates and calculated exposure levels for exposure via drinking water, according to the intended uses of the product FBR-1 in vines. The calculated ratios do not exceed 3000, which is the trigger in the case of more sorptive substances (Koc ≥ 500 L/kg). The results of the assessment indicate an acceptable risk for mammals due to the intended use of FBR-1 in vines according to the label.

A risk assessment for exposure of birds and mammals via secondary poisoning is not required. No data submitted. Page 9 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

9.1.1.2 Effects on aquatic organisms (KCP 10.2)

9.1.1.3 Effects on bees (KCP 10.3.1)

Please refer to the core assessment Part B9.

9.1.1.4 Please refer to the core assessment Part B9.

9.1.1.5 Effects on arthropods other than bees (KCP 10.3.2)

Based on the calculated rates of Potassium Phosphonates/ FBR-1 in off-field areas, the calculated TER values describing the risk resulting from an exposure of non-target arthropods to Potassium Phosphonates / FBR-1 according to the GAP of the formulation FBR-1 achieve the acceptability criteria of TER ≥ 10 (Tier 1), according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for non-target arthropods due to the intended use of FBR-1 in vines according to the label.

9.1.1.6 Effects on non-target soil meso- and macrofauna (KCP 10.4), Effects on soil microbial activity (KCP 10.5)

Based on the chemical composition of the products Stamina (ZA 7207 Veriphos), Alginure Bio Schutz (ZA 7839), FBR-1 (ZA 8837, ZA 8838, ZA 8632), it can be expected that the chronic studies on earthworms represent the toxicity of the active ingredient Potassium Phosphonates, or rather phosphonic acid. The studies with Potassium Phosphonates conducted with Alginure Bio Schutz and FBR-1, however, indicate an acceptable risk for soil organisms. The study conducted with Stamina (Veriphos) indicates an unacceptable risk for soil organisms. Overall, it can be concluded that the risk is acceptable in the intended use grape vine if the remaining uncertainty is addressed in a field test with phosphonates on earthworm populations. The submission of the study is mandatory within 3 years after authorisation of the product in the intended uses.

Consequences for authorization: Authorisation possible only in combination with the mandatory condition of use “provision of a field test with phosphonates on earthworm populations”

Page 10 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

9.1.1.7 Effects on non-target terrestrial plants (KCP 10.6)

9.1.1.8 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)

No data submitted.

9.1.2 Grouping of intended uses for risk assessment

Please refer to the core assessment.

9.1.3 Consideration of metabolites

Please refer to the core assessment.

9.2 Effects on birds (KCP 10.1.1)

9.2.1 Toxicity data

Please refer to the core assessment.

9.2.2 Risk assessment for spray applications

9.2.2.1 First-tier assessment (screening/generic focal species)

Please refer to the core assessment.

9.2.2.2 Higher-tier risk assessment

Please refer to the core assessment. Page 11 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

9.2.2.3 Drinking water exposure

Please refer to the core assessment.

9.2.2.4 Effects of secondary poisoning

Please refer to the core assessment.

9.2.2.5 Biomagnification in terrestrial food chains

Not relevant.

