Art. 51 Extension of authorisation for minor uses. Risk Management

Transcription

1 Part A Core Assessment Dantop Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Draft Registration Report Central Zone Country Germany Page 1 of 12 Art. 51 Extension of authorisation for minor uses REGISTRATION REPORT Part A Risk Management Product code: Dantop Active Substances: Clothianidin 500 g/kg COUNTR: Germany Central Zone Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT Applicant: Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 08/07/2013 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen (Pflschd NRW) Date: 08/07/2013

2 Part A Core Assessment Dantop Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Draft Registration Report Central Zone Country Germany Page 2 of 12 Table of Contents PART A Risk Management Details of the application Application background Annex I inclusion Regulatory approach Uses applied for and registration decision Public interest and minor use Data protection claims Letters of Access Details of the authorisation Product identity Classification and labelling Classification and labelling under Directive 99/45/EC R and S phrases under Directive 2003/82/EC (Annex IV and V) Other phrases Restrictions linked to the PPP Specific restrictions linked to the intended uses Product uses Risk management Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties Methods of analysis Analytical method for the formulation Analytical methods for residues Mammalian Toxicology Residues and Consumer Exposure Residues Consumer exposure Environmental fate and behaviour Ecotoxicology Efficacy Conclusions Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation Appendix 1 Copy of the product authorisation Appendix 2 Copy of the product label Appendix 3 Letter of Access BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen (Pflschd NRW) Date: 08/07/2013

3 Part A Core Assessment Dantop Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Draft Registration Report Central Zone Country Germany Page 3 of 12 PART A Risk Management This document describes the acceptable use conditions required for extension of the registration of Dantop containing clothianidin in Germany. The risk assessment conclusions are based on the already existing registration of the PPP. The following sections of Registration Report, Part B were prepared on basis of new data: Section 4. Assessments for the safe use of Dantop have been made using endpoints agreed in the EU reviews of clothianidin. Appendix 4 of this document provides a copy of the final product authorisation in Germany. 1 Details of the application Application to extend the authorisation of a plant protection product (PPP) already authorised in Germany to minor uses not yet covered by that authorisation. The application is intended for use in Germany only. 1.1 Application background Details on applicant and application Plant protection product Type of application Dantop Registration number /04 Applicant Authorisation holder Function Type of formulation Zonal application according to Article 51, ZRMS = DE, first application (GV1) Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen, Siebengebirgsstraße 200, Bonn, Deutschland Spiess-Urania Chemicals GmbH Frankenstraße 18b Hamburg Insecticide Expiration of authorisation Water dispersible granule BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen (Pflschd NRW) Date: 08/07/2013

4 Part A Core Assessment Dantop Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Draft Registration Report Central Zone Country Germany Page 4 of Annex I inclusion The active substances included in the plant protection product are approved according Regulation (EC) No 1107/2009. The present application is in line with the provisions of the approvals. Active substance (BVL Number) Clothianidin (1030) Content in PPP 500 g/kg Approval status Approved according Regulation (EC) No 1107/2009 Approval Regulation (EC) No 540/2011 Expiration of approval 31/07/ Regulatory approach The PPP is already registered in Germany according to Directive 91/414/EEC taking into account the uniform principles of Annex VI. Therefore the evaluation of the current application is limited to the points not covered by the existing registration Uses applied for and registration decision Number of use Plant/commodity/object Harmful organism/purpose decision 001 headed brassica (white, red, oxheart, cabbage whitefly, small cabbage fly, savoy cabbage and Brussels sprouts) mealy cabbage aphid (for seedling cultivation) 002 brussels sprouts (for seedling cultivation) 003 flowering brassicas (for seedling cultivation) 004 leafy brassicas (for seedling cultivation) cabbage whitefly, small cabbage fly, mealy cabbage aphid cabbage whitefly, small cabbage fly, mealy cabbage aphid cabbage whitefly, small cabbage fly, mealy cabbage aphid Authorisation Authorisation Authorisation Authorisation Public interest and minor use BVL_FO_05_2422_200_V1.0 According to Article 51 (2) a and c of the Regulation (EC) No 1107/2009 extensions of authorisation are only possible if the intended use applied for is minor in nature and in public interest. In Germany the cultivated area for seedling cultivationof headed brassica (white, red, oxheart, savoy cabbage and Brussels sprouts) is about 33 ha, of which approx. 13 ha need to be controlled. The cultivated area for seedling cultivation of brussels sprouts is about 33 ha, of which approx. 13 ha need to be controlled. The cultivated area for seedling cultivation of flowering brassicas is about 33 ha, of which approx. 13 ha need to be controlled. The cultivated area for seedling cultivation of leafy brassicas is about 33 ha, of which approx. 13 ha need to be controlled. Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen (Pflschd NRW) Date: 08/07/2013

5 Part A Core Assessment Dantop Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Draft Registration Report Central Zone Country Germany Page 5 of 12 Calculation shows that authorisation holder will not profit from an authorisation of the requested use(s). Upon this calculation and the examination of available alternative measures for the applied use(s) it can be stated that the applied use(s) is minor in nature and the authorisation is in the public interest. 1.4 Data protection claims The applicant is owner of the new studies submitted and claims data protection. 1.5 Letters of Access The applicant is owner of the new studies submitted. Authorisation holder agrees to the current application to extend the authorisation. 2 Details of the authorisation 2.1 Product identity Product name Dantop Authorisation number Composition Type of formulation Function Authorisation holder Clothianidin 500g/kg Water dispersible granule Insecticide 2.2 Classification and labelling Spiess-Urania Chemicals GmbH Frankenstraße 18b Hamburg Classification and labelling under Directive 99/45/EC N Xn Dangerous for the environment Harmful BVL_FO_05_2422_200_V1.0 RK050 RX022 SX002 SX013 SX046 SX035 SX057 SP001 R50/53: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment R 22: Harmful if swallowed S 2: Keep out of the reach of children S 13: Keep away from food, drink and animal feeding stuffs S 46: If swallowed, seek medical advice immediately and show this container or label S35: This material and its container must be disposed of in a safe way. S57: Use appropriate container to avoid environmental contamination. To avoid risks to man and the environment, comply with the instructions for use. Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen (Pflschd NRW) Date: 08/07/2013

