U 46 D Fluid Central Zone Zonal Rapporteur Member

REGISTRATION REPORT Part A Risk Management

Product code: CA2971 Product name: U 46 D Fluid Chemical active substance: 2,4-D 500 g/L (602 g/L as DMA salt)

Central Zone Zonal Rapporteur Member State: Germany

NATIONAL ASSESSMENT GERMANY (authorisation)

Applicant: Nufarm Deutschland GmbH Submission date: 19/12/2013 MS Finalisation date: 27/04/2017 U 46 D Fluid Page 2 /54 Part A - National Assessment Template for chemical PPP zRMS version Version 10/12/2015

Version history

When What

10/12/2015 Draft registration report provided for commenting.

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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 ...... 5 1.4 Data protection claims ...... 5

2 Details of the authorization decision ...... 5 2.1 Product identity ...... 5 2.2 Conclusion ...... 6 2.3 Substances of concern for national monitoring ...... 6 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) ...... 11

3 Background of authorization decision and risk management ...... 14 3.1 Physical and chemical properties (Part B, Section 2) ...... 14 3.2 Efficacy (Part B, Section 3) ...... 14 3.3 Efficacy data ...... 14 3.3.1 Information on the occurrence or possible occurrence of the development of resistance ...... 15 3.3.2 Adverse effects on treated crops ...... 15 3.3.3 Observations on other undesirable or unintended side-effects ...... 16 3.4 Methods of analysis (Part B, Section 5) ...... 16 3.4.1 Analytical method for the formulation ...... 16 3.4.2 Analytical methods for residues ...... 16 3.5 Mammalian toxicology (Part B, Section 6) ...... 16 3.5.1 Acute toxicity ...... 16 3.5.2 Operator exposure ...... 16 3.5.3 Worker exposure ...... 17 3.5.4 Bystander and resident exposure ...... 17 3.6 Residues and consumer exposure (Part B, Section 7) ...... 17 3.6.1 Residues ...... 17 3.6.2 Consumer exposure ...... 17 3.7 Environmental fate and behaviour (Part B, Section 8) ...... 18 3.7.1 Predicted environmental concentrations in soil (PECsoil) ...... 18 3.7.2 Predicted environmental concentrations in groundwater (PECgw) ...... 18 3.7.3 Predicted environmental concentrations in surface water (PECsw)...... 19 3.7.4 Predicted environmental concentrations in air (PECair) ...... 19 3.8 Ecotoxicology (Part B, Section 9) ...... 19 U 46 D Fluid Page 4 /54 Part A - National Assessment Template for chemical PPP zRMS version Version 10/12/2015

3.8.1 Effects on terrestrial vertebrates ...... 20 3.8.2 Effects on aquatic species ...... 20 3.8.3 Effects on bees ...... 21 3.8.4 Effects on other arthropod species other than bees ...... 21 3.8.5 Effects on soil organisms ...... 21 3.8.6 Effects on non-target terrestrial plants ...... 22 3.8.7 Effects on other terrestrial organisms (Flora and Fauna) ...... 22 3.9 Relevance of metabolites (Part B, Section 10) ...... 22

4 Conclusion of the national comparative assessment (Art. 50 of Regulation (EC) No 1107/2009) ...... 22

5 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorization ...... 22

Appendix 1 Copy of the product authorization (see Appendix 5) ...... 23

Appendix 2 Copy of the product label ...... 24

Appendix 3 Letter of Access ...... 25

Appendix 4 Lists of data considered for national authorization ...... 26

Appendix 5 Copy of the product authorization ...... Fehler! Textmarke nicht definiert.

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PART A RISK MANAGEMENT

1 Details of the application

1.1 Application background

This application was submitted by Nufarm Deutschland GmbH on 19 December 2013 in order to allow the re-registration of this product in Germany.

The product name Spritz-Hormin 500 has been changed during evaluation into U 46 D FLUID by the applicant.

The application is for re-approval of U 46 D FLUID containing 500 g/L 2,4-D. The product is intended to be used as herbicide to control dicotyledonous weeds in cereals and grassland.

While working on this application in Germany, the approval of the active substance 2,4-D was re- newed on 1 January 2016 by Commission Implementing Regulation (EU) 2015/2033 from 13 No- vember 2015. The conditions of renewal were checked for this product. This authorisation fulfils the conditions of renewal (2,4-D).

1.2 Letters of Access

Letter of access isn’t necessary. The applicant is a member of the 2, 4-D Task Force and has full access to the active ingredient data.

1.3 Justification for submission of tests and studies

Justification not submitted by the applicant.

1.4 Data protection claims

Where protection for data is being claimed for information supporting registration of U 46 D Fluid, it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B, sections 1 - 9 and Part C.

2 Details of the authorization decision

2.1 Product identity

Product code CA 2971 Product name in MS U 46 D Fliud

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Authorization number 034066-00 Function herbicide Applicant Nufarm Deutschland GmbH Active substance(s) 2,4 D 500 g/L, (incl. content) as dimethylamine salt 602 g/L Formulation type Soluble concentrate [Code: SL] Packaging 1 to 20 L HDPE bottle, 1 to 20 L PET bottle for professional users Coformulants of concern for none national authorizations Restrictions related to identiy none Mandatory tank mixtures none Recommended tank mixtures none

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.

Concerning analytical methods for residues an authorisation can be granted.

Regarding toxicology, residues and consumer protection an authorisation can be granted.

With respect to fate and ecotoxicology assessment, an authorisation can be granted for use 001 and 003. Considering an application in accordance with the evaluated use pattern and good agricultural practice as well as strict observance of the conditions of use no harmful effects on groundwater or adverse effects on the ecosystem are to be apprehended. For the use in spring cereals (use No. 00-002) the assessment indicated an unacceptable risk for aquatic organisms (exposure by surface runoff and drainage).

From the efficacy point of view, an authorisation can be granted to all uses applied for.

An authorisation can be granted except for use 002.

2.3 Substances of concern for national monitoring

None.

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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: Eye Dam. 1, Acute Tox. 4, Aquatic Chronic 1

The following labelling information is derived from the classification and to be mentioned in the safety data sheet. The information which is determined for the label is formatted bold:

Hazard pictograms: GHS05 corrosion GHS07 exclamation mark GHS09 environment Signal word: Danger Hazard statement(s): H302 Harmful if swallowed. H318 Causes serious eye damage. H400 Very toxic to aquatic life. H410 Very toxic to aquatic life with long lasting effects. Precautionary statement(s): P101 If medical advice is needed, have product container or label at hand. P102 Keep out of reach of children. P270 Do no eat, drink or smoke when using this product. P280 Wear protective gloves/protective clothing/eye protection/face protection. P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. P308+P310 IF exposed or concerned: Immediately call a POISON CENTER or a doctor/physician. P501 Dispose of contents/container to ... Additional labelling phrases: none

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: EUH 208-0193 Contains dimethylamine salt of 2,4-D . May produce an allergic reaction.

See Part C for justifications of the classification and labelling proposals.

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

None

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. SB110 The directive concerning requirements for personal protective gear in plant protection, "Personal protective gear for handling plant protection products" of the Federal Office of Consumer Protection and Food Safety must be observed. SE110 Wear tight fitting eye protection when handling the undiluted product. SS110 Wear standard protective gloves (plant protection) when handling the undiluted 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. SS2101 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when handling the undiluted product. Worker protection: SF245-01 Treated areas/crops may not be entered until the spray coating has dried. Integrated pest management (IPM)/sustainable use: WMHO Mode of action (HRAC-group): O 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) Environmental protection NW 468 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 respective code if no other national requirements available

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

Integrated pest management (IPM)/sustainable use:

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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.

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. WH9161 The instructions for use must include a summary of weeds use number 001 - which can be controlled well, less well and insufficiently by 003 the product, as well as a list of species and/or varieties showing which crops are tolerant of the intended application rate and which are not. WP777 Yield reduction possible in oats. use number 001, 002 WP7791 Yield reduction is possible in spring triticale. use number 002 WP7801 Yield reduction is possible in durum wheat. use number 001, 002 WP7802 Yield reduction is possible in spelt. use number 001 WW742 The product has no sustainable effect in perennial weeds. use number 003 Environmental protection: Relevant for use no. NW 605-1 When applying the product on areas adjacent to surface use number 002 and waters - except only occasionally but including periodically 003 water bearing surface waters - the product must be applied with equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 ('Bundesanzeiger' [Federal Gazette] No 205, p. 9780) as amended. Depending on the drift reduction classes for the equipment stated below, the following buffer zones must be kept from surface waters. In addition to the minimum buffer zone from surface waters stipulated by state law, the ban on application in or in the immediate vicinity of waters must be observed at all times for drift reduction classes marked with "*".Drift reduction by 90% * 75 % 5 m 50% 5 m NW 606 The only case in which the product may be applied without use number 002 and loss reducing equipment is when at least the buffer zone 003 stated below is kept from surface waters - except only occasionally but including periodically water bearing surface waters. Violations may be punished by fines of up to 50 000 Euro. Buffer zone of 10 m NW706 Between treated areas which have an incline of more than 2 use number 002 and % and surface waters - including periodically but excluding 003 occasionally water-bearing surface waters- there must be a buffer zone under complete plant cover. The buffer zone's

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protective function must not be impaired by the use of im- plements. It must be at least 20 m wide. This buffer zone 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 conservation or no-tillage methods. NW800 Application not allowed on drained surfaces between 1 No- use number 002 and vember and 15 March. 003 NT103 In a strip at least 20 m wide which is adjacent to other areas, use number 002 and the product must be applied using loss reducing equipment 003 which is registered in the index of 'Loss Reducing Equip- ment' of 14 October 1993 (Federal Gazette No 205, p. 9780) as amended, and be registered in at least drift reducing class 90 % (except agriculturally or horticulturally used areas, roads, paths and public places). Loss reducing equipment is not required if the product is applied with portable plant protection equipment or if adjacent areas (field boundaries, hedges, groups of woody plants) are less than 3 m wide or the product is applied in an area which has been declared by the Biologische Bundesanstalt in the "Index of regional pro- portions of ecotones" of 7 February 2002 (Federal Gazette no. 70 a of 13 April 2002), as amended, as agrarian landscape with a sufficient proportion of natural and semi- natural structures. Other specific restrictions: Relevant for use no. - - -

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2.6 Intended uses (only NATIONAL GAP)

GAP rev. 1, date: 2015-11-23 PPP (product name/code): Spritz-Hormin 500 Formulation type: SL (a, b) Active substance 1: 2,4 D Conc. of as 1: 500 g/L(c) Safener: - Conc. of safener: - (c) Synergist: - Conc. of synergist: - (c) Applicant: Nufarm Professional use: X Zone(s): central(d) Non professional use: Verified by MS: yes

Field of use: herbicide,

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 e.g. g safener/synergist (crop destination / G, (additionally: developmen- Kind stage of crop & a) per use between ha L/ha per ha purpose of crop) Gn, tal stages of the pest or season b) per crop/ applications a) max. rate per a) max. rate per (f) Gpn pest group) season (days) appl. appl. min / or b) max. total rate b) max. total rate max I per crop/season per crop/season Zonal uses (field or outdoor uses, certain types of protected crops)

001 DE Winter soft wheat F Dicotyledonous weeds Spraying After emergence a) 1 a) 1.5 L/ha a) 750 g as/ha 200 - 400 F* Use 001 of all GAPS TRZAW TTTDD Spring b) 1 b) 1.5 L/ha b) 750 g as/ha NT103, NW605-1, spelt BBCH 21 - 32 NW606, NW706, NW800 TRZSP WH9161, WP777, winter durum wheat WP7801, WP7802 TRZDW

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winter barley * The PHI is covered by HORVW the conditions of use and/or the vegetation winter rye period remaining be- SECCW tween the application of winter triticale the plant protection product and the use of TTLWI the product (e. g. har- winter oats vest) or the setting of a AVESW PHI in days is not required resp.

002 DE Spring soft wheat F Dicotyledonous weeds Spraying After emergence a) 1 a) 1.5 L/ha a) 750 g as/ha 200 - 400 F Use 002 of all GAPS TRZAS TTTDD Spring b) 1 b) 1.5 L/ha b) 750 g as/ha except for seed produc- spring durum wheat BBCH 11 - 32 tion TRZDS WH9161, WP777, WP7791, WP7801 spring barley No authorization - HORVS unacceptable risk for spring rye aquatic plants SECCS spring triticale TTLSO spring oat AVEFA

003 DE Grassland, pasture, F Buckhorn plantain Spraying during growing a) 1 a) 1.5 L/ha a) 750 g as/ha 200 - 400 14 Use 003 of all GAPS meadow Plantago lanceolata season (March to b) 1 b) 1.5 L/ha b) 750 g as/ha NT103, NW605-1, October) NNNFW PLALA NW606, NW706, BBCH 25 - 35 NW800 Dicotyledonous weeds WH9161, WP742 TTTDD

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.

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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 - XF*: The PHI is covered by the conditions of use and/or the vegetation period remaining be- type of equipment used must be indicated. tween the application of the plant protection product and the use of the product (e. g. harvest) or the setting of a PHI in days is not required resp. 14 Remarks may include: Extent of use/economic importance/restrictions

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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 brown liquid with an amine like odour. It is not explo-sive, has no oxidising properties, has no flash point up to 200 °C and no self ignition temperature up to 600 °C. In aqueous solution, it has a pH value around 7 at 20 °C. 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 has changed. The stability data indicate a shelf life of at least 2 years at ambient temperature when stored in HDPE. The technical characteristics are acceptable for a soluble concentrate formulation.

The intended concentration of use is 1.5 L or 2 L product in 100 to 400 L water which equals 0.38 % to 2.0 %.

According to the label the product can be mixed in the tank together with different formulations. No studies regarding the combination were submitted and the application as tank mixture cannot be evaluated.

3.2 Efficacy (Part B, Section 3)

Based on the data given and long-term experiences of herbicides containing the active 2,4-D, 2.0 L/ha U 46 D Fluid is sufficiently effective and can be considered as sufficiently safe in the uses applied for.

3.3 Efficacy data

The evaluation is based on data which have been submitted by earlier applications and additional field trials focussing on minimum effective dose and efficacy which were conducted in 2013. Due to the process of re-registration of U 46 D Fluid, the data set is limited. However, supported by the long-term experiences using 2,4-D in cereals, the zRMS considers that the data provided support the uses 1, 2 and 3. The data indicate different sensitivity of the herbicide U 46 D Fluid for the main target weed species. Thus, a label advice regarding the different sensitivity is proposed. The instructions for use should include a summary of weeds which can be controlled well, less well and insufficiently by the product, as well as a list of species and/or varieties showing which crops are tolerant of the intended application rate and which are not. Use 1: Winter cereals: Based on the data given and long-term experiences of herbicides containing the active 2,4-D, 1.5 L/ha U 46 D Fluid is sufficiently effective against some relevant weed species in winter cereals. The risk of crop damage is considered low for winter cereals. As it is well known that 2,4-D does not have any effect on grasses/grass crops as long it is applied not later than crop stage BBCH 32, existing crop safety data of winter wheat, winter barley and winter rye can be extrapolated to some extent. This is true for spelt (TRZSP), winter durum wheat (TRZDW), winter oat (AVESW) and winter triticale (TTL- WI). However, because of the limited data set, a label warning on possible phytotoxicity and yield reduction should be addressed to these crops which have not yet been registered in Germany (TRZSP, TRZDW and AVESW). Registration on these crops should be decided on national level.

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Use 2: Spring cereals: Based on the data given and long-term experiences of herbicides containing the active 2,4-D, 1.5 L/ha U 46 D Fluid is sufficiently effective against some relevant weed species in spring cereals. The effects on spring cereals are similar to the findings in winter cereals. The data provided indicate a risk for phytotoxicity of spring oat (AVESA). This may even lead to yield reduction. An appropriate warning regarding phytotoxicity and possibly yield reduction should be addressed on the label. Spring durum wheat (TRZDS), spring triticale (TTLSO) and spring oat (AVESA) have not been registered in Germany but are now intended. Concerning efficacy, an extrapolation of data appears possible. Regarding selectivity damage cannot be fully excluded due to the findings in oat and the limited data set. Thus, a label warning is proposed to avoid possible damage to the crop. Due to the limited data, authorisation of spring rye (SECCS), spring durum wheat (TRZDS), spring triticale (TTLSO) and spring oat (AVESA) should be decided on national level. Use 3: Grassland: Due to the applicants letter dated on 2016/07/15, the application rate of use 003 (Grassland, pasture, meadow) is reduced to 1.5 L/ha. Based on the data given, 1.5 L/ha U 46 D Fluid is sufficiently effective against PLALA. Adequate data to support more weeds than PLALA are missing.

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

The evaluation on herbicide resistance indicates a medium inherent and agronomic risk of resistance development for Spritz-Hormin 500 for use in cereals and a low risk for use in grassland. The applicant has not provided any information on the individual inherent and agronomic resistance risk within the different Member States in the Central zone.

3.3.2 Adverse effects on treated crops

Use 1: Winter cereals Only slight and transient phytotoxicity in winter wheat (TRZAW) was observed after the application of the target application rate of 1.5 L/ha. Because of the limited data set, a warning on possible phytotoxicity and yield reduction should be addressed to spelt (TRZSP), winter durum wheat (TRZDW) and winter oat (AVESW). Selectivity trials did not indicate any significant yield losses. However, submitted data are very limited for winter durum wheat (TRZDW) and winter oat (AVESW)

Use 2: Spring cereals Phytotoxicity was visible after the application of the target application rate of 1.5 L/ha. Oat (AVESA) showed stunting and curling of plants. No data are available for spring triticale (TTLSO) and spring durum wheat (TRZDS). A warning on possible phytotoxicity and yield reduction should be addressed to use 002 for spring triticale (TTLSO), oat (AVESA) and spring durum wheat (TRZDS). Data did not show yield reducing effects on spring barley and spring wheat but for spring oat, a yield loss of more than 15% was observed. This should be addressed on the label for use 002. For spelt (TRZSP), submitted data are very limited.

Use 3: Grassland Data did not indicate any negative effects for use in grassland (use 3), but no specific data or information concerning processing were provided. However, based on the long-term experience of 2,4-D products, the product is not expected to have any impact on the processing procedure of plants and plant products.

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3.3.3 Observations on other undesirable or unintended side-effects

Due to the short persistence for 2,4-D, the theoretical risk analysis based on PEC- and TER-calculation do not indicate a risk for succeeding crops. The test product is classified as non-hazardous to bees, even when the maximum application rate as stated for authorisation is applied. The test product is classified as not harmful for populations of relevant beneficial insects. The slight sublethal effects found on ground beetle Poecilus cupreus are not considered relevant, because no mortality was observed. The test product is classified as not harmful for populations of relevant beneficial predatory mites and spiders. The slight effects on predatory mite Typhlodromus pyri are not considered relevant here, because T. pyri is not a relevant antagonist in the proposed crop and spiders of the genus Pardosa were not affected.

3.4 Methods of analysis (Part B, Section 5)

3.4.1 Analytical method for the formulation

The active substance 2,4-D can be quantified in the formulation using the submitted analytical HPLC method. The method is sufficiently validated. No relevant impurities are defined for 2,4 D.

3.4.2 Analytical methods for residues

Adequate analytical methods are available to monitor all compounds given in the respective residue definition in food of plant and animal origin, soil, water and air. Analytical methods used to meet the requirements of the Annex to Regulation (EU) No 544/2011, Part A, point 4.2 can be also applied for the product. 2,4-D residues can be monitored in food of plant and animal origin, soil, water and air by LC-MS/MS. Methods for body fluids and tissues are not required since 2,4-D is not considered to be toxic or very toxic.

3.5 Mammalian toxicology (Part B, Section 6)

3.5.1 Acute toxicity

U 46 D Fluid, containing 500 g/L 2,4-D is toxic in respect to oral toxicity (H302). Its dermal and acute inhalation toxicity is low. It has no sensitizing properties. It is not irritating to skin but to eyes (H318).

3.5.2 Operator exposure

Operator exposure was assessed against the AOEL agreed in the EU review (2,4-D 0.15 mg/kg bw/d). Dermal absorption data of studies conducted with a different but comparable 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 U 46 D Fluid in cereals and grassland is acceptable with the use of personal protective equipment described in 2.5.1.

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3.5.3 Worker exposure

The worker exposure was estimated using the model “German model”. Even without any PPE the estimated consumption of AOEL was not higher than 2 %.

3.5.4 Bystander and resident exposure

The bystander and/or resident exposure estimations indicated that the acceptable operator exposure level (AOEL) for 2,4-D will not be exceeded under conditions of intended uses.

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

3.6.1 Residues

The data available are considered sufficient for risk assessment. The assessment of this application is based on the toxicological reference values and endpoints determined in the framework of the renewal of the active substance 2,4-D (EFSA Conclusion, 2014). This risk assessment does not lead to relevant differences compared to the assessment based on the review report for 2,4-D (2001). An exceedance of the MRLs set in Regulation (EC) No 396/2005 (last amendment Regulation (EC) No 1317/2013) for 2,4-D at 0.05 mg/kg in barley and oat and at 2 mg/kg in rye and wheat respectively is not expected. When comparing the level of the estimated maximum dietary burden to the results of the feeding study on lactating cows it appears that no exceedance of the MRLs laid down in Regulation (EC) No 396/2005 (last amendment Regulation (EU) No 1317/2013) for commodities of animal origin is to be anticipated.

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

2,4-D ADI: 0.05 mg/kg bw TMDI, EFSA PRIMo, 47 % WHO cluster diet

ARfD: 0.75 mg/kg bw IESTI, EFSA PRIMo, UK 4 % 4-6 years old children

The chronic and the short-term intake of 2,4-D residues are unlikely to present a public health concern.

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

The exposure assessment of the plant protection product U 46 D Fluid in its intended uses in spring and winter cereals and in grassland is documented in detail in the core assessment of the plant protection product U 46 D Fluid dated from August 2915 performed by zRMS Germany. Here the risk assessment for groundwater and the exposure assessment of surface water and soil for authorization of the plant protection product U 46 D Fluid in Germany is summarised according to uses listed in chapter 2.6 of this document. No new study on the fate and behaviour of 2,4-D or the formulation U 46 D Fluid has been performed. Hence no potentially new metabolites need to be considered. The risk assessment for the metabolite 2,4-DCP and 2,4-DCA has already been performed for EU approval (see EFSA Journal 2014;12(9):3812). They were regarded as having low risk to soil organisms (2,4 DCA) and aquatic organism (2,4-DCP and 2,4-DCA). Therefore no new risk assessment hence no exposure assessment for these metabolites is necessary.

The risk assessment for groundwater by direct leaching for the intended uses of the formulation U 46 D Fluid includes the soil metabolites of 2,4-D. Additionally, the soil metabolites of 2,4-D were also included in the groundwater risk assessment considering the entry path surface run-off and drainage with subsequent bank filtration. The reduction of application rate for use 00-003 from 1000 g/ha to 750 g/ha did not change the outcome of the risk assessment.

3.7.1 Predicted environmental concentrations in soil (PECsoil)

For the intended use of the formulation U 46 D Fluid in cereals and grassland according to use No 00-001 till 00-003 PECsoil was calculated for the active substance 2,4-D considering a soil depth of 2.5 cm. Due to the fast degradation of the active substance 2,4-D in soil the accumulation potential of 2,4-D was not considered.

Details are given in Part B National Addendum-Germany, Section8, chapter 8.6.

The results for PEC soil for the active substance and the metabolites were used for the eco-toxicological risk assessment.

3.7.2 Predicted environmental concentrations in groundwater (PECgw)

Results of modelling with FOCUS PELMO 5.5.3 as well as from the lysimeter study show that the active substance 2,4-D is not expected to penetrate into groundwater at concentrations of ≥ 0.1µg/L in the intended uses of U 46 D Fluid uses in cereals and grassland according to use No 00-001, 00-002 and 00- 003.

For the metabolites 2,4-DCP and 2,4-DCA concentrations of ≥ 0.1µg/L in groundwater can be excluded.

For details see Part B, National Addendum-Germany, Section 8, chapter 8.7.1.

According modelling with EXPOSIT 3.01, groundwater contamination at concentrations ≥ 0.1 µg/L by the active substance 2,4-D and its soil metabolites 2,4-DCP and 2,4-DCA due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration can be excluded.

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For details see Part B, National Addendum-Germany, Section 8, chapter 8.7.2.

3.7.3 Predicted environmental concentrations in surface water (PECsw)

For the intended use of the plant protection product U 46 D Fluid in cereals and grassland according to use No 00-001 till 00-003 PECsw was calculated for the active substance 2,4-D considering the two routes of entry (i) spraydrift and volatilization with subsequent deposition and (ii) run-off, drainage separately. The calculation of concentrations in surface water was based on spray drift data by Rautmann and Gan- zelmeier. The vapour pressure at 20 °C of the active substance 2,4-D is < 10-5 Pa. Hence the active substance 2,4-D is regarded as non-volatile. Therefore, exposure of surface water by the active substance 2,4-D due to deposition following volatilization was not considered. The concentrations of the active substance 2,4-D in adjacent ditch due to surface run-off and drainage were calculated using the model EXPOSIT 3.

PECsw- values used for risk assessment for the intended uses of U 46 D Fluid in Germany are documented in the national addendum of Germany, Part B, section 9, chapter 9.5. Details of the input parameters are given in Part B, National Addendum-Germany, Section 8, chapter 8.8.

The results for PEC surface water for the active substance and its metabolites were used for the ecotoxicological risk assessment.

3.7.4 Predicted environmental concentrations in air (PECair)

The vapour pressure at 20 °C of the active substance active substance 1 is < 10-5 Pa. Hence the active substance 2,4-D is regarded as non-volatile. Therefore, exposure of surface water or off-field environment by the active substance 2,4-D due to deposition following volatilization was not considered.

3.8 Ecotoxicology (Part B, Section 9)

A full risk assessment according to Uniform Principles for the plant protection product U 46 D Fluid in its intended uses in cereals and grassland is documented in detail in the core assessment of the plant protection product U 46 D Fluid by Germany. The intended use of U 46 D Fluid in Germany is generally covered by the uses evaluated in the course of the core assessment by Germany. The following chapters summarise specific risk assessment for non-target organisms and hence risk mitigation measures for the authorization of U 46 D Fluid in Germany according to its intended use in cereals and grassland (use No. 00-001 till 00-003).

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3.8.1 Effects on terrestrial vertebrates

The risk assessment for effects on birds and other terrestrial vertebrates was carried out according to the European Food Safety Authority Guidance Document on Risk Assessment for Birds and Mammals on request from EFSA (EFSA Journal 2009; 7(12): 1438).

Birds: Based on the presumptions of the Tier 1, the calculated TER values for the acute and long-term risk resulting from an exposure of birds to the active substance 2,4-D according to the intended use of the formulation U 46 D Fluid in cereals and on grassland achieve the acceptability criteria TER ≥ 10 and TER ≥ 5, respectively, 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 birds.

Mammals: Use No 00-001 and 00-002 (cereals) The risk assessment in the core assessment indicates an acceptable acute and long-term risk for mammals due to the intended use of U 46 D Fluid in cereals according to the label.

Use No 00-003 (grassland): Based on tier 1 (acute) and higher tier (long-term) assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of mammals to 2,4-D according to the GAP of the formulation U 46 D Fluid do not achieve the modified 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. However, after national higher tier risk assessment, a TER ≥ 2 in the long-term exposure scenario may be accepted as sufficient and acute and long-term risk for mammals due to the intended use of U 46 D Fluid on grassland (use No. 00-003) according to the label can be considered acceptable.

For details see Part B, National Addendum-Germany, Section 9, chapters 9.2 and 9.3.

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.

Exposure by spraydrift and deposition following volatilization Based on the calculated concentrations of 2,4-D in surface water (EVA), the calculated TER values for the acute and long-term risk resulting from an exposure of aquatic organisms to 2,4-D according to the GAP of the formulation U 46 D Fluid achieve the acceptability criteria TER ≥ 100 and TER ≥ 10, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. if appropriate risk mitigation measures (buffer strip or drift reducing technique) are applied. The results of the assessment indicate an acceptable risk for aquatic organisms due to the intended uses of U 46 D Fluid in cereals and in grassland according to the label.

For details see Part B, National Addendum-Germany, Section 9, chapters 9.5.2

Exposure by surface run-off and drainage

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The concentration of 2,4-D in adjacent ditch due to surface runoff and drainage was calculated using the model EXPOSIT.

The calculated TER values for the risk to aquatic organisms resulting from an exposure of surface water by 2,4-D due to run-off and drainage according to the use No 00-001 and 00-003 and due to drainage for use No 00-002 achieve the acceptability criteria of TER ≥ 100 or 10 respectively, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5. if appropriate risk mitigation (vegetated buffer strip and no application on drained fields in autumn and winter) are applied.

For the use in spring cereals (use No. 00-002) the calculated TER values for the risk to aquatic organisms resulting from an exposure of surface water by 2,4-D due to run-off do not achieve the acceptability criteria of TER ≥ 100 or 10 respectively, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5. The results of the assessment indicate an unacceptable risk for aquatic organisms due to the intended use of U 46 D Fluid in spring cereals (use No. 00-002) according to the label.

For details see Part B, National Addendum-Germany, Section 9, chapters 9.5.3.

3.8.3 Effects on bees

Due to the results of laboratory tests U 46 D Fluid (2,4-D 500 g/L) is considered to be practically non- toxic to bees. All hazard quotients are clearly below the trigger of 50, indicating that the intended use poses a low risk to bees in the field. Bee brood testing is not required since the test item is not an IGR.

It is concluded that U 46 D Fluid (2,4-D 500 g/L) will not adversely affect bees or bee colonies when used as recommended. The product is classified as non-hazardous to bees, even when the maximum application rate as stated for authorisation is applied.

3.8.4 Effects on other arthropod species other than bees

Based on the calculated rates of 2,4-D in off-field areas, the calculated HQ describing the risk resulting from an exposure of non-target arthropods to 2,4-D according to the GAP of the formulation U 46 D Flu- id achieve the acceptability criteria HQ ≤ 2 (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 U 46 D Fluid in grassland and cereals according to the label.

For details see Part B, National Addendum-Germany, Section 9, chapters 9.7.

3.8.5 Effects on soil organisms

U 46 D Fluid Page 22 /54 Part A - National Assessment Template for chemical PPP zRMS version Version 10/12/2015 ples, point 2.5.2. The results of the assessment indicate an acceptable risk for soil organisms due to the intended use of U 46 D Fluid in cereals and grassland according to the label.

For details see Part B, National Addendum-Germany, Section 9, chapters 9.8 and 9.9.

3.8.6 Effects on non-target terrestrial plants

Based on the predicted rates of 2,4-D in off-field areas, the TER values describing the risk for non-target plants following exposure to 2,4-D according to the GAP of the formulation U 46 D Fluid achieve the acceptability criteria TER ≥ 5 according to commission implementing regulation (EU) No 546/2011, An- nex, Part I C , 2. Specific principles, point 2.5.2 if appropriate risk mitigation measures are applied. The results of the assessment indicate an acceptable risk for non-target terrestrial plants due to the intended use of U 46 D Fluid according to the label.

For details see Part B, National Addendum-Germany, Section 9, chapters 9.10.

3.8.7 Effects on other terrestrial organisms (Flora and Fauna)

Not relevant

3.9 Relevance of metabolites (Part B, Section 10)

Not relevant, since no metabolites are expected in groundwater at concentrations ≥ 0.1 µg/L for the intended for uses of U 46 D Fluid in cereals and grassland according to use No. 00-001 till 00-003.

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

The active substance 2,4-D is not approved as a candidate of substitution, therefore 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

None

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Appendix 1 Copy of the product authorization

See below.

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Appendix 2 Copy of the product label

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 label has to fulfil the requirements according to Article 16 of Directive 91/414/EEC.

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Appendix 3 Letter of Access

Letter of access isn’t necessary. The applicant is a member of the 2, 4-D Task Force and has full access to the active ingredient data.

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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, 2 , 4 KCP 2.1 Mahmood, T. 2012 2,4-D DMA 500 g/l – Accelerated Storage Stability N NUF KCP 2.4 Nufarm UK Limited KCP 2.6 12/0711 KCP 2.7 GLP, unpublished KCP 2.7 2574843 KCP 2.8.2 KCP 2.8.4 KCP 2.2 Hutchinson, N. D. 2000 Theoretical Assessment of the Explosivity of Herboxone N NUF A H Marks & Company Limited 00/0108 GLP, unpublished Contains confidential information 2574853 KCP 2.2 Hale, M. 2003 Oxidising Properties of 2,4-D DMA Solutions N NUF A H Marks & Company Limited MH/03/2,4-D Not GLP, unpublished 2574851 KCP 2.3 Bass, R. V. 2000 Determination of the Flash Points of D DMA at 600 g l-1 AI, D N NUF DMA at 500 g l-1 AI and D 2EH at 600 g l-1 AI A H Marks & Company Limited 00/0110 GLP, unpublished 2574855 KCP 2.3 Merritt, M. 2000 To Determine the Auto-Ignition Temperature on a Sample of D N NUF DMA 500 g/l AI (Product Code U834A) Chilworth Laboratories, UK 172300 GLP, unpublished 2574861

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KCP 2.7 Ackroyd, C. 2001 Two Year Storage Stability of D DMA 500 g l-1 N A H Marks & Company Limited 99/0076 GLP, unpublished 2574863 Section B 3

KCP Warmers, C. 2008 2,4-D DMA salt (500 g acid/L) assessment of side effects N J Nufarm 10.3.2.1 on the egg parasitoid, trichogramma cacoeciae marchal (hymenoptera, trichogrammatidae) under laboratory conditions (dose response)

20071072/01-NLTc J/J N 2597233/346373 KCP Goßmann, A. 1997 Effects of Herbizid Marks D on the predatory mite N J AHM 10.3.2.1 Typhlodromus pyri Scheuten (Acari, Phytoseiidae) in the laboratory

2303063 J/O N 2597913/346376 KCP Schmitzer, S., 1997 Effects of Herbizid Marks D on the wolf spider pardosa N J GWE 10.3.2.1 Breitweiser, H. spec (aranae, lycosidae) in the laboratory

2304065 J/O N 2597922/346377

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KCP Goßmann, A. 1997 Effects of Herbizid Marks D on the reproduction of rove N J AHM 10.3.2.1 beetles Aleochara bilineata Gyll. Coleoptera, Staphylinidae) in the laboratory

2305070 J/O N 2597940/346378 KCP Moll, M. 1997 Effects of Herbizid Marks D on the carabid beetle Poecilus N J AHM 10.3.2.1 cupreus L. (Coleoptera, Carabidae) in the laboratory

2301006 J/O N 2597941/346379 KCP 3.8 Anonymous 2013 Vorläufiges Produktetikett zu Spritz-Hormin 500 N J Nufarm

O/O N 2582319/346370 KCP 4.2 Remnant, V. 2009 2,4-D DMA SL Determination of the efficiency of the N J Nufarm normal procedures used for cleaning spray tanks after use

NUF0417 J/O N 2574871/346356

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KCP Schönhammer, A., 2002 Antrag auf erneute Zulassung für das Pflanzenschutzmittel N J Nufarm Section 6 Gall, A. U 46 D-Fluid (BAS 140 01 H) Angaben zur Wirksamkeit gemäß Liste 4a

N/N N 2574954/346364 KCP Anonymous 2013 Biological Assessment Dossier Section 7: Efficacy Data N J Nufarm Section 6 and Information Detailed summary

N/J N 2575005/346365 KCP Anonymous 2013 Biological Assessment Dossier 2013-12-17-final N J Nufarm Section 6

O/O N 2807959/396449 KCP Anonymous 2015 Biological Assessment Dossier Appendix 5 N J Nufarm Section 6

Appendix 5 O/O N 2807960/396450 KCP Anonymous 2015 Biological Assessment Dossier Appendix 6 N J Nufarm Section 6

O/O N 2807961/396451

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KCP Anonymous 2015 Biological Assessment Dossier Appendix 7 Test facilities N J Nufarm Section 6 including GEP-certificates

O/O N 2807962/396452 KCP Anonymous 2015 Biological Assessment Dossier Appendix GEP- N J Nufarm Section 6 Bescheinigungen

O/O N 2807963/396453 KCP Anonymous 2015 Amendment to the Biological Assessment Dossier N J Nufarm Section 6 (6.1.4.3)

O/O N 2807965/396455 KCP Anonymous 2015 Amendment to the Biological Assessment Dossier N J Nufarm Section 6 (6.1.4.3)

O/O N 2807966/396456

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KCP 6.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds in N J Nufarm winter cereals

13 1047 1818 N/J N 2574679/346339 KCP 6.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds in N J Nufarm winter cereals

13 1069 5060 N/J N 2574687/346340 KCP 6.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds in N J Nufarm winter cereals

13 1069 5061 N/J N 2574697/346341 KCP 6.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds in N J Nufarm winter cereals

13 1061 1819 N/J N 2574708/346342

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KCP 6.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds in N J Nufarm winter cereals

13 1066 1820 N/J N 2574712/346343 KCP 6.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds in N J Nufarm spring cereals

13 1060 1898 N/J N 2574716/346344 KCP 6.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds in N J Nufarm spring cereals

13 1061 1899 N/J N 2574720/346345 KCP 6.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds in N J Nufarm spring cereals

13 1069 5098 N/J N 2574723/346346

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KCP 6.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds in N J Nufarm grassland

13 1047 1918 N/J N 2574736/346347 KCP 6.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds in N J Nufarm grassland

13 1047 1919 N/J N 2574814/346348 KCP 6.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds in N J Nufarm grassland

13 1047 1920 N/J N 2574818/346349 KCP 6.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds in N J Nufarm grassland

13 1069 5105 N/J N 2574819/346350

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KCP 6.2 Zickart, U. 2013 Efficacy of U 46 M-Fluid against dicotyledonous weeds in N J Nufarm grassland

13 1047 1921 N/J N 2582280/346366 KCP 6.2 Zickart, U. 2013 Efficacy of U 46 M-Fluid against dicotyledonous weeds in N J Nufarm grassland

13 1069 5106 N/J N 2582283/346367 KCP 6.2 Zickart, U. 2013 Efficacy of U 46 M-Fluid against dicotyledonous weeds in N J Nufarm grassland

13 1047 1922 N/J N 2582284/346368 KCP 6.2 Zickart, U. 2013 Efficacy of U 46 M-Fluid against dicotyledonous weeds in N J Nufarm grassland

13 1047 1923 N/J N 2582293/346369 KCP 6.2 Anonymous 2015 KIIIA1 6.1.2 Revised tables from dRR Part B Section 7 N J Nufarm

O/O N 2807964/396454

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KCP 6.4.2 Reh, P. 2003 AN EVALUATION OF SELECTIVITY OF SPRITZ- N J Nufarm HORMIN 500 TO PASTURE IN GERMANY 2002

VP02-4-23 O/J N 2807957/396447 KCP 6.4.2 Jullian, E. 2015 KIIIA1 6.1.4.3-3 Determination of Crop Safety of Various N J Nufarm 2,4-D Formulations in Grassland in NorthEast Zone, 4 sites, 2014

S14-01026-01 bis -04 O/J N 2807958/396448 KCP 6.5.1 Schmidt, O. 2002 BAS 140 01 H (U46 D-Fluid): Bioassay mit ausgewählten N J Nufarm Nachbaukulturen zur Ermittlung von EC10-(NOEL) und EC50-Werten für Wirkstoff im Boden

2002/1004425 N/J N 2574933/346363 KCP 6.5.2 Brockmann, A., 2011 Evaluation of the Phytotoxicity of LAF-74 (2,4-D N J Nufarm Teresiak, H. dimethylammonium 600 g ae/L SL), GLP Seedling Emergence and Seedling Growth Test Terrestrial Non Target Plants (based on OECD Guideline 208) - Europe 2011

101418 J/N N 2574867/346355

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KCP 6.5.2 Brockmann, A., 2011 Evaluation of the Phytotoxicity of LAF-74 (2,4-D N J Nufarm Teresiak, H. dimethylammonium 600 g ae/L SL), GLP Seedling Emergence and Seedling Growth Test Terrestrial Non Target Plants (based on OECD Guideline 208) - Europe 2011

101419 J/N N 2574900/346361

Section B 5 KCP 5.1.1 Mahmood, T. 2011 Validation of Analytical Method for the Determination of 2,4-D N Y NUF Content of 2,4-D DMA Formulations Nufarm UK Limited, 11/0632 GLP, unpublished 2574873 Section B 6 KCP 7.1.1 XXXXX 1997 Acute oral toxicity test in the rat Y N Nufarm 1095/001 Deutschland GmbH 23.07.1997 GLP: Y/GEP: N Published: N 2618698 KCP 7.1.2 XXXXX 1997 Acute dermal toxicity (limit test) in the rat Y N Nufarm 1095/002 Deutschland GmbH 23.07.1997 GLP: Y/GEP: N Published: N 2618704 KCP 7.1.3 XXXXX 1997 Acute inhalation toxicity (nose only) in the rat Y N Nufarm 1095/003 Deutschland GmbH 16.09.1997 GLP: Y/GEP: N Published: N 2618789

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KCP 7.1.4 XXXXX 1997 Acute dermal irritation test in the rabbit Y N Nufarm 1095/004 Deutschland GmbH 23.07.1997 GLP: Y/GEP: N Published: N 2618802 KCP 7.1.5 XXXXX 1997 Acute eyes irritation test in the rabbit Y N Nufarm 11095/005 Deutschland GmbH 23.07.1997 GLP: Y/GEP: N Published: N 2618813 KCP 7.1.6 XXXXX 1997 Buehler delayed contact hypersensitivity study in the guinea pig Y N Nufarm 1095/006 Deutschland GmbH 23.09.1997 GLP: Y/GEP: N Published: N 2618841 Section B 7 KIIA 6.3 Klimmek, S., Tanguy, 2012 Determination of residues of 2,4-D in pasture grass specimens N Y Nufarm M. after one application of 2,4-D DMA 600g a.i/L at 4 sites in Deutschland northern Europe 2010 GmbH S10-02108

14.02.2012 GLP: Y/GEP: N Published: N 2618921 KIIA 6.3 Pfarl, C. 1993 Residues of 2,4-D in grassland treated with 1.5 l and 2.3 l Spritz N N **AHM Hormin 600/ha and 2.0 l U 46 D-Fluid/ha [Hist.] R 92-02 ! 1156

01.05.1993 GLP: Y/GEP: N Published: N 2347891 Section B 8

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KCP 9.1. Schnitzler, F. 2012 Kinetic Modelling Analysis of the Degradation Behaviour N Nufarm of 2,4-Dichlorophenoxyacetic acid (2,4-D) and its Metabolites 2,4-DCP and 2,4-DCA in Laboratory Soil Degradation Studies under Aerobic Conditions Dr Knoell Consult Report number: 346402-1 Not GLP Unpublished KCP Budde 2012 Kinetic modelling analysis of the degradation behaviour of N Nufarm 9.2.4 2,4-Dichlorophenoxyacetic acid (2,4-D) and its metabolite 2,4-DCP in water-sediment studies Dr Knoell Consult 346402-1 Not GLP Unpublished KCP Simmons 2013 Calculation of Predicted Environmental Concentrations in N Nufarm 9.2.4 Groundwater (PECGW) and Surface Water (PECSW) of KCP the Active Substance 2,4-D and its Metabolites 2,4-DCP 9.2.5 and 2,4-DCA Following Application to Spring and Winter Cereals using FOCUS PELMO 5.5.3, EXPOSIT 3.0 Beta and EVA 2.1 Nufarm UK Ltd. NUF2013-48 Not GLP Unpublished KCP Simmons 2013 Calculation of Predicted Environmental Concentrations in N Nufarm 9.2.4 Groundwater (PECGW) and Surface Water (PECSW) of KCP the Active Substance 2,4-D and its Metabolites 2,4-DCP 9.2.5 and 2,4-DCA Following Application to Grassland using FOCUS PELMO 5.5.3, EXPOSIT 3.0 Beta and EVA 2.1 Nufarm UK Ltd. NUF2013-49 Not GLP Unpublished Section B 9

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KCP XXX 1997 Acute Toxicity of Herbizid Marks D to Rainbow Trout Y Nufarm 10.2.1 (Oncorhynchus mykiss) in a 96 hour static test XXX XXX 655918 GLP Not published KCP Memmert 1997 Acute Toxicity of Herbizid Marks D to Daphnia magna in N Nufarm 10.2.1 a 48-hour Immobilisation Test RCC Umweltchemie, Germany 655931 GLP Not published KCP Eckenstein 2013 2,4-D DMA 500 g/l (CA2971): Toxicity to N Nufarm 10.2.1 Pseudokirchnierealla subcapitata in a 72-hour algal growth inhibition test Harlan Laboratories Ltd, Switzerland D76268 GLP Not published KCP Irzyk, M. 2004 AMINOPIELIK STANDARD 600 SL: Toxicity for N Nufarm 10.3.1.1 honey-bees (Apis mellifera L.) B/06/04 GLP Unpublished KCP Goßmann 1997 Effects of Herbizid Marks D on the Predatory Mite N AHM 10.3.2.1 Typhlodromus pyri SCHEUTEN (Acari, Phytoseiidae) in the Laboratory IBACON GMBH, Germany 2303063 GLP Not published KCP Warners 2008 2,4-D DMA salt (500 g acid/L) Assessment of Side N Nufarm 10.3.2.1 Effects on the Egg Parasitoid, Trichogramma cacoeciae Marchal (Hymenoptera, Trichogrammatidae) under Laboratory Conditions (Dose Response) Eurofins, Germany 20071962/01-NLTc GLP Not published

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KCP Eckenstein 2013 Toxicity to the Aquatic Higher Plant Lemna gibba in a 7- N Nufarm 10.2.1 day Growth Inhibition Test Harlan Laboratories Ltd, Swtizerland D76270 GLP Not published

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 Justification if data protection is Owner Company Report No. brate protec- claimed Source (where different from company) study tion GLP or GEP status Y/N claimed Published or not Y/N Section B 1, 2, 4 ------Section B 3 ------Section B 5 KCP 5.2 Bendler, S. E. 2013 Independent laboratory validation of an analytical method for the N Y EUT determination of 2,4-D and its esters in crop matrices 130888 ! 205G585 GLP: Yes Published: No BVL-2588571, BVL-2588609, ASB2014-5640 KCP 5.2 Bendler, S. E. 2013 Independent laboratory validation of an analytical method for the N Y EUT determination of 2,4-D and its esters in bovine and poultry tissues 130889 ! 205G584 GLP: Yes Published: No BVL-2588573, BVL-2588611, ASB2014-5641 KCP 5.2 Gesell, J. T.; Li, Q. 2013 Method validation of the determination of residues of (2,4- N Y EUT Dichlorophenoxy)acetic acid and its esters and conjugates in agricultural commodities using liquid chromatography with tandem mass spectrometry detection 130886 GLP: Yes Published: No BVL-2588564, BVL-2588608, ASB2014-5638 KCP 5.2 Gesell, J. T.; Li, Q. 2013 Method validation of the determination of residues of (2,4- Di- N Y EUT chlorophenoxy)acetic acid and its esters in bovine and poultry matrices using liquid chromatography with tandem mass spec-

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Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protec- claimed Source (where different from company) study tion GLP or GEP status Y/N claimed Published or not Y/N trometry detection 130887 GLP: Yes Published: No BVL-2588572, BVL-2588610, ASB2014-5639 KCP 5.2 Gesell, J. T. 2012 Method validation study for the determination of residues (2,4- N Y EUT dichlorophenoxy) acetic Acid and its metabolites in soil 110503 GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2534439, BVL-2588505, ASB2013-8714 KCP 5.2 Garcia-Alix, M. 2012 Independent laboratory validation of an analytical method for the N Y EUT determination of (2,4-dichlorophenoxy) acetic Acid, 2,4- dichlorophenol, 4-chlorophenol and 2,4-dichloroanisole in water 110821 ! CEMS-5324 GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2534438, BVL-2588524, ASB2013-8716 KCP 5.2 Gesell, J. T. 2012 Method validation study for the determination of residues of (2,4- N Y EUT dichlorophenoxy) acetic Acid and its metabolites in surface water, ground water and drinking water 110504 GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2534437, BVL-2588506, ASB2013-8715 KCP 5.2 Class, T. 2011 2,4-D: Development and validation of an analytical method for N Y EUT the determination of 2,4-D in air 110026 ! P 2166 G GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2534409, BVL-2588507, ASB2013-9139 Section B 6 KCP XXXXX 2011 LOCAL LYMPH NODE ASSAY (LLNA) IN MICE WITH Y Y Nufarm 7.1.6 Chardol 600 SL (2,4-D DMA 600)REPORT Deutschland 1444300 GmbH

05.12.2011 GLP: Y/GEP: O Published: N 2807968 KCP 7.3 Hassler, S. 2011 2,4-D: Percutaneous penetration of C-2,4-D formulated as 600 N Y EU TASK SL through human splitthickness skin membranes (in vitro) FORCE 2,4-D D27163

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30.11.2011 GLP: Y/GEP: N Published: N 2618835 Section B 7 KCA Klimmek, S.; 2011 Determination of residues of 2,4-D in spring wheat after one N Y NUF 6.1.2 Tanguy, M. application of 2,4-D DMA 600 g/l and 2,4-D 2EHE 600 g/l at 4 sites in Northern Europe 2010 S10-02109 GLP: Yes Published: No BVL-2618893, ASB2013-9141 KCA 6.1 Barker, W. 1995 Determination of frozen storage stability for 2,4- N Y **AHM Dichlorophenoxy acetic acid (2,4-D) in/on crops [Hist.] EN-CAS # 93-0044

02.10.1995 GLP: Y/GEP: N Published: N 2347676 KCA 6.1 Rawle, N.W. 2002 Storage Stability of Residues of 2,4-DCP, 2,4-D, 2,4-DB and 2,4- N Y Nufarm DP-p in Cereal Whole Plant, Grain and Straw Deutschland CEMS-1397 ! AHM R 99 142 GmbH

04.07.2002 GLP: Y/GEP: O Published: N 2961565 KCA Feung, C.S., Loerch, 1978 Comparative metabolic fate of 2,4-Dichlorophenoxyacetic acid in N N LIT 6.2.1 S.L., Hamilton, R.H., plants and plant tissue culture Mumma, R.O. J. Agric. Food Chem. 01.01.1978 GLP: N/GEP: O Published: Y 2356226 KCA Puglis, J.M., Smith, 1992 Metabolism of uniformly ring labeled [14C] 2,4- N N Nufarm 6.2.1 G.A. Dichlorophenoxyacetic acid 2-Ethylhexyl ester in potatoes Deutschland

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29.07.1992 GLP: Y/GEP: N Published: N 2347903 KCA Puvanesarajah, V. 1992 Metabolism of Uniformly 14C-Ring Labeled 2,4 N N Nufarm 6.2.1 Dichlorophenoxyacetic Acid 2-Ethylhexyl Ester in Wheat Deutschland 38076 GmbH

08.08.1992 GLP: Y/GEP: N Published: N 2347906 KCA Puvanesarajah, V. 1992 Supplemental data for the study, "metabolism of uniformly 14C- N N Nufarm 6.2.1 ring labeled 2,4-Dichlorophenoxyacetic acid 2-Ethylhexyl ester Deutschland in wheat," EPA MRID No. 42439701 GmbH 38076-01

29.12.1992 GLP: Y/GEP: N Published: N 2347904 KCA Smith, G.A. 1991 Metabolism of 14C-(2,4-Dichlorophenoxy) acetic acid, N N **AHM 6.2.1 Dimethylamine salt in apples [Hist.] 38072

20.08.1991 GLP: Y/GEP: N Published: N 2347902 KCA XXXXX 1992 Metabolism of uniformly ring labeled [14C]2,4- Y N **AHM 6.2.2 Dichlorophenoxyacetic acid in poultry [Hist.] 38077

22.12.1992 GLP: Y/GEP: N Published: N

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Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protec- claimed Source (where different from company) study tion GLP or GEP status Y/N claimed Published or not Y/N 2348192 KCA XXXXX 1993 Metabolism of uniformly 14C-ring labeled 2,4- Y N DOW 6.2.3 dichlorophenoxyacetic acid in lactating goats. 40630

22.04.1993 GLP: Y/GEP: N Published: N 2345828 KCA 6.3 Buchta, A. 2006 Aminopielik 600 SL. Determination of active substance residues N Y EU TASK in corn, straw and soil FORCE 2,4-D C/01/05

01.04.2006 GLP: Y/GEP: N Published: N 2618946 KCA 6.3 Pfarl, C. 1993 Residues of 2,4-D in cereals treated with 1.1 l Spritz Hormin N N **AHM 600/ha and 1.5 U 46 D-Fluid/ha [Hist.] R 92-01 ! 1153

01.04.1993 GLP: Y/GEP: N Published: N 2347890 KCA 6.3 Pfarl, C. 1993 Residues of 2,4-D in cereals treated with 2.0 l Dicopur flüssig/ha N N **AHM R 92-18 ! 1169 [Hist.]

01.09.1993 GLP: Y/GEP: N Published: N 2347899 KCA 6.3 Pfarl, C. 1993 Residues of 2,4-D in cereals treated with 1.0 l Dicopur fluid/ha N N **AHM R 92-22! 1166 [Hist.]

01.09.1993 GLP: Y/GEP: N Published: N

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Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protec- claimed Source (where different from company) study tion GLP or GEP status Y/N claimed Published or not Y/N 2347889 KCA 6.3 Rozalski, K. 2008 Residues of 2,4-D and Dicamba after one application of N Y EU TASK Aminopielik D 450 SL in spring barley, one site in Poland 2007 FORCE 2,4-D 20074502/PL1-FPSH

18.12.2008 GLP: Y/GEP: N Published: N 2619101 KCA 6.3 Rozalski, K. 2008 Residues of 2,4-D and Dicamba after one application of N Y EU TASK Aminipielik D 450 SL in winter wheat, one site in Poland 2007 FORCE 2,4-D 20074502/PL1-FPWW

18.12.2008 GLP: Y/GEP: N Published: N 2619049 KCA 6.3 Rozalski, K. 2008 Residues of 2,4-D, Dicamba and Mecoprop after one application N Y EU TASK of Aminopielik Tercet 500 SL in spring barley, one site in Poland FORCE 2,4-D 2007 20074503/PL1-FPSH

18.12.2008 GLP: Y/GEP: N Published: N 2619105 KCA 6.3 Rozalski, K. 2008 Residues of 2,4-D, Dicamba and Mecoprop after one application N Y EU TASK of Aminopielik Tercet 500 SL in winter wheat, one site in Poland FORCE 2,4-D 2007 20074503/PL1-FPWW

18.12.2008 GLP: Y/GEP: N Published: N 2619074 KCA 6.3 Rozalski, K. 2009 Residues of 2,4-D and Dicamba after one application of N Y EU TASK Aminopielik D450 SL applied at two dose rates in spring barley FORCE 2,4-D and wheat, Poland 2008

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01.01.2009 GLP: Y/GEP: N Published: N 2619085 KCA 6.3 Zmijowska, A. 2007 Aminopielik D 450 SL determination of residues of 2,4-D and N Y EU TASK Dicamba in grain, straw and soil FORCE 2,4-D C/03/07

01.10.2007 GLP: Y/GEP: N Published: N 2619051 KCA 6.3 Zmijowska, A. 2007 AMINOPIELIK TERCET 500 SL DETERMINATION OF N Y EU TASK RESIDUESOF 2,4-D, MCPP AND DICAMBA IN GRAIN, FORCE 2,4-D STRAW AND SOIL C/04/07

01.11.2007 GLP: Y/GEP: N Published: N 2619075 KCA 6.3 Zmijowska, A. 2010 AMINOPIELIK D 450 SL DETERMINATION OF N Y EU TASK RESIDUESOF 2,4-D AND DICAMBA IN GRAIN, SOIL AND FORCE 2,4-D STRAW C/09/08

01.01.2010 GLP: Y/GEP: N Published: N 2619096 KCA 6.3 Zmijowska, A. 2010 AMENDMENT No 1 to the FINAL REPORT AMINOPIELIK D N Y EU TASK 450 SLDetermination of residues of 2,4-D and dicamba in grain, FORCE 2,4-D soil and straw C/03/07

01.01.2010

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Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protec- claimed Source (where different from company) study tion GLP or GEP status Y/N claimed Published or not Y/N GLP: Y/GEP: N Published: N 2619055 KCA 6.3 Zmijowska, A. 2010 AMENDMENT No 1 to the FINAL REPORT AMINOPIELIK D N Y EU TASK 450 SL Determination of residues of 2,4-D and dicamba in grain, FORCE 2,4-D straw and soil C/09/08

01.01.2010 GLP: Y/GEP: N Published: N 2619098 KCA XXXXX 1996 2,4-D: Magnitude of residues in meat and milk of lactating dairy Y N **AHM 6.4.2 cows [Hist.] XXXXX 886! XXXXX 1889

24.05.1996 GLP: Y/GEP: N Published: N 2347888 KCA 6.6 Pfarl, C. 1993 Residues of 2,4-D in grassland treated with 1.5 l and 2.3 l Spritz N N AHM Hormin 600/ha and 2.0 l U 46 D-Fluid/ha [residues for 2,4-D only] R 92-02 ! 1156 ! 1113 GLP: Open Published: Open BVL-2347891, RIP2003-466 Section B 8 ------Section B 9 KCP Goßmann 1997 Effects of Herbizid Marks D on the reproduction of Rove N AHM 10.3.2.1 Beetles Aleochara bilineata Gyll. (Coleoptera, Staphylinidae) in the Laboratory IBACON GMBH , Germany 2305070 GLP Not published KCP Moll 1997 Effects of Herbizid Marks D on the Carabid Beetle N AHM

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Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protec- claimed Source (where different from company) study tion GLP or GEP status Y/N claimed Published or not Y/N 10.3.2.1 Poecilus cupreus L. (Coleoptera, Carabidae) in the Laboratory IBACON GMBH , Germany 2301006 GLP Not published KCP Schmitzer S, 1997 Effects of Herbizid Marks D on the Wolf Spider Pardosa N GWE 10.3.2.1 Breitweiser H spec. (Araneae, Lycosidae) in the Laboratory IBACON GMBH, , Germany 2304065 GLP Not published KCP Gehring 2011 LAF-74: Assessment of the Side Effects of LAF-74 on the N Nufarm 10.5 Activity of the Soil Microflora Eurofins GmbH, Germany S10-03059 GLP Not published KCP Brockmann, A.; 2011 Evaluation of the phytotoxicity of LAF-74 (2,4-D N Nufarm 10.6.2 Teresiak, H. dimethylammonium 600 g ae/l, SL) GLP Vegetative Vigour Test Terrestrial Non Target Plants (based on OECD Guideline 227) –Europe 2011 Agro-Check (Dr. Teresiak & Erdmann GbR), Germany AC/DOW/11/04 (101419) GLP Not published KCP Brockmann, A.; 2011 Evaluation of the phytotoxicity of LAF-74 (2,4‑D N Nufarm 10.6.2 Teresiak, H. dimethylammonium 600 g ae/l, SL) GLP Seedling Emergence and Seedling Growth Test Terrestrial Non Target Plants. (Based on OECD Guideline 208) – Europe 2011 Agro-Check (Dr. Teresiak & Erdmann GbR), Germany AC/DOW/11/03 (101418) GLP

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Data point Author(s) Year Title Verte- Data Justification if data protection is Owner Company Report No. brate protec- claimed Source (where different from company) study tion GLP or GEP status Y/N claimed Published or not Y/N Not published KCP Dohmen; Kubitza 2003 Effect of BAS 140 01 H on the Growth of the Aquatic N Nufarm 10.2.1 Plant Myriophyllum aquaticum BASF Aktiengesellschaft, Germany 165337 (2001/1012045) GLP Not published KCA 8.5 Cyon 2004 KWAS 2,4-D Evaluation of the Toxic Effect on Microbial N Nufarm Activity – Influence on the Nitrogen and Carbon Transformation Process in Soil Department of Organic Industry, Branch Pszczyna, Poland G/16/03 GLP Not published

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, 2, 4 KCP 2.1 Hersey, R 1997 Determination of the Physical and Chemical Properties of 2,4-D N Y NUF KCP 2.4 Acid DMA Salt Solution at 500 g/l 2,4-D Acid Concentration KCP 2.4 A H Marks & Company Limited KCP 2.5 97/0012 KCP 2.5 GLP KCP 2.6 Not published KCP 2.7 2574834 KCP 2.8.2 KCP 2.8.4 KCP 4.2 Remnant, V. 2009 2,4-D DMA SL Determination of the Efficiency of the Normal N Y NUF Procedures used for Cleaning Spray Tanks after use Huntingdon Life Sciences Ltd, UK

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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 NUF0417 GLP, Not published 2574871 Section B 3 ------Section B 5 KCP 5.2 Bacher, R. 2011 2,4-D Acid: Independent laboratory validation of a multi-residue N Y EUT method for the determination of 2,4-D Acid in crop and animal matrices P 2168 G ! 110286 GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2534407, BVL-2588508, ASB2013-8713 KCP 5.2 Weber, H. 2011 Validation of a multi-residue method for the determination of N Y EUT 2,4-D Acid in crop matrices and animal tissues S11-02664 GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2534406, BVL-2588509, ASB2013-8712 KCP 5.2 Senciuc, M. 2011 2,4-D: development and validation of an analytical method for N Y EUT the determination of 2,4-D in body fluid(s) 110027 ! P 2167 G GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2534472, BVL-2588504, ASB2013-9140 KCA 4.3 Anon. 1989 Determination of 2,4-Dichlorophenoxyacetic acid (2,4-D) in feed N Y DOW 2184-117 GLP: Open Published: Open BVL-2343758, MET2003-123 KCA 4.3 Howard, J. 1996 Development and validation of analytical methodology for the N Y DOW quantitation of residues of 2,4-D-Dichlorophenoxyacetic Acid (2,4-D) in beef muscle, liver, kidney, fat and milk 1848 ! 912 GLP: Open Published: Open BVL-2343756, MET2000-360 KCA 4.3 Howards, J. 1996 Development, validation and radiovalidation of analytical meth- N Y DOW odology for the quantitation of residues of 2,4-D- Dichlorophenoxyacetic Acid (2,4-D) in poultry muscle, liver, fat and eggs 1874 ! 0027 GLP: Open Published: Open

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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 BVL-2343767, MET2000-359 KCA 4.3 James, J. W. 1994 Radiovalidation of EN-CAS Method ENC-2/93 for the determi- N Y DOW nation of 2,4-Dichlorphenoxy acetic acid (2,4-D) in/on wheat forage, straw and grain treated with [Phenyl(U)14C] 2,4- dichlorophenoxy acetic acid 93-0018 GLP: Open Published: Open BVL-2343926, MET2003-122 KCA 4.3 Ormand, J. R. 1992 Automated method for monitoring 2,4-Dichlorophenoxyacetic N Y DOW acid in laboratory rodent chow K-002372-063 GLP: Open Published: Open BVL-2343930, MET2003-125 KCA 4.7 Reichert, N. 1994 Development and validation of a method for the determination of N DOW 2,4-D, MCPA, Dichlorprop-P and Mecoprop-P in air 94/10505 ! 439705 GLP: Open Published: Open BVL-2343761, MET1999-814 Section B 6 KCP 7.1.3 XXXXX 2002 Acute inhalation toxicity study of test item 2,4-D technical active Y Y EU TASK ingredient in rats FORCE 2,4-D 01/644-004P

01.01.2002 GLP: Y/GEP: N Published: N 2618736 KCP 7.1.3 XXXXX 2007 2,4-D Acid Technical: Acute inhalation toxicity study (nose only) Y Y EU TASK in the rat FORCE 2,4-D 06/337-004P

05.03.2007 GLP: Y/GEP: N Published: N 2618762 KCP 7.1.6 XXXXX 2010 1st Amendment to report local lymph node assay (LLNA) in Y Y EU TASK mice FORCE 2,4-D 1368600

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20.12.2010 GLP: Y/GEP: N Published: N 2618821 KCP 7.1.6 Simmons, K. 2015 Nufam Statement N Y Nufarm Deutschland GmbH 06.03.2015 GLP: N/GEP: N Published: N 2807969 Section B 7 KCA 6.3 Hastings, M.; Brett, 1995 Residues of metosulam and 2,4-D in winter barley at harvest N N DOW R. following a single application of EF-1223 - Italy 1994 GHE-P-3922 k.A. 06.02.1995 GLP: Y/GEP: N Published: N 2348431 KCA 6.3 Hastings, M.; Brett, 1995 Residues of metosulam and 2,4-D in winter wheat at intervals N N DOW R. following application of EF-1223 - Italy 1994 GHE-P-3923 k.A. 08.02.1995 GLP: Y/GEP: N Published: N 2348430 KCA 6.3 Zmijowska, A. 2010 AMENDMENT No 1 to the FINAL REPORT AMINOPIELIK N Y EU TASK STANDARD 600 SL Determination of residues of active FORCE 2,4-D substance in corn,straw and soil C/01/05

01.01.2010 GLP: Y/GEP: N Published: N 2618954

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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 6.6 Pfarl, C. 1993 Residues of 2,4-D in cereals treated with 1.1 l Spritz Hormin N N AHM 600/ha and 1.5 U 46 D-Fluid/ha [residues for 2,4-D only] R 92-01 ! 1153 ! 1113 GLP: Open Published: Open BVL-2347890, RIP2003-464 KCA 6.6 Pfarl, C. 1993 Residues of 2,4-D in cereals treated with 2.0 l Dicopur flüssig/ha N N AHM [residues only for 2,4-D] R 92-18 ! 1169 ! 1113 GLP: Open Published: Open BVL-2347899, RIP2003-462 KCA 6.6 Pfarl, C. 1993 Residues of 2,4-D in cereals treated with 1.0 l Dicopur fluid/ha N N AHM [residues for 2,4-D only] R 92-22 ! 1166 ! 1113 GLP: Open Published: Open BVL-2347889, RIP2003-463 Section B 8 ------Section B 9 KCP Goßmann 1997 Effects of Herbizid Marks D on the reproduction of Rove N AHM 10.3.2.1 Beetles Aleochara bilineata Gyll. (Coleoptera, Staphylinidae) in the Laboratory IBACON GMBH , Germany 2305070 GLP Not published

List of data relied on and not submitted by the applicant but necessary for evaluation 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, 2, 4 ------

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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 3 ------Section B 5 ------Section B 6 ------Section B 7 ------Section B 8 ------Section B 9 ------

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dr. Dietmar Gottschild Dienstsitz Braunschweig • Postfach 15 64 • 38005 Braunschweig Referent

TELEFON +49 (0)531 299-3512 Nufarm Deutschland GmbH TELEFAX +49 (0)531 299-3002 Im MediaPark 4 e E-MAIL [email protected] 50670 Köln IHR ZEICHEN IHRE NACHRICHT VOM

AKTENZEICHEN 200.22100.034066-00/00.96930 (bitte bei Antwort angeben)

DATUM 27. April 2017

ZV1 034066-00/00 U 46 D Fluid Zulassungsverfahren für Pflanzenschutzmittel Bescheid

Das oben genannte Pflanzenschutzmittel

mit dem Wirkstoff: 500 g/l 2,4-D (als Dimethylamin-Salz 602 g/l)

Zulassungsnummer: 034066-00

Versuchsbezeichnungen: NUD-01903-H-1-SL

Antrag vom: 19. Dezember 2013

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 31. Dezember 2031.

Festgesetzte Anwendungsgebiete bzw. Anwendungen

Es werden folgende Anwendungsgebiete bzw. Anwendungen festgesetzt (siehe Anlage 1): BVL_FO_05_2437_200_V1.8

Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet: www.bvl.bund.de SEITE 2 VON 16

Anwendungs- Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck nummer Zweckbestimmung Objekte 034066-00/00-003 Spitz-Wegerich Wiesen, Weiden 034066-00/00-001 Zweikeimblättrige Winterweichweizen, Unkräuter Dinkel, Winterhartwei- zen, Wintergerste, Win- terroggen, Wintertriti- cale, Winterhafer

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: (NW468) Anwendungsflüssigkeiten und deren Reste, Mittel und dessen Reste, entleerte Behältnisse oder Packungen sowie Reinigungs- und Spülflüssigkeiten nicht in Gewässer gelangen las- sen. Dies gilt auch für indirekte Einträge über die Kanalisation, Hof- und Straßenabläufe sowie Regen- und Abwasserkanäle. Begründung: Der im o.g. Pflanzenschutzmittel enthaltene Wirkstoff 2,4-D weist aufgrund seiner Toxizität ein hohes Gefährdungspotenzial für aquatische Organismen auf. Jeder Eintrag von Rück- ständen in Oberflächengewässer, der den Eintrag als Folge der bestimmungsgemäßen und sachgerechten Anwendung des Mittels entsprechend der guten fachlichen Praxis übersteigt, würde daher zu einer Gefährdung des Naturhaushaltes aufgrund von nicht akzeptablen Aus- wirkungen auf Gewässerorganismen führen. Da ein erheblicher Anteil der in Oberflächenge- wässern nachzuweisenden Pflanzenschutzmittelfrachten auf Einträge aus kommunalen Klär- anlagen zurückzuführen ist, muss dieser Gefährdung durch die bußgeldbewehrte Anwen- dungsbestimmung durchsetzbar begegnet werden.

Siehe anwendungsbezogene Anwendungsbestimmungen in Anlage 1, jeweils unter Nr. 3.

Verpackungen

Gemäß § 36 Abs. 1 S. 2 Nr. 1 PflSchG sind für das Pflanzenschutzmittel die nachfolgend näher beschriebenen Verpackungen für den beruflichen Anwender zugelassen: BVL_FO_05_2437_200_V1.8 SEITE 3 VON 16

Verpackungs- Verpackungs- Anzahl Inhalt art material von bis von bis Einheit Flasche HDPE 1 1,00 20,00 l Flasche PET 1 1,00 20,00 l

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: (NW265) Das Mittel ist giftig für höhere Wasserpflanzen.

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

(SB110) Die Richtlinie für die Anforderungen an die persönliche Schutzausrüstung im Pflanzenschutz "Persönliche Schutzausrüstung beim Umgang mit Pflanzenschutzmitteln" des Bundesamtes für Verbraucherschutz und Lebensmittelsicherheit ist zu beachten.