9.2.2.6 Birds - Indirect effects via trophic interactions

According to Art. 4 (3) of the Commission Regulation (EC) No 1107/2009 the pre-requisite for the authorization of a PPP ist the absence of unacceptable effects on non-target organisms, the biodiversity, and the ecosystem. The regulation does not foresee a restriction of the assessment to direct effects only but also includes indi-rect effects. This view is also confirmed by the current data requirements (Annex to Commis- sion Regulation (EC) No 283/2013) which state that „the potential impact of the active substance on biodiversity and the ecosystem, including potential indirect effects via alteration of the food web, shall be considered“. The EFSA PPR Panel de-cision making criteria associate acceptability/unacceptability of effects with im-pacts/effects that could occur in the field “including the possibility for indirect effects at the food chain/community level (birds and other terrestrial vertebrates)” (EFSA PPR panel, 2010 ). Overall, the assessment of the impact of effects via alternation of the food web on the abundance and diversity of non- target organisms and the bio-diversity has to be considered as an integral part of the environmental risk assess-ment in the light of the current scientific and technical knowledge (see also article 29 (1) (e) and 36 (1) (1) of the Commission Regulation (EC) No 1107/2009). The general principles for the evaluation stated in the Commission Regulation (EU) No 546/2011) also point out that relevant technical or scientific information shall be evaluated by Member States “having regard to current scientific and technical knowledge” (see Part B 1.1 (b) in connection to Part A 2 (c)). This general require-ment for the risk assessment implies that indirect effects have to be considered in the product authorization even though they are not explicitly considered in the Spe-cific Principles of Evaluation and Decision Making. In this respect it is acknowl- edged that the specific provisions laid down in the Uniform Principles can never form a definitive list of criteria for evaluation and decision making. The zRMS considered the potential for a relevant impairment of the function of the in-field NTTP and in- field NTA in the food web as given if critical effect thresholds on the in-field communities of these groups have been exceeded due to direct effects of the plant protection product under consideration. For NTAs, we consider the critical effect thresholds to be exceeded if the harmonized EU risk assessment approach for in- field communities (see 9.7.2.1 NTA - Risk assessment for in-field expo-sure) indicates a high in-field risk (HQ ≥ 2 at Tier 1 or effects ≥ 50% at Tier 2). As there exists no guidance on the assessment of the risk for in-field NTTP communities so far the critical effect threshold to be considered for the NTTP assessment is ≥ 50% effects at the single field rate. The Tier 1 approach of the NTA in-field assessment is not applicable to NTTP as the HQ of 2 resulted from a calibration with NTA field studies and is therefore worthless as a possible acceptability criterion for the risk assessment for in-field NTTP communities. The focus on the toxicity data of the test species without using a correction or safety factor for the extrapolation to more sensitive species already acknowledges that species of in-field NTTP communities are less diverse. As pointed out by the EFSA PPR Panel resulting risks for upper levels of the food web due to effects on lower trophic levels depend on the magnitude of the effects and the time-scale of resulting impairment of the ecosystem service ´food web sup-port´ in the context of the agricultural landscape. Following the recent state of scientific knowledge as provided by the above mentioned Scientific Opinion of the EFSA PPR Panel the zRMS does not see any value in the consideration of field recovery studies, which usually can Page 12 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany only demonstrate recovery rates over a longer time scale than relevant for the protection of the food web functioning especially when considering that short times of food shortage might have a significant impact on chick survival for farmland birds.

Step 1: Assessment of the general potential for indirect effects via trophic interaction caused by effects on the primary producer level (in-field NTTP) and/ or the first (invertebrate) consumer level of the food web due to the use of FBR-1 in vines (uses 00-001 and 00-002).

To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use 00-001 also covers the risk for birds and mammals from all other intended uses (see 9.1.2).

The assessment of the in-field exposure and the risk for negative food web effects at the level of primary (invertebrate) consumers caused by impairment on the in-field NTA community completely follows the approach as described by the Terrestrial Guidance Document and used the submitted toxicity data in the context of the applied formulation in subchapter 9.7.2.1 (NTA - Risk assessment for in-field exposure). With respect to the risk for an interruption of the food web at the primary producer level (in-field NTTP) the zRMS refers to the toxicity data presented in 9.10.2 (NTTP - risk assessment) and the assessment approach used for the primary consumer level.

The assessment of direct effects on the primary producer level (in-field NTTP) and/ or the primary (invertebrate) consumer level of the food web due to the use of FBR-1 in vines (uses 00-001 and 00-002) indicates a low potential for indirect effects via trophic interaction.

Conclusion of zRMS: Based on the results of the assessment in step 1 and 2 the zRMS concludes that the FBR-1 containing Potassium Phosphonates demonstrates a low potential to cause unacceptable effects on biodiversity and the ecosystem via trophic interaction.