6 Part A Core Assessment Dantop Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Draft Registration Report Central Zone Country Germany Page 6 of R and S phrases under Regulation (EC) No 547/2011 EO005-1 SPo 5: Treated areas my not be entered until spray coating has dried Other phrases Restrictions linked to the PPP The authorization of the PPP is linked to the following conditions (mandatory labelling): Operator protection SB001 Avoid any unnecessary contact with the product. Misuse can lead to health damage. Ecosystem protection NG321 NW263 NW468 Honeybee NB6611 The maximum application rate of 150 g active substance per hectare and year must not be exceeded, not even in combination with other plant protection products containing this active substance. The product is toxic for aquatic invertebrates. 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 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 Integrated Pest Management (IPM) NN234 NN360 NN370 NN380 The product is classified as slightly harmful for populations of the species Typhlodromus pyri (predatory mite). The product is classified as harmful for populations of the species Aleochara bilineata (staphylinid beetle). The product is classified as harmful for populations of the species Chrysoperla carnea (lacewing). The product is classified as harmful for populations of the species Trichogramma cacoeciae (chalcid wasp). Mode of action (FRAC/HRAC/IRAC-Group): 4A Active substance The authorization of the PPP is linked to the following conditions (voluntary labelling): BVL_FO_05_2422_200_V1.0 Honeybee - Integrated Pest Management (IPM) Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen (Pflschd NRW) Date: 08/07/2013

7 Part A Core Assessment Dantop Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Draft Registration Report Central Zone Country Germany Page 7 of Specific restrictions linked to the intended uses Some of the authorized uses are linked to the following conditions (mandatory labelling): See 2.3 (Product uses) Ecosystem protection BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen (Pflschd NRW) Date: 08/07/2013

8 Part A Core Assessment Dantop Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Draft Registration Report Central Zone Country Germany Page 8 of Product uses PPP (product name/code) Dantop ( ) active substance 1 Clothianidin Formulation type: Conc. of as 1: WG 500g/kg safener - synergist - Conc. of safener: - Conc. of synergist: - Applicant: Zone(s): Verified by MS: j Landesanstalt für Landwirtschaft, Forsten und Gartenbau - LLFG Dezernat Pflanzenschutz central EU professional use non professional use Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) F G or I Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Method / Kind Application Timing / Growth stage of crop & season Max. number (min. interval between applications) a) per use b) per crop/ season kg, L product / ha a) max. rate per appl. b) max. total rate per crop/season Application rate g, kg as/ha a) max. rate per appl. b) max. total rate per crop/season Water L/ha min / max PHI (days) Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures 1 DE headed brassica (white, red, oxheart, savoy cabbage and Brussels sprouts) (NNNKO) G cabbage whitefly (ALEUPR), small cabbage fly (HLEBR), mealy cabbage aphid (BRVCBR) douse BBCH > 12; for risks of infestation and/or after warning service appeal a) 1 b) 1 a) 96 g/ha b) 96 g/ha a) 48 g as/ha b) 48 g as/ha restrictions (see ) for seedling cultivation the application rate of 2,4 g applies to plants per m² with plants/ha BVL_FO_05_2422_200_V1.0 (seedlings in seeding bowls) Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen (Pflschd NRW) Date: 08/07/2013

9 Part A Core Assessment Dantop Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Draft Registration Report Central Zone Country Germany Page 9 of DE brussels sprouts G cabbage whitefly (ALEUPR), small cabbage fly (HLEBR), mealy cabbage aphid (BRVCBR) douse BBCH > 12; for risks of infestation and/or after warning service appeal a) 1 b) 1 a) 96 g/ha b) 96 g/ha a) 48 g as/ha b) 48 g as/ha restrictions (see ) for seedling cultivation the application rate of 2,4 g applies to plants per m² with plants/ha (seedlings in seeding bowls) 003 DE flowering brassicas G cabbage whitefly (ALEUPR), small cabbage fly (HLEBR), mealy cabbage aphid (BRVCBR) douse BBCH > 12; for risks of infestation and/or after warning service appeal a) 1 b) 1 a) 96 g/ha b) 96 g/ha a) 48 g as/ha b) 48 g as/ha restrictions (see ) for seedling cultivation the application rate of 2,4 g applies to plants per m² with plants/ha (seedlings in seeding bowls) 004 DE leafy brassicas G cabbage whitefly (ALEUPR), small cabbage fly (HLEBR), mealy cabbage aphid (BRVCBR) douse BBCH > 12; for risks of infestation and/or after warning service appeal a) 1 b) 1 a) 96 g/ha b) 96 g/ha a) 48 g as/ha b) 48 g as/ha restrictions (see ) for seedling cultivation the application rate of 2,4 g applies to plants per m² with plants/ha BVL_FO_05_2422_200_V1.0 (seedlings in seeding bowls) Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen (Pflschd NRW) Date: 08/07/2013

