GF-2626 Active Substance: Sulfoxaflor 120 G/L

Part A Product code Draft Registration Report – All Zones National Assessment - GF 2626 Page 1 of 28 Federal Republic of Germany 008447-00/00

REGISTRATION REPORT Part A

Risk Management

Product name: Closer Product code: GF-2626 Active Substance: Sulfoxaflor 120 g/L

COUNTRY: Germany All Zones Zonal Rapporteur Member State: France

NATIONAL ASSESSMENT

Applicant: Dow AgroSciences GmbH München Submission date: 06/05/2015 Finalisation date: 05/12/2018

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Table of Contents

PART A – Risk Management 4 1 Details of the application 4 1.1 Application background 4 1.2 Annex I inclusion 4 1.3 Regulatory approach 5 1.4 Data protection claims 5 1.5 Letters of Access 5 2 Details of the authorisation 5 2.1 Product identity 5 2.2 Classification and labelling 6 2.2.1 Classification and labelling under Directive 99/45/EC Fehler! Textmarke nicht definiert. 2.2.2 Classification and labelling under Regulation (EC) No 1272/2008 6 2.2.3 Standard phrases under Regulation (EC) No 547/2011 6 2.3 Other phrases notified under Regulation (EC) No 547/2011 6 2.3.1 Restrictions linked to the PPP 6 2.3.2 Specific restrictions linked to the intended uses 8 2.4 Product uses 9 3 Risk management 15 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles 15 3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) 15 3.1.2 Methods of analysis (Part B, Section 2, Point 5) 15 3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) 15 3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) 15 3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7) 16 3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) 16 3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) 16 3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) 16 3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) 16 3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8) 17 3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) 17 3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) 17 3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9) 18

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3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5) 18 3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6) 18 3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8) 19 3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9) 19 3.1.6 Ecotoxicology (Part B, Section 6, Point 10) 20 3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3) 20 3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2) 21 3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5) 21 3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6) 22 3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) 23 3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) 23 3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8) 23 3.1.7 Efficacy (Part B, Section 7, Point 8) 24 3.2 Conclusions 25 3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation 25 Appendix 1 – Copy of the product authorisation (see Appendix 4) 26 Appendix 2 – Copy of the product label 27 Appendix 3 – Letter of Access 28 Appendix 4 – Copy of the product authorisation 28

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PART A – Risk Management This document describes the acceptable use conditions required for the registration of Closer containing sulfoxaflor in Germany.

The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C and where appropriate the addendum for Germany. The information, data and assessments provided in Registration Report, Parts B includes assessment of further data or information as required at national registration by the EU review. It also includes assessment of data and information relating to Closer where that data has not been considered in the EU review. Otherwise assessments for the safe use of Closer have been made using endpoints agreed in the EU review of sulfoxaflor.

This document describes the specific conditions of use and labelling required for Germany> for the re- registration/registration of Closer.

Appendix 1 should include the authorisation of the final product in Germany. Due to technical reasons, the authorisation of the final product in Germany is inserted under Appendix 4.

Appendix 2: The submitted draft product label has been checked by the competent authority. The applicant is requested to amend the product label in accordance with the decisions made by the competent authority. The final version of the label has to fulfil the requirements according to Article 31 of Regulation (EC9 No 1107/2009.

Appendix 3: Letter(s) of access is/are classified as confidential and, thus, are not attached to this document.

Appendix 4 of this document provides a copy of the final product authorisation Germany.

1 Details of the application

1.1 Application background

This application was submitted by Dow AgroSciences GmbH München on 6 May 2015.

The application was for authorisation of Closer, a suspension concentrate (SC) containing 120 g/L sulfoxaflor for use as an insecticide in various vegetable cultures and ornamentals in greenhouses.

1.2 Annex I inclusion

Sulfoxaflor was approved in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 with Commission Implementing regulation (EU) 2015/1295 on 18 August 2015.

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The approval for sulfoxaflor (2015/1295 /EC) provides specific provisions under Part B which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation.

For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on sulfoxaflor, and in particular Appendices I and II thereof, shall be taken into account.

In this overall assessment Member States shall pay particular attention to:

(a) the risk to bees and other non-target arthropods;

(b)the risk to bees and bumble bees released for pollination, when the substance is applied in glasshouses.

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

These concerns were all addressed in the submission.

1.3 Regulatory approach To obtain authorisation the product Closer must meet the conditions of EU active approval and be supported by dossiers satisfying the requirements of Commission Regulation (EU) 545/2011 with an assessment to Uniform Principles, using approved end-points.

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

1.4 Data protection claims Where protection for data is being claimed for information supporting registration of CLOSER (GF-2626), it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections 1-7.

1.5 Letters of Access Not necessary: the applicant has provided sufficient data to show that access is not required.

2 Details of the authorisation

2.1 Product identity

Product Name Closer GF-2626 Authorisation Number 008447-00/00 (for re-registration) Function insecticide Applicant (Dow AgroSciences GmbH München) Evaluator BVL Date .06/12/2018

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Applicant Dow AgroSciences Composition 120 g/L sulfoxaflor Formulation type Suspension concentrate [Code: SC] Packaging Bottle, HDPE or PET 0,25 - 20 L

2.2 Classification and labelling

2.2.1 Classification and labelling under Regulation (EC) No 1272/2008 The following labelling is proposed in accordance with Regulation (EC) No 1272/2008:

Hazard classes and categories: Aquatic acute 1, Aquatic chronic 1 Hazard pictograms: GHS09 environment Signal word: Warning Hazard statements: H400 Very toxic to aquatic life. H410 Very toxic to aquatic life with long lasting effects. Precautionary statemtents: Not proposed by cMS Germany, to be decided by applicant P273 Avoid release to the environment. P391 Collect spillage. P501 Dispose of contents/container to …

Special rule for labelling of PPP: EUH401 To avoid risks to man and the environment, comply with the instructions for use. Further labelling statements under Regulation (EC) No 1272/2008: EUH 208 Contains 1,2-benzisothiazole-3(2H)-one. May produce an allergic reaction.

2.2.2 Standard phrases under Regulation (EC) No 547/2011 None.

2.2.3 Other phrases notified under Regulation (EC) No 547/2011

2.2.3.1 Restrictions linked to the PPP The authorisation of the PPP is linked to the following conditions (mandatory labelling):

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Human health protection SB001 Avoid any unnecessary contact with the product. Misuse can lead to health damage. SB005 If medical advice is needed, have product container or label at hand. SB010 Keep out of the reach of children. SB111 Concerning the requirements for personal protective gear for handling the plant protection product the material safety data sheet and the instructions for use of the plant protection product as well as the guideline "Personal protective gear for handling plant protection prod-ucts" of the Federal Office of Consumer Protection and Food Safety (www.bvl.bund.de) must be observed. SB166 Do not eat, drink or smoke when using this product. SF245-02 It must be ensured that treated areas/crops may not be entered until the film of the plant protection product has dried. SS110-1 Protective gloves (plant protection) must be worn when handling the undiluted product. SS206 Working clothes (if no specific protective suit is required) and sturdy footwear (e.g. rubber boots) must be worn when applying/handling plant protection products. SS2101 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when handling the undiluted product.

Integrated pest management (IPM)/sustainable use WMI4C Mode of action (IRAC-group): 4C (for sulfoxaflor) WH952 The indication identifying the mode of action must be assigned directly to each corresponding name of the active substance as supplementary information on the packaging and in the instructions for use. NB6611 The product is classified as hazardous to bees (B1). It must not be used on plants which are in flower or which are visited by bees; this also applies to weeds. See Bee Protection Ordinance of 22 July 1992, BGBl. (Federal Law Gazette) I p. 1410. NN3001 The product is classified as harmful for populations of relevant beneficial insects. Ecosystem protection NW263 The product is toxic for aquatic invertebrates. NW468 Fluids left over from application and their remains, products and their remains, empty containers and packaging, and cleansing and rinsing fluids must not be dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and to rain-water and sewage canals.

The authorisation of the PPP is linked to the following conditions (voluntary labelling): Integrated pest management (IPM)/sustainable use NN1002 The product is classified as non-harmful for populations of relevant beneficial predatory mites and spiders.

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2.2.3.2 Specific restrictions linked to the intended uses Some of the authorised uses are linked to the following conditions (mandatory labelling):

Integrated pest management (IPM)/sustainable use -- -- Ecosystem protection NZ113 For use exclusively in greenhouses on completely sealed surfaces where the entry of the product into the soil can be excluded.

Uses: 001 – 010

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2.3 Product uses GAP-Table of intended uses for Germany GAP rev. 1, date: 2018-01-15

PPP (product Closer Formulation type: SC (a, b) name/code): Active substance 1: sulfoxaflor Conc. of as 1: 120 g/L (c) Safener: -- Conc. of safener: -- (c) Synergist: -- Conc. of synergist: -- (c)

Applicant: Dow AgroSciences GmbH Professional use: Zone(s): central/interzonal (d) Non professional use: Verified by MS: yes

Field of use: insecticide 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 (days) (e) Fpn Method / Timing / Growth Max. Min. kg or L g or kg as/ha Water L/ha e.g. g (crop G, (additionally: Kind stage of crop & number interval product / ha safener/synergist destination / Gn, developmental stages of season a) per use between a) max. rate a) max. rate min / max per ha purpose of crop) Gpn the pest or pest group) b) per crop/ applications per appl. per appl. (f) or season (days) b) max. total b) max. total I rate per rate per crop/season crop/season 001 DE aubergine G aphids (APXXSP), spraying At beginning of a) 2 treatments a) a) plant 1 For use exclusively (SOLME), Whiteflies (ALEUSP) infestation and/or b) 2 must be at plant height plant height height up in greenhouses on tomato when first least 7 days up to 50 cm: up to 50 cm: to 50 cm: completely sealed (LYPES), symptoms/harmful apart 0.1 L/ha 0.012 kg/ha 500 - 750 surfaces where the sweet pepper organisms become plant height plant height L/ha entry of the product (CPSAN), visible 50 up to 125 50 up to 125 plant into the soil can be melon pear 21 to 87 cm: cm: height 50 excluded. (SOLMU) 0.15 L/ha 0.018 kg/ha up to 125 plant height plant height cm: more than more than 500 - 125 cm: 125 cm: 1200 0.2 L/ha 0.024 kg/ha L/h

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b) b) plant 0.4 L/ha 0.048 kg/ha height more than 125 cm: 500 - 1500 L/ha 002 DE aubergine G Whiteflies (ALEUSP) spraying At beginning of a) 1 n. a. a) a) plant 1 For use exclusively (SOLME), infestation and/or b) 2 plant height plant height height up in greenhouses on tomato when first up to 50 cm: up to 50 cm: to 50 cm: completely sealed (LYPES), symptoms/harmful 0.2 L/ha 0.024 kg/ha 500 - 750 surfaces where the sweet pepper organisms become plant height plant height L/ha entry of the product (CPSAN), visible 50 up to 125 50 up to 125 plant into the soil can be melon pear 21 to 87 cm: cm: height 50 excluded. (SOLMU) 0.3 L/ha 0.036 kg/ha up to 125 plant height plant height cm: more than more than 500 - 125 cm: 125 cm: 1200 0.4 L/ha 0.048 kg/ha L/h b) b) plant 0.4 L/ha 0.048 kg/ha height more than 125 cm: 500 - 1500 L/ha 003 DE ornamentals G aphids (APXXSP), spraying At beginning of a) 2 treatments a) a) plant XN For use exclusively (NNNZZ) Whiteflies (ALEUSP) infestation and/or b) 2 must be at plant height plant height height up in greenhouses on when first least 7 days up to 50 cm: up to 50 cm: to 50 cm: completely sealed symptoms/harmful apart 0.1 L/ha 0.012 kg/ha 500 - 750 surfaces where the organisms become plant height plant height L/ha entry of the product visible 50 up to 125 50 up to 125 plant into the soil can be 21 to 59 cm: cm: height 50 excluded. 0.15 L/ha 0.018 kg/ha up to 125 plant height plant height cm: more than more than 500 - 125 cm: 125 cm: 1200 0.2 L/ha 0.024 kg/ha L/h b) b) plant 0.4 L/ha 0.048 kg/ha height more than 125 cm: 500 -

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1500 L/ha 004 DE ornamentals G Whiteflies (ALEUSP) spraying At beginning of a) 1 n. a. a) a) plant XN For use exclusively (NNNZZ) infestation and/or b) 2 plant height plant height height up in greenhouses on when first up to 50 cm: up to 50 cm: to 50 cm: completely sealed symptoms/harmful 0.2 L/ha 0.024 kg/ha 500 - 750 surfaces where the organisms become plant height plant height L/ha entry of the product visible 50 up to 125 50 up to 125 plant into the soil can be 21 to 59 cm: cm: height 50 excluded. 0.3 L/ha 0.036 kg/ha up to 125 plant height plant height cm: more than more than 500 - 125 cm: 125 cm: 1200 0.4 L/ha 0.048 kg/ha L/ha b) b) plant 0.4 L/ha 0.048 kg/ha height more than 125 cm: 500 - 1500 L/ha 005 DE cucumber G aphids (APXXSP), spraying At beginning of a) 2 treatments a) a) plant 1 For use exclusively (CUMSA) Whiteflies (ALEUSP) infestation and/or b) 2 must be at plant height plant height up height up in greenhouses on when first least 7 days up to 50 cm: to 50 cm: to 50 cm: completely sealed symptoms/harmful apart 0.1 L/ha 0.012 kg/ha 500 - 750 surfaces where the organisms become plant height plant height 50 L/ha entry of the product visible 50 up to 125 up to 125 cm: plant into the soil can be 21 to 87 cm: 0.018 kg/ha height 50 excluded. 0.15 L/ha plant height up to 125 plant height more than 125 cm: more than 125 cm: 500 - 1200 cm: 0.024 kg/ha L/ha 0.2 L/ha b) plant b) 0.048 kg/ha height 0.4 L/ha more than 125 cm: 500 - 1500 L/ha

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006 DE cucumber G Whiteflies (ALEUSP) spraying At beginning of a) 1 n. a. a) a) plant 1 For use exclusively (CUMSA) infestation and/or b) 2 plant height plant height up height up in greenhouses on when first up to 50 cm: to 50 cm: to 50 cm: completely sealed symptoms/harmful 0.2 L/ha 0.024 kg/ha 500 - 750 surfaces where the organisms become plant height plant height 50 L/ha entry of the product visible 50 up to 125 up to 125 cm: plant into the soil can be 21 to 87 cm: 0.036 kg/ha height 50 excluded. 0.3 L/ha plant height up to 125 plant height more than 125 cm: more than 125 cm: 500 - 1200 cm: 0.048 kg/ha L/ha 0.4 L/ha b) plant b) 0.048 kg/ha height 0.4 L/ha more than 125 cm: 500 - 1500 L/ha 007 DE cantaloupe G aphids (APXXSP), spraying At beginning of a) 2 treatments a) a) plant 1 For use exclusively (CITLA) Whiteflies (ALEUSP) infestation and/or b) 2 must be at plant height plant height up height up in greenhouses on use without peal when first least 7 days up to 50 cm: to 50 cm: to 50 cm: completely sealed symptoms/harmful apart 0.1 L/ha 0.012 kg/ha 500 - 750 surfaces where the organisms become plant height plant height 50 L/ha entry of the product visible 50 up to 125 up to 125 cm: plant into the soil can be 21 to 87 cm: 0.018 kg/ha height 50 excluded. 0.15 L/ha plant height up to 125 plant height more than 125 cm: Notes on dose rate: more than 125 cm: 500 - 1200 the height scale cm: 0.024 kg/ha L/ha applies only to 0.2 L/ha b) plant trained crops. In the b) 0.048 kg/ha height case of non-trained 0.4 L/ha more than crops, the 125 cm: maximum 500 - 1500 application rate L/ha may be necessary to achieve satisfactory efficacy

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008 DE cantaloupe G Whiteflies (ALEUSP) spraying At beginning of a) 1 n. a. a) a) plant 1 For use exclusively (CITLA) infestation and/or b) 2 plant height plant height up height up in greenhouses on use without peal when first up to 50 cm: to 50 cm: to 50 cm: completely sealed symptoms/harmful 0.2 L/ha 0.024 kg/ha 500 - 750 surfaces where the organisms become plant height plant height 50 L/ha entry of the product visible 50 up to 125 up to 125 cm: plant into the soil can be 21 to 87 cm: 0.036 kg/ha height 50 excluded. 0.3 L/ha plant height up to 125 plant height more than 125 cm: Notes on dose rate: more than 125 cm: 500 - 1200 the height scale cm: 0.048 kg/ha L/ha applies only to 0.4 L/ha b) plant trained crops. In the b) 0.048 kg/ha height case of non-trained 0.4 L/ha more than crops, the 125 cm: maximum 500 - 1500 application rate L/ha may be necessary to achieve satisfactory efficacy 009 DE zucchini G aphids (APXXSP), spraying At beginning of a) 2 treatments a) 0.1 L/ha a)0.012kg/ha 500 - 750 1 For use exclusively (CUUPG) Whiteflies (ALEUSP) infestation and/or b) 2 must be at b) 0.40 L/ha b)0.048kg/ha L/ha in greenhouses on when first least 7 days completely sealed symptoms/harmful apart surfaces where the organisms become entry of the product visible into the soil can be 21 to 87 excluded. 010 DE zucchini G Whiteflies (ALEUSP) spraying At beginning of a) 1 n. a. a) 0.2 L/ha a)0.024kg/ha 500 - 750 1 For use exclusively (CUUPG) infestation and/or b) 2 b) 0.40 L/ha b)0.048kg/ha L/ha in greenhouses on when first completely sealed symptoms/harmful surfaces where the organisms become entry of the product visible into the soil can be 21 to 87 excluded.

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 heading: International Technical Monograph n°2, 6th Edition Revised May 2008 be given in column 1 (c) g/kg or g/l (f) No authorization possible for uses where the line is highlighted in grey, Use should be crossed out when the notifier no longer supports this use.

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

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3 Risk management

3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles

3.1.1 Physical and chemical properties (Part B, Section 1, Points 2 and 4) Overall Summary: The formulation CLOSER (GF-2626) is a suspension concentrate (SC). All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. The appearance of the product is that of a tan liquid with a mild odor. It is not explosive and has no/ oxidizing properties. The product has a flash point > 100°C. It has a self-ignition temperature of 380°C. In aqueous solution (1 % v/v), it has a pH value of 4.2 at 24 °C.

There is no effect of low and high temperatures on the stability of the formulation, since after 7 days at 0°C and 14 days at 54°C/8 weeks at 40°C, neither the active ingredient content nor the technical properties were changed. The stability data indicate a shelf life of at least 1 year at ambient temperature when stored in the commercial HDPE and PET packaging. The finalized long-term storage stability is required for a 2 years shelf life assessment.

Implications for labelling: none.

Compliance with FAO specifications: The product CLOSER (GF-2626) complies with the general FAO specifications.

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 CLOSER (GF-2626) has been provided and is considered to be acceptable.

3.1.2 Methods of analysis (Part B, Section 2, Point 5)

3.1.2.1 Analytical method for the formulation (Part B, Section 2, Point 5.2) Analytical method for the determination of active substance sulfoxaflor in the formulation CLOSER (GF- 2626) is available and validated. As the active substance sulfoxaflor does not contain relevant impurities, no analytical method is required.

3.1.2.2 Analytical methods for residues (Part B, Section 2, Points 5.3 – 5.8) Analytical methods were provided in the EU review of sulfoxaflor and were considered adequate according to the respective residue definition for food of plant and animal origin, soil, drinking and surface water and air.

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Methods for body fluids and tissues are not required, because sulfoxaflor 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).

3.1.3 Mammalian Toxicology (Part B, Section 3, Point 7)

3.1.3.1 Acute Toxicity (Part B, Section 3, Point 7.1) Acute toxicity studies have not been conducted on Closer (GF-2626) on the basis of animal welfare. It is possible to bridge from a similar formulation, GF-2032, which is a suspension concentrate (SC) containing 240 g/L sulfoxaflor. The nominal compositions of GF-2626 and GF-2032 are considered similar enough to allow GF-2032 acute toxicity data to be used as a surrogate in the absence of GF-2626. Because the concentration of sulfoxaflor in GF-2032 is double that in GF-2626, it can be considered a worst-case scenario. Skin and eye irritation studies in the NZW rabbit showed minimal to slight irritation and all effects resolved by 72 hours. No skin sensitization potential was evident in a mouse local lymph node assay.