9.2.3 Risk assessment for baits, pellets, granules, prills or treated seed

Not relevant.

9.2.4 Overall conclusions

Dietary risk assessment

Based on tier 1 assessment step, the calculated TER values for the acute risk resulting from an exposure of birds to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 achieve the acceptability criteria TER ≥ 10, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute effects. Based on tier 1 assessment step, the calculated TER values for the long-term risk resulting from an exposure of birds to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 do achieve the acceptability criteria TER ≥ 5, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for chronic effects. The results of the assessment indicate an acceptable acute and long-term risk for birds due to the intended use of FBR-1 in in vines according to the label.

Risk assessment for exposure via drinking water

Based on the assessment of the risk arising from the uptake of Potassium Phosphonates via drinking water, a TER calculation is not necessary. A low risk can be concluded since. The ratios of effective application rate (in g/ha) to relevant endpoint (in mg/kg bw/d) for birds were calculated, taking into account the relevant toxicity data for Potassium Phosphonates and calculated exposure levels for exposure via drinking water, according to the intended uses of the product FBR-1 in vines. The calculated ratios do not exceed 3000, Page 13 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany which is the trigger in the case of more sorptive substances (Koc ≥ 500 L/kg). The results of the assessment indicate an acceptable risk for birds due to the intended use of FBR-1 in vines according to the label.

9.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2)

9.3.1 Toxicity data

Please refer to the core assessment.

9.3.2 Risk assessment for spray applications

The risk assessment is based on the methods presented in the Guidance Document on Risk Assessment for Mammals and Mammals on request from EFSA (EFSA Journal 2009; 7(12): 1438; hereafter referred to as EFSA/2009/1438). The risk assessment for terrestrial vertebrates other than birds for the intended uses of the product FBR-1 indicates an unacceptable acute and long-term risk for terrestrial vertebrates other than birds based on the screening and first tier risk assessment step for the active substance phosphonic acid.

Under specific conditions in Germany refined risk assessment on the acceptability criteria can be applied as follows:

Required level of protection

The specific ecological properties of voles in combination with a relatively low uncertainty regarding the extrapolation of toxicity values from test species to species in the wild allow for a reduction of the numerical TER acceptability criteria. Thus, a TER value ≥ 5 for acute effects and a TER value ≥ 2 for long-term reproductive effects are considered to indicate an acceptable risk for voles.1

To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use 001 also covers the risk for mammals from the intended use 002.

9.3.2.1 First-tier assessment (screening/generic focal species)

Table 9.3-1 First-tier assessment of the acute and long-term/reproductive risk for mammals due to the use of FBR-1 in Vineyard – Use 001

Intended use 001

Active substance/product Potassium phosphonates/FBR-1 Application rate (g/ha) 6 × 1881 (phosphonic acid equivalent*) Acute toxicity (mg/kg bw) 1736 (Phosphonic acid) TER criterion 5

1 Announcement BVL 10/02/14 in the Federal Gazette (Bundesanzeiger) Nr. 94. p. 2228 ff., 29.06.2010 Page 14 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