10 Part A Core Assessment Dantop Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Draft Registration Report Central Zone Country Germany Page 10 of 12 3 Risk management 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties Not relevant for extension of authorisation according article Methods of analysis Analytical method for the formulation Not relevant for extension of authorisation according article Analytical methods for residues Head cabbage, Brussels sprouts, flowering brassica and leafy brassica belong to the group of high water content commodities. A fully validated analytical method is available for enforcing clothianidin in head cabbage, Brussels sprouts, flowering brassica and leafy brassica Mammalian Toxicology The PPP is already registered in Germany according to Directive 91/414/EEC. If used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected Residues and Consumer Exposure The residue behaviour of the active substance clothianidin has been evaluated within the EU review process. Information about metabolism is sufficient to evaluate the intended uses in head cabbage, Brussels sprouts, flowering brassica and leafy brassica Residues The available residue information is sufficient to perform an adequate assessment. Residues that are expected from the intended use of the plant protection product will not exceed the MRL of 0.02 mg/kg for flowering brassica, Brussels sprout and head cabbage and 2 mg/kg for leafy brassica set in Regulation (EC) No 396/2005 for clothianidin. BVL_FO_05_2422_200_V Consumer exposure An assessment of residue uptake by consumers (TMDI calculation, EFSA PRIMo rev. 2) results in a maximum ADI (0.097 mg/kg bw) consumption of 4 % (Dutch children). Long-term dietary intake of residues of clothianidin is unlikely to present a public health concern for European consumers. No acute risk is expected from the consumption of head cabbage, Brussels sprouts, flowering brassica and leafy brassica treated according to the intended uses Environmental fate and behaviour Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen (Pflschd NRW) Date: 08/07/2013

11 Part A Core Assessment Dantop Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Draft Registration Report Central Zone Country Germany Page 11 of 12 No new studies were presented; all data were reviewed within the EU review for the active substance clothianidin and the national authorisation procedure for the product Dantop ( /00), respectively, and assessed according to the uniform principles of Directive 91/414/EEC. The environmental exposure due to the minor use extension applied for (spraying of vegetable varieties in greenhouses) is covered by the uses already authorised. Neither accumulation in soil nor leaching to groundwater of the active substance or relevant metabolites in concentrations above 0.1 µg/l has to be expected. Specific additional risk mitigation measures are not required Ecotoxicology No new studies were presented; all data were reviewed within the EU review for the active substance clothianidin and the national authorisation procedure for the product Dantop ( /00), respectively, and assessed according to the uniform principles of Directive 91/414/EEC. The risk for non-target organisms as a consequence of the minor use extension applied for is considered acceptable since exposure due to the intended uses (spraying of vegetable varieties in greenhouses) is covered by the uses already authorised. Specific additional risk mitigation measures for the protection of non-target organisms are not required. The product Dantop as well as the active substance clothianidin is toxic to the aquatic environment. Therefore, additional labelling with risk phrases (NW263) and safety phrases (NW468) is assigned, particularly to encourage prevention of any point source entry into surface waters; see also chapter 2.2. Risk Assessment for Honeybees The honeybee risk assessment for the main application covers the use(s) in accordance with Article 51 of regulation (EC) No 1107/2009 (see also point 2.2) Efficacy Labelling in accordance with the requirements of ANNEX III General Principles of integrated pest management under directive 2009/128/EC (see also point 2.2): -The classification of effects on beneficial arthropods for the main application covers the use(s) applied for under the terms of Article 51 of regulation (EC) No 1107/ The categories and labelling for mode of action for the main application cover the use(s) applied for under the terms of Article 51 of regulation (EC) No 1107/2009. According to Article 51 of the regulation (EC) No 1107/2009 the requirements for approval concerning the sufficient effect and any unacceptable effects on plants and plant products not need to be checked. Depending on crops, varieties, cultivation methods and environmental conditions the product may cause phytotoxic effects. The sensitivity of the crop should be tested under the specific conditions of the application. BVL_FO_05_2422_200_V Conclusions PPP Dantop is already registered in Germany according to Directive 91/414/EEC taking into account the Uniform Principles of Annex VI. The intended use is minor in nature and the extension of authorisation is in public interest. Effects on bees and other beneficials were evaluated in the frame of the already authorised uses. No additional effects are anticipated because of the extension of uses. Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen (Pflschd NRW) Date: 08/07/2013

12 Part A Core Assessment Dantop Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Draft Registration Report Central Zone Country Germany Page 12 of 12 The indended uses in head cabbage, Brussels sprouts, flowering brassica and leafy brassica will not result in residues above the MRLs set in Regulation (EC) No 396/2005. A risk for consumers through the consumption of food with these residues of clothianidin is not expected. There is no special risk mitigation necessary which deviate from the existing registration. If used according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected Considering the minor use extensions applied for neither harmful effects on groundwater nor unacceptable effects on the environment have to be apprehended as a consequence of proper use consistent with good plant protection practice. Specific additional risk mitigation measures are not required. 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 None Appendix 1 Copy of the product authorisation Will be inserted in final registration report Appendix 2 Copy of the product label No product label available. Not mandatory according to Article 51 (5) Appendix 3 Letter of Access No letter of access necessary. The applicant is owner of the new studies submitted. Authorisation holder agrees to the current application to extend the authorisation. BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen (Pflschd NRW) Date: 08/07/2013