3.1.3.2 Operator Exposure (Part B, Section 3, Point 7.3) Estimation of operator exposure assuming personal protective equipment (PPE) is used is required when the AOEL may be exceeded in the absence of PPE, or based on hazard classification requirements. Exposure based on no PPE indicates that PPE will not be required for use of Closer on greenhouse fruiting vegetables, and ornamentals according to predicted exposures using the German, UK and Greenhouse models. In addition, Closer is not classified for acute toxicity in accordance with criteria in Council Directive 1272/2008/EC (Classification, labelling and packaging of substances and mixtures) and 99/45/EEC (Dangerous Preparations Directive). Therefore, an estimation of operator exposure assuming PPE is used is not required and has not been performed.

3.1.3.3 Bystander Exposure (Part B, Section 3, Point 7.4) Since Closer is only intended for indoor use, it is reasonable to assume that residents are not exposed during and after application. Therefore, resident exposure is not relevant.

3.1.3.4 Worker Exposure (Part B, Section 3, Point 7.5) The worker exposure was estimated using the model “German model”. Even without any PPE the estimated consumption of AOEL was below 60 %; with PPE below 6 %.

Implications for labelling resulting from operator, worker, bystander assessments:

See 2.2

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3.1.4 Residues and Consumer Exposure (Part B, Section 4, Point 8)

3.1.4.1 Residues (Part B, Section 4, Points 8.3 and 8.7) Please refer to the registration report of the zonal RMS FR.

3.1.4.2 Consumer exposure (Part B, Section 4, Point 8.10) Please refer to the registration report of the zonal RMS FR.

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3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9)

The exposure assessment for the plant protection product Closer in its intended uses in aubergines, pepinos, bulbs, ornamentals, flowers, cucurbits including edible peel – cucumbers, courgettes, gherkins; inedible peel – melons, pumpkins/ squash, zucchini, watermelons, pepper including chilli pepper and tomatoes is documented in detail in the core assessment performed by zRMS France.

This national addendum has been produced to support a national decision on the authorisation of the product Closer in Germany for the uses applied for. It reflects the impact of specific German environmental or agricultural circumstances on the exposure and risk assessment for Closer including risk mitigation measures.

The following tables document the grouping of the intended uses to support application of the risk envelope approach with regard to entry into soil in-crop and entry into adjacent non-target areas via spray drift, respectively.

Grouping according to soil

Group Intended uses Application rate (g/ha) Soil-relevant effective applic. (interception, %) rate, cumulative (g/ha) S01 00-004 1 x 48 (10%) 43.2 S02 00-003 2 x 24 (10%) 43.2 S03 00-002; 00-006; 00-008 1 x 48 (50%) 24 S04 00-001; 00-005; 00-007 2 x 24 (50%) 24 S05 00-010 1 x 24 (50%) 12 S06 00-009 2 x 12 (50%) 12

Grouping according to spray drift

Group Intended uses Application rate (g/ha) Drift scenario (interval, d) D01 00-001 – 00-010 2 x 12 (50%) – 1 x 48 (10%) No drift

3.1.5.1 Predicted Environmental Concentration in Soil (PECsoil) (Part B, Section 5, Points 9.4 and 9.5)

PECsoil was calculated for the active substance sulfoxaflor considering a soil depth of 2.5 cm. Due to the fast degradation of the active substance sulfoxaflor in soil the accumulation potential of sulfoxaflor was not considered.

Initial PECsoil values for the worst-case use 004 are 1.015 mg/kg and 0.115 mg/kg for the product Closer and the active substance sulfoxaflor, respectively. The PECsoil values for the active substance were used in the ecotoxicological risk assessment for the intended uses of the plant protection product Closer in Germany.

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6)

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Direct leaching into groundwater Results of modelling with FOCUS PELMO show that the active substance sulfoxaflor is not expected to penetrate into groundwater at concentrations above 0.1µg/L in all intended uses of Closer in Germany.

For the metabolites of sulfoxaflor concentrations above 0.1µg/L in groundwater cannot be excluded. For the worst-case use 004 PECGW values are 4.874 µg/L, 2.263 µg/L and 3.391 µg/L for the metabolites X11719474, X11519540 and X11579457, respectively. For the assessment of the relevance of these metabolite of the active substance sulfoxaflor please refer to the results of EU approval of sulfoxaflor and the core assessment, Part B, section 8. The metabolites X11719474, X11579457 and X11519540 are classified as not relevant for groundwater.

Consequences for authorisation: None.

Groundwater contamination by bank filtration due to surface water exposure via runoff and drainage According modelling with EXPOSIT 3, groundwater contamination at concentrations above 0.1 µg/L by the active substance sulfoxaflor and its soil metabolites X11719474, X11579457 and X11519540 due to surface runoff and drainage into the adjacent ditch with subsequent bank filtration can be excluded.

Consequences for authorisation: None.

Specific additional risk mitigation measures are not required.

3.1.5.3 Predicted Environmental Concentration in Surface Water (PECSW) (Part B, Section 5, Points 9.7 and 9.8)

Risk mitigation measures for the intended uses of plant protection products in Germany due to exposure of surface water consider two routes of entry (i) spray drift and volatilisation with subsequent deposition and (ii) runoff, drainage separately.

Surface water exposure including effects of risk mitigation via spray drift and volatilisation with subsequent deposition is estimated with the model EVA 3. The route spray drift is deemed unlikely for the intended greenhouse uses and not further considered.

Surface water exposure including effects of risk mitigation via surface runoff and drainage is estimated using the model EXPOSIT 3. The route of entry via run-off is deemed unlikely for the intended greenhouse uses and is not further considered. PECSW values due to entry via drainage for the worst-case use 004 are 0.1 µg as/L and 0.31 µg as/L for application in spring/summer and in autumn/winter, respectively.

The results of the specific national exposure assessment for the active substance were used in the ecotoxicological risk assessment.

3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point

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9.9)

The vapour pressure at 20 °C of the active substance sulfoxaflor is < 10-5 Pa. Hence the active substance sulfoxaflor is regarded as non-volatile. Therefore, exposure of adjacent surface waters and terrestrial ecosystems by the active substance sulfoxaflor due to volatilisation with subsequent deposition was not considered.

Implications for labelling resulting from environmental fate assessment:

Active substance and the product are considered to be not readily biodegradable.

3.1.6 Ecotoxicology (Part B, Section 6, Point 10) The ecotoxicological risk assessment for the plant protection product Closer in its intended uses is documented in detail in the core assessment performed by zRMS France.

The tables in chapter 3.1.5 document the grouping of the intended uses to support application of the risk envelope approach with regard to entry into soil in-crop and entry into adjacent non-target areas via spray drift, respectively.

3.1.6.1 Effects on Terrestrial Vertebrates (Part B, Section 6, Points 10.1 and 10.3)

Birds The uses of the product Closer on fruiting vegetables and ornamentals grown in greenhouses will not lead to significant exposure of populations of wildlife birds, thus the risk to this wildlife group is considered to be negligible.

Mammals The uses of the product Closer on fruiting vegetables and ornamentals grown in greenhouses will not lead to significant exposure of populations of wildlife mammals, thus the risk to this wildlife group is considered to be negligible.

Other terrestrial vertebrates The uses of the product Closer on fruiting vegetables and ornamentals grown in greenhouses will not lead to significant exposure of populations of wildlife terrestrial vertebrates, thus the risk to this wildlife group is considered to be negligible.

Specific additional risk mitigation measures are not required.

Consequences for authorisation: None.

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3.1.6.2 Effects on Aquatic Species (Part B, Section 6, Point 10.2)

Sulfoxaflor acts, like the neonicotinoids, as a nAChR-agonist. The substance binds like neonicotinoids at the nAChR-agonist and causes conformational change at the receptor, initiating the opening of the receptor channel. As a result, sodium and calcium ions stream into the cell, and potassium ions stream out. This provokes a depolarisation of the cell and eventually causes the known symptoms on the nervous system.

As observed for neonicotinoid active substance too, the sensitivity of Daphnia towards sulfoxaflor is low and it can be assumed that sublethal effects of sulfoxaflor are not covered by standard studies. Therefore, following the precautionary principle, and since no reliable data on the effects of sulfoxaflor to Ephemeroptera are available, and (as far as it is known) since Ephemeroptera are the most sensitive insect taxon for neonicotinoids, an extrapolation from the endpoint of the midge Chironomus to Ephemeropterans is recommended and necessary. By applying read-across from the data available for imidacloprid a factor of 74 between the NOEC for Chironomus and Ephemeroptera is extrapolated to sulfoxaflor resulting in the relevant chronic endpoint of 0.519 µg as/L. Using the standard chronic assessment factor, this leads to a RAC of 0.0519 µg as/L.

Based on this ecotoxicological endpoint and PECSW due to drainage entry the calculated TER values do achieve the adjusted acceptability criterion TER ≥ 1 for effects on aquatic organisms provided that risk mitigation measures (reduction of entries via drainage) are applied.

Consequences for authorisation: For the authorisation of the plant protection product Closer, labelling and conditions of use are therefore mandatory as follows:

NW263 The product is toxic for aquatic invertebrates.

Sulfoxaflor: Ephemeroptera RAC = 0.0519 µg/L NW468 Fluids left over from application and their remains, products and their remains, empty containers and packaging, and cleansing and rinsing fluids must not be dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and to rain-water and sewage canals.

Use number Condition 004 / S01 NG405 Not to be used on drained surfaces. 003 / S02 NG405 Not to be used on drained surfaces. 002, 006, 008 / S03 NG405 Not to be used on drained surfaces. 001, 005, 007 / S04 NW800 Application not allowed on drained areas between 1 November and 15 March. 010 / S05 NW800 Application not allowed on drained areas between 1 November and 15 March. 009 / S06 NW800 Application not allowed on drained areas between 1 November and 15 March.

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)

Honey bees

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GF-2626 (Closer) was a representative formulation in the EU review of sulfoxaflor. However new risk assessment parameters are considered in the assessment of risk to bees; appropriate risk assessments have been provided and are considered adequate.

Risk mitigation proposal (on product level for open field and greenhouse use): NB6611 The product is classified as hazardous to bees (B1). It must not be used on plants which are in flower or which are visited by bees; this also applies to weeds. See Bee Protection Ordinance of 22 July 1992, BGBl. (Federal Law Gazette) I p. 1410.

Other non-target arthropods

Wildlife bumble bees and solitary bees A screening step has been calculated for bumblebees and solitary bees in order to estimate the risk for wild pollinators. Hazard quotients for solitary bees and bumblebees were calculated, taking into account the relevant toxicity data for sulfoxaflor and estimated in-field exposure levels, according to the intended uses of the product Closer. The calculated indicator values do not achieve the acceptability criteria. The results of the assessment indicate an unacceptable risk for bumblebees and solitary bees due to the intended use of Closer according to the label. It must therefore be ensured that wildlife bumblebees and solitary bees are not exposed to Closer. According to the outcome of the core assessment a re-introduction of pollinator’s colonies in permanent covered crops must be realized at least 10 days after spray dried.

Other non-target arthropods To avoid a risk for off-field arthropods it must be ensured that no off-field exposure due to spray drift, runoff or other paths is possible.

Consequences for authorisation: None.

3.1.6.4 Effects on Earthworms and Other Soil Macro-organisms (Part B, Section 6, Point 10.6)

Earthworms The outcome of the PEC and TER calculations, taking into account adjusted soil layer depth, indicated a high risk for Eisenia fetida and Folsomia candida. Since no reliable higher tier studies are available, the risk assessment is based on tier 1 data.

TER values for earthworms were calculated, taking into account the relevant toxicity data for Closer and calculated exposure concentrations in soil, according to the intended uses of the product Closer. The calculated TER values do not achieve the acceptability criterion TER ≥ 5 for chronic 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 unacceptable risk for earthworms due to the intended use of Closer in all intended uses.

Authorisation is therefore possible only in greenhouses with closed crop systems where no entry into the soil is possible.

Effects on other soil non-target macro-organisms Applicant (Dow AgroSciences GmbH München) Evaluator BVL Date .06/12/2018

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TER values for other organisms of the soil macro- and mesofauna were calculated, taking into account the relevant toxicity data for Closer and calculated exposure concentrations in soil, according to the intended uses. For use groups S3, S4, S5 and S6, the calculated TER values do achieve the acceptability criterion TER ≥ 5 for chronic effects (as adopted from the risk assessment for earthworms) on other organisms of the soil macro- and mesofauna, 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 other organisms of the soil macro- and mesofauna due to the intended use of Closer in these intended uses. No safe use is demonstrated for use groups S1 and S2.

Consequences for authorisation: For the authorisation of the plant protection product Closer, labelling and conditions of use are therefore mandatory as follows:

Use number Condition All uses NZ113 For use exclusively in greenhouses on completely sealed surfaces where the entry of the product into the soil can be excluded.

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6) Assessment not triggered.

Consequences for authorisation: None.

3.1.6.6 Effects on Soil Non-target Micro-organisms (Part B, Section 6, Point 10.7) The results of the assessment indicate an acceptable risk for soil microorganisms due to the intended use of Closer according to the label.

Specific additional risk mitigation measures are not required.

Consequences for authorisation: None.

3.1.6.7 Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) (Part B, Section 6, Point 10.8)

Non-Target Plants The uses of the product Closer on fruiting vegetables and ornamentals grown in greenhouses will not lead to significant exposure of populations of wildlife non-target terrestrial plants, thus the risk to this group is considered to be negligible.

Other non-target species (Flora and Fauna) The uses of the product Closer on fruiting vegetables and ornamentals grown in greenhouses will not lead to significant exposure of populations of other wildlife non-target species, thus the risk to this group is considered to be negligible.

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Specific additional risk mitigation measures are not required.

Consequences for authorisation: None.

Implications for labelling resulting from ecotoxicological assessment:

Classification and labelling of the product Closer

Relevant toxicity/basis for Sulfoxaflor: classification Ephemeroptera EC10 = 0.000519 mg/L Classification and labelling according to Regulation 1272/2008 Hazard symbol GHS09 Signal word Warning Hazard statement H400; H410 Precautionary statement P273; P391; P501

Labelling requirements according to § 36 (3) PflSchG

NW263 Sulfoxaflor: Ephemeroptera EC10 = 0.000519 mg/L

Conditions of use according to § 36 (1) PflSchG

NW468 Fluids left over from application and their remains, products and their remains, empty containers and packaging, and cleansing and rinsing fluids must not be dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and to rain-water and sewage canals.

Use number Condition All uses NZ113 For use exclusively in greenhouses on completely sealed surfaces where the entry of the product into the soil can be excluded.

3.1.7 Efficacy (Part B, Section 7, Point 8) All the data regarding the efficacy of the product have been submitted. These data demonstrate that Closer fulfils all criteria for the authorization of preparations described in Directive 97/57/EC (Uniform Principles, Annex VI to Directive 91/414/EEC). No phytotoxicity, effects on neighbouring or following crops were observed. No negative impact on the quality of plants and plant products is to be expected when sulfoxaflor is applied as recommended.

Beneficials (on product level for open field and greenhouse use):

NN3001 The product is classified as harmful for populations of relevant beneficial insects.

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NN1002 The product is classified as non-harmful for populations of relevant beneficial predatory mites and spiders.

3.2 Conclusions

Closer showed a sufficient effect against the diseases for all uses applied for and no unacceptable effects on the plants or plant products occur. With regard to efficacy/sustainability, all uses applied for can be authorised.

With regard to identity, physical, chemical and technical properties, further information and analytical methods an authorization can be granted.

Considering an application of the product in accordance with the intended and evaluated use pattern and good agricultural practice no harmful effects on groundwater are to be expected. Authorisation of the plant protection product Closer in its intended uses is only possible where the use is restricted to greenhouses on completely sealed surfaces where the entry of the product into the soil can be excluded because of the risk for soil organisms.

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

An authorisation has been recommended.

3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation The following information is required in order to obtain (a prolongation of) the authorisation.

Annex II and Data III point

2.7.5 The final results of the stability study after two year storage at room temperature.

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Appendix 1 – Copy of the product authorisation (see Appendix 4)

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

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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.

Appendix 4 – Copy of the product authorisation

Applicant (Dow AgroSciences GmbH München) Evaluator BVL Date .06/12/2018

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dr. Susanne Luttmann Dienstsitz Braunschweig • Postfach 15 64 • 38005 Braunschweig Referentin

TELEFON +49 (0)531 299-3612 Dow AgroSciences GmbH TELEFAX +49 (0)531 299-3002 Truderinger Straße 15 E-MAIL [email protected] 81677 München IHR ZEICHEN IHRE NACHRICHT VOM

AKTENZEICHEN 200.22100.008447-00/00.126900 (bitte bei Antwort angeben)

DATUM 17. Dezember 2018

ZV3 008447-00/00 Closer Zulassungsverfahren für Pflanzenschutzmittel Bescheid

Das oben genannte Pflanzenschutzmittel

mit dem Wirkstoff: 120 g/l Sulfoxaflor

Zulassungsnummer: 008447-00

Versuchsbezeichnungen: DOW-02626-I-0-SC

Antrag vom: 6. Mai 2015

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 18. August 2026.

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 27

Anwendungs- Schadorganismus/ Pflanzen/-erzeugnisse/ Verwendungszweck nummer Zweckbestimmung Objekte 008447-00/00-001 Blattläuse, Weiße Aubergine, Tomate, Fliegen Gemüsepaprika, Pepino 008447-00/00-005 Blattläuse, Weiße Gurke Fliegen 008447-00/00-007 Blattläuse, Weiße Wassermelone Verwendung ohne Fliegen Schale 008447-00/00-003 Blattläuse, Weiße Zierpflanzen Fliegen 008447-00/00-009 Blattläuse, Weiße Zucchini Fliegen 008447-00/00-002 Weiße Fliegen Aubergine, Tomate, Gemüsepaprika, Pepino 008447-00/00-006 Weiße Fliegen Gurke 008447-00/00-008 Weiße Fliegen Wassermelone Verwendung ohne Schale 008447-00/00-004 Weiße Fliegen Zierpflanzen 008447-00/00-010 Weiße Fliegen Zucchini

Festgesetzte Anwendungsbestimmungen

Es werden folgende Anwendungsbestimmungen gemäß § 36 Abs. 1 S. 1 des Gesetzes zum Schutz der Kulturpflanzen (Pflanzenschutzgesetz - PflSchG) vom 6. Februar 2012 (BGBl. I S. 148, 1281), zuletzt geändert durch Artikel 4 Absatz 84 des Gesetzes vom 18. Juli 2016 (BGBl. I S. 1666), festgesetzt: (NW468) Anwendungsflüssigkeiten und deren Reste, Mittel und dessen Reste, entleerte Behältnisse oder Packungen sowie Reinigungs- und Spülflüssigkeiten nicht in Gewässer gelangen las- sen. Dies gilt auch für indirekte Einträge über die Kanalisation, Hof- und Straßenabläufe sowie Regen- und Abwasserkanäle. Begründung: Der im o.g. Pflanzenschutzmittel enthaltene Wirkstoff Sulfoxaflor weist aufgrund seiner Toxi- zität ein hohes Gefährdungspotenzial für aquatische Organismen auf. Jeder Eintrag von Rückständen in Oberflächengewässer, der den Eintrag als Folge der bestimmungsgemäßen und sachgerechten Anwendung des Mittels entsprechend der guten fachlichen Praxis über- steigt, würde daher zu einer Gefährdung des Naturhaushaltes aufgrund von nicht akzepta- blen Auswirkungen auf Gewässerorganismen führen. Da ein erheblicher Anteil der in Ober- flächengewässern nachzuweisenden Pflanzenschutzmittelfrachten auf Einträge aus kommu- BVL_FO_05_2437_200_V1.8 SEITE 3 VON 27

nalen Kläranlagen zurückzuführen ist, muss dieser Gefährdung durch die bußgeldbewehrte Anwendungsbestimmung durchsetzbar begegnet werden.