(SE110) Dicht abschließende Schutzbrille tragen beim Umgang mit dem unverdünnten Mittel.

(SF245-01) Behandelte Flächen/Kulturen erst nach dem Abtrocknen des Spritzbelages wieder betreten.

(SS110) Universal-Schutzhandschuhe (Pflanzenschutz) tragen beim Umgang mit dem unverdünnten Mittel.

(SS206) Arbeitskleidung (wenn keine spezifische Schutzkleidung erforderlich ist) und festes Schuh- werk (z.B. Gummistiefel) tragen bei der Ausbringung/Handhabung von Pflanzenschutzmit- teln. BVL_FO_05_2437_200_V1.8 SEITE 4 VON 16

(SS2101) Schutzanzug gegen Pflanzenschutzmittel und festes Schuhwerk (z.B. Gummistiefel) tragen beim Umgang mit dem unverdünnten Mittel.

(WMO) Wirkungsmechanismus (HRAC-Gruppe): O

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 Wirk- stoff-namen zuzuordnen.

Vorbehalt

Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder Ergänzung von Anwendungsbestimmungen und Auflagen verbunden.

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

Signalwort: (S2) Gefahr

Gefahrenpiktogramme: (GHS05) Ätzwirkung (GHS07) Ausrufezeichen (GHS09) Umwelt

Gefahrenhinweise (H-Sätze): (H302) Gesundheitsschädlich bei Verschlucken.

(H318) Verursacht schwere Augenschäden.

(H400) Sehr giftig für Wasserorganismen. BVL_FO_05_2437_200_V1.8 SEITE 5 VON 16

(H410) Sehr giftig für Wasserorganismen mit langfristiger Wirkung.

(EUH 208-0193) Enthält 2,4-D Dimethylaminsalz. Kann allergische Reaktionen hervorrufen.

(EUH 401) Zur Vermeidung von Risiken für Mensch und Umwelt die Gebrauchsanleitung einhalten.

Sicherheitshinweise (P-Sätze): (P101) Ist ärztlicher Rat erforderlich, Verpackung oder Kennzeichnungsetikett bereithalten.

(P102) Darf nicht in die Hände von Kindern gelangen.

(P270) Bei Gebrauch nicht essen, trinken oder rauchen.

(P280) Schutzhandschuhe/Schutzkleidung/Augenschutz/Gesichtsschutz tragen.

(P305+P351+P338) BEI KONTAKT MIT DEN AUGEN: Einige Minuten lang behutsam mit Wasser spülen. Eventu- ell vorhandene Kontaktlinsen nach Möglichkeit entfernen. Weiter spülen.

(P308+P310) BEI Exposition oder falls betroffen: Sofort GIFTINFORMATIONSZENTRUM oder Arzt anru- fen.

(P501) Inhalt/Behälter ... zuführen. BVL_FO_05_2437_200_V1.8 SEITE 6 VON 16

Abgelehnte Anwendungsgebiete bzw. Anwendungen

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

Anwendungs- Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck nummer Zweckbestimmung Objekte 034066-00/00-002 Zweikeimblättrige Sommerweichweizen, Unkräuter Sommerhartweizen, Sommergerste, Som- merroggen, Sommertri- ticale, Sommerhafer

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 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_V1.8 SEITE 7 VON 16

Rechtsbehelfsbelehrung

Gegen diesen Bescheid kann innerhalb eines Monats nach Bekanntgabe Widerspruch erhoben werden. Der Widerspruch ist bei dem Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Messeweg 11/12, 38104 Braunschweig, schriftlich oder zur Niederschrift 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_V1.8 SEITE 8 VON 16

Anlage 1 zugelassene Anwendung: 034066-00/00-001 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Zweikeimblättrige Unkräuter Pflanzen/-erzeugnisse/Objekte: Winterweichweizen, Dinkel, Winterhartweizen, Win- tergerste, Winterroggen, Wintertriticale, Winterhafer Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

Einsatzgebiet: Ackerbau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Erläuterung zur Kultur: Ausgenommen zur Saatguterzeugung Stadium der Kultur: 21 bis 32 Anwendungszeitpunkt: Nach dem Auflaufen; Frühjahr Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 1 Anwendungstechnik: spritzen Aufwand: - 1,5 l/ha in 200 bis 400 l Wasser/ha

2.2 Sonstige Kennzeichnungsauflagen (WH9161) In die Gebrauchsanleitung ist eine Zusammenstellung der Unkräuter aufzunehmen, die durch die Anwendung des Mittels gut, weniger gut und nicht ausreichend bekämpft werden, sowie eine Arten- und/oder Sortenliste der Kulturpflanzen, für die der vorgesehene Mittelauf- wand verträglich oder unverträglich ist.

(WP777) Bei Hafer Ertragsminderung möglich.

(WP7801) Bei Hartweizen Ertragsminderung möglich.

(WP7802) Bei Dinkel Ertragsminderung möglich. BVL_FO_05_2437_200_V1.8 SEITE 9 VON 16

2.3 Wartezeiten (F) Freiland: Winterweichweizen Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

(F) Freiland: Dinkel Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

(F) Freiland: Winterhartweizen Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

(F) Freiland: Wintergerste Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

(F) Freiland: Winterroggen Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

(F) Freiland: Wintertriticale Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich. BVL_FO_05_2437_200_V1.8 SEITE 10 VON 16

(F) Freiland: Winterhafer Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich.

3 Anwendungsbezogene Anwendungsbestimmungen (NT103) Die Anwendung des Mittels muss in einer Breite von mindestens 20 m zu angrenzenden Flä- chen (ausgenommen landwirtschaftlich oder gärtnerisch genutzte Flächen, Straßen, Wege und Plätze) mit einem verlustmindernden Gerät erfolgen, das in das Verzeichnis "Verlustmin- dernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung, mindestens in die Abdriftminderungsklasse 90 % eingetragen ist. Bei der Anwendung des Mittels ist der Einsatz verlustmindernder Technik nicht erforderlich, wenn die Anwendung mit tragbaren Pflanzenschutzgeräten erfolgt oder angrenzende Flächen (z. B. Feldraine, Hecken, Gehölzinseln) weniger als 3 m breit sind oder die Anwendung des Mit- tels in einem Gebiet erfolgt, das von der Biologischen Bundesanstalt im "Verzeichnis der regionalisierten Kleinstrukturanteile" vom 7. Februar 2002 (Bundesanzeiger Nr. 70a vom 13. April 2002) in der jeweils geltenden Fassung, als Agrarlandschaft mit einem ausreichenden Anteil an Kleinstrukturen ausgewiesen worden ist. Begründung: Das o.g. Pflanzenschutzmittel bzw. der darin enthaltene Wirkstoff 2,4-D weist ein hohes Gefährdungspotenzial für terrestrische Nichtzielpflanzen auf. Bewertungsbestimmend ist hier die ER50 von 19,2 g a.s./ha für Lactuca sativa im Wachstumshemmtest. Ausgehend von den geltenden Modellen zur Abdrift und einem Sicherheitsfaktor von 5 ist nach dem Stand der wissenschaftlichen Erkenntnisse die o.g. Anwendungsbestimmung erforderlich, um einen ausreichenden Schutz von terrestrischen Nichtzielpflanzen in Saumbiotopen zu gewährleis- ten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registration Report zu entnehmen.

Gefährdungspotenzial für aquatische Organismen, insbesondere höhere Wasserpflanzen auf. Bewertungsbestimmend ist hier die EC50 für Myriophyllum aquaticum von 11 µg/L. Aus- gehend von den geltenden Modellen zur Abdrift und einem Sicherheitsfaktor von 10 ist nach dem Stand der wissenschaftlichen Erkenntnisse die o.g. Anwendungsbestimmung erforderlich, um einen ausreichenden Schutz von Gewässerorganismen zu gewährleisten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registration Report zu entnehmen.

(NW606) Ein Verzicht auf den Einsatz verlustmindernder Technik ist nur möglich, wenn bei der Anwen- dung des Mittels mindestens unten genannter Abstand zu Oberflächengewässern - ausgenommen nur gelegentlich wasserführende, aber einschließlich periodisch wasserführender Oberflächengewässer - eingehalten wird. Zuwiderhandlungen können mit einem Bußgeld bis zu einer Höhe von 50.000 Euro geahndet werden. 10 m Begründung: Siehe NW605-1.

(NW706) 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 20 m haben. Dieser Randstrei- fen ist nicht erforderlich, wenn: - ausreichende Auffangsysteme für das abgeschwemmte Wasser bzw. den abgeschwemm- ten Boden vorhanden sind, die nicht in ein Oberflächengewässer münden, bzw. mit der Kanalisation verbunden sind oder - die Anwendung im Mulch- oder Direktsaatverfahren erfolgt. Begründung: Der im o.g. Pflanzenschutzmittel enthaltene Wirkstoff 2,4-D weist ein hohes Gefährdungspo- tenzial für aquatische Organismen, insbesondere höhere Wasserpflanzen auf. Bewertungs- bestimmend ist hier die EC50 für Myriophyllum aquaticum von 11 µg/L. Ausgehend von einem Datensatz charakteristischer Eigenschaften des Wirkstoffs (Wasserlöslichkeit = 24300 mg/L; DT50 Boden = 42,3 d; KOC = 25), einer Berechnung der über den Pfad Oberflächen- abfluss (Run-off) zu erwartenden Einträge mit dem Modell Exposit 3.01 und einem Sicher- heitsfaktor von 10 ist nach dem Stand der wissenschaftlichen Erkenntnisse die o.g. Anwen- dungsbestimmung erforderlich, um einen ausreichenden Schutz von Gewässerorganismen zu gewährleisten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registration Report zu entnehmen.

tenzial für aquatische Organismen, insbesondere höhere Wasserpflanzen auf. Bewertungs- bestimmend ist hier die EC50 für Myriophyllum aquaticum von 11 µg/L. Ausgehend von einem Datensatz charakteristischer Eigenschaften des Wirkstoffs (Wasserlöslichkeit = 24300 mg/L; DT50 Boden = 42,3 d; KOC = 25), einer Berechnung der über den Pfad Drainage zu erwartenden Einträge mit dem Modell Exposit 3.01 und einem Sicherheitsfaktor von 10 ist nach dem Stand der wissenschaftlichen Erkenntnisse die o.g. Anwendungsbestimmung erforderlich, um einen ausreichenden Schutz von Gewässerorganismen zu gewährleisten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registra- tion Report zu entnehmen. BVL_FO_05_2437_200_V1.8 SEITE 13 VON 16

Anlage 1 zugelassene Anwendung: 034066-00/00-003 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Spitz-Wegerich Pflanzen/-erzeugnisse/Objekte: Wiesen, Weiden Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

Einsatzgebiet: Grünland Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: 25 bis 35 Anwendungszeitpunkt: Während der Vegetationsperiode (März bis Oktober) Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 1 Anwendungstechnik: spritzen Aufwand: - 1,5 l/ha in 200 bis 400 l Wasser/ha

(WW742) Das Mittel besitzt keine nachhaltige Wirkung gegen ausdauernde Unkräuter.

2.3 Wartezeiten 14 Tage Freiland: Wiesen, Weiden

tenden Fassung, mindestens in die Abdriftminderungsklasse 90 % eingetragen ist. Bei der Anwendung des Mittels ist der Einsatz verlustmindernder Technik nicht erforderlich, wenn die Anwendung mit tragbaren Pflanzenschutzgeräten erfolgt oder angrenzende Flächen (z. B. Feldraine, Hecken, Gehölzinseln) weniger als 3 m breit sind oder die Anwendung des Mit- tels in einem Gebiet erfolgt, das von der Biologischen Bundesanstalt im "Verzeichnis der regionalisierten Kleinstrukturanteile" vom 7. Februar 2002 (Bundesanzeiger Nr. 70a vom 13. April 2002) in der jeweils geltenden Fassung, als Agrarlandschaft mit einem ausreichenden Anteil an Kleinstrukturen ausgewiesen worden ist. Begründung: Das o.g. Pflanzenschutzmittel bzw. der darin enthaltene Wirkstoff 2,4-D weist ein hohes Gefährdungspotenzial für terrestrische Nichtzielpflanzen auf. Bewertungsbestimmend ist hier die ER50 von 19,2 g a.s./ha für Lactuca sativa im Wachstumshemmtest. Ausgehend von den geltenden Modellen zur Abdrift und einem Sicherheitsfaktor von 5 ist nach dem Stand der wissenschaftlichen Erkenntnisse die o.g. Anwendungsbestimmung erforderlich, um einen ausreichenden Schutz von terrestrischen Nichtzielpflanzen in Saumbiotopen zu gewährleis- ten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registration Report zu entnehmen.

(NW605-1) Die Anwendung des Mittels auf Flächen in Nachbarschaft von Oberflächengewässern - ausgenommen nur gelegentlich wasserführende, aber einschließlich periodisch wasserführender Oberflächengewässer - muss mit einem Gerät erfolgen, das in das Verzeichnis "Verlustmin- dernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung eingetragen ist. Dabei sind, in Abhängigkeit von den unten aufgeführten Abdriftminderungsklassen der verwendeten Geräte, die im Folgenden genannten Abstände zu Oberflächengewässern einzuhalten. Für die mit "*" gekennzeichneten Abdriftminderungs- klassen ist, neben dem gemäß Länderrecht verbindlich vorgegebenen Mindestabstand zu Oberflächengewässern, das Verbot der Anwendung in oder unmittelbar an Gewässern in jedem Fall zu beachten. reduzierte Abstände: 50 % 5 m, 75 % 5 m, 90 % * Begründung: Das o.g. Pflanzenschutzmittel bzw. der darin enthaltene Wirkstoff 2,4-D weist ein hohes Gefährdungspotenzial für aquatische Organismen, insbesondere höhere Wasserpflanzen auf. Bewertungsbestimmend ist hier die EC50 für Myriophyllum aquaticum von 11 µg/L. Aus- gehend von den geltenden Modellen zur Abdrift und einem Sicherheitsfaktor von 10 ist nach dem Stand der wissenschaftlichen Erkenntnisse die o.g. Anwendungsbestimmung erforderlich, um einen ausreichenden Schutz von Gewässerorganismen zu gewährleisten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registration Report zu entnehmen.

zu einer Höhe von 50.000 Euro geahndet werden. 10 m Begründung: Siehe NW605-1.

(NW800) Keine Anwendung auf gedrainten Flächen zwischen dem 01. November und dem 15. März. Begründung: Der im o.g. Pflanzenschutzmittel enthaltene Wirkstoff 2,4-D weist ein hohes Gefährdungspo- tenzial für aquatische Organismen, insbesondere höhere Wasserpflanzen auf. Bewertungs- bestimmend ist hier die EC50 für Myriophyllum aquaticum von 11 µg/L. Ausgehend von einem Datensatz charakteristischer Eigenschaften des Wirkstoffs (Wasserlöslichkeit = 24300 mg/L; DT50 Boden = 42,3 d; KOC = 25), einer Berechnung der über den Pfad Drainage zu erwartenden Einträge mit dem Modell Exposit 3.01 und einem Sicherheitsfaktor von 10 ist nach dem Stand der wissenschaftlichen Erkenntnisse die o.g. Anwendungsbestimmung erforderlich, um einen ausreichenden Schutz von Gewässerorganismen zu gewährleisten. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registra- tion Report zu entnehmen. BVL_FO_05_2437_200_V1.8 SEITE 16 VON 16

Anlage 2 nicht zugelassene Anwendung: 034066-00/00-002 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Zweikeimblättrige Unkräuter Pflanzen/-erzeugnisse/Objekte: Sommerweichweizen, Sommerhartweizen, Sommer- gerste, Sommerroggen, Sommertriticale, Sommerha- fer Verwendungszweck:

2 Angaben zur sachgerechten Anwendung

Einsatzgebiet: Ackerbau Anwendungsbereich: Freiland Anwendung im Haus- und Kleingartenbereich: Nein Erläuterung zur Kultur: Ausgenommen zur Saatguterzeugung Stadium der Kultur: 11 bis 32 Anwendungszeitpunkt: Nach dem Auflaufen, Frühjahr Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 1 Anwendungstechnik: spritzen Aufwand: - 1,5 l/ha in 200 bis 400 l Wasser/ha

3 Begründung Naturhaushalt: Die Zulassungsvoraussetzung für die Anwendung 034066-00/00-002 ist gemäß Art. 29 Abs. 1 Buchst. e i.V.m. Art. 4 Abs. 3 Buchst. e der Verordnung (EG) Nr. 1107/2009 nicht erfüllt. Der im o.g. Pflanzenschutzmittel enthaltene Wirkstoff 2,4-D weist ein hohes Gefährdungspo- tenzial für aquatische Organismen, insbesondere höhere Wasserpflanzen auf. Bewertungs- bestimmend ist hier die EC50 für Myriophyllum aquaticum von 11 µg/L. Ausgehend von einem Datensatz charakteristischer Eigenschaften des Wirkstoffs (Wasserlöslichkeit = 24300 mg/L; DT50 Boden = 42,3 d; KOC = 25), einer Berechnung der über den Pfad Oberflächen- abfluss (Run-off) zu erwartenden Einträge mit dem Modell Exposit 3.01 wird das Akzeptabili- tätskriterium TER >= 10 gemäß Anhang der Verordnung (EU) Nr. 546/2011, Teil 1, Abschnitt C 2 Entscheidungsverfahren - Spezielle Grundsätze, Punkt 2.5 für die Anwendung 00-002 auch bei Ausschöpfung aller praktikablen Risikominderungsmaßnahmen nicht erreicht. Unvertretbare Auswirkungen auf aquatische Organismen infolge der bestimmungsgemäßen und sachgerechten Anwendung sind somit nicht auszuschließen. Weitere Informationen hierzu sind dem nationalen Addendum zum Part B des Draft Registration Report zu entnehmen. BVL_FO_05_2437_200_V1.8 REGISTRATION REPORT Part B Section 0 Product Background, Regulatory Context and GAP information

Product code: CA2971 Product name: U 46 D Fluid (Spritz-Hormin 500) Chemical active substance: 2,4-D 500 g/L (602 g/L as DMA salt)

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT (authorisation)

Applicant: Nufarm Deutschland GmbH Submission date: 19/12/2013 MS Finalisation date: 27/04/2017 U 46 D Fluid Page 2 /12 Part B – Section 0 - Core Assessment Template for chemical PPP zRMS version Version 10/12/2015

Version history

When What

10/12/2015 Draft registration report provided for commenting.

U 46 D Fluid Page 3 /12 Part B – Section 0 - Core Assessment Template for chemical PPP zRMS version Version 10/12/2015

Table of Contents

0 Product background, regulatory context and GAP information ...... 4 0.1 Introduction ...... 4 0.1.1 Reason for application ...... 4 0.1.2 Details of zRMS(s) and concerned MS ...... 4 0.1.3 Regulatory history of the active substance 2,4-D ...... 5 0.1.4 Regulatory history of the product ...... 6 0.2 zRMS conclusion ...... 6

Appendix 1 ALL intended uses ...... 8

Appendix 1.1 ALL INTENDED USES ...... 8

Appendix 1.2 MATCHING TABLE DE USES (German code number: 034066- 00/00) ...... 10

U 46 D Fluid Page 4 /12 Part B – Section 0 - Core Assessment Template for chemical PPP zRMS version Version 10/12/2015

0 Product background, regulatory context and GAP information

0.1 Introduction

0.1.1 Reason for application

This application was submitted by Nufarm Deutschland GmbH on 19 December 2013 in order to allow the re-registration of this product in Germany.

The product name Spritz-Hormin 500 has been changed during evaluation into U 46 D FLUID by the applicant.

The application was for re-approval of U 46 D FLUID containing 500 g/L 2,4-D in Germany. The product is intended to be used as herbicide to control dicotyledonous weeds in cereals and grassland.

No assessment of equivalence is required.

This application follows the data requirements for the active substance 2,4-D laid down in Regulation (EC) No. 544/2011 and the data requirements for the plant protection product laid down in Regulation (EC) No. 545/2011.

0.1.2 Details of zRMS(s) and concerned MS

Table 0.1-1: Overview of zRMS and cMS

zRMS, product name and authorization (if relevant) Concerned MS, MS’ product no. (if relevant) name and authorization number (if applicable)

Northern zone - -

Central zone Germany - U 46 D FLUID (former: Spritz-Hormin 500) German code number: 034066-00/00 Southern zone - -

Inter-zonal - -

U 46 D Fluid Page 5 /12 Part B – Section 0 - Core Assessment Template for chemical PPP zRMS version Version 10/12/2015

0.1.3 Regulatory history of the active substance 2,4-D

Table 0.1-2: Summary of regulatory history of CAS No: 94-75-7

Status

Approved in EU Y Original Inclusion Directive Commission Directive 2001/103/EC or Commission Implementing Regulation (EU) Commission Implementing Regulation No 2011/540 Amendment (EU) No 2015/1885 Commission Implementing Regulation (EU) 2015/2033 (Renewal) RMS EL Date of Renewal of Active Substance 01/01/2016 (date of Regulation to be applied) Date of first Commission (re-registration) deadline (Step 1) or date of - deadline for renewal of authorization (renewal) Date of final Commission (re-registration) deadline (Step 2) - Current expiration of approval 31/12/2030 Low risk substance or Candidate for Substitution? N/A

Issues that need to be considered as part of the EU approval are listed below.

In this overall assessment Member States shall pay particular attention to the risk to aquatic organisms, terrestrial organisms and consumers in cases of uses above 750 g/ha.

Conditions of use shall include risk mitigation measures, where appropriate.

The applicant shall submit to the Commission, the Member States and the Authority:

(1) confirmatory information in the form of the submission of the complete results from the existing extended one-generation study;

(2) confirmatory information in the form of the submission of the Amphibian Metamorphosis Assay (AMA) (OECD (2009) Test No 231) as to verify the potential endocrine properties of the substance.

The information set out in point (1) shall be submitted by 4 June 2016 and the information set out in point (2) by 4 December 2017.

The finalised SANCO report for 2,4-D (SANCO/11961/2014) is considered to provide the relevant information on the evaluation or a reference to where such information can be found. An EFSA Scientific Report was made available on 11 March 2015.

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Table 0.1-3: Information on minimum purity of 2,4-D EU agreed minimum purity from Inclusion Directive (if different) Minimum purity of active substance or Implementing regulation used in the product / information on available equivalency report *, **

960 g/kg 960 g/kg Evaluation of the equivalence of the specification: RAR, Volume 4, Addendum (January 2014) RMS: Greece * Since EU approval new studies on the active substance have been performed (e.g. new manufacturing site, new specification) and as a result the purity of the active substance has changed (see Part C). **. If the specification of the active substance is different to that used as reference specification for EU approval then please refer to the equivalency document from the RMS.

0.1.4 Regulatory history of the product

The following table provides corresponding information of product codes, product names and authorizations in different EU Member States.

Table 0.1-4: Summary of regulatory history of the product U 46 D FLUID (CA2971)

Product code Product name(s) MS Authorization Date of initial Date of the last No. registration re-registration

CA2971 U 46 D FLUID DE 034066-00/00 11/02/1999 22/12/2004 (former Spritz-Hormin 500)

The intended uses applied for have not been evaluated as part of the renewal of 2,4-D. The maximum application rate for renewal was 600 g/a.s./ha in cereals, grassland and oilseeds have not been evaluated at all.

0.2 zRMS conclusion

The risk assessment conclusions are based on the information, data and assessments provided in Registra- tion Report, Part B Sections 1-9 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 re-registration in Germany by the EU review. It also includes assessment of data and information relating to U 46 D FLUID where that data has not been considered in the EU review.

Otherwise assessments to Uniform Principles for the safe use of U 46 D FLUID have been made using endpoints agreed in EU reviews of 2,4-D. List of endpoints refers to EFSA conclusion 2014 (EFSA Jour- nal 2014;12(9):3812) published on 11 March 2015.

Uses to be considered safe on the basis of EU methodology:

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None

Uses to be considered non-safe on the basis of EU methodology:

None

Uses for which safety has been established only following additional risk mitigation at a national (non- core) level or for which the evaluation is to be confirmed by relevant cMS:

All uses: Higher tier exposure assessment for aquatic organisms needs to be performed on member state level. Appropriate risk mitigation measures are necessary on member state level for non-target terrestrial plants

Use 1: For 4 out of 7 crops listed in use 1 efficacy evaluation is to be confirmed on member state level (winter triticale (TTLWI), spelt (TRZSP), winter durum wheat (TRZDW) winter oat (AVESW))

Use 2: For 2 out of 7 crops listed in use 2 efficacy evaluation is to be confirmed on member state level (spring durum wheat (TRZDS), spring rye (SECCS), spring triticale (TTLSO));

Use 3: Further refinement of risk assessment for mammals needs to be performed on member state level.

All uses/ GAPs are covered by established MRLs.

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Appendix 1 ALL intended uses

Appendix 1.1 ALL INTENDED USES

GAP rev. , 2015-11-23 PPP (product name/code): Spritz-Hormin 500 Formulation type: SL (a, b) Active substance 1: 2,4 D Conc. of as 1: 500 g/L(c) Safener: - Conc. of safener: conc. (c) Synergist: - Conc. of synergist: conc. (c)

Applicant: Nufarm Professional use: Zone(s): central(d) Non professional use: Verified by MS: yes

Field of use: herbicide

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 e.g. g safener/synergist (crop destination / G, (additionally: developmen- Kind stage of crop & a) per use between ha L/ha per ha purpose of crop) Gn, tal stages of the pest or season b) per crop/ applications a) max. rate per a) max. rate per (f) Gpn pest group) season (days) appl. appl. min / or b) max. total b) max. total rate max I rate per per crop/season crop/season

Zonal uses (field or outdoor uses, certain types of protected crops)

1 DE Winter soft wheat F Dicotyledonous weeds Spraying After emergence a) 1 a) 1.5 L/ha a) 750 g as/ha 200 - 400 F* For TTLWI, TRZSP, TRZAW TTTDD Spring b) 1 b) 1.5 L/ha b) 750 g as/ha TRZDW, AVESW efficacy evaluation is winter barley BBCH 21 - 32 to be confirmed by HORVW relevant cMS winter rye Higher tier exposure SECCW assessment for aquatic organisms needs to be winter triticale performed on member U 46 D Fluid Page 9 /12 Part B – Section 0 - Core Assessment Template for chemical PPP zRMS version Version 10/12/2015

TTLWI state level spelt TRZSP * The PHI is covered by winter durum wheat the conditions of use and/or the vegetation TRZDW period remaining be- winter oat tween the application of AVESW the plant protection product and the use of the product (e. g. harvest) or the setting of a PHI in days is not required resp.

2 DE Spring soft wheat F Dicotyledonous weeds Spraying After emergence a) 1 a) 1.5 L/ha a) 750 g as/ha 200 - 400 F except for seed produc- TRZAS TTTDD Spring b) 1 b) 1.5 L/ha b) 750 g as/ha tion spring barley BBCH 11 - 32 for TRZDS, SECCS, TTLSO efficacy evalu- HORVS ation is to be confirmed spring oat by relevant cMS AVESA Higher tier exposure spring durum wheat assessment for aquatic organisms needs to be TRZDS performed on member spring rye state level SECCS spring triticale TTLSO

3 DE Grassland, pasture, F Dicotyledonous weeds Spraying during growing a) 1 a) 1.5 L/ha a) 750 g as/ha 200 - 400 14 Further refinements of meadow TTTDD season (March to b) 1 b) 1.5 L/ha b) 750 g as/ha the risk assessment for NNNFW October) mammals need to be BBCH 25 - 35 performed on member state level Higher tier exposure assessment for aquatic U 46 D Fluid Page 10 /12 Part B – Section 0 - Core Assessment Template for chemical PPP zRMS version Version 10/12/2015

Interzonal uses (use as seed treatment, in greenhouses (or other closed places of plant production), as post-harvest treatment or for treatment of empty storage rooms)

------

Minor uses according to Article 51 (field uses)

------

Minor uses according to Article 51 (interzonal uses)

------

Appendix 1.2 MATCHING TABLE DE USES (German code number: 034066-00/00)

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 e.g. g safener/synergist (crop destination / G, (additionally: developmen- Kind stage of crop & a) per use between ha L/ha per ha purpose of crop) Gn, tal stages of the pest or season b) per crop/ applications a) max. rate per a) max. rate per (f) Gpn pest group) season (days) appl. appl. min / or b) max. total rate b) max. total rate max I per crop/season per crop/season U 46 D Fluid Page 11 /12 Part B – Section 0 - Core Assessment Template for chemical PPP zRMS version Version 10/12/2015

001 DE Winter soft wheat F Dicotyledonous weeds Spraying After emergence c) 1 c) 1.5 L/ha c) 750 g as/ha 200 - 400 F* Use 001 of all GAPS TRZAW TTTDD Spring d) 1 d) 1.5 L/ha d) 750 g as/ha NT103, NW605, spelt BBCH 21 - 32 NW606, NW706, TRZSP WH9161, WP777, WP7801, WP7802 winter durum wheat

TRZDW * The PHI is covered by winter barley the conditions of use HORVW and/or the vegetation winter rye period remaining between the application of SECCW the plant protection winter triticale product and the use of TTLWI the product (e. g. harvest) or the setting of a winter oats PHI in days is not AVESW required resp.

002 DE Spring soft wheat F Dicotyledonous weeds Spraying After emergence c) 1 c) 1.5 L/ha c) 750 g as/ha 200 - 400 F Use 002 of all GAPS TRZAS TTTDD Spring d) 1 d) 1.5 L/ha d) 750 g as/ha except for seed produc- spring durum wheat BBCH 11 - 32 tion TRZDS WH9161, WP777, WP7791, WP7801 spring barley No authorization - HORVS unacceptable risk for spring rye aquatic plants SECCS spring triticale TTLSO spring oat AVEFA U 46 D Fluid Page 12 /12 Part B – Section 0 - Core Assessment Template for chemical PPP zRMS version Version 10/12/2015

003 DE Grassland, pasture, F Dicotyledonous weeds Spraying during growing c) 1 c) 1.5 L/ha a) 750 g as/ha 200 - 400 14 Use 003 of all GAPS meadow TTTDD season (March to d) 1 d) 1.5 L/ha b) 750 g as/ha WH9161, WP742 October) NNNFW BBCH 25 - 35

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 plication use 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.

REGISTRATION REPORT Part B Section 1: Identity Section 2: Physical and chemical properties Section 4: Further information Detailed summary of the risk assessment

Product code: CA 2971 Product name(s): U 46 D Fluid Chemical active substance: 2,4-D, 500 g/L (602 g/L as DMA salt)

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT (authorization)

Applicant: Nufarm Deutschland GmbH Submission date: 19/12/2013 MS Finalisation date: 27/04/2017 CA 2971 / U 46 D Fluid Page 2 /19 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version September 2016

Version history

When What

CA 2971 / U 46 D Fluid Page 3 /19 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version September 2016

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 2,4-D ...... 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) ...... 6 1.5 Type and code of the plant protection product (KCP 1.5) ...... 6 1.6 Function (KCP 1.6) ...... 6

2 Section 2: Physical, chemical and technical properties of the plant protection product ...... 7

3 Section 3 is presented as a separate document ...... 15

4 Section 4: Further information on the plant protection product ...... 15 4.1 Packaging and Compatibility with the Preparation (KCP 4.4) ...... 15

Appendix 1 Lists of data considered in support of the evaluation ...... 16

Appendix 2 Additional data on the physical, chemical and technical properties of the active substance ...... 19 A 2.1 2,4-D ...... 19

CA 2971 / U 46 D Fluid Page 4 /19 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version September 2016

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).

Noticed data gaps are: • none

1 Section 1: Identity of the plant protection product

1.1 Applicant (KCP 1.1)

Name: Nufarm Deutschland GmbH Address: Im MediaPark 4e 50670 Köln, Germany

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 2,4-D

2,4-D min. 960 g/kg

Further information on the specification of the technical active substance is provided in Part C.

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

Trade name: Please refer to Registration Report Part A for the relevant country. Example trade names are: U 46 D Fluid Spritz Hormin 500 Herboxone Depitox CA 2971 / U 46 D Fluid Page 5 /19 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version September 2016

Dicopur 500 flussig Company code number: CA 2971

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)

The formulation was not the representative formulation.

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) (%w/w) stance / variant (g/L)

2,4 D as acid 500 475 – 525 g/L 520.8 44.67 2,4 D as DMA salt 602 n.a. 622.8 53.69

* Based on the minimum purity of the active substance declared for registration in the active substance dossiers ** Based on the density of the formulation = 1.166 g/mL

Table 1.4-2: Safener and synergists

Safener / synergist Declared content of FAO Limits Technical content* Technical content** the safener / (min – max) (g/L or g/kg) (%w/w) synergist (g/L or g/kg) n.a.

Table 1.4-3: Relevant impurities

Relevant impurity Maximum content (g/L or g/kg) n.a. n.a. According to the EFSA conclusion (11 March 2015) dioxins and (10 ppb TCDD toxic equivalents (TEQ)) furans are considered as relevant impurities.

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

Table 1.4-4: Information on 2,4-D

Type Name/Code Number

ISO common name 2,4-D 2,4-D-dimethylammonium salt CAS No. 94-75-7 2008-39-1 EC No. 202-361-1 217-915-8 CA 2971 / U 46 D Fluid Page 6 /19 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version September 2016

Type Name/Code Number

CIPAC No. 1 1.102

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

no safeners / synergists; further confidential data see 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)

The product will be used as herbicide. CA 2971 / U 46 D Fluid Page 7 /19 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version September 2016

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

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 brown liquid with an amine like odour. It is not explosive, has no oxidising properties, has no flash point up to 200 °C and no self ignition temperature up to 600 °C. In aqueous solution, it has a pH value around 7 at 20 °C. 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 has changed. The stability data indicate a shelf life of at least 2 years at ambient temperature when stored in HDPE. The technical characteristics are acceptable for a soluble concentrate formulation.

The intended concentration of use is 1.5 L or 2 L product in 100 to 400 L water which equals 0.38 % to 2.0 %.

Justified Proposals for Classification and Labelling (KCP 12) for physical chemical part only No labelling necessary.

Notifier Proposals for Risk and Safety Phrases (KCP 12) none

Compliance with FAO specifications: The product CA 2971 complies with the FAO specification 1.1/SL/S/F (1992).

Formulation used for tests Some of the test were conducted using a different (former) composition, but most of the test were conducted also with the actual composition applied for.

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 and dilution stability. Some deviations from the data submitted by the applicant were detected for colour (olive green instead of brown) and volume of foam after 1 min, but these differences are not considered as critical. The formulation complies with the chemical, physical and technical criteria which are stated for this type of formulation in the FAO/WHO manual (2010).

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

Annex point Method used / Test mate- Findings GLP Reference Acceptability / deviations rial Y/N comments

Colour and There are significant physical state Visual assessment and DG/220/80: The preparation is a pale yellow liquid (Munsell: Y Hersey, R, 1997, differences between (KCP 2.1) organoleptic determina- 496 g/L 2.5Y 8/3) with a phenolic odour. 97/0012 both descriptions. tion 2,4-D Based on old composition Acceptable 18-32-110 The preparation is a brown liquid with an amine like Y Mahmood, T., 2012, 488 g/L odour. 12/0711 2,4-D

Explosive properties Acceptable (KCP 2.2.1) Statement - Based on the composition the formulation is incapa- N Hutchinson, N., 2000, ble of exothermic reaction. 00/0108

Oxidizing properties Acceptable (KCP 2.2.2) Statement - Aqueous solutions of 2,4-D DMA are not consid- N Hale, M., 2003, ered to possess oxidising properties. MH/032/2,4-D

Flash point Acceptable (KCP 2.3.1) EEC A 9 DG/291/120: Flash point > 200 °C Y Bass, R. V., 2000, 514 g/L 00/0110 2,4-D

Flammability - - not required for SL formulations - - Acceptable (KCP 2.3.2) Self-heating Acceptable (KCP 2.3.3) EEC A 15 DG/345/74: Auto-ignition > 600 °C Y Merritt, M., 2000, 503 g/L 17200 2,4-D

Acidity or alkalinity and Acceptable pH CIPAC MT 75 D DMA 500 0.03% w/w as sodium hydroxide Y Hersey, R, 1997, (KCP 2.4.1) g/L 97/0012 CA 2971 / U 46 D Fluid Page 9 /19 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version September 2016

Annex point Method used / Test mate- Findings GLP Reference Acceptability / deviations rial Y/N comments

DG/220/80: 496 g/L 2,4- D pH of a 1% aqueous Acceptable as dilution, emulsion or CIPAC MT 75 D DMA 500 Before storage: Y Hersey, R, 1997, additional information g/L 97/0012 dispersion deionised water, 25 °C: 6.9 (KCP 2.4.2) DG/220/80: Old composition 496 g/L 2,4- Neat formulation, 23 °C: 8.4 D

Acceptable D DMA 500 Before storage: Y Mahmood, T., 2012, g/L 12/0711 Batch:18-32- deionised water, 20 °C: 7.4 110 488 Neat formulation, 23 °C: 8.2 g/L 2,4-D After 14 days at 54°C: deionised water, 20 °C: 7.3 Neat formulation, 23 °C: 8.0

Viscosity Acceptable as (KCP 2.5.1) OECD 114 DG/220/80: 13.9 mPa s (20 °C) Y Hersey, R, 1997, additional information 496 g/L 97/0012

2,4-D Old composition

Surface tension Acceptable as (KCP 2.5.2) EEC A 5 DG/220/80: neat, 21 °C: 45.7 mN/m Y Hersey, R, 1997, additional information OECD 115 496 g/L 97/0012

2,4-D Old composition

Relative density 20 Acceptable as (KCP 2.6.1) EEC A 3 DG/220/80: Before storage: d4 = 1.171 Y Hersey, R, 1997, additional information OECD 109 496 g/L 2,4- 97/0012

D Old composition CA 2971 / U 46 D Fluid Page 10 /19 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version September 2016

Annex point Method used / Test mate- Findings GLP Reference Acceptability / deviations rial Y/N comments

20 Acceptable EEC A 3 Batch:18-32- Before storage: d4 = 1.166 Y Mahmood, T., 2012, 110 488 12/0711 20 g/L 2,4-D After 14 days at 54°C: d4 = 1.167

Bulk density - - not required for liquid formulations - - Acceptable (KCP 2.6.2) Storage Stability after Acceptable 14 days at 54º C CIPAC MT 46.3 Batch:18-32- Storage material: glass Y Mahmood, T., 2012, (KCP 2.7.1) 110 488 12/0711 g/L 2,4-D The content of the active substance does not decrease > 5 %. Content of 2,4-D: before storage: 488 g/L after storage: 495 g/L Content of Free phenol as 2,4-DCP: before storage: 0.55 g/L after storage: 0.61 g/L The changes of the physical and chemical properties are negligible.

Stability after storage Acceptable for other periods and/or please refer to 2.7.1 temperatures (KCP 2.7.2) Minimum content after Acceptable heat stability testing - - Not necessary, since the decrease of the active sub- - - (KCP 2.7.3) stance did not exceed 5 %.

Effect of low Acceptable as temperatures on CIPAC MT 39.3 DG/220/80: No separated material, homogeneous liquid. Y Hersey, R, 1997, additional information stability 496 g/L 2,4- 97/0012 D The product shows good low temperature stability, (KCP 2.7.4) the effects are negligible. Old composition CA 2971 / U 46 D Fluid Page 11 /19 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version September 2016

Annex point Method used / Test mate- Findings GLP Reference Acceptability / deviations rial Y/N comments

Acceptable Batch:18-32- No separated material, homogeneous liquid. Y Mahmood, T., 2012, 110 12/0711 488 g/L 2,4- The product shows good low temperature stability, D the effects are negligible.

Ambient temperature Acceptable shelf life DG/291/120: Storage material: HDPE bottle Y Ackroyd, C., 2001, old composition? (KCP 2.7.5) 518 g/L 2,4- 99/0076 D Average temperature: ambient The content of the active substance does not decrease > 5 %. Content of 2,4-D: before storage: 518 g/L after storage: 517 g/L The changes of the physical and chemical properties appearance, pH, specific gravity, dilution stability and integrity of packaging are negligible.

Shelf life in months please refer to 2.7.5 Acceptable (if less than 2 years) (KCP 2.7.6) Wettability - - not required for SL formulations - - Acceptable (KCP 2.8.1) Persistence of foaming Acceptable as (KCP 2.8.2) CIPAC MT 47 DG/220/80: No foam observed after 10 seconds, 1, 3 or 12 Y Hersey, R, 1997, additional information 496 g/L 2,4- minutes. 5 % dilution in CIPAC hard water D 97/0012 D Old composition

Acceptable CIPAC MT 47.2 Batch:18-32- CIPAC water D, 0.5 %: Y Mahmood, T., 2012, 110 488 12/0711 g/L 2,4-D Before storage 10s: 10 mL 1 min: 8 mL CA 2971 / U 46 D Fluid Page 12 /19 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version September 2016

Annex point Method used / Test mate- Findings GLP Reference Acceptability / deviations rial Y/N comments

3 min: 6 mL 12 min: 2 mL 2 weeks, 54 °C 10s: 10 mL 1 min: 8 mL 3 min: 6 mL 12 min: 4 mL CIPAC water D, 2 %: Before Storage 10s: 26 mL 1 min: 18 mL 3 min: 14 mL 12 min: 10 mL 2 weeks, 54 °C 10s: 22 mL 1 min: 20 mL 3 min: 16 mL 12 min: 10 mL CIPAC water D, 5 %: Before Storage 10s: 10 mL 1 min: 4 mL 3 min: 0 mL 12 min: 0 mL 2 weeks, 54 °C 10s: 10 mL 1 min: 6 mL 3 min: 0 mL 12 min: 0 mL

Suspensibility - - not required for SL formulations - - Acceptable (KCP 2.8.3.1) Spontaneity of - - not required for SL formulations - - Acceptable dispersion (KCP 2.8.3.2) CA 2971 / U 46 D Fluid Page 13 /19 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version September 2016

Annex point Method used / Test mate- Findings GLP Reference Acceptability / deviations rial Y/N comments

Dispersion stability - - not required for SL formulations - - (KCP 2.8.3.3) Degree of dissolution Acceptable as and dilution stability CIPAC MT 41 D DMA 500 CIPAC Water D, 5%: Y Hersey, R, 1997, additional information (KCP 2.8.4) g/L 97/0012 No precipitation after 18 hours. DG/220/80: Old composition 496 g/L 2,4- D

Acceptable D DMA 500 CIPAC Water D, 0.5%, 2 %, 5 %, Y Mahmood, T., 2012, g/L 12/0711 Batch:18-32- before and after storage at 54 °C 110 488 g/L 2,4-D No precipitation after 18 hours.

Particle size distribution - - not required for SL formulations - - Acceptable / nominal size range of granules (KCP 2.8.5.1.1) Wet sieve test - - not required for SL formulations - - Acceptable (KCP 2.8.5.1.2) Dust content - - not required for SL formulations - - Acceptable (KCP 2.8.5.2.1) Particle size of dust - - not required for SL formulations - - Acceptable (KCP 2.8.5.2.2) Attrition - - not required for SL formulations - - Acceptable (KCP 2.8.5.3) Hardness and integrity - - not required for SL formulations - - Acceptable (KCP 2.8.5.4) Emulsifiability - - not required for SL formulations - - Acceptable (KCP 2.8.6.1) CA 2971 / U 46 D Fluid Page 14 /19 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version September 2016

Annex point Method used / Test mate- Findings GLP Reference Acceptability / deviations rial Y/N comments

Emulsion stability - - not required for SL formulations - - Acceptable (KCP 2.8.6.2) Re-emulsifiability - - not required for SL formulations - - Acceptable (KCP 2.8.6.3) Flowability - - not required for SL formulations - - Acceptable (KCP 2.8.7.1) Pourability - - not required for SL formulations - - Acceptable (KCP 2.8.7.2) Dustability following - - not required for SL formulations - - Acceptable accelerated storage (KCP 2.8.7.3) Physical compatibility Tank mixes are well known unspecific information of tank mixes (see Tomlin, C. The Pesticides Manual (UK)) (KCP 2.9.1) Chemical compatibility Tank mixes are well known unspecific information of tank mixes (see Tomlin, C. The Pesticides Manual (UK)) (KCP 2.9.2) Adhesion to seeds - - not intended for seed treatment - - Acceptable (KCP 2.10.1) Distribution to seed - - not intended for seed treatment - - Acceptable (KCP 2.10.2) Other/special studies (KCP 2.11) Not required by regulation (EU) 2011/545. Acceptable.

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3 Section 3 is presented as a separate document

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

4 Section 4: Further information on the plant protection product

4.1 Packaging and Compatibility with the Preparation (KCP 4.4)

PET and HDPE bottles in the range 1 … 20 L are intended.

Specimens of the packaging were not provided as there was no request.

Table 4.1-1: Packaging information for 10 litre bottle (as example)

Type Description Material: High density polyethylene (HDPE) or Polyethylene terephtalate (PET)

Shape/size: 375 mm x 240 mm x 179 mm

Opening: 63 mm inner diameter

Closure: Tamper evident cap

Seal: compression or heat seal

Manner of construction n.a. UN/ADR approved

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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

2.1 Mahmood, T. 2012 2,4-D DMA 500 g/l – Accelerated Storage Stability Y NUF 2.4.2 Nufarm UK Limited 2.6.1 12/0711 2.7.1 GLP 2.7.4 Not published 2.8.2 2.8.4 2.2.1 Hutchinson, N. D. 2000 Theoretical Assessment of the Explosivity of Herboxone N NUF A H Marks & Company Limited 00/0108 GLP Not published Contains confidential information 2.2.2 Hale, M. 2003 Oxidising Properties of 2,4-D DMA Solutions N NUF A H Marks & Company Limited MH/03/2,4-D Not GLP Not published 2.3.1 Bass, R. V. 2000 Determination of the Flash Points of D DMA at 600 g l-1 AI, D DMA at 500 g l-1 AI and D 2EH N NUF CA 2971 / U 46 D Fluid Page 17 /19 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version September 2016

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

at 600 g l-1 AI A H Marks & Company Limited 00/0110 GLP Not published 2.3.3 Merritt, M. 2000 To Determine the Auto-Ignition Temperature on a Sample of D DMA 500 g/l AI (Product Code N NUF U834A) Chilworth Laboratories, UK 172300 GLP Not published KIIIA Ackroyd, C. 2001 Two Year Storage Stability of D DMA 500 g l-1 N 2.7.5 A H Marks & Company Limited 99/0076 GLP Not published

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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

2.1 Hersey, R 1997 Determination of the Physical and Chemical Properties of 2,4-D Acid DMA Salt Solution at 500 N NUF 2.4.1 g/l 2,4-D Acid Concentration 2.4.2 A H Marks & Company Limited 2.5.2 97/0012 2.5.3 GLP 2.6.1 Not published 2.7.4 2.8.2 2.8.4 KIIIA Remnant, V. 2009 2,4-D DMA SL Determination of the Efficiency of the Normal Procedures used for Cleaning Y NUF 4.2.2 Spray Tanks after use Huntingdon Life Sciences Ltd, UK NUF0417 GLP Not published

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

A 2.1 2,4-D

Additional data on the physical, chemical and technical properties of 2,4-D were not provided.

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

Product code: ZV1 034066-00/00 Product name(s): U 46 D Fluid (Spritz-Hormin 500) Chemical active substance(s): 2,4-D DMA, 500 g/L

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT/

Applicant: Nufarm Deutschland GmbH Submission date: 29/12/2013 MS Finalisation date: 27/04/2017 Page 2 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Version history

When What 13/11/2015 Version 1 of zRMS DE 07/11/2016 Version 2 of zRMS DE: Reduction of application rate in use 003 (grassland)

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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) ...... 9 3.2.1 Preliminary tests (KCP 6.1) ...... 19 3.2.2 Minimum effective dose tests (KCP 6.2) ...... 19 3.2.3 Efficacy tests (KCP 6.2) ...... 23 3.3 Information on the occurrence or possible occurrence of the development of resistance (KCP 6.3) ...... 34 3.4 Adverse effects on treated crops (KCP 6.4) ...... 36 3.4.1 Phytotoxicity to host crop (KCP 6.4.1) ...... 36 3.4.2 Effect on the yield of treated plants or plant product (KCP 6.4.2) ...... 40 3.4.3 Effects on the quality of plants or plant products (KCP 6.4.3) ...... 43 3.4.4 Effects on transformation processes (KCP 6.4.4) ...... 43 3.4.5 Impact on treated plants or plant products to be used for propagation (KCP 6.4.5) ...... 43 3.5 Observations on other undesirable or unintended side-effects (KCP 6.5) ... 44 3.5.1 Impact on succeeding crops (KCP 6.5.1) ...... 44 3.5.2 Impact on other plants including adjacent crops (KCP 6.5.2) ...... 45 4.1.1 Effects on beneficial and other non-target organisms (KCP 6.5.3) ...... 46 4.2 Other/special studies ...... 48 4.3 List of test facilities including the corresponding certificates ...... 48

Appendix 1 Lists of data considered in support of the evaluation ...... 49

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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 present document is basing on the new template of the draft registration report (Version April 2015). It has been prepared as an example for applicants to demonstrate how to generate a draft registration report (dRR) according to the new guidance. The present dRR has been rewritten by zRMS basing on the applicant`s dRR from 31/12/2013. Some tables have been modified related to the draft template document (Version April 2015). Modified tables are marked. For future applications please use original tables from new template of April 2015.

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

Abstract The evaluation is based on data which have been submitted by earlier applications and additional field trials focussing on minimum effective dose and efficacy which were conducted in 2013. Due to the process of re-registration of U 46 D Fluid, the data set is limited. However, supported by the long-term experiences using 2,4-D in cereals, the zRMS considers that the data provided support the uses 1 and 2. The data indicate different sensitivity of the herbicide U 46 D Fluid for the main target weed species. Thus, a label advice regarding the different sensitivity is proposed. The instructions for use should include a summary of weeds which can be controlled well, less well and insufficiently by the product, as well as a list of species and/or varieties showing which crops are tolerant of the intended application rate and which are not. Regarding use 003 (grassland, pasture, meadow), only PLALA (Plantago lanceolata) is supported by adequate efficacy data. Therefore, use 003 should be limited to PLALA.

Use 1: Winter cereals: Based on the data given and long-term experiences of herbicides containing the active 2,4-D, 1.5 L/ha U 46 D Fluid is sufficiently effective against some relevant weed species in winter cereals. The risk of crop damage is considered low for winter cereals. As it is well known that 2,4-D does not have any effect on grasses/grass crops as long it is applied not later than crop stage BBCH 32, existing crop safety data of winter wheat, winter barley and winter rye can be extrapolated to some extent. This is true for spelt (TRZSP), winter durum wheat (TRZDW), winter oat (AVESW) and winter triticale (TTLWI). However, because of the limited data set, a label warning on possible phytotoxicity and yield reduction should be addressed to these crops which have not yet been registered in Germany (TRZSP, TRZDW and AVESW). Registration on these crops should be decided on national level.

Use 2: Spring cereals: Based on the data given and long-term experiences of herbicides containing the active 2,4-D, 1.5 L/ha U 46 D Fluid is sufficiently effective against some relevant weed species in spring cereals. The effects on spring cereals are similar to the findings in winter cereals. The data provided indicate a risk for phytotoxicity of spring oat (AVESA). This may even lead to yield reduction. An appropriate warning regarding phytotoxicity and possibly yield reduction should be addressed on the label. Spring durum wheat (TRZDS), spring triticale (TTLSO) and spring oat (AVESA) have not been registered Page 5 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version in Germany but are now intended. Concerning efficacy, an extrapolation of data appears possible. Regard- ing selectivity damage cannot be fully excluded due to the findings in oat and the limited data set. Thus, a label warning is proposed to avoid possible damage to the crop. Due to the limited data, authorisation of spring rye (SECCS), spring durum wheat (TRZDS), spring triticale (TTLSO) and spring oat (AVESA) should be decided on national level.

Use 3: Grassland: Due to the applicants letter dated on 2016/07/15, the application rate of use 003 (Grassland, pasture, meadow) is reduced to 1.5 L/ha. Based on the data given, 1.5 L/ha U 46 D Fluid is sufficiently effective against PLALA. Adequate data to support more weeds than PLALA are missing.

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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 15

Use-No. Member Crop and/ F, Pests or Group of Application Application rate PHI Remarks: zRMS * state(s) or situation Fn, pests controlled (days) Conclusion Fnp Method / Timing / Max. number Min. inter- kg or L product g or kg as/ha Water e.g. g safener/ (crop destination G, (additionally: develop- Kind Growth a) per use val between / ha L/ha synergist per ha, (efficacy) / purpose of Gn, mental stages of the stage of crop b) per crop/ applications a) max. rate per a) max. rate other dose rate crop) Gnp pest or pest group) & season season (days) appl. per appl. min / expression, dose or b) max. total b) max. total max range (min- I ** rate per rate per max) crop/season crop/season Zonal uses (field or outdoor uses, certain types of protected crops) 1 DE Winter soft wheat F Dicotyledonous weeds Spraying After emer- a) 1 a) 1.5 L/ha a) 750 g 200 - XF* except for seed A TRZAW TTTDD gence b) 1 b) 1.5 L/ha a.s./ha 400 production winter barley Spring b) 750 g HORVW BBCH 21 - a.s./ha winter rye 32 SECCW winter triticale C TTLWI spelt TRZSP winter durum wheat TRZDW winter oat AVESW 2 DE Spring soft wheat F Dicotyledonous weeds Spraying After emer- a) 1 a) 1.5 L/ha a) 750 g 200 - XF* except for seed A TRZAS TTTDD gence b) 1 b) 1.5 L/ha a.s./ha 400 production spring barley Spring b) 750 g HORVS BBCH 11 - a.s./ha spring oat 32 AVESA spring rye SECCS C spring durum wheat TRZDS spring triticale Page 7 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

3 DE Grassland, pas- F Dicotyledonous weeds Spraying during grow- a) 1 a) 1.5 L/ha a) 750 g a.s./ha 200 - 14 d N ture, meadow TTTDD ing season b) 1 b) 1.5 L/ha b) 750 g a.s./ha 400 NNNFW (March to October) BBCH 25-35 Interzonal uses (use as seed treatment, in greenhouses (or other closed places of plant production), as post-harvest treatment or for treatment of empty storage rooms) 3 4 Minor uses according to Article 51 (field uses) 5 6 Minor uses according to Article 51 (interzonal uses) 7 8 * 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 Page 8 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

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 Page 9 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

3.2 Efficacy data (KCP 6)

Introduction During evaluation the name of the plant protection product “Spritz-Hormin 500” has been changed to “U 46 D Fluid” (see application from 2015-04-28). Germany is the zonal Rapporteur member state. According to Regulation EC No 1107/2009 Germany belongs to the central registration zone (zone B). As defined in the EPPO standard PP1/241 (Guidance on comparable climates), Germany is part of the maritime EPPO zone. The present application is a re-registration of U 46 D Fluid resp. Spritz-Hormin 500. U 46 D-Fluid is mar- keted since 1946; Spritz-Hormin 500 is registered in Germany since 2002. Herbicides which contains 500 g/L 2,4-D are also registered under different brand names in Austria, the Czech Republic, Ireland and the United Kingdom. However, dosages vary between uses and countries from 0.7 to 3.3 L/ha. 2,4 D was added to the list of approved active substances contained in Commission Implementing Regula- tion (EU) No 540/2011 (date of approval 01/01/2016).

The following evaluation is based on data which have been submitted by earlier applications. Additional field trials focussing on minimum effective dose and efficacy were conducted in 2013.

Description of active substances

Table 3.2-1: Details of the active substances

Parameter Active substance 1 Active substance 2 Active substance 3

Concentration 500 g a.s./L 2,4-D (Unit: g/kg or g/L...) Chemical group Phenoxy-carboxylic-acid Mode of action like Indole acetic acid (synthetic

auxins) HRAC code O Biological action Selective systemic

post-emergence herbicide Formulation type: soluble concentrate, SL IUPAC name: (2,4-dichlorophenoxy) acetic

acid

Mode of action 2,4-D (2,4-dichlorophenoxy acetic acid) belongs to the chemical group of phenoxy carbonic acids. Like other acid herbicides, current formulations utilize either an amine salt (usually trimethylamine) or one of many esters of the parent compound. These are easier to handle than the acid. Salts are readily absorbed by the roots, whilst esters are readily absorbed by the foliage. 2,4-D is a selective systemic herbicide. 2,4-D exhibits relatively good selectivity, meaning, that it controls a wide number of broadleaf weeds while causing little to no injury to grass weeds at normal application rates. 2,4-D gets adsorbed by leaves, green stalks and by roots. Translocation occurs, with accumulation at the meristematic regions of shoots and roots. 2,4-D acts as a growth inhibitor with hormone-like activity. The primary action appears to affect cell wall Page 10 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version plasticity and nucleic acid metabolism. High concentrations of the herbicide inhibit cell division and growth, usually in meristematic regions that accumulate photosynthate assimilates and herbicides from the phloem. Low concentrations lead to uncontrolled cell division and growth, which results in vascular tissue destruction. Mode of action of all phenoxy carbonic acids is similar. The major metabolic pathways of 2,4- D in plants involve hydroxylation, decarboxylation, cleavage of the acid side chain, ring opening and the formation of conjugates with amino acids or sugars. The pathways and metabolites vary with species. In cereals, the metabolite 1-O-(2,4-dichlorophenoxyacetyl)-ß-D-glucose was found. In maize, degradation occurs by hydroxylation of the benzene ring followed by a glycosylation and the formation of glucose esters. Site of action (HRAC-group): O

Description of the plant protection product U 46 D Fluid resp. Spritz-Hormin 500 is a soluble concentrate formulation (SL) containing 500 g/L 2,4-D for use in winter cereals (TRZSS, HORVW, SECCW, TTLSS), spring cereals (TRZSS, HORVS, SECCS, AVESS) and grassland. For more details on the currently registered/requested and the intended uses see table 3.2-2 and table “All intended uses” in Part B - Section 0.

Table 3.2-2: Currently registered uses and requested uses for the product code.*

Formu- Authori- Currently Re- Comments / Other Member lation Product sation registered Use(s) quested relevant details on State Type / No. rate(s) rate(s) GAPs Conc. Austria Damine SL / 2850/0 1.5 cereals 1.5 L/ha TRZSP, TRZDW, 500 SL 500 g/L AVESW new requested BBCH Crop was limited from 13-29 to 21-32 now TRZDS, TTLSO new requested BBCH Crop was limited from 13-29 to 11-32 now 2.0 grassland 2 L/ha Belgium Aminex SL 1648P/B 1.2 - 1.6 wheat, barley, 500 g/L rye, oat, triticale, spelt, maize 1.6 - 2.4 grassland Salvo SL 9865P/B 0.8 spring wheat, 500 g/L spring barley, spring oat 1.2 - 1.6 winter wheat, winter barley, rye, triticale, spelt, grassland, pasture U-46-D- SL 7013P/B 1.2 - 1.6 wheat, barley, 500 500 g/L rye, oat, triticale, spelt, maize, grassland Page 11 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Formu- Authori- Currently Re- Comments / Other Member lation Product sation registered Use(s) quested relevant details on State Type / No. rate(s) rate(s) GAPs Conc. Czech Dicopur SL / 3859-1 1.25 maize Republic D 500 g/L U46 D SL 3860-1 1.5 winter and Fluid 500 g/L spring wheat, winter and spring barley, winter rye, winter triticale 2.0 maize, grass- seed stands Germany 2,4-D SL / 040941- 1.5 winter wheat, Berghoff 500 g/L 60 winter barley, winter rye, spring wheat, spring barley, oat, spring rye 2.0 grassland Salvo SL / 007084- 1.5 winter wheat, 500 g/L 00 winter barley, winter rye, spring wheat, spring barley, spring oat 1.0 wheat, barley, rye, oat (un- dersown with grass) Germany Spritz- SL / 024066- 1.5 winter wheat, 1.5 L/ha TRZSP, TRZDW, Hormin 500 g/L 00 winter barley, AVESW new 500 winter rye, requested triticale, BBCH Crop was spring wheat, limited from 13-29 spring barley, to 21-32 now spring rye TRZDS, TTLSO new requested BBCH Crop was limited from 13-29 to 11-32 now 2.0 grassland 2 L/ha U46 D- SL / 040941- 1.5 winter wheat, Fluid 500 g/L 00 winter barley, winter rye, spring wheat, spring barley, oat, spring rye 2.0 grassland Ireland D50 SL / 02366 1.0 barley, wheat 500 g/L and rye (un- dersown with grass) 2.0 winter barley, spring barley, Page 12 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Formu- Authori- Currently Re- Comments / Other Member lation Product sation registered Use(s) quested relevant details on State Type / No. rate(s) rate(s) GAPs Conc. winter oat, spring wheat 2.5 winter wheat and rye 2.8 apple and pear – around the base of the tree 3.3 amenity and established grassland Depitox SL / 02365 1.0 barley, wheat 500 g/L and rye (un- dersown with grass) 2.0 winter barley, spring barley, winter oat, spring wheat 2.5 winter wheat and rye 2.8 apple and pear – around the base of the tree 3.3 amenity and established grassland Dio- SL / 02719 1.0 barley under- Weed 50 500 g/L sown, oat un- dersown, wheat under- sown 2.0 winter barley, winter oat, spring wheat, spring barley 2.5 winter wheat, winter rye 3.3 amenity grassland, grassland Herbox- SL / 02416 1.0 barley, wheat one 500 g/L and rye (un- dersown with grass) 2.0 winter barley, spring barley, winter oat, spring wheat 2.5 winter wheat and rye Page 13 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Formu- Authori- Currently Re- Comments / Other Member lation Product sation registered Use(s) quested relevant details on State Type / No. rate(s) rate(s) GAPs Conc. 3.3 amenity grassland established grassland Mortox SL / 02635 3.3 amenity grass- 50 500 g/L land, grassland * modified table; for registration purpose use standard table from template (Version April 2015, see Table 3.2-2a)

Table 3.2-2a: Standard table from dRR template (Version April 2015)

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

Description of the target pests Winter and spring cereals (use 1, 2): The target weeds Stellaria media, Matricaria spp., Viola spp. and Lamium spp. are some the most important and common annual dicotyledonous weeds in European small grain cereal production. The weeds germi- nate all the year and thus deploy their importance primarily in winter and spring cereals. The detrimental effects on yield of competition from weeds are well documented. Weeds compete directly with the crops for light, water and soil nutrients but may also exacerbate crop harvest as it is the case for example when weeds grow through lodging cereals. In addition, high weed densities support the microclimate for fungal infections. Yield loss depends on the weed species, the weed density, the length of the period of competition, the availability of water and nutrients. Overall, weed management is one of the key elements of cereal cropping.

Grassland (use 3): Grassland normally consists of 60% different grass varieties, 10 to 30% clover and 30% herbs. Some weeds (like: Ranunculus repens, Achillea millefolium, Plantago lanceolata) have a moderate to good nutritional value. According to their ingredients the flavour could be increased. Weeds in grassland are distinguished in poisonous plants (like: Ranunculus acris, Colchicum autumnale; parasitic plants, Orobanche minor) or plants which are not eaten by animals (like: Cirsium arvense, Urtica dioica, Lamium sp.). Accumulation of weeds in grassland occur mostly by management errors (high fertilization, early or through their frequent use, pest or diseases). The specific nature of weed control in grassland is to avoid the damage of desirable grass, clover and herbs.

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Glossary of pests mentioned in the dossier.

Table 3.2-3a: Target weed species which occurred in minimum effective dose and efficacy trials in winter and spring cereals:

EPPO code Scientific name Common name*

ARBTH Arabidopsis thaliana BRSNW Brassica napus (winter) CAPBP Capsella bursa-pastoris CHEAL Chenopodium album CIRAR Cirsium arvense GAETE Galeopsis tetrahit GASPA Galinsoga parviflora LAMAM Lamium amplexicaule MATCH Matricaria recutita POLCO Fallopia convolvulus STEME Stellaria media THLAR Thlaspi arvense VERAR Veronica arvensis VERHE Veronica hederifolia VERPE Veronica persica VIOAR Viola arvensis URTUR Urtica urens * optional

Table 3.2-3b: Target weed species which occurred in minimum effective dose and efficacy trials in grassland:

EPPO code Scientific name Common name*

ACHMI Achillea millefolium ANRSY Anthriscus sylvestris CAPBP Capsella bursa-pastoris CHEAL Chenopodium album CIRAR Cirsium arvense LAMPU Lamium purpureum MATCH Matricaria recutita PLALA Plantago lanceolata PLAMA Plantago major POLLA Persicaria lapathifolia Page 15 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

EPPO code Scientific name Common name*

POLAV Polygonum aviculare POLPE Persicaria maculosa POLSS Polygonum sp. RANAC Ranunculus acris RANRE Ranunculus repens RUMAC Rumex acetosa STEME Stellaria media TAROF Taraxacum officinale THLAR Thlaspi arvense TRFPR Trifolium pratense TRFRE Trifolium repens VERHE Veronica hederifolia VIOAR Viola arvensis URTDI Urtica dioica * optional

In Germany, the intended target weeds and crops can be classified as follows (Table 3.2-4):

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

Crop status Pest status Pests or group of pests Crop and/or situation controlled Major Minor Major Minor

DE dicotyledonous weeds* DE winter soft wheat (TTTDD)

DE winter barley CAPBPS, CHEAL, CI- winter rye DE RAR, GAETE, GALAP, LAMAM, spelt DE MATRE, POLCO, DE STEME, THLAR, winter durum wheat VERAR, VERHE, VI- winter triticale DE OAR winter oat DE spring soft wheat DE dicotyledonous weeds* DE (TTTDD) DE spring barley AMARE, CHEAL, spring rye DE GASPA, GAETE, spring durum wheat DE GALAP, MATIN, MERAN, POLCO, spring triticale DE POLPE, VERHE Page 16 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Crop status Pest status Pests or group of pests Crop and/or situation controlled Major Minor Major Minor

spring oat DE dicotyledonous weeds* DE grassland DE (TTTDD) * List single key weeds and/or most important weed species

Compliance with the Uniform Principles The overall assessment was performed according the uniform principles. Some data have been used from former registrations without GEP. These data are only for supportive use.

Information on trials submitted (3.1 Efficacy data)

Table 3.2-5: Presentation of trials (efficacy trials, preliminary trials...)

Number of trials GEP, Type Comments (any Crop(s) Tar- Coun- Year (number of valid trials) non-GEP, of other relevant in- * get(s)* try s offi- trial** Maritime formation) SE zone NE zone cial*** zone

MED + 2013 5 GEP E

Winter 2000 MED 6 GEP TTTDS DE cereals 2002 MED 2 GEP 1979- Only supportive E 32 Non GEP 2002 data MED + 2013 3 GEP E Spring TTTDS DE 2000 MED 6 GEP cereals 1979- Only supportive E 17 Non GEP 2002 data

Grass- 2013 MED 4 GEP TTTDD DE land 2013 E 8 GEP * According to GAP table. Timing of the application(s) can be added if relevant (e.g. Pre-mergence vs post-emergence, spring vs autumn). ** P = preliminary trial, MED = minimum effective dose, E = efficacy trial. *** GEP: Good Experimental Practices. Official: carried out by a national official organisation.

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Location of efficacy trials in winter cereals in Germany 2013 (use 1)

Location of efficacy trials in spring cereals in Germany 2013 (use 2)

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Location of efficacy trials in grassland in Germany 2013 (use 3)

Maps of supportive trials (1979-2002) are not available.

Table 3.2-6: Presentation of reference standards used in efficacy trials, 2013

Coun- Formulation Applica- try(ies) Regis- Authori- Active tion Reference where the tered ap- Re- Crop(s) zation sub- Concen- standard product is plication rate in tri- mark(4) number stance(s) Type(2) tration of registered (3) als (per a.s. rate (1) treatment)

TRZAW HORVW SECCW Duplosan Mecoprop- 2.0-3.0 TTLWI DE 3678-00 SC 600 g/L 2.0 L/ha KV P L/ha TRZSP TRZDW AVESW TRZAS Clopyralid HORVS Fluroxy- 80 g/l SECCS Ariane C DE 6218-00 pyr EC 100 g/l 1.5 L/ha 1.5 L/ha AVEFA Florasu- 2.5 g/l TTLSO lam TRZDS Page 19 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

NNNFW U 46 M- 1.5-4.0 DE 0939-00 MCPA SC 500 g/L 2.0 L/ha Fluid L/ha (1) only on use(s) applied for (with the test product). (2) e.g. WP (wettable powder), EC (emulsifiable concentrate), etc. (3) dose(s) / dose range authorized on that use in the country. (4) Other relevant information (e.g. uses, number of applications, spray volume, method of application, etc.).

3.2.1 Preliminary tests (KCP 6.1)

As 2,4-D is a well-known herbicidal active ingredient, first described in the 1940’s, range finding tests (laboratory or glasshouse and small scale field trials) are not required. It is therefore considered that further preliminary screening is not necessary, since the efficacy of the product is well established.

3.2.2 Minimum effective dose tests (KCP 6.2)

Winter cereals (use 1) There are 13 minimum effectives dose trials available, which were conducted in Germany in 2000 (6), 2002 (2) and 2013 (5). As reported by the applicant, trials were conducted by officially recognized organizations in accordance with the principles of Good Experimental Practice (GEP). Additional trials conducted in 1979-2002 without GEP were submitted for supporting reasons. The trials were performed according to the EPPO standards PP1/93, PP 1/225, PP1/152 and PP1/181. In 2000 and 2002 Spritz-Hormin 500 was tested at 1.5 L/ha (current registered application rate for winter cereals in Germany), 1.2 L/ha and 0.9 L/ha. In 2013 the dosages were 1.5 L/ha, 1.0 L/ha and 0.75 L/ha. In all minimum effective dose trials Spritz-Hormin 500 was applied once in spring at BBCH crop 23 to 30 by overall spray with a spraying volume of 300 L/ha. For information on trial design and assessments see Table 3.2-12.

In the five winter cereal trials performed in 2013, twelve different weed species were monitored and assessed at the last assessment 35 to 53 days after application (Table 3.2-8). Results of the trials from 2000- 2002 are described in Table 3.2-7.

