Helioterpen Soufre Product Name(S) (Country)

REGISTRATION REPORT Part A Risk Management

Product code: Helioterpen Soufre Product name(s) (Country): Helioterpen Schwefel (Germany/Austria) Helioterpen Soufre/Helioterpen Zwavel (Belgium) Helioterpen Zwavel (the Netherlands) Helioterpen Soufre (Luxembourg) Helioterpen Síra (Czech Republic)

Interzonal (greenhouse) Zonal Rapporteur Member State: Germany

NATIONAL ASSESSMENT Germany (new authorization)

Applicant: ACTION PIN Submission date: 22/03/2017 MS Finalisation date: 14.10.2019

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Version history

When What

- Pre-meeting 22.03.2017 Submission of application 01.09.2017 Addition of information following BVL letter 21.05.2019 First draft for commenting by MS 01.07.2019 Comments from applicant 18.09.2019 Further information about SDS 14.10.2019 Authorisation – upload of final documents on CIRCABC

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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 ...... 6

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

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

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

4 Conclusion of the national comparative assessment (Art. 50 of Regulation (EC) No 1107/2009) ...... 18

5 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorization ...... 18

Appendix 1 Copy of the product authorization (see Appendix 5) ...... 19

Appendix 2 Copy of the product label ...... 20

Appendix 3 Letter of Access ...... 21

Appendix 4 Lists of data considered for national authorization ...... 22

Appendix 5 Copy of the product authorization ...... 47

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PART A RISK MANAGEMENT

1 Details of the application

1.1 Application background

This application was submitted by Action Pin on 22 March 2017 in order to allow the new registration of a new plant protection product under Reg. (EU) 1107/2009 of Helioterpen in Germany.

The application is for the new product Helioterpen Schwefel (Soufre) containing 700 g/L sulphur. The product is intended to be used as a fungicide in greenhouse (protected crops) against Sphaerotheca fuliginea (SPHRFU) and Erysiphe cichoracearum (ERYSCI) in cucumber. It is a suspension concentrate (SC) formulation. Another dossier (extension of use) will be submitted for the uses in field in pome fruits and in grapevines (the extension of use was withdrawn on 25.07.2019).

The GAP is identical in all targeted countries in terms of applied quantities of active substances (the dose expression between countries could vary depending on the national requirements). The zRMS is Germany and the target cMS are the Netherlands, Austria, Belgium, Luxembourg and Czech Republic.

The risk assessment conclusions are based on the information, data and assessments provided in the Reg- istra-tion Report, Part B Sections 1 to 10 and Part C. The information, data and assessments provided in Regis-tration Report, Parts B includes assessment of further data or information as required at national registra-tion by the EU review. National addenda are presented in Part B8 and Part B9 for the use under green-house. It also includes assessment of data and information relating to Helioterpen Schwefel where that data has not been considered in the EU review. Otherwise assessments for the safe use of Helioterpen Schwefel have been made using endpoints agreed in the EU review of sulphur.

This document describes the specific conditions of use and labelling required for the German registration of Helioterpen Schwefel under greenhouse.

1.2 Letters of Access

Action Pin submitted the studies for Helioterpen Schwefel or similar formulations. For the data for the active substance sulphur a letter of access from Julio Cabrero & CIA, member of the Sulfur Task Force, is provided in this submission and grants Action Pin access to the active substance data (existing and future owned by the Sulfur Task Force) submitted at EU level for gaining and maintaining the inclusion of the active substance sulphur.

1.3 Justification for submission of tests and studies

To obtain approval the product Helioterpen Schwefel must meet the conditions of Annex I inclusion of Commission Directive 2009/70 of 25 June 2009 and be supported by dossiers satisfying the requirements according to of Commission Regulation (EU) No 284/ 2013), with an assessment to Uniform Principles, using agreed end-points.

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This application was submitted in order to allow the first approval of this product/use in Germany in accordance with the above.

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

Helioterpen Schwefel was never registered in Germany. Therefore, product data on physical and chemical properties, analytical methods, efficacy, residues, toxicological and ecotoxicological studies have been submitted.

1.4 Data protection claims

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

2 Details of the authorization decision

2.1 Product identity

Product code Helioterpen Soufre Product name in MS Helioterpen Schwefel Authorization number 008989-00/00 Function Fungicide Applicant ACTION PIN Active substance(s) Sulphur 700 g/L (incl. content) Formulation type Suspension Concentrate [SC] Packaging Packaging for professional uses: - 1L bottle (HDPE) - 1L bottle (HDPE/PA) - 10L can (HDPE) - 600L IBC (HDPE) Coformulants of concern for Not applicable national authorizations Restrictions related to identiy Not applicable Mandatory tank mixtures Not applicable Recommended tank mixtures Not applicable

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.

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

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

With respect to fate and ecotoxicology assessment, an authorisation can be granted. Considering an application 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.

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

The evaluation of the application for Helioterpen Schwefel resulted in the decision to grant the authorization on cucumber in glasshouses.

2.3 Substances of concern for national monitoring

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), Eye Dam. 1 categories: Hazard pictograms: GHS05 corrosion

Signal word: Danger Hazard statement(s): H318 Causes serious eye damage.

Precautionary statement(s):

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P101 If medical advice is needed, have product container or label at hand. P102 Keep out of reach of children. P280 Wear protective gloves/protective clothing/eye protection/face protection. P305+P351+P338+ IF IN EYES: Rinse cautiously with water for P310 several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER or doctor/physician. P501 Dispose of contents/container to …. 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: -

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

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

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

None.

2.5 Risk management

2.5.1 Restrictions linked to the PPP

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

Operator protection: SB001 Avoid any unnecessary contact with the product. Misuse can lead to health damage. SB005 If medical advice is needed, have product container or label at hand. SB010 Keep out of the reach of children. SB111 Concerning the requirements for personal protective gear for handling the plant protection product the material safety data sheet and the instructions for use of the plant protection product as well as the guideline "Personal protective gear for handling plant protection prod-ucts" of the Federal Office of Consumer Protection and Food Safety

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(www.bvl.bund.de) must be observed. SB166 Do not eat, drink or smoke when using this product. SE110 Wear tight fitting eye 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. Worker protection: SF245-02 It must be ensured that treated areas/crops may not be entered until the film of the plant protection product has dried. Integrated pest management (IPM)/sustainable use: NN3001 The product is classified as harmful for populations of relevant beneficial insects. NN3002 The product is classified as harmful for populations of relevant predatory mites and spiders. WMFM2 Mode of action (FRAC-group): M2 (for sulphur) Environmental protection NW470 Where applicable, fluids left over from application, granules and their remains as well as 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. NW263 The product is toxic for aquatic invertebrates. Other specific restrictions -

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

Integrated pest management (IPM)/sustainable use: NB6641 The product is classified as non-hazardous to bees, even when the maximum application rate, or concentration if no application rate is stipulated, as stated for authorisation is applied. (B4)

2.5.2 Specific restrictions linked to the intended uses

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

Integrated pest management (IPM)/sustainable use: Relevant for use no. WA861 A visible spray coating may be left on the fruit after application. 001 and 002 Environmental protection: Relevant for use no. None

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2.6 Intended uses (only NATIONAL GAP)

Reg.-No. 008989-00/00 GAP rev.2, date: 2019-08-13 PPP (product name/code): Helioterpen Schwefel Formulation type: SC (a, b) Active substance 1: Schwefel Conc. of as 1: 700.00 g/L (c) Applicant: ACTION PIN Professional use: Yes Zone(s): central/interzonal (d) Non professional use: No Verified by MS: Yes Field of use: Fungicide

1 2 3 4 5 6 7 8 9 10 11 12 13 14 Use- Member Crop and/ F, Pests or Group of Application Application rate PHI Remarks: No. state(s) or situation Fn, pests controlled Method / Timing / Max. Min. interval kg or L g or kg as/ha Water L/ha (days) (e) Fpn Kind Growth number between product / ha e.g. g safener/synergist (crop destina- G, (additionally: devel- stage of a) per applications a) max. rate a) max. rate per min / max per ha tion / purpose Gn, opmental stages of the crop & use (days) per appl. appl. (f) of crop) Gpn pest or pest group) season b) per b) max. total b) max. total rate or crop/ rate per per crop/season I season crop/season 001 DE cucumber G powdery mildew spraying At begin- a) 6 7 days a) plant a) 1.05 kg/ha plant height 3 Corresponding to (CUMSA) (Sphaerotheca fuligi- ning of b) 6 height up to up to 50 cm: LWA: 1.85 L/ha nea) of cucumber infestation 50 cm: 600 L/ha LWA (SPHRFU) and/or 1.5 L/ha L.product/hL (min- when first a) plant a) 1.75 kg/ha plant height max): 0.3 L/hL – 1 symptoms height 50 up 50 up to 125 L/hL become to 125 cm: cm: visible 2.5 L/ha 900 L/ha a) plant a) 2.10 kg/ha plant height height more more than than 125 cm: 125 cm: 3 L/ha 1200 L/ha b) 18 L/ha b) 12,6 kg/ha 002 DE cucumber G powdery mildew (Ery- spraying At begin- a) 6 7 days a) plant a) 1.05 kg/ha plant height 3 Corresponding to (CUMSA) siphe cichoracearum) ning of b) 6 height up to up to 50 cm: LWA: 1.85 L/ha (ERYSCI) infestation 50 cm: 1.5 600 L/ha LWA and/or L/ha L.product/hL (min- when first a) plant 1.75 kg/ha plant height max): 0.3 L/hL – 1 symptoms height 50 up 50 up to 125 L/hL become to 125 cm: cm:

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visible 2.5 L/ha 900 L/ha a) plant 2.10 kg/ha plant height height more more than than 125 cm: 125 cm: 3 L/ha 1200 L/ha b) 18 L/ha b) 12,6 kg/ha

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

Remarks 1 Numeration necessary to allow references 8 The maximum number of application possible under practical conditions of use must be provided. columns: 2 Use official codes/nomenclatures of EU Member States 9 Minimum interval (in days) between applications of the same product 3 For crops, the EU and Codex classifications (both) should be used; when relevant, the 10 For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty use situation should be described (e.g. fumigation of a structure) rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products. 4 F: professional field use, Fn: non-professional field use, Fpn: professional and non- 11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g, kg professional field use, G: professional greenhouse use, Gn: non-professional green- or L product / ha). house use, Gpn: professional and non-professional greenhouse use, I: indoor application 5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when relevant, 12 If water volume range depends on application equipment (e.g. ULVA or LVA) it should be mentioned the common names of the pest groups (e.g. biting and sucking insects, soil born in- under “application: method/kind”. sects, foliar fungi, weeds) and the developmental stages of the pests and pest groups at 13 PHI - minimum pre-harvest interval the moment of application must be named. 14 Remarks may include: Extent of use/economic importance/restrictions 6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated. 7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 38263-3152-4), including where relevant, information on season at time of application

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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 beige/yellow opaque liquid, with a medium sulphur odour. It is not explosive, has no oxidising properties. The product is not flammable. It has a self- ignition temperature of 281 °C. In aqueous solution, it has a pH value around 6.9 at 20.8 °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 were changed. The stability data indicate a shelf life of at least 2 years at ambient temperature when stored in HDPE layered packaging, although it still have to be confirmed by an ongoing GLP study as detailed in table 2-1. Its technical characteristics are acceptable for a SC formulation. The intended concentration of use is 0.14% v/v to 6.88% v/v.

Justified Proposals for Classification and Labelling (KCP 12) for physical chemical part only According to CLP Regulation (Regulation (EC) No 1272/2008), Helioterpen Soufre shall not be classified for physical chemical part.

Notifier Proposals for Risk and Safety Phrases (KCP 12) Helioterpen Soufre is not classified under Regulation (EC) No 1272/2008 for physical chemical properties and is compliant with the FAO specifications, before and after the required storage procedures.

Therefore no specific Risk and Safety phrases are required for Helioterpen Soufre.

Compliance with FAO specifications: The product Helioterpen Soufre complies with FAO specifications for SC formulations, according to the Manual on development and use of FAO and WHO specifications for Pesticides, First edition, Third revi- sion (2016).

Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents of the packaging, have been submitted, evaluated and is considered to be acceptable.

Nature and characteristics of the protective clothing and equipment: Information regarding the required protective clothing and equipment for the safe handling of Helioterpen Soufre has been provided and is considered to be acceptable.

3.2 Efficacy (Part B, Section 3)

Helioterpen Soufre contains 700 g/L sulphur and is for professional use as a foliar treatment on cucumber under protected conditions against powdery mildews (Sphaerotheca fuliginea and Erysiphe cichoracearum)

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3.3 Efficacy data

Preliminary range finding tests were not submitted and are not considered necessary because the active substance is well known and has been used for years to control powdery mildews. The co-formulant of the product was changed in 2016, therefore the applicant submitted bridging trials to prove the comparability of the formulations. The formulations are similar enough to justify the use of data from both sulphur formulations for the evaluation. A dose rate of 3 L/ha is acceptable as minimum effective dose rate. Dose reduction resulted in a decrease of disease control. The submitted information on efficacy supports the proposed claim of control against powdery mildews on cucumber.

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

As a multi-site inhibitor sulphur is considered to be at low risk of inducing resistance in the target diseases. Cross-resistance with other fungicide classes used against powdery mildew such as CAA, QoI, cymoxanil and phenylamines can be excluded. No further risk mitigation measures are necessary.

3.3.2 Adverse effects on treated crops

Phytotoxicity did not occur in any of the submitted trials. No further information is necessary. Effects on the quantity of yield or yield components are not expected. The quality of plants or plant products is not adversely effected. Nevertheless, in two trials, residues of the spray applications were visible and the fruits had to be washed. Accordingly, a label warning was added. Cucumbers are only used fresh and will not be processed, therefore no information on possible effects on transformation processes was necessary. The crop is not used for propagation purposes. No data regarding an impact on treated plants or plant products to be used for propagation is required.

3.3.3 Observations on other undesirable or unintended side-effects

An impact on succeeding crops, other plants including adjacent crops has not been previously reported, therefore, no undesirable or unintended side-effects are expected. Laboratory tests indicate a detrimental effect of the product towards populations of beneficial insects and relevant predatory mites and spiders. A label warning was added.

3.4 Methods of analysis (Part B, Section 5)

3.4.1 Analytical method for the formulation

An analytical HPLC-UV method for the determination of sulphur in Helioterpen Soufre was provided and was considered acceptable according to SANCO/3030/99 rev.4.

The plant protection product Helioterpen Soufre does not contain relevant impurities which are formed during manufacturing or storage of the product. Therefore, methods for determination of impurities and formulants of toxicological, ecotoxicological or environmental concern are not required.

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3.4.2 Analytical methods for residues

Analytical methods for the determination of residues of sulfur in food and feed commodities are not required as no MRL are set for sulfur. Analytical methods for residues in soil, water and air are also not required considering that sulfur is a naturally occurring low toxic active substance. Methods for body fluids and tissues are not required, because sulfur is not considered to be toxic or very toxic (T / T+) nor is it classified according to GHS as follows: Acute toxicity (cat. 1 - 3), CMR (cat. 1) or STOT (cat. 1).

3.5 Mammalian toxicology (Part B, Section 6)

3.5.1 Acute toxicity

All toxicological studies submitted were carried out using a similar formulation, i.e. Heliosoufre S. These studies are deemed applicable for Helioterpen Schwefel. Helioterpen Schwefel, containing 700 g/L sulphur, has a low toxicity with respect to acute oral and dermal toxicity. Its acute inhalation toxicity is not determined. 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 (not derived, but background of normal dietary sulphur intake, i.e. 26 mg/kg bw/d taken as a surrogate reference value for risk assessment). No data on dermal absorption for sulphur in Helioterpen Schwefel are available. Therefore, default values are 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 Helioterpen Schwefel in cucumber is acceptable with the use of personal protective equipment described in 2.5.1.

3.5.3 Worker exposure

The worker exposure was estimated using the EFSA model. Even without any PPE the estimated consumption of the normal dietary sulphur intake was below 60 %. It is concluded that there is no unacceptable risk anticipated for the worker wearing adequate work clothing (but no PPE), when re-entering crops treated with Helioterpen Schwefel. As a standard rule treated crops should not be re-entered before spray deposits on leaf surfaces have completely dried.

3.5.4 Bystander and resident exposure

Not relevant since only greenhouse applications are intended.

3.6 Residues and consumer exposure

The residue behaviour of the active substance sulphur has been evaluated within the EU review process. Information about metabolism is sufficient to evaluate the intended uses.

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3.6.1 Residues

Residue studies were not considered relevant for evaluation nor were they considered necessary for An- nex I inclusion (Commission Directive 2008/127/EC) due to the nature and properties of the active substance. As no MRLs are required; the substance was included in annex IV to Regulation (EC) No 396/2005. No Part B Section 7 is prepared by the zonal RMS.

3.6.2 Consumer exposure

No risk assessment is necessary due to the intrinsic properties of the active ingredient. Chronic as well as short-term intake of sulphur residues is unlikely to present a public health concern.

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

3.7.1 Predicted environmental concentrations in soil (PECsoil)

PECsoil was calculated for the active substance sulfur considering a soil depth of 1 cm. The accumulation potential of sulfur was not considered because the inorganic compound is not persistent in its elemental form and will be oxidated in soil. The PECsoil values for the active substance were used in the ecotoxicological risk assessment for the intended uses of the plant protection product Helioterpen Schwefel in Germany.

3.7.2 Predicted environmental concentrations in groundwater (PECgw)

Direct leaching into groundwater As indicated in the core assessment the active substance sulfur applied to soil in amounts of the intended use as plant protection procuct is not of concern for the contamination of groundwater. There is no need to estimate the risk for groundwater contamination for the active substance sulfur according to use No. 00-001 and 00-002.

For the degradation product sulfate of sulfur concentrations of ≥ 0.1µg/L in groundwater cannot be excluded. According to the PECGW modelling with the worst case flux method a groundwater contamination of sulfate at a concentration of ≥ 0.1 µg/L is expected for the groundwater Scenario Hamburg relevant for authorisation in Germany. A maximum PECGW of 8.3 mg/L is estimated for the scenario Hamburg in the intended uses No. 00-001 and 00-002 of Helioterpen Schwefel in cucumbers.

The worst case PECGW estimation gave evidence, that the concentrations of sulfate in groundwater is lower than the limit value of 250 mg/L for drinking water (Directive 98/83/CE). In conclusion, no risk for groundwater occurs from the intended uses 00-001 and 00-002 of Helioterpen Schwefel in cucumbers.

Groundwater contamination by bank filtration due to surface water exposure via runoff and drainage Groundwater contamination at concentrations ≥ 0.1 µg/L by the degradation product sulfate due to surface runoff and drainage into the adjacent ditch with subsequent bank filtration cannot be excluded according to the results of conservative PEC modelling based on the principles of EXPOSIT 3.

PECGW of 3.6 mg/L were estimated after runoff into the adjacent ditch with subsequent bank filtration for the use of Helioterpen Schwefel in cucumbers (00-001, 00-002). It has to be taken into account, that the exposure of sulfate in groundwater by bank filtration due to surface water exposure via runoff from both

Helioterpen Sourfe / Helioterpen Schwefel (ZV1 008989-00/00) Page 16 /47 Part A - National Assessment Template for chemical PPP MS version MS finalization date: 14.10.2019 intended uses 00-001 and 00-002 in greenhouses would be negligible. Additionally ,PECGW of 1.2 mg/L were estimated after drainage and subsequent bank filtration for the use of Helioterpen Schwefel in cucumbers.

The PECGW estimation gave evidence, that the concentrations of sulfate in groundwater are much lower than the limit of 250 mg/L for drinking water (Directive 98/83/CE, TrinkwV 2012). Finally, no risk for groundwater occurs from both intended uses (00-001, 00-002) of Helioterpen in cucumbers.

3.7.3 Predicted environmental concentrations in surface water (PECsw)

Surface water exposure was assessed in the core assessment for all uses applied for in Germany. For the intended uses 00-001 and 00-002 of Helioterpen Schwefel in cucumbers in the greenhouse, this assessment is also valid for a national authorisation in Germany.The results of the specific national exposure assessment for the active substance were used in the eco-toxicological risk assessment.

3.7.4 Predicted environmental concentrations in air (PECair)

Elemental sulfur from Helioterpen Schwefel is classified as semivolatile, because a vapour pressure between 10-5 and 10-4 Pa (9.8 x 10-5 Pa) was measured at 20 °C. Therefore, a volatilisation of the active substance from plant surfaces into the air can be expected. As a consequence, exposure of adjacent surface waters and terrestrial ecosystems by the active substance sulfur due to volatilization with subsequent deposition should be normally considered, for example by using the program EVA 2.1. However, it is highly questionable, if the deposition rate of the elemental sulfur to adjacent surface water bodies is comparable to measured values from studies with organic pesticides, which are usually used in the EVA 2.1. The deposition rate for elemental sulfur might be quite low under field conditions and the pathway via volatilization and deposition to adjacent water bodies seems negligible. Therefore exposure of adjacent surface waters and terrestrial ecosystems by the active substance sulfur due to volatilization with subsequent deposition was not considered.

3.8 Ecotoxicology (Part B, Section 9)

3.8.1 Effects on terrestrial vertebrates

The risk to birds and mammals was assessed in the core assessment for all uses applied for in Germany. The results of this assessment indicate an acceptable risk for birds and mammals due to the intended use of Helioterpen Schwefel in cucumber according to the label.

3.8.2 Effects on aquatic species

The risk to aquatic organisms was assessed in the core assessment for all uses applied for in Germany. For the uses in the greenhouse, this assessment is also valid for a national authorisation in Germany. Its results indicate an acceptable risk for aquatic organisms without a need for risk mitigation measures due to the intended use of Helioterpen Schwefel in cucumber according to the label.

Labelling requirements according to § 36 (3) PflSchG NW263 Sulfur: Daphnia magna NOEC = 0.8 mg/L

Mandatory conditions of use according to § 36 (1) PflSchG for the protection of aquatic organisms (product)

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SP1 SP1: Do not contaminate water with the product or its container (Do not clean application equipment near surface water./Avoid contamination via drains from farmyards and roads). NW470 Where applicable, fluids left over from application, granules and their remains as well as 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.

3.8.3 Effects on bees

Effects on bees for Helioterpen Schwefel were not evaluated as part of the EU review of sulphur. Risk assessments for Helioterpen Schwefel with the proposed use pattern were provided with a comparable formulation and are considered adequate.

The risks of Helioterpen Schwefel to honey-bees were assessed from hazard quotients between toxicity endpoints, estimated from acute oral and contact studies with active ingredient and formulated product, and the maximum single application rate of 4065 g formulation/ha (2100 g a.s./ha).

Max. single appli- Exposure LD50 Hazard quo- HQ Test substance cation rate route (µg prod./bee) tient (HQ) trigger (g prod./ha)

oral > 100 µg 40.65 Helioterpen Schwe- 4065 50 fel* contact > 100 µg 40.65 * tested as Heliosoufre S (710 g sulphur/L)

All the hazard quotients are less than 50, indicating that the active ingredient poses a low risk to bees.

The already provided data does not indicate unacceptable risks for honey bees and bee colonies or other managed bee species and taking into account all information available at present, the subsequent provision of the required data on chronic toxicity can be carried out in support of the authorisation procedure for the plant protection product within 18 months after the approval.

For the time being, the product is classified as non-hazardous to bees when applied up to the maximum application rate.

3.8.4 Effects on other arthropod species other than bees

The risk to non-target arthropods in off-field habitats was assessed in the core assessment for all uses applied for in Germany. For the uses in the greenhouse, this assessment is also valid for a national authorisation in Germany. Its results indicate an acceptable risk for non-target arthropods in off-field habitats without a need for risk mitigation measures due to the intended use of Helioterpen Schwefel in cucumber according to the label.

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3.8.5 Effects on soil organisms

Earthworms The risk to earthworms was assessed in the core assessment for all uses applied for in Germany. The results of this assessment indicate an acceptable risk for earthworms in off-field habitats due to the intended use of Helioterpen Schwefel in cucumber according to the label. Since the calculated TER values confirm a large margin of safety of the zonal risk assessment, its conclusions are also valid for the specific conditions in Germany. Other organisms of the soil macro- and mesofauna No risk assessment was required. All available information indicate that risk for other organisms of the soil macro- and mesofauna due to the intended use of Helioterpen Schwefel in cucumber according to the label is acceptable. Soil microorganisms The risk to soil microorganisms was assessed in the core assessment for all uses applied for in Germany. The results of this assessment indicate an acceptable risk for soil microorganisms due to the intended use of Helioterpen Schwefel in cucumber according to the label.

3.8.6 Effects on non-target terrestrial plants

The risk to non-target terrestrial plants was assessed in the core assessment for all uses applied for in Germany. For the uses in the greenhouse, this assessment is also valid for a national authorisation in Germany. Its results indicate an acceptable risk for non-target terrestrial plants without a need for risk mitigation measures due to the intended use of Helioterpen Schwefel in cucumber according to the label.

3.8.7 Effects on other terrestrial organisms (Flora and Fauna)

See core assessment – no assessment required.

3.9 Relevance of metabolites (Part B, Section 10)

There are no metabolites to be considered in the ecotoxicological risk assessment for an inorganic mineral as active substance.

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

The active substance sulphur 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

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

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Appendix 2 Copy of the product label

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

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Appendix 3 Letter of Access

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

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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 protec- Owner Company Report No. brate protection tion is claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not KCP 2.1 Demangel B. 2016a Physico-chemical tests on HELIOTERPEN SOUFRE N Y Data/study report never sub- Action Pin Report No 16-901011-001 mitted before Germany DEFITRACES, Brindas, France GLP Unpublished BVL 3290588 KCP 2.3 Demangel B. 2016a Physico-chemical tests on HELIOTERPEN SOUFRE N Y Data/study report never sub- Action Pin Report No 16-901011-001 mitted before Germany DEFITRACES, Brindas, France GLP Unpublished BVL 3290589 KCP 2.4 Demangel B. 2016b Physico-chemical tests and analyses before and after an N Y Data/study report never sub- Action Pin accelerated storage procedure for 14 days at 54 °C ± 2 °C on mitted before Germany HELIOTERPEN SOUFRE Report No 16-901011-003 DEFITRACES, Brindas, France GLP Unpublished BVL 3290590 KCP 2.5 Demangel B. 2016a Physico-chemical tests on HELIOTERPEN SOUFRE N Y Data/study report never sub- Action Pin Report No 16-901011-001 mitted before Germany DEFITRACES, Brindas, France GLP Unpublished BVL 3290591

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Data point Author(s) Year Title Verte- Data Justification if data protec- Owner Company Report No. brate protection tion is claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not KCP 2.6 Demangel B. 2016a Physico-chemical tests on HELIOTERPEN SOUFRE N Y Data/study report never sub- Action Pin Report No 16-901011-001 mitted before Germany DEFITRACES, Brindas, France GLP Unpublished BVL 3290592 KCP 2.7 Demangel B. 2016c Physico-chemical tests and chemical analysis after a low N Y Data/study report never sub- Action Pin temperature stability at 0 ± 2 °C for 7 days on HELIOTERPEN mitted before Germany SOUFRE Report No 16-901011-002 DEFITRACES, Brindas, France GLP Unpublished BVL 3290593 KCP 2.7 Demangel B. 2016b Physico-chemical tests and analyses before and after an N Y Data/study report never sub- Action Pin accelerated storage procedure for 14 days at 54 °C ± 2 °C on mitted before Germany HELIOTERPEN SOUFRE Report No 16-901011-003 DEFITRACES, Brindas, France GLP Unpublished BVL 3290594 KCP 2.8.2 Demangel B. 2016b Physico-chemical tests and analyses before and after an N Y Data/study report never sub- Action Pin accelerated storage procedure for 14 days at 54 °C ± 2 °C on mitted before Germany HELIOTERPEN SOUFRE Report No 16-901011-003 DEFITRACES, Brindas, France GLP Unpublished BVL 3290595 KCP 2.8.3 Demangel B. 2016b Physico-chemical tests and analyses before and after an N Y Data/study report never sub- Action Pin accelerated storage procedure for 14 days at 54 °C ± 2 °C on mitted before Germany HELIOTERPEN SOUFRE Report No 16-901011-003

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Data point Author(s) Year Title Verte- Data Justification if data protec- Owner Company Report No. brate protection tion is claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not DEFITRACES, Brindas, France GLP Unpublished BVL 3290596 KCP 2.8.3 Demangel B. 2016c Physico-chemical tests and chemical analysis after a low N Y Data/study report never sub- Action Pin temperature stability at 0 ± 2 °C for 7 days on HELIOTERPEN mitted before Germany SOUFRE Report No 16-901011-002 DEFITRACES, Brindas, France GLP Unpublished BVL 3290597 KCP 2.8.5.1 Demangel B. 2016b Physico-chemical tests and analyses before and after an N Y Data/study report never sub- Action Pin accelerated storage procedure for 14 days at 54 °C ± 2 °C on mitted before Germany HELIOTERPEN SOUFRE Report No 16-901011-003 DEFITRACES, Brindas, France GLP Unpublished BVL 3290598 KCP 2.8.5.1 Demangel B. 2016c Physico-chemical tests and chemical analysis after a low N Y Data/study report never sub- Action Pin temperature stability at 0 ± 2 °C for 7 days on HELIOTERPEN mitted before Germany SOUFRE Report No 16-901011-002 DEFITRACES, Brindas, France GLP Unpublished BVL 3290599 KCP 2.8.7 Demangel B. 2016b Physico-chemical tests and analyses before and after an N Y Data/study report never sub- Action Pin accelerated storage procedure for 14 days at 54 °C ± 2 °C on mitted before Germany HELIOTERPEN SOUFRE Report No 16-901011-003 DEFITRACES, Brindas, France GLP

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Data point Author(s) Year Title Verte- Data Justification if data protec- Owner Company Report No. brate protection tion is claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not Unpublished BVL 3290600 KCP 3.8 Anonymous 2017 draft Label Helioterpen Schwefel N N Data/study report never sub- –Word- mitted before Germany ACTION PIN, Castets, France non GLP/GEP published BVL 3292423 KCP 3.8 Anonymous 2017 draft Label Helioterpen Schwefel N N Data/study report never sub- ACTION PIN, Castets, France mitted before Germany non GLP/GEP published BVL 3305392 KCP 3.8 Anonymous 2017 Helioterpen Schwefel (draft label, Germany) N N Data/study report never sub- –Word- mitted before Germany ACTION PIN, Castets, France non GLP/GEP published BVL 3391324 KCP 3.8 Anonymous 2017 Helioterpen Schwefel (draft label, Germany)l N N Data/study report never sub- ACTION PIN, Castets, France mitted before Germany non GLP/GEP published BVL 3391323 KCP 5.1.1 Ricau H. 2016 Validation of the analytical method for the determination of N Y Data/study report never sub- Action Pin sulphur in HELIOTERPEN SOUFRE mitted before Germany Report No 16-901011-005 DEFITRACES, Brindas, France GLP Unpublished BVL 3290601 KCP 6.0 Giraud, F. 2017 Biological Assessment dossier – Helioterpen Soufre N Y Data/study report never sub- Action Pin ACTION PIN mitted before Germany Not GLP Unpublished

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Data point Author(s) Year Title Verte- Data Justification if data protec- Owner Company Report No. brate protection tion is claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not BVL 3290602 KCP 6.0 Giraud, F. 2017 Biological Assessment dossier – Helioterpen Soufre –Word- N Y Data/study report never sub- Action Pin ACTION PIN mitted before Germany Not GLP Unpublished BVL 3290603 KCP 6.0 Giraud, F. 2017 Biological Assessment dossier – Helioterpen Soufre –Word- N Y Data/study report never sub- Action Pin ACTION PIN mitted before Germany Not GLP Unpublished BVL 3391340 KCP 6.2/01 De Rooster, 2016 The efficacy of Helioterpen Soufre against powdery mildew in N Y Data/study report never sub- Action Pin L. greenhouse cucumber mitted before Germany GEP-kk16ecmi-red Proefstation Voor de Groenteteelt GEP Unpublished BVL 3290604 KCP 6.2/02 Bylemans, D. 2017 Determination of eficacy and selectivity of the fungicide N Y Data/study report never sub- Action Pin Heloterpen Soufre (sulphur; 700,0 L) against Venturia inaequalis mitted before Germany on apple tree, 2016 16M/VENTIN/JONA/V1/RED/GEP-26 Proefcentrum Fruitteelt v.z.w. (pcfruit) GEP Unpublished BVL 3292400 KCP 6.2/03 Koch, M. 2014 GEP Efficacy trial of Heloterpen Soufreand effect of adjuvants of N Y Data/study report never sub- Action Pin sulphur based products against appel scab, Germany, 2014 mitted before Germany MKH-14-17611-DE01 GEP Unpublished BVL 3290606 KCP 6.2/04 Koch, M. 2014 GEP Efficacy trial of HELIOTERPEN SOUFRE and effect of N Y Data/study report never sub- Action Pin adjuvants on sulphur based products against apple scab, Germany, mitted before Germany

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Data point Author(s) Year Title Verte- Data Justification if data protec- Owner Company Report No. brate protection tion is claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not 2014 MKH-14-17611-DE02 GEP Unpublished BVL 3290607 KCP 6.2/05 Motais, F. 2013 Determination of efficacy of HELIOTERPEN SOUFRE against N Y Data/study report never sub- Action Pin powdery mildew (Uncinula necator) in vine, 1 site in Germany, mitted before Germany 2013 S13-01725-01 GEP Unpublished BVL 3290608 KCP 6.2/06 Motais, F. 2015 Determination of efficacy of HELIOTERPEN SOUFRE against N Y Data/study report never sub- Action Pin powdery mildew (Uncinula necator) in grapevine, 1 site in mitted before Germany Germany, 2015 S15-02624-01 GEP Unpublished BVL 3290609 KCP 6.2/07 Motais, F. 2015 Determination of efficacy of HELIOTERPEN SOUFRE against N Y Data/study report never sub- Action Pin powdery mildew (Uncinula necator) in grapevine, 1 site in mitted before Germany Germany, 2015 S15-02624-03 GEP Unpublished BVL 3290610 KCP 6.2/08 Motais, F. 2015 Determination of efficacy of HELIOTERPEN SOUFRE against N Y Data/study report never sub- Action Pin powdery mildew (Uncinula necator) in grapevine, 1 site in mitted before Germany Germany, 2015 S15-02624-04 GEP Unpublished BVL 3290611 KCP 6.2/09 Perrin, E. 2016 Efficacy against powdery mildew on cucumber, under greenhouse N Y Data/study report never sub- Action Pin

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Data point Author(s) Year Title Verte- Data Justification if data protec- Owner Company Report No. brate protection tion is claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not conditions in Germany 2015 mitted before Germany 15-00092-01 SGS (trial permorfed by Biochem Agrar GmbH) GEP Unpublished BVL 3290612 KCP 6.2/10 Perrin, E. 2016 Efficacy against powdery mildew on cucumber, under greenhouse N Y Data/study report never sub- Action Pin conditions in Germany 2015 mitted before Germany 15-00092-02 SGS (trial performed by Biochem Agrar GmbH) GEP Unpublished BVL 3290613 KCP 6.2/11 Robyns, R. 2016 Determination of efficacy and selectivity of the fungicide N Y Data/study report never sub- Action Pin Helioterpen Soufre against Venturia inaequalis on apple tree, mitted before Germany 2016 ARI-16-F-049-01 GEP Unpublished BVL 3290614 KCP 6.2/12 Robyns, R. 2016 Determination of efficacy and selectivity of the fungicide N Y Data/study report never sub- Action Pin Helioterpen Soufre against Venturia inaequalis on apple tree, mitted before Germany 2016 161004 GEP Unpublished BVL 3290615 KCP 6.2/13 Robyns, R. 2016 Determination of efficacy and selectivitu of the fungicide N Y Data/study report never sub- Action Pin Helioterpen Soufre against Venturia inaequalis on apple mitted before Germany H-16-O-238-01 GEP Unpublished BVL 3290616 KCP 6.2/14 Robyns, R. 2016 Determination of efficacy and selectivity of the fungicide N Y Data/study report never sub- Action Pin

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Data point Author(s) Year Title Verte- Data Justification if data protec- Owner Company Report No. brate protection tion is claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not Helioterpen Soufre against Uncinula necator on grapevine mitted before Germany H-16-W-238-01 GEP Unpublished BVL 3290617 KCP 6.2/15 Robyns, R. 2016 Determination of efficacy and selectivity of the fungicide N Y Data/study report never sub- Action Pin Helioterpen Soufre against Powdery mildew on cucumber, 2016 mitted before Germany 2865 GEP Unpublished BVL 3290618 KCP 6.2/16 Robyns, R. 2016 Determination of efficacy and selectivity of the fungicide N Y Data/study report never sub- Action Pin Helioterpen Soufre against Erysiphe cichoracearum (powdery mitted before Germany mildew) on cucumber on normal conditions under greenhouse, 2016 16 1069 5116 REDEBEL (trial performed byBiochem Agrar GmbH) GEP Unpublished BVL 3290619 KCP 6.2/17 Robyns, R. 2016 Determination of efficacy and selectivity of the fungicide N Y Data/study report never sub- Action Pin Helioterpen Soufre against powdery mildew on cucumber mitted before Germany H-16-V-240 REDEBEL (trial performed by Agro Trial Center, GmbH) GEP Unpublished BVL 3290620 KCP 6.2/18 Villeton, C. 2013 Fungicide Vine Efficacy on powdery mildew N Y Data/study report never sub- Action Pin 13ACF5044GE501 mitted before Germany GEP Unpublished BVL 3290621 KCP 6.2/19 Zickart, U. 2014 Efficacy against powdery mildew on cucumber, under greenhouse N Y Data/study report never sub- Action Pin conditions mitted before Germany

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Data point Author(s) Year Title Verte- Data Justification if data protec- Owner Company Report No. brate protection tion is claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not 14 1047 1364 Biochem Agrar GmbH GEP Unpublished BVL 3290622 KCP 6.4/01 Agulhon, O., 1996 Rapport d’étude des effets non intentionnels sur l’élaboration et la N Y Data/study report never sub- Action Pin Volle, C. qualité des mouts et des vins mitted before to Germany 94F0300401 Viti R&D Not GEP Not published BVL 3290623 KCP 6.4/02 Buysen S. 2017 Taint study on apples HELIOTERPEN SOUFRE CF151 and N Y Data/study report never sub- Action pin and Gobin B. CF116 mitted before to Germany SM16APGB01_04 PCG – Vegetable Research Centre GEP Unpublished BVL 3290624 KCP 6.4/03 Anonymous 2008 Influence d’une pulvérisation foliaire azotée sur le potentiel aro- N Y Data/study report never sub- Action Pin matique en thiols variétaux du Muscat à petits grains mitted before to Germany V0803F Chambre d’Agriculture du Roussillon Not GEP Not published BVL 3290625 KCP 6.4/04 Cuinier, C., 1995 Etude des effets non intentionnels de produits phytopharmaceu- N Y Data/study report never sub- Action Pin Laurent, J.C. tiques sur l’élaboration et la qualité du vin mitted before to Germany ITV Orange 94F0300201 Not GEP Not published BVL 3290626 KCP 6.4/05 Dufourcq, T. 2008 Evaluation de l’efficacité des préparations commerciales HELIO- N Y Data/study report never sub- Action Pin

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Data point Author(s) Year Title Verte- Data Justification if data protec- Owner Company Report No. brate protection tion is claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not SOUFRE et fertipen de la société Action Pin utilisées en pulvéri- mitted before to Germany sation foliaire sur la qualité aromatique d’un vin de Colombard produit dans les vignobles du Sud-Ouest de la France 08/01/AP/VI IFV Sud Ouest Not GEP Not published BVL 3290627 KCP 6.4/06 Motais, F. 2015 Determination of efficacy of HELIOTERPEN SOUFRE against N Y Data/study report never sub- Action Pin powdery mildew (Uncinula necator) in grapevine, 1 site in mitted before to Germany Germany, 2015 S15-02624-02 Eurofins Agroscience Service GmbH GEP Unpublished BVL 3290628 KCP 6.4/07 Noe P., Grau 1990 Compte rendu des essais réalisés en appliquant la méthode CEB N Y Data/study report never sub- Action Pin H. n°143 concernant la première phase de la méthode « étude en mitted before to Germany plein champ » dans le cas d’obtention des vins 90F0300201 Laboratoire œnologique Phillipe Noé Not GEP Not published BVL 3290629 KCP 6.4/08 Vinsonneau, 1995 Etude des effets non intentionnels de produits phytopharmaceu- N Y Data/study report never sub- Action Pin M. tiques (anti oïdium) sur l’élaboration et la qualité des vins (Mini- mitted before to Germany Barrere, C. vinification avec deux dégustations) Cuinier, C. 94F0300101 ITV Bordeaux Not GEP Not published BVL 3290630 KCP 6.4/09 Zickart, U. 2014 HELIOTERPEN SOUFRE fungicide used to control powdery N Y Data/study report never sub- Action Pin mildew of grapevine mitted before to Germany

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Data point Author(s) Year Title Verte- Data Justification if data protec- Owner Company Report No. brate protection tion is claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not 14 1069 5031 Biochem Agrar GmbH GEP Unpublished BVL 3290631 KCP 6.4/10 Zickart U. 2014 HELIOTERPEN SOUFRE fungicide used to control powdery N Y Data/study report never sub- Action Pin mildew of grapevine mitted before to Germany 14 1061 1365 Biochem Agrar GmbH GEP Unpublished BVL 3290632 KCP 6.4/11 Agulhon, O.; 1996 English Translation of KCP 6.4/01 N Y Data/study report never sub- Action Pin Volle, C. Rapport d’étude des effets non intentionnels sur l’élaboration et la mitted before to Germany qualité des mouts et des vins 94F0300401 Viti R&D Not GEP Not published BVL 3290633 KCP 6.4/12 Anonymous 2008 English Translation of KCP 6.4/03 N Y Data/study report never sub- Action Pin Influence d’une pulverization foliaire azotée sur le potentiel aro- mitted before to Germany matique en thiols variétaux du Muscat à petits grains V0803F Chambre d’Agriculture du Roussillon Not GEP Not published BVL 3290634 KCP 6.4/13 Cuinier, C.; 1995 English Translation of KCP 6.4/04 N Y Data/study report never sub- Action Pin Laurent, J.C. Etude des effets non intentionnels de produits phytopharmaceu- mitted before to Germany tiques sur l’élaboration et la qualité du vin ITV Orange 94F0300201 Not GEP

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Data point Author(s) Year Title Verte- Data Justification if data protec- Owner Company Report No. brate protection tion is claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not Not published BVL 3290635 KCP 6.4/14 Dufourcq, T. 2009 English Translation of KCP 6.4/05 N Y Data/study report never sub- Action Pin Evaluation de l’efficacité des préparations commercials HELIO- mitted before to Germany SOUFRE et fertipen de la société Action Pin utilisées en pulvéri- sation foliaire sur la qualité aromatique d’un vin de Colombard produit dans les vignobles du Sud-Ouest de la France 08/01/AP/VI IFV Sud Ouest Not GEP Not published BVL 3290636 KCP 6.4/15 Noe, P.; 1990 English Translation of KCP 6.4/07 N Y Data/study report never sub- Action Pin Grau, H. Compte rendu des essais réalisés en applicant la méthode CEB mitted before to Germany n°143 concernant la première phase de la méthode « étude en plein champ » dans le cas d’obtention des vins 90F0300201 Laboratoire œnologique Phillipe Noé Not GEP Not published BVL 3290637 KCP 6.4/16 Vinsonneau 1995 English Translation of KCP 6.4/08 N Y Data/study report never sub- Action Pin M.; Etude des effets non intentionnels de produits phytopharmaceu- mitted before to Germany Barrere, C.; tiques (anti oïdium) sur l’élaboration et la qualité des vins (Mini- Cuinier, C. vinification avec deux dégustations) 94F0300101 ITV Bordeaux Not GEP Not published BVL 3290638 KCP 7.1.1 XXXXX 1993a Acute Oral Toxicity Study in Rats of the preparation Y Y Data/study report never sub- Action Pin HELIOSOUFRE S – Batch 31007 (limit test) mitted before Germany Report n° T 830/1952 EVIC-CEBA laboratories, France

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Data point Author(s) Year Title Verte- Data Justification if data protec- Owner Company Report No. brate protection tion is claimed Source (where different from company) study claimed GLP or GEP status Y/N Y/N Published or not Non GLP Unpublished BVL 3290639 KCP 7.1.2 XXXXX 1993b Acute Dermal Toxicity Study in the Rat of the preparation Y Y Data/study report never sub- Action Pin HELIOSOUFRE S – Batch 31007 (Limit test) mitted before Germany Report n° T831/1952 Report n° (EVIC-CEBA laboratories, France) Non GLP Unpublished BVL 3290640 KCP 7.1.4 XXXXX 1993c Acute dermal irritation/corrosion of the preparation Y Y Data/study report never sub- Action Pin HELIOSOUFRE S – Batch 31007 mitted before Germany Report n° T 833/1952 EVIC-CEBA laboratories, France Non GLP Unpublished BVL 3290642 KCP 7.1.5 XXXXX 1993d Acute eye irritation/corrosion of the preparation HELIOSOUFRE Y Y Data/study report never sub- Action Pin S – Batch 31007 mitted before Germany Report n° T 832/1952 EVIC-CEBA laboratories, France Non GLP Unpublished BVL 3290643 KCP 9.3.1/01 Cuvelier N. 2016 ESCAPE 2.0 Calculations N Y Data/study report never sub- Action Pin Report N° ACT-201612-01 mitted before Germany Redebel Regulatory Affairs Non GLP Unpublished 3290645

KCP 10.2.1/01 XXX 2002a Fish, acute toxicity test according to the 203 OECD guideline Y Y Data/study report never sub- Action Pin Report No. PC/66/091/01F/cd/BPL/e mitted before Germany CTBA, Bordeaux, FRANCE

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KCP 10.2.1/02 Marchal P. 2002b Daphnia sp., acute immobilisation test according to the 202 N Y Data/study report never sub- Action Pin OECD Part 1 guideline mitted before Germany Report n° PC/66/091/01F/bd/BPL/e CTBA, Bordeaux, FRANCE GLP Unpublished 3290647

KCP 10.2.1/03 Marchal P. 2002c Alga, growth inhibition test according to the OECD 201 guideline N Y Data/study report never sub- Action Pin Report n° PC/66/091/01F/ad/BPL/e mitted before Germany CTBA, Bordeaux, FRANCE GLP Unpublished 3290648

KCP Servajean E. 2007 Laboratory determination of the contact and oral toxicity of a N Y Data/study report never sub- Action Pin 10.3.1.1.1/01 formulation to honey bees (Apis mellifera L.) (OECD 213 and mitted before Germany OECD 214, September 1998) No.07-40-008-ES Phytosafe, Pau, FRANCE GLP Unpublished 3290649

KCP Clausse M., 2017 Statement on the chronic toxicity of Helioterpen Soufre on bees N N - Action Pin 10.3.1.1.2 Lopez M., based on a scientific review open literature Rolin C. Ref: ACT-201701-01 Redebel Regulatory Affairs SCRL Not GLP Unpublished 3290650

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List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review Title Verte- Data pro- Company Report No. brate tection Justification if data protec- Data point Author(s) Year Source (where different from company) Owner study claimed tion is claimed GLP or GEP status Y/N Y/N Published or not Acute oral toxicity (LD50) study of sulphur Data submitted as confirmato- dust in Japanese quail ry data under Directive Jai Research Foundation, Valvada (Gujarat), 91/414, it doesn’t attract data KCP 10.1.1 XXXXX 2008 India Y N STF/SWG protection. Report no. 7715 Furthermore, it is also cov- GLP ered by the Letter of Access unpublished Avian dietary toxicity study of sulphur dust Data submitted as confirmato- in Japanese quail ry data under Directive Jai Research Foundation, Valvada (Gujarat), 91/414, it doesn’t attract data KCP 10.1.1 XXXXX 2008 India Y N STF/SWG protection. Report no. 7714 Furthermore, it is also cov- GLP ered by the Letter of Access unpublished Acute Oral Toxicity Study (Acute Toxic Class Method) with Sulfur Dust in Japanese Quails Data submitted for the inclu- Toxicology Department Rallis Research Center Bangalore India sion of the active substance. KCP 10.1.1 XXXXX 2005 Y N STF Report No.: Report No.: 4263/05 (final) The data protection ended the GLP/GEP (Y/N): Y 01/01/2015 Published (Y/N): N Acute oral toxicity study of sulphur dust in Data submitted as confirmato- rats. ry data under Directive KCP 10.1.3 XXXXX 2009 Jai Research Foundation, Valvada (Gujarat), Y N 91/414, it doesn’t attract data STF/SWG India protection. Report no. 8390 Furthermore, it is also cov-

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Title Verte- Data pro- Company Report No. brate tection Justification if data protec- Data point Author(s) Year Source (where different from company) Owner study claimed tion is claimed GLP or GEP status Y/N Y/N Published or not GLP ered by the Letter of Access unpublished Report on testing for acute toxicity: rainbow trout BASF AG; Ludwigshafen/Rhein; Germany Fed.Rep. Data submitted for the inclu- Non-GLP, studies were conducted prior to the implementation of GLP, sion of the active substance. KCP 10.2 XXXXX 1979b Y N SWG but are scientifically valid The data protection ended the Unpublished 01/01/2015 1979/10131; Syngenta file No. SAN7116/5237. Bericht ueber die Pruefung der akuten Toxizitaet. Orientierende Prue- Data submitted for the inclu- fung: Regenbogenforelle (Oncorhynchus mykiss WALBAUM 1792) sion of the active substance. KCP 10.2 XXXXX 1990 BASF AG; Ludwigshafen/Rhein; Germany Fed.Rep. Y N SWG The data protection ended the Non-GLP, Unpublished 01/01/2015 1990/0417; Syngenta File N° SAN7116/5290 Report on testing for acute toxicity: carp BASF AG; Ludwigshafen/Rhein; Germany Fed.Rep. Data submitted for the inclu- Non-GLP, studies were conducted prior to the implementation of GLP sion of the active substance. KCP 10.2 XXXXX 1979a Y N SWG but are scientifically valid The data protection ended the Unpublished 01/01/2015 1979/10095 • Fish toxicity trials with Cobox and Kumulus S BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Germany Fed.Rep. Data submitted for the inclusion of the active substance. KCP 10.2 XXXXX 1961 Y N SWG Non-GLP, studies were conducted prior to the implementation of GLP The data protection ended the but are scientifically valid 01/01/2015 Unpublished 1961/10049; Syngenta file No. SAN7116/5224 The prolonged toxicity of BAS 175 01 F to rainbow trout (28 days, flow- through system, OECD 204) Data submitted for the inclu- Dr. U. Noack - Laboratorium fuer angewandte Biologie; Sarstedt; Ger- sion of the active substance. KCP 10.2 XXXXX 1991 Y N SWG many Fed.Rep. The data protection ended the GLP, Unpublished 01/01/2015 1991/10122, Syngenta File N° SAN7116/5296 Determination of the acute toxicity (48 h) to Daphnia magna STRAUS of Data submitted for the inclu- BAS 175 01 F Noack M. et sion of the active substance. KCP 10.2 1990b Dr. U. Noack - Laboratorium fuer angewandte Biologie; Sarstedt; Ger- N N SWG al. The data protection ended the many Fed.Rep. 01/01/2015 GLP, Unpublished

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Title Verte- Data pro- Company Report No. brate tection Justification if data protec- Data point Author(s) Year Source (where different from company) Owner study claimed tion is claimed GLP or GEP status Y/N Y/N Published or not 1990/10085; Syngenta file No. SAN7116/5293. 1. Amendment to report: Determination of the acute toxicity (48 h) to Daphnia magna STRAUS of BAS 175 01 F Data submitted for the inclu- Noack M. et Dr. U. Noack - Laboratorium fuer angewandte Biologie; Sarstedt; Ger- sion of the active substance. KCP 10.2 2000 N N SWG al. many Fed.Rep. The data protection ended the GLP, Unpublished 01/01/2015 2000/1018545 Determination of the acute toxicity of Kumulus S BAS 175 01 F to the waterflea Daphnia magna STRAUS Data submitted for the inclu- BASF AG; Ludwigshafen/Rhein; Germany Fed.Rep. Mueller H., sion of the active substance. KCP 10.2 1981 Non-GLP, studies were conducted prior to the implementation of GLP N N SWG Buechs H. The data protection ended the but are scientifically valid 01/01/2015 Unpublished 1981/11161; Syngenta file No. SAN7116/5277. Determination of the acute toxicity (48 h) to Daphnia magna STRAUS of Netzschwefel Stulln Data submitted for the inclu- Noack M. et Dr. U. Noack - Laboratorium fuer angewandte Biologie; Sarstedt; Ger- sion of the active substance. KCP 10.2 1990a N N SWG al. many Fed.Rep. The data protection ended the GLP, unpublished 01/01/2015 1990/1000563; Syngenta file No. SAN7116/5292 Effect of BAS 175 01 F on the reproduction of Daphnia magna STRAUS (OECD 202, semi-static, 21 days) Data submitted for the inclu- Noack M. et Dr. U. Noack - Laboratorium fuer angewandte Biologie; Sarstedt; Ger- sion of the active substance. KCP 10.2 1991 N N SWG al. many Fed.Rep. The data protection ended the GLP, unpublished 01/01/2015 1991/10232; Syngenta file No. SAN7116/5202. The effects of Microthiol Special WG on reproduction in Daphnia magna Data submitted for the inclu- Mallet M.J. et CEM Analytical Services Ltd.; Berkshire SL5 8JB; United Kingdom sion of the active substance. KCP 10.2 2000 N N SWG al. GLP, unpublished The data protection ended the 2000/1021241 01/01/2015 Effect of BAS 175 01 F on the growth of the green alga Ankistrodesmus bibraianus Data submitted for the inclu- BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Germany sion of the active substance. KCP 10.2 Dohmen G.P. 1990c N N SWG Fed.Rep. The data protection ended the GLP, unpublished 01/01/2015 1990/10217; Syngenta file No. SAN7116/5295 Einfluss von Kumulus S (BAS 175 01 F) auf das Wachstum von Chlorel- Data submitted for the inclu- KCP 10.2 Hamm R. 1983 N N SWG la fusca sion of the active substance.