13 Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dienstsitz Braunschweig Postfach Braunschweig Dr. Birgit Schreiber Referentin Mit Zustellungsurkunde Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Siebengebirgsstraße Bonn TELEFON TELEFAX INTERNET IHR ZEICHEN IHRE NACHRICHT VOM AKTENZEICHEN (bitte bei Antwort angeben) +49 (0) (0) / DATUM 2. August 2013 GV /04 Dantop Verfahren zur Erweiterung einer Zulassung nach Artikel 51 Abs. 1 der Verordnung (EG) Nr. 1107/2009 Bescheid Die Zulassung des oben genannten Pflanzenschutzmittels mit dem Wirkstoff: 500 g/kg Clothianidin Zulassungsnummer: Versuchsbezeichnung: SPU I-0-WG Antrag vom: 3. Juli 2012 wird wie in Anlage 1 beschrieben auf der Grundlage von Art. 51 der Verordnung (EG) Nr. 1107/2009 des Europäischen Parlaments und des Rates vom 21. Oktober 2009 über das Inverkehrbringen von Pflanzenschutzmitteln und zur Aufhebung der Richtlinien 79/117/EWG und 91/414/EWG des Rates (Abl. L 309 vom , S. 1) um folgende Anwendungsgebiete bzw. Anwendungen erweitert: BVL_FO_05_2468_200_V1.1 Dienstsitz Braunschweig Bundesallee 50, Geb Braunschweig Abt. Pflanzenschutzmittel Messeweg 11/ Braunschweig Dienststelle Berlin Mauerstraße Berlin Referatsgr. Untersuchungen Diedersdorfer Weg Berlin Tel: +49 (0) Tel: +49 (0) Tel: +49 (0) Tel: +49 (0) Fax: +49 (0) Fax: +49 (0) Fax: +49 (0) Fax: +49 (0)

14 SEITE 2 VON 11 Anwendungsnummer Zweckbestimmung Schadorganismus/ / Kohlmottenschildlaus, Kleine Kohlfliege, Mehlige Kohlblattlaus / Kohlmottenschildlaus, Kleine Kohlfliege, Mehlige Kohlblattlaus / Kohlmottenschildlaus, Kleine Kohlfliege, Mehlige Kohlblattlaus / Kohlmottenschildlaus, Kleine Kohlfliege, Mehlige Kohlblattlaus Pflanzen/-erzeugnisse/ Objekte Blattkohle Blumenkohle Kopfkohl (Rot-, Weiß-, Spitz- und Wirsingkohl) Rosenkohl Verwendungszweck 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) festgesetzt: Siehe anwendungsbezogene Anwendungsbestimmungen in Anlage 1, jeweils unter Nr. 3. Auflagen Die Zulassung wird mit folgenden Auflagen gemäß 36 Abs. 3 S. 1 PflSchG verbunden: Siehe Anlage 1, jeweils unter Nr. 2. Vorbehalt Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder Ergänzung von Anwendungsbestimmungen und Auflagen verbunden. Abgelehnte Anwendungsgebiete bzw. Anwendungen BVL_FO_05_2468_200_V1.1 Für folgende Anwendungsgebiete bzw. Anwendungen lehne ich Ihren Antrag ab (siehe Anlage 2): - keine -

15 SEITE 3 VON 11 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, Braunschweig, schriftlich oder zur Niederschrift einzulegen. Mit freundlichen Grüßen im Auftrag gez. Dr. Johannes Siebers Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig. Anlage BVL_FO_05_2468_200_V1.1

16 SEITE 4 VON 11 Anlage 1 zugelassene Anwendung: / Anwendungsgebiet Schadorganismus/Zweckbestimmung: Kohlmottenschildlaus, Kleine Kohlfliege, Mehlige Kohlblattlaus Pflanzen/-erzeugnisse/Objekte: Verwendungszweck: 2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: - Erläuterungen: Anwendung im Haus- und Kleingartenbereich: Erläuterung zum Schadorganismus: Stadium des Schadorganismus: - Erläuterungen: Erläuterung zur Kultur: Kopfkohl (Rot-, Weiß-, Spitz- und Wirsingkohl) Gemüsebau Jungpflanzenanzucht (Gewächshaus) Nein Stadium der Kultur: ab 12 - Erläuterungen: Anwendungszeitpunkt: - Erläuterungen: Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 1 - Abstand: - Erläuterungen Anzahl Behandlungen: Mischungspartner: - Erläuterungen: Anwendungstechnik: - Erläuterungen: Aufwand: Jungpflanzen in Anzuchtgefäßen Bei Befallsgefahr bzw. nach Warndiensthinweis gießen - 2,4 g/m² in 3 l Wasser/m² - Erläuterungen: Mittelaufwand gilt bei 1000 Pflanzen pro m² Sonstige Ergänzungen und Hinweise: - keine - BVL_FO_05_2468_200_V Sonstige Kennzeichnungsauflagen - keine -

17 SEITE 5 VON Wartezeiten 70 Tage Jungpflanzenanzucht (Gewächshaus): Kopfkohl (Rot-, Weiß-, Spitz- und Wirsingkohl) 3 Anwendungsbezogene Anwendungsbestimmungen - keine - BVL_FO_05_2468_200_V1.1

18 SEITE 6 VON 11 Anlage 1 zugelassene Anwendung: / Anwendungsgebiet Schadorganismus/Zweckbestimmung: Kohlmottenschildlaus, Kleine Kohlfliege, Mehlige Kohlblattlaus Pflanzen/-erzeugnisse/Objekte: Verwendungszweck: 2 Kennzeichnungsauflagen Rosenkohl 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: - Erläuterungen: Anwendung im Haus- und Kleingartenbereich: Erläuterung zum Schadorganismus: Stadium des Schadorganismus: - Erläuterungen: Erläuterung zur Kultur: Gemüsebau Jungpflanzenanzucht (Gewächshaus) Nein Stadium der Kultur: ab 12 - Erläuterungen: Anwendungszeitpunkt: - Erläuterungen: Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 1 - Abstand: - Erläuterungen Anzahl Behandlungen: Mischungspartner: - Erläuterungen: Anwendungstechnik: - Erläuterungen: Aufwand: Jungpflanzen in Anzuchtgefäßen Bei Befallsgefahr bzw. nach Warndiensthinweis gießen - 2,4 g/m² in 3 l Wasser/m² - Erläuterungen: Mittelaufwand gilt bei 1000 Pflanzen pro m² Sonstige Ergänzungen und Hinweise: - keine - BVL_FO_05_2468_200_V Sonstige Kennzeichnungsauflagen - keine -