Application crop directed Small omnivorous mammal “mouse” 5.2 1.6 15.7 110.9 BBCH ≥ 40 Combination (invertebrates without interception) 25% weeds 50% weed seeds 25% ground arthropods Application crop directed Small herbivorous mammal "vole” 81.9 1.6 246.6 7.0 BBCH 10 - 19 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” 10.3 1.6 31.0 56.0 BBCH 10 - 19 Combination (invertebrates without interception) 25% weeds 50% weed seeds 25% ground arthropods Application crop directed Small herbivorous mammal "vole” 68.2 1.6 205.4 8.5 BBCH 20 - 39 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” 8.6 1.6 25.9 67.0 BBCH 20 - 39 Combination (invertebrates without interception) 25% weeds 50% weed seeds 25% ground arthropods BBCH ≥ 20 Small insectivorous mammal “shrew” 5.4 1.6 16.3 106.8 ground dwelling invertebrates with interception 100% ground arthropods BBCH ≥ 40 Large herbivorous mammal 8.1 1.6 24.4 71.2 “lagomorph” Non-grass herbs 100% Plant matter BBCH 10 - 19 Small insectivorous mammal “shrew” 7.6 1.6 22.9 75.9 ground dwelling invertebrates without interception 100% ground arthropods BBCH 10 - 19 Large herbivorous mammal 16.3 1.6 49.1 35.4 “lagomorph” Non-grass herbs 100% Plant matter BBCH 20 - 39 Large herbivorous mammal 13.6 1.6 41.0 42.4 “lagomorph” Non-grass herbs 100% Plant matter Reprod. toxicity (mg/kg bw/d) 302.9 (Phosphonic acid) TER criterion 2

Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Application crop directed Small herbivorous mammal "vole” 21.7 2.0 x 0.53 43.3 7.0 BBCH ≥ 40 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” 2.3 2.0 x 0.53 4.6 66.0 BBCH ≥ 40 Combination (invertebrates without interception) 25% weeds 50% weed seeds 25% ground arthropods Application crop directed Small herbivorous mammal "vole” 43.4 2.0 x 0.53 86.6 3.5 BBCH 10 - 19 Grass + cereals 100% grass Application crop directed Small omnivorous mammal “mouse” 4.7 2.0 x 0.53 9.4 32.3 BBCH 10 - 19 Combination (invertebrates without interception) 25% weeds 50% weed seeds 25% ground arthropods Application crop directed Small herbivorous mammal "vole” 36.1 2.0 x 0.53 72.0 4.2 BBCH 20 - 39 Grass + cereals 100% grass Page 15 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

Application crop directed Small omnivorous mammal “mouse” 3.9 2.0 x 0.53 7.8 38.9 BBCH 20 - 39 Combination (invertebrates without interception) 25% weeds 50% weed seeds 25% ground arthropods BBCH ≥ 20 Small insectivorous mammal “shrew” 1.9 2.0 x 0.53 3.8 79.9 ground dwelling invertebrates with interception 100% ground arthropods BBCH ≥ 40 Large herbivorous mammal 3.3 2.0 x 0.53 6.6 46.0 “lagomorph” Non-grass herbs 100% Plant matter BBCH 10 - 19 Small insectivorous mammal “shrew” 4.2 2.0 x 0.53 8.4 36.2 ground dwelling invertebrates without interception 100% ground arthropods BBCH 10 - 19 Large herbivorous mammal 6.7 2.0 x 0.53 13.4 22.7 “lagomorph” Non-grass herbs 100% Plant matter BBCH 20 - 39 Large herbivorous mammal 5.5 2.0 x 0.53 11.0 27.6 “lagomorph” Non-grass herbs 100% Plant matter SV: shortcut value; MAF: multiple application factor; TWA: time-weighted average factor; DDD: daily dietary dose; TER: toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger. * Please refer to Part C for detailed calculation on phosphonic acid equivalent

9.3.2.2 Higher-tier risk assessment

Not necessary.

9.3.2.3 Drinking water exposure

Please refer to the core assessment.

9.3.2.4 Effects of secondary poisoning

Please refer to the core assessment.

9.3.2.5 Biomagnification in terrestrial food chains

Not relevant.

9.3.3 Risk assessment for baits, pellets, granules, prills or treated seed

Not relevant.

9.3.4 Overall conclusions

Based on screening assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of mammals to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 indicated a risk for herbivorous mammals. A first tier assessment has been performed based on the focal species bank vole. The calculated TER values for the acute and long-term risk resulting Page 16 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany from an exposure of mammals to Potassium Phosphonates (oral exposure) according to the GAP of the formulation FBR-1 do achieve the refined acceptability criteria TER ≥ 5 resp. TER ≥ 2, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute and chronic effects, respectively. The results of the assessment indicate an acceptable acute and long-term risk for mammals due to the intended uses of FBR-1 in vines according to the label.