Table 3.2-7: Efficacy of Spritz-Hormin 500 in minimum effective dose trials in winter cereals (maritime EPPO zone), 2000-2002*

Infestation in the Control Spritz-Hormin 500 (%) untreated con- Num- trol** 0.75 L/ha 1.0 L/ha 1.5 L/ha Target ber of (% ground cover) (50% N) (66% N) (N) trials Mea Min Max Mean Min Max Mean Min Max Mean Min Max n

ARBTH 2 - - - 86 75 97 91 83 99 91 83 99 Page 20 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

GALAP 3 - - - 0 0 0 4 0 12 19 0 42 LAMAM 1 - - - 87 - - 95 - - 88 - - MATIN 2 - - - 47 13 80 69 52 85 72 57 88 MYOAR 2 - - - 50 30 69 80 70 90 83 73 92 PAPRH 3 - - - 84 67 98 91 83 99 96 93 99 STEME 3 - - - 32 27 37 56 48 63 71 67 77 VERHE 1 - - - 92 - - 97 - - 98 - - VERPE 2 - - - 68 52 83 73 57 88 76 60 92 VIOAR 3 - - - 37 0 63 54 22 78 68 40 83 *modified table **not recorded

Table 3.2-8: Efficacy of Spritz-Hormin 500 in minimum effective dose trials in winter cereals (maritime EPPO zone), 2013*

Control Spritz-Hormin 500 (%) Infestation in the Num- untreated control 0.9 L/ha 1.2 L/ha 1.5 L/ha Target ber of (% ground cover) (60% N) (80% N) trials (N) Mean Min Max Mean Min Max Mean Min Max Mean Min Max

BRSNW 2 8.2 5.8 10.5 78 74 81 94 90 98 99 97 100 CAPBPs 2 7.0 3.5 10.5 55 37 71 71 48 94 85 71 100 CHEAL 2 15.4 15.0 15.8 74 74 74 89 84 95 100 100 100 GAETE 1 n. r. - - 0 - - 0 - - 6 - - LAMAM 2 n. r. - - 37 37 38 54 45 62 65 60 71 MATRE 4 n. r. - - 36 5 70 58 45 75 73 36 98 POLCO 1 12.0 - - 59 - - 80 - - 90 - - STEME 3 n. r. - - 37 0 64 44 6 69 62 13 99 THLAR 1 5.2 - - 64 - - 83 - - 93 - - VERAR 1 n. r. - - 4 - - 5 - - 11 - - VERHE 2 n. r. - - 16 0 33 21 0 43 31 5 58 VIOAR 1 n. r. - - 41 - - 58 - - 72 - - *modified table Page 21 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version n. r.: not recorded

The dose response data from the minimum effective dose trials indicate that the requested dosage is needed for a sufficient weed control in winter cereals and should not be reduced.

Spring cereals (use 2) There are nine minimum effective dose trails available which were conducted in Germany in 2000 (6) and 2013 (3). For information on trial design and assessments see Table 3.2-12. Trial and spraying conditions were similar to the trials in winter cereals (see above). However, efficacy was generally higher than in winter cereals, probably weeds were smaller and therefore more sensitive (Ta- ble 3.2-9 and 3.2-10).

Table 3.2-9: Efficacy of Spritz-Hormin 500 in minimum effective dose trials in spring cereals (maritime EPPO zone), 2013*

Control Spritz-Hormin 500 (%) Infestation in the untreated control Number 0.9 L/ha 1.2 L/ha 1.5 L/ha Target (% ground cover) of trials (60% N) (80% N) ( N)

Mean Min Max Mean Min Max Mean Min Max Mean Min Max

CAPBP 1 n. r. - - 94 - - 96 - - 100 - - CHEAL 3 n. r. 5.8 10.5 77 58 88 90 85 96 98 97 100 CIRAR 1 n. r. - - 45 - - 58 - - 98 - - GASPA 1 n. r. - - 23 - - 38 - - 55 - - STEME 2 7.4 2.5 12.3 69 65 74 72 64 80 74 60 89 THLAR 2 7.3 6.0 8.5 74 65 84 86 73 99 98 98 99 URTUR 1 n. r. - - 70 - - 80 - - 75 - - *modified table n. r.: not recorded

Table 3.2-10: Efficacy of Spritz-Hormin 500 in minimum effective dose trials in spring cereals (maritime EPPO zone), 2000*

Control Spritz-Hormin 500 (%) Infestation of the untreated con- Number 0.75 L/ha 1.2 L/ha 1.5 L/ha Target trol** (unit) of trials (50% N) (80% N) (N)

Mean Min Max Mean Min Max Mean Min Max Mean Min Max

AMARE 1 - - - 87 - - 96 - - 98 - - CENCY 5 - - - 74 37 95 86 47 97 91 53 100 CHEAL 6 - - - 96 90 100 99 95 100 100 100 100 Page 22 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Control Spritz-Hormin 500 (%) Infestation of the untreated con- Number 0.75 L/ha 1.2 L/ha 1.5 L/ha Target trol** (unit) of trials (50% N) (80% N) (N)

Mean Min Max Mean Min Max Mean Min Max Mean Min Max

CIRAR 1 - - - 52 - - 92 - - 100 - - GASPA 1 - - - 85 - - 95 - - 98 - - GAETE 1 - - - 43 - - 60 - - 67 - - GALAP 4 - - - 36 0 75 45 0 80 59 17 89 GERPU 1 - - - 87 - - 95 - - 97 - - MATIN 1 - - - 73 - - 82 - - 88 - - MERAN 2 - - - 93 80 85 88 87 89 94 94 95 PAPRH 1 - - - 0 - - 0 - - 10 - - POLCO 1 - - - 87 - - 95 - - 97 - - POLPE 2 - - - 98 97 98 100 100 100 100 100 100 SINAR 4 - - - 98 94 100 100 100 100 100 100 100 SINAL 2 - - - 92 90 93 96 95 96 99 98 100 VERHE 1 - - - 50 - - 60 - - 63 - - VERPE 1 - - - 92 - - 93 - - 95 - - VIOAR 1 - - - 0 - - 0 - - 0 - - *modified table ** not recorded

The dose response data from the minimum effective dose trials indicate that the requested dosage is needed for a sufficient weed control in spring cereals and should not be reduced.

Grassland (use 3) There were four minimum effective dose trials conducted in Germany in 2013. For information on trial design and assessments see Table 3.2-19. The results of the dose rates 1.5 L/ha - 0.9 L/ha are in line with the trials in winter and spring cereals. There are only few data available but there is a clear dose-response also for those weed species which are more frequent on grassland (Table 3.2-11).

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Table 3.2-11: Efficacy of Spritz-Hormin 500 in minimum effective dose trials in grassland (maritime EPPO zone), 2013*

Control Spritz-Hormin 500 (%) Infestation of the untreated control Number 0.9 L/ha 1.2 L/ha 1.5 L/ha Target (unit) of trials (60% N) (80% N) (N)

Mean Min Max Mean Min Max Mean Min Max Mean Min Max

ANRSY 1 n. r. - - 0 - - 0 - - 0 - - CAPBP 1 n. r. - - 100 - - 100 - - 100 - - MATCH 1 n. r. - - 63 - - 69 - - 78 - - PLALA 3 n. r. 3.0 8.8 84 62 96 93 79 100 97 93 100 PLAMA 1 n. r. - - 100 - - 100 - - 100 - - POLLA 1 n. r. - - 66 - - 99 - - 94 - - POLPE 1 4.5 - - 86 - - 93 - - 94 - - RANAC 2 n. r. - - 52 11 93 70 46 95 73 46 100 RUMAC 1 n. r. - - 100 - - 100 - - 100 - - STEME 1 1.8 - - 53 - - 95 - - 98 - - TAROF 4 n. r. - - 44 13 100 58 31 100 69 42 100 THLAR 1 n. r. - - 100 - - 100 - - 100 - - TRFPR 2 n. r. - - 39 9 100 42 11 94 51 23 94 URTDI 1 n. r. - - 0 - - 0 - - 0 - - *modified table n. r.: not recorded

The dose response data from the minimum effective dose trials indicate that at least only for a few weed species (e.g. PLALA) the requested dosage is needed for a sufficient weed control in grassland and should not be reduced.

Summary and conclusions - minimum effective dose The trial data demonstrate that the intended dosage of 1.5 L/ha U 46 D Fluid should not be reduced for a sufficient weed control as far as the herbicide is applied alone. However, a high efficacy even at the full dosage was only achieved in very few cases. This is true for winter cereals (use 1), spring cereals (use 2) and grassland (use 3).

3.2.3 Efficacy tests (KCP 6.2)

Winter cereals (use 1) A total of five trials were carried out to evaluate the efficacy of Spritz-Hormin 500 for the control of dicotyledonous weeds in winter cereals. Additionally 32 trials were performed in 1979 - 2002 (20 trials in winter wheat, 7 trials in winter barley and 5 trials in winter rye). These trials are only supportive.

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The five trials in winter cereals (all trials in winter wheat) were conducted in Germany in 2013. The intended target application rate (1.5 L/ha Spritz-Hormin 500 equivalent to 750 g a.s./ha; designation in the trial reports: U46 D Fluid) was tested in all trials in comparison to the standard reference product Duplosan KV at registered application rate of 2.0 L/ha. All reported trials were conducted by officially recognized organizations in accordance with the Principles of Good Experimental Practice (GEP). The trials were performed according to EPPO standards PP1/93, PP1/152 and PP1/181. For more information on trial design see Table 3.2-12.

Table 3.2-12: Details on trial methodology in winter cereals, trials of 2013

Guidelines General guidelines PP 1/152(2/3), PP 1/181(4) Specific guidelines EPPO PP 1/93(3) Experimental Plot design RCBD (4) design Plot size 15 m2 - 24 m2 Number of replications 4 Crop Trials per crop winter wheat (5) Varieties per crop winter wheat: Kerubino (1), Matrix (2), Cubus (1), Potenzial (1) Sowing period winter wheat: 23.01.2012; 28.09.2012; 05.10.2012; 01.11.2012: 03.05.2013 Application Crop stage (BBCH) at winter wheat: BBCH 23 - 30 application Timing Post-emergence Pest stage at CHEAL (BBCH 13-51), LAMAM (15-30), MATCH (15-30), STEME application (1) (10-61), VERHE (15-51), BRSNW (13-55), CAPBP (19-51), POLCO (10-12), VERAR (14), GAETE (10), THLAR (30-61), VIOAR (14-21) Number of 1 (all trials) applications Intervals between applications Spray volumes 300 L/ha Assessment Assessment types Percentage (%) of weed coverage compared to untreated Assessment dates 22 DAT - 55 DAT Other rele- e.g. Soil type, pH (in Not reported vant infor- case of soil active mation substance …)

The efficacy data of 2013 are presented in Table 3.2-13.

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Table 3.2-13: Efficacy of Spritz-Hormin 500 in winter cereals (maritime EPPO zone), 2013*

Control (%) Infestation in the No of trials untreated control Number Spritz-Hormin 500 Duplosan KV where product Target (% ground cover) is >, <, = com- of trials (1.5 L/ha) (2.0 L/ha) pared to standard(s)** Mean Min Max Mean Min Max Mean Min Max

BRSNW 2 15.1 12.5 17.8 99 97 100 100 100 100 CAPBP 2 7.0 3.5 10.5 85 71 100 89 79 100 CHEAL 2 15.4 15.0 15.8 100 100 100 100 100 100 GAETE 1 3.5 - - 6 - - 48 - - LAMAM 2 5.6 4.0 7.2 65 60 71 29 0 58 MATCH 4 12.0 5.8 18.8 79 36 98 81 0 90 POLCO 1 12.0 - - 90 - - 95 - - STEME 3 7.3 6.5 12.5 75 13 99 98 83 100 THLAR 1 5.3 - - 93 - - 79 - - VERAR 1 3.3 - - 11 - - 73 - - VERHE 2 6.1 4.5 7.8 31 5 58 86 74 99 VIOAR 1 6.5 - - 72 - - 1 - - *modified table **optional

In Table 3.2-14 the supportive efficacy trials from 1979-2002 are presented. The data consists of a mixture of data in winter and spring cereals, which is not acceptable for registration purpose. Minimum and maximum values have not been reported. The infestation in the untreated control is missing as well. Due to the incomplete dataset and missing GEP, these data are only for supportive use.

Table 3.2-14: Efficacy of Spritz-Hormin 500 in winter and spring cereals (maritime EPPO zone), 1979 - 2002*

Control (%) Infestation in the Num- untreated control** No of trials Spritz-Hormin 500 where product is Target ber (% ground cover) Reference product (1.5 L/ha) >, <, = compared of trials to standard(s)*** Mean Min Max Mean Min Max Mean Min Max

ANTAR 1 - - - 57 - - 94 - - ARBTH 2 - - - 91 - - 96 - - BRSNW 1 - - - 95 - - 100 - - CENCY 6 - - - 91 - - 91 - - CHEAL 11 - - - 99 - - 98 - - CHEHY 1 - - - 100 - - 100 - - Page 26 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

CIRAR 3 - - - 89 - - 82 - - GAETE 3 - - - 60 - - 73 - - GALAP 29 - - - 43 - - 72 - - GERPU 1 - - - 97 - - 96 - - LAMAM 3 - - - 69 - - 91 - - LAMPU 1 - - - 73 - - 90 - - MATCH 2 - - - 94 - - 93 - - MATIN 7 - - - 82 - - 90 - - MERAN 3 - - - 94 - - 93 - - MYOAR 3 - - - 83 - - 87 - - PAPRH 13 - - - 85 - - 83 - - POLAV 5 - - - 99 - - 96 - - POLCO 11 - - - 87 - - 89 - - POLLA 2 - - - 99 - - 98 - - POLPE 2 - - - 100 - - 100 - - RAPRA 3 - - - 98 - - 99 - - SINAL 3 - - - 99 - - 66 - - SINAR 6 - - - 99 - - 99 - - SONAR 1 - - - 100 - - 100 - - STEME 13 - - - 67 - - 68 - - VERHE 11 - - - 88 - - 83 - - VERPE 6 - - - 80 - - 87 - - VIOAR 7 - - - 64 - - 68 - - *modified table **not recorded ***optional

Finally, the results from 1979 - 2013 show a sufficient weed control for some weed species relevant for winter cereals (e. g CHEAL, BRSNW, MERAN, POLCO, SINAR and VERHE).

The following Table 3.2-15 is optional. It should be used for an orthogonal comparison between the test product and the reference standard. In case of the present application a comparison is not possible because of missing data.

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Table 3.2-15: Comparison between the test product and the reference standard *

% of control Number

of trials Test product Standard 1 Standard 2

Average of all trials with test product and the -

reference standards Orthogonal comparison, with main reference - product *optional

Spring cereals (use 2) For spring cereals data of three efficacy trials are available which were conducted in 2013 in Germany. Additionally 17 trials (nine trials in spring wheat and eight trials in spring barley) were performed in Ger- many in 1979 - 2002. These trials are only supportive. The intended target application rate of 1.5 L/ha of Spritz-Hormin 500, equivalent to 750 g a.s./ha, was tested in comparison to the standard reference product at registered application rate. For the application a backpack or bicycle sprayer was used to supply the spray volume of 300 L/ha. As reference product 1.5 L/ha Ariane C was applied (80 g/L Clopyralid + 100 g/L Fluroxypyr + 2.5 g/L Florasulam).

Table 3.2-16: Details on trial methodology in spring cereals, trials of 2013

Guidelines General guidelines PP 1/152(2/3), PP 1/181(4) Specific guidelines EPPO PP 1/93(3) Experimental Plot design RCBD (4) design Plot size 15 m2 - 24 m2 Number of replications 4 Crop Trials per crop spring barley (2), spring rye (1) Varieties per crop spring barley: Quench (1), Propino (1) spring rye: Arates (1) Sowing period spring barley: 20.04.2013; 14.04.2013 spring rye: 11.04.2013 Application Crop stage (BBCH) at spring barley: BBCH 15 - 27 application spring rye: BBCH 29 Timing Post-emergence Pest stage at CHEAL (BBCH 10-16), GASPA (12-13), STEME (15-23), URTUR (12- application 14), CAPBP (25-28), CHEAL (23-25), THLAR (12-28), CIRAR (12-13) Number of 1 (all trials) applications Intervals between applications Spray volumes 300 L/ha Assessment Assessment types Percentage (%) of weed coverage compared to untreated Assessment dates 40 DAT - 50 DAT Page 28 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Other rele- Soil type, pH (in case spring barley: sandy loam (1), sand (1) vant infor- of soil active substance spring rye: sandy loam (1) mation …)

The results of the efficacy data from 2013 are presented in Table 3.2-17.

Table 3.2-17: Efficacy of Spritz-Hormin 500 in spring cereals, (maritime EPPO zone), 2013*

Control (%) Infestation in the un- No of trials Num- treated control Spritz-Hormin 500 ARIANE C where prod- Target ber (% ground cover) uct is >, <, = (1.5 L/ha) (1.5 L/ha) of trials compared to standard(s)** Mean Min Max Mean Min Max Mean Min Max

CAPBP 1 9.5 - - 100 - - 100 - - CHEAL 3 8.6 5.8 10.5 98 97 100 50 43 55 CIRAR 1 4.5 - - 98 - - 99 - - GASPA 1 22.5 - - 55 - - 100 - - STEME 2 7.4 2.5 12.2 74 60 89 100 100 100 THLAR 2 7.3 6.0 8.5 98 98 99 75 53 98 URTUR 1 2.5 - - 75 - - 100 - - *modified table **optionals

Finally, the results from 2013 show a sufficient weed control for some of the recorded weed species relevant for spring cereals (e. g. CHEAL, THLAR). This assessment is supported by the additional efficacy data from 1979-2002 (see Table 3.2-14).

The following Table 3.2-18 is optional. It should be used for an orthogonal comparison between the test product and the reference standard. In case of the present application a comparison is not possible because of missing data.

Table 3.2-18: Comparison between the test product and the reference standard *

% of control Number

of trials Test product Standard 1 Standard 2

Average of all trials with test product and the -

reference standards Orthogonal comparison, with main reference -

product *optional

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Basing on the data given in cereals, the applicant suggests the following classification for the label of Spritz- Hormin 500:

Label claim appropriate Level of effectiveness Scientific name EPPO Code Susceptible to highly sus- 85-100% Arabidopsis thaliana ARBTH ceptible Cirsium arvense CIRAR Sonchus arvensis SONAR Capsella bursa-pastoris CAPBP Convolvulus arvensis CONAR Polygonum sp. POLSS Geranium pusillum GERPU Raphanus sp. RAPSS Thlaspi arvense THLAR Centaurea cyanus CENCY Chenopodium sp. CHESS Spergula arvensis SPRAR Vicia sp. VICSS Brassica napus (winter) BRSNW Sinapis sp. SINSS Veronica hederifolia VERHE Mercurialis annua MERAN Papaver rhoeas PAPRH Moderately susceptible 70-84.9% Fumaria officinalis FUMOF Matricaria recutita MATCH Matricaria inodora MATIN Myosotis arvensis MYOAR Lamium purpureum LAMPU Veronica persica VERPE Urtica urens URTUR Tolerant 0-69.9% Galeopsis sp. GAESS Lamium amplexicaule LAMAM Anthemis agrestis ANTAR Galium aparine GALAP Galeopsis parviflora GASPA Ranunculus sp. RANSS Rumex sp. RUMSS Tussilago farfara TUSFA Veronica arvensis VERAR Stellaria media STEME Viola arvensis VIOAR

Grassland (use 3) Efficacy data of eight trials conducted in Germany in 2013 were provided by the applicant. All reported trials were conducted by officially recognized organizations in accordance with the principles of Good Experimental Practice (GEP). The trials were performed according to the EPPO standards PP1/61, PP1/152 and PP1/181. In contrast to the uses in cereals, the application rate in the submitted efficacy trials is 2.0 L/ha Spritz-Hormin 500. This is due to the formerly requested dose rate of 2.0 L/ha in grassland. Due to the applicants’ letter dated on 2016/07/15, the application rate in grassland was reduced to 1.5 L/ha. Thus, efficacy trials at a dose rate of 2.0 L/ha are not relevant for the evaluation any longer. As reference standard 2.0 L/ha U 46 M-Fluid (500 g/L MCPA) were applied. For more information on trial design see Table 3.2-19.

Table 3.2-19: Details on trial methodology in grassland Guidelines General guidelines PP 1/152, PP 1/181 Page 30 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Specific guidelines EPPO PP 1/61(3) Experimental Plot design RCBD (4) design Plot size 15 m2 - 24 m2 Number of replications 4 Crop Trials per crop grassland (8) Varieties per crop Not relevant Sowing period n. r. Application Crop stage (BBCH)* at grassland: BBCH 25 - 29 application Timing Post-emergence Pest stage at TRFPR (BBCH 12-55), PLALA (14-69), RANAC (12-29), ANRSY (13- application (1) 15), TRFRE (25-69), TAROF (13-33), CAPBP (65), PLAMA (37-39), MATCH (61), POLAV (31-33), STEME (65), RUMAC (31-33), THLAR (65), CIRAR (14-16), ACHMI (55-61), POLAV (31-32) Number of 1 (all trials) applications Intervals between applications Spray volumes 300 L/ha Assessment Assessment types Percentage of weed control in relation to untreated Assessment dates 15 - 49 DAT Other rele- e.g. Soil type, pH (in Not reported vant infor- case of soil active mation substance …)

The few data indicate an acceptable and good control of Plantago species and Taraxacum officinale. Other weed species which are abundant on grassland like Ranunculus sp. are not fully affected by 2.0 L/ha Spritz- Hormin 500 (Table 3.2-20).

Table 3.2-20: Efficacy of Spritz-Hormin 500 in grassland (maritime EPPO zone), 2013.*

Control (%) No of tri- Infestation in the un- als where treated control Spritz-Hormin 500 U 46 M-Fluid product is Number (% ground cover) Target (2.0 L/ha) (2.0 L/ha) >, <, = of trials compared to stand- Mean Min Max Mean Min Max Mean Min Max ard(s)**

ACHMI 1 9.0 - - 90 - - 37 - - ANRSY 2 2.5 2.5 2.5 0 0 0 0 0 0 CAPBP 2 4.8 1.1 8.4 99 98 100 98 96 100 CIRAR 1 9.5 - - 0 - - 0 - - MATCH 2 12.5 12.5 12.5 75 73 78 75 75 75 Page 31 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

PLALA 6 5.5 2.5 11.3 99 85 100 99 48 100 PLAMA 2 2.8 2.8 2.8 100 100 100 100 100 100 POLAV 1 7.0 - - 89 - - 99 - - POLLA 2 2.0 0.9 3.1 94 94 95 83 73 94 POLPE 1 4.5 - - 94 - - 96 - - POLSS 1 8.3 - - 93 - - 96 - - RANAC 4 2.6 1.6 3.6 68 46 100 76 50 100 RUMAC 1 0.5 - - 100 - - 100 - - STEME 2 6.8 1.8 11.8 84 70 98 88 78 98 TAROF 7 5.7 0.7 20.0 88 25 100 62 25 100 THLAR 2 5.7 5.0 6.3 100 100 100 100 100 100 TRFPR 5 8.1 2.6 10.7 54 42 94 46 0 100 TRPRE 5 10.2 2.2 22.5 35 23 94 38 21 100 URTDI 1 7.0 - - 0 - - 0 - - *modified table **optional

Efficacy trials at an application rate of 1.5 L/ha have not been submitted. Thus, use 003 (grassland) is not supported by data. If the MED trials are taken into account, the only weed which is supported by adequate data is PLALA (see Table 3.2 11). The efficacy level of U 46 D Fluid on PLALA is acceptable. Therefore, the scope of the intended target should be limited to PLALA (Plantago lanceolata).

The following Table 3.2-21 is optional. It should be used for an orthogonal comparison between the test product and the reference standard. In case of the present application a comparison is not possible because of missing data.

Table 3.2-21: Comparison between the test product and the reference standard *

% of control Number

of trials Test product Standard 1 Standard 2

Average of all trials with test product and the -

reference standards Orthogonal comparison, with main reference - product *optional

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Proposed adapted label for re-registration of Spritz-Hormin 500 in grassland:

Weed species Label claim appropriate Level of effective- Scientific name EPPO Code ness Susceptible to highly 85-100% Rumex acetosa THLAR susceptible Thlaspi arvense RUMAC Juncus sp. IUNSS Capsella bursa-pastoris CAPBP Plantago sp. PLASS Polygonum sp. POLSS Taraxacum officinale TAROF Achillea millefolium ACHMI Allium vineale ALLVI Moderately susceptible 70-84.9% Ranunculus sp. RANSS Achillea millefolium ACHMI Geranium pratense GERPR Matricaria recutita MATCH Stellaria media STEME Tolerant 0-69.9% Rumex sp. RUMSS Heracleum sp. HERSS Cirsium arvense CIRAR Urtica sp. URTSS Tussilago farfara TUSFA Ranunculus acris RANAC Anthriscus sylvestris ANRSY Trifolium repens TRFRE Trifolium pratense TRFPR

Summary and conclusions – efficacy Winter and spring cereals (use 1, use 2) The efficacy data demonstrate a sufficient efficacy against some weed species relevant in winter and spring cereals. However, frequent species like Matricaria sp., Lamium sp. or Stellaria media are more or less tolerant against Spritz-Hormin 500. Therefore this herbicide is probably used as a mixing partner in cereals. Although not all crops were included in the trials, it can be assumed that the efficacy is comparable to other cereal crops because of similar growing and application conditions. In this case extrapolation is possible but has to be confirmed on national level. For some weeds which are described in the label as being controlled well, only a few or no efficacy results were submitted. Thus, the label should include a summary of weeds which can be controlled well, less well and insufficiently by the product.

Grassland (use 3) The only weed which is supported by adequate efficacy data is PLALA (Plantago lanceolata). Thus, the use should be limited to PLALA. In contrast to EPPO standard PP1/207 there are no efficacy data assessed in the following year. Consequently there is no clear proof on a sustainable control of perennial weeds. This should be addressed on the label.

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Yield (and relevant quality indicators), from efficacy trials (in the presence of challenging pest populations)

Winter cereals (use 1): In 18 efficacy trials (1979-2002) in winter barley, winter wheat and winter rye performed in Germany, yield was assessed. Except one trial conducted 1979 in winter rye, there was no clear negative yield effect (Table 3.2-22).

Table 3.2-22: Yield (quantity) effect of Spritz-Hormin 500 in efficacy trials in winter cereals (maritime EPPO zone), 1979-2002*

% yield relative to untreated No of tri- Untreated control** als where Spritz-Hormin 500 Num- (t/ha) Reference product product (1.5 L/ha) Crop ber of Year is >, <, = trials compared Mean Min Max Mean Min Max Mean Min Max to standard(s)***

Winter 1 1995 - - - 100 - - 101 - - barley 4 2000 - - - 102 - - 107 - - 4 1979 - - - 108 - - 107 - - 2 1993 - - - 95 - - 101 - - 1 1994 - - - 95 - - 94 - - Winter 1 1995 - - - 106 - - 105 - - wheat 1 1998 - - - 104 - - 111 - - 2 2000 - - - 107 - - 119 - - 1 2001 - - - 125 - - - - - Winter 1 1979 - - - 88 - - 98 - - rye *modified table **not recorded ***optional

Compared to untreated, the yield ranged from 88% to 125% which was similar to the effect of the reference standard (except for the trial in winter rye).

Spring cereals (use 2): In seven efficacy trials in spring barley and spring wheat, performed in Germany in 1979-2002, yield was assessed (Table 3.2-23).

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Table 3.2-23: Yield (quantity) effect of Spritz-Hormin 500 in efficacy trials in spring cereals (maritime EPPO zone)*

% yield relative to the untreated No of trials Untreated control** where product Num- Spritz-Hormin (t/ha) Reference product is >, <, = com- Crop ber of Year 500 (1.5 L/ha) trials pared to stand- Mean Min Max Mean Min Max Mean Min Max ard(s)***

Spring 2 1993 - - - 94 - - 91 - - barley 1 1994 - - - 102 - - 109 - - 1 1979 - - - 104 - - 103 - - Spring 2 1993 - - - 109 - - 96 - - wheat 1 2002 - - - 95 - - 102 - - *modified table **not recorded ***optional

Compared to untreated, the yield ranged from 95% to 109% which was similar to the effects caused by the reference standard.

Grassland (use 3) The applicant did not provide any yield data of efficacy trials from grassland.

Summary and conclusions - yield (efficacy trials) Winter cereals (use 1): The yield of the tested winter cereals in the efficacy trials ranged from 88% to 125%. The submitted data are very limited for spelt (TRZSP), winter durum wheat (TRZDW) and winter oat (AVESW), which were not yet registered but which are now intended. This issue is discussed in combination with possible phytotoxicity effects (3.4.1).

Spring cereals (use 2): The effects on spring cereals are similar to the findings in winter cereals. So far, Spritz-Hormin 500 was not registered for oat but the risk is already known from other herbicides containing 2,4-D. Therefore, a warning on possible yield loss should be put on the label. The submitted data are very limited for spring durum wheat (TRZDS), spring triticale (TTLSO) and spring oat (AVESA), which were not yet registered but which are now intended: This issue is discussed in combination with possible phytotoxicity effects (3.4.1).

Grassland (use 3): The applicant did not provide any yield data of efficacy trials from grassland.

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

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The herbicide Spritz-Hormin 500 contains the active substance 2,4-D. 2,4-D works as such as synthetic auxins. Due to its primary target site and its chemical family, 2,4-D is classified as group O herbicide in the HRAC mode of action classification. Although the mechanism of resistance of group O herbicides has not been determined, resistance may be due to an insensitive target site.

Evidence of resistance and cross resistance Against group O herbicides, 32 weed species have developed resistance as demonstrated by the international survey of herbicide resistant weeds (www.weedscience.org, November 2016). For 29 biotypes resistance against 2,4-D has been detected. Due to higher impact of 2,4-D and other synthetic auxins on the metabolism of dicotyledonous, more cases of resistance have been observed for this group of actives. Among the species resistant to synthetic auxin and 2,4-D herbicides in Europe are: Centaurea cyanus [dicamba; Poland], Cirsium arvense [MCPA and 2,4-D; Sweden, Hungary], Stellaria media [Mecoprop; UK] and Papaver rhoeas [2,4-D; Spain, Italy]. Weed species resistant to one active ingredient from HRAC group O may also be resistant to other actives from this group as indicated by several weed species with resistance to multiple actives from group O. In Europe, cases of multiple resistance including HRAC group O and group B herbicides are reported for biotypes of Papaver rhoeas in Spain and Italy.

Analysis of the inherent risk As some cases of resistance to 2,4-D are reported on Europe, the inherent risk of 2,4-D can be classified as medium. The key target organisms of Spritz-Hormin 500 are annual broad-leaved weeds in cereals and grassland. The target species in cereals include some species against which resistance has already been detected in Europe. Regarding the target species in grassland, only Cirsium arvense can be regarded as a high risk species. The applicant has not provided any data on the variation of sensitivity because the active substance has been used commercially in Europe for many years without any reported cases of reduced activity in field trials.

Agronomic risk The herbicide is intended to be used in against dicotyledonous species post-emergent in winter and spring cereals and in grassland. In a typical crop rotation scheme in Central Europe, cereals can be rotated with dicotyledonous crops in which 2,4-D cannot be applied. However, crop rotations consisting solely of cereal crops are also not uncommon. In these rotations, the application frequency of Spritz-Hormin 500 or other active substances from the HRAC group O and therefore the selection pressure might be enhanced. The same applies for the intended use in grassland. 2,4-D is usually applied in addition to other herbicides to close effectiveness gaps. However, the design of the respective crop rotations and the associated frequency of application of Spritz-Hormin 500 may differ in the various Member States in the Central Zone and a national-specific assessment of the agronomic risk is therefore recommended. Within one year, the number of treatments applied of Spritz-Hormin 500 is limited to one. This limits selection pressure and the risk of resistance development. There are other active substances available with alternative MoA controlling key target weeds (ALS inhibitors, bifenox, IPU, CTU, pendimethalin, pico- linafen).

Management strategy The applicant has provided a management strategy that is based on upon Good Agricultural Practices (GAP).

Summary and conclusions - resistance The evaluation on herbicide resistance indicates a medium inherent and agronomic risk of resistance development for Spritz-Hormin 500 for use in cereals and a low risk for use in grassland. The applicant has not provided any information on the individual inherent and agronomic resistance risk within the different Member States in the Central zone. Page 36 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

3.4 Adverse effects on treated crops (KCP 6.4)

Table 3.4-1: Presentation of trials (selectivity trials, transformation trials...)

Number of trials GEP, non- Comments (any Type of Crop* Country Years GEP, offi- other relevant trial** Maritime Mediterranean cial*** information) zone zone

winter 1996-2002 Germany S 8 cereals spring 1996-2002 Germany S 13 cereals grassland Germany S 2 2002 * According to the GAP table ** S = selectivity trial, Y = trial with yield assessment, Q = trial with quality assessment, T = trial on the basis of the study of impact on transformation process (TP: Physical transformation, TF: transformation involving microbial fermentation), P = trial with assessment of impact on propagation *** Official: carried out by a national official organisation

Table 3.4-2: Presentation of reference standards used in trials (selectivity trials, transformation trials...)

Coun- Formulation Applica- Refer- Active Registered try(ies) Authori- tion Crop/ ence sub- applica- Re- where the zation Concen- s stand- stance(s) tion rate in tri- mark(4) product is number Type(2) tration of als (per ards (a.s) rate(3) registered(1) a.s. treatment)

Winter U 46 M- Germany 0939-00 MCPA WG 500 g/L 1.5 L/ha 1.5 L/ha cereals Fluid 3.0 L/ha Spring U 46 M- Germany 0939-00 MCPA WG 500 g/L 1.5 L/ha 1.5 L/ha cereals Fluid 3.0 L/ha (1) only on use(s) applied for (with the test product) (2) e.g.WP (wettable powder), EC (emulsifiable concentrate), etc. (3) Dose / dose range authorized in the country (4) Other relevant information (e.g. uses, number of applications, spray volume, method of application…)

3.4.1 Phytotoxicity to host crop (KCP 6.4.1)

Winter cereals (use1)

Efficacy trials The crop phytotoxicity of Spritz-Hormin 500 was determined in all efficacy trials in winter cereals. For detailed information on materials and methods see Table 3.2-12.

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Table 3.4-3: Phytotoxicity at single (N) application rate in efficacy trials (maritime EPPO zone), 1979-2002 *

Mean Phytotoxicity [%] Max. Phytotoxicity [%] Number Crop Spritz-Hormin 500 Reference product Spritz-Hormin 500 Reference product of trials (1.5 L/ha) (1.5 L/ha) (1.5 L/ha) (1.5 L/ha)

Winter barley 8 1 1 5 7 Winter wheat 20 1 1 10 12 Winter rye 6 2 4 8 11 *modified table; for registration purpose use standard table from template (Version April 2015, see Table 3.4-3a).

Table 3.4-3a: Standard table from template (Version April 2015)*

Selectivity trials (20 trials) Efficacy trials (x trials)

Test product Standard 1 Test product Standard 1 Number of trials with… 2N (or N N 2N (or other) N N other)

Maximum of phy- 0% to 5% totoxicity recorded >5% to 10% during the trials >10% to 15% >15% Level of symptoms 0% to 5% at the last assess- >5% to 10% ments >10% to 15% >15% * cannot be filled due to missing data

In five minimum effective dose trials of 2013, phytotoxicity did not occur. In 34 efficacy trials performed in Germany in 1979 - 2002, slight and transient phytotoxicity was observed. The reference standard showed higher phytotoxic symptoms at 1.5 L/ha on average 34 efficacy trials compared to Spritz-Hormin 500.

Selectivity trials Phytotoxicity assessments were carried out in Germany in 1996-2002 according to EPPO standard PP1/135 (each 2 trials of winter barley, winter wheat, triticale and winter rye at single (N), double (2 N) and triple (3 N) application rate. Any visible symptoms were quantified and described (i.e. phytotoxicity as % of total leaf area affected by chlorosis and necrosis). Any other symptom of plot differences observed was assessed by a scale appropriate to symptom.

In eight selectivity trials phytotoxic symptoms have not been detected.

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Spring cereals (use 2)

Efficacy trials The crop phytotoxicity of Spritz-Hormin 500 was determined in all efficacy trials in spring cereals. For detailed information on materials and methods see Table 3.2-12.

Table 3.4-4: Phytotoxicity at single (N) application rate in efficacy trials (maritime EPPO zone), 1979-2002

Num- Mean Phytotoxicity [%] Max. Phytotoxicity [%] ber Crop Spritz-Hormin 500 Reference product Spritz-Hormin 500 Reference product of (1.5 L/ha) (1.5 L/ha) (1.5 L/ha) (1.5 L/ha) trials spring barley 8 1 2 6 15 spring wheat 9 2 1 8 3 *modified table; for registration purpose use standard table from template (Version April 2015, see Table 3.4-3a).

In 17 efficacy trials performed in Germany, slight phytotoxicity was observed up to 6% in spring barley and up to 8% in spring wheat. On average, the reference standard showed comparable phytotoxicity.

Selectivity trials Phytotoxicity assessments were carried out according to EPPO standard PP1/135 (spring barley (10), spring wheat (1) and spring oat (2), at single (N), double (2 N) and triple (3 N) application rate in the maritime EPPO zone, 1996-2002.)

Table 3.4-5: Phytotoxicity at single (N) / double (2 N) and triple (3 N) application rate in selectivity trials (maritime EPPO zone), 1996-2002

Phytotoxicity [%] (max. in [%]) Number Crop Spritz-Hormin 500 (L/ha) Reference product (L/ha) of trials 1.5 (N) 3.0 (2 N) 4.5 (3 N) 1.5 (N) 3.0 (2 N) 4.5 (3 N) 8 0 (0) -- 6 (13) 0 (0) -- 4 (8) Spring barley 2 6 (6) 10 (13) -- 2 (4) 4 (6) -- Spring wheat 1 7 (11) 11 (11) -- 0 (0) 4 (4) -- Spring oat 2 16 (18) 23 (25) -- 2 (3) 5 (6) -- *modified table; for registration purpose use standard table from template (Version April 2015, see Table 3.4-3a).

After the application of the target (1.5 L/ha) and the double dose rate (3.0 L/ha) of Spritz-Hormin 500, phytotoxicity was visible only for a short time but on a higher level than the reference product. Especially on oat, stunting and curling on plants was clearly visible. These assessments are in line with the yield data (see above). Therefore a specific warning for oat regarding possible crop damage and yield loss should be put on the label.

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Grassland (use3)

Efficacy trials Phytotoxicity assessments were carried out according to EPPO standard PP1/135. Phytotoxicity was assessed in all 4 minimum effective dose trials and 8 efficacy trials in 2013. Crop safety was assessed as percentage of crop damage on a plot basis.

The applicant mentioned that in none of the efficacy and minimum effective dose trials any sign of phytotoxicity has been observed at any assessment timing.

Selectivity trials The selectivity of Spritz-Hormin 500 was assessed in 2 selectivity trials. In the pasture of both trials in all treatments weak chlorosis and necrosis were visible. The symptoms became more intense from the first assessment (6-8 days after application) to the last assessment (26-28 days after application) in all plots (treated and control plots). In the untreated plots symptoms of phytotoxicity also appeared. Therefore, these symptoms cannot attribute to the selectivity of Spritz-Hormin 500. The pasture showed heavy lodging in all tested plots of both trials (Table 3.4-6). There was the highest damage in the double dose rate of Spritz-Hormin 500. Since even in the untreated control lodging appeared the lodging is not related to the application of Spritz-Hormin 500. No findings regarding crop vigour reduction were visible in any of the tested plots of both trials.

Table 3.4-6: Phytotoxicity in weed-free selectivity trials (maritime EPPO zone), 2002* Num- Grassland ber Days after Reference of treatment Untreated Spritz-Hormin 500 product trials -- 2.0 L/ha 4.0 L/ha 2.0 L/ha Chlorosis / Necrosis [%] Mean 2 6-8 0.4 1.1 1.4 1.3 Min. 0 1 1 1 Max. 1 2 2 2

Mean 2 14-15 2.8 3 3.5 3.5 Min. 1 1 2 3 Max. 4 5 5 4

Mean 2 26-28 5.7 6.1 7.1 7.1 Min. 2 2 2 2 Max. 10 12 12 12 Lodging [%] Mean 2 6-8 0.5 9.5 19.50 9 Min. 0 5 10 0 Max. 5 15 30 20

Mean 2 14-15 39.5 54 63 60.5 Min. 20 30 40 40 Max. 60 85 80 75

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*modified table; for registration purpose use standard table from template (Version April 2015, see Table 3.4-3a)

The data did not indicate any relevant negative effects of Spritz-Hormin 500 on treated grassland.

Summary and conclusion - Phytotoxicity to host crop Winter cereals (use 1) In 34 efficacy trials performed in Germany in 1979 - 2002, slight and transient phytotoxicity was observed. The reference product showed higher phytotoxic symptoms at 1.5 L/ha on average of 34 efficacy trials compared to Spritz-Hormin 500. Eight selectivity trials did not show any phytotoxic symptoms. The submitted data are very limited for spelt (TRZSP), winter durum wheat (TRZDW) and winter oat (AVESW) which were not yet registered but which are now intended. Because of the limited data set, a warning on possible phytotoxicity and yield reduction should be addressed to these cereals as well.

Spring cereals (use 2) In spring cereals, phytotoxicity was visible after the application of the target application rate of 1.5 L/ha and the double dose rate of 3.0 L/ha. Especially on oat, stunting and curling on plants was clearly visible. These assessments are in line with the yield data (see above). No data are available for spring triticale (TTLSO) and spring durum wheat (TRZDS). Because of the limited data set, a warning on possible phytotoxicity and yield reduction should also be addressed also on these cereals.

Grassland (use 3) The data did not indicate any negative effects of Spritz-Hormin 500.

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

Winter cereals (use1): 5 of 8 selectivity trials were harvested and did not show any negative effects on the yield of winter cereals (Table 3.4-7). In some cases the yield was even higher than in untreated but the applicant did not give any explanation for this.

Table 3.4-7: Relationship between phytotoxicity and yield. Yield effect in weed-free selectivity trials (maritime EPPO zone), 2002*

Maximum phyto. Maximum phyto. Yield Yield (%) (%) Yield % of untreated % of untreated Num- untreated crop ber of 1N** 2N** 1N 2N control trials Test Standard Test Stand- (dt/ha) Test Stand- Test Stand- product 1 product ard 1 product ard 1 product ard 1

Winter 1 - - - - 83.5 101 95 98 100 barley Winter 2 - - - - 67.9 100 105 103 108 wheat Winter 1 - - - - 87.4 113 104 110 114 rye Page 41 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Triti- 1 - - - - 80.1 109 116 108 106 cale *modified table; for registration purpose use standard table from template (Version April 2015, see Table 3.4-7a) ** not recorded

Data are missing for winter durum wheat (TRZDW) and winter oat (AVESW).

Table 3.4-7a: Standard table from template (Version April 2015)*

Maximum phyto. Maximum phyto. Yield at 2N (or Yield at 1N as % at 1N rate (%) at 2N (or other) Yield in the other) rate as % of untreated (DAA) rate (%) (DAA) untreated con- of untreated Test Vari- trol report ety Test Stand- Test Stand- Absolute fig- Test Stand- Test Stand- prod- ard 1 product ard 1 ures (unit) product ard 1 product ard 1 uct

* cannot be filled due to missing data

Spring cereals (use 2): Eleven selectivity trials in spring barley and spring wheat did not show any yield reducing effects (Table 3.4-8 and 3.4-9).

Table 3.4-8: Yield effect in weed-free selectivity trials (maritime EPPO zone), 1996*

Yield Maximum phyto. Yield Maximum phyto. % of untreated 3N (or other) (%) Yield in the % of untreated 1N (%) (DAA)** 1N (DAA)** untreated 3N crop n control Absolute fig- Test Stand- Test Stand- ures (dt/ha) Test Stand- Test Stand- prod- ard 1 product ard 1 product ard 1 product ard 1 uct

Spring 8 - - - - 56.2 100 92 103 95 barley *modified table; for registration purpose use standard table from template (Version April 2015, see Table 3.4-7a). ** not recorded

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Table 3.4-9: Yield effect in weed-free selectivity trials (maritime EPPO zone), 2002*

Maximum phyto. Maximum phyto. Yield at 1N as % Yield at 2N rate at 1N rate (%) at 2N rate (%) Yield in the of untreated as % of untreated (DAA)** (DAA)** untreated crop n control Test Stand- Test Stand- Absolute fig- Test Stand- Test Stand- prod- ard 1 product ard 1 ures (dt/ha) product ard 1 product ard 1 uct

Spring 2 - - - - 40.0 112 108 110 112 barley Spring 1 - - - - 56.1 107 103 105 104 wheat Spring 2 - - - - 62.7 87 83 102 104 oat *modified table; for registration purpose use standard table from template (Version April 2015, see Table 3.4-7a). ** not recorded

Spring oat was - in contrast to the reference herbicide - negatively affected by Spritz-Hormin 500. This risk is already known from herbicides containing 2,4-D and should be considered as a warning on the label.

Grassland (use 3) Two selectivity trials in grassland were carried out in the region of Bremen in Germany. The trials were laid out as completely randomized blocks with 4 treatments and 5 replicates. The plot size was 25 m2. The size of the harvested plot was 10 m2. The yield determination was performed with a one-wheel tractor with a mowing bar. Spritz-Hormin 500 was applied with the normal rate of 2.0 L/ha and with the double dose rate (4.0 L/ha). The fresh weight (dt/ha), dry matter content (%) as well as dry matter (dt/ha) were determined Table 3.2-10.

Table 3.4-10: Yield effect in weed-free selectivity trials in grassland (maritime EPPO zone), 2002

% yield relative to the untreated or absolute figures (unit) No of tri- Untreated control als where Num Absolute figures Spritz-Hormin 500 Spritz-Hormin 500 Reference product product Pa- ber (2.0 L/ha) (4.0 L/ha) (2.0 L/ha) rame- of is >, <, = ter tri- com- als pared to Mean Min Max Mean Min Max Mean Min Max Mean Min Max standard(s)**

fresh weight 2 84.3 73.0 95.0 116 90 142 103 63 141 100 85 115 [dt/ha] dry matter 2 31.5 27.8 35.3 116 92 138 110 83 143 105 93 116 content [%]A dry matter 2 25.8 12.5 36.3 126 105 209 115 61 159 102 51 124 [dt/ha] *modified table; for registration purpose use standard table from template (Version April 2015, see Table 3.4-10a). Page 43 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

**optional

Table 3.4-10a: Standard table from template (Version April 2015)*

Maximum phyto. at Maximum phyto. at Yield in the un- Yield at 1N as % of Yield at 2N (or other) 1N rate (%) (DAA) 2N (or other) rate untreated rate as % of untreated Test re- Vari- (%) (DAA) treated control port ety Absolute figures Test Standard Test prod- Standard (unit) Test Standard Test prod- Standard product 1 uct 1 product 1 uct 1

* cannot be filled due to missing data

The data demonstrate that there is no negative effect on the yield of grasses after an application of 2.0 L/ha and 4.0 L/ha Spritz-Hormin 500.

Summary and conclusion - Effect on the yield in selectivity trials Winter cereals (use 1) The selectivity trials did not indicate any significant yield losses, neither by the single nor the double dosage. The submitted data are very limited for winter durum wheat (TRZDW) and winter oat (AVESW).

Spring cereals (use 2) The data did not show yield reducing effects on spring barley and spring wheat but show a yield loss of more than 15% for spring oat. This should be addressed on the label. The submitted data are very limited for spelt (TRZSP).

Grassland (use 3) The data demonstrate that there were no negative yield effects after the application of 2.0 and 4.0 L/ha Spritz-Hormin 500.

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

The applicant did not provide any specific data or information concerning quality. However, based on the long-term experience of 2,4-D products, it can be assumed that 2,4-D is not expected to have any impact on the quality of plants and plant products.

3.4.4 Effects on transformation processes (KCP 6.4.4)

The applicant did not provide any specific data or information concerning processing. However, based on the long-term experience of 2,4-D products, it can be assumed that 2,4-D is not expected to have any impact on the processing procedure of plants and plant products.

3.4.5 Impact on treated plants or plant products to be used for propagation (KCP Page 44 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

6.4.5)

U 46 D Fluid resp. Spritz-Hormin 500 is not intended to be used on parts of plants for propagating purpose. After request, an appropriate indication will be given on the label or the registered uses (see revised GAP table).

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

3.5.1 Impact on succeeding crops (KCP 6.5.1)

The risk assessment for succeeding crops is based on a comparison of the PEC at the time of planting/sowing and the EC10 values of succeeding crops. The PECsoil-values are calculated under worst-case assumptions [dry soil bulk density: 1,1g/cm³; DT50 = 13.67 days for 2,4-D for 2 scenarios [shallow soil cultivation (5 cm cultivation depth) and deep soil cultivation (20 cm cultivation depth)]. Although the interception for the Post-emergence uses in cereals during leaf development phase is considered 25% according to EPPO standard PP1/207(2), an interception of 0% was used for calculation. The calculations show that the critical TER of ‘1’ is reached after shallow tillage (5 cm) by maize and spring oat already on the day of application. By winter barley this value is reached after 30 days, by pea, rape and sugar beet it is reached after 60 days (Table 3.5-1). After deep tillage (20 cm) a safe TER of >1 is already reached on the day of application by maize, winter barley and spring oat, after 30 days by pea, rape and sugar beet.

Table 3.5-1: PEC-values and TER-calculation of test product (active substance) based on EC10- values.

PEC(4) TER(5) Days after ap- EC10 Succeeding crop(1) plication(2) mg/kg soil(3) mg/kg soil mg/kg soil EC10/PEC EC10/PEC e.g. 5 cm e.g. 20 cm e.g. 5 cm e.g. 20 cm

HORVW 150 0.781 0.0007 0.0002 1151.16 4604.63 AVESA 360 1.747 1,61E-05 4,03E-06 1,08E+08 4,34E+08 ZEAMX 360 1.747 1,61E-05 4,03E-06 1,08E+08 4,34E+08 BRSNS 120 0.075 0.0030 0.0008 24.15 35.04 BEAVA 360 0.078 1,61E-05 4,03E-06 4,84E+06 1,94E+07 PIBSA 360 0.196 1,61E-05 4,03E-06 1,22E+07 4,87E+07 (1) possible following crops in a regular crop rotation (2) adequate value for following crop in a regular crop rotation (3) EC10-values of succeeding crops (4) PEC (soil depth e.g. 5/20 cm) (5) TER (soil depth e.g. 5/20 cm)

These results show that pea, sugar beet and rape are the most sensitive succeeding crops, followed by maize, winter barley and spring oat. After deep tillage pea, rape and sugar beet may be re-sown 30 days after application. The monocotyledonous crops barley, oat and maize are far less sensitive and may be replanted already on the day of application if deep tillage is done. Page 45 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Finally, the TER values do not indicate any risk for succeeding crops in a normal crop rotation.

Summary and conclusion - impact on succeeding crops Due to the short persistence for 2,4-D, the theoretical risk analysis based on PEC- and TER-calculation do not indicate a risk for succeeding crops.

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

Based on the OECD guideline 208 for Seedling Emergence and Growth, two glasshouse trials were carried out in Germany in 2011 to calculate the EC50 value for different plant species (three monocotyledonous and ten dicotyledonous species). Risk assessments are conducted based on the current Guidance Document on Terrestrial Ecotoxicology (SANCO/10329/2002) for the worst-case use in cereals at an intended maximum use rate of 2.0 L product/ha (corresponding to 1000 g 2,4-D/ha). PEC values are calculated based on the maximum applied single application rate (2.0 L/ha) and the drift values are provided by the former BBA (Table 3.5.2-1). The statistically calculated ED50- values are demonstrated in Table 3.5.2-2. The TER values are calculated as the quotient of ED50 - and PECini-values for the most sensitive plant Lactuca sativa (LACSA) based on 19 g/ha 2,4 D in the vegetative vigour test. Accord- ing to the applicant, TER-values >10 indicate an acceptable risk for the adjacent non-target plant (Table 3.5.2-3).

Table 3.5.2-1: PEC-values (g/ha) (drift) based on 1000 g/ha 2,4-D Drift values PEC (g/ha) Distance [90th percentile] Conventional Drift reducing nozzles [m] (%) nozzles 50% 75% 90% 1 2.77 27.7 13.9 6.9 2.8 5 0.57 5.7 2.9 1.4 0.6 10 0.29 2.9 1.5 0.7 0.3 15 0.2 2.0 1.0 0.5 0.2 20 0.15 1.5 0.8 0.4 0.2

Table 3.5.2-2: ED50-values [g/ha 2,4 D] of different mono- and dicotyledonous plant species based on plant dry weight

Test plant 4 ED50 Spritz-Hormin 500 (g/ha) EPPO Code Common name Scientific name (lat.) Seedling-emergence-test Vegetative-vigour-test

Oat Avena sativa AVESA >3690 >3690 Rye grass Lolium perenne LOLPE 612 >3690 Onion Allium cepa ALLCE 3199 1535 Oilseed rape Brassica napus BRSNN 2464 937 Soybean Glycine max GLXMA >1230 655 Lettuce Lactuca sativa LACSA 27 19 Cucumber Cucumis sativa CUMSA 3476 >1230 Page 46 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Sugar Beet Beta vulgaris BEAVA 388 279 Carrot Daucus carota DAUCS 286 413

Table 3.5.2-3: TER-values (ED50 / PECini) - based on the ED50-values (19 g/ha 2,4 D) of the most susceptible plant species (LACSA) Drift values TER Distance [90th percen- Drift reducing nozzles Conventional (m) tile] nozzles 50% 75% 90% (%) 1 2.77 0.69 1.37 2.74 6.86 5 0.57 3.33 6.67 13.33 33.33 LACSA 10 0.29 6.55 13.10 26.21 65.52 15 0.20 9.50 19.00 38.00 95.00 20 0.15 12.67 25.33 50.67 126.67

With acceptable TERs above the trigger for both, pre emergence and post emergence application, the risk assessments for the intended worst-case use for Spritz-Hormin 500 indicates an acceptable risk provided that a 20 m distance to the field edge is respected or other means of drift reduction are applied (10 m with 50% drift reducing nozzles, 5 m with 75% or 95% drift reducing nozzles) (Table 3.5.2-3).

Summary and conclusion - impact on other plants including adjacent crops With acceptable TERs above the trigger for both, pre emergence and post emergence application, the risk assessments for the intended worst-case use for Spritz-Hormin 500 indicates an acceptable risk provided that a 20 m distance to the field edge is respected or other means of drift reduction are applied (10 m with 50% drift reducing nozzles, 5 m with 75% or 95% drift reducing nozzles).

Tank cleaning The applicant did not provide any specific data or information concerning tank cleaning.

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

The herbicide Spritz-Hormin 500 (500 g/L 2,4-D, SL) has been proposed for a single post-emergence treatment per crop and season in cereals and grassland/pasture with an application rate of 2 L/ha (corresponding to 1000 g/ha 2,4-D). During the course of the trials on effectiveness and selectivity observations indicating any effects whatso- ever on beneficial organisms were not reported. Appropriate studies on the potential adverse effects of the test product on beneficial arthropods were available from Registration Report Part B, Section 6, Annex Point IIIA 10.5 (Effects on Arthropods Other Than Bees), Core Assessment. The toxicity on beneficial organisms has been investigated by carrying out laboratory tests on artificial substrates with the parasitoid wasp Aphidius rhopalosiphi using Desormone liquid (600 g/L 2,4-D), with the parasitoid wasp Trichogramma cacoeciae using the formulation 2,4-D DMA-salt (500 g acid/L), and with the predatory mite Typhlodromus pyri and three soil dwelling species using the formulation Marks D (514 g/L 2,4-D): Page 47 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Results of a laboratory study with Aphidius rhopalosiphi using Desormone liquid (600 g/L 2,4-D DMA) on glass plates showed only marginal lethal and sublethal effects <30% at 3000 g a.s. (Kühner, 1998, 98117/01-NLA-p). In the study with Trichogramma cacoeciae, only sublethal effects were investigated. The proposed rate of 2,4-D in a formulation of 500 g a.s./L had only marginal effects < 30% on the parasitization rate/female (Table 6.2.4-1).

Table 3.5-6: Effects of 2,4-D DMA-salt (500 g 2,4-D/L) on beneficial arthropods Species Substrate Rate Sublethal Effect Reference (Exposed Stage) Product (Parasitization rate) [L/ha] [%] T. cacoeciae Glass 2 1 20071072/01-NLTc (Adults) 0.8 2 0.32 4 0.128 2 0.052 -1

The proposed rate of 2,4-D in the formulation Marks D (Table 6.2.4-2) had lethal and sublethal effects < 30% on the predatory mite Typhlodromus pyri but the combined (overall) effect was calculated to be 42%. Spiders of the genus Pardosa (mainly P. palustris and P. amentata) and the rove beetle Aleochara bilineata were not affected. The ground beetle Poecilus cupreus was not lethally affected but showed a 33% reduction of the food uptake.

Table 3.5-7: Effects of Marks D (514 g/L 2,4-D) on beneficial arthropods Species Substrate Rate Corrected Sublethal Combined Reference (Exposed Stage) Product Mortality Effect Effect [L/ha] [%] [%] [%] T. pyri (PN) Glass 2 26 22 (Re) 42 2304065* Pardosa spec. Quartz sand 2 0 -14 (F) -14 2304065 A. bilineata (DC) Quartz sand 2 1 (Re) 1 2305070 P. cupreus (A) Quartz sand 2 -3 33 (F) 31 2301006 PN = protonymphs, A = adults, DC = developmental cycle, Re = reproduction, F = food uptake * The elimination of one replication as outlier in the study cannot be accepted for the calculation of the corrected mortality but only for effects on the reproduction (eggs/female).

On the basis of the results of a laboratory test with the parasitoid wasp Aphidius rhopalosiphi using a formulation with 600 g/L 2,4-D at 3fold the proposed application rate of 2,4-D, the test product can be classified as not harmful for this antagonist. The results with the parasitoid wasp Trichogramma cacoeciae underline the low effect on the parasitization rate but should not lead to a classification, as effects on the mortality were not regarded. On the basis of the results of a laboratory test using a formulation with 500 g/L 2,4-D, the proposed rate of the active ingredient is to be considered as slightly harmful for the predatory mite Typhlodromus pyri. This Page 48 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version species is not a relevant antagonist in the proposed culture, hence, no classification is proposed for this species. The results of laboratory tests with three soil dwelling species using this formulation show that the test product can be classified as not harmful for spiders of the genus Pardosa and the rove beetle Aleochara bilineata and as slightly harmful for the ground beetle Poecilus cupreus.

Classification according to IOBC: Extended laboratory tests on natural substrates < 25% = harmless 25 - 50% = slightly harmful > 50% = harmful

Adverse effects on soil quality indicators (e. g. microorganisms, earthworms) are considered in Section 6 Ecotoxicological Studies in the Registration Report.

Summary and conclusion - Effects on beneficial and other non-target organisms The test product is classified as not harmful for populations of the parasitic wasp Aphidius rhopalosiphi, of spiders of the genus Pardosa and of the rove beetle Aleochara bilineata. It is slightly harmful for populations of the ground beetle Poecilus cupreus.

Compatibility with current management practices including IPM This is not an EC data requirement.

4.2 Other/special studies

4.3 List of test facilities including the corresponding certificates

Table 4.3-1: List of test facilities

Test facility Address Certificate (Yes or No)

BioChem agrar GmbH Kupferstraße 6 yes D-04827 Machern OT Gerichshain Germany BASF AG Agrarzentrum Limburger Hof yes E-APE/DT D-67114 Limburgerhof agro-check Dorfstr. 15 yes D-16833 Lentzke

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Appendix 1 Lists of data considered in support of the evaluation

List of data submitted by the applicant and relied on

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes O=Open Published O=Open N=No) Authority registration No./JKI-No. N=No) Document N Nufarm 2013 dRR - A - DE - 034066-00/00 - Spritz-Hormin 500 N O Nufarm Deutschland GmbH O/O N 2572045/346324 MIIIA1 Sec 1 Nufarm 2013 dRR - B1 - core assess. - DE - 034066-00/00 - Spritz- N O Nufarm Deutschland Hormin 500 GmbH

O/O N 2572059/346326 Page 50 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

O/O N 2572065/346328 MIIIA1 Sec 7 Nufarm 2013 dRR - B7 - core assess. - DE - 034066-00/00 - Spritz- N O Nufarm Deutschland Hormin 500 GmbH

O/O N 2572066/346329 Document N Nufarm 2013 dRR - B8 - core assess. - DE - 034066-00/00 - Spritz- N O Nufarm Deutschland Hormin 500 GmbH

O/O N 2572067/346330 Page 51 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) Document N Nufarm 2013 dRR - A - DE - 034066-00/00 - Spritz-Hormin 500 N O Nufarm Deutschland GmbH O/O N 2572415/346333 MIIIA1 Sec 1 Nufarm 2013 dRR - B1 - core assess. - DE - 034066-00/00 - Spritz- N O Nufarm Deutschland Hormin 500 GmbH

O/O N 2572419/346334 MIIIA1 Sec 6 Nufarm 2013 dRR - B6 - core assess. - DE - 034066-00/00 - Spritz- N O Nufarm Deutschland Hormin 500 GmbH

O/O N 2572443/346336 Page 52 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

O/O N 2572452/346337 Document N Nufarm 2013 dRR - B8 - core assess. - DE - 034066-00/00 - Spritz- N O Nufarm Deutschland Hormin 500 GmbH

O/O N 2572467/346338 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds N J Nufarm in winter cereals 13 1047 1818

N/J N 2574679/346339 Page 53 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds N J Nufarm in winter cereals 13 1069 5060

N/J N 2574687/346340 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds N J Nufarm in winter cereals 13 1069 5061

N/J N 2574697/346341 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds N J Nufarm in winter cereals 13 1061 1819

N/J N 2574708/346342 Page 54 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds N J Nufarm in winter cereals 13 1066 1820

N/J N 2574712/346343 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds N J Nufarm in spring cereals 13 1060 1898

N/J N 2574716/346344 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds N J Nufarm in spring cereals 13 1061 1899

N/J N 2574720/346345 Page 55 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds N J Nufarm in spring cereals 13 1069 5098

N/J N 2574723/346346 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds N J Nufarm in grassland 13 1047 1918

N/J N 2574736/346347 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds N J Nufarm in grassland 13 1047 1919

N/J N 2574814/346348 Page 56 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds N J Nufarm in grassland 13 1047 1920

N/J N 2574818/346349 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 D-Fluid against dicotyledonous weeds N J Nufarm in grassland 13 1069 5105

N/J N 2574819/346350 KIIIA1 6.1.3 Zickart, U. 2013 Efficacy of U 46 M-Fluid against dicotyledonous weeds N J Nufarm in grassland 13 1047 1921

N/J N 2574822/346351 Page 57 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 6.1.3 Zickart, U. 2013 Efficacy of U 46 M-Fluid against dicotyledonous weeds N J Nufarm in grassland 13 1069 5106

N/J N 2574826/346352 KIIIA1 6.1.3 Zickart, U. 2013 Efficacy of U 46 M-Fluid against dicotyledonous weeds N J Nufarm in grassland 13 1047 1922

N/J N 2574833/346353 KIIIA1 6.1.3 Zickart, U. 2013 Efficacy of U 46 M-Fluid against dicotyledonous weeds N J Nufarm in grassland 13 1047 1923

N/J N 2574844/346354 Page 58 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 6.2.7 Brockmann, A., 2011 Evaluation of the Phytotoxicity of LAF-74 (2,4-D N J Nufarm Teresiak, H. dimethylammonium 600 g ae/L SL), GLP Seedling Emergence and Seedling Growth Test Terrestrial Non Target Plants (based on OECD Guideline 208) - Europe 2011 101418

J/N N 2574867/346355 KIIIA1 4.2.2 Remnant, V. 2009 2,4-D DMA SL Determination of the efficiency of the N J Nufarm normal procedures used for cleaning spray tanks after use NUF0417

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Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 6.2.7 Brockmann, A., 2011 Evaluation of the Phytotoxicity of LAF-74 (2,4-D N J Nufarm Teresiak, H. dimethylammonium 600 g ae/L SL), GLP Seedling Emergence and Seedling Growth Test Terrestrial Non Target Plants (based on OECD Guideline 208) - Europe 2011 101419

J/N N 2574900/346361 KIIIA1 6.2.6 Schmidt, O. 2002 BAS 140 01 H (U46 D-Fluid): Bioassay mit N J Nufarm ausgewählten Nachbaukulturen zur Ermittlung von EC10-(NOEL) und EC50-Werten für Wirkstoff im Boden 2002/1004425

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Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 6 Schönhammer, 2002 Antrag auf erneute Zulassung für das N J Nufarm A., Gall, A. Pflanzenschutzmittel U 46 D-Fluid (BAS 140 01 H) Angaben zur Wirksamkeit gemäß Liste 4a

N/N N 2574954/346364 KIIIA1 6 Anonymous 2013 Biological Assessment Dossier Section 7: Efficacy Data N J Nufarm and Information Detailed summary

N/J N 2575005/346365 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M-Fluid against dicotyledonous weeds N J Nufarm in grassland 13 1047 1921

N/J N 2582280/346366 Page 61 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M-Fluid against dicotyledonous weeds N J Nufarm in grassland 13 1069 5106

N/J N 2582283/346367 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M-Fluid against dicotyledonous weeds N J Nufarm in grassland 13 1047 1922

N/J N 2582284/346368 KIIIA1 6.1.2 Zickart, U. 2013 Efficacy of U 46 M-Fluid against dicotyledonous weeds N J Nufarm in grassland 13 1047 1923

N/J N 2582293/346369 Page 62 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 3.9 Anonymous 2013 Vorläufiges Produktetikett zu Spritz-Hormin 500 N J Nufarm

O/O N 2582319/346370 KIIIA1 10.5.1 Warmers, C. 2008 2,4-D DMA salt (500 g acid/L) assessment of side N J Nufarm effects on the egg parasitoid, trichogramma cacoeciae marchal (hymenoptera, trichogrammatidae) under laboratory conditions (dose response) 20071072/01-NLTc

J/J N 2597233/346373 Page 63 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 Brockmann, A., 2011 Evaluation of the Phytotoxicity of lAF-74 (2,4-0 N J Nufarm 10.8.1.2 Teresiak, H. dimethylammonium 600 g ae/l SL), GLP Vegetative Vigour Test Terrestrial Non Target Plants (based on OECO Guideline 227) - Europe 2011. AC/DOW/11/04 ! 101419

J/J N 2597346/346374 KIIIA1 Brockmann, A., 2011 Evaluation of the Phytotoxicity of lAF-74 (2,4-0 N J Nufarm 10.8.1.3 Teresiak, H. dimethylammonium 600 g ae/L SL),GLP Seedling Emergence and Seedling Growth TestTerrestrial Non Target Plants (based on OECO Guideline 208) - Europe 2011. AC/DOW/11/03 ! 101418

J/J N 2597396/346375 Page 64 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 10.5.1 Goßmann, A. 1997 Effects of Herbizid Marks D on the predatory mite N J AHM Typhlodromus pyri Scheuten (Acari, Phytoseiidae) in the laboratory 2303063

J/O N 2597913/346376 KIIIA1 10.5.1 Schmitzer, S., 1997 Effects of Herbizid Marks D on the wolf spider pardosa N J GWE Breitweiser, H. spec (aranae, lycosidae) in the laboratory 2304065

J/O N 2597922/346377 KIIIA1 10.5.1 Goßmann, A. 1997 Effects of Herbizid Marks D on the reproduction of rove N J AHM beetles Aleochara bilineata Gyll. Coleoptera, Staphylinidae) in the laboratory 2305070

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Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 10.5.1 Moll, M. 1997 Effects of Herbizid Marks D on the carabid beetle N J AHM Poecilus cupreus L. (Coleoptera, Carabidae) in the laboratory 2301006

J/O N 2597941/346379 KIIIA1 Reh, P. 2003 AN EVALUATION OF SELECTIVITY OF SPRITZ- N J Nufarm 6.1.4.3 HORMIN 500 TO PASTURE IN GERMANY 2002 VP02-4-23

O/J N 2807957/396447 KIIIA1 Jullian, E. 2015 KIIIA1 6.1.4.3-3 Determination of Crop Safety of N J Nufarm 6.1.4.3 Various 2,4-D Formulations in Grassland in NorthEast Zone, 4 sites, 2014 S14-01026-01 bis -04

O/J N 2807958/396448 Page 66 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 6 Anonymous 2013 Biological Assessment Dossier 2013-12-17-final N J Nufarm

O/O N 2807959/396449 KIIIA1 6 Anonymous 2015 Biological Assessment Dossier Appendix 5 N J Nufarm Appendix 5

O/O N 2807960/396450 KIIIA1 6 Anonymous 2015 Biological Assessment Dossier Appendix 6 N J Nufarm

O/O N 2807961/396451 Page 67 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 6 Anonymous 2015 Biological Assessment Dossier Appendix 7 Test N J Nufarm facilities including GEP-certificates

O/O N 2807962/396452 KIIIA1 6 Anonymous 2015 Biological Assessment Dossier Appendix GEP- N J Nufarm Bescheinigungen

O/O N 2807963/396453 KIIIA1 6.1.2 Anonymous 2015 KIIIA1 6.1.2 Revised tables from dRR Part B Section 7 N J Nufarm

O/O N 2807964/396454 Page 68 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) KIIIA1 6 Anonymous 2015 Amendment to the Biological Assessment Dossier N J Nufarm (6.1.4.3)

O/O N 2807965/396455 KIIIA1 6 Anonymous 2015 Amendment to the Biological Assessment Dossier N J Nufarm (6.1.4.3)

O/O N 2807966/396456 Document N Nufarm 2015 dRR - A - DE - 034066-00/00 - U 46 D Fluid N O Nufarm Deutschland Deutschland GmbH GmbH O/O N 3138508/448746 Page 69 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) MCP Section Nufarm 2015 dRR - B6 - core - DE - 034066-00/00 - U 46 D Fluid N O Nufarm 6 Deutschland Deutschland GmbH GmbH O/O N 3138509/448747 Document N Nufarm 2015 dRR - A - DE - 034066-00/00 - U 46 D Fluid (word) N O Nufarm Deutschland Deutschland GmbH GmbH O/O N 3138522/448750 Document N Nufarm 2015 dRR - B0 - core - DE - 034066-00/00 - U 46 D Fluid N O Nufarm Deutschland (word) Deutschland GmbH GmbH

O/O N 3138523/448751 Page 70 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

O/O N 3138524/448752 MCP Section Nufarm 2015 dRR - B3 - core - DE - 034066-00/00 - U 46 D Fluid N O Nufarm 3 Deutschland (word) Deutschland GmbH GmbH

O/O N 3138525/448753 MCP Section Nufarm 2015 dRR - B6 - core - DE - 034066-00/00 - U 46 D Fluid N O Nufarm 6 Deutschland (word) Deutschland GmbH GmbH

O/O N 3138527/448754 Page 71 /73 Template for chemical PPP Version November 2016 ZV1 034066-00/00 / U 46 D Fluid Part B – Section 3 - Core Assessment zRMS version

Data Point Author(s) Year Title Verte- Data pro- Justification if Owner Report-No. brate tection data protection claimed Source study is claimed (J=Yes GLP/GEP (J=Yes Published O=Open O=Open Authority registration No./JKI-No. N=No) N=No) Document N Nufarm 2015 dRR - B0 - core - DE - 034066-00/00 - U 46 D Fluid N O Nufarm Deutschland Deutschland GmbH GmbH O/O N 3142834/448760 MCP Section Nufarm 2015 dRR - B1-B2-B4 - core - DE - 034066-00/00 - U 46 D N O Nufarm 1 Deutschland Fluid Deutschland GmbH GmbH

O/O N 3142835/448761 MCP Section Nufarm 2015 dRR - B3 - core - DE - 034066-00/00 - U 46 D Fluid N O Nufarm 3 Deutschland Deutschland GmbH GmbH O/O N 3142836/448762

List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review

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Data Author(s) Year Title Vertebrate Data pro- Justification if Owner Point Report-No. study tection data protection claimed Source (J=Yes is claimed (J=Yes GLP/GEP O=Open Published N=No) O=Open Authority registration No./JKI-No. N=No) KIIA Brockmann, A., 2011 Evaluation of the phytotoxicity of LAF-74 (2,4-D N J Nufarm 8.14.2 Teresiak, H. dimethylammonium 600 g ae/L SL), GLP Seedling emergence and seedling growth test terrestrial non target plants (based on OECD Guideline 208) - Europe 2011 101419

J/N N 2763464/397825 KIIA Brockmann, A., 2011 Evaluation of the phytotoxicity of lAF-74 (2,4-D dimethylammonium N J Nufarm 8.14.1 Teresiak, H. 600 g ae/l SL), GLP vegetative Vigour test terrestrial non target plants (based on OECO Guideline 227) - Europe 2011 AC/DOW/11/04 ! 101419

J/J N 2763475/397826

List of data submitted by the applicant and not relied on

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Data Point Au- Year Title Vertebrate Data protection Justification if data protection is Owner thor(s) Report-No. study claimed claimed Source (J=Yes (J=Yes GLP/GEP O=Open O=Open Published N=No) N=No) Authority registration No./JKI- No.

