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

Transcription

1 Part A Core Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /2 Registration Report Central Zone Country Germany Page 1 of 14 Art. 51 Extension of authorisation for minor uses REGISTRATION REPORT Part A Risk Management Product code: Signum Active Substances: Boscalid 26 g/kg and Pyraclostrobin 6 g/kg COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: BASF SE E-APE/DT, Li 556 Date: 4/6/214 BVL_FO_5_2422_2_V1. Applicant BASF SE E-APE/DT, Li 556 Date: 4/6/214

2 Part A Core Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /2 Registration Report Central Zone Country Germany Page 2 of 14 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 or Regulation (EC) No 122/ R and S phrases under Regulation (EC) No 54/ 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_5_2422_2_V1. Applicant BASF SE E-APE/DT, Li 556 Date: 4/6/214

3 Part A Core Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /2 Registration Report Central Zone Country Germany Page 3 of 14 PART A Risk Management This document describes the acceptable use conditions required for extension of the registration of Signum containing Boscalid and Pyraclostrobin 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 Signum have been made using endpoints agreed in the EU reviews of Boscalid and Pyraclostrobin. Appendix 1 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 Signum Type of application Zonal application according to Article 51, ZRMS=DE, first application (GV1) Registration number /2 Applicant BASF SE E-APE/DT, Li 556, Speyerer Straße 2, 611 Limburgerhof, Deutschland Authorisation holder BASF SE E-APE/DT, Li 556, Speyerer Straße 2, 611 Limburgerhof, Deutschland Function Fungicide Type of formulation Water dispersible granule (WG) Expiration of authorisation BVL_FO_5_2422_2_V1. Applicant BASF SE E-APE/DT, Li 556 Date: 4/6/214

4 Part A Core Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /2 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 11/29. The present application is in line with the provisions of the approvals. Active substance (BVL Number) Boscalid (123) Content in PPP 26 g/kg Approval status Approved according Regulation (EC) No 11/29 Approval Regulation (EC) No 54/211 Expiration of approval 31//218 Pyraclostrobin (113) Content in PPP 6 g/kg Approval status Approved according Regulation (EC) No 11/29 Approval Regulation (EC) No 54/211 and Regulation (EU) No 823/212 Expiration of approval 31/1/ 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 BVL_FO_5_2422_2_V1. Number of Plant/commodity/object Harmful organism/purpose decision use 1 tomate leaf mould (Fulvia fulva) Authorise 2 aubergine Sclerotinia species Authorise 3 rocket species grey mould (Botrytis cinerea) No authorisation possible 4 spinach and related species turnip tops vegetable cabbage turnip (stubble turnip, early turnip etc.) radish, small radish, garden lettuce species pea swedish turnip (utilisation as baby leaf salat) grey mould (Botrytis cinerea) No authorisation possible Applicant BASF SE E-APE/DT, Li 556 Date: 4/6/214

5 Part A Core Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /2 Registration Report Central Zone Country Germany Page 5 of 14 5 spinach and related species turnip tops vegetable cabbage turnip (stubble turnip, early turnip etc.) radish, small radish, garden lettuce species pea swedish turnip (utilisation as baby leaf salat) grey mould (Botrytis cinerea) Authorise Public interest and minor use According to Article 51 (2) a and c of the Regulation (EC) No 11/29 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 of tomate is about 321 ha, of which approx.,4 ha need to be controlled, the cultivated area of aubergine is about 5 ha, of which approx.,4 ha need to be controlled, the cultivated area of rocket species is about 3 ha, of which approx.,4 ha need to be controlled, the cultivated area of spinach and related species, turnip tops, vegetable cabbage, turnip (stubble turnip, early turnip etc.), radish, small, radish, garden, lettuce species, pea and swedish turnip (utilisation as baby leaf salat ) is about 1 ha (4) and 2 ha (5), of which approx.,4 ha need to be controlled. Calculation shows that authorisation holder will not profit from an authorisation of the requested uses. All data are valid for greenhouse, excluding (5) for open field. Upon this calculation and the examination of available alternative measures for the applied uses it can be stated that the applied uses is minor in nature and the authorisation is in the public interest. 1.4 Data protection claims The applicant is authorisation holder and claims data protection. 1.5 Letters of Access The Authorisation holder is also the applicant for the extension of the authorisation. No letter of access necessary. 2 Details of the authorisation 2.1 Product identity Product name Signum Authorisation number Composition Type of formulation Boscalid 26 g/kg and Pyraclostrobin 6 g/kg Water dispersible granule (WG) BVL_FO_5_2422_2_V1. Function Authorisation holder Fungicide BASF SE E-APE/DT, Li 556, Speyerer Straße 2, 611 Limburgerhof, Deutschland Applicant BASF SE E-APE/DT, Li 556 Date: 4/6/214

6 Part A Core Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /2 Registration Report Central Zone Country Germany Page 6 of Classification and labelling Classification and labelling under Directive 99/45/EC or Regulation (EC) No 122/28 N R 5/53 S 35 S 5 SP1 Dangerous for the environment Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment This material and its container must be disposed of in a safe way. Use appropriate container to avoid environmental contamination. To avoid riks to man and the environment, comply with the instructions for use R and S phrases under Regulation (EC) No 54/211 None Other phrases Restrictions linked to the PPP The authorization of the PPP is linked to the following conditions (mandatory labelling): Operator protection SB1 Avoid any unnecessary contact with the product. Misuse can lead to health damage. SB1 Keep out of children reach. SF245-1 Treated areas/crops may not be entered until the spray coating has dried. Ecosystem protection NW262 The product is toxic for algae. NW264 The product is toxic for fish and 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. Integrated Pest Management (IPM) Mode of action (FRAC Group): Pyraclostrobin: C3, Boscalid: C2 Active substance VH329 The content of dimethylsulfate (DMS) in the technical active substance pyraclostrobin may not exceed 1 mg/kg. VH41 The instructions for use must contain details on replanting which specify which crops or groups of crops must not be replanted after applying the plant protection product