9.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3)

No data submitted.

9.5 Effects on aquatic organisms (KCP 10.2)

9.5.1 Toxicity data

Please refer to the core assessment.

9.5.2 Risk assessment

For authorization in Germany, exposure assessment of surface water considers the two routes of entry (i) spraydrift and volatilisation with subsequent deposition and (ii) run-off, drainage separately in order to allow risk mitigation measures separately for each entry route. Hence, aquatic risk assessment differs from those in the core assessment.

The calculation of concentrations in surface water is based on spray drift data by Rautmann and Ganzel- meier. No vapour pressure at 20 °C of the active substance phosphonic acid is available. As a worst case, a vapour pressure of < 10-5 Pa is therefore assumed and phosphonic acid is therefore classified as volatile (volatilisation from soil and plant surfaces). Hence, deposition following volatilization has been considered. The input parameters for Potassium Phosphonates are given in Section 8.9.2.

Table 9.5-1: Risk assessment for Potassium Phosphonates for aquatic organisms for the entry route via spraydrift and deposition following volatilization under the implementation of different risk mitigation measures Compound: phosphonic acid Crop/Application rate: “vines” 1 x 470 g/ha phosphonic acid 1 x 940 g/ha phosphonic acid 1 x 1411 g/ha phosphonic acid 3 x 1881 g/ha phosphonic acid Growth stage and season BBCH 15-89 Intended use group: 00-001 covering use 00-002

DT50 water (SFO): 1000 PEC-selection: actual Drift-Percentile: 74th Page 17 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

Buffer Entry via spray- Entry via deposi- PECsw; conventional and drift reducing technique zone drift tion following volatilization 0% conv. 50% red. 75% red. 90% red. [m] [%] [g/ha] [%] [µg/L] [µg /L] 3 6.41% 179 2.789% 17.4 196 Relevant toxicity endpoint: LC50 > 118000 µg a.i./L (Daphnia magna) Relevant TER: 100 Buffer zone [m] TER 3 602 - - - Risk mitigation measures None PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger.

Table 9.5-2: Risk assessment for Potassium Phosphonates for aquatic organisms for the entry route via run-off and drainage under the implementation of different risk mitigation measures Compound: Potassium Phosphonates Application rate: “vines” 1 x 726 g/ha potassium phosphonate (1 x 470 g/ha phosphonic acid) 1 x 1452 g/ha potassium phosphonate (1 x 940 g/ha phosphonic acid) 1 x 2178 g/ha potassium phosphonate (1 x 1411 g/ha phosphonic acid) 3 x 2904 g/ha potassium phosphonate (3 x 1881 g/ha phosphonic acid) Intended use 00-001 covering use 00-002

Relevant toxicity endpoint: LC50 > 118000 µg a.s./L (Daphnia magna)

Relevant TER: 100

Run-off Buffer zone PEC TER

[m] [µg/L] 0 17.17 > 6873 Drainage Time of application PEC TER

[µg/L] Autumn/winter/early spring 21.04 > 5608 Spring/summer 6.84 > 17000 Risk mitigation measures None PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger.

Table 9.5-3: Risk assessment for Phosphate ions for aquatic organisms for the entry route via run-off and drainage under the implementation of different risk mitigation measures Compound: Phosphate ions Application rate: “vines” 1 x 554 g/ha phosphate ions* 1 x 1109 g/ha phosphate ions* 1 x 1663 g/ha phosphate ions* 3 x 2217 g/ha g/ha phosphate ions* Page 18 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

Intended use 00-001 covering use 00-002

Relevant toxicity endpoint: 20 µg ortho-Phosphates/L

Relevant trigger value: 1

Run-off Buffer zone PEC PEC below trigger value (=1)?

[m] [µg/L] 0 20.24 0.99 Drainage Time of application PEC PEC below trigger value (=1)?