(SS110-1) Beim Umgang mit dem unverdünnten Mittel sind Schutzhandschuhe (Pflanzenschutz) zu tragen. 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)).

(SS2101) Schutzanzug gegen Pflanzenschutzmittel und festes Schuhwerk (z.B. Gummistiefel) 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.

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 24 0,25 20,00 l Flasche PET 1 24 0,25 20,00 l

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

Auflagen

Die Zulassung wird mit folgenden Auflagen gemäß § 36 Abs. 3 S. 1 PflSchG verbunden: Kennzeichnungsauflagen: (NB6611) BVL_FO_05_2437_200_V1.8 SEITE 4 VON 27

Das Mittel wird als bienengefährlich eingestuft (B1). Es darf nicht auf blühende oder von Bie- nen beflogene Pflanzen ausgebracht werden; dies gilt auch für Unkräuter. Bienenschutzver- ordnung vom 22. Juli 1992, BGBl. I S. 1410, beachten.

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

(NW263) Das Mittel ist giftig für Fischnährtiere.

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

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

(SB010) Für Kinder unzugänglich aufbewahren.

(SB111) Für die Anforderungen an die persönliche Schutzausrüstung beim Umgang mit dem Pflan- zenschutzmittel sind die Angaben im Sicherheitsdatenblatt und in der Gebrauchsanweisung des Pflanzenschutzmittels sowie die BVL-Richtlinie "Persönliche Schutzausrüstung beim 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. BVL_FO_05_2437_200_V1.8 SEITE 5 VON 27

(WMI4C) Wirkungsmechanismus (IRAC-Gruppe): 4C

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

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

Vorbehalt

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

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

Signalwort: (S1) Achtung

Gefahrenpiktogramme: (GHS09) Umwelt

Gefahrenhinweise (H-Sätze): (H400) Sehr giftig für Wasserorganismen.

(H410) Sehr giftig für Wasserorganismen mit langfristiger Wirkung.

(EUH 208-0098) Enthält 1,2-Benzisothiazol-3(2H)-on. Kann allergische Reaktionen hervorrufen.

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

Sicherheitshinweise (P-Sätze): (P273) BVL_FO_05_2437_200_V1.8 SEITE 6 VON 27

Freisetzung in die Umwelt vermeiden.

(P391) Verschüttete Mengen aufnehmen.

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

Weitere Hinweise und Bemerkungen Zu KIIIA1 1.4.4: Die Alternativen aus Ihrem Schreiben vom 4. Juli 2017 zu Kelzan S wurden registiert.

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

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

Hinsichtlich der Gebühren erhalten Sie einen gesonderten Bescheid. BVL_FO_05_2437_200_V1.8 SEITE 7 VON 27

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 27

Anlage 1 zugelassene Anwendung: 008447-00/00-001 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Blattläuse, Weiße Fliegen Pflanzen/-erzeugnisse/Objekte: Aubergine, Tomate, Gemüsepaprika, Pepino Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

Einsatzgebiet: Gemüsebau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: 21 bis 87 Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen Maximale Zahl der Behandlungen - in dieser Anwendung: 2 - für die Kultur bzw. je Jahr: 2 - Erläuterungen Anzahl Behandlungen: zeitlicher Abstand der Behandlungen mindestens 7 Tage Anwendungstechnik: spritzen Aufwand: - Pflanzengröße bis 50 cm 0,1 l/ha in 500 bis 750 l Wasser/ha

- Pflanzengröße 50 bis 125 cm 0,15 l/ha in 500 bis 1200 l Wasser/ha

- Pflanzengröße über 125 cm 0,2 l/ha in 500 bis 1500 l Wasser/ha

- Erläuterungen: maximaler Mittelaufwand für die vorgesehene Kultur pro Jahr 0,4 l/ha

2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten 1 Tag Gewächshaus: Gemüsepaprika

1 Tag Gewächshaus: Tomate

1 Tag Gewächshaus: Aubergine

1 Tag Gewächshaus: Pepino BVL_FO_05_2437_200_V1.8 SEITE 9 VON 27

3 Anwendungsbezogene Anwendungsbestimmungen (NZ113) Anwendung nur in Gewächshäusern auf vollständig versiegelten Flächen, die einen Eintrag des Mittels in den Boden ausschließen. Begründung: Die Anwendungsbestimmung NZ113 ist erforderlich, um einen ausreichenden Schutz von Bodenorganismen vor Rückständen des Wirkstoffs Sulfoxaflor zu gewährleisten. Durch die Einhaltung der Vorgaben der Anwendungsbestimmung NZ113 wird auch der Schutz der Gewässerorganismen vor Einträgen des Wirkstoffs Sulfoxaflor gewährleistet. Für Anwendungen in Gewächshäusern auf nicht versiegelten Flächen wären andernfalls die Anwendungen auf solche Gewächshäuser zu beschränken, die auf nicht drainierten Flächen errichtet sind. Dies wäre für die Anwendungen 00-002, 00-003, 00-004, 00-006, 00-008 ganzjährig (NG405) und für die Anwendungen 00-001, 00-005, 00-007, 00-009 und 00-010 in dem Zeitraum vom 1. November bis 15. März (NW800) notwendig. Die Vergabe dieser Beschränkung resultiert aus der Berechnung der zu erwartenden Einträge in Oberflächenge- wässer über den Pfad Drainage mit dem Modell Exposit 3.0, ausgehend von einem Daten- satz zu expositionsbestimmenden Eigenschaften (Wasserlöslichkeit = 670 mg/L; DT50 Boden = 385.08 d; KOC = 30). Weitere Informationen hierzu sind dem Registration Report, Part B, nationales Addendum zu entnehmen (Sektion 5). BVL_FO_05_2437_200_V1.8 SEITE 10 VON 27

Anlage 1 zugelassene Anwendung: 008447-00/00-002 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Weiße Fliegen Pflanzen/-erzeugnisse/Objekte: Aubergine, Tomate, Gemüsepaprika, Pepino Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

Einsatzgebiet: Gemüsebau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: 21 bis 87 Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 2 Anwendungstechnik: spritzen Aufwand: - Pflanzengröße bis 50 cm 0,2 l/ha in 500 bis 750 l Wasser/ha

- Pflanzengröße 50 bis 125 cm 0,3 l/ha in 500 bis 1200 l Wasser/ha

- Pflanzengröße über 125 cm 0,4 l/ha in 500 bis 1500 l Wasser/ha

- Erläuterungen: maximaler Mittelaufwand für die vorgesehene Kultur pro Jahr 0,4 l/ha

2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten 1 Tag Gewächshaus: Gemüsepaprika

1 Tag Gewächshaus: Tomate

1 Tag Gewächshaus: Aubergine

1 Tag Gewächshaus: Pepino

3 Anwendungsbezogene Anwendungsbestimmungen (NZ113) BVL_FO_05_2437_200_V1.8 SEITE 11 VON 27

Anwendung nur in Gewächshäusern auf vollständig versiegelten Flächen, die einen Eintrag des Mittels in den Boden ausschließen. Begründung: Die Anwendungsbestimmung NZ113 ist erforderlich, um einen ausreichenden Schutz von Bodenorganismen vor Rückständen des Wirkstoffs Sulfoxaflor zu gewährleisten. Durch die Einhaltung der Vorgaben der Anwendungsbestimmung NZ113 wird auch der Schutz der Gewässerorganismen vor Einträgen des Wirkstoffs Sulfoxaflor gewährleistet. Für Anwendungen in Gewächshäusern auf nicht versiegelten Flächen wären andernfalls die Anwendungen auf solche Gewächshäuser zu beschränken, die auf nicht drainierten Flächen errichtet sind. Dies wäre für die Anwendungen 00-002, 00-003, 00-004, 00-006, 00-008 ganzjährig (NG405) und für die Anwendungen 00-001, 00-005, 00-007, 00-009 und 00-010 in dem Zeitraum vom 1. November bis 15. März (NW800) notwendig. Die Vergabe dieser Beschränkung resultiert aus der Berechnung der zu erwartenden Einträge in Oberflächenge- wässer über den Pfad Drainage mit dem Modell Exposit 3.0, ausgehend von einem Daten- satz zu expositionsbestimmenden Eigenschaften (Wasserlöslichkeit = 670 mg/L; DT50 Boden = 385.08 d; KOC = 30). Weitere Informationen hierzu sind dem Registration Report, Part B, nationales Addendum zu entnehmen (Sektion 5). BVL_FO_05_2437_200_V1.8 SEITE 12 VON 27

Anlage 1 zugelassene Anwendung: 008447-00/00-003 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Blattläuse, Weiße Fliegen Pflanzen/-erzeugnisse/Objekte: Zierpflanzen Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

Einsatzgebiet: Zierpflanzenbau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: 12 bis 59 Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen Maximale Zahl der Behandlungen - in dieser Anwendung: 2 - für die Kultur bzw. je Jahr: 2 - Erläuterungen Anzahl Behandlungen: zeitlicher Abstand der Behandlungen mindestens 7 Tage Anwendungstechnik: spritzen Aufwand: - Pflanzengröße bis 50 cm 0,1 l/ha in 200 bis 1000 l Wasser/ha

- Pflanzengröße 50 bis 125 cm 0,15 l/ha in 200 bis 1500 l Wasser/ha

- Pflanzengröße über 125 cm 0,2 l/ha in 200 bis 2000 l Wasser/ha

- Erläuterungen: maximaler Mittelaufwand für die vorgesehene Kultur pro Jahr 0,4 l/ha

2.2 Sonstige Kennzeichnungsauflagen (WH915) In die Gebrauchsanleitung ist eine Arten- und/oder Sortenliste der Kulturpflanzen aufzuneh- men, für die der vorgesehene Mittelaufwand verträglich ist (Positivliste).

2.3 Wartezeiten (N) Gewächshaus: Zierpflanzen Die Festsetzung einer Wartezeit ist ohne Bedeutung. BVL_FO_05_2437_200_V1.8 SEITE 13 VON 27

Anlage 1 zugelassene Anwendung: 008447-00/00-004 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Weiße Fliegen Pflanzen/-erzeugnisse/Objekte: Zierpflanzen Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

Einsatzgebiet: Zierpflanzenbau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: 12 bis 59 Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 2 Anwendungstechnik: spritzen Aufwand: - Pflanzengröße bis 50 cm 0,2 l/ha in 200 bis 1000 l Wasser/ha

- Pflanzengröße 50 bis 125 cm 0,3 l/ha in 200 bis 1500 l Wasser/ha

- Pflanzengröße über 125 cm 0,4 l/ha in 200 bis 2000 l Wasser/ha

- Erläuterungen: maximaler Mittelaufwand für die vorgesehene Kultur pro Jahr 0,4 l/ha

2.3 Wartezeiten (N) Gewächshaus: Zierpflanzen Die Festsetzung einer Wartezeit ist ohne Bedeutung.

Begründung: Die Anwendungsbestimmung NZ113 ist erforderlich, um einen ausreichenden Schutz von Bodenorganismen vor Rückständen des Wirkstoffs Sulfoxaflor zu gewährleisten. Durch die Einhaltung der Vorgaben der Anwendungsbestimmung NZ113 wird auch der Schutz der Gewässerorganismen vor Einträgen des Wirkstoffs Sulfoxaflor gewährleistet. Für Anwendungen in Gewächshäusern auf nicht versiegelten Flächen wären andernfalls die Anwendungen auf solche Gewächshäuser zu beschränken, die auf nicht drainierten Flächen errichtet sind. Dies wäre für die Anwendungen 00-002, 00-003, 00-004, 00-006, 00-008 ganzjährig (NG405) und für die Anwendungen 00-001, 00-005, 00-007, 00-009 und 00-010 in dem Zeitraum vom 1. November bis 15. März (NW800) notwendig. Die Vergabe dieser Beschränkung resultiert aus der Berechnung der zu erwartenden Einträge in Oberflächenge- wässer über den Pfad Drainage mit dem Modell Exposit 3.0, ausgehend von einem Daten- satz zu expositionsbestimmenden Eigenschaften (Wasserlöslichkeit = 670 mg/L; DT50 Boden = 385.08 d; KOC = 30). Weitere Informationen hierzu sind dem Registration Report, Part B, nationales Addendum zu entnehmen (Sektion 5). BVL_FO_05_2437_200_V1.8 SEITE 16 VON 27

Anlage 1 zugelassene Anwendung: 008447-00/00-005 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Blattläuse, Weiße Fliegen Pflanzen/-erzeugnisse/Objekte: Gurke Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

- Pflanzengröße 50 bis 125 cm 0,15 l/ha in 500 bis 1200 l Wasser/ha

- Pflanzengröße über 125 cm 0,2 l/ha in 500 bis 1500 l Wasser/ha

- Erläuterungen: maximaler Mittelaufwand für die vorgesehene Kultur pro Jahr 0,4 l/ha

2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten 1 Tag Gewächshaus: Gurke

Anlage 1 zugelassene Anwendung: 008447-00/00-006 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Weiße Fliegen Pflanzen/-erzeugnisse/Objekte: Gurke Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

Einsatzgebiet: Gemüsebau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: 21 bis 87 Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 2 Anwendungstechnik: spritzen Aufwand: - Pflanzengröße bis 50 cm 0,2 l/ha in 500 bis 750 l Wasser/ha

- Pflanzengröße 50 bis 125 cm 0,3 l/ha in 500 bis 1200 l Wasser/ha

- Pflanzengröße über 125 cm 0,4 l/ha in 500 bis 1500 l Wasser/ha

- Erläuterungen: maximaler Mittelaufwand für die vorgesehene Kultur pro Jahr 0,4 l/ha

2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten 1 Tag Gewächshaus: Gurke

Schutz der Gewässerorganismen vor Einträgen des Wirkstoffs Sulfoxaflor gewährleistet. Für Anwendungen in Gewächshäusern auf nicht versiegelten Flächen wären andernfalls die Anwendungen auf solche Gewächshäuser zu beschränken, die auf nicht drainierten Flächen errichtet sind. Dies wäre für die Anwendungen 00-002, 00-003, 00-004, 00-006, 00-008 ganzjährig (NG405) und für die Anwendungen 00-001, 00-005, 00-007, 00-009 und 00-010 in dem Zeitraum vom 1. November bis 15. März (NW800) notwendig. Die Vergabe dieser Beschränkung resultiert aus der Berechnung der zu erwartenden Einträge in Oberflächenge- wässer über den Pfad Drainage mit dem Modell Exposit 3.0, ausgehend von einem Daten- satz zu expositionsbestimmenden Eigenschaften (Wasserlöslichkeit = 670 mg/L; DT50 Boden = 385.08 d; KOC = 30). Weitere Informationen hierzu sind dem Registration Report, Part B, nationales Addendum zu entnehmen (Sektion 5). BVL_FO_05_2437_200_V1.8 SEITE 20 VON 27

Anlage 1 zugelassene Anwendung: 008447-00/00-007 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Blattläuse, Weiße Fliegen Pflanzen/-erzeugnisse/Objekte: Wassermelone Verwendungszweck: Verwendung ohne Schale

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

- Pflanzengröße 50 bis 125 cm 0,15 l/ha in 500 bis 1200 l Wasser/ha

- Pflanzengröße über 125 cm 0,2 l/ha in 500 bis 1500 l Wasser/ha

- Erläuterungen: maximaler Mittelaufwand für die vorgesehene Kultur pro Jahr 0,4 l/ha / Die Höhenstaffelung gilt nur für aufgeleitete Kulturen. Für nicht aufgeleitete Kulturen kann die in der Anwendung höchst angegebene Auf- wandmenge zur Erzielung der hinreichenden Wirk- samkeit erforderlich werden

2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten 1 Tag Gewächshaus: Wassermelone BVL_FO_05_2437_200_V1.8 SEITE 21 VON 27

Anlage 1 zugelassene Anwendung: 008447-00/00-008 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Weiße Fliegen Pflanzen/-erzeugnisse/Objekte: Wassermelone Verwendungszweck: Verwendung ohne Schale

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

Einsatzgebiet: Gemüsebau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: 21 bis 87 Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 2 Anwendungstechnik: spritzen Aufwand: - Pflanzengröße bis 50 cm 0,2 l/ha in 500 bis 750 l Wasser/ha

- Pflanzengröße 50 bis 125 cm 0,3 l/ha in 500 bis 1200 l Wasser/ha

- Pflanzengröße über 125 cm 0,4 l/ha in 500 bis 1500 l Wasser/ha

2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten 1 Tag Gewächshaus: Wassermelone

Anlage 1 zugelassene Anwendung: 008447-00/00-009 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Blattläuse, Weiße Fliegen Pflanzen/-erzeugnisse/Objekte: Zucchini Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten 1 Tag Gewächshaus: Zucchini

Anwendungen auf solche Gewächshäuser zu beschränken, die auf nicht drainierten Flächen errichtet sind. Dies wäre für die Anwendungen 00-002, 00-003, 00-004, 00-006, 00-008 ganzjährig (NG405) und für die Anwendungen 00-001, 00-005, 00-007, 00-009 und 00-010 in dem Zeitraum vom 1. November bis 15. März (NW800) notwendig. Die Vergabe dieser Beschränkung resultiert aus der Berechnung der zu erwartenden Einträge in Oberflächenge- wässer über den Pfad Drainage mit dem Modell Exposit 3.0, ausgehend von einem Daten- satz zu expositionsbestimmenden Eigenschaften (Wasserlöslichkeit = 670 mg/L; DT50 Boden = 385.08 d; KOC = 30). Weitere Informationen hierzu sind dem Registration Report, Part B, nationales Addendum zu entnehmen (Sektion 5). BVL_FO_05_2437_200_V1.8 SEITE 26 VON 27

Anlage 1 zugelassene Anwendung: 008447-00/00-010 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Weiße Fliegen Pflanzen/-erzeugnisse/Objekte: Zucchini Verwendungszweck:

2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung

Einsatzgebiet: Gemüsebau Anwendungsbereich: Gewächshaus Anwendung im Haus- und Kleingartenbereich: Nein Stadium der Kultur: 21 bis 87 Anwendungszeitpunkt: Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome/Schadorganismen Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 2 Anwendungstechnik: spritzen Aufwand: - 0,2 l/ha in 500 bis 750 l Wasser/ha

2.2 Sonstige Kennzeichnungsauflagen - keine -

2.3 Wartezeiten 1 Tag Gewächshaus: Zucchini

dem Zeitraum vom 1. November bis 15. März (NW800) notwendig. Die Vergabe dieser Beschränkung resultiert aus der Berechnung der zu erwartenden Einträge in Oberflächenge- wässer über den Pfad Drainage mit dem Modell Exposit 3.0, ausgehend von einem Daten- satz zu expositionsbestimmenden Eigenschaften (Wasserlöslichkeit = 670 mg/L; DT50 Boden = 385.08 d; KOC = 30). Weitere Informationen hierzu sind dem Registration Report, Part B, nationales Addendum zu entnehmen (Sektion 5). BVL_FO_05_2437_200_V1.8

REGISTRATION REPORT Part B Section 5 Environmental Fate Detailed summary of the risk assessment

Product code: ZV3 008447-00/00 Product name: Closer Chemical active substance: Sulfoxaflor 120 g/L

Central Zone Zonal Rapporteur Member State: France

NATIONAL ADDENDUM – GERMANY (authorisation)

Applicant: Dow AgroSciences GmbH Submission date: 06.05.2015 MS Finalisation date: 17/10/2018

ZV3 008447-00/00 / Closer Page 2 / 30 Part B – Section 5 – National Addendum Template for chemical PPP Germany Version April 2015

Version history

When What

[10 2018] final assessment by UBA

ZV3 008447-00/00 / Closer Page 3 / 30 Part B – Section 5 – National Addendum Template for chemical PPP Germany Version April 2015