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Title Verte- Data pro- Company Report No. brate tection Justification if data protec- Data point Author(s) Year Source (where different from company) Owner study claimed tion is claimed GLP or GEP status Y/N Y/N Published or not BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Germany The data protection ended the Fed.Rep. 01/01/2015 Non-GLP, studies were conducted prior to the implementation of GLP but are scientifically valid Unpublished 1983/11024; Syngenta file No. SAN7116/5282 Acute Toxicity of Sulfur Dust to Rainbow Trout (Oncorhynchus mykiss) in a 96-hour Semi Static Test. Data submitted for the inclu- Institute für Biologische Analytik und Consulting IBACON GmbH, Pawlowski, S; sion of the active substance. KCP 10.2 2005 Rossdorf, Germany Y N STF Wydra, V. The data protection ended the Report No.: Report No.: 23121230 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Acute Toxicity of Sulfur Dust to Rainbow Trout (Oncorhynchus mykiss) in a 96-hour Semi Static Test. Data submitted for the inclu- Institute für Biologische Analytik und Consulting IBACON GmbH, Pawlowski, S; sion of the active substance. KCP 10.2 2005 a’ Rossdorf, Germany Y N STF Wydra, V. The data protection ended the Report No.: Report No.: 23121230 (final) 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Acute Toxicity of Sulfur Dust to Daphnia magna in a 48-hour Immobili- zation Test. Data submitted for the inclu- Institute für Biologische Analytik und Consulting IBACON GmbH, Moll, M.; sion of the active substance. KCP 10.2 2005 Rossdorf, Germany N N STF Wydra, V. The data protection ended the Report No.: Report No.: 23122220 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Acute Toxicity of Sulfur Dust to Daphnia magna in a 48-hour Immobili- zation Test. Data submitted for the inclu- Institute für Biologische Analytik und Consulting IBACON GmbH, Moll, M.; sion of the active substance. KCP 10.2 2005 Rossdorf, Germany N N STF Wydra, V. The data protection ended the Report No.: Report No.: 23122220 (final) 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Toxixity of Sulfur Dust to Desmodesmus Subspicatus in an Algal Data submitted for the inclu- Growth Inhibition Test sion of the active substance. KCP 10.2 / 2005 N N STF Institute für Biologische Analytik und Consulting IBACON GmbH, The data protection ended the Rossdorf, Germany 01/01/2015

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Title Verte- Data pro- Company Report No. brate tection Justification if data protec- Data point Author(s) Year Source (where different from company) Owner study claimed tion is claimed GLP or GEP status Y/N Y/N Published or not Report No.: Report No.: 23123210 GLP/GEP (Y/N): Y Published (Y/N): N Toxixity of Sulfur Dust to Desmodesmus Subspicatus in an Algal Growth Inhibition Test Data submitted for the inclu- Institute für Biologische Analytik und Consulting IBACON GmbH, sion of the active substance. KCP 10.2 / 2005 b’ Rossdorf, Germany N N STF The data protection ended the Report No.: Report No.: 23123210 (final) 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Sediment-water chironomid toxicity test Data submitted as confirmato- using sediment spiked with sulphur dust ry data under Directive Desmares- NOTOX B.V., Hertogenbosch, The 91/414, it doesn’t attract data KCP 10.2 Koopmans 2010 Netherlands N N STF/SWG protection. M.J.E Report no. 490607 Furthermore, it is also cov- GLP ered by the Letter of Access unpublished Sediment-water chironomid toxicity test Data submitted as confirmato- using water spiked with sodium sulphate ry data under Directive Desmares- NOTOX B.V., Hertogenbosch, The 91/414, it doesn’t attract data KCP 10.2 Koopmans, 2009 Netherlands N N STF/SWG protection. M.J.E Report no. 490606 Furthermore, it is also cov- GLP ered by the Letter of Access unpublished Ergebnisse der Laboratoriumspruefung auf Bienengefaehrlichkeit von BAS 175 06 F BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Germany Data submitted for the inclu- Fed.Rep. sion of the active substance. KCP 10.3.1 Adolphi H. 1979 N N SWG Non-GLP, studies were conducted prior to the implementation of GLP The data protection ended the but are scientifically valid 01/01/2015 Unpublished 1979/11241 Zulassung als bienenungefaehrliches Pflanzenschutzmittel: Kumulus Netzschwefel Data submitted for the inclu- Biologische Bundesanstalt für Land- und Forstwirtschaft; Berlin- sion of the active substance. KCP 10.3.1 Herfs W. 1973 N N SWG Dahlem; Germany Fed.Rep. The data protection ended the Non-GLP, studies were conducted prior to the implementation of GLP 01/01/2015 but are scientifically valid

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Title Verte- Data pro- Company Report No. brate tection Justification if data protec- Data point Author(s) Year Source (where different from company) Owner study claimed tion is claimed GLP or GEP status Y/N Y/N Published or not Unpublished 1973/10731 Ergebnisse der Laboratoriumspruefung auf Bienengefaehrlichkeit von BAS 175 06 F BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Germany Data submitted for the inclu- Fed.Rep. sion of the active substance. KCP 10.3.1 Adolphi H. 1979 N N SWG Non-GLP, studies were conducted prior to the implementation of GLP The data protection ended the but are scientifically valid 01/01/2015 Unpublished 1979/11241 Effects of Sulfur Dust (Acute Contact and Oral) on Honey Bees (Apis mellifera L.) in the Laboratory Data submitted for the inclu- Institute für Biologische Analytik und Consulting IBACON GmbH, sion of the active substance. KCP 10.3.1 Schmitzer, S. 2005 Rossdorf, Germany N N STF The data protection ended the Report No.: Report No.: 23124035 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N A laboratory test to determine the effect of Microthiol Special WG (an 80% w/w formulation of Sulfur) on the parasitic wasp, Aphidius Data submitted for the inclu- rhopalosiphi sion of the active substance. KCP 10.3.2 Baxter I. 2000a N N SWG Mambo-Tox Ltd.; Southampton; United Kingdom The data protection ended the GLP, unpublished 01/01/2015 2000/1021237 Auswirkung von BAS 175 01 F auf Trichogramma cacoeciae Marchal (Hym., Trichogrammatidae) als Vertreter der Mikrohymenopteren im Data submitted for the inclu- Labor; Pruefung an Imagines (Test A) sion of the active substance. KCP 10.3.2 Kuehner C. 1991a N N SWG GAB Biotechnologie GmbH; Niefern-Oeschelbronn; Germany Fed.Rep. The data protection ended the GLP, unpublished 01/01/2015 1991/10709 A laboratory test to determine the effect of Microthiol Special WG (an 80% w/w formulation of Sulfur) on the parasitic wasp, Aphidius Data submitted for the inclu- rhopalosiphi sion of the active substance. KCP 10.3.2 Baxter I. 2000a N N SWG Mambo-Tox Ltd.; Southampton; United Kingdom The data protection ended the GLP, unpublished 01/01/2015 2000/1021237 • Aenderungserklaerung zum Abschlussbericht der Studie Data submitted for the inclu- KCP 10.3.2 Kuehner C. 1991b 172/01-Tc: Auswirkung von BAS 175 01 F auf Trichogramma cacoeciae N N sion of the active substance. SWG Marchal (Hym., Trichogrammatidae) als Vertreter der Mikrohymenopte- The data protection ended the

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Title Verte- Data pro- Company Report No. brate tection Justification if data protec- Data point Author(s) Year Source (where different from company) Owner study claimed tion is claimed GLP or GEP status Y/N Y/N Published or not ren im Labor; Pruefung an Imagines (Test A) 01/01/2015 GAB Biotechnologie GmbH; Niefern-Oeschelbronn; Germany Fed.Rep. GLP, unpublished 1991/11115; Syngenta file No. SAN7116/5297. Effects on predatory mites (Typhlodromus pyri) exposed to BAS 175 01 F in a laboratory trail (non-GLP) Data submitted for the inclu- BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Germany sion of the active substance. KCP 10.3.2 Ufer A. 2005 N N SWG Fed.Rep. The data protection ended the Non-GLP, unpublished 01/01/2015 2005/1010983 A laboratory test to determine the effect of Microthiol Special WG (an 80% w/w formulation of Sulfur) on the ground-active beetle, Aleochara Data submitted for the inclu- bilineata sion of the active substance. KCP 10.3.2 Vinall S. 2000 N N SWG Mambo-Tox Ltd.; Southampton; United Kingdom The data protection ended the GLP, unpublished 01/01/2015 2000/1021238 A laboratory test to determine the effect of Microthiol Special WG (an 80% w/w formulation of Sulfur) on the ground beetle, Poecilus cupreus Data submitted for the inclu- Agrochemical Evaluation Unit; Southampton SO16 7PX; United King- sion of the active substance. KCP 10.3.2 Baxter I. 2000c N N SWG dom The data protection ended the GLP, unpublished 01/01/2015 2000/1021240 A laboratory test to determine the effect of Microthiol Special WG (an 80% w/w formulation of Sulfur) on the green lacewing, Chrysoperla Data submitted for the inclu- carnea sion of the active substance. KCP 10.3.2 Baxter I. 2000b N N SWG Mambo-Tox Ltd.; Southampton; United Kingdom The data protection ended the GLP, unpublished 01/01/2015 2000/1021239 Zulassungspruefung 1991 an Nutzarthropoden im Laboratorium: Cocci- Data submitted for the inclu- nella septempunctata L. sion of the active substance. KCP 10.3.2 Kock H. 1991 Landwirtschaftskammer Westfalen-Lippe; Münster; Germany Fed.Rep. N N SWG The data protection ended the Non-GLP, unpublished 01/01/2015 1991/10751, Syngenta File N° SAN7116/5213 An extended laboratory study to evaluate the effects of BAS 175 01 F on Data submitted for the inclu- the aphid parasitoid, Aphidius rhopalosiphi De Stefani Perez (Hymenop- sion of the active substance. KCP 10.3.2 Warmers C. 2003b N N SWG tera, Braconidae) (dose response) The data protection ended the GAB Biotechnologie GmbH & IFU Umweltanalytik GmbH; Niefern- 01/01/2015

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Title Verte- Data pro- Company Report No. brate tection Justification if data protec- Data point Author(s) Year Source (where different from company) Owner study claimed tion is claimed GLP or GEP status Y/N Y/N Published or not Oeschelbronn; Germany Fed.Rep. GLP, unpublished 2003/1012056; Syngenta file No. SAN7116/5222. An extended laboratory study to evaluate the effect of BAS 175 01 F on the egg parasitoid, Trichogramma cacoeciae Marchal (Hymenoptera, Data submitted for the inclu- Trichogrammatidae) (dose reponse) sion of the active substance. KCP 10.3.2 Warmers C. 2003a GAB Biotechnologie GmbH & IFU Umweltanalytik GmbH; Niefern- N N SWG The data protection ended the Oeschelbronn; Germany Fed.Rep. 01/01/2015 GLP, unpublished 2003/1012055; Syngenta file No. SAN7116/5221. Effects of Sulfur Dust on the Parasitoid Aphidius rhopalosiphi in the Laboratory – Dose Response Test – Data submitted for the inclu- Institute für Biologische Analytik und Consulting IBACON GmbH, Moll, M. and sion of the active substance. KCP 10.3.2 2005 Rossdorf, Germany N N STF Bützler, R The data protection ended the Report No.: Report No.: 23125001 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Effects of Sulfur Dust on the Predatory Mite Typhlodromus pyri in the Laboratory – Dose Response Test – Data submitted for the inclu- Institute für Biologische Analytik und Consulting IBACON GmbH, Rosenkranz, sion of the active substance. KCP 10.3.2 2005 Rossdorf, Germany N N STF B. The data protection ended the Report No.: Report No.: 23126063 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Effects of Sulfur Dust on the Carabid Beetle Poecilus cupreus L. in the Laboratory Data submitted for the inclu- Institute für Biologische Analytik und Consulting IBACON GmbH, sion of the active substance. KCP 10.3.2 Schmitzer, S. 2005 Rossdorf, Germany N N STF The data protection ended the Report No.: Report No.: 23128006 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Effects of Sulfur Dust on the Lacewing Chrysoperla carnea in the Labor- atory – Limit Test – Data submitted for the inclu- Institute für Biologische Analytik und Consulting IBACON GmbH, Rosenkranz, sion of the active substance. KCP 10.3.2 2005 Rossdorf, Germany N N STF B. The data protection ended the Report No.: Report No.: 23127046 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N

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Title Verte- Data pro- Company Report No. brate tection Justification if data protec- Data point Author(s) Year Source (where different from company) Owner study claimed tion is claimed GLP or GEP status Y/N Y/N Published or not Effects of Sulfur Dust on the Parasitoid Aphidius rhopalosiphi, Extended Laboratory Study- Dose Response Test – Data submitted for the inclu- Institute für Biologische Analytik und Consulting IBACON GmbH, sion of the active substance. KCP 10.3.2 Moll, M. 2005 Rossdorf, Germany N N STF The data protection ended the Report No.: Report No.: 25671002 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Effects of Sulfur Dust on the Predatory Mite Typhlodromus pyri Extend- ed Laboratory Study – Dose Response Test Data submitted for the inclu- Rosenkranz, Institute für Biologische Analytik und Consulting IBACON GmbH, sion of the active substance. KCP 10.3.2 B. and Blütz- 2005 Rossdorf, Germany N N STF The data protection ended the ler, R. Report No.: Report No.: 25673062 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Effects of Sulfur Dust on the Lacewing Chrysoperla carnea – Extended Laboratory Study – Data submitted for the inclu- Institute für Biologische Analytik und Consulting IBACON GmbH, Rosenkranz, sion of the active substance. KCP 10.3.2 2005 Rossdorf, Germany N N STF B. The data protection ended the Report No.: Report No.: 25672047 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N An aged residues study to evaluate the duration of effects of Sulfur 80 WG (BAS 17501F) on the egg parasitoid, Data submitted as confirmato- Trichogramma cacoeciae (Hymenoptera, ry data under Directive Trichogrammatidae) 91/414, it doesn’t attract data KCP 10.3.2 Warmers C. 2005 GAB Biotechnologie GmbH & GAB N N SWG protection. Analytik GmbH, Niefern-Öschelbronn, Furthermore, it is also cov- Germany ered by the Letter of Access Report no. 20041260/01-NETc GLP unpublished Effect of BAS 175 01 F on the mortality of the earthworm Eisenia fetida Data submitted for the inclu- BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Germany sion of the active substance. KCP 10.4 Dohmen G.P. 1990a Fed.Rep. N N SWG The data protection ended the GLP, unpublished 01/01/2015 1990/10185; Syngenta file No. SAN7116/5294. KCP 10.4 Lührs, U. 2005 Acute Toxicity (14 Days) of Sulfur Dust to the Earthworm Eisenia fetida N N Data submitted for the inclu- STF

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Title Verte- Data pro- Company Report No. brate tection Justification if data protec- Data point Author(s) Year Source (where different from company) Owner study claimed tion is claimed GLP or GEP status Y/N Y/N Published or not in Artificial Soil sion of the active substance. Institute für Biologische Analytik und Consulting IBACON GmbH, The data protection ended the Rossdorf, Germany 01/01/2015 Report No.: Report No.: 23129021 GLP/GEP (Y/N): Y Published (Y/N): N Effect of Kumulus WG (BAS 175 01 F) on nitrification Data submitted for the inclu- BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Germany sion of the active substance. KCP 10.5 Dohmen G.P. 1990a Fed.Rep. N N SWG The data protection ended the GLP, unpublished 01/01/2015 1990/0146 Effect of Kumulus WG (BAS 175 01 F) on soil respiration Data submitted for the inclu- BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Germany sion of the active substance. KCP 10.5 Gerhardt R. 1989 Fed.Rep. N N SWG The data protection ended the GLP, unpublished 01/01/2015 1989/10172; Syngenta file No. SAN7116/5287. Effects of Sulfur Dust on the Activity of the Soil Microflora in the La- boratory Data submitted for the inclu- Institute für Biologische Analytik und Consulting IBACON GmbH, sion of the active substance. KCP 10.5 Reis, K.-H 2005 Rossdorf, Germany N N STF The data protection ended the Report No.: Report No.: 23120080 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N BAS 175 01 F: Effects on non-target plants in the greenhouse - A limit test Data submitted for the inclu- Oberwalder BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Germany sion of the active substance. KCP 10.6 C., Schmidt 2000 N N SWG Fed.Rep. The data protection ended the O. Non-GLP, not subject to GLP regulations 01/01/2015 Unpublished 2000/1017176; Syngenta file No. SAN7116/5214.

Helioterpen Sourfe / Helioterpen Schwefel (ZV1 008989-00/00) Page 46 /47 Part A - National Assessment Template for chemical PPP MS version MS finalization date: 14.10.2019

List of data submitted by the applicant and not relied on Data point Author(s) Year Title Verte- Data pro- Justification if data protection Owner Company Report No. brate study tection is claimed Source (where different from company) Y/N claimed GLP or GEP status Y/N Published or not KCP 7.1.3 XXXXX 1996a Evaluation of acute toxicity by inhalation in the Rat of the product Y Y Data/study report never submitted Action HELIOSOUFRE S – Batch 51019 (Limit test) before Germany Pin Report n° Tb 741 / 1612 EVIC-CEBA laboratories, France Non GLP Unpublished BVL 3290641 KCP 7.1.6 XXXXX 1996b Evaluation of the sensitizing potential of the material HELIOSOUFRE S Y Y Data/study report never submitted Action - Batch 51019 – Guinea pig Maximisation Test (G.P.M.T.) before Germany Pin Report n° Tb 740 / 1612 EVIC-CEBA laboratories, France Non GLP Unpublished BVL 3290644 Owner

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 Owner Company Report No. brate study protection is claimed Source (where different from company) Y/N claimed GLP or GEP status Y/N Published or not KCP 7.2.1 Mich. G. 1996 Operator Exposure in Greenhouses during Practical Use of Plant Pro- N N Bayer tection Products CropScience 688 ! EF 94-02-03 Langenfeld GLP: N/GEP: N Published: N 3748214 Owner

Helioterpen Sourfe / Helioterpen Schwefel (ZV1 008989-00/00) Page 47 /47 Part A - National Assessment Template for chemical PPP MS version MS finalization date: 14.10.2019

Appendix 5 Copy of the product authorization

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dr. Birgit Schreiber Dienstsitz Braunschweig • Postfach 15 64 • 38005 Braunschweig Referentin

TELEFON +49 (0)531 299-3457 ACTION PIN TELEFAX +49 (0)531 299-3002 Z.l. de Cazalieu - CS 60030 E-MAIL [email protected] 40260 Castets IHR ZEICHEN FRANKREICH IHRE NACHRICHT VOM

AKTENZEICHEN 200.22100.008989-00/00.184613 (bitte bei Antwort angeben)

DATUM 14. Oktober 2019

ZV1 008989-00/00 Helioterpen Schwefel Zulassungsverfahren für Pflanzenschutzmittel Bescheid

Das oben genannte Pflanzenschutzmittel

mit dem Wirkstoff: 700 g/l Schwefel

Zulassungsnummer: 008989-00

Versuchsbezeichnungen: ACP-00700-F-0-SC

Antrag vom: 22. März 2017

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 2021.

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 9

Anwendungs- Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck nummer Zweckbestimmung Objekte 008989-00/00-002 Echter Mehltau (Ery- Gurke siphe cichoracearum) 008989-00/00-001 Echter Mehltau Gurke (Sphaerotheca fuliginea)

Festgesetzte Anwendungsbestimmungen

Es werden folgende Anwendungsbestimmungen gemäß § 36 Abs. 1 S. 1 des Gesetzes zum Schutz der Kulturpflanzen (Pflanzenschutzgesetz - PflSchG) vom 6. Februar 2012 (BGBl. I S. 148, 1281), zuletzt geändert durch Artikel 4 Absatz 84 des Gesetzes vom 18. Juli 2016 (BGBl. I S. 1666), festgesetzt: (NW470) Etwaige Anwendungsflüssigkeiten, Granulate und deren Reste sowie Reinigungs- und Spül- flüssigkeiten nicht in Gewässer gelangen lassen. Dies gilt auch für indirekte Einträge über die Kanalisation, Hof- und Straßenabläufe sowie Regen- und Abwasserkanäle. Begründung: Der im o.g. Pflanzenschutzmittel enthaltene Wirkstoff Schwefel weist aufgrund seiner Toxizi- tät 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.

(SE110) Dicht abschließende Schutzbrille tragen beim Umgang mit dem unverdünnten Mittel. Begründung: Aufgrund der Einstufung und Kennzeichnung des Mittels (vgl. Bundesanzeiger: "Bekanntma- chung über die Ableitung von gefahrenbasierten Kennzeichnungsauflagen zur Anwendungs- sicherheit im Zulassungsverfahren für Pflanzenschutzmittel nach Inkrafttreten der CLP-Ver- ordnung für Gemische (BVL 15/02/13) vom 23. September 2015 " (BAnz AT 19.10.2015 B2)).

Siehe anwendungsbezogene Anwendungsbestimmungen in Anlage 1, jeweils unter Nr. 3. BVL_FO_05_2437_200_V1.8 SEITE 3 VON 9

Verpackungen

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

Verpackungs- Verpackungs- Anzahl Inhalt art material von bis von bis Einheit Flasche HDPE 1 1,00 l Flasche HDPE/PA 1 1,00 l IBC HDPE 1 600,00 l Kanister HDPE 1 10,00 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: (EB001-2) SP 1: Mittel und/oder dessen Behälter nicht in Gewässer gelangen lassen. (Ausbringungsge- räte nicht in unmittelbarer Nähe von Oberflächengewässern reinigen./Indirekte Einträge über Hof- und Straßenabläufe verhindern.)

(NN3001) Das Mittel wird als schädigend für Populationen relevanter Nutzinsekten eingestuft.

(NN3002) Das Mittel wird als schädigend für Populationen relevanter Raubmilben und Spinnen eingestuft.

(NW263) Das Mittel ist giftig für Fischnährtiere.

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

(SB005) BVL_FO_05_2437_200_V1.8 SEITE 4 VON 9

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

(SB010) Für Kinder unzugänglich aufbewahren.

(SB111) Für die Anforderungen an die persönliche Schutzausrüstung beim Umgang mit dem Pflan- zenschutzmittel sind die Angaben im Sicherheitsdatenblatt und in der Gebrauchsanweisung des Pflanzenschutzmittels sowie die BVL-Richtlinie "Persönliche Schutzausrüstung beim Umgang mit Pflanzenschutzmitteln" des Bundesamtes für Verbraucherschutz und Lebens- mittelsicherheit (www.bvl.bund.de) zu beachten.

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

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

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

(WMFM2) Wirkungsmechanismus (FRAC-Gruppe): M2

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

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

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

Dem Bundesamt für Verbraucherschutz und Lebensmittelsicherheit sind Unterlagen zu den

BVL_FO_05_2437_200_V1.8 nachfolgend aufgeführten Punkten und den dabei jeweils genannten Terminen vorzulegen: SEITE 5 VON 9

Antragspunkt: KCP 10.3.1 Termin: 31. März 2021 Forderung: Vorlage von Unterlagen zu den chronischen Auswirkungen auf Bienen Begründung: Eine Exposition gegenüber dem Pflanzenschutzmittel kann nicht ausgeschlossen werden, da kommerziell genutzte Bestäuber in Gewächshäuser eingesetzt werden können. Gemäß Verordnung (EU) Nr. 284/2013, Teil A, 10.3.1, müssen bei allen Zulassungsanträgen, die ab dem 01.01.2016 gestellt wurden, auch Studien zur chronischen Toxizität für Honigbie- nen (adulte Honigbienen, Honigbienenlarven) eingereicht werden. Aufgrund fehlender Daten zur chronischen Toxizität konnte das Risiko durch eine chronische Exposition nicht bewertet werden. Daher müssen Studien zur chronischen Toxizität, die mit dem beantragten Pflanzen- schutzmittel oder einem vergleichbaren Pflanzenschutzmittel durchgeführt wurden, unter den Antragspunkten KCP 10.3.1.2 (adulte Bienen) und KCP 10.3.1.3 (Bienenlarven) nachgereicht werden. Bitte reichen Sie die Unterlagen zum nächstmöglichen Zeitpunkt, spätestens aber bis zum 2021-03-31 ein.

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

Vorbehalt

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

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

Signalwort: (S2) Gefahr

Gefahrenpiktogramme: (GHS05) Ätzwirkung BVL_FO_05_2437_200_V1.8 SEITE 6 VON 9

Gefahrenhinweise (H-Sätze): (H318) Verursacht schwere Augenschäden.

(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.

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

(P305+P351+P338+P310) BEI KONTAKT MIT DEN AUGEN: Einige Minuten lang behutsam mit Wasser spülen. Vorhan- dene Kontaktlinsen nach Möglichkeit entfernen. Sofort GIFTINFORMATIONSZENTRUM oder Arzt anrufen.

(P501) Inhalt/Behälter ... zuführen.

Abgelehnte Anwendungsgebiete bzw. Anwendungen

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

Hinweise

Auf dem Etikett und in der Gebrauchsanleitung kann angegeben werden: (NB6641) Das Mittel wird bis zu der höchsten durch die Zulassung festgelegten Aufwandmenge oder Anwendungskonzentration, falls eine Aufwandmenge nicht vorgesehen ist, als nicht bienen- gefährlich eingestuft (B4). BVL_FO_05_2437_200_V1.8 SEITE 7 VON 9

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.

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 9

Anlage 1 zugelassene Anwendung: 008989-00/00-001 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Echter Mehltau (Sphaerotheca fuliginea) Pflanzen/-erzeugnisse/Objekte: Gurke Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

Einsatzgebiet: Gemüsebau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome Maximale Zahl der Behandlungen - in dieser Anwendung: 6 - für die Kultur bzw. je Jahr: 6 - Abstand: 7 Tage Anwendungstechnik: spritzen Aufwand: - Pflanzengröße bis 50 cm 1,5 l/ha in maximal 600 l Wasser/ha

- Pflanzengröße 50 bis 125 cm 2,5 l/ha in maximal 900 l Wasser/ha

- Pflanzengröße über 125 cm 3 l/ha in maximal 1200 l Wasser/ha

2.2 Sonstige Kennzeichnungsauflagen (WA861) Durch die Anwendung können sichtbare Spritzbeläge auf den Früchten auftreten.

2.3 Wartezeiten 3 Tage Gewächshaus: Gurke

3 Anwendungsbezogene Anwendungsbestimmungen - keine - BVL_FO_05_2437_200_V1.8 SEITE 9 VON 9

Anlage 1 zugelassene Anwendung: 008989-00/00-002 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Echter Mehltau (Erysiphe cichoracearum) Pflanzen/-erzeugnisse/Objekte: Gurke Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

- Pflanzengröße 50 bis 125 cm 2,5 l/ha in maximal 900 l Wasser/ha

- Pflanzengröße über 125 cm 3 l/ha in maximal 1200 l Wasser/ha

2.2 Sonstige Kennzeichnungsauflagen (WA861) Durch die Anwendung können sichtbare Spritzbeläge auf den Früchten auftreten.

2.3 Wartezeiten 3 Tage Gewächshaus: Gurke

3 Anwendungsbezogene Anwendungsbestimmungen - keine - BVL_FO_05_2437_200_V1.8 REGISTRATION REPORT Part B Section 0 Product Background, Regulatory Context and GAP information

Interzonal (glasshouse) Zonal Rapporteur Member State: Germany

CORE ASSESSMENT/ NATIONAL ADDENDUM Germany (authorisation of a new product)

Applicant: Action Pin Submission date: 22 March 2017 MS Finalisation date: 14.10.2019 Page 2 /12 Template for chemical PPP Ms finalization date 14.10.2019 Version history

When What - Pre-meeting 22.03.2017 Submission of application 01.09.2017 Addition of information following BVL letter 21.05.2019 First draft for commenting by MS 01.07.2019 Comments from applicant 18.09.2019 Further information about SDS 14.10.2019 Authorisation – upload of final documents on CIRCABC

Page 3 /12 Template for chemical PPP Ms finalization date 14.10.2019 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(s) ...... 5 0.1.3.1 Active substance 1 (Sulphur) ...... 5 0.1.4 Regulatory history of the product (if relevant) ...... 7 0.2 zRMS conclusion ...... 8

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

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

Appendix 1.2 MATCHING TABLE DE USES (German code number: 0xxxxxx- 00/00) ...... 10

Page 4 /12 Template for chemical PPP Ms finalization date 14.10.2019

0 Product background, regulatory context and GAP information

0.1 Introduction

0.1.1 Reason for application

Helioterpen Soufre is a new formulation intended to be used as a fungicide. It is a liquid formulation (SC) containing the active substance Sulphur (700g/l). The intended GAP is in field against Venturia inaequalis in apple, Venturia pyrina in pear and against Uncinula necator in vineyard and in greenhouse against Sphaerothe- ca fuliginea and Erysiphe cichoracearum in cucumber. This application is divided in two dossiers which will be submitted at the same time: one dossier for Heli- oterpen Soufre in green-house (considered as the main dossier) and one dossier for Helioterpen Soufre in field (attached to the first application).

This application follows the data requirements for the active substance laid down in Regulation (EC) No. 544/2011 and the data requirements for the plant protection product laid down in Regulation (EC) No. 284/2013.

In addition to the submission of studies as listed in section(s) B1, B2, B4, B5, B6, B8 and B9 exemp-tion from the submission of studies is requested in accordance with Article 34 of Regulation (EC) No. 1107/2009

0.1.2 Details of zRMS(s) and concerned MS

Table 0.1-1: Overview of zRMS and cMS

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

Northern zone Not applicable Not applicable Central zone Not applicable Not applicable Southern zone Not applicable Not applicable Inter-zonal zRMS : Gemany cMS : Belgium Page 5 /12 Template for chemical PPP Ms finalization date 14.10.2019 zRMS, product name and authorization no. (if relevant) (if relevant) Concerned MS, MS’ product name and authorization number (if applicable)

Product name : Helioterpen Schwefel Product name : Helioterpen Soufre / Helioterpen Zwavel

cMS : Luxembourg Product name : Helioterpen Soufre

cMS : Netherlands Product name : Helioterpen Zwavel

cMS : Austria Product name : Helioterpen Schwevel

cMS : Czech Republic Product name : Helioterpen Síra

0.1.3 Regulatory history of the active(s)

0.1.3.1 Active substance 1 (Sulphur)

Sulphur was included on Annex I of Directive 91/414/EEC on 01/01/2010 under Inclusion Directive 2009/70/EC. Expiration of approval: 30/12/2019.

Table 0.1-2: Summary of regulatory history of CAS No: 7704-34-9

Status

Approved in EU Y Original Inclusion Directive Commission Directive 2009/70/EC and Regulation 540/2011. or Commission Implementing Regulation RMS France Page 6 /12 Template for chemical PPP Ms finalization date 14.10.2019 Status

Date of Approval (or most recent renewal) of Active Substance 01/01/2010 (date of Regulation to be applied) Current expiration of approval 31/12/2020

Low risk substance or Candidate for Substitution? N/A

For the implementation of the uniform principles of Regulation (EU) No.546/2011, the conclusions of the review report on Sulphur, as finalised in the Standing Committee on the Food Chain and Animal Health on 12/03/2009 shall be taken into account.

In this overall assessment Member States must pay particular attention to: - the protection of birds, mammals, aquatic organisms and non-target arthropods. Conditions of authorisation shall include risk mitigation measures, where appropriate. These concerns have been addressed within the current submission.

The SANCO report for Sulphur (SANCO/2676/08 final, 13/07/2012) is considered to provide the relevant review information or a reference to where such information can be found, as well as the EFSA Scientific report for Sulphur (Conclusion on pesticide peer review – Peer review of the pesticide risk assessment of the active substance Sulphur, EFSA Scientific Report (2008) 221, 1-70) and the DAR and its subsequent addendum.

The applicant Action Pin has a letter of access to Sulphur data from his supplier Julio Cabrero y Cia S.L. As a member of the Sulphur Task Force, he grants Action Pin access to all the data submitted in support of Annex I inclusion.

There is no need to perform an equivalence assessment for the active substance of Helioterpen Soufre in the framework of this application. Indeed, the supplier is a member of the Sulphur Task Force and the equivalency already has been assessed during the process of active substance registration.

The SANCO report for sulphur (SANCO/2676/08) 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 19 December 2008.

Table 0.1-3: Information on minimum purity of sulphur EU agreed minimum purity from Inclusion Directive or Implementing regulation (if different) Minimum purity of active substance used in the product / information on available equivalency report *, ** min 990 g/kg not relevant Page 7 /12 Template for chemical PPP Ms finalization date 14.10.2019 * 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.

The following table provides the endpoints used in the evaluation in the case that they deviate from EU endpoints.

Active Substance Endpoint EU agreed endpoint from EFSA scientific report Endpoint used*

No deviations reported in the environmental section. * Since EU approval new studies on the active substance have been performed (e.g. new manufacturing site, new specification, confirmatory data)

0.1.4 Regulatory history of the product (if relevant)

Helioterpen Soufre is a new formulation, intended to be used as a fungicide. It is a liquid formulation (SC) based on the active substance Sulphur (700g/l).

It is important to highlight that Helioterpen Soufre formulation was never registered in any EU Member State, but an equivalent formulation (Heliosoufre S) from which toxicological data and ecotoxicological data were extrapolated for this application (Details are provided in Part C) has a regulatory history. Heliosoufre S is registered in the Southern zone: in France, in Greece, in Italy, in Spain and in Portugal. 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

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

Page 8 /12 Template for chemical PPP Ms finalization date 14.10.2019

0.2 zRMS conclusion

With respect to fate and ecotoxicology assessment, an authorisation can be granted. 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.

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

Use – 001 cucumber against Sphaerotheca fuliginea (SPHRFU)

Use -002 cucumber against Erysiphe cichoracearum (ERYSCI)

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:

None

As no MRLs are required; the substance was included in annex IV to Regulation (EC) No 396/2005.

Appendix 1 ALL intended uses

Appendix 1.1 ALL INTENDED USES

PPP (product name/code): Helioterpen Schwefel Formulation type: SC (a, b) Page 9 /12 Template for chemical PPP Ms finalization date 14.10.2019 Active substance 1: sulphur Conc. of as 1: 700 g/L(c) Applicant: ACTION PIN Professional use: Zone(s): central/interzonal (d) Non professional use: Verified by MS: yes Field of use: fungicide

1 2 3 4 5 6 7 8 9 10 11 12 13 14 Use- Member Crop and/ F, Pests or Group of pests Application Application rate PHI Remarks: No. (e) state(s) or situation Fn, controlled (days) Fpn Method / Timing / Growth Max. number Min. interval kg or L product / g or kg as/ha Water e.g. g safener/synergist (crop destination / G, (additionally: developmen- Kind stage of crop & a) per use between ha L/ha per ha 204 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 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) 1 DE, BE, Cucumber (Cu- G Sphaerotheca fuliginea Foliar All stages a) 6 7 a) 3 L/ha a) 2.1 kg/ha 300/1000 3 DE: NL, LU, cumis sativitus (SPHRFU) spray b) 6 b) 18 L/ha b) 12,6 kg/ha Dose rate and ap- AT, CZ (CUMSA) plication volume vary with crop height <50 cm: 1.5 L/ha (max. spray volume: 600 L/ha) 50-125 cm: 2.5 L/ha (max. spray volume: 900 L/ha) >125 cm: 3 L/ha (máx. spray volume: 1200 L/ha) cMS:

Corresponding to LWA: 1.85 L/ha LWA L.product/hL (min- max): 0.3 L/hL – 1 L/hL Assumptions1 2 DE, BE, Cucumber (Cu- G Erysiphe cichoracea- Foliar All stages a) 6 7 a) 3 L/ha a) 2.1 kg/ha 300/1000 3 DE: NL, LU, cumis sativitus rum (ERYSCI) spray b) 6 b) 18 L/ha b) 12,6 kg/ha Dose rate and ap- AT, CZ (CUMSA) plication volume Page 10 /12 Template for chemical PPP Ms finalization date 14.10.2019 vary with crop height <50 cm: 1.5 L/ha (max. spray volume: 600 L/ha) 50-125 cm: 2.5 L/ha (max. spray volume: 900 L/ha) >125 cm: 3 L/ha (máx. spray volume: 1200 L/ha)

Corresponding to LWA: 1.85 L/ha LWA L.product/hL (min- max): 0.3 L/hL – 1 L/hL Assumptions1

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

Remarks 1 Numeration necessary to allow references 7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, columns: 2 Use official codes/nomenclatures of EU Member States Blackwell, ISBN 3-8263-3152-4), including where relevant, information on season at time of ap- 3 For crops, the EU and Codex classifications (both) should be used; when relevant, the 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.

Appendix 1.2 MATCHING TABLE DE USES (German code number: 0xxxxxx-00/00) Page 11 /12 Template for chemical PPP Ms finalization date 14.10.2019

Reg.-No. 008989-00/00 GAP rev.1, date: 2018-02-27 PPP (product name/code): Helioterpen Schwefel Formulation type: SC (a, b) Active substance 1: Schwefel Conc. of as 1: 700.00 g/L (c) Applicant: ACTION PIN Professional use: Yes Zone(s): central/interzonal (d) Non professional use: No Verified by MS: Yes Field of use: Fungicide

1 2 3 4 5 6 7 8 9 10 11 12 13 14 Use- Member Crop and/ F, Pests or Group of pests Application Application rate PHI Remarks: No. state(s) or situation Fn, controlled Method / Timing / Max. Min. interval kg or L prod- g or kg as/ha Water L/ha (days) (e) Fpn Kind Growth number between ap- uct / ha e.g. g safener/synergist per ha (crop destination G, (additionally: develop- stage of a) per plications a) max. rate a) max. rate per min / max (f) / purpose of Gn, mental stages of the pest crop & use (days) per appl. appl. crop) Gpn or pest group) season b) per b) max. total b) max. total or crop/ rate per rate per I season crop/season crop/season 001 DE cucumber G powdery mildew (Sphaer- spraying At begin- a) 6 7 days a) plant height a) 1.05 kg/ha plant height up 3 Corresponding to LWA: 1.85 (CUMSA) otheca fuliginea) of cu- ning of b) 6 up to 50 cm: to 50 cm: -/600 L/ha LWA cumber (SPHRFU) infestation 1.5 L/ha L/ha L.product/hL (min-max): 0.3 and/or a) plant height 1.75 kg/ha plant height 50 L/hL – 1 L/hL when first 50 up to 125 up to 125 cm: - symptoms cm: 2.5 L/ha /900 become L/ha visible a) plant height 2.10 kg/ha plant height more than 125 more than 125 cm: 3 L/ha cm: -/1200 L/ha b) 18 L/ha b) 12,6 kg/ha 002 DE cucumber G powdery mildew (Ery- spraying At begin- a) 6 7 days a) plant height a) 1.05 kg/ha plant height up 3 Corresponding to LWA: 1.85 (CUMSA) siphe cichoracearum) ning of b) 6 up to 50 cm: to 50 cm: -/600 L/ha LWA (ERYSCI) infestation 1.5 L/ha L/ha L.product/hL (min-max): 0.3 and/or a) plant height 1.75 kg/ha plant height 50 L/hL – 1 L/hL when first 50 up to 125 up to 125 cm: - symptoms cm: 2.5 L/ha /900 become L/ha visible a) plant height 2.10 kg/ha plant height more than 125 more than 125 cm: 3 L/ha cm: -/1200 L/ha b) 18 L/ha b) 12,6 kg/ha

Remarks (a) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (d) Select relevant Page 12 /12 Template for chemical PPP Ms finalization date 14.10.2019 table (b) Catalogue of pesticide formulation types and international coding system Crop Life (e) Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in heading: International Technical Monograph n°2, 6th Edition Revised May 2008 column 1 (c) g/kg or g/l (f) No authorization possible for uses where the line is highlighted in grey, Use should be crossed out when the notifier no longer supports this use.

Remarks 1 Numeration necessary to allow references 8 The maximum number of application possible under practical conditions of use must be provided. columns: 2 Use official codes/nomenclatures of EU Member States 9 Minimum interval (in days) between applications of the same product 3 For crops, the EU and Codex classifications (both) should be used; when relevant, the 10 For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty use situation should be described (e.g. fumigation of a structure) rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products. 4 F: professional field use, Fn: non-professional field use, Fpn: professional and 11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usu- non-professional field use, G: professional greenhouse use, Gn: non- ally g, kg or L product / ha). professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application 5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when 12 If water volume range depends on application equipment (e.g. ULVA or LVA) it should be relevant, the common names of the pest groups (e.g. biting and sucking in- mentioned under “application: method/kind”. sects, soil born insects, foliar fungi, weeds) and the developmental stages of 13 PHI - minimum pre-harvest interval the pests and pest groups at the moment of application must be named. 14 Remarks may include: Extent of use/economic importance/restrictions 6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated. 7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 38263-3152-4), including where relevant, information on season at time of application

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: Helioterpen Soufre Product name(s): Helioterpen Schwefel Chemical active substance: Sulphur 700 g/L

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT authorization

Applicant: Action Pin Submission date: 22/03/2017 MS Finalisation date: July 2019 Helioterpen Soufre Page 2 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

Version history

When What

March 2019 zRMS version July 2019 Final RR

Helioterpen Soufre Page 3 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

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 Active substance ...... 4 1.3 Trade names and producer’s development code numbers for the preparation (KCP 1.3) ...... 5 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 ...... 14

4 Section 4: Further information on the plant protection product ...... 14 4.1 Packaging and Compatibility with the Preparation (KCP 4.4) ...... 14 4.2 Procedures for cleaning application equipment (KCP 4.2) ...... 16 4.3 Measures in the case of an accident (KCP 4.5) ...... 16

Appendix 1 Lists of data considered in support of the evaluation ...... 19

Appendix 2 Additional data on the physical, chemical and technical properties of the active substance ...... 21 A 2.1 Sulphur ...... 21

Helioterpen Soufre Page 4 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

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: ACTION PIN Address: 30 rue Gambetta BP 206 - 40105 DAX FRANCE

Tel: XXXXXXXXXXX Fax: XXXXXXXXXXX

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

1.2.1 Producer(s) of the preparation

Name: CIR SIPC Address: rue J. Coste BP 613 Courchelettes 59505 Douai France

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 Active substance

Sulphur min 990 g/kg

The active substance does not contain any relevant impurity of toxicological or ecotoxicological concern. Helioterpen Soufre Page 5 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

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

Trade name: Helioterpen Schwefel Trade name: Belgium: Helioterpen Soufre / Helioterpen Zwavel Luxembourg: Helioterpen Soufre Netherlands: Helioterpen Zwavel Czech Republic: Helioterpen Síra Company code number: Helioterpen Soufre

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 the representative formulation for the different testing detailed in the dRR, except when specified in the relevant sections.

Sulphur is not present in the formulation in the form of a salt, ester, anion or cation. The detailed composition is confidential and is stated in Part C.

Table 1.4.1-1: Active substance(s) and variant(s) of the active substance(s)

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

Sulphur 700 g/L 675– 725 g/L 707 g/L 52.2 %w/w * Based on the minimum purity of the active substance declared for registration in the active substance dossiers ** Based on the density of the formulation = 1.355 (Note: only applies if a liquid formulation – delete this comment if not needed)

Table 1.4.1-2: Safener and synergists This section is not relevant. Neither safener nor synergist is used for the formulation.

Table 1.4.1-3: Relevant impurities This section is not relevant. The active substance does not contain any relevant impurity of toxicological or ecotoxicological concern. Information on the active substance(s) (KCP 1.4.2)

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

Table 1.4-4: Information on sulphur

Type Name/Code Number

ISO common name Sulphur No variant present CAS No. 7704-34-9 – EC No. 231-722-6 – CIPAC No. 18 – Helioterpen Soufre Page 6 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

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

This section is not relevant. Neither safener nor synergist is used for the formulation.

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

Type: Suspension concentrate [Code: SC]

1.6 Function (KCP 1.6)

The function of the formulation is: Fungicide Helioterpen Soufre Page 7 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

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

Therefore no specific Risk and Safety phrases are required for Helioterpen Soufre.

Compliance with FAO specifications:

The product Helioterpen Soufre complies with FAO specifications for SC formulations, according to the Manual on development and use of FAO and WHO specifications for Pesticides, First edition, Third revi- sion (2016).

After gentle agitation the material shall be homogeneous and suitable for further dilution in water.

Formulation used for tests The product used in the tests stated in this section has the same composition as the one cited in Part C. Helioterpen Soufre Page 8 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

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 Visual and sensory Helioterpen Beige/Yellow opaque liquid. Y Demangel B., 2016a, Acceptable. physical state description Soufre, 16-901011-001 Odour of the (KCP 2.1) batch formulation is not 213107-M1 described. Explosive and oxidizing Statement The composition and the formulation type (liquid Acceptable. properties formulation), no explosive property is expected as (KCP 2.2) far as: - no coformulant has explosive properties (no coformulant has any chemical group with explosive properties) - no coformulant has oxidizing properties The formulation does not have any oxidizing properties. The composition and the formulation type (liquid formulation), no oxidizing property is expected as far as no coformulant has oxidizing properties (no oxygen, fluorin, or chlorine, or oxygens are bonded with carbons or hydrogens) The formulation does not have any explosive properties. Flash point, EC A 9 Helioterpen No flash point was observed up to 130.0 °C Y Demangel B., 2016a, Acceptable. Flammability Soufre, 16-901011-001 and Self-ignition batch EC A 15 The auto-ignition temperature of the test item was (KCP 2.3) 213107-M1 281 °C ± 3°C pH and pH of a 1% CIPAC MT 75 Helioterpen Before storage: Y Demangel B., 2016b, Acceptable. aqueous dilution, Soufre, CIPAC water D, 20.8 °C: 6.89 16-901011-003 emulsion or dispersion batch (KCP 2.4) 213107-M1 After 2 weeks, 54 °C: Andrieux, A., 2018 CIPAC water D, 21.6 °C: 6.91 16-901011-004 Helioterpen Soufre Page 9 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

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

After 2 years, RT: CIPAC water D, 21.6 °C: 7.00 Viscosity and surface OECD 114 Helioterpen The test item has non-newtonian properties. The Y Demangel B., 2016a, Acceptable. tension Soufre, dynamic viscosity varied as following: 16-901011-001 (KCP 2.5) batch Before storage: 213107-M1 20 °C, shear rate = 0.50 – 50.0 s-1: 5577 - 301 mPa s 40 °C, shear rate = 1.50 – 50.0 s-1: 1859 - 214 mPa s After 2 weeks, 54 °C: Y Demangel B., 2016b, 20 °C, shear rate = 0.50 – 50.0 s-1: 16-901011-003 5202 - 303 mPa s 40 °C, shear rate = 1.50 – 50.0 s-1: 1718 - 214 mPa s After 2 years, RT: Andrieux, A., 2018 20 °C, shear rate = 0.50 – 50.0 s-1: 16-901011-004 5952 - 338 mPa s 40 °C, shear rate = 1.50 – 50.0 s-1: 1953 - 233 mPa s EC A 5 6.88 %, distilled water, 20.1 °C: 28.2 mN/m Y Demangel B., 2016a, The test item was considered as surface-active in the 16-901011-001 experimental conditions used.

21 Relative density EC A 3 Helioterpen Before storage: d4 = 1.355 Y Demangel B., 2016a, Acceptable. (KCP 2.6) Soufre, 16-901011-001 batch 213107-M1 Storage Stability CIPAC MT 46.3 Helioterpen Storage material: HDPE Y Demangel B., 2016b , Acceptable. after 14 days at 54º C, Soufre, The content of the active substance does not 16-901011-003 or other periods and/or batch decrease > 5 %. The changes of the physical and HPLC-UV method temperatures, 213107-M1 chemical properties are negligible. according Ricau, H., low temperatures, 2016 was used for minimum content after Content of Sulphur: determiantion of sulphur Helioterpen Soufre Page 10 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

Annex point Method used / Test mate- Findings GLP Reference Acceptability / deviations rial Y/N comments heat stability before storage: 70.2 % content. (KCP 2.7) after 14 days at 54º C: 70.3 %

CIPAC MT 39.3 Storage material: glass flask Y Demangel B., 2016c, The content of the active substance does not 16-901011-002 Analytical HPLC-UV decrease > 5 %. The changes of the physical and method chemical properties are negligible. Content of Sulphur: before storage: 70.2 % after 7 days at 0º C: 68.4 %

No separated material, homogeneous liquid. The product shows good low temperature stability, the effects are negligible. Analytical HPLC-UV Storage stability for 2 years at ambient temperature:: Andrieux, A., 2018 method Before storage: a.s. content: 70.2% w/v 16-901011-004 After 24 months: a.s. content: 71.4% w/v

Package material: HDPE flask Shelf life in months (if less than 2 years) Not required. (KCP 2.7) Wettability Not applicable for SC formulations. Acceptable. (KCP 2.8.1) Helioterpen Soufre Page 11 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

Persistence of foaming CIPAC MT 47.2 Helioterpen CIPAC water D, 0.14 %: Y Demangel B., 2016b, Acceptable. (KCP 2.8.2) Soufre, Before storage: 1 min: 21 mL 16-901011-003 batch After 2 weeks, 54 °C: 1 min: 18 mL 213107-M1 After 2 years, RT: 1 min: 21 mL Andrieux, A., 2018 16-901011-004 CIPAC water D, 6.88 %: Before storage: 1 min: 0 mL After 2 weeks, 54 °C: 1 min: 0 mL After 2 years, RT: 1 min: 3 mL Suspensibility, CIPAC MT 184 Helioterpen CIPAC water D, 0.14 %: Y Demangel B., 2016b, Acceptable. Spontaneity of Soufre, Before storage: 86 % 16-901011-003 dispersion batch After 2 weeks, 54 °C: 86 % (KCP 2.8.3) 213107-M1 After 2 years, RT: 88% Andrieux, A., 2018 16-901011-004 CIPAC water D, 6.88 %: Before storage: 87 % After 2 weeks, 54 °C: 74 % After 2 years, RT: 88% CIPAC water D, 0.14 % Y Demangel B., 2016c, Before storage: 86 % 16-901011-002 After 7 days, 0°C: 84 %

CIPAC water D, 6.88 % Before storage: 87 % After 7 days, 0°C: 81 % CIPAC MT 160 Before storage: 93 % Y Demangel B., 2016b, After 2 weeks, 54 °C: 93 % 16-901011-003 Before storage: 93 % Y Demangel B., 2016c, After 7 days, 0°C: 92 % 16-901011-002 Before storage: 93 % Y Andrieux, A., 2018 After 2 years, RT: 88 % 16-901011-004 Degree of dissolution Not applicable for SC formulations. Acceptable. and dilution stability (KCP 2.8.4) Helioterpen Soufre Page 12 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

Particle size distribution CIPAC MT 187 Helioterpen Before storage: Y Demangel B., 2016b, Acceptable. and wet sieve test Soufre, < 10 %: 0.464 µm 16-901011-003 (KCP 2.8.5.1) batch > 90 %: 7.20 µm 213107-M1 Andrieux, A., 2018 After 2 weeks, 54 °C: 16-901011-004 < 10 %: 0.539 µm > 90 %: 7.38 µm

After 2 years, RT: < 10 %: 0.385 µm > 90 %: 7.20 µm CIPAC MT 185 Before storage: Y Demangel B., 2016b, 0.1 % on 75 µm sieve 16-901011-003

After 2 weeks, 54 °C: Andrieux, A., 2018 0.1 % on 75 µm sieve 16-901011-004

After 2 years, RT: < 0.1% on 75 µm sieve Before storage: Y Demangel B., 2016c, 0.1 % on 75 µm sieve 16-901011-002 After 7 days, 0°C: 0.1 % on 75 µm sieve Dust content and Not applicable for SC formulations. Acceptable. particle size of dust (KCP 2.8.5.2) Attrition Not applicable for SC formulations. Acceptable. (KCP 2.8.5.3) Hardness and integrity Not applicable for SC formulations. Acceptable. (KCP 2.8.5.4) Emulsifiability, Not applicable for SC formulations. Acceptable. Emulsion stability, Re- emulsifiability (KCP 2.8.6) Pourability (KCP 2.8.7) CIPAC MT 148 Helioterpen Before storage: Y Demangel B., 2016b, Acceptable. Helioterpen Soufre Page 13 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

Soufre, remaining residue: 3.5 % 16-901011-003 batch residue after rinsing: 0.15 % 213107-M1 Andrieux, A., 2018 After 2 weeks, 54 °C: 16-901011-004 remaining residue: 3.6 % residue after rinsing: 0.15 %

After 2 years, RT: remaining residue: 3.6 % residue after rinsing: 0.10 % Chemical and physical No data available. Acceptable. compatibility of tank mixes (KCP 2.9) Adhesion and Not required. Acceptable. distribution to seeds (KCP 2.10) Other/special studies or Not required. Acceptable. tests (KCP 2.11)

Helioterpen Soufre Page 14 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

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)

Helioterpen Soufre is not classified under ADR and does not require any UN/ADR certified packaging. It is designed to be packaged in the following: - 1L bottle (HDPE) - 1L bottle (HDPE/PA Coex) - 10L can (HDPE) - 600L IBC (HDPE)

Stability tests at ambient temperature and after an accelerated storage procedure have been performed with the 10L can. They show that the formulation is compatible with the HDPE materials. It means all the intended package suits to the formulations (for COEX 1L bottle, the inner layer is HDPE)

The material proposed for use is known to be resistant enough to the product chemistry. Odour has not been demonstrated to be passed from film to product. The contents have no negative affect on package integrity.

1L and 10 L containers

Packaging of 1 and 10 L shall be used according to the general hygiene rules and good agricultural practices. A handle is present on the 10L packaging to facilitate its use. Diameter of the packaging are adapted to the viscosity of the formulation in order to avoid any uncontrolled spillage. Closures systems are adapted to the formulation in order to avoid any leak. In case of incident, application of general hygiene principles and a relevant cleaning shall ensure the protection of the area. These packagings are used for a long time for equivalent formulations and no significant quality problems concerning the packaging materials have been experienced.

600L IBC

Packaging of 600L (IBC) is intended to be stored and used on a chemical-proof and retentive area. The IBC (packaging of 600L) shall then be lifted using an adapted equipment. Helioterpen Soufre can then be transferred to the tank for preparing the tank mix through the 50 mm opening. This opening is closed using a screw cap and a valve. The adapted spout shall be used in order to avoid any uncontrolled spillage. Closures systems are adapted to the formulation in order to avoid any leak. In case of incident, application of general hygiene principles and a relevant cleaning shall ensure the protection of the area. This packaging is used for a long time for equivalent formulations and no significant quality problems concerning the packaging materials have been experienced.

Helioterpen Soufre Page 15 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

Table 4.1-1: Packaging information for 1 litre HDPE bottle

Type Description Material: HDPE Shape/size: cylindrical / approx. 235 x 89 diameter, 92 g Opening: 42 mm inner diameter Closure: screw cap Seal: HF-seal Manner of construction extruded UN/ADR Not relevant (not classified under ADR)

Table 4.1-2: Packaging information for 1 litre COEX bottle

Type Description Material: HDPE / PA (COEX, HDPE is the inner layer) Shape/size: cylindrical / approx. 234.5 x 88.5 diameter, 115 g Opening: 40 mm inner diameter Closure: screw cap Seal: HF-seal Manner of construction extruded UN/ADR Not relevant (not classified under ADR)

Table 4.1-3: Packaging information for 10 litre HDPE can

Type Description Material: HDPE Shape/size: rectangular / approx. 192 mm x 232 mm x 321 mm Opening: 49 mm inner diameter Closure: screw cap Seal: HF-seal Manner of construction extruded UN/ADR Not relevant (not classified under ADR)

Helioterpen Soufre Page 16 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

Table 4.1-4: Packaging information for Packaging information for 600 litre IBC

Type Description Material: HDPE Shape/size: cube / approx. 1200 mm x 800 mm x 990 mm, 49 kg Opening: 50 mm inner diameter Closure: Screw cap and valve. An adapted spout can be screwed on the opening for transferring the mixture Seal: HF-seal Manner of construction extruded UN/ADR Not relevant (not classified under ADR)

4.2 Procedures for cleaning application equipment (KCP 4.2)

The procedure for cleaning the packaging and the application equipment are described in the SDS of the product (KCP 4.2/01).

The carefully emptied packaging must be rinsed twice with water. The rinsed packaging must be disposed of by the user at the designated collection point. The reusing of the packaging is forbidden.

Used equipment should be cleaned daily after use. Final cleaning of the equipment with water or deter- gents is recommended.

Slightly contaminated clothing may be washed with usual detergent and several changes of water, separated from other clothing. Heavily contaminated articles and those which cannot be decontaminated, e.g., leather boots, together with rags, cotton waste, etc., which have been used for cleaning up spillages, must be burnt in a licensed incinerator. Clothes must be torn or cut up before being sent to the licensed incinerator.

Effectiveness of the cleaning procedures The recommendations made are based on normal good practice when handling plant protection products. No specific information is available as to the effectiveness of the cleaning procedures proposed.

4.3 Measures in the case of an accident (KCP 4.5)

The measures in the case of an accident are indicated in the SDS of the product (KCP 4.2/01). The measures are the following:

Measures against fire: Extinguishing media: Dry powder, foam, carbon dioxide or water spray Media to be avoided: High volume water jet Further information: Standard procedure for chemical fires Combustion can produce toxic or irritating fumes: carbon and sulphur oxides. Collect contaminated fire extinguishing water separately. This must not be discharged into drains.

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Nature of protective clothing proposed Protective equipment for storage and transport: - Wear safety glasses and gloves. Special protective equipment for fire fighters: - Use personal protective equipment. In the event of fire, wear self-contained breathing apparatus. Wear protection for eyes and face.

Characteristics of protective clothing proposed No information is provided on the suitability of such clothing as its use is recommended on the basis of general advice for all plant protection products.

Suitability and effectiveness of protective clothing and equipment Only minimal equipment is recommended, which has been proved to be suitably protecting man against plant protection products.

Procedures to minimise the generation of waste Only purchase and store quantities of product required in the short term. Do not open larger containers than is necessary for immediate requirements.

Combustion products likely to be generated in the event of fire Combustion can produce toxic or irritating fumes: carbon oxide, carbon dioxide and sulphur dioxide.

Detailed Procedures for Use in the Event of an Accident During Transport, Storage or Use

Containment of spillages Do not release into drain or watercourses. Contain and control the leaks or spills with non-combustible absorbent materials such as sand, earth, vermiculite, diatomaceous earth in drums for waste disposal.

Decontamination of areas, vehicles and buildings Treat contaminated surfaces with water. Collect washings in containers to avoid any contamination of surface and ground water, water supplies and drains.

Disposal of damaged packaging, adsorbents and other materials Dispose of all waste and contaminated clothing in the same manner as waste chemicals (i.e. via an authorized disposal facility).

Protection of emergency workers and bystanders Use protective clothing as proposed (see above).

First aid measures

- In case of skin contact, take off all contaminated clothing. Wash immediately affected parts with plenty of water and soap. Wash clothing before re-use. - In case of contact with eyes, wash thoroughly with soft, clean water for several minutes holding the eyelids open. Regardless of the initial state, refer the patient to an ophthalmologist and show him the label. - In the event of massive inhalation, remove the person exposed to fresh air. Keep warm and at rest. - In case of swallowing, clean mouth with water. Do not induce vomiting. Do not give the patient anything orally. Seek medical advice immediately and show the container or label. Treat symp- tomatically.

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Neutralisation Procedure for Use in the Event of Accidental Spillage Not necessary as the product is neither strongly acid nor alkaline.

Pyrolytic Behaviour of the Active Substance Not applicable for this product as HELIOSOUFRE S does not have a halogen content > 60%.

Disposal Procedures for the Plant Protection Product

Detailed instructions for safe disposal of product and its packaging For disposal of non-usable products, refer to a licensed contractor for collection and disposal of hazardous products. Deliver empty containers to suitable assembly points. Do not re-use empty containers. Dispose of empty packages through the specific collection services.

Methods other than controlled incineration for disposal No other methods are currently available. Helioterpen Soufre Page 19 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

Appendix 1 Lists of data considered in support of the evaluation

List of data submitted by the applicant and relied on

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

KCP 2.1 Demangel, B. 2016a Physico-chemical tests on HELIOTERPEN SOUFRE Report No 16-901011-001 N Action Pin KCP 2.3 DEFITRACES, Brindas, France KCP 2.5 GLP KCP 2.6 Unpublished KCP 2.4 Demangel, B. 2016b Physico-chemical tests and analyses before and after an accelerated storage procedure for 14 days at 54 °C N Action Pin KCP 2.7 ± 2 °C on HELIOTERPEN SOUFRE Report No 16-901011-003 KCP 2.8.2 DEFITRACES, Brindas, France KCP 2.8.3 GLP KCP 2.8.5.1 Unpublished KCP 2.8.7 KCP 2.7 Demangel, B. 2016c Physico-chemical tests and chemical analysis after a low temperature stability at 0 ± 2 °C for 7 days on N Action Pin KCP 2.8.3 HELIOTERPEN SOUFRE KCP 2.8.5.1 Report No 16-901011-002 DEFITRACES, Brindas, France GLP Unpublished KCP 2.4 Andrieux, A 2018 Physico-chemical tests and chemical stability after a storage procedure for 24 months at 20 °C ± 2 °C on N Action Pin KCP 2.5 HELIOTERPEN SOUFRE KCP 2.7 Report No 16-901011-004 KCP 2.8.2 GLP KCP 2.8.3 Unpublished KCP 2.8.5.1 KCP 2.8.7 KCP 4.2 Anonymous 2016 Material SaftyData Sheet Helioterpen Schwefel Action Pin N Action Pin Not GLP Helioterpen Soufre Page 20 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

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

Unpublished

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

List of data submitted by the applicant and not relied on None.

List of data relied on and not submitted by the applicant but necessary for evaluation None. Helioterpen Soufre Page 21 /21 Part B – Section 1, 2 and 4 - Core Assessment Template for chemical PPP zRMS version Version July 2018

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

A 2.1 Sulphur

Additional studies on the active substance have not been submitted.