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

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

Product code: CA 2971 Product name(s): U 46 D Fluid Chemical active substance: 2,4-D, 500 g/L (602 g/L as DMA salt)

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT (authorization)

Applicant: Nufarm Deutschland GmbH Submission date: 19/12/2013 MS Finalisation date: 27/04/2017 CA 2971 / U 46 D Fluid Page 2 /17 Part B – Section 5 Core Assessment Template for chemical PPP zRMS version Version September 2016

Version history

When What

CA 2971 / U 46 D Fluid Page 3 /17 Part B – Section 5 Core Assessment Template for chemical PPP zRMS version Version September 2016

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) ...... 4 5.2.1 Analysis of the plant protection product (KCP 5.1.1) ...... 4 5.2.1.1 Determination of active substance and/or variant in the plant protection product (KCP 5.1.1) ...... 4 5.2.1.2 Description of analytical methods for the determination of relevant impurities (KCP 5.1.1) ...... 5 5.2.1.3 Description of analytical methods for the determination of formulants (KCP 5.1.1) ...... 6 5.2.1.4 Applicability of existing CIPAC methods (KCP 5.1.1) ...... 6 5.2.2 Methods for the determination of residues (KCP 5.1.2) ...... 6 5.3 Methods for post-authorization control and monitoring purposes (KCP 5.2) ...... 6 5.3.1 Analysis of the plant protection product (KCP 5.2) ...... 6 5.3.2 Description of analytical methods for the determination of residues of 2,4-D (KCP 5.2) ...... 6 5.3.2.1 Overview of residue definitions and levels for which compliance is required ...... 7 5.3.2.2 Description of analytical methods for the determination of residues in plant matrices (KCP 5.2) ...... 8 5.3.2.3 Description of analytical methods for the determination of residues in animal matrices (KCP 5.2) ...... 9 5.3.2.4 Description of methods for the analysis of soil (KCP 5.2) ...... 10 5.3.2.5 Description of methods for the analysis of water (KCP 5.2) ...... 10 5.3.2.6 Description of methods for the analysis of air (KCP 5.2) ...... 11 5.3.2.7 Description of methods for the analysis of body fluids and tissues (KCP 5.2) ...... 11 5.3.2.8 Other studies/ information ...... 11

Appendix 1 Lists of data considered in support of the evaluation ...... 12

Appendix 2 Detailed evaluation of submitted analytical methods ...... 17 A 2.1 Analytical methods for 2,4 D ...... 17 A 2.1.1 Methods used for the generation of pre-authorization data (KCP 5.1) ...... 17 A 2.1.2 Methods for post-authorization control and monitoring purposes (KCP 5.2) ...... 17

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5 Analytical methods

5.1 Conclusion and summary of assessment

Sufficiently sensitive and selective analytical methods are available for the active substance in the plant protection product.

Noticed data gaps are: • none

Sufficiently sensitive and selective analytical methods for residues are available for all analytes included in the residue definitions.

Noticed data gaps are: • none

Commodity/crop Supported/ Not supported Winter wheat, winter barley, winter rye, winter triticale, winter oats Supported Spring wheat, spring barley, spring rye, spring triticale, spring oats Supported Grassland, pature, meadow Supported

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 2,4 -D in plant protection product is provided as follows:

Reference: 5.1.1 Report Mahmood, T., 2011 Validation of Analytical Method for the Determination of 2,4-D Content of 2,4-D DMA Formulations 11/0632 Guideline(s): SANCO 3030/99 rev. 4 Deviations: no GLP: VES Acceptability: Yes CA 2971 / U 46 D Fluid Page 5 /17 Part B – Section 5 Core Assessment Template for chemical PPP zRMS version Version September 2016

Materials and methods The sample is dissolved in acetonitrile, 4-bromophenol is used as internal standard. The analytes are determined by reversed-phase HPLC on a ZORBAX ODS or ACE 5 C18 column (250 x 4.6 mm, dp = 5 µm) at room temperature. Injection volume is 10 µl. Detection is performed with a UV detector at 280 nm. The mobile phase consists of 35 % acetonitrile and 65 % 0.1 M acetic acid. The analytes are quantified by comparing the specific response ratios of the samples with those of standards of known quality.

Validation - Results and discussions

Table 5.2-1: Methods suitable for the determination of active substances 2,4-D in plant protection product CA 2971

2,4-D

Author(s), year Mahmood, 2011 Principle of method HPLC Linearity 80 – 120 % n = 6 r = 0.9999 Precision – Repeatability Mean 0.12 n = 5 (mean content 507.8 g/L) (%RSD) RSDr = 1.49 % Accuracy 101.3 n = 6 at 80 – 120 % (% Recovery) Interference/ Specificity No interferences were noted. Chromatograms of formulation with and without active substance present were submitted. Retention time matching with stamdard. Comment acceptable

Conclusion The active substance 2,4-D can be quantified using the analytical HPLC method. The method is sufficiently validated.

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

No relevant impurities are defined for 2,4 D.

According to the EFSA conclusion (11 March 2015) dioxins and furans are considered as relevant impurities.

In the FAO specification 1.1/SL/S/F (1992) free phenols are defined as relevant impurities (possible taint of neighbouring crops and as a potential source for generating chlorinated micro-contaminants). For the determination of free phenols CIPAC method MT69.1 can be applied. CA 2971 / U 46 D Fluid Page 6 /17 Part B – Section 5 Core Assessment Template for chemical PPP zRMS version Version September 2016

5.2.1.3 Description of analytical methods for the determination of formulants (KCP 5.1.1) not required

5.2.1.4 Applicability of existing CIPAC methods (KCP 5.1.1)

CIPAC Method 1.4/SL/M2/- (CIPAC Handbook 1C, page 2066) is suitable for 2,4-D salt aqueous solutions.

5.2.2 Methods for the determination of residues (KCP 5.1.2)

An overview on the acceptable methods and possible data gaps for analysis of residues of 2,4-D for the generation of pre-authorization data is given in the following table for residues trials only. All studies have been previously evaluated at EU level and are described in detail in the RAR (Greece, 2013). New studies were not submitted.

Table 5.2-2: Validated methods for the generation of pre-authorization data

Component of residue definition: 2,4-D including its salts, esters and conjugates

Principle of method Author(s), year / missing / EU Matrix type Method type Method LOQ (i.e. GC-MS or agreed HPLC-UV)

Wheat whole Primary 0.02 mg/kg LC-MS/MS, Luna Klimmek, 2011 (method ref. S10- plant, wheat (confirmatory C18, ESI-, m/z 02109, ASB2013-9141) / EU grain, wheat method included) 219→161, 221→163 agreed straw, maize silage; (Residues) Wheat grain plant, Primary 0.01 mg/kg GC-ECD, HP-5 Buchta, 2006 (method ref. wheat grain, (green plant) C/01/05, ASB2013-9158) / EU wheat straw; 0.04 mg/kg agreed (Residues) (grain) 0.02 mg/kg (straw) Wheat grain, Primary 0.01 mg/kg GC-ECD, HP-5 Zmijowska, 2007 (method ref. straw; (Residues) (grain) C/04/07; ASB2013-9163) / EU 0.1 mg/kg agreed (straw) Cereal plant, Primary 0.05 mg/kg GC-ECD (as methyl Pfarl, 1993 (method ref. Agrolinz cereal grain, (grain, whole ester) 1166, RIP2003-466)/ EU agreed straw; (Residues) plant, straw)

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)

The methods evaluated under point 5.2.1 can be applied.

5.3.2 Description of analytical methods for the determination of residues of 2,4-D CA 2971 / U 46 D Fluid Page 7 /17 Part B – Section 5 Core Assessment Template for chemical PPP zRMS version Version September 2016

(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 Renewal Assessment Report (incl. its addenda) (Greece, 2013) the current legal residue definition is identical.

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 Sum of 2,4-D, its salts, its 0.05 mg/kg Regulation (EU) No esters and its conjugates 1317/2013, annex II expressed as 2,4-D Plant, high acid content 0.05 mg/kg Regulation (EU) No 1317/2013, annex II Plant, high protein/high 0.05 mg/kg Regulation (EU) No starch content (dry 1317/2013, annex II commodities) Plant, high oil content 0.05 mg/kg Regulation (EU) No 1317/2013, annex II Plant, difficult matrices 0.1 mg/kg Regulation (EU) No (coffee beans, hops, 1317/2013, annex II spices) Muscle Sum of 2,4-D, its salts, its 0.05 mg/kg Regulation (EU) No esters and its conjugates 1317/2013, annex II expressed as 2,4-D Milk 0.01 mg/kg Regulation (EU) No 1317/2013, annex II Eggs 0.01 mg/kg Regulation (EU) No 1317/2013, annex II Fat 0.05 mg/kg Regulation (EU) No 1317/2013, annex II Liver, kidney 0.05 mg/kg Regulation (EU) No 1317/2013, annex II Soil 2,4-D 0.05 mg/kg common limit (Ecotoxicology) Drinking water 2,4-D 0.1 µg/L general limit for drinking (Human toxicology) water

Surface water 2,4-D 11 µg/L EC50 Myriophyllum spicatum, (Ecotoxicology) EFSA Journal 2014;12(9):3812 Air 2,4-D 45 µg/m3 AOEL sys: 0.15 mg/kg bw/d; EFSA Journal 2014;12(9):3812 Tissue (meat or liver) Not residue relevant Not required not classified as T / T+ Body fluids Not required not classified as T / T+

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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 2,4-D in plant matrices is given in the following tables. New studies were not provided.

Table 5.3-2: Validated methods for food and feed of plant origin (required for all matrix types, “difficult” matrix only when indicated by intended GAP)

Component of residue definition: Sum of 2,4-D, its salts, its esters and its conjugates expressed as 2,4-D

Principle of method Author(s), year / missing / EU Matrix type Method type Method LOQ (i.e. GC-MS or agreed HPLC-UV)

High water Primary 0.01 mg/kg LC-MS/MS, ESI-, Gesell & Li, 2013/ EU agreed content 2,4-D: m/z 219→161, ASB2014-5638 221→163 ILV 0.01 mg/kg LC-MS/MS, ESI-, Bendler, 2013 / EU agreed 2,4-D: m/z 219→161, ASB2014-5640 221→163 Confirmatory Included in primary (if required) method High acid Primary 0.01 mg/kg LC-MS/MS, ESI-, Gesell & Li, 2013/ EU agreed content 2,4-D: m/z 219→161, ASB2014-5638 221→163 ILV Not required, ILV for 2 matrices available Confirmatory Included in primary (if required) method High oil content Primary 0.01 mg/kg LC-MS/MS, ESI-, Gesell & Li, 2013/ EU agreed 2,4-D: m/z 219→161, ASB2014-5638 221→163 ILV Not required, ILV for 2 matrices available Confirmatory Included in primary (if required) method High Primary 0.01 mg/kg LC-MS/MS, ESI-, Gesell & Li, 2013/ EU agreed protein/high 2,4-D: m/z 219→161, ASB2014-5638 starch content 221→163 (dry) ILV 0.01 mg/kg LC-MS/MS, ESI-, Bendler, 2013 / EU agreed 2,4-D: m/z 219→161, ASB2014-5640 221→163 Confirmatory Included in primary (if required) method Difficult (if Primary Not required for required, intended uses depends on ILV Not required for intended use) intended uses Confirmatory Not required for (if required) intended uses CA 2971 / U 46 D Fluid Page 9 /17 Part B – Section 5 Core Assessment Template for chemical PPP zRMS version Version September 2016

Table 5.3-3: Statement on extraction efficiency

Method for products of plant origin

Required, available from: Renewal Assessment Report, Final Addendum, vol. 3, B.5.2.1 Not required, because:

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

An overview on the acceptable methods and possible data gaps for analysis of 2,4-D in animal matrices is given in the following tables. New studies were not provided.

Table 5.3-4: Validated methods for food and feed of animal origin (if appropriate)

Component of residue definition: Sum of 2,4-D, its salts, its esters and its conjugates expressed as 2,4-D

Matrix type Method type Method LOQ Principle of method Author(s), year / missing (i.e. GC-MS or HPLC-UV)

Milk Primary 0.01 mg/kg LC-MS/MS, ESI-, Gesell & Li, 2013 / EU agreed 2,4-D: m/z 219→161, method 221→163 ASB2014-5639 ILV 0.01 mg/kg LC-MS/MS, ESI-, Bendler, 2013 / EU agreed method 2,4-D: m/z 219→161, ASB2014-5641 221→163 Confirmatory Included in primary (if required) method Eggs Primary 0.01 mg/kg LC-MS/MS, ESI-, Gesell & Li, 2013 / EU agreed 2,4-D: m/z 219→161, method 221→163 ASB2014-5639 ILV 0.01 mg/kg LC-MS/MS, ESI-, Bendler, 2013 / EU agreed method 2,4-D: m/z 219→161, ASB2014-5641 221→163 Confirmatory Included in primary (if required) method Muscle Primary 0.01 mg/kg LC-MS/MS, ESI-, Gesell & Li, 2013 / EU agreed 2,4-D: m/z 219→161, method 221→163 ASB2014-5639 ILV 0.01 mg/kg Not required, ILV for 3 matrices available Confirmatory Included in primary (if required) method Fat Primary 0.01 mg/kg LC-MS/MS, ESI-, Gesell & Li, 2013 / EU agreed 2,4-D: m/z 219→161, method 221→163 ASB2014-5639 ILV 0.01 mg/kg Not required, ILV for 3 matrices available Confirmatory Included in primary CA 2971 / U 46 D Fluid Page 10 /17 Part B – Section 5 Core Assessment Template for chemical PPP zRMS version Version September 2016

Component of residue definition: Sum of 2,4-D, its salts, its esters and its conjugates expressed as 2,4-D

Matrix type Method type Method LOQ Principle of method Author(s), year / missing (i.e. GC-MS or HPLC-UV)

(if required) method Kidney, liver Primary 0.01 mg/kg LC-MS/MS, ESI-, Gesell & Li, 2013 / EU agreed 2,4-D: m/z 219→161, method 221→163 ASB2014-5639 ILV 0.01 mg/kg LC-MS/MS, ESI-, Bendler, 2013 / EU agreed method 2,4-D: m/z 219→161, ASB2014-5641 221→163 Confirmatory Included in primary (if required) method

Table 5.3-5: Statement on extraction efficiency

Method for products of animal origin

Required, available from: Renewal Assessment Report, Final Addendum, vol. 3, B.5.2.2 Not required, because:

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

An overview on the acceptable methods and possible data gaps for analysis of 2,4-D in soil is given in the following tables. New studies were not provided.

Table 5.3-6: Validated methods for soil (if appropriate)

Component of residue definition: 2,4-D

Method type Method LOQ Principle of method Author(s), year / missing (i.e. GC-MS or HPLC-UV)

Primary 0.05 mg/kg LC-MS/MS, APCI-, m/z Gesell, 2012 / EU agreed 219→161, 221→163 method ASB2013-8714 Confirmatory Included in primary method

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 2,4-D in surface and drinking water is given in the following tables. New studies were not provided.

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Table 5.3-7: Validated methods for water (if appropriate)

Component of residue definition: 2,4-D Matrix type Method type Method LOQ Principle of method Author(s), year / missing (i.e. GC-MS or HPLC- UV) Drinking water Primary 0.1 µg/L LC-MS/MS, APCI-, m/z Gesell, 2012 / EU agreed 219→161, 221→163 method ASB2013-8715 ILV 0.1 µg/L LC-MS/MS, APCI-, m/z Garcia-Alix, 2012 / EU agreed 219→161, 221→163 method ASB2013-8716 Confirmatory Not required, included in primary method Surface water Primary 0.1 µg/L LC-MS/MS, APCI-, m/z Gesell, 2012 / EU agreed 219→161, 221→163 method ASB2013-8715 Confirmatory Not required, included in primary method

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

An overview on the acceptable methods and possible data gaps for analysis of 2,4-D in air is given in the following tables. New studies were not provided.

Table 5.3-8: Validated methods for air (if appropriate)

Component of residue definition: 2,4-D

Method type Method LOQ Principle of method Author(s), year / missing (i.e. GC-MS or HPLC- UV)

Primary 4.5 µg/m3 LC-MS/MS, YMC Triart Class, 2011 / EU agreed C18, ESI-, m/z 219→161, ASB2013-9139 219→125 Confirmatory Not required, included in primary method

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

Analytical methods for body fluids and tissues are not necessary, because 2,4-D is not classified as toxic or very toxic.

5.3.2.8 Other studies/ information

Not required

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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 5.1.1 Mahmood, T. 2011 Validation of Analytical Method for the Determination of 2,4-D Content of 2,4-D DMA Formulations N NUF Nufarm UK Limited 11/0632 GLP, unpublished

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

KIIA 4.3, Bendler, S. E. 2013 Independent laboratory validation of an analytical method for the determination of 2,4-D and its esters in N EUT KIIIA1 5.3 crop matrices 130888 ! 205G585 GLP: Yes Published: No BVL-2588571, BVL-2588609, ASB2014-5640 KIIA 4.3, Bendler, S. E. 2013 Independent laboratory validation of an analytical method for the determination of 2,4-D and its esters in N EUT KIIIA1 5.3 bovine and poultry tissues 130889 ! 205G584 GLP: Yes Published: No BVL-2588573, BVL-2588611, ASB2014-5641 CA 2971 / U 46 D Fluid Page 13 /17 Part B – Section 5 Core Assessment Template for chemical PPP zRMS version Version September 2016

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

KIIA 4.3, Gesell, J. T.; Li, Q. 2013 Method validation of the determination of residues of (2,4-Dichlorophenoxy)acetic acid and its esters and N EUT KIIIA1 5.3 conjugates in agricultural commodities using liquid chromatography with tandem mass spectrometry detection 130886 GLP: Yes Published: No BVL-2588564, BVL-2588608, ASB2014-5638 KIIA 4.3, Gesell, J. T.; Li, Q. 2013 Method validation of the determination of residues of (2,4- Dichlorophenoxy)acetic acid and its esters in N EUT KIIIA1 5.3 bovine and poultry matrices using liquid chromatography with tandem mass spectrometry detection 130887 GLP: Yes Published: No BVL-2588572, BVL-2588610, ASB2014-5639 KIIA 4.4, Gesell, J. T. 2012 Method validation study for the determination of residues (2,4-dichlorophenoxy) acetic Acid and its me- N EUT KIIIA1 5.4 tabolites in soil 110503 GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2534439, BVL-2588505, ASB2013-8714 KIIA 4.5, Garcia-Alix, M. 2012 Independent laboratory validation of an analytical method for the determination of (2,4-dichlorophenoxy) N EUT KIIIA1 5.6 acetic Acid, 2,4-dichlorophenol, 4-chlorophenol and 2,4-dichloroanisole in water 110821 ! CEMS-5324 GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2534438, BVL-2588524, ASB2013-8716 KIIA 4.5, Gesell, J. T. 2012 Method validation study for the determination of residues of (2,4-dichlorophenoxy) acetic Acid and its N EUT KIIIA1 5.6 metabolites in surface water, ground water and drinking water 110504 GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2534437, BVL-2588506, ASB2013-8715 KIIA 4.7, Class, T. 2011 2,4-D: Development and validation of an analytical method for the determination of 2,4-D in air N EUT KIIIA1 5.7 110026 ! P 2166 G GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2534409, BVL-2588507, ASB2013-9139 CA 2971 / U 46 D Fluid Page 14 /17 Part B – Section 5 Core Assessment Template for chemical PPP zRMS version Version September 2016

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

KIIA 6.1.2 Klimmek, S.; 2011 Determination of residues of 2,4-D in spring wheat after one application of 2,4-D DMA 600 g/l and 2,4-D N NUF Tanguy, M. 2EHE 600 g/l at 4 sites in Northern Europe 2010 S10-02109 GLP: Yes Published: No BVL-2618893, ASB2013-9141 KIIA 6.3 Buchta, A. 2006 Aminopielik Standard 600 SL: Determination of active substance residues in corn, straw and soil [wheat] N NUF C/01/05 GLP: Yes Published: No BVL-2618946, ASB2013-9158 KIIA 6.3 Zmijowska, A. 2007 Aminopielik Tercet 500 SL: Determination of residues of 2,4-D, MCPP and Dicamba in grain, straw and N NUF soil [analytical report] C/04/07 GLP: Yes Published: No BVL-2619075, ASB2013-9163 KIIA 6.6 Pfarl, C. 1993 Residues of 2,4-D in grassland treated with 1.5 l and 2.3 l Spritz Hormin 600/ha and 2.0 l U 46 D-Fluid/ha N AHM [residues for 2,4-D only] R 92-02 ! 1156 ! 1113 GLP: Open Published: Open BVL-2347891, RIP2003-466

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

KIIA 4.3 Anon. 1989 Determination of 2,4-Dichlorophenoxyacetic acid (2,4-D) in feed N DOW CA 2971 / U 46 D Fluid Page 15 /17 Part B – Section 5 Core Assessment Template for chemical PPP zRMS version Version September 2016

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

2184-117 GLP: Open Published: Open BVL-2343758, MET2003-123 KIIA 4.3 Howard, J. 1996 Development and validation of analytical methodology for the quantitation of residues of 2,4-D- N DOW Dichlorophenoxyacetic Acid (2,4-D) in beef muscle, liver, kidney, fat and milk 1848 ! 912 GLP: Open Published: Open BVL-2343756, MET2000-360 KIIA 4.3 Howards, J. 1996 Development, validation and radiovalidation of analytical methodology for the quantitation of residues of N DOW 2,4-D-Dichlorophenoxyacetic Acid (2,4-D) in poultry muscle, liver, fat and eggs 1874 ! 0027 GLP: Open Published: Open BVL-2343767, MET2000-359 KIIA 4.3 James, J. W. 1994 Radiovalidation of EN-CAS Method ENC-2/93 for the determination of 2,4-Dichlorphenoxy acetic acid N DOW (2,4-D) in/on wheat forage, straw and grain treated with [Phenyl(U)14C] 2,4-dichlorophenoxy acetic acid 93-0018 GLP: Open Published: Open BVL-2343926, MET2003-122 KIIA 4.3 Ormand, J. R. 1992 Automated method for monitoring 2,4-Dichlorophenoxyacetic acid in laboratory rodent chow N DOW K-002372-063 GLP: Open Published: Open BVL-2343930, MET2003-125 KIIA 4.3, Bacher, R. 2011 2,4-D Acid: Independent laboratory validation of a multi-residue method for the determination of 2,4-D N EUT KIIIA1 5.3 Acid in crop and animal matrices P 2168 G ! 110286 GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2534407, BVL-2588508, ASB2013-8713 KIIA 4.3, Weber, H. 2011 Validation of a multi-residue method for the determination of 2,4-D Acid in crop matrices and animal N EUT KIIIA1 5.3 tissues CA 2971 / U 46 D Fluid Page 16 /17 Part B – Section 5 Core Assessment Template for chemical PPP zRMS version Version September 2016

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

S11-02664 GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2534406, BVL-2588509, ASB2013-8712 KIIA 4.7 Reichert, N. 1994 Development and validation of a method for the determination of 2,4-D, MCPA, Dichlorprop-P and N DOW Mecoprop-P in air 94/10505 ! 439705 GLP: Open Published: Open BVL-2343761, MET1999-814 KIIA 4.8, Senciuc, M. 2011 2,4-D: development and validation of an analytical method for the determination of 2,4-D in body fluid(s) N EUT KIIIA1 5.8 110027 ! P 2167 G GLP: Open (1) Yes (1) Published: No (1) Open (1) BVL-2534472, BVL-2588504, ASB2013-9140 KIIA 6.6 Pfarl, C. 1993 Residues of 2,4-D in cereals treated with 1.1 l Spritz Hormin 600/ha and 1.5 U 46 D-Fluid/ha [residues for N AHM 2,4-D only] R 92-01 ! 1153 ! 1113 GLP: Open Published: Open BVL-2347890, RIP2003-464 KIIA 6.6 Pfarl, C. 1993 Residues of 2,4-D in cereals treated with 2.0 l Dicopur flüssig/ha [residues only for 2,4-D] N AHM R 92-18 ! 1169 ! 1113 GLP: Open Published: Open BVL-2347899, RIP2003-462 KIIA 6.6 Pfarl, C. 1993 Residues of 2,4-D in cereals treated with 1.0 l Dicopur fluid/ha [residues for 2,4-D only] N AHM R 92-22 ! 1166 ! 1113 GLP: Open Published: Open BVL-2347889, RIP2003-463

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Appendix 2 Detailed evaluation of submitted analytical methods

A 2.1 Analytical methods for 2,4 D

A 2.1.1 Methods used for the generation of pre-authorization data (KCP 5.1)

New or additional studies have been submitted and are evaluated above.

No new or additional studies for determination of residues have been submitted.

A 2.1.2 Methods for post-authorization control and monitoring purposes (KCP 5.2)

No new or additional studies for determination of residues have been submitted.

REGISTRATION REPORT Part B Section 6 Mammalian Toxicology Detailed summary of the risk assessment

Product code: CA 2971 Product name: U 46 D Fluid Chemical active substance: 2,4-Dichlorophenoxyacetic acid (2,4-D), 500 g/L (as its Dimethylamine salt, 602 g/L)

Central Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: Nufarm Deutschland GmbH Submission date: 19/12/2013 Finalisation date: 27/04/2017 CA2971 / U 46 D Fluid Page 2 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

Version history

When What

29.11.2013 dRR version of applicant 15.09.2015 dRR version of zRMS

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Table of Contents

6 Mammalian Toxicology (KCP 7) ...... 4 6.1 Summary ...... 4 6.2 Toxicological Information on Active Substance ...... 6 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 ...... 8 6.6 Exposure Assessment of Plant Protection Product (KCP 7.2) ...... 9 6.6.1 Selection of critical uses and justification ...... 9 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 ...... 10 6.6.3 Worker exposure (KCP 7.2.3) ...... 11 6.6.3.1 Estimation of worker exposure ...... 11 6.6.3.2 Measurement of worker exposure ...... 11 6.6.4 Bystander and resident exposure (KCP 7.2.2) ...... 11 6.6.4.1 Estimation of bystander and resident exposure ...... 11 6.6.4.2 Measurement of bystander and/or resident exposure ...... 12 6.6.5 Combined exposure ...... 12

Appendix 1 Lists of data considered in support of the evaluation ...... 13

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) ...... 18 A 2.4 Acute inhalation toxicity (KCP 7.1.3) ...... 19 A 2.5 Skin irritation (KCP 7.1.4) ...... 20 A 2.6 Eye irritation (KCP 7.1.5) ...... 22 A 2.7 Skin sensitisation (KCP 7.1.6) ...... 23 A 2.7.1 Study 1 ...... 23 A 2.7.2 Study 2 ...... 24 A 2.8 Data on co-formulants (KCP 7.4) ...... 25 A 2.8.1 Material safety data sheet for each co- formulant ...... 25 A 2.8.2 Available toxicological data for each co-formulant ...... 26 A 2.9 Studies on dermal absorption (KCP 7.3) ...... 26 A 2.10 Other/Special Studies ...... 28

Appendix 3 Exposure calculations ...... 29 A 3.1 Operator exposure calculations (KCP 7.2.1.1) ...... 29 A 3.1.1 Calculations for 2,4-Dichlorophenoxyacetic acid (2,4-D) ...... 29 A 3.2 Worker exposure calculations (KCP 7.2.3.1) ...... 33 A 3.2.1 Calculations for 2,4-D ...... 33 A 3.3 Bystander and resident exposure calculations (KCP 7.2.2.1) ...... 33 A 3.3.1 Calculations for 2,4-D ...... 33

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6 Mammalian Toxicology (KCP 7)

6.1 Summary

Table 6.1-1: Information on CA 2971 / U 46 D Fluid *

Product name and code CA 2971 / U 46 D Fluid Formulation type Soluble concentrate [Code: SL] Active substance (incl. content) 2,4-Dichlorophenoxyacetic acid (2,4-D), 500 g/L as its dimethylamine salt (602 g/L) Function Herbicide 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 CA 2971 / U 46 D Fluid 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 CA 2971 / U 46 D Fluid according to Regulation (EC) No 1272/2008

Hazard classes, categories: Acute Tox. 4, Eye Dam. 1 Hazard pictograms or Codes for GHS07, GHS05 hazard pictograms: Signal word: Danger Hazard statements: H302-318 Precautionary statements: P101-102-270-280-305+351+338-308+310-501 Additional labelling phrases: To avoid risks to man and the environment, comply with the instructions for use. [EUH401] 'Contains dimethylamine salt of 2,4-D (CAS No. 2008-39-1). May produce an allergic reaction.' [EUH208]

Table 6.1-3: Summary of risk assessment for operators, workers, bystanders and residents for CA 2971 / U 46 D Fluid

Result PPE / Risk mitigation measures Operators Acceptable Avoid any unnecessary contact with the product. Misuse can lead to health damage. [SB001], The directive concerning requirements for personal protective gear in plant protection, "Personal protective gear for handling plant protection products" of the Federal Office of Consumer Protection and Food Safety must be observed. [SB110], Wear tight fitting eye protection when handling the undiluted product. [SE110], CA2971 / U 46 D Fluid Page 5 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

Result PPE / Risk mitigation measures Wear standard protective gloves (plant protection) when handling the undiluted product. [SS110], Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when handling the undiluted product. [SS2101] Workers Acceptable Treated areas/crops may not be entered until the spray coating has dried. [SF245-01] Bystanders Acceptable None Residents Acceptable None

No unacceptable risk for operators, workers, bystanders and residents was identified according to the German model when the product is used as intended. No specific PPE is necessary.

No unacceptable risk for operators was identified according to the UK POEM when the product is used as intended and provided that the PPE stated in Table 6.1-3 are applied.

A summary of the critical uses and the overall conclusion regarding exposure for operators, workers and bystanders/residents is presented in the following table.

Table 6.1-4 Critical use 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.1) situation Fn, (d) exposure as- (e.g. growth Fpn (e.g. safener/ sessment stage of crop) G, synergist (L/ha)) Gn, Method / Max. number Max. applica- Water Gpn Kind (min. interval tion rate L/ha critical gap for or between kg as/ha operator, worker, 2) (incl. applica- I 3 applications) min / max bystander or tion technique a) per use resident exposure b) per crop/ based on [Expo- season sure model] Operator Worker Bystander Residents 3 Meadow and F Spraying, a) 1 1 200 - 600 14 Operators [German A A A pasture (during LCTM b) 1 model and UK growing season, POEM], bystand- March to Octo- ers and residents ber), R BBCH 25 – 35 1) Use number in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 2) 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 3) LC: low crops, HC: high crop, TM: tractor-mounted, HH: hand-held

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 CA2971 / U 46 D Fluid Page 6 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

6.2 Toxicological Information on Active Substance

Information regarding classification of the active substances and on EU endpoints and critical areas of concern identified during the EU review are given in Table 6.2-1. It is noted that IARC recently published an opinion1 classifying 2,4-D into category 2B (possibly carcinogenic to humans). This is in line with the recommendations of Pesticides Peer Review Meeting 109, to present the relevant data to RAC for consideration of the carcinogenic potential of 2,4-D.

Table 6.2-1: Information on active substance(s)

2,4-D

CAS-No. 94-75-7 as free acid 2008-39-1 as dimethylamine salt Classification and proposed labelling With regard to toxicological 2,4-D: endpoints (according to the Regulation (EC) No 1272/2008 (as amended): criteria in Reg. 1272/2008, as Warning, Acute Tox. 4, H302*: Harmful if swallowed amended) Warning, Skin Sens. 1, H317: May cause an allergic skin reaction Danger, Eye Dam. 1, H318: Causes serious eye damage Warning, STOT SE 3, H335: May cause respiratory irritation

Salts of 2,4-D: Regulation (EC) No 1272/2008 (as amended): Warning, Acute Tox. 4, H302*: Harmful if swallowed Warning, Skin Sens. 1, H317: May cause an allergic skin reaction Danger, Eye Dam. 1, H318: Causes serious eye damage Additional C&L proposal 2,4-D: Proposal EU Peer Review (EFSA Journal 2014;12(9):3812 (revised)): EUH066: Repeated exposure may cause skin dryness or cracking Warning, Acute Tox. 4, H302: Harmful if swallowed Danger, Eye Dam. 1, H318: Causes serious eye damage Warning, STOT SE 3, H335: May cause respiratory irritation

Proposal zRMS: none additional to EU

Salts of 2,4-D: Proposal zRMS: none additional Agreed EU endpoints AOEL systemic 0.15 mg/kg bw/d (correction for limited oral absorption: n.n.) Reference Review Report 7599/VI/97-final 1 October 2001 EFSA Journal 2014;12(9):3812 (revised) (2015-03-11) Conditions to take into account/critical areas of concern with regard to toxicology Review Report 7599/VI/97-final Operator safety: Member States should pay particular attention to dermal 1 October 2001 absorption of the active substance under different conditions of use.

1 Loomis D, Guyton K, Grosse Y, El Ghissasi F, Bouvard V, Benbrahim-Tallaa L, Guha N, Mattock H, Straif K; International Agency for Research on Cancer Monograph Working Group, IARC, Lyon, France. Carcinogenicity of lindane, DDT, and 2,4-dichlorophenoxyacetic acid. Lancet Oncol. 2015 Jun 22. pii: S1470-2045(15)00081-9. doi: 10.1016/S1470-2045(15)00081-9. CA2971 / U 46 D Fluid Page 7 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

EFSA Journal 2014;12(9):3812 1. 2,4-D is not classified or proposed to be classified as carcinogenic category 2 or (revised) (2015-03-11) toxic for reproduction category 2, in accordance with the provisions of Regulation (EC) No 1272/2008, and therefore the conditions of the interim provisions of Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009 concerning human health for the consideration of endocrine disrupting properties are not met. However, adverse effects on endocrine organs have been observed in apical studies that may be endocrine-mediated, which should be further clarified to assess their relevance on the developing offspring.

4. The batches used in the key toxicological and ecotoxicological studies do not fully support the currently proposed technical specifications as it appears that some impurities have not been tested at an appropriate level. * Minimum classification based on the translation table in Annex VII to Regulation (EC) No 1272/2008. Annex VI, section 1.2.1 clarifies: if there is access to data or other information as specified in Part 1 of Annex I that lead to classification in a more severe category compared to the minimum classification, classification in the more severe category must then be applied.

6.3 Toxicological Evaluation of Plant Protection Product

A summary of the toxicological evaluation for CA 2971 / U 46 D Fluid is given in the following tables. Except the second study on skin sensitisation (LLNA) all studies were performed using the similar formulation Herbizid Marks D, containing also 500 g/L 2,4-D as its dimethylamine salt (602 g/L). The compo- sitions of both formulations differ with regard to two co-formulants, whose concentration makes up about 0.43 % w/w in total. Bridging is deemed acceptable (see also Appendix 2, A 2.1). The LLNA was carried out using Chardol 600 SL, i.e. one of the representative formulations in the RAR for 2,4-D (for detailed composition, please, see Vol. 4 of this report). This formulation contains 600 g/L 2,4-D instead of 500 g/L in CA 2971 / U 46 D Fluid. Co-formulants are the same in both products but at higher concentrations in Chardol 600 SL. Thus the result of the LLNA on Chardol 600 SL has been deemed to represent ‘worst case’ for CA 2971 / U 46 D. Full summaries of studies on the product are described in detail in Appendix 2.

Table 6.3-1: Summary of evaluation of the studies on acute toxicity including irritancy and skin sensitisation for CA 2971 / U 46 D Fluid

Classification Type of test, species, model Result Acceptability (acc. to the criteria Reference system (Guideline) in Reg. 1272/2008)

LD50 oral, rat 1189 mg/kg bw in Yes H302 XXXXX, (OECD 401) females, 1997a 1498 mg/kg bw in males, 1297 mg/kg bw for both sexes

LD50 dermal, rat > 4000 mg/kg bw Yes None XXXXX, (US EPA 81-2) 1997b

LC50 inhalation, rat > 5.01 mg/L air Yes None XXXXX, (US EPA 81-3) 1997 Skin irritation, in vivo Non-irritant Yes None XXXXX, (OECD 404) 1997c Eye irritation, in vivo Irritant Yes H318 XXXXX, (OECD 405) 1997d Skin sensitisation, guinea pig Non-sensitising Yes None XXXXX, (OECD 406) (Buehler, 3 x) 1997e Skin sensitisation, mouse Non-sensitising Yes None XXXXX, 2011 (OECD 429) (LLNA) CA2971 / U 46 D Fluid Page 8 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

Supplementary studies for No data – not required combinations of plant protection products

Table 6.3-2: Additional toxicological information relevant for classification/labelling of CA 2971 / U 46 D Fluid

Substance Classification of the Reference Classification of product (Concentration substance (acc. to the criteria in in product, (acc. to the criteria in Reg. 1272/2008) % w/w) Reg. 1272/2008) Toxicological 2,4-D as its H317; EUH208 ≥ 0.1 % Reg. EUH208 properties of active dimethylamine (w/w) 1272/2008 substance (relevant for salt (51.6 % classification of (w/w)) product) Toxicological None properties of non-active substances (relevant for classification of product) Further toxicological No data – not information required

6.4 Toxicological Evaluation of Groundwater Metabolites

All metabolite concentrations are predicted to stay below 0.1 µg/L – no groundwater assessment is required.

6.5 Dermal Absorption (KCP 7.3)

A summary of the dermal absorption rates for the active substances in CA 2971 / U 46 D Fluid are presented in the following table.

Table 6.5-1: Dermal absorption rates for active substances in CA 2971 / U 46 D Fluid

2,4-D

Value Reference

Concentrate 0.1 % Study reported in Appendix 2 Dilution (1 : 400) 6 % Study reported in Appendix 2

6.5.1 Justification for proposed values

No data on dermal absorption for 2,4-D in CA 2971 / U 46 D Fluid is available. The applicant proposed to use the dermal absorption rates for 2,4-D determined in dermal absorption studies conducted with a 600 g/L SL formulation instead. The study results are summarized in the following table. Full summaries of studies on the dermal absorption are described in detail in Appendix 2. CA2971 / U 46 D Fluid Page 9 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

The dermal absorption studies were conducted with a formulation comparable to CA 2971 / U 46 D Fluid The results of the experiments with an SL formulation containing 600 g/L 2,4-D, i.e. one of the representative formulations in the RAR for 2,4-D by Greece are applicable for the risk assessment of the present application. The 2,4-D concentrations in the tested formulation and in CA 2971 / U 46 D Fluid are in an acceptably comparable range (600 g/L and 500 g/L 2,4-D, respectively) and the tested dilution covers the dilution for intended uses of CA 2971 / U 46 D Fluid (1.5 g/L and minimally 1.875 g/L). For the detailed composition of the test substance it is referred to Vol. 4 of the RAR for 2,4-D.

Table 6.5-2: Summary of the results of submitted dermal absorption studies

Test Concentrate Spray Formulation Acceptability Justification on Acceptability Reference* dilution in study of study representativity of study formu- (600 g/L) lation for cur- (1.5 g/L, rent product 1:400)

In vitro 0.1 % 6 % 600 SL Yes No explicit Endpoint can Hassler, (human) formulation justification be used for 2011 provided by the current product ASB2013- applicant 9123* * indicates that a study was reviewed at EU level

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 CA 2971 / U 46 D Fluid Formulation type Soluble concentrate; SL Category Herbicide Container sizes, short PET and HDPE bottles: 1 - 20 L description opening of 10 L bottles: 63 mm (no information given for other bottles)

Active substance 2,4-D, free acid (500 g/L) (incl. content) as its dimethylamine salt (602 g/L) AOEL systemic 0.15 mg/kg bw/d Inhalation absorption 100 % Oral absorption 100 % Dermal absorption Concentrate: 0.1 % Dilution: 6 % (Dilution rate: 1:400) (Based on an SL formulation containing 600 g/L 2,4-D, i.e. one of the representative formulations in the RAR)

6.6.1 Selection of critical uses and justification

The critical GAP used for the exposure assessment of the plant protection product is shown in Ta- ble 6.1-4. It has been selected from the individual GAPs in the central zone for cereals and grassland. A list of all intended uses within the zone is given in Part B, Section 0.

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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 CA 2971 / U 46 D Fluid according to the critical use(s) is presented in Table 6.6-2. Outcome of the estimation is presented in Table 6.6-3. Detailed calculations are in Appendix 3.

Table 6.6-2: Exposure models for intended uses

Critical uses Meadow and pasture (max. 2 L product/ha) Model(s) German model [Uniform Principles for Safeguarding the Health of Applicators of Plant Protection Products (Uniform Principles for Operator Protection), Mitteilungen aus der Biologischen Bundesanstalt für Land-und Forstwirtschaft, Berlin-Dahlem, Heft 277, 1992] Critical uses Meadow and pasture (max. 2 L product/ha) Model(s) Revised UK-POEM [Estimation of Exposure and Absorption of Pesticides by Spray Operators, Scientific subcommittee on Pesticides and British Agrochemical Association Joint Medical Panel Report (UK MAFF), 1986 and the Predictive Operator Exposure Model (POEM) V 1.0, (UK MAFF), 1992]

Table 6.6-3: Estimated operator exposure

2,4-D

Model data Level of PPE Total absorbed dose % of systemic AOEL (mg/kg/day)

Tractor mounted boom spray application outdoors to low crops Application rate: 1 kg a.s./ha German Model no PPE1) 0.036114 24.1 (Geometric mean) 0.035435 Body weight: 70 kg + Gloves mixing/loading 23.6 UK POEM no PPE2) 0.2169 144.6 Application volume: + Gloves mixing/loading 0.2130 142.0 200 L/ha Container: 10 L, 63 mm + Gloves mixing/loading opening 0.0375 25.0 and application Body weight: 60 kg 1) no PPE: Operator wearing T-shirt and shorts 2) no PPE: Operator wearing long sleeved shirt, long trousers (“permeable”) but no gloves

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 and considering above mentioned personal protective equipment (PPE), a study to provide measurements of operator exposure was not necessary and was therefore not performed. CA2971 / U 46 D Fluid Page 11 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

6.6.3 Worker exposure (KCP 7.2.3)

6.6.3.1 Estimation of worker exposure

Table 6.6-4 shows the exposure model used for estimation of worker exposure after entry into a previously treated area or handling a crop treated with CA 2971 / U 46 D Fluid according to the critical use. Out- come of the estimation is presented in Table 6.6-5. Detailed calculations are in Appendix 3.

Table 6.6-4: Exposure models for intended uses

Critical uses Meadow and pasture (max. 2 L product/ha) Model German re-entry model, Krebs et al. (2000)

Table 6.6-5: Estimated worker exposure

2,4-D

Model data Total absorbed dose % of systemic AOEL Level of PPE (mg/kg/day)

Number of applications and application rate: 1 x 1.0 kg a.s./ha 2 hours/day 1), no PPE 3) 0.00300 2.00 TC: 1500 cm2/person/h 2) (‘worst case’) with PPE 4) 0.00015 0.10 Body weight: 60 kg 1) 2 h/day for professional applications for maintenance, inspection or irrigation activities etc. 2) US-EPA policy paper [EPA, Science Advisory Council for Exposure; Agricultural Transfer Coefficients, Policy # 3.]. TC: Transfer coefficient 3) no PPE: Worker wearing long sleeved shirt, long trousers (“permeable”) but no gloves 4) with PPE: see 'Instructions for use'

6.6.3.2 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 mention PPE, a study to provide measurements of worker exposure was not necessary and was therefore not performed.

6.6.4 Bystander and resident exposure (KCP 7.2.2)

6.6.4.1 Estimation of bystander and resident exposure

Table 6.6-6 shows the exposure model(s) used for estimation of bystander and resident exposure to 2,4-D. Outcome of the estimation is presented in Table 6.6-7. Detailed calculations are in Appendix 3.

Table 6.6-6: Exposure models for intended uses

Critical use Meadow and pasture (max. 1 x 2 L product/ha) Model Martin S. et al. (2008) [Guidance for Exposure and Risk Evaluation for Bystanders and Residents Exposed to Plant Protection Products During and After Application; J. Verbr. Lebensm. 3 (2008): 272-281 Birkhäuser Verlag Basel] and Bundesanzeiger (BAnz), 06 January 2012, Issue No. 4, pp. 75-76. CA2971 / U 46 D Fluid Page 12 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

Table 6.6-7: Estimated bystander and resident exposure

2,4-D

Model data Total absorbed dose % of systemic AOEL (mg/kg/day)

Tractor mounted boom spray application outdoors on meadow and pasture Application rate: 1 x 1 kg a.s./ha Bystanders (adult) Drift rate: 2.77 % (1 m) 0.002775 1.85 Body weight: 60 kg Bystanders (children) Drift rate: 16.15 % (1 m) 0.002171 1.45 Body weight: 16.15 kg Residents (adult) Deposit: 100 % 0.007576 5.05 Body weight: 60 kg Residents (children) Deposit: 100 % 0.025654 17.10 Body weight: 16.15 kg

6.6.4.2 Measurement of bystander and/or resident exposure

Since the bystander and resident exposure estimations carried out indicated that the acceptable operator exposure level (AOEL) for 2,4-D will not be exceeded under conditions of intended uses, a study to provide measurements of bystander/resident exposure was not necessary and was therefore not performed.

6.6.5 Combined exposure

Not relevant. The product contains only one active substance.

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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 study Data point Author(s) Year Source (where different from company) Owner GLP or GEP status Y/N Published or not KCP 7.1.3 XXXXX 1997 Herbizid Marks D: Acute inhalation toxicity (nose only) study in the rat. Y Nufarm 1095/003 GLP Unpublished BVL-2618789, TOX9850999 KCP 7.1.1 XXXXX 1997a Herbizid Marks D: Acute oral toxicity test in the rat Y Nufarm 1095/001 GLP Unpublished BVL-2618698, TOX9850997 KCP 7.1.2 XXXXX 1997b Herbicid Marks D: Acute dermal toxicity (limit test) in the rat Y Nufarm 1095/002 GLP Unpublished BVL-2618704, TOX9850998 KCP 7.1.4 XXXXX 1997c Herbicid Marks D: Acute dermal irritation test in the rabbit Y Nufarm 1095/004 GLP Unpublished BVL-2618802, TOX9851000 KCP 7.1.5 XXXXX 1997d Herbicid Marks D: Acute eye irritation test in the rabbit Y Nufarm 1095/005 GLP Unpublished BVL-2618813, TOX9851001 CA2971 / U 46 D Fluid Page 14 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

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

KCP XXXXX 1997e Herbizid Marks D: Buehler delayed contact hypersensitivity study in the guinea pig Y Nufarm 7.1.6/01 1095/006 GLP Unpublished BVL-2618841, TOX1999-1391 * Applicants need to include company report numbers of the studies, authority study reference numbers (e.g. BVL-…, RIP2003-…,ASB2013-…) will be added by the evaluating competent authority.

List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review

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

KCP XXXXX 2011 LOCAL LYMPH NODE ASSAY (LLNA) IN MICE WITH Chardol 600 SL (2,4-D DMA 600) REPORT Y Nufarm 7.1.6 1444300 GLP Unpublished ASB2013-9122 KCP 7.3 Hassler, S. 2011 2,4-D: Percutaneous penetration of 14C-2,4-D formulated as 600 SL through human split-thickness N Nufarm skin membranes (in vitro) D27163 GLP Unpublished ASB2013-9123 * Applicants need to include company report numbers of the studies, authority study reference numbers (e.g. BVL-…, RIP2003-…,ASB2013-…) will be added by the evaluating competent authority.

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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

------

List of data relied on and 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

------

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Appendix 2 Detailed evaluation of the studies relied upon

A 2.1 Statement on bridging possibilities

No toxicological studies have been carried out using CA 2971 / U 46 D Fluid. All studies concerning acute toxicity, skin and eye irritation as well as the Buehler test were performed using the formulation Herbizid Marks D (cf. titles of the studies). No bridging statement was given for these studies by the applicant.

Since the composition of Herbizid Marks D is available to the RMS, it can be stated that it contains 500 g/L 2,4-D as its dimethylamine salt like CA 2971 / U 46 D Fluid and is similar to the latter. The composition of both formulations differs only with regard to two co-formulants, whose concentrations make up about 0.43 % w/w in total. The detailed composition of Herbizid Marks D has been included into Part C of this dRR by the RMS.

Comments of zRMS: Bridging is considered acceptable

For the LLNA, a bridging statement was provided by the applicant. This study was performed on one of the representative formulations of the RAR for 2,4-D, i.e. Chardol 600 SL (for the detailed composition it is referred to Vol. 4 of this report). This formulation contains 600 g/L 2,4-D instead of 500 g/L in CA 2971 / U 46 D Fluid. Co-formulants are the same in both products but at higher concentrations in Chardol 600 SL. Thus, the results of the LLNA on Chardol 600 SL represent ‘worst case’ for CA 2971 / U 46 D Fluid.

Comments of zRMS: Bridging is deemed acceptable

A 2.2 Acute oral toxicity (KCP 7.1.1)

Comments of zRMS: Acceptable; no deficiencies, according to mentioned guidelines, used for evaluation

Reference: OECD KIIIA1 7.1.1 Report Herbizid Marks D: Acute oral toxicity test in the rat, XXXXX, 1997a, 1095/001, TOX9850997 Guidelines: OECD 401 (1987), Commission Directive 92/69/EEC, US EPA Guidelines section 81-1 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods

Test material (Lot/Batch No.) Herbizid Marks D (JAS/97/01) Species Rat, Sprague-Dawley CD (Crl : CD ® BR) CA2971 / U 46 D Fluid Page 17 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

No. of animals (group size) 5 rats/sex and dose group Dose(s) 1000, 1414 and 2000 mg/kg bw Exposure Once by gavage Vehicle/Dilution None Post exposure observation period 14 days Remarks None

Results and discussions

Table A 1: Results of acute oral toxicity study in rats of Herbizid Marks D

1) Dose Toxicological results Duration of signs Time of death LD50 [mg/kg bw] [mg/kg bw] (14 days) Male rats 1000 1/5/5 1st hour – day 6 day 1 1st hour – day 5 or till 1414 2/5/5 day 0 and 1 death, respectively 1st hour – day 11 or 2000 4/5/5 day 0, 1, 2 and 6 till death, respectively 1498 (1076 – 2087) Female rats 1000 0/5/5 1st hour – day 5 - 1414 5 2)/5/5 1st hour – death day 0, 1, 2 and 4 2000 5/5/5 1st hour – death day 0 and 1 1189 (1000 – 1414) Both sexes 1297 (1117 - 1505 1) Number of animals which died/number of animals with clinical signs/number of animals used 2) One female was killed in extremis on day 4.

Table A 2: Summary of findings of acute oral toxicity study in rats of Herbizid Marks D

Mortality: Yes, please, see table above. Clinical signs: Common signs of systemic toxicity noted in all dose groups were ataxia, hunched posture, lethargy and decreased respiratory rate with additional signs of ptosis. Additional signs of systemic toxicity in the 1414 and 2000 mg formulation/kg bw treatment groups were pilo- erection and laboured respiration with incidences of diarrhoea, dehydration, emaciation and loss of righting reflex. Incidences of splayed or tiptoe gait were noted in animals treated with 1000 or 2000 mg formulation/kg bw. An isolated incidence of hypothermia was noted in one female treated with 1414 mg formulation/kg bw. An incidence of red/brown staining around the eyes was noted in one male treated with 2000 mg formulation/kg bw. Body weight: Surviving animals showed expected gain in bodyweight except for four females at 1000 mg formulation/kg and one male at 2000 g/kg, which showed bodyweight loss in the first week, followed by gain in the second week. Macroscopic exam- Common abnormalities noted at necropsy were haemorrhagic or abnormally red lungs, dark ination: liver, dark kidneys and thickening and/or haemorrhage or severe haemorrhage of the gastric CA2971 / U 46 D Fluid Page 18 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

mucosa. Sloughing of the non-glandular epithelium of the stomach was noted at necropsy of one male at 2000 mg formulation/kg bw. Necropsy of a female treated at 1414 mg formulation/kg bw that was killed in extremis during the study found a dark brown, hard material in the stomach and hardened faeces in the small intestines. One male decedant from each of the 1000 or 2000 mg formulation/kg bw groups was found cannibalised. Necropsies were therefore not performed on these animals.

Conclusion

Under the experimental conditions, the oral LD50 of Herbizid Marks D and thus also of CA 2971 / U 46 D Fluid is 1189 mg/kg bw in female rats, 1498 mg/kg bw in male rats and 1297 mg/kg bw for both sexes. Thus, classification for both products is required as Acute Tox. 4; H302 according to Regulation (EC) No. 1272/2008.

A 2.3 Acute percutaneous (dermal) toxicity (KCP 7.1.2)

Comments of zRMS: Acceptable; no deficiencies, according to mentioned guideline, used for evaluation

Reference: OECD KIIIA1 7.1.2 Report Herbizid Marks D: Acute dermal toxicity (limit test) in the rat, XXXXX, 1997b 1095/002, TOX9850998 Guidelines: US EPA Guidelines Section 81-2, 1984 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods

Test material (Lot/Batch No.) Herbizid Marks D (JAS/97/01) Species Rat, Sprague-Dawley CD (Crl : CD ® BR) No. of animals (group size) 5 rats/sex Dose(s) 4000 mg/kg bw Exposure 24 hours (dermal, semi-occlusive) Vehicle/Dilution None Post exposure observation period 14 days Remarks None

Results and discussions

Table A 3: Results of acute dermal toxicity study in rats of Herbizid Marks D

1) Dose Toxicological results Duration of signs Time of death LD50 [mg/kg bw] [mg/kg bw] (14 days)

Male rats 4000 0/0/5 - - > 4000 CA2971 / U 46 D Fluid Page 19 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

Female rats 4000 0/0/5 - - > 4000 1) Number of animals which died/number of animals with clinical signs/number of animals used

Table A 4: Summary of findings of acute dermal toxicity study in rats of Herbizid Marks D

Mortality: No mortality occurred. Clinical signs: No clinical signs of toxicity were observed. No skin irritation was noted during the study. Body weight: One female showed slight body weight loss during the first week, whereas body weight gain of another female was slightly reduced during the first week of the study. All other animals showed expected gain in body weight during the study. Macroscopic exam- The necropsies performed at the end of the study revealed no apparent findings. ination:

Conclusion

Under the experimental conditions, the dermal LD50 of Herbizid Marks D and thus also of CA 2971 / U 46 D Fluid is higher than 4000 mg/kg bw in rats. Thus, no classification is required according to Regu- lation (EC) No. 1272/2008.

A 2.4 Acute inhalation toxicity (KCP 7.1.3)

Comments of zRMS: Acceptable; no deficiencies, according to mentioned guideline, used for evaluation

Reference: OECD KIIIA1 7.1.3 Report Herbizid Marks D: Acute inhalation toxicity (nose only) study in the rat, XXXXX, 1997, 1095/003, TOX9850999 Guideline: US EPA Section 81-3 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods

Test material (Lot/Batch No.) Herbizid Marks D (JAS/97/01) Species Rat, Sprague-Dawley Crl : CD ® BR No. of animals (group size) 5 rats/sex Concentration 5 mg/L Exposure 4 hours (nose only) Vehicle/Dilution None Post exposure observation period 14 days Remarks None

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Results and discussions

Table A 5: Concentration(s) and exposure conditions

Target conc. Nominal conc. Actual conc. MMAD 1) GSD 2) [mg/L air] [mg/L air] [mg/L air] [µm] [µm]

5.0 24.0 5.01 1.8 ± 0.45 1) MMAD = Mass Median Aerodynamic Diameter 2) GSD = Geometric Standard Deviation

Table A 6: Results of acute inhalation toxicity study in rats of Herbizid Marks D

1) Concentration Toxicological results Duration of signs Time of death LC50 [mg/L air] [mg/L air] (14 days)

Male rats

5.01 0/5/5 day 0 - 1 - > 5.01 Female rats 5.01 0/5/5 day 0 - 1 - > 5.01 1) Number of animals which died/number of animals with clinical signs/number of animals used

Table A 7: Summary of findings of acute inhalation toxicity study in rats of Herbizid Marks D

Mortality: No mortality occurred. Clinical signs: Common abnormalities noted included wet fur, hunches posture, pilo-erection and increased respiratory rate. Isolated incidents of red/brown staining around the eyes or snout were also observed. Animals recovered to appear normal by day 2 after exposure. Body weight: One female showed no body weight gain during week 2 of the study. For all other animals normal body weight development was noted. Macroscopic exam- The necropsies performed at the end of the study revealed no apparent findings with the ination: exception of one male showing dark foci on the lungs.

Conclusion

Under the experimental conditions, the inhalation LC50 of Herbizid Marks and thus also of CA 2971 / U 46 D Fluid D is higher than 5.01 mg/L air in rats. Thus, no classification is required according to Regu- lation (EC) No. 1272/2008.

A 2.5 Skin irritation (KCP 7.1.4)

Comments of zRMS: Acceptable; no deficiencies, according to mentioned guidelines, used for evaluation

Reference: OECD KIIIA1 7.1.4 Report Herbizid Marks D: Acute dermal irritation test in the rabbit, XXXXX, 1997c, 1095/004, TOX9851000 Guidelines: OECD 404, 1992 Commission Directive 92/69/EEC, B.4, 1992 CA2971 / U 46 D Fluid Page 21 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

US EPA Section 81-5, 1984 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods

Test material (Lot/Batch No.) Herbizid Marks D (JAS/97/01) Species Rabbit, New Zealand White No. of animals (group size) 5 males and 1 female Initial test using one animal No Exposure 0.5 mL (4 hours, semi-occlusive) Vehicle/Dilution None Post exposure observation period 7 days Remarks None

Results and discussions

Table A 8: Skin irritation of Herbizid Marks D

Animal Scores after treatment 1) Mean scores Reversible No. (24-72 h) [day] 1 h 24 h 48 h 72 h

1 Erythema 2 2 1 1 1.3 day 7 2) Oedema 2 2 1 1 1.3 2 Erythema 2 1 1 0 0.7 day 3 Oedema 2 1 0 0 0.3 3 Erythema 2 2 1 1 1.3 day 7 2) Oedema 2 2 1 0 1.0 4 Erythema 2 1 1 1 1.0 day 7 Oedema 2 1 0 0 0.3 5 Erythema 2 2 1 1 1.3 day 7 2) Oedema 1 1 1 1 1.0 6 Erythema 2 1 1 0 0.7 day 3 Oedema 1 1 0 0 0.3 1) scores in the range of 0 to 4 2) scores 0 but barely perceptible desquamation

Clinical signs: Not reported

Conclusion Under the experimental conditions, Herbizid Marks D and thus also CA 2971 / U 46 D Fluid D is not a skin irritant. Thus, no classification is required according to Regulation (EC) No. 1272/2008.

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A 2.6 Eye irritation (KCP 7.1.5)

Comments of zRMS: Acceptable; no deficiencies, according to mentioned guidelines, used for evaluation

Reference: OECD KIIIA1 7.1.5 Report Herbizid Marks D: Acute eye irritation test in the rabbit, XXXXX, 1997d, 1095/005, TOX9851001 Guidelines: OECD 405, 1987 European Commission 92/69/EEC, B.5, 1992 US EPA Section 81-4, 1984 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods

Test material (Lot/Batch No.) Herbizid Marks D (JAS/97/01) Species Rabbit, New Zealand White No. of animals (group size) 1 female Initial test using one animal Not applicable Exposure 0.1 mL (single instillation into conjunctival sac) Irrigation (time point) No Vehicle/Dilution None Post exposure observation period 1 day Remarks None

Results and discussions

Table A 9: Eye irritation of Herbizid Marks D

Animal Scores after treat- No. ment 1)

1 h 24 h

1 Corneal opacity 2 2 Iritis 1 1 Redness conjunctivae 2 2) 2 2), 3) Chemosis conjunctivae 2 3 1) scores in the range of 0 to 4 for cornea opacity and chemosis, 0 to 3 for redness of conjunctivae and 0 to 2 for iritis 2) nictitating membrane and lower conjunctival membrane green/brown in appearance (possible necrosis) 3) pale area approximately 3 mm x 4 mm located in the centre of the nictitating membrane and sloughing of lower conjunctival membrane

Clinical signs: An initial pain reaction of 3 was recorded. An explanation of this score was not given.

The animal was killed for humane reasons immediately after the 24-hour observation. CA2971 / U 46 D Fluid Page 23 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

Although possible necrosis at the nictitating and lower conjunctival membranes was reported 1 hour and 24 hours after treatment, there is no indication of corrosion in the corresponding study on skin irritation.

Conclusion Under the experimental conditions, Herbizid Marks D and thus also CA 2971 / U 46 D Fluid D is an eye irritant. Thus, classification for both products is required as Eye Dam.1; H318 according to Regulation (EC) No. 1272/2008.

A 2.7 Skin sensitisation (KCP 7.1.6)

A 2.7.1 Study 1

Comments of zRMS: Acceptable; no deficiencies, according to mentioned guidelines, used for evaluation

Reference: OECD KIIIA1 7.1.6/01 Report Herbizid Marks D: Buehler delayed contact hypersensitivity study in the guinea pig, XXXXX, 1997e, 1095/006, TOX1999-1391 Guidelines: OECD 406, 1992 European Commission 92/69/EEC, B.6 US EPA Section 81-6, 1984 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods

Test material (Lot/Batch No.) Herbizid Marks D (JAS/97/01) Species Guinea pig, Hartley albino No. of animals (group size) Test substance group: 20 male guinea pigs Vehicle control goup: 10 male guinea pigs Range finding: Yes Exposure (concentration(s), no. of applica- Topical induction: Undiluted (3 x) tions) Challenge: 50 % (v/v) and 75 % (v/v) Vehicle Distilled water Pretreatment prior to topical application No Reliability check Dinitrochlorobenzene ( 0.5 % (w/v) in ethanol for topical induction and 0.025 and 0.05 % (w/v) in ethanol for challenge) Remarks No justification given for using the adjuvant-free Buehler test instead of an M & K test or an LLNA

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Results and discussions

Table A 10: Results of skin sensitisation study of Herbizid Marks D

24 hours 48 hours After challenge Herbizid Marks D 50 % v/v 0/20 0/20 75 % v/v 0/20 0/20 Test Vehicle Control 50 % v/v 0/10 0/10 75 % v/v 0/10 0/10 Positive control 10/10 10/10 1) Number of animals with positive dermal response (scores of 1-3) /number of animals in dose group

Clinical signs: Not reported

Conclusion Under the experimental conditions, Herbizid Marks D and thus also CA 2971 / U 46 D Fluid D is not a skin sensitiser. Thus, no classification is required according to Regulation (EC) No. 1272/2008.

A 2.7.2 Study 2

Comments of zRMS: Acceptable; no deficiencies, according to mentioned guidelines, used for evaluation

Reference: OECD KIIIA1 7.1.6/02 Report Local lymph node assay (LLNA) in mice with Chardol 600 SL (2,4-D DMA 600), XXXXX, 2011, 1444300, ASB2013-9122 Guidelines: OECD 429, 2010 Commission Regulation (EC) No 440/2008, B.42, 2008 Deviations: During the acclimation phase of the animals used for the pre-experiment, the relative humidity in the animal room was between 31-65 % instead of 45-65 % for a few hours. In the main experiment, the animals were accidentally weighed immediately after the first application of the test item instead of prior to the first application. Both deviations should not have had impact on the outcome of the study. GLP: Yes Acceptability: Yes

Materials and methods

Test material (Lot/Batch No.) Chardol 600 SL; 2,4-D DMA 600, containing 600 g/L 2,4-D as the acid (2011-130-01-A01) Species Mouse, CBA/CaCrl for the pre-test CA2971 / U 46 D Fluid Page 25 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

CBA/CaOlaHsd for the main test No. of animals (group size) Test substance group: 4 female mice Vehicle control goup: 4 female mice Range finding: Yes (pre-test with 2 animals) Exposure (concentration(s), no. of 10 %, 25 % and 50 % w/w, 3 applications on 3 consecutive days applications) Vehicle Dimethylformamide Reliability check Α-Hexyl cinnamaldehyde in acetone:olive oil (4+1 v/v)(5 %, 10 % and 25 % w/v) Remarks Ear thickness and ear weight were recorded during the pre-test, so was ear weight during the main study.

Results and discussions

Table A 11: Results of skin sensitisation study of Chardol 600 SL

No. of Concentration DPM / group Stimulation index animals [%] (SI)

Chardol 600 SL 4 10 5390 1.42 4 25 6540 1.72 4 50 8547 2.25 Test Vehicle Control 4 - 3807 1.00 Group Positive control 5 5 621.1 1.35 5 10 1004.3 2.18 5 25 3720.5 8.08 Test Vehicle Control 5 - 460.5 1.00 Group

Clinical signs: None Body weight: Body weights were within the range commonly recorded for animals of this strain and age.

No relevant or statistically significant increase in ear weights was observed for all treated animals.

Conclusion Under the experimental conditions, Chardol 600 SL and thus also CA 2971 / U 46 D is not a skin sensitiser. Thus, no classification is required according to Regulation (EC) No. 1272/2008.

A 2.8 Data on co-formulants (KCP 7.4)

A 2.8.1 Material safety data sheet for each co- formulant

Information regarding material safety data sheets of the co-formulants can be found in the confidential CA2971 / U 46 D Fluid Page 26 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015 dossier of this submission (Registration Report - Part C).

A 2.8.2 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 2.9 Studies on dermal absorption (KCP 7.3)

The following summary was taken from the RAR on 2,4-D prepared by RMS Greece (January 2014) and adapted to reflect the study evaluation according to EFSA GD on dermal absorption (EFSA Journal 2012;10(4):2665).

Characteristics Reference Hassler, S., 2011 ASB2013-9123 Type of study 2,4-D: Percutaneous Penetration of 14C-2,4-D formulated as 600 SL through human split- thickness skin membranes (in vitro) Test substance; Purity 2,4-D acid formulated as a 600 g/l soluble liquid (SL); 100% purity radiolabeled 2,4- D; 99.4% purity Vehicle purified water was used to produce a 1:400 dilution; methanol was used to dissolve the radio- labelled test substance but was properly removed before using the stock solution Stability/Homogeneity Stability was tested using HPLC at the time of application Study design Two doses were tested, with target low and high dose levels of 14µg/cm2 (751 kBq/mg, pH of 8.9) and 5625µg/cm2 (12.31 kBq/mg, pH of 9.6), respectively. The low dose used is considered representative of the lowest concentration for the in-use field dilution (ranging from 1.875 to 7.5). The human skin membranes to be used were prepared properly and set up in flow-through diffusion cells. Membrane integrity was checked with tritiated water. Any skin membranes found to have Kp >2.5x10-3 cm/h were excluded from the study. A 6µl aliquot of the test solutions was applied to each skin membrane (exposed area: 0.64 cm²). The donor chambers were covered with permeable tape (non-occluded conditions). Receptor fluid / perfusate was saline. After 8 hours exposure the skin membrane was rinsed three times with a mild detergent solution and once with water. After 24 hours the membrane was washed again. Membranes were then removed from the diffusion cell and consecutively (up to 15x) stripped with adhesive tape until the stratum corneum was removed. The remaining membranes were digested and the radioactivity determined. Radioactivity was measured by Liquid Scintillation Counting (LSC). The radioactivity in tape strips and skin membranes was determined after digestion in tissue solubilizer. Counting was for 1 minute or 2 sigma error if shorter. High Performance Liquid Chromatography (HPLC) was carried out using a Merck HPLC system. The radioactivity signal was monitored with a Radiometric 500TR radioactivity flow monitor. Guideline In compliance with OECD 428 testing method GLP Yes CA2971 / U 46 D Fluid Page 27 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

QA Yes Acceptance Yes

Results All selected membranes passed the integrity check (here: Table A 12, RAR:Table B.5.12/02-1).