19 SEITE 7 VON Wartezeiten 90 Tage Jungpflanzenanzucht (Gewächshaus): Rosenkohl 3 Anwendungsbezogene Anwendungsbestimmungen - keine - BVL_FO_05_2468_200_V1.1

20 SEITE 8 VON 11 Anlage 1 zugelassene Anwendung: / Anwendungsgebiet Schadorganismus/Zweckbestimmung: Kohlmottenschildlaus, Kleine Kohlfliege, Mehlige Kohlblattlaus Pflanzen/-erzeugnisse/Objekte: Verwendungszweck: 2 Kennzeichnungsauflagen Blumenkohle 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: - Erläuterungen: Anwendung im Haus- und Kleingartenbereich: Erläuterung zum Schadorganismus: Stadium des Schadorganismus: - Erläuterungen: Erläuterung zur Kultur: Gemüsebau Jungpflanzenanzucht (Gewächshaus) Nein Stadium der Kultur: ab 12 - Erläuterungen: Anwendungszeitpunkt: - Erläuterungen: Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 1 - Abstand: - Erläuterungen Anzahl Behandlungen: Mischungspartner: - Erläuterungen: Anwendungstechnik: - Erläuterungen: Aufwand: Jungpflanzen in Anzuchtgefäßen Bei Befallsgefahr bzw. nach Warndiensthinweis gießen - 2,4 g/m² in 3 l Wasser/m² - Erläuterungen: Mittelaufwand gilt bei 1000 Pflanzen pro m² Sonstige Ergänzungen und Hinweise: - keine - BVL_FO_05_2468_200_V Sonstige Kennzeichnungsauflagen - keine -

21 SEITE 9 VON Wartezeiten 70 Tage Jungpflanzenanzucht (Gewächshaus): Blumenkohle 3 Anwendungsbezogene Anwendungsbestimmungen - keine - BVL_FO_05_2468_200_V1.1

22 SEITE 10 VON 11 Anlage 1 zugelassene Anwendung: / Anwendungsgebiet Schadorganismus/Zweckbestimmung: Kohlmottenschildlaus, Kleine Kohlfliege, Mehlige Kohlblattlaus Pflanzen/-erzeugnisse/Objekte: Verwendungszweck: 2 Kennzeichnungsauflagen Blattkohle 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: - Erläuterungen: Anwendung im Haus- und Kleingartenbereich: Erläuterung zum Schadorganismus: Stadium des Schadorganismus: - Erläuterungen: Erläuterung zur Kultur: Gemüsebau Jungpflanzenanzucht (Gewächshaus) Nein Stadium der Kultur: ab 12 - Erläuterungen: Anwendungszeitpunkt: - Erläuterungen: Maximale Zahl der Behandlungen - in dieser Anwendung: 1 - für die Kultur bzw. je Jahr: 1 - Abstand: - Erläuterungen Anzahl Behandlungen: Mischungspartner: - Erläuterungen: Anwendungstechnik: - Erläuterungen: Aufwand: Jungpflanzen in Anzuchtgefäßen Bei Befallsgefahr bzw. nach Warndiensthinweis gießen - 2,4 g/m² in 3 l Wasser/m² - Erläuterungen: Mittelaufwand gilt bei 1000 Pflanzen pro m² Sonstige Ergänzungen und Hinweise: - keine - BVL_FO_05_2468_200_V Sonstige Kennzeichnungsauflagen - keine -

23 SEITE 11 VON Wartezeiten 70 Tage Jungpflanzenanzucht (Gewächshaus): Blattkohle 3 Anwendungsbezogene Anwendungsbestimmungen - keine - BVL_FO_05_2468_200_V1.1

24 REGISTRATION REPORT Part B Section 4: Metabolism and Residues Detailed summary of the risk assessment Product code: Dantop Active Substance: 500 g/kg Clothianidin Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 08/07/2013 Page 1 / 37

25 IIIA 8 METABOLISM AND RESIDUES DATA...4 IIIA 8.1 Evaluation of the active substances...4 IIIA Clothianidin...4 IIIA Storage stability...4 IIIA IIIA IIIA Metabolism in plants and plant residue definition(s)...4 Metabolism in livestock and animal residue definition(s)...5 Residues in rotational crops...6 IIIA Residues in livestock...6 IIIA 8.2 Evaluation of the intended use(s)...7 IIIA IIIA Selection of critical use and justification...7 Flowering brassica...9 IIIA Residues in primary crops...9 IIIA Distribution of the residue in peel/pulp...9 IIIA Residues in processed commodities...9 IIIA Proposed pre-harvest intervals, withholding periods...9 IIIA Brussels sprouts...9 IIIA Residues in primary crops...9 IIIA Distribution of the residue in peel/pulp...10 IIIA Residues in processed commodities...10 IIIA IIIA Proposed pre-harvest intervals, withholding periods...10 Head cabbage...10 IIIA Residues in primary crops...10 IIIA Distribution of the residue in peel/pulp...10 IIIA Residues in processed commodities...10 IIIA IIIA Proposed pre-harvest intervals, withholding periods...10 Leafy brassica...10 IIIA Residues in primary crops...10 IIIA Distribution of the residue in peel/pulp...11 IIIA Residues in processed commodities...11 IIIA IIIA 8.3 Proposed pre-harvest intervals, withholding periods...11 Consumer intake and risk assessment...11 IIIA 8.4 Proposed maximum residue levels (MRLs)...12 IIIA 8.5 Conclusion...12 Appendix 1 List of data submitted in support of the evaluation...13 Appendix 2 Detailed evaluation of the additional studies relied upon...18 A 2.1 Storage stability...18 A 2.2 Residues in primary crops...18 Page 2 / 37