Table of Contents

5 Fate and behaviour in the environment (KCP 9) ...... 5 5.1 Critical GAP and overall conclusions ...... 6 5.1.1 Table of critical GAPs ...... 6 5.1.2 Overall conclusion ...... 11 5.1.2.1 Predicted environmental concentrations in soil (PECsoil) ...... 11 5.1.2.2 Predicted environmental concentrations in groundwater (PECgw) ...... 11 5.1.2.3 Predicted environmental concentrations in surface water (PECsw)...... 11 5.1.2.4 Fate and behaviour in air ...... 12 5.1.3 Grouping of intended uses for risk assessment ...... 12 5.2 Metabolites considered in the assessment ...... 13 5.3 Rate of degradation in soil (KCP 9.1.1) ...... 13 5.4 Aerobic degradation in soil (KCP 9.1.1.1) ...... 13 5.4.1 Anaerobic degradation in soil (KCP 9.1.1.1) ...... 13 5.5 Field studies (KCP 9.1.1.2) ...... 13 5.5.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1) . 13 5.5.2 Soil accumulation testing (KCP 9.1.1.2.2) ...... 13 5.6 Mobility in soil (KCP 9.1.2) ...... 13 5.6.1 Adsorption and desorption in soil (KCP 9.1.2.1) ...... 13 5.6.2 Column leaching (KCP 9.1.2.1) ...... 13 5.6.3 Lysimeter studies (KCP 9.1.2.2) ...... 14 5.6.4 Field leaching studies (KCP 9.1.2.3) ...... 14 5.7 Degradation in the water/sediment systems (KCP 9.2, KCP 9.2.1, KCP 9.2.2, KCP 9.2.3) ...... 14 5.7.1 Water/sediment study (KCP 9.2.2) ...... 14 5.8 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3) ...... 15 5.8.1 Justification of new endpoints ...... 15 5.8.2 Active substance and relevant metabolite(s) ...... 15 5.8.2.1 PECsoil ...... 16 5.9 Predicted Environmental Concentrations in groundwater (PECgw) (KCP 9.2.4) ...... 19 5.9.1 Justification of new endpoints ...... 19 5.9.2 Sulfoxaflor and relevant metabolite(s) (KCP 9.2.4.1) Direct Leaching into groundwater ...... 19 5.9.2.1 Sulfoxaflor and its metabolites ...... 20 5.9.2.2 Sulfoxaflor and its metabolites ...... 20 5.9.3 Summary on estimation of PECgw after direct leaching ...... 22 5.9.4 Groundwater contamination by bank filtration due to surface water exposure via runoff and drainage ...... 22 5.9.4.1 Sulfoxaflor and its metabolites ...... 22 5.10 Predicted Environmental Concentrations in surface water (PECsw) (KCP 9.2.5) ...... 26 5.10.1 Justification of new endpoints ...... 26 5.10.2 PECsw after exposure by spray drift and volatilization with subsequent deposition ...... 26 5.10.2.1 Sulfoxaflor and its metabolites ...... 26 5.10.3 PECsw after exposure by surface runoff and drainage ...... 27 ZV3 008447-00/00 / Closer Page 4 / 30 Part B – Section 5 – National Addendum Template for chemical PPP Germany Version April 2015

5.11 Fate and behaviour in air (KCP 9.3, KCP 9.3.1) ...... 28 5.12 Classification and labelling ...... 28 5.12.1 GHS Classification and labelling ...... 28 5.12.2 National labelling and conditions of use ...... 28

Appendix 1 Lists of data considered in support of the evaluation ...... 29

Appendix 2 Detailed evaluation of the new Annex II studies ...... 30

Appendix 3 Additional information provided by the applicant (e.g. detailed modelling data) ...... 30

ZV3 008447-00/00 / Closer Page 5 / 30 Part B – Section 5 – National Addendum Template for chemical PPP Germany Version April 2015

5 Fate and behaviour in the environment (KCP 9)

The exposure assessment of the plant protection product Closer in its intended uses in aubergines, pepinos, bulbs, ornamentals, flowers, Cucurbits including edible peel – cucumbers, courgettes, gherkins; inedible peel – melons, pumpkins/ squash, zucchini, watermelons, Pepper including Chilli pepper and tomatoes is documented in detail in the core assessment of the plant protection product Closer (GF-2626) dated from October 2017 performed by France. This national addendum has been produced to support a national decision on the authorisation of the product Closer in Germany for the uses listed below. It reflects the impact of specific German environmental or agricultural circumstances on the exposure and risk assessment for Closer including risk mitigation measures.

ZV3 008447-00/00 / Closer Page 6 / 30 Part B – Section 5 – National Addendum Template for chemical PPP Germany Version April 2015

5.1 Critical GAP and overall conclusions

5.1.1 Table of critical GAPs

Table 5.1-1: 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 L product/ha kg as/ha Water L/ha ener/ syner- Groundwater / purpose of Gn, mental stages of the Growth a) per use between ap- a) max. rate min/max gist per ha crop) Gpn pest or pest group) stage of crop b) per crop/ plications per appl. a) max. rate or & season season (days) b) max. total per appl. I ** rate per b) max. total crop/season rate per crop/season Intended for uses in Germany

001 DE Aubergine G aphids (APXXSP), spraying At begin- a) 2 7 a) plant a) 0.012 500 – 750 - A (SOLME), Whiteflies (ALEUSP) ning of in- b) 2 height up to kg/ha L/ha tomato festation 50 cm: (LYPES), and/or when 0.1 L/ha sweet pepper first symp- (CPSAN), melon toms/harm- plant height 0.018 kg/ha 500 – 1200 pear (SOLMU) ful organ- 50 up to 125 L/ha isms become cm: visible 0.15 L/ha 21 to 87 Plant height 0.024 kg/ha 500 – 1500 more than L/ha 125 cm: 0.2 L/ha b) 0.048 b) 0.4 L/ha kg/ha

002 DE Aubergine G Whiteflies (ALEUSP) spraying At begin- a) 1 - a) plant a) 0.024 500 – 750 - A (SOLME), ning of in- b) 2 height up to kg/ha L/ha tomato festation 50 cm: (LYPES), and/or when 0.2 L/ha sweet pepper first symp- (CPSAN), toms/harm- plant height 0.036 kg/ha 500 – 1200 melon pear 50 up to 125 L/ha ZV3 008447-00/00 / Closer Page 7 / 30 Part B – Section 5 – National Addendum Template for chemical PPP Germany Version April 2015

(SOLMU) ful organ- cm: isms become 0.3 L/ha visible 21 to 87 Plant height 0.048 kg/ha 500 – 1500 more than L/ha 125 cm: 0.4 L/ha b) 0.048 b) 0.4 L/ha kg/ha

003 DE ornamentals G aphids (APXXSP), spraying At begin- a) 2 7 a) plant a) 0.012 200 – 1000 - A (NNNZZ) Whiteflies (ALEUSP) ning of in- b) 2 height up to kg/ha L/ha festation 50 cm: and/or when 0.1 L/ha first symptoms/harm- plant height 0.018 kg/ha 200 – 1500 ful organ- 50 up to 125 L/ha isms become cm: visible 0.15 L/ha 12 to 59 Plant height 0.024 kg/ha 200 – 2000 more than L/ha 125 cm: 0.2 L/ha b) 0.048 b) 0.4 L/ha kg/ha

004 DE ornamentals G Whiteflies (ALEUSP) spraying At begin- a) 1 - a) plant a) 0.024 200 – 1000 - A (NNNZZ) ning of in- b) 2 height up to kg/ha L/ha festation 50 cm: and/or when 0.2 L/ha first symptoms/harm- plant height 0.036 kg/ha 200 – 1500 ful organ- 50 up to 125 L/ha isms become cm: visible 0.3 L/ha 12 to 59 Plant height 0.048 kg/ha 200 – 2000 more than L/ha 125 cm: 0.4 L/ha b) 0.048 b) 0.4 L/ha kg/ha

005 DE cucumber G aphids (APXXSP), spraying At begin- a) 2 7 a) plant a) 0.012 500 – 750 - A (CUMSA) Whiteflies (ALEUSP) ning of in- b) 2 height up to kg/ha L/ha festation 50 cm: and/or when 0.1 L/ha ZV3 008447-00/00 / Closer Page 8 / 30 Part B – Section 5 – National Addendum Template for chemical PPP Germany Version April 2015

first symptoms/harm- plant height 0.018 kg/ha 500 – 1200 ful organ- 50 up to 125 L/ha isms become cm: visible 0.15 L/ha 21 to 87 Plant height 0.024 kg/ha 500 – 1500 more than L/ha 125 cm: 0.2 L/ha b) 0.048 b) 0.4 L/ha kg/ha

006 DE cucumber G Whiteflies (ALEUSP) spraying At begin- a) 1 - a) plant a) 0.024 500 – 750 - A (CUMSA) ning of in- b) 2 height up to kg/ha L/ha festation 50 cm: and/or when 0.2 L/ha first symptoms/harm- plant height 0.036 kg/ha 500 – 1200 ful organ- 50 up to 125 L/ha isms become cm: visible 0.3 L/ha 21 to 87 Plant height 0.048 kg/ha 500 – 1500 more than L/ha 125 cm: 0.4 L/ha

b) 0.4 L/ha b) 0.048 kg/ha

007 DE Cantaloupe (CI- G aphids (APXXSP), spraying At begin- a) 2 7 a) plant a) 0.012 500 – 750 A TLA) use with- Whiteflies (ALEUSP) ning of in- b) 2 height up to kg/ha L/ha out peal festation 50 cm: and/or when 0.1 L/ha first symptoms/harm- plant height 0.018 kg/ha 500 – 1200 ful organ- 50 up to 125 L/ha isms become cm: visible 0.15 L/ha 21 to 87 Plant height 0.024 kg/ha 500 – 1500 more than L/ha 125 cm: 0.2 L/ha b) 0.048 b) 0.4 L/ha kg/ha

008 DE Cantaloupe (CI- G Whiteflies (ALEUSP) spraying At begin- a) 1 - a) plant a) 0.024 500 – 750 - A b) 2 height up to kg/ha L/ha ZV3 008447-00/00 / Closer Page 9 / 30 Part B – Section 5 – National Addendum Template for chemical PPP Germany Version April 2015

TLA) use with- ning of in- 50 cm: out peal festation 0.2 L/ha and/or when first symp- plant height 0.036 kg/ha 500 – 1200 toms/harm- 50 up to 125 L/ha ful organ- cm: isms become 0.3 L/ha visible 21 to 87 Plant height 0.048 kg/ha 500 – 1500 more than L/ha 125 cm: 0.4 L/ha b) 0.048 b) 0.4 L/ha kg/ha

009 DE zucchini G aphids (APXXSP), spraying At begin- a) 2 7 a) 0.1 L/ha a) 0.012 500 – 750 - A (CUUPG) Whiteflies (ALEUSP) ning of in- b) 2 b) 0.2 L/ha kg/ha L/ha festation b) 0.024 and/or when kg/ha first symptoms/harmful organisms become visible 21 to 87

010 DE zucchini G Whiteflies (ALEUSP) spraying At begin- a) 1 - a) 0.2 L/ha a) 0.024 500 – 750 - A (CUUPG) ning of in- b) 2 b) 0.2 L/ha kg/ha L/ha festation b) 0.024 and/or when kg/ha first symptoms/harmful organisms become visible 21 to 87 Minor uses according to Article 51 (Germany) --

* Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 ** F: professional field use, Fn: non-professional field use, Fpn: professional and non-professional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application

Explanation for column 15 “Conclusion” A Safe use R Further refinement and/or risk mitigation measures required ZV3 008447-00/00 / Closer Page 10 / 30 Part B – Section 5 – National Addendum Template for chemical PPP Germany Version April 2015

N No safe use ZV3 008447-00/00 / Closer Page 11 /30 Part B – Section 5 – National Template for chemical PPP Addendum Version April 2015 Germany

5.1.2 Overall conclusion

5.1.2.1 Predicted environmental concentrations in soil (PECsoil)

PECsoil was calculated for the active substance Sulfoxaflor considering a soil depth of 2.5 cm. Due to the fast degradation of the active substance Sulfoxaflor in soil the accumulation potential of Sulfoxaflor was not considered.

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

5.1.2.2 Predicted environmental concentrations in groundwater (PECgw)

Direct leaching into groundwater Results of modelling with FOCUS PELMO show that the active substance Sulfoxaflor is not expected to penetrate into groundwater at concentrations of ≥ 0.1µg/L in all intended uses of Closer in Germany.

For the metabolites of sulfoxaflor concentrations of ≥ 0.1µg/L in groundwater cannot be excluded. For the assessment of the relevance of metabolite X11719474, X11579457 and X11519540 of active substance sulfoxaflor please refer to the results of EU approval of sulfoxaflor and the core assessment, Part B, section 8. The metabolites X11719474, X11579457 and X11519540 are classified as not relevant for groundwater.

Consequences for authorization: None.

Groundwater contamination by bank filtration due to surface water exposure via runoff and drainage According modelling with EXPOSIT 3, groundwater contamination at concentrations ≥ 0.1 µg/L by the active substance Sulfoxaflor and its soil metabolites X11719474, X11579457 and X11519540 due to surface runoff and drainage into the adjacent ditch with subsequent bank filtration can be excluded.

Consequences for authorization: The authorization of the plant protection product Closer is linked with following labelling:

Use No. 001 - 010 none

5.1.2.3 Predicted environmental concentrations in surface water (PECsw)

Risk mitigation measures for the intended uses of plant protection products in Germany due to exposure of surface water consider two routes of entry (i) spray drift and volatilization with subsequent deposition and (ii) runoff, drainage separately. Surface water exposure including effects of risk mitigation via spray drift and volatilization with subsequent deposition was estimated with the model EVA 3 using drift data by Rautmann and Ganzelmeier. Surface water exposure including effects of risk mitigation via surface runoff and drainage was estimated ZV3 008447-00/00 / Closer Page 12 /30 Part B – Section 5 – National Template for chemical PPP Addendum Version April 2015 Germany using the model EXPOSIT 3. The results of the specific national exposure assessment for the active substance were used in the ecotoxicological risk assessment.

5.1.2.4 Fate and behaviour in air

The vapour pressure at 20 °C of the active substance Sulfoxaflor is < 10-5 Pa. Hence the active substance Sulfoxaflor is regarded as non-volatile. Therefore exposure of adjacent surface waters and terrestrial ecosystems by the active substance Sulfoxaflor due to volatilization with subsequent deposition was not considered.

5.1.3 Grouping of intended uses for risk assessment

The following table documents the grouping of the intended uses to support application of the risk envelope approach (according to SANCO/11244/2011). Grouping and sorting approach is based on the German Ex- cel tool.

Table 5.1-2: Critical use pattern of Closer grouped according to soil

Grouping according to soil

Group Intended uses Application rate (g/ha) (inter- Soil-relevant effective applic. ception, %) rate, cumulative (g/ha) S01 00-004 1 x 48 (10%) 43.2 S02 00-003 2 x 24 (10%) 43.2 S03 00-002; 00-006; 00-008 1 x 48 (50%) 24 S04 00-001; 00-005; 00-007 2 x 24 (50%) 24 S05 00-010 1 x 24 (50%) 12 S06 00-009 2 x 12 (50%) 12

For the intended uses in ornamentals (use no.: 003 & 004), the applicant used a crop interception of 65%, but zRMS assessed the interception value for the growing stage of BBCH 12 as too high (see core assessment p. 18). In accordance with the core assessment, a crop interception of 10% for ornamentals was considered as appropriate. For the intended uses 001, 002, 005 – 010, the applicant used an interception value of 70%. This is representative for tomatoes at a BBCH 21, but considered as too high for the fruiting vegetables aubergines, sweet pepper, melon pear, cucumber, cantaloupe and zucchini (use no.: 001, 002, 005 – 010) at a growing stage of BBCH 21. According to EFSA Journal 20014;12(5):3662 a crop interception of 50 % is representative for fruiting vegetables for the growing stage of 21. This interception value was used for the intended uses 001, 002, 005 – 010.

Table 5.1-3: Critical use pattern of Closer grouped according to spray drift

Grouping according to spray drift

Group Intended uses Application rate (g/ha) (inter- Drift scenario val, d) D01 00-001 – 00-010 2 x 12 (50%) – 1 x 48 (10%) No drift ZV3 008447-00/00 / Closer Page 13 /30 Part B – Section 5 – National Template for chemical PPP Addendum Version April 2015 Germany

5.2 Metabolites considered in the assessment

Please refer to the core assessment.

5.3 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.

5.4 Aerobic degradation in soil (KCP 9.1.1.1)

Please refer to the core assessment.

5.4.1 Anaerobic degradation in soil (KCP 9.1.1.1)

Not relevant for assessment.

5.5 Field studies (KCP 9.1.1.2)

5.5.1 Soil dissipation testing on a range of representative soils (KCP 9.1.1.2.1)

Please refer to the core assessment.

5.5.2 Soil accumulation testing (KCP 9.1.1.2.2)

Please refer to the core assessment.

5.6 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.

5.6.1 Adsorption and desorption in soil (KCP 9.1.2.1)

Please refer to the core assessment.

5.6.2 Column leaching (KCP 9.1.2.1)

Please refer to the core assessment. ZV3 008447-00/00 / Closer Page 14 /30 Part B – Section 5 – National Template for chemical PPP Addendum Version April 2015 Germany

5.6.3 Lysimeter studies (KCP 9.1.2.2)

Please refer to the core assessment.

5.6.4 Field leaching studies (KCP 9.1.2.3)

Please refer to the core assessment.

5.7 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.

5.7.1 Water/sediment study (KCP 9.2.2)

Please refer to the core assessment

Table 5.7-1: Accumulation of active substance Sulfoxaflor and relevant metabolites in the sediment

Active substance sulfoxaflor

Accumulation potential in sediment no (DT90,whole system < 1 year, maximum, see core assessment) Accumulation factor (SFO) - -kt -kt faccu = e /(1 – e )

Active substance X11719474

Accumulation potential in sediment yes (DT90,whole system > 1 year, see core assessment)

Accumulation factor (SFO) 3.47 based on DT50, whole system = 1000 d (conservative value, see core -kt -kt faccu = e /(1 – e ) assessment, Part B Section 5, chapter 9.7), t=365 d

ZV3 008447-00/00 / Closer Page 15 /30 Part B – Section 5 – National Template for chemical PPP Addendum Version April 2015 Germany

5.8 Predicted Environmental Concentrations in soil (PECsoil) (KCP 9.1.3)

Results of PECsoil calculation for Closer and its intended for uses in ornamentals and fruiting vegetables according to EU assessment considering 5 cm soil depth are given in the core assessment, part B, section 5, chapter 5.4. In the German exposure assessment, the considered soil layer depth is based on experimental 1 data. Generally, a soil layer depth of 2.5 cm is applied in the calculation for active substances with a KFoc <500, whereas a soil layer depth of 1 cm is applied for active substances with a KFoc >500. A soil bulk density of 1.5 g/cm³ is assumed as in the core assessment.

5.8.1 Justification of new endpoints

Not applicable as no new endpoints used.

5.8.2 Active substance and relevant metabolite(s)

The PECsoil calculations were performed with ESCAPE 2.0 and Excel based on the input parameters as presented in the tables below.

Table 5.8-1: Input parameters 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

Sulfoxaflor Not required - 7.43 (SFO, not applicable Maximum, Field studies, see Table 9.1- 2 (core assesment)) X11719474 295.3 100 385.08 (DFOB, not applicable Maximum, Field studies, see Table 9.1- 4 (core assesment)) X11519540 253.24 12.2 1155.24 (Pseudo- not applicable SFO, Maximum, Labotary studies, see Table 9.1-6 (core assesment)) X11579457 252.25 9.2 346.57 (Pseudo - not applicable SFO, Maximum, Labotary studies, see Table 9.1-8 (core assesment))

Due to the fast degradation of sulfoxaflor in soil (DT90 < 365 d, laboratory & field data) the accumulation potential of sulfoxaflor does not need to be considered. Due to the slow degradation of the soil metabolites of sulfoxaflor, X11719474, X11519540 and X11579457 in soil (DT90> 365 d laboratory and field data,

1 Fent, Löffler, Kubiak: Ermittlung der Eindringtiefe und Konzentrationsverteilung gesprühter Pflanzenschutzmittelwirkstoffe in den Boden zur Berechnung des PEC-Boden. Abschlussbericht zum Forschungsvorhaben FKZ 360 03 018, UBA, Berlin 1999 ZV3 008447-00/00 / Closer Page 16 /30 Part B – Section 5 – National Template for chemical PPP Addendum Version April 2015 Germany the accumulation potential of the metabolites needs to be considered.