[µg/L] Autumn/winter/early spring 24.8 0.81 Spring/summer 8.06 2.48 Risk mitigation measures None (according to GAP no application from 1 Nov to 31 May) PEC: predicted environmenral concentration; Values in bold fall above the relevant trigger. * corrected with the molecular weight correction factor (80.5/94.9)

Table 9.5-4: Risk assessment for Phosphate ions for aquatic organisms for the entry route via run-off and drainage under the implementation of different risk mitigation measures Compound: Phosphate ions Application rate: “vines” 1 x 1109 g/ha phosphate ions* 4 x 2217 g/ha g/ha phosphate ions* Intended use 00-002

Relevant toxicity endpoint: 20 µg ortho-Phosphates/L

Relevant trigger value: 1

Run-off Buffer zone PEC PEC below trigger value (=1)?

[m] [µg/L] 0 18.8 1.1 Drainage Time of application PEC PEC below trigger value (=1)?

[µg/L] Autumn/winter/early spring 23.0 0.87 Spring/summer 7.49 2.67 Risk mitigation measures None (according to GAP no application from 1 Nov to 31 May) PEC: predicted environmenral concentration; Values in bold fall above the relevant trigger. * corrected with the molecular weight correction factor (80.5/94.9)

9.5.3 Overall conclusions

Based on the calculated concentrations of Potassium Phosphonates in surface water (EVA 3, EXPOSIT 3.0.1), the calculated TER values for the acute and long-term risk resulting from an exposure of aquatic Page 19 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany organisms to Potassium Phosphonates according to the GAP of the formulation FBR-1 achieve the acceptability criteria TER ≥ 10 and TER ≥ 100, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. for acute and long-term effects, respectively. The results of the assessment indicate an acceptable risk for aquatic organisms due to the intended use of FBR-1 in vines according to the label.

9.6 Effects on bees (KCP 10.3.1)

Please refer to the core assessment Part B9.

9.7 Effects on arthropods other than bees (KCP 10.3.2)

9.7.1 Toxicity data

Please refer to the core assessment.

9.7.2 Risk assessment

9.7.2.1 Risk assessment for off-field exposure

A risk assessment according to the recommendations of the “Guidance Document on Terrestrial Ecotoxi- cology” (SANCO/10329/2002) and in consideration of the recommendations of the guidance document ESCORT 2 is documented in the core assessment. For authorisation in Germany, a modified off-field risk assessment is relevant that takes into account the possible additional exposure route via volatilisation with subsequent deposition and addresses the availability of specific national risk mitigation measures.2 Exposure assessment Exposure levels of phosphonic acid in terrestrial off-field habitats due to spray drift and volatilisation with subsequent deposition are calculated using the model EVA3 (see chapter on effects on aquatic organisms for further explanations).

To extrapolate from exposure in a 2-dimensional toxicity test system to exposure in 3-dimensional field vegetation structures, a 2D/3D correction factor analogous to the ESCORT 2 ‘vegetation distribution factor’ (vdf) is applied in the risk assessment for national authorisations in Germany. This factor is derived from experimental data on spray drift deposits on meadows and hedgerows3 and recalculated quotients of theoretically expected vs. measured residues. While several quotients were found to be lower than the ES- CORT 2 vdf of 10, a 2D/3D correction factor of 5 was considered to appropriately define the required re- alistic worst case for a risk assessment.