26 A Nature of residues...18 A Magnitude of residues in Flowering brassica...19 A Magnitude of residues in Brussels Sprouts...25 A Magnitude of residues in Savoy Cabbage...28 A Magnitude of residues in Kale...33 A 2.3 Residues in processed commodities...36 A 2.4 Residues in rotational crops...36 A 2.5 Residues in livestock...36 A 2.6 Other studies/information...36 Appendix 3 Pesticide Residue Intake Model (PRIMo)...37 Page 3 / 37

27 IIIA 8 IIIA 8.1 METABOLISM AND RESIDUES DATA Evaluation of the active substances IIIA Clothianidin Table IIIA 8.1-1: Structural formula Identity of the active substance N H H N N Cl S CH 3 N NO 2 Common Name Clothianidin CAS number IIIA Storage stability A brief summary of the storage stability data on clothianidin is given in the following table. Data has been previously evaluated at EU level and is described in detail in the DAR (RMS Belgium, ASB ). Table IIIA 8.1-2: Stability of residues (Annex IIA, point 6.1) Stability of clothianidin Residues of clothianidin were stable for at least 12 months in apples (RIP ) and for at least 24 months in sugar beet roots, maize (grain, forage, straw) and rape seed (RIP ) after freezer storage at -18 C. IIIA Metabolism in plants and plant residue definition(s) A brief summary of the metabolism of clothianidin in plants is given in the following table. Data has been previously evaluated at EU level and is described in detail in the DAR (RMS Belgium, ASB ). Table IIIA 8.1-3: Metabolism in plants (Annex IIA, point 6.2.1; 6.5.1, 6.5.2, and 6.7.1) Plant groups covered - Maize: nitroimino- 14 C label (RIP ), thiazolyl C label (RIP ), seed dressing - sugar beet: nitroimino- 14 C label (RIP ), seed dressing - tomato: nitroimino- 14 C label (RIP : preplanting application to soil; RIP : foliar spray) - apple: nitroimino- 14 C label (fruit: RIP , leaves: RIP ), foliar spray The metabolism in plants treated with clothianidin either via foliar treatment or seed dressing was comparable, showing unchanged parent substance as major residue. The parent molecule was subject to hydrolysis (forming TZMU), cleavage of the C-N-bond at the ring structure (forming MNG) or denitrification (forming TMG). Page 4 / 37

28 Rotational crops Metabolism in rotational crops similar to metabolism in primary crops? (yes/no) Distribution of the residue in peel/ pulp Processed commodities (nature of residue) Residue pattern in raw and processed commodities similar? (yes/no) Plant residue definition for monitoring Turnips, chard, wheat, nitroimino- 14 C label, rotational crops planted after soil treatment with 328 g as/ha, PBI: 29, 153 and 314 d (RIP ) The metabolic pattern in rotational crops was comparable to primary treated crops with parent being the major residue in all investigated matrices. es Not applicable No study available and none required due to a no residue situation in crops at harvest. Not applicable Clothianidin This is in accordance with Reg. (EC) No 396/2005. Plant residue definition for risk assessment Clothianidin Conversion factor(s) (monitoring to risk assessment) None IIIA Metabolism in livestock and animal residue definition(s) A brief summary of the metabolism of clothianidin in livestock is given in the following table. Data has been previously evaluated at EU level and is described in detail in the DAR (RMS Belgium, ASB ). Table IIIA 8.1-4: Metabolism in livestock (Annex IIA, point to and 6.7.1) Animals covered Time needed to reach a plateau concentration in milk and eggs Animal residue definition for monitoring Lactating goats (RIP ), laying hens (RIP ), nitroimino- 14 C label, dose 10 mg/kg bw, 3 days The metabolic pathways in goats and hens differed. While in goats most of the residue was present as unchanged parent substance, the main residue in poultry matrices was TZNG, found in eggs at levels of up to 87 % TRR. Although unchanged clothianidin was also found in all poultry matrices, its relative share was below 10 % TRR in liver, muscle and fat. Milk: very low residues in 28 days feeding study. Plateau not possible to estimate. Eggs: 1 day (no change of TRR within 5 days). Clothianidin (ruminants only); for other livestock species no residue definition is needed (no residues expected in animal commodities). Animal residue definition for risk assessment Conversion factor(s) (monitoring to risk assessment) None Note: In Reg. (EC) No 396/2005, MRLs for all animal commodities have been established based on the DoR clothianidin (which would be adequate for ruminants only). Clothianidin (ruminants only); for other livestock species no residue definition is needed (no residues expected in animal commodities). Page 5 / 37