5.8.2.1 PECsoil

The calculated PECsoil used for German risk assessment for Sulfoxaflor as well as for the formulation Closer are summarised in Table 5.8-2 and Table 5.8-7.

Table 5.8-2: Results of PECsoil calculation for the intended use in ornamentals used for German risk assessment

Plant protection product: Closer Use: 004 Density of formulation (kg/L) 1.0572 Number of applications/interval: 1 Application rate (g/ha): Closer: 422.88 Sulfoxaflor: 48 Crop interception (%): 10

Active substance/ Soil relevant ap- Soil depthact PECact Tillage PECbkgd PECaccu = formulation plication rate (cm) (mg/kg) depth (cm) (mg/kg) PECact + (g/ha) PECbkgd (mg/kg) Closer 380.59 2.5 1.015 - - - Sulfoxaflor 43.2 2.5 0.115 - X11719474 46.0 2.5 0.123 0 0.013 0.135 X11519540 4.8 2.5 0.013 0 0.026 0.039 X11579457 3.6 2.5 0.010 0 0.004 0.014

Table 5.8-3: Results of PECsoil calculation for the intended use in ornamentals used for German risk assessment

Plant protection product: Closer Use: 003 Density of formulation (kg/L) 1.0572 Number of applications/interval: 2/ 7 d Application rate (g/ha): Closer: 211.44 Sulfoxaflor: 24 Crop interception (%): 10

Active substance/ Soil relevant ap- Soil depthact PECact Tillage PECbkgd PECaccu = formulation plication rate (cm) (mg/kg) depth (cm) (mg/kg) PECact + (g/ha) PECbkgd (mg/kg) Closer 2 x 190.30 2.5 0.772 - - - Sulfoxaflor 2 x 21.6 2.5 0.088 - - - ZV3 008447-00/00 / Closer Page 17 /30 Part B – Section 5 – National Template for chemical PPP Addendum Version April 2015 Germany

Table 5.8-4: Results of PECsoil calculation for the intended use in aubergine, cucumber and cantaloupe used for German risk assessment

Plant protection product: Closer Use: 002, 006, 008 Density of formulation (kg/L) 1.0572 Number of applications/interval: 1 Application rate (g/ha): Closer: 422.88 Sulfoxaflor: 48 Crop interception (%): 50

Table 5.8-5: Results of PECsoil calculation for the intended use in aubergine, cucumber and cantaloupe used for German risk assessment

Plant protection product: Closer Use: 001, 005, 007 Density of formulation (kg/L) 1.0572 Number of applications/interval: 2/ 7 d Application rate (g/ha): Closer: 211.44 Sulfoxaflor: 24 Crop interception (%): 50

Table 5.8-6: Results of PECsoil calculation for the intended use in zucchini used for German risk assessment

Plant protection product: Closer Use: 010 Density of formulation (kg/L) 1.0572 Number of applications/interval: 1 Application rate (g/ha): Closer: 211.44 Sulfoxaflor: 24 Crop interception (%): 50 ZV3 008447-00/00 / Closer Page 18 /30 Part B – Section 5 – National Template for chemical PPP Addendum Version April 2015 Germany

Table 5.8-7: Results of PECsoil calculation for the intended use in zucchini used for German risk assessment

Plant protection product: Closer Use: 009 Density of formulation (kg/L) 1.0572 Number of applications/interval: 2/ 7 Application rate (g/ha): Closer: 105.72 Sulfoxaflor: 12 Crop interception (%): 50

Active substance/ Soil relevant ap- Soil depthact PECact Tillage PECbkgd PECaccu = formulation plication rate (cm) (mg/kg) depth (cm) (mg/kg) PECact + (g/ha) PECbkgd (mg/kg) Closer 2 x 52.86 2.5 0.214 - - - Sulfoxaflor 2 x 6 2.5 0.024 - - - ZV3 008447-00/00 / Closer Page 19 /30 Part B – Section 5 – National Template for chemical PPP Addendum Version April 2015 Germany

5.9 Predicted Environmental Concentrations in groundwater (PECgw) (KCP 9.2.4)

Results of the PECgw calculation of Sulfoxaflor for the intended uses of Closer in tomatoes, aubergines, peppers and cucurbits and ornamentals according to EU assessment using FOCUS PELMO and PEARL made for outdoor uses to cover the indoor uses provided by the applicant are given in the core assessment, part B, section 5, chapter 5.8.

Risk assessment for groundwater for authorisation of plant protection products in Germany considers two pathways, (i) direct leaching of the active substance into the groundwater after soil passage and (ii) surface runoff and drainage of the active substance into an adjacent ditch with subsequent bank filtration into the groundwater. The latter pathway was not addressed neither by core assessment nor for EU assessment of the active substances. The risk assessment for groundwater of the pathway direct leaching after soil passage follows the recommendation of the Ground Water Work Group of FOCUS as provided by the Commission Services (Sanco/13144/2010, version 3, 10 October 2014) as also done by the zRMS in the core assessment.

Risk assessment for groundwater for the pathway surface runoff and drainage into an adjacent ditch with subsequent bank filtration into the groundwater are estimated using the model EXPOSIT 3 stipulating also risk mitigation measures, if applicable.

5.9.1 Justification of new endpoints

To address the national requirements of Germany, the applicant provided PECgw calculations of sulfoxaflor and its metabolites (Jarvis, T. and Montesano V., 2014b). The study is presented in the core assessment (part B, section 5, chapter 5.8), but calculations were not further checked or validated by the zRMS. The applicant carried out groundwater modelling for uses on tomatoes, aubergines, peppers and cucurbits with strawberries as surrogate crop, an application rate of 1 x 48 g a.s./ha and 70% crop interception. But this interception value is considered as too high for the fruiting vegetables aubergines, sweet pepper, melon pear, cucumber, cantaloupe and zucchini at a growing stage of BBCH 21. According to EFSA Journal 20014;12(5):3662 a crop interception of 50 % is representative for fruiting vegetables for this growing stage. Thus PECgw was recalculated by the German authority for the intended uses 001, 002, 005 – 010 with strawberries as surrogate crop, an application rate of 1 x 48 g a.s./ha and a crop interception 50%.

For the use in ornamentals, modelling was carried out by the applicant using pome and stone fruit as surrogate crop, an application rate of 1 x 48 g a.s./ha and 65% crop interception. The zRMS assessed the assumption of a crop interception of 65% for the growing stage of a BBCH of 12 as too high (see core assessment p. 18). In accordance with the core assessment, a crop interception of 10% for ornamentals was considered as appropriate. Furthermore the use of pome and stone fruit as surrogated crop is not considered as the adequate one (see comment by the zRMS in the core assessment p. 27). Thus PECgw was recalculated by the German authority for the intended in ornamentals using an application rate of 1 x 48 g a.s./ha, 10% crop interception and cabbage as surrogate crop.

5.9.2 Sulfoxaflor and relevant metabolite(s) (KCP 9.2.4.1) ZV3 008447-00/00 / Closer Page 20 /30 Part B – Section 5 – National Template for chemical PPP Addendum Version April 2015 Germany

Direct Leaching into groundwater

5.9.2.1 Sulfoxaflor and its metabolites

5.9.2.2 Sulfoxaflor and its metabolites

Table 5.9-1: Input parameters related to application of Closer for PECgw calculations

Use No. 004 002 Surrogated crop (Crop) Cabbage (ornamentals) Strawberries (aubergine) Application rate (kg as/ha) Sulfoxaflor: 0.048 Sulfoxaflor: 0.048 Number of applications/in- 1 1 terval (d) Relative application date 27.04. 01.03 Crop interception (%) 10 50 Frequency of application annual annual Models used for calculation FOCUS PELMO FOCUS PELMO

In adapting the risk envelope approach PECgw for use No 003 is covered by PECgw for use No 004 and use No. 001, 005 - 010 is covered by 002 due to the same surrogated crop, same application same and the same or lower application rates. Therefore only PECgw for use No 004 and 002 is documented below.

Table 5.9-2: Input parameters related to active substance sulfoxaflor for PECgw calculations

Parent Sulfoxaflor Remarks/Reference to core assessment, part B, section 5

Molecular weight (g/mol) 277.3 Not applicable

DT50 in soil (d) 0.1 LoEP (2014)

KFoc (mL/g) 35 LoEP (2014) 1/n 0.965 LoEP (2014) Plant uptake factor 0 LoEP (2014)

Table 5.9-3: Input parameters for the metabolites of Sulfoxaflor for PECgw calculations

Remarks/Reference to core assessment, part B, section 8

Metabolite X11719474

Molecular weight (g/mol) 295 LoEP (2014) Formation fraction 1 LoEP (2014)

DT50 in soil (d) 76.6 LoEP (2014) ZV3 008447-00/00 / Closer Page 21 /30 Part B – Section 5 – National Template for chemical PPP Addendum Version April 2015 Germany

KFoc (mL/g) 30 LoEP (2014) 1/n 0.99 LoEP (2014) Plant uptake factor 0

Metabolite X11519540

Molecular weight (g/mol) 253.2 LoEP (2014) Formation fraction 0.5 LoEP (2014)

DT50 in soil (d) 40.5 LoEP (2014)

KFoc (mL/g) 14 LoEP (2014) 1/n 1.012 LoEP (2014) Plant uptake factor 0

Metabolite X11579457

Molecular weight (g/mol) 252.3 LoEP (2014) Formation fraction 0.5 LoEP (2014)

DT50 in soil (d) 186.7 LoEP (2014)

KFoc (mL/g) 21 LoEP (2014) 1/n 0.817 LoEP (2014) Plant uptake factor 0

PECgw of Sulfoxaflor and its metabolites due to direct leaching

Table 5.9-4: PECgw for Sulfoxaflor and its metabolite(s) for the application of Closer in ornamentals considered relevant for German exposure assessment

th -1 Group/use No. Scenario 80 percentile PECgw at 1 m soil depth (µg L ) groundwater model: FOCUS PELMO 5.5.3

Sulfoxaflor X11719474 X11519540 X11579457

004 Hamburg >0.001 4.874 2.263 3.391

Table 5.9-5: PECgw for Sulfoxaflor and its metabolite(s) for the application of Closer in fruiting vegetables considered relevant for German exposure assessment

th -1 Group/use No. Scenario 80 percentile PECgw at 1 m soil depth (µg L ) groundwater model: FOCUS PELMO 5.5.3

Sulfoxaflor X11719474 X11519540 X11579457

002 Hamburg >0.001 2.799 1.287 1.906

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5.9.3 Summary on estimation of PECgw after direct leaching

Results of modelling with FOCUS PELMO show that the active substance sulfoxaflor is not expected to penetrate into groundwater at concentrations of ≥ 0.1µg/L in all intended uses of Closer.

For the metabolites X11719474, X11519540 and X11579457 concentrations of ≥ 0.1µg/L in groundwater cannot be excluded. For the assessment of the relevance of metabolite X11719474, X11519540 and X11579457 of sulfoxaflor please refer to the results of EU approval of sulfoxaflor and the core assessment, Part B, section 8. The metabolites X11719474, X11519540 and X11579457 are classified as not relevant for groundwater.

Consequences for authorization: None

5.9.4 Groundwater contamination by bank filtration due to surface water exposure via runoff and drainage

Surface runoff and drainage into an adjacent ditch with subsequent bank filtration into the groundwater are estimated using the model EXPOSIT 3. Runoff can be generally neglected in greenhouses. However, as worst case assumption, the route was considered to assess the risk of groundwater contamination by bank filtration.

Table 5.9-6: Input parameters related to application of Closer for PECgw and PECsw calculations with EXPOSIT 3

Use No. 004 Crop ornamentals Application rate (g as/ha) Sulfoxaflor: 48 Number of applications/in- 1 terval (d) Crop interception (%) 10

In adapting the risk envelope approach PECgw for use No 001 – 003, 005 – 010 is covered by PECgw for use No 004 due to highest soil relevant application rate.

5.9.4.1 Sulfoxaflor and its metabolites

Table 5.9-7: Input parameters for Sulfoxaflor used for PECgw calculations with EXPOSIT 3 Parameter Sulfoxaflor Reference Molecular weight (g/mol) 277.3

KFoc 35 arithm. mean (LoEP (2014))

DT50 soil (d) 7.43 Worst case field data (LoEP (2014)) Solubility in water (mg/L) 568 Mobility class 4 ZV3 008447-00/00 / Closer Page 23 /30 Part B – Section 5 – National Template for chemical PPP Addendum Version April 2015 Germany

Reduction by bank filtration 100

The soil metabolites of Sulfoxaflor are formed >10 % in soil. Therefore potential groundwater contamination due to bank filtration via surface water exposure by runoff and drainage needs to be assessed.

Table 5.9-8: Input parameter for soil metabolites of Sulfoxaflor for EXPOSIT 3 Parameter Metabolite X11719474 Reference Molecular weight (g/mol) 295.0 Correction factor molecular weight 1.064 Maximum occurrence in soil (%) 100 LoEP (2014)

K Foc 30 arithm. mean (LoEP (2014))

DT50 soil (d) 385.08 90th percentile, laboraty data Solubility in water (mg/L) 670 Mobility class 2 Reduction by bank filtration 75%

Table 5.9-9: Input parameter for soil metabolites of Sulfoxaflor for EXPOSIT 3 Parameter Metabolite X11519540 Reference Molecular weight (g/mol) 253.24 Correction factor molecular weight 0.91 Maximum occurrence in soil (%) 12.2 LoEP (2014)

K Foc 14 arithm. mean (LoEP (2014))

DT50 soil (d) 95.1 maximum field data Solubility in water (mg/L) 670 Mobility class 2 Reduction by bank filtration 75%

Table 5.9-10: Input parameter for soil metabolites of Sulfoxaflor for EXPOSIT 3 Parameter Metabolite X11579457 Reference Molecular weight (g/mol) 252.25 Correction factor molecular weight 0.91 Maximum occurrence in soil (%) 9.2 LoEP (2014)

K Foc 22 arithm. mean (LoEP (2014))

DT50 soil (d) 337.12 90th percentile, laboraty data Solubility in water (mg/L) 670 Mobility class 2 Reduction by bank filtration 75%

PECgw of Sulfoxaflor and its metabolites due to bank filtration As the reduction by bank filtration is assumed to be 100 % for Sulfoxaflor, no calculation for Sulfoxaflor is necessary. But for the soil metabolites, the reduction by bank filtration is not assumed to be 100 % and calculation for soil metabolites are necessary.

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Table 5.9-11: PECgw for soil metabolites of Sulfoxaflor after surface runoff and drainage with subsequent bank filtration (modelled with EXPOSIT 3) Metabolite X11719474

Use No. Application PECgw due to rate ( a.s./ha); Runoff Drainage Interzeption Vegetated buffer Bank filtrate Time of applica- Bank filtrate strip (µg/L) tion (µg/L) (m) 004 48, 10% 0 0.005 spring/summer 0.003 5 0.005 10 0.004 autumn/winter/ 0.009 20 0.003 early spring Required labelling none

Table 5.9-12: PECgw for soil metabolites of Sulfoxaflor after surface runoff and drainage with subsequent bank filtration (modelled with EXPOSIT 3) Metabolite X11519540

Use No. Application PECgw due to rate ( a.s./ha); Runoff Drainage Interzeption Vegetated buffer Bank filtrate Time of applica- Bank filtrate strip (µg/L) tion (µg/L) (m) 004 5.3; 10% 0 <0.001 spring/summer <0.001 5 <0.001 10 <0.001 autumn/winter/ 0.001 20 <0.001 early spring Required labelling none

Table 5.9-13: PECgw for soil metabolites of Sulfoxaflor after surface runoff and drainage with subsequent bank filtration (modelled with EXPOSIT 3) Metabolite X11579457

Use No. Application PECgw due to rate ( a.s./ha); Runoff Drainage Interzeption Vegetated buffer Bank filtrate Time of applica- Bank filtrate strip (µg/L) tion (µg/L) (m) 004 4; 10% 0 <0.001 spring/summer <0.001 5 <0.001 10 <0.001 autumn/winter/ 0.001 20 <0.001 early spring Required labelling none

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According modelling with EXPOSIT 3, groundwater contamination at concentrations ≥ 0.1 µg/L by the active substance Sulfoxaflor due to surface runoff and drainage into the adjacent ditch with subsequent bank filtration can be excluded. Groundwater contamination at concentrations ≥ 0.1 µg/L by the soil metabolites of Sulfoxaflor due to surface runoff and drainage into the adjacent ditch with subsequent bank filtration can be excluded.

Consequences for authorization: The authorization of the plant protection product Closer is linked with following labeling:

Use No. 001 - 010 none

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5.10 Predicted Environmental Concentrations in surface water (PECsw) (KCP 9.2.5)

Risk mitigation measures for the intended uses of plant protection products in Germany due to exposure of surface water consider the two routes of entry (i) spray drift and volatilization with subsequent deposition and (ii) runoff, drainage separately. Surface water exposure including effects of risk mitigation via spray drift and volatilization with subsequent deposition is estimated with the model EVA. Surface water exposure including effects of risk mitigation via surface runoff and drainage is estimated using the model EXPOSIT. The route (i) spray drift is deemed unlikely and not further considered.

5.10.1 Justification of new endpoints

Not applicable as no new endpoints used.

5.10.2 PECsw after exposure by spray drift and volatilization with subsequent deposition

The calculation of PECsw after exposure via spray drift and volatilization with subsequent deposition is performed using the model EVA 3. For a single application, the exposure assessment via spray drift is based on the application rate in conjunction with the 90th percentile of the drift values. For multiple applications, lower percentiles of the drift values for each application are applied, resulting in an overall 90th percentile of drift probabilities. Only one volatilization event following the last use of pesticide is generally considered.

Table 5.10-1: Input parameters for Closer related to the application used for PECsw calculations with EVA 3

Use No.: 004 Number of applica- 1 tions/ interval: Application rate Sulfoxaflor: 48 (g a.s./ha)

The route (i) spray drift is deemed unlikely and not further considered.

5.10.2.1 Sulfoxaflor and its metabolites

The calculation of concentrations in surface water is based on spray drift data by Rautmann and Ganzel- meier. The vapour pressure at 20 °C of the active substance Sulfoxaflor is < 10-5 Pa. Hence the active substance Sulfoxaflor is regarded as non-volatile. Therefore exposure of surface water by the active substance Sulfoxaflor due to volatilization with subsequent deposition does not need to be considered.

The input parameters used for modelling of surface water exposure via spray drift and volatilization with subsequent deposition with EVA 3 are summarised below. ZV3 008447-00/00 / Closer Page 27 /30 Part B – Section 5 – National Template for chemical PPP Addendum Version April 2015 Germany

Table 5.10-2: Input parameters for Sulfoxaflor used for the PECsw calculations with EVA 3 Parameter Sulfoxaflor Reference Vapour pressure at 20 °C (Pa) not required since no v/d LoEP (2014) Solubility in water at 20 °C (mg/L) not required since no v/d

For PECsw/sed due to spray drift and volatilization with subsequent deposition for Sulfoxaflor please refer to national Addendum Germany, Part B, Section 6, chapter 6.5.

5.10.3 PECsw after exposure by surface runoff and drainage

The concentration of the active substance Sulfoxaflor in adjacent ditch due to surface runoff and drainage is calculated using the model EXPOSIT 3. In general in greenhouses application surface runoff can be neglected, only the route of entry via drainage is considered. The input parameters for Closer related to the application used for PECsw calculations with Exposit 3 are summerised in Table 5.9-6.

The substance specific input parameters used for modelling surface water exposure via runoff and drainage in an adjacent ditch with EXPOSIT 3 are summarised in chapter 5.9.4 of this document.

For PECsw/sed due to drainage please refer to national Addendum Germany, Part B, Section 6, chapter 6.5. ZV3 008447-00/00 / Closer Page 28 /30 Part B – Section 5 – National Template for chemical PPP Addendum Version April 2015 Germany

5.11 Fate and behaviour in air (KCP 9.3, KCP 9.3.1)

Please refer to chapter 5.10.2.