2 Schulte et al., UWSF (5) 261-266 (1999), Bewertungskriterien des Umweltbundesamtes: Auswirkungen von Pflanzenschutzmitteln auf terrestrische Arthropoden. 3 Koch H, Weißer P and Landfried M (2003): Effect of drift potential on drift exposure in terrestrial habitats. Nachrichtenblatt Deut. Pflanzenschutzd., 55, 181-188. Page 20 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

Table 9.7-1: Assessment of the risk for non-target arthropods in off-field habitats due to the use of FBR-1 in vines

Active substance/product: Potassium Phosphonates Intended use: 00-001 covering use 00-002 (vines) Application parameters: 6 x 4 L/ha x 1407.9 g/L = 6 x 5631.6 g/ha FBR-1 Equivalent to 6 x 1881 g/ha phosphonic acid MAF: 4.6 soil Scenario, drift percentile: vines; 74. percentile 2D/3D correction factor: 5

Buffer Spray drift Deposition follow- PERoff-field; conventional and drift-reducing technique zone ing volatilisation 0 % red. 50 % red. 75 % red. 90 % red. (m) (%) (g/ha) (%) (g/ha) (g/ha) 3 6.41% 1654 -/- -/- 1654 -/- -/- -/- Endpoint (g/ha): 36608 (Typhlodromus pyri) TER acceptability criterion: 10

Buffer zone (m) TER 3 22.1 -/- -/- -/- Risk mitigation measures: none PER: predicted environmenral rate; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger

9.7.2.2 Additional higher-tier risk assessment

Not relevant.

9.7.2.3 Risk mitigation measures

No risk mitigation needed.

9.7.3 Overall conclusions

Based on the calculated rates of Potassium Phosphonates/ FBR-1 in off-field areas, the calculated TER values describing the risk resulting from an exposure of non-target arthropods to Potassium Phosphonates / FBR-1 according to the GAP of the formulation FBR-1 achieve the acceptability criteria of TER ≥ 10 (Tier 1), according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results of the assessment indicate an acceptable risk for non-target arthropods due to the intended use of FBR-1 in vines according to the label.

Page 21 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

9.8 Effects on non-target soil meso- and macrofauna (KCP 10.4)

9.8.1 Toxicity data

Please refer to the core assessment.

9.8.2 Risk assessment

9.8.2.1 First-tier risk assessment

Exposure assessment In the German exposure assessment, the considered soil layer depth is based on experimental data.4 Gen- erally, a soil layer depth of 2.5 cm is applied in the calculation for active substances with a Kf,oc <500, whereas a soil layer depth of 1 cm is applied for active substances with a Kf,oc >500. A soil bulk density of 1.5 g/cm³ is assumed as in the core assessment.

Table 9.8-1: First-tier assessment of the acute and chronic risk for earthworms and other non-target soil organisms (meso- and macrofauna) due to the use of FBR-1 in vines

Intended use 00-001 (vines) Acute effects on earthworms

Product/active substance LC50 PECsoil TERa (mg/kg dw) (mg/kg dw) (criterion TER ≥ 10) Potassium Phosphonates 1000 14.53 69 Chronic effects on earthworms

Product/active substance NOEC PECsoil TERlt (mg/kg dw) (mg/kg dw) (criterion TER ≥ 5) Potassium Phosphonates 62.5 14.53 4.3 52.1 (EC10) 3.6 FBR-1 437.5 38.69 11 TER values shown in bold fall below the relevant trigger.

4 Fent, Löffler, Kubiak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirkstoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ 360 03 018, UBA, Berlin 1999 Page 22 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

Table 9.8-2: First-tier assessment of the acute and chronic risk for earthworms and other non-target soil organisms (meso- and macrofauna) due to the use of FBR-1 in vines

Intended use 00-002 (vines) Acute effects on earthworms

Product/active substance LC50 PECsoil TERa (mg/kg dw) (mg/kg dw) (criterion TER ≥ 10) Potassium Phosphonates 1000 13.2 75 Chronic effects on earthworms

Product/active substance NOEC PECsoil TERlt (mg/kg dw) (mg/kg dw) (criterion TER ≥ 5) Potassium Phosphonates 62.5 13.2 4.7 52.1 3.9 FBR-1 437.5 35.07 12 TER values shown in bold fall below the relevant trigger.

9.8.2.2 Higher-tier risk assessment

Not relevant.