Appendix 3 Experimental testing of the physical, chemical and technical characteristics of the product:

The following physical, chemical and technical properties of the plant protection product were experimentally tested in BVL laboratory: relative density, pH (1 %), persistent foaming, surface tension, pourability, wet sieve, suspensibility, storage stability at elevated temperature (2 weeks at 54 °C) and stability at low temperature. No significant deviations from the data submitted by the applicant were detected.

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

Chemical active substance : 700 g/L sulphur Interzonal Zonal Rapporteur Member State: Germany

CORE ASSESSMENT (authorization)

Applicant: Action Pin Submission date: March 2017 New Version : August 2017 MS Finalisation date: 02/08/2019 Helioterpen Soufre Page 2 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Version history

When What

10/02/2017 Applicant version of dRR

21/08/2017 Answers to German authority

05/03/2018 DE evaluation of dRR, green boxes have been added at the end of each chapter

13/03/2019 DE evaluation of dRR with additional information, green boxes have been added at the end of each chapter, additional information has been considered in the green boxes, highlighting of additional information in dRR has been removed

02/08/2019 Final RR of DE, comments received from applicant and cMSs concerning the DE evaluation have been considered and the green boxes have been amended accordingly Helioterpen Soufre Page 3 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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) ...... 10 3.2.1 Preliminary tests (KCP 6.1) ...... 19 3.2.2 Minimum effective dose tests (KCP 6.2) ...... 20 3.2.3 Efficacy tests (KCP 6.2) ...... 28 3.3 Information on the occurrence or possible occurrence of the development of resistance (KCP 6.3) ...... 41 3.4 Adverse effects on treated crops (KCP 6.4) ...... 42 3.4.1 Phytotoxicity to host crop (KCP 6.4.1) ...... 46 3.4.2 Effect on the yield of treated plants or plant product (KCP 6.4.2) ...... 48 3.4.3 Effects on the quality of plants or plant products (KCP 6.4.3) ...... 48 3.4.4 Effects on transformation processes (KCP 6.4.4) ...... 52 3.4.5 Impact on treated plants or plant products to be used for propagation (KCP 6.4.5) ...... 53 3.5 Observations on other undesirable or unintended side-effects (KCP 6.5) ... 54 3.5.1 Impact on succeeding crops (KCP 6.5.1) ...... 55 3.5.2 Impact on other plants including adjacent crops (KCP 6.5.2) ...... 55 3.5.3 Effects on beneficial and other non-target organisms (KCP 6.5.3) ...... 55 3.6 Other/special studies ...... 59 3.7 List of test facilities including the corresponding certificates ...... 59

Appendix 1 Lists of data considered in support of the evaluation ...... 60

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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 following data and information’s were mainly provided by the applicant submitted as dRR and BAD. Additional comments and the final evaluation by the zRMS in this Registration Report are marked by green boxes. This application has been submitted by the applicant Action Pin for their product ‘Helioterpen Soufre’. The product is for professional use containing 700 g/L sulphur. The applicant has submitted a dossier supporting the registration for use as a foliar treatment on cucumber under protected conditions against powdery mildew (Sphaerotheca fuliginea and Erysiphe cichoracearum) in the following countries of the Central Zone (Martime EPPO climatic zone): Austria, Belgium, Czech Republic, Germany (zRMS), Luxembourg, and The Netherlands.

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

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

Summary and Assessment of data according to points 3.2.1 to 3.6. The following are the conclusions from the Central zonezRMS evaluation.

3.2.1 Preliminary tests (KCP 6.1). Sulphur is a well known active substance, and sulphur products have been used more than 150 years as plant protection products to control powdery mildews, no data are required. Sulphur products are still effective to control powdery mildews after so many years of use.

Formulation Comparison/Bridging Trials. Because of a coformulant change in the product (‘Helioterpen Soufre’ CF 151) in the year 2016 the applicant conducted 4 trails with both formulations (first formulation ‘Helioterpen Soufre’ CF 116). The bridging trials support the contention that data from both sulphur formulations can support the authorisation as there were no significant differences in efficacy between the two formulations.

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3.2.2 Minimum Effective Dose [MED] tests (KCP 6.2).

For the evaluation of the minimum effective dose against powdery mildew 7 trials were presented by the applicant. The trials were realised between 2014 and 2016. All trials were conducted to GEP and are stated as carried out in line accordance with EPPO standards: 1/57 (2), PP 1/115 (3; 4), PP 1/52 (4), PP 1/181 (3; 4). The applicant tested concentrations of 1 N / 57 % / 33 % whereby 3.0 L/ha was the recommended dose. In all trials Erysiphe cichoracearum (ERYCI) was named as the powdery mildew by the applicant/farmers. They were working with natural infections. It is not known if they distinguish by morphological or molecularbiological methods the species of powdery mildew. The disease pressure in the untreated control was sufficient. In these MED trials the infestation on the leaves in the untreated control was low in two trial (< 10 %) and medium to high in 5 trials (35-100 %).

For the calculation of LWA the applicant use inoperative tables for calculation. All trials are not conducted for LWA calculation and cannot display the correct values for LWA. For an approach for a revise LWA the values were calculated. On the basic that 3.0 L/ha is the MED a rough calculation to LWA gives following values: min. LWA of 1.30 ha/LWA corresponds with 2.3 L product/ha and for the max. LWA of 2.4 ha/LWA correlates with 1.25 L product/ha with a mean of 1.85 L product /ha LWA. The cMS should consider the data evaluated under this application and the zRMS conclusions in relation to their specific circumstances. In most of the trials a dose response was visible and the proposed dose of 3.0 L/ha shows the highest efficacy.

3.2.3 Efficacy tests (KCP 6.2).

For the evaluation of the efficacy of ‘Helioterpen Soufre’ against powdery mildew 7 trials were presented by the applicant. All trials were conducted to GEP and are stated as carried out in line accordance with EPPO standards: 1/57 (2), PP 1/115 (3; 4), PP 1/52 (4), PP 1/181 (3; 4). The trials included 4 replicates and were laid out in a randomised complete block. In all trials Erysiphe cichoracearum (ERYCI) was named as the powdery mildew by the applicant/farmers. They were working with natural infections. It is not known if they distinguish by morphological or molecular biological methods the species of powdery mildew. Assessments were done according to EPPO standard PP 1/57. Pest severity and incidence on 25-30 leaves sample per plot were recorded. Pest severity was indicated as infected leaf surface or as disease spot number per leaf. Infected leaf surface was expressed in percentage or according to a 0-5 scale as indicated in the EPPO standard. The number of application was in one trial five times with an interval of 7-15 days and in the other six trials six times with intervals of 7-10 days. The spray volumes vary between of 600-1.500 L/ha depending on growth stage. The disease pressure in the untreated control was sufficient. In the trials the infestation on the leaves in the untreated control was low in two trials (< 10 %) and medium to high in 5 trials (35-100 %). The efficacy of ‘Helioterpen Soufre’ with low or medium infestation of powdery mildew was with over 80 % compared to the untreated control acceptable. When the infestation was higher the efficacy is reduced to moderate 65 %. Depending on the reference product efficacy with the recommended dose of ‘Helioterpen Soufre’ of 3.0 L/ha was equal or higher in the variants with the reference products. For the LWA see the MED paragraph. The results for Erysiphe cichoracearum can be extrapolated to Sphaerotheca fuliginea and vice versa.

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Conclusion: The applicant has submitted sufficient efficacy data to support the proposed control claim against powdery mildew on cucumber. Calculation of LWA gave only an assumption. The concerned MS should consider the data evaluated under this application and the zRMS conclusions in relation to their specific circumstances.

3.3 Information on the occurrence or possible occurrence of the development of resistance (KCP 6.3). The applicant presented a resistance risk evaluation in line with the EPPO standard PP 1/213. As a multi-site inhibitor sulphur is considered to be at low risk of resistance developing. Sulphur is not cross-resistant with other fungicides classes, CAA, QoI, cymoxanil and phenylamines used against powdery mildew pathogens. Because of the low resistance risk of sulphur a specific resistance management strategy for ‘Helioterpen soufre’ is not recommended.

3.4.1 Phytotoxicity to host crop (KCP 6.4.1). No phytotoxic effects were observed in trials conducted on cucumber. No further consideration was required on any other crop safety points.

3.4.2 Effect on the yield of treated plants or plant product (KCP 6.4.2). The data supports the contention that when ‘Helioterpen Soufre’ is applied as proposed no adverse effects on the quantity of yield or yield components are to be expected on crops of cucumber.

3.4.3 Effects on the quality of plants or plant products (KCP 6.4.3). The data supports the contention that when ‘Helioterpen Soufre’ is applied as proposed less adverse effects on the quality of plants or plant products are to be expected on crops of cucumber. In two trials residue of the spray was visible and fruits needed washing before being marketable.

Label amendment The zRMS will recommend following label warning for Germany: A visible spray coating may be left on the fruit after application. The cMS should consider in relation to their specific circumstances.

3.4.4 Effects on transformation processes (KCP 6.4.4). The applicant concluded that the product is not intended to be used on plants that are going for processing production and that therefore argued that no data are required. No further consideration is required from the zRMS perspective.

3.4.5 Impact on treated plants or plant products to be used for propagation (KCP 6.4.5). The applicant concluded that this was not investigated as the product is for cucumber plants used for the production of fruits which are not subject to propagation on a routine basis. As the product is a fungicide and crop safety has been evaluated for cucumber, specific data on plant parts for propagation is not required.

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3.5.1 Impact on succeeding crops (KCP 6.5.1).

No impact on succeeding crops has be experienced over then e years if using sulphur and no impact on succeeding crops is to be expected. No further consideration is required.

3.5.2 Impact on other plants including adjacent crops (KCP 6.5.2). No effects to be expected either due to the absence of phytotoxic effects in the efficacy trials and years of practical use of the active ingredient. No further consideration is required.

3.5.3 Effects on beneficial and other non-target organisms (KCP 6.5.3). ‘Helioterpen Soufre’ is classified as: - not harmful for the ground beetle Poecilus cupreus - not harmful for the rove beetle Aleochara bilineata - not harmful for the parasitoid was Aphidius rhopalosiphi. - harmful for the predatory mite Typhlodromus pyri. - harmful for the lacewing Chrysoperla carnea. - harmful for the parasitoid wasp Trichogramma cacoeciae.

3.6 Other/special studies. No additional data were presented.

Overall conclusion: The information provided is acceptable. The evaluation was carried out in accordance with the Uniform Principles.

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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- Member Crop and/ F, Pests or Group of Application Application rate PHI Remarks: zRMS No. state(s) or situation Fn, pests controlled (days) Conclusion * Fnp Method / Timing / Max. number Min. interval kg or L product g or kg as/ha Water e.g. g safener/ (crop destination / G, (additionally: Kind Growth stage a) per use between / ha L/ha synergist per ha, (efficacy) purpose of crop) Gn, developmental stages of crop & b) per crop/ applications a) max. rate per a) max. rate per other dose rate Gnp of the pest or pest season season (days) appl. appl. min / max expression, dose or group) b) max. total b) max. total range (min-max) I ** rate per rate per crop/season crop/season 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) 1 DE Cucumber G Sphaerotheca fuliginea Foliar spray All stages a) 6 7 a) 3 L/ha a) 2.1 kg/ha 300 / 3 DE A (Cucumis sativitus (SPHRFU) b) 6 b) 18 L/ha b) 12.6 kg/ha 1000 Dose rate and (CUMSA) application volume vary with crop height <50 cm: 1.5 L/ha (max. spray volume: 600 L/ha) 50-125 cm: 2.5 L/ha (max. spray volume: 900 L/ha) >125 cm: 3 L/ha (máx. spray volume: 1200 L/ha) Corresponding to LWA: 1.85 L/ha LWA L.prod uct/hL (min- max): 0.3 L/hL – 1 L/hL Assumptions1 2 DE Cucumber G Erysiphe Foliar spray All stages a) 6 7 a) 3 L/ha a) 2.1 kg/ha 300 / 3 DE A (Cucumis sativitus cichoracearum b) 6 b) 18 L/ha b) 12.6 kg/ha 1000 Dose rate and (CUMSA) (ERYSCI) application volume vary with crop height Helioterpen Soufre Page 9 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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

* 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

1 Assumptions for cucumbers: The LWA conversion was based on the parameters derived from the efficacy trials

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 Helioterpen Soufre Page 10 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

3.2 Efficacy data (KCP 6)

Introduction HELIOTERPEN SOUFRE is a fungicide and acaricide containing 700 g/L of sulphur already authorized in Southern Zone (France, Italy, Spain, Portugal, Greece), under tradename HELIOSOUFRE S.

This dossier presents HELIOTERPEN SOUFRE efficacy assessment for its first registration in Central Zone (Germany, Belgium, Netherlands, Luxembourg, Austria and Czech Republic) for following uses: cucumber powdery mildew. Apple scab, pear scab and grapevine powdery mildew are assessed in the dossier corresponding to “field uses”. Germany is zRMS, in charge of the evaluation of the dossier Concerned Member States (cMS) are Belgium, Netherlands, Luxembourg, Austria and Czech Republic)

During HELIOTERPEN SOUFRE experiments in Central Zone, product formulation has evolved with a coformulant change. In this dossier, previous formulation is named “HELIOTERPEN SOUFRE (CF 116)” and new formulation is named “HELIOTERPEN SOUFRE (CF 151)”. In some trials, comparative efficacy study between both formulations was performed to allow use data concerning the previous formulation in case of similar results.

Description of active substance Sulphur (CAS No.7704-34-9) was first included in Annex I of Directive 91/414/EEC (Directive 2009/70/EC, date of inclusion: 01/01/2010, RMS: France), now repealed by Regulation (EC) No.1107/2009 and the Annex of Regulation (EC) No.540/2011.

Mode of action

Table 3.2-01: Details of the active substances

Active substance Sulphur

Concentration 700 g/L (Unit: g/kg or g/L...) Chemical group mineral Mode of action Multisite contact activity FRAC group: M2 Preventive fungicide acts by contact and vapour Affects numerous biochemical processes especially related to cell respiration Biological action Inhibit spore germination and mycelium development. Biological targets Sulphur is efficient against: Powdery mildew (Erysiphales, Ascomycota) Apple and pear scab (Venturia sp., Ascomycota) Rust and blister mites

Description of the plant protection product HELIOTERPEN SOUFRE is a suspension concentrate (SC) containing 700 g/L of sulphur. Helioterpen Soufre Page 11 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Table 3.2-02: Simplified table of currently registered uses and requested uses for the product code.

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

Grapevine Powdery France 7.5 L/ha mildew Greece 0.125-0.4 L/hL (0.65-6 L/ha) Italy Low disease pressure: 0.15-0.3 L/hL High disease pressure: 0.35-0.5 L/hL Portugal 0.3-0.75 L/hL Spain 0.3-0.6 L/hL Germany Before BBCH 61 : 4 L/ha BBCH 61-69: 5.5 L/ha BBCH 71-73: 2.7 L/ha After BBCH 75: 3.5 L/ha Belgium 5.5 L/ha (Before BBCH 61: 3.56-3.78 L/ha LWa; From BBCH 61 : 275-3.36 L/ha LWA)

Netherlands 5.5 L/ha (0.37-6.88 L/hL) not confirmed by MS

The field use in grapevine is currently applied in AT as follows: 5.5 l/ha (3.56- 3.78 l/ha LWA before BBCH 61; 2.75-3.36 l/ha LWA after BBCH 61). The field use in grapevine is applied with the following dose expressions: 7 l/ha; 2.33 l/ha and m canopy height; 4.5- 4.9 l/ha LWA.

Luxembourg 5.5 L/ha Austria 5.5 L/ha Helioterpen Soufre Page 12 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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

Czech 5.5 L/ha Republic Grapevine Mites France 7.5 L/ha (Colomerus Greece 0.85 L/hL (4.25-12.75 vitis) L/ha) Nut trees Powdery France 1 L/hL mildew Stone fruits Powdery France 0.5 L/hL (peach, apricots, mildew Greece 0.09-0.2 L/hL (1.-2.5 nectarins) L/ha) Italy After BBCH 69: 0.3- 0.5 L/hL Portugal After BBCH 69: 0.23- 0.34 L/hL Stone fruits Monilinia sp. Portugal Before BBCH 61: (peach, apricots, 0.34-0.46 L/hL nectarins, plum) After BBCH 69: 0.23- 0.34 L/hL Plum Taphrina Portugal Before BBCH 61: pruni 0.34-0.46 L/hL After BBCH 69: 0.23- 0.34 L/hL

Apple and Pear Venturia France 0.7 L/hL inaequalis / Greece 0.09-0.4 L/hL (0.9 – 8 Venturia L/ha) pyrina Portugal Before BBCH 61: 0.685-0.8 L/hL After BBCH 69: 0.46 L/hL Germany 7 L/ha (LWH 2.33 L/ha and m of canopy heigh) Belgium 7 L/ha (4.5-4.9 L/ha LWA) Netherlands 7 L/ha (0.47-1.4 L/hL) not confirmed by MS Luxembourg 7 L/ha (4.5-4.9 L/ha LWA) Austria 7 L/ha Czech 7 L/ha Republic Apple and Pear Powdery France 0.5 L/hL mildew Greece 0.09-0.35 L/hL (3.5-7 L/ha) Helioterpen Soufre Page 13 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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

Italy Before BBCH 61: 0.4- 0.5 L/hL After BBCH 69: 0.3- 0.5 L/hL Portugal 0.385 L/hL Red beet Powdery France 6 L/ha mildew Carrots Powdery France 6 L/ha mildew Portugal 0.23-0.34 L/hL Celery Powdery France 6 L/ha mildew Witloof chicory Powdery France 6 L/ha (roots) mildew Cucumber Powdery Germany Crop heigh <50cm: 0.85 L/ha mildew Crop heigh 50-125 cm: 1.4 L/ha Crop height>125 cm: 1.7 L/ha Belgium 3 L/ha (5.7 L/ha LWA) Netherlands 3 L/ha (0.3-1 L/hL) not confirmed by MS Luxembourg 3 L/ha (5.7 L/ha LWA) Austria 3 L/ha Czech 3 L/ha Republic

Cucumber, Powdery France 6 L/ha gerkins, zucchini mildew Greece 0.075-0.1 L/hL (0.4-2 L/ha) Portugal 0.23-0.34 L/hL Spinach Powdery France 6 L/ha mildew Strawberry Powdery France 6 L/ha mildew Italy 0.15-0.3 L/hL Portugal 0.23 L/hL French bean Powdery France 6 L/ha mildew Dry legumes Powdery France 6 L/ha (beans, lentils, mildew peas) Melon, Powdery France 6 L/ha Helioterpen Soufre Page 14 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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

watermelon, mildew Greece 0.075-0.1 L/hL (0.4-1 pumpkins L/ha) Portugal 0.34-0.4 L/hL Peas Powdery France 6 L/ha mildew Portugal 0.17-0.23 L/hL Pepper Powdery France 6 L/ha mildew Greece 0.2-0.3 L/hL (1-3 L/ha) Portugal 0.2-0.34 L/hL Potato Powdery Italy 0.15-0.3 L/hL mildew Salsify Powdery France 6 L/ha mildew Tomato, eggplant Powdery France 6 L/ha mildew Greece 0.2-0.3 L/hL (1-6 L/ha) Portugal 0.23-0.46 L/hL Tomato, eggplant Mites France 7.5 L/ha (Aculops lycipersici) Oat Powdery France 6 L/ha mildew Italy 4-5 L/ha Wheat Powdery France 6 L/ha mildew Italy 4-5 L/ha Barley Powdery France 6 L/ha mildew Italy 4-5 L/ha

Sugar beet Powdery France 5 L/ha mildew Italy 4-5 L/ha Hops Powdery France 1.5 L/hL mildew Soybean Powdery Italy 4-5 L/ha mildew Sunflower Powdery Italy 4-5 L/ha mildew Ornemental trees Powdery France 6 L/hL and bushes mildew Chrysanthemum, Powdery Portugal 0.115-0.46 L/hL Bogonia mildew Rose Powdery France 0.3 L/hL Helioterpen Soufre Page 15 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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

mildew Greece 0.2-0.3 L/hL (1-3 L/ha) Portugal 0.23-0.46 L/hL Ornemental Powdery Italy 0.15-0.3 L/hL crops milew

Further details are in the table “All intended uses” in Part B - Section 0 Helioterpen Soufre Page 16 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Description of the target pests

Table 3.2-03: Glossary of pests mentioned in the dossier.

EPPO code Scientific name Common name*

ERYSCI Erysiphe cichoracearum Powdery mildew of cucurbits SPHRFU Sphaerotheca fuliginea Powdery mildew of cucurbits * optional

Erysiphe cichoracearum, Sphaerotheca fuliginea (PP2/31(1): Cucurbits under protected cultivation) Two fungi, Podosphaera xanthii (synonym Sphaerotheca fuliginea, S. Fusca) and Erisphe cichoracearum, can cause powdery mildew on curcurbits. Powdery mildew causes significant diseases on a range of crops, including the Curcurbitaceae, a group which contains several important fruit and vegetable crops like melon, cucumber, watermelon, pumpkin and squash. A study on the occurrence and geographic distribution of powdery mildew on curcurbits revealed that from all collected samples of powdery mildew; both fungi were detected in Czech Republic, Austria, France, Germany, Great Britain, Italy, Slovakia, Slovenia, Switzerland, the Netherlands. The first symptoms are small pale diffuse spots on the upper surface of old leaves, followed by infection of stems and young leaves. These lesions expand and become a white to palegrey powdery mass composed of mycelium and countless numbers of spores. Severely infected leaves become brown, desiccate and die. As the disease develops, severe infection may cause premature leaf senescence and plant death. Powdery mildew is seldom seen on the fruits, but decreased photosynthesis may cause significant reductions in the quality and yield of fruits. Development of powdery mildew is favoured by moderate temperatures and relative humidity, dry soil conditions, reduced light intensity and abundant plant growth. On curcurbits in the glasshouse, conidium release is triggered by irrigation or air movement, which then disperse conidia from plant to plant. Conidia can survive the winter period on curcurbits in glasshouses and are dispersed by wind from glasshouse to field crops during the spring and summer.

Table 3.2-04 below presents the importance of cucumbers production, area harvested and yield in 2014 in the countries where the product is applied for.

Table 3.2-04: Importance of crops production for all cMS and zRMS in 2014².

ha tonnes hg/ha

Austria 397 45537 1148423 Fc Belgium 52 17600 3384615 Fc Cucumbers Czech 353 17154 485949 Fc and Republic gherkins Germany 294 255060 865490 Fc

Luxembourg 1 48 571429 Fc Netherlands 598 440000 7357860 Fc These values are official data unless otherwise is mentioned. *Unofficial figure, FFAO estimate, Fc Calculated data; Im FAO data based on imputation methodology.

1 Křístková, E., Lebeda, A. et Sedláková, B., 2009, Species spectra, distribution and host range of cucurbit powdery mildews in the Czech Republic, and in some other European and Middle Eastern countries. Phytoparasitica 37, 337-350 2 FAO, 2017. FAOSTAT Production/Crops, available on the internet in July 2017 under http://www.fao.org/faostat/en/#data Helioterpen Soufre Page 17 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Table 3.2-05: 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 Cucumber - DE, BE, Erysiphe cichoracearum DE, BE, NL, - NL, LU, (ERYSCI) LU, AT, CZ AT, CZ Sphaerotheca fuliginea DE, BE, NL, - (SPHRFU) LU, AT, CZ

Compliance with the Uniform Principles

All greenhouse efficacy trials were GEP trials and were performed according EPPO general and specific guidelines.

Information on trials submitted (3.1 Efficacy data)

Table 3.2-1: Presentation of trials (efficacy trials, preliminary trials...)

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

Maritime zone

Cucumber Erysiphe Germany 2014- MED, E 3 (3) GEP (Cucumis cichoracearum 2015 sativitus, (ERYSCI) and Belgium 2016 MED, E 1 (1) GEP CUMSA) Sphaerotheca fuliginea Netherlands 2016 MED, E 2 (2) GEP (SPHRFU) Czech 2016 MED, E 1 (1) GEP Republic TOTAL - - 2014- - 7 (7) GEP 2016 * According to the 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.

Helioterpen Soufre Page 18 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Graph 3.2-01: Efficacy greenhouse trial location map – Central Zone – EPPO maritime zone

Table 3.2-02: Presentation of reference standards used in trials (efficacy trials, preliminary trials...)

Country(ies) Formulation Registered Application Reference where the Authorization Active application rate in trials (4) Crop(s) product is Remark standard number substance(s) (2) Concentration (3) (per registered (1) Type of a.s. rate treatment)

Cucumber KUMULUS Belgium 9185P/B Sulphur WG 800 g/kg 5 kg/ha 5 kg/ha / powdery WG LWA (4000 LWA (4000 mildew g a.s./ha g a.s./ha LWA) LWA) ROCKET EC Netherlands 13378N Triflumizole EC 150 g/L 0.1 L/hL (15 0.1 L/hL (15 g a.s./hL) g a.s./hL) 0.5 L/ha (75 g a.s./ha) THIOVIT JET Czech 5308-0 Sulphur WG 800 g/kg 5-7.5 kg/ha 7.5 kg/ha Republic (4000-6000 (6000 g g a.s./ha) a.s./ha) THIOVIT JET Germany 050498-00 Sulphur WG 800 g/ha 1.5 kg/ha 1.5 kg/ha (1200 g (1200 g a.s./ha) a.s./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.). Helioterpen Soufre Page 19 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

3.2.1 Preliminary tests (KCP 6.1)

HELIOTERPEN SOUFRE contains the well-known active substance sulphur has been used as fungicide since middle of nineteenth century. It is known that sulphur provides a good efficacy against powdery mildew in several crops. HELIOTERPEN SOUFRE is authorized against cucumber powdery mildew in France and Greece. Considering these facts, no preliminary test is required.

However, according to EPPO PP1/278(1): Principles of zonal data production and evaluation an EPPO PP1/226(2): Number of efficacy trials in case of different formulations of the same plant protection product, comparability or “bridging” trials should be conducted in which the direct efficacy and crop safety of the proposed new formulation is compared with an existing formulation of the product for which direct efficacy and safety has been demonstrated. Moreover, for a minor change in formulation, are reduced number of trials (<5 trials) would be required, conducted across a representative range of the crops and pests for which approval is sought. Nine Trials (4 applescab, 1 powdery mildew on grape and 4 powdery mildew on cucumber) were thus carried trials were carried out to compare HELIOTERPEN SOUFRE (CF 151) with HELIOTERPEN SOUFRE (CF 116) to assess coformulant change impact on efficacy and adverse effects on treated crops. These assessments are presented in point 3.2.3 and point 3.4 respectively.

3.2.1 Preliminary Tests (KCP 6.1). Sulphur is a well known active substance, and sulphur products have been used more than 150 years as plant protection products to control powdery mildews no data are required. Sulphur products are still effective to control powdery mildews after so many years of use. No additional data are required.

Formulation Comparison/Bridging Trials. Because of a change of one coformulant in the product ‘Helioterpen Soufre’ CF 151 in the year 2016 the applicant conducted 4 trails with both formulations (first formulation ‘Helioterpen Soufre’ CF 116). The table below summarized the efficacy of the 4 trials.

Table 3.2.1-1: Bridging studies with the formulations CF 151 (new) and CF 116 (old) Abbott’s efficacy (%)

Trail - ID Untreated HELIOTERPEN HELIOTERPEN Reference control SOUFRE (CF 151) SOUFRE (CF 116) products 3 L/ha 3 L/ha 2100 g a.s./ha 2100 g a.s./ha GEP-kk16ecmi-red 61.2 61.3 70.5 73.6 NL-ACT-102-02 100 72.7 76.8 9.4 16 1069 5116 4.8* 100 100 70.3 H-16-V-240 2.5* 95.5 98.2 100 Mean 82.4 86.4 STDEV 18.4 14.9 *scale 0-5 Source: BAD for Helioterpen Soufre®, table modified

The bridging trials support the contention that data from both sulphur formulations can support the authorisation as there were no significant differences in efficacy between the two formulations.

Helioterpen Soufre Page 20 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

3.2.2 Minimum effective dose tests (KCP 6.2)

HELIOTERPEN SOUFRE minimum effective dose was determined on one fungicide use: 7 greenhouse trials on powdery mildew on cucumber.

Table 3.2-07: Details on trial methodology – Cucumber / Erysiphe cichoracearum (ERYSCI)

Guidelines General guidelines EPPO PP 1/135(3/4), PP 1/154(4), PP 1/181(3/4) Specific guidelines EPPO PP 1/057(3) Experimental Plot design RCBD (7) design Plot size 2.0-5.0 m² Number of replications 4 (7) Crop Trials per crop Cucumber (7) Varieties per crop Cucumber: Cordoba, Dominica, Euphoria, Lausanne, Roxana, Saladin Sowing period Cucumber : from May (01) to August (04) Application Crop stage (BBCH)* at Cucumber: from BBCH 22 to BBCH 89 application Timing ERYSCI: preventive applications Pest stage at application (1) Number of applications 5 (1 trial) with intervals of 7-15 days Intervals between 6 (6 trials) with intervals of 7-10 days applications Spray volumes 300 - 1500 L/ha Assessment Assessment types % of infected leaf surface Assessment dates 6-21 DAT Other e.g. Natural / artificial Natural infection (7) relevant innoculation… information * BBCH for weeds, pre-emergence, preventive / curative application, insect stage…

Statistical data analysis Data statistical analysis consisted in an ANOVA with 5% of alpha risk, Newman-Keuls test was used as mean test comparison.

Greenhouse Cucumber : Erysiphe cichoracearum (ERYSCI), Sphaerotheca fuliginea (SPHRFU) Fungicide rate in L/ha 7 field trials were established in order to determine the minimum effective dose for the control of cucumber powdery mildew (Erysiphe cichoracearum, ERYSCI) , between 2014 and 2016 in Germany, Belgium, Netherlands and Czech Republic. The rates reflect the proposed label rate (3 L/ha) and 57 % (1.7 L/ha) and 33 % (1 L/ha) of the full recommended rate of HELIOTERPEN SOUFRE, in accordance with the EPPO standard PP 1/225 “Minimum effective dose”. Results are summarized in table 3.2-08 Helioterpen Soufre Page 21 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Table 3.2-08: Minimum effective dose. Efficacy of HELIOTERPEN SOUFRE at proposed label rate, at 57% and 33 % dose rate against Erysiphe cichoracearum (ERYSCI) related to infected leaf surface (%) Grouping Number Infected leaf surface Abbott’s efficacy (%) of trials of the untreated HELIOTERPEN SOUFRE (CF 151) HELIOTERPEN SOUFRE (CF 116) control (%) 3 L/ha 1.7 L/ha 1 L/ha 3 L/ha 1.7 L/ha 1 L/ha (full rate) (57 % of full rate) (33 % of full rate) (full rate) (57 % of full (33 % of full rate) rate) 2100 g a.s./ha 1190 g a.s./ha 700 g a.s./ha 2100 g a.s./ha 1190 g a.s./ha 700 g a.s./ha (full rate) (57 % of full rate) (33 % of full rate) (full rate) (57 % of full (33 % of full rate) rate) Mean Min & Mean Min & Mean Min & Mean Min & Mean Min & Mean Min & Mean Min Max Max Max Max Max Max & Max All (all HELIOTERPEN SOUFRE at 3 L/ha: 86.5 a 9.0 – formulations) 7 49.1 HELIOTERPEN SOUFRE at 1.7 L/ha : 81.1 a 100.0 HELIOTERPEN SOUFRE at 1 L/ha : 69.2 b A : HELIOTERPEN 90.0 - 85.1 - 71.3 – 3 26.6 9.0 - 35.4 ------94.1 a 92.1 a 85.3 a SOUFRE (CF 116) 100.0 100 90.0 B : HELIOTERPEN 15.0 - 56.1 – 41.7 – 32.1 – 4 66.0 80.8 a 72.8 ab 57.2 b ------SOUFRE (CF 151) 100.0 100.0 100.0 100.0 Helioterpen Soufre Page 22 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Minimum effective dose of HELIOTERPEN SOUFRE against Erysiphe cichoracearum (ERYSCI) was assessed in seven greenhouse trials carried out during spring and summer. Both HELIOTERPEN SOUFRE were assessed. Minimum effective dose of the formulation HELIOTERPEN SOUFRE (CF 116) was assessed in Germany, in three trials under low to moderate disease pressure (PESSEV). Dose response was visible but not significant. Mean efficacies were 94.1 %, 92.1 % and 85.3 % when fungicide was applied at 3 L/ha (2100 g a.s./ha), 1.7 L/ha (1190 g a.s./ha) and 1 L/ha (700 g a.s./ha) respectively. Minimum effective dose of the formulation HELIOTERPEN SOUFRE (CF 151) was assessed in Belgium, Netherlands and Czech Republic, in four trials under low to high disease pressure. Dose response was significant. Mean efficacies were 80.8 %; 72.8 % and 57.2 % when fungicide was applied at 3 L/ha (2100 g a.s./ha), 1.7 L/ha (1190 g a.s./ha) and 1 L/ha (700 g a.s./ha) respectively. HELIOTERPEN SOUFRE (CF 151) at 3 L/ha (2100 g a.s./ha) was as efficient as HELIOTERPEN SOUFRE (CF 116) at the same rate (80.8 % mean efficacy against 83.6 % mean efficacy respectively). It is possible to group all trials, considering just fungicide rate. Mean efficacy levels were 86.5, 81.1 and 69.2 when HELIOTERPEN SOUFRE was applied at 3 L/ha (2100 g a.s./ha), 1.7 L/ha (1190 g a.s./ha) and 1 L/ha (700 g a.s./ha) respectively.

To control Erysiphe cichoracearum (ERYSCI) in greenhouse cucumber crop, HELIOTERPEN SOUFRE rate of 2100 g a.s./ha (3 L F.P./ha) is required to reach correct efficacy level, especially when disease pressure is high. Considering fungus biological closeness, it is reasonable to extrapolate these results on Sphaerotheca fuliginea (SPHRFU).

Fungicide rate in L/ha LWA

7 field trials were established in order to determine the minimum effective dose for the control of cucumber powdery mildew (Erysiphe cichoracearum, ERYSCI), between 2014 and 2016 in Germany, Belgium, Netherlands and Czech Republic. Rates expressed in L/ha LWA were related to row spacing (1 m, 1.2-1.25 m and 1.5-1.6 m) and crop height (from 0.25 to 0.5 m, from 0.5 to 1.25 m and 1.25 to 1.75 m). Trial grouping considered row spacing. The rates reflect the proposed label rates according row spacing and crop growing, 57 % and 33 % of full recommended rates of HELIOTERPEN SOUFRE, in accordance with the EPPO standard PP 1/225 “Minimum effective dose”. Results are summarized in table 3-2-09.

Helioterpen Soufre Page 23 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Table 3.2-09: Minimum effective dose. Efficacy of HELIOTERPEN SOUFRE at proposed label rate, at 57% and 33 % dose rate against Erysiphe cichoracearum (ERYSCI) related to infected leaf surface (%)

Groupi Numb Infected leaf Crop Abbott’s efficacy (%) ng er of surface of heig Row spacing : 1.5-1.6 m Row spacing: 1.2-1.25 m Row spacing: 1 m trials the ht HELIOTERPEN SOUFRE (CF 151) HELIOTERPEN SOUFRE (CF 151) HELIOTERPEN SOUFRE (CF 116) HELIOTERPEN SOUFRE (CF 116) untreated Full rate 57 % of full 33 % of full Full rate 57 % of full 33 % of full Full rate 57 % of full 33 % of full Full rate 57 % of full 33 % of full control rate rate rate rate rate rate rate rate (%) 0.25- 4.5-9.6 L/ha 2.55-5.44 1.5-3.2 L/ha 3.6-7.5 L/ha 2.04-4.25 1.2-2.5 L/ha 3.6-7.5 L/ha 2.04-4.25 1.2-2.5 L/ha 3-6 L/ha 1.7-3.4 L/ha 1-2 L/ha 0.5 LWA L/ha LWA LWA LWA L/ha LWA LWA LWA L/ha LWA LWA LWA LWA LWA m 0.5- 1.8-4.8 L/ha 1.02-2.72 0.6-1.6 L/ha 1.4-3.75 0.82-2.13 0.48-1.25 1.4-3.75 0.82-2.13 0.48-1.25 1.2-3 L/ha 0.68-1.7 0.4-1 L/ha 1.25 LWA L/ha LWA LWA L/ha LWA L/ha LWA L/ha LWA L/ha LWA L/ha LWA L/ha LWA LWA L/ha LWA LWA m 1.25- 1.29-1.92 0.6-1.09 0.43-0.96 1.03-1.5 0.58-0.85 0.34-0.5 1.03-1.5 0.58-0.85 0.34-0.5 0.86-1.2 0.49-0.68 0.29-4 L/ha 1.75 L/ha LWA L/ha LWA L/ha LWA L/ha LWA L/ha LWA L/ha LWA L/ha LWA L/ha LWA L/ha LWA L/ha LWA L/ha LWA LWA m 0.25- 3150-6720 g 1785-3808 g 1050-2240 g 2520-5250 g 1428-2975 g 840-1750 g 2520-5250 g 1428-2975 g 840-1750 g 2100-4200 g 1190-2380 g 700-1400 g 0.5 a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA m 0.5- 1260-3360 g 704-1904 g 420-1120 g 980-2625 g 574-1491 g 336-875 g 980-2625 g 574-1491 g 336-875 g 840-2100 g 476-1190 g 280-700 g 1.25 a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA m 1.25- 903-1344 g 420-763 g 301-92 g 721-1050 g 406-595 g 238-350 g 721-1050 g 406-595 g 238-350 g 602-840 g 343-476 g 203-280 g 1.75 a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA m Mea Min Mea Min Mea Mi Mea Mi Mea Mi Mea Mi Mea Mi Mea Mi Mea Mi Mea Mi Mea Min Mea Min Mea Mi n & n & n n & n n & n n & n n & n n & n n & n n & n n & n & n & n n & Ma Ma Ma Ma Ma Ma Ma Ma Ma Ma Ma Ma Ma x x x x x x x x x x x x x All 41. 19. 71. 9.0 56.1 98. 90.0 85.1 7 – 4 – 3 – 7 49.1 - 74.3 - 63.8 42.9 94.5 - 100 - 100 - 99.1 2 - 100 - 90.0 - 91.2 - 88.2 - 77.9 94. 77. 84. 100 100 100 92.4 91.2 8 3 5 A 100 100 90.0 1 9.0 ------a a a B 71. 35.3 90.0 85.1 91.2 88.2 77.9 3 – 2 35.3 ------a a a 84. 35.4 92.4 91.2 5 C 41. 19. 50.0 56.1 74.3 63.8 7 – 42.9 4 – 3 82.9 – ------a ab 94. b 77. 100 100 8 3 D 94.5 100 100 98.2 1 15.0 ------a a a a Helioterpen Soufre Page 24 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

For row spacing 1.5-1.6 m, HELIOTERPEN SOUFRE (CF 151) efficacy related to infected leaf surface (PESSEV) was assessed in three greenhouse trials. Disease infection was very high in untreated (98.7-100 % of infected leaf surface). Under these conditions, dose response was very clear and significant. HELIOTERPEN SOUFRE (CF 151) at full rates (6720-3150 g a.s./ha LWA at 0.25-0.5 cm respectively, 3360-1260 g a.s./ha LWA at 0.5-1.25 m respectively and 1344-903 g a.s./ha LWA at 1.25-1.75 m respectively) reached 74.3 % mean control. Applied at 57 % and 33 % of its full rates, HELIOTERPEN SOUFRE (CF 151) reached 63.8 % and 42.9 % mean efficacy respectively. For row spacing 1.2-1.25 m, HELIOTERPEN SOUFRE (CF 151) and HELIOTERPEN SOUFRE (CF 116) efficacy related to infected leaf surface (PESSEV) was assessed in two greenhouse trials. Disease infection was low to moderate in untreated (9.0-15.0 % of infected leaf surface). . Under these conditions, dose response was not visible for both formulations. Efficacy ranged from 94.5 to 100.0 %. Both formulations at full rate were equivalent, this fact is confirmed in point 3.2.3 with trials carried out in Belgium, Netherlands and Czech Republic. It is possible to include results with HELIOTERPEN SOUFRE (CF 116) in this assessment. For row spacing 1 m, HELIOTERPEN SOUFRE (CF 116) efficacy related to infected leaf surface (PESSEV) was assessed in two greenhouse trials. Disease infection was medium in untreated (around 35 % of infected leaf surface). Under these condition dose response was visible but not significant. HELIOTERPEN SOUFRE (CF 116) at full rates (4200-2100 g a.s./ha LWA at 0.25-0.5 cm respectively, 2100-840 g a.s./ha LWA at 0.5-1.25 m respectively and 602-840 g a.s./ha LWA at 1.25-1.75 m respectively) reached 91.2 % mean control. Applied at 57 % and 33 % of its full rates, HELIOTERPEN SOUFRE (CF 116) reached 88.2 % and 77.9 % mean efficacy respectively.

To control Erysiphe cichoracearum (ERYSCI) in greenhouse cucumber crop, HELIOTERPEN SOUFRE full rates, as indicated in following table, are required to reach correct efficacy level, especially when disease pressure is high.

Full rate LWA related to row spacing and crop height is summarized in following table: Row spacing 1.0 m 1.2-1.25 m 1.6 m 0.25-0.5 m height 2100-4200 g a.s./ha LWA 2520-5250 g a.s./ha LWA 3150-6720 g a.s./ha LWA (3-6 L F.P./ha LWA (3.6-7.5 L F.P./ha LWA) (4.5-9.6 L F.P./ha LWA) 0.5-1.25 m height 840-2100 g a.s./ha LWA 980-2625 g a.s./ha LWA 1260-3360 g a.s./ha LWA (1.2-3 L F.P./ha LWA) (1.4-3.75 L F.P./ha LWA) (1.8-4.8 L F.P./ha LWA) 1.25-1.75 m height 602-840 g a.s./ha LWA 721-1050 g a.s./ha LWA 903-1344 g a.s./ha LWA (0.86-1.2 L F.P./ha LWA) (1.03-1.5 L F.P./ha LWA) (1.29-1.92 L F.P./ha LWA)

Considering fungus biological closeness, it is reasonable to extrapolate these results on Sphaerotheca fuliginea (SPHRFU).

Summary and conclusions on the minimum effective dose HELIOTERPEN SOUFRE minimum effective dose was determined for one greenhouse fungicide use: Erysiphe cichoracearum (ERYSCI) in cucumber.

Fungicide rate expressed in L/ha

Erysiphe cihoracearum (ERYSCI) in greenhouse cucumber Minimum effective dose of HELIOTERPEN SOUFRE was assessed in seven greenhouse trials carried out from 2014 to 2016 in Germany, Belgium, Czech Republic and Netherlands. To control Erysiphe cichoracearum (ERYSCI) in greenhouse cucumber crop, HELIOTERPEN SOUFRE rate of 2100 g a.s./ha (3 L F.P./ha) is required to reach correct efficacy level, especially when disease pressure is high. Considering fungus biological closeness, it is reasonable to extrapolate these results on Sphaerotheca fuliginea (SPHRFU).

Helioterpen Soufre Page 25 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Fungicide rate expressed in L/ha LWA

Erysiphe cihoracearum (ERYSCI) in greenhouse cucumber Minimum effective dose of HELIOTERPEN SOUFRE was assessed in seven greenhouse trials carried out from 2014 to 2016 in Germany, Belgium, Netherlands and Czech Republic. To control Erysiphe cichoracearum (ERYSCI) in greenhouse cucumber crop, HELIOTERPEN SOUFRE full rates, as indicated in following table, are required to reach correct efficacy level, especially when disease pressure is high.

Considering fungus biological closeness, it is reasonable to extrapolate these results on Sphaerotheca fuliginea (SPHRFU).

3.2.2 Minimum Effective Dose [MED] tests (KCP 6.2).

For the evaluation of the minimum effective dose against powdery mildew 7 trials were presented by the applicant. In Germany 3 trials were conducted with the formulation CF 116 and one trial with the new formulation CF 151. In The Netherland 2 trials were conducted and each one in Belgium and Czech Republic, all with the new formulation CF 151. The trials were realised between 2014 and 2016. All trials were conducted to GEP and are stated as carried out in line accordance with EPPO standards: 1/57 (2), PP 1/115 (3; 4), PP 1/52 (4), PP 1/181 (3; 4). The trials included 4 replicates and were laid out in a randomised complete block. The EPPO standard PP 1/225 (2) stated out that at least one lower dose to that which would be recommended shout be tested. The applicant tested concentrations of 1 N / 57 % / 33 % whereby 3.0 L/ha was the recommended dose. In all trials Erysiphe cichoracearum (ERYCI) was named as the powdery mildew by the applicant/farmers. They were working with natural infections. It is not known if they distinguish by morphological or molecularbiological methods the species of powdery mildew. Assessments were done according to EPPO standard PP 1/57. Pest severity and incidence on 25-30 leaves sample per plot were recorded. Pest severity was indicated as infected leaf surface or as disease spot number per leaf. Infected leaf surface was expressed in percentage or according to a 0-5 scale as indicated in the EPPO standard. Harvested fruit number and weight were recorded to assess effect on yield. The number of application was in one trial five times with an interval of 7-15 days and in the other six trials six times with intervals of 7-10 days. The spray volumes vary between of 600-1.500 L/ha depending on growth stage. The disease pressure in the untreated control was sufficient. In these MED trials the infestation on the leaves in the untreated control was low in two trials (< 10 %) and medium to high in 5 trials (35-100 %). For the evaluation of the efficacy for pest severity the trials were grouped slightly different by zRMS because of the different infestation levels, assessment dates and rating used by the applicant. In most of the trials a dose response was visible and the proposed dose of 3.0 L/ha shows the highest efficacy (see Table 3.2.2-1 below). Helioterpen Soufre Page 26 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Table 3.2.2-1: Trials of ‚Helioterpen Soufre‘ for MED to the control of powdery mildew on cucumber Trial n° Assess- Untreated Abbott’s efficacy (%) Country ment check Spray volume date (infected HELIOTERPEN SOUFRE HELIOTERPEN SOUFRE leaf (CF 151) (CF 116) surface) 3 L/ha 1.7 L/ha 1 L/ha 3 L/ha 1.7 L/ha 1 L/ha (full rate) (57 % of (33 % of (full rate) (57 % of (33 % of full rate) full rate) full rate) full rate) 2100 1190 700 2100 1190 g 700 g g a.s./ha g a.s./ha g a.s./ha g a.s./ha a.s./ha a.s./ha (full rate) (57 % of (33 % of (full rate) (57 % of (33 % of full rate) full rate) full rate) full rate) 14 1047 1364 14 DAE 9.0 % - - - 100.0 a 100.0 a 90.0 a Germany 600 L/ha 15-00092-01 14 DAF 35.3 % - - - 92.4 a 91.2 ab 84.5 c Germany 600 L/ha 15-00092-02 14 DAF 35.4 % - - - 90.0 a 85.1 b 71.3 c Germany 600 L/ha Efficacy 94.1 a 92.1 a 81.9 a

GEP- 14 DAF 98.7 % 56.1 ab 41.7 bc 32.1 c 59.3 ab - - kk16ecmi-red Belgium 995 L/ha NL16-ACT- 14 DAF 100.0 % 39.0 a 25.1 b 10.5 c 40.8 a - - 102-02 Netherlands 1000-1500 L/ha Efficacy 47.6 a 33.4 b 21.3 c 50.1 a

16 1069 5116 9 DAF 4.8 (0-5 100.0 a 94.8 a 77.3 b 100.0 a - - Netherlands index) - H-16-V-240 8 DAF 2.5 (0-5 94.5 a 100.0 a 100.0 a 98.2 a - - Czech index) Republic 300-500 L/ha Efficacy 97.3 a 97.4 a 88.7 b 99.1 a

Source: BAD for Helioterpen Soufre®, table modified For the calculation of LWA the applicant use unusable table for calculation. All trials are not conducted for LWA calculation and cannot display the correct values for LWA. For an approach for a revise LWA the area was calculated. For this calculation, 5 of the 7 efficacy trials records the LWA per ground ha (Table 3.2.2-2). Table 3.2.2-2: Assumption to convert the MED to LWA Trail ID Leaf wall area min max 14 1047 1364 0.83 1.4 15-00092-01 2.00 3.50 15-00092-02 2.00 3.50 GEP-kk16ecmi- 2.19 red Helioterpen Soufre Page 27 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

H-16-V-240 0.40 1.28 mean 1.30 2.37 1.82

On the basic that 3.0 L/ha is the MED a rough calculation to LWA gives following values: min. LWA of 1.30 ha/LWA corresponds with 2.3 L product/ha and for the max. LWA of 2.4 ha/LWA correlates with 1.25 L product/ha with a mean of 1.85 L product /ha LWA. The Concerned MS should consider the data evaluated under this application and the ZRMS conclusions in relation to their specific circumstances. The results for Erysiphe cichoracearum can be extrapolated to Sphaerotheca fuliginea and vice versa. The cMS should consider the data evaluated under this application and the zRMS conclusions in relation to their specific circumstances.

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3.2.3 Efficacy tests (KCP 6.2)

HELIOTERPEN SOUFRE efficacy was assessed on one greenhouse fungicide use: 7 trials on powdery mildew on cucumber. Trials were carried out between 2014 and 2016 in Germany, Belgium, Netherlands and Czech Republic.

Table 3.2-10: Details on trial methodology – Cucumber / Erysiphe cichoracearum (ERYSCI)

Guidelines General guidelines EPPO PP 1/135(3/4), PP 1/154(4), PP 1/181(3/4) Specific guidelines EPPO PP 1/057(3) Experimental Plot design RCBD (7) design Plot size 2.0-5.0 m² Number of replications 4 (7) Crop Trials per crop Cucumber (7) Varieties per crop Cucumber: Cordoba, Dominica, Euphoria, Lausanne, Roxana, Saladin Sowing period Cucumber : from May (01) to August (04) Application Crop stage (BBCH)* at Cucumber: from BBCH 22 to BBCH 89 application Timing ERYSCI: preventive applications Pest stage at application (1) Number of applications 5 (1 trial) with intervals of 7-15 days Intervals between 6 (6 trials) with intervals of 7-10 days applications Spray volumes 300 - 1500 L/ha Assessment Assessment types % of infected leaf surface, yield (fruit number per plant and fruit weight per plant) Assessment dates 6-21 DAT Other e.g. Natural / artificial Natural infection (7) relevant innoculation… information * BBCH for weeds, pre-emergence, preventive / curative application, insect stage…

Statistical data analysis Data statistical analysis consisted in an ANOVA with 5% of alpha risk, Newman-Keuls test was used as mean test comparison.

Greenhouse Cucumber: Erysiphe cichoracearum (ERYSCI), Sphaerotheca fuliginea (SPHRFU) Fungicide rate in L/ha 7 trials were carried out between 2014 and 2016 in Germany, Belgium, Netherlands and Czech Republic to assess HELIOTERPEN SOUFRE efficacy against Erysiphe cichoracearum (ERYSCI) in greenhouse cucumber crop. HELIOTERPEN SOUFRE (CF 151) was compared with HELIOTERPEN SOUFRE (CF 116), to assess coformulant change effect on efficacy. HELIOTERPEN SOUFRE (3 L/ha) efficacy was compared with standard WG sulphur based fungicides applied at their authorized rates in Germany, Belgium and Czech Republic. In Netherlands, where none sulphur based fungicide is authorized against cucumber powdery mildew, chosen standard was a triflumizole based fungicide. Results are summarized in tables 3.2-11 to 3.2-14.

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Table 3.2-11: Efficacy of HELIOTERPEN SOUFRE against Erysiphe cichoracearum (ERYSCI) related to infected leaf surface Abbott’s efficacy (%) Untreated check HELIOTERPEN HELIOTERPEN KUMULUS THIOVIT JET (sulphur) ROCKET EC (Triflumizole) (infected leaf SOUFRE (CF 151) SOUFRE (CF 116) WG (sulphur) No of trials where Number surface) 3 L/ha 3 L/ha 1.5 kg/ha 7.5 kg/ha 10.93 kg/ha 0.5 L/ha 0.1 L/hL HELIOTERPEN Grouping of trials 2100 g a.s./ha 2100 g a.s./ha 1200 g a.s./ha 6000 g a.s./ha 8744 g a.s./ha 75 g a.s./ha 15 g a.s./hL SOUFRE is >, <, = Min Min Min Min Min compared to standards Min & Min & Min & Mean Mean Mean Mean & Mean & Mean & Mean & Mean & Max Max Max Max Max Max Max Max 9.0 – 56.1- 59.3 – 82.0 – 4 trials > All 7 49.1 81.6 88.1 90.3 100.0 - 64.7 - 9.4 - 70.3 - 100.0 100.0 100.0 100.0 3 trials = 9.0 – 90.0 – 90.3 82.0 – 2 trials > A 3 26.6 - - 94.1 a ------35.4 100.0 b 100.0 1 trial = B 1 98.7 - 56.1 ab - 59.3 a - - - - - 64.7 a - - - - - 1 trial = C 1 100.0 - 72.7 a - 76.8 a ------9.4 cd - - - 1 trial > 70.3 D 1 50.0 - 100.0 a - 100.0 a ------1 trial > b 100.0 E 1 15.0 - 95.5 a - 98.2 a ------1 trial = a

Table 3.2-12: Mean table of efficacy of HELIOTERPEN SOUFRE against Erysiphe cichoracearum (ERYSCI) related to infected leaf surface

% of control

HELIOTERPEN HELIOTERPEN Number of SOUFRE (CF THIOVIT JET THIOVIT JET KUMULUS WG ROCKET EC ROCKET EC SOUFRE (CF 151) trials 116) 3 L/ha 3 L/ha 1.5 kg/ha 7.5 kg/ha 10.93 kg/ha 0.5 L/ha 0.1 L/hL 2100 g a.s./ha 2100 g a.s./ha 1200 g a.s./ha 6000 g a.s./ha 8744 g a.s./ha 75 g a.s./ha 15 g a.s./hL Average of all trials with the test product 7 - 88.1 ------Orthogonal comparison, with main reference product(s) 4 81.6 83.6 - - - - - 3 - 94.1 90.3 - - - - 1 56.1 59.3 - - 64.7.= 14 DAF - - 70.5 73.6 = 7 DAF 1 72.7 76.8 - - - 9.4 = 6 DAF - 1 100.0 100.0 - - - - 70.3 = 9 DAF 1 95.5 98.2 - 100.0 = 8 DAF Helioterpen Soufre Page 30 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Table 3.2-13: HELIOTERPEN SOUFRE effect on cucumber yield in presence of Erysiphe cichoracearum (ERYSCI) –Fruit number per plant Absolute figures (cumulative harvested fruit number per plant) Untreated control HELIOTERPEN HELIOTERPEN KUMULUS WG ROCKET EC (Triflumizole) Aboslute figures (cumulative SOUFRE (CF 151) SOUFRE (CF 116) (sulphur) No of trials where HELIOTERPEN Number of harvested fruit number per 3 L/ha 3 L/ha 5 kg/ha LWA 0.5 L/ha 0.1 L/hL Grouping SOUFRE is >, <, = compared to trials plant) 4000 g a.s./ha 2100 g a.s./ha 2100 g a.s./ha 75 g a.s./ha 15 g a.s./hL standards LWA Min & Min & Min & Min & Mean Min & Max Mean Mean Min & Max Mean Mean Mean Max Max Max Max All 3 16.7 a 13.5 – 21.1 17.3 a 13.3 – 24.2 18.1 a 13.3 -25.4 ------3 trials = A 1 15.4 a - 14.5 a - 15.7 a - 15.7 a - - - - - 1 trial = 24.0 1 trial = B 1 21.1 c - 24.2 ab - 25.4 a ------ab C 1 13.5 a - 13.3 a - 13.3 a - - - - - 12.8 a - 1 trial =

Table 3.2-14: HELIOTERPEN SOUFRE effect on cucumber yield in presence of Erysiphe cichoracearum (ERYSCI) –Fruit weight per plant (kg) Absolute figures (kg/plant) HELIOTERPEN HELIOTERPEN KUMULUS WG Untreated control ROCKET EC (Triflumizole) SOUFRE (CF 151) SOUFRE (CF 116) (sulphur) Aboslute figures Number of 3 L/ha 3 L/ha 5 kg/ha LWA 0.5 L/ha 0.1 L/hL No of trials where HELIOTERPEN Grouping (kg/plant) trials 4000 g a.s./ha SOUFRE is >, <, = compared to standards 2100 g a.s./ha 2100 g a.s./ha 75 g a.s./ha 15 g a.s./hL LWA Min & Min & Min & Min & Mean Mean Min & Max Mean Min & Max Mean Mean Mean Max Max Max Max All 3 5.8 a 4.3 – 7.0 6.2 a 4.5 – 8.2 6.3 a 4.3 – 8.6 ------3 trials = A 1 6.1 a - 5.8 a - 6.1 a - 6.2 a - - - - - 1 trial = B 1 7.0 c - 8.2 ab - 8.6 a - - - 8.3 ab - - - 1 trial = C 1 4.3 a - 4.5 a - 4.3 a - - - - - 4.3 a - 1 trial = Helioterpen Soufre Page 31 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

HELIOTERPEN SOUFRE efficacy related to infected leaf surface (PESSEV) was assessed in seven greenhouse trials. HELIOTERPEN SOUFRE formulations comparison was performed in four trials. HELIOTERPEN SOUFRE (CF 151) at 3 L/ha (2100 g a.s./ha) was equivalent to HELIOTERPEN SOUFRE (CF 116) at the same rate with 81.6 and 83.6 % mean control respectively. Coformulant change did not affect fungicide efficacy level. Under low to medium disease level, HELIOTERPEN SOUFRE (CF 116) at 3 L/ha (2100 g a.s./ha) reached higher efficacy level than that of standard WG sulphur at 1200 g a.s./ha, as expected (94.1 % mean control against 90.3 % mean control respectively). Both formulations of HELIOTERPEN SOUFRE 3 L/ha (2100 g a.s./ha) were equivalent to standard WG sulphur based products applied at 6000 g a.s./ha or at 8744 g a.s./ha. In one trial, standard based triflumizole based product (75 g a.s./ha) was poor, efficacy around 9.4 %. This result could be explained by a possible DMI resistance and a very high disease pressure. Efficacy of both HELIOTERPEN SOUFRE formulations at 3 L/ha (2100 g a.s./ha) ranged from 72.7 and 76.8 %. Standard based triflumizole based product (15 g a.s./hL) had a correct efficacy level (70.3 %). Both HELIOTERPEN SOUFRE formulations at 3 L/ha (2100 g a.s./ha) were better with 100.0 % disease control.