5.12 Classification and labelling

5.12.1 GHS Classification and labelling

Please refer to the core assessment Part B Section 9.

5.12.2 National labelling and conditions of use

Table 5.12-1 Mandatory conditions of use according to § 36 (1) PflSchG

use group/use No Conditions of use 001 - 010 none ZV3 008447-00/00 / Closer Page 29 /30 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

Appendix 1 Lists of data considered in support of the evaluation none ZV3 008447-00/00 / Closer Page 30 /30 Part B – Section 8 – National Addendum Template for chemical PPP Germany Version April 2015

Appendix 2 Detailed evaluation of the new Annex II studies none

Appendix 3 Additional information provided by the applicant (e.g. detailed modelling data) none REGISTRATION REPORT Part B Section 6 Ecotoxicology Detailed summary of the risk assessment

Product code: GF-2626 Product name: Closer Chemical active substance: Sulfoxaflor, 120 g/L

Interzonal Zonal Rapporteur Member State: France

National Addendum Germany (authorisation)

Applicant: DOW AgroSciences Submission date: 10/2017 MS Finalisation date: 23/10/2018 Page 2 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

Version history

When What

10/2017 Core Assessment written by France 10/2018 First draft NA by UBA

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Table of Contents

6 Ecotoxicology (KCP 10) ...... 5 6.1 Critical GAP and overall conclusions ...... 7 6.1.1 Overall conclusions ...... 12 6.1.1.1 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) ...... 12 6.1.1.2 Effects on aquatic organisms (KCP 10.2) ...... 12 6.1.1.3 Effects on bees (KCP 10.3.1) ...... 13 6.1.1.4 Effects on arthropods other than bees (KCP 10.3.2) ...... 13 6.1.1.5 Effects on non-target soil meso- and macrofauna (KCP 10.4), Effects on soil microbial activity (KCP 10.5) ...... 13 6.1.1.6 Effects on non-target terrestrial plants (KCP 10.6) ...... 13 6.1.1.7 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ...... 14 6.1.2 Grouping of intended uses for risk assessment ...... 14 6.1.3 Consideration of metabolites ...... 14 6.2 Effects on birds (KCP 10.1.1) ...... 15 6.2.1 Overall conclusions ...... 15 6.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2) ...... 15 6.3.1 Overall conclusions ...... 16 6.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3) ...... 16 6.4.1 Overall conclusions ...... 16 6.5 Effects on aquatic organisms (KCP 10.2) ...... 16 6.5.1 Toxicity data ...... 16 6.5.1.1 Justification for new endpoints ...... 16 6.5.2 Risk assessment ...... 17 6.5.3 Overall conclusions ...... 21 6.6 Effects on bees (KCP 10.3.1) ...... 22 6.6.1 Toxicity data ...... 22 6.6.1.1 Justification for new endpoints ...... 23 6.6.2 Risk assessment ...... 23 6.6.2.1 Hazard quotients for bees ...... 23 6.6.3 Effects on bumble bees ...... 24 6.6.4 Effects on solitary bees ...... 25 6.6.5 Overall conclusions ...... 27 6.7 Effects on arthropods other than bees (KCP 10.3.2) ...... 29 6.7.1 Toxicity data ...... 29 6.7.1.1 Justification for new endpoints ...... 29 6.7.2 Risk assessment ...... 29 6.7.2.1 Risk assessment for in-field exposure ...... 29 6.7.2.2 Risk assessment for off-field exposure ...... 29 6.7.2.3 Additional higher-tier risk assessment ...... 29 6.7.2.4 Risk mitigation measures ...... 29 6.7.3 Overall conclusions ...... 29 Page 4 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

6.8 Effects on non-target soil meso- and macrofauna (KCP 10.4) ...... 30 6.8.1 Toxicity data ...... 30 6.8.1.1 Justification for new endpoints ...... 31 6.8.2 Risk assessment ...... 31 6.8.2.1 First-tier risk assessment ...... 31 6.8.2.2 Higher-tier risk assessment ...... 34 6.8.3 Overall conclusions ...... 34 6.9 Effects on soil microbial activity (KCP 10.5) ...... 35 6.9.1 Toxicity data ...... 35 6.9.1.1 Justification for new endpoints ...... 35 6.9.2 Risk assessment ...... 35 6.9.3 Overall conclusions ...... 36 6.10 Effects on non-target terrestrial plants (KCP 10.6) ...... 36 6.10.1 Overall conclusions ...... 36 6.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7) ...... 36 6.11.1 Overall conclusions ...... 36 6.12 Monitoring data (KCP 10.8) ...... 37 6.13 Classification and Labelling ...... 37 6.13.1 National labelling and conditions of use ...... 37

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6 Ecotoxicology (KCP 10)

This document is the national addendum, based on the core assessment for the application of Closer (8447) in the EU. Where appropriate, reference is made to the core assessment.

This document summarises the ecotoxicological effects of the plant protection product GF-2626 containing the active substance sulfoxaflor, and where appropriate, the active substance and potentially relevant metabolites and evaluates the potential risk to various representatives of terrestrial, aquatic and soil organisms. A risk assessment according to Uniform Principles is provided.

Sulfoxaflor is a new active substance which has been approuved since 18/08/2015 in the EU. Ireland (Pes- ticide Registration and Control Division, PRCD) is the rapporteur Member State (RMS). A dossier for the active substance was submitted by Dow AgroSciences, under Regulation (EC) 1107/2009, to the RMS in July 2011.

The active substance submission followed a zonal approach where the evaluation was shared by four Mem- ber States participating under a work-share umbrella as follows: Ireland - RMS, lead reviewer for the sections Toxicology, Residues and Metabolism along with coordination of the work-share project. France: Lead reviewer for the sections Identity/Physical-Chemical properties, Methods of Analysis and Effi- cacy/Biology. Poland: Lead reviewer for the section Environmental Fate. Czech Republic: Lead reviewer for the section Ecotoxicology.

The Draft Assessment Report (DAR) on sulfoxaflor was finalised and distributed by Ireland in November 2012, with a recommendation for approval of the active substance according to Regulation (EC) 1107/2009. The EFSA peer review process was conducted and the EFSA conclusion was published in May 2014.

Dow AgroSciences submitted an EU MRL dossier to the RMS, Ireland, in April 2011. The EU MRL evaluation was integrated with the active substance evaluation under 1107/2009. The adoption of MRL/Import tolerances was therefore aligned with the same timing as that of the active substance approval.

There were two representative formulations for the EU active approval submission. These were GF-2372 (500 g/kg WG) and GF-2626 (120 g/L SC). This current submission is for one of these two formulations, GF-2626. This is the first submission for authorisation of plant protection products containing sulfoxaflor in EU Member States. The proposed zonal RMS for Central Zone and Southern Zone are Ireland and France respectively. Where appropriate, this document refers to the conclusions of the EFSA review report (EFSA Journal 2014; 12(5):3692) of sulfoxaflor (hereafter referred to as EFSA conclusion 2014). This will be where: the active substance data are relied upon in the risk assessment of the formulation; or when the EU review concluded that additional data/information should be considered at national registration.

The core assessment reviews data (active substance or plant protection product) and additional information that has not previously been considered within the EU review process, as part of the active approval decision. Studies for the active substance which have already been evaluated during the approval process are not summarised. New active substance data are only included if they are considered essential for the evaluation and a full study summary is provided.

According to Regulation (EU) 2015/1295, the applicant shall submit confirmatory information as regards: (a) the risk to honey bees via the different routes of exposure, in particular nectar, pollen, guttation fluid and dust; Page 6 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

(b) risk to honey bees foraging in nectar or pollen in succeeding crops and flowering weeds; (c) the risk to pollinators other than honey bees; (d) the risk to bee brood.

NOTE Sulfoxaflor is also referred to as manufacture’s code numbers X11422208, XR-208, XDE-208 and DE-208 in the section. Page 7 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

6.1 Critical GAP and overall conclusions

Table 6.1-1: Table of critical GAPs

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 Use- Member Crop and/or situ- F, Pests or Group of pests Application Application rate PHI Remarks: Conclusion No. state(s) ation Fn, controlled (days) e.g. g saf- * (crop destination Fpn (additionally: develop- Method / Timing / Max. num- Min. interval kg or L g or kg as/ha Water L/ha ener/ syn-

/ purpose of G, mental stages of the Kind Growth ber between ap- product/ha min/max ergist per crop) Gn, pest or pest group) stage of crop a) per use plications a) max. rate a) max. rate ha Gpn & season b) per crop/ (days) per appl. per appl. season b) max. total b) max. total or

rate per rate per arthro- -target plants -target I ** d

crop/season 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) 001 DE Aubergine G aphids (APXXSP), spraying At begin- a) 2 7 a) plant a) 0.012 500 – 750 - (SOLME), to- Whiteflies (ALEUSP) ning of in- b) 2 height up to kg/ha L/ha mato (LYPES), festation 50 cm: sweet pepper and/or when 0.1 L/ha (CPSAN), melon first symp- pear (SOLMU) toms/harm- plant height 0.018 kg/ha 500 – 1200 ful organ- 50 up to 125 L/ha isms become cm: visible 0.15 L/ha 21 to 87 Plant height 0.024 kg/ha 500 – 1500 more than L/ha 125 cm: 0.2 L/ha b) 0.048 b) 0.4 L/ha kg/ha 002 DE Aubergine G Whiteflies (ALEUSP) spraying At begin- a) 1 - a) plant a) 0.024 500 – 750 - (SOLME), to- ning of in- b) 2 height up to kg/ha L/ha mato (LYPES), festation 50 cm: sweet pepper and/or when 0.2 L/ha (CPSAN), melon first symp- pear (SOLMU) toms/harm- plant height 0.036 kg/ha 500 – 1200 ful organ- 50 up to 125 L/ha isms become cm: Page 8 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 visible 0.3 L/ha 21 to 87 Plant height 0.048 kg/ha 500 – 1500 more than L/ha 125 cm: 0.4 L/ha b) 0.048 b) 0.4 L/ha kg/ha 003 DE ornamentals G aphids (APXXSP), spraying At begin- a) 2 7 a) plant a) 0.012 200 – 1000 - (NNNZZ) Whiteflies (ALEUSP) ning of in- b) 2 height up to kg/ha L/ha festation 50 cm: and/or when 0.1 L/ha first symptoms/harm- plant height 0.018 kg/ha 200 – 1500 ful organ- 50 up to 125 L/ha isms become cm: visible 0.15 L/ha 12 to 59 Plant height 0.024 kg/ha 200 – 2000 more than L/ha 125 cm: 0.2 L/ha b) 0.048 b) 0.4 L/ha kg/ha 004 DE ornamentals G Whiteflies (ALEUSP) spraying At begin- a) 1 - a) plant a) 0.024 200 – 1000 - (NNNZZ) ning of in- b) 2 height up to kg/ha L/ha festation 50 cm: and/or when 0.2 L/ha first symptoms/harm- plant height 0.036 kg/ha 200 – 1500 ful organ- 50 up to 125 L/ha isms become cm: visible 0.3 L/ha 12 to 59 Plant height 0.048 kg/ha 200 – 2000 more than L/ha 125 cm: 0.4 L/ha b) 0.048 b) 0.4 L/ha kg/ha Page 9 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 005 DE cucumber G aphids (APXXSP), spraying At begin- a) 2 7 a) plant a) 0.012 500 – 750 - (CUMSA) Whiteflies (ALEUSP) ning of in- b) 2 height up to kg/ha L/ha festation 50 cm: and/or when 0.1 L/ha first symptoms/harm- plant height 0.018 kg/ha 500 – 1200 ful organ- 50 up to 125 L/ha isms become cm: visible 0.15 L/ha 21 to 87 Plant height 0.024 kg/ha 500 – 1500 more than L/ha 125 cm: 0.2 L/ha b) 0.048 b) 0.4 L/ha kg/ha 006 DE cucumber G Whiteflies (ALEUSP) spraying At begin- a) 1 - a) plant a) 0.024 500 – 750 - (CUMSA) ning of in- b) 2 height up to kg/ha L/ha festation 50 cm: and/or when 0.2 L/ha first symptoms/harm- plant height 0.036 kg/ha 500 – 1200 ful organ- 50 up to 125 L/ha isms become cm: visible 0.3 L/ha 21 to 87 Plant height 0.048 kg/ha 500 – 1500 more than L/ha 125 cm: 0.4 L/ha

b) 0.4 L/ha b) 0.048 kg/ha 007 DE Cantaloupe (CI- G aphids (APXXSP), spraying At begin- a) 2 7 a) plant a) 0.012 500 – 750 Notes on TLA) use with- Whiteflies (ALEUSP) ning of in- b) 2 height up to kg/ha L/ha dose rate: out peal festation 50 cm: the height and/or when 0.1 L/ha scale ap- first symp- plies only toms/harm- plant height 0.018 kg/ha 500 – 1200 to trained ful organ- 50 up to 125 L/ha crops. In isms become cm: the case of Page 10 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 visible 0.15 L/ha non-rained 21 to 87 crops, the Plant height 0.024 kg/ha 500 – 1500 maximum more than L/ha application 125 cm: rate may 0.2 L/ha be neces- b) 0.048 sary to b) 0.4 L/ha kg/ha achieve satisfactory efficacy 008 DE Cantaloupe (CI- G Whiteflies (ALEUSP) spraying At begin- a) 1 - a) plant a) 0.024 500 – 750 - TLA) use with- ning of in- b) 2 height up to kg/ha L/ha out peal festation 50 cm: and/or when 0.2 L/ha first symptoms/harm- plant height 0.036 kg/ha 500 – 1200 ful organ- 50 up to 125 L/ha isms become cm: visible 0.3 L/ha 21 to 87 Plant height 0.048 kg/ha 500 – 1500 more than L/ha 125 cm: 0.4 L/ha b) 0.048 b) 0.4 L/ha kg/ha 009 DE zucchini G aphids (APXXSP), spraying At begin- a) 2 7 a) 0.1 L/ha a) 0.012 500 – 750 - (CUUPG) Whiteflies (ALEUSP) ning of in- b) 2 b) 0.2 L/ha kg/ha L/ha festation b) 0.024 and/or when kg/ha first symptoms/harmful organisms become visible 21 to 87 010 DE zucchini G Whiteflies (ALEUSP) spraying At begin- a) 1 - a) 0.2 L/ha a) 0.024 500 – 750 - (CUUPG) ning of in- b) 2 b) 0.2 L/ha kg/ha L/ha festation b) 0.024 and/or when kg/ha Page 11 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 first symptoms/harmful organisms become visible 21 to 87

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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6.1.1 Overall conclusions

6.1.1.1 Effects on birds (KCP 10.1.1), Effects on terrestrial vertebrates other than birds (KCP 10.1.2), Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3)

Birds: The uses of GF-2626 on fruiting vegetables and ornamentals grown under protection will not lead to significant exposure of natural populations of birds, thus the risk to this wildlife group is considered to be negligible.

Mammals: The uses of GF-2626 on fruiting vegetables and ornamentals grown under permanent covered crops will not lead to significant exposure of natural populations of mammals, thus the risk to this wildlife group is considered to be negligible.

Other terrestrial vertebrates: No data available. The uses of GF-2626 on fruiting vegetables and ornamentals grown under permanent covered crops will not lead to significant exposure of natural populations of terrestrial vertebrates, thus the risk to this wildlife group is considered to be negligible.

6.1.1.2 Effects on aquatic organisms (KCP 10.2)

The calculated TER values do achieve the acceptability criterion the adjusted criterion TER ≥ 1 for effects on aquatic organisms provided that risk mitigation measures (reduction of entries via drainage) are applied.

For the authorisation of the plant protection product Closer, labelling and conditions of use are mandatory as follows:

Table 6.1-2 Labelling requirements according to § 36 (3) PflSchG

NW263 The product is toxic for aquatic invertebrates.

Table 6.1-3 Mandatory conditions of use according to § 36 (1) PflSchG for the protection of aquatic organisms

Use number Condition 004 / S01 NG405 Not to be used on drained surfaces. 003 / S02 NG405 Not to be used on drained surfaces. 002, 006, 008 / S03 NG405 Not to be used on drained surfaces. 001, 005, 007 / S04 NW800 Application not allowed on drained areas between 1 November and 15 March. Page 13 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

010 / S05 NW800 Application not allowed on drained areas between 1 November and 15 March. 009 / S06 NW800 Application not allowed on drained areas between 1 November and 15 March.

6.1.1.3 Effects on bees (KCP 10.3.1)

The risk assessment for honey bees is conducted by JKI.

A screening step has been calculated for bumble bees and solitary bees in order to estimate the risk for wild pollinators. Hazard quotients for solitary bees and bumble bees were calculated, taking into account the relevant toxicity data for Sulfoxaflor and estimated in-field exposure levels, according to the intended uses of the product Closer. The calculated indicator values do not achieve the acceptability criteria. The results of the assessment indicate an unacceptable risk for bumble bees and solitary bees due to the intended use of Closer according to the label.

It must be ensured that bumble bees and solitary bees are not exposed to Closer. According to the outcome of the core assessment a re-introduction of pollinator’s colonies in permanent covered crops must be realized at least 10 days after spray dried.

6.1.1.4 Effects on arthropods other than bees (KCP 10.3.2)

To avoid a risk for off-field arthropods it must be ensured that no off-field exposure due to spray drift, runoff or other paths is possible.

6.1.1.5 Effects on non-target soil meso- and macrofauna (KCP 10.4), Effects on soil microbial activity (KCP 10.5)

Soil meso- and macrofauna: Authorisation is possible only in greenhouses with closed crop systems where no entry within the soil is possible.

Use number Condition All uses NZ113 For use exclusively in greenhouses on completely sealed surfaces where the entry of the product into the soil can be excluded.

Soil microbial activity: The results of the assessment indicate an acceptable risk for soil microorganisms due to the intended use of Closer according to the label.

6.1.1.6 Effects on non-target terrestrial plants (KCP 10.6)

The uses of GF-2626 on fruiting vegetables and ornamentals grown under protection will not lead to significant exposure of natural populations of non target terrestrial plants, thus the risk to this group is considered to be negligible. Page 14 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

6.1.1.7 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)

The uses of GF-2626 on fruiting vegetables and ornamentals grown under protection will not lead to significant exposure of natural populations of other flora and fauna, thus the risk to this group is considered to be negligible.

6.1.2 Grouping of intended uses for risk assessment

It is noted that for the use numbers 002, 004, 006, 008 and 010 a second treatment for another pest organism within the same season with Closer is possible according to the GAP. This would lead to a higher total application rate than is covered by the risk assessment. However, according to the core assessment the application is limited to only one application per year for the same area. The risk assessment has been conducted under the assumption that in a distinct culture and year only one pest organism is treated.

Table 6.1-4: Critical use pattern of Closer grouped according to soil

Grouping according to soil

Table 6.1-5: Critical use pattern of Closer grouped according to spray drift

Grouping according to spray drift

Group Intended uses Application rate (g/ha) (inter- Drift scenario val, d) D01 00-001 – 00-010 2 x 12 (50%) – 1 x 48 (10%) No drift

6.1.3 Consideration of metabolites

A list of metabolites found in environmental compartments is provided below. The need for conducting a metabolite-specific risk assessment in the context of the evaluation of Closer is indicated in the table. Page 15 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

Table 6.1-6 Metabolites of Sulfoxaflor

Metabolite Maximum occurrence in compartments Risk assessment required?

Soil, groundwater, surface water, All Sulfoxaflor sediment, air Soil (100%), Aquatic, soil organisms, groundwater, terrestrial vertebrates X11719474 surface water/sediment (70.9%), plants X11519540 Soil (12.2%), Aquatic, soil organisms, groundwater, Terrestrial vertebrates surface water/sediment (0.0001%), (secondary poisoning) plants (2.1% - 6.9%) Soil (9.2%) Aquatic, X11579457 surface water/sediment (0.0001%), Soil organisms Groundwater X11721061 Plants Terrestrial vertebrates

6.2 Effects on birds (KCP 10.1.1)

Please refer to the core assessment.