Table A 12: Integrity of human skin membranes Mean Permeability Coefficient (Kp) of tritiated Water (cm/h·10-3) Test System Human Skin Membrane Low Dose Level 1.70 ± 0.51 High Dose Level 1.18 ± 0.36

The results from HPLC showed that the test item remained stable, with 99.3% purity in the field dilution and 99.0% purity in the concentrate at application. After application of the low dose (representing the typical concentration recommended for field application) 0.66% of the applied dose penetrated through the human skin membrane during 8 hours exposure. At the end of the experiment (24h) a total of 1.53% penetrated the membranes. For the concentrate penetration through the skin was <0.01% at 8 h and total penetration after 24 hours was calculated to be 0.03% (here: Table A 13, RAR: Table B.5.12/02-2).

Table A 13: In vitro percutaneous penetration of 2,4-D through human skin membranes

In the membranes after tape stripping 0.14% and <0.01% of the applied activity was found for the low and the high dose, respectively. Therefore the amount that penetrated into the skin is 1.67% of the low dose and less than 0.03% of the high dose. Together with the percentage of the dose remaining in the membrane and on the tape strips III-XV, the total percentage of the dose considered absorbed in 24 hours was 4.03% and 0.08% of the low and high doses, respectively (here: Table A 14, RAR: Table B.5.12/02-3).

Table A 14: Percutaneous penetration of 14C-2,4-D formulated as 600 SL through human split-thickness skin membranes (in vitro): recovered radioactivity at the end of exposure % dose applied 14 µg/cm2 5625 µg/cm2 Dose level Field dilution (1.5 g a.i./L) Concentrate (600 g/L) Donor cell wash 0.26 0.04 Skin membrane rinse at 8 hours 90.54 99.34 Skin membrane rinse at 24 hours 5.01 0.12 Tape strip I* 1.25 0.04 Tape strip II* 0.69 0.02 CA2971 / U 46 D Fluid Page 28 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

Subtotal (considered as non absorbed) 97.5 99.65 Tape strip III* 0.56 <0.01 Tape strip IV* 0.74 0.01 Tape strip V* 0.51 0.01 Tape strip VI** 0.52 0.02 Tape strip VII** 0.03 <0.01 Skin membrane 0.14 <0.01 Perfusate 0-24 hr 1.53 0.03 Subtotal (considered as absorbed) 4.03±2.26 0.08±0.04 TOTAL Recovery 101.77 99.63 * Individual pool strips ** “Tape strip VI” includes the pool strips 6 to 10 while “Tape strip VII” includes the pool strips 11 to 15

The radioactivity in the tape strips was found to be predominantly in the first 5 strips with the first 2 strips accounting for about 2 and 0.06% of the applied dose for the dilution and the concentrate, respectively. The total amount of the product which actually penetrated through the skin after 24 hours was 0.209 µg/cm2 for the low dose and for the high dose a conservative estimate (sum of all values

Conclusion The cumulative penetration through human skin membrane of 14C-2,4-D formulated as a 600 g/l soluble liquid (SL) was 1.53 and 0.03 % of the applied dose during 24 hours at the low and high dose level, respectively. The calculated mean flux at the low dose level was 0.022 µg/cm2/h through human skin membranes while in case of the high dose tested the mean flux was not calculated, since the values obtained were below LOQ. Considering the amount of radioactivity recovered from the stratum corneum (excluding the first two tape strips) the penetration of 14C-2,4-D through human skin has been calculated to be 4.03% ± 2.26% at the low dose and 0.08% ± 0.04% at the high dose tested. For the operator, worker and bystander exposure assessment the rounded dermal absorption values of 6 (RAR: 4 %) and 0.1% have been used for the dilution and the concentrate, respectively.

Comments of zRMS: The study is considered acceptable.

Skin samples were taken from 3 or 2 donors for experiments with the dilution or the concentrate, respectively. The area of exposed skin was very small (0.64 cm² vs. 2.54 cm² recommended in OECD TG).In the study report, the solubility of the test material in receptor fluid was not demonstrated.

Dermal absorption was slow (below 75 % within first half of the study). The amount in tape strips III to VII, skin membrane and receptor fluid is considered as absorbed. Results need to be corrected for high variability (mean + 1xSD).

Under the condition of this study, dermal absorption rate was 0.1 % for the concentrate (600 g/L, applied dose appr. 5682 µg/cm²) and 6 % for the dilution (1.5 g/L, applied dose appr. 13.7 µg/cm²) based on in vitro human skin

A 2.10 Other/Special Studies

There are no other or special studies available. CA2971 / U 46 D Fluid Page 29 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

Appendix 3 Exposure calculations

A 3.1 Operator exposure calculations (KCP 7.2.1.1)

A 3.1.1 Calculations for 2,4-Dichlorophenoxyacetic acid (2,4-D)

Table A 15: Input parameters considered for the estimation of operator exposure

Formulation type: SL Application technique: Field Crop Tractor Mounted (FCTM) Application rate (AR): 1kg a.s./ha

Area treated per day (A): 20ha Dermal hands m/l (DM(H)): 2.4mg/person/kg a.s.

0.1% (concentr.) Dermal hands appl. (DA(H)): 0.38mg/person/kg a.s. Dermal absorption (DA): 6% (dilution) Dermal body appl. (DA(B)): 1.6mg/person/kg a.s.

Inhalation absorption (IA): 100% Dermal head appl. (DA(C)): 0.06mg/person/kg a.s.

Body weight (BW): 70kg/person Inhalation m/l (IM): 0.0006mg/person/kg a.s.

AOEL 0.15mg/kg bw/d Inhalation appl. (IA): 0.001mg/person/kg a.s.

Table A 16: Estimation of operator exposure towards 2,4-D using the German model

Without PPE With PPE Operators: Systemic dermal exposure after application in Meadow and pasture Dermal exposure during mixing/loading Hands Hands 1) SDEOM(H) = (DM(H) x AR x A x DA) / BW SDEOM(H) = (DM(H) x AR x A x PPE x DA) / BW (2.4 x 1 x 20 x 0.1%) / 70 (2.4 x 1 x 20 x 0.01 x 0.1%) / 70 External dermal exposure 48 mg/person External dermal exposure 0.48 mg/person External dermal exposure 0.685714 mg/kg bw/d External dermal exposure 0.006857 mg/kg bw/d Systemic dermal exposure 0.000686 mg/kg bw/d Systemic dermal exposure 0.000007 mg/kg bw/d Dermal exposure during application Hands Hands

SDEOA(H) = (DA(H) x AR x A x DA) / BW SDEOA(H) = (DA(H) x AR x A x PPE x DA) / BW (0.38 x 1 x 20 x 6%) / 70 (0.38 x 1 x 20 x 1 x 6%) / 70 External dermal exposure 7.6 mg/person External dermal exposure 7.6 mg/person External dermal exposure 0.108571 mg/kg bw/d External dermal exposure 0.108571 mg/kg bw/d Systemic dermal exposure 0.006514 mg/kg bw/d Systemic dermal exposure 0.006514 mg/kg bw/d Body Body

SDEOA(B) = (DA(B) x AR x A x DA) / BW SDEOA(B) = (DA(B) x AR x A x PPE x DA) / BW (1.6 x 1 x 20 x 6%) / 70 (1.6 x 1 x 20 x 1 x 6%) / 70 External dermal exposure 32 mg/person External dermal exposure 32 mg/person External dermal exposure 0.457143 mg/kg bw/d External dermal exposure 0.457143 mg/kg bw/d Systemic dermal exposure 0.027429 mg/kg bw/d Systemic dermal exposure 0.027429 mg/kg bw/d Head Head

SDEOA(C) = (DA(C) x AR x A x DA) / BW SDEOA(C) = (DA(C) x AR x A x PPE x DA) / BW (0.06 x 1 x 20 x 6%) / 70 (0.06 x 1 x 20 x 1 x 6%) / 70 External dermal exposure 1.2 mg/person External dermal exposure 1.2 mg/person External dermal exposure 0.017143 mg/kg bw/d External dermal exposure 0.017143 mg/kg bw/d Systemic dermal exposure 0.001029 mg/kg bw/d Systemic dermal exposure 0.001029 mg/kg bw/d

Total systemic dermal exposure: SDEO = SDEOM(H) + SDEOA(H) + Total systemic dermal exposure: SDEO = SDEOM(H) + SDEOA(H) + SDE- SDEOA(B) + SDEOA(C) OA(B) + SDEOA(C) Total external dermal exposure 88.8 mg/person Total external dermal exposure 41.28 mg/person Total external dermal exposure 1.268571 mg/kg bw/d Total external dermal exposure 0.589714 mg/kg bw/d Total systemic dermal expo- 0.035657 mg/kg bw/d Total systemic dermal exposure 0.034978 mg/kg bw/d sure Operators: Systemic inhalation exposure after application in Meadow and pasture Inhalation exposure during mixing/loading

SIEOM = (IM x AR x A x IA) / BW SIEOM = (IM x AR x A x PPE x IA) / BW (0.0006 x 1 x 20 x 100%) / 70 (0.0006 x 1 x 20 x 1 x 100%) / 70 External inhalation exposure 0.012 mg/person External inhalation exposure 0.012 mg/person CA2971 / U 46 D Fluid Page 30 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

External inhalation exposure 0.000171 mg/kg bw/d External inhalation exposure 0.000171 mg/kg bw/d Systemic inhalation exposure 0.000171 mg/kg bw/d Systemic inhalation exposure 0.000171 mg/kg bw/d Inhalation exposure during application

SIEOA = (IA x AR x A x IA) / BW SIEOA = (IA x AR x A x PPE x IA) / BW (0.001 x 1 x 20 x 100%) / 70 (0.001 x 1 x 20 x 1 x 100%) / 70 External inhalation exposure 0.02 mg/person External inhalation exposure 0.02 mg/person External inhalation exposure 0.000286 mg/kg bw/d External inhalation exposure 0.000286 mg/kg bw/d Systemic inhalation exposure 0.000286 mg/kg bw/d Systemic inhalation exposure 0.000286 mg/kg bw/d

Total systemic inhalation exposure: SIEO = SIEOM + SIEOA Total systemic inhalation exposure: SIEO = SIEOM + SIEOA Total external inhalation expo- 0.032 mg/person Total external inhalation exposure 0.032 mg/person sure Total external inhalation expo- 0.000457 mg/kg bw/d Total external inhalation exposure 0.000457 mg/kg bw/d sure Total systemic inhalation Total systemic inhalation expo- 0.000457 mg/kg bw/d 0.000457 mg/kg bw/d exposure sure

Total systemic exposure: SEO = SDEO + SIEO Total systemic exposure: SEO = SDEO + SIEO Total systemic exposure 2.528 mg/person Total systemic exposure 2.48048 mg/person Total systemic exposure 0.036114 mg/kg bw/d Total systemic exposure 0.035435 mg/kg bw/d % of AOEL 24.1 % % of AOEL 23.6 % 1) reduction factor for gloves is 0.01 (professional appl.)

Table A 17: Estimation of operator exposure towards 2,4-D using the UK-POEM Without PPE Active substance 2,4-D Product U 46 D Fluid

Formulation type water-based

Concentration of a.s. 500 mg/mL

Dose 2 L preparation/ha (1 ) Application volume 200 L/ha

Application method Tractor-mounted/trailed boom sprayer: hydraulic nozzles Container 10 litres 63 mm closure

Work rate/day 50 ha

Duration of spraying 6 h

PPE during mix./loading None

PPE during application None

Dermal absorption from product 0.1 %

Dermal absorption from spray 6 %

EXPOSURE DURING MIXING AND LOADING Container size 10 Litres

Hand contamination/operation 0,05 mL

Application dose 2 Litres product/ha

Work rate 50 ha/day

Number of operations 10 /day

Hand contamination 0.5 mL/day

Protective clothing None

Transmission to skin 100 %

Dermal exposure to formulation 0.5 mL/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Tractor-mounted/trailed boom sprayer: hydraulic nozzles Application volume 200 spray/ha

Volume of surface contamination 10 mL/h

Distribution Hands Trunk Legs 65% 10% 25% Clothing None Permeable Permeable Penetration 100% 5% 15% Dermal exposure 6.5 0.05 0.375 mL/h Duration of exposure 6 h

Total dermal exposure to spray 41.55 mL/day CA2971 / U 46 D Fluid Page 31 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

ABSORBED DERMAL DOSE Mix/load Application

Dermal exposure 0.5 mL/day 41.55 mL/day Concen. of a.s. product or spray 500 mg/mL 5 mg/mL Dermal exposure to a.s. 250 mg/day 207.75 mg/day Percent absorbed 0.1 % 6 % Absorbed dose 0.25 mg/day 12.465 mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation exposure 0.01 mL/h

Duration of exposure 6 h

Concentration of a.s. in spray 5 mg/mL

Inhalation exposure to a.s. 0.3 mg/day

Percent absorbed 100 %

Absorbed dose 0.3 mg/day PREDICTED EXPOSURE Total absorbed dose 13.015 mg/day

Operator body weight 60 kg

Operator exposure 0.217 mg/kg bw/day Amount of AOEL 144.6 %

With Gloves during mixing/loading Active substance 2,4-D Product U 46 D Fluid

Formulation type water-based

Concentration of a.s. 500 mg/mL

Dose 2 L preparation/ha (1 ) Application volume 200 L/ha

Application method Tractor-mounted/trailed boom sprayer: hydraulic nozzles Container 10 litres 63 mm closure

Work rate/day 50 ha

Duration of spraying 6 h

PPE during mix./loading Gloves

PPE during application None

Dermal absorption from product 0.1 %

Dermal absorption from spray 6 %

EXPOSURE DURING MIXING AND LOADING Container size 10 Litres

Hand contamination/operation 0,05 mL

Application dose 2 Litres product/ha

Work rate 50 ha/day

Number of operations 10 /day

Hand contamination 0.5 mL/day

Protective clothing Gloves

Transmission to skin 5 %

Dermal exposure to formulation 0.025 mL/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Tractor-mounted/trailed boom sprayer: hydraulic nozzles Application volume 200 spray/ha

Volume of surface contamination 10 mL/h

Distribution Hands Trunk Legs 65% 10% 25% Clothing None Permeable Permeable Penetration 100% 5% 15% Dermal exposure 6.5 0.05 0.375 mL/h Duration of exposure 6 h

Total dermal exposure to spray 41.55 mL/day ABSORBED DERMAL DOSE Mix/load Application

Dermal exposure 0.025 mL/day 41.55 mL/day CA2971 / U 46 D Fluid Page 32 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

Concen. of a.s. product or spray 500 mg/mL 5 mg/mL Dermal exposure to a.s. 12.5 mg/day 207.75 mg/day Percent absorbed 0.1 % 6 % Absorbed dose 0.013 mg/day 12.465 mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation exposure 0.01 mL/h

Duration of exposure 6 h

Concentration of a.s. in spray 5 mg/mL

Inhalation exposure to a.s. 0.3 mg/day

Percent absorbed 100 %

Absorbed dose 0.3 mg/day PREDICTED EXPOSURE Total absorbed dose 12.778 mg/day

Operator body weight 60 kg

Operator exposure 0.213 mg/kg bw/day Amount of AOEL 142.0 %

With gloves during mixing/loading and application Active substance 2,4-D Product U 46 D Fluid

Formulation type water-based

Concentration of a.s. 500 mg/mL

Dose 2 L preparation/ha (1 ) Application volume 200 L/ha

Application method Tractor-mounted/trailed boom sprayer: hydraulic nozzles Container 10 litres 63 mm closure

Work rate/day 50 ha

Duration of spraying 6 h

PPE during mix./loading Gloves

PPE during application Gloves

Dermal absorption from product 0.1 %

Dermal absorption from spray 6 %

EXPOSURE DURING MIXING AND LOADING Container size 10 Litres

Hand contamination/operation 0,05 mL

Application dose 2 Litres product/ha

Work rate 50 ha/day

Number of operations 10 /day

Hand contamination 0.5 mL/day

Protective clothing Gloves

Transmission to skin 5 %

Dermal exposure to formulation 0.025 mL/day DERMAL EXPOSURE DURING SPRAY APPLICATION Application technique Tractor-mounted/trailed boom sprayer: hydraulic nozzles Application volume 200 spray/ha

Volume of surface contamination 10 mL/h

Distribution Hands Trunk Legs 65% 10% 25% Clothing Gloves Permeable Permeable Penetration 10% 5% 15% Dermal exposure 0.65 0.05 0.375 mL/h Duration of exposure 6 h

Total dermal exposure to spray 6.45 mL/day ABSORBED DERMAL DOSE Mix/load Application

Dermal exposure 0.025 mL/day 6.45 mL/day Concen. of a.s. product or spray 500 mg/mL 5 mg/mL Dermal exposure to a.s. 12.5 mg/day 32.25 mg/day Percent absorbed 0.1 % 6 % CA2971 / U 46 D Fluid Page 33 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

Absorbed dose 0.013 mg/day 1.935 mg/day INHALATION EXPOSURE DURING SPRAYING Inhalation exposure 0.01 mL/h

Duration of exposure 6 h

Concentration of a.s. in spray 5 mg/mL

Inhalation exposure to a.s. 0.3 mg/day

Percent absorbed 100 %

Absorbed dose 0.3 mg/day PREDICTED EXPOSURE Total absorbed dose 2.248 mg/day

Operator body weight 60 kg

Operator exposure 0.0375 mg/kg bw/day Amount of AOEL 25.0 %

A 3.2 Worker exposure calculations (KCP 7.2.3.1)

A 3.2.1 Calculations for 2,4-D

Table A 18: Input parameters considered for the estimation of worker exposure

Dislodgeable foliar residues Intended use(s): Meadow and pasture 1 µg/cm2/kg a.s. (DFR): Application rate (AR): 1 kg a.s./ha Transfer coefficient (TC): 1500 cm2/person/h Number of applications (NA): 1 Work rate per day (WR): 2 h/d Body weight (BW): 60 kg/person PPE 5 % Dermal absorption (DA): 6 % ('worst case') AOEL 0.15 mg/kg bw/d

Table A 19: Estimation of worker exposure towards 2,4-D using the German re-entry model

Without PPE 1) With PPE 2) Worker (re-entry): Systemic dermal exposure after application on meadow and pasture

SDEW = (DFR x TC x WR x AR x NA x DA) / BW SDEW = (DFR x TC x WR x AR x NA x PPE x DA) / BW (1 x 1500 x 2 x 1 x 1 x 6%) / 60 (1 x 1500 x 2 x 1 x 1 x 5% x 6%) / 60 External dermal exposure 3 mg/person External dermal exposure 0.15 mg/person External dermal exposure 0.05 mg/kg bw/d External dermal exposure 0.0025 mg/kg bw/d Total systemic exposure 0.18 mg/person Total systemic exposure 0.009 mg/person Total systemic exposure 0.003 mg/kg bw/d Total systemic exposure 0.00015 mg/kg bw/d % of AOEL 2.0 % % of AOEL 0.1 % 1) acceptable without PPE: Worker wearing long sleeved shirt, long trousers (“permeable”) but no gloves 2) acceptable only with PPE: see instructions for use

A 3.3 Bystander and resident exposure calculations (KCP 7.2.2.1)

A 3.3.1 Calculations for 2,4-D

Table A 20: Input parameters considered for the estimation of bystander exposure

Intended uses: Meadow and pasture Drift (D): 2.77 % (FC, 1 m) 1kg a.s./ha 1 m² (adults) Application rate (AR): Exposed body surface area (BSA): 100mg/m2 0.21 m² (children) 60kg/person (adults) 0.001 mg/kg a.s. (6 hours, adults) Body weight (BW): Specific Inhalation Exposure (I*A): mg/kg a.s. (6 hours, chil- 16.15kg/person (children) 0.000575 dren) Dermal absorption (DA): 6% ('worst case') Area Treated (A): 20ha/d (based on FCTM) CA2971 / U 46 D Fluid Page 34 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

Inhalation absorption (IA): 100% AOEL: 0.15mg/kg bw/d Exposure duration (T): 5 min

Table A 21: Estimation of bystander exposure towards 2,4-D

Adults Children Bystander: Systemic dermal exposure during/after application (via spray drift)

SDEB = (AR x D x BSA x DA) / BW SDEB = (AR x D x BSA x DA) / BW (100 x 2.77% x 1 x 6%) / 60 (100 x 2.77% x 0.21 x 6%) / 16.15 External dermal exposure 2.77mg/person External dermal exposure 0.5817mg/person External dermal exposure 0.046167mg/kg bw/d External dermal exposure 0.036019mg/kg bw/d Systemic dermal exposure 0.00277mg/kg bw/d Systemic dermal exposure 0.002161mg/kg bw/d Bystander: Systemic inhalation exposure during/after application (via spray drift)

SIEB = (I*A x AR x A x T x IA) / BW SIEB = (I*A x AR x A x T x IA) / BW (0.001 / 360 x 1 x 20 x 5 x 100%) / 60 (0.000575 / 360 x 1 x 20 x 5 x 100%) / 16.15 External inhalation exposure 0.000278mg/person External inhalation exposure 0.00016mg/person External inhalation exposure 0.000005mg/kg bw/d External inhalation exposure 0.00001mg/kg bw/d Systemic inhalation exposure 0.000005mg/kg bw/d Systemic inhalation exposure 0.00001mg/kg bw/d

Total systemic exposure: SEB = SDEB + SIEB Total systemic exposure: SEB = SDEB + SIEB Total systemic exposure 0.166478mg/person Total systemic exposure 0.035062mg/person Total systemic exposure 0.002775mg/kg bw/d Total systemic exposure 0.002171mg/kg bw/d % of AOEL 1.85% % of AOEL 1.45%

Table A 22: Input parameters considered for the estimation of resident exposure

Intended uses: Meadow and pasture Drift (D): 100% (FC, 1 m) 1kg a.s./ha 7300cm2/h (adults) Application rate (AR): Transfer coefficient (TC): 0.01mg/cm2 2600cm2/h (children) Turf Transferable Residues Number of applications (NA): 1 5% (TTR): 60kg/person (adults) Exposure Duration (H): 2h Body weight (BW): Airborne Concentration of Va- 16.15kg/person (children) 0.001mg/m3 pour (ACV): Dermal absorption (DA): 6% ('worst case') 16.57m3/d (adults) Inhalation Rate (IR): Inhalation absorption (IA): 100% 8.31m3/d (children) Oral absorption (OA): 100% Saliva Extraction Factor (SE): 50% AOEL: 0.15mg/kg bw/d Surface Area of Hands (SA): 20cm2 Frequency of Hand to Mouth 20events/h (Freq): Dislodgeable foliar residues 20% (DFR): Ingestion Rate for Mouthing of 25cm2/d Grass/Day (IgR):

Table A 23: Estimation of resident exposure towards 2,4-D

Adults Children Residents: Systemic dermal exposure after application (via deposits caused by spray drift)

SDER = (AR x NA x D x TTR x TC x H x DA) / BW SDER = (AR x NA x D x TTR x TC x H x DA) / BW (0.01 x 1 x 100% x 5% x 7300 x 2 x 6%) / 60 (0.01 x 1 x 100% x 5% x 2600 x 2 x 6%) / 16.15 External dermal exposure 7.3 mg/person External dermal exposure 2.6 mg/person External dermal exposure 0.121667 mg/kg bw/d External dermal exposure 0.160991 mg/kg bw/d Systemic dermal exposure 0.0073 mg/kg bw/d Systemic dermal exposure 0.009659 mg/kg bw/d Residents: Systemic inhalation exposure after application (via vapour)

SIER = (ACV x IR x IA) / BW SIER = (ACV x IR x IA) / BW (0.001 x 16.57 x 100%) / 60 (0.001 x 8.31 x 100%) / 16.15 External inhalation exposure 0.01657 mg/person External inhalation exposure 0.00831 mg/person External inhalation exposure 0.000276 mg/kg bw/d External inhalation exposure 0.000515 mg/kg bw/d Systemic inhalation exposure 0.000276 mg/kg bw/d Systemic inhalation exposure 0.000515 mg/kg bw/d Residents: Systemic oral exposure (hand-to-mouth transfer)

SOER(H) = (AR x NA x D x TTR x SE x SA x Freq x H x OA) / BW (0.01 x 1 x % x 5% x 50% x 20 x 20 x 2 x 100%) / 16.15 CA2971 / U 46 D Fluid Page 35 /35 Part B – Section 6 - Core Assessment Template for chemical PPP zRMS version Version 15/09/2015

External oral exposure 0.2 mg/person External oral exposure 0.012384 mg/kg bw/d Systemic oral exposure 0.012384 mg/kg bw/d Residents: Systemic oral exposure (object-to-mouth transfer)

SOER(O) = (AR x NA x D x DFR x IgR x OA) / BW (0.01 x 1 x % x 20% x 25 x 100%) / 16.15 External oral exposure 0.05 mg/person External oral exposure 0.003096 mg/kg bw/d Systemic oral exposure 0.003096 mg/kg bw/d

Total systemic exposure: SER = SDER + SIER Total systemic exposure: SER = SDER + SIER + SOER(H) + SOER(O) Total systemic exposure 0.45457 mg/person Total systemic exposure 0.41431 mg/person Total systemic exposure 0.007576 mg/kg bw/d Total systemic exposure 0.025654 mg/kg bw/d % of AOEL 5.05 % % of AOEL 17.10 %

REGISTRATION REPORT Part B Section 7 Metabolism and Residues Detailed summary of the risk assessment

Product code: CA2971 Product name: U 46 D fluid Chemical active substance: 2,4-Dichlorophenoxyacetic acid (2,4-D), 500 g/L (as its Dimethylamine salt, 602 g/L)

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: Nufarm Deutschland GmbH Submission date: 19/12/2013 Finalisation date: 27/04/2017 CA2971 / U 46 D Fluid Page 2 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

Version history

When What

29/11/2013 dRR version of applicant 24/07/2015 dRR version of zRMS

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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 2,4-D ...... 7 7.1.2.2 Summary for U46 D Fluid ...... 7 7.2 2,4-D ...... 8 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 (KCA 6.1) ...... 9 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) ...... 11 7.2.2.3 Nature of residues in processed commodities (KCA 6.5.1) ...... 11 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) ...... 13 7.2.3 Magnitude of residues in plants (KCA 6.3) ...... 14 7.2.3.1 Summary of European data and new data supporting the intended uses ..... 14 7.2.3.2 Conclusion on the magnitude of residues in plants ...... 16 7.2.4 Magnitude of residues in livestock ...... 16 7.2.4.1 Dietary burden calculation ...... 16 7.2.4.2 Livestock feeding studies (KCA 6.4.1-6.4.3) ...... 17 7.2.5 Magnitude of residues in processed commodities (Industrial Processing and/or Household Preparation) (KCA 6.5.2-6.5.3) ...... 20 7.2.5.1 Available data for all crops under consideration ...... 20 7.2.5.2 Conclusion on processing studies ...... 20 7.2.6 Magnitude of residues in representative succeeding crops ...... 20 7.2.6.1 Field rotational crop studies (KCA 6.6.2) ...... 20 7.2.7 Other / special studies (KCA6.10, 6.10.1) ...... 20 7.2.8 Estimation of exposure through diet and other means (KCA 6.9) ...... 20 7.2.8.1 Input values for the consumer risk assessment ...... 21 7.2.8.2 Conclusion on consumer risk assessment ...... 21 7.3 Combined exposure and risk assessment ...... 22 7.4 References ...... 23

Appendix 1 Lists of data considered in support of the evaluation ...... 24

Appendix 2 Detailed evaluation of the additional studies relied upon ...... 31 A 2.1 2,4-D ...... 31 A 2.1.1 Stability of residues ...... 31 A 2.1.2 Nature of residues in plants, livestock and processed commodities ...... 31 A 2.1.3 Magnitude of residues in plants ...... 32 A 2.1.4 Magnitude of residues in livestock ...... 41 CA2971 / U 46 D Fluid Page 4 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

A 2.1.5 Magnitude of residues in processed commodities (Industrial Processing and/or Household Preparation) ...... 41 A 2.1.6 Magnitude of residues in representative succeeding crops ...... 41 A 2.1.7 Other/Special Studies ...... 41

Appendix 3 Pesticide Residue Intake Model (PRIMo) ...... 42 A 3.1 TMDI calculations ...... 42

CA2971 / U 46 D Fluid Page 5 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

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 GAPs most critical with respect to consumer intake and risk assessment for the preparation CA2971 / U 46 D Fluid are presented in Table 7.1-1. They have been selected from the individual GAPs in the central zone for cereals and grassland. 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. The assessment of this application is based on the toxicological reference values and endpoints determined in the framework of the renewal of the active substance 2,4-D (EFSA Conclusion, 2014). This risk assessment, which considered the current state of knowledge, does not lead to relevant differences compared to the assessment based on the review report for 2,4-D (2001).

An exceedance of the MRLs currently established in EU residue legislation (Reg. (EU) 396/2005 (last amendment Regulation (EU) No 1317/2013) for 2,4-D at 0.05 mg/kg in barley and oats grain and at 2 mg/kg in rye and wheat grain respectively is not expected. The chronic and the short-term intakes of 2,4-D 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.

No specific mitigation measures are needed.

Data gaps No data gaps were identified.

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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

F, Fn, Formulation Application Application rate per treatment GAP Fpn Pests or PHI number Crop and/ Product G, Zone Group of pests (days) Conclusion (see part or situation ** code Gn, B.0)* Gpn controlled Type Conc. method growth number interval kg as/hL water L/ha kg as/ha or of as kind stage & season min max between I*** applications (min) min max min max min max

1 winter soft Central CA2971 / F dicotyledonous SL 602 g/L spraying post- 1 0.1875- 200-400 0.75 XF A wheat, spelt, zone U 46 D weeds 2,4-D emergence, 0.375 winter durum Fluid DMA spring, wheat, winter BBCH 21-32 triticale (500 g/L (0500090) 2,4-D)

winter barley (0500010)

winter rye (0500070)

winter oats (0500050) 3 grassland, Central CA2971 / F dicotyledonous SL 602 g/L spraying during growing 1 0.25-0.5 200-400 1 14 A pasture, zone U 46 D weeds 2,4-D season (March meadow Fluid DMA to October) BBCH 25-35 (no code no. (500 g/L available) 2,4-D) * Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 ** Use also code numbers according to Annex I of Regulation (EU) No 396/2005 *** 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 11 “Conclusion” A Exposure acceptable without risk mitigation measures, safe use R Further refinement and/or risk mitigation measures required N Exposure not acceptable, no safe use CA2971 / U 46 D Fluid Page 7 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

7.1.2 Summary of the evaluation

The preparation U 46 D Fluid is composed of active substance 2,4-D.

Table 7.1-2: Toxicological reference values for the dietary risk assessment of 2,4-D

Reference Source Year Value Study relied upon Safety factor value

ADI Review Report 2001 0.05 mg/kg bw/d long term (mouse and rat) 100 ADI EFSA Conclusion 2014 0.05 mg/kg bw/d 2-year studies (mouse and rat) 100 (Renewal) ARfD Review Report 2001 not applicable - - ARfD EFSA Conclusion 2014 0.75 mg/kg bw/d acute neurotoxicity, rat 100 (Renewal)

The assessment of this application is based on the toxicological reference values determined in the framework of the renewal of the active substance 2,4-D (EFSA Conclusion, 2014).

7.1.2.1 Summary for 2,4-D

Table 7.1-3: Summary for 2,4-D

Sample Chronic Acute risk Plant Sufficient PHI suffi- storage Use- MRL com- risk for for con- Crop metabolism residue ciently sup- covered No.* pliance consumers sumers covered? trials? ported? by stabil- identified? identified? ity data?

1 Cereals Yes Yes Yes Yes Yes No (20 trials) No 3 Grassland Yes Yes Yes Yes Yes (animal No (animal (12 trials) matrices) matrices) * Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1

7.1.2.2 Summary for U46 D Fluid

Table 7.1-4: Information on U46 D Fluid (KCA 6.8)

PHI for U46 PHI PHI for U46 D zRMS Comments D Fluid Fluid Crop (if different PHI proposed by proposed by 2,4-D proposed) applicant zRMS

Cereals F** Yes/ NR F** n.a. Grassland 14 days Yes/ NR 14 days n.a. NR: not relevant * Purpose of withholding period to be specified ** F: PHI is defined by the application stage at last treatment (time elapsing between last treatment and harvest of the crop).

CA2971 / U 46 D Fluid Page 8 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

Assessment

7.2 2,4-D

General data on 2,4-D are summarised in the table below (last updated 2015/07/16)

Table 7.2-1: General information on 2,4-D Active substance (ISO Common Name) 2,4-D IUPAC (2,4-dichlorophenoxy) acetic acid Chemical structure

Molecular formula C8H6Cl2O3 Molar mass 221.0 g/mol Chemical group phenoxy acetic compounds Mode of action (if available) 2,4-D induces uncontrolled cell division in the plant tissues which causes such a disproportion between assimilation performed and water balance on the one hand, and the normal vegetative growth process on the other hand, that eventually the plant dies. Systemic Yes Companies European Union 2,4-D Task Force 2012*: − Nufarm GmbH & Co KG − Dow AgroSciences B.V. − Makhteshim Agan Agro Poland S.A. Rapporteur Member State (RMS) RMS: Greece, Co-RMS: Poland Approval status Approved (01/10/2001, COMMISSION DIRECTIVE 2001/103/EC and COMMISSION DIRECTIVE 2010/77/EU)

Note: Renewal of approval is pending. Restriction(s) Only uses as herbicide may be authorised. Review Report First approval: 7599/VI/97 – final (01/10/2001)

Note: Review Report for Renewal of approval is not yet available (expected in 2015) Current MRL regulation Regulation (EC) No 1317/2013 Peer review of MRLs according to Article 12 of Reg No Yes 396/2005 EC performed EFSA Journal: Conclusion on the peer review Yes for Renewal (EFSA, 2014, ASB2014-9962)**

Note: No EFSA conclusion is available for the peer review of the first approval. EFSA Journal: conclusion on article 12 Yes (EFSA, 2011, ASB2012-3216)** Current MRL applications on intended uses Not applicable * Notifier in the EU process to whom the a.s. belong(s) ** If yes: EFSA, YYYY - see list of references CA2971 / U 46 D Fluid Page 9 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

7.2.1 Stability of Residues (KCA 6.1)

7.2.1.1 Stability of residues during storage of samples

Available data No new data were submitted in the framework of this application. A summary of the storage stability data on 2,4-D is given in the following table. Data has been previously evaluated at EU level and is described in detail in the final addendum to the RAR (Greece, 2014; ASB2014-6804), in EFSA’s Conclusion on the peer review of the pesticide risk assessment of the active substance 2,4-D (EFSA, 2014; ASB2014-9962) and in EFSA’s RO on the review of the existing MRLs for 2,4-D according to Article 12 of Regulation (EC) No 396/2005 (EFSA, 2011; ASB2012-3216).

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 Data relied on in EU Plant products Sugar cane, grass, wheat High water content 12 months Greece, 2014 and maize forage EFSA, 2014 RIP2003-510 Wheat, rice, maize and High starch content 12 months sorghum grain Soya bean High lipid content 12 months Cereal straw, hay Dry matrices 12 months Cereal greens High water content 18 months Greece, 2014 EFSA, 2014 Cereal grain High starch content 18 months RIP2007-339 Cereal straw Dry matrices 18 months Animal Products Ruminant Milk and tissues 4 months Greece, 2014 EFSA, 2014 RIP2003-509

Conclusion on stability of residues during storage The available residue trials supporting the intended uses were performed in compliance with the above reported storage conditions.

7.2.1.2 Stability of residues in sample extracts (KCA 6.1)

Not relevant. CA2971 / U 46 D Fluid Page 10 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

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)

Available data No new data submitted in the framework of this application. A summary of the metabolism of 2,4-D in plants is given in the following table. Data has been previously evaluated at EU level and is described in detail in the RAR (Greece, 2013; ASB2013-4350), in the final Addendum to the RAR (Greece, 2014; ASB2014-6804), in EFSA’s Conclusion on the peer review of the pesticide risk assessment of the active substance 2,4-D (EFSA, 2014; ASB2014-9962) and in EFSA’s RO on the review of the existing MRLs for 2,4-D according to Article 12 of Regulation (EC) No 396/2005 (EFSA, 2011; ASB2012-3216).

Table 7.2-3: Summary of plant metabolism studies

Application and sampling details Label Crop Group Crop Method, Rate No Sampling Remarks Reference position F or G (a) (kg (DAT) a.s./ha) EU data Fruits and fruit- Apple U-14C- Application 2.13 2 56 RMS, 2014 ing vegetable phenyl around the EFSA, 2014 labelled trunk RIP2003-467 Root and tuber Potato U-14C- Foliar 0.07 2 82 RMS, 2014 vegetables phenyl EFSA, 2014 labelled RIP2003-470 Potato U-14C- Foliar 0.14 and 2 29 RMS, 2014 phenyl 0.28 EFSA, 2014 labelled Pulses and Soya bean 1-14C-2,4- Injection, 21 µg/plant 1 Plants: 14 Publication RMS, 2014 oilseeds D greenhouse or callus Callus: 7 EFSA, 2014 RIP2003-471 Cereals Wheat U-14C- Foliar 1.68 1 0, 10, 28, RMS, 2014 phenyl 49 EFSA, 2014 labelled RIP2003-468 RIP2003-469 Wheat Unlabelled Foliar 0.5 1 1, 2, 3, 5, RMS, 2014 9, 19, 35 EFSA, 2014 Wheat 1-14C-2,4- Injection, 21 µg/plant 1 Plants: 14 Publication RMS, 2014 D greenhouse or callus Callus: 7 EFSA, 2014 RIP2003-471

Summary of plant metabolism studies reported in the EU Residue levels were too low for identification in apples (total residues: 0.009 mg/kg) and in potatoes (total residues: 0.0054 mg/kg). In wheat grain, nearly 50% of the TRR was associated with natural products (protein, starch and cellulose fractions). The remaining residue consisted primarily of polar unknowns and unextractable compounds. Parent 2,4-D accounted for 6% TRR and was the only component identified. In wheat forage and wheat straw, parent 2,4-D was the main component of the residue (72-77% TRR, free + conjugated). The remaining residue comprised a large number of distinct metabolites, out of which 4-OH- 2,5-D was the major metabolite of 2,4-D. It accounted for 8% TRR. Other metabolites were defined as CA2971 / U 46 D Fluid Page 11 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015 hydroxylated derivatives of 2,4-D and unknowns, none of them exceeding 2.5% of the TRR. The results obtained for soya beans and maize plants, revealed similar metabolic pathways, i.e. conjuga- tion of 2,4-D, and, to a much lesser extent, hydroxylation of the phenyl ring. Based on these studies, it is concluded that metabolic pathways are similar in all tested crops.

Conclusion on metabolism in primary crops The intended uses are covered by the available metabolism studies reported in the EU.

7.2.2.2 Nature of residue in rotational crops (KCA 6.6.1)

Available data A metabolism study on rotational crops was not available and no new data were submitted in the framework of this application.

Summary of plant metabolism studies reported in the EU

According to the soil degradation studies evaluated in the framework of the peer review, the DT90 value calculated of 2,4-D, was 67.7 days which is below the trigger value of 100 days. Relevant soil metabolites were also not identified. Further investigation of residues in rotational crops is not required as relevant residues in these crops are not expected.

Conclusion on metabolism in rotational crops No studies on rotational crops are available and none are required due to the fast degradation of 2,4-D in soil.

7.2.2.3 Nature of residues in processed commodities (KCA 6.5.1)

Available data No processing study is available and no new data is submitted in the framework of this application.

Conclusion on nature of residues in processed commodities No processing study is available. As, based on available residue data, no quantifiable residues of 2,4-D are expected in edible parts of crops, there is no need to investigate effects of industrial and/or household processing.

7.2.2.4 Conclusion on the nature of residues in commodities of plant origin (KCA 6.7.1)

Table 7.2-4: Summary of the nature of residues in commodities of plant origin Endpoints Plant groups covered Fruits (apples), Root and tuber vegetables (potatoes), Cereals (wheat) and Pulses/oilseeds (soya beans) Rotational crops covered No study is available and none is required due to the fast degradation in soil (DT90 = 67.7 days). CA2971 / U 46 D Fluid Page 12 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

Metabolism in rotational crops similar to metabolism Not applicable in primary crops? Processed commodities Due to low residues at harvest, no study is required. Residue pattern in processed commodities similar to Not applicable pattern in raw commodities? Plant residue definition for monitoring Sum of 2,4-D, its salts, esters and conjugates, expressed as 2,4-D (Reg. (EC) No 396/2005) Plant residue definition for risk assessment Sum of 2,4-D, its salts, esters and conjugates, expressed as 2,4-D (EFSA 2014, ASB2014-9962) Conversion factor from enforcement to RA None

7.2.2.5 Nature of residues in livestock (KCA 6.2.2-6.2.5)

Available data No new data were submitted in the framework of this application. A summary of the metabolism of 2,4-D in livestock is given in the following table. Data has been previously evaluated at EU level and is described in detail in the RAR (Greece, 2013; ASB2013-4350), in the final Addendum to the RAR (Greece, 2014; ASB2014-6804), in EFSA’s Conclusion on the peer review of the pesticide risk assessment of the active substance 2,4-D (EFSA, 2014; ASB2014-9962) and in EFSA’s RO on the review of the existing MRLs for 2,4-D according to Article 12 of Regulation (EC) No 396/2005 (EFSA, 2011; ASB2012-3216).

Table 7.2-5: Summary of animal metabolism studies

Application details Sample details Label No of Group Species Rate Duration Commodity Time of Reference position animal (mg/kg bw/d) (days) sampling EU data

Lactating Goat U-14C- 1 24 3 Milk daily RMS, 2014 ruminants phenyl EFSA, 2014 labelled Urine and faeces daily RIP2003- Tissues after 472 sacrifice Laying Hens U-14C- 15 1.4 7 Eggs daily RMS, 2014 poultry phenyl EFSA, 2014 labelled Excreta daily RIP2003- 473 Tissues after sacrifice

Summary of plant metabolism studies reported in the EU In both goat and poultry, 2,4-D was extensively excreted in urine and faeces (≥90% TRR); less than 0.1% of the administered radioactivity was recovered in milk, eggs and tissues, resulting in TRRs below 0.2 mg/kg in all animal matrices, except for kidney (0.7 mg/kg and 1.4 mg/kg for poultry and goat, respectively). The parent 2,4-D, free and conjugated, was identified as the major compound in the residue in milk (47% TRR), eggs (23% TRR), chicken liver, fat and kidney (18, 25 and 76% TRR). In addition, 4-chlorophenoxyacetic acid was identified in milk (6.9% TRR) and 2,4-DCP was found in milk, eggs and chicken liver up to 7.3% TRR. CA2971 / U 46 D Fluid Page 13 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

Conclusion on metabolism in livestock The metabolic patterns identified for goats and hens were consistent with the rat metabolism and therefore considered applicable to pigs as well. Considering that 2,4-D conjugates were identified in animal matrices, the same residue definitions as for plant commodities were proposed for products of animal origin.

7.2.2.6 Conclusion on the nature of residues in commodities of animal origin (KCA 6.7.1)

Table 7.2-6: Summary on the nature of residues in commodities of animal origin

Endpoints

Animals covered Lactating goats Laying hens Time needed to reach a plateau 28 days in milk concentration No data for eggs Animal residue definition for monitoring Sum of 2,4-D, its salts, esters and conjugates, expressed as 2,4-D (Reg. (EC) No 396/2005) Animal residue definition for risk Sum of 2,4-D, its salts, esters and conjugates, expressed as 2,4-D assessment (EFSA Conclusion: EFSA 2014, ASB2014-9962)

Conversion factor Not applicable Metabolism in rat and ruminant similar Yes Fat soluble residue No

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7.2.3 Magnitude of residues in plants (KCA 6.3)

7.2.3.1 Summary of European data and new data supporting the intended uses

New studies on the magnitude of residues in cereals have been submitted by the applicant in the framework of the renewal process of the inclusion of active substance 2,4-D to Regulation (EC) No 1107/2009. These results of the studies and those of further older studies are summarized in the table below. They are described in detail in the final Addendum to the RAR (RMS Greece, 2014; ASB2014-6804) and in EFSA’s conclusion on the peer review of the pesticide risk assessment of the active substance 2,4-D (EFSA, 2014; ASB2014-9962). New studies on the magnitude of residues in grassland have been submitted by the applicant in the framework of this application. The results of these studies and those of former, older studies are summarized in the table below. The detailed assessment of these studies is presented in Appendix 2.

Table 7.2-7: Summary of EU reported and new data supporting the intended uses of U 46 D Fluid and conformity to existing MRL

Residue Evaluation zone (N- Unrounded Current GAP MRL com- EU, S- STMR HR OECD calcu- EU MRL Commodity Source Residue levels (mg/kg) pliance EU, EU, (mg/kg) (mg/kg) lator MRL (mg/kg) E = according to enforcement residue definition outside (mg/kg) RA = according to risk assessment residue definition * EU)

Cereal grain EFSA, 2014; N-EU GAP on which MRL/EU a.s. assessment is based: 1 x 0.75 kg N/A (barley, oats RMS Greece, as/ha, BBCH 21-32, PHI n.a., outdoor and wheat) 2013/2014; E: 2x <0.01, 6x <0.02, <0.04, 11x <0.05 (including overdosed ASB2013-9158 trials that were considered for MRL setting as all values

rye)

Cereal straw EFSA, 2014; N-EU GAP on which MRL/EU a.s. assessment is based: 1 x 0.75 kg N/A (barley, oats Greece, as/ha, BBCH 21-32, PHI XF, outdoor and wheat) 2013/2014 E: 3x <0.02, 0.025, 8x<0.05, 0.06, 0.08, 2x <0.10, 0.19, 0.28, ASB2013-9158 0.65, 1.4 mg/kg to (including overdosed trials that were taken into account as a ASB2013-9168 ASB2013-9141 worst case to derive STMR and HR for animal burden RIP2003-464 calculations) RIP2003-462 RA: 3x <0.02, 0.025, 8x<0.05, 0.06, 0.08, 2x <0.10, 0.19, 0.28, RIP2003-463 0.65, 1.4 mg/kg (including overdosed trials that were taken into account as a worst case to derive STMR and HR for animal burden calculations) New trials N-EU No new data. Overall N-EU E: 3x <0.02, 0.025, 8x<0.05, 0.06, 0.08, 2x <0.10, 0.19, 0.28, 0.05 1.4 -- -- n.a. supporting 0.65, 1.4 mg/kg data for cGAP RA: 3x <0.02, 0.025, 8x<0.05, 0.06, 0.08, 2x <0.10, 0.19, 0.28, 0.65, 1.4 mg/kg Grass EU data N-EU No supporting data. N/A

New trials N-EU Trials GAP: 1 x 0.91-1.1 kg as/ha, PHI 14 d ASB2014-5642 E: 1.8, 2x 2.1, 2.9, 4.0, 4.1, 4.2, 6.2, 9.0, 10.3, 15, 21 mg/kg RIP2003-466 RA: 1.8, 2x 2.1, 2.9, 4.0, 4.1, 4.2, 6.2, 9.0, 10.3, 15, 21 mg/kg Overall N-EU E: 1.8, 2x 2.1, 2.9, 4.0, 4.1, 4.2, 6.2, 9.0, 10.3, 15, 21 mg/kg 4.15 21 -- -- n.a. supporting RA: 1.8, 2x 2.1, 2.9, 4.0, 4.1, 4.2, 6.2, 9.0, 10.3, 15, 21 mg/kg data for cGAP * Source of EU MRL: Reg. (EU) No 1317/2013 amending Reg. (EC) No 396/2005

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7.2.3.2 Conclusion on the magnitude of residues in plants

The available data package is considered sufficient for dietary risk assessment.

A total of 20 residues trials were available on cereals (11 trials on wheat, 8 trials on barley and 1 trial on oats). Out of these, 14 trials were performed according to the critical GAP and were considered in risk assessment. Although the remaining 6 trials were performed with higher application rates compared to the intended rate (1-1.3 kg as/ha) they were considered in the risk assessment as well since all residue values were below the LOQ. Treatment of cereal grains is intended at early growth stages of the crops only (up to BBCH 32). The residue trials on wheat, barley and oat were combined since prior to the formation of the generative parts of the plants, residue data on barley, oats, rye, and wheat can be considered mutually supportive when gained on compatible GAPs (appendix D of EU guidelines).

A total of 16 trials were available on grassland, out of which 12 trials represented the critical GAP and were considered in risk assessment. Further four trials were performed with higher application rates and were therefore disregarded. 14 days after treatment, residues of 2,4-D in grass were found in a range between 1.8 and 21 mg/kg.

An exceedance of the current MRLs of 0.05 mg/kg for 2,4-D in barley and oats grain as well as 2 mg/kg for 2,4-D in rye and wheat grain (including triticale) as laid down in Reg. (EU) 396/2005 (last amendment Regulation (EU) No 1317/2013) is not expected. The expected residue levels in animal matrices at the calculated dietary burden were below the current MRLs for animal products.

The data submitted show that no exceedance of the MRL is to be envisaged. The intended uses on cereals and grassland are considered acceptable.

7.2.4 Magnitude of residues in livestock

7.2.4.1 Dietary burden calculation

Table 7.2-8: Input values for the dietary burden calculation, based on uses evaluated in the framework of Art. 12 of Reg (EC) No 396/2005- ASB2012-3216 (and the uses under consideration)

Median dietary burden Maximum dietary burden Feed Commodity Input value Input value Comment Comment (mg/kg) (mg/kg)

Risk assessment residue definition: sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D Grass (fresh) 12.6 Median residue 26.0 Highest residue (EFSA 2011) (EFSA 2011) Maize silage 0.055 Median residue 0.06 Highest residue (EFSA 2011) (EFSA 2011) Apple pomace 0.01 Median residue 0.01 Median residue (EFSA 2011) CA2971 / U 46 D Fluid Page 17 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

Median dietary burden Maximum dietary burden Feed Commodity Input value Input value Comment Comment (mg/kg) (mg/kg)

Hay 50.4 Median residue 104.0 Highest residue 12.6 x PF 4) (26.0 x PF 4) (EFSA 2004) (EFSA 2011) Cereal grain except 0.05 Median residue 0.05 Median residue maize (EFSA 2011) (EFSA 2011) Maize grain 0.05 Median residue 0.05 Median residue (EFSA 2011) (EFSA 2011) Cereal bran 0.40 Median residue x PF 8 0.40 Median residue x PF 8 (EFSA, 2011) (EFSA, 2011) Cereal straw 0.05 Median residue 1.88 Highest residue (EFSA 2011) (EFSA 2011)

Table 7.2-9: Results of the dietary burden calculation

Animal species Median Maximum die- Highest contrib- Max dietary Trigger dietary burden tary burden uting commodity burden (mg/kg exceeded (mg/kg bw/d) (mg/kg bw/d) DM) (Y/N)

Risk assessment residue definition: sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D Beef cattle* 2.70 5.571 Grass (fresh) 130.0 Yes Dairy cattle* 2.291 4.727 Grass (fresh) 130.0 Yes Ram/ewe n.a. n.a. n.a. n.a. n.a. Lamb n.a. n.a. n.a. n.a. n.a. Breeding swine n.a. n.a. n.a. n.a. n.a. Finishing swine* 0.359 0.738 Apple pomace 18.44 Yes Broiler poultry n.a. n.a. n.a. n.a. n.a. Layer poultry* 0.004 0.004 Cereal bran 0.067 No Turkey n.a. n.a. n.a. n.a. n.a. * These categories correspond to those (formerly) assessed at EU level.

The dietary burden levels calculated from residues of 2,4 D in feed of dairy ruminants, meat ruminants and pigs exceed the trigger value of 0.1 mg/kg DM. Further investigation on the magnitude of residues in commodities from these animals is therefore required. The trigger is not exceeded for poultry. It is not anticipated that residues due the intended uses will further add to the overall dietary burden.

7.2.4.2 Livestock feeding studies (KCA 6.4.1-6.4.3)

Available data No new data were submitted in the framework of this application. A summary of the available livestock feeding study is given in the following table. Data has been previously evaluated at EU level and is described in detail in the RAR (Greece, 2013; ASB2013-4350), in the final Addendum to the RAR (Greece, 2014; ASB2014-6804), in EFSA’s Conclusion on the peer review of the pesticide risk assessment of the active substance 2,4-D (EFSA, 2014; ASB2014-9962) and in EFSA’s RO on the review of the existing MRLs for 2,4-D according to Article 12 of Regulation (EC) No 396/2005 (EFSA, 2011; ASB2012-3216). CA2971 / U 46 D Fluid Page 18 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

Table 7.2-10: Overview of the values derived from livestock feeding studies

Dietary burden Results of the livestock feeding study

Med. Max. Dose Level No Result for enforce- Result for RA Median Highest Calculated CF for Commodity (mg/kg (mg/kg (mg/kg ment residue residue MRL RA(d) bw/d) bw/d) bw/d)(a) (mg/kg)(b) (mg/kg)(c) (mg/kg) Mean Max. Mean Max. (mg/kg) (mg/kg) (mg/kg) (mg/kg) EU data (Greece, 2014; EFSA, 2011; EFSA, 2014) Enforcement and risk assessment residue definition: sum of 2,4-D, its salts, esters and conjugates expressed as 2,4-D Pig meat 0.359 0.738 52.58 3 0.21 0.24 0.21 0.24 0.05 0.05 0.05* 1 105.1 3 0.41 0.51 0.41 0.51 210.1 3 0.76 1.1 0.76 1.1 Pig fat 52.58 3 0.42 0.51 0.42 0.51 0.05 0.05 0.05* 1 105.1 3 0.59 0.75 0.59 0.75 210.1 3 2.5 3.6 2.5 3.6 Pig liver 52.58 3 0.12 0.20 0.12 0.20 0.05 0.05 0.05* 1 105.1 3 1.9 2.4 1.9 2.4 210.1 3 3.0 3.5 3.0 3.5 Pig kidney 52.58 3 3.9 6.5 3.9 6.5 0.05 0.091 0.1 1 105.1 3 14 18 14 18 210.1 3 17 29 17 29 Ruminant meat 2.70 5.571 52.58 3 0.21 0.24 0.21 0.24 0.05 0.05 0.05* 1 105.1 3 0.41 0.51 0.41 0.51 210.1 3 0.76 1.1 0.76 1.1 CA2971 / U 46 D Fluid Page 19 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

Dietary burden Results of the livestock feeding study

Ruminant fat 2.70 5.571 52.58 3 0.42 0.51 0.42 0.51 0.05 0.054 0.1 1 105.1 3 0.59 0.75 0.59 0.75 210.1 3 2.5 3.6 2.5 3.6 Ruminant liver 52.58 3 0.12 0.20 0.12 0.20 0.05 0.05 0.05* 1 105.1 3 1.9 2.4 1.9 2.4 210.1 3 3.0 3.5 3.0 3.5 Ruminant kidney 52.58 3 3.9 6.5 3.9 6.5 0.195 0.689 1 1 105.1 3 14 18 14 18 210.1 3 17 29 17 29 Milk 2.291 4.727 52.58 3 0.04 (e) N/A 0.04 (e) N/A 0.01 0.01 0.01* 1 105.1 3 0.12 (e) N/A 0.12 (e) N/A 210.1 3 0.29 (e) N/A 0.29 (e) N/A N/A: Not applicable – only the mean values are considered for calculating MRLs in milk. n.r.: Not reported (*): Indicates that the MRL is set at the limit of analytical quantification. (F): MRL is expressed as mg/kg of fat contained in the whole product. (a): Based on a 565 kg animal consuming 17.9 kg feed DM/day. (b): Median residue value according to the enforcement residue definition, derived by interpolation/extrapolation from the feeding study for the median dietary burden (FAO, 2009). (c): Highest residue value (tissues, eggs) or mean residue value (milk) according to the enforcement residue definition, derived by interpolation/extrapolation of the maximum dietary burden between the relevant feeding groups of the study (FAO, 2009). (d): The median conversion factor for enforcement to risk assessment. (e): Mean residue level from day 7 until day 28 (3 cows, 7 sampling days).

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Conclusion on feeding studies When comparing the level of the estimated maximum dietary burden (Table 7.2-9) to the results of the feeding study on lactating cows it appears that no exceedance of the MRLs laid down in Regulation (EC) No 396/2005 (last amendment Regulation (EU) No 1317/2013) for commodities of animal origin is to be anticipated.

7.2.5 Magnitude of residues in processed commodities (Industrial Processing and/or Household Preparation) (KCA 6.5.2-6.5.3)

7.2.5.1 Available data for all crops under consideration

No processing study is available and no new data were submitted in the framework of this application.

7.2.5.2 Conclusion on processing studies

As quantifiable residues of 2,4-D are not expected in edible part of the crops on which authorisation is sought, specific processing studies are not required.

7.2.6 Magnitude of residues in representative succeeding crops

7.2.6.1 Field rotational crop studies (KCA 6.6.2)

Due to fast degradation of 2,4-D in soil (see 7.2.2.2) no field rotational crop study is required.

Available data No field rotational crop study was available and no new data was submitted in the framework of the current application.

Conclusion on rotational crops studies

According to the soil degradation studies evaluated in the framework of the peer review, the DT90 value of 2,4-D was 67.7 days. This figure is below the trigger value of 100 days for further considerations. Rel- evant soil metabolites were also not identified. No field studies for the investigation of residues in rotational crops are required and significant residues are not expected in food and feed commodities from rotated crops (consequent to uses in compliance with cGAP).

7.2.7 Other / special studies (KCA6.10, 6.10.1)

The available data for the active substance sufficiently addresses aspects of the residue situation that may arise from the use of U 46 D Fluid. Other / special studies are therefore 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). CA2971 / U 46 D Fluid Page 21 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

7.2.8.1 Input values for the consumer risk assessment

Table 7.2-11: Input values for the consumer risk assessment

Chronic risk assessment Acute risk assessment Commodity Input value Input value Comment Comment (mg/kg) (mg/kg) sum of 2,4-D, its salts, esters and conjugates, expressed as 2,4-D Barley (0500010), oats 0.05* MRL 0.05 STMR (0500050)

Rye (0500070), wheat (including 2 MRL 0.05 STMR triticale, 0500090)

Muscle of swine (1011010), 0.2 MRL 0.05 HR bovine (1012010), sheep (1013010) and goats (1014010) Fat of swine (1011020), bovine 0.2 MRL 0.05 HR (1012020), sheep (1013020) and goats (1014020) Liver of swine (1011030), bovine 5 MRL 0.05 HR (1012030), sheep (1013030) and goats (1014030) Kidney of swine (1011040) 5 MRL 0.091 HR

Kidney of bovine (1012040), 5 MRL 0.69 HR sheep (1013040) and goats (1014040) Poultry products (10160000) 0.05* MRL 0.01 HR Milk (1020000) 0.01* MRL 0.01 HR Bird Eggs (1030000) 0.01* MRL 0.05 HR All other commodities variable MRL Not applicable Reg. (EU) No 1317/2013

7.2.8.2 Conclusion on consumer risk assessment

Extensive calculation sheets are presented in Appendix 3.

Table 7.2-12: Consumer risk assessment

TMDI (% ADI) according to EFSA PRIMo 47% (based on WHO cluster diet B, mean body weight) IEDI (% ADI) according to EFSA PRIMo Not necessary CA2971 / U 46 D Fluid Page 22 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

IESTI (% ARfD) according to EFSA PRIMo* Barley, oats: each <1% (based on UK 4-6 years old children and 2-4 years old German children, respectively, mean body weights) Rye: 2% (based on UK infants, mean body weight) Wheat: 4% (based on UK 4-6 years old children, mean body weight)

Bovine kidney: <1% (based on UK toddler, mean body weight) NTMDI (% ADI) ** 35% (based on on 2-4 years old German children, individual consumption/body weight ratio) NEDI (% ADI)** Not necessary NESTI (% ARfD) ** Barley, oats: each <1% (based 2-4 years old German children, individual consumption/body weight ratio) Rye: 1% (based on 2-4 years old German children, individual consumption/body weight ratio) Wheat: 3% (based on 2-4 years old German children, individual consumption/body weight ratio)

Bovine kidney: <1% (based on general population, individual consumption/body weight ratio) * include raw and processed commodities if both values are required for PRIMo ** if national model is available

Residues of 2,4 D which may be present in food and/or feed consequent to the proposed uses of U 46 D Fluid® do not pose an unacceptable risk for any of the EU consumer groups (based on diets included in EFSA PRIMo rev.2).

7.3 Combined exposure and risk assessment

Not relevant. The product contains only one active substance. CA2971 / U 46 D Fluid Page 23 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

7.4 References

EFSA (European Food Safety Authority), 2011. Review of the existing maximum residue levels (MRLs) for 2,4-D according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2011;9(11):2431. ASB2012-3216 EFSA (European Food Safety Authority), 2014 . Conclusion on the peer review of the pesticide risk assessment of the active substance 2,4-D. EFSA Journal 2014;12(9):3812. ASB2014-9962 Greece, Poland. 2013. 2,4-D: Renewal Assessment Report, Vol. 1-3. ASB2013-4350 Greece, Poland. 2014. 2,4-D: Final addendum to the Renewal Assessment Report. ASB2014-6804

European Commission, 2001, Review report for the active substance 2,4-D, 7599/VI/97-final, 01/10/2001 CA2971 / U 46 D Fluid Page 24 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

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

KCA 6.3 Klimmek, S.; 2012 Determination of residues of 2,4-D in pasture grass specimens after one application of 2,4-D DMA 600g N Nufarm Tanguy, M. a.i/L at 4 sites in Northern Europe 2010 Study No. S10-02108 (NUA-1006) GLP: Yes Published: No ASB2014-5642 KCA 6.3 Pfarl, C. 1993 Residues of 2,4-D in grassland treated with 1.5 l and 2.3 l Spritz Hormin 600/ha and 2.0 l U 46 D-Fluid/ha N AHM Project No. R 92-02, Report No. 1156 and 1113 GLP: Open Published: Open RIP2003-466 * Applicants need to include company report numbers of the studies, authority study reference numbers (e.g. BVL-…, RIP2003-…,ASB2013-…) will be added by the evaluating competent authority.

CA2971 / U 46 D Fluid Page 25 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

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

KCA 6.1 Barker, W. 1995 Determination of frozen storage stability for 2,4-Dichlorophenoxy acetic acid (2,4-D) in/on crops - N AHM BAS Volume I of II, Final Report CAG CEL Project No. 93-0044 NUD GLP: Yes Published: No (10) Open (1) RIP2003-510 KCA 6.1 Rawle, N. W. 2002 Storage stability of residues of 2,4-DCP, 2,4-D, 2,4-DB and 2,4-DP-p in cereals whole plant, grain and N BAS NUD straw Report No. CEMS-1397; Study No. AHM R 99 142 GLP: Yes Published: No RIP2007-339 KCA 6.2.1 Feung, C. S.; Loerch, 1978 Comparative metabolic fate of 2,4-Dichlorophenoxyacetic acid in plants and plant tissue culture N AHM BAS S. L.; Hamilton, R. Publication: J. Agric. Food Chem., Vol. 26, No. 5, 1978, p.1064-1067 CAG CEL H. et al. GLP: No LIT NUD Published: Yes RIP2003-471 KCA 6.2.1 Puglis, J. M.; Smith, 1992 Metabolism of uniformly ring labeled [14C]2,4-Dichlorophenoxyacetic acid 2-Ethylhexyl ester in potatoes N Nufarm G. A. Report No. 38075 GLP: Open Published: Open RIP2003-470 KCA 6.2.1 Puvanesarajah, V. 1992 Metabolism of uniformly 14C-ring labeled 2,4-Dichlorophenoxyacetic acid 2-Ethylhexyl ester in wheat N Nufarm Report No. 38076 GLP: Open Published: Open RIP2003-468 CA2971 / U 46 D Fluid Page 26 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

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

KCA 6.2.1 Puvanesarajah, V. 1992 Supplemental data for the study, "Metabolism of uniformly 14C-ring labeled 2,4-Dichlorophenoxyacetic N Nufarm acid 2-Ethylhexyl ester in wheat," EPA MRID No. 42439701 Report No. 38076-01 GLP: Open Published: Open RIP2003-469 KCA 6.2.1 Smith, G. A. 1991 Metabolism of 14C-(2,4-Dichlorophenoxy) Acetic Acid, Dimethylamine salt in apples N AHM Report No. 38072 GLP: Open Published: Open RIP2003-467 KCA 6.2.2 XXXXX 1992 Metabolism of uniformly ring labeled [14C]2,4-Dichlorophenoxyacetic acid in poultry Y AHM Report No. 38077 GLP: Open Published: Open RIP2003-473 KCA 6.2.3 XXXXX 1993 Metabolism of uniformly 14C-ring labeled 2,4-Dichlorophenoxyacetic acid in lactating goats Y DOW Reprot No. 40630 GLP: Open Published: Open RIP2003-472 KCA 6.3 Buchta, A. 2006 Aminopielik Standard 600 SL: Determination of active substance residues in corn, straw and soil N Nufarm Project No. C/01/05 GLP: Yes Published: No ASB2013-9158 CA2971 / U 46 D Fluid Page 27 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

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

KCA 6.3 Klimmek, S.; 2011 Determination of residues of 2,4-D in spring wheat after one application of 2,4-D DMA 600 g/l and 2,4-D N Nufarm Tanguy, M. 2EHE 600 g/l at 4 sites in Northern Europe 2010 Study No. S10-02109 (NUA-1007) GLP: Yes Published: No ASB2013-9141 KCA 6.3 Pfarl, C. 1993 Residues of 2,4-D in cereals treated with 1.1 l Spritz Hormin 600/ha and 1.5 U 46 D-Fluid/ha N AHM Project No. R 92-01, Report No. 1153 and 1113 GLP: Open Published: Open RIP2003-464 KCA 6.3 Pfarl, C. 1993 Residues of 2,4-D in cereals treated with 2.0 l Dicopur flüssig/ha [residues only for 2,4-D] N AHM Project No. R 92-18, Report No. 1169 and 1113 GLP: Open Published: Open RIP2003-462 KCA 6.3 Pfarl, C. 1993 Residues of 2,4-D in cereals treated with 1.0 l Dicopur fluid/ha N AHM Project No. R 92-22, Report No. 1166 and 1113 GLP: Open Published: Open RIP2003-463 KCA 6.3 Rozalski, K. 2008 Residues of 2,4-D and Dicamba after one application of Aminopielik D 450 SL in spring barley, one site N Nufarm in Poland 2007 Study code 20074502/PL1-FPSH, Trial code PL07W094R GLP: Yes Published: No ASB2013-9167 CA2971 / U 46 D Fluid Page 28 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

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

KCA 6.3 Rozalski, K. 2008 Residues of 2,4-D and Dicamba after one application of Aminopielik D 450 SL in winter wheat, one site N Nufarm in Poland 2007 Study code 20074502/PL1-FPWW, Trial code PL07W093R GLP: Yes Published: No ASB2013-9159 KCA 6.3 Rozalski, K. 2008 Residues of 2,4-D, Dicamba and Mecoprop after one application of Aminopielik Tercet 500 SL in spring N Nufarm barley, one site in Poland 2007 Study code 20074503/PL1-FPSH, Trial code PL07W085R GLP: Yes Published: No ASB2013-9168 KCA 6.3 Rozalski, K. 2008 Residues of 2,4-D, Dicamba and Mecoprop after one application of Aminopielik Tercet 500 SL in winter N Nufarm wheat, one site in Poland 2007 Study code 20074503/PL1-FPWW, Trial code PL07W086R GLP: Yes Published: No ASB2013-9162 KCA 6.3 Rozalski, K. 2009 Residues of 2,4-D and Dicamba after one application of Aminopielik D 450 SL applied at two dose rates N Nufarm in spring barley and wheat, Poland 2008 Report No. S08-02158 GLP: Yes Published: No ASB2013-9164 KCA 6.3 Zmijowska, A. 2007 Aminopielik D 450 SL: Determination of residues of 2,4-D and Dicamba in grain, soil and straw N Nufarm Study code C/03/07 GLP: Yes Published: No ASB2013-9161 CA2971 / U 46 D Fluid Page 29 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

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 KCA 6.3 Zmijowska, A. 2007 Aminopielik Tercet 500 SL: Determination of residues of 2,4-D, MCPP and Dicamba in grain, straw and N Nufarm soil Study code C/04/07 GLP: Yes Published: No ASB2013-9163 KCA 6.3 Zmijowska, A. 2008 Aminopielik D 450 SL: Determination of residues of 2,4-D and Dicamba in grain, soil and straw N Nufarm Study code C/09/08 GLP: Yes Published: No ASB2013-9166 KCA 6.3 Zmijowska, A. 2010 Aminopielik D 450 SL: Determination of residues of 2,4-D and Dicamba in grain, soil and straw - N Nufarm Amendment No. 1 to the final report [soil] Study code C/03/07 GLP: Yes Published: No ASB2013-9160 KCA 6.3 Zmijowska, A. 2010 Aminopielik D 450 SL: Determination of residues of 2,4-D and dicamba in grain, straw and soil - N Nufarm Amendment No. 1 to the final report Study code C/09/08 GLP: Yes Published: No ASB2013-9165 KCA 6.4.2 XXXXX 1996 2,4-D: Magnitude of residues in meat and milk of lactating dairy cows Y AHM BAS XXXXX Project No. 886, XXXXX Report No. 1889 CAG CEL GLP: Yes NUD Published: No RIP2003-509 * Applicants need to include company report numbers of the studies, authority study reference numbers (e.g. BVL-…, RIP2003-…,ASB2013-…) will be added by the evaluating competent authority. CA2971 / U 46 D Fluid Page 30 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

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

KCA 6.3 Hastings, M.; Brett, 1995 Residues of Metosulam and 2,4-D in winter barley at harvest following a single application of EF-1223 - N DOW R. Italy 1994 Report No. GHE-P-3922, Protocol No. R94-148 GLP: Open Published: Open RIP2005-435 KCA 6.3 Hastings, M.; Brett, 1995 Residues of Metosulam and 2,4-D in winter wheat at intervals following application of EF-1223 - Italy N DOW R. 1994 Report No. GHE-P-3923, Protocol No. R94-149 GLP: Open Published: Open RIP2005-431 KCA 6.3 Zmijowska, A. 2010 Aminopielik Standard 600 SL: Determination of residues of active substance in corn, straw and soil - N Nufarm Amendment No. 1 to the final report Study Code C/01/05 GLP: Yes Published: No ASB2013-9156 * Applicants need to include company report numbers of the studies, authority study reference numbers (e.g. BVL-…, RIP2003-…,ASB2013-…) will be added by the evaluating competent authority. 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

------

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Appendix 2 Detailed evaluation of the additional studies relied upon

A 2.1 2,4-D

A 2.1.1 Stability of residues

A 2.1.1.1 Stability of residues during storage of samples

No further study on storage stability was submitted/needed.