29 Metabolism in rat and ruminant similar (yes/no) Fat soluble residue: (yes/no) Partially (different pathways, but all livestock metabolites also found in rats) No, log P O/W = 0.9 (ph 4-10, 25 C) IIIA Residues in rotational crops A brief summary of the field rotational crop studies on clothianidin is given in the following table. Data has been previously evaluated at EU level and is described in detail in the DAR (RMS Belgium, ASB ). Table IIIA 8.1-5: Residues in rotational crops (Annex IIA, point 6.6.3) Field studies Turnips, wheat and mustard greens, planted 1, 4, 8 and 12 months after treated maize seeds (0.19 kg as/ha) were sewn (RIP , investigation for TZNG: RIP , Addendum: ASB ). No residues above 0.02* mg/kg were found in rotational crops at any plant-back interval. Significant residues are therefore not expected in food and feed commodities obtained from succeeding crops (consequent to uses in compliance with cgap). IIIA Residues in livestock An actual calculation of the dietary burden (based on all relevant uses authorized in Germany) is provided in the following table. Table IIIA 8.1-6: Calculation of the dietary burden (based on all relevant uses authorized in the Germany) Percent of daily livestock diet (dry feed basis) Intake (mg/kg, dry feed basis) Feedstuff % DM Chicken 1.9 kg bw daily maximum feed (DM) 120 g Dairy cattle 550 kg bw daily maximum feed (DM) 20 kg Beef cattle 350 kg bw daily maximum feed (DM) 15 kg Pig 75 kg bw daily maximum feed (DM) 3 kg Residue (mg/kg) Chicken Dairy cattle Beef cattle Pig Forage (cereals) a Kale/ Cabbage b Maize grain c Swede/ Turnip d Oilseed rape e Intake (mg/kg dry weight feed) Intake (mg/kg bw/d) Intake (mg/animal/d) a HR, based on the following cgap: 1 x 80 g as/ha (seed dressing), PHI: F b HR, based on the following cgap: 1 x 1.2 g as/m 2 (seedling production, before transplanting), PHI: 70 d c STMR, based on the following cgap: 1 x 80 g as/ha (seed dressing), PHI: F d STMR, based on the following cgap: 1 x 78 g as/ha (seed dressing), PHI: F e STMR, based on the following cgap: 1 x 50 g as/ha (seed dressing), PHI: F Page 6 / 37

30 Table IIIA 8.1-7: Conditions of requirement of livestock feeding studies on clothianidin Expected intakes by livestock 0.1 mg/kg diet (dry weight basis) (yes/no If yes, specify the level) Ruminant: Poultry: Pig: es 0.95 Potential for accumulation (yes/no): No No No Metabolism studies indicate potential level of residues 0.01 mg/kg in edible tissues (yes/no) No es 0.22 es No es (ruminant) A summary of the available livestock feeding study is given in the following table. Data has previously been evaluated at EU level and is described in detail in the DAR (RMS Belgium, ASB ). Table IIIA 8.1-8: Results of livestock feeding studies (Annex IIA, point 6.4) Feeding levels (mg/kg feed dry matter) in feeding studies Ruminant: Poultry: Pig: Lactating cows: 0.28, 0.84 and 2.8 (RIP ) Not applicable Not applicable Relevant dosing levels in feeding study: 0.84 Not applicable Not applicable Expected residue levels in animal matrices (mg/kg): Muscle <0.01 <0.01 <0.01 Liver <0.01 <0.01 <0.01 Kidney <0.01 <0.01 <0.01 Fat <0.01 <0.01 <0.01 Milk <0.01 Eggs <0.01 IIIA 8.2 Evaluation of the intended use(s) IIIA Selection of critical use and justification The critical GAP used for consumer intake and risk assessment is presented in Table IIIA Page 7 / 37

31 Table IIIA 8.2-1: Critical Use (worst case) used for consumer intake and risk assessment Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) (a) F G or I (b) Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) (c) Application Method / Kind (d-f) Timing / Growth stage of crop & season (g) Max. number (min. interval between applications) a) per use b) per crop/ season (h) Application rate g product / m 2 a) max. rate per appl. b) max. total rate per crop/season g as/ha a) max. rate per appl. b) max. total rate per crop/season Water L/ha min / max PHI (days) (i) Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures (j) 1 DE Head Cabbage (red, white, pointed, savoy cabbage); seedling production, seedlings in seeding bowls G Cabbage whitefly, Small cabbage fly, Mealy cabbage aphid douse from BBCH 12 onwards a) 1 b) 1 a) 2.4 g/m² b) 2.4 g/m² a) 1.2 g as/m² b) 1.2 g as/m² 3 l/m² plants/m², application before transplanting 2 DE Brussels Sprouts; seedling production, seedlings in seeding bowls G Cabbage whitefly, Small cabbage fly, Mealy cabbage aphid douse from BBCH 12 onwards a) 1 b) 1 a) 2.4 g/m² b) 2.4 g/m² a) 1.2 g as/m² b) 1.2 g as/m² 3 l/m² plants/m², application before transplanting 3 DE Flowering brassica; seedling production, seedlings in seeding bowls G Cabbage whitefly, Small cabbage fly, Mealy cabbage aphid douse from BBCH 12 onwards a) 1 b) 1 a) 2.4 g/m² b) 2.4 g/m² a) 1.2 g as/m² b) 1.2 g as/m² 3 l/m² plants/m², application before transplanting 4 DE Leafy brassica; seedling production, seedlings in seeding bowls G Cabbage whitefly, Small cabbage fly, Mealy cabbage aphid douse from BBCH 12 onwards a) 1 b) 1 a) 2.4 g/m² b) 2.4 g/m² a) 1.2 g as/m² b) 1.2 g as/m² 3 l/m² plants/m², application before transplanting Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use situation should be described (e.g. fumigation of a structure) (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds (d) All abbreviations used must be explained (e) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (f) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated (g) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application (h) The minimum and maximum number of application possible under practical conditions of use must be provided (i) PHI - minimum pre-harvest interval (j) Remarks may include: Extent of use/economic importance/restrictions Page 8 / 37