A possible exposure of birds is via contaminated surface water and subsequent secondary poisoning. How- ever, the log Pow of Sulfoxaflor amounts to 0.806 – 0.799 and thus does not exceed the trigger value of 3. A risk assessment for effects due to secondary poisoning is not required.

6.2.1 Overall conclusions

The uses of GF-2626 on fruiting vegetables and ornamentals grown under protection will not lead to significant exposure of natural populations of birds, thus the risk to this wildlife group is considered to be negligible.

Consequences for authorisation

None.

6.3 Effects on terrestrial vertebrates other than birds (KCP 10.1.2)

Please refer to the core assessment. A possible exposure of mammals is via contaminated surface water and subsequent secondary poisoning. However, the log Pow of Sulfoxaflor amounts to 0.806 – 0.799 and thus does not exceed the trigger value of 3. A risk assessment for effects due to secondary poisoning is not required.

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6.3.1 Overall conclusions

The uses of GF-2626 on fruiting vegetables and ornamentals grown under permanent covered crops will not lead to significant exposure of natural populations of mammals, thus the risk to this wildlife group is considered to be negligible.

Consequences for authorisation

None.

6.4 Effects on other terrestrial vertebrate wildlife (reptiles and amphibians) (KCP 10.1.3)

No data available.

6.4.1 Overall conclusions

The uses of GF-2626 on fruiting vegetables and ornamentals grown under permanent covered crops will not lead to significant exposure of natural populations of terrestrial vertebrates, thus the risk to this wildlife group is considered to be negligible.

Consequences for authorisation

None.

6.5 Effects on aquatic organisms (KCP 10.2)

6.5.1 Toxicity data

Please refer to the core assessment. The selection of studies and endpoints for the risk assessment is in line with the results of the EU review process.

6.5.1.1 Justification for new endpoints

Sulfoxaflor acts, like the neonicotinoids, as a nAChR-agonist. The substance binds like neonicotinoids at the nAChR – agonist and causes conformational change at the receptor, initiating the opening of the receptor channel. As a result, sodium and calcium ions stream into the cell, and potassium ions stream out. This provokes a depolarisation of the cell and eventually causes the known symptoms on the nervous system. These effects of Sufloxaflor binding at the receptor were verified by Watson et al. (20111, cited in Sparks

1 G.B. Watson, M.R. Loso, J.M. Babcock, J.M. Hasler, T.J. Letherer, C.D. Young, Y. Zhu, J.E. Casida, T.C. Sparks, Novel nicotinic action of the sulfoximine insecticide sulfoxaflor, Insect Biochem. Mol. Biol. 41 (2011) 432–439 Page 17 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

et al. 20132). They used cloned and expressed nAChRs from Drosophila melanogaster to show that the nAChR mediated currents induced by sulfoxaflor (Imax = 348%) are significantly larger than those for other nAChR-acting insecticides (the neonicotinoids; Imax = 12.2–47.2%) except clothianidin (Imax = 273%). According to Watson et al. (20173) Sulfoxaflor also binds at the neonicotinoid binding sides but with a significantly lower affinity. However, Watson et al. (2017) found a “single relatively high affinity nAChR binding site” for Sulfoxaflor. The binding of Sulfoxaflor was shown to be directly correlated with the toxicity of the substance. Alike in a neonicotinoid, the sensitivity of Daphnia towards Sulfoxaflor is low and it can be assumed that sublethal effects of Sulfoxoflor are not covered by standard studies. The paper of Siviter et al. (20184) shows clearly that sublethal effects occur on insects at doses far below the typical field rate of Sulfoxoflor. A paper of Lu Xu et al. (20165) shows that sulfoxaflor has a clearly higher toxicity towards distinct insects than the neonicotinoid imidacloprid.

Therefore, following the precautionary principle, and since no reliable data on the effects of Sulfoxaflor to Ephemeroptera are available, and (as far as it is known) since Ephemeroptera are the most sensitive insect taxon for neonicotinoides (see EFSA peer review imidacloprid, 2014), an extrapolation from the endpoint of the midge Chironomus to Ephemeropterans is recommended and necessary. Indeed only the Chironomus endpoint NOEC = 0.0384 mg/Lmm is available for sulfoxaflor.

The dataset in the peer review on imidacloprid indicates that the difference of sensitivity between the 2 groups of organisms is a factor of about 74 (Chironomus endpoint has an EC10 emergence of 2.09 µg/L and the Ephemeropterans Cloeon dipterum and Caenis horaria have EC10 of 0.033 µg/L and 0.024 µg/L, respectively, leading to an EC10,geomean = 0.028 µg/L; the ratio of the endpoints is EC10,Chironomus / EC10,geomean = 74.26).

By using such read-across with the extrapolation factor of 74, the calculated Ephemeropteran endpoint for sulfoxaflor is based on the following:

Chironomus NOEC / extrapolation factor = Ephemeroptera chronic extrapolated 38.4 µg a.s./L / 74 = 0.519 µg a.s./Lextrapolated.

Using the chronic AF of 10, this leads to a RAC = 0.0519 µg a.s./L. This RAC is the relevant endpoint for the risk assessment.

6.5.2 Risk assessment

Please refer to the core assessment.

For authorisation in Germany, three entry routes are considered separately in the exposure assessment for surface water: (i) spray drift together with volatilisation and subsequent deposition (where relevant), (ii)

2 T.C. Sparks, G.B. Watson, M.R. Loso, Chaoxian Geng, J.M. Babcock, J.D. Thomas, Sulfoxaflor and the sulfoximine insecticides: Chemistry, mode of action and basis for efficacy on resistant insects, Pesticide Biochemistry and Physiology 107 (2013) 1–7 3 G.B. Watson, M.B. Olson, K.W. Beavers, M.R. Loso, T.C. Sparks, Characterization of a nicotinic acetylcholine receptor binding site for sulfoxaflor, a new sulfoximine insecticide for the control of sap-feeding insect pests, Pesti- cide Biochemistry and Physiology 143 (2017) 90–94 4 H. Siviter, M.J.F. Brown, E. Leadbeater, Sulfoxaflor exposure reduces bumblebee reproductive success, Na- turevolume 561 (2018) 109–112 5 Lu Xu, Chun-Qing Zhao, Ya-Nan Zhang, Ying Liu, Zhong-Yan Gu, Lethal and sublethal effects of sulfoxaflor on the small brown planthopper Laodelphax striatellus, Journal of Asia-Pacific Entomology 19,3 (2016) 683-689 Page 18 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

run-off, and (iii) drainage. Consequently, specific risk mitigation measures are defined and can be im- posed separately for each entry route. Thus, the risk assessment from the core assessment is replaced by a specific national assessment for Germany, which is described below.

Exposure of surface water bodies via spray drift and volatilisation with subsequent deposition

Exposure via spray drift and volatilization is not relevant.

Exposure of surface water bodies via run-off or drainage

Exposure assessment The concentrations of the active substance Sulfoxaflor in an adjacent ditch due to surface run-off or drainage are calculated using the model EXPOSIT 3.01. The relevant input parameters for exposure modelling are provided in the Environmental Fate section.

Run-off is deemed unlikely and is not further considered.

Selection of relevant toxicity endpoint See above (assessment for exposure via spray drift and volatilisation with subsequent deposition).

Table 6.5-1: Assessment of the risk for aquatic organisms due to the use of Closer (004 / S01) – exposure to entries of Sulfoxaflor via drainage, considering risk mitigation measures

Active substance: Sulfoxaflor Intended use 004 / S01 Application parameters: 1 x 48 g/ha, 10 % interception RAC (µg/L): 0.0519 a.s. Drainage Time of application PEC (µg/L) TER Spring/summer 0.10 0.51 Autumn/winter 0.31 0.17 Risk mitigation measures: NG405 PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger; AF: Assessment factor; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

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Table 6.5-2: Assessment of the risk for aquatic organisms due to the use of Closer (003 / S02) – exposure to entries of Sulfoxaflor via drainage, considering risk mitigation measures

Active substance: Sulfoxaflor Intended use 003 / S02 Application parameters: 2 x 24 g/ha, 10 % interception RAC (µg/L): 0.0519 a.s. Drainage Time of application PEC (µg/L) TER Spring/summer 0.08 0.67 Autumn/winter 0.24 0.22 Risk mitigation measures: NG405 PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger; AF: Assessment factor; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

Table 6.5-3: Assessment of the risk for aquatic organisms due to the use of Closer (002, 006, 008 / S03) – exposure to entries of Sulfoxaflor via drainage, considering risk mitigation measures

Active substance: Sulfoxaflor Intended use 002, 006, 008 / S03 Application parameters: 1 x 48 g/ha, 50 % interception RAC (µg/L): 0.0519 a.s. Drainage Time of application PEC (µg/L) TER Spring/summer 0.06 0.92 Autumn/winter 0.17 0.30 Risk mitigation measures: NG405 PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger; AF: Assessment factor; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

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Table 6.5-4: Assessment of the risk for aquatic organisms due to the use of Closer (001, 005, 007 / S04) – exposure to entries of Sulfoxaflor via drainage, considering risk mitigation measures

Active substance: Sulfoxaflor Intended use 001, 005, 007 / S04 Application parameters: 2 x 24 g/ha, 50 % interception RAC (µg/L): 0.0519 a.s. Drainage Time of application PEC (µg/L) TER Spring/summer 0.04 1.20 Autumn/winter 0.13 0.39 Risk mitigation measures: NW800 PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger; AF: Assessment factor; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

Table 6.5-5: Assessment of the risk for aquatic organisms due to the use of Closer (010 / S05) – exposure to entries of Sulfoxaflor via drainage, considering risk mitigation measures

Active substance: Sulfoxaflor Intended use 010 / S05 Application parameters: 1 x 24 g/ha, 50 % interception RAC (µg/L): 0.0519 a.s. Drainage Time of application PEC (µg/L) TER Spring/summer 0.03 1.83 Autumn/winter 0.09 0.60 Risk mitigation measures: NW800 PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger; AF: Assessment factor; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

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Table 6.5-6: Assessment of the risk for aquatic organisms due to the use of Closer (009 / S06) – exposure to entries of Sulfoxaflor via drainage, considering risk mitigation measures

Active substance: Sulfoxaflor Intended use 009 / S06 Application parameters: 2 x 12 g/ha, 50 % interception RAC (µg/L): 0.0519 a.s. Drainage Time of application PEC (µg/L) TER Spring/summer 0.02 2.41 Autumn/winter 0.07 0.78 Risk mitigation measures: NW800 PEC: predicted environmenral concentration; TER: Toxicity exposure ratio. TER values in bold fall below the relevant trigger; AF: Assessment factor; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold

6.5.3 Overall conclusions

TER values for aquatic organisms were calculated, taking into account the relevant toxicity data for Sul- foxaflor and calculated exposure levels, according to the intended uses of the product Closer. The calculated TER values do achieve the acceptability criterion the adjusted criterion TER ≥ 1 for effects on aquatic organisms, according to Commission Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.2, provided that risk mitigation measures (reduction of entries via drainage) are applied. The results of the assessment indicate an acceptable risk for aquatic organisms due to the intended use of Closer in greenhouses according to the label.

Consequences for authorisation

For the authorisation of the plant protection product Closer, labelling and conditions of use are mandatory as follows:

Table 6.5-7 Labelling requirements according to § 36 (3) PflSchG

NW263 The product is toxic for aquatic invertebrates.

Table 6.5-8 Mandatory conditions of use according to § 36 (1) PflSchG for the protection of aquatic organisms

Use number Condition 004 / S01 NG405 Not to be used on drained surfaces. Page 22 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

003 / S02 NG405 Not to be used on drained surfaces. 002, 006, 008 / S03 NG405 Not to be used on drained surfaces. 001, 005, 007 / S04 NW800 Application not allowed on drained areas between 1 November and 15 March. 001 / S05 NW800 Application not allowed on drained areas between 1 November and 15 March. 009 / S06 NW800 Application not allowed on drained areas between 1 November and 15 March.

6.6 Effects on bees (KCP 10.3.1)

Regarding the risk assessment for honey bees it is referred to the core assessment.

In the following subchapters, the risk assessment refers only to wildlife pollinators (solitary bees and bumble bees).

6.6.1 Toxicity data

Studies on the toxicity to bees have been carried out with Sulfoxaflor and its relevant metabolites. Full details of these studies are provided in the respective EU DAR and related documents.

Effects on bees of Closer were evaluated as part of the EU assessment of Sulfoxaflor.

The selection of studies and endpoints for the risk assessment is in line with the results of the EU review process.

Table 6.6-1: Endpoints and effect values relevant for the risk assessment for bees

Species Substance Exposure Results Reference System [µg/bee]

Apis mellifera Sulfoxaflor Oral LD50 = 0.146 a.s. EFSA Conclusion 2014

Apis mellifera Sulfoxaflor Contact LD50 = 0.379 a.s. EFSA Conclusion 2014

Apis mellifera X11719474 Oral LD50 > 100 EFSA Conclusion 2014

Apis mellifera X11519540 Oral LD50 > 91.2 EFSA Conclusion 2014

Apis mellifera X11579457 Oral LD50 = 45.7 EFSA Conclusion 2014

Apis mellifera X11721061 Oral LD50 > 103.5 EFSA Conclusion 2014

Apis mellifera GF-2626 Oral LD50 = 0.065 a.s. EFSA Conclusion 2014

Apis mellifera GF-2626 Contact LD50 = 0.283 a.s. EFSA Conclusion 2014 Page 23 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

Species Substance Exposure Results Reference System [µg/bee]

Bombus terrestris GF-2032 Oral 72 h LD50 = 0.027 a.s. EFSA Conclusion 2014

Bombus terrestris GF-2032 Contact 72 h LD50 = 7.554 a.s. EFSA Conclusion 2014

6.6.1.1 Justification for new endpoints

Since no data for solitary bees have been provided, the respective endpoints have been extrapolated from honey bee data. Bumble bee data from GF-2032 are used in the risk assessment.

Table 6.6-2: Endpoints and effect values relevant for the risk assessment for solitary bees and bumble bees

Species Substance Honey bee endpoint Extrapolated endpoint [µg/bee]

Solitary bee / Bumble bee Sulfoxaflor Oral LD50 = 0.146 a.s. Oral LD50 = 0.0146 a.s.

Solitary bee / Bumble bee Sulfoxaflor Contact LD50 = 0.379 a.s. Contact LD50 = 0.0379 a.s.

Solitary bee / Bumble bee X11719474 Oral LD50 > 100 Oral LD50 > 10

Solitary bee / Bumble bee X11519540 Oral LD50 > 91.2 Oral LD50 > 9.12

Solitary bee / Bumble bee X11579457 Oral LD50 = 45.7 Oral LD50 = 4.57

Solitary bee / Bumble bee X11721061 Oral LD50 > 103.5 Oral LD50 > 10.35

Solitary bee GF-2626 Oral LD50 = 0.065 a.s. Oral LD50 = 0.0065 a.s.

Solitary bee GF-2626 Contact LD50 = 0.283 a.s. Contact LD50 = 0.0283 a.s.

6.6.2 Risk assessment

The evaluation of the risk for bees was performed in accordance with the recommendations of the “Guid- ance Document on Terrestrial Ecotoxicology”, as provided by the Commission Services (SANCO/10329/2002 rev.2 (final), October 17, 2002).

6.6.2.1 Hazard quotients for bees

Regarding the risk assessment for honey bees it is referred to the core assessment.

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6.6.3 Effects on bumble bees

Table 6.6-3: Screening assessment of the risk for bumble bees due to the use of Closer (application rate = 48 g a.s./ha)

Intended use 002, 004, 006, 008, 010 Application rate (g/ha) 48 g a.s./ha Single applica- LD50 (µg Shortcut Substance tion rate (g QH trigger QH, ETR a.s./bee) value a.s./ha) DW = 11.2 DW = 19.911 0.048 kg/ha Oral = 0.027 ETR > 0.036 SUW = 13.3 SUW = 23.644 GF-2032 DW > 7 DW = 6.4 48 g/ha contact = 7.554 N/A SUW > 14 SUW = 6.4 DW = 11.2 DW = 36.822 0.048 kg/ha Oral = 0.0146 ETR > 0.036 SUW = 13.3 SUW = 43.726 Sulfoxaflor DW > 7 DW = 1266.5 48 g/ha Contact = 0.0379 N/A SUW > 14 SUW = 1266.5 DW = 11.2 DW > 0.054 X11719474 Oral > 10 ETR > 0.036 SUW = 13.3 SUW > 0.064 DW = 11.2 DW > 0.059 X11519540 Oral > 9.12 ETR > 0.036 SUW = 13.3 SUW > 0.070 0.048 kg/ha * DW = 11.2 DW = 0.118 X11579457 Oral = 4.57 ETR > 0.036 SUW = 13.3 SUW = 0.140 DW = 11.2 DW > 0.052 X11721061 Oral > 10.35 ETR > 0.036 SUW = 13.3 SUW > 0.062 QHO, QHC: Hazard quotients for oral and contact exposure. QH values shown in bold breach the relevant trigger; DW: downward spray; SUW: siedeward and upward spray; *Risk assessment conducted assuming 100% formation of metabolites as a worst-case approach.

Table 6.6-4: Screening assessment of the risk for bumble bees due to the use of Closer (application rate = 24 g a.s./ha)

Intended use 001, 003, 005, 007, 009 Application rate (g/ha) 24 g/ha Single applica- LD50 (µg Shortcut Substance tion rate (g QH trigger QH, ETR a.s./bee) value a.s./ha) DW = 11.2 DW = 9.956 0.024 kg/ha Oral = 0.027 ETR > 0.036 SUW = 13.3 SUW = 11.822 GF-2032 DW > 7 DW = 3.2 24 g/ha contact = 7.554 N/A SUW > 14 SUW = 3.2 DW = 11.2 DW = 18.411 0.024 kg/ha Oral = 0.0146 ETR > 0.036 SUW = 13.3 SUW = 21.863 Sulfoxaflor DW > 7 DW = 633.2 24 g/ha Contact = 0.0379 N/A SUW > 14 SU W = 633.2 DW = 11.2 DW > 0.027 X11719474 Oral > 10 ETR > 0.036 SUW = 13.3 SUW > 0.032 DW = 11.2 DW > 0.029 X11519540 Oral > 9.12 ETR > 0.036 SUW = 13.3 SUW > 0.035 0.024 kg/ha * DW = 11.2 DW = 0.059 X11579457 Oral = 4.57 ETR > 0.036 SUW = 13.3 SUW = 0.070 DW = 11.2 DW > 0.026 X11721061 Oral > 10.35 ETR > 0.036 SUW = 13.3 SUW > 0.031 QHO, QHC: Hazard quotients for oral and contact exposure. QH values shown in bold breach the relevant trigger; DW: Page 25 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

downward spray; SUW: siedeward and upward spray; *Risk assessment conducted assuming 100% formation of metabolites as a worst-case approach.

6.6.4 Effects on solitary bees

Table 6.6-5: Screening assessment of the risk for solitary bees due to the use of Closer (application rate = 48 g/ha)

Intended use 002, 004, 006, 008, 010 Application rate (g/ha) 48 g/ha Single applica- LD50 (lab.) Shortcut Substance QH trigger QH, ETR tion rate (µg/bee) value DW = 5.7 DW = 42.092 0.048 kg/ha Oral = 0.0065 ETR > 0.04 SUW = 7.3 SUW = 53.908 GF-2626 DW > 8 DW = 1696.1 48 g/ha Contact = 0.0283 N/A SUW > 16 SU W = 1696.1 DW = 5.7 DW = 18.740 0.048 kg/ha Oral = 0.0146 ETR > 0.04 SUW = 7.3 SUW = 24.000 Sulfoxaflor DW > 8 DW = 1266.5 48 g/ha Contact = 0.0379 N/A SUW > 16 SUW = 1266.5 DW = 5.7 DW > 0.027 X11719474 Oral > 10 ETR > 0.04 SUW = 7.3 SUW > 0.035 DW = 5.7 DW > 0.030 X11519540 Oral > 9.12 ETR > 0.04 SUW = 7.3 SUW > 0.038 0.048 kg/ha * DW = 5.7 DW = 0.060 X11579457 Oral = 4.57 ETR > 0.04 SUW = 7.3 SUW = 0.077 DW = 5.7 DW > 0.026 X11721061 Oral > 10.35 ETR > 0.04 SUW = 7.3 SUW > 0.034 QHO, QHC: Hazard quotients for oral and contact exposure. QH values shown in bold breach the relevant trigger; DW: downward spray; SUW: siedeward and upward spray; *Risk assessment conducted assuming 100% formation of metabolites as a worst-case approach.