A 2.1.2 Nature of residues in plants, livestock and processed commodities

A 2.1.2.1 Nature of residue in plants

A 2.1.2.1.1 Nature of residue in primary crops

No further study on nature of residues submitted/needed.

A 2.1.2.1.2 Nature of residue in rotational crops

No new study on the nature of residues in rotational crops has been submitted.

A 2.1.2.1.3 Nature of residues in processed commodities

No new study on residues in processed commodities has been submitted and none is needed due to low residues at harvest.

A 2.1.2.2 Nature of residues in livestock

No new study on the nature of residues in livestock has been submitted.

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A 2.1.3 Magnitude of residues in plants

A 2.1.3.1 Grass

Table A 1: Comparison of intended and critical EU GAPs

Type of GAP Number of Application rate Interval be- Growth stage at PHI (days) applications per treatment tween applica- last application (precise unit) tion cGAP EU (Art. 12, 1 1.5 kg as/ha n.a. n.a. 15 EFSA, 2011) Intended cGAP 1 1 kg as/ha n.a. BBCH 25-35 14 (use number 3*) * Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0

A 2.1.3.1.1 Study 1

Comments of zRMS: Eight out of twelve supervised residue trials were performed according to the noti- fied critical GAP and considered in the corresponding risk assessment. Further four trials included higher application rates (outside the ±25 % tolerance) and were therefore disregarded for risk assessment purposes.

Reference: KCA 6.3 Report Residues of 2,4-D in grassland treated with 1.5 l and 2.3 l Spritz Hormin 600/ha and 2.0 l U 46 D-Fluid/ha, Pfarl C., 1993, Project No. R 92-02, Re- port No. 1156 and 1113, RIP2003-466 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: Yes Acceptability: acceptable unless stated otherwise in the commenting box

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Table A 2: Summary of the study 1 trials RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : 2,4-D (Application on agricultural and horticultural crops) Crop / crop group : Grassland, Pasture, Meadow Crop Code : NNNFW Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2010-06-14

Content of a.i. (g/kg or g/l) : 500 g/L (602 g/L 2,4-D dimethylammonium) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SL (Soluble concentrate) Other a.i. in formulation Commercial product (name) : U 46 D-Fluid (content and common name) : Applicant : Compo GmbH & Co. KG Residues calculated as : sum of 2,4-D, its salts and esters, calculated as 2,4-D

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) R 92-02, 1156, no data 1) 1.1 300 0.37 1992-06-244) BBCH grass 118 0 4) spraying trial 01, plot 3 2) 2.1 13 analytical method: Report No. 1113 (GC-ECD) 3) 1992-07-28 0.47 28 LOQ(s): 0.05 mg/kg (grass, hay), Austria 0.27 34 max. sample storage time 10 months

Seitenstetten compared to Spritz-Hormin 600, mean of two hay 0.77 28 0.76 34 analyses, validated level in this study: 0.1 1993-05-01 mg/kg

RIP2003-466

R 92-02, 1156, no data 1) 1.1 300 0.37 1992-06-294) BBCH grass 136 0 4) spraying trial 02, plot 3 2) 4.2 14 analytical method: Report No. 1113 (GC-ECD) 3) 1992-08-03 2.0 28 LOQ(s): 0.05 mg/kg (grass, hay), Austria 2.7 35 max. sample storage time 9 months

St. Magdalena, hay 6.2 28 compared to Spritz Hormin 600, mean of two Linz analyses, validated level in this study: 0.1 3.4 35 mg/kg 1993-05-01 RIP2003-466

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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) R 92-02, 1156, no data 1) 1.1 300 0.37 1992-07-104) BBCH grass 138 0 4) spraying trial 03, plot 3 2) 6.2 12 analytical method: Report No. 1113 (GC-ECD) 3) 1992-08-13 0.31 28 LOQ(s): 0.05 mg/kg (grass, hay), Austria 0.066 34 max. sample storage time 9 months

Niederneukirchen hay 1.7 28 compared to Spritz-Hormin 600, mean of two analyses, validated level in this study: 0.1 0.75 34 1993-05-01 mg/kg

RIP2003-466

R 92-02, 1156, no data 1) 1.1 300 0.37 1992-07-164) BBCH grass 135 0 4) spraying trial 04, plot 3 2) 9.0 12 analytical method: Report No. 1113 (GC-ECD) 3) 1992-08-19 3.7 28 LOQ(s): 0.05 mg/kg (grass, hay), Austria 2.1 34 max. sample storage time 9 months

Behamberg hay 12.6 28 compared to Spritz-Hormin 600, mean of two 6.0 34 analyses, validated level in this study: 0.1 1993-05-01 mg/kg

RIP2003-466

Remarks: (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

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RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : 2,4-D (Application on agricultural and horticultural crops) Crop / crop group : Grassland, Pasture, Meadow Crop Code : NNNFW Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2010-06-14

Content of a.i. (g/kg or g/l) : 600 g/L (722 g/L 2,4-D dimethylammonium) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SL (Soluble concentrate) Other a.i. in formulation Commercial product (name) : Spritz Hormin 600 (content and common name) : Applicant : Compo GmbH & Co. KG Residues calculated as : sum of 2,4-D, its salts and esters, calculated as 2,4-D

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 treat- and date 3) Harvest a.i./ha l/ha a.i./hl and last date ment or date (a) (b) (c) (a) (d) (e) R 92-02, 1156, trial no data 1) 0.91 300 0.30 1992-06-244) BBCH grass 93.8 0 4) spraying 01, plot 1 2) 1.8 13 analytical method: Report No. 1113 (GC-ECD) 3) 1992-07-28 0.49 28 LOQ(s): 0.05 mg/kg (grass, hay), Austria (AT) 0.17 34 max. sample storage 10 months

Seitenstetten compared to U 46 D-Fluid, mean of two analyses hay 0.71 28 1.1 34 (for grass PHI 34 0.28 mg/kg and <0.05 mg/kg), 1993-05-01 validated level in this study: 0.1 mg/kg

RIP2003-466

R 92-02, 1156, trial no data 1) 1.4 300 0.47 1992-06-244) BBCH grass 154 0 4) spraying 01, plot 2 2) 1.5 13 analytical method: 3) 1992-07-28 0.44 28 Report No. 1113 (GC-ECD), Austria (AT) 0.27 34 LOQ(s): 0.05 mg/kg (grass, hay),

Seitenstetten hay 1.6 28 max. sample storage 10 months compared to U 46 D-Fluid, mean of two analyses, 1.5 34 1993-05-01 validated level in this study: 0.1 mg/kg

RIP2003-466

R 92-02, 1156, trial no data 1) 0.91 300 0.30 1992-06-294) BBCH grass 109 0 4) spraying 02, plot 1 2) 2.1 14 analytical method: Report No. 1113 (GC-ECD) 3) 1992-08-03 1.0 28 LOQ(s): 0.05 mg/kg (grass, hay), Austria 0.51 35 max. sample storage 9 months

St. Magdalena, Linz compared to U 46 D-Fluid, mean of two analyses, hay 2.6 28 1.7 35 validated level in this study: 0.1 mg/kg 1993-05-01 RIP2003-466

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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 treat- and date 3) Harvest a.i./ha l/ha a.i./hl and last date ment or date (a) (b) (c) (a) (d) (e) R 92-02, 1156, trial no data 1) 1.4 300 0.47 1992-06-294) BBCH grass 173 0 4) spraying 02, plot 2 2) 6.7 14 analytical method: Report No. 1113 (GC-ECD) 3) 1992-08-03 2.9 28 LOQ(s): 0.05 mg/kg (grass, hay), Austria 1.1 35 max. sample storage 9 months

St. Magdalena, Linz hay 5.9 28 compared to U 46 D-Fluid, mean of two analyses, 3.5 35 validated level in this study: 0.1 mg/kg 1993-05-01 RIP2003-466

R 92-02, 1156, trial no data 1) 0.91 300 0.30 1992-07-104) BBCH grass 75.4 0 4) spraying 03, plot 1 2) 4.1 12 analytical method: Report No. 1113 (GC-ECD) 3) 1992-08-13 0.38 28 LOQ(s): 0.05 mg/kg (grass, hay), Austria 0.11 34 max. sample storage 9 months

Niederneukirchen hay 1.3 28 compared to U 46 D-Fluid, mean of two analyses, validated level in this study: 0.1 mg/kg 0.82 34 1993-05-01 RIP2003-466

R 92-02, 1156, trial no data 1) 1.4 300 0.47 1992-07-104) BBCH grass 153 0 4) spraying 03, plot 2 2) 7.2 12 analytical method: Report No. 1113 (GC-ECD) 3) 1992-08-13 0.35 28 LOQ(s): 0.05 mg/kg (grass, hay), Austria 0.13 34 max. sample storage time in month(s): 9

Niederneukirchen hay 2.8 28 compared to U 46 D-Fluid, mean of two analyses, validated level in this study: 0.1 mg/kg 1.5 34 1993-05-01 RIP2003-466

R 92-02, 1156, trial no data 1) 0.91 300 0.30 1992-07-164) BBCH grass 84.2 0 4) spraying 04, plot 1 2) 10.3 12 analytical method: Report No. 1113 (GC-ECD) 3) 1992-08-19 3.0 28 LOQ(s): 0.05 mg/kg (grass, hay), Austria 4.2 34 max. sample storage 9 months

Behamberg hay 9.0 28 compared to U 46 D-Fluid, mean of two analyses, validated level in this study: 0.1 mg/kg 10.0 34 1993-05-01 RIP2003-466

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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 treat- and date 3) Harvest a.i./ha l/ha a.i./hl and last date ment or date (a) (b) (c) (a) (d) (e) R 92-02, 1156, trial no data 1) 1.4 300 0.47 1992-07-164) BBCH grass 140 0 4) spraying 04, plot 2 2) 16.6 12 analytical method: Report No. 1113 (GC-ECD) 3) 1992-08-19 4.7 28 LOQ(s): 0.05 mg/kg (grass, hay), Austria 2.9 34 max. sample storage 9 months

Behamberg hay 13.3 28 compared to U 46 D-Fluid, mean of two analyses, 5.0 34 validated level in this study: 0.1 mg/kg 1993-05-01 RIP2003-466

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A 2.1.3.1.2 Study 2

Comments of zRMS: Acceptable. Trials were performed according to the critical GAP.

Reference: KCA 6.3 Report Determination of residues of 2,4-D in pasture grass specimens after one application of 2,4-D DMA 600g a.i/L at 4 sites in Northern Europe 2010, Klimmek S., Tanguy M., 2012, Study No. S10-02108 (NUA-1006), ASB2014-5642 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: Yes Acceptability: Yes

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Table A 3: Summary of the study 2 trials RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : 2,4-D (Application on agricultural and horticultural crops) Crop / crop group : Grassland, Pasture, Meadow Crop Code : NNNFW Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : 2014-05-20

Content of a.i. (g/kg or g/l) : 600 g/L (723 g/L 2,4-D dimethylammonium) Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : SL (Soluble concentrate) Other a.i. in formulation Commercial product (name) : 2,4-D DMA 600 g/L (content and common name) : Applicant : Nufarm Deutschland GmbH Residues calculated as : sum of 2,4-D, its salts and esters, calculated as 2,4-D

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) S10-02108, NUA- no data 1) 1998 1.0 260 0.39 2010-06-074) BBCH 71 grass 51.0 0 4) spraying 1006, trial 01 (sowing) 24.0 1 analytical method: 2) 2010-05 29.0 2 Report No. 1172 (modified, see Germany - 2010-06 8.3 3 CEMR-965) (LC-MS/MS), 69124 Heidelberg 3) 2010-06-28 5.9 5 LOQ(s): 0.02 mg/kg (grass), 4.2 7 max. sample storage time 11 months 2012-02-14 4.0 14 3.6 21 ASB2014-5642

S10-02108, NUA- Country 2015 1) 1995 1.1 260 0.42 2010-06-224) BBCH grass 73.0 0 4) spraying 1006, trial 02 (sowing) 32-65 52.0 1 analytical method: 2) 37.0 2 Report No. 1172 (modified, see Germany 3) 2010-07-13 45.0 3 CEMR-965) (LC-MS/MS), 21709 Breiten- 41.0 5 LOQ(s): 0.02 mg/kg (grass), wisch 29.0 7 max. sample storage time 11 months 21.0 14 2012-02-14 14.0 21 ASB2014-5642

39 CA2971 / U 46 D Fluid Page 40 /42 Part B – Section 7 - Core Assessment Template for chemical PPP zRMS version Version 24/07/2015

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) S10-02108, NUA- no data 1) 1995 1.1 260 0.42 2010-09-224) BBCH 59 grass 68.0 0 4) spraying 1006, trial 03 (sowing) 44.0 1 analytical method: 2) 2010-09-27 41.0 2 Report No. 1172 (modified, see Poland - 2010-10-13 42.0 3 CEMR-965) (LC-MS/MS), 64551 Otorowo, 3) 2010-10-13 13.0 5 LOQ(s): 0.02 mg/kg (grass), Wielkopolska 8.3 7 max. sample storage time 8 months 15.0 14 first flowering period: 2010-05-20 to 2012-02-14 11.0 21 2010-05-25

ASB2014-5642

S10-02108, NUA- no data 1) 1995 1.0 250 0.41 2010-09-084) BBCH 36 grass 70.0 0 4) spraying 1006, trial 04 (sowing) 6.3 1 analytical method: 2) 2010-10 5.3 2 Report No. 1172 (modified, see Poland - 2010-10 4.9 3 CEMR-965) (LC-MS/MS), 64600 Uscikowo, 3) 2010-09-29 5.0 5 LOQ(s): 0.02 mg/kg (grass), Wielkopolska 3.3 7 max. sample storage time 8 months 2.9 14 first flowering period: 2010-05-10 to 2012-02-14 1.2 21 2010-05-20

ASB2014-5642

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A 2.1.4 Magnitude of residues in livestock

A 2.1.4.1 Livestock feeding studies

No new study on magnitude of residues in livestock has been submitted.

A 2.1.5 Magnitude of residues in processed commodities (Industrial Processing and/or Household Preparation)

A 2.1.5.1 Distribution of the residue in peel/pulp

Not applicable.

A 2.1.5.2 Processing studies on a core set of representative processes

No new study on residues in processed commodities has been submitted and none is needed due to low residues at harvest.

A 2.1.6 Magnitude of residues in representative succeeding crops

No new study on magnitude of residues in succeeding crops has been submitted.

A 2.1.7 Other/Special Studies

None.

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Appendix 3 Pesticide Residue Intake Model (PRIMo)

A 3.1 TMDI calculations

2,4-D (sum of 2,4-D, its salts, its esters and its Prepare workbook for refined conjugates, expressed as 2,4-D) calculations Status of the active substance: Code no. LOQ (mg/kg bw): proposed LOQ: Toxicological end points ADI (mg/kg bw/day): 0,05 ARfD (mg/kg bw): 0,75 Undo refined calculations Source of ADI: EFSA Source of ARfD: EFSA Year of evaluation: 2014 Year of evaluation: 2014 Explain choice of toxicological reference values. The risk assessment has been performed on the basis of the MRLs collected from Member States in April 2006. For each pesticide/commodity the highest national MRL was identified (proposed temporary MRL = pTMRL). The pTMRLs have been submitted to EFSA in September 2006. Chronic risk assessment TMDI (range) in % of ADI minimum - maximum 2 46 No of diets exceeding ADI: --- Highest calculated Highest contributor 2nd contributor to 3rd contributor to pTMRLs at TMDI values in % to MS diet Commodity / MS diet Commodity / MS diet Commodity / LOQ of ADI MS Diet (in % of ADI) group of commodities (in % of ADI) group of commodities (in % of ADI) group of commodities (in % of ADI) 46,5 WHO Cluster diet B 34,1 Wheat 3,1 Citrus fruit 1,5 Bovine: Edible offal 43,9 DK child 22,0 Wheat 17,7 Rye 1,3 Bovine: Liver 35,6 NL child 19,0 Wheat 8,1 Citrus fruit 2,4 Potatoes 34,2 WHO cluster diet D 26,0 Wheat 1,6 Potatoes 1,6 Rye 33,3 DE child 16,4 Wheat 9,2 Citrus fruit 3,2 Rye 30,5 IE adult 9,2 Wheat 5,6 Other swine products 5,3 Citrus fruit 29,3 IT kids/toddler 26,6 Wheat 1,5 Citrus fruit 0,4 Potatoes 26,8 ES child 17,7 Wheat 4,7 Citrus fruit 0,7 Potatoes 26,0 UK Toddler 15,7 Wheat 4,6 Citrus fruit 2,3 SUGAR PLANTS 25,3 WHO cluster diet E 15,8 Wheat 1,7 Rye 1,7 Citrus fruit 24,7 WHO Cluster diet F 14,4 Wheat 3,1 Rye 2,3 Citrus fruit 21,6 PT General population 15,7 Wheat 2,1 Potatoes 1,5 Citrus fruit 21,6 FR toddler 10,5 Wheat 4,7 Citrus fruit 2,0 Potatoes 19,9 SE general population 90th percentile 12,8 Wheat 2,8 Citrus fruit 1,7 Potatoes 19,7 WHO regional European diet 11,9 Wheat 1,6 Citrus fruit 1,6 Potatoes 18,7 UK Infant 10,5 Wheat 2,7 Citrus fruit 1,3 Potatoes 18,7 IT adult 16,5 Wheat 1,2 Citrus fruit 0,2 Potatoes 17,3 FR all population 13,2 Wheat 1,3 Citrus fruit 0,8 Berries & small fruit 15,5 NL general 8,3 Wheat 3,7 Citrus fruit 1,1 Potatoes 14,8 ES adult 9,4 Wheat 2,9 Citrus fruit 0,4 Potatoes 13,5 DK adult 8,1 Wheat 2,7 Rye 0,6 Potatoes 12,3 UK vegetarian 8,2 Wheat 2,1 Citrus fruit 0,5 Potatoes 11,5 LT adult 4,3 Rye 4,2 Wheat 1,3 Potatoes 10,3 UK Adult 6,7 Wheat 1,4 Citrus fruit 0,6 Potatoes 10,0 FI adult 3,9 Wheat 2,7 Rye 2,3 Citrus fruit 9,5 FR infant 3,4 Wheat 2,1 Citrus fruit 1,7 Potatoes 2,3 PL general population 1,4 Potatoes 0,3 Citrus fruit 0,2 Pome fruit

Conclusion: The estimated Theoretical Maximum Daily Intakes (TMDI), based on pTMRLs were below the ADI. A long-term intake of residues of 2,4-D (sum of 2,4-D, its salts, its esters and its conjugates, expressed as 2,4-D) is unlikely to present a public health concern.

42 REGISTRATION REPORT Part B Section 8 Environmental Fate Detailed summary of the risk assessment

Product code: ZV1 034066-00/00 Product name(s): U 46 D Fluid (Spritz-Hormin 500) Chemical active substance(s): 2,4-D 500 g/L

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: Nufarm GmbH Submission date: 19.12.2013 MS Finalisation date: 27/04/2017 ZV1 034066 /U 46 D Fluid Page 2 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Version history

When What

August 2015 First Draft RR by UBA December 2016 Revision 1 by UBA (application rate for use in grassland changed from 2 L/ha to 1.5 l/ha, reference to PEC calculation for EU renewal of 2,4-D are added.)

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Table of Contents

8 Fate and behaviour in the environment (KCP 9) ...... 4 8.1 Critical GAP and overall conclusions ...... 4 8.1.1 Grouping of intended uses for risk assessment ...... 5 8.2 Metabolites considered in the assessment ...... 6 8.3 Rate of degradation in soil (KCP 9.1.1) ...... 7 8.3.1 Laboratory studies - Aerobic degradation in soil (KCP 9.1.1.1) ...... 7 8.3.2 Laboratory studies- Anaerobic degradation in soil (KCP 9.1.1.1) ...... 9 8.3.3 Field studies (KCP 9.1.1.2) ...... 9 8.3.3.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1) ... 9 8.3.3.2 Soil accumulation testing (KCP 9.1.1.2.2) ...... 9 8.4 Mobility in soil (KCP 9.1.2) ...... 9 8.4.1 Adsorption and desorption in soil (KCP 9.1.2.1) ...... 10 8.4.2 Column leaching (KCP 9.1.2.1) ...... 11 8.4.3 Lysimeter studies (KCP 9.1.2.2) ...... 12 8.4.4 Field leaching studies (KCP 9.1.2.3) ...... 12 8.5 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1, KCP 9.2.2, KCP 9.2.3) ...... 12 8.5.1 Water/sediment study (KCP 9.2.2) ...... 12 8.6 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3) ...... 13 8.6.1 Input-Parameters ...... 13 8.6.1.1 Jusitification of new endpoints ...... 13 8.6.2 PECsoil ...... 13 8.7 Predicted Environmental Concentrations in groundwater (PECgw) (KCP 9.2.4.1) ...... 14 8.7.1 Input-Parameters (related to intended uses and to active substance) ...... 14 8.7.1.1 Jusitification of new endpoints ...... 15 8.7.2 PECgw ...... 15 8.7.3 Additional field test (KCP 9.2.4.2) ...... 16 8.7.4 Summary of the risk assessment for ground water ...... 16 8.8 Predicted Environmental Concentrations in surface water (PECsw) (KCP 9.2.5) ...... 16 8.8.1 Input parameters ...... 16 8.8.2 PECsw/sed-FOCUS SW Step 1, 2 and 3 ...... 18 8.8.3 Risk mitigation measures (PECsw - FOCUS Step 4) ...... 18 8.9 Fate and behaviour in air (KCP 9.3, KCP 9.3.1) ...... 18

Appendix 1 Lists of data considered in support of the evaluation ...... 19

Appendix 2 Detailed evaluation of the new Annex II studies ...... 20

Appendix 3 Additional information provided by the applicant (e.g. detailed modelling data) ...... 20

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8 Fate and behaviour in the environment (KCP 9)

8.1 Critical GAP and overall conclusions

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 Us Mem- Crop F, Pests or Group Application Application rate PH Re- Conclu- e- ber and/or Fn, of pests con- I marks: sion N state(s situation Fp trolled (da e.g. g o. ) (crop n (additionally: Method / Timing Max. Min. kg or L g or kg Water ys) safener/ Ground * destina- G, developmental Kind / number interval prod- as/ha L/ha syner- water tion / Gn stages of the Growth a) per between uct/ha min/ma gist per purpose of , pest or pest stage of use applica- a) max. a) max. x ha crop) Gp group) crop & b) per tions rate per rate per n season crop/ (days) appl. appl. or season b) max. b) max. I total rate total rate ** per per crop/sea crop/sea son son Zonal uses (field or outdoor uses, certain types of protected crops)

00 DE Winter F Dicotyle- Spraying After a) 1 -- a) 1.5 a) 75 200 - XF except A 1 soft wheat donous weeds emer- b) 1 L/ 0 g 400 * for seed TRZAW TTTDD gence ha as/ produc- ha tion spelt Spring b) 1.5 L/ b) 75 TRZSP BBCH 21 - 32 ha 0 g winter as/ durum ha wheat TRZDW winter barley HORVW winter rye SECCW winter triticale TTLWI winter oats AVESW

00 DE Spring soft F Dicotyle- Spraying After c) 1 -- a) 1.5 a) 75 200 - XF A 2 wheat donous weeds emer- d) 1 L/ 0 g 400 * TRZAS TTTDD gence ha as/ ha spring Spring b) 1.5

durum BBCH L/ b) 75 wheat 11 - 32 ha 0 g as/ TRZDS ha spring barley HORVS spring rye SECCS spring triticale TTLSO spring oat AVEFA ZV1 034066 /U 46 D Fluid Page 5 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

00 DE Grassland, F Dicotyle- Spraying during a) 1 -- a) 1.5 a) 7500 200 - 14 A 3 pasture, donous weeds grow- b) 1 L/ g as/ha 400 d meadow TTTDD ing ha b) 7500 NNNFW season b) 1.5 g as/ha (March L/ to ha Octo- ber) BBCH 25 - 35

Interzonal uses (use as seed treatment, in greenhouses (or other closed places of plant production), as post-harvest treatment or for treatment of empty storage rooms) -- Minor uses according to Article 51 (zonal uses) -- Minor uses according to Article 51 (interzonal uses) --

* 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

8.1.1 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).

Please note that the uses in spring and winter cereals according to use No 00-001 and 00-002 have been assessed during renewal of approval of 2,4-D (see EFSA conclusion March 2015, EFSA Journal 2014;12(9):3812).

Table 8.1-2: Critical use pattern of U 46 D Fluid grouped according to soil

Grouping according to soil

Group Intended uses AR (interception) "eff. AR (cumulated)" S01 00-002 spring cereals 1 × 750 (25 %) 562.500 S02 00-003 grassland* 1 × 750 (60 %) 300.000 S03 00-001 winter cereals 1 × 750 (50 %) 375.000 * After renewal of approval of 2,4-D GAP has changed regarding application rate (1.5 L product/ha instead of 2 L product/ha).

Table 8.1-3: Critical use pattern of U 46 D Fluid grouped according to spraydrift

Grouping according to spraydrift

Group Intended uses AR (interval) drift scenario ZV1 034066 /U 46 D Fluid Page 6 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Grouping according to spraydrift

Group Intended uses AR (interval) drift scenario D01 00-001, 00-002, 00-003 1 × 750 Arable crop

8.2 Metabolites considered in the assessment

Environmental occurring metabolites of 2,4-D requiring further assessment according to the results of the assessment of 2,4-D for EU renewal assessment are summarized in Table 8.2-1. No new study on the fate and behaviour of 2,4-D or “U 46 D Fluid” has been performed. Hence no potentially new metabolites need to be considered. The risk assessment for the metabolite 2,4-DCP and 2,4-DCA has already been performed for EU approval (see EFSA Journal 2014;12(9):3812). They were regarded as having low risk to soil organismen (2,4 DCA) and aquatic organism (2,4-DCP and 2,4-DCA). Therefore no new risk assessment hence no exposure assessment for these metabolites is necessary. However, the leaching potential into groundwater of the soil metabolites 2,4-DCP and 2,4-DCA will be assessed for the application of the plant protection product and its intended uses.

Table 8.2-1: Metabolites of 2,4-D potentially relevant for exposure assessment

Metabolite Molar mass Chemical structure Maximum observed Exposure assessment (g/mol) occurence in com- required due to partements

2,4-DCP 163 Cl Cl Soil: max. 8.7 % at day PECgw: leaching po- (2,4 – 10 (2x > 5 %) tential to groundwater Dichlorophenol) OH Sediment: max. 31.8 % at day 31 O 2,4-DCA 177 Soil: max. 15 % at day PECgw: leaching po- (2,4 – 17 tential to groundwater Dichloroanisole) Cl Cl 1,2,4- 126 Water (photolytic): max. No* benzenetriol OH OH 31.7 %

*According to EFSA the metabolite metabolite 1,2,4-benzenetriol cannot be ruled out (see Pesticides Peer Review written procedure on additional information (11.02.2014 – 25.02.2014). In the original study light intensity was set to simulate Phoenix sunlight, therefore its results may be relevant to southern European latitudes. In the new study light intensity is lower than in the original and adequately simulates northern European situations. There further shortcomings of the argumentation of the applicant towards the metabolite (see DRAR, chapter B.8.4.2). However, considering the occurance of the metabolite within the artificial test system and the additional results regarding photodegradtion of 2,4-D, the metabolite is not considered further in the assessment.

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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 Laboratory studies - Aerobic degradation in soil (KCP 9.1.1.1)

2,4-D

A new study has been submitted regarding route and rate of degradation in soil of 2,4-D for the renewal of the EU approval of the 2,4-D (Lui et al. 2011 and kinetic analysis by Schnitzler 2012). The applicant has used this study in its core assessment too. The environmental exposure assessment is based on the EU agreed DT50 values from the laboratory as summarized in Table 8.3-1. Please note that the EU renewal is still awaiting. However, a final EFSA conclusion (September 2014 revised May 2015 – no exposure relevant revision, EFSA Journal 2014;12(9):3812) is available and the applicant belongs to the European Union 2,4-D Task Force 2012 that submitted the dossier for the renewal of approval of 2,4-D. Therefore it seems to be acceptable to use new EU values.

Table 8.3-1: Summary of aerobic degradation rates for 2,4-D - laboratory studies

DT50 (d) Evaluated on EU pH t. MWHC DT50 DT90 Chi2 Kinetic Soil type 20°C level y/ (H2O) (oC) (%) (d) (d) (%) model pF2/10kPa Reference

Silt loam 7.4 25 -- 58.9 195.6 94.6* 7.4 SFO Cohen, 1991 (Mississippi) LoEP 2014**

Clay loam 6.2 20 50 7.5 24.8 5.3 6.3 SFO Lui et al. 2011 and (Fayette) Schnitzler 2012 LoEP 2014

Clay loam 6.2 20 50 1.6 5.4 1.2 6.3 SFO Lui et al. 2011 and (RefSol 03-G) Schnitzler 2012 LoEP2014

Sandy loam 6.7 20 50 2.2 7.4 1.6 4.5 SFO Lui et al. 2011 and (Site E1) Schnitzler 2012 LoEP 2014

Sandy loam 7.8 20 50 2.0 6.5 1.8 7.8 SFO Lui et al. 2011 and (Site I2) Schnitzler 2012 LoEP2014

Geometric mean (n=5) 4.4

pH-dependency no * Only temperature normalised ** LoEP 2014 … see EFSA Journal 2014;12(9):3812

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Table 8.3-2: Summary of aerobic degradation rates for metabolite 2,4-DCP - laboratory studies

DT50 (d) Evaluated on EU pH t. MWHC DT50 Chi2 Kinetic Soil type f.f. 20°C level y/ (H2O) (oC) (%) (d) (%) model pF2/10kPa Reference

Clay loam 6.2 20 50 - - - - - Lui et al. 2011 and (Fayette) Schnitzler 2012 LoEP 2014*

Clay loam 6.2 20 50 15.5 1 11.1 6.3 HS Lui et al. 2011 and (RefSol 03-G) 2.Phase Schnitzler 2012 LoEP2014

Sandy loam 6.7 20 50 6.2 1 4.4 9.2 SFO Lui et al. 2011 and (Site E1) Schnitzler 2012 LoEP 2014

Sandy loam 7.8 20 50 7.7 1 6.9 12.8 FOMC Lui et al. 2011 and (Site I2) DegT90/ Schnitzler 2012 3,32 LoEP2014

Geometric mean (n=3) 7.0

th 90 percentil (n=3) 10.3

pH-dependency no * LoEP 2014 … see EFSA Journal 2014;12(9):3812

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Table 8.3-3: Summary of aerobic degradation rates for metabolite 2,4-DCA - laboratory studies

DT50 (d) Evaluated on EU pH t. MWHC DT50 Chi2 Kinetic Soil type f.f. 20°C level y/ (H2O) (oC) (%) (d) (%) model pF2/10kPa Reference

Clay loam 6.2 20 50 - - - - - Lui et al. 2011 and (Fayette) Schnitzler 2012 LoEP 2014*

Clay loam 6.2 20 50 15.5 11.7 3.7 SFO Lui et al. 2011 and (RefSol 03-G) Schnitzler 2012 LoEP2014

Sandy loam 6.7 20 50 6.2 9.8 6.3 SFO Lui et al. 2011 and (Site E1) Schnitzler 2012 LoEP 2014

Sandy loam 7.8 20 50 7.7 9.8 8.5 SFO Lui et al. 2011 and (Site I2) Schnitzler 2012 LoEP2014

Geometric mean (n=3) 10.4

th 90 percentil (n=3) 11.3

pH-dependency no * LoEP 2014 … see EFSA Journal 2014;12(9):3812

8.3.2 Laboratory studies- Anaerobic degradation in soil (KCP 9.1.1.1)

Not relevant for assessment.

8.3.3 Field studies (KCP 9.1.1.2)

8.3.3.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1)

2,4-D and its metabolites No field studies available. Please note that according to EFSA conclusion (EFSA Journal 2014;12(9):3812) a data gap was identified for a field study as the DT50 value of the study by Cohen 1991 is above 60 d.

8.3.3.2 Soil accumulation testing (KCP 9.1.1.2.2)

No data available, not required.

8.4 Mobility in soil (KCP 9.1.2)

Studies on mobility in soil with the formulation were not performed, since it is possible to extrapolate ZV1 034066 /U 46 D Fluid Page 10 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015 from data obtained with the active substance.

8.4.1 Adsorption and desorption in soil (KCP 9.1.2.1)

2,4-D and its metabolites New studies (Yoder and Adusumili 2011, Swoboda 2006, Fathulla 1996) have been submitted regarding adsorption/desorption in soil of 2,4-D. These studies were also assessed by RMS for the EU renewal of 2,4-D and the study summaries are provided in the Renewal Assessment Report (RAR) for 2,4-D. The study by Barriuso and Calvet (1991) that was also submitted by the applicant is regarded as additional information as it comprises information from published literature rather than a study report. This study summary is also provided in the RAR of 2,4-D. In the EU renewal of 2,4-D only the Kfoc values by Yoder and Adusumili (2011) were used for the exposure assessment (see EFSA Journal 2014;12(9):3812) as they are regarded as worst case.

The study by Yoder and Adusumili (2011) comprises also Kfoc values for the soil metabolites 2,4-DCP and 2,4-DCA. The Kfoc values are summarized in the tables below.

The Kfoc values of 2,4-D and its soil metabolites 2,4-DCP and 2,4-DCA are summarized in the tables below.

Table 8.4-1: Summary of soil adsorption/desorption for 2,4-D

Soil name/soil type OC pH Kf Kfoc 1/n Evaluated on (%) (-) (mL/g) (mL/g) (-) EU level y/ Ref- erence

Louisiana (Clay) 2.1 7.3 1.33 63.3 0.83 Cohen, 1991 DAR+RAR Illinois, Silt Loam 2.23 5.9 0.91 41 0.8958 Mc Coy, (M172) Lehmann, 1988 North Dakota, Loam 3.08 6.8 1.1 35 0.9301 DAR+RAR (M177) Mississippi, Clay 1.26 7.0 0.93 74 0.7948 (M192) Plainfield 0.46 5.6 0.357 76 0.882 Fathulla, 1996 RAR Arizona 0.9 7.9 0.517 59 0.816 M800 (Yolo) 1.3 7.1 0.55 42 0.83 Yoder and Adusumili, 2011 M801 (RefSol 01-A) 1.1 5.2 0.45 41 0.83 RAR M802 (RefSol 03-G) 2.5 5.0 0.42 17 0.82 LoEP 2014* M803 (Site E) 3.6 5.9 0.83 23 0.87 M804 (Site I2) 1.4 7.5 0.19 14 0.81 M816 (Fayette) 0.9 5.9 0.21 23 0.78 M822 (Site K) 4.4 7.2 0.51 12 0.90 Soil I 6.1 6.18 4.5 56.62 0.85 Swoboda 2006 Soil V 1.6 5.33 1.25 52.60 0.83 RAR Arithmetic mean n=7 25 0.834 ZV1 034066 /U 46 D Fluid Page 11 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Soil name/soil type OC pH Kf Kfoc 1/n Evaluated on (%) (-) (mL/g) (mL/g) (-) EU level y/ Ref- erence

(only Kfoc values by Yoder and Adusumili 2011, LoEP 2014) pH-dependency no * LoEP 2014 … see EFSA Journal 2014;12(9):3812

Table 8.4-2: Summary of soil adsorption/desorption for metabolite 2,4-DCP

Soil Name/soil type OC pH Kf Kfoc 1/n Evaluated on (%) (-) (mL/g) (mL/g) (-) EU level y/ Ref- erence

M800 (Yolo) 1.3 7.1 10 765 0.85 Yoder and Adusumili, 2011 M801 (RefSol 01-A) 1.1 5.2 4 405 0.80 RAR M802 (RefSol 03-G) 2.5 5.0 16 655 0.94 LoEP 2014 M803 (Site E) 3.6 5.9 25 690 0.94 M804 (Site I2) 1.4 7.5 3 244 0.88 M816 (Fayette) 0.9 5.9 5 574 0.83 M822 (Site K) 4.4 7.2 11 250 0.93 Arithmetic mean (n=7) 512 0.88 pH-dependency no

Table 8.4-3: Summary of soil adsorption/desorption for metabolite 2,4-DCA

Soil Name/soil type OC pH Kf Kfoc 1/n Evaluated on (%) (-) (mL/g) (mL/g) (-) EU level y/ Ref- erence

M800 (Yolo) 1.3 7.1 18 1386 0.85 Yoder and Adusumili, 2011 M801 (RefSol 01-A) 1.1 5.2 18 1630 0.93 RAR M802 (RefSol 03-G) 2.5 5.0 21 841 0.93 LoEP 2014 M803 (Site E) 3.6 5.9 27 746 0.95 M804 (Site I2) 1.4 7.5 12 836 0.92 M816 (Fayette) 0.9 5.9 10 1137 0.92 M822 (Site K) 4.4 7.2 27 622 0.92 Arithmetic mean (n=7) 1028 0.92 pH-dependency no

8.4.2 Column leaching (KCP 9.1.2.1)

No data, not required for assessment. ZV1 034066 /U 46 D Fluid Page 12 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.4.3 Lysimeter studies (KCP 9.1.2.2)

Please refer to EU assessment report (RAR) for information on the lysimeter study available (Burger, 1993, study code RCC 272586).

8.4.4 Field leaching studies (KCP 9.1.2.3)

No data submitted, not required for assessment.

8.5 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.

8.5.1 Water/sediment study (KCP 9.2.2)

2,4-D and its metabolites A new water/sediment study (Laughlin et al. 2011) has been submitted. This study was assessed by RMS for the EU renewal of 2,4-D and the study summary is provided in the RAR for 2,4-D. The DT50 values of the water/sediment study according to EU renewal (see EFSA Journal 2014;12(9):3812) are summarized in the table below.

Table 8.5-1: Summary of degradation in water/sediment of 2,4-D

Distribution: 2,4-D: max in water 100 % after 0 d. Max. sed 24.7 % after 7 d

Water/sediment pH DegT50 DegT9 Kinet- DissT5 DissT9 Kinet- DissT5 Kinet- Evaluated system water/ whole 0 whole ic, Fit 0 water 0 water ic, Fit 0 sed. ic, Fit on EU syst. (Χ²) level y/ sed. syst. (d) (d) (d) (d) Reference (d) Pond system 6.5/ 18 60 SFO, 12.6 41.9 SFO, 9.8 SFO, Laughlin (loamy sand) 6.4 2.6 4.0 8.6 et al. 2011 LoEP* Pond system 8.3/ 6.4 21.1 SFO, 4.7 15.7 SFO, - (silt loam) 7.8 8.8 9.9 Pond system 6.9 / 52 SFO - - - Concha, (silty clay 7.8 Shepler, loam) 1993 LoEP Geometric mean (n=3) 18.16 * LoEP … see EFSA Journal 2014;12(9):3812

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8.6 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3)

8.6.1 Input-Parameters

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 with ESCAPE 2.0 based on the input parameters as presented in the tables below.

Table 8.6-1: Input parameters related to application for PECsoil calculations

Use No/use group 00-002 (spring cereals)/S01 Crop Spring cereals BBCH 11-32 Application rate (g as/ha) 2,4-D: 750 g as/ha

Number of applications/interval 1x Crop interception (%) 25 Depth of soil layer (relevant for plateau no tillage depth required concentration) (cm)

Table 8.6-2: Input parameter for active substance(s) and relevant metabolite(s) for PECsoil calculation

Compound Molecular Max. occur- DT50 Value in ac- weight (g/mol) rence (%) (days) cordance to EU endpoint

2,4-D Not required - Not required yes

Due to the fast degradation of 2,4-D in soil (DT90 < 365 d, SFO, laboratory data) the accumulation potential of 2,4-D does not need to be considered.

8.6.1.1 Jusitification of new endpoints

Not applicable as no new endpoints used.

8.6.2 PECsoil

To achieve a concise exposure assessment, the risk envelope approach is applied. Here, the assessment for the use group S01 also covers the exposure from all other intended uses in groups S02 and S03 (see 8.1.1).

Table 8.6-3: PECsoil for active substance 2,4-D applied as U 46 D Fluid for use in spring cereals (use 00-002/use group S01)

use/use Active Soil rele- PECact PECtwa21 Tillage PECsoil,plat PECaccu = group substance/ vant appli- depth (cm) (mg/kg) d (mg/kg) eau (mg/kg) PECact + formulation cation rate (soil depth: PECsoil,plat (g/ha) 5 cm) eau (mg/kg)

00-002/S01 2,4-D 563 0.750 n.r. ------ZV1 034066 /U 46 D Fluid Page 14 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.7 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.

8.7.1 Input-Parameters (related to intended uses and to active substance)

The PEC of 2,4-D and its metabolites in ground water have been assessed with standard FOCUS scenarios to obtain outputs from the FOCUS PELMO. The calculation was performed by zRMS.

Table 8.7-1: Input parameters related to application for PECgw calculations

Use No. 00-001 00-002 00-003 Crop Winter cereals Spring cereals Lawns (FOCUS PELMO 5.5.3 crop: grass and alfalfa) Application rate (g as/ha) 2,4-D: 750 2,4-D: 750 2,4-D: 750 Number of 1 1 1 applications/interval (d) Relative application date Spring* 1st April (HH) 1st March (HH) = day of emergence Crop interception (%) 50 25 60 Frequency of application annual annual annual Models used for calculation FOCUS PELMO FOCUS PELMO v5.5.3 FOCUS PELMO v5.5.3 v5.5.3

* In adapting the risk envelope approach the PECgw for winter cereals is covered by PECgw spring cereals due to the lower application rate in winter cereals and the intended application in spring.

2,4-D and its metabolites

Table 8.7-2: Input parameters related to active substance 2,4-D for PECgw calculations

Parent 2,4 D Remarks Value in accordance with EU endpoint y/n*

Molecular weight (g/mol) 221

DT50 in soil (d) 4.4 Geometric mean see yes Table 8.3-1 (EU endpoint*)

Kfoc (mL/g)/Kfom 25 Arithmetric mean see yes Table 8.4-1 (EU endpoint*) 1/n 0.834 Arithmetric mean see yes Table 8.4-1 (EU endpoint*) Plant uptake factor 0 yes * EU endpoint according to draft EFSA conclusion July 2014 (EFSA Journal 2014;12(9):3812; Note, that EFSA conclusion was revised in March 2015. However, that revision did not affect section “environmental fate and behaviour”)

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Table 8.7-3: Input parameters metabolites of 2,4-D for PECgw calculations

metabolite 2,4-DCP Remarks Value in accordance with EU endpoint y/n*

Molecular weight (g/mol) 163 Formation fraction 1 from parent yes

DT50 in soil (d) 7.0 geom. mean see Table 8.3-2 yes

Kfoc (mL/g)/Kfom 512 arithm. mean see Table 8.4-2 yes 1/n 0.88 arithm. mean see Table 8.4-2 yes Plant uptake factor 0 yes

metabolite 2,4-DCA

Molecular weight (g/mol) 177 Formation fraction 1 from 2,4-DCP yes

DT50 in soil (d) 10.4 geom. mean see Table 8.3-3 yes

Kfoc (mL/g)/Kfom 1028 arithm. mean see Table 8.4-3 yes 1/n 0.92 arithm. mean see Table 8.4-3 yes Plant uptake factor 0 yes * EU endpoint according to draft EFSA conclusion July 2014 (EFSA Journal 2014;12(9):3812; Note, that EFSA conclusion was revised in March 2015. However, that revision did not affect section “environmental fate and behaviour”)

8.7.1.1 Jusitification of new endpoints

Not applicable as no new endpoints used.

8.7.2 PECgw

2,4-D and its metabolites

Table 8.7-4: PECgw for 2,4-D and metabolite(s) for the application of U 46 D Fluid in grass and spring cereals

80th Percentile PECgw at 1 m Soil Depth (µg/L) groundwater model: FOCUS PELMO 5.5.3 Crop Scenario 2,4-D Metabolit Metabolit 2,4-DCP 2,4-DCA Grassland all scenarios <0.001 <0.001 <0.001

Spring ce- all relevant scenarios <0.001 <0.001 <0.001 reals

According to the PECGW modelling with FOCUS PELMO 5.5.3 a groundwater contamination of the active substance 2,4-D and its metabolites 2,4-DCP and 2,4-DCA at a concentration of ≥ 0.1 µg/L is not ZV1 034066 /U 46 D Fluid Page 16 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015 expected for all the FOCUS groundwater scenarios for the use in grassland and spring cereals according to the label. In adapting the risk envelope approach the PECgw for winter cereals is covered by PECgw for spring cereals due to the lower application rate in winter cereals and the intended application in spring. Hence also for the intended application in winter cereals a concentration of the active substance 2,4-D and its soil metabolites 2,4-DCP and 2,4-DCA ≥ 0.1 µg/L in the groundwater is not expected.

The results of PECgw simulation are confirmed by results for renewal of approval of 2,4-D.

8.7.3 Additional field test (KCP 9.2.4.2)

Not relevant

8.7.4 Summary of the risk assessment for ground water

Results of modelling with FOCUS PELMO 5.5.3 show that the active substance 2,4-D and its soil metabolites 2,4-DCP and 2,4-DCA is not expected to penetrate into groundwater at concentrations of ≥ 0.1 µg/L in the intended uses of the formulation U 46 D Fluid in grassland, spring and winter cereals.

8.8 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 spraydrift, drainage and runoff.

8.8.1 Input parameters

To achieve a concise exposure assessment, the risk envelope approach is applied. Here, the assessment for the use group D01 also covers the exposure from all other intended uses in groups D02 (see 8.1.1).

Table 8.8-1: Input parameters related to application for PECSW/SED calculations

Plant protection product U 46 D Fluid Use No./use group 00-003 /D01 Crop Grass/alfafa Application rate (kg as/ha) 2,4-D: 1000 g as/ha* Number of applications/interval (d) 1 Crop interception Minimal crop cover (relevant for STEP 1 and 2 only) Application window March-May (relevant for STEP 1 and 2 only) Application method spraying CAM (Chemical application method) - Soil depth (cm) - Models used for calculation STEPS 1 and 2 ZV1 034066 /U 46 D Fluid Page 17 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

* Please note that applicant has lowered the application rate the use in grassland (750 g as/ha instead of 1000 g as/ha). PECsw calculation are still based on the application rate of 1000 g as/ha as new PECsw will not alter the outcome of the risk assessment for the core assessment.

2,4-D

Table 8.8-2: Input parameters related to active substance 2,4-D for PECsw/sed calculations

Compound 2,4-D Remarks Value in accordance to EU endpoint y/n/*

Molecular weight (g/mol) 221 Saturated vapour pressure (Pa) not required for Step -- 1+2/ Water solubility (mg/L) 24300 yes Diffusion coefficient in water not required for Step default -- (m²/d) 1+2/ 4.3 x 10-5 Diffusion coefficient in air (m²/d) not required for Step default -- 1+2/0.43

Kfoc (mL/g) 25 arithm. mean yes seeTable 8.4-1 Freundlich Exponent not required for Step 1/n 1+2/ Plant Uptake not required for Step -- 1+2 Wash-Off factor from Crop (1/mm) not required for Step -- 1+2/ 0.05 (MACRO) 0.50 (PRZM)

DT50,soil (d) 4.4 Geomean (1st order, Yes pF2,20°C) Laboratory data (see Table 8.3-1 )

DT50,water (d) 18.16 Geomean of DegT50 whole Yes system (1st order, 20°C) see Table 8.5-1

DT50,sed (d) 18.16 Geomean of DegT50 whole Yse system (1st order, 20°C) see Table 8.5-1

DT50,whole system (d) 18.16 Geomean of DegT50 whole yes system (1st order, 20°C) see Table 8.5-1 * EU endpoint according to draft EFSA conclusion July 2014 (EFSA Journal 2014;12(9):3812; Note, that EFSA conclusion was revised in March 2015. However, that revision did not affect section “environmental fate and behaviour”) ZV1 034066 /U 46 D Fluid Page 18 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.8.2 PECsw/sed-FOCUS SW Step 1, 2 and 3

2,4-D

Table 8.8-3: FOCUS Step 1 and 2 PECsw and PECsed for 2,4-D following single application(s) of U46 D Fluid to spring cereals

Scenario Waterbody Max PECsw Dominant entry xx d- PECsw,twa Max PECsed route (µg/L) (µg/L)** (µg/kg) FOCUS

Step 1 --- 331.78 n.r. n.r. 80.65 Step 2 Northern Europe 28.34 n.r. n.r 6.80 March-May ** twa-time as required by ecotox

The applicant has not provided FOCUS SW Step 3 and 4 values. Therefore only FOCUS SW Step 1 and 2 values are documented below. For national assessment specific PEC sw calculation performed to derive national specific risk mitigation measures (see dRR Part B, Section 8, National Addendum Germany).

8.8.3 Risk mitigation measures (PECsw - FOCUS Step 4)

Not submitted by applicant.

8.9 Fate and behaviour in air (KCP 9.3, KCP 9.3.1)

Table 8.9-1 Summary of atmospheric degradation and behaviour*

Compound 2,4 D Direct photolysis in air no significant degradation (DT50 > 30 d , pH 7)* Quantum yield of direct phototransformation Φ = 6.1 * 10-3 mol*Einstein-1* Photochemical oxidative degradation in air DT50 (h): 1.6 days derived by the Atkinson model OH (12h) concentration assumed =1.5 x 106 Volatilisation Vapour pressure (Pa): 9.9 x 10-6 Henry's Law Constant (Pa.m3/mol): 4.0 x 10-6 Metabolites * see EFSA Journal 2014;12(9):3812 (11 March 2015)

The vapour pressure at 20 °C of the active substance active substance 1 is < 10-5 Pa. Hence the active substance 2,4-D is regarded as non-volatile.

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Appendix 1 Lists of data considered in support of the evaluation

List of data submitted by the applicant and relied on ---

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

KIIIA1 Schnitzler, F. 2012 Kinetic Modelling Analysis of the Degradation Behaviour of 2,4-Dichlorophenoxyacetic acid (2,4-D) and N Nufarm 9.1. its Metabolites 2,4-DCP and 2,4-DCA in Laboratory Soil Degradation Studies under Aerobic Conditions Dr Knoell Consult Report number: 346402-1 Not GLP Unpublished KIIIA1 9.6 Budde 2012 Kinetic modelling analysis of the degradation behaviour of 2,4-Dichlorophenoxyacetic acid (2,4-D) and N Nufarm its metabolite 2,4-DCP in water-sediment studies Dr Knoell Consult 346402-1 Not GLP Unpublished

List of data submitted by the applicant and not relied on ---

List of data relied on not submitted by the applicant but necessary for evaluation --- ZV1 034066 /U 46 D Fluid Page 20 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Appendix 2 Detailed evaluation of the new Annex II studies

---

Appendix 3 Additional information provided by the applicant (e.g. detailed modelling data)

--- REGISTRATION REPORT Part B Section 8 Environmental Fate Detailed summary of the risk assessment

Product code: ZV1 034066-00/00 Product name(s): U 46 D Fluid (Spritz-Hormin 500) Chemical active substance(s): 2,4-D 500 g/L

Central Zone Zonal Rapporteur Member State: Germany

NATIONAL ADDENDUM Germany (authorization)

Version history

When What

August 2015 First Draft RR National addendum by UBA December 2016 Revision 1 by UBA (application rate for use in grassland changed from 2 L/ha to 1.5 l/ha)

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Table of Contents

8 Fate and behaviour in the environment (KCP 9) ...... 4 8.1 Proposed use pattern for Germany ...... 4 8.1.1 Grouping of intended uses for risk assessment ...... 4 8.2 Metabolites considered in the assessment ...... 4 8.3 Rate of degradation in soil (KCP 9.1.1) ...... 5 8.3.1 Laboratory studies - Aerobic degradation in soil (KCP 9.1.1.1) ...... 5 8.3.2 Field studies (KCP 9.1.1.2) ...... 6 8.4 Mobility in soil (KCP 9.1.2) ...... 6 8.4.1 Adsorption and desorption in soil (KCP 9.1.2.1) ...... 6 8.4.2 Lysimeter studies (KCP 9.1.2.2) ...... 8 8.4.3 Field leaching studies (KCP 9.1.2.3) ...... 8 8.5 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1, KCP 9.2.2, KCP 9.2.3) ...... 8 8.6 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3) ...... 8 8.6.1 Input-Parameters ...... 8 8.6.2 PECsoil ...... 9 8.7 Predicted Environmental Concentrations in groundwater (PECgw) (KCP 9.2.4.1)/ Risk assessment for ground water ...... 9 8.7.1 Direct leaching into groundwater ...... 9 8.7.1.1 PECgw modelling ...... 9 8.7.1.2 Experimental data to the leaching behavior ...... 12 8.7.1.3 Summary on risk assessment for groundwater after direct leaching ...... 12 8.7.2 Ground water contamination by bank filtration due to surface water exposure via run-off and drainage ...... 12 8.8 Predicted Environmental Concentrations in surface water (PECsw) (KCP 9.2.5) ...... 14 8.8.1 PECSW after exposure by spraydrift and volatilization with subsequent deposition ...... 15 8.8.2 PECsw-after exposure by surface run-off and drainage ...... 15 8.9 Fate and behaviour in air (KCP 9.3, KCP 9.3.1) ...... 16 8.10 Specific restrictions linked to the intended uses resulting from assessment of fate and behaviour in the environment of the PPP/active substance ...... 17

Appendix 1 Lists of data considered in support of the evaluation ...... 18

Appendix 2 Detailed evaluation of the new Annex II studies ...... 20

Appendix 3 Additional information provided by the applicant (e.g. detailed modelling data) ...... 20

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8 Fate and behaviour in the environment (KCP 9)

The exposure assessment of the plant protection product U 46 D Fluid in its intended uses in spring and winter cereals and in grassland is documented in detail in the core assessment of the plant protection product U 46 D Fluid dated from August 2915 performed by zRMS Germany. This document comprises the risk assessment for groundwater and the exposure assessment of surface water and soil for authorization of the plant protection product U 46 D Fluid in Germany according to uses listed in listed in Part B.0. Regarding PECgw relevant risk mitigation measures, if necessary, are documented in this document. PECsoil, PECsw are used for risk assessment to derive specific risk mitigation measures if necessary (see National addendum Germany, part B, section 9 and part A).

8.1 Proposed use pattern for Germany

8.1.1 Grouping of intended uses for risk assessment

Full details of the proposed use pattern of the formulation U 46 M Fluid that are intended for uses in Germany are presented in Part B.0 and are summarised in the table below. The intended uses in Germany are covered by the core assessment performed by zRMS Germany.

Table 8.1-1: Critical use pattern of U 46 D Fluid grouped according to soil

Grouping according to soil

Group Intended uses AR (interception) "eff. AR (cumulated)" (see CA) S01 00-002 spring cereals 1 × 750 (25 %) 562.500 S02 00-003 grassland 1 ×750 (60 %) 300.000 S03 00-001 winter cereals 1 × 750 (50 %) 375.000 CA… core assessment

Table 8.1-2: Critical use pattern of U 46 D Fluid grouped according to spraydrift

Grouping according to spraydrift

Group Intended uses AR (interval) drift scenario (see CA) D01 00-001, 00-002, 00-003 1 × 750 Arable crop CA… core assessment

8.2 Metabolites considered in the assessment

Please refer to the core assessment.

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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 Laboratory studies - Aerobic degradation in soil (KCP 9.1.1.1)

2,4-D

The DT50 values of 2,4-D and its soil metabolites 2,4-DCP and 2,4-DCA listed in the core assessment, part B, section 8, chapter 8.3.1.were analysed according to Holdt et al. 2011 (Holdt et al: Recommenda- tions for simulations to predict environmental concentrations of active substances of plant protection products and their metabolites in groundwater (PECGW) in the National assessment for authorization in Germany, Texte Umweltbundesamt 56, 2011). The statistical results for 2,4-D according to the program INPUT DECISION 3.3 are listed in the table below.

Table 8.3-1: Statistic values according to INPUT DECISION 3.3 for 2,4-D for PECGW modeling (n= 5)

Active substance 2,4-D

Number of DT50 values from laboratory 5 See core assessment table 8.3-1 studies Does the active substance dissociate ? Yes

correlation DT50 and pH Kendall-τ: 0.316 not significant p-value: 0.613 coefficient of variation 197 Too high

DT50 for PECGW (d) 10. percentile: 1.4 d Scenario Hamburg 90. percentile: 42.3 d* * To calculate the DT50 value of 42.3 d (90. Percentile, n = 5) the DT50 value of the study by Cohen (1991) was not only normalized to temperature (as done in the EU renewal ‰ 94.6 d) but also moisture normalised (75% at 1/3 bar) resulting in a DT50 value of 67 days.

Table 8.3-2: Statistic values according to INPUT DECISION 3.3 for the metabolite 2,4- DCP for PECGW modelling

metabolite 2,4-DCP

Number of DT50 values from laboratory 3 See core assessment table 8.3-2 studies Does the active substance dissociate ? no

correlation DT50 and pH Kendall-τ: -0.333 not significant p-value: 1.0 coefficient of variation 45 sufficiently low ZV1 034066 /U 46 D Fluid Page 6 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

DT50 for PECGW (d) 7.0 geom.mean

DT50 for PECGW (d) (runoff/drainage) 10.3 90.Perc. for Exposit

Table 8.3-3: Statistic values according to INPUT DECISION 3.3 for the metabolite 2,4- DCA for PECGW modelling

metabolite 2,4-DCA

Number of DT50 values from laboratory 3 See core assessment table 8.3-3 studies Does the active substance dissociate ? no

correlation DT50 and pH Kendall-τ: -0.816 not significant p-value: 1.0 coefficient of variation 11 Sufficiently low

DT50 for PECGW (d) 10.4 Geom.mean

DT50 for PECGW (d) (runoff/drainage) 11.3 90.Perc. for Exposit

8.3.2 Field studies (KCP 9.1.1.2)

Please refer to the core assessment.

8.4 Mobility in soil (KCP 9.1.2)

8.4.1 Adsorption and desorption in soil (KCP 9.1.2.1)

2,4-D and its metabolites Please refer to the core assessment. The Kfoc values of the study by Yoder and Adusumili, 2011(n= 7) were analysed according to Holdt et al. 2011 (Holdt et al: Recommendations for simulations to predict environmental concentrations of active substances of plant protection products and their metabolites in groundwater (PECGW) in the National assessment for authorization in Germany, Texte Umweltbundesamt 56, 2011).

Table 8.4-1: Statistic values according to INPUT DECISION 3.3 for 2,4-D for PECGW modelling

Active substance 2,4-D

Number of Kfoc values analysed 7 Yoder and Adusumili, 2011 See core assessment table 8.4.1 Does the active substance dissociate? yes, pKs = 3.4

correlation Kfoc and pH Kendall-τ:-0195 not significant p-value:0.645 ZV1 034066 /U 46 D Fluid Page 7 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

correlation Kf and pH Kendall-τ: -0.098 not significant p-value: 0.879 correlation Kf and oc Kendall-τ:0.333 not relevant/ (p-Wert > significance p-value:0.184 level) coefficient of variation Kfoc 50 sufficiently low (≤ 60%)

coefficient of variation Kf -- not relevant

Correlation Kf and other soil param- -- not relevant eters (clay, CEC) Kfoc/Kf for PECGW 25 arithmetic mean all soils

1/n PECgw 0.834 arithmetic mean all soils

Table 8.4-2: Statistic values according to INPUT DECISION 3.3 for metabolite 2,4-DCP for PECGW modelling

Active substance/Metabolite Metabolite 2,4-DCP

Number of Kfoc values analysed 7 Yoder and Adusumili, 2011 See core assessment table 8.4.2 Does the active substance dissociate? no

Correlation KF and oc Kendall-τ: 0.429 not significnatly positive p-value: 0.115 (p-value > significance level)

Coefficient of variation KFoc 45 sufficiently low (≤ 60%)

Correlation KF and pH Kendall-τ: -0.195 not significant p-value: 0.645 (p-value > significance level)

Correlation KF and other soil param- -- not relevant/ positive/not significant eters (clay, CEC)

KFoc for PECGW 512 arithmetic mean all soils

1/n PECGW 0.88 arithmetic mean all soils

Table 8.4-3: Statistic values according to INPUT DECISION 3.3 for metabolite 2,4-DCA for PECGW modelling

Active substance/Metabolite Metabolite 2,4-DCA

Number of Kfoc values analysed 7 Yoder and Adusumili, 2011 See core assessment table 8.4.3 Does the active substance dissociate? no

Correlation KF and oc Kendall-τ: 0.751 significnatly positive p-value: 0.016 (p-value < significance level)

Coefficient of variation KFoc 36 sufficiently low (≤ 60%)

Correlation KF and pH Kendall-τ: -0.103 not significant p-value: 0.877 (p-value > significance level)

Correlation KF and other soil param- -- not relevant/ positive/not significant eters (clay, CEC) ZV1 034066 /U 46 D Fluid Page 8 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

KFoc for PECGW 1028 arithmetic mean all soils

1/n PECGW 0.92 arithmetic mean all soils

8.4.2 Lysimeter studies (KCP 9.1.2.2)

Please refer to EU assessment report (RAR) for information on the lysimeter study available (Burger, 1993, study code RCC 272586).

8.4.3 Field leaching studies (KCP 9.1.2.3)

No data submitted, not required for assessment.

8.5 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1, KCP 9.2.2, KCP 9.2.3)

Please refer to the core assessment.

Accumulation of active substance and relevant metabolites in the sediment

active substance 2,4-D

accumulation potential in sediment no (DT90,whole system < 1 year, see core assessment) accumulation factor (SFO) -- -kt -kt faccu = e /(1 – e )

8.6 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3)

Results of PECsoil calculation for U 46 D Fluid according to EU assessment considering 5 cm soil depth are given in the core assessment. For German exposure assessment the applied soil depth is based on experimental data (Fent, Löffler, Ku- biak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirk- stoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ 360 03 018, UBA, Berlin 1999). Generally for active substances with a Kf,oc < 500 a soil depth of 2.5 cm is applied whereas for active substances with a Kf,oc > 500 a soil depth of 1 cm is applied. As soil bulk density 1.5 g cm-3is assumed.

8.6.1 Input-Parameters

Please refer to the core assessment.

Due to the fast degradation of the active substance 2,4-D in soil (DT90 < 365 d, SFO, laboratory data) the accumulation potential of 2,4-D does not need to be considered. ZV1 034066 /U 46 D Fluid Page 9 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.6.2 PECsoil

Table 8.6-1: PECsoil for active substance 2,4-D applied as U 46 D Fluid for use in spring cereals (use 00-002/use group S01)

use/use group Active Soil rele- PECact PECtwa21 d Tillage PECsoil,plate PECaccu = substance/ vant appli- depth (cm) (mg/kg) (mg/kg) au (mg/kg) PECact + formulation cation rate (soil depth: PECsoil,plate (g/ha) 2.5 cm) au (mg/kg)

00-002/S01 2,4-D 563 1.5 n.r. ------

8.7 Predicted Environmental Concentrations in groundwater (PECgw) (KCP 9.2.4.1)/ Risk assessment for ground water

Results of the PECgw calculation of 2,4-D for the intended uses of U 46 D Fluid in cereals and grassland according to EU assessment using FOCUS PELMO are given in the core assessment, part B, section 8, chapter 8.7.

For authorization in Germany, risk assessment for groundwater considers two pathways, (i) direct leaching of the active substance into the groundwater after soil passage and (ii) surface run-off and drainage of the active substance into an adjacent ditch with subsequent bank filtration into the groundwater.

Direct leaching after soil passage is assessed following the recommendations of the publication of Holdt et al. 2011 (Holdt et al: Recommendations for simulations to predict environmental concentrations of active substances of plant protection products and their metabolites in groundwater (PECGW) in the Na- tional assessment for authorization in Germany, Texte Umweltbundesamt 56, 2011) for tier 1 and tier 2 risk assessment. According to Hold et al, 2011, endpoints for groundwater modelling are derived with the program INPUT DECISION 3.1 and subsequent simulations are performed for the groundwater scenarios “Hamburg” or with the scenarios “Hamburg” and “Kremsmünster” of FOCUS PELMO. In tier 3 risk assessment, results of experimental studies (lysimeter studies and/or field leaching studies) can also be considered in German groundwater risk assessment.

Surface run-off and drainage into an adjacent ditch with subsequent bank filtration into the groundwater are estimated using the model EXPOSIT 3. The German risk assessment for groundwater is given in the following chapters.

8.7.1 Direct leaching into groundwater

8.7.1.1 PECgw modelling

The worst case scenario used for PECgw modelling is summarized in the table below. PECgw for winter cereals (use No 00-001) is covered by PECgw spring cereals due to the lower application rate in winter cereals and the intended application in spring. See also tablen 8.7.-1 in the core assessment. ZV1 034066 /U 46 D Fluid Page 10 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Table 8.7-1: Input parameters related to application for PECgw calculations (see also core assessment) for simulation with FOCUS PELMO v5.5.3

Use No. 00-002 00-003 (00-001)

Crop Spring cereals Lawns (FOCUS PELMO 5.5.3 crop: grass and alfalfa) Application rate (g as/ha) 2,4-D: 750 2,4-D: 1000* Number of applications/interval (d) 1 1 Relative application date 1st April (HH) 1st March (HH) = day of emergence Crop interception (%) 25 60 Frequency of application annual annual Soil moisture 100 % FC 100 % FC Q10-factor 2.58 2.58 Moisture exponent 0.7 0.7 *Note that application rate is reduced to 750 g as/ha

2,4-D and its metabolites The endpoints used for groundwater modelling for 2,4-D and its metabolites 2,4-DCA and 2,4-DCP according to INPUT DECISION 3.1 are summarised in the tables below.

Table 8.7-2: Input parameters related to active substance 2,4-D for PECgw calculations

Parent 2,4 D Remarks

Molecular weight (g/mol) 221

DT50 in soil (d) 10. perc. 1.4 HH 90/10. percentile 90. perc. 42.3 see Table 8.3-1

Kfoc (mL/g)/Kfom 25 Arithmetric mean see Table 8.4-1 (see also core assessment) 1/n 0.834 Arithmetric mean see Table 8.4-1 (see also core assessment)

Higher tier Kfoc 45 Arithmetic mean all Kfoc values ( n= 15) see core assessment table 8.4.-1 Higher tier 1/n 0.845 Arithmetic mean all Kfoc values ( n= 15) see core assessment table 8.4.-1 Plant uptake factor 0 See core assessment

Table 8.7-3: Input parameters metabolites of 2,4-D for PECgw calculations

metabolite 2,4-DCP Remarks

Molecular weight (g/mol) 163 Formation fraction 1 from parent see core assessment

DT50 in soil (d) 7.0 geom. mean see Table 8.3-2 (see also core assessment)

Kfoc (mL/g)/Kfom 512 arithm. mean see Table 8.4-2 (see also core assessment) ZV1 034066 /U 46 D Fluid Page 11 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

metabolite 2,4-DCP Remarks

1/n 0.88 arithm. mean see Table 8.4-2 (see also core assessment) Plant uptake factor 0 see core assessment

metabolite 2,4-DCA

Molecular weight (g/mol) 177 Formation fraction 1 from 2,4-DCP see core assessment

DT50 in soil (d) 10.4 geom. mean see Table 8.3-3 (see also core assessment)

Kfoc (mL/g)/Kfom 1028 arithm. mean see Table 8.4-3 (see also core assessment) 1/n 0.92 arithm. mean see Table 8.4-3 (see also core assessment) Plant uptake factor 0 see core assessment

The results of the groundwater simulation are presented in the tables below.

Table 8.7-4: PECGW at 1 m soil depth of 2,4-D and its metabolite considered relevant for German exposure assessment

80th Percentile PECGW at 1 m soil depth (µg L-1) modeled by FOCUS PELMO 5.5.3 Use No. Scenario DT50 Koc 2,4 D Metabolit Metabolit 2,4-DCP 2,4-DCA

Hamburg 90. percentile EU 8.821 0.336 0.258 00-003

(grassland) 10. percentile EU <0.001 <0.001 <0.001 ** 90. percentile all values* 1.391 0.056 0.061 Hamburg 90. percentile EU 8.821 0.336 0.258 00-001 10. percentile EU <0.001 <0.001 <0.001 (cereals) 90. percentile all values* 2.483 0.092 0.083 Values in bold relevant for decision. *higher tier PECgw calculation considering all Kfoc values of 2,4-D resulting in an arithm. mean value of Kfoc = 45 and 1/n = 0.845 ** Simulation based on 1000 g as/ha. Although application rate is now reduced to 750 g as/ha no relevant alteration of the results is expected.

According to the results of the groundwater simulation with FOCUS-PELMO 4.4.3, a groundwater contamination of the active substance 2,4-D in concentrations ≥ 0.1 µg/L cannot be excluded for the intended use in cereals and grassland.