32 IIIA Flowering brassica IIIA Residues in primary crops The following table gives a brief overview of the supervised residue trials selected for the assessment of clothianidin in flowering brassica. For the detailed evaluation of new residue trials it is referred to Appendix 2. Table IIIA 8.2-2: Overview of the selected supervised residue trials for clothianidin in flowering brassica Commodity Region (a) Outdoor/ Indoor Cauliflower and broccoli Individual trial results (mg/kg) Enforcement (clothianidin) Risk assessment (clothianidin) STMR (mg/kg) (b) HR (mg/kg) (c) NEU Indoor <0.01 (7); 0.01 <0.01 (7); Median CF (d) (a): NEU, SEU, EU or Import (country code). In the case of indoor uses there is no necessity to differentiate between NEU and SEU. (b): Median value of the individual trial results according to the risk assessment residue definition. (c): Highest value of the individual trial results according to the risk assessment residue definition. (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial. Analytical methods for commodities of high water content such as flowering brassica are available and acceptable for enforcing clothianidin. IIIA Not relevant. IIIA Distribution of the residue in peel/pulp Residues in processed commodities Not relevant. Due to low residues at harvest, no processing studies are required. IIIA Proposed pre-harvest intervals, withholding periods A pre-harvest interval (PHI) of 70 days is proposed for the intended use on flowering brassica. IIIA Brussels sprouts IIIA Residues in primary crops The following table gives a brief overview of the supervised residue trials selected for the assessment of clothianidin in Brussels sprout. For the detailed evaluation of new residue trials, it is referred to Appendix 2. Table IIIA 8.2-3: Overview of the selected supervised residue trials for clothianidin in Brussels sprout Commodity Region (a) Outdoor/ Indoor Brussels sprout Individual trial results (mg/kg) Enforcement (clothianidin) Risk assessment (clothianidin) STMR (mg/kg) (b) HR (mg/kg) (c) NEU Indoor <0.01 (4) <0.01 (4) Median CF (d) (a): NEU, SEU, EU or Import (country code). In the case of indoor uses there is no necessity to differentiate between NEU+SEU (b): Median value of the individual trial results according to the risk assessment residue definition. (c): Highest value of the individual trial results according to the risk assessment residue definition. (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial. Page 9 / 37

33 Analytical methods for commodities of high water content such as Brussels sprout are available and acceptable for enforcing clothianidin. IIIA Not relevant. IIIA Distribution of the residue in peel/pulp Residues in processed commodities Not relevant. Due to low residues at harvest, no processing studies are required. IIIA Proposed pre-harvest intervals, withholding periods A pre-harvest interval (PHI) of 90 days is proposed for the intended use on Brussels sprouts. IIIA Head cabbage IIIA Residues in primary crops The following table gives a brief overview of the supervised residue trials selected for the assessment of clothianidin in head cabbage. For the detailed evaluation of new residue trials, it is referred to Appendix 2. Table IIIA 8.2-4: Overview of the selected supervised residue trials for clothianidin in head cabbage Commodity Region (a) Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (clothianidin) Risk assessment (clothianidin) STMR (mg/kg) (b) HR (mg/kg) (c) Savoy cabbage NEU Indoor <0.01 (7); 0.02 <0.01 (7); Median CF (d) (a): NEU, SEU, EU or Import (country code). In the case of indoor uses there is no necessity to differentiate between NEU and SEU. (b): Median value of the individual trial results according to the risk assessment residue definition. (c): Highest value of the individual trial results according to the risk assessment residue definition. (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial. Analytical methods for commodities of high water content such as head cabbage are available and acceptable for enforcing clothianidin. IIIA Not relevant. IIIA Distribution of the residue in peel/pulp Residues in processed commodities Not relevant. Due to low residues at harvest, no processing studies are required. IIIA Proposed pre-harvest intervals, withholding periods A pre-harvest interval (PHI) of 70 days is proposed for the intended use on head cabbage. IIIA Leafy brassica IIIA Residues in primary crops The following table gives a brief overview of the supervised residue trials selected for the assessment of clothianidin in leafy brassica. For the detailed evaluation of new residue trials, it is referred to Appendix 2. Page 10 / 37

34 Table IIIA 8.2-5: Overview of the selected supervised residue trials for clothianidin in leafy brassica Commodity Region (a) Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (clothianidin) Kale NEU Indoor <0.01; 0.01; 0.08; 0.09 Risk assessment (clothianidin) STMR (mg/kg) (b) HR (mg/kg) (c) <0.01; 0.01; 0.08; Median CF (d) (a): NEU, SEU, EU or Import (country code). In the case of indoor uses there is no necessity to differentiate between NEU and SEU. (b): Median value of the individual trial results according to the risk assessment residue definition. (c): Highest value of the individual trial results according to the risk assessment residue definition. (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial. Analytical methods for commodities of high water content such as leafy brassicas are available and acceptable for enforcing clothianidin. IIIA Not relevant. IIIA Distribution of the residue in peel/pulp Residues in processed commodities Not relevant. Due to low residues at harvest, no processing studies are required. IIIA Proposed pre-harvest intervals, withholding periods A pre-harvest interval (PHI) of 70 days is proposed for the intended use on leafy brassica. IIIA 8.3 Consumer intake and risk assessment The consumer intake and risk assessment is based on the appropriate input values given in Table IIIA and the toxicological reference values stated in Table IIIA For the detailed calculation results it is referred to Appendix 3. Table IIIA 8.3-1: Residue input values for the consumer risk assessment Commodity Chronic risk assessment Input value (mg/kg) Comment Acute risk assessment Input value (mg/kg) Comment Flowering brassica MRL Reg. (EC) No 0.01 HR (=LOQ) Brussels sprout 396/ HR (=LOQ) Head cabbage 0.02 HR Leafy brassica 0.09 HR All other commodities Not applicable Table IIIA 8.3-2: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8) ADI TMDI (% ADI) according to EFSA PRIMo NTMDI (% ADI) according to German NVS II model IEDI (EFSA PRIMo) (% ADI) mg/kg bw 4.1 % (based on Dutch children) 3.7 % (based on 2-4 years old German children) Not required Page 11 / 37