9.8.3 Overall conclusions

Based on the predicted concentrations of Potassium Phosphonates in soils, the TER values describing long- term risk for earthworms and other non-target soil organisms following exposure to Potassium Phospho- nates according to the GAP of the formulation FBR-1 do not achieve the acceptability criterion TER ≥ 5 according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2. The results of the assessment indicate an unacceptable risk for soil organisms due to the intended use of FBR-1 in vines according to the label. Based on the chemical composition of the products Stamina (ZA 7207 Veriphos), Alginure Bio Schutz (ZA 7839), FBR-1 (ZA 8837, ZA 8838, ZA 8632), it can be expected that the chronic studies on earthworms represent the toxicity of the active ingredient Potassium Phosphonates, or rather phosphonic acid. The studies with Potassium Phosphonates conducted with Alginure Bio Schutz and FBR-1, however, indicate an acceptable risk for soil organisms. The study conducted with Stamina (Veriphos) indicates an unacceptable risk for soil organisms. Overall, it can be concluded that the risk is acceptable in the intended use grape vine if the remaining uncertainty is addressed in a field test with phosphonates on earthworm populations. The submission of the study is mandatory within 3 years after authorisation of the product in the intended uses.

Consequences for authorization: Authorisation possible only in combination with the mandatory condition of use “provision of a field test with phosphonates on earthworm populations”

9.9 Effects on soil microbial activity (KCP 10.5)

9.9.1 Toxicity data

Please refer to the core assessment. Page 23 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

9.9.2 Risk assessment

Table 9.9-1: Assessment of the risk for effects on soil micro-organisms due to the use of FBR-1 in vines

Intended use 00-001 covering use 00-002 N-mineralisation

Product/active substance Max. conc. with effects PECsoil Risk acceptable? ≤ 25 % (mg/kg dw) (mg/kg dw) Potassium Phosphonates 26.99 (at 28 d) 13.2 yes C-mineralisation

Product/active substance Max. conc. with effects PECsoil Risk acceptable? ≤ 25 % (mg/kg dw) (mg/kg dw) Potassium Phosphonates 26.99 (at 28 d) 13.2 yes

9.9.3 Overall conclusions

9.10 Effects on non-target terrestrial plants (KCP 10.6)

9.10.1 Toxicity data

Please refer to the core assessment.

9.10.2 Risk assessment

Please refer to the core assessment.

9.10.3 Overall conclusions

9.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)

No data available.

9.12 Monitoring data (KCP 10.8)

No data available.

9.13 Classification and Labelling

The following labelling for the formulation FBR-1 is proposed in accordance with Directive 1999/45/EC:

Symbol(s)/Indication(s) of danger: None Risk phrases: None Safety phrases: SP001 To avoid riks to man and the environment, comply with the instructions for use. Specific labelling requirement: To avoid risks to man and the environment, comply with the instructions for use.

9.13.1 GHS Classification and Labelling

9.13.2 National labelling and conditions of use

All uses: Authorisation possible only in combination with the mandatory condition of use “provision of a field test with phosphonates on earthworm populations”. Page 25 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

Table 9.13-2 Labelling requirements according to § 36 (3) PflSchG

NW 642 "The product may not be applied in or in the immediate vicinity of surface or coastal waters. Irrespective of this, the minimum buffer zone from surface waters stipulated by state law must be observed. Violations may be punished by fines of up to 50 000 EUR."

Table 9.13-3 Mandatory conditions of use according to § 36 (1) PflSchG (use 00-001)

EB001-2 "SP1: Do not contaminate water with the product or its container (Do not clean application equipment near surface water./Avoid contamination via drains from farmyards and roads)." Page 26 /26 ZV1 008632-00/00 /FBR-1 Template for chemical PPP Part B – Section 9 - National Addendum Version April 2015 Germany

Appendix 1 Lists of data considered in support of the evaluation

Please refer to the main core assessment, Section 9.

Appendix 2 Detailed evaluation of the new studies

Please refer to the main core assessment, Section 9.