For the metabolites 2,4-DCP and 2,4-DCA of 2,4-D a groundwater concentrations ≥ 0.1 µg/L can be excluded for the application in cereals and grassland according to the results of the groundwater simulation with FOCUS-PELMO 5.5.3 considering all available Kfoc and 1/n values.

In addition to the PECgw modelling experimental data from lysimeter studies are used to assess the leaching behaviour of the active substance 2,4-D. ZV1 034066 /U 46 D Fluid Page 12 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.7.1.2 Experimental data to the leaching behavior

In case of the active substance 2,4 D exposure assessment is based additionally on results of a lysimeter study. The study by Burgener (1993, study code: RCC 272586) is described in detail in DRAR, Volume 3, chapter B.8.2.2.3.1). The lysimeter study was performed on summer wheat at an application rate of 750 g a.s./ha. 2,4-D as well as its identified metabolites (2,4-DCP, 2-CP, 4-CP) were not detected in any of the analysed leachates or in the soil layers of the lysimeters. Considering the soil relevant application rate tested, the lysimeter study covers all intended for uses in cereals and in grassland. For the intended use of the formulation U 46 D Fluid in spring cereals the application was carried out at the upper end of the growth stage of the intended use in spring cereals (BBCH 30) However, the study states that every second plant was cut just above soil level. Therefore the crop interception values at the relevant growth stage are considered to be smaller and hence the study can also be used as higher tier assessment for the intended use in spring cereals according to use No. 00-002.

The experimental data on the leaching behaviour of the active substance 2,4-D show that the active substance 2,4-D is not expected to penetrate into groundwater at concentrations of ≥ 0.1µg/L in the intended uses of U 46 D Fluid in winter and spring cereals and grassland.

8.7.1.3 Summary on risk assessment for groundwater after direct leaching

Results of modelling with FOCUS PELMO 5.5.3/lysimeter study show that the active substance 2,4-D is not expected to penetrate into groundwater at concentrations of ≥ 0.1µg/L in the intended uses of U 46 D Fluid uses in cereals and grassland according to use No 00-001, 00-002 and 00-003.

For the metabolites 2,4-DCP and 2,4-DCA of the active substance 2,4-D concentrations of ≥ 0.1µg/L in groundwater can be excluded.

Consequences for authorization: none

8.7.2 Ground water contamination by bank filtration due to surface water exposure via run-off and drainage

2,4-D The input parameters for 2,4-D and its metabolites used for modelling surface water exposure via run-off and drainage in an adjacent ditch with subsequent bank filtration into the groundwater with EXPOSIT 3.0 are summarized in the tables below.

Table 8.7-5: Input parameters for 2,4-D used for PECGW calculations with EXPOSIT 3.01

Parameter 2,4-D Reference

Kfoc, Runoff 25 arithm. mean (see core assessment) Kfoc, mobility class 25 arithm. mean (see core assessment) DT50 soil (d) 42.3 90. percentile see Table 8.3-1 Solubility in water (mg/L) 24300 EU value Mobility class 3 ZV1 034066 /U 46 D Fluid Page 13 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Reduction by bank filtration 91.4

Table 8.7-6 PECgw for 2,4-D after surface run-off and drainage with subsequent bank filtration (modelled with EXPOSIT 3.01)

Active substance 2,4-D

Use No. application rate PECgw due to interception run-off drainage vegetated buffer bank filtrate time of bank filtrate strip (µg/L) application (µg/L) (m) 00-002 (S01) 750 g a.s./ha 0 0.021 spring/summer 0.012 25 % 5 10 autumn/winter/ 0.035 early spring 20 Required labelling none

According modelling with EXPOSIT 3.01, groundwater contamination at concentrations ≥ 0.1 µg/L by the active substance 2,4-D due to surface run-off and drainage into the adjacent ditch with subsequent bank filtration can be excluded.

Metabolites of 2,4-D For the soil metabolites of 2,4-D potential ground water contamination due to bank filtration via surface water exposure by run-off and drainage needs to be assessed using EXPOSIT 3.01. The input parameters for the model EXPOSIT 3.01 are taken from the EU assessment. The input parameters and the results of the assessment are summarised in the tables below.

Table 8.7-7: Input parameters for metabolite 2,4-DCP used for PECGW calculations with EXPOSIT 3.01

Parameter 2,4-DCP Reference

Molecular weight (g/mol) 163 Correction factor molecular weight 0.738 Maximum occurrence in soil (%) 8.7 Kfoc, Runoff 512 arithm. mean see Table 8.4-2 (see also core assessment) Kfoc, mobility class 512 arithm. mean see Table 8.4-2 (see also core assessment) DT50 soil (d) 7.0 geom. mean see Table 8.3-2 (see also core assessment) Solubility in water (mg/L) -- EU value Mobility class 2 ZV1 034066 /U 46 D Fluid Page 14 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Reduction by bank filtration 75 %

The maximum occurrence of metabolite 2,4-DCP is with 8.7 % very low leading in a maximum rate of 36.1 g/ha. That is factor 16 less than the rate for the parent. Although the reduction by bank filtration is with 75 % lower than for the parent (91.5 %) a contamination of groundwater by the metabolite 2,4-DCP at concentration ≥ 0.1 µg/L is not expected.

Table 8.7-8: Input parameters for metabolite 2,4-DCA used for PECGW calculations with EXPOSIT 3.01

Parameter 2,4-DCA Reference

Molecular weight (g/mol) 177 Correction factor molecular weight 0.801 Maximum occurrence in soil (%) 15 Kfoc, Runoff 1028 arithm. mean see Table 8.4-3 (see also core assessment) Kfoc, mobility class 1028 arithm. mean see Table 8.4-3 (see also core assessment) DT50 soil (d) 10.4 geom. mean see Table 8.3-3 (see also core assessment) Solubility in water (mg/L) -- EU value Mobility class 1 Reduction by bank filtration 100%

As the reduction by bank filtration is assumed to be 100 % for metabolite 2,4-DCA, no calculation of PECgw is necessary.

Consequences for authorization: none

8.8 Predicted Environmental Concentrations in surface water (PECsw) (KCP 9.2.5)

Results of PECsw calculation of 2,4-D for the intended uses of U 46 D Fluid in cereals and grassland using FOCUS Surface Water are given in the core assessment, part B, section 8, chapter 8.8. 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. Surface water exposure via spray drift and volatilization with subsequent deposition is estimated with the model EVA 2.1. Surface water exposure via surface run-off and drainage is estimated using the model EXPOSIT 3.0.

PECsw- values used for risk assessment for the intended uses of U 46 D Fluid in Germany are documented in the national addendum of Germany, Part B, section 9, chapter 9.5. The input parameters for the PECsw calculation are provided in the chapters below. ZV1 034066 /U 46 D Fluid Page 15 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.8.1 PECSW after exposure by spraydrift and volatilization with subsequent deposition

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 2,4-D is < 10-5 Pa. Hence the active substance 2,4-D is regarded as non-volatile. Therefore exposure of surface water by the active substance 2,4-D due to volatilization with subsequent deposition does not need to be considered

The endpoints and use related input parameters used for modelling of surface water exposure via spray drift and volatilization with subsequent deposition with EVA 3 are summarized below.

Table 8.8-1: Endpoints of 2,4-D used for PECsw calculations with EVA 3 Parameter 2,4-D Reference vapour pressure at 20 °C (Pa) not required since no v/d -- Solubility in water at 20 °C (mg/L) not required since no v/d --

DissT50 water (d) not required for single applications --

DegT50 water/sediment study, total not relevant/ only water phase is -- system (d) considered)

Table 8.8-2: Use related input parameters s of 2,4-D used for PECsw calculations with EVA 3

Use No./use group 00-001, 00-002, 00-003/D01 Number of applications/ interval: 1 Application rate 2,4-D: 1 x 750 g a.s./ha Drift scenario/percentile Arable crops/90. percentile

8.8.2 PECsw-after exposure by surface run-off and drainage

The concentration of the active substance 2,4-D in adjacent ditch due to surface runoff and drainage is calculated using the model EXPOSIT 3.01. The substance specific input parameters used for modelling surface water exposure via run-off and drainage in an adjacent ditch with EXPOSIT 3.01 are summarized in chapter 8.7.2 of this document. The calculated PECSW in an adjacent ditch due to surface run-off and drainage for the active substance 2,4-D according to use No. 00-001 till 00-003 are presented in the National addendum Germany, part B, section 9, chapter 9.5 considering the following input parameters related to the application.

Table 8.8-3: FOCUS Step 1 and 2 PECsw and PECsed for 2,4-D following single application(s) of U46 D Fluid to spring cereals

Use No./use group 00-002/S01 00-003/S02 00-001/S03 Number of applications/ 1 1 1 interval: Application rate 2,4-D: 1 x 750g a.s./ha 2,4-D: 1 x 750 g a.s./ha 2,4-D: 1 x 750g a.s./ha Crop interception 25 % 60% 50%

ZV1 034066 /U 46 D Fluid Page 16 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.9 Fate and behaviour in air (KCP 9.3, KCP 9.3.1)

Please refer to the core assessment.

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8.10 Specific restrictions linked to the intended uses resulting from assessment of fate and behaviour in the environment of the PPP/active substance

For the authorization of the plant protection product U 46 D Fluid no specific labelling and no specific conditions of use are mandatory that are resulted from the assessment of the fate and behaviour in the environment.

ZV1 034066 /U 46 D Fluid Page 18 /20 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

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

KIIIA19.6/ Simmons 2013 Calculation of Predicted Environmental Concentrations in Groundwater (PECGW) and Surface Water N Nufarm KIIA1 (PECSW) of the Active Substance 2,4-D and its Metabolites 2,4-DCP and 2,4-DCA Following 9.7/9.8 Application to Spring and Winter Cereals using FOCUS PELMO 5.5.3, EXPOSIT 3.0 Beta and EVA 2.1 Nufarm UK Ltd. NUF2013-48 Not GLP Unpublished KIIIA19.6/ Simmons 2013 Calculation of Predicted Environmental Concentrations in Groundwater (PECGW) and Surface Water N Nufarm KIIA1 (PECSW) of the Active Substance 2,4-D and its Metabolites 2,4-DCP and 2,4-DCA Following 9.7/9.8. Application to Grassland using FOCUS PELMO 5.5.3, EXPOSIT 3.0 Beta and EVA 2.1 Nufarm UK Ltd. NUF2013-49 Not GLP Unpublished

List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review ---

List of data submitted by the applicant and not relied on --- ZV1 034066 /U 46 D Fluid Page 19 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

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

ZV1 034066 /U 46 D Fluid Page 20 /20 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Appendix 2 Detailed evaluation of the new Annex II studies

Please note, that the studies listen in Appendix 1, table 1 comprise PEC-caluclation. These calcultation were provided by zRMS as input parameters were altered. An detailed description of the calaculation is not considered to provide more information for concerned Member States.

Appendix 3 Additional information provided by the applicant (e.g. detailed modelling data)

REGISTRATION REPORT Part B Section 9 Ecotoxicology Detailed summary of the risk assessment

Product code: ZV1 034066-00/00 Product name(s): U 46 D Fluid (Spritz-Hormin 500) Chemical active substance(s): 2,4-D 500 g/L

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

(authorization)

Applicant: Nufarm GmbH Submission date: 19.12.2013 MS Finalisation date: 27/04/2017 034066-00/00 / U 46 D Fluid Page 2 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Version history

When What

August 2015 Draft RR by UBA February 2017 Revision 1 by UBA (application rate for use in grassland changed from 2 L/ha to 1.5 l/ha)

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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) ...... 9 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 ...... 11 9.2 Effects on birds (KCP 10.1.1) ...... 11 9.2.1 Toxicity data ...... 11 9.2.1.1 Justification for new endpoints ...... 12 9.2.2 Risk assessment for spray applications ...... 12 9.2.2.1 First-tier assessment (screening/generic focal species) ...... 12 9.2.2.2 Higher-tier risk assessment ...... 13 9.2.2.3 Drinking water exposure ...... 13 9.2.2.4 Effects of secondary poisoning ...... 14 9.2.2.5 Biomagnification in terrestrial food chains ...... 14 9.2.3 Risk assessment for baits, pellets, granules, prills or treated seed ...... 14 9.2.4 Overall conclusions ...... 14 9.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2) ...... 14 9.3.1 Toxicity data ...... 14 9.3.1.1 Justification for new endpoints ...... 15 9.3.2 Risk assessment for spray applications ...... 15 9.3.2.1 First-tier assessment (screening/generic focal species) ...... 15 9.3.2.2 Higher-tier risk assessment ...... 17 9.3.2.3 Drinking water exposure ...... 18 9.3.2.4 Effects of secondary poisoning ...... 19 9.3.2.5 Biomagnification in terrestrial food chains ...... 19 9.3.3 Risk assessment for baits, pellets, granules, prills or treated seed ...... 19 9.3.4 Overall conclusions ...... 19 9.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3) ...... 20 9.5 Effects on aquatic organisms (KCP 10.2) ...... 20 9.5.1 Toxicity data ...... 20 9.5.1.1 Justification for new endpoints ...... 22 9.5.2 Risk assessment ...... 22 9.5.3 Overall conclusions ...... 24 9.6 Effects on bees (KCP 10.3.1) ...... 24 9.6.1 Toxicity data ...... 24 9.6.1.1 Justification for new endpoints ...... 25 034066-00/00 / U 46 D Fluid Page 4 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

9.6.2 Risk assessment ...... 25 9.6.2.1 Hazard quotients for bees ...... 25 9.6.2.2 Higher-tier risk assessment for bees (tunnel test, field studies) ...... 25 9.6.3 Effects on bumble bees ...... 25 9.6.4 Effects on solitary bees ...... 25 9.6.5 Overall conclusions ...... 26 9.7 Effects on arthropods other than bees (KCP 10.3.2) ...... 26 9.7.1 Toxicity data ...... 26 9.7.1.1 Justification for new endpoints ...... 27 9.7.2 Risk assessment ...... 27 9.7.2.1 Risk assessment for in-field exposure ...... 27 9.7.2.2 Risk assessment for off-field exposure ...... 27 9.7.2.3 Additional higher-tier risk assessment ...... 28 9.7.2.4 Risk mitigation measures ...... 28 9.7.3 Overall conclusions ...... 28 9.8 Effects on non-target soil meso- and macrofauna (KCP 10.4) ...... 28 9.8.1 Toxicity data ...... 28 9.8.1.1 Justification for new endpoints ...... 29 9.8.2 Risk assessment ...... 29 9.8.2.1 First-tier risk assessment ...... 29 9.8.2.2 Higher-tier risk assessment ...... 30 9.8.3 Overall conclusions ...... 30 9.9 Effects on soil microbial activity (KCP 10.5) ...... 30 9.9.1 Toxicity data ...... 30 9.9.1.1 Justification for new endpoints ...... 31 9.9.2 Risk assessment ...... 31 9.9.3 Overall conclusions ...... 32 9.10 Effects on non-target terrestrial plants (KCP 10.6) ...... 32 9.10.1 Toxicity data ...... 32 9.10.1.1 Justification for new endpoints ...... 33 9.10.2 Risk assessment ...... 34 9.10.2.1 Tier-1 risk assessment (based screening data) ...... 34 9.10.2.2 Tier-2 risk assessment (based on dose-response data) ...... 34 9.10.2.3 Higher-tier risk assessment ...... 34 9.10.2.4 Risk mitigation measures ...... 34 9.10.3 Overall conclusions ...... 36 9.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ...... 36 9.12 Monitoring data (KCP 10.8) ...... 36 9.13 Classification and Labelling ...... 36

Appendix 1 Lists of data considered in support of the evaluation ...... 37

Appendix 2 Detailed evaluation of the new studies ...... 42 A 2.1 KCP 10.1 Effects on birds and other terrestrial vertebrates ...... 42 A 2.2 KCP 10.2 Effects on aquatic organisms ...... 42 A 2.3 KCP 10.3 Effects on arthropods ...... 52 A 2.4 KCP 10.4 Effects on non-target soil meso- and macrofauna ...... 58 A 2.5 KCP 10.5 Effects on soil nitrogen transformation ...... 58 034066-00/00 / U 46 D Fluid Page 5 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

A 2.6 KCP 10.6 Effects on terrestrial non-target higher plants ...... 61 A 2.7 KCP 10.7 Effects on other terrestrial organisms (flora and fauna) ...... 63 A 2.8 KCP 10.8 Monitoring data ...... 63

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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 F, Pests or Group of pests Application Application rate PHI Remarks: Conclusion No. state(s) situation Fn, controlled (days) e.g. g saf- * (crop destination Fpn (additionally: devel- Method / Timing / Max. num- Min. interval kg or L g or kg as/ha Water L/ha ener/

/ purpose of G, opmental stages of the Kind Growth ber between product/ha min/max synergist crop) Gn, pest or pest group) stage of crop a) per use applications a) max. rate a) max. rate per ha 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 Non pods organisms Soil Non Zonal uses (field or outdoor uses, certain types of protected crops)

001 DE Winter soft wheat F Dicotyledonous weeds Spraying After emer- a) 1 -- a) 1.5 a) 750 g 200 - 400 XF* except for A A R A A A R TRZAW TTTDD gence b) 1 L/ha as/ha seed production spelt Spring b) 1.5 b) 750 g L/ha as/ha TRZSP BBCH 21 - 32 winter durum wheat TRZDW winter barley HORVW winter rye SECCW winter triticale TTLWI winter oats AVESW

002 DE Spring soft wheat F Dicotyledonous weeds Spraying After emer- c) 1 -- a) 1.5 750 g as/ha 200 - 400 XF* A A R A A R 750 g as/ha TRZAS TTTDD gence d) 1 L/ha b) 1.5 034066-00/00 / U 46 D Fluid Page 7 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21

spring durum Spring L/ha wheat BBCH 11 - TRZDS 32 spring barley HORVS spring rye SECCS spring triticale TTLSO spring oat AVEFA

003 DE Grassland, F Dicotyledonous weeds Spraying during a) 1 -- a) 1.5 a) 750 g 200 - 400 14 d A R R A A R pasture, meadow TTTDD growing b) 1 L/ha as/ha NNNFW season b) 1.5L/ha b) 750 g (March to as/ha October) BBCH 25 - 35

-- Minor uses according to Article 51 (interzonal uses) --

Explanation for column 15 – 21 “Conclusion” A Acceptable, Safe use R Further refinement and/or risk mitigation measures required 034066-00/00 / U 46 D Fluid Page 8 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

C To be confirmed by cMS N No safe use

Remarks (1) Numeration necessary to allow references (7) Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, table: (2) Use official codes/nomenclatures of EU 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; where 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 use, (10) For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty 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 men- application must be named tioned 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 - type (14) Remarks may include: Extent of use/economic importance/restrictions of equipment used must be indicated

034066-00/00 / U 46 D Fluid Page 9 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

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: The results of the assessment indicate an acceptable acute and long-term risk for birds due to the intended use of U 46 D Fluid in cereals and grassland according to the label.

Mammals: The results of the assessment indicate an acceptable acute and long-term risk for mammals due to the intended use of U 46 D Fluid in cereals according to the label (use No. 00-001 and 00-002). For the use on grassland (use No 00-003) the results of the assessment indicate an unacceptable acute and long-term risk for mammals due to the intended use of U 46 D Fluid according to the label. Further refinements of the risk assessment might be applied on member state level.

9.1.1.2 Effects on aquatic organisms (KCP 10.2)

Based on the calculated concentrations of 2,4-D in surface water (PECSW FOCUS Step 1 and 2), the calculated TER values for the most sensitive aquatic species (Myriophyllum aquaticum) does not achieve the acceptability criteria PEC/RAC < 1. However, the exposure assessment was performed on a lower level, hence higher tier exposure assessment (e.g. FOCUS Step 3 or specific national exposure assessment) linked with risk mitigation measures need to be performed on member state level. For specific risk assessment for Germany please refer to the national addendum Part B section 9.

9.1.1.3 Effects on bees (KCP 10.3.1)

It is concluded that U 46 D Fluid (2,4-D 500 g/L) will not adversely affect bees or bee colonies when used as recommended.

9.1.1.4 Effects on arthropods other than bees (KCP 10.3.2)

The results of the assessment indicate an acceptable risk for non-target arthropods due to the intended use of U 46 D Fluid in grassland and cereals according to the label.

9.1.1.5 Effects on non-target soil meso- and macrofauna (KCP 10.4), Effects on soil microbial activity (KCP 10.5)

The results of the assessment indicate an acceptable risk for soil organisms due to the intended use of U 46 D Fluid in cereals and grassland according to the label. 034066-00/00 / U 46 D Fluid Page 10 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

9.1.1.6 Effects on non-target terrestrial plants (KCP 10.6)

The results of the assessment indicate an acceptable risk for non-target terrestrial plants due to the intended use of U 46 D Fluid according to the label if appropriate risk mitigation measures are applied (buffer strip 10 m or drift reducing technique 90 %).

9.1.1.7 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)

Not relevant

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). Please note that the uses in spring and winter cereals according to use No 00-001 and 00-002 have been assessed during renewal of approval of 2,4-D (see EFSA conclusion March 2015, EFSA Journal 2014;12(9):3812).

Table 9.1-2: Critical use pattern of U 46 D Fluid grouped according to soil

Grouping according to soil

Group Intended uses AR (interception) "eff. AR (cumulated)" S01 00-002 spring cereals 1 × 750 (25 %) 562.500 S02 00-003 grassland* 1 ×750 (60 %) 300.000 S03 00-001 winter cereals 1 × 750 (50 %) 375.000 After renewal of approval of 2,4-D GAP has changed regarding application rate (1.5 L product/ha instead of 2 L product/ha).

Table 9.1-3: Critical use pattern of U 46 D Fluid grouped according to vertebrates

Grouping according to vertebrates

Group Intended uses AR (interval) crop scenario B02M01 00-003 1 × 750 (1 d) grassland B01M02 00-001 winter cereals 1 × 750 (1 d) cereals 00-002 spring cereals

Table 9.1-4: Critical use pattern of U 46 D Fluid grouped according to spraydrift

Grouping according to spraydrift

Group Intended uses AR (interval) drift scenario D01 00-001, 00-002, 00-003 1 × 750 Arable crop

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Table 9.1-5: Critical use pattern of U 46 D Fluid grouped according to arthropods/terrestrial plants

Grouping according to arthropods/terrestrial plants

Group Intended uses max. AR (single) AR H01A01 00-001, 00-002, 00-003 750 1 × 750

9.1.3 Consideration of metabolites

A list of metabolites potentially relevant for risk assessment is provided below. The need for conducting a metabolite-specific risk assessment in the context of the evaluation of U 46 D Fluid is indicated in the table below.

The risk assessment for the metabolite 2,4-DCP and 2,4-DCA has already been performed for EU approval (see EFSA Journal 2014;12(9):3812). They were regarded as having low risk to soil organismen (2,4 DCA) and aquatic organism (2,4-DCA and 2,4-DCP). Therefore no new risk assessment for these metabolites was performed.

Table 9.1-6 Metabolites of 2,4-D

Metabolite Chemical structure Molar mass Maximum occurrence in Risk assessment compartments required?

2,4-DCP Cl Cl 163 Soil: max. 8.7 % at day 10 No, covered by EU (2,4 – (2x > 5 %) risk assessment Dichlorophenol) OH Sediment: max. 31.8 % at day 31 2,4-DCA O 177 Soil: max. 15 % at day 17 No, covered by EU (2,4 – risk assessment Dichloroanisole) Cl Cl

9.2 Effects on birds (KCP 10.1.1)

9.2.1 Toxicity data

Avian toxicity studies have been carried out with 2,4-D. Full details of these studies are provided in the respective EU DAR and related documents. Effects on birds of U 46 D Fluid were not evaluated as part of the EU assessment of 2,4-D. However, the provision of further data on the U 46 D Fluid U 46 D Fluid is not considered essential, because the formulation comprises only one active substance. An increase of the toxicity by the co-formulants is not expected.

The selection of studies and endpoints for the risk assessment is in line with the results of the EU review process. 034066-00/00 / U 46 D Fluid Page 12 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Table 9.2-1: Endpoints and effect values relevant for the risk assessment for birds

Species Substance Exposure Results Reference Internal code System

1 Serinus canarius 2,4 D-acid Oral LD50 = 633 mg LoEP 84871 1 d a.s/kg bw XXX 2011 Acute 379-239

Coturnix coturnix 2,4 D-acid Oral LD50 = 617.3 mg LoEP 84870 japonica) 1 d a.s./kg bw/d XXX Acute 2004 G/64/03

Colinus 2,4 D-acid Oral LD50 = 500 mg LoEP 80579 virginianus 1 d a.s./kg bw XXX 1990 Acute 103-310 Colinus 2,4 D-acid Dietary NOEL = LoEP 42701 virginianus Reproductive 100mg/kg bw/d XXX 2000 toxicity 467-106 1 LoEP refers to EFSA conclusion 2014 (EFSA Journal 2014;12(9):3812) (Please note, that EFSA conclusion was revised in March 2015. However, that revision did not affect ecotoxicology.)

For the acute risk assessment the geometric mean value of 580.3 mg/kg bw is applied (see EFSA conclusion 2014). The assessment for long-term/reproductive risk is conducted with the lowest endpoint (58 mg/kg bw based on LD50/10) in accordance with the current EFSA Guidance (2009) (see also EFSA conclusion 2014).

9.2.1.1 Justification for new endpoints

Not required.

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 group B01M02 also covers the risk for birds from all other intended uses in groups B02M01 (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 U 46 D Fluid in grassland (00-003/B01M01)

Intended use B01M02(00-001, 00-002

Active substance/product 2,4-D Application rate (g/ha) 1 × 750 034066-00/00 / U 46 D Fluid Page 13 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Acute toxicity (mg/kg bw) 580.3 TER criterion 10

Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) cereals Large herbivorous bird "goose"* 30.5 1 22.9 25.3 Reprod. toxicity (mg/kg bw/d) 58 TER criterion 5

Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) cereals Large herbivorous bird "goose"* 16.2 0.53 6.4 9.1 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.

* most sensitive generic focal species (highest shortcut value)

9.2.2.2 Higher-tier risk assessment

Not required.

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 U 46 D Fluid is 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 25, 2,4-D belongs to the group of less sorptive substances. To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use group B01M01 also covers the risk for birds from all other intended uses in groups B02M02 (see 9.1.2).

Table 9.2-3: Assessment of risk for birds due to uptake of contaminated drinking water (puddle scenario) for the intended use on grassland (use group B01M01/use 00-003)

Effective application rate (g/ha) = 750 Acute toxicity (mg/kg bw) = 580.3 quotient = 1.3 Reprod. toxicity (mg/kg bw/d) = 58 quotient = 13 034066-00/00 / U 46 D Fluid Page 14 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

effective application rate = application rate multiplied by mean MAF

9.2.2.4 Effects of secondary poisoning

The log Pow of 2,4-D amounts to -0.82 (pH 7) and thus does not exceed the trigger value of 3. A risk assessment for effects due to secondary poisoning is not required. The pertinent metabolites 2,4-DCP and 2,4-DCA have a log Pow value of 3.06 and 3.36, respectively. Therefore, based on the log Pow values, the risk assessment from bioaccumulation to fish and earthworm- eating birds was only triggered for the metabolites. The risk assessment for earthworm eating birds and fish-eating birds via secondary poising by the metabolites 2,4-DCP and 2,4-DCA was performed for renewal of approval of 2,4-D (see RAR Volume 3 B.9 January 2014). The risk assessment resulted in an acceptable risk for earthworm eating birds and fish- eating birds. The use examined for renewal of EU approval covers the intended for uses of the formulation U 46 D Fluid (use No 00-001, 00-002 and 00-003). Although a risk assessment was also performed for fish-eating birds showing an acceptable risk it should be noted that, the metabolites 2,4-DCP and 2,4-DCA are soil metabolites with a maximum observed of 8.7 % at day 10 and 15 % at day 17, respectively. Bioaccumulation of the metabolites in fish and hence a risk for fish-eating birds is only possible via exposure of surface water due to runoff. Considering the rapid degradation of the metabolites in soil (DT 50 = 7-10 days.) and their low occurrence in soil the risk for fish-eating birds due to the accumulation of the soil metabolites in fish is considered to be low.

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

Based on the tier 1 assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of birds to 2,4-D (oral exposure and exposure via drinking water and secondary poisoning) according to the GAP of the formulation U 46 D Fluid 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 effects. The results of the assessment indicate an acceptable acute and long-term risk for birds due to the intended use of U 46 D Fluid in cereals and grassland according to the label.

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 2,4-D. Full details of these studies are provided in the respective EU DAR and related documents. Effects on mammals of U 46 D Fluid were not evaluated as part of the EU assessment of 2,4-D. However, the provision of further data on the U 46 D Fluid U 46 D Fluid is not considered essential, be- 034066-00/00 / U 46 D Fluid Page 15 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015 cause the formulation comprises only one active substance. An increase of the toxicity by the co- formulants is not expected.

The selection of studies and endpoints for the risk assessment is in line with the results of the EU review process.

Table 9.3-1: Endpoints and effect values relevant for the risk assessment for mammals

Species Substance Exposure Results Reference Internal code System

1 Rat 2,4-D acid Acute toxicity, LD50 699 mg/kg bw LoEP 80518 oral XXX 1981 490-001 Rat 2,4-D acid Acute toxicity LD50 486 mg/kg bw LoEP 74072 XXX 1994 SA 94107 Rat 2,4-D acid Acute toxicity LD50 > 500 mg/kg LoEP -- bw XXX 2 2003 OS-31/103 Rat 2,4-D acid Reproductive NOAEL 20.6 mg/kg LoEP -- toxicity (2- bw/d XXX 2010 generation) 081104 1 LoEP refers to EFSA conclusion 2014 (EFSA Journal 2014;12(9):3812) (Please note that EFSA conclusion was revised in March 2015. However, that revision did not affect ecotoxicology.) 2 The reference is given in the RAR Table B.9.3.3-1. However in the RAR Part B.6. chapter B.6.2.1(acute Oral Toxicity) the study is not documented but the study by Leonie, A.L., 2011 shows these results.

For the acute risk assessment the geometric mean value of >554 mg/kg bw is applied (see also EFSA conclusion 2014).

9.3.1.1 Justification for new endpoints

Not relevant.

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 group B02M01 also covers the risk for mammals from all other intended uses in groups B01M02 (see 9.1.2).

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. 034066-00/00 / U 46 D Fluid Page 16 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Table 9.3-2: First-tier assessment of the acute and long-term/reproductive risk for mammals due to the use of U 46 D Fluid in grassland (00-003/B02M01)

Intended use B01M01 (00-003) Active substance/product 2,4-D Application rate (g/ha) 1 × 750 Acute toxicity (mg/kg bw) > 554 TER criterion 10

Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Grassland/ all season Large herbivorous mammal 32.6 1 24.5 >23 "lagomorph" Grassland/ all season Small herbivorous mammal 136.4 1 102.3 >5 "vole" Reprod. toxicity (mg/kg bw/d) 20.6 TER criterion 5

Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Grassland/ all season Large herbivorous mammal 17.3 0.53 6.9 3.0 "lagomorph" Grassland/ all season Small herbivorous mammal 72.3 0.53 28.7 0.7 "vole" 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.

Table 9.3-3: First-tier assessment of the acute and long-term/reproductive risk for mammals due to the use of U 46 D Fluid in cereals (00-001 and 00-002/B01M02)

Intended use B02M02 (00-001 and 00-002) Active substance/product 2,4-D Application rate (g/ha) 1 × 750 Acute toxicity (mg/kg bw) > 554 TER criterion 10

Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Cereals/early (shoots) Large herbivorous mammal 42.1* 1 31.575 >17.5 "lagomorph"* Reprod. toxicity (mg/kg bw/d) 20.6 TER criterion 5

Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Cereals/early (shoots) Large herbivorous mammal 22.3 0.53 8.81 2.3 "lagomorph" Cereals/BBCH 10-29 Small omnivorous mammal 7.8 0.53 3.08 6.7 "mouse"** 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. 034066-00/00 / U 46 D Fluid Page 17 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

*most sensitive generic focal species (highest SV90) ** Generic focal species with the second highest SV exceeding the applicable acceptability criteria. Therefore risk assessment for further generic focal species will not be documented.

For the use in grassland (use No 00-003) the calculated TER values for the long-term risk resulting from exposure of mammals to 2,4-D do not achieve the acceptability criteria TER ≥ 5. For the use in cereals (use No 00-001 and 00-002) the calculated TER values for the long-term risk resulting from exposure of mammals to 2,4-D do not achieve the acceptability criteria TER ≥ 5. A refined risk assessment for long-term/reproductive effects is required.

9.3.2.2 Higher-tier risk assessment

Decline of residues (DT50): In the EU assessment the following refinement was applied: The geometric mean DT50 of 2.30 days on cereals (2.09 days on winter cereals and 2.39 days on spring cereals) can be considered in the refined long-term risk assessment. This value corresponds to a 21-day time-weighted-average factor (fTWA) of 0.1579.

Relevant endpoint: LD50: The applicant proposes using the endpoint of a dietary study (XXX 2011) to refine the acute toxicity of 2,4-D. The dietary study was conducted on mice whereas the acute toxicity values are derived from studies on rats. As different species, rats versus mice, were tested the effects of the administration of the active substance (gavage versus dietary) on the toxicity cannot be extrapolated. Therefore zRMS doesn’t follow this refinement.

NOAEL: The applicant proposes to use a NOAEL of 48 mg/kg bw/d for refined assessment. This value is dereived from the study by Szewczyk (1997). In the expert meeting all available studies regarding long-term endpoint for risk assessment (including the study by Szewczyk, 1997) were discussed resulting in the endpoint of NOAEL of 20.6 mg/kg bw/d as listed in the LoEP. Therefore zRMS does not follow the proposed refinement. PD value: The applicant proposes a higher tier risk assessment based on the refinement of the PD-factor considering a food composition of 35% monocotyledonous and 65% dicotyledonous leaves. However, the diet of the vole considered in the Guidance Document EFSA/2009/1438 is based on broad data base that the argumentation of the applicant is not followed.

Acceptability criteria: Please refer to the national addendum, Germany for further specific refinements of the acceptability criteria for small herbivorous mammals.

Table 9.3-4: Higher-tier assessment of the acute and long-term/reproductive risk for mammals due to the use of U 46 D Fluid in grassland (00-003 / B02M01) – refined parameters (*) are further described and justified in the text

Intended use B02M01 (00-003) Active substance/product 2,4-D Application rate (g/ha) 1 × 750 Acute toxicity (mg/kg bw) > 554 TER criterion 10 034066-00/00 / U 46 D Fluid Page 18 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Grassland/ all season Large herbivorous mammal 17.3 0.16* 2.1 10.1 "lagomorph" Grassland/ all season Small herbivorous mammal 72.3 0.16* 8.6 2.4 "vole" 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.

Table 9.3-5: Higher-tier assessment of the long-term/reproductive risk for mammals due to the use of U 46 D Fluid in cereals (00-002 , 00-001/B01M02) – refined parameters (*) are further described and justified in the text

Intended use B01M02 (00-001 and 00-002) Active substance/product 2,4-D Application rate (g/ha) 1 × 750 Reprod. toxicity (mg/kg bw/d) 20.6 TER criterion 5

Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Cereals/early (shoots) Large herbivorous mammal 22.3 0.16* 8.81 7.8 "lagomorph" Cereals/BBCH 10-29 Small omnivorous mammal 7.8 0.53 3.08 6.7 "mouse"** 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.

** Generic focal species with the second highest SV exceeding the applicable acceptability criteria (without refinement). Therefore risk assessment for further generic focal species will not be documented.

9.3.2.3 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).

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 034066-00/00 / U 46 D Fluid Page 19 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015 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 25, 2,4-D belongs to the group of less sorptive substances. To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use group B02M01 also covers the risk for mammals from all other intended uses in groups B01M02 (see 9.1.2).

Table 9.3-6: Assessment of risk for mammals due to uptake of contaminated drinking water (puddle scenario) for the intended use on grassland (use group B02M01/use 00-003)

Effective application rate (g/ha) = 750 Acute toxicity (mg/kg bw) = > 554 quotient = < 1.4 Reprod. toxicity (mg/kg bw/d) = 20.6 quotient = 36

9.3.2.4 Effects of secondary poisoning

The log Pow of 2,4-D amounts to -0.82 (pH 7) and thus does not exceed the trigger value of 3. A risk assessment for effects due to secondary poisoning is not required. The pertinent metabolites 2,4-DCP and 2,4-DCA have a log Pow value of 3.06 and 3.36, respectively. Therefore, based on the log Pow values, the risk assessment from bioaccumulation to fish and earthworm- eating mammals is triggered for the metabolites. The risk assessment for earthworm eating mammals and fish-eating mammals via secondary poising by the metabolites 2,4-DCP and 2,4-DCA was performed for renewal of approval of 2,4-D (see RAR Vol- ume 3 B.9 January 2014). The risk assessment resulted in an acceptable risk for for earthworm eating mammals and fish-eating mammals. The use examined for renewal of EU approval covers the intended for uses of the formulation U 46 D Fluid (use No 00-001, 00-002 and 00-003). Although a risk assessment was also performed for fish-eating mammals showing an acceptable risk it should be noted that, the metabolites 2,4-DCP and 2,4-DCA are soil metabolites with a maximum observed of 8.7 % at day 10 and 15 % at day 17, respectively. Bioaccumulation of the metabolites in fish and hence a risk for fish-eating mammals is only possible via exposure of surface water due to runoff. Considering the rapid degradation of the metabolites in soil (DT 50 = 7-10 days.) and their low occurrence in soil the risk for fish-eating mammals due to the accumulation of the soil metabolites in fish is considered to be low.

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

Use No. 00-001 and 00-002 (cereals):

Based on tier 1 (acute) and higher tier (long-term) assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of mammals to 2,4-D (oral exposure and exposure 034066-00/00 / U 46 D Fluid Page 20 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015 via drinking water and secondary poisoning) according to the GAP of the formulation U 46 D Fluid 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 acute and long-term risk for mammals due to the intended use of U 46 D Fluid in cereals according to the label.

Use No 00-003 (grassland):

Based on tier 1 (acute) and higher tier (long-term) assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of mammals to 2,4-D (oral exposure and exposure via drinking water and secondary poisoning) according to the GAP of the formulation U 46 D Fluid 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. The results of the assessment indicate an unacceptable acute and long-term risk for mammals due to the intended use of U 46 D Fluid on grassland according to the label.

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 2,4-D / and its relevant metabolites. Full details of these studies are provided in the respective EU DAR and related documents, as well as in Appendix 2 of this document (new studies).

Effects on aquatic organisms of U 46 D Fluid were not evaluated as part of the EU assessment of 2,4-D. 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 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 – 2,4-D

Species Substance Exposure Results Reference Internal System code

Pimephales 2,4-D 4 d, f LC50 = 100 mg LoEP1 47412 promelas a.s./L nom. 2001/2013

Pimephales 2,4-D 32 d f, ELS NOEL= 63.4 LoEP 54574 promelas mg/L m.m. XXX 1990 ES-DR-0002-2297-10

Daphnia magna 2,4-D 48 h, s EC50 = 134.2 LoEP 84912 mg a.s./L nom. Fochtmann, P. 2003 W/22/03 034066-00/00 / U 46 D Fluid Page 21 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Species Substance Exposure Results Reference Internal System code

Daphnia magna 2,4-D 21 d, ss NOEC = 46. 2 LoEP mg a.s./L U. Mark & E. Hantink-de Rooy 1989

Pseudokirchneriell 2,4-D acid 72 h, s ErC50 > 78 mg/L LoEP 84783 a subcapitata m.m. Porch, J.R., Kendall, EyC50 >78 mg/L T., Krueger, H.O. m.m 2011 NOEC = 39 379A-148A mg/L m.m.

Lemna minor 2,4-D acid 7 d, ss EyC50 = 10.66 LoEP 84913 mg/L nom. Nierzedska, E. ErC50 = 17.51 2004 mg/L nom.* W/57/03

Myriophyllum 2,4-D 14 d Total root LoEP aquaticum Maletzki length, EC50 = 0.011 mg/L nom 2011 FKZ: 363 01 294

2 Myriophyllum 2,4-D 14 d, s not valid Gonisor 89312 spicatum with sediment 2014 S14-03290 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 1 LoEP refers to EFSA conclusion 2014 (EFSA Journal 2014;12(9):3812) (Please note, that EFSA conclusion was revised in March 2015. However, that revision did not affect ecotoxicology.) 2 newly submitted by applicant

Table 9.5-2: Endpoints and effect values relevant for the risk assessment for aquatic organisms – 2,4-D DMA 500 (U 46 D Fluid)

Species Substance Exposure Results Reference Internal System code

Oncorhynchus 2,4-D DMA 96 h, s LC50 > 88 mg XXX 1997 84865 mykiss 500 a.s./L (>200 mg 655918 (Herbizid Marks formulation/L nom) D)

Daphnia magna 2,4-D DMA 500 48 h, s EC50 >88 mg Memmert, U. 84864 (Herbizid Marks a.s./L (> 200 mg 1997 D) formulation/Lnom) 655931

Pseudokirchneriel 2,4-D DMA 500 72 h, s EbC50 > 100 mg Eckenstein, H. 84852 la subcapitata g/L formulation /L nom 2013 (CA2971 (> 43.3 mg D76268 508.6 g/L; a.s/Lnom) density 1.174 ErC50> 100 mg g/mL) formulation /L nom (> 43.3 mg a.s/Lnom) NOEC = 25 mg/L

Lemna gibba 2,4-D DMA 500 7 d, s EyC50 = 7 mg Eckenstein, H. 84855 034066-00/00 / U 46 D Fluid Page 22 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Species Substance Exposure Results Reference Internal System code

g/L (CA2971) formulation/L 2013 508.6 g/L; nom. (= 3 mg D76270 density 1.174 a.s./L) g/mL) ErC50 = 44 mg/L nom. (=19 mg a.s./L) s: static; ss: semi-static; f: flow-through; nom: based on nominal concentrations; mm: based on mean measured concentrations a.s. … 2,4-D (acid)

9.5.1.1 Justification for new endpoints

Not relevant

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 and 2 PECSW for risk assessments covering the proposed 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 00-003 (grassland) also covers the risk for aquatic organisms from all other intended uses 00-001 and 00-002 (see 9.1.2). Please note that exposure assessment is only based on FOCUS SW Step 1 and 2 PEC values.

For the formulation U 46 D Fluid, containing 500 g /L active substance 2,4-D as DMA alt, toxicity data were submitted see Table 9.5-2. The toxicity of the formulation is similar as expected by the concentration of the active substance 2,4-D in the formulation. The risk assessment is therefore based on the toxicity of the active substance 2,4-D.

034066-00/00 / U 46 D Fluid Page 23 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

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. Please note that applicant has lowered the application rate the use in grassland (750 g as/ha instead of 1000 g as/ha). PECsw calculation are still based on the application rate of 1000 g as/ha as new PECsw values will not alter the outcome of the risk assessment.

Table 9.5-3: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for 2,4-D for each organism group based on FOCUS Steps 1, 2 and 3 calculations for the use of U 46 D Fluid in grasssland (00-003)

Inverteb. Inverteb. Sed. dwell. Group Fish acute Fish prolonged Algae Aquatic plants acute prolonged prolonged Test spe- Oncorhynchus Oncorhynchus Daphnia Daphnia Pseudokirchn. Chironomus Myriophyllum cies mykiss mykiss magna magna subcapitata riparius aquaticum

Endpoint LC50 NOEC EC50 NOEC ErC50/EyC50 NOEC EC50 (µg/L) 100 x 10³ 63.4 x 10³ 134.2 x 10³ 46.2 x 10³ > 78 x 10³ n.r. 11 AF 100 10 100 10 10 10 10 RAC 1000 6340 1342 4620 > 7800 n.r 1.1 (µg/L)

PEC gl- FOCUS max Scenario (µg/L)* Step 1 331.78 0.33 0.05 0.25 0.07 <0.04 -- 302 Step 2 N-Europe 28.34 0.028 0.004 0.02 0.006 <0.004 -- 25.8 AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold *PEC values based on application rate of 1000 g as/ha 034066-00/00 / U 46 D Fluid Page 24 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

For the intended uses 00-003, calculated PEC/RAC ratios do not indicate an acceptable risk for the most sensitive group of aquatic organisms (risk for aquatic plants as characterised by an EC50 of 11 µg/L for Myriophyllum aquaticum of 2,4-D in connection with an assessment factor of 10) based on FOCUS Step 2 PEC values. Therefore, further PEC/RAC ratios needs to be calculated based on FOCUS SW Step 3 and FOCUS SW Step 4 PECSW considering reduced exposure of surface water bodies. As the applicant has not submitted further FOCUS SW Step3 or Step4 PEC values risk assessment using these values needs to be performed on Member State level.

A specific risk assessment for Germany is provided in the national addendum Part B section 9.

9.5.3 Overall conclusions

Based on the calculated concentrations of 2,4-D in surface water (PECSW FOCUS Step 1 and 2), the calculated TER values for the most senstivie aquatic species (Myriophyllum aquaticum) does not achieve the acceptability criteria PEC/RAC < 1. However, the exposure assessment was performed on a lower level, hence higher tier exposure assessment (e.g. FOCUS Step 3 or specific national exposure assessment) link with risk mitigation measures need to be performed on member state level. For specific risk assessment for Germany please refer to the national addendum Part B section 9.

9.6 Effects on bees (KCP 10.3.1)

9.6.1 Toxicity data

Studies on the toxicity to bees have been carried out with 2,4-D technical. Full details of these studies are provided in the respective EU DAR and related documents.

Effects on bees of the formulation U 46 M Fluid were not evaluated as part of the EU assessment of 2,4- D. New data submitted with a comparable formulation (Aminopielik standard 600 SL) are listed in Table 9.6-1 and summarised in Appendix 2.

Table 9.6-1: Endpoints and effect values relevant for the risk assessment for bees

Species Substance Exposure Results Reference

System LD50

Oral > 100 µg prod./bee 48 h (> 51.2 µg a.s./bee) Aminopielik Irzyk M. (2004) Apis mellifera standard 600 SL* Study no. B/06/04 Contact > 200 µg prod./bee 48 h (> 102.4 µg a.s./bee)

Oral 94 µg a.s./bee 2,4-D acid 48 h Review report for the active Apis mellifera substance 2,4-D (2001); (technical) Contact 7599/VI/97-final >100 µg a.s./bee 48 h 034066-00/00 / U 46 D Fluid Page 25 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Species Substance Exposure Results Reference

System LD50

Higher-tier studies (tunnel test, field studies)

Not required. No data submitted.

* 618 g a.s./L, density= 1.206 g/cm³

9.6.1.1 Justification for new endpoints

Please refer to the risk assessment.

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 (SAN- CO/10329/2002 rev.2 (final), October 17, 2002).

9.6.2.1 Hazard quotients for bees

Table 9.6-2: First-tier assessment of the risk for bees due to the use of U 46 D Fluid Intended use Spray application in cereals and grassland Product U 46 D Fluid (2,4-D 500 g/L) Application rate 1 × max. 2 L/ha

Test design LD50 (µg a.s./bee) Single application rate QHO, QHC (g a.s./ha) criterion: QH ≤ 50

Oral toxicity > 51.2 < 19.5 1000* Contact toxicity > 102.4 < 9.7

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

9.6.2.2 Higher-tier risk assessment for bees (tunnel test, field studies)

Not required. No data submitted.

9.6.3 Effects on bumble bees

Not required. No data submitted.

9.6.4 Effects on solitary bees

Not required. No data submitted. 034066-00/00 / U 46 D Fluid Page 26 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

9.6.5 Overall conclusions

It is concluded that U 46 D Fluid (2,4-D 500 g/L) will not adversely affect bees or bee colonies when used as recommended.

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 2,4-D or monoformulations of 2,4-D. Full details of these studies are provided in the respective EU RAR and related documents as well as in Appendix 2 of this document (new studies).

Effects on non-target arthropods of U 46 D Fluid were not evaluated as part of the EU assessment of 2,4- D. However, the provision of further data on the U 46 D Fluid is not considered essential, because the formulation comprises only one active substance. An increase of the toxicity by the co-formulants is not expected. The selection of studies and endpoints for the risk assessment is in line with the results of the EU review process.

Table 9.7-1: Endpoints and effect values relevant for the risk assessment for non-target arthropods

Species Substance Exposure Results Reference Internal System code

1 Typhlodromus Desormon liquid Laboratory test LR50 > 3 kg LoEP 43292 pyri (2,4-D DMA glass plates (2D) a.s./ha Kuhner (protonymphs) 600) 1998 98117/01-NLTp

Aphidius Desormon liquid Laboratory test LR50 > 3 kg a.s. LoEP 43295 rhopalosiphi (2,4-D DMA glass plates (2D) /ha Kuhner (adults) 600) 1998 98117/01-NLAp Trichogramma 2,4-D DMA salt laboratory, ER50 > 1 kg Warmers, C. 84858 cacoeciae (500 g acid /L) residues a.i./ha 2008 on glass, 2D 20071072/01-NLTc

Poecilus cupreus Marks D (514 g laboratory, LR50 > 1000g LoEP 84859 2,4-D/L) residues a.s. /ha Moll, M. on sand, 2D ER50 > 1000g 1997 a.s./ha 2301006

Aleochara Marks D (514 g Reproduction, ER50 > 1000g LoEP 84862 bilineata 2,4-D/L) on sand ,2D a.s./ha Goßmann, A. 1997 2305070

Pardosa sp. Marks D (514 g Reproduction, 9 LR50 > 1000g LoEP 84861 2,4-D/L) weeks a.s. /ha Schmitzer, S., Breitwei- ER50 > 1000g ser, H. 034066-00/00 / U 46 D Fluid Page 27 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Species Substance Exposure Results Reference Internal System code

a.s./ha 1997 2304065 Field or semi-field tests -- 1 LoEP refers to EFSA conclusion 2014 (EFSA Journal 2014;12(9):3812) (Please note that EFSA conclusion was revised in March 2015. However, that revision did not affect ecotoxicology.)

9.7.1.1 Justification for new endpoints

Not relevant.

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 group H01A01 also covers the risk for non-target arthropods from all other intended uses in groups H02A02 (see 9.1.2).

Table 9.7-2: First- tier assessment of the in-field risk for non-target arthropods due to the use of U 46 D Fluid in grassland (00-003/H01A01)

Intended use 00-003 (H01A01) Active substance/product 2,4-D/ U 46 D Fluid Application rate (g/ha) 1 x 1000 g a.s./ha MAF 1

Test species LR50 (lab.) PERin-field HQin-field Tier I (g/ha) (g/ha) criterion: HQ ≤ 2 Typhlodromus pyri > 3000 0.3 1000* Aphidius rhopalosiphi > 3000 0.3 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. * Note that maximum application rate applied for is only 750 g as/ha leading to no alterations of the risk assessment.

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 U 46 D Fluid in cereals and grassland (H01A01)

Intended use 00-001, 00-002, 00-003 (H01A01) 034066-00/00 / U 46 D Fluid Page 28 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Active substance/product 2,4-D/ U 46 D Fluid Application rate (g/ha) 1 x 750 g a.s./ha MAF 1 vdf 10 (Tier 1)

Test species LR50 (lab.) Drift rate PERoff-field CF HQoff-field Tier I (g/ha) (g/ha) criterion: HQ ≤ 2 Typhlodromus pyri > 3000 <<2 2.77 2.08 10 Aphidius rhopalosiphi > 3000 <<2 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.

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 Based on the calculated rates of 2,4-D in in-field areas, the calculated HQ describing the risk resulting from an exposure of non-target arthropods to 2,4-D according to the GAP of the formulation U 46 D Flu- id achieve the acceptability criteria HQ ≤ 2 (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 U 46 D Fluid in grassland and cereals according to the label.

Off-field Based on the calculated rates of 2,4-D in off-field areas, the calculated HQ describing the risk resulting from an exposure of non-target arthropods to 2,4-D according to the GAP of the formulation U 46 D Flu- id achieve the acceptability criteria HQ ≤ 2 (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 U 46 D Fluid in grassland and cereals according to the label.

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 2,4-D and its relevant metabolites. 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 U 46 D Fluid were 034066-00/00 / U 46 D Fluid Page 29 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015 not evaluated as part of the EU assessment of 2,4-D. However, the provision of further data on the U 46 D Fluid is not considered essential, because the formulation comprises only one active substance. An increase of the toxicity by the co-formulants is not expected. The selection of studies and endpoints for the risk assessment is in line with the results of the EU review process.

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 Internal code System

1 Eisenia fetida 2,4-D Mixed into LC50 = 350 LoEP 76795 substrate 28 d, mg/kg dw Adema, D. M. M., acute Roza, P. 1989 10 % peat content R 89/153 ! MTJT06/D

Eisenia fetida 2,4-D Mixed into NOEC = 62.5 LoEP 84979 substrate, mg/kg dw Cycon, M. 56 d, chronic 2004 10 % peat content G/63/03

Field studies -- -- Litter bag test -- -- * Corrected value derived by dividing the endpoint by a factor of 2 in accordance with the EPPO earthworm scheme 2002. 1 LoEP refers to EFSA conclusion 2014 (EFSA Journal 2014;12(9):3812) (Please note that EFSA conclusion was revised in March 2015. However, that revision did not affect ecotoxicology.)

9.8.1.1 Justification for new endpoints

Not relevant

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 Eco- toxicology”, 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 8.6, Table 8.6-3. According to the assessment of environmental-fate data, multi-annual accumulation in soil is considered for 2,4-D. To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use group S01 (00-002) also covers the risk for earthworms and other non-target soil organisms (meso- 034066-00/00 / U 46 D Fluid Page 30 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015 and macrofauna) from all other intended uses in groups S02 and S03 (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 U 46 D Fluid in spring cereals (use 00-002/use group S01)

Intended use/use group 00-002/S01 Acute effects on earthworms

Product/active substance LC50 PECsoil TERa (mg/kg dw) (mg/kg dw) (criterion TER ≥ 10) 2,4-D 350 0.750 467 Chronic effects on earthworms

Product/active substance NOEC PECsoil TERlt (mg/kg dw) (mg/kg dw) (criterion TER ≥ 5) 2,4-D 62.5 0.750 83 TER values shown in bold fall below the relevant trigger.

Please refer to the chapter 9.1.3 for the consideration of the metabolites.

9.8.2.2 Higher-tier risk assessment

Not relevant.

9.8.3 Overall conclusions

Based on the predicted concentrations of 2,4-D in soils, the TER values describing the acute and long- term risk for earthworms and other non-target soil organisms following exposure to 2,4-D according to the GAP of the formulation U 46 D Fluid 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 U 46 D Fluid in cereals and grassland according to the label.

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 2,4-D. Full details of these studies are provided in the respective EU RAR and related documents as well as in Appendix 2 of this document (new studies).

Effects on soil microorganisms of U 46 D Fluid were not evaluated as part of the EU assessment of 2,4-D. However, the provision of further data on the U 46 D Fluid U 46 D Fluid is not considered essential, because the formulation comprises only one active substance. An increase of the toxicity by the co- formulants is not expected.

The selection of studies and endpoints for the risk assessment is in line with the results of the EU review process. 034066-00/00 / U 46 D Fluid Page 31 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Table 9.9-1: Endpoints and effect values relevant for the risk assessment for soil microorganisms

Endpoint Substance Exposure Results Reference Internal System code

N-mineralisation 2,4-D 28 d, aerobic Nitrate formation rate Cyon, M. (KWAS) soil type 3 mg/kg soil dw 2004 < 25 % G716/032

C-mineralisation 2,4-D 28 d, aerobic CO2 formation Cyon, M. (KWAS) soil type 3 mg/kg soil dw < 25 2004 % G716/032 N-mineralisation LAF-74 56 d, aerobic Nitrate formation rate LoEP1 84856 (597 g a.e./L)3 sandy loam 29.9 mg a.s./kg soil dw Gehrig, M. < 25 % 2011 S10-03059 C-mineralisation LAF-74 28 d, aerobic CO2 formation LoEP 84856 (597 g a.e./L)3 sandy loam 29.9 mg a.s./kg soil dw Gehrig, M. < 25 % 2011 S10-03059 1 LoEP refers to EFSA conclusion 2014 (EFSA Journal 2014;12(9):3812) (Please note that EFSA conclusion was revised in March 2015. However, that revision did not affect ecotoxicology.) 2 Study is listed in LoEP (EFSA Journal 2014;12(9):3812) and in RAR, Volume 3, B.9. chapter B.9.8.1/02 and table B.9.8.2.-1. A study summary is not provided in the RAR. For study summary refer to Appendix 2 of this document. 3 a.e. … acid equivalent (= 2,4-D)

9.9.1.1 Justification for new endpoints not relevant

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). To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use group S01 also covers the risk for the soil microorganisms from all other intended uses in groups S02 and S03 (see 9.1.2).

Table 9.9-2: Assessment of the risk for effects on soil micro-organisms due to the use of U 46 D Fluid in spring cereals (use 00-002/use group S01)

Intended use/use group 00-002 / S01 N-mineralisation

Product/active substance Max. conc. with effects PECsoil Risk acceptable? ≤ 25 % (mg/kg dw) (mg/kg dw) 2,4-D 29.9 (at 56 d) 0.750 yes 034066-00/00 / U 46 D Fluid Page 32 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

C-mineralisation

Product/active substance Max. conc. with effects PECsoil Risk acceptable? ≤ 25 % (mg/kg dw) (mg/kg dw) 2,4-D 29.9 (at 28 d) 0.750 yes

9.9.3 Overall conclusions

Based on the predicted concentrations of 2,4-D in soils, the risk to soil microbial processes following exposure to 2,4-D according to the GAP of the formulation U 46 M Fluid is considered to be acceptable/ not acceptable according to commission implementing regulation (EU) No 546/2011, Annex, Part I C, 2. Specific principles, point 2.5.2.

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 2,4-D. Full details of these studies are provided in the respective EU RAR and related documents.

Effects on non-target terrestrial plants of U 46 D Fluid were not evaluated as part of the EU assessment of 2,4-D. However, the provision of further data on the U 46 D Fluid is not considered essential, because the formulation comprises only one active substance. An increase of the toxicity by the co-formulants is not expected.

The selection of studies and endpoints for the risk assessment is in line with the results of the EU review process.

Table 9.10-1: Endpoints and effect values relevant for the risk assessment for non-target terrestrial plants

Species Substance Exposure Results Reference Internal 2 (m/d) System code

1 Lactus sativa(d) 2,4-D 21 d ER50 = 19.2 g 2,4- LoEP 84868 Monocotyl: dimethylammonium Vegetative D/ha (shoot fresh Brockmann, A., Avena sativa 600 g a.e./L (LAF- vigour weight) Teresiak, H.2011 Lolium multiforum 74)3 AC/DOW/11/04 Allium cepa ! 101419 Dicotyl: Brassica napus Brassica rapa Glycine max Vicia faba Daucus carota Cucumis sativa Beta vulgaris Heliantus annuus Lycopersicon esculentum Monocotyl: 2,4-D 21 d HC5 = 23.76 g 2,4- LoEP Allium cepa dimethylammonium Vegetative D/ha (RAR vol 3 Dicotyl: 600 g a.e./L (LAF- vigour B.9.9.2, January 034066-00/00 / U 46 D Fluid Page 33 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Species Substance Exposure Results Reference Internal 2 (m/d) System code

Lactus sativa Brassica napus 74)3 2014) Glycine max Vicia faba Daucus carota Beta vulgaris Heliantus annuus Lycopersicon esculentum

Lactus sativa(d) 2,4-D 21 d ER50 = 27 g 2,4-D LoEP 84867 Monocotyl: dimethylammonium Seedling /ha (shoot fresh Brockmann, A., Avena sativa 600 g a.e./L (LAF- emergence weight) Teresiak, H.2011 Lolium multiforum 74) AC/DOW/11/03; Allium cepa 101418 Dicotyl: Brassica napus Glycine max Vicia faba Daucus carota Cucumis sativa Beta vulgaris Heliantus annuus Lycopersicon esculentum Monocotyl: 2,4-D 21 d HC5= 41.88 g 2,4- LoEP Lolium multiforum dimethylammonium Seedling D /ha (shoot fresh (RAR vol 3 Allium cepa 600 g a.e./L (LAF- emergence weight) B.9.9.2, January Dicotyl: 74) 2014) Lactus sativa Brassica napus Daucus carota Cucumis sativa Beta vulgaris Heliantus annuus Lycopersicon esculentum 1 LoEP refers to EFSA conclusion 2014 (EFSA Journal 2014;12(9):3812) (Please note that EFSA conclusion was revised in March 2015. However, that revision did not affect ecotoxicology.) 2 m: monocotyledonous; d: dicotyledonous 3 a.e. … acid equivalent (= 2,4-D)

The risk assessment is based on the results of the vegetative vigour test. The risk assessment is follows the deterministic as well as the probabilistic approach. However in contrast to the guidance document zRMS does not recommend using a safety factor of 1 in the probabilistic approach. Both endpoints, ER50 and HC5, are a surrogate for the most sensitive endpoint. Because they are based on the same data set the same protection goal should be applied hence the same safety factor should be applied. Therefore risk assessment by zRMS is based on the safety factor of 5 for deterministic and probabilistic approach.

9.10.1.1 Justification for new endpoints

Not relevant 034066-00/00 / U 46 D Fluid Page 34 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

9.10.2 Risk assessment

9.10.2.1 Tier-1 risk assessment (based screening data)

Not relevant.

9.10.2.2 Tier-2 risk assessment (based on dose-response data)

The risk assessment is based on the “Guidance Document on Terrestrial Ecotoxicology”, (SAN- CO/10329/2002 rev.2 final, 2002). It is restricted to off-field situations, as non-target plants are non-crop plants located outside the treated area.

Table 9.10-2: Assessment of the risk for non-target plants due to the use of U 46 D Fluid in cereals and grassland (use 00-001, 00-002, 00-003/use group H01A01) – deterministic approach

Intended use/use group 00-001, 00-002, 00-003/H01A01 Active substance/product 2,4-D/U 46 D Fluid Application rate (g/ha) 1× 750 MAF 1

Test species ER50 Drift rate PERoff-field TER (g/ha) (g/ha) criterion: TER ≥ 5 Lactus sativa 19.2 2.77 20.8 0.9 MAF: Multiple application factor; PER: Predicted environmental rate; TER: toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.

Table 9.10-3: Assessment of the risk for non-target plants due to the use of U 46 D Fluid in cereals and grassland (use 00-001, 00-002, 00-003/use group H01A01) – probabilistic approach

Intended use/use group 00-001, 00-002, 00-003/H01A01 Active substance/product 2,4-D/U 46 D Fluid Application rate (g/ha) 1× 750 MAF 1

Test species HC5 Drift rate PERoff-field TER (g/ha) (g/ha) criterion: TER ≥ 5 Lactus sativa 23.76 2.77 20.8 1.1 MAF: Multiple application factor; PER: Predicted environmental rate; TER: toxicity to exposure ratio. TER values shown in bold fall below the relevant trigger.

9.10.2.3 Higher-tier risk assessment

Not relevant.

9.10.2.4 Risk mitigation measures

In order to reduce the off-field exposure, risk mitigation measures can be implemented. These correspond to unsprayed in-field buffer strips of a given width and/or the usage of drift reducing nozzles. The results of the risk assessment using typical mitigation measures (no-spray buffer zones of 5 or 10 m; drift- 034066-00/00 / U 46 D Fluid Page 35 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015 reducing nozzles with reduction by 50 %, 75 %, or 90 %) are summarised in the following table.

Table 9.10-4: Risk assessment for non-target terrestrial plants due to the use of U 46 D Fluid in cereals and grassland (use 00-001, 00-002, 00-003/use group H01A01) considering risk mitigation (in-field no-spray buffer zones, and drift-reducing nozzles)

Intended use 00-001, 00-002, 00-003/H01A01 Active substance/product 2,4-D/U 46 D Fluid Application rate (g/ha) 1× 750 MAF 1

Buffer strip Drift rate PERoff-field PERoff-field PERoff-field PERoff-field (m) (%) (g/ha) 50 % drift red. 75 % drift red. 90 % drift red. (g/ha) (g/ha) (g/ha)

1 2.77 20.775 10.388 5.194 2.078 5 0.57 4.275 2.138 1.069 0.428 10 0.29 2.175 Toxicity value TER

ER50 = 19.2 g/ha criterion: TER ≥ 5 1 0.9 1.8 3.7 9.1 5 4.4 68.9 17.8 10 8.8 MAF: Multiple application factor; PER: Predicted environmental rates; TER: toxicity to exposure ratio. Criteria values shown in bold breach the relevant trigger.

Table 9.10-5: Risk assessment for non-target terrestrial plants due to the use of U 46 D Fluid in grassland (use 00-001, 00-002, 00-003/use group H01A01) considering risk mitigation (in-field no-spray buffer zones, and drift-reducing nozzles) – probabilistic approach

Intended use 00-001, 00-002, 00-003/H01A01 Active substance/product 2,4-D/U 46 D Fluid Application rate (g/ha) 1× 750 MAF 1

Buffer strip Drift rate PERoff-field PERoff-field PERoff-field PERoff-field (m) (%) (g/ha) 50 % drift red. 75 % drift red. 90 % drift red. (g/ha) (g/ha) (g/ha)

1 2.77 20.775 10.388 5.194 2.078 5 0.57 4.275 2.138 1.069 0.428 Toxicity value TER

ER50 = 23.76 g/ha criterion: TER ≥ 5 1 1.1 2.3 4.6 11.4 5 5.6 11.1 22.2 MAF: Multiple application factor; PER: Predicted environmental rates; TER: toxicity to exposure ratio. Criteria values shown in bold breach the relevant trigger.

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9.10.3 Overall conclusions

9.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)

Not relevant

9.12 Monitoring data (KCP 10.8)

Not relevant

9.13 Classification and Labelling

For the authorization of the plant protection product U 46 D Fluid the following labelling and conditions of use are mandatory:

Classification and labelling Relevant toxicity Active substance: 2,4-D (content 50 %) EC50 = 0.011 mg/L (Myriophyllum aquaticum) Aquatic Acute 1, H400; Aquatic Chronic 1, H410 M-factor : 10 (akut), 1 (chronic) Classification and labelling according to Regulation 1272/2008 using summation method Hazard sysmbol GHS09 Signal word warning Hazard statement Aquatic Acut 1 H400 Aquatic Chronic 1 H410

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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

KIIIA1 XXX 1997 Acute Toxicity of Herbizid Marks D to Rainbow Trout (Oncorhynchus mykiss) in a 96 hour static test Y Nufarm 10.2.2.1 RCC Umweltchemie, Germany 655918 GLP Not published KIIIA1 Memmert 1997 Acute Toxicity of Herbizid Marks D to Daphnia magna in a 48-hour Immobilisation Test N Nufarm 10.2.2.2 RCC Umweltchemie, Germany 655931 GLP Not published KIIIA1 Eckenstein 2013 2,4-D DMA 500 g/l (CA2971): Toxicity to Pseudokirchnierealla subcapitata in a 72-hour algal growth N Nufarm 10.2.2.3 inhibition test Harlan Laboratories Ltd, Switzerland D76268 GLP Not published KCP Irzyk, M. 2004 AMINOPIELIK STANDARD 600 SL: Toxicity for honey-bees (Apis mellifera L.) N Nufarm 10.3.1.1-1 B/06/04 GLP Unpublished KIIIA1 Goßmann 1997 Effects of Herbizid Marks D on the Predatory Mite Typhlodromus pyri SCHEUTEN (Acari, N AHM 10.5.1. Phytoseiidae) in the Laboratory IBACON GMBH, Germany 2303063 034066-00/00 / U 46 D Fluid Page 38 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

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 Not published KIIIA1 Warners 2008 2,4-D DMA salt (500 g acid/L) Assessment of Side Effects on the Egg Parasitoid, Trichogramma N Nufarm 10.5.1 cacoeciae Marchal (Hymenoptera, Trichogrammatidae) under Laboratory Conditions (Dose Response) Eurofins, Germany 20071962/01-NLTc GLP Not published KIIIA1 Eckenstein 2013 Toxicity to the Aquatic Higher Plant Lemna gibba in a 7-day Growth Inhibition Test N Nufarm 10.8.2.1. Harlan Laboratories Ltd, Swtizerland D76270 GLP Not published

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

KIIIA1 Goßmann 1997 Effects of Herbizid Marks D on the reproduction of Rove Beetles Aleochara bilineata Gyll. (Coleoptera, N AHM 10.5.1. Staphylinidae) in the Laboratory IBACON GMBH , Germany 2305070 GLP Not published KIIIA1 Moll 1997 Effects of Herbizid Marks D on the Carabid Beetle Poecilus cupreus L. (Coleoptera, Carabidae) in the N AHM 034066-00/00 / U 46 D Fluid Page 39 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

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

10.5.1. Laboratory IBACON GMBH , Germany 2301006 GLP Not published KIIIA1 Schmitzer S, 1997 Effects of Herbizid Marks D on the Wolf Spider Pardosa spec. (Araneae, Lycosidae) in the Laboratory N GWE 10.5.1. Breitweiser H IBACON GMBH, , Germany 2304065 GLP Not published KIIIA1 Gehring 2011 LAF-74: Assessment of the Side Effects of LAF-74 on the Activity of the Soil Microflora N Nufarm 10.7.1 Eurofins GmbH, Germany S10-03059 GLP Not published KIIIA1 Brockmann, A.; 2011 Evaluation of the phytotoxicity of LAF-74 (2,4-D dimethylammonium 600 g ae/l, SL) GLP Vegetative N Nufarm 10.8.1.2 Teresiak, H. Vigour Test Terrestrial Non Target Plants (based on OECD Guideline 227) –Europe 2011 Agro-Check (Dr. Teresiak & Erdmann GbR), Germany AC/DOW/11/04 (101419) GLP Not published KIIIA1 Brockmann, A.; 2011 Evaluation of the phytotoxicity of LAF-74 (2,4‑D dimethylammonium 600 g ae/l, SL) GLP Seedling N Nufarm 10.8.1.3 Teresiak, H. Emergence and Seedling Growth Test Terrestrial Non Target Plants. (Based on OECD Guideline 208) – Europe 2011 Agro-Check (Dr. Teresiak & Erdmann GbR), Germany AC/DOW/11/03 (101418) GLP Not published KIIIA1 Dohmen; Kubitza 2003 Effect of BAS 140 01 H on the Growth of the Aquatic Plant Myriophyllum aquaticum N Nufarm 10.8.2 BASF Aktiengesellschaft, Germany 034066-00/00 / U 46 D Fluid Page 40 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

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

165337 (2001/1012045) GLP Not published KIIA8.10. Cyon 2004 KWAS 2,4-D Evaluation of the Toxic Effect on Microbial Activity – Influence on the Nitrogen and N Nufarm Carbon Transformation Process in Soil Department of Organic Industry, Branch Pszczyna, Poland G/16/03 GLP Not published

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

KIIIA1 XXX 2011 Acute Dietary Toxicity of 2,4-D DMA in Mice Y Nufarm 10.3 Eurofins PSL, USA 29401 GLP Not published KIIIA Gonisor 2014 2,4-Dichlorophenoxyacetic acid: Growth Inhibition of Myriophyllum spicatum in a Wa- N Nufarm ter/Sediment System Testing S14-03290; DAS study No: 140784 GLP Not published

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

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Appendix 2 Detailed evaluation of the new studies

A 2.1 KCP 10.1 Effects on birds and other terrestrial vertebrates

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

Memmert; 1997, Rep. No. 655918

Reference: IIIA 10.2.2.1 Report Memmert (1997): Acute Toxicity of Herbizid Marks D to Rainbow Trout (Oncorhynchus mykiss) in a 96 hour static test RCC Umweltchemie, Germany 655918 GLP Not published Guideline(s): OECD 203 Deviations: No GLP: Yes Acceptability: yes Duplication yes (if vertebrate study)

Materials and Method Test Material Test item: Herbizid Marks D Purity: 2,4-D DMA 514 g a.i/l Description: Clear brown liquid Lot No./Batch No. : JAS/97/03 1.172 mg/l (hence 1 mg test formulation contains 0.44 Density mg 2,4-D) Shown to be stable in ambient conditions for at least 2 Stability of test compound years, but will degrade in the presence of microorganisms or strong sunlight Test system Organism (Species): Rainbow Trout (Oncorhynchus mykiss) (Walbaum 1792) Source P. Hohler, Zeiningen, Switzerland Study Type: Acute Acclimitisation Period 1 week Housing 15 litre aquarium for each treatment.