Table 6.6-6: Screening assessment of the risk for solitary bees due to the use of Closer (application rate = 24 g/ha)

Intended use 00-004, 00-005, 00-007 Application rate (g/ha) 24 g/ha Single applica- LD50 (lab.) Shortcut Substance QH trigger QH, ETR tion rate (µg/bee) value DW = 5.7 DW = 21.046 0.024 kg/ha Oral = 0.0065 ETR > 0.04 SUW = 7.3 SUW = 26.954 GF-2626 DW > 8 DW = 848.1 24 g/ha Contact = 0.0283 N/A SUW > 16 SUW = 848.1 DW = 5.7 DW = 9.370 0.024 kg/ha Oral = 0.0146 ETR > 0.04 SUW = 7.3 SUW = 12.000 Sulfoxaflor DW > 8 DW = 633.2 24 g/ha Contact = 0.0379 N/A SUW > 16 SU W = 633.2 DW = 5.7 DW > 0.014 X11719474 0.024 kg/ha * Oral > 10 ETR > 0.04 SUW = 7.3 SUW > 0.018 Page 26 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

DW = 5.7 DW > 0.015 X11519540 Oral > 9.12 ETR > 0.04 SUW = 7.3 SUW > 0.019 DW = 5.7 DW = 0.030 X11579457 Oral = 4.57 ETR > 0.04 SUW = 7.3 SUW = 0.038 DW = 5.7 DW > 0.013 X11721061 Oral > 10.35 ETR > 0.04 SUW = 7.3 SUW > 0.017 QHO, QHC: Hazard quotients for oral and contact exposure. QH values shown in bold breach the relevant trigger; DW: downward spray; SUW: siedeward and upward spray; *Risk assessment conducted assuming 100% formation of metabolites as a worst-case approach.

The indicator values indicate a high risk for bumble bees and solitary bees. A refined risk assessment is required.

Sublethal effects Sulfoxaflor causes sublethal effects on bumble bees at a rate of 5 µg a.s./L in nectar. A residual trial conducted in Germany (IIIA 10.4.7/04, Liepold K., 2011) did show that residues of the active substance and its metabolite X11719474 occur in relevant concentrations in nectar and pollen at treatment rates of 24 g a.s./ha and 48 g a.s./ha. For details please refer to the core assessment. The pre-flowering application has been conducted at -10 DAA.

Table 6.6-7: Residues of sulfoxaflor found in nectar and pollen of Phacelia tanacetifolia (IIIA 10.4.7/04, Liepold K., 2011) Ratio Application rate (g Sulfoxaflor resi- Timing Treatment Residues / effect a.s./ha) dues (µg/kg) value Nectar 0 DAA C - < 3 < 0.6 < 3 < 0.6 < 3 < 0.6 T1 24 (pre-flowering) < 3 < 0.6 < 3 < 0.6 < 3 < 0.6 T2 48 (pre-flowering) < 3 < 0.6 < 3 < 0.6 < 3 < 0.6 T3 24 (flowering) 43.8 8.76 46.2 9.24 42.4 8.48 T4 48 (flowering) 88.9 17.78 54.8 10.96 50.3 10.06 5 DAA C - < 3 < 0.6 < 3 < 0.6 < 3 < 0.6 T1 24 (pre-flowering) < 3 < 0.6 < 3 < 0.6 < 3 < 0.6 T2 48 (pre-flowering) < 3 < 0.6 < 3 < 0.6 < 3 < 0.6 T3 24 (flowering) 5 1.0 5 1.0 Page 27 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

4 0.8 T4 48 (flowering) 10.6 2.12 11.0 2.2 11.1 2.22 6 DAA C - < 3 < 0.6 < 3 < 0.6 < 3 < 0.6 T1 24 (pre-flowering) < 3 < 0.6 < 3 < 0.6 < 3 < 0.6 T2 48 (pre-flowering) < 3 < 0.6 < 3 < 0.6 < 3 < 0.6 T3 24 (flowering) 4 0.8 4 0.8 5 1.0 T4 48 (flowering) 9.7 1.94 6 1.2 8 1.6 Pollen (Residues given in µg a.s./kg) 0 DAA C - < 3 < 0.6 T1 24 (pre-flowering) < 3 < 0.6 T2 48 (pre-flowering) 5 1.0 T3 24 (flowering) 290 58 T4 48 (flowering) 809 161.8 5 DAA C - < 3 < 0.6 T1 24 (pre-flowering) < 3 < 0.6 T2 48 (pre-flowering) < 3 < 0.6 T3 24 (flowering) 3 0.6 T4 48 (flowering) 19.1 3.82 6 DAA C - < 3 < 0.6 T1 24 (pre-flowering) < 3 < 0.6 T2 48 (pre-flowering) < 3 < 0.6 T3 24 (flowering) 16.0 3.2 T4 48 (flowering) 32.5 6.5

6.6.5 Overall conclusions

Regarding the risk assessment for honey bees it is referred to the core assessment.

Standard assessment A screening step has been calculated for bumble bees and solitary bees in order to estimate the risk for wild pollinators. Hazard quotients for solitary bees and bumble bees were calculated, taking into account the relevant toxicity data for Sulfoxaflor and estimated in-field exposure levels, according to the intended uses of the product Closer. The calculated indicator values do not achieve the acceptability criteria, according to Commission Regulation (EU) No 546/2011, Annex, Part I C, point 2.5.2.3. The results of the assessment indicate an unacceptable risk for bees due to the intended use of Closer according to the label. Page 28 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

Sublethal effects The results show that residues of Sulfoxaflor at T3 and T4 (application during flowering, 0 DAA), exceed the effect value for bumble bees. Even at treatment T2 (application at -10 DAA) residues are measurable in pollen. No safety factor has been used for this calculation and it can be assumed that effects on solitary bees are larger compared to effects on bumble bee colonies.

A high risk to bumble bees has been shown for applications at flowering. Since the effect value of 5 µg a.s./L nectar is below to the LQQ of 10 µg a.s./L nectar, effects on solitary bees and bumble bees at an application at -10 DAA cannot been ruled out.

Consequences for authorisation

It must be ensured that bumble bees and solitary bees are not exposed to Closer.

According to the outcome of the core assessment a re-introduction of pollinator’s colonies in permanent covered crops must be realized at least 10 days after spray dried.

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6.7 Effects on arthropods other than bees (KCP 10.3.2)

6.7.1 Toxicity data

Please refer to the core assessment.

The selection of studies and endpoints for the risk assessment is in line with the results of the EU review process.

6.7.1.1 Justification for new endpoints

Not relevant.

6.7.2 Risk assessment

6.7.2.1 Risk assessment for in-field exposure

The in-field risk assessment is provided by JKI.

6.7.2.2 Risk assessment for off-field exposure

Please refer to the core assessment. For greenhouses, since no drift is assumed, the off-field risk assessment is not required and can be omitted.

6.7.2.3 Additional higher-tier risk assessment

Not relevant.

6.7.2.4 Risk mitigation measures

It must be ensured that no off-field exposure due to spray drift, run-off or other paths is possible.

6.7.3 Overall conclusions

The zRMS concluded in the core assessment that “field studies cannot be omitted since effects on arthropods communities are observed. Then, considering that a recovery of the entire community in approxi- mately two months is observed for a double application at 24 g sulfoxaflor/ha (21 days interval), zRMS proposes the following recommendation: Following application of sulfoxaflor in greenhouses, wait for a period of 2 months before introducing beneficial organisms as biological control agents”.

To avoid a risk for off-field arthropods it must be ensured that no off-field exposure due to spray drift, runoff or other paths is possible.

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6.8 Effects on non-target soil meso- and macrofauna (KCP 10.4)

6.8.1 Toxicity data

Studies on the toxicity to earthworms and other non-target soil organisms (meso- and macrofauna) have been carried out with Sulfoxaflor and its relevant metabolites. Full details of these studies are provided in the respective EU DAR and related documents.

Effects on earthworms and other non-target soil organisms (meso- and macrofauna) of Closer were evaluated as part of the EU assessment of Sulfoxaflor.

The selection of studies and endpoints for the risk assessment deviates from the results of the EU review process. Justifications are provided below.

Table 6.8-1: 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 [mg/kg dw]

Eisenia fetida Sulfoxaflor 14 d, acute LC50 = 0.885 a.s. EFSA Conclusion 10 % peat content 2014

Eisenia fetida X11719474 14 d, acute LC50 > 1000* EFSA Conclusion 10 % peat content 2014

Eisenia fetida GF-2626 14 d, acute LC50 = 5.527 PPP EFSA Conclusion 10 % peat content LC50 = 0.66 a.s. 2014 Eisenia fetida Sulfoxaflor 56 d, chronic NOEC = 0.1 a.s. EFSA Conclusion 10 % peat content 2014 Eisenia fetida X11719474 56 d, chronic NOEC = 10* EFSA Conclusion 10 % peat content 2014 Eisenia fetida X11519540 56 d, chronic NOEC = 10* EFSA Conclusion 10 % peat content 2014 Eisenia fetida GF-2626 56 d, chronic NOEC = 0.75 PPP EFSA Conclusion 10 % peat content NOEC = 0.09 a.s. 2014 Folsomia candida GF-2626 28 d, chronic NOEC = 2.67 PPP EFSA Conclusion 5 % peat content NOEC = 0.3204 a.s. 2014 Folsomia candida X11719474 28 d, chronic NOEC = 10* EFSA Conclusion 5 % peat content 2014 Folsomia candida X11519540 28 d, chronic NOEC = 10* EFSA Conclusion 5 % peat content 2014 Hypoaspis aculeifer X11519540 14 d, chronic NOEC = 10* EFSA Conclusion 5 % peat content 2014 Hypoaspis aculeifer GF-2626 14 d, chronic NOEC = 100 PPP EFSA Conclusion 5 % peat content NOEC = 12 a.s. 2014 Page 31 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

Species Substance Exposure Results Reference System [mg/kg dw]

Field studies GF-2626 – Earthworm field test - Germany; Klein (2012): Field study to evaluate the effects of XDE-208 (as GF-2626 12% SC formulation) and its primary soil metabolite X11719474 on earthworms in southern Germany; ICS 91785

The dataset of analytical measurements of sulfoxaflor residues in the study is very small with only 4 values above the limit of detection and, therefore, it is not considered sufficiently robust to be compared to PECsoil values calculated according to proposed GAP. Since it could not be demonstrated that the proposed GAP is covered with the exposure of earthworms in the study, the study cannot be used in the risk assessment. Further shortcomings have been identified: - The surface monitoring is not expected to produce reliable date, since dead or moribund earthworms are unlikely to occur at the surface. Any dead or moribund earthworms at the surface will be quickly removed by scavengers. - Both extraction methods are limited to epigaeic species. Earthworms inhabiting deeper soil layers are not covered by this sampling method.

This study cannot be used in the risk assessment. GF-2626 – Soil micro-arthropod field test - Germany; Mack (2012): Field Study to Evaluate the Effects of Sulfoxaflor (as GF-2626 12% SC formulation) and its primary soil metabolite X11719474 on Soil Micro-Arthropods in Southern Germany; ICS 91761

6.8.1.1 Justification for new endpoints

Not relevant.

6.8.2 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).

6.8.2.1 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 Sulfoxaflor, but for its metabolites. Page 32 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

Table 6.8-2: First-tier assessment of the acute and chronic risk for earthworms and other non-target soil organisms (meso- and macrofauna) due to the use of Closer (004 / S01)

Intended use 004 / S01 Application pattern 1 x 48 g/ha, 10 % interception

Species and effect type substance Endpoint PECsoil,max TER (mg/kg dw) (mg/kg dw)

Closer LC50 = 0.66 a.s. 0.115 (a.s.) 5.7

Eisenia fetida, acute X11719474 LC50 > 1000 0.135 >7407 X11519540 N/A 0.039 N/A Closer NOEC = 0.09 a.s. 0.115 (a.s.) 0.78 Eisenia fetida, chronic X11719474 NOEC = 10 0.135 74 X11519540 NOEC = 10 0.039 256

Closer LC50 = 0.3204 a.s. 0.115 (a.s.) 2.78 Folsomia candida, X11719474 NOEC = 10 0.135 74 chronic X11519540 NOEC = 10 0.039 256

Closer LC50 = 12 a.s. 0.115 (a.s.) 104 Hypoaspis aculeifer, X11719474 N/A 0.135 N/A chronic X11519540 NOEC = 10 0.039 256 TER values shown in bold fall below the relevant trigger.

The chronic risk assessment indicates a high risk for Eisenia and Folsomia. For these species the other use groups are calculated. The risk assessment for metabolites is covered by the worst case risk assessment.

Table 6.8-3: First-tier assessment of the acute and chronic risk for earthworms and other non-target soil organisms (meso- and macrofauna) due to the use of Closer (003 / S02)

Intended use 003 / S02 Application pattern 2 x 24 g/ha, 10 % interception

Species and effect type substance Endpoint PECsoil,max TER (mg/kg dw) (mg a.s./kg dw) Eisenia fetida, chronic Closer NOEC = 0.09 a.s. 0.088 1.02

Folsomia candida, Closer LC50 = 0.3204 a.s. 0.088 3.6 chronic TER values shown in bold fall below the relevant trigger.

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Table 6.8-4: First-tier assessment of the acute and chronic risk for earthworms and other non-target soil organisms (meso- and macrofauna) due to the use of Closer (002, 006, 008 / S03)

Intended use 002, 006, 008 / S03 Application pattern 1 x 48 g/ha, 50 % interception

Species and effect type substance Endpoint PECsoil,max TER (mg/kg dw) (mg a.s./kg dw) Eisenia fetida, chronic Closer NOEC = 0.09 a.s. 0.064 1.4

Folsomia candida, Closer LC50 = 0.3204 a.s. 0.064 5.0 chronic TER values shown in bold fall below the relevant trigger.

Table 6.8-5: First-tier assessment of the acute and chronic risk for earthworms and other non-target soil organisms (meso- and macrofauna) due to the use of Closer (001, 005, 007 / S04)

Intended use 001, 005, 007 / S04 Application pattern 2 x 24 g/ha, 50 % interception

Species and effect type substance Endpoint PECsoil,max TER (mg/kg dw) (mg a.s./kg dw) Eisenia fetida, chronic Closer NOEC = 0.09 a.s. 0.049 1.8

Folsomia candida, Closer LC50 = 0.3204 a.s. 0.049 6.5 chronic TER values shown in bold fall below the relevant trigger.

Table 6.8-6: First-tier assessment of the acute and chronic risk for earthworms and other non-target soil organisms (meso- and macrofauna) due to the use of Closer (010 / S05)

Intended use 010 / S05 Application pattern 1 x 24 g/ha, 50 % interception

Species and effect type substance Endpoint PECsoil,max TER (mg/kg dw) (mg a.s./kg dw) Eisenia fetida, chronic Closer NOEC = 0.09 a.s. 0.032 2.8

Folsomia candida, Closer LC50 = 0.3204 a.s. 0.032 10 chronic TER values shown in bold fall below the relevant trigger.

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Table 6.8-7: First-tier assessment of the acute and chronic risk for earthworms and other non-target soil organisms (meso- and macrofauna) due to the use of Closer (009 / S06)

Intended use 009 / S06 Application pattern 2 x 12 g/ha, 50 % interception

Species and effect type substance Endpoint PECsoil,max TER (mg a.s./kg dw) (mg/kg dw) Eisenia fetida, chronic Closer NOEC = 0.09 a.s. 0.024 3.75

Folsomia candida, Closer LC50 = 0.3204 a.s. 0.024 13 chronic TER values shown in bold fall below the relevant trigger.

6.8.2.2 Higher-tier risk assessment

Higher-tier risk assessment is required. However, since no reliable field studies have been submitted, a safe use cannot be demonstrated, unless exposition of the unprotected soil is possible.

6.8.3 Overall conclusions

Earthworms

The outcome of the national calculations, taking into account adjusted soil layer depth, indicated a high risk for Eisenia fetida and Folsomia candida. Since no reliable higher tier studies are available, the risk assessment is based on tier 1 data.

The calculated TER values do not achieve the acceptability criterion TER ≥ 5 for chronic 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 unacceptable risk for earthworms due to the intended use of Closer in all uses according to the label.

Despite an adverse result of the first-tier assessment, no higher-tier studies according to current data requirements were submitted with the product dossier. Hence, no conclusion on an acceptable risk under realistic conditions of use is possible.

Other organisms of the soil macro- and mesofauna

TER values for other organisms of the soil macro- and mesofauna were calculated, taking into account the relevant toxicity data for Closer and calculated exposure concentrations in soil, according to the intended uses of the product Closer. For use groups S3, S4, S5 and S6, the calculated TER values do achieve the acceptability criterion TER ≥ 5 for chronic effects (as adopted from the risk assessment for earthworms) on other organisms of the soil macro- and mesofauna, 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 Page 35 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

other organisms of the soil macro- and mesofauna due to the intended use of Closer in all uses according to the label. No safe use is demonstrated for use groups S1 and S2.

Consequences for authorisation

Table 6.8-8 Mandatory conditions of use

Use number Condition All uses NZ113 For use exclusively in greenhouses on completely sealed surfaces where the entry of the product into the soil can be excluded.

6.9 Effects on soil microbial activity (KCP 10.5)

6.9.1 Toxicity data

Please refer to the core assessment. EU-agreed endpoints have been used.

6.9.1.1 Justification for new endpoints

Not relevant.

6.9.2 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 6.8). To achieve a concise risk assessment, the risk envelope approach is applied. Here, the assessment for the use group S01 also covers the risk for the soil microorganisms from all other intended uses (see 6.1.2).

Table 6.9-1: Assessment of the risk for effects on soil micro-organisms due to the use of closer in ornamentals (004 / S01, worst case)

Intended use 004 / S01 N-mineralisation

Product/active substance Max. conc. with effects PECsoil Risk acceptable? ≤ 25 % (mg/kg dw) (mg/kg dw) Sulfoxaflor 0.33 0.115 yes Closer 2.85 1.015 yes X11719474 0.16 0.135 yes Page 36 /37 Template for chemical PPP Version April 2015 GF-2626 / Closer Part B – Section 6 – National Addendum

X11519540 0.32 0.039 yes C-mineralisation

Product/active substance Max. conc. with effects PECsoil Risk acceptable? ≤ 25 % (mg/kg dw) (mg/kg dw) Sulfoxaflor 0.33 0.115 yes Closer 2.85 1.015 yes X11719474 0.16 0.135 yes X11519540 0.32 0.039 yes

6.9.3 Overall conclusions

Concentrations of Closer and Sulfoxaflor 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 Closer. The comparison indicates a slight 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 Closer according to the label.

Consequences for authorisation

None

6.10 Effects on non-target terrestrial plants (KCP 10.6)

Please refer to the core assessment.

6.10.1 Overall conclusions

The uses of GF-2626 on fruiting vegetables and ornamentals grown under protection will not lead to significant exposure of natural populations of non target plants, thus the risk to this group is considered to be negligible.

6.11 Effects on other terrestrial organisms (flora and fauna) (KCP 10.7)

Please refer to the core assessment.

6.11.1 Overall conclusions

The uses of GF-2626 on fruiting vegetables and ornamentals grown under protection will not lead to significant exposure of natural populations of other terrestrial organisms, thus the risk to this group is considered to be negligible.

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6.12 Monitoring data (KCP 10.8)

Not relevant.

6.13 Classification and Labelling

Classification and labelling of Sulfoxaflor / Closer

6.13.1 National labelling and conditions of use

Table 6.13-1 Labelling requirements according to § 36 (3) PflSchG

NW263 Sulfoxaflor: Ephemeroptera EC10 = 0.000519 mg/L