HELIOTERPEN SOUFRE effect on yield, during harvest time, was assessed in three greenhouse trials. Yield was measured as cumulative fruit number per plant and as cumulative fruit weight per plant. In two trials, there was not significant difference between treatments considering harvested fruit number or harvested fruit weight. In one trial, untreated had significantly lower yield than treated conditions, with 3-4 more fruits per plant (yield gain ranged from 14 to 19 %) and 1-1.6 more kg per plant (yield gain ranged from 14 to 23 %) in treated conditions. There were not significant difference between both HELIOTERPEN SOUFRE formulations at 3 L/ha (2100 g a.s./ha) and standard triflumizole based fungicide at its authorized rate.

To assess HELIOTERPEN SOUFRE efficacy against Erysiphe cichoracearum (ERYSCI) in greenhouse cucumber crop, seven trials were carried out between 2014 and 2016 in Germany, Belgium, Netherlands and Czech Republic.

HELIOTERPEN SOUFRE (CF 151) at 3 L/ha (2100 g a.s./ha) was compared with HELIOTERPEN SOUFRE (CF 116) at same rate. Their efficacies on leaves were very similar. Coformulant change did not affect significantly HELIOTERPEN SOUFRE efficacy against grapevine powdery mildew.

On leaves, HELIOTERPEN SOUFRE at 3 L/ha (2100 g a.s./ha) was, at least, equivalent to standard WG sulphur based products at their authorized rates in Germany, Belgium and Czech Republic. HELIOTERPEN SOUFRE at 3 L/ha (2100 g a.s./ha) was better than standard triflumizole based fungicide at its authorized rate in Netherlands.

In significant presence of Erysiphe cichoracearum, HELIOTERPEN SOUFRE at 3 L/ha could increase cucumber yield. Yield gain could reach 14 and 19 %.

Considering fungus biological closeness, it is reasonable to extrapolate these results on Sphaerotheca fuliginea (SPHRFU).

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Fungicide rate in L/ha LWA 7 trials were carried out between 2014 and 2016 in Germany, Belgium, Netherlands and Czech Republic to assess HELIOTERPEN SOUFRE efficacy against Erysiphe cichoracearum (ERYSCI) in greenhouse cucumber crop. HELIOTERPEN SOUFRE (CF 151) was compared with HELIOTERPEN SOUFRE (CF 116), to assess coformulant change effect on efficacy. HELIOTERPEN SOUFRE efficacy was compared with standard WG sulphur based fungicides applied at their authorized rates in Germany, Belgium and Czech Republic. In Netherlands, where none sulphur based fungicide is authorized against cucumber powdery mildew, chosen standard was a triflumizole based fungicide. Rates expressed in L/ha LWA were related to row spacing (1 m, 1.2-1.25 m and 1.5-1.6 m) and crop height (from 0.25 to 0.5 m, from 0.5 to 1.25 m and 1.25 to 1.75 m). Trial grouping considered row spacing. Results are summarized in tables 3.2-15 to 3.2-18.

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Table 3.2-15: Efficacy of HELIOTERPEN SOUFRE against Erysiphe cichoracearum (ERYSCI) related to infected leaf surface

Crop Abbott’s efficacy (%) heig KUMULUS HELIOTERPEN SOUFRE ROCKET EC ht HELIOTERPEN SOUFRE (CF 116) THIOVIT JET (sulphur) WG (CF 151) (Triflumizole) (sulphur) Row Row Row Row Row Row Row Row Row spacing 1.2- spacing 1.5- spacing 1.2- spacing 1.5- spacing 1.2 spacing 1.25 spacing 1.6 Row spacing 1.6 m spacing 1 m spacing 1 m 1.25 m 1.6 m 1.25 m 1.6 m m m m 0.25- 3.6-7.5 L/ha 4.5-9.6 L/ha 3-6 L/ha 3.6-7.5 L/ha 4.5-9.6 L/ha 1.5-3 kg/ha 1.8-3.6 9.38-18.75 0.8-1.6 L/ha 0.5 LWA LWA LWA LWA LWA LWA kg/ha LWA kg/ha LWA LWA m Infected leaf 0.5- 1.4-3.75 1.8-4.8 L/ha 1.2-3 L/ha 1.4-3.75 1.8-4.8 L/ha 0.6-1.5 0.72-1.8 3.75-9.38 5 kg/ha 0.32-0.8 Numb surface in 1.25 L/ha LWA LWA LWA L/ha LWA LWA 0.1 L/hL No of trials Groupi kg/ha LWA kg/ha LWA kg/ha LWA LWA L/ha LWA er of the m where ng trials untreated 1.25- 1.03-1.5 1.29-1.92 0.86-1.2 1.03-1.5 1.29-1.92 HELIOTERP 0.43-0.6 0.51-0.72 2.68-3.75 0.23-0.32 control (%) 1.75 L/ha LWA L/ha LWA L/ha LWA L/ha LWA L/ha LWA EN SOUFRE kg/ha LWA kg/ha LWA kg/ha LWA L/ha LWA m is >, <, = 0.25- 2520-5250 g 3150-6720 g 2100-4200 g 2520-5250 g 3150-6720 g 1200-2400 g 1440-2880 g 7504-15000 120-240 g compared to 0.5 a.s./ha a.s./ha a.s./ha a.s./ha a.s./ha a.s./ha a.s./ha g a.s./ha a.s./ha standards m LWA LWA LWA LWA LWA LWA LWA LWA LWA 0.5- 980-2625 g 1260-3360 g 840-2100 g 980-2625 g 1260-3360 g 480-1200 g 576-1440 g 3000-7504 g 4000 g 48-120 g 1.25 a.s./ha a.s./ha a.s./ha a.s./ha a.s./ha a.s./ha a.s./ha a.s./ha a.s./ha a.s./ha 15 g a.s./hL m LWA LWA LWA LWA LWA LWA LWA LWA LWA LWA 1.25- 721-1050 g 903-1344 g 602-840 g 721-1050 g 903-1344 g 344-480 g 408-576 g 2144-3000 g 34.5-48 g 1.75 a.s./ha a.s./ha a.s./ha a.s./ha a.s./ha a.s./ha a.s./ha a.s./ha a.s./ha m LWA LWA LWA LWA LWA LWA LWA LWA LWA Mi Mi Mi Mi Mi Mi Mi Mi Mi Mi Mi Mi Mea n & Mea n & Mea n & Mea n & Mea n & Mea n & Mea n & Mea n & Mea n & Mea n & Mea n & Mea n &

n Ma n Ma n Ma n Ma n Ma n Ma n Ma n Ma n Ma n Ma n Ma n Ma x x x x x x x x x x x x 90. 82. 50. 98. 59. 0 – 0 - 4 trials > All 7 49.1 97.5 - 76.3 1 - 91.2 99.1 2 - 78.7 3 - 83.3 100 - 100 - 64.7 - 9.4 - 70.3 - 92. 85. 3 trials = 100 100 100 4 5 100 100 A 1 9.0 ------1 trial = a a 35. 90. 82. 3 - 91.2 0 – 83.3 0 – B 2 35.4 ------2 trials > 35. a 92. b 85. 4 4 5 56.1 59.3 64.7 C 1 98.7 ------1 trial = ab a a 100. 72.7 76.8 9.4 D 1 ------1 trial > 0 a a cd 100 100 70.3 E 1 50.0 ------1 trial > a a b 97.5 98.2 100 F 1 15.0 ------1 trial = a a a

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Table 3.2-16: Mean table of efficacy of HELIOTERPEN SOUFRE against Erysiphe cichoracearum (ERYSCI) related to infected leaf surface

Crop height % of control

HELIOTERPEN SOUFRE KUMULUS HELIOTERPEN SOUFRE (CF 116) THIOVIT JET ROCKET EC (CF 151) WG

Row spacing Row spacing Row spacing Row spacing Row spacing Row spacing Row spacing Row spacing Row spacing Row spacing 1.6 m 1.2-1.25 m 1.5-1.6 m 1 m 1.2-1.25 m 1.5-1.6 m 1 m 1.2 m 1.25 m 1.6 m

0.25-0.5 m 3.6-7.5 L/ha 4.5-9.6 L/ha 3-6 L/ha 3.6-7.5 L/ha 4.5-9.6 L/ha 1.5-3 kg/ha 1.8-3.6 kg/ha 9.38-18.75 0.8-1.6 L/ha LWA LWA LWA LWA LWA LWA LWA kg/ha LWA LWA

0.5-1.25 m 1.4-3.75 L/ha 1.8-4.8 L/ha 1.2-3 L/ha 1.4-3.75 L/ha 1.8-4.8 L/ha 0.6-1.5 kg/ha 0.72-1.8 3.75-9.38 0.32-0.8 L/ha Number 5 kg/ha LWA 0.1 L/hL of trials LWA LWA LWA LWA LWA LWA kg/ha LWA kg/ha LWA LWA 1.25-1.75 m 1.03-1.5 L/ha 1.29-1.92 0.86-1.2 L/ha 1.03-1.5 L/ha 1.29-1.92 0.43-0.6 0.51-0.72 2.68-3.75 0.23-0.32 LWA L/ha LWA LWA LWA L/ha LWA kg/ha LWA kg/ha LWA kg/ha LWA L/ha LWA

0.25-0.5 m 2520-5250 g 3150-6720 g 2100-4200 g 2520-5250 g 3150-6720 g 1200-2400 g 1440-2880 g 7504-15000 g 120-240 g a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA

0.5-1.25 m 980-2625 g 1260-3360 g 840-2100 g 980-2625 g 1260-3360 g 480-1200 g 576-1440 g 3000-7504 g 4000 g a.s./ha 48-120 g 15 g a.s./hL a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA LWA a.s./ha LWA

1.25-1.75 m 721-1050 g 903-1344 g 602-840 g 721-1050 g 903-1344 g 344-480 g 408-576 g 2144-3000 g 34.5-48 g a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA a.s./ha LWA --Orthogonal comparison, with main 1 - - - 100.0 - - 100.0 - - - - reference product(s) 2 - - 91.2 - - 83.3 - - - - - 3 - 76.3 - - 78.7 ------1 - 56.1 - - 59.3 - - - 64.7 - - 1 - 72.7 - - 76.8 - - - - 9.4 - 1 - 100 - - 100 - - - - - 70.3 1 97.5 - - 98.2 - - - 100 - - -

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Table 3.2-17: HELIOTERPEN SOUFRE effect on cucumber yield in presence of Erysiphe cichoracearum (ERYSCI) –Fruit number per plant Crop Absolute figures (cumulative harvested fruit number per plant) height HELIOTERPEN HELIOTERPEN KUMULUS WG ROCKET EC (Triflumizole) SOUFRE (CF 151) SOUFRE (CF 116) (sulphur) Row spacing 1.5- Row spacing 1.5-1.6 m Row spacing 1.5-1.6 m Row spacing 1.5-1.6 m 1.6 m 0.25-0.5 4.5-9.6 L/ha LWA 4.5-9.6 L/ha LWA 0.8-1.6 L/ha m LWA Untreated control 0.5-1.25 1.8-4.8 L/ha LWA 1.8-4.8 L/ha LWA 0.32-0.8 L/ha Aboslute figures 5 kg/ha LWA 0.1 L/hL m LWA (cumulative harvested fruit Number 1.25- 1.29-1.92 L/ha LWA 1.29-1.92 L/ha LWA 0.23-0.32 L/ha No of trials where Grouping number per plant) HELIOTERPEN SOUFRE is >, <, of trials 1.75 m LWA = compared to standards 0.25-0.5 3150-6720 g a.s./ha 3150-6720 g a.s./ha 120-240 g m LWA LWA a.s./ha LWA 0.5-1.25 1260-3360 g a.s./ha 1260-3360 g a.s./ha 4000 g a.s./ha 48-120 g a.s./ha 15 g a.s./hL m LWA LWA LWA LWA 1.25- 903-1344 g a.s./ha 903-1344 g a.s./ha 34.5-48 g a.s./ha 1.75 m LWA LWA LWA Min Min & Min & Min & Mean Min & Max Mean Mean Min & Max Mean Mean Mean & Max Max Max Max All 3 16.7 a 13.5 – 21.1 17.3 13.3 – 24.2 18.1 13.3 – 25.4 15.7 - 24.0 - 12.8 - 3 trials = A 1 15.4 a - 14.5 a - 15.7 a - 15.7 a - - - - - 1 trial = B 24.0 1 trial = 1 21.1 c - 24.2 ab - 25.4 a ------ab C 1 13.5 a - 13.3 a - 13.3 a - - - - - 12.8 a - 1 trial =

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Table 3.2-18: HELIOTERPEN SOUFRE effect on cucumber yield in presence of Erysiphe cichoracearum (ERYSCI) –Fruit weight per plant (kg) Crop Absolute figures (kg/plant) height HELIOTERPEN HELIOTERPEN KUMULUS WG ROCKET EC (Triflumizole) SOUFRE (CF 151) SOUFRE (CF 116) (sulphur) Row spacing 1.5- Row spacing 1.5-1.6 m Row spacing 1.5-1.6 m Row spacing 1.5-1.6 m 1.6 m 0.25-0.5 4.5-9.6 L/ha LWA 4.5-9.6 L/ha LWA 0.8-1.6 L/ha m LWA 0.5-1.25 Untreated control 1.8-4.8 L/ha LWA 1.8-4.8 L/ha LWA 0.32-0.8 L/ha 5 kg/ha LWA 0.1 L/hL m Aboslute figures LWA Number of No of trials where HELIOTERPEN Grouping 1.25- (kg/plant) 1.29-1.92 L/ha LWA 1.29-1.92 L/ha LWA 0.23-0.32 L/ha SOUFRE is >, <, = compared to trials 1.75 m LWA standards 0.25-0.5 3150-6720 g a.s./ha 3150-6720 g a.s./ha 120-240 g a.s./ha m LWA LWA LWA 0.5-1.25 1260-3360 g a.s./ha 1260-3360 g a.s./ha 4000 g a.s./ha 48-120 g a.s./ha 15 g a.s./hL m LWA LWA LWA LWA 1.25- 903-1344 g a.s./ha LWA 903-1344 g a.s./ha LWA 34.5-48 g a.s./ha 1.75 m LWA Min & Min & Min & Min & Mean Mean Min & Max Mean Min & Max Mean Mean Mean Max Max Max Max All 3 5.8 4.3 – 7.0 6.2 4.5 – 8.2 6.3 4.3 – 8.6 6.2 - 8.3 - 4.3 - 3 trials = A 1 6.1 a - 5.8 a - 6.1 a - 6.2 a - - - - - 1 trial = B 1 7.0 c - 8.2 ab - 8.6 a - - - 8.3 ab - - - 1 trial = C 1 4.3 a - 4.5 a - 4.3 a - - - - - 4.3 - 1 trial =

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HELIOTERPEN SOUFRE efficacy related to infected leaf surface (PESSEV) was assessed in seven greenhouse trials. HELIOTERPEN SOUFRE formulations comparison was performed in four trials. In trials with 1.5-1.6 m row spacing, HELIOTERPEN SOUFRE (CF 151) at 6720-903 g a.s./ha LWA according crop height 0.25- 1.75 m respectively, was equivalent to HELIOTERPEN SOUFRE (CF 116) at the same rates (76.3 % mean control against 78.7 % mean control respectively). In trial with 1.25 m row spacing, HELIOTERPEN SOUFRE (CF 151) at 5250-721 g a.s./ha LWA according crop height 0.25-1.75 m respectively, was equivalent to HELIOTERPEN SOUFRE (CF 116) at the same rates (97.5 % mean control against 98.2 % mean control respectively). Coformulant change did not affect fungicide efficacy level.

In trials with 1 m row spacing, HELIOTERPEN SOUFRE (CF 116) at 4200-602 g a.s./ha LWA according crop height 0.25-175 m respectively, reached higher efficacy level than that of standard WG sulphur at 2400-408 g a.s./ha LWA according crop height,, as expected (91.2 % mean control against 83.3 % mean control respectively).

Both formulations of HELIOTERPEN SOUFRE at 6720-903 g a.s./ha LWA according crop height 0.25- 1.75 m respectively, was equivalent to standard WG sulphur based products applied at 4000 g a.s./ha LWA. Both formulations of HELIOTERPEN SOUFRE at 5250-721 g a.s./ha LWA according crop height 0.25- 1.75 m respectively, was equivalent to standard WG sulphur based products applied at 15000-2144 g a.s./ha LWA according crop height 0.25-1.75 m respectively.

In one trial, standard based triflumizole based product (240-34.5 g a.s./ha LWA according crop height 0.25- 1.75 m respectively) was poor, efficacy around 9.4 %. This result could be explained by a possible DMI resistance and a very high disease pressure. Efficacy of both HELIOTERPEN SOUFRE formulations at 6720-903 g a.s./ha LWA according crop height 0.25-1.75 m respectively, ranged from 72.7 and 76.8 %. Standard based triflumizole based product (15 g a.s./hL) had a correct efficacy level (70.3 %). Both HELIOTERPEN SOUFRE formulations at 6720-903 g a.s./ha LWA according crop height 0.25-1.75 m respectively, were better with 100.0 % disease control.

HELIOTERPEN SOUFRE effect on yield, during harvest time, was assessed in three greenhouse trials. Yield was measured as cumulative fruit number per plant and as cumulative fruit weight per plant. In two trials, there was not significant difference between treatments considering harvested fruit number or harvested fruit weight. In one trial, untreated had significantly lower yield than treated conditions, with 3-4 more fruits per plant (yield gain ranged from 14 to 19 %) and 1-1.6 more kg per plant (yield gain ranged from 14 to 23 %) in treated conditions. There were not significant difference between both HELIOTERPEN SOUFRE formulations at 6720-903 g a.s./ha LWA according crop height 0.25-1.75 m respectively, and standard triflumizole based fungicide at its authorized rate.

HELIOTERPEN SOUFRE full rates expressed in L/LWA is summarized in following table: Row spacing 1.0 m 1.2-1.25 m 1.6 m 0.25-0.5 m height 2100-4200 g a.s./ha 2520-5250 g a.s./ha 3150-6720 g a.s./ha LWA LWA LWA (3-6 L F.P./ha LWA (3.6-7.5 L F.P./ha LWA) (4.5-9.6 L F.P./ha LWA) 0.5-1.25 m height 840-2100 g a.s./ha LWA 980-2625 g a.s./ha LWA 1260-3360 g a.s./ha (1.2-3 L F.P./ha LWA) (1.4-3.75 L F.P./ha LWA LWA) (1.8-4.8 L F.P./ha LWA) 1.25-1.75 m height 602-840 g a.s./ha LWA 721-1050 g a.s./ha LWA 903-1344 g a.s./ha LWA (0.86-1.2 L F.P./ha (1.03-1.5 L F.P./ha (1.29-1.92 L F.P./ha LWA) LWA) LWA) Helioterpen Soufre Page 38 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

HELIOTERPEN SOUFRE (CF 151) with rate ranged from 721 to 6720 g a.s./ha LWA according row spacing and crop growing, was compared with HELIOTERPEN SOUFRE (CF 116) at same rate. Their efficacies on leaves were very similar. Coformulant change did not affect significantly HELIOTERPEN SOUFRE efficacy against grapevine powdery mildew.

On leaves, HELIOTERPEN SOUFRE with rate ranged from 602 to 6720 g a.s/ha LWA according row spacing and crop growing, was, at least, equivalent to standard WG sulphur based products at their authorized rates in Germany, Belgium and Czech Republic. HELIOTERPEN SOUFRE with rate ranged from 903 to 6720 g a.s./ha LWA according crop growing, was better than standard triflumizole based fungicide at its authorized rate in Netherlands.

In significant presence of Erysiphe cichoracearum, HELIOTERPEN SOUFRE with rate ranged from 903 to 6720 g a.s./ha LWA according crop growing, could increase cucumber yield. Yield gain could reach 14 and 19 %.

Considering fungus biological closeness, it is reasonable to extrapolate these results on Sphaerotheca fuliginea (SPHRFU).

Summary and conclusion Fungicide rate expressed in L/ha

Erysiphe cihoracearum (ERYSCI) in greenhouse cucumber To assess HELIOTERPEN SOUFRE efficacy against Erysiphe cichoracearum (ERYSCI) in greenhouse cucumber crop, seven trials were carried out between 2014 and 2016 in Germany, Belgium, Netherlands and Czech Republic.

In significant presence of Erysiphe cichoracearum, HELIOTERPEN SOUFRE at 3 L/ha could increase cucumber yield. Yield gain could reach 14 and 19 %.

Considering fungus biological closeness, it is reasonable to extrapolate these results on Sphaerotheca fuliginea (SPHRFU).

Fungicide rate expressed in L/ha LWA

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HELIOTERPEN SOUFRE full rates expressed in L/LWA is summarized in following table: Row spacing 1.0 m 1.2-1.25 m 1.6 m 0.25-0.5 m height 2100-4200 g a.s./ha LWA 2520-5250 g a.s./ha LWA 3150-6720 g a.s./ha LWA (3-6 L F.P./ha LWA (3.6-7.5 L F.P./ha LWA) (4.5-9.6 L F.P./ha LWA) 0.5-1.25 m height 840-2100 g a.s./ha LWA 980-2625 g a.s./ha LWA 1260-3360 g a.s./ha LWA (1.2-3 L F.P./ha LWA) (1.4-3.75 L F.P./ha LWA) (1.8-4.8 L F.P./ha LWA) 1.25-1.75 m height 602-840 g a.s./ha LWA 721-1050 g a.s./ha LWA 903-1344 g a.s./ha LWA (0.86-1.2 L F.P./ha LWA) (1.03-1.5 L F.P./ha LWA) (1.29-1.92 L F.P./ha LWA)

Considering fungus biological closeness, it is reasonable to extrapolate these results on Sphaerotheca fuliginea (SPHRFU).

3.2.3 Efficacy tests (KCP 6.2)

For the evaluation of the efficacy of ‘Helioterpen Soufre’ against powdery mildew 7 trials were presented by the applicant. In Germany 3 trials were conducted with the formulation CF 116 and one trial with the new formulation CF 151. In The Netherland 2 trials were conducted and each one in Belgium and Czech Republic, all with the new formulation CF 151. The trials were realised between 2014 and 2016. Bridging studies with the formulation CF 116 and CF 151 showed the same level of efficacy in the tested crop when applied in the same conditions at equivalent rates. All trials were conducted to GEP and are stated as carried out in line accordance with EPPO standards: 1/57 (2), PP 1/115 (3; 4), PP 1/52 (4), PP 1/181 (3; 4). The trials included 4 replicates and were laid out in a randomised complete block. 3.0 L/ha of the test product was the recommended dose. In all trials Erysiphe cichoracearum (ERYCI) was named as the powdery mildew by the applicant/farmers. They were working with natural infections. It is not known if they distinguish by morphological or molecularbiological methods the species of powdery mildew. Assess- ments were done according to EPPO standard PP 1/57. Pest severity and incidence on 25-30 leaves sample per plot were recorded. Pest severity was indicated as infected leaf surface or as disease spot number per leaf. Infected leaf surface was expressed in percentage or according to a 0-5 scale as indicated in the EPPO standard. Harvested fruit number and weight were recorded to assess effect on yield. The number of application was in one trial five times with an interval of 7-15 days and in the other six trials six times with intervals of 7-10 days. The spray volumes vary between of 600- 1.500 L/ha depending on growth stage. Helioterpen Soufre Page 40 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

For the evaluation of the efficacy for pest severity the trials were grouped slightly different by zRMS because of the different infestation levels, assessment dates and rating used by the applicant. The disease pressure in the untreated control was sufficient. In the trials the infestation on the leaves in the untreated control was low in two trials (< 10 %) and medium to high in 5 trials (35-100 %).

Table 3.2.3-1: Efficacy trials of ‚Helioterpen Soufre‘ to the control of powdery mildew on cucumber Trial n° Assessment Untreated Abbott’s efficacy (%) Country date check Spray volume (infected leaf HELIOTERPEN HELIOTERPEN Reference surface) SOUFRE SOUFRE (diverse) (CF 151) (CF 116) 3 L/ha 3 L/ha (full rate) (full rate) 2100 2100 g a.s./ha g a.s./ha (full rate) (full rate) 14 1047 1364 14 DAE 9.0 % - 100.0 a 100.a Germany (Maritime zone) 600 L/ha 15-00092-01 14 DAF 35.3 % - 92.4 a 88.9 b Germany (Maritime zone) 600 L/ha 15-00092-02 14 DAF 35.4 % - 90.0 a 82.0 b Germany (Maritime zone) 600 L/ha

Efficacy 94.1 a

GEP- 14 DAF 98.7 % 56.1 a 59.3 a 64.7 a kk16ecmi-red Belgium (Maritime zone) 995 L/ha NL16-ACT- 14 DAF 100.0 % 39.0 a 40.8 a 9.4 b 102-02 Netherlands (Maritime zone) 1000-1500 L/ha

Efficacy 47,6 a 50,1 a

16 1069 5116 9 DAF 4.8 (0-5 index) 100.0 a 100.0 a 70.3 b Netherlands (Maritime zone) - H-16-V-240 8 DAF 2.5 (0-5 index) 94.5 a 98.2 a 100.0 a Czech Republic (Maritime zone) 300-500 L/ha Efficacy 97.25 99.1 a

Source: BAD for Helioterpen Soufre®, table modified Helioterpen Soufre Page 41 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

The efficacy of ‘Helioterpen Soufre’ with low or medium infestation of powdery mildew was with over 80 % compared to the untreated control acceptable. When the infestation was higher the efficacy is reduced to moderate 65 %. Depending on the reference product efficacy was equal or higher than in the variants with ‘Helioterpen Soufre’. For the LWA see the MED paragraph. The results for Erysiphe cichoracearum can be extrapolated to Sphaerotheca fuliginea and vice versa. Conclusion: The applicant has submitted sufficient efficacy data to support the proposed control claim against powdery mildew on cucumber. The concerned MS should consider the data evaluated under this application and the zRMS conclusions in relation to their specific circumstances.

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

Information on the possible occurrence of the development of resistance or cross-resistance after application of HELIOTERPEN SOUFRE (Sulphur) following the uses intended in this dossier is provided according EPPO PP1/213(4): Resistance risk analysis. Active ingredients(s) HELIOTERPEN SOUFRE is a suspension concentrate (SC) with fungicide activity containing 700 g/L of sulphur for use on apple, pear, grapevine and cucumber.

Mode of action Sulphur belongs to the FRAC (Fungicide Resistance Action Committee) group M2 (Multiple site contact activity). Sulphur is a mineral active substance with multisite mode of action. Sulphur affects numerous biochemical reactions implicated in cell respiration.

Status Resistance to crop protection chemicals is a common biological phenomenon that occurs in insects, fungi and weeds. It usually becomes evident after the repeated use of a particular pesticide selecting the naturally occurring resistant biotypes and thus allowing them to multiply over several seasons until they become an obvious problem.

Sulphur has been used as fungicide for 150 years and no fungal resistant strain has been observed. No case of a fungus resistant to sulphur was ever reported by the FRAC. Powdery mildew and other diseases resistant strains are unlikely to exist.

Mechanism(s) of resistance The FRAC ( Fungicide Resistance Action Committee) classifies sulphur as a low risk fungicide with no signs of resistance developing (FRAC³, 2017).

Evidence of resistance No case of a fungus resistant to sulphur was ever reported by the FRAC¹.

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Cross resistance There are no recorded instances of sulphur resistance in fungi in Europe and therefore there is no current evidence of cross resistance or the potential for cross-resistance.

Baseline Sensitivity data Sulphur has been used as fungicide for 150 years. It is therefore no longer possible to conduct true baseline sensitivity testing.

3.3.1 Determination of Inherent Risk for Resistance Development of the Target Species

If not noted differently the information presented is based on information being available on the FRAC (Fungicide Resistance Action Committee) homepage on the internet.

Determination of inherent risk for resistance of target pathogens The analysis of inherent risk of plant pathogens to develop resistance to fungicides is done according to EPPO guideline 1/213(4) - Resistance Risk Analysis - Appendix II4, focussing on a historical analysis of the occurrence of plant pathogens resistance of the target species and a historical analysis of the occurrence of fungi resistance to the chemical (mode of action) group of the product.

Sphaerotheca fuliginea causes powdery mildew on cucurbits. Several cases of resistance were recorded for this pathogen to some groups of fungicides: Hydroxy (2 amino) pyrimidines: Adenosine-deaminase and MBC fungicides (Methyl Benzimidazole Carbamates). Based on this situation and according to FRAC Pathogen risk list3, Sphaerotheca fuliginea is considered to present a high risk for resistance development to fungicides.

Erysiphe cichoracearum causes powdery mildew on cucurbits. Only one case of resistance was recorded for this pathogen to the group of fungicides: MBC fungicides (Methyl Benzimidazole Carbamates). Based on this situation and according to FRAC Pathogen risk list3, Erysiphe cichoracearum is considered to present a low risk for resistance development to fungicides.

Regarding the active substance, as described above, no case of a fungus resistant to sulphur was ever reported by the FRAC. For this reason, the risk of sulphur to force the resistance development of target pathogens is scored low.

Combined inherent risk Based on the above determined risks of substance and pathogens, the combined inherent resistance risk (pathogen x product) of the target pathogens to develop resistance to Sulphur is considered low (table 3.3.1- 1).

3 FRAC Code List 2017: Fungicides sorted by mode of action (2017) http://www.frac.info/docs/default-source/publications/frac-code-list/frac-code-list-2017-final.pdf?sfvrsn=fab94a9a_2 4 EPPO: Standard of the efficacy evaluation of plant protection products [PP 1/213(4)], Resistance Risk Analysis – Appendix II, Specific details on different types of plant protection products

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Table 3.3.1-1: Modified combined resistance risk diagram based on inherent fungicide risk and inherent pathogen risk Fungicide Classes Fungicide Risk Combined Risk (fungicide risk x pathogen risk) benzimidazoles dicarboximides phenylamides; Qol high = 3 3 6 9 fungicides carboxamides; SBI fungicides anilinopyrimidines;phenylpyrroles medium = 2 2 4 6

multisite fungicides (e.g. dithicarbamates,Copper, Sulphur), low = 1 1 2 3 MBI-R inhibitors, SAR inducers Pathogen risk low = 1 medium = 2 high = 3 Pathogen groups Erysiphe e.g. Rhynchosporium Sphaerotheca cichoraearum secalis, Septoria tritici fuliginea Oculimacula spp. *Fungicides and pathogen risks are classified from 1 [low] to 3 [high; Combined risk is the product of both. Combined risk: 1-3 = low, 2-6-= medium, 9 = high.

3.3.2 Determination of Agronomic Risk for resistance

Agronomic parameters reducing the risk of a development of resistance are: • No repeated applications in the same crop per season, • Applications in mixture with other (different mode of action) active substances, • Sequential applications with other (different mode of action) active substances, • High level of activity on the target pathogen, • Protective use of the fungicide, • Chemical diversity.

Agronomic parameters increasing the risk of a development of resistance are: • Repeated applications (repeated exposure of successive generations of a pathogen to the fungicide), • Control of pathogen with sole active substance (mostly meaning a single site of action), • Application of sub-lethal concentrations of the fungicide, • Eradicative use of the fungicide

With respect to the above mentioned agronomic parameters and an unrestricted use pattern, the following can be stated for HELIOTERPEN SOUFRE. • HELIOTERPEN SOUFRE contains one active ingredient with a multisite contact activity; • It provides protective and curative action; • For the control of the pathogens across the season as a rule, multiple consecutive applications are required (dependent on the duration of the crop cycle); • Alternative chemically diverse effective products are available for the control of the target pathogens; • At the recommended use rate HELIOTERPEN SOUFRE provides a control of the target pathogens.

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Conclusions for agronomic risk estimation If HELIOTERPEN SOUFRE is used unrestrictedly as a sole product for the control of apple and pear scab or powdery mildew on cucurbits and grapevine, the agronomic risk for the development of pathogen resistance against HELIOTERPEN SOUFRE in this intended indications is considered low.

Conclusions inherent and agronomic risk analysis

Taking into consideration inherent and agronomic risk resistance development, iz can be concluded that the risk of target pathogens to develop resistance to HELIOTERPEN SOUFRE is low (table 3.3.2-1)

Table 3.3.2-1:”Modified combined resistance risk diagram (FRAC) based on inherent fungicide risk, inherent pathogen risk and agronomic risk

Fungicide Classes Fungicide Risk Combined Risk Agronomic (fungicide risk x pathogen risk x agronomic risk) Risk

benzimidazoles 6 12 18 high = 1 dicarboximides- phenylamides- 3 6 9 medium = 0.5 high = 6 Qol fungicides 1.5 3 4.5 low = 0.25 SDHI fungicides**

high = 1 SBI fungicides 4 8 12 anilinopyrimidines; medium = 4 2 4 6 medium = 0.5 phenylpyrroles 1 2 3 low = 0.25

multisite fungicides 1 2 3 high = 1 (e.g.dithiocarbamates) MBI-Rinhibitors low = 1 0.5 1 1.5 medium = 0.5 SAR inducers 0.25 0.5 0.75 low = 0.25

Pathogen risk low = 1 medium = 2 high = 3 Pathogen groups Erysiphe e.g.Rhynchosporium Sphaerotheca cichoracearum secalis, Septoria fuliginea tritici Oculimacula spp.

Only most important classes and groups mentioned *medium to high risk

Summary and Conclusions

The risk for the development of resistance of fungi to HELIOTERPEN SOUFRE was analysed following EPPO guideline PP 1/213(4). Based on this analysis and historical data, the combined inherent risk of Sphaerotheca fuliginea and Erysiphe cichoracearum to develop resistance to sulphur is considered low. The agronomic risk analysis has shown low agronomic risk if HELIOTERPEN SOUFRE would be used unrestrictedly. Taking into consideration inherent and agronomical risk for resistance development, it is Concluded that the risk of target pathogens to develop resistance to HELIOTERPEN SOUFRE is low.

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3.3.3 Resistance Management Strategy

As the resistance risk to sulphur is considered low, no specific resistance management strategy is considered to be required, beyond adhering to the instructions on the proposed label. In addition, sulphur could be used in fungicide programs in resistant management of unisite fungicides.

3.3 Information on the occurrence or possible occurrence of the development of resistance (KCP 6.3) For point 3.3 the applicant presented a resistance risk evaluation in line with the EPPO standard PP 1/213 (4). According to the Fungicide Resistance Action Committee (FRAC) sulphur belongs to the Mode of Action Group M2, which shows multi-site contact activity. The multi-site nature of sulphur activity against fungi has been observed to inhibit respiration, disrupt proteins and form heavy metal chelates within fungal cells resulting in the inhibition of spore germination and hyphal growth. This group is generally considered as a low risk group of fungicides without any signs of resistance development, and with no cross resistance between group members M1 to M9. Powdery mildews of Cucurbits Podosphaera xanthii, formerly Sphaerotheca fuliginea is classified as a high-risk pathogens and Golovinomyces cichoracearum formerly Erysiphe cichoracearum as a low-risk pathogen. As a multi-site inhibitor sulphur is considered to be at low risk of resistance developing. Sulphur reacts not cross-resistant with other fungicides classes, CAA, QoI, cymoxanil and phenylamines used against powdery mildew pathogens. The multi-site activity of sulfur is a useful tool in the phytopathogen resistance management of systemic fungicides with more specific single-site modes of action, as the combination of sulphur with these types of product not only increases their spectrum of activity but also decreases the chances of pathogen resistance. The overall risk of resistance arising to the ‘Helioterpen Soufre’ is regarded as low and therefore considered to be acceptable. The suggestion is to include the following FRAC recommendations for minimising any risk of resistance arising a sulphur products on label: - Maintain the label dose rate - Application for preventative control and within the maximum specified number of applications per season - Use as part of a spray program in sequence and tank mixtures with other fungicides with different modes of action where relevant.

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3.4 Adverse effects on treated crops (KCP 6.4)

Information on trials submitted (3.4: Adverse effects on treated crops)

Table 3.4-01: Presentation of trials (selectivity trials, transformation trials...)

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

Cucumber Germany S 3 (3) - 2014-2015 GEP

Belgium S, Q 1 (1) - 2016 GEP

Czech S 1 (1) - 2016 GEP Republic Netherlands S 1 (1) - 2016 GEP

S, Q 1 (1) - 2016 GEP

TOTAL - - 7 (7) - 2014-2016 GEP * 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 3.4-02: Presentation of reference standards used in trials (selectivity trials, transformation trials...)

Country(ies) Formulation Application Active Registered Reference where the Authorization Crop(s) substance(s) application rate in Remark(4) standards product is number Concentration trials (per (1) (a.s) (2) rate(3) registered Type of a.s. treatment)

Cucumber KUMULUS Belgium 9185P/B Sulphur WG 800 g/kg 5 kg/ha 5 kg/ha WG LWA LWA (4000 (4000 g g a.s./ha a.s./ha LWA) LWA) ROCKET EC Netherlands 13378N Triflumizole EC 150 g/L 0.1 L/hL 0.1 L/hL (15 g (15 g a.s./hL) a.s./hL) 0.5 L/ha (75 g a.s./ha) THIOVIT JET Czech 5308-0 Sulphur WG 800 g/kg 5-7.5 kg/ha 7.5 kg/ha Republic (4000-6000 (6000 g g a.s./ha) a.s./ha) THIOVIT JET Germany 050498-00 Sulphur WG 800 g/ha 1.5 kg/ha 1.5 kg/ha (1200 g (1200 g a.s./ha) a.s./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)

HELIOTERPEN SOUFRE selectivity was assessed on each crop: 7 greenhouse trials on cucumber, in presence of disease. Phytotoxicity data was collected from efficacy trials. Helioterpen Soufre Page 47 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Table 3.4-03: Details on trial methodology – Cucumber

Guidelines General guidelines EPPO PP 1/135(3/4), PP 1/154(4), PP 1/181(3/4) Specific guidelines EPPO PP 1/057(3) Experimental Plot design RCBD (7) design Plot size 2.0-5.0 m² Number of replications 4 (7) Crop Trials per crop Cucumber (7) Varieties per crop Cucumber: Cordoba, Dominica, Euphoria, Lausanne, Roxana, Saladin Sowing period Cucumber : from May (01) to August (04) Application Crop stage (BBCH)* at Cucumber: from BBCH 22 to BBCH 89 application Number of 5 (1 trial) with intervals of 7-15 days applications 6 (6 trials) with intervals of 7-10 days Intervals between applications Spray volumes 300 - 1500 L/ha Assessment Assessment types % of infected leaf surface, yield (fruit number per plant and fruit weight per plant) Assessment dates 6-21 DAT

Statistical data analysis Data statistical analysis consisted in an ANOVA with 5% of alpha risk, Newman-Keuls test was used as mean test comparison.

Greenhouse Cucumber (Cucumis sativitus, CUMSA) Fungicide rate in L/ha HELIOTERPEN SOUFRE phytotoxicity was assessed on cucumber in seven greenhouse trials carried out between 2014 and 2016 in Germany, Belgium, Netherlands and Czech Republic, in presence of disease.

No phytotoxicity symptom caused by HELIOTERPEN SOUFRE (CF 151) at 1 to 3 L/ha (700 to 2100 g a.s./ha) or HELIOTERPEN SOUFRE (CF 116) at the same rates, was recorded. Coformulant change did not affect HELIOTERPEN SOUFRE selectivity on cucumber.

Fungicide rate in L/ha LWA HELIOTERPEN SOUFRE phytotoxicity was assessed on cucumber in seven greenhouse trials carried out between 2014 and 2016 in Germany, Belgium, Netherlands and Czech Republic, in presence of disease.

No phytotoxicity symptom caused by HELIOTERPEN SOUFRE (CF 151) at its full rates or HELIOTERPEN SOUFRE (CF 116) at the same rates, was recorded. Helioterpen Soufre Page 48 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Coformulant change did not affect HELIOTERPEN SOUFRE selectivity on cucumber.

HELIOTERPEN SOUFRE was perfectly selective on cucumber when product was applied at 50 % of its full rate to its full rate.

3.4.1 Phytotoxicity to host crop (KCP 6.4.1). Overall, seven selectivity trials were conducted with cucumber and assessed for phytotoxicity of ‘Helioterpen Soufre’. These trials were conducted to GEP and in line with the EPPO standards PP 1/135, 1/154 and 1/181. In these trials six of commercially important crop varieties were tested. Trials were carried out in a time period from 2014 to 2016 in Belgium, Czech Republic, the Netherlands, and in Germany. Assessment was done by estimation of phytotoxicity symptoms in percent of the leaves and fruits. No phytotoxic effects were observed at the proposed dose in these seven trails. No further information is required.

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

In greenhouse cucumber, HELIOTERPEN SOUFRE did not cause phytotoxicity symptom. Negative effect on yield is not expected when the fungicide is applied at its recommended rates. Furthermore, in trials carried out in cucumber crop, in presence of disease, HELIOTERPEN SOUFRE increased its marketable yield in the most cases, as presented in point 3.2.2.

3.4.2 Effect on the yield of treated plants or plant product (KCP 6.4.2). In four of the effectiveness trials (GEP-kk16ecmi-red, NL16-ACT-102-02, 16 1069 5116, H- 16- V-240) the applicant conducted a yield assessment. The harvestable fruits were collected, counted and weighed during these trials. The applicant showed that in the presence of disease no negative effects of ‘Helioterpen Soufre’ on yield could be determined. In some trials a slight positive impact on the yield was found for ‘Helioterpen Soufre’ (CF 151). According to EPPO standard PP 1/135, for a foliar applied fungicide, observations for phytotoxic effects should be made in the efficacy (effectiveness) trials. If any adverse phytotoxic effects occur at 1N or if the risk of phytotoxicity is expected, then the effects of 2N doses should be investigated and specific crop safety trials (including yield assessments) should be conducted. No phytotoxic effects were observed in cucumber and therefore yield data is not considered necessary for this proposed crop.

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

HELIOTERPEN SOUFRE effect on the quality on plants or plant products was assessed in 2 greenhouse trials on cucumber (fruit quality), in presence of disease. Data was collected from efficacy trials.

Table 3.4-04: Details on trial methodology – Cucumber

Guidelines General guidelines EPPO PP 1/135(3/4), PP 1/154(4), PP 1/181(3/4) Helioterpen Soufre Page 49 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Specific guidelines EPPO PP 1/057(3) Experimental Plot design RCBD (2) design Plot size 2.0-3.84 m² Number of replications 4 (2) Crop Trials per crop Cucumber (2) Varieties per crop Cucumber: Lausanne, Roxana Sowing period Cucumber : from July (04) to July (14) Application Crop stage (BBCH)* at Cucumber: from BBCH 22 to BBCH 89 application Number of 6 (2 trials) with intervals of 7-10 days applications Intervals between applications Spray volumes 995 L/ha Assessment Assessment types % bent fruits, % pointy fruits, % stained fruits (need to be washed), fruit langht Assessment dates Harvest Statistical data analysis Data statistical analysis consisted in an ANOVA with 5% of alpha risk, Newman-Keuls test was used as mean test comparison.

Cucumber (Cucumis sativitus, CUMSA) Fungicide rate in L/ha HELIOTERPEN SOUFRE effect on harvested cucumber quality was assessed in two greenhouse trials carried out in 2016 in Belgium and Netherlands, in presence of disease. Results are summarized in tables 3.4-05 to 3.4-06.

Table 3.4-05: HELIOTERPEN SOUFRE effect on harvested cucumber quality HELIOTERPEN SOUFRE (CF HELIOTERPEN KUMULUS 151) SOUFRE (CF 116) WG Number of Untreated Grouping 3 L/ha 1.7 L/ha 1 L/ha 3 L/ha 10.93 kg/ha trials check 2100 g 1190 g 700 g 2100 g a.s./ha 8744 g a.s./ha a.s./ha a.s./ha a.s./ha Percent of bent fruits (%) All 1 0.66 a 1.14 a 0.40 a 0.61 a 1.29 a 0.19 a Percent of pointy fruits (%) All 1 0.00 a 0.84 a 0.59 a 0.59 a 0.65 a 1.34 a

Percent of stained fruit need to be washed before being marketable (%) All 1 6.21 d 50.25 b 29.84 bc 23.66 cd 50.84 b 82.97 a Helioterpen Soufre Page 50 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Table 3.4-06: HELIOTERPEN SOUFRE effect on harvested cucumber quality – fruits length

Trial No. (report) Fungicides Country Fruit length (cm) Rate Fungus Trade name Rate a.s. species F.P. 16 1069 5116 6 DAC 8 DAD 5 DAE 9 DAF Netherlands 28.6 a 27.1 a 28.5 a (Maritime Untreated check - - 27.7 a zone) 0.1 29.2 a 26.7 a 28.6 a ROCKET EC 15 g a.s./hL 28.0 a L/hL HELIOTERPEN 2100 g 28.3 a 27.2 a 29.4 a 3 L/ha 27.5 a SOUFRE (CF 151) a.s./ha HELIOTERPEN 1.7 1190 g 29.0 a 27.0 a 30.3 a 28.4 a SOUFRE (CF 151) L/ha a.s./ha HELIOTERPEN 28.7 a 27.0 a 28.4 a 1 L/ha 700 g a.s./ha 27.2 a SOUFRE (CF 151) HELIOTERPEN 2100 g 28.9 a 27.0 a 29.2 a 3 L/ha 27.9 a SOUFRE (CF 116) a.s./ha

There was not significant difference between HELIOTERPEN SOUFRE (CF 151) at 3 L/ha (2100 g a.s./ha), HELIOTERPEN SOUFRE (CF 116) at the same rate, standard fungicides and untreated concerning percentage of bent fruits, pointy fruits and about mean fruit length.

HELIOTERPEN SOUFRE increased percentage of stained fruits (with visible residues) that required to be wash, with clear dose-effect : 23.7 % at 1 L/ha (700 g a.s./ha), 29.8 % at 1.7 L/ha (1190 g a.s./ha) and 80.3 % at 3 L/ha (2100 g a.s./ha) against 6.2 % in untreated. Percentages of stained fruits in HELIOTERPEN SOUFRE (CF 151) at 3 L/ha (2100 g a.s./ha) and in HELIOTERPEN SOUFRE (CF 116) at the same rate were similar. In comparison, stained fruit percent in HELIOTERPEN SOUFRE at its maximum rate remained lower than stained fruit percent in standard WG sulphur based product at 8744 g a.s./ha.

HELIOTERPEN SOUFRE effect on harvested cucumber quality was assessed in two greenhouse trials carried out in 2016 in Belgium and Netherlands, in presence of disease.

HELIOTERPEN SOUFRE at 3 L/ha (2100 g a.s./ha) did not affect significantly bent fruit percentage, pointy fruit percentage or fruit length.

In comparison with untreated, HELIOTERPEN SOUFRE at 1 to 3 L/ha (700 to 2100 g a.s./ha) increased the percent of stained fruits need to be washed before being marketable. However HELIOTERPEN SOUFRE results were lower than that of standard WG sulphur based fungicide at its authorized rate. It is reasonable to consider HELIOTERPEN SOUFRE effect concerning stained fruits as acceptable.

Fungicide rate in L/ha LWA HELIOTERPEN SOUFRE effect on harvested cucumber quality was assessed in two greenhouse trials carried out in 2016 in Belgium and Netherlands, in presence of disease. Results are summarized in tables 3.4-07 to 3.4-08.

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Table 3.4-07: HELIOTERPEN SOUFRE effect on harvested cucumber quality HELIOTERPEN SOUFRE (CF HELIOTERPEN KUMULUS 151) SOUFRE (CF 116) WG 1.37 L/ha 0.78 L/ha 0.46 L/ha Number Untreated 1.37 L/ha LWA 5 kg/ha LWA Grouping LWA LWA LWA of trials check 959 g 546 g 322 g 4000 g a.s./ha a.s./ha a.s./ha a.s./ha 959 g a.s./ha LWA LWA LWA LWA LWA Percent of bent fruits (%) All 1 0.66 a 1.14 a 0.40 a 0.61 a 1.29 a 0.19 a Percent of pointy fruits (%) All 1 0.00 a 0.84 a 0.59 a 0.59 a 0.65 a 1.34 a

Percent of stained fruit need to be washed before being marketable (%) All 1 6.21 d 50.25 b 29.84 bc 23.66 cd 50.84 b 82.97 a

Table 3.4-08: HELIOTERPEN SOUFRE effect on harvested cucumber quality – fruits length

Fungicides Trial No. (report) Country Fruit length (cm) Fungus species Trade name Rate F.P. Rate a.s.

16 1069 5116 6 DAC 8 DAD 5 DAE 9 DAF Netherlands (Maritime zone) Untreated check - - 27.7 a 28.6 a 27.1 a 28.5 a ROCKET EC 0.1 L/hL 15 g a.s./hL 28.0 a 29.2 a 26.7 a 28.6 a A: 4.5-9 L/ha LWA A: 3150-6300 g a.s./ha LWA 28.3 a 27.2 a 29.4 a HELIOTERPEN SOUFRE (CF 151) B: 1.8-4.5 L/ha LWA B: 1260-3150 g a.s./ha LWA 27.5 a C: 1.28-1.8 L/ha LWA C: 896-1260 g a.s./ha LWA A: 2.55-5.1 L/ha LWA A: 1785-3570 g a.s./ha LWA 29.0 a 27.0 a 30.3 a HELIOTERPEN SOUFRE (CF 151) B: 1.02-2.55 L/ha LWA B: 714-1785 g a.s./ha LWA 28.4 a C: 0.73-1.02 L/ha LWA C:511-714 g a.s./ha LWA A: 1.5-3 L/ha LWA A: 1050-2100 g a.s./ha LWA 28.7 a 27.0 a 28.4 a HELIOTERPEN SOUFRE (CF 151) B: 0.6-1.5 l/ha LWA B: 420-1050 g a.s./ha LWA 27.2 a C: 0.43-0.6 L/ha LWA C: 301-420 g a.s/ha LWA A: 4.5-9 L/ha LWA A: 3150-6300 g a.s./ha LWA 28.9 a 27.0 a 29.2 a HELIOTERPEN SOUFRE (CF 116) B: 1.8-4.5 L/ha LWA B: 1260-3150 g a.s./ha LWA 27.9 a C: 1.28-1.8 L/ha LWA C: 896-1260 g a.s./ha LWA A: crop height between 0.25 and 0.5 m; B: crop height between 0.5-1.25 m, C: crop height between 1.25-1.75 m There was not significant difference between HELIOTERPEN SOUFRE (CF 151) at 1.37 L/ha LWA (959 g a.s./ha LWA), HELIOTERPEN SOUFRE (CF 116) at the same rate, standard fungicides and untreated concerning percentage of bent fruits, pointy fruits.

There was not significant difference between HELIOTERPEN SOUFRE (CF 151) at its full rate (ranged from 896 to 6300 g a.s./ha LWA according crop height), HELIOTERPEN SOUFRE (CF 116) at same rates, standard fungicide and untreated about mean fruit length

HELIOTERPEN SOUFRE increased percentage of stained fruits (with visible residues) that required to be wash, with clear dose-effect : 23.7 % at 0.46 L/ha LWA (322 g a.s./ha LWA), 29.8 % at 0.78 L/ha LWA (546 g a.s./ha LWA) and 80.3 % at 1.37 L/ha LWA (959 g a.s./ha LWA) against 6.2 % in untreated. Percentages of stained fruits in HELIOTERPEN SOUFRE (CF 151) at 1.37 L/ha LWA (959 g a.s./ha LWA) and in HELIOTERPEN SOUFRE (CF 116) at the same rate were similar. In comparison, stained fruit percent in HELIOTERPEN SOUFRE at its maximum rate remained lower than stained fruit percent in standard WG sulphur based product at 4000 g a.s./ha LWA.

HELIOTERPEN SOUFRE effect on harvested cucumber quality was assessed in two greenhouse Helioterpen Soufre Page 52 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017 trials carried out in 2016 in Belgium and Netherlands, in presence of disease.

HELIOTERPEN SOUFRE at 1.28 to 9 L/ha LWA according crop height (1.75 m and 0.25 m respectively) (896-6300 g a.s./ha LWA) did not affect significantly bent fruit percentage, pointy fruit percentage or fruit length.

In comparison with untreated, HELIOTERPEN SOUFRE at 0.46 to 1.37 L/ha LWA (322 to 959 g a.s./ha LWA) increased the percent of stained fruits need to be washed before being marketable. However HELIOTERPEN SOUFRE results were lower than that of standard WG sulphur based fungicide at its authorized rate. It is reasonable to consider HELIOTERPEN SOUFRE effect concerning stained fruits as acceptable.

3.4.3 Effects on the quality of plants or plant products (KCP 6.4.3). Additionally to the assessment of yield, in the same trials the quality of the fruits was evaluated (GEP-kk16ecmi-red, NL16-ACT-102-02, 16 1069 5116, H-16-V-240). For the trials 16 1069 5116 and H-16-V-240 the quality was assess after the number of cucumber classified to 9 different grades (grade 1 = unmarketable, grades 2-8 were summarized as marketable). Grading into 9 different classes did not reveal any effects. Number of unmarketable and marketable cucumbers did neither differ from untreated check nor in between treatments. In the trials NL16-ACT-102-02 and GEP-kk16ecmi-red not atypical residue in the sulphur treated variants were visible. The residue was detection on leaves and fruits depending on the sulphur concentration in the spray mixture. In trial GEP-kk16ecmi-red the same residue was detected on the leaves sprayed with the reference Kumulus WG (800 g/kg sulphur). In both trails the water volume was higher (>1000L) than in all other trials without residue. For example in trial H-16-V-240 the spray volume was 300-500 L/ha and the test product and the reference product was Thiovit Jet (800 g/kg sulphur) but no residue was reported. Comments from the cMS are welcome to this hypotheses. This residue has no negative effects on the quality regarding growth of the plant, leaves and fruit and no significant effects on yield and length of cucumber were found, but the fruits would have to be washed before being marketable. Recommendation in the label could be: A visible spray coating may be left on the fruit after application.

3.4.4 Effects on transformation processes (KCP 6.4.4)

Cucumber transformation processes does not required fermentation. Negative effect cause by HELIOTERPEN SOUFRE on cucumber transformation processes is not expected.

3.4.4 Effects on transformation processes (KCP 6.4.4) No data have been submitted to address this aspect. The applicant concluded that the product is not intended to be used on plants that are going for processing production and that therefore argued that no data are required. No further consideration is required from the zRMS perspective.

Helioterpen Soufre Page 53 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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

HELIOTERPEN SOUFRE is not indeed to be used on plant or plant products to be used for propagations. Assessment concerning this point is not required.

Summary and conclusion Phytotoxicity to host crops

Doses in L/ha

Greenhouse cucumber: HELIOTERPEN SOUFRE phytotoxicity was assessed on cucumber in seven greenhouse trials carried out between 2014 and 2016 in Germany, Belgium, Netherlands and Czech Republic, in presence of disease.

Doses in L/ha LWA

No phytotoxicity symptom caused by HELIOTERPEN SOUFRE (CF 151) at its full rates or HELIOTERPEN SOUFRE (CF 116) at the same rates, was recorded. Coformulant change did not affect HELIOTERPEN SOUFRE selectivity on cucumber.

HELIOTERPEN SOUFRE was perfectly selective on cucumber when product was applied at 50 % of its full rate to its full rate.

Effect on the yield pf treated plants or plant product In cucumber, HELIOTERPEN SOUFRE did not cause phytotoxicity symptom. Negative effect on yield is not expected when the fungicide is applied at its recommended rates. Furthermore, in trials carried out in cucumber crop, in presence of disease, HELIOTERPEN SOUFRE increased their marketable yield in the most cases, as presented in point 3.2.2.

Effect on the quality of plants or plant products

Dose in L/ha

Cucumber: HELIOTERPEN SOUFRE effect on harvested cucumber quality was assessed in two greenhouse trials Helioterpen Soufre Page 54 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017 carried out in 2016 in Belgium and Netherlands, in presence of disease.

HELIOTERPEN SOUFRE at 3 L/ha (2100 g a.s./ha) did not affect significantly bent fruit percentage, pointy fruit percentage or fruit length.

Dose in L/ha LWA

Cucumber: HELIOTERPEN SOUFRE effect on harvested cucumber quality was assessed in two greenhouse trials carried out in 2016 in Belgium and Netherlands, in presence of disease.

Effects on transformation processes

Cucumber transformation processes does not required fermentation. Negative effect cause by HELIOTERPEN SOUFRE on cucumber transformation processes is not expected.

Impact on treated plant or plant products to be used for propagations HELIOTERPEN SOUFRE is not indeed to be used on plant or plant products to be used for propagations. Assessment concerning this point is not required.

3.4.5 Impact on treated plants or plant products to be used for propagation (KCP 6.4.5) The applicant concluded that this was not investigated as the product is for cucumber plants used for the production of fruits which are not subject to propagation on a routine basis. As the product is a fungicide and crop safety has been evaluated for cucumber, specific data on plant parts for propagation is not required. This is also in line with the EPPO criteria for the circumstances where data are required (PP 1/135 Phytotoxicity assessments). No further consideration is required for this section.

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

Summary and conclusion on other undesirable or unintended side-effects Adverse effects on beneficial organisms (other than bees)

Helioterpen Soufre Page 55 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Helioterpen Schwefel is classified as not harmful for the ground beetle Poecilus cupreus, for the rove beetle Aleochara bilineata and for the parasitoid wasp Aphidius rhopalosiphi, and as harmful for the predatory mite Typhlodromus pyri, for the lacewing Chrysoperla carnea, and for the parasitoid wasp Trichogramma cacoeciae.

3.5.1 Impact on succeeding crops (KCP 6.5.1)

According to EPPO PP1/207(2): Effects on succeeding crops, the persistence and availability of the active substance in soil should be examined to determine if the active substance poses a risk to succeeding crops. In this case, HELIOTERPEN SOUFRE contains sulphur which is a mineral active substance already present in the soil. In the soil, sulphur is oxidized into sulphate that is absorbed by plant root before to be included in amino-acids. Sulphur quantity applied as fungicide is very low in comparison with natural sulphur rate in soil. Therefore, no further testing is necessary and no negative impact on succeeding crops is expected.

3.5.1 Impact on succeeding crops (KCP 6.5.1). The applicant concluded that no impact on succeeding crops has been experienced over the years and no impact on succeeding crops is to be expected. No further consideration is required.

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

According to EPPO PP1/256(1): Effects on adjacent crops, the phytotoxic properties of the plant protection product should be assessed and if no phytotoxic symptoms occurred, no further testing is necessary. In Point 3.4.1, it was demonstrated that HELIOTERPEN SOUFRE has an acceptable selectivity on tested crops when the fungicide is used as recommended. So, no further testing is necessary and no negative impact on other plants including adjacent crops is expected.

3.5.2 Impact on other plants including adjacent crops (KCP 6.5.2) The applicant concluded that effects are not to be expected either due to the absence of phytotoxic effects in the efficacy trials and years of practical use of the active ingredient. No further consideration is required.

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

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

Furthermore, some observations were made in efficacy trials, concerning HELIOTERPEN SOUFRE side effect on non-target organism.

In greenhouse cucumber crops: These observations were made in five trials (14 1047 1364, 15-00092-01, 15-00092-02, 16 1069 5116 and H-16-V-240): During whole assessment period, no side-effects on non-target or beneficial organisms were noticed. Helioterpen Soufre Page 56 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Summary and conclusion Impact on succeeding crops According to EPPO PP1/207(2), the persistence and availability of the active substance in soil should be examined to determine if the active substance poses a risk to succeeding crops. In this case HELIOTERPEN SOUFRE contains sulphur which is a mineral active substance already present in the soil. In the soil, sulphur is oxidized into sulphate that is absorbed by plant root before to be included in amino-acids. Sulphur quantity applied as fungicide is very low in comparison with natural sulphur rate in soil. Therefore, no further testing is necessary and no negative impact on succeeding crops is expected.

Impact on other plants including adjacent crops According to EPPO PP1/256(1), the phytotoxic properties of the plant protection product should be assessed and if no phytotoxic symptoms occurred, no further testing is necessary. In Point 3.4.1, it was demonstrated that HELIOTERPEN SOUFRE has an acceptable selectivity on tested crops when the fungicide is used as recommended. So, no further testing is necessary and no negative impact on other plants including adjacent crops is expected.

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

Furthermore, some observations were made in efficacy trials, concerning HELIOTERPEN SOUFRE side effect on non-target organism.

In greenhouse cucumber crops: These observations were made in five trials: During whole assessment period, no side-effects on non-target or beneficial organisms were noticed.

3.5.3 Effects on beneficial and other non-target organisms (KCP 6.5.3). The fungicide ‘Helioterpen Soufre’ (700 g/L sulphur) has been proposed for application in cucumber at a total maximum application rate of 18 L/ha and year (6 applications, max. rate per application: 3 L product/ha).Taking into account the potential disappearance of the active ingredient between the applications (using the maximum default value MAF of 3.2), this corresponds to 6.72 kg active substance/ha and year. Throughout the field trials on effectiveness and selectivity there have been no reports or observations to suggest a detrimental impact of ‘Helioterpen Soufre’ on beneficial or non- target organisms. Appropriate studies on the potential adverse effects on beneficial arthropods were available from Registration Report Part B, Section 9, 9.7 (Effects on arthropods other than bees), Core Assessment. The toxicity of ‘Helioterpen Soufre’ have been tested by carrying out - laboratory tests on Aphidius rhopalosiphi, Chrysoperla carnea, Poecilus cupreus, Trichogramma cacoeciae, Aleochara bilinieata and Typhlodromus pyri. - extended laboratory tests on Chrysoperla carnea, Trichogramma cacoeciae and Aphidius rhopalosiphi. - field tests on Typhlodromus pyri and Phytoseius plumifer. When laboratory tests and higher tier tests were available for the same species, only the results from the higher tier test are being used for the assessment. These results are presented in Table 3.5.3-1.

Helioterpen Soufre Page 57 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Table 3.5.3-1: Effects of ‘Helioterpen Soufre’ on beneficial arthropods in laboratory tests, extended laboratory tests and field tests. Species Substrate Rate Corrected Sublethal Reference (Exposed Stage) sulphur Mortality Effect [g a.i./ha] [%] [%] Aleochara Damp sand CAS-99-3, BASF DocID bilineata (A) 9.813 0.0 2.3 2000/1021238 Vinall, 2000 Chrysoperla Glass CAS-99-4, BASF DocID carnea (L) 9.813 6.0 -22.7 2000/1021239 Baxter, 2000 23127406 30.000 60.4 - Rosenkranz, 2005 Chrysoperla Bean leaves 1.250 42.9 50.0 25672047 carnea (L) 2.500 50.0 18.9 Rosenkranz, 2006 5.000 71.4 - 10.000 66.7 - 20.000 78.6 - Poecilus cupreus Quartz sand CAS-99-2, BASF DocID (L) 9,813 0.0 -4.2 2000/1021240 Baxter, 2000 Poecilus cupreus Quartz sand 30,000 0.0 -1.0 23128006 (A) 90,000 0.0 -3.0 Schmitzer, 2005 Aphidius barley 13,486 0.0 -3.1 20031086/01-NEAp rhopalosiphi (A) 15,960 44.8 27.6 Warmers, 2003 20,110 48.3 -12.6 25,337 55.2 - 31,920 51.7 - Trichogramma Bean leave 1 - 38.3 20031086/01-NETc cacoeciae (A) discs 3 - 15.4 Warmers, 2003 12 - 43.6 50 - 28.4 200 - 79.1 798 - 91.1 Trichogramma vine 2008 20041260/01-NETc cacoeciae (A) 0 DAT - 100.0 Warmers, 2005 6 DAT - 99.9 13 DAT - 83.6 27 DAT - -14.1 41 DAT - - 49 DAT - - 3854 0 DAT - 100.0 6 DAT - 99.9 13 DAT - 96.7 27 DAT - 89.3 41 DAT - -23.3 49 DAT - 25.9 6023 0 DAT - 99.9 6 DAT - 98.2 13 DAT - 99.9 Helioterpen Soufre Page 58 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

27 DAT - 99.3 41 DAT - 41.4 49 DAT - 11.3 Phytoseius vineyard 5 6 DAA 1 30.2 30951826 plumifer (PN) Applicatio 3 DAA 2 27.9 Rosenkranz, 2007 ns of 30, 3 DAA 3 9.7 30, 25, 5 DAA 5 -9.4 20, 20 kg/ha (BBCH 57 31 DAA 5 -72.3 - 73) Typhlodromus vineyard 5 4 DAA 1 -36.8 30952064 pyri (PN) Applicatio 4 DAA 2 33.7 Rosenkranz, 2007 ns of 30, 5 DAA 3 28.7 30, 25, 5 DAA 5 51.7 20, 20 30 DAA 5 45.8 kg/ha (BBCH 65 56 DAA 5 9.6 - 77) 8 7 DAA 8 30.4 BASF 88/10200 Applicatio 28 DAA 8 -57.9 ns of 7.2, 9, 7.2, 8, 3.6, 4 kg/ha 5 27 DAA 5 25.6 BASF 88/10201 Applicatio 42 DAA 5 17.3 ns of 0.036, 0.036, 0.024, 0.024, 0.012 kg/ha 8 DAA 6 7.4 BASF 88/10202 28 DAA 6 1.56 7 DAA 6 54.255 bi0011-5/17.11.1988 28 DAA 6 50.25 5 7 DAA 6 52.83 Applicatio 28 DAA 6 35.03 ns of 3.6, 7 DAA 6 33.83 3.6, 2.4, 28 DAA 6 24.2 2.4, 3.2, 7 DAA 6 14.4 3.2 kg/ha 28 DAA 6 -45.3 7 DAA 6 -36.5 28 DAA 6 5.73 7 DAA 6 54.53 28 DAA 6 46.02 A = adults, PN = protonymphs, L = larvae On the basis of the presented results no effects > 30 % are expected for populations of Poecilus cupreus, Aleochara bilineata and Aphidius rhopalosiphi when ‘Helioterpen Soufre’ is applied according to the recommended use pattern. Effects > 50 % are expected for Chrysoperla carnea, Typhlodromus pyri and Trichogramma cacoeciae when ‘Helioterpen Helioterpen Soufre Page 59 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Soufre’ is applied according to the recommended use pattern. No assessment is possible for Phytoseius plumifer. Classification scheme of the effects: Laboratory tests on artificial substrates (glass, quartz sand) < 30 % = not harmful 30 – 80 % = slightly harmful > 80 % = harmful Extended laboratory tests on natural substrates, semi-field and field tests < 25 % = not harmful 25 – 50 % = slightly harmful > 50 % = harmful

Proposal for classification: ‘Helioterpen Soufre’ is classified as: - not harmful for the ground beetle Poecilus cupreus - not harmful for the rove beetle Aleochara bilineata - not harmful for the parasitoid was Aphidius rhopalosiphi. - harmful for the predatory mite Typhlodromus pyri. - harmful for the lacewing Chrysoperla carnea. - harmful for the parasitoid wasp Trichogramma cacoeciae. Adverse effects on soil quality indicators (e. g. microorganisms, earthworms) are considered in Section 9 Ecotoxicological Studies in the Registration Report.

3.6 Other/special studies

No further pertinent study is available.

3.7 List of test facilities including the corresponding certificates

Table 3.7-1: List of test facilities

Test facility Address Certificate (Yes or No)

AEGISTO BV Dr. Droesenweg 7, 56964 NC Meterik, Yes Netherlands AGRO TRIAL CENTER GmbH Organizacni slozka, Blatnicka 179, 687 24 Yes Uhersky Ostroh, Czech Republic BIOCHEM AGRAR GmbH Kupferstrasse 6, 04827 Gerishain, Germany Yes BIOCHEM AGRAR GmbH Niederlassung AGROPLAN, Bünnert 72, Yes 47589 Uedem, Germany PROEFSTATION VOOR DE Duffelsesteenwag 101, 2860 Sint-Katelijne- Yes GROENTETEELT Waver, Belgium Helioterpen Soufre Page 60 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Appendix 1 Lists of data considered in support of the evaluation

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

List of data submitted by the applicant and relied on

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

KCP 6.0 Giraud F. 2017 Biological Assessment dossier – Helioterpen Soufre N Action Pin ACTION PIN Not GLP Unpublished KCP 6.2/01 De Rooster L. 2016 The efficacy of Helioterpen Soufre against powdery mildew in greenhouse cucumber N Action Pin GEP-kk16ecmi-red Proefstation Voor de Groenteteelt GEP Unpublished KCP 6.2/02 Dorcier C. 2016 Biological efficacy evaluation of Helioterpen Soufre (sulphur; 700,0 L) against scab, Venturia inaequalis, N Action Pin on apple 16M/VENTIN/JONA/V1/RED/GEP-26 REDEBEL (trial performed by Proefcentrum Fruitteelt vzw) GEP Unpublished Helioterpen Soufre Page 61 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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

KCP 6.2/03 Koch M. 2014 GEP Efficacy trial of HELIOTERPEN SOUFRE and effect of adjuvants on sulphur based products N Action Pin against apple scab, Germany, 2014 MKH-14-17611-DE01 Staphyt GmbH GEP Unpublished KCP 6.2/04 Koch M. 2014 GEP Efficacy trial of HELIOTERPEN SOUFRE and effect of adjuvants on sulphur based products N Action Pin against apple scab, Germany, 2014 MKH-14-17611-DE02 Staphyt GmbH GEP Unpublished KCP 6.2/05 Motais F. 2013 Determination of efficacy of HELIOTERPEN SOUFRE against powdery mildew (Uncinula necator) in N Action Pin vine, 1 site in Germany, 2013 S13-01725-01 Eurofins Agroscience Services GmbH GEP Unpublished KCP 6.2/06 Motais F. 2015 Determination of efficacy of HELIOTERPEN SOUFRE against powdery mildew (Uncinula necator) in N Action Pin grapevine, 1 site in Germany, 2015 S15-02624-01 Eurofins Agroscience Service GmbH GEP Unpublished KCP 6.2/07 Motais F. 2015 Determination of efficacy of HELIOTERPEN SOUFRE against powdery mildew (Uncinula necator) in N Action Pin grapevine, 1 site in Germany, 2015 S15-02624-03 Eurofins Agroscience Service GmbH GEP Unpublished Helioterpen Soufre Page 62 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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

KCP 6.2/08 Motais F. 2015 Determination of efficacy of HELIOTERPEN SOUFRE against powdery mildew (Uncinula necator) in N Action Pin grapevine, 1 site in Germany, 2015 S15-02624-04 Eurofins Agroscience Service GmbH GEP Unpublished KCP 6.2/09 Perrin E. 2015 Efficacy against powdery mildew on cucumber, under greenhouse conditions in Germany 2015 N Action Pin 15-00092-01 SGS (trial permorfed by Biochem Agrar GmbH) GEP Unpublished KCP 6.2/10 Perrin E. 2015 Efficacy against powdery mildew on cucumber, under greenhouse conditions in Germany 2015 N Action Pin 15-00092-02 SGS (trial performed by Biochem Agrar GmbH) GEP Unpublished KCP 6.2/11 Robyns R. 2016 Determination of efficacy and selectivity of the fungicide Helioterpen Soufre against Venturia inaequalis N Action Pin on apple tree, 2016 ARI-16-F-049-01 REDEBEL (trial performed by Agro Research International B.V.) GEP Unpublished KCP 6.2/12 Robyns R. 2016 Determination of efficacy and selectivity of the fungicide Helioterpen Soufre against Venturia inaequalis N Action Pin on apple tree, 2016 161004 REDEBEL (trial performed by Proeftuin Zwaagdijk) GEP Unpublished Helioterpen Soufre Page 63 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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

KCP 6.2/13 Robyns R. 2016 Determination of efficacy and selectivitu of the fungicide Helioterpen Soufre against Venturia inaequalis N Action Pin on apple H-16-O-238-01 REDEBEL (trial performed by Agro Trial Center GmbH) GEP Unpublished KCP 6.2/14 Robyns R. 2016 Determination of efficacy and selectivity of the fungicide Helioterpen Soufre against Uncinula necator N Action Pin on grapevine H-16-W-238-01 REDEBEL (trial performed by Agro Trial Center, GmbH) GEP Unpublished KCP 6.2/15 Robyns R. 2016 Efficacy of Helioterpen Soufre 151 against powdery mildew in cucumber N Action Pin NL16-ACT-102-02 REDEBEL (trial performed by Aegisto BV) GEP Unpublished KCP 6.2/16 Robyns R. 2016 Dertermination of efficacy and selectivity of the fungicide Helioterpen Soufre against Erysiphe N Action Pin cichoracearum (powdery mildew) on cucumber on normal conditions under greenhouse, 2016 16 1069 5116 REDEBEL (trial performed byBiochem Agrar GmbH) GEP Unpublished KCP 6.2/17 Robyns R. 2016 Determination of efficacy and selectivity of the fungicide Helioterpen Soufre against powdery mildew on N Action Pin cucumber H-16-V-240 REDEBEL (trial performed by Agro Trial Center, GmbH) GEP Unpublished Helioterpen Soufre Page 64 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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

KCP 6.2/18 Villeton C. 2013 Fungicide – Vine – Efficacy on powdery mildew N Action Pin 13ACF5044GE50 ANADIAG France (trial preformed by Agrartest GmbH) GEP Unpublished KCP 6.2/19 Zickart U. 2014 Efficacy against powdery mildew on cucumber, under greenhouse conditions N Action Pin 14 1047 1364 Biochem Agrar GmbH GEP Unpublished KCP 6.4/01 Agulhon O., 1994 Rapport d’étude des effets non intentionnels sur l’élaboration et la qualité des mouts et des vins N Action Pin Volle C. 94F0300401 94F0300402 Viti R&D Not GEP Not published KCP 6.4/02 Buysen S. and 2016 Taint study on apples HELIOTERPEN SOUFRE CF151 and CF116 N Action pin Gobin B. SM16APGB01_04 PCG – Vegetable Research Centre GEP Unpublished KCP 6.4/03 Chambre 2008 Influence d’une pulverization foliaire azotée sur le potentiel aromatique en thiols variétaux du Muscat à N Action Pin d’Agriculture du petits grains Roussillon V0803F Chambre d’Agriculture du Roussillon Not GEP Not published Helioterpen Soufre Page 65 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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

KCP 6.4/04 Cuinier C., 1994 Etude des effets non intentionnels de produits phytopharmaceutiques sur l’élaboration et la qualité du vin N Action Pin Laurent J.C. ITV Orange 94F0300201 Not GEP Not published KCP 6.4/05 Dufourcq T. 2008 Evaluation de l’efficacité des préparations commercials HELIOSOUFRE et fertipen de la société Action N Action Pin Pin utilisées en pulvérisation foliaire sur la qualité aromatique d’un vin de Colombard produit dans les vignobles du Sud-Ouest de la France 08/01/AP/VI IFV Sud Ouest Not GEP Not published KCP 6.4/06 Motais F. 2015 Determination of efficacy of HELIOTERPEN SOUFRE against powdery mildew (Uncinula necator) in N Action Pin grapevine, 1 site in Germany, 2015 S15-02624-02 Eurofins Agroscience Service GmbH GEP Unpublished KCP 6.4/07 Noe P., Grau H. 1990 Compte rendu des essais réalisés en applicant la méthode CEB n°143 concernant la première phase de la N Action Pin méthode « étude en plein champ » dans le cas d’obtention des vins 90F0300201 Laboratoire œnologique Phillipe Noé Not GEP Not published KCP 6.4/08 Vinsonneau M., 1994 Etude des effets non intentionnels de produits phytopharmaceutiques (anti oïdium) sur l’élaboration et la N Action Pin Barrere C., qualité des vins (Minivinification avec deux dégustations) Cuinier C. 94F0300101 ITV Bordeaux Not GEP Not published Helioterpen Soufre Page 66 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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

KCP 6.4/09 Zickart U. 2014 HELIOTERPEN SOUFRE fungicide used to control powdery mildew of grapevine N Action Pin 14 1069 5031 Biochem Agrar GmbH GEP Unpublished KCP 6.4/10 Zickart U. 2014 HELIOTERPEN SOUFRE fungicide used to control powdery mildew of grapevine N Action Pin 14 1061 1365 Biochem Agrar GmbH GEP Unpublished KCP 6.4/11 Agulhon O., 1994 English Translation of KCP 6.4/01 N Action Pin Volle C. Rapport d’étude des effets non intentionnels sur l’élaboration et la qualité des mouts et des vins 94F0300401 94F0300402 Viti R&D Not GEP Not published KCP 6.4/12 Chambre 2008 English Translation of KCP 6.4/03 N Action Pin d’Agriculture du Influence d’une pulverization foliaire azotée sur le potentiel aromatique en thiols variétaux du Muscat à Roussillon petits grains V0803F Chambre d’Agriculture du Roussillon Not GEP Not published KCP 6.4/13 Cuinier C., 1994 English Translation of KCP 6.4/04 N Action Pin Laurent J.C. Etude des effets non intentionnels de produits phytopharmaceutiques sur l’élaboration et la qualité du vin ITV Orange 94F0300201 Not GEP Not published Helioterpen Soufre Page 67 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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

KCP 6.4/14 Dufourcq T. 2008 English Translation of KCP 6.4/05 N Action Pin Evaluation de l’efficacité des préparations commercials HELIOSOUFRE et fertipen de la société Action Pin utilisées en pulvérisation foliaire sur la qualité aromatique d’un vin de Colombard produit dans les vignobles du Sud-Ouest de la France 08/01/AP/VI IFV Sud Ouest Not GEP Not published KCP 6.4/15 Noe P., Grau H. 1990 English Translation of KCP 6.4/07 N Action Pin Compte rendu des essais réalisés en applicant la méthode CEB n°143 concernant la première phase de la méthode « étude en plein champ » dans le cas d’obtention des vins 90F0300201 Laboratoire œnologique Phillipe Noé Not GEP Not published KCP 6.4/16 Vinsonneau M., 1994 English Translation of KCP 6.4/08 N Action Pin Barrere C., Etude des effets non intentionnels de produits phytopharmaceutiques (anti oïdium) sur l’élaboration et la Cuinier C. qualité des vins (Minivinification avec deux dégustations) 94F0300101 ITV Bordeaux Not GEP Not published

Helioterpen Soufre Page 68 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

List of data submitted by the applicant and relied on

Data Point Author(s) Year Title Vertebrate Data Justification if Owner Report-No. study protection data protection Source (J=Yes claimed is claimed GLP/GEP O=Open (J=Yes Published N=No) O=Open Authority registration No./JKI-No. N=No) KCP Giraud, F. 2017 Biological Assessment dossier - Helioterpen N J ACTION Section 6 Soufre PIN

Action Pin N/N N 3290602/514286 KCP Giraud F. 2017 Biological Assessment dossier - Helioterpen N J ACTION Section 6 Soufre -Word- PIN

Action Pin N/N N 3290603/514287 KCP 6.2 De Rooster, L. 2016 The efficacy of Helioterpen Soufre against N J ACTION powdery mildew in greenhouse cucumber PIN GEP-kk16ecmi-red Proefstation Voor de Groenteteelt N/J N 3290604/514288 Helioterpen Soufre Page 69 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

KCP 6.2 Koch, M. 2014 GEP Efficacy trial of HELIOTERPEN SOUFRE N J ACTION and effect of adjuvants on sulphur based products PIN against apple scab, Germany, 2014 MKH-14-17611-DE01 Staphyt GmbH N/J N 3290606/514289 KCP 6.2 Koch, M. 2014 GEP Efficacy trial of HELIOTERPEN SOUFRE N J ACTION and effect of adjuvants on sulphur based products PIN against apple scab, Germany, 2014 MKH-14-17611-DE02 Staphyt GmbH N/J N 3290607/514290 KCP 6.2 Motais, F. 2013 Determination of efficacy of HELIOTERPEN N J ACTION SOUFRE against powdery mildew (Uncinula PIN necator) in vine, 1 site in Germany, 2013 S13-01725-01 Eurofins Agroscience Services GmbH N/J N 3290608/514291 Helioterpen Soufre Page 70 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

KCP 6.2 Motais, F. 2015 Determination of efficacy of HELIOTERPEN N J ACTION SOUFRE against powdery mildew (Uncinula PIN necator) in grapevine, 1 site in Germany, 2015 S15-02624-01 Eurofins Agroscience Service GmbH N/J N 3290609/514292 KCP 6.2 Motais, F. 2015 Determination of efficacy of HELIOTERPEN N J ACTION SOUFRE against powdery mildew (Uncinula PIN necator) in grapevine, 1 site in Germany, 2015 S15-02624-03 Eurofins Agroscience Service GmbH N/J N 3290610/514293 KCP 6.2 Motais, F. 2015 Determination of efficacy of HELIOTERPEN N J ACTION SOUFRE against powdery mildew (Uncinula PIN necator) in grapevine, 1 site in Germany, 2015 S15-02624-04 Eurofins Agroscience Service GmbH N/J N 3290611/514294 KCP 6.2 Perrin, E. 2016 Efficacy against powdery mildew on cucumber, N J ACTION under greenhouse conditions in Germany 2015 PIN 15-00092-01 SGS (trial permorfed by Biochem Agrar GmbH) N/J N 3290612/514295 Helioterpen Soufre Page 71 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

KCP 6.2 Perrin, E. 2016 Efficacy against powdery mildew on cucumber, N J ACTION under greenhouse conditions in Germany 2015 PIN 15-00092-02 SGS (trial performed by Biochem Agrar GmbH) N/J N 3290613/514296 KCP 6.2 Robyns, R. 2016 Determination of efficacy and selectivity of the N J ACTION fungicide Helioterpen Soufre against Venturia PIN inaequalis on apple tree, 2016 ARI-16-F-049-01 REDEBEL (trial performed by Agro Research International B.V.) N/J N 3290614/514297 KCP 6.2 Robyns, R. 2016 Determination of efficacy and selectivity of the N J ACTION fungicide Helioterpen Soufre against Venturia PIN inaequalis on apple tree, 2016 161004 REDEBEL (trial performed by Proeftuin Zwaagdijk) N/J N 3290615/514298 Helioterpen Soufre Page 72 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

KCP 6.2 Robyns, R. 2016 Determination of efficacy and selectivitu of the N N ACTION fungicide Helioterpen Soufre against Venturia PIN inaequalis on apple H-16-O-238-01 REDEBEL (trial performed by Agro Trial Center GmbH) N/J N 3290616/514299 KCP 6.2 Robyns, R. 2016 Determination of efficacy and selectivity of the N J ACTION fungicide Helioterpen Soufre against Uncinula PIN necator on grapevine H-16-W-238-01 REDEBEL (trial performed by Agro Trial Center, GmbH) N/J N 3290617/514300 KCP 6.2 Robyns, R. 2016 Determination of efficacy and selectivity of the N J ACTION fungicide Helioterpen Soufre against Powdery PIN mildew on cucumber, 2016 2865 REDEBEL (trial performed by Aegisto BV) N/J N 3290618/514301 Helioterpen Soufre Page 73 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

KCP 6.2 Robyns, R. 2017 Determination of efficacy and selectivity of the N J ACTION fungicide Helioterpen Soufre against Erysiphe PIN cichoracearum (powdery mildew) on cucumber on normal conditions under greenhouse, 2016 16 1069 5116 REDEBEL (trial performed byBiochem Agrar GmbH) N/J N 3290619/514302 KCP 6.2 Robyns, R. 2016 Determination of efficacy and selectivity of the N J ACTION fungicide Helioterpen Soufre against powdery PIN mildew on cucumber H-16-V-240 REDEBEL (trial performed by Agro Trial Center, GmbH) N/J N 3290620/514303 KCP 6.2 Villeton, C. 2013 Fungicide Vine Efficacy on powdery mildew N J ACTION 13ACF5044GE501 PIN ANADIAG France (trial preformed by Agrartest GmbH) N/J N 3290621/514304 Helioterpen Soufre Page 74 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

KCP 6.2 Zickart, U. 2014 Efficacy against powdery mildew on cucumber, N J ACTION under greenhouse conditions PIN 14 1047 1364 Biochem Agrar GmbH N/J N 3290622/514305 KCP 6.4 Agulhon, O.; 1996 Rapport d`étude des effets non intentionnels sur N N ACTION Volle, C. l`élaboration et la qualité des mouts et des vins PIN 94F0300401 Viti R&D N/N N 3290623/514306 KCP 6.4 Buysen, S.; 2017 Taint study on apples HELIOTERPEN SOUFRE N J ACTION Gobin, B. CF151 and CF116 PIN SM16APGB01_04 PCG – Vegetable Research Centre N/J N 3290624/514307 KCP 6.4 Anonymous 2008 Influence d' une pulverization foliaire azotée sur le N N ACTION potentiel aromatique en thiols variétaux du Muscat PIN à petits grains V0803F Chambre d’Agriculture du Roussillon N/N N 3290625/514308 Helioterpen Soufre Page 75 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

KCP 6.4 Cuinier, C.; 1995 Etude des effets non intentionnels de produits N N ACTION Laurent, J.C. phytopharmaceutiques sur l`élaboration et la PIN qualité du vin 94F0300201 ITV Orange N/N N 3290626/514309 KCP 6.4 Dufourcq, T. 2009 Evaluation de l`efficacité des préparations N N ACTION commercials HELIOSOUFRE et fertipen de la PIN société Action Pin utilisées en pulvérisation foliaire sur la qualité aromatique d`un vin de Colombard produit dans les vignobles du Sud- Ouest de la France 08/01/AP/VI IFV Sud Ouest N/N N 3290627/514310 KCP 6.4 Motais, F. 2015 Determination of efficacy of HELIOTERPEN N J ACTION SOUFRE against powdery mildew (Uncinula PIN necator) in grapevine, 1 site in Germany, 2015 S15-02624-02 Eurofins Agroscience Service GmbH N/J N 3290628/514311 Helioterpen Soufre Page 76 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

KCP 6.4 Noe, P.; Grau, 1990 Compte rendu des essais réalisés en applicant la N N ACTION H. méthode CEB n°143 concernant la première PIN phase de la méthode « étude en plein champ » dans le cas d`obtention des vins 90F0300201 Laboratoire œnologique Phillipe Noé N/N N 3290629/514312 KCP 6.4 Vinsonneau, 1995 Etude des effets non intentionnels de produits N N ACTION M.; Barrere, C.; phytopharmaceutiques (anti oïdium) sur PIN Cuinier C. l`élaboration et la qualité des vins (Minivinification avec deux dégustations) 94F0300101 ITV Bordeaux N/N N 3290630/514313 KCP 6.4 Zickart, U. 2014 HELIOTERPEN SOUFRE fungicide used to N J ACTION control powdery mildew of grapevine PIN 14 1069 5031 Biochem Agrar GmbH N/J N 3290631/514314 Helioterpen Soufre Page 77 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

KCP 6.4 Zickart, U. 2014 HELIOTERPEN SOUFRE fungicide used to N J ACTION control powdery mildew of grapevine PIN 14 1061 1365 Biochem Agrar GmbH N/J N 3290632/514315 KCP 6.4 Agulhon, O.; 2016 English Translation of KCP 6.4/01- Rapport N N ACTION Volle, C. d`étude des effets non intentionnels sur PIN l`élaboration et la qualité des mouts et des vins 94F0300401 Viti R&D N/N N 3290633/514316 KCP 6.4 Anonmous 2008 English Translation of KCP 6.4/03 - Influence N N ACTION d`une pulverization foliaire azotée sur le potentiel PIN aromatique en thiols variétaux du Muscat à petits grains V0803F Chambre d’Agriculture du Roussillon N/N N 3290634/514317 Helioterpen Soufre Page 78 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

KCP 6.4 Cuinier, C.; 1995 English Translation of KCP 6.4/04 - Etude des N N ACTION Laurent, J.C. effets non intentionnels de produits PIN phytopharmaceutiques sur l`élaboration e`t la qualité du vin 94F0300201 ITV Orange N/N N 3290635/514318 KCP 6.4 Dufourcq, T. 2009 English Translation of KCP 6.4/05 - Evaluation de N N ACTION l`efficacité des préparations commercials PIN HELIOSOUFRE et fertipen de la société Action Pin utilisées en pulvérisation foliaire sur la qualité aromatique d`un vin de Colombard produit dans les vignobles du 08/01/AP/VI IFV Sud Ouest N/N N 3290636/514319 KCP 6.4 Noe, P.; Grau, 1990 English Translation of KCP 6.4/07 - Compte rendu N N ACTION H. des essais réalisés en applicant la méthode CEB PIN n°143 concernant la première phase de la méthode « étude en plein champ » dans le cas d¿obtention des vins 90F0300201 Laboratoire œnologique Phillipe Noé N/N N 3290637/514320 Helioterpen Soufre Page 79 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

KCP 6.4 Vinsonneau, 1995 English Translation of KCP 6.4/08 - Etude des N N ACTION M.; Barrere, C.; effets non intentionnels de produits PIN Cuinier C. phytopharmaceutiques (anti oïdium) sur l`élaboration et la qualité des vins (Minivinification avec deux dégustations) 94F0300101 ITV Bordeaux N/N N 3290638/514321 Document Action Pin 2017 dRR - B0 - core - DE - 008989-00/00 - Helioterpen N N ACTION N Schwefel PIN k.A. k.A. N/N N 3290660/514333 Document Action Pin 2017 dRR - B0 - core - DE - 008989-00/00 - Helioterpen N N ACTION N Schwefel (word) PIN k.A. k.A. N/N N 3290661/514334 MCP Action Pin 2017 dRR - B1-B2-B4 - core - DE - 008989-00/00 - N N ACTION Section 1 Helioterpen Schwefel PIN k.A. k.A. N/N N 3290662/514335 Helioterpen Soufre Page 80 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

MCP Action Pin 2017 dRR - B1-B2-B4 - core - DE - 008989-00/00 - N N ACTION Section 1 Helioterpen Schwefel (word) PIN k.A. k.A. N/N N 3290663/514336 MCP Action Pin 2017 dRR - B3 - core - DE - 008989-00/00 - Helioterpen N N ACTION Section 3 Schwefel PIN k.A. k.A. N/N N 3290664/514337 MCP Action Pin 2017 dRR - B3 - core - DE - 008989-00/00 - Helioterpen N N ACTION Section 3 Schwefel (word) PIN k.A. k.A. N/N N 3290665/514338 MCP Action Pin 2017 dRR - B6 - core - DE - 008989-00/00 - Helioterpen N N ACTION Section 6 Schwefel PIN k.A. k.A. N/N N 3290668/514339 Helioterpen Soufre Page 81 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

MCP Action Pin 2017 dRR - B6 - core - DE - 008989-00/00 - Helioterpen N N ACTION Section 6 Schwefel (word) PIN k.A. k.A. N/N N 3290669/514340 MCP Action Pin 2017 dRR - B10 - core - DE - 008989-00/00 - N N ACTION Section 10 Helioterpen Schwefel PIN k.A. k.A. N/N N 3290680/514349 MCP Action Pin 2017 dRR - B10 - core - DE - 008989-00/00 - N N ACTION Section 10 Helioterpen Schwefel (word) PIN k.A. k.A. N/N N 3290681/514350 Document Action Pin 2017 dRR - A - DE - 008989-00/00 - Helioterpen N N ACTION N Schwefel PIN k.A. k.A. N/N N 3290682/514351 Helioterpen Soufre Page 82 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Document Action Pin 2017 dRR - A - DE - 008989-00/00 - Helioterpen N N ACTION N Schwefel (word) PIN k.A. k.A. N/N N 3290683/514352 KCP 6.2 Bylemans, D. 2017 Biological efficacy evaluation of Helioterpen N J ACTION Soufre (sulphur; 700,0 L) against scab, Venturia PIN inaequalis, on apple

N/J N 3292400/514353 KCP 3.8 Anonymous 2017 draft Label Helioterpen Schwefel -Word- N N ACTION PIN

N/N N 3292423/514355 KCP 3.8 Anonymous 2017 draft Label Helioterpen Schwefel N N ACTION PIN

N/N N 3305392/514356 Helioterpen Soufre Page 83 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

KCP 3.8 Anonymous 2017 Helioterpen Schwefel (draft label, Germany) N N ACTION PIN Action Pin N/N N 3391323/514357 KCP 3.8 Anonymous 2017 Helioterpen Schwefel (draft label, Germany) N N ACTION [Word] PIN

Action Pin N/N N 3391324/514358 KCP Anonyomous 2017 Biological Assessment dossier - Helioterpen N N ACTION Section 6 Soufre PIN

Action Pin N/N N 3391340/514369 Document Action Pin 2017 dRR - B0 - core - DE - 008989-00/00 - Helioterpen N N ACTION N Schwefel - update PIN k.A. Action Pin N/N N 3391343/514370 Helioterpen Soufre Page 84 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

MCP Action Pin 2017 dRR - B1-B2-B4 - core - DE - 008989-00/00 - N N ACTION Section 1 Helioterpen Schwefel - update PIN k.A. Action Pin N/N N 3391344/514371 MCP Action Pin 2017 dRR - B3 - core - DE - 008989-00/00 - Helioterpen N N ACTION Section 3 Schwefel - update PIN k.A. Action Pin N/N N 3391345/514372 Document Action Pin 2017 dRR - A - DE - 008989-00/00 - Helioterpen N N ACTION N Schwefel - update PIN k.A. Action Pin N/N N 3391346/514373 MCP Action Pin 2017 dRR - B1-B2-B4 - core - DE - 008989-00/00 - N N ACTION Section 1 Helioterpen Schwefel - update (word) PIN

N/N N 3433401/515094 Helioterpen Soufre Page 85 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

MCP Action Pin 2017 dRR - B3 - core - DE - 008989-00-00 Helioterpen N N ACTION Section 3 Schwefel - update (word) PIN

N/N N 3433402/515095

The following tables are to be completed by MS

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

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

Helioterpen Soufre Page 86 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

List of data submitted by the applicant and not relied on

Data Author(s) Year Title Vertebrate Data protection Justification if data protection is Owner Point 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 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

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

Helioterpen Soufre Page 87 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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

Helioterpen Soufre Page 88 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

Appendix 2 GAP-Tables

Reg.-No. 008989-00/00 GAP rev.1, date: 2018-02-27 PPP (product name/code): Helioterpen Schwefel Formulation type: SC (a, b) Active substance 1: Schwefel Conc. of as 1: 700.00 g/L (c) Active substance 2: Conc. of as 2: 0 (c) Active substance 3: Conc. of as 3: 0 (c) Active substance 4: Conc. of as 4: 0 (c) Active substance 5: Conc. of as 5: 0 (c) Applicant: ACTION PIN Professional use: Yes Zone(s): interzonal (d) Non professional use: No Verified by MS: Yes Field of use: Fungicide

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Use- Member Crop and/ F, Pests or Group of Application Application rate PHI Remarks: Conclusion No. state(s) or situation Fn, pests controlled (days) (efficacy) (e) Fpn Method / Timing / Max. Min. interval kg or L g or kg as/ha Water e.g. g (crop G, (additionally: Kind Growth number between product / ha L/ha safener/synergist destination / Gn, developmental stages stage of a) per applications a) max. rate a) max. rate per ha purpose of Gpn of the pest or pest crop & use (days) per appl. per appl. min / max (f) crop) or group) season b) per b) max. total b) max. total I crop/ rate per rate per season crop/season crop/season 001 DE cucumber G powdery mildew spraying At a) 6 7 days a) plant a) 1.05 kg/ha plant - A (CUMSA) (Sphaerotheca beginning b) 6 height up to height up fuliginea) of cucumber of 50 cm: 1.5 to 50 cm: (SPHRFU) infestation L/ha -/600 and/or L/ha when first symptoms become visible

a) plant 1.75 kg/ha plant - height 50 up height 50 to 125 cm: up to 125 2.5 L/ha cm: -/900 L/ha a) plant 2.10 kg/ha plant - height more height than 125 cm: more than 3 L/ha 125 cm: - /1200 L/ha Helioterpen Soufre Page 89 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

002 DE cucumber G powdery mildew spraying At a) 6 7 days a) plant a) 1.05 kg/ha plant - A (CUMSA) (Erysiphe beginning b) 6 height up to height up cichoracearum) of 50 cm: 1.5 to 50 cm: (ERYSCI) infestation L/ha -/600 and/or L/ha when first symptoms become visible

a) plant 1.75 kg/ha plant - height 50 up height 50 to 125 cm: up to 125 2.5 L/ha cm: -/900 L/ha a) plant 2.10 kg/ha plant - height more height than 125 cm: more than 3 L/ha 125 cm: - /1200 L/ha

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

Remarks 1 Numeration necessary to allow references 8 The maximum number of application possible under practical conditions of use must be columns: provided. 2 Use official codes/nomenclatures of EU Member States 9 Minimum interval (in days) between applications of the same product 3 For crops, the EU and Codex classifications (both) should be used; when 10 For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of relevant, the use situation should be described (e.g. fumigation of a structure) empty rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products. 4 F: professional field use, Fn: non-professional field use, Fpn: professional and 11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment non-professional field use, G: professional greenhouse use, Gn: non- (usually g, kg or L product / ha). professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application 5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when 12 If water volume range depends on application equipment (e.g. ULVA or LVA) it should be relevant, the common names of the pest groups (e.g. biting and sucking mentioned under “application: method/kind”. insects, soil born insects, foliar fungi, weeds) and the developmental stages of 13 PHI - minimum pre-harvest interval the pests and pest groups at the moment of application must be named. 14 Remarks may include: Extent of use/economic importance/restrictions 6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, 15 A: Acceptable drench R: Acceptable with further restriction Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between C: To be confirmed by cMS the plants - type of equipment used must be indicated. N: Not acceptable / evaluation not possible Helioterpen Soufre Page 90 /90 Part B – Section 3 - Core Assessment - Greenhouse Template for chemical PPP Action Pin version Version August 2017

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

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

Product code: Helioterpen Soufre Product name(s): Helioterpen Schwefel Chemical active substance: Sulphur 700 g/L

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT authorization

Applicant: Action Pin Submission date: 22/03/2017 MS Finalisation date: july 2019 Helioterpen Soufre Page 2 /11 Part B – Section 5 - Core Assessment Template for chemical PPP zRMS version Version july 2019

Version history

When What

March 2019 zRMS Version July 2049 Final RR

Helioterpen Soufre Page 3 /11 Part B – Section 5 - Core Assessment Template for chemical PPP zRMS version Version july 2019

Table of Contents 5.1 Conclusion and summary of assessment ...... 4 5.2 Methods used for the generation of pre-authorization data (KCP 5.1) ...... 5 5.2.1 Analysis of the plant protection product (KCP 5.1.1) ...... 5 5.2.1.1 Determination of active substance and/or variant in the plant protection product (KCP 5.1.1) ...... 5 5.2.1.2 Description of analytical methods for the determination of relevant impurities (KCP 5.1.1) ...... 6 5.2.1.3 Description of analytical methods for the determination of formulants (KCP 5.1.1) ...... 7 5.2.1.4 Applicability of existing CIPAC methods (KCP 5.1.1) ...... 7 5.2.2 Methods for the determination of residues (KCP 5.1.2) ...... 7 5.3 Methods for post-authorization control and monitoring purposes (KCP 5.2) ...... 7 5.3.1 Analysis of the plant protection product (KCP 5.2) ...... 7 5.3.2 Description of analytical methods for the determination of residues of Sulphur (KCP 5.2) ...... 7 5.3.2.1 Overview of residue definitions and levels for which compliance is required ...... 8 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) ...... 8 5.3.2.4 Description of methods for the analysis of soil (KCP 5.2) ...... 8 5.3.2.5 Description of methods for the analysis of water (KCP 5.2) ...... 9 5.3.2.6 Description of methods for the analysis of air (KCP 5.2) ...... 9 5.3.2.7 Description of methods for the analysis of body fluids and tissues (KCP 5.2) ...... 9 5.3.2.8 Other studies/ information ...... 9

Appendix 1 Lists of data considered in support of the evaluation ...... 10

Helioterpen Soufre Page 4 /11 Part B – Section 5 - Core Assessment Template for chemical PPP zRMS version Version july 2019

5.1 Conclusion and summary of assessment

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

No EU maximum residue limits (MRLs) have been set for Sulphur in accordance with the recommendation of the EFSA Review Report (EFSA Scientific Report (2008) 221, December 2008). Annex IV of Council Regulation (EC) No 369/2005 has been amended (see Commission Regulation (EU) No 459/2010) to include Sulphur.

During the evaluation of sulphur for Annex I listing, the Rapporteur Member State (France) concluded in the Draft Assessment Report (public version published March 2008) that extensive literature on function, uptake and metabolism of sulphur compounds in plants exist. The RMS also made reference to an evaluation report by the European Medicines Agency (EMEA) on elemental sulphur, used as therapeutic agent in food-producing animals. The report concluded that residues in animal tissues from sulphur administra- tion could not be regarded as being of any concern, neither in terms of human health nor effects on microorganisms used during processing of food stuffs. It is reported in the EFSA Review Report (EFSA Scien- tific Report (2008) 221, December 2008) that the PRAPeR 60 meeting of experts on residues concluded that with respect to the assessment of plant protection uses of sulphur in terms of consumer safety elabo- ration on residue levels in plants and food of animal origin is not required, since no toxicological reference values were set for sulphur by the PRAPeR 59 meeting of experts on toxicology.

Subsequently, it was reported in the EFSA Review Report (EFSA Scientific Report (2008) 221, Decem- ber 2008) that the PRAPeR 60 meeting of experts on residues did not propose a residue definition for monitoring nor an MRL for elemental sulphur. The experts agreed that sulphur was a candidate to be placed in Annex IV of Council Regulation (EC) No 369/2005. Indeed, sulphur is currently included in Annex IV of Council Regulation (EC) No 369/2005 as amended by Council Regulation (EC) No 459/2010.

The EFSA Scientific Report also concluded that no dietary risk assessment needs to be carried out since no toxicological reference values were set for sulphur by the PRAPeR 59 meeting of experts on toxicology.

It may be concluded that the use of Helioterpen Soufre would not pose an unacceptable risk to humans neither from a short term nor from a long term point of view.

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

Analytical methods for determination of residues of sulphur are not necessary because no residue definition for monitoring is proposed in food and feeding stuff, and in soil, water and air. No method is required for body fluids and tissues. No data gaps are noticed.

Commodity/crop Supported/ Not supported Cucumber supported Helioterpen Soufre Page 5 /11 Part B – Section 5 - Core Assessment Template for chemical PPP zRMS version Version july 2019

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)

Reference: KCP 5.1.1, Ricau, H., 2016 Report Validation of the analytical method for the determination of sulphur in Helioterpen Soufre, Report No 16-901011-005, DEFITRACES, Brindas, France Guideline(s): SANCO/3030/99 rev. 4 from 11/07/00 Deviations: No GLP: Yes Acceptability: Yes

Materials and methods Material used for the validation of the analytical method has the same composition of the formulation detailed in Part C (Helioterpen Soufre / Batch 231107-M1).

An analytical method validation of sulphur in Helioterpen Soufre is performed during this study by definition of the specificity, the linearity, the accuracy, the precision and the reproducibility of the method.

Sulphur is analysed after extraction from the formulation and quantified by liquid chromatography using a reverse phase column and a UV detector. Helioterpen Soufre Page 6 /11 Part B – Section 5 - Core Assessment Template for chemical PPP zRMS version Version july 2019

Validation - Results and discussions

Table 5.2-1: Methods suitable for the determination of active substance Sulphur in plant protection product Helioterpen Soufre

Sulphur

Author(s), year Ricau H., 2016 Principle of method HPLC-UV using a reverse phase column Linearity The response of the detector during the analysis of sulfur was linear n = 5 within the range of 101.85 mg/L to 301.54 mg/L (50 – 150 %). (linear between mg/L / % range of the declared y = 4.91 *104x – 1.30 *104 content) r = 0.9972 (correlation coefficient, expressed as r) Precision – Repeatability Mean The concentration of sulfur in the test item was equal to 705 g/L or n = 5 70.5% w/v. (%RSD) The precision was acceptable as the RSD was lower than the result of the modified Horwitz equation: 0.78 < 1.48. Accuracy The recovery results should be in the range 98% - 102% and they n = 2 were experimentally equal to 98.2% and 98.3%. (% Recovery) Interference/ Specificity No interference issue has been showed in the study. The analytical method showed a good specificity for analysis of sulfur. Comment Reproducibility The mean average content of sulfur for the two reproducibilities was equal to 70.7% w/v. The mean Relative Standard Deviation of sulfur for the two reproducibilities was equal to 0.72%.

Conclusion An analytical HPLC-UV method for the determination of sulphur in Helioterpen Soufre was provided and was considered acceptable according to SANCO/3030/99 rev.4.

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

There are no relevant impurities for Sulphur.

Helioterpen Soufre Page 7 /11 Part B – Section 5 - Core Assessment Template for chemical PPP zRMS version Version july 2019

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

No method for the determination of formulants or constituents of formulants in the formulation is required.

5.2.1.4 Applicability of existing CIPAC methods (KCP 5.1.1)

There is a CIPAC method available for the determination of sulphur in the technical material and in WP, SC and DP formulations.

Sulphur can be identified and analysed in formulation product using CIPAC method 18/TC/M/3. This method is suitable for all formulations based on sulphur. As this method is a CIPAC method, guidelines for validation of the method are not relevant. This method is based on titration with standard iodine solution after conversion of sulphur into sodium thiosulphate.

The method detailed in section 5.2.1.1 does not follow this CIPAC method.

5.2.2 Methods for the determination of residues (KCP 5.1.2)

Analytical methods for the analysis of residues of sulphur used in support of generation of pre- authorization data were not provided by the applicant, nor deemed necessary by the zRMS.

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

5.3.1 Analysis of the plant protection product (KCP 5.2)

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

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

The conclusion regarding the peer review of the analytical methods for residues of Sulphur are summarized in EFSA’s Scientific Report (2008) 221,1-70; ASB2012-831.

Table 5.3-1: Information on the active substance Sulphur

Name of component of residue definition substance code Structural formula IUPAC name formula Sulphur

Helioterpen Soufre Page 8 /11 Part B – Section 5 - Core Assessment Template for chemical PPP zRMS version Version july 2019

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

As already proposed in the Draft Assessment Report (incl. its addenda), a legal residue definition has not been established and is not required.

Table 5.3-2: Relevant residue definitions for monitoring/enforcement and levels for which compliance is required

Matrix Residue defini- MRL / Reference for MRL/level tion limit Remarks all commodities of plant not defined not Listed in Annex IV of regulation (EC) No 396/2005 origin required all commodities of animal not defined not Listed in Annex IV of regulation (EC) No 396/2005 origin required Soil not defined not EFSA Scientific report (2008) 221, 1-70, required ASB2012-831 Drinking water not defined not EFSA Scientific report (2008) 221, 1-70, required ASB2012-831 Surface water not defined not EFSA Scientific report (2008) 221, 1-70, required ASB2012-831 Air not defined not EFSA Scientific report (2008) 221, 1-70, required ASB2012-831 Tissue (meat or liver) not defined not not classified as T / T+ required Body fluids not not classified as T / T+ required

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

Methods for the determination of residues of Sulphur in plant matrices are not required, because no residue definition for monitoring and no MRLs are proposed. Sulphur is included in Annex IV of Council Regulation (EC) No 396/2005.

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

Methods for the determination of residues of Sulphur in animal matrices are not required, because no residue definition for monitoring and no MRLs are proposed. Sulphur is included in Annex IV of Council Regulation (EC) No 396/2005.

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

Methods for the determination of residues of Sulphur in soil are not required, because Sulphur is a naturally occurring compound of low toxicity. Helioterpen Soufre Page 9 /11 Part B – Section 5 - Core Assessment Template for chemical PPP zRMS version Version july 2019

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

Methods for the determination of residues of Sulphur in drinking and surface water are not required, because Sulphur is a naturally occurring compound of low toxicity.

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

Methods for the determination of residues of Sulphur in air are not required, because no residue definition for monitoring is proposed. No AOEL is allocated.

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

Methods for body fluids and tissues are not required, because Sulphur is not considered to be toxic or very toxic (T / T+) nor is it classified according to GHS as follows: Acute toxicity (cat. 1 - 3), CMR (cat. 1) or STOT (cat. 1).

5.3.2.8 Other studies/ information none

Helioterpen Soufre Page 10 /11 Part B – Section 5 - Core Assessment Template for chemical PPP zRMS version Version March 2019

Appendix 1 Lists of data considered in support of the evaluation

List of data submitted by the applicant and relied on

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

KCP 5.1.1 Ricau, H. 2016 Validation of the analytical method for the determination of sulphur in Helioterpen Soufre N ACTION PIN Report No 16-901011-005 DEFITRACES, Brindas, France 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 Author(s) Year Source (where different from company) study Owner point GLP or GEP status Y/N Published or not

– – – – – –

Helioterpen Soufre Page 11 /11 Part B – Section 5 - Core Assessment Template for chemical PPP zRMS version Version March 2019

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 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

– – – – – –

References EFSA Scientific report (2008) 221, 1-70, ASB2012-831

Helioterpen Schwefel / 008989-00/00 Part B – Section 6 - Core Assessment zRMS version

DRAFT REGISTRATION REPORT Part B

Section 6: Mammalian Toxicology Detailed summary of the risk assessment

Product name: Helioterpen Schwefel Active Substance: Sulphur 700 g/L

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT

Applicant: Action Pin Date: February 2019

Page 1 / 26 Helioterpen Schwefel / 008989-00/00 Part B – Section 6 - Core Assessment zRMS version

Version history

When What

February 2019 Draft Registration Report: zRMS assessment

Page 2 / 26 Helioterpen Schwefel / 008989-00/00 Part B – Section 6 - Core Assessment zRMS version

Table of Contents

6 Mammalian Toxicology (KCP 7) ...... 4 6.1 Summary ...... 4 6.2 Toxicological Information on active substance(s) ...... 6 6.3 Toxicological Evaluation of Plant Protection Product ...... 6 6.4 Dermal Absorption (KCP 7.3) ...... 8 6.4.1 Justification for proposed values - sulphur ...... 8 6.5 Exposure Assessment of Plant Protection Product (KCP 7.2) ...... 8 6.5.1 Selection of critical use(s) and justification ...... 9 6.5.2 Operator exposure (KCP 7.2.1) ...... 9 6.5.2.1 Estimation of operator exposure ...... 9 6.5.2.2 Measurement of operator exposure ...... 9 6.5.3 Worker exposure (KCP 7.2.3) ...... 10 6.5.3.1 Estimation of worker exposure ...... 10 6.5.3.2 Refinement of generic DFR value (KCP 7.2) ...... 10 6.5.3.3 Measurement of worker exposure ...... 10 6.5.4 Resident and bystander exposure (KCP 7.2.2) ...... 10 6.5.5 Combined exposure ...... 10

Appendix 1 Reference list ...... 11

Appendix 2 Detailed evaluation of the studies relied upon ...... 13 A 2.1 Statement on bridging possibilities ...... 13 A 2.2 Acute oral toxicity (KCP 7.1.1) ...... 13 A 2.3 Acute percutaneous (dermal) toxicity (KCP 7.1.2) ...... 14 A 2.4 Acute inhalation toxicity (KCP 7.1.3) ...... 15 A 2.5 Skin irritation (KCP 7.1.4) ...... 17 A 2.6 Eye irritation (KCP 7.1.5) ...... 18 A 2.7 Skin sensitisation (KCP 7.1.6) ...... 19 A 2.8 Supplementary studies for combinations of plant protection products (KCP 7.1.7) ...... 21 A 2.9 Data on co-formulants (KCP 7.4) ...... 21 A 2.9.1 Material safety data sheet for each co-formulant ...... 21 A 2.9.2 Available toxicological data for each co-formulant ...... 21 A 2.10 Other/Special Studies ...... 21

Appendix 3 Exposure calculations ...... 22 A 3.1 Operator exposure calculations (KCP 7.2.1.1) ...... 22 A 3.1.1 Calculations for sulphur ...... 22 A 3.2 Worker exposure calculations (KCP 7.2.3.1) ...... 23 A 3.2.1 Calculations for sulphur ...... 23

Appendix 4 Detailed evaluation of exposure and/or DFR studies relied upon (KCP 7.2, KCP 7.2.1.2, KCP 7.2.2.1, KCP 7.2.3.1) ...... 25

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

Commenting boxes and conclusion boxes were used by zRMS only for the detailed evaluation of studies in Appendix 2 and Appendix 4 of the dRR. The description of the studies in Appendix 2 and Appendix 4 is based on the dRR originally submitted by the applicant. Some text passages therefore may be taken from the applicants dRR, however, the text will be adapted such that it in the end reflects the assessment of the zRMS based on the original data.

6 Mammalian Toxicology (KCP 7)

6.1 Summary

Table 6.1-1: Information on Helioterpen Schwefel*

Product name and code Helioterpen Schwefel (BVL code: ACP-00700-F-0-SC) Formulation type Suspension concentrate [Code: SC] Active substance(s) (incl. content) Sulphur; 700 g/L Function Fungicide Product already evaluated as the ‘representative No formulation’ during the approval of the active substance(s) Product previously evaluated in another MS according Yes, by FR for the southern zone, registration no 9000222, to Uniform Principles corresponding RR not submitted * Information on the detailed composition of Helioterpen Schwefel 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 Helioterpen Schwefel according to Regulation (EC) No 1272/2008

Hazard classes, categories Eye Dam. 1 Hazard pictograms or Codes for hazard pictograms GHS05 Signal word Danger Hazard statements H318 Precautionary statements P101-102-280-305+351+338+310 Additional labelling phrases To avoid risks to man and the environment, comply with the instructions for use. [EUH401]

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Table 6.1-3: Summary of risk assessment for operators, workers, residents and bystanders for Helioterpen Schwefel

Result PPE / Risk mitigation measures Operators Acceptable - Avoid any unnecessary contact with the product. Misuse can lead to health damage. [SB001] - Concerning the requirements for personal protective gear for handling the plant protection product the material safety data sheet and the instructions for use of the plant protection product as well as the guideline "Personal protective gear for handling plant protection products" of the Federal Office of Consumer Protection and Food Safety (www.bvl.bund.de) must be observed. [SB111] - Do not eat, drink or smoke when using this product. [SB166] - Wear tight fitting eye protection when handling the undiluted product. [SE110] - Working clothes (if no specific protective suit is required) and sturdy footwear (e.g. rubber boots) must be worn when applying/handling plant protection products. [SS206] Workers Acceptable - It must be ensured that treated areas/crops may not be entered until the film of the plant protection product has dried. [SF245-02] Residents Not relevant for intended use Bystanders Not relevant for intended use

No unacceptable risk for operators and workers was identified when the product is used as intended. No specific PPE is necessary.

A summary of the critical uses and the overall conclusion regarding exposure for operators, workers and residents / bystanders is presented in the following table.

Further reduction of exposure is to be expected due to necessary PPE allocated according to dangerous substances regulations.

Table 6.1-4 Critical uses and overall conclusion of exposure assessment

1 2 3 4 5 6 7 8 9 10

Use- Crops and F, Application Application rate PHI Remarks: Acceptability of No.* situation Fn, (d) (e.g. exposure (e.g. growth Fpn safener/synergist assessment stage of crop) G, [L/ha]) Gn, Method / Max. number Max. application Water Gpn, Kind (min. interval rate critical gap for between min – I, In, (incl. operator, worker, Ipn** applications) per application / max bystander or application per crop and technique) a) per use resident exposure season [L/ha] based on b) per crop/ [kg as/ha] season [Exposure model] Operator Worker Residents Bystander 1 Cucumber >125 G Spraying, 6 ; 6 a) 2.1 1200 3 Operators: German A A N.R. N.R. cm HCHH*** b) 12.6 model and data by Mich, 1996, Worker: EFSA Journal 2014;12(10):3874 * Use numbers in accordance with the list of all intended GAPs in section 0, Part B 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, In: non-professional indoor use; Ipn: professional and non-professional indoor use *** HCHH: high crop hand-held

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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 N. R. Not relevant

Data gaps Noticed data gaps are: • None

6.2 Toxicological Information on active substance(s)

The active substance was evaluated under directive No 94/414/EEC (as amended) or regulation (EC) No 1107/2009 (as amended). Information regarding classification of the active substances and on EU endpoints identified during the EU review is given in the following table(s). Further information on active substances is included in the reports on the results of the peer review process and in the respective background documents. Table 6.2-1: Information on sulphur

Classification and labelling With regard to toxicological Hazard classes , category: Skin Irrit. 2 endpoints (according to the Code for hazard pictogram: GHS07 criteria in Regulation (EC) No Signal word: Warning 1272/2008, as amended) Hazard statement: H315 Proposals for additional None classification and labelling Agreed EU endpoints AOEL systemic Not derived, considered not necessary Background of normal dietary 26 mg/kg bw/day sulphur intake Reference EFSA Scientific Report (2008) 221, 40-70, ASB2012-831

6.3 Toxicological Evaluation of Plant Protection Product

All toxicological studies submitted were carried out using a similar formulation, i.e. Heliosoufre S. These studies are deemed applicable for Helioterpen Schwefel. For a comparison of formulations as well as for detailed bridging justification it is referred to Part C of this dRR. A summary of the toxicological evaluation for Helioterpen Schwefel is given in the following tables. Full summaries of studies on Heliosoufre S that have not been previously considered within an EU peer review process are described in detail in Appendix 2.

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Table 6.3-1: Summary of evaluation of the studies on acute toxicity including irritancy and skin sensitisation for Helioterpen Schwefel

Classification and Type of test, species, Result labelling model system Acceptability Reference (acc. to the criteria in (Guideline) Reg. 1272/2008)

LD50 oral, rat > 2000 mg/kg bw Yes None XXXXX, 1993a; (OECD 401) ASB2017-15018

LD50 dermal, rat > 2000 mg/kg bw Yes None XXXXX, 1993b; (OECD 402) ASB2017-15019

LC50 inhalative Inconclusive, No None* XXXXX, 1996a; No guideline given but concentration of test ASB2017-15021 major deviations substance not compared with OECD determined 403 Skin irritation, rabbit Non irritant Yes None XXXXX, 1993c; in vivo (OECD 404) ASB2017-15017 Eye irritation, rabbit Irritant Yes H318 XXXXX, 1993d; in vivo (OECD 405) ASB2017-15020 Skin sensitisation, High fraction of Not acceptable as None** XXXXX, 1996b; guinea pig (M&K-test) animals with positive a stand-alone test ASB2017-15022 (OECD 406) challenge reaction in the negative control group, but, no re- challenge carried out; study therefore deemed not valid.

* Based on calculation method according to Reg. (EC) Nr. 1272/2008: LC50 >5 mg/L air ** Primarily based on the fact that neither the active substance nor any of the co-formulants are known sensitisers.

Table 6.3-2: Additional toxicological information relevant for classification/labelling of Helioterpen Schwefel

Substance Classification and Reference Classification and (Concentration labelling of the substance labelling of product (acc. in product, (acc. to the criteria in to the criteria in Reg. % w/w) Reg. 1272/2008) 1272/2008) Toxicological None properties of active substance (relevant for classification of Helioterpen Schwefel) Toxicological None properties of co- formulants (relevant for classification of Helioterpen Schwefel)

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6.4 Dermal Absorption (KCP 7.3)

A summary of the dermal absorption rates used in the exposure assessment of the present application are presented in the following table.

Table 6.4-1: Dermal absorption rates for active substances in Helioterpen Schwefel

Sulphur

Value Reference

Concentrate 25% EFSA Guidance on dermal absorption, (EFSA Journal 2012; 10(4):2665); ASB2012-6959 Dilution 75% EFSA Guidance on dermal absorption, (EFSA Journal 2012; 10(4):2665); ASB2012-6959

6.4.1 Justification for proposed values - sulphur

No data on dermal absorption for sulphur in Helioterpen Schwefel are available. Justifications for default values according to Guidance on Dermal Absorption (EFSA Journal 2012; 10(4):2665) are presented in the following table.

Table 6.4-2: Default dermal absorption rates for sulphur

Value Justification for value

Concentrate 25% The concentration of the active substance in the undiluted product is > 5%. Dilution 75% The concentration of the active substance in dilution is ≤ 5%.

6.5 Exposure Assessment of Plant Protection Product (KCP 7.2)

Table 6.5-1: Product information and toxicological reference values used for exposure assessment

Product name and code Helioterpen Schwefel (BVL code: ACP-00700-F-0-SC) Formulation type Suspension concentrate [code: SC] Category Fungicide

Active substance (incl. content) Sulphur (700 g/L) AOEL systemic Not derived, but background of normal dietary sulphur intake, i.e. 26 mg/kg bw/d taken as a surrogate reference value for risk assessment Inhalation absorption 100% Oral absorption 100% Dermal absorption Concentrate: 25% Dilution: 75% (1.75 g/L) (Default)

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6.5.1 Selection of critical use(s) and justification

The critical GAP used for the exposure assessment of the plant protection product is shown in Table 6.1-4.

6.5.2 Operator exposure (KCP 7.2.1)

As long as no harmonised approach on the setting of acute reference values for non-dietary human exposure is available, no acute exposure calculations are necessary.

6.5.2.1 Estimation of operator exposure

A summary of the exposure models used for estimation of operator exposure to the active substances during application of Helioterpen Schwefel according to the critical use is presented in Table 6.5-2. The outcome of the estimation is presented in Table 6.5-3 (longer term exposure). Detailed calculations are in Appendix 3.

6.5.2.2 Measurement of operator exposure

Operator exposure was estimated using a GLP study performed for the generic assessment of products applied in greenhouses. Detailed considerations and calculations as well as a summary of the greenhouse study it is referred to Appendix 4.

Estimation of operator exposure based on measured values after greenhouse applications and risk assessment

Table 6.5-2: Exposure models for intended uses

Critical use Cucumber (max. 3 L product/ha) Models 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] and Exposure study according to Mich (1996)

Table 6.5-3: Estimated operator exposure Sulphur Model data Level of PPE Total absorbed dose % of normal dietary (mg/kg/day) sulphur intake Knapsack spray applications in greenhouses to high crops Application rate: 2.1 kg a.s./ha German Model and no PPE1) 4.3515 16.7 Exposure study + Gloves during 2.5756 9.9 Body weight: 60 kg mixing/loading 1) no PPE: Operator wearing T-shirt and shorts

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6.5.3 Worker exposure (KCP 7.2.3)

6.5.3.1 Estimation of worker exposure

Table 6.5.-4 shows the exposure model used for estimation of worker exposure after entry into a previously treated area or handling a crop treated with Helioterpen Schwefel according to the critical uses. Outcome of the estimation is presented in Table 6.5-5 (longer term exposure). Detailed calculations are in Appendix 3.

Table 6.5-4: Exposure models for intended uses

Critical uses Cucumber (max. 6 x 3 L product/ha) Model Guidance on the assessment of exposure of operators, workers, residents and bystanders in risk assessment for plant protection products; EFSA Journal 2014;12(10):3874 calculator version: 30/03/2015

Table 6.5-5: Estimated worker exposure (longer term exposure)

Sulphur

Model data Level of PPE Total absorbed dose % of normal (mg/kg bw/day) dietary sulphur intake

Reaching, picking Indoor Work rate: 8 hours/day DT50: 30 days DFR: 3.0 µg/cm2/kg a.s./ha Interval between treatments: 7 days Number of applications and application rate: 6.0 x 2.1 kg a.s./ha Body weight: Potential 15.2 58.4 60 kg TC: 5800 cm2/person/h Work wear (arms, body and legs covered) 6.55 25.2 TC: 2500 cm2/person/h Work wear (arms, body and legs covered) and gloves 1.52 5.84 TC: 580.0 cm2/person/h

6.5.3.2 Refinement of generic DFR value (KCP 7.2) No studies on dislodgeable foliar residues have been provided.

6.5.3.3 Measurement of worker exposure Since the worker exposure estimations carried out indicated that the normal dietary sulphur intake 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.

6.5.4 Resident and bystander exposure (KCP 7.2.2) Not relevant since only greenhouse applications are intended.

6.5.5 Combined exposure Not relevant. The product contains only one active substance.

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Appendix 1 Reference list

Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered Authority registration No claimed in dRR * EFSA 2008 Conclusion on pesticide peer review regarding the risk assessment of the active substance sulfur

GLP: No Published: No ASB2012-831 EFSA 2012 Guidance on dermal absorption - EFSA Panel on Plant Protection Products and their Residues (PPR) EFSA Journal 2012;10(4):2665 ! EFSA- Q-2010-01324 EFSA Journal 2012; 10(4): 2665. vol.10, 4 (2012) 2665 GLP: No Published: Yes BVL-2716916, ASB2012-6959 Mich, G. 1996 Operator exposure in greenhouses BAY Add during practical use of plant protection BAY1 products DOW IAB EF 94-02-03 ! MO-00-002686 ! M- SCM SYD 024096-01-1 Syngenta Novartis Crop Protection AG, Basel, Agro TRF Switzerland GLP: No (4) Open (5) Yes (42) Published: No BVL-1752398, BVL-1760625, BVL- 1771380, BVL-1771381, BVL- 1937458, BVL-2616003, BVL- 2770167, BVL-2959870, TOX2000- 2081 KCP 7.1.1 XXXXX 1993a Acute oral toxicity study in rats of the No Action Pin Y preparation HELIOSOUFRE S - Batch 31007 (limit test) T 830/1952 EVIC-CEBA laboratories, France GLP: No Published: No BVL-3290639, ASB2017-15018 KCP 7.1.2 XXXXX 1993b Acute dermal toxicity study in the rat of No Action Pin Y the preparation HELIOSOUFRE S - Batch 31007 (Limit test) T831/1952 EVIC-CEBA laboratories, France GLP: No Published: No BVL-3290640, ASB2017-15019 KCP 7.1.3 XXXXX 1996a Evaluation of acute toxicity by No Action Pin N inhalation in the rat of the product HELIOSOUFRE S - Batch 51019 (Limit test) Tb 741 / 1612 EVIC-CEBA laboratories, France GLP: No Published: No BVL-3290641, ASB2017-15021 KCP 7.1.4 XXXXX 1993c Acute dermal irritation/corrosion of the No Action Pin Y preparation HELIOSOUFRE S T 833/1952 EVIC-CEBA laboratories, France GLP: No Published: No BVL-3290642, ASB2017-15017

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Annex point/ Author(s) Year Title Data Owner How reference No Report-No. protection considered Authority registration No claimed in dRR * KCP 7.1.5 XXXXX 1993d Acute eye irritation/corrosion of the No Action Pin Y preparation HELIOSOUFRE S - Batch 31007 T 832/1952 EVIC-CEBA laboratories, France GLP: No Published: No BVL-3290643, ASB2017-15020 KCP 7.1.6 XXXXX 1996b Evaluation of the sensitizing potential of No Action Pin N the material HELIOSOUFRE S - Batch 51019 - Guinea pig Maximisation Test (G.P.M.T.) Tb 740 / 1612 EVIC-CEBA laboratories, France GLP: No Published: No BVL-3290644, ASB2017-15022 * Y: Yes, relied on N: No, not relied on Add: Relied on, study not submitted by applicant but necessary for evaluation

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Appendix 2 Detailed evaluation of the studies relied upon

A 2.1 Statement on bridging possibilities

All toxicological studies on the product were conducted using a similar formulation compared to Helioterpen Schwefel, i.e. Heliosoufre S. One co-formulant of Heliosoufre S was exchanged, i.e. 8.7% of an adhesive were replaced by another in Helioterpen Schwefel. Since toxicological properties of both co- formulants are comparable, bridging of the studies is deemed acceptable. For a detailed comparison of compositions of both products it is referred to Part C of this dRR.

Comments of zRMS: Acceptable

A 2.2 Acute oral toxicity (KCP 7.1.1)

Comments of zRMS: Acceptable; no deficiencies, according to mentioned guideline, used in evaluation

Reference: KCP 7.1.1 Report Acute oral toxicity study in rats of the preparation HELIOSOUFRE S - Batch 31007 (limit test) XXXXX, 1993a, T 830/1952, ASB2017-15018 Guideline: OECD Guideline 401 (Acute Oral Toxicity), 1987 Deviations: No GLP: Prior to GLP, but performed in an accredited laboratory Acceptability: Not applicable Duplication No, according to available information. (if vertebrate study)

Materials and methods

Test material (Lot/Batch No.) HELIOSOUFRE S (Batch No. 31007) Species Rat, Sprague-Dawley No. of animals (group size) 5 rats/sex Dose(s) 2000 mg/kg bw Exposure Once by gavage Vehicle/Dilution Distilled water Post exposure observation period 14 days Remarks None

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Results and discussions

Table A 1: Results of acute oral toxicity study in rats of HELIOSOUFRE S

Dose Toxicological results* Duration of signs Time of death LD50 (mg/kg bw) (mg/kg bw) (14 days) Male rats 2000 0/0/5 -- -- > 2000 Female rats 2000 0/0/5 -- -- > 2000 * Number of animals which died/number of animals with clinical signs/number of animals used

Table A 2: Summary of findings of acute oral toxicity study in rats of HELIOSOUFRE S

Mortality: No mortality occurred. Clinical signs: No clinical signs of toxicity were observed. Body weight: Body weight gain was considered to be normal.

Conclusion of zRMS

Under the experimental conditions, the oral LD50 of HELIOSOUFRE S is higher than 2000 mg/kg bw in rats. Thus, no classification is required 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 in evaluation

Reference: KCP 7.1.2 Report Acute dermal toxicity study in the rat of the preparation HELIOSOUFRE S - Batch 31007 (Limit test) XXXXX, 1993b, T831/1952, ASB2017-15019 Guideline: OECD Guideline 402 (Acute Dermal Toxicity), 1987 Deviations: No GLP: Prior to GLP, but performed in an accredited laboratory Acceptability: Yes Duplication No, according to available information. (if vertebrate study)

Materials and methods

Test material (Lot/Batch No.) HELIOSOUFRE S (Batch No. 31007) Species Rat, Sprague-Dawley OFA No. of animals (group size) 5 rats/sex Dose(s) 2000 mg/kg bw Exposure 24 hours (dermal, semi-occlusive)

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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 HELIOSOUFRE S

Dose Toxicological results * Duration of signs Time of death LD50 (mg/kg bw) (mg/kg bw) (14 days) Male rats 2000 0/5/5 up to 1 h -- > 2000 Female rats 2000 0/5/5 up to 1 h -- > 2000 * 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 HELIOSOUFRE S

Mortality: No mortality occurred. Clinical signs: A slight diminution of motor activity due to the mechanical constraints produced by the patch was observed in all the animals 1 hour after the treatment. Some signs of desquamation were reported in five males and one female one week after treatment. Body weight: Body weight gain was considered to be normal. Macroscopic The necropsies performed at the end of the study revealed no apparent findings. examination:

Conclusion of zRMS

Under the experimental conditions, the dermal LD50 of HELIOSOUFRE S is higher than 2000 mg/kg bw in rats. Thus, no classification is required according to Regulation (EC) No. 1272/2008.

A 2.4 Acute inhalation toxicity (KCP 7.1.3)

Comments of zRMS: Not acceptable, not according to any harmonised test guideline; used only as additional information

Reference: KCP 7.1.3 Report Evaluation of acute toxicity by inhalation in the rat of the product HELIOSOUFRE S - Batch 51019 (Limit test) XXXXX, 1996a, Tb 741 / 1612, ASB2017-15021 Guideline: Although, e.g. OECD 403 (1981) or Directive 92/69/EEC, method B.2 were already implemented before 1996 when this study was carried out, the test was not performed according to any of these guidelines.

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Deviations: N/A GLP: Prior to GLP Acceptability: No Duplication No, according to available information. (if vertebrate study)

Materials and methods

Test material (Lot/Batch No.) HELIOSOUFRE S (Batch No. 51019) Species Rat, Sprague-Dawley No. of animals (group size) 6 rats/sex/dose Concentration Nominal 400 mg/L air applied pre-diluted as a 18.7% suspension of the product Exposure 4 hours (whole body), 2 rats in a plastic box of 20 L, product spray pulses à 2.7 g (duration one second) every 15 minutes, i.e. 16 pulses in 4 hours Vehicle/Dilution Distilled water Post exposure observation period 14 days Remarks Shortcomings: Neither the test substance concentration in the test atmosphere was measured nor were the size of the aerosol droplets or their size distribution determined. A static exposure chamber was used, where the test substance was not applied continuously but in portions four times per hour.

Results and discussions

Table A 5: Concentrations and exposure conditions

Nominal whole amount of Nominal conc. Actual conc. MMAD* GSD** product used in 4 (mg/L air) (mg/L air) (µm) (µm) hours

43.2 g/20 L Not given Not given Not given Not given * MMAD = Mass Median Aerodynamic Diameter ** GSD = Geometric Standard Deviation

Table A 6: Results of acute inhalation toxicity study in rats of HELIOSOUFRE S

Theoretical Toxicological results* Duration of signs Time of death LC50 (mg/L air) Concentration (14 days) (mg/L air) Male rats 400 0/0/6 -- -- >400 Female rats 400 0/0/6 -- -- >400 * Number of animals which died/number of animals with clinical signs/number of animals used

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Table A 7: Summary of findings of acute inhalation toxicity study in rats of HELIOSOUFRE S

Mortality: No mortality occurred. Clinical signs: No clinical signs of toxicity were observed. Body weight: Body weight gain was considered to be normal. Macroscopic The necropsies performed at the end of the study revealed no apparent findings. examination:

Conclusion of zRMS Due to methodological shortcomings, this study is not considered valid. Even though no rats died following inhalation of an unknown amount of HELIOSOUFRE S with unknown size of droplets, no reliable LC50 can be derived. Thus, classification for acute inhalation toxicity according to Regulation (EC) No. 1272/2008 is not possible based on this study. Applying the conventional calculation method for classification with respect to acute inhalation toxicity for HELIOSOUFRE S and thus for Helioterpen Schwefel according to Regulation (EC) No. 1272/2008 an LC50 >5 mg/L air results (actually >100 mg/L air). Therefore, no classification is necessary for the product.

A 2.5 Skin irritation (KCP 7.1.4)

Comments of zRMS: Acceptable; no deficiencies, according to mentioned guidelinet, used in evaluation

Reference: KCP 7.1.4 Report Acute dermal irritation/corrosion of the preparation HELIOSOUFRE S XXXXX, P., 1993c, T 833/1952, ASB2017-15017 Guidelines: OECD Guideline 404 (Acute Dermal Irritation / Corrosion), 1992 Deviations: No GLP: Prior to GLP, but performed in an accredited laboratory Acceptability: Yes Duplication No, according to available information. (if vertebrate study)

Materials and methods

Test material (Lot/Batch No.) HELIOSOUFRE S (Batch No. 31007) Species Rabbit, New Zealand White No. of animals (group size) 3 males Initial test using one animal Yes Exposure 0.5 mL (4 hours, semi-occlusive) Vehicle/Dilution None Post exposure observation period 8 days Remarks None

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Results and discussions

Table A 8: Skin irritation of HELIOSOUFRE S

Animal Scores after treatment* Mean scores Reversible

No. 1 h 24 h 48 h 72 h (24-72 h) (day) 1 Erythema 1 1 1 1 1.0 8 Oedema 0 0 0 0 0.0 - 2 Erythema 1 1 1 1 1.0 8 Oedema 1 2 2 0 1.3 3 3 Erythema 1 1 1 1 1.0 6 Oedema 2 1 1 0 0.7 3 * Scores in the range of 0 to 4

Clinical signs: No clinical signs of toxicity were observed.

Conclusion of zRMS

Under the experimental conditions, HELIOSOUFRE S is not a skin irritant. Thus, no classification is required according to Regulation (EC) No. 1272/2008.

A 2.6 Eye irritation (KCP 7.1.5)

Comments of zRMS: Acceptable; no deficiencies, according to mentioned guideline, used in evaluation

Reference: KCP 7.1.5 Report Acute eye irritation/corrosion of the preparation HELIOSOUFRE S - Batch 31007 XXXXX, P., 1993d, T 832/1952, ASB2017-15020 Guideline: OECD Guideline 405 (Acute Eye Irritation / Corrosion), 1987 Deviations: No GLP: Prior to GLP, but performed in an accredited laboratory. Acceptability: Yes Duplication No, according to available information. (if vertebrate study)

Materials and methods

Test material (Lot/Batch No.) HELIOSOUFRE S (Batch No. 31007) Species Rabbit, New Zealand White No. of animals (group size) 1 male Initial test using one animal Yes Exposure 0.1 mL (single instillation in conjunctival sac)

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Irrigation (time point) No Vehicle/Dilution None Post exposure observation period 5 days Remarks None

Results and discussions

Table A 9: Eye irritation of HELIOSOUFRE S

Animal Scores after treatment* Mean scores Reversible

No. 1 h 24 h 48 h 72 h (24-72 h) (day) 1 Corneal opacity 0 1 2 ** >1.0 -- Iritis 1 1 2 ** >1.0 -- Redness conjunctivae 3 3 3 3 3.0 -- Chemosis conjunctivae 1 4 4 4 4.0 -- * 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 ** Scoring impossible (eye closed)

Remarks: For ethical reasons, the rabbit was killed after the fourth reading. The product was not tested in two more animals. Clinical signs: No clinical signs of toxicity were observed.

Conclusion of zRMS Under the experimental conditions, HELIOSOUFRE S produces severe eye damage. Thus, labelling with H318 is required according to Regulation (EC) No. 1272/2008.

A 2.7 Skin sensitisation (KCP 7.1.6)

Comments of zRMS: Not acceptable as a stand-alone test; not conclusive, due to positive readings in the negative control group, largely according to mentioned guideline, used only as additional information

Reference: EG KCP 7.1.6 Report Evaluation of the sensitizing potential of the material HELIOSOUFRE S - Batch 51019 - Guinea pig Maximisation Test (G.P.M.T.) XXXXX, 1996b, Tb 740 / 1612, ASB2017-15022 Guideline: OECD Guideline 406 (Skin Sensitisation: GPMT), 1992 Deviations: Challenge of control animals treated with undiluted product was 48 hours instead of 24 hours inadvertently, so that the readings were carried out 48 and 72 hours after the product had been applied. GLP: Stated, but there is no proof Acceptability: Not applicable as a stand-alone test Duplication No, according to available information. (if vertebrate study)

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Materials and methods

Test material (Lot/Batch No.) HELIOSOUFRE S (Batch No. 51019) Species Guinea pig, Hartley albino No. of animals (group size) Test substance group: 20 female guinea pigs Vehicle control goup: 10 female guinea pigs Range finding: Yes Exposure (concentration(s), no. of Intradermal induction: 10% applications) Topical induction: 100% Challenge: 50% and 100% Vehicle Destilled water Pretreatment prior to topical application Yes (sodium lauryl sulfate: 10% in liquid petrolatum) Reliability check 2-Mercapto benzisothiazole (5% and 2%, not mentioned for which step of the protocol, in liquid petrolatum, i.e. a different vehicle than the test substance) Remarks Challenge of control animals treated with undiluted product was 48 hours instead of 24 hours inadvertently, so that the readings were carried out 48 and 72 hours after the product had been applied.

Results and discussions

24 hours 48 hours After challenge* HELIOSOUFRE S 0/20 (50% product) 3/20 (50% product) 2/20 (100% product) 4/20 (100% product) Test Vehicle Control 0/10 (50% product) 2/10 (50% product) Group ** (100% product) 8/10 (100% product) Positive control 60% positive animals*** 60% positive animals*** * Number of animals with positive dermal response (scores of 1-4)/number of animals in dose group ** No scoring possible, since yellow colouration of the skin *** Neither number of tested animals nor number of animals showing positive reactions or individual scores given; moreover, not stated when the reading resulted in 60% animals with positive skin reaction (i.e. after 24 or 48 hours)

Clinical signs: None

Conclusion of zRMS Due to unequivocal results (i.e. more negative control animals using undiluted product than animals treated with test substance showed positive skin reactions after challenge), this study is not considered valid as a stand-alone study. Even though, from a formal point of view, the threshold value for classification was not exceeded by the treated animals using undiluted HELIOSOUFRE S, i.e. 30% of animals exhibiting positive reactions after challenge, re-challenge would have been mandatorily necessary to clarify results. Thus, classification for skin sensitisation according to Regulation (EC) No. 1272/2008 is not possible based on this study. But, considering sensitising properties of the active substance and all co-formulants there is no evidence that classification for skin sensitisation is necessary for HELIOSOUFRE S or Helioterpen Schwefel.

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A 2.8 Supplementary studies for combinations of plant protection products (KCP 7.1.7)

There are no studies available for combinations of plant protection products.

A 2.9 Data on co-formulants (KCP 7.4)

A 2.9.1 Material safety data sheet for each co-formulant

Information regarding material safety data sheets of the co-formulants can be found in the confidential dossier of this submission (Registration Report - Part C).

A 2.9.2 Available toxicological data for each co-formulant

Available toxicological data for each co-formulant can be found in the confidential dossier of this submission (Registration Report - Part C).

A 2.10 Other/Special Studies

There are no other or special studies available.

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Appendix 3 Exposure calculations

A 3.1 Operator exposure calculations (KCP 7.2.1.1)

A 3.1.1 Calculations for sulphur

Table A 10: Input parameters considered for the estimation of operator exposure

Formulation type: SC Application technique: High crops hand held Application rate (AR): 2.1 kg a.s./ha

Area treated per day (A): 1 ha Dermal hands m/l (DM(H)): 205 mg/person/kg a.s.

25 % (concentr.) Dermal hands appl. (DA(H)): 13.1884 mg/person/kg a.s. Dermal absorption (DA): 75 % (dilution) Dermal body appl. (DA(B)): 82.47509 mg/person/kg a.s.

Inhalation absorption (IA): 100 % Dermal head appl. (DA(C)): 1.56194 mg/person/kg a.s.

Body weight (BW): 60 kg/person Inhalation m/l (IM): 0.05 mg/person/kg a.s.

Normal dietary sulphur intake 26 mg/kg bw/d Inhalation appl. (IA): 0.10841 mg/person/kg a.s.

Table A 11: Estimation of longer term operator exposure towards sulphur in the greenhouse according to the German model and application data by Mich, 1996

Without PPE With PPE Operators: Systemic dermal exposure after application in cucumber 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 (205 x 2.1 x 1 x 25%) / 60 (205 x 2.1 x 1 x 0.01 x 25%) / 60 External dermal exposure 430.5 mg/person External dermal exposure 4.305 mg/person External dermal exposure 7.175 mg/kg bw/d External dermal exposure 0.07175 mg/kg bw/d Systemic dermal exposure 1.79375 mg/kg bw/d Systemic dermal exposure 0.017938 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 (13.1884 x 2.1 x 1 x 75%) / 60 (13.1884 x 2.1 x 1 x 1 x 75%) / 60 External dermal exposure 27.69564 mg/person External dermal exposure 27.69564 mg/person External dermal exposure 0.461594 mg/kg bw/d External dermal exposure 0.461594 mg/kg bw/d Systemic dermal exposure 0.346196 mg/kg bw/d Systemic dermal exposure 0.346196 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 (82.47509 x 2.1 x 1 x 75%) / 60 (82.47509 x 2.1 x 1 x 1 x 75%) / 60 External dermal exposure 173.197689 mg/person External dermal exposure 173.197689 mg/person External dermal exposure 2.886628 mg/kg bw/d External dermal exposure 2.886628 mg/kg bw/d Systemic dermal exposure 2.164971 mg/kg bw/d Systemic dermal exposure 2.164971 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 (1.56194 x 2.1 x 1 x 75%) / 60 (1.56194 x 2.1 x 1 x 1 x 75%) / 60 External dermal exposure 3.280074 mg/person External dermal exposure 3.280074 mg/person External dermal exposure 0.054668 mg/kg bw/d External dermal exposure 0.054668 mg/kg bw/d Systemic dermal exposure 0.041001 mg/kg bw/d Systemic dermal exposure 0.041001 mg/kg bw/d

Total systemic dermal exposure: SDEO = SDEOM(H) + SDEOA(H) + Total systemic dermal exposure: SDEO = SDEOM(H) + SDEOA(H) + SDEOA(B) + SDEOA(C) SDEOA(B) + SDEOA(C) Total external dermal exposure 634.673403 mg/person Total external dermal exposure 208.478403 mg/person Total external dermal exposure 10.57789 mg/kg bw/d Total external dermal exposure 3.47464 mg/kg bw/d Total systemic dermal Total systemic dermal 4.345918 mg/kg bw/d 2.570105 mg/kg bw/d exposure exposure

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Operators: Systemic inhalation exposure after application in cucumber 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 (0.05 x 2.1 x 1 x 100%) / 60 (0.05 x 2.1 x 1 x 1 x 100%) / 60 External inhalation exposure 0.105 mg/person External inhalation exposure 0.105 mg/person External inhalation exposure 0.00175 mg/kg bw/d External inhalation exposure 0.00175 mg/kg bw/d Systemic inhalation exposure 0.00175 mg/kg bw/d Systemic inhalation exposure 0.00175 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 (0.10841 x 2.1 x 1 x 100%) / 60 (0.10841 x 2.1 x 1 x 1 x 100%) / 60 External inhalation exposure 0.227661 mg/person External inhalation exposure 0.227661 mg/person External inhalation exposure 0.003794 mg/kg bw/d External inhalation exposure 0.003794 mg/kg bw/d Systemic inhalation exposure 0.003794 mg/kg bw/d Systemic inhalation exposure 0.003794 mg/kg bw/d

Total systemic inhalation exposure: SIEO = SIEOM + SIEOA Total systemic inhalation exposure: SIEO = SIEOM + SIEOA Total external inhalation Total external inhalation 0.332661 mg/person 0.332661 mg/person exposure exposure Total external inhalation Total external inhalation 0.005544 mg/kg bw/d 0.005544 mg/kg bw/d exposure exposure Total systemic inhalation Total systemic inhalation 0.005544 mg/kg bw/d 0.005544 mg/kg bw/d exposure exposure

Total systemic exposure: SEO = SDEO + SIEO Total systemic exposure: SEO = SDEO + SIEO Total systemic exposure 261.087713 mg/person Total systemic exposure 154.538963 mg/person Total systemic exposure 4.351462 mg/kg bw/d Total systemic exposure 2.575649 mg/kg bw/d % of normal dietary sulphur % of normal dietary sulphur 16.7 % 9.9 % intake intake 1) reduction factor for gloves is 0.01 (professional appl.)

A 3.2 Worker exposure calculations (KCP 7.2.3.1)

A 3.2.1 Calculations for sulphur

Table A 12: Input parameters considered for the estimation of worker exposure

Intended use(s) Fruiting vegetables Dislodgeable foliar residue 3.0 µg/cm2/kg a.s./ha Reaching, picking (DFR) Indoor Application rate (AR) 2.1 kg a.s./ha Dermal absorption (DA) 75.0 % (worst case) Number of applications (NA) 6.0 Inhalation absorption (IA) 100.0 % Interval between applications 7 days Work rate per day (WR) 8.0 h/d Half-life of active substance 30.0 days TC dermal (potential) 5800 cm2/h Multiple application factor (MAF) 4.16 TC dermal (work wear) 2500 cm2/h Body weight (BW) 60.0 kg/person TC dermal (work wear, 580.0 cm2/h gloves) Normal dietary sulphur intake 26.0 mg/kg bw/d Task specific factor N/A ha/h x 10-3 (automated appl)

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Table A 13: Estimation of longer term worker exposure towards sulphur according to EFSA guidance Potential With work wear With work wear and gloves Worker (re-entry): Dermal exposure after application (DFR x TC x WR x AR x MAF x DA) / BW Systemic exposure 15.2 mg/kg bw/d 6.55 mg/kg bw/d 1.52 mg/kg bw/d Worker (re-entry): Total Systemic exposure 15.2 mg/kg bw/d 6.55 mg/kg bw/d 1.52 mg/kg bw/d % of normal 58.4 % 25.2 % 5.84 % dietary sulphur intake

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Appendix 4 Detailed evaluation of exposure and/or DFR studies relied upon (KCP 7.2, KCP 7.2.1.2, KCP 7.2.2.1, KCP 7.2.3.1)

Reference: KCP 7.2.1.2 Report Mich, G.; 1996; Operator exposure in greenhouses during practical use of plant protection products. Report No. EF 94-02-03, Doc. No. M-024096-01, June 6, 1996; ECON GmbH Ingelheim, conducted in Germany, Dates of work July, 1994 – June, 1996, TOX2000-2081 Guidelines: Following the OECD guidance document for the conduct of studies of occupational exposure to pesticides during agricultural application, Series on Testing and Assessment No. 9, 1997 GLP: Yes (certified laboratory) Acceptability: The study is considered to be acceptable.

Materials and methods To elucidate the potential of operator’s exposure by application of plant protection products in greenhouses an exposure study was performed. Dermal and inhalation exposure were measured using the patch technique (passive dosimetry technique), by analysis of whole body underwear, glove and hand rinsing and absorbent air filters during mixing/loading. The following plant protection products were applied on ornamentals at 2 sites in Germany: the wettable powder fungicide Euparen WP 50 (a.s. dichlofluanid), the insecticide Rody (a.s. fenpropathrin) and the fungicide Saprol Neu (a.s. triforine) (both emulsifiable concentrates). Twelve experienced operators were monitored. The products were applied with conventionally used knapsack sprayers at recommended rates. All analytical methods were validated for the various matrixes in a wide range of concentrations.

Samples were extracted for analysis followed by gas chromatographic determination. The results of the measurements are reported as determined (i.e. µg active substance per sample) and as specific exposure values, i.e. as mg of exposure per kg of active substance handled. The latter facilitates the use of the data for generic purposes. Samples were analysed for each of the 3 active substances.

The following scenarios were investigated: a) mixing and loading Euparen WP 50 for hydraulic knapsack sprayers, b) application using knapsack sprayers to low cultures on tables, c) application using knapsack sprayers to high cultures, d) airborne concentrations after application.

The test substances Euparen WP 50, Rody and Saprol Neu were applied in 4 greenhouses in the low crop scenario. 4 trials were performed in each house. The treated plants (hibiscus, cyclamen, anturium and scutelarium) had a height of 10-25 cm (+ 1.15 m table height). In the high crop scenario the test substances Euparen WP 50, Rody and Saprol Neu were applied in 3 greenhouses. Again 4 trials were performed in each house. In this scenario roses were treated. They covered a height from 1.2-1.75 metres.

Results and discussion All data were evaluated according to Lundehn et al., 1992 (TOX2003-430, German Model). For the calculation of exposure recorded values below limit of quantification were calculated as half the limit of quantification. Results of geometric mean exposure during application for the three scenarios are given below.

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Table A 14: Specific exposure during knapsack application in greenhouse low crops Route of exposure during application in low crops Exposure [mg/kg a.s. handled] Actual Potential Dermal (head) 0.43926 0.43926 Dermal (hands) 0.00894 0.7357 Dermal (body) 0.22265 6.31994 Inhalation 0.39849 0.39849

Table A 15: Specific exposure during knapsack application in greenhouse high crops Route of exposure during application in high crops Exposure (mg/kg a.s. handled) Actual Potential Dermal (head) 1.56194 1.56194 Dermal (hands) 0.00746 13.1884 Dermal (body) 0.22789 82.47509 Inhalation 0.10841 0.10841

Conclusions of zRMS The study provides appropriate data for hand held scenarios in greenhouses. Application data may be used for generic purposes. Mixing/loading data are available for one wettable powder preparation (WP) only. However, it should be considered that the process of mixing/loading for both indoor and outdoor applications is comparable. Therefore, generic exposure estimates for mixing/loading can be taken from other models.

Page 26 / 26 REGISTRATION REPORT Part B Section 7 Metabolism and Residues Detailed summary of the risk assessment

Product code: Helioterpen Soufre Product name(s): Helioterpen Schwefel Chemical active substance: Sulphur 700 g/L

Interzonal (greenhouse) Zonal Rapporteur Member State: Germany

CORE ASSESSMENT Germany (new authorisation)

Applicant: ACTION PIN Submission date: 22/03/2017

MS Finalisation date: 10.10.2019 Helioterpen Sourfe / Helioterpen Schwefel (ZV1 008989-00/00) Page 2 /4 Part A - National Assessment Template for chemical PPP MS version Version April 2015 Version history

When What

Helioterpen Sourfe / Helioterpen Schwefel (ZV1 008989-00/00) Page 3 /4 Part A - National Assessment Template for chemical PPP MS version Version April 2015 Table of Contents

7 Metabolism and residue data (KCA section 6) ...... 4 7.1 Summary and zRMS Conclusion ...... 4

Helioterpen Sourfe / Helioterpen Schwefel (ZV1 008989-00/00) Page 4 /4 Part A - National Assessment Template for chemical PPP MS version Version April 2015

7 Metabolism and residue data (KCA section 6)

7.1 Summary and zRMS Conclusion

DRAFT REGISTRATION REPORT Part B Section 8 Environmental Fate Detailed summary of the risk assessment

Product code: ZV1 008989-00/00 Product name: Helioterpen Soufre Country-specific Product names: Helioterpen Schwefel (Germany/Austria), Helioterpen Sou- fre/Helioterpen Zwavel (Belgium), Helioterpen Zwavel (the Netherlands), Helioterpen Soufre (Luxembourg), Helioterpen Síra (Czech Republic) Chemical active substance: sulfur 700 g/L

Central Zone Zonal Rapporteur Member State: Germany

CORE ASSESSMENT zRMS version (authorisation)

Applicant: Action Pin Submission date: March 2017 MS Finalisation date: 13/12/2018 ZV1 008989-00/00 / Helioterpen Soufre Page 2 / 25 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

ZV1 008989-00/00 / Helioterpen Soufre Page 3 / 25 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Version history

When What

02/12/2016 Initial version by applicant 12/2018 assessment by zRMS DE (UBA) based on draft documents by applicant

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Table of Contents

8 Fate and behaviour in the environment (KCP 9) ...... 5 8.1 Critical GAP and overall conclusions ...... 6 8.1.1 Table of critical GAPs ...... 6 8.1.2 Overall conclusion ...... 9 8.1.3 Grouping of intended uses for risk assessment ...... 9 8.2 Metabolites considered in the assessment ...... 10 8.3 Rate of degradation in soil (KCP 9.1.1) ...... 11 8.3.1 Aerobic degradation in soil (KCP 9.1.1.1) ...... 11 8.3.1.1 Sulfur ...... 11 8.3.2 Anaerobic degradation in soil (KCP 9.1.1.1) ...... 12 8.4 Field studies (KCP 9.1.1.2) ...... 12 8.4.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1) . 12 8.4.1.1 Sulfur and sulfate ...... 12 8.4.2 Soil accumulation testing (KCP 9.1.1.2.2) ...... 12 8.5 Mobility in soil (KCP 9.1.2) ...... 12 8.5.1 Adsorption and desorption in soil (KCP 9.1.2.1) ...... 13 8.5.1.1 Sulfur and sulfate ...... 13 8.5.2 Column leaching (KCP 9.1.2.1) ...... 13 8.5.3 Lysimeter studies (KCP 9.1.2.2) ...... 13 8.5.4 Field leaching studies (KCP 9.1.2.3) ...... 14 8.6 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1, KCP 9.2.2, KCP 9.2.3) ...... 15 8.6.1 Water/sediment study (KCP 9.2.2) ...... 15 8.6.1.1 Sulfur ...... 15 8.7 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3) ...... 15 8.7.1 Justification of new endpoints ...... 15 8.7.2 Active substance and relevant metabolite(s) ...... 15 8.7.2.1 PECsoil ...... 16 8.8 Predicted Environmental Concentrations in groundwater (PECgw) (KCP 9.2.4.1) ...... 18 8.8.1 Justification of new endpoints ...... 18 8.8.2 Active substance and degradation products (KCP 9.2.4.1) ...... 18 8.8.3 Additional field test (KCP 9.2.4.2) ...... 19 8.8.4 Summary of the risk assessment for groundwater ...... 19 8.9 Predicted Environmental Concentrations in surface water (PECsw/PECsed) (KCP 9.2.5) ...... 20 8.9.1 Justification of new endpoints ...... 21 8.9.2 Active substance, relevant metabolite(s) and the formulation (KCP 9.2.5) 21 8.9.2.1 Sulfur and its metabolites ...... 21 8.9.2.2 PECsw/sed of formulation ...... 23 8.10 Fate and behaviour in air (KCP 9.3, KCP 9.3.1) ...... 23

Appendix 1 Lists of data considered in support of the evaluation ...... 24

Appendix 2 Detailed evaluation of the new Annex II studies ...... 25

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8 Fate and behaviour in the environment (KCP 9)

General comment zRMS Germany as zRMS has reviewed this document as part of the application for authorisation of the product Helioterpen Soufre in accordance with article 33 of Regulation (EC) No 1107/2009. Austria, Belgium, the Netherlands, Luxembourg, and the Czech Republic are concerned Member States. This document provides the results of the fate and exposure and groundwater risk assessment of the above-mentioned product in the intended uses according to the application submitted by the applicant Action Pin. It is based on the content of the dossier originally submitted by the applicant. To ensure consistency with previous evaluations of sulfur-containing products by Germany and by other Member States acting as zRMS in the Central Zone, the description of the assessment was re-written by the zRMS and calculations amended where appropriate. Insofar, the descriptive text, the exposure calculations and the groundwater risk assessment all reflect the position of the zRMS.

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8.1 Critical GAP and overall conclusions

8.1.1 Table of critical GAPs

Table 8.1-1: Critical use pattern of the formulated product

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Use- Member Crop and/or situ- F, Fn, Pests or Group of pests Application Application rate PHI Remarks: Conclusion No. state(s) ation Fpn controlled (days) e.g. g saf- * (crop destination G, (additionally: develop- Method / Kind Timing / Max. number Min. interval kg or L g or kg as/ha Water L/ha ener/ syner- Groundwater / purpose of Gn, mental stages of the Growth a) per use between ap- product/ha min/max gist per ha crop) Gpn pest or pest group) stage of crop b) per crop/ plications a) max. rate a) max. rate or & season season (days) per appl. per appl. I ** b) max. total b) max. total rate per rate per crop/season crop/season 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) 00- DE Cucumber (Cu- G Sphaerotheca fuligi-nea Foliar spray All stages a) 6 7 a) 3 L/ha a) 2.1 kg/ha 300 / 1000 3 Dose rate 001 cumis sativitus (SPHRFU) b) 6 b) 18 L/ha b) 12.6 kg/ha and applica- (CUMSA) tion volume vary with crop height <50 cm: 0.85 L/ha (max. spray volume: 600 L/ha) 50-125 cm: 1.4 L/ha (max. spray volume: 900 L/ha) >125 cm: 1.7 L/ha (max. spray volume: 1200 L/ha) 00- BE, NL, Cucumber (Cu- G Sphaerotheca fuligi-nea Foliar spray All stages a) 6 7 a) 3 L/ha a) 2.1 kg/ha 300 / 1000 3 Correspond- 001 LU, AT, cumis sativitus (SPHRFU) b) 6 b) 18 L/ha b) 12.6 kg/ha ing to CZ (CUMSA) LWA: 5.7 ZV1 008989-00/00 / Helioterpen Soufre Page 7 / 25 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

L/ha LWA L product/hL (min- max): 0.3 L/hL – 1L/hL Assump- tions1 00- DE Cucumber (Cu- G Erysiphe cichoracea- Foliar spray All stages a) 6 7 a) 3 L/ha a) 2.1 kg/ha 300 / 1000 3 Dose rate 002 cumis sativitus rum (ERYSCI) b) 6 b) 18 L/ha b) 12.6 kg/ha and applica- (CUMSA) tion volume vary with crop height <50 cm : 0.85 L/ha (max spray volume : 600 L/ha) 50-125 cm : 1.4 L/ha (max spray volume : 900 L/ha) >125 cm : 1.7 L/ha (max spray volume : 1200 L/ha 00- BE, NL, Cucumber (Cu- G Erysiphe cichoracea- Foliar spray All stages a) 6 7 a) 3 L/ha a) 2.1 kg/ha 300 / 1000 3 Correspond- 002 LU, AT, cumis sativitus rum (ERYSCI) b) 6 b) 18 L/ha b) 12.6 kg/ha ing to CZ (CUMSA) LWA: 5.7 L/ha LWA L product/hL (min- max): 0.3 L/hL – 1L/hL Assump- tions1

* 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

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A Safe use R Further refinement and/or risk mitigation measures required C To be confirmed by cMS N No safe use

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8.1.2 Overall conclusion

Sulfur applied to soil in amounts of the intended use as plant protection procuct is not of concern for the contamination of groundwater. High adsorption of elementary sulfur to soil and a fast degradation in soil due to oxidative or reductive processes are expected to occur. There is no need for leaching calculations for the active substance sulfur and a risk for groundwater contamination is negligible.

For the inorganic degradation product sulfate of the active substance sulfur concentrations between 3.9 and 22 mg/L in groundwater were estimated with the worst case flux method for all FOCUS groundwater scenarios for the intended uses 00-001 and 00-002 of Helioterperpen Soufre in cucumbers.

This conservative PECGW calculation gave evidence, that the concentrations of sulfate in groundwater is lower than the limit value of 250 mg/L for drinking water (Directive 98/83/CE). In conclusion, no risk for groundwater occurs from the use of Helioterpen Soufre in cucumbers.

8.1.3 Grouping of intended uses for risk assessment

The following table documents the intended uses 00-001 and 00-002, which are fully equivalent with regard to environmental exposure of and possible effects on non-target organisms. Hence, no grouping of the intended uses to support application of the risk envelope approach (according to SANCO/11244/2011) is necessary, since the same risk assessment is applicable for both uses.

Table 8.1-2: Critical use pattern of Helioterpen Soufre grouped according to soil

Grouping according to soil

Group Intended uses Application rate (g/ha) applic. rate, cumulative Soil-relevant effective (interception, %) (g as/ha) applic. rate, cumulative (g as/ha) -/- 00-001, 00-002 6 x, 7 d, spring-autumn sulfur: sulfur: 1.-3. 25 %, 6 x 2100 1.-3. 1575 4.-6. 50 % = 12600 4.-6. 1050 = 7875

Table 8.1-3: Critical use pattern of Helioterpen Soufre grouped according to spray drift

Grouping according to spray drift

Group Intended uses Application rate (g/ha) (interval, d) Drift scenario -/- 00-001, 00-002 2100, (7) No drift

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8.2 Metabolites considered in the assessment

Metabolites of sulfur Elemental sulfur occurs abundantly in nature, and it is constantly exposed to all the three environmental compartments (soil, water, air). It is stable under sterile conditions, but readily undergoes degradation through oxidative or reductive processes under aerobic or anaerobic conditions by specific microbial or- 2- - ganisms to sulfate ions (SO4 ) or sulfites (-S ), respectively, both of which in turn are abundant in nature. These processes will also govern the fate of sulfur added as a fungicide to the same environment. (EFSA Scientific Report 2008, 221, p. 15). The degradation product sulfate of sulfur occuring in the environment and requiring further assessment according to the results of the assessment of sulfur for EU approval is summarized in Table 8.2-1.

Potential groundwater contamination by the soil degradation product sulfate was evaluated for EU approval 2- of sulfur. It was discussed during the EU assessment, that the oxidation product (sulfate, SO4 ) can interact with soil surfaces by anion adsorption. The movement of sulfate is influenced by anion exchange capacity, solution sulfate concentration, pH, competition with other anions, notably phosphate, calcium addition (co- precipitation) and moisture content (EFSA Scientific Report 2008, 221, p. 16).

PECgw modelled using the flux method during the EU risk assessment (EU-LoEP) was less than 100 mg/L for the degradation product sulfate in all 7 scenarios based on an application of 30000 g as/ha in grapes. However, the leaching potential into groundwater of sulfate will be assessed for the application of the plant protection product and its intended uses.

Table 8.2-1: Metabolites of sulfur potentially relevant for exposure assessment

Degradation Molar mass Chemical structure Maximum observed oc- Exposure assessment product (g/mol) currence in compartments required due to

2- Sulfate 96.06 S04 Quantitative data not PECgw: leaching available and not applicable potential to groundwater

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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 Aerobic degradation in soil (KCP 9.1.1.1)

8.3.1.1 Sulfur

No new studies have been submitted regarding route and rate of degradation in soil of sulfur.

Sulfur is a component of the environment, and there is a natural cycle of oxidation and reduction reactions, which transforms sulfur into both organic and inorganic products. A description of the environmental fate and behaviour of sulfur in soil, based on literature review, was provided by the applicants and summarised in the EU-DAR (2007). This general introduction provided an overview of the processes (chemical and biological transformation, oxidation-reduction) that govern the behaviour of naturally occurring sulfur in the environment, in view of the fact that these processes will also govern the fate of sulfur added as a fungicide to the same environment. Elemental sulfur is known to enter the sulfur cycle immediately after application, i.e. elemental sulfur is transformed by micro-organisms into various stages of oxidation (e.g. sulfate and sulfite), which are soluble and thus made available for uptake by plants and animals. This is an active uptake process, since sulfur is an essential element required for maintaining crucial life functions. (EFSA Scientific Report 2008, 221, p. 15)

The rate of oxidation of elemental sulfur is the process that determines the rate, at which sulfate is available to plants. Oxidation is preceded by a short incubation period allowing the formulated granules to absorb moisture from the soil, and then disintegrate to release sulfur. Oxidation then proceeds quickly and smoothly, the kinetics being a function of temperature, soil pH, organic content of soil, and particle size of elemental sulfur. It has been shown on published literature during the EU assessment that the oxidation rate of sulfur increases with the particle size of the elemental sulfur used, and with temperature. The view of the Member State experts was that because of the complexity of the laboratory studies, including the lack of information on the method of calculation of the oxidation rates, the results of these studies should not be used quantitatively (i.e. derived “DT50”) in the exposure assessment. It was also agreed that taking into account the natural background concentration of sulfur in the top 15 cm layer of agricultural soils of 50- 1000 mg S/kg soil, reliable halflife values for elemental sulfur are not necessary to finalise the risk assessment. Sulfur is not expected to be persistent in elemental form, and therefore no accumulation of elemental sulfur is anticipated. (EFSA Scientific Report 2008, 221, p. 15f) The same conclusion can be applied to the oxidation product sulfate (see Table 8.3-1).

The application of elemental sulfur and its oxidation and chemical reaction in the soil causes soil acidification. It is normally advised to counteract soil acidification by liming in order to preserve the typical soil pH values. This should be a common practice especially in permanent crops, where sulfur is typically added in elemental form every year over a long time period.

Table 8.3-1: Summary of aerobic degradation rates for sulfur and sulfate

Aerobic degradation Outcome of the EU Assessment DT50 (d)

Sulfur Not applicable to an active substance that is a mineral.

Not necessary for risk assessment in the light of natural background concentration of sulfur in the top soil layer of agricultural soils (50-1000 mg S/kg).

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Aerobic degradation Outcome of the EU Assessment DT50 (d)

Results of the provided degradation studies during EU assessment should not be used quantitatively because of the complexity of the laboratory studies and the lack of information on the method of calculation of the oxidation rates. Sulfate Not applicable to an an inorganic oxidation product of a natural mineral.

Not necessary for risk assessment in the light of natural background concentration of sulfur ans sulfate in agricultural soils.

8.3.2 Anaerobic degradation in soil (KCP 9.1.1.1)

Not relevant for assessment.

8.4 Field studies (KCP 9.1.1.2)

8.4.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1)

8.4.1.1 Sulfur and sulfate

Field dissipation rates of sulfur were evaluated during EU assessment. The only available field experiment from published literature was conducted on a soil site in New Zealand. Because climatic conditions and the nature of the soil are not representative of European conditions, the results from the study are not useful for risk assessment in Europe (see Vol. 3, B.8, Corrigendum 2 from december 2008). No additional studies have been performed.

Finally, it was agreed during the EU assessment that taking into account the natural background concentration of sulfur in the top soil layer of agricultural soils, reliable halflife values for elemental sulfur are not necessary to finalise the risk assessment. Sulfur is not expected to be persistent in elemental form, and therefore no accumulation of elemental sulfur is anticipated. (EFSA Scientific Report 2008, 221, p. 15f).

8.4.2 Soil accumulation testing (KCP 9.1.1.2.2)

No data available, not required.

8.5 Mobility in soil (KCP 9.1.2)

Studies on mobility in soil with the formulation were not performed, since it is possible to extrapolate from data obtained with the active substance. ZV1 008989-00/00 / Helioterpen Soufre Page 13 /25 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.5.1 Adsorption and desorption in soil (KCP 9.1.2.1)

8.5.1.1 Sulfur and sulfate

Elemental sulfur is not adsorbed to soil surfaces by the normal electrostatic forces common to other chem- 2- ical pesticides. However, the oxidation product (sulfate, SO4 ) can interact with soil surfaces by anion adsorption. The movement of sulfate is influenced by anion exchange capacity, solution sulfate concentration, pH, competition with other anions, notably phosphate, calcium addition (co-precipitation) and moisture content. (EFSA Scientific Report 2008, 221, p. 16)

No new studies have been submitted regarding adsorption/desorption in soil of sulfur. The exposure mod- eling is based on the most conservative EU Koc value of 1950 mL/g, which was estimated from Kow and water solubility of sulfur, as summarized in the table below.

The pH dependency of the adsorption of sulfur in soil might be relevant, but could not be discovered based on the available data.

Table 8.5-1: Summary of soil adsorption/desorption for sulfur

Soil name/soil type OC pH KF KFoc 1/n Reference

(%) (H2O, (mL/g) (mL/g) (-) CaCl2)

EU-RMS calculation -/- -/- -/- 1950 1.0 EFSA Scientific Report (2008)

Further data about the adsorption of the oxidation product of elementary sulfur in soil, i.e. the sulfate ions 2- (SO4 ), is considered to be unnecessary, because sulfate ions occur predominantly in natural soil and are 2- thereafter incorporated in the natural sulfate ion pool. Based on observation made on lysimeters, SO4 can be considered as poorly adsorbed to soil. (Vol. 3, B.8, Corrigendum 2, December 2008, p. 501). Therefore, a conservative approach considering no adsorption is provided in section 8.8 to finalise the risk assessment of sulfate ions for groundwater from the intended uses of Helioterpen Soufre in cucumbers.

8.5.2 Column leaching (KCP 9.1.2.1)

No data, not required for assessment.

8.5.3 Lysimeter studies (KCP 9.1.2.2)

Two lysimeter studies conducted in California, USA (Jones et al. 1968) and England, UK (Riley et al. 2002) were available during EU assessment both with application rates more than 50 kg S/ha. Results from both studies cannot be quantitatively used for risk assessment, because application rates are to high compared with the intended fungicide uses of sulfur. Beside, the soil conditions from two soils from the US lysimeter study are not conservative in the light of chromatical soil water fluxes and climate conditions in California may vary from European conditions. Finally, only the lysimeter study conducted in UK was accepted during the EU assessment as additional information.

In the UK lysimeter study (Riley et al. 2002), a sandy loam soil was treated with bentonite/elemental sulfur mixture, micronized elemental sulfur, and ammonium sulfate applied in the solid form to the soil surface at 50 kg/ha. Additionally, atmospheric deposition of sulfur varied between 6.7-7.8 kg a.s./ha/year. The average annual rainfall for the three years was 615 mm. Results indicated that sulfate was highly mobile and prone to leaching under the experimental conditions, whereas the slow release characteristics of elemental sulfur led to smaller leaching losses (EFSA Scientific Report 2008, 221, p. 16). ZV1 008989-00/00 / Helioterpen Soufre Page 14 /25 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.5.4 Field leaching studies (KCP 9.1.2.3)

No data available from EU assessment of sulfur.

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8.6 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1, KCP 9.2.2, KCP 9.2.3)

Studies on degradation in water/sediment systems with the formulation were not performed, since it is possible to extrapolate from data obtained with the active substance.

8.6.1 Water/sediment study (KCP 9.2.2)

8.6.1.1 Sulfur

No new water/sediment study has been submitted. The exposure modelling is based on the outcome of the EU assessment.

No water/sediment study has been submitted during the EU assessment. There was agreement from the discussion between member states and EFSA that it was not necessary to require data to address the route and rate of degradation of sulfur in natural aquatic systems, because the cycle of sulfur in the environment is well understood (EFSA Scientific Report 2008, 221, p. 17). Beside, elemental sulfur occurs abundantly in nature, and it is constantly exposed to all the three environmental compartments (soil, water, air) (Vol.3, B.8, Corrigendum 2, 2008, p. 515).

Sulfur is insoluble in water (maximum water solubility: 63 µg/L). Sulfur is stable under sterile conditions, but readily undergoes degradation through oxidative or reductive processes under aerobic or anaerobic en- 2- - vironmental conditions by specific microbial organisms to sulfate ions (SO4 ) or sulfites (-S ), respectively, both of which in turn are abundant in nature (Vol.3, B.8, Corrigendum 2, 2008, p. 515). Sulfur, when entering an aquatic system, is expected to preferentially adsorb to sediment and will then be oxidized (EFSA Scientific Report 2008, 221, p. 17). An intermittent formation of sulfuric acid in the water phase is not expected, because oxidation of sulfur to sulfate occurs over a certain time period.

8.7 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3)

8.7.1 Justification of new endpoints

Not applicable as no EU agreed endpoints are available for the active substance sulfur.

8.7.2 Active substance and relevant metabolite(s)

Following the discussions from the PRAPeR Expert Meeting 57 in 2008, no valid DT50 could be determined from the available studies for the degradation of the the inorganic compound sulfur in soil, which could be used for exposure assessment. Considering the relatively high background levels of sulfur in agricultural soils (1 g/kg), it was further concluded that a DT50 for exposure assessment would not be required. Sulfur is not expected to be persistent in elemental form and therefore no accumulation of the elemental form is expected. It was agreed during the EU assessment that the initial PECsoil based on the maximum annual total dose of sulfur applied to soil would be appropriate for further risk assessment.

Table 8.7-1: Input parameters related to application for PECsoil calculations

Use No/use group 00-001, 00-002 Crop Cucumber Application rate (g as/ha) 2100 ZV1 008989-00/00 / Helioterpen Soufre Page 16 /25 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Number of applications/interval 6 / 7 d Number of applications 1. 2. 3. 4. 5. 6. Application rate (L product/ha) 3 3 3 3 3 3 Application rate (g as/ha) 2100 2100 2100 2100 2100 2100 Crop interception (%) 25 25 25 50 50 50 Application rate to soil (L product/ha) 2.25 2.25 2.25 1.5 1.5 1.5 Application rate to soil (g as/ha) 1575 1575 1575 1050 1050 1050 Application rate to soil in 1 year (L product/ha) 11.25 Density of formulation (kg/L) 0.7 Application rate to soil in 1 year (kg as/ha) 7.875

Depth of soil layer (relevant for plateau concentra- 5 (no tillage); PECsoil based on the maximum annual total tion) (cm) dose of sulfur applied, no plateau concentration calculated

Table 8.7-2: Input parameter for active substance and relevant metabolite(s) for PECsoil calculation

Compound Molecular weight Max. occurrence DT50 DT50 (g/mol) (%) (days) (days) EU endpoint updated endpoint

sulfur Not required - not available, not not applicable required for the inorganic compound

8.7.2.1 PECsoil

To achieve a concise exposure assessment, the risk envelope approach is usually applied. However, the intended uses 00 001 and 00 002 are fully equivalent with regard to environmental exposure. Hence, no grouping of the intended uses to support application of the risk envelope approach is necessary. (see 8.1.3).

PECsoil calculation is based on the maximum annual total dose of the intended uses of the active substance sulfur and the formulation Helioterpen Soufre in cucumbers. No PECtwa was calculated due to a missing reliable halflife for sulfur in soil. PECsoil calculations are further 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 were assumed. The PECsoil calculations were performed by zRMS with ESCAPE 2.0 based on the input parameters as presented in the tables below.

Table 8.7-3: PECsoil for Helioterpen Soufre in cucumbers according to use group/use No 00-001 and 00-002

Active Soil relevant PECact PECtwa21 d Tillage depth PECsoil,plateau PECaccu = PE- substance/ application (mg/kg) (mg/kg) (cm) (mg/kg) Cact + formulation rate (g/ha) PECsoil,plateau (mg/kg)

sulfur 7875 10.5 -/- -/- -/- -/- Helioterpen 11250 15.0 -/- -/- -/- -/- Soufre ZV1 008989-00/00 / Helioterpen Soufre Page 17 /25 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

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8.8 Predicted Environmental Concentrations in groundwater (PECgw) (KCP 9.2.4.1)

Groundwater contamination by direct leaching of the active substance and its metabolites, degradation or reaction products through soil is generally assessed by groundwater model calculations.

8.8.1 Justification of new endpoints

Not applicable as no new endpoints used.

8.8.2 Active substance and degradation products (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 FOCUS groundwater model calculations with standard FOCUS scenarios. However, it was decided during EU assessment, that standard FOCUS modelling would not lead to suitable results for inorganic compounds, e.g. sulfur and its degradation products. Ac- cording to the discussions occurred during the PRAPeR 57 Expert Meeting of October 2008, it was further considered that sulfur is not of concern for the contamination of groundwater, but that the risk of sulfate might be necessary to be assessed in this compartment.

According to the EU risk assessment, the PECs of sulfates in groundwater have been assessed with the worst case flux method (no degradation or adsorption are assumed) by the applicant considering a simulation period over 26 years (see Final Addendum 2008). In the flux method an oxidation of 100 % of sulfur 2- applied to soil to sulfates (SO4 ) and a 100 % of sulfates leaching to groundwater was considered. Accord- ing to the EU-DAR (2007), the calculations by the applicant were performed using the water volume percolated at 1 m soil depth determined for each FOCUS scenario for the crop cucumbers (sugar beet as surrogate crop). The zRMS followed this approach, but the PEC calculation was reduced to a 20 years instead of 26 years application period, because the first 6 years in the FOCUS models are used as warming up period for simulations only. Finally, the amounts of total sulfur and sulfate applied (see Table 8.8-1) and the water volume percolated (L/m2) for all scenarios available in FOCUS PELMO 4.4.3 for sugar beets (as surrogate crop for cucumber) were determined for a 20 years application period.

Both uses 00-001-and 00-002 of Helioterpen Soufre in cucumbers are intended for greenhouse uses, only. Because of missing guidance and scenarios for groundwater risk assessment in greenhouses, the standard assumptions from FOCUS modelling of field uses are considered as worst acse assumptions.

Table 8.8-1: Input parameters related to application of Helioterpen Soufre for PECgw calculations

Use No. 00-001, 00-002 Crop Cucumber (sugar beet as surrogate crop) Models used for calculation FOCUS PELMO 4.4.3 Number of applications/interval 6 / 7 d (d) Frequency of application annual Applications per season 1. 2. 3. 4. 5. 6. Application rate (g sulfur/ha) 2100 2100 2100 2100 2100 2100 Crop interception (%) 25 25 25 50 50 50 Application rate to soil 1575 1575 1575 1050 1050 1050 (g sulfur/ha) ZV1 008989-00/00 / Helioterpen Soufre Page 19 /25 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

Annual application rate 7.875 (kg sulfur/ha) Application rate in the simulation 157.5 period of 20 years (kg sulfur/ha) Application rate in the simulation 157.5 x 8 x (96.1/256.6) = 471.85 period of 20 years (kg sulfate/ha)

The PECGW was then calculated as:

2- 2- 6 4 PECGW SO4 = Total amount of SO4 x 10 / water volume for each groundwater scenario (C) x 10 = B x 102 / C

Table 8.8-2: Results of groundwater risk assessment for the degradation product sulfate

Sulfates (as degradation product of sulfur)

Crop Scenario Total amount of Water volume 2- SO4 in 20 years percolate, 20 years Maximum PECGW at 1 m soil depth (kg ha-1) (L m-2) (mg L-1) (B) (C)

Sugar beet (as surrogate Châteaudun 471.85 4763.27 9.9 for cucumber/ Hamburg 471.85 5707.40 8.3 00-001, 00-002 Jokioinen 471.85 5006.11 9.4 Kremsmünster 471.85 6205.09 7.6 Okehampton 471.85 9025.20 5.2 Piacenza 471.85 7795.00 6.1 Porto 471.85 12046.00 3.9 Sevilla 471.85 2731.20 17.3 Thiva 471.85 2141.57 22.0

According to the PECgw modelling with the worst case flux method a groundwater contamination of the inorganic degradation product sulfate at a concentration of ≥ 0.1 µg/L is expected for all nine FOCUS groundwater scenarios. Maximum PECGW between 3.9 and 22 mg/L are estimated for nine FOCUS scenarios for the use of Helioterpen Soufre in cucumbers.

Finally, the worst case PECGW estimation based on the flux method gave evidence, that the concentrations of sulfates in groundwater is lower than the limit value of 250 mg/L for drinking water (Directive 98/83/CE). In conclusion, no risk for groundwater occurs from the use of Helioterpen Soufre in cucumbers.

8.8.3 Additional field test (KCP 9.2.4.2)

See section 8.5.3.

8.8.4 Summary of the risk assessment for groundwater

Sulfur applied to soil in amounts of the intended use as plant protection procuct is not of concern for the contamination of groundwater. High adsorption of elementary sulfur to soil and a fast degradation in soil due to oxidative or reductive processes are expected to occur. There is no need for leaching calculations for ZV1 008989-00/00 / Helioterpen Soufre Page 20 /25 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015 the active substance sulfur and a risk for groundwater contamination is negligible.

This conservative PECGW estimation gave evidence, that the concentrations of sulfate in groundwater is lower than the limit value of 250 mg/L for drinking water (Directive 98/83/CE). In conclusion, no risk for groundwater occurs from the use of Helioterpen Soufre in cucumbers.

The degradation product sulfate of the active substance sulfur can be classified as not relevant for groundwater, because sulfate ions are a wide spreaded naturally compound in the environment.

8.9 Predicted Environmental Concentrations in surface water (PECsw/PECsed) (KCP 9.2.5)

Sulfur is slightly soluble in water with a maximum determined water solubility of 63 µg/L. It was discussed by the member states and EFSA during EU risk assessment, that the use of FOCUS modelling would not be appropriate for inorganic substances. And it was finally agreed to use the highest water solubility limit of 63 µg/L of sulfur as maximum value to estimate the PEC in the water phase (PECSW).

The entry of dissolved sulfur as active substance into adjacent ditches or streams via the pathways run-off and drainage is not expected to occur due to the high adsorption (minimum koc = 1950) of the elemental sulfur on organic and anorganic solid soil materials and due to its fast oxidation to sulfate. However, it could be expected that on solid material bound sulfur is washed out from fields via erosion (run-off) during strong rains and enters adjacent water bodies and will be finally deposited in the sediment and then it will be oxidized.

It was agreed by the member states and EFSA that the use of FOCUS modelling would not be appropriate for the risk assessment of inorganic substances, e.g. sulfur. However, it was further concluded that a conservative PECSED estimation should be performed based on the partition properties of sulfur, the maximum total annual dose, and taking into account the percentage values for drift and run-off/drainage entry routes as prescribed by FOCUS (EFSA Scientific Report 2008, 221, p. 17).

Therefore, a PECSED calculation is provided following the RMS approach in the revised Addendum for confirmatory data from April 2012 Vol. 3, B.8, p. 14ff, which considers the total annual dose of sulfur for the intended uses. Any sulfur specific parameters (water solubility, DT50, KOC) were not considered and two worst-case assumptions were defined: 100 % of drift entry of sulfur to the surface water body is deposited immediately to the sediment, and 100 % of sulfur entering the water body via run-off/erosion is pre- cipitated immediately to the sediment simultaneously with the drift entry event. Both PECs are finally summarized. Crop specific spray drift values from the program STEP 1 und STEP 2 have been taken into account. Interception values and specific run-off/erosion fractions have been selected according to STEP1 and STEP 2. No dilution factor was considered. The water/sediment system dimension is based on the FOCUS assumptions. The relevant input parameters used for PECSED calculation are summarised in Ta- ble 8.9-2.

It has to be taken into accout for national risk assessment, that the exposure of sulfur in surface water and sediment from both intended uses 00-001 and 00-002 of Helioterpen Soufre in cucumbers in greenhouses could be negligible. PECsw and PECSED , how they would be estimated for field uses, are still provided in this section, because a risk assessment for aquatic organism has been provided by the applicant. ZV1 008989-00/00 / Helioterpen Soufre Page 21 /25 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

8.9.1 Justification of new endpoints

Not applicable as no new endpoints used.

8.9.2 Active substance, relevant metabolite(s) and the formulation (KCP 9.2.5)

Table 8.9-1: Input parameters related to application for PECsed calculations

Use No./use group 00-001, 00-002 Crop cucumber (vegetable fruiting) Application rate (kg as/ha) sulfur: 12.6 kg as/ha / 6 applications per year with 2.1 kg as/ha cumulatively considered Number of applications/interval (d) 6 / 7 d Season of application (step 2) North Europe, Oct-Feb (as worst case assumption) Crop interception (step 2) minimal crop cover: 25 % Application method (step 3) -/- CAM (Chemical application method) Spraying Soil depth (cm) Models used for calculation STEP 1/ STEP 2

8.9.2.1 Sulfur and its metabolites

Table 8.9-2: Input parameters related to active substance sulfur for PECsed calculations

Values in accord- Endpoint used for Parameter ance to EU end- Remarks PECsw/sed calculation point in LoEP Active substance sulfur Molecular weight (g/mol) 32.064 yes not required for modelling Saturated vapour pressure 9.8 x 10-5 yes not required for modelling (Pa) Water solubility (µg/L) 63 yes

Koc (d) 1950 yes not used for modelling (total amount of sulfur added to the sediment)

DT50,soil (d) not available yes not required for modelling (total amount of sulfur added to the sediment)

DT50,water (d) not available yes not required for modelling (total amount of sulfur added to the sediment)

DT50,sediment (d) not available yes not required for modelling (annual rate of sulfur as single application assumed) ZV1 008989-00/00 / Helioterpen Soufre Page 22 /25 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

DT50,whole system (d) not available yes not required for modelling (annual rate of sulfur as single application assumed)

Table 8.9-3: Percentages of drift and run-off/erosion entry into adjacent water/sediment system used in the PECSED calculation

Run-off/erosion Distance of edge of Drift values field to adjacent values Group (STEP 1 / STEP 2) Use No. Crop water body (STEP 1 / STEP 2) Dseq (STEP 1 / STEP 2) (%) (%) (m)

10.0 / 5.0 00-001, vegetable, (North EU, Oct-Feb., -/- 1 2.8 / 2.8 00-002 fruiting as worst case for run- off, drainage)

Table 8.9-4: Standard assumptions for the water/sediment system considered in FOCUS

Parameter Value

Ratio of field:water body (-) 10 Water depth (cm) 30 Sediment depth (cm) 5 Sediment bulk density (g/ml) 0.8

PECsw/sed-FOCUS SW Step 1, 2

Table 8.9-5: FOCUS Step 1 PECsed for sulfur following maximum annual application rate of Helioterpen Soufre in cucumber (use No: 00-001, 00-002)

STEP 1: PECSED sulfur

Scenario PECSED (via spraydrift, run-off/erosion) (mg/kg)

total amount interception sulfur load via sulfur load PECSED PECSED Total PECSED of sulfur – – runoff, spray drift via runoff, via spray drift via runoff, via spraydrift, spray drift/ drainage draiange drainage runoff, drainage runoff, (%) (mg/m2) drainage

(kg as/ha/y) (%) (mg/m2) (mg as/kg) (mg as/kg) (mg as/kg) A/B A B A B A+B 12.6 0 35.28 1260 0.88 31.50 32.38

Table 8.9-6: FOCUS Step 2 PECsed for sulfur following maximum annual application rate of Helioterpen Soufre in cucumber (use No: 00-001, 00-002)

STEP 2: PECSED sulfur

Scenario PECSED (via spraydrift, run-off/erosion) (mg/kg) ZV1 008989-00/00 / Helioterpen Soufre Page 23 /25 Part B – Section 8 - Core Assessment Template for chemical PPP zRMS version Version April 2015

(kg as/ha/y) (%) (mg/m2) (mg as/kg) (mg as/kg) (mg as/kg) A/B A B A B A+B 12.6 25 35.28 472.5 0.88 11.81 12.69

Metabolite(s) of sulfur Not required.

8.9.2.2 PECsw/sed of formulation

Not relevant.

8.10 Fate and behaviour in air (KCP 9.3, KCP 9.3.1)

Elemental sulfur from Helioterpen Soufre is classified as semivolatile, because a vapour pressure between 10-5 and 10-4 Pa (9.8 x 10-5 Pa) was measured at 20 °C. Therefore, a volatilisation of the active substance from plant surfaces into the air can be expected. As a consequence, exposure of adjacent surface waters and terrestrial ecosystems by the active substance sulfur due to volatilization with subsequent deposition should be normally considered, for example by using the program EVA 2.1. However, it is highly questionable, if the deposition rate of the elemental sulfur to adjacent surface water bodies is comparable to measured values from studies with organic pesticides, which are usually used in the EVA 2.1. The deposition rate for elemental sulfur might be quite low under field conditions and the pathway via volatilization and deposition to adjacent water bodies seems negligible.

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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 No data.

List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review No data.

List of data submitted by the applicant and not relied on No data.

List of data relied on not submitted by the applicant but necessary for evaluation No additional data required. ZV1 008989-00/00 / Helioterpen Soufre Page 25 /25 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

No additional studies was performed for this section in Helioterpen Soufre.

DRAFT REGISTRATION REPORT Part B Section 9 Ecotoxicology Detailed summary of the risk assessment

Interzonal Zonal Rapporteur Member State: Germany

Core Assessment zRMS version (authorisation) Page 2 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Applicant: Action Pin Submission date: March 2017 MS Finalisation date: 13/12/2018 Page 3 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Version history

When What

02/12/2016 Initial version by applicant 12/2018 assessment by zRMS DE (UBA) based on draft documents by applicant

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Table of Contents

9 Ecotoxicology (KCP 10) ...... 7 9.1 Critical GAP and overall conclusions ...... 8 9.1.1 Overall conclusions ...... 11 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) ...... 11 9.1.1.2 Effects on aquatic organisms (KCP 10.2) ...... 11 9.1.1.3 Effects on bees (KCP 10.3.1) ...... 11 9.1.1.4 Effects on arthropods other than bees (KCP 10.3.2) ...... 11 9.1.1.5 Effects on non-target soil meso- and macrofauna (KCP 10.4), Effects on soil microbial activity (KCP 10.5) ...... 12 9.1.1.6 Effects on non-target terrestrial plants (KCP 10.6) ...... 12 9.1.1.7 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ...... 12 9.1.2 Grouping of intended uses for risk assessment ...... 12 9.1.3 Consideration of metabolites ...... 13 9.2 Effects on birds (KCP 10.1.1) ...... 13 9.2.1 Toxicity data ...... 13 9.2.1.1 Justification for new endpoints ...... 13 9.2.2 Risk assessment for spray applications ...... 13 9.2.2.1 First-tier assessment (screening/generic focal species) ...... 14 9.2.2.2 Higher-tier risk assessment ...... 14 9.2.2.3 Drinking water exposure ...... 14 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) ...... 15 9.3.1 Toxicity data ...... 15 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 ...... 15 9.3.2.3 Drinking water exposure ...... 15 9.3.2.4 Effects of secondary poisoning ...... 16 9.3.2.5 Biomagnification in terrestrial food chains ...... 16 9.3.3 Risk assessment for baits, pellets, granules, prills or treated seed ...... 16 9.3.4 Overall conclusions ...... 16 9.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3) ...... 16 9.5 Effects on aquatic organisms (KCP 10.2) ...... 16 9.5.1 Toxicity data ...... 16 9.5.1.1 Justification for new endpoints ...... 18 9.5.2 Risk assessment ...... 18 9.5.3 Overall conclusions ...... 19 9.6 Effects on bees (KCP 10.3.1) ...... 19 Page 5 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

9.6.1 Toxicity data ...... 20 9.6.1.1 Justification for new endpoints ...... 21 9.6.2 Risk assessment ...... 21 9.6.2.1 Hazard quotients for bees ...... 21 9.6.2.2 Higher-tier risk assessment for bees (tunnel test, field studies) ...... 21 9.6.3 Effects on bumble bees ...... 21 9.6.4 Effects on solitary bees ...... 21 9.6.5 Overall conclusions ...... 21 9.7 Effects on arthropods other than bees (KCP 10.3.2) ...... 22 9.7.1 Toxicity data ...... 22 9.7.1.1 Justification for new endpoints ...... 25 9.7.2 Risk assessment ...... 25 9.7.2.1 Risk assessment for in-field exposure ...... 25 9.7.2.2 Risk assessment for off-field exposure ...... 26 9.7.2.3 Additional higher-tier risk assessment ...... 27 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 ...... 33 9.10.2.1 Tier-1 risk assessment (based on screening data) ...... 33 9.10.2.2 Tier-2 risk assessment (based on dose-response data) ...... 33 9.10.2.3 Higher-tier risk assessment ...... 33 9.10.2.4 Risk mitigation measures ...... 33 9.10.3 Overall conclusions ...... 33 9.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ...... 34 9.12 Monitoring data (KCP 10.8) ...... 34 9.13 Classification and Labelling ...... 34

Appendix 1 Lists of data considered in support of the evaluation ...... 35

Appendix 2 Detailed evaluation of the new studies ...... 51 A 2.1 KCP 10.1 Effects on birds and other terrestrial vertebrates ...... 51 A 2.1.1 KCP 10.1.1 Effects on birds ...... 51 Page 6 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

A 2.1.2 KCP 10.1.2 Effects on terrestrial vertebrates other than birds ...... 51 A 2.1.3 KCP 10.1.3 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) ...... 51 A 2.2 KCP 10.2 Effects on aquatic organisms ...... 51 A 2.2.1 KCP 10.2.1 Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes ...... 51 A 2.2.2 KCP 10.2.2 Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms ...... 57 A 2.2.3 KCP 10.2.3 Further testing on aquatic organisms ...... 57 A 2.3 KCP 10.3 Effects on arthropods ...... 57 A 2.3.1 KCP 10.3.1 Effects on bees ...... 57 A 2.3.2 KCP 10.3.2 Effects on non-target arthropods other than bees ...... 60 A 2.4 KCP 10.4 Effects on non-target soil meso- and macrofauna ...... 61 A 2.4.1 KCP 10.4.1 Earthworms ...... 61 A 2.4.2 KCP 10.4.2 Effects on non-target soil meso- and macrofauna (other than earthworms) ...... 61 A 2.5 KCP 10.5 Effects on soil nitrogen transformation ...... 61 A 2.6 KCP 10.6 Effects on terrestrial non-target higher plants ...... 61 A 2.6.1 KCP 10.6.1 Summary of screening data ...... 61 A 2.6.2 KCP 10.6.2 Testing on non-target plants ...... 61 A 2.6.3 KCP 10.6.3 Extended laboratory studies on non-target plants ...... 61 A 2.6.4 KCP 10.6.4 Semi-field and field tests on non-target plants ...... 61 A 2.7 KCP 10.7 Effects on other terrestrial organisms (flora and fauna) ...... 61 A 2.8 KCP 10.8 Monitoring data ...... 61

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9 Ecotoxicology (KCP 10)

General comment zRMS Germany as zRMS has reviewed this document as part of the application for authorisation of the product Helioterpen Soufre in accordance with article 33 of Regulation (EC) No 1107/2009. Austria, Belgium, the Netherlands, Luxembourg, and the Czech Republic are concerned Member States. This document provides the results of the exposure and risk assessment of the above-mentioned product in the intended uses according to the application submitted by the applicant Action Pin. It is based on the content of the dossier originally submitted by the applicant. To ensure consistency with previous evaluations of sulfur-containing products by Germany and by other Member States acting as zRMS in the Central Zone, the description of the risk assessment was re-written by the zRMS and calculations amended where appropriate. Insofar, the descriptive text, the calculations of risk quotients and the conclusions for each part of the assessment all reflect the position of the zRMS.

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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 sit- F, Pests or Group of Application Application rate PHI Remarks: Conclusion

No. state(s) uation Fn, pests controlled (days) e.g. g safener/ * (crop destination Fpn (additionally: devel- Method / Timing / Max. num- Min. inter- kg or L g or kg Water synergist per ha / purpose of G, opmental stages of the Kind Growth ber val between product/ha as/ha L/ha

crop) Gn, pest or pest group) stage of a) per use applications a) max. rate min/max Gpn crop & sea- b) per crop/ (days) per appl. a) max. rate or son season b) max. to- per appl. tal rate per b) max. to- I **

crop/season tal rate per arthropods -target plants -target

crop/season Mammals Birds organisms Aquatic Bees organisms Soil Non Non 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) 00- DE Cucumber (Cu- G Sphaerotheca fuligi- Foliar spray All stages a) 6 7 a) 3 L/ha a) 2.1 kg/ha 300 / 1000 3 Dose rate and 001 cumis sativitus nea (SPHRFU) b) 6 b) 18 L/ha b) 12.6 application vol- (CUMSA) kg/ha ume vary with crop height <50 cm: 0.85 L/ha (max. spray volume: 600 L/ha) 50-125 cm: 1.4 L/ha (max. spray volume: 900 L/ha) >125 cm: 1.7 L/ha (max. spray volume: 1200 L/ha) Page 9 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 00- BE, NL, Cucumber (Cu- G Sphaerotheca fuligi- Foliar spray All stages a) 6 7 a) 3 L/ha a) 2.1 kg/ha 300 / 1000 3 Corresponding 001 LU, AT, cumis sativitus nea (SPHRFU) b) 6 b) 18 L/ha b) 12.6 to CZ (CUMSA) kg/ha LWA: 5.7 L/ha LWA L product/hL (min- max): 0.3 L/hL – 1L/hL Assumptions1 00- DE Cucumber (Cu- G Erysiphe cichoracea- Foliar spray All stages a) 6 7 a) 3 L/ha a) 2.1 kg/ha 300 / 1000 3 Dose rate and 002 cumis sativitus rum (ERYSCI) b) 6 b) 18 L/ha b) 12.6 application vol- (CUMSA) kg/ha ume vary with crop height <50 cm : 0.85 L/ha (max spray volume : 600 L/ha) 50-125 cm : 1.4 L/ha (max spray volume : 900 L/ha) >125 cm : 1.7 L/ha (max spray volume : 1200 L/ha 00- BE, NL, Cucumber (Cu- G Erysiphe cichoracea- Foliar spray All stages a) 6 7 a) 3 L/ha a) 2.1 kg/ha 300 / 1000 3 Corresponding 002 LU, AT, cumis sativitus rum (ERYSCI) b) 6 b) 18 L/ha b) 12.6 to CZ (CUMSA) kg/ha LWA: 5.7 L/ha LWA L product/hL (min- max): 0.3 L/hL – 1L/hL Assumptions1

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Explanation for column 15 – 21 “Conclusion” A Acceptable, Safe use R Further refinement and/or risk mitigation measures required C To be confirmed by cMS N No safe use

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

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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)

Due to lack of exposure of wild birds and mammals from greenhouse use, no specific risk assessment was necessary for the intended uses of the product Helioterpen Soufre in cucumber. Hence, it can be concluded that the risk for birds and mammals due to the intended use of Helioterpen Soufre in cucumber according to the label is acceptable.

9.1.1.2 Effects on aquatic organisms (KCP 10.2)

Risk ratios of predicted environmental versus regulatory acceptable concentrations (PEC/RAC) for aquatic organisms were calculated. Calculated exposure concentrations in surface water sediment, according to the intended uses of the product Helioterpen Soufre in cucumber were considered in the exposure term. The regulatory acceptable concentration (RAC) is obtained by division of the relevant toxicity data for sulfur by an assessment factor of 10 for chronic effects on sediment-dwelling organisms. The calculated risk ratios do achieve the acceptability criterion PEC/RAC ≤ 1 for aquatic organisms, as derived from the prescriptions in Commission Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.2. The results of the assessment indicate an acceptable risk for aquatic organisms due to the intended use of Helioterpen Soufre in cucumber according to the label.

9.1.1.3 Effects on bees (KCP 10.3.1)

For the time being, the product is classified as non-hazardous to bees when applied up to the maximum application rate. Member states may decide how to address the chronic risk to honey bees and may consider risk mitigation measures at national level.

9.1.1.4 Effects on arthropods other than bees (KCP 10.3.2)

In-field

Risk indicator values for non-target arthropods in treated areas were calculated, taking into account the relevant toxicity data for sulfur and estimated in-field exposure levels, according to the intended uses of the product Helioterpen Soufre in cucumber. The calculated indicator values do not achieve the acceptability criteria HQ ≤ 2 / of less than 50 % effect level for effects on non-target arthropods, according to agreed EU Guidance in Document SANCO/10329/2002 rev 2 that overrides the prescriptions of Commission Regula- tion (EU) No 546/2011, Annex, Part I C, point 2.5.2.4. The results of the assessment indicate an unacceptable risk for non-target arthropods in treated areas due to the intended use of Helioterpen Soufre in cucumber according to the label. While the assessment based on studies with fresh residues indicates an unacceptable risk for non-target arthropods, studies with aged residues demonstrate dissipation of toxicity to acceptable levels within an ecologically relevant time frame. It must be evaluated by Member States, whether those studies meet the requirements for the risk assessment with regard to their specific environmental or agricultural circumstances. Page 12 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Off-field

Due to lack of exposure of non-target arthropods in off-field areas from greenhouse use, no specific risk assessment was necessary for the intended uses of the product Helioterpen Soufre in cucumber. Hence, it can be concluded that the risk for non-target arthropods in off-field areas due to the intended use of Heli- oterpen Soufre in cucumber according to the label is acceptable.

9.1.1.5 Effects on non-target soil meso- and macrofauna (KCP 10.4), Effects on soil microbial activity (KCP 10.5)

Earthworms

TER values for earthworms were calculated, taking into account the relevant toxicity data for sulfur and calculated exposure concentrations in soil, according to the intended uses of the product Helioterpen Soufre in cucumber. The calculated TER values do achieve the acceptability criterion TER ≥ 10 for acute effects on earthworms, according to Commission Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.5. The results of the assessment indicate an acceptable risk for earthworms due to the intended use of Heli- oterpen Soufre in cucumber according to the label.

Other organisms of the soil macro- and mesofauna

No risk assessment was required. All available information indicate that risk for other organisms of the soil macro- and mesofauna due to the intended use of Helioterpen Soufre in cucumber according to the label is acceptable.

Soil microorganisms

Concentrations of sulfur in soil were determined where effects on nitrogen and carbon mineralisation processes remained ≤ 25 % and were compared to calculated exposure concentrations in soil, according to the intended uses of the product Helioterpen Soufre in cucumber. The comparison indicates no exceedance of the acceptability criterion ≤ 25 % effects on soil microorganisms, according to Commission Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.6. The results of the assessment indicate an acceptable risk for soil microorganisms due to the intended use of Helioterpen Soufre in cucumber according to the label.

9.1.1.6 Effects on non-target terrestrial plants (KCP 10.6)

Due to lack of exposure of non-target plants from greenhouse use, no specific risk assessment was necessary for the intended uses of the product Helioterpen Soufre in cucumber. Hence, it can be concluded that the risk for non-target plants due to the intended use of Helioterpen Soufre in cucumber according to the label is acceptable.

9.1.1.7 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)

No assessment required.

9.1.2 Grouping of intended uses for risk assessment

The intended uses 00-001 and 00-002 are fully equivalent with regard to environmental exposure of and Page 13 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version possible effects on non-target organisms. Hence, no grouping is necessary, since the same risk assessment is applicable for both uses.

9.1.3 Consideration of metabolites

There are no metabolites to be considered in the ecotoxicological risk assessment for an inorganic mineral as active substance.

9.2 Effects on birds (KCP 10.1.1)

9.2.1 Toxicity data

Avian toxicity studies have been carried out with sulfur. Full details of these studies are provided in the respective EU DAR and related documents. Effects on birds of Helioterpen Soufre were not evaluated as part of the EU assessment of sulfur. However, the provision of further data on the Helioterpen Soufre is not considered essential, because toxicity data on the formulation can be extrapolated from the data on the active substance. The selection of studies and endpoints for the risk assessment is in line with the results of the EU review process.

Table 9.2-1: Endpoints and effect values relevant for the risk assessment for birds

Species Substance Exposure Results Reference System

C. coturnix japonica Sulfur Acute > 3500 mg a.s./kg bw XXXXX (confirmatory data, please refer to Appendix 3) C. virginianus Sulfur Short-term > 1334.75 mg a.s./kg EFSA Scientific bw/day or Report (2008) 221, > 5339 mg a.s./kg 54-70

9.2.1.1 Justification for new endpoints

EU agreed endpoints were used for risk assessment.

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). The LD50 for acute toxicity to Coturnix japonica of > 3500 mg a.s./kg bw from the study by Desai (2008) is based on the observation of 6 treated animals, none of which showing signs of intoxication after treatment. According to chapter 2.1.2 of EFSA (2009) of birds and mammals guidance, an extrapolation factor of 1.614 can be applied to the greater value of the LD50 to obtain a still conservative but more realistic definitive value for that endpoint. Hence, an LD50 of 5649 mg a.s./kg bw can be used in the risk assessment. According to the EFSA conclusion of sulfur, no long-term toxicity studies were required for the toxicology Page 14 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version assessment. Indeed, long-term risk to birds and mammals is considered as low because of the low acute and short-term toxicity.

9.2.2.1 First-tier assessment (screening/generic focal species)

For uses in the greenhouse, no exposure of birds is expected.

9.2.2.2 Higher-tier risk assessment

Not relevant.

9.2.2.3 Drinking water exposure

Not relevant.

9.2.2.4 Effects of secondary poisoning

The log Pow is not applicable for sulfur (inorganic compound). A risk assessment for effects due to secondary poisoning is not required.

Risk assessment for earthworm-eating birds via secondary poisoning Not required.

Risk assessment for fish-eating birds via secondary poisoning Not required.

9.2.2.5 Biomagnification in terrestrial food chains

Not relevant.

9.2.3 Risk assessment for baits, pellets, granules, prills or treated seed

Not relevant.

9.2.4 Overall conclusions

Due to lack of exposure of wild birds from greenhouse use, no specific risk assessment was necessary for the intended uses of the product Helioterpen Soufre in cucumber. Hence, it can be concluded that the risk for birds due to the intended use of Helioterpen Soufre in cucumber according to the label is acceptable. Page 15 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

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 sulfur. Full details of these studies are provided in the respective EU DAR and related documents. Effects on mammals of Helioterpen Soufre were not evaluated as part of the EU assessment of sulfur. However, the provision of further data on the formulation Helioterpen Soufre is not considered essential, because toxicity data on the formulation can be extrapolated from the data on the active substances. 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 System

Rat Sulfur Acute > 35000 mg a.s./kg bw XXXXX (confirmatory data, please refer to Appendix 3)

9.3.1.1 Justification for new endpoints

EU agreed endpoints were used for risk assessment.

9.3.2 Risk assessment for spray applications

The risk assessment is based on the methods presented in the Guidance Document on Risk Assessment for Mammals and Mammals on request from EFSA (EFSA Journal 2009; 7(12): 1438; hereafter referred to as EFSA/2009/1438). The LD50 for acute toxicity to rat is > 35000 mg a.s./kg bw from the study by Patani (2009). According to the EFSA conclusion of sulfur, no long-term toxicity studies were required for the toxicology assessment. Indeed, long-term risk to birds and mammals is considered as low because of the low acute and short-term toxicity.

9.3.2.1 First-tier assessment (screening/generic focal species)

For uses in the greenhouse, no exposure of mammals is expected.

9.3.2.2 Higher-tier risk assessment

Not relevant.

9.3.2.3 Drinking water exposure

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9.3.2.4 Effects of secondary poisoning

The log Pow is not applicable for sulfur (inorganic compound). A risk assessment for effects due to secondary poisoning is not required.

Risk assessment for earthworm-eating birds via secondary poisoning Not required.

Risk assessment for fish-eating birds via secondary poisoning Not required.

9.3.2.5 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

Due to lack of exposure of wild mammals from greenhouse use, no specific risk assessment was necessary for the intended uses of the product Helioterpen Soufre in cucumber. Hence, it can be concluded that the risk for mammals due to the intended use of Helioterpen Soufre in cucumber according to the label is acceptable.

9.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3)

There is no available or relevant data regarding the potential effects of sulfur to reptiles and amphibians.

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 sulfur. Full details of these studies are provided in the respective EU DAR and related documents. Effects on aquatic organisms of Helioterpen Soufre were not evaluated as part of the EU assessment of sulfur. However, the provision of further data on the formulation Helioterpen Soufre is not considered essential, because toxicity data on the formulation can be extrapolated from the data on the active substance. Nevertheless, toxicity studies on aquatic organisms were conducted with the formulation named as Helio- soufre S which is similar to Helioterpen Soufre (see to Part C for the bridging statement). The selection of studies and endpoints for the risk assessment is in line with the results of the EU review process.

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Table 9.5-1: Endpoints and effect values relevant for the risk assessment for aquatic organisms – Sulfur

Species Substance Exposure Results Reference System

Fish

Oncorhynchus Sulfur 80% WG 96 h, s EC50 > 0.063 mg a.s./L EFSA Scientific mykiss (solubility limit) Report (2008) 221, 57-70 Oncorhynchus Sulfur 80% WG 28 d, f Growth NOEC > 0.063 mg a.s./L EFSA Scientific mykiss (solubility limit) Report (2008) 221, 57-70 Aquatic invertebrate

Daphnia magna Sulfur 80% WG 48 h, s EC50 > 0.063 mg a.s./L EFSA Scientific (solubility limit) Report (2008) 221, 57-70 Sediment dwelling organisms Chironomus Sulfur Dust 28 d, spiked NOEC > 608 mg a.s./kg sed. (dw) Desmares-Koopmans, riparius sediment M.J.E, 2009/2010 (confirmatory data, please refer to Appendix 3) Algae

S. subspicatus Sulfur Dust 72 h, s EbC50 = 0.002 mg a.s./L mm EFSA Scientific ErC50 = 0.002 mg a.s./L mm Report (2008) 221, 57-70 Higher plant Not required Higher-tier studies (micro- or mesocosm studies) Not required 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; sol lim = solubility limit

Studies on the effects on aquatic organisms of Helioterpen Soufre were not performed. However, studies of similar formulation Heliosoufre S are available and can be extrapolated to Helioterpen Soufre. In these studies, the presence of Heliosoufre S in the test solutions was determined by analysing for the organic fraction of the product (which amounts to 30 % w/w of the formulation). No specific analysis for sulfur was conducted during the studies, also due to the low solubility of sulfur in water. As mentioned in the EFSA conclusion of sulfur, solubility in water is 63 µg/L at 20 °C. Data on the composition of Heliosoufre S and on bridging to Helioterpen Soufre are provided in the confidential part of this report.

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Table 9.5-2: Endpoints and effect values relevant for the risk assessment for aquatic organisms – Helioterpen Soufre

Species Substance Exposure Results Reference System

Oncorhynchus Heliosoufre S 96 h, s EC50 > 107 mg a.s./L KCP 10.2.1/01 mykiss XXX, 2002a

Daphnia magna Heliosoufre S 48 h, s EC50 > 140 mg a.s./L KCP 10.2.1/02 Marchal, P., 2002b

Pseudokirchneriella Heliosoufre S 72 h, s EbC50 > 70 mg a.s./L mm KCP 10.2.1/03 subcapitata ErC50 > 70 mg a.s./L mm Marchal, P., 2002c

9.5.1.1 Justification for new endpoints

EU agreed endpoints were used for risk assessment.

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).

Sulfur is an inorganic substance, which is slightly soluble in water. The maximum determined water solubility is 63 µg a.s./L. According to the EFSA conclusion of sulfur, no adverse effects of a sulfur WG 80 formulation on tested organisms were observed at this concentration level of the active substance in the studies with fish (96-h mortality, 28-d growth) and daphnids (48-h immobilisation). The effects observed on algae growth in a study with sulfur dust were attributed to the light inhibition caused by continuously re-suspended sulfur particles (shaking of test vessels). In the overall evaluation, the solubility limit of sulfur of 63 µg/L was proposed as relevant endpoint to be used in the risk assessment for aquatic organisms in the water phase.

Complementary data have been submitted by the Sulfur Task force for invertebrates and sediment dwelling organisms. The applicant Action Pin has got a letter of access that authorizes Competent Authorities to refer to these data for risk assessments. A study on Chironomus riparus is available in the data package of the Sulfur Task Force and the NOEC from that study is compared to the PECsed calculated for Helioterpen Soufre.

As sulfur disappears quickly from the water phase due to its very low solubility, but accumulates in the sediment, the risk assessments focuses on the risk to sediment dwellers. In the following table, the ratios between predicted environmental concentrations in sediment (PECSED) and regulatory acceptable concentrations (RAC) for aquatic organisms are given per intended use for scenarios of cucumber and sediment dwelling organisms. Calculations are made based on entry by spray drift added with run-off and drainage, which calculations are based on FOCUS Step 2 assumptions (please refer to Section 8 (Environmental Fate), Chapter 8.9.2, Table 8.9-6).

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Table 9.5-2: Aquatic organisms: acceptability of risk (PEC/RAC < 1) for sulfur for sediment-dwelling organisms based on added entries by spray drift and run-off/ drainage for the use of Helioterpen Soufre in cucumber (uses 00-001, 00-002)

Group Sed. dwell. prolonged Test species Chironomus riparius Endpoint NOEC (µg/kg dw) > 608000 AF 10 RAC (µg/kg dw) > 60800

Scenario Total PECsed (µg/kg) PEC/RAC ratios added entries by spray drift and run- off/drainage according to FOCUS Step 2 assumptions Cucumber 12690 0.209

9.5.3 Overall conclusions

9.6 Effects on bees (KCP 10.3.1)

Helioterpen Schwefel (700 g sulphur/L) is suspension concentrate (SC) containing the active substance sulphur. It is intended as fungicide for controlling powdery mildew of cucumber growing. Effects of Heli- oterpen Schwefel on bees were not evaluated as part of the EU review of sulphur in 2008. Therefore, all relevant data and assessments are reported here. Based on the results of laboratory tests with the comparable product (Heliosoufre S), Helioterpen Schwefel is considered practically non-toxic to adult honey bees with regard to acute oral and contact exposure. All corresponding hazard quotients are below the trigger of 50, indicating that the intended use poses an acceptable risk to bees in the field. However, due to a lack of data on chronic toxicity, the potential risk of Helioterpen Schwefel for honey bees with regard to chronic exposure cannot be assessed. This is depending on the following facts (1) the commercially used pollinators can be used in greenhouses (2) the greenhouses are not always considered to be bee-safe locker rooms. Therefore, in order to finalise the risk assessment, the applicant has to provide data on chronic toxicity to adult honey bees and honey bee larvae from studies using the product Helioterpen Schwefel or a comparable formulation. Data have to be provided under the points KCP 10.3.1.2 (adult honey bees) and KCP 10.3.1.3 (honey bee larvae). Nevertheless, since the data already provided do not indicate unacceptable risks for honey bees and bee colonies or other managed bee species when Helioterpen Schwefel is used as proposed, and taking into Page 20 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version account all information available at present, the subsequent provision of the required data on chronic toxicity can be carried out in support of the authorisation procedure for the plant protection product within 18 months after the approval. For the time being, the product is classified as non-hazardous to bees when applied up to the maximum application rate. Member states may decide how to address the chronic risk to honey bees and may consider risk mitigation measures at national level.

9.6.1 Toxicity data

Table 10.3.1-1 presents the results of laboratory bee toxicity studies with a comparable formulation (Heli- osoufre S: 710 g sulphur/L). Further study details are provided in section 10.3.1.1. For the sake of completeness the table also presents results of laboratory bee toxicity studies with the active substance.

Table 9.6.1-1: Results of laboratory bee toxicity studies Test sub- Exposure Endpoint Reference stance route

oral > 100 µg prod./bee Servajean E. (2007) Helioterpen Adult, 48 h LD50 Study no.: 07-40-008- Schwefel** acute contact > 100 µg prod./bee ES 48 h oral > 106.8 µg a.s./bee * Conclusion on the peer sulphur dust Adult, 48 h review of sulfur dust LD50 tech. acute contact EFSA Scientific Report > 100 µg a.s./bee * 48 h (2008) 221, 58-70 * EU agreed endpoint ** tested as Heliosoufre S (710 g sulphur /L), 1.373 kg/m3

Exposure

The recommended use pattern for Helioterpen Schwefel includes applications in cucumber growing at a maximum application rate of up to 3 L product/ha. This maximum single application rate is equivalent to 4.065 g product/ha (2100 g a.s./ha).

Bees may be exposed to Helioterpen Schwefel by contact either through direct spraying during the forag- ing on flowers or through contact with fresh or dried residues. Additionally, the bees could be exposed orally to Helioterpen Schwefel by uptake of contaminated pollen, nectar and honey dew. Honey bee larvae may be exposed by feeding on royal jelly, pollen and honey containing residues of He- lioterpen Schwefel or its degradations products. Page 21 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

9.6.1.1 Justification for new endpoints

9.6.2 Risk assessment

Due to the results of laboratory acute oral and contact tests with a comparable formulation, Helioterpen Schwefel is considered to have low toxicity to adult honey bees. Moreover, all hazard quotients are lower than the trigger of 50. However, the applicant provided no data on chronic adult or chronic larval toxicity with the formulation Helioterpen Schwefel or a comparable formulation. Accordingly, the applicant did not fulfill the new An- nex III data requirements regarding the provision of data on chronic toxicity to adult honey bees and honey bee larvae, as laid out in Commission Regulation (EU) No 284/2013. This

9.6.2.1 Hazard quotients for bees

Hazard quotients for oral and contact exposure according to EPPO (2003) Environmental risk assessment scheme for plant protection products (Chapter 10: Honey bees (PP 3/10(2)). Bulletin OEPP/EPPO Bulle- tin 33: 141-145) were calculated as follows:

Hazard Quotient = max. application rate (g prod./ha) / LD50 (µg prod./bee)

Table 9.6.2.1-1: Hazard quotients for honey bees Max. single appli- Exposure LD50 Hazard quo- HQ Test substance cation rate route (µg prod./bee) tient (HQ) trigger (g prod./ha)

oral > 100 µg 40.65 Helioterpen Schwe- 4065 50 fel* contact > 100 µg 40.65 * tested as Heliosoufre S (710 g sulphur/L)

9.6.2.2 Higher-tier risk assessment for bees (tunnel test, field studies)

9.6.3 Effects on bumble bees

9.6.4 Effects on solitary bees

9.6.5 Overall conclusions

Based on the results of laboratory tests with the comparable product, the product is considered practically non-toxic to adult honey bees with regard to acute oral and contact exposure. All corresponding hazard quotients are below the trigger of 50, indicating that the intended use poses an acceptable risk to bees in the field. Page 22 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

However, due to a lack of data on chronic toxicity, the potential risk of Helioterpen Schwefel for honey bees with regard to chronic exposure cannot be assessed. Therefore, in order to finalise the risk assessment, the applicant has to provide data on chronic toxicity to adult honey bees and honey bee larvae from studies using the product Helioterpen Schwefel or a comparable formulation. Data have to be provided under the points KCP 10.3.1.2 (adult honey bees) and KCP 10.3.1.3 (honey bee larvae). Nevertheless, since the data already provided do not indicate unacceptable risks for honey bees and bee colonies or other managed bee species when Helioterpen Schwefel is used as proposed, and taking into account all information available at present, the subsequent provision of the required data on chronic toxicity can be carried out in support of the authorisation procedure for the plant protection product within 18 months after the approval. For the time being, the product is classified as non-hazardous to bees when applied up to the maximum application rate. Member states may decide how to address the chronic risk to honey bees and may consider risk mitigation measures at national level.

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 sulfur. Full details of these studies are provided in the respective EU DAR and related documents. Effects on non-target arthropods of Helioterpen Soufre were not evaluated as part of the EU assessment of sulfur. However, the provision of further data on the Helioterpen Soufre is not considered essential, because toxicity data on the formulation can be extrapolated from the data on the active substance. 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 according to laboratory tests

Species Substance Exposure Results Reference System

Typhlodromus pyri Sulfur Dust Laboratory test LR50 = 10340 g/ha EFSA Scientific (protonymphs) glass plates (2D) Report (2008) 221, 59-70

Aphidius Sulfur Dust Laboratory test LR50 = 486 g/ha EFSA Scientific rhopalosiphi glass plates (2D) Report (2008) 221, (adults) 59-70

Table 9.7-2: Endpoints and effect values relevant for the risk assessment for non-target arthropods according to further laboratory and extended laboratory tests

Species Substance Dose (g Endpoint % effect Trigger Reference Duration a.s./ha) value

Aphidius Sulfur 80% WG 1000 Mortality 100 - EFSA Scientific Report rhopalosiphi 48h (2008) 221, 59-70 (adults) Page 23 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Species Substance Dose (g Endpoint % effect Trigger Reference Duration a.s./ha) value

Aphidius Sulfur 80% WG 12720 Mortality 0.0 50 % EFSA Scientific Report rhopalosiphi 48h 16000 44.83 (2008) 221, 59-70 (adults) 20160 48.28 25400 55.18 32000 51.72 LR50 = 19.89 Aphidius Sulfur 80% WG 12720 Reproduction 3.06 50 % EFSA Scientific Report rhopalosiphi 48h 16000 + 27.61 (2008) 221, 59-70 (adults) 20160 12.6- 25400 - 32000 - Aphidius Sulfur 80% WG 8000 Mortality 22.0 50 % EFSA Scientific Report rhopalosiphi 48h 16000 25.4 (2008) 221, 59-70 24000 45.8 32000 93.2 40000 79.7 LR50 = 19600 Aphidius Sulfur 80% WG 8000 Parasitisation 25.8 50 % EFSA Scientific Report rhopalosiphi 48h 16000 efficiency (% 21.1 (2008) 221, 59-70 24000 inhibition) 45.38 32000 - 40000 - T. cacoeciae Sulfur 80% WG 812 Reproduction 100 50 % EFSA Scientific Report (adults) (2008) 221, 59-70 T. cacoeciae Sulfur 80% WG 0.8 Reproduction 33.98 50 % EFSA Scientific Report (adults) 48h 3.12 8.68 (2008) 221, 59-70 12.58 42.45 50 35.94 200 77.66 800 90.24 EC50 = 74 P. cupreus Sulfur 80% WG 10000 Mortality 0 50 % EFSA Scientific Report (adults) 14d Food 4.2 (2008) 221, 59-70 consumption C. carnea Sulfur 80% WG 10000 Mortality 6 50 % EFSA Scientific Report (larvae) 21d Fecundity 0 (2008) 221, 59-70 A. bilineata Sulfur 80% WG 10000 Mortality 0 50 % EFSA Scientific Report (adults) 7d Reproduction 2.3 (2008) 221, 59-70 Typhlodromus Sulfur Dust 5000 Mortality 21.8 50 % EFSA Scientific Report pyri 48h 10000 12.8 (2008) 221, 59-70 (adults) 20000 20.1 40000 63.7 60000 25.5 LR50 > 60000 Page 24 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Species Substance Dose (g Endpoint % effect Trigger Reference Duration a.s./ha) value

Typhlodromus Sulfur Dust 5000 Reproduction 50 50 % EFSA Scientific Report pyri 48h 10000 51.4 (2008) 221, 59-70 (adults) 20000 44.4 40000 - 60000 84.7 NOEC < 5000 P. cupreus Sulfur Dust 30000 Mortality 0 50 % EFSA Scientific Report (adults) 14d 90000 0 (2008) 221, 59-70 P. cupreus Sulfur Dust 30000 Food 1 50 % EFSA Scientific Report (adults) 14d 90000 consumption 3 (2008) 221, 59-70 C. carnea Sulfur Dust 30000 Mortality 60.4 50 % EFSA Scientific Report (larvae) 48h (2008) 221, 59-70 C. carnea Sulfur Dust 1250 Mortality 42.9 50 % EFSA Scientific Report (larvae) 48h 2500 50.1 (2008) 221, 59-70 5000 71.4 10000 66.7 20000 78.6 LR50 = 2000 C. carnea Sulfur Dust 1250 Reproduction 9.45 50 % EFSA Scientific Report (larvae) 48h 2500 0 (2008) 221, 59-70 5000 - 10000 - 20000 - Field or semi-field tests Studies on grapes on 9 experimental sites selected in Germany. 8 applications per season for 1 experimental site, and 6 applications per season for the 8 other experimental sites Rate up to 2.56 kg a.s./ha Maximum short-term effects = 40% No impact on T. pyri populations after the 4-month duration study Study in vineyard in Germany. Typhlodromus pyri – Predatory mites (Acari: Phytoseiidae) 5 applications: 30 kg product/ha ; 30 kg product/ha ; 25 kg product/ha ; 20 kg product/ha ; 20 kg product/ha NOEC ≥ field application rate (52% effect after 5 days since the last application; 46% effect after 30 days since the last application; the test was prolonged to 56 days after the last application, when the effect was 9.6%). Study in vineyard in Italy. Phytoseius plumifer - Predatory mites (Acari: Phytoseiidae) 5 applications: 30 kg product/ha ; 30 kg product/ha ; 25 kg product/ha ; 20 kg product/ha ; 20 kg product/ha NOEC ≥ field application rate (Highest effect was 30% 6 days after the first application; -72% effect 31 days after the last application) Page 25 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Table 9.7-11: Endpoints and effect values relevant for the risk assessment for non-target arthropods according to aged residues study

Species Substance Exposure Results Reference System

Trichogramma SULFUR 80 % Aged-residues DAT 27: Warmers, C. cacoeciae WG test Sublethal eff. < 50 % at ≤ 2.0 kg a.s./ha 2005 (adults) Grapevines (confirmatory data, leaves (3D) DAT 49: please refer to Sublethal eff. < 50 % at ≤ 6.0 kg a.s./ha Appendix 3)

9.7.1.1 Justification for new endpoints

EU agreed endpoints were used for risk assessment.

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

Non-target arthropods living in the crop can be exposed to residues from Helioterpen Soufre by direct contact either as a result of overspray or through contact with residues on plants and soil or in food items. Helioterpen Soufre is applied at a maximum rates of 6 × 2100 g a.s./ha for cucumbers. The maximum in- field exposure to foliar-dwelling or soil-dwelling organisms from a single application is therefore 2100 g a.s./ha, assuming the respective worst-cases of either 100 % or 0 % crop interception. The in-field exposure (predicted environmental residue, PER) for the actual application sequence is calculated according to ES- CORT 2 using a factor for multiple applications (MAF) and the following equation: PERin-field = application rate × MAF. For assessing the risk of Helioterpen Soufre to in-field non-target arthropods in the first tier, hazard quotient (HQ = exposure/toxicity) based on LR50 values from laboratory testing on inert substrate are calculated for the standard test species Typhlodromus pyri and Aphidius rhopalosiphi (Escort 2 acceptability criterion: HQ ≤ 2). Where necessary, a higher-tier risk assessment is performed by comparing effect rates from extended laboratory tests on natural substrate with the PERin-field (Escort 2 acceptability criterion: ≤ 50 % effect at PERin-field, equivalent to a risk quotient PER/ER50 ≤ 1). Since the toxicity studies have shown that both standard species were significantly less sensitive than the wasp Trichogramma cacoeciae, the higher-tier risk assessment was also conducted for this additional species. The calculated HQ values and PERin-field/ER50 quotients indicated an acceptable risk for Typhlodromus pyri (first tier) and for Aphidius rhopalosiphi (higher tier), but not for Trichogramma cacoeciae. Therefore, the potential for recovery of this species after exposure to sulfur was evaluated, using an aged-residue study on the duration of effects of Sulfur 80 WG on the Trichogramma cacoeciae that was conducted and submitted by the Sulfur Working Group as confirmatory data in the EU evaluation of sulfur. Page 26 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Table 9.7-2: First- and higher-tier assessment of the in-field risk for non-target arthropods due to the use of Helioterpen Soufre in cucumber (uses 00-001, 00-002)

Intended use 00-001, 00-002 Active substance/product sulfur Application rate (g/ha) 6 × 2100 MAF 3.2

Test species LR50 (lab.) PERin-field HQin-field Tier I (g/ha) (g/ha) criterion: HQ ≤ 2 Typhlodromus pyri 10340 0.650 6720 Aphidius rhopalosiphi 486 13.8

Test species ER50 (ext. lab.)* PERin-field RQ = PERin-field/ER50 Higher-tier (g/ha) (g/ha) criterion: RQ ≤ 1 Typhlodromus pyri 60000 0.112 Aphidius rhopalosiphi 19600 6720 0.343 Trichogramma cacoeciae 74 90.8

Test species Rate with ≤ 50 % effect PERin-field PERin-field below rate with Higher-tier (g/ha) at 27/49 DALT (g/ha) ≤ 50 % effect? ≤ 2000: no at 27 DALT (no effect) Trichogramma cacoeciae 6720 ≤ 6000: no at 49 DALT (11 % effect) 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. * ER50 from relevant extended laboratory tests are available and are be considered in place of the rate with ≤ 50 % effect.

9.7.2.2 Risk assessment for off-field exposure

In principle, exposure to Helioterpen Soufre of non-target arthropods living in non-target off-field areas will mainly be due to spray drift from field applications. Off-field predicted environmental rates (PERoff-field) are calculated from PERin-field values by multiplication with the established BBA drift values (see Escort 2 report). To account for interception and dilution in the three-dimensional vegetation in off-crop areas, these values are divided by a vegetation distribution or dilution factor (vdf). A vdf of 10 is recommended in the Escort 2 report when the off-field risk assessment is based on toxicity endpoints obtained in a test design with two-dimensional exposure. Although the applicability of this figure is questioned in the relevant Guid- ance Document SANCO/10329/2002, it is applied in zonal risk assessments as long as there is no agreement on another more reliable figure. For toxicity endpoints obtained in a test design with three-dimensional exposure, the vdf is 1. Sulfur has a vapour pressure in the range of 10-5-10-4 Pa and is therefore classified as semivolatile. Hence, deposition following volatilisation will also contribute to off-field exposure of non-target arthropods. Since there is currently no zonal-agreed guidance how to consider deposition following volatilisation in the exposure assessment, this aspect needs to be addressed on Member State level. Page 27 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

The same toxicity data and tiered approach as in the risk assessment for in-field exposure are considered in the off-field risk assessment. To account for possible higher sensitivity of not tested arthropod species, a correction factor (CF) is applied to the calculated PERoff-field. This factor amounts to 10 in the first tier based on laboratory tests with Typhlodromus pyri and Aphidius rhopalosiphi and is reduced to 5 in the higher-tier based on extended laboratory tests with the standard and at least two additional test species.

For the intended uses of Helioterpen Soufre in cucumber in the greenhouse, no relevant exposure of terrestrial off-field habitats is expected from spray drift. The vapour pressure of sulfur is below the trigger value for conducting an exposure assessment for greenhouse uses. Therefore, no quantitative risk assessment for off-field arthropods is necessary.

9.7.2.3 Additional higher-tier risk assessment

Although the aged-residue study with Trichogramma cacoeciae indicates a decrease of toxicity of sulfur residues within 27-49 days, the calculated PERin-field from the uses in cucumber of 6720 g a.s./ha slightly exceeds the highest tested rate of 6000 g a.s./ha in the aged-residue test and the nominal acceptability criterion from Escort 2 is thus not met. Still, the small numeric distance between the calculated PERin-field and the highest tested rate in the aged- residue test as well as the low level of effects observed in the test after aging suggest that a potential for recovery of affected in-field populations does exist. To explore this potential, a kinetical evaluation of the aged-residue tests was performed, assuming that the observed loss of toxicity after 29 d and 47 d corresponds to a decline of residues from the initial levels of 2000 g a.s./ha or 6000 g a.s./ha to levels ≤ 74 g a.s./ha. It is then possible to derive DT50 estimates according to the following equation: t × ln2 DT = − 50 c ln final cinitial where cinitial and cfinal are the initial and final residue levels and t is the time required to reach cfinal. For cinitial = 2000 g a.s./ha, cfinal = 74 g a.s./ha and t = 27 d, the estimated DT50 amounts to 5.7 d. With cinitial = 6000 g a.s./ha, again cfinal = 74 g a.s./ha and t = 49 d, a quite similar DT50 estimate of 7.7 d is achieved. Both values are well in line with the conceptual model for residue dynamics in the risk assessment for birds and mammals, where a default DT50 of 10 d for residue decline on plant and other food items is assumed. In the case of sulfur, a fairly rapid dissipation of residues from plant surfaces can be expected by sublimation of the active substance in combination with limited uptake by the leaves, wash-off to the ground (where sulfur is rapidly oxidised and subjected to the sulfur cycle) and dilution of residues by plant growth. On closer inspection, both DT50 estimates could even be interpreted as being conservative, because the observations in the aged-residue test after 27 d and 49 d for the respective dose levels (no effect or a small effect of 11 % on reproduction, respectively) indicate a residue decline well below the ER50 of 74 g a.s./ha. Taking into account a DT50 range of 5.7-7.7 d, a refined calculation of residue levels from multiple application as well as of an estimated time for residue decline below 74 g a.s./ha is possible, applying the following equations: 1− e −nkt MAF = 1− e−kt with n = number of applications, k = ln 2/DT50, and t = application interval, and c DT × ln final 50 c t = − initial ln2 Page 28 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

(see above for explanation of the parameters).

Table 9.7-3: Refined risk assessment for non-target arthropods (Tier 2 with adjusted residue decline data) for in-field exposure

Applic. rate & inter- Time to reach DT50 PER Intended use val MAF in-field non-critical level (d) (g/ha) (g/ha) (74 g a.s./ha) 5.7 1.73 3633 32.0 00-001, 00-002 6 × 2100 (7 d) 7.7 2.09 4389 45.4 MAF: Multiple application factor; PER: Predicted environmental rates

9.7.2.4 Risk mitigation measures

No risk mitigation needed.

9.7.3 Overall conclusions

In-field

Off-field

9.8 Effects on non-target soil meso- and macrofauna (KCP 10.4)

9.8.1 Toxicity data

Studies on the toxicity to earthworms and other non-target soil organisms (meso- and macrofauna) have been carried out with sulfur. Full details of these studies are provided in the respective EU DAR and related documents. Page 29 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Effects on earthworms and other non-target soil organisms (meso- and macrofauna) of Helioterpen Soufre were not evaluated as part of the EU assessment of sulfur. However, the provision of further data on the Helioterpen Soufre is not considered essential, because toxicity data on the formulation can be extrapolated from the data on the active substance. 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 System

Eisenia fetida Sulfur 80% WG 14 d, acute LC50 > 2000 mg product/kg dw EFSA Scientific Report LC50 > 1576 mg a.s./kg dw (2008) 221, 62-70

Eisenia fetida Sulfur 80% WG 14 d, acute LC50 > 1000 mg product/kg dw EFSA Scientific Report LC50 > 788 mg a.s./kg dw (2008) 221, 62-70

Eisenia fetida Sulfur Dust 14 d, acute LC50 > 1000 mg product/kg dw EFSA Scientific Report LC50 > 985 mg a.s./kg dw (2008) 221, 62-70 Field studies Not required

9.8.1.1 Justification for new endpoints

EU agreed endpoints were used for risk assessment.

9.8.2 Risk assessment

The evaluation of the risk for earthworms and other non-target soil organisms (meso- and macrofauna) was performed in accordance with the recommendations of the “Guidance Document on Terrestrial Ecotoxicol- ogy”, as provided by the Commission Services (SANCO/10329/2002 rev 2 (final), October 17, 2002).

9.8.2.1 First-tier risk assessment

The relevant PECsoil for risk assessments covering the proposed use pattern are taken from Section 8 (En- vironmental Fate), Chapter 8.7.2, Table 8.7-3. According to the assessment of environmental-fate data, multi-annual accumulation in soil does not need to be considered for sulfur.

Table 9.8-2: First-tier assessment of the acute risk for earthworms due to the use of Heli- oterpen Soufre in cucumber (uses 00-001, 00-002)

Intended use 00-001, 00-002 Acute effects on earthworms

Product/active substance LC50 PECsoil TERa (mg/kg dw) (mg/kg dw) (criterion TER ≥ 10) Sulfur >1576 10.5 150.1 TER values shown in bold fall below the relevant trigger.

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As stated in the DAR for sulfur (March 2008) and in the EFSA Scientific Report (2008) 221, no long-term studies for earthworms are required as long as no acute effect is observed on earthworms and the acute risk is acceptable (which is the case here). Additionally, elemental sulfur is known to enter the sulfur cycle immediately after application and does not accumulate in the environment in case of multiple applications in accordance with good agricultural practice. Since sulfur does not give rise to metabolites other than those that are well known to be intermediary or end products of physiological metabolic reactions, the intent of chronic testing requirements does not apply to elemental sulfur and its possible metabolites. Chronic exposure to sulfur is a natural state (EPA 1991, R.E.D. Facts Sulfur). Thus, no chronic risk assessment for earthworms is deemed necessary It was discussed during the EU evaluation of sulfur whether studies with other soil-dwelling non-target arthropods should be required, since the in-field HQ values for the indicator non-target species A. rhopalosiphi was >2. The rapporteur Member State suggested that no studies were needed, since the risk to earthworms and to soil non-target micro-organisms was assessed as low. The experts agreed that no further studies were required, considering also that no effects were observed in the studies with soil surface-dwelling arthropods (P. cupreus), at application rates of up to 10 kg a.s./ha and 90 kg a.s./ha. (EFSA Scientific Report, 2008).

9.8.2.2 Higher-tier risk assessment

Not relevant.

9.8.3 Overall conclusions

Earthworms

Other organisms of the soil macro- and mesofauna

9.9 Effects on soil microbial activity (KCP 10.5)

9.9.1 Toxicity data

Studies on effects on soil microorganisms have been carried out with sulfur. Full details of these studies are provided in the respective EU DAR and related documents. Effects on soil microorganisms of Helioterpen Soufre were not evaluated as part of the EU assessment of sulfur. However, the provision of further data on the formulation Helioterpen Soufre is not considered essential, because toxicity data on the formulation can be extrapolated from the data on the active substance. The selection of studies and endpoints for the risk assessment is in line with the results of the EU review Page 31 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version process.

Table 9.9-1: Endpoints and effect values relevant for the risk assessment for soil microorganisms

Endpoint Substance Exposure Results Reference System

N-mineralisation Sulfur Dust - 0% effect at day 28 at 400 mg EFSA Scientific Report prod/kg d.w. soil (300 kg prod/ha) (2008) 221, 63-70 Sulfur 80% WG - at 13.3 mg prod./kg d.w. soil (10 EFSA Scientific Report kg prod/ha): (2008) 221, 63-70 - no effect during 77 days

at 133 mg prod/kg d.w. soil (100 kg prod/ha): - 14% effect at day 77 - maximum effect of 86 % inhibition at day 21 C-mineralisation Sulfur Dust - 6% effect at day 28 at 40 mg EFSA Scientific Report prod/kg d.w.soil (30 kg prod/ha) (2008) 221, 63-70

2% effect at day 28 at 400 mg prod/kg d.w. soil (300 kg prod/ha) Sulfur 80% WG - at 13.3 mg prod./kg d.w. soil (10 EFSA Scientific Report kg prod/ha): (2008) 221, 63-70 - no effect during 28 days

at 133 mg prod/kg d.w. soil (100 kg prod/ha) - 6.3% effect (inhibition) at day 28 in sandy loam soil - 26.8% effect (inhibition) at day 28 in loamy sand soil

9.9.1.1 Justification for new endpoints

EU agreed endpoints were used for risk assessment.

9.9.2 Risk assessment

The evaluation of the risk for soil microorganisms was performed in accordance with the recommendations of the “Guidance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services (SANCO/10329/2002 rev 2 (final), October 17, 2002). The relevant PECsoil for risk assessments covering the proposed use pattern are taken from Section 8 (En- vironmental Fate), Chapter 8.7.2, Table 8.7-3 and were already used in the risk assessment for earthworms and other non-target soil organisms (meso- and macrofauna) (see 9.8). Page 32 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Table 9.9-2: Assessment of the risk for effects on soil micro-organisms due to the use of He- lioterpen Soufre in cucumber (uses 00-001, 00-002)

Intended use N-mineralisation

Product/active substance Max. conc. with effects PECsoil Risk acceptable? ≤ 25 % (mg/kg dw) (mg/kg dw) Sulfur Dust/Sulfur 400 mg prod/kg d.w. soil 10.5 yes (at 28 d) or 394 mg a.s./kg d.w. soil (at 28 d) C-mineralisation

9.9.3 Overall conclusions

9.10 Effects on non-target terrestrial plants (KCP 10.6)

9.10.1 Toxicity data

Studies on the toxicity to non-target terrestrial plants have been carried out with sulfur. Full details of these studies are provided in the respective EU DAR and related documents. Effects on non-target terrestrial plants of Helioterpen Soufre were not evaluated as part of the EU assessment of sulfur. However, the provision of further data on the formulation Helioterpen Soufre is not considered essential, as toxicity data can be extrapolated from the active substance data. The selection of studies and endpoints for the risk assessment is in line with the results of the EU review process. Page 33 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Table 9.10-1: Endpoints and effect values relevant for the risk assessment for non-target terrestrial plants

Species Substance Exposure Results Reference System

Zea mays Sulfur 80% WG 21 d ER50 > 25200 g/ha EFSA Scientific Report Avena sativa Vegetative vigour (2008) 221, 64-70 Allium cepa Brassica oleracea Pisum sativum Daucus carota

9.10.1.1 Justification for new endpoints

EU agreed endpoints were used for risk assessment.

9.10.2 Risk assessment

9.10.2.1 Tier-1 risk assessment (based on 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”, (SANCO/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. As discussed above for non-target arthropods, no relevant exposure of terrestrial off-field habitats is expected from spray drift, due to the intended uses of Helioterpen Soufre in cucumber in the greenhouse. The vapour pressure of sulfur is below the trigger value for conducting an exposure assessment for greenhouse uses. Therefore, no quantitative risk assessment for non-target plants is necessary.

9.10.2.3 Higher-tier risk assessment

Not relevant.

9.10.2.4 Risk mitigation measures

No risk mitigation needed.

9.10.3 Overall conclusions

Due to lack of exposure of non-target plants from greenhouse use, no specific risk assessment was necessary for the intended uses of the product Helioterpen Soufre in cucumber. Hence, it can be concluded that the Page 34 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version risk for non-target plants due to the intended use of Helioterpen Soufre in cucumber according to the label is acceptable.

9.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)

Not required.

9.12 Monitoring data (KCP 10.8)

Not available, not required.

9.13 Classification and Labelling

Classification of Helioterpen Soufre regarding the environmental hazard can be performed according to Reg. No. 1272/2008 and Reg. No 547/2011. Data from laboratory testing are available for active substance and an equivalent product as detailed in chapter 9.5. These data indicate that the relevant NOEC for chronic effects is > 1 mg/L; hence, Helioterpen Soufre shall not be classified for chronic hazard, according to legal criteria.

Table 9.13.13: Justification for classification for ecotoxicological hazard according to Reg. No 1272/2008

Relevant endpoints for classification Cut-off criteria acc. to Conclusion Reg No. 1272/2008 – ap- Species Results pendix 1 section 4.1.3.3

Fish (Oncorhynchus EC50 > 153 mg a.s./L (96 h, s) > 100 mg/L Not classified mykiss)

Aquatic invertebrates EC50 > 200 mg a.s./L (48 h, s) > 100 mg/L Not classified (Daphnia magna)

Algae (Pseudokirch- EbC50 > 100 mg a.s./L mm (72 h, s) > 100 mg/L Not classified neriella subcapitata) ErC50 > 100 mg a.s./L mm (72 h, s)

As demonstrated in the risk assessment, the intended use of Helioterpen Soufre in cucumber does not pose an unacceptable risk for the environment. Therefore, the following labelling for risk mitigation (safety phrase) according to Reg. No 547/2011 is applicable:

Table 9.13-1 Labelling requirements according to Reg. No 547/2011

SP1 Do not contaminate water with the product or its container (Do not clean application equipment near surface water/Avoid contamination via drains from farmyards and roads).

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

KCP XXX 2002a Fish, acute toxicity test according to the 203 OECD guideline Y Action Pin 10.2.1/01 Report No. PC/66/091/01F/cd/BPL/e CTBA, Bordeaux, FRANCE GLP Unpublished KCP Marchal P. 2002b Daphnia sp., acute immobilisation test according to the 202 OECD Part 1 guideline N Action Pin 10.2.1/02 Report n° PC/66/091/01F/bd/BPL/e CTBA, Bordeaux, FRANCE GLP Unpublished KCP Marchal P. 2002c Alga, growth inhibition test according to the OECD 201 guideline N Action Pin 10.2.1/03 Report n° PC/66/091/01F/ad/BPL/e CTBA, Bordeaux, FRANCE GLP unpublished KCP Servajean E. 2007 Laboratory determination of the contact and oral toxicity of a formulation to honey bees (Apis mellifera N Action Pin 10.3.1.1.1/01 L.) (OECD 213 and OECD 214, September 1998) No.07-40-008-ES Phytosafe, Pau, FRANCE GLP Unpublished Page 36 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

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

KCP Clausse M., Lopez 2017 Statement on the chronic toxicity of Helioterpen Soufre on bees based on a scientific review open N Action Pin 10.3.1.1.2 M., Rolin C. literature Ref: ACT-201701-01 Redebel Regulatory Affairs SCRL Not GLP Unpublished

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

Title Data Verte- Company Report No. protec- Data brate Justification if data protection Author(s) Year Source (where different from company) tion Owner point study is claimed GLP or GEP status claimed Y/N Published or not Y/N Acute oral toxicity (LD50) study of sulphur dust in Japanese quail Data submitted as confirmatory Jai Research Foundation, Valvada (Gujarat), data under Directive 91/414, it KCP XXXXX 2008 India Y N doesn’t attract data protection. STF/SWG 10.1.1 Report no. 7715 Furthermore, it is also covered GLP by the Letter of Access unpublished Avian dietary toxicity study of sulphur dust in Japanese quail Data submitted as confirmatory Jai Research Foundation, Valvada (Gujarat), data under Directive 91/414, it KCP XXXXX 2008 India Y N doesn’t attract data protection. STF/SWG 10.1.1 Report no. 7714 Furthermore, it is also covered GLP by the Letter of Access unpublished Page 37 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Title Data Verte- Company Report No. protec- Data brate Justification if data protection Author(s) Year Source (where different from company) tion Owner point study is claimed GLP or GEP status claimed Y/N Published or not Y/N Acute Oral Toxicity Study (Acute Toxic Class Method) with Sulfur Dust in Japanese Quails Toxicology Department Rallis Research Center Bangalore Data submitted for the inclusion KCP XXXXX 2005 India Y N of the active substance. The data STF 10.1.1 Report No.: Report No.: 4263/05 (final) protection ended the 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Acute oral toxicity study of sulphur dust in rats. Data submitted as confirmatory Jai Research Foundation, Valvada (Gujarat), data under Directive 91/414, it KCP XXXXX 2009 India Y N doesn’t attract data protection. STF/SWG 10.1.3 Report no. 8390 Furthermore, it is also covered GLP by the Letter of Access unpublished Report on testing for acute toxicity: rainbow trout BASF AG; Ludwigshafen/Rhein; Germany Fed.Rep. Data submitted for the inclusion Non-GLP, studies were conducted prior to the KCP 10.2 XXXXX 1979b Y N of the active substance. The data SWG implementation of GLP, but are scientifically valid protection ended the 01/01/2015 Unpublished 1979/10131; Syngenta file No. SAN7116/5237. Bericht ueber die Pruefung der akuten Toxizitaet. Orientierende Pruefung: Regenbogenforelle Data submitted for the inclusion (Oncorhynchus mykiss WALBAUM 1792) KCP 10.2 XXXXX 1990 Y N of the active substance. The data SWG BASF AG; Ludwigshafen/Rhein; Germany Fed.Rep. protection ended the 01/01/2015 Non-GLP, Unpublished 1990/0417; Syngenta File N° SAN7116/5290 Page 38 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Title Data Verte- Company Report No. protec- Data brate Justification if data protection Author(s) Year Source (where different from company) tion Owner point study is claimed GLP or GEP status claimed Y/N Published or not Y/N Report on testing for acute toxicity: carp BASF AG; Ludwigshafen/Rhein; Germany Fed.Rep. Data submitted for the inclusion Non-GLP, studies were conducted prior to the KCP 10.2 XXXXX 1979a Y N of the active substance. The data SWG implementation of GLP but are scientifically valid protection ended the 01/01/2015 Unpublished 1979/10095 Fish toxicity trials with Cobox and Kumulus S BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Germany Fed.Rep. Data submitted for the inclusion KCP 10.2 XXXXX 1961 Non-GLP, studies were conducted prior to the Y N of the active substance. The data SWG implementation of GLP but are scientifically valid protection ended the 01/01/2015 Unpublished 1961/10049; Syngenta file No. SAN7116/5224 The prolonged toxicity of BAS 175 01 F to rainbow trout (28 days, flow-through system, OECD 204) Data submitted for the inclusion Dr. U. Noack - Laboratorium fuer angewandte Biologie; KCP 10.2 XXXXX 1991 Y N of the active substance. The data SWG Sarstedt; Germany Fed.Rep. protection ended the 01/01/2015 GLP, Unpublished 1991/10122, Syngenta File N° SAN7116/5296 Determination of the acute toxicity (48 h) to Daphnia magna STRAUS of BAS 175 01 F Data submitted for the inclusion Dr. U. Noack - Laboratorium fuer angewandte Biologie; KCP 10.2 Noack M. et al. 1990b N N of the active substance. The data SWG Sarstedt; Germany Fed.Rep. protection ended the 01/01/2015 GLP, Unpublished 1990/10085; Syngenta file No. SAN7116/5293. Page 39 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Title Data Verte- Company Report No. protec- Data brate Justification if data protection Author(s) Year Source (where different from company) tion Owner point study is claimed GLP or GEP status claimed Y/N Published or not Y/N 1. Amendment to report: Determination of the acute toxicity (48 h) to Daphnia magna STRAUS of BAS 175 01 F Data submitted for the inclusion KCP 10.2 Noack M. et al. 2000 Dr. U. Noack - Laboratorium fuer angewandte Biologie; N N of the active substance. The data SWG Sarstedt; Germany Fed.Rep. protection ended the 01/01/2015 GLP, Unpublished 2000/1018545 Determination of the acute toxicity of Kumulus S BAS 175 01 F to the waterflea Daphnia magna STRAUS BASF AG; Ludwigshafen/Rhein; Germany Fed.Rep. Data submitted for the inclusion Mueller H., Buechs KCP 10.2 1981 Non-GLP, studies were conducted prior to the N N of the active substance. The data SWG H. implementation of GLP but are scientifically valid protection ended the 01/01/2015 Unpublished 1981/11161; Syngenta file No. SAN7116/5277. Determination of the acute toxicity (48 h) to Daphnia magna STRAUS of Netzschwefel Stulln Data submitted for the inclusion Dr. U. Noack - Laboratorium fuer angewandte Biologie; KCP 10.2 Noack M. et al. 1990a N N of the active substance. The data SWG Sarstedt; Germany Fed.Rep. protection ended the 01/01/2015 GLP, unpublished 1990/1000563; Syngenta file No. SAN7116/5292 Effect of BAS 175 01 F on the reproduction of Daphnia magna STRAUS (OECD 202, semi-static, 21 days) Data submitted for the inclusion Dr. U. Noack - Laboratorium fuer angewandte Biologie; KCP 10.2 Noack M. et al. 1991 N N of the active substance. The data SWG Sarstedt; Germany Fed.Rep. protection ended the 01/01/2015 GLP, unpublished 1991/10232; Syngenta file No. SAN7116/5202. Page 40 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Title Data Verte- Company Report No. protec- Data brate Justification if data protection Author(s) Year Source (where different from company) tion Owner point study is claimed GLP or GEP status claimed Y/N Published or not Y/N The effects of Microthiol Special WG on reproduction in Daphnia magna Data submitted for the inclusion CEM Analytical Services Ltd.; Berkshire SL5 8JB; United KCP 10.2 Mallet M.J. et al. 2000 N N of the active substance. The data SWG Kingdom protection ended the 01/01/2015 GLP, unpublished 2000/1021241 Effect of BAS 175 01 F on the growth of the green alga Ankistrodesmus bibraianus Data submitted for the inclusion BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; KCP 10.2 Dohmen G.P. 1990c N N of the active substance. The data SWG Germany Fed.Rep. protection ended the 01/01/2015 GLP, unpublished 1990/10217; Syngenta file No. SAN7116/5295 Einfluss von Kumulus S (BAS 175 01 F) auf das Wachstum von Chlorella fusca BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Data submitted for the inclusion Germany Fed.Rep. KCP 10.2 Hamm R. 1983 N N of the active substance. The data SWG Non-GLP, studies were conducted prior to the protection ended the 01/01/2015 implementation of GLP but are scientifically valid Unpublished 1983/11024; Syngenta file No. SAN7116/5282 Acute Toxicity of Sulfur Dust to Rainbow Trout (Oncorhynchus mykiss) in a 96-hour Semi Static Test. Institute für Biologische Analytik und Consulting Data submitted for the inclusion KCP 10.2 XXXXX 2005 IBACON GmbH, Rossdorf, Germany Y N of the active substance. The data STF Report No.: Report No.: 23121230 protection ended the 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Page 41 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Title Data Verte- Company Report No. protec- Data brate Justification if data protection Author(s) Year Source (where different from company) tion Owner point study is claimed GLP or GEP status claimed Y/N Published or not Y/N Acute Toxicity of Sulfur Dust to Rainbow Trout (Oncorhynchus mykiss) in a 96-hour Semi Static Test. Institute für Biologische Analytik und Consulting Data submitted for the inclusion 2005 KCP 10.2 XXXXX IBACON GmbH, Rossdorf, Germany Y N of the active substance. The data STF a’ Report No.: Report No.: 23121230 (final) protection ended the 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Acute Toxicity of Sulfur Dust to Daphnia magna in a 48- hour Immobilization Test. Institute für Biologische Analytik und Consulting Data submitted for the inclusion Moll, M.; Wydra, KCP 10.2 2005 IBACON GmbH, Rossdorf, Germany N N of the active substance. The data STF V. Report No.: Report No.: 23122220 protection ended the 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Acute Toxicity of Sulfur Dust to Daphnia magna in a 48- hour Immobilization Test. Institute für Biologische Analytik und Consulting Data submitted for the inclusion Moll, M.; Wydra, KCP 10.2 2005 IBACON GmbH, Rossdorf, Germany N N of the active substance. The data STF V. Report No.: Report No.: 23122220 (final) protection ended the 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Toxixity of Sulfur Dust to Desmodesmus Subspicatus in an Algal Growth Inhibition Test Institute für Biologische Analytik und Consulting Data submitted for the inclusion KCP 10.2 / 2005 IBACON GmbH, Rossdorf, Germany N N of the active substance. The data STF Report No.: Report No.: 23123210 protection ended the 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Page 42 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Title Data Verte- Company Report No. protec- Data brate Justification if data protection Author(s) Year Source (where different from company) tion Owner point study is claimed GLP or GEP status claimed Y/N Published or not Y/N Toxixity of Sulfur Dust to Desmodesmus Subspicatus in an Algal Growth Inhibition Test Institute für Biologische Analytik und Consulting Data submitted for the inclusion 2005 KCP 10.2 / IBACON GmbH, Rossdorf, Germany N N of the active substance. The data STF b’ Report No.: Report No.: 23123210 (final) protection ended the 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Sediment-water chironomid toxicity test using sediment spiked with sulphur dust Data submitted as confirmatory NOTOX B.V., Hertogenbosch, The data under Directive 91/414, it Desmares- KCP 10.2 2010 Netherlands N N doesn’t attract data protection. STF/SWG Koopmans M.J.E Report no. 490607 Furthermore, it is also covered GLP by the Letter of Access unpublished Sediment-water chironomid toxicity test using water spiked with sodium sulphate Data submitted as confirmatory Desmares- NOTOX B.V., Hertogenbosch, The data under Directive 91/414, it KCP 10.2 Koopmans, 2009 Netherlands N N doesn’t attract data protection. STF/SWG M.J.E Report no. 490606 Furthermore, it is also covered GLP by the Letter of Access unpublished Ergebnisse der Laboratoriumspruefung auf Bienengefaehrlichkeit von BAS 175 06 F BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Data submitted for the inclusion KCP Germany Fed.Rep. Adolphi H. 1979 N N of the active substance. The data SWG 10.3.1 Non-GLP, studies were conducted prior to the protection ended the 01/01/2015 implementation of GLP but are scientifically valid Unpublished 1979/11241 Page 43 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Title Data Verte- Company Report No. protec- Data brate Justification if data protection Author(s) Year Source (where different from company) tion Owner point study is claimed GLP or GEP status claimed Y/N Published or not Y/N Zulassung als bienenungefaehrliches Pflanzenschutzmittel: Kumulus Netzschwefel Biologische Bundesanstalt für Land- und Forstwirtschaft; Data submitted for the inclusion KCP Berlin-Dahlem; Germany Fed.Rep. Herfs W. 1973 N N of the active substance. The data SWG 10.3.1 Non-GLP, studies were conducted prior to the protection ended the 01/01/2015 implementation of GLP but are scientifically valid Unpublished 1973/10731 Ergebnisse der Laboratoriumspruefung auf Bienengefaehrlichkeit von BAS 175 06 F BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Data submitted for the inclusion KCP Germany Fed.Rep. Adolphi H. 1979 N N of the active substance. The data SWG 10.3.1 Non-GLP, studies were conducted prior to the protection ended the 01/01/2015 implementation of GLP but are scientifically valid Unpublished 1979/11241 Effects of Sulfur Dust (Acute Contact and Oral) on Honey Bees (Apis mellifera L.) in the Laboratory Institute für Biologische Analytik und Consulting Data submitted for the inclusion KCP Schmitzer, S. 2005 IBACON GmbH, Rossdorf, Germany N N of the active substance. The data STF 10.3.1 Report No.: Report No.: 23124035 protection ended the 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N A laboratory test to determine the effect of Microthiol Special WG (an 80% w/w formulation of Sulfur) on the Data submitted for the inclusion KCP parasitic wasp, Aphidius rhopalosiphi Baxter I. 2000a N N of the active substance. The data SWG 10.3.2 Mambo-Tox Ltd.; Southampton; United Kingdom protection ended the 01/01/2015 GLP, unpublished 2000/1021237 Page 44 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Title Data Verte- Company Report No. protec- Data brate Justification if data protection Author(s) Year Source (where different from company) tion Owner point study is claimed GLP or GEP status claimed Y/N Published or not Y/N Auswirkung von BAS 175 01 F auf Trichogramma cacoeciae Marchal (Hym., Trichogrammatidae) als Vertreter der Mikrohymenopteren im Labor; Pruefung an Data submitted for the inclusion KCP Imagines (Test A) Kuehner C. 1991a N N of the active substance. The data SWG 10.3.2 GAB Biotechnologie GmbH; Niefern-Oeschelbronn; protection ended the 01/01/2015 Germany Fed.Rep. GLP, unpublished 1991/10709 A laboratory test to determine the effect of Microthiol Special WG (an 80% w/w formulation of Sulfur) on the Data submitted for the inclusion KCP parasitic wasp, Aphidius rhopalosiphi Baxter I. 2000a N N of the active substance. The data SWG 10.3.2 Mambo-Tox Ltd.; Southampton; United Kingdom protection ended the 01/01/2015 GLP, unpublished 2000/1021237 Aenderungserklaerung zum Abschlussbericht der Studie 172/01-Tc: Auswirkung von BAS 175 01 F auf Trichogramma cacoeciae Marchal (Hym., Trichogrammatidae) als Vertreter der Mikrohymenopteren Data submitted for the inclusion KCP Kuehner C. 1991b im Labor; Pruefung an Imagines (Test A) N N of the active substance. The data SWG 10.3.2 GAB Biotechnologie GmbH; Niefern-Oeschelbronn; protection ended the 01/01/2015 Germany Fed.Rep. GLP, unpublished 1991/11115; Syngenta file No. SAN7116/5297. Effects on predatory mites (Typhlodromus pyri) exposed to BAS 175 01 F in a laboratory trail (non-GLP) Data submitted for the inclusion KCP BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Ufer A. 2005 N N of the active substance. The data SWG 10.3.2 Germany Fed.Rep. protection ended the 01/01/2015 Non-GLP, unpublished 2005/1010983 Page 45 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Title Data Verte- Company Report No. protec- Data brate Justification if data protection Author(s) Year Source (where different from company) tion Owner point study is claimed GLP or GEP status claimed Y/N Published or not Y/N A laboratory test to determine the effect of Microthiol Special WG (an 80% w/w formulation of Sulfur) on the Data submitted for the inclusion KCP ground-active beetle, Aleochara bilineata Vinall S. 2000 N N of the active substance. The data SWG 10.3.2 Mambo-Tox Ltd.; Southampton; United Kingdom protection ended the 01/01/2015 GLP, unpublished 2000/1021238 A laboratory test to determine the effect of Microthiol Special WG (an 80% w/w formulation of Sulfur) on the ground beetle, Poecilus cupreus Data submitted for the inclusion KCP Baxter I. 2000c Agrochemical Evaluation Unit; Southampton SO16 7PX; N N of the active substance. The data SWG 10.3.2 United Kingdom protection ended the 01/01/2015 GLP, unpublished 2000/1021240 A laboratory test to determine the effect of Microthiol Special WG (an 80% w/w formulation of Sulfur) on the Data submitted for the inclusion KCP green lacewing, Chrysoperla carnea Baxter I. 2000b N N of the active substance. The data SWG 10.3.2 Mambo-Tox Ltd.; Southampton; United Kingdom protection ended the 01/01/2015 GLP, unpublished 2000/1021239 Zulassungspruefung 1991 an Nutzarthropoden im Laboratorium: Coccinella septempunctata L. Data submitted for the inclusion KCP Landwirtschaftskammer Westfalen-Lippe; Münster; Kock H. 1991 N N of the active substance. The data SWG 10.3.2 Germany Fed.Rep. protection ended the 01/01/2015 Non-GLP, unpublished 1991/10751, Syngenta File N° SAN7116/5213 Page 46 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Title Data Verte- Company Report No. protec- Data brate Justification if data protection Author(s) Year Source (where different from company) tion Owner point study is claimed GLP or GEP status claimed Y/N Published or not Y/N An extended laboratory study to evaluate the effects of BAS 175 01 F on the aphid parasitoid, Aphidius rhopalosiphi De Stefani Perez (Hymenoptera, Braconidae) Data submitted for the inclusion KCP (dose response) Warmers C. 2003b N N of the active substance. The data SWG 10.3.2 GAB Biotechnologie GmbH & IFU Umweltanalytik protection ended the 01/01/2015 GmbH; Niefern-Oeschelbronn; Germany Fed.Rep. GLP, unpublished 2003/1012056; Syngenta file No. SAN7116/5222. An extended laboratory study to evaluate the effect of BAS 175 01 F on the egg parasitoid, Trichogramma cacoeciae Marchal (Hymenoptera, Trichogrammatidae) (dose Data submitted for the inclusion KCP reponse) Warmers C. 2003a N N of the active substance. The data SWG 10.3.2 GAB Biotechnologie GmbH & IFU Umweltanalytik protection ended the 01/01/2015 GmbH; Niefern-Oeschelbronn; Germany Fed.Rep. GLP, unpublished 2003/1012055; Syngenta file No. SAN7116/5221. Effects of Sulfur Dust on the Parasitoid Aphidius rhopalosiphi in the Laboratory – Dose Response Test – Institute für Biologische Analytik und Consulting Data submitted for the inclusion KCP Moll, M. and 2005 IBACON GmbH, Rossdorf, Germany N N of the active substance. The data STF 10.3.2 Bützler, R Report No.: Report No.: 23125001 protection ended the 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Page 47 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Title Data Verte- Company Report No. protec- Data brate Justification if data protection Author(s) Year Source (where different from company) tion Owner point study is claimed GLP or GEP status claimed Y/N Published or not Y/N Effects of Sulfur Dust on the Predatory Mite Typhlodromus pyri in the Laboratory – Dose Response Test – Data submitted for the inclusion KCP Institute für Biologische Analytik und Consulting Rosenkranz, B. 2005 N N of the active substance. The data STF 10.3.2 IBACON GmbH, Rossdorf, Germany protection ended the 01/01/2015 Report No.: Report No.: 23126063 GLP/GEP (Y/N): Y Published (Y/N): N Effects of Sulfur Dust on the Carabid Beetle Poecilus cupreus L. in the Laboratory Institute für Biologische Analytik und Consulting Data submitted for the inclusion KCP Schmitzer, S. 2005 IBACON GmbH, Rossdorf, Germany N N of the active substance. The data STF 10.3.2 Report No.: Report No.: 23128006 protection ended the 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Effects of Sulfur Dust on the Lacewing Chrysoperla carnea in the Laboratory – Limit Test – Institute für Biologische Analytik und Consulting Data submitted for the inclusion KCP Rosenkranz, B. 2005 IBACON GmbH, Rossdorf, Germany N N of the active substance. The data STF 10.3.2 Report No.: Report No.: 23127046 protection ended the 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Effects of Sulfur Dust on the Parasitoid Aphidius rhopalosiphi, Extended Laboratory Study- Dose Response Test – Data submitted for the inclusion KCP Institute für Biologische Analytik und Consulting Moll, M. 2005 N N of the active substance. The data STF 10.3.2 IBACON GmbH, Rossdorf, Germany protection ended the 01/01/2015 Report No.: Report No.: 25671002 GLP/GEP (Y/N): Y Published (Y/N): N Page 48 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Title Data Verte- Company Report No. protec- Data brate Justification if data protection Author(s) Year Source (where different from company) tion Owner point study is claimed GLP or GEP status claimed Y/N Published or not Y/N Effects of Sulfur Dust on the Predatory Mite Typhlodromus pyri Extended Laboratory Study – Dose Response Test Data submitted for the inclusion KCP Rosenkranz, B. and Institute für Biologische Analytik und Consulting 2005 N N of the active substance. The data STF 10.3.2 Blützler, R. IBACON GmbH, Rossdorf, Germany protection ended the 01/01/2015 Report No.: Report No.: 25673062 GLP/GEP (Y/N): Y Published (Y/N): N Effects of Sulfur Dust on the Lacewing Chrysoperla carnea – Extended Laboratory Study – Institute für Biologische Analytik und Consulting Data submitted for the inclusion KCP Rosenkranz, B. 2005 IBACON GmbH, Rossdorf, Germany N N of the active substance. The data STF 10.3.2 Report No.: Report No.: 25672047 protection ended the 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N An aged residues study to evaluate the duration of effects of Sulfur 80 WG (BAS 17501F) on the egg parasitoid, Trichogramma cacoeciae (Hymenoptera, Data submitted as confirmatory Trichogrammatidae) data under Directive 91/414, it KCP Warmers C. 2005 GAB Biotechnologie GmbH & GAB N N doesn’t attract data protection. SWG 10.3.2 Analytik GmbH, Niefern-Öschelbronn, Furthermore, it is also covered Germany by the Letter of Access Report no. 20041260/01-NETc GLP unpublished Page 49 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Title Data Verte- Company Report No. protec- Data brate Justification if data protection Author(s) Year Source (where different from company) tion Owner point study is claimed GLP or GEP status claimed Y/N Published or not Y/N Effect of BAS 175 01 F on the mortality of the earthworm Eisenia fetida Data submitted for the inclusion BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; KCP 10.4 Dohmen G.P. 1990a N N of the active substance. The data SWG Germany Fed.Rep. protection ended the 01/01/2015 GLP, unpublished 1990/10185; Syngenta file No. SAN7116/5294. Acute Toxicity (14 Days) of Sulfur Dust to the Earthworm Eisenia fetida in Artificial Soil Institute für Biologische Analytik und Consulting Data submitted for the inclusion KCP 10.4 Lührs, U. 2005 IBACON GmbH, Rossdorf, Germany N N of the active substance. The data STF Report No.: Report No.: 23129021 protection ended the 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Effect of Kumulus WG (BAS 175 01 F) on nitrification BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Data submitted for the inclusion KCP 10.5 Dohmen G.P. 1990a Germany Fed.Rep. N N of the active substance. The data SWG GLP, unpublished protection ended the 01/01/2015 1990/0146 Effect of Kumulus WG (BAS 175 01 F) on soil respiration BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Data submitted for the inclusion KCP 10.5 Gerhardt R. 1989 Germany Fed.Rep. N N of the active substance. The data SWG GLP, unpublished protection ended the 01/01/2015 1989/10172; Syngenta file No. SAN7116/5287. Effects of Sulfur Dust on the Activity of the Soil Microflora in the Laboratory Institute für Biologische Analytik und Consulting Data submitted for the inclusion KCP 10.5 Reis, K.-H 2005 IBACON GmbH, Rossdorf, Germany N N of the active substance. The data STF Report No.: Report No.: 23120080 protection ended the 01/01/2015 GLP/GEP (Y/N): Y Published (Y/N): N Page 50 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Title Data Verte- Company Report No. protec- Data brate Justification if data protection Author(s) Year Source (where different from company) tion Owner point study is claimed GLP or GEP status claimed Y/N Published or not Y/N BAS 175 01 F: Effects on non-target plants in the greenhouse - A limit test BASF AG, Agrarzentrum Limburgerhof; Limburgerhof; Data submitted for the inclusion Oberwalder C., KCP 10.6 2000 Germany Fed.Rep. N N of the active substance. The data SWG Schmidt O. Non-GLP, not subject to GLP regulations protection ended the 01/01/2015 Unpublished 2000/1017176; Syngenta file No. SAN7116/5214.

List of data submitted by the applicant and not relied on No data.

List of data relied on not submitted by the applicant but necessary for evaluation No additional data required. Page 51 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Appendix 2 Detailed evaluation of the new studies

A 2.1 KCP 10.1 Effects on birds and other terrestrial vertebrates

A 2.1.1 KCP 10.1.1 Effects on birds

A 2.1.1.1 KCP 10.1.1.1 Acute oral toxicity

A 2.1.1.2 KCP 10.1.1.2 Higher tier data on birds

A 2.1.2 KCP 10.1.2 Effects on terrestrial vertebrates other than birds

A 2.1.2.1 KCP 10.1.2.1 Acute oral toxicity to mammals

A 2.1.2.2 KCP 10.1.2.2 Higher tier data on mammals

A 2.1.3 KCP 10.1.3 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)

A 2.2 KCP 10.2 Effects on aquatic organisms

A 2.2.1 KCP 10.2.1 Acute toxicity to fish, aquatic invertebrates, or effects on aquatic algae and macrophytes

A 2.2.1.1.1 Fish, acute toxicity

Comments of zRMS: The validity criteria of the OECD TG 203 are met. The LC50 > 153 mg prod./L (> 107 mg a.s./L) is confirmed.

Reference: KCP 10.2.1/01 Report Fish, acute toxicity test according to the 203 OECD guideline, XXX, 2002a, Report n° PC/66/091/01F/cd/BPL/e, CTBA (Bordeaux, France), unpublished Guideline(s): OECD 203 Deviations: No GLP: Yes Acceptability: Yes Page 52 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Duplication Study dated from 2002 (if vertebrate study)

Environmental conditions Temperature: Test solution 24 H 48 H 72 H 96 H temperature Lowest temper- 13.9°C* 13.7°C* 14.6°C 14.5°C ature Highest temper- 19.2°C* 15.6°C* 15.3°C 16.2°C ature * data recoreded after 24 hours and 48 hours must not been considered: a wrong position of the temperature probe was responsible for these variations out of the accepted interval. pH: 7.1 - 7.8 Concentration in oxygen: dissolved oxygen: between 75 % and 95% of saturation Photoperiod: cycle of 16 hours light and 8 hours darkness

Study design and methods: 1. In life dates: between 10 and 29 January 2002 2. Organisms assignment and treatment A semi-static test system was used to determine the toxicity for rainbow trout (Oncorhynchus mykiss) exposed to HELIOSOUFRE S in freshwater. The test vessels were filled with 15 L volume of test media. At the start of the test 7 fish were introduced to each aquarium in a random order. Test concentrations used were 0 (control), 30, 45, 68, 102, and 153 mg HELIOSOUFRE S/L. The test medium was replaced every 24 hours in order to keep the concentrations of HELIOSOUFRE S as constant as possible during the test period. Fish were held in test water for at least 12 days before the start of the test. 3. Test item analysis The HELIOSOUFRE S presence in the test solutions was followed via the organic fraction analysis, which was made with the D.O.C. (Dissolved Organic Carbon) analysis of the test solution containing the highest test substance concentration without fish at the beginning and at the end of the first renewal. 4. Observations Page 53 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Fish were observed for symptoms of intoxication and mortality after 24, 48, 72 and 96 hours. Water temperature, pH values, and dissolved oxygen concentrations were determined before the test solutions renewal.

Results and discussions At the start of the experiment (T0H), the measured HELIOSOUFRE S concentration was 97.5% of the nominal concentration expressed as D.O.C. Before the first renewal after 24 hours (T24H), the measured HELIOSOUFRE S concentration was 107.6% of the nominal D.O.C. value at the beginning of the test. In the study conditions, the T0H and T24H D.O.C. concentrations of the 153 mg/L test solution were constant within the 24 hours period. All results are thus expressed as nominal concentrations. A deposit of the test substance was present in the aquarium containing the test substance: this deposit corresponded to the test substance Sulfur particles sedimentation during experimentation. In the control and in all tested concentrations, all fish survived until the end of the test. Some abnormal behaviour was noted during the course of the test. After 24 hours, trouts in the 153 mg/L test solution were more emphatic than the trouts from the other aquaria. Detailed results are shown in Table A KCP 10.2.1-1. The 96-hour LC50 for HELIOSOUFRE S was > 153 mg formulation/L.

During the test, pH ranged from 7.1 to 7.8, dissolved oxygen concentrations were 75 % – 95% air saturation value and temperatures ranged between 13.7 and 19.2°C°C. Table A KCP 10.2.1-1 Mortality of fish exposed for 96 hours to HELIOSOUFRE S Nominal concen- Cumulative number of dead fish at every observation time Number of tration of test item fish 24 h 48 h 72 h 96 h (mg/L) control 7 0 0 0 0 30 7 0 0 0 0 45 7 0 0 0 0 68 7 0 0 0 0 102 7 0 0 0 0 153 7 0 0 0 0

Conclusion

In the conditions of the test, the 96 hours LC50 of HELIOSOUFRE S to Oncorhynchus mykiss was determined to be > 153 mg/L. (XXX, 2002a)

A 2.2.1.1.2 Aquatic invertebrates, acute toxicity

Comments of zRMS: The validity criteria of the OECD TG 202 are met. The EC50 > 200 mg prod./L (> 140 mg a.s./L) is confirmed.

Reference: KCP 10.2.1/02

Report Daphnia sp., acute immobilisation test according to the 202 OECD Part 1 guideline, Marchal P., 2002b, Report n° PC/66/091/01F/bd/BPL/e, CTBA (Bordeaux, France), unpublished Guideline(s): OECD 202 Deviations: No Page 54 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

GLP: Yes Acceptability: Yes Duplication NA (if vertebrate study)

Materials and methods Materials 1. Test Material: HELIOSOUFRE S Description: yellow coloured suspension hydrodispersable Lot/Batch #: 12013 Purity: 693 g Sulfur/L (analysed) Stability of test compound: stable in test conditions 2. System: static (reconstituted water) 3. Test organism Species: daphnid (Daphnia magna Straus, clone 5) Age: less than 24 hours (size between 560 µm and 800 µm) Source: in-house laboratory cultures Acclimation period: not necessary since the test used daphnids derived from in-house laboratory cultures Diet: None Holding conditions: test tubes containing 10 mL of test medium / 5 animals / 4 replicates Environmental conditions Temperature: 19 - 21 °C Concentration in oxygen: dissolved oxygen: between 8.0 to 8.9 mg O2/L pH: 7.9 – 8.0 Photoperiod: darkness

Study design and methods: 1. In life dates: between 17 and 29 January 2002 2. Organisms assignment and treatment Daphnids were assigned to the test groups listed in Table IIIA 10.2.2-2. They were exposed by groups of 5 in 4 replicates for 48 hours to nominal concentrations of 0, 6.25, 12.5, 25.0, 50.0, 100 and 200 mg HELI- OSOUFRE S/L in reconstituted water. 3. Test item analysis HELIOSOUFRE S presence in the test solutions was followed via the organic fraction analysis, which was made with the D.O.C. (Dissolved Organic Carbon) analysis of the test solution containing the highest test substance concentration without daphnids at the beginning and at the end of the test. 4. Observations Immobilisation was observed by visual control after 24 and 48 hours of exposure.

Results and discussions At the start of the experiment (T0H), the measured HELIOSOUFRE S concentration was 94.2 % of the nominal concentration expressed as D.O.C. At the end of the test, the measured HELIOSOUFRE S concentration was 98.5% of the nominal D.O.C. value. In the study conditions, the T0H and T48H D.O.C. concentrations of the 200 mg/L test solution were constant within the test period. All results are thus expressed as nominal concentrations. A deposit of the test substance was present in the test tubes containing the test substance: this deposit corresponded to the test substance Sulfur particles sedimentation during experimentation.

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IMMOBILISATION Details are provided in Table A KCP 10.2.1-2 immobilisation occurred for each concentration up to 48 hours. The 48 hours EC50 was determined to be > 200 mg/L.

Table A KCP 10.2.1-2 Immobilisation of daphnids exposed for 24 and 48 hours to HELIOSOUFRE S Nominal concen- Immobilization at Nb of tration of test item 24 hours 48 hours daphnids (mg/L) Nb. % Nb. % control 4 * 5 0 0 0 0 6.25 4 * 5 0 0 0 0 12.5 4 * 5 0 0 0 0 25.0 4 * 5 0 0 0 0 50.0 4 * 5 0 0 0 0 100 4 * 5 0 0 0 0 200 4 * 5 0 0 0 0

Conclusion

In the conditions of the test, the 48 hours EC50 of HELIOSOUFRE S to Daphnia magna was determined to be > 200 mg/L. (Marchal P., 2002b)

A 2.2.1.1.3 Algae, acute toxicity

Comments of zRMS: The validity criteria of the OECD TG 201 are met. The analytical determination of the product via DOC measurement (of the organic fraction in the product) is suitable for confirming correct initial concentrations the product in test solutions/suspensions, but will not provide information on the course of concentrations of the a.s. sulfur during the test. Based on the knowledge from other tests, it can be expected that sulfur contents in the test test solutions/suspensions will remain sufficiently stable over the test duration. According to the test results, the formulants in Helioterpen Soufre are unlikely to exert a relevant adverse effect to algae. Hence, expressing the endpoints as nominal concentrations is considered meaningful. The EbC50 and ErC50 > 100 mg prod./L (> 70 mg a.s./L) is confirmed.

Reference: KCP 10.2.1/03

Report Alga, growth inhibition test according to the OECD 201 guideline, Marchal P., 2002c, Report n° PC/66/091/01F/ad/BPL/e, CTBA (Bordeaux, France), unpublished Guideline(s): OECD 201 Deviations: No Page 56 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

GLP: Yes Acceptability: Yes Duplication NA (if vertebrate study)

Materials and methods Materials 1. Test Material: HELIOSOUFRE S Description: yellow coloured suspension hydrodispersable Lot/Batch #: 12013 Purity: 693 g Sulfur/L (analysed) Stability of test compound: stable in test conditions 2. System: static (reconstituted water) 3. Test organism Species: Pseudokirchneriella subcapitata, strain number CAP 278.4 Initial cell count: 1 * 104 cells/mL Source: in-house laboratory cultures Acclimation period: not necessary since the test used algae derived from in-house laboratory cultures Holding conditions: Erlenmeyrs flasks containing 250 mL of test medium / 3 replicates for each concentration and the double (six erlenmeyers) for the controls Environmental conditions Temperature: 23 - 25 °C pH: 7.7 – 9.6 Photoperiod: continuous illumination (7472 lux)

Study design and methods: 1. In life dates: between 18 and 29 January 2002 2. Organisms assignment and treatment Algae were exposed in 3 replicates for each concentration for 72 hours to nominal concentrations of 0, 1.2, 3.7, 11.0, 33.0 and 100 mg Héliosoufre S/L in reconstituted water as listed in Table IIIA 10.2.2-3. 3. Test item analysis HELIOSOUFRE S presence in the test solutions was followed via the organic fraction analysis, which was made with the D.O.C. (Dissolved Organic Carbon) analysis of the test solution containing the highest test substance concentration without algae at the beginning and at the end of the test. 4. Observations Algal concentrations were measured after 24, 48 and 72 hours of exposure with a Malassez counting cell, in order to avoid the Sulfur particle counting.

Results and discussions At the start of the experiment (T0H), the measured HELIOSOUFRE S concentration was 109.7 % of the nominal concentration expressed as D.O.C. At the end of the test, the measured HELIOSOUFRE S concentration was 70.9% of the nominal D.O.C. value at T0H. All results are thus expressed as nominal concentrations. There was no problem of sedimentation as the algae study was made under agitation. The Sulfur particles Page 57 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version of the test substance Héliosoufre S had a size around 5 µm which was near the size of the algae.

Algal concentrations values expressed as cell number * 104/mL of dilution water were shown in Table A KCP 10.2.1-3. Measurements were made on a Malassez counting cell. Growth curves (algal concentration via time) were presented in the report. The graphic determination on a log-probit scale gave a linear regres- sion concentration/effetcts (biomass inhibition and growth rate inhibition) with the scientific software Sig- maPlot 2000.

Table A KCP 10.2.1-3 Mean algal cell densities during the test period of 72 hours Nominal Concentra- Density of Algal Cells (* 104) tion (mg /L) Heliosoufre S 0 h 24 h 48 h 72 h 0 1.0 7.25 57.7 310 1.2 1.0 6.17 33.5 283 3.7 1.0 9.00 40.5 261 11.0 1.0 6.17 44.2 244 33.0 1.0 7.17 40.8 234 100 1.0 6.67 36.0 225

The effects on algal biomass and growth rate were less than 50 %.

Conclusion

In the conditions of the test, the 72 hours EbC50 and ErC50 of HELIOSOUFRE S to Pseudokirchneriella subcapitata were determined to be > 100 mg/L. (Marchal P., 2002c)

A 2.2.2 KCP 10.2.2 Additional long-term and chronic toxicity studies on fish, aquatic invertebrates and sediment dwelling organisms

A 2.2.3 KCP 10.2.3 Further testing on aquatic organisms

A 2.3 KCP 10.3 Effects on arthropods

A 2.3.1 KCP 10.3.1 Effects on bees

A 2.3.1.1 KCP 10.3.1.1 Acute toxicity to bees

The following bee acute toxicity study performed on Heliosoufre S is provided in support of the assessment and has not been previously evaluated. Since no major deviations from the guideline were reported which could have influenced the results of the study only a brief summary and the endpoints are presented below.

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Servajean E. 2007, Laboratory determination of the contact and oral acute toxicity of a formulation to honey bees (Apis mellifera). Phytosafe s.a.r.I. Pau, France, study no. 07-40-008-ES

Document No: Study no. 07-40-008-ES

Guidelines: OECD 213 and 214

GLP: Yes

Materials and Methods

In a test under laboratory conditions Heliosoufre S 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 caucasica triple hybrid

Test substance: Heliosoufre S (sulphur 710 g/L)

Control: Oral: 50 % aqueous sucrose solution Contact: water/acetone 50/50 v/v solution

Toxic standard: Dimethoate Oral: 0.10, 0.20, 0.35, µg a.s./bee Contact: 0.10, 0.17, 0.30 µg a.s./bee dissolved in water/acetone 50/50 v/v solution

Doses: Oral (Heliosoufre S sucrose solution): 100 µg product/bee Contact (Heliosoufre S dissolved in water/acetone 50/50 v/v solution): 100 µg product/bee

Bees per dose: oral: 10 contact: 20, control: 20

Replicates: 3

Oral toxicity study: In a limit test, three replicates of 10 bees (20 in control) were fed with a sugar/water solution containing Heliosoufre S. The tested concentration was 100 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 20 - 28°C. Biological observations including mortality and behavioural changes were recorded at 4, 24 and 48 hours after dosing. Results are based on nominal concentrations of the product per bee.

Contact toxicity study: In a limit test, three replicates of 20 bees were exposed to Heliosoufre S dissolved in water/acetone 50/50 v/v solution, administered topically in a small droplet (1 µl) to the thorax of each bee. The tested concentration was 100 µg product/bee. A group of bees treated with an equivalent volume of water/acetone 50/50 v/v solution was used as control. Dimethoate solved in water/acetone 50/50 v/v solution was used as toxic standard. The test was conducted at darkness and a temperature of 20 - 28°C. Biological observations, including mortality and behavioural changes were recorded at 4, 24 and 48 hours after application. Page 59 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

Findings Oral toxicity study The ingestion of the test item treated syrup was difficult to obtain: the treated units consisted of 8-12 bees only for 14 to 20 in control units. It was thus concluded that the test item was slightly repellent. The oral application of the test item at 100.9 µg/bee had no adverse effect on the bee viability. The percentage of mortality was similar to that of the control group. The oral test is valid as the control mortality was ≤ 10 % and the LD50 value for dimethoate occurred between 0.10 and 0.35 µg/bee.

Table 10.3.1.1-1: Mortality of bees in the oral toxicity test Mean Mean % mortality Treatment µg/bee treated 4 h 24 h 48 h number* Control - 17.3 0.00 2.36 10.1 Heliosoufre S 100.9 10.0 0.00 4.17 11.7 0.10 15.3 0.00 3.77 9.17 Dimethoate 0.20 14.0 22.5 100 100 0.35 12.7 49.3 100 100 *Mean of three replicates

Contact toxicity study The test item was also not harmful when applied at 100 µg/bee via contact exposure. Percent mortality ranged between 0 and 15 % of the treated populations, and mean values were calculated as 3.3 % and 10.0 %, 24 h and 48 h after the treatment application, respectively, as compared to 1.7 % and 6.7 % for the control group.

Table 10.3.1.1-2: Mortality of bees in the contact toxicity test Mean Mean % mortality Treatment µg/bee treated 4 h 24 h 48 h number* Control - 20.0 0.00 1.67 6.67 Heliosoufre S 100.5 20.0 0.00 3.33 10.0 0.10 20.0 0.00 16.7 35.0 Dimethoate 0.17 20.0 0.00 90.0 95.0 0.30 20.0 0.00 95.0 98.3 *Mean of three replicates

Conclusions

The oral LD50 of Heliosoufre S was determined to be > 100 µg product/bee. The contact LD50 of Heliosoufre S was determined to be > 100 µg product/bee.

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A 2.3.1.1.1 KCP 10.3.1.1.1 Acute oral toxicity to bees

Refer to A 2.3.1.1

A 2.3.1.1.2 KCP 10.3.1.1.2 Acute contact toxicity to bees

Refer to A 2.3.1.1

A 2.3.1.2 KCP 10.3.1.2. Chronic toxicity to bees

No 10-day chronic feeding test on bees with the formulation or a comparable formulation ac-cording to the new Annex III data requirements (Nr. 284/2013) has been submitted.

A 2.3.1.3 KCP 10.3.1.3 Effects on honey bee development and other honey bee life stages

No chronic larval toxicity test with the formulation or a comparable formulation according to the new An- nex III data requirements (Nr. 284/2013) has been submitted.

A 2.3.1.4 KCP 10.3.1.4 Sub-lethal effects

Not required.

A 2.3.1.5 KCP 10.3.1.5 Cage and tunnel tests

Not required.

A 2.3.1.6 KCP 10.3.1.6 Field tests with honeybees

Not required.

A 2.3.2 KCP 10.3.2 Effects on non-target arthropods other than bees

A 2.3.2.1 KCP 10.3.2.1 Standard laboratory testing for non-target arthropods

A 2.3.2.2 KCP 10.3.2.2 Extended laboratory testing, aged residue studies with non-target arthropods

A 2.3.2.3 KCP 10.3.2.3 Semi-field studies with non-target arthropods

A 2.3.2.4 KCP 10.3.2.4 Field studies with non-target arthropods Page 61 /61 Template for chemical PPP Version April 2015 ZV1 008989-00/00 / Helioterpen Schwefel Part B – Section 9 - Core Assessment zRMS version

A 2.3.2.5 KCP 10.3.2.5 Other routes of exposure for non-target arthropods

A 2.4 KCP 10.4 Effects on non-target soil meso- and macrofauna

A 2.4.1 KCP 10.4.1 Earthworms

A 2.4.1.1 KCP 10.4.1.1 Earthworms - sub-lethal effects

A 2.4.1.2 KCP 10.4.1.2 Earthworms - field studies

A 2.4.2 KCP 10.4.2 Effects on non-target soil meso- and macrofauna (other than earthworms)

A 2.4.2.1 KCP 10.4.2.1 Species level testing

A 2.4.2.2 KCP 10.4.2.2 Higher tier testing

A 2.5 KCP 10.5 Effects on soil nitrogen transformation

A 2.6 KCP 10.6 Effects on terrestrial non-target higher plants

A 2.6.1 KCP 10.6.1 Summary of screening data

A 2.6.2 KCP 10.6.2 Testing on non-target plants

A 2.6.3 KCP 10.6.3 Extended laboratory studies on non-target plants

A 2.6.4 KCP 10.6.4 Semi-field and field tests on non-target plants

A 2.7 KCP 10.7 Effects on other terrestrial organisms (flora and fauna)

A 2.8 KCP 10.8 Monitoring data