Guideline deviations reported by Study None Director: 034066-00/00 / U 46 D Fluid Page 43 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Duration of study: 23/06/1997 - 17/07/1997 Parameters measured: Effects on fish: % mortality Observation intervals: Effects on fish after 4, 24, 48, 72 and 96 hr. Weight and length of fish at test initiation: Weight =1.3 ± 0.2 g Mean total length = 4.9 ± 2 cm body length Test concentrations: Nominal: 200 mg/l (equivalent to 88 mg/l of 2,4-D).

Reference substance: CaCl2 x 2H2O : 2.0 mmol/l MgSO4 x 7H2O : 0.5 mmol/l NaHCO3 : 0.75 mmol/l KCl : 0.075 mmol/l No. of holding days before dosing: 1 week Number of fish per dose group: 7 Number of fish per control group: 7 Feeding: During acclimatisation until one day before the test, the fish were fed HOKOVIT 502, 1.2mm supplied by H.U. Hoffmann AG, Switzerland. The fish were not fed during the test. Environmental conditions: Temperature: 14°C Photoperiod: 16 hr light / 8 hr dark Dissolved oxygen concentration: aerated to saturation Loading: 0.060 g/L/day pH: 7.3 to 7.5

Statistics No statistical analysis was performed.

Results Mortality Details are presented in the table below

Table 9.13-1 Mortality/toxic effects observed in fish

Observation Time (hours) Dose (mg 2,4-D/l) 4 24 48 72 96 Control 0/0 0/0 0/0 0/0 0/0 88 0/0 0/0 0/0 0/0 0/0

No mortality was noted in either group. Therefore: LC0 = > 88 mg a.s./L

Observations There was no mortality in either group nor were any signs of toxicity observed. Therefore:

NOEC = > 88 mg a.s./l (200 mg formulation/l) LC50 = > 88 mg a.s./l (200 mg formulation/l)

Conclusion No toxic effects were noted. Therefore, the acute NOEC and LC50 to rainbow trout are > 88 mg 2,4-D/l, the highest dose tested. This is equivalent to 200 mg/l of the test formulation (514 mg a.s./l at a density of 1.172 g/ml). 034066-00/00 / U 46 D Fluid Page 44 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

These results suggest that 2,4-D DMA 514 g/l will not be harmful to fish.

Comments of zRMS: Study acceptable and valid.

Memmert; 1997, Rep. No. 655931

Reference: IIIA 10.2.2.2 Report Memmert (1997): Acute Toxicity of Herbizid Marks D to Daphnia magna in a 48-hour Immobilisation Test RCC Umweltchemie, Germany 655931 GLP Not published Guideline(s): OECD 202 Deviations: No GLP: Yes Acceptability: yes Duplication no (if vertebrate study)

Materials and Method Test Material Test item: Herbizid Marks D Purity: 2,4-D DMA 514 g a.i./l Description: Clear brown liquid Lot No./Batch No. : JAS/97/03 1.172 mg/l (hence 1 mg test formulation contains 0.44 mg Density 2,4-D) Shown to be stable in ambient conditions for at least 2 years, Stability of test compound but will degrade in the presence of micro-organisms or strong sunlight.

Organism (Species): Daphnia magna Straus Study Type: Acute Source: Original clone supplied by University of Sheffield, UK

Guideline deviations reported by Study None Director: Duration of study: 96 hour In life dates: 01 July to 17 July 1997 Parameters measured: Effects on fish: % mortality Observation intervals: Effects on fish after 24 and 48 hours Age of fish at test initiation: 6-24 hrs at the start of the test Test concentrations: 200 mg/l of test material (equivalent to 88 mg/l of 2,4-D).

Reference substance: CaCl2 x 2H2O:2.0 mmol/l MgSO4 x 7H2O:0.5 mmol/l 034066-00/00 / U 46 D Fluid Page 45 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

NaHCO3:0.75 mmol/l KCl:0.075 mmol/l Number of fish per dose group: 20 Number of fish per control group: 20 Feeding: The Daphnia were not fed during the test. Environmental conditions: Temperature: 20 - 21 ºC (including continuous temperature monitoring) Photoperiod: 16 hr light / 8 hr dark; 530 to 840 lux, Dissolved oxygen concentration: aerated to saturation

Statistics No statistical analysis was performed.

Results and discussion Mortality Details are presented in the table below

Table 9.13-2 Immobility of Daphnia at Observations

Immobility at time point (in %) Dose (mg 2,4-D/l) No. of Daphnia 24 48 Control 20 0 0 88 20 0 0

No immobility was noted in either group. Therefore: EC50 = > 88 mg a.s./l NOEC = > 88 mg a.s./l

Conclusion No toxic effects were noted. Therefore, the acute NOEC and LC50 Daphnia magna is > 88 mg 2,4-D/l, the highest dose tested. This is equivalent to 200 mg/l of the test formulation (514 mg a.s./l at a density of 1.172 g/ml). These results suggest that 2,4-D DMA 514 g/l will not be harmful to Daphnia magna.

Comments of zRMS: Study acceptable and valid.

Eckenstein, 2013

Reference: IIIA 10.2.2.3 Report Eckenstein (2013): 2,4-D DMA 500 g/l (CA2971): Toxicity to Pseudokirch- nierealla subcapitata in a 72-hour algal growth inhibition test Harlan Laboratories Ltd, Switzerland D76268 GLP Not published Guideline(s): OECD 201, EC 761/2009 C.3 Deviations: No GLP: Yes Acceptability: yes 034066-00/00 / U 46 D Fluid Page 46 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Duplication no (if vertebrate study)

Materials and Method Test Material Test item: 2,4-D DMA 500 g/l Purity: 508.6 g/l Description: Yellow liquid Lot No./Batch No.: JPB/560/81

Test system Organism (Species): Pseudokirchneriella subcapitata Study Type: Laboratory study Guideline deviations reported by Study None Director: Duration of study: 72 hours Parameters measured: Effects of 2,4-D DMA 500 g/l on Algal growth. Environmental conditions: Test solution pH: 7.6-8.7 Test solution temperature: 24°C Photoperiod: Continuous illumination Light intensity: 6500-7680 Lux Test concentrations (for toxicity 6.25, 12.5, 25, 50 and 100 mg/l determination): Test concentrations (for metabolism 100 mg/l evaluation): Acclimation period/conditions: Not specified No. of replicates per concentration: 3 for test and 6 for control

Methodology An inoculum culture was set up three days before the start of the exposure. The algae were cultivated under the test conditions and were kept in the exponential growth phase until inoculation of the test solutions.

Experimental Conditions The test flasks were incubated in a temperature-controlled water bath at a temperature of 24 °C and illuminated by fluorescent tubes (Philips TLD 36W-1/840), installed above the test flasks. They were posi- tioned randomly and repositioned daily. The mean measured light intensity at the level of the test solutions was approximately 7100 Lux (range: 6500 to 7680 Lux, measured at nine places in the experimental area). Light intensity over the incubation area was within a ±15%-deviation from the average light intensity as recommended by the guideline.

Study Design Selection of the test concentrations was based on the results of a range-finding test.The following nominal concentrations of the test item were tested: 6.25, 12.5, 25, 50 and 100 mg/l. Additionally, a control was tested in parallel (test water without test item). The test design included three replicates per test concentration and six replicates of the control. At the start of test a nominal algal cell density of 5000 cells/mL was used. This initial cell density was selected according to the recommendations of the OECD test guideline. The test design was baed upon a static model, with a duration of 72 hours.

Results Test item dosing Measured concentrations of CA2971 (based on the active ingredient 2,4-D) in the test media of the test concentrations of 25 to 100 mg/l were between 97 and 102% of the nominal values at the start of the test and between 90 and 99% at the end of the test. 034066-00/00 / U 46 D Fluid Page 47 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Thus, the correct dosing of the test item CA2971 was confirmed. The active ingredient was stable in the test media over the test period of 72 hours. The biological results were related to the nominal concentrations of the test item.

Effects of test item The test item had a significant inhibitory effect on the growth rate (µ) of the algae after the test period of 72 hours at the concentration of 50 mg/l and at all higher test concentrations

Yield (Y) of the algae was also statistically significantly reduced at the test concentration of 50 mg/l

The 72-hour NOEC based on the growth rate (µ) was determined to be 25 mg/l, since up to and including this test concentration the growth rate of the algae after 72 hours was not significantly lower than in the control. The NOEC and ECX-values for growth rate are summarised in the conclusion. Additionally, the corresponding values for yield are given.

The microscopic examination of the algal cells at the end of the test showed no difference between the algae growing at the nominal test concentration of 100 mg/l and the algal cells in the control. Shape and size of the algal cells were not affected by the test item up to at least this concentration.

Validity criteria In the control, the biomass increased by a factor of 159 over 72 hours. Therefore validity criterion of increase of biomass by at least a factor of 16 within three days was fulfilled. The mean coefficient of variation of the daily growth rates in the control (section-by-section growth rates) during 72 hours was 29%. According to the OECD test guideline, the mean coefficient of variation must not be higher than 35%. Thus, the validity criterion was fulfilled. The coefficient of variation of the average specific growth rates in the replicates of the control after 72 hours was 1.0%. According to the OECD test guideline, the coefficient of variation must not be higher than 7%. Thus, the validity criterion was fulfilled.

Conclusion The biological results can be summarised in the table below (based on nominal concentrations of the test item CA2971).

Table 9.13-3 Effects of 2,4-D DMA 500 (CA2971) on Algal growth

Parameter Growth rate (µ) Yield (Y) (0-72 h)

EC50 [mg/l] >100 >100 95% confidence interval n.d. n.d. EC20 [mg/l] >100 52 95% confidence interval n.d. 38-62 EC10 [mg/l] 86 35 95% confidence interval 75-98 20-46 NOEC [mg/l] 25 25 LOEC [mg/l] 50 50 n.d. could not be determined

The resulting EC50 was > 100 mg/l, based upon both assessment of yield and of growth rate. 034066-00/00 / U 46 D Fluid Page 48 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Comments of zRMS: Study acceptable and valid.

Gonisor, 2014 (KCA 8.27)

Reference: KIIIA1 A 3.1 Report Gonisor, G (2014): 2,4-Dichlorophenoxyacetic acid: Growth Inhibition of Myriophyllum spicatum in a Water/Sediment System Testing S14-03290; DAS study No: 140784 Not published Guideline(s): OECD 239 Deviations: Yes (see comment zRMS) GLP: Yes Acceptability: no Duplication no (if vertebrate study)

Materials and Method Test Material Test item: 2,4-Dichlorophenoxyacetic acid (2,4-D) Purity: 98.4 % w/w Description: solid Lot No./Batch No.: UB7161101

Test system Organism (Species): Rooted aquatic macrophyte, Myriophyllum spicatum Study Type: laboratory study static water-sediment system Guideline deviations reported by Study none Director: Duration of study: 14 days Parameters measured: Test solution pH (range): 7.98 ± 0.44 (main test), 8.11 ± 0.64 (pulse test) Test solution temperature (range): 20.7 ± 0.4 C° (main test), 20.9 ± 0.5 C° (pulse test) Environmental conditions: Photoperiod: 16 h day length 120 – 160 µE*m-2*s-1 Observation intervals: 0, 7 and 14 days Test concentrations: Nominal: 0.00954, 0.0305, 0.0977, 0.313, and 1 mg test item/L. Acclimation period/conditions: Two days before test start submerged apical shoots of Myriophyllum spicatum were planted in an artificial sediment was under test conditions. Growth medium: Name: ANDREWS Medium Dilution water: Type: SMART AND BARKO medium Method of test item added to the test A stock solution was prepared and appropriate volumes added to medium: dilution water to give the required concentrations. No. of control replicates: 10 No. of test concentration replicates : 5 Analytical verification: Method: HPLC-MS/MS Samples taken: 0 and 14 days, in addition at the concentration level of 1.00 mg/L at day 7 Limit of Detection: 30 % of the LOQ (=0.00024 mg 2,4-D/L in test 034066-00/00 / U 46 D Fluid Page 49 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

medium resp. 0.0012 mg 2,4-D/kg in sediment) Limit of Quantitation: 0.0008 mg/L of 2,4-D in test medium and 0.004 mg 2,4-D/kg in sediment

Methodology Test with Myriophyllum spicatum was conducted an in-house culture is maintained in a growth medium. Five replicates per test item concentration and ten replicates for the control were used. The duration of the test was 14 days. The test was performed under static test conditions. The nominal concentrations of the test item during the test were 0.00954, 0.0305, 0.0977, 0.313 and 1.00 mg/L and control. The test item was spiked to the water. Test item concentrations in the de-finitive test were verified by analyses of 2,4-D at all concentration levels by analysing the overly-ing water at test start and test end and wet sediment at test termination on day 14. Further a 24-hour pulsed exposure test (parallel treatment group) with the same test item concentrations was run in parallel. After 24 h of exposure the test solution (water phase) was exchanged with untreated test medium. The objective of this parallel test was to quantify the effect of short term exposure to the test item on the growth of the rooted aquatic macrophyte, Myriophyllum spicatum. On day 14 plants were harvested from each treatment group for assessment of shoot length, total plant (i.e. shoots plus roots) fresh weight, total plant (i.e. shoots plus roots) dry weight and number and length of side shoots. Additionally the main shoot length was measured by use of a ruler on days 0, 7 and 14 during the test. Endpoints reported are the EC50 for yield (EyC50) and growth rate (ErC50) based on the increase in total shoot length and total plant (i.e. shoots plus roots) biomass respectively after 14 days of ex-posure. The NOEC and LOEC for yield and growth rate were also determined. Temperature, pH and oxygen saturation [%] of the test solutions, measured after 0, 7 and 14 days, are reported.

Results The measured concentration of the test item based on the 2,4-D content in the test vessels at test start ranged between 98 and 110 % of nominal in the overlying water. As the content of 2,4-D was > 80 % and below 120 % of nominal at test start all toxicological endpoints were evaluated using nominal concentrations of the test item. After 14 days 2,4-D concentrations in the water ranged between 78 and 92 % of nominal. In the sediment, concentrations of 2,4-D ranged between 11 – 14 % of the amount applied. Additionally all concentration levels of the pulsed exposure test were measured after 24 h of exposure. The maximum 2,4-D concentration detected in the overlying water did not exceed 1 % of the amount applied at any test concentration. Following exposure to 2,4-D, fresh weight and total shoot length was found to be more sensitive than biomass dry weight as indicated in the table below.

Table 9.13-4 Summary of Biological Results based on Nominal Concentrations of 2,4-D and Total Shoot Length

Growth rate Yield Parameter (total shoot length in cm) [mg/L] (total shoot length in cm) [mg/L] Main test

14-day EC50 0.346 0.169 95% Conf. Limits 0.287 – 0.423 0.143 – 0.199 14-day NOEC 0.0305 0.0305 14-day LOEC 0.0977 0.0977 034066-00/00 / U 46 D Fluid Page 50 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Growth rate Yield Parameter (total shoot length in cm) [mg/L] (total shoot length in cm) [mg/L] 24-hour Pulsed Exposure test

14-day EC50 >1.00 >1.00 95% Conf. Limits - - 14-day NOEC 0.0977 0.0977 14-day LOEC 0.313 0.313

Table 9.13-5 Summary of Biological Results based on Nominal Concentrations of 2,4-D and Fresh Weight

Growth rate Yield Parameter (total shoot length in cm) [mg/L] (total shoot length in cm) [mg/L] Main test

14-day EC50 0.373 0.152 95% Conf. Limits 0.296 – 0.485 0.124 – 0.188 14-day NOEC 0.0305 0.0305 14-day LOEC 0.0977 0.0977 24-hour Pulsed Exposure test

14-day EC50 >1.00 >1.00 95% Conf. Limits - - 14-day NOEC 0.0977 0.0977 14-day LOEC 0.313 0.313

Table 9.13-6 Summary of Biological Results based on Nominal Concentrations of 2,4-D and Dry Weight

Growth rate Yield Parameter (total shoot length in cm) [mg/L] (total shoot length in cm) [mg/L] Main test 1 14-day EC50 >1.00 0.560 95% Conf. Limits - 0.466 – 0.692 14-day NOEC 0.0977 0.0977 14-day LOEC 0.313 0.313 24-hour Pulsed Exposure test

14-day EC50 >1.00 0.560 95% Conf. Limits - 0.466 – 0.692 14-day NOEC 0.0977 0.0977 14-day LOEC 0.313 0.313

The average pH-value was determined to be 7.98 ± 0.44 (main test) and 8.11 ± 0.64 (pulse test), the average temperature was measured to be 20.7 ± 0.4 °C (main test) and 20.9 ± 0.5 °C (pulse test) and the oxygen saturation was determined to be 115 ± 36 % (main test) and 129 ± 44 % (pulse test). The test item had no influence on the pH-value of the test solutions.

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Conclusion Following exposure of the aquatic macrophyte Myriophyllum spicatum to 2,4-D for 14 days in the main test, the ErC50 and EyC50 values based on total shoot length were 0.346 mg/L and 0.169 mg/L respectively. The NOEC for growth rate and yield based on total shoot length was 0.0305 mg/L. The ErC50 and EyC50 values based on biomass (fresh weight) were 0.373 mg/L and 0.152 mg/L respectively. The NOEC for growth rate and yield based on biomass (fresh weight) was 0.0305 mg/L. The ErC50 and EyC50 values based on biomass (dry weight) were 0.499 mg/L and 0.276 mg/L, respectively. The NOEC for growth rate and yield based on biomass (dry weight) was 0.0977 mg/L. No EC50 could be determined following a 24-hour pulsed exposure, since there was no inhibition above 50 % in the highest test item concentration of 1.00 mg/L. The overall NOEC following the pulsed exposure was 0.0977 mg/L. The data showed that at the test item concentration of 0.0977 mg/L and below Myriophyllum spicatum plants could nearly recover in the pulse test after a 24-hour exposure whereas at the higher concentrations (0.313 and 1.00 mg/L) growth was inhibited until the end of the test. However reduced toxicity on total shoot length, biomass fresh and dry weight was observed also at the higher concentration level of 0.313 and 1.00 mg/L after a 24-hours exposure in the pulse test compared to the main test. Overall, Myriophyl- lum spicatum is much less sensitive to 2,4-D after a 24-hour pulsed exposure to the test item.

Comments of zRMS: The study is not acceptable and not valid. The quantitative analysis of the tests is based on the total plant weight (plant and roots). Roots may influence the results as sediment might stick to them or side roots might be cut during cleaning. Therefore quantification of the results should be based on the shoots of the plant only. This was a main outcome of the ring test and is incorporated in the guideline OECD 239 that explicitly requires a quantitative analysis of the shoot. For the roots only a qualitative results is required. In the study a reduced number of roots was observed at the two highest concentration levels. That finding supports the results for Myriophyllum spic. by Maletzki (2011) although the test was performed without sediment.

As the result on total shoot fresh weight are missing some validity criteria cannot be applied as well as variation coefficient.

Additionally the number of plants tested is far below the required number. The test design comprised 1 plant for each test vessel. Considering the number of test vessel for the control and each concentration level only 10 plants were tested for the control and 5 for each concentration level. In contrast the guideline requires at least 18 plants for the control and at least 12 plants for each concentration level.

Given that the test laboratory participated in the ring test the problems with sediment for quantitative analysis and therefore the requirements of the guidelines should be known.

The results of the test are not used for risk assessment.

A 2.2.2 KCP 10.2.2 Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms

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A 2.3 KCP 10.3 Effects on arthropods

A 2.3.1 KCP 10.3.1 Effects on bees

A 2.3.1.1 KCP 10.3.1.1 Acute toxicity to bees

Comments of zRMS: This study is considered valid and acceptable for the risk assessment.

Reference: KCP 10.3.1.1-1 Report AMINOPIELIK STANDARD 600 SL: Toxicity for honey-bees (Apis mellifera L.), Irzyk, M., 2004, Study no. B/06/04, Institute of Organic Industry, Poland Guideline(s): Yes. OECD 213 and 214 Deviations: No relevant deviations GLP: Yes Acceptability: Yes

Materials and methods In a test under laboratory conditions AMINOPIELIK STANDARD 600 SL was offered to worker honey bees (Apis mellifera L.) in oral and contact route. Treatments with the test substance, the control and the reference item (dimethoate) were carried out in three replicates containing 10 bees each.

Test species: Worker honey bees Apis mellifera

Test substance: AMINOPIELIK STANDARD 600 SL (620 g a.s.)

Control: oral: 50% aqueous sugar solution contact: water

Toxic standard: Dimethoate oral: 0.0375, 0.0750, 0.1500 µg a.s./bee contact: 0.05, 0.10, 0.20 µg a.s./bee dissolved in acetone

Doses: oral (AMINOPIELIK STANDARD 600 SL sucrose solution): 12.5, 25.0, 50.0, 100.0 µg product/bee contact (AMINOPIELIK STANDARD 600 SL dissolved in acetone): 25.0, 50.0, 100.0, 200.0 µg product/bee

Bees per dose: 10

Replicates: 3

Oral toxicity study: In a dose response, three replicates of 10 bees were fed with a sugar/water solution containing AMI- NOPIELIK STANDARD 600 SL. The tested concentration was 12.5, 25.0, 50.0, 100.0 µg product/bee. An untreated sugar/water solution was used as water control. Dimethoate was used as toxic standard. The test was conducted at darkness and a temperature of 19 - 21°C and humidity between 55 and 68%. Bio- 034066-00/00 / U 46 D Fluid Page 53 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015 logical observations including mortality and behavioural changes were recorded at 4, 24, 48, 72 and 96 hours after dosing. Results are based on nominal concentrations of the product per bee.

Contact toxicity study: In a dose response, three replicates of 10 bees were exposed to AMINOPIELIK STANDARD 600 SL + acetone, administered topically in a small droplet (1µl) to the thorax of each bee. The tested concentration was 25.0, 50.0, 100.0, 200.0 µg product/bee. A group of bees treated with an equivalent volume of water was used as water control. Dimethoate solved in acetone was used as toxic standard. The test was conducted at darkness and a temperature of 19 - 21°C and humidity between 55 and 68%. Biological observations, including mortality and behavioural changes were recorded at 4, 24, 48, 72 and 96 hours after application.

Results and discussions

Findings Since less than 50% mortality occurred during the tests at the highest test concentrations, the 96 hr LD50 for oral toxicity is > 100 µg product/bee and for contact toxicity 96 hr LD50 > 200 µg product/bee. The 24 hr LD50 for the reference substance dimethoate was 0.07 µg/bee for oral and 24 hr LD50 for contact was 0.15 µg/bee

Table 10.3.1.1-1: Toxicity of AMINOPIELIK STANDARD 600 SL to honey bees in contact and oral toxicity test. Contact Test Oral Test Treatment Mortality (%) Mortality (%) µg product/bee 4 h 24 h 48 h 72 h 96 h 4 h 24 h 48 h 72 h 96 h control 0.00 0.00 3.33 3.33 3.33 0.00 0.00 0.00 3.33 6.67 12.5 - - - - - 0.00 3.33 3.33 3.33 6.67 25.0 0.00 3.33 3.33 3.33 6.67 0.00 0.00 3.33 6.67 6.67 50.0 0.00 6.67 10.00 13.33 23.33 0.00 0.00 6.67 10.00 13.33 100.0 0.00 3.33 6.67 6.67 20.00 3.33 6.67 10.00 16.67 20.00 200.0 0.00 3.33 3.33 6.67 6.67 - - - - - Contact LD50 > 200 µg product/bee Oral LD50 > 100 µg product/bee Contact LD50 (24 h) value of the reference item: 0.15 µg a.s./bee Oral LD50 (24 h) value of the reference item: 0.07 µg a.s./bee

Conclusion The 96 hr LD50 of AMINOPIELIK STANDARD 600 SL to honey bee (Apis mellifera) is > 100 µg product/bee for oral toxicity and > 200 µg product/bee for contact toxicity.

A 2.3.1.2 KCP 10.3.1.1.1 Acute oral toxicity to bees

Refer to A 2.3.1.1 (KCP 10.3.1.1)

A 2.3.1.3 KCP 10.3.1.1.2 Acute contact toxicity to bees

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A 2.3.1.4 KCP 10.3.1.2. Chronic toxicity to bees

Not required. No data submitted.

A 2.3.1.5 KCP 10.3.1.3 Effects on honey bee development and other honey bee life stages

Not required. No data submitted.

A 2.3.1.6 KCP 10.3.1.4 Sub-lethal effects

Not required. No data submitted.

A 2.3.1.7 KCP 10.3.1.5 Cage and tunnel tests

Not required. No data submitted.

KCP 10.3.1.6 Field tests with honeybees

Not required. No data submitted.

A 2.3.2 KCP 10.3.2. Effects on arthropods other than bees

Goßmann, 1997

Reference: IIIA 10.5.1 Report Goßmann (1997): Effects of Herbizid Marks D on the Predatory Mite Typh- lodromus pyri SCHEUTEN (Acari, Phytoseiidae) in the Laboratory IBACON GMBH, Germany 2303063 GLP Not published Guideline(s): ESCORT I Guidance Document (Barrett et al., 1994), ESCORT II Guidance Document (Candolfi et al., 2001) and Hassan et al., (2000) Deviations: No GLP: Yes Acceptability: yes Duplication no (if vertebrate study)

Materials and Method Test material Test item: Herbicide Marks D (2,4-D DMA 500 g a.s./L) Purity: Nominal: 475 – 525 g 2,4-D/L Measured: 514 g 2,4-D/L 034066-00/00 / U 46 D Fluid Page 55 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Description: clear light brown liquid Lot No./Batch No.: JAS/ 97/ 02

Test system Organism (Species): Predatory mite (Typhlodromus pyri) Source of organism: Dr. Peter Katz, PK Nützlingszuchten, Welzheim, Germany In life dates: 26 May 1997 to the 09 June 1997 Guideline deviations reported by Study None Director: Study design: Mortality and reproduction rate Duration of study: 7 days for assessment of mortality 14 days for assessment of reproduction Age of test organisms at test initiation: Test subjects used had hatched three days prior to the study. (Protonymphs) No. of pairs per dose group: 20 No. of test concentration replicates: 5 No. of pairs per control group: 20 No. of control replicates: 5 Test rate: 2 L Herbizid Marks D/hain 200 L/ha (equivalent to 11.72 g product/L) Acclimatisation period: 1 week Feeding: During acclimatisation and exposure period, mites were fed on a mixture of 3:1 of pine (Pinus nigra) and Birch (Betula spp.) pollen and libitum. Housing: Plastic trays with lids (11x11x6 cm). Open test design for predatory mite. Environmental conditions: Temperature: 25 ± 3 °C Photoperiod: 16 h light, 8 h dark – 510 to1230 lux Humidity: 75 ± 5 % Analytical verification: Method: measuring concentrations of 2,4-D using HPLC Limit of Detection: 0.07 g 2,4-D

Reference substance: Atlas (400 g dimethoate/L)

Methodology Animals were assigned to three groups (test substance, negative control and positive control) with each group consisting of 5 replicates of 20 animals for a total of 100 animals per group. Before introduction of the mites, the test trays were treated with 2,4-D DMA 500 g/l a.i at an application rate of 2 L in 200 L water/ ha (equivalent to 1 kg 2,4-D/ha). The negative control trays were sprayed with tap water and the positive control with Dimethoate. The trays were allowed to dry for approximately 2 hours, then the mites were introduced (20 mites per tray). The mites were observed for effects on mortality at 1, 3 and 7 days after test initiation. After 7 days, the surviving individuals were sexed and the number of eggs, juveniles and male and female predators were counted on days 7, 9, 11 and 14. Reproduction of the mites was determined by calculating the number of eggs and live and dead juvenile stages per surviving female.

Results A. MORTALITY Statistical analysis of the mortality results of the mites, which include the outlier, show that there was a 26.13% higher mortality rate compared to the water treated control. Statistical analysis of mortality rates excluding the outlier was only 7.67% compared to the mortality rates of the water treated control.

B. REPRODUCTION After test initiation the survivors of the test groups were sexed and egg production started at Day 7 for both treated and control groups. The adult mites exposed to the test substance laid 5.3 eggs with a standard deviation of 2.0 (4.3 with 2.9 SD including outlier) per female during the second experimental 034066-00/00 / U 46 D Fluid Page 56 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015 week compared to 6.8 eggs per female, with a standard deviation of 2.5 in the control. Thus, under laboratory test conditions the beneficial capacity of the predatory mite in the substance treatment group was reduced by 27.98% (53.46% including outlier). When the outlier is excluded, the reduction in reproduction is not statistically significant (Dunnett-test α = 0.05).

Conclusions When outlying data is discarded, the test group mortality was 7.67 % higher than the control and the reproduction rate was 27.98 % lower. Neither of these results is statistically significant (Dunnett-test α = 0.05). The table below summarises these results.

Table 9.13-7 Effects of Herbizid Marks D on the survival and reproductive success of Typhlodromous pyri, when the outlier is excluded

Test rate Increase in mortality rela- Reduction in reproduction rate relative to the control [%] tive to the control [%] Control 0 0 2 L Herbizid Marks D/ha 7.67 27.98 Toxic Reference 4300 100* *No reproduction occurred with the toxic reference

Therefore, according to the IOBC/WPRS recommendations 2,4-D DMA 500 (CA2971) can be assessed as harmless to Typhlodromus pyri in this laboratory study at a rate of 2.0 L product/ha.

Comments of zRMS: Study acceptable and valid.

Warmers, 2008

Reference: IIIA 10.5.1 Report Warmers (2008) 2,4-D DMA salt (500 g acid/L) Assessment of Side Effects on the Egg Parasitoid, Trichogramma cacoeciae Marchal (Hymenoptera, Trichogrammatidae) under Laboratory Conditions (Dose Response) Eurofins, Germany 20071962/01-NLTc GLP Not published Guideline(s): ESCORT I Guidance Document (Barrett et al., 1994), ESCORT II Guidance Document (Candolfi et al., 2001) and Hassan et al., (2000) Deviations: No GLP: Yes Acceptability: yes Duplication no (if vertebrate study)

Materials and Method Test Material Test item: 2,4-D DMA 500 g/l Description: Light yellow liquid Lot No./Batch No.: 0203/2006

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Test system Organism (Species): Trichogramma cacoeciae Study Type: Laboratory study Guideline deviations reported by Study No Major deviations Director: Duration of study: 96 hours Parameters measured: Reduction in parasitic capacity Test concentrations (for toxicity 51.2, 128.0, 320.0, 800.0 and 2000.0 mL product/ha determination): No. of replicates per concentration: Control: 6 Treatment: 4

Methodology 2,4-D DMA salt (500 g acid/L) (Batch no.: 0203/2006) containing 500 g 2,4-D DMA/L (nominal content) was diluted deionised water and applied once to glass plates at five different concentrations: 51.2, 128.0, 320.0, 800.0 and 2000.0 mL product/ha. In order to confirm the efficacy of the test system Perfekthion (400 g a.i./L dimethoate, nominal content) was used as a reference item. A water-treated control was also included in the test design. Glass plates were sprayed with an automatic laboratory track sprayer (Company Schachtner, Ludwigs- burg, Germany). For the control 6 replicates were used and for the other treatment groups 4 replicates. During the exposure, the adults were provided with artificial food (honey-gelatine mixture). For assessment of the possible effects on viability of the wasps, eggs of the grain moth Sitotroga cerealella were offered to the adults 24 h, 48 h and 96 h after initiation of wasps’ exposure. After 7 days of exposure the exposure cages were removed and the S. Cerealella eggs retrieved. The egg cards were incubated for development of the parasitoids. After recording the original parasitoid population and the number of parasi- tized eggs, the parasitic capacity per female was evaluated for each replicate of the treated variants, for the reference item and for the control group. The parasitic capacity of the females in the exposure units with test item treated leaves was compared to the control. The calculation of the parasitic capacity of the control group was done with 5 replicates instead of 6 replicates. The replicate 2 was omitted from calculation of parasitic capacity after performance of an outlier- test (Grubbs-test, G= 1.9977, U= 0.0422, p < 0.002029).

Results The effects of 2,4-D DMA 500 on the parasitic capacity of the egg parasitoid Trichogramma cacoeciae is displayed in the table below.

Table 9.13-8 Effects of 2,4-D DMA 500 on the egg parasitoid Trichogramma cacoeciae

Treatment Groups Mean no. Of parasitoid eggs per Reduction of parasitic capacity female [%]1) Control 16.82) - Test item at 51.2 mL/ha (25.6 g 16.6 1.19 a.i./ha) Test item at 128.0 mL/ha (64.0 g 16.5 1.79 a.i./ha) Test item at 320.0 mL/ha (160.0 g 16.1 4.17 a.i./ha) Test item at 800.00 mL/ha (400.0 g 16.5 1.79 a.i./ha) Test item at 2000.0 mL/ha (1000.0 g 16.9 -0.60 a.i./ha) Reference item 1.0 mL/ha at 0.4 g 0.1 99.40 a.i./ha 1) Reduction of parasitic capacity calculated according to the formula of ABBOTT (1925) 2) One replicate was omitted from calculation 034066-00/00 / U 46 D Fluid Page 58 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Conclusion With respect to the test results it can be concluded that test item caused no statistically significantly adverse effects on reproduction (parasitic capacity) of Trichogramma cacoeciae (Dunnett’s t-test, p > 0.05) under worst case conditions up to and including 2000.0 mL/ha. No ER50 value could be determined, as none of the test item rates caused a statistically significant adverse effect on reproduction (parasitic capacity) of T. Cacoeciae. Therefore, it can be assumed, that the ER50 value is > 2000.0 mL/ha, the highest rate tested in this study.

Comments of zRMS: Study acceptable and valid.

A 2.4 KCP 10.4 Effects on non-target soil meso- and macrofauna

A 2.5 KCP 10.5 Effects on soil nitrogen transformation

Cyon; 2004

Reference: IIIA 10.7/02 Report Cyon, M. (2004), KWAS 2,4-D: Evaluation of the toxic effect on microbial activity – influence on the nitrogen and carbon transformation process in soil. Study number: G/16/03 Date: 22 December 2003 Guideline(s): OECD 216 and 217 Deviations: No GLP: Yes Acceptability: yes Duplication Not relevent (if vertebrate study)

Materials and methods Test material Test item: KWAS2,4-D Purity: 98% Description: White powder with characteristic smell Lot No./Batch No.: Not stated Test system Organism (Species): Soil microorganisms Guideline deviations reported by Study None stated Director: Study design: Assessment of nitrogen and carbon transformation process (No. of replicates, assessments made etc.) (3 units per treatment group) Duration of study: 28 d Observation intervals: Nitrogen turnover: 0, 7, 14 and 28 d Carbon turnover: 0, 7, 14 and 28 d Test concentrations: 0.6 and 3 mg 2,4-D/kg soil 034066-00/00 / U 46 D Fluid Page 59 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Soil parameters: Agricultural soil which had no plant protection products or cultivation for the previous 3 years. pH (in H20): 7.2 to 7.4 Total organic carbon: 1.09% d.w Soil water content: 40% to 60% of MWHC Environmental conditions: Temperature:18 - 22 °C

Methodology Soil freshly collected from a grass covered area adjoining the Insitute of Organic Industry was manually cleared of large objects (i.e. stones, parts of plants, etc) and sieved to particle size equal to 2 mm, and then was for kept two weeks in 4°C. Before the experiment soil was pre-incubated 14 days in the same conditions as in the experiment. Prepared soil was divided into two portions: • The first portions were intended for test of the influence of KWAS 2,4-D on the nitrogen transformation process (according to the OECD guideline No 216)

• The second portions were intended for test of the influence of KWAS 2,4-D on the carbon transformation process (according to the OECD guideline No 217)

Nitrogen transformation test: The soil was divided into three portions of equal weight. Two portions were mixed with the carrier (water) containing the test substance and the third was mixed with water without the test substance (control). The soil was amended with lucerne (C-31.1 % d.w.; N-249% d.w) as an organic substrate in ratio of 5g of lucerne per kilogram of soil (dry weight). At the beginning of the test, the moisture content of the soil was adjusted with distilled water to a value of 50% of the maximum water holding capacity. Carbon transformation test: The soil was divided into three portions of equal weight. Two portions were mixed with the carrier (water) containing the test substance and the third was mixed with water without the test substance (control). The soil intended for the carbon transformation test was left without organic substrate. At the beginning of the test, the moisture content of the soil was adjusted with distilled water to a value of 50% of the maximum water holding capacity. Measurement of respiration rates: After 0, 7, 14 and 28 days of incubation, in samples of treated and control soils, respiration rates were determined. To assess the glucose-induced respiration rates three samples from treated and untreated soils were collected. Samples (each 100g) were thoroughly mixed with glucose in ratio of 2000 mg of glucose per kilogram of soil (dry weight). Prepared soil samples were incubated for 12 or 24 hours in temperature of 20 ± 2°C in an apparatus for continuous measurements of respiration rates (system sensomat from Aq- ua Lytic Firm) and the measurements were started as soon as glucose was added. The system comprised of the sensomat-scientific control unit, the sensor-IR, the quiver with CO2 absorber, adapter and the glass flask (Volume 0.6l). During 12 or 24 hours the total quantities of oxygen consumption and mean respiration rates were determined. The principle of operation was based on the measurements of the pressure difference in a closed system. During respiration generated carbon dioxide was bound to an absorber (45% KOH), that resulted in pressure-drop, which was proportional to the soil respiration. The mean oxygen consumption in each sample of soil treated with the test substance was compared with that in the control, and the percent deviation from the control was calculated.

Results and discussions Nitrogen transformation The mean nitrate formation rate in the course of the study of toxicity evaluation of KWAS 2,4-D on nitrogen transformation in soil in shown in below. 034066-00/00 / U 46 D Fluid Page 60 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Table 9.13-9: Effect of 2,4-D on nitrogen transformation rate

The nitrate formation rate (mg/kg dry weight of soil) Control PEC- 0.6 mg/kg of soil 5 x PEC- 3.0 mg/kg soil Day Deviation from Deviation from Mean value Mean value Mean value control control 0 11.02 b 10.58 ab -4.0% 10.71 a -7.8% 7 6.69 a 8.15 b 21.8% 8.96 c 33.9% 14 12.50 a 14.83 b 18.6% 15.34 b 22.7% 28 27.17 a 27.15 a -0.1% 30.15 b 10.9%

During the nitrogen transformation test, in concentration of 0.6 mg/kg of soil, differences in nitrate rate after 7 and 14 days of incubation in comparison to the control were observed. In these days the amount of nitrates was on the higher level. However, differences were statistically significant; the percent deviation from the control was less than 25%. After 0 and 28 days of incubation between control and lower concentration differences were not observed. In concentration of 3.0 mg/kg of soil nitrate formation rate was on the higher level during all tests, with exception of first day, when less formation nitrate rate was observed. Because the soil was amended with lucerne, as an organic substrate, at the beginning of the test, during the nitrogen formation transformation test progressive increase of nitrate formation rate in control, as well as in soil treated with preparation was observed. Because the variations between replicate samples in control are less than ± 15%, the obtained results in nitrogen transformation test can be evaluated as valid.

Carbon transformation The mean oxygen consumption rate in the course of the study of toxicity evaluation of KWAS 2,4-D on carbon transformation in soil in shown in table below.

Table 9.13-10: Effect of 2,4-D on carbon transformation

The oxygen (O2) consumption rate (mg/kg dry weight of soil /hour) Control PEC- 0.6 mg/kg of soil 5 x PEC- 3.0 mg/kg soil Day Deviation from Deviation from Mean value Mean value Mean value control control 0 21.2 a 21.6 ab 1.8% 22.6 b 6.6% 7 16.1 a 16.9 b 4.9% 17.4 b 8.0% 14 15.6 b 14.9 a -4.5% 15.5 b -0.7% 28 10.6 a 10.2 a -3.8% 10.2 a -3.8%

During the carbon transformation test, in concentration of 0.6 mg/kg of soil differences in respiration intensity after 7 and 14 days of incubation in comparison to the control were observed. In these days respiration was more intensive. However, differences were statistically significant, the percent deviation from the control were less that 25%. After 0 and 28 days of incubation between the control and lower concentration differences were not observed. In concentration 3.0 mg/kg of soil respiration was more intensive in comparison to the control soil after 1 and 7 days of incubation. During the carbon transformation test, in control as well as in soil treated with the test preparation, decrease in respiration intensity was observed. Because the soil was left without organic substrate at the beginning of the test, source of readily available carbon in the soil was rapidly depleted, and in conse- quence of this rapid loss of metabolically active microbial biomass was observed. Because the variations between replicate samples in control are less than ±15%, the obtained results in carbon transformation test can be evaluated as valid.

Conclusion Taking into account the obtained results, it was assessed that KWAS 2,4-D in concentration of 0.6 mg/kg 034066-00/00 / U 46 D Fluid Page 61 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015 of soil, corresponding to the dose of preparation in practical condition, can be evaluated as having no long-term influence on nitrogen and carbon transformation in soil. Additionally the higher rate of 3.0 mg/kg soil can also be deemed to have no long-term influence on nitrogen or carbon transformation in soil.

Comments of zRMS: Study acceptable.

A 2.6 KCP 10.6 Effects on terrestrial non-target higher plants

Eckenstein, 2013

Reference: IIIA 10.8.2.1 Report Eckenstein (2013): Toxicity to the Aquatic Higher Plant Lemna gibba in a 7- day Growth Inhibition Test Harlan Laboratories Ltd, Swtizerland D76270 GLP Not published Guideline(s): ESCORT I Guidance Document (Barrett et al., 1994), ESCORT II Guidance Document (Candolfi et al., 2001) and Hassan et al., (2000) Deviations: No GLP: Yes Acceptability: yes Duplication no (if vertebrate study)

Materials and Method Test material Test item: 2,4-D DMA 500 g/l Description: Not specified Lot No./Batch No.: JPB/560/81

Test system Organism (Species): Aquatic plant, Lemna gibba Study Type: Laboratory study Static Guideline deviations reported by Study None Director: Duration of study: 7 days Parameters measured: Growth effects from 2,4-D DMA 500 g/l Environmental conditions: Test solution pH: 7.5-8.2 Test solution temperature: 25°C Photoperiod: Continuous illumination Light intensity: 7680-8590 Lux Test concentrations (for toxicity 0.050, 0.16, 0.50, 1.6, 5.0,16 and 50 mg/l determination): Test concentrations (for metabolism 100 mg/l evaluation): Acclimation period/conditions: Not specified Method of test item added to the test Aseptically from the pre-culture medium: 034066-00/00 / U 46 D Fluid Page 62 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Initial frond number: Not specified No. of replicates per treatment: 3

Methodology Each replicate consisted of a 250-mL glass dish (diameter of approx. 9.5 cm) filled with 150 mL of test medium, resulting in a water depth of approximately 21 mm. The test vessels were covered with glass dishes and incubated in a water bath in a randomized order. They were then repositioned at each counting date and were labeled with the study number and all necessary additional information to ensure unique identification.

Experimental Conditions The test vessels were incubated in a temperature-controlled water bath with a temperature of 25 °C. They were continuously illuminated using fluorescent tubes (Philips TLD 36W-1/840) installed above the test vessels in order to achieve a light intensity of 7680–8590 Lux.

Study Design The following nominal concentrations of the test item were tested: 0.050, 0.16, 0.50, 1.6, 5.0, 16 and 50 mg/L. Additionally, a control was tested in parallel (test water without test item). Selection of the test concentrations was based on the results of a range-finding test. At the start of the test, Lemna colonies were transferred aseptically from the pre-culture into the different test vessels in a randomized order. The test was started with three randomly selected colonies per vessel.

Determination of the Growth Inhibition and Calculation of Results On Days 2 and 4 and at the end of the test on Day 7, the number of fronds and colonies of the Lemna plants were counted. Fronds visibly projecting over the edge of the mother frond were counted as separate fronds. At the same dates, the plants were inspected for changes in appearance (e.g., discoloration, sink- ing, root length, or other abnormalities).

The dry weight of a sample of twelve fronds was determined at the start of the test. At the test termination, the dry weight of the plants of each test vessel was determined. The plants were dried at about 60 °C in a laboratory vacuum oven for 48 hours (sufficient to reach a constant weight).

Results The test item 2,4-D DMA 500 had a statistically significant inhibitory effect on the growth rate based on frond number of Lemna gibba after the exposure period of 7 days at the concentration of 1.6 mg/L and at all higher test concentrations. At all lower test item concentrations, the growth rate based on frond number was statistically significantly lower than in the control, however not estimated as a biologically relevant toxic effect, since the inhibition was <10% and no concentration-response dependency could be observed.

The test item 2,4-D DMA 500 had a statistically significant inhibitory effect on the yield based on frond number of Lemna gibba after the exposure period of 7 days at the concentration of 0.50 mg/L and at all higher test concentrations. At all lower test item concentrations, the yield based on frond number was statistically significantly lower than in the control however not estimated as a biologically relevant toxic effect, since the inhibition was <10% and no concentration-response dependency could be observed.

The test item 2,4-D DMA 500 had a statistically significant inhibitory effect on the growth of Lemna gibba (growth rate and yield based on dry weight) after the exposure period of 7 days at the concentration of 5.0 mg/L and at all higher test concentrations. At all lower test item concentrations, the growth rate and yield based on dry weight were not statistically significantly lower than in the control.

No abnormalities in appearance of the test plants were recorded in the control and the test concentrations of 0.050 to 1.6 mg/L. At the concentrations of 5.0 to 50 mg/L some fronds showed chlorosis (Day 4 and 034066-00/00 / U 46 D Fluid Page 63 /63 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

7) and gibbosity (Day 7). At the concentration of 50 mg/L, the roots of the plants were also shorter compared to the control based on visual assessment on day 7.

The concentration of 0.50 mg/L was determined to be the 7-day LOEC as the yield based on frond numbers after the exposure period of 7 days was statistically significantly lower than in the control. The 7-day NOEC was determined to be 0.16 mg/L since the growth of the plants was not inhibited after the exposure period of 7 days at this test concentration.

Conclusion The biological results can be summarised as in the table below (based on nominal concentrations of the test item 2,4-D DMA 500g/L).

Table 9.13-11 Summary of the results for effects of 2,4-D DMA 500 (CA2971) on Lemna gibba Parameter based on: EC values frond numbers dry weight of the plants [mg/L] Growth rate Yield Growth rate Yield

7-day EC50 44 7.0 >50 32

95% C.I. 38-51 5.9-8.4 n.d. 23-49

7-day EC20 4.2 0.80 26 4.9 95% C.I. 3.6-4.8 0.59-1.0 21-33 2.8-7.0

7-day EC10 1.2 0.26 7.4 1.8

95% C.I. 0.95-1.5 0.17-0.36 4.8-10 0.78-3.1

7-day NOEC 0.5 0.16 1.6 1.6

7-day LOEC 1.6 0.5 5.0 5.0 95% C.I.: 95% confidence interval n.d.: could not be determined

Comments of zRMS: Study acceptable and valid.

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 034066-00/00 Product name(s): U 46 D Fluid (Spritz-Hormin 500) Chemical active substance(s): 2,4-D 500 g/L

Central Zone Zonal Rapporteur Member State: Germany

NATIONAL ADDENDUM Germany (authorization)

Applicant: Nufarm GmbH Submission date: 19.12.2013 MS Finalisation date: 27/04/2017 034066-00/00 / U 46 D Fluid Page 2 /15 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Version history

When What

August 2015 Draft RR National addendum by UBA February 2017 Revision 1 by UBA due to renewal of approval of active substance 2,4-D and change of application rate (application rate for use in grassland changed from 2 L/ha to 1.5 l/ha)

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Table of Contents

9 Ecotoxicology (KCP 10) ...... 4 9.1 Proposed use pattern for Germany ...... 4 9.1.1 Grouping of intended uses for risk assessment ...... 4 9.1.2 Consideration of metabolites ...... 4 9.2 Effects on birds (KCP 10.1.1) ...... 4 9.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2) ...... 4 9.3.1.1 Higher-tier risk assessment specific Germany (use No 00-003) ...... 5 9.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3) ...... 6 9.5 Effects on aquatic organisms (KCP 10.2) ...... 6 9.5.1 Toxicity data ...... 6 9.5.2 Risk assessment-Exposure by spraydrift and deposition following volatilisation ...... 6 9.5.3 Risk assessment- Exposure by surface run-off and drainage ...... 7 9.6 Effects on bees (KCP 10.3.1) ...... 10 9.7 Effects on arthropods other than bees (KCP 10.3.2) ...... 10 9.8 Effects on non-target soil meso- and macrofauna (KCP 10.4) ...... 10 9.8.1 Toxicity data ...... 10 9.8.2 First tier risk assessment ...... 11 9.9 Effects on soil microbial activity (KCP 10.5) ...... 11 9.10 Effects on non-target terrestrial plants (KCP 10.6) ...... 11 9.10.1 Toxicity data ...... 12 9.10.2 Risk assessment and risk mitigation measures ...... 12 9.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ...... 13 9.12 Monitoring data (KCP 10.8) ...... 13 9.13 Classification and Labelling ...... 13 9.14 Restrictions linked to the PPP and specific restrictions linked to the intended uses resulting from ecotoxicological assessment ...... 14

Appendix 1 Lists of data considered in support of the evaluation ...... 15

Appendix 2 Detailed evaluation of the new studies ...... 15

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9 Ecotoxicology (KCP 10)

A full risk assessment according to Uniform Principles for the plant protection product U 46 M Fluid in its intended uses in cereals and grassland is documented in detail in the core assessment of the plant protection product U 45 D Fluid dated from August 2015 performed by zRMS Germany. This document comprises specific risk assessment for some annex points for authorization of the plant protection product U 46 D Fluid in Germany according to the uses listed in Part B.0.

9.1 Proposed use pattern for Germany

9.1.1 Grouping of intended uses for risk assessment

Table 9.1-1: Critical use pattern of U 46 D Fluid grouped according to soil

Grouping according to soil

Group Intended uses AR (interception) "eff. AR (cumulated)" (see CA) S01 00-002 spring cereals 1 × 750 (25 %) 562.500 S02 00-003 grassland 1 × 750 (60 %) 300.000 S03 00-001 winter cereals 1 × 750 (50 %) 375.000 CA… core assessment

9.1.2 Consideration of metabolites

Please refer to the core assessment.

9.2 Effects on birds (KCP 10.1.1)

Please refer to the core assessment.

Consequences for authorization: none

9.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2)

Use No 00-001 and 00-002 (cereals) The risk assessment in the core assessment indicates an acceptable acute and long-term risk for mammals due to the intended use of U 46 D Fluid in cereals according to the label.

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The results of the assessment indicate an unacceptable acute and long-term risk for mammals due to the intended use of U 46 D Fluid on grassland according to the label.

9.3.1.1 Higher-tier risk assessment specific Germany (use No 00-003)

As shown in table 9.3-4 of the core assessment the acceptability criteria of TER ≥ 10 resp. TER ≥ 5 for acute and long-term risk to mammals was not achieved for the generic focal specie “vole”. Thereas for the generic focal species “lagomorphs” the acceptability criteria of TER ≥ 10 resp. TER ≥ 5 for acute and long-term risk to mammals was met. Therefore the higher tier risk assessment deals only with the generic focal species “vole”.

Decline of residues (DT50): See core assessment

Acceptability criteria: In cases where the relevant model species for the risk assessment is a mouse or a vole, the TER acceptability criterion according to Annex VI of Directive 91/414/EEC may be modified. In terms of size and potential exposure, mice and voles already represent the ‘worst case’ for agricultural areas in Europe’s middle zone. Furthermore, the toxicological endpoints and effect values for the assessment are determined on phylogenetically closely related species. Hence, a TER ≥ 5 in the acute exposure scenario and a TER ≥ 2 in the long-term exposure scenario may be accepted as sufficient. It should additionally be noted that there are currently no indications for a significant impact of pesticides on the population dynamics of mice or voles in the agricultural landscape, which are apparently determined by other biological factors (e.g. periodical increases in vole populations creating the necessity for control measures).

Table 9.3-1: Higher-tier assessment of the acute and long-term/reproductive risk for mammals due to the use of U 46 D Fluid in grassland (00-003) for the generic focal species “vole”

Intended use B02M01 (00-003) Active substance/product 2,4-D Application rate (g/ha) 1 × 750 Acute toxicity (mg/kg bw) > 554/5831) TER criterion 5

Crop scenario Indicator/generic focal species SV90 MAF90 DDD90 TERa Growth stage (mg/kg bw/d) Grassland/ all season Small herbivorous mammal 136.4 1 102.3 >5 "vole" Reprod. toxicity (mg/kg bw/d) 20.6 TER criterion 2

Crop scenario Indicator/generic focal species SVm MAFm × DDDm TERlt Growth stage TWA (mg/kg bw/d) Grassland/ all season Small herbivorous mammal 72.3 0.16 8.6 2.4 "vole" 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.

Based on tier 1 (acute) and higher tier (long-term) assessment step, the calculated TER values for the acute and long-term risk resulting from an exposure of mammals to 2,4-D according to the GAP of the 034066-00/00 / U 46 D Fluid Page 6 /15 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015 formulation U 46 D Fluid achieve the modified 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. The results of the assessment indicate an acceptable acute and long-term risk for mammals due to the intended use of U 46 D Fluid on grassland (use No. 00-003) according to the label.

Consequences for authorization: none

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)

Results of aquatic risk assessment for the intended for uses of U 46 D Fluid in cereals and grassland based on FOCUS Surface Water PEC values is presented in the core assessment, Part B, Section 9, chapter 9.5. 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 risk assessment for aquatic organism for authorization of U 46 D Fluid for all intended uses in Ger- many considering risk mitigation measures applicable in Germany is provided in the chapters below.

9.5.1 Toxicity data

Please refer to the core assessment.

9.5.2 Risk assessment-Exposure by spraydrift and deposition following volatilisation

Exposure: The calculation of concentrations in surface water is based on spray drift data by Rautmann and Ganzel- meier. The vapour pressures at 20 °C of the active substance 2,4-D is < 10-5 Pa. Hence the active substance 2,4-D is regarded as non-volatile. Therefore exposure of surface water by the active substance 2,4- D due to deposition following volatilization does not need to be considered. For details refer to national addendum Germany, Part B, section 8, chapter 8.8.

Considering the relevant toxicity of 2,4-D following TER-values are calculated for the use of U 46 D Fluid according to use No. 00-001,00-002 and 00-003 considering also risk mitigation measures that are applicable for Germany.

Table 9.5-1 TER calculation for use of BAS 812 00 H in cereals according to use No. 00- 001, 00-002 and 00-003 formulation U 46 D Fluid use No/ use group 00-001, 00-002, 00-003/D01 application rate 1 x 750 g/ha 034066-00/00 / U 46 D Fluid Page 7 /15 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

number of applications / 1/- interval DissT50 (SFO) in water not applicable relevant PEC Actual if applicable twa-interval scenario/percentile: Arable crops / 90th percentile buffer PECsw via drift PECsw via PECsw (via drift and volatilisation) (µg/L) (m) volatilisation depending on application technique (drift reduction) (%) (µg/L) (%) (µg/L) common 50% red. 75% red. 90% red. 1 2.77 6.925 - - 6.925 3.463 1.731 0.693 5 0.57 1.425 - - 1.425 0.713 0.356 0.143 10 0.29 0.725 - - 0.725 0.363 0.181 0.073 Toxicity: Myriophyllum aquat. EC50 = 0.011 mg/L TER: 10 buffer (m) TER calculated 1 1.6 3.2 6.4 15.9 5 7.7 15.4 30.9 10 15.2 required labelling: NW 605-1 /606 (conv. 10m, 50 %: 5 m, 75 %: 5 m, 90 % *) TER values shown in bold fall below the relevant trigger.

Based on the calculated concentrations of 2,4-D in surface water (EVA), the calculated TER values for the acute and long-term risk resulting from an exposure of aquatic organisms to 2,4-D according to the GAP of the formulation U 46 D Fluid achieve the acceptability criteria TER ≥ 100 and TER ≥ 10, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5.2. if appropriate risk mitigation measures (buffer strip, drift reducing technique) are applied. The results of the assessment indicate an acceptable risk for aquatic organisms due to the intended use of U 46 D Fluid in cereals and in grassland according to the label.

9.5.3 Risk assessment- Exposure by surface run-off and drainage

The concentration of the active substance 2,4-D in adjacent ditch due to surface runoff and drainage is calculated using the model EXPOSIT 3.01. The input parameters are summarised in the following tables (see also National addendum-Germany, Part B, section 8, chapter 8.7.2).

Parameter 2,4-D Reference

Kfoc, Runoff 25 arithm. mean (see core assessment, section 8, chapter 8.4) Kfoc, mobility class 25 DT50 soil (d) 42.3 90. percentile see Table 8.3-1 of national addendum Germany, Part B, section 8. Solubility in water (mg/L) 24300 EU value Mobility class 3 Reduction by bank filtration 91.4

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Table 9.5-2 TER calculation for exposure of surface water by 2,4-D due to runoff and drainage during application of U 46 F Fluid in cereals (use No. 00-002) Active substance: 2,4-D Use No.: 00-002 Application rate: 750g a.s./ha / 25 % interception

Toxicity: Myriophyllum spic. EC50 = 11 µg/L TER: 10 Exposure by surface runoff vegetated buffer strip (m) PECsw in adjacent ditch calculated TER (µg/L) (runoff) 0 3.11 3.5 5 2.70 4.1 10 2.31 4.8 20 1.62 6.8 Exposure by drainage Drainage time of application PECsw in adjacent ditch calculated TER (µg/L) autuum/winter/early spring 5.2 Not relevant Spring/summer 1.7 6.6 required labelling: no authorisation due to runoff; drainage NG 405 TER values shown in bold fall below the relevant trigger.

Table 9.5-3 TER calculation for exposure of surface water by 2,4-D due to runoff and drainage during application of U 46 F Fluid in grassland (use No. 00-003) Active substance: 2,4-D Use No.: 00-003 Application rate: 750g a.s./ha /60 % interception

Toxicity: Myriophyllum spic. EC50 = 11 µg/L TER: 10 Exposure by surface runoff vegetated buffer strip (m) PECsw in adjacent ditch calculated TER (µg/L) (runoff) 0 2.21 6.6 5 1.92 7.7 10 1.64 8.9 20 1.15 12.75 Exposure by drainage Drainage time of application PECsw in adjacent ditch calculated TER (µg/L) autuum/winter/early spring 3.66 not relevant Spring/summer 1.19 12.32 required labelling: NW706 (20 m vegetated buffer strip) 034066-00/00 / U 46 D Fluid Page 9 /15 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

TER values shown in bold fall below the relevant trigger.

Table 9.5-4 TER calculation for exposure of surface water by 2,4-D due to runoff and drainage during application of U 46 F Fluid in cereals (use No. 00-001) Active substance: 2,4-D Use No.: 00-001 Application rate: 750g a.s./ha /50 % interception

Toxicity: Myriophyllum spic. EC50 = 11 µg/L TER: 10 Exposure by surface runoff vegetated buffer strip (m) PECsw in adjacent ditch calculated TER (µg/L) (runoff) 0 2.07 5.3 5 1.80 6.1 10 1.54 7.1 20 1.08 10.2 Exposure by drainage Drainage time of application PECsw in adjacent ditch calculated TER (µg/L) autuum/winter/early spring 3.43 not relevant Spring/summer 1.12 10 required labelling: NW 706 (20 m vegetated buffer strip) TER values shown in bold fall below the relevant trigger.

The calculated TER values for the risk to aquatic organisms resulting from an exposure of surface water by 2,4-D due to run-off and drainage according to the use No 00-001 and 00-003 and due to drainage for use No 00-002 achieve the acceptability criteria of TER ≥ 100 or 10 respectively, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5. if appropriate risk mitigation (measures vegetated buffer strip and no application on drained fields)are applied.

For the use in spring cereals (use No. 00-002) the calculated TER values for the risk to aquatic organisms resulting from an exposure of surface water by 2,4-D due to run-off do not achieve the acceptability criteria of TER ≥ 100 or 10 respectively, according to commission implementing regulation (EU) No 546/2011, Annex, Part I C , 2. Specific principles, point 2.5. The results of the assessment indicate an unacceptable risk for aquatic organismen due to the intended use of U 46 D Fluid in spring cereals (use No. 00-002) according to the label.

Consequences for authorization: No authorisation for use No 00-002 (spring cereals). For the authorization of the plant protection product U 46 F Fluid following labeling and conditions of use are mandatory:

Required Labelling

NW 265 2,4-D: Myriophyllum spicatum NOEC 0.0047 mg/L 034066-00/00 / U 46 D Fluid Page 10 /15 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Conditions for use

All uses NW 468 Use No. 00-001 (winter NW 605-1 /606 (conv. 10m, 50 %: 5 m, 75 %: 5 m, 90 % *), NW 706 cereals)

Use No 00-003 (grassland) NW 605-1 /606 (conv. 10m, 50 %: 5 m, 75 %: 5 m, 90 % *), NW 706

(Use No 00-002 (spring NW 605-1 /606 (conv. 10m, 50 %: 5 m, 75 %: 5 m, 90 % *), NG 405) cereals)

9.6 Effects on bees (KCP 10.3.1)

Please refer to the core assessment.

Consequences for authorization: none

9.7 Effects on arthropods other than bees (KCP 10.3.2)

Please refer to the core assessment.

Consequences for authorization: none

9.8 Effects on non-target soil meso- and macrofauna (KCP 10.4)

Results of risk assessment for non-target soil meso- and macrofauna for the intended for uses of U 46 D Fluid in cereals and grassland based on PEC values as calculated for EU assessment is presented in the core assessment, Part B, Section 9, chapter 9.8.

For German exposure assessment the applied soil depth is based on experimental data (Fent, Löffler, Ku- biak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirk- stoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ 360 03 018, UBA, Berlin 1999). Generally for active substances with a Kf,oc < 500 a soil depth of 2.5 cm is applied whereas for active substances with a Kf,oc > 500 a soil depth of 1 cm is applied. As soil bulk density 1.5 g cm-3is assumed. Hence risk assessment differs from those in the core assessment and is summarised below.

9.8.1 Toxicity data

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9.8.2 First tier risk assessment

For the calculations of predicted environmental concentrations in soils (PEC soil), reference is made to the environmental fate section (Part B, Section 8, chapter 8.6.) of the national addendum. The assessment for the use group S01 (00-002) also covers the risk for earthworms and other non-target soil organisms (meso- and macrofauna) from all other intended uses in groups S02 and S03 (see 9.1).

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 U 46 D Fluid in spring cereals (use 00-002/use group S01)

Intended use/use group 00-002/S01 Acute effects on earthworms

Product/active substance LC50 PECsoil TERa (mg/kg dw) (mg/kg dw) (criterion TER ≥ 10) 2,4-D 350 1.50 233 Chronic effects on earthworms

Product/active substance NOEC PECsoil TERlt (mg/kg dw) (mg/kg dw) (criterion TER ≥ 5) 2,4-D 62.5 1.50 42 TER values shown in bold fall below the relevant trigger.

Consequences for authorization: none

9.9 Effects on soil microbial activity (KCP 10.5)

Please refer to the core assessment.

Consequences for authorization: none

9.10 Effects on non-target terrestrial plants (KCP 10.6)

Results of risk assessment for non-target terrestrial plants for the intended for uses of U 46 D Fluid in cereals and grassland are presented in the core assessment, Part B, Section 9, chapter 9.10 aplying thr rsik envelope approach. The outcome of the core assessment indicates that risk mitigation measures are required (see Part B, Sec- tion 10, core assessment, Table 9.10.-4) for the use of U 46 D Fluid in cereals and grassland. In the following chapter the risk assessment is provided for all intended for uses of U 46 M Fluid in Ger- 034066-00/00 / U 46 D Fluid Page 12 /15 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015 many considering risk mitigation measures applicable in Germany.

9.10.1 Toxicity data

Please refer to the core assessment. As already shown in the core assessment the risk assessment is based on the results of the vegetative vigour test and follows the deterministic approach. In the risk assessment in Germany is based in a safety factor of 10. However as the toxicity tests (vegetative vigour and seedling emergence) comprised 13 species among them species from plant family (4 fami- lys) that are highly susceptible to the formulation U 46 D Fluid. The safety factor applied for risk assessment can be reduced from 10 to 5.

9.10.2 Risk assessment and risk mitigation measures

Exposure Effects on non-target plants are of concern in the off-field environment, where they may be exposed to spray drift. The amount of spray drift reaching off-crop habitats is calculated using the 90th percentile estimates derived by the BBA (2000) from the spray-drift predictions of Ganzelmeier & Rautmann (2000). Any dilution over the 3-dimensional vegetation surface is accounted for in the study design. Therefore, in contrast to the assessment of risks to arthropods from standard laboratory tests, no vegetation distribution factor is considered here. The vapour pressures at 20 °C of the active substance 2,4-D is < 10-5 Pa. Hence the active substance 2,4- D is regarded as non-volatile. Therefore exposure of the off-field environment by the active substance 2,4-D due to deposition following volatilization does not need to be considered.

The results of the risk assessment using mitigation measures applicable for Germany for the intended uses in Germany (use No. 00-001 till 00-003) are summarised in the following tables.

Table 9.10-1: Risk assessment for non-target terrestrial plants due to the use of U 46 D Fluid in cereals and grassland (use No. 00-001, 00-002 and 00-003) considering risk mitigation applicable for Germany

Intended use 00-001, 00-002, 00-003 Active substance/product 2,4-D/U 46 D Fluid Application rate (g/ha) 1× 750 MAF 1

Buffer Entry via spray- Entry via deposi- PERoff-field; conventional and drift reducing technique zone drift tion following volatilization 0% conv. 50% red. 75% red. 90% red. (m) (%) (g/ha) (%) (g/ha) (g/ha)

1 2.77 27.0 -- -- 20.78 10.39 5.19 2.08 5 0.57 5.7 -- -- 4.28 2.14 1.07 0.43

Relevant toxicity endpoint: ER50 = 19.2 g a.s./ha (Lactuca sativa) Relevant TER: 5

Buffer zone [m] TER 1 0.9 1.8 3.7 9.2 5 4.5 9.0 18.0 44.9 034066-00/00 / U 46 D Fluid Page 13 /15 Part B – Section 9 - Core Assessment Template for chemical PPP zRMS version Version August 2015

Risk mitigation measures NT 103 MAF: Multiple application factor; PER: Predicted environmental rates; TER: toxicity to exposure ratio. Criteria values shown in bold breach the relevant trigger.

Consequences for authorization: For the authorization of the plant protection product U 46 F Fluid following labeling and conditions of use are mandatory:

Conditions for use

All uses NT 103

9.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)

Not relevant

9.12 Monitoring data (KCP 10.8)

Not relevant

9.13 Classification and Labelling

Please refer to the core assessment.

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9.14 Restrictions linked to the PPP and specific restrictions linked to the intended uses resulting from ecotoxicological assessment

An authorisation of the plant protection product U 46 D Fluid is not possible for the following uses: Use No. Reason

00-002 Unacceptable risk for aquatic organism due to exposure of surface water of 2,4-D by runoff (see chapter 9.5)

Table 9.14-1 Labelling requirements according to § 36 (3) PflSchG

NW 265 2,4-D: Myriophyllum spicatum NOEC 0.0047 mg/L

Table 9.14-2 Mandatory conditions of use according to § 36 (1) PflSchG (use No 00-001, 00-003)

Use No: 00-001, 00-003

NW 468 NW 605_1 50 %: 5 m, 75 %: 5 m, 90 % * NW 606 conv.: 10 m NW 706 Vegetated buffer strip: 20 m NT103 90 % drift reduction

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Appendix 1 Lists of data considered in support of the evaluation

List of data submitted by the applicant and relied on --

List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review --

List of data submitted by the applicant and not relied on --

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

Appendix 2 Detailed evaluation of the new studies

Not required, since no new data submitted or used for risk assessment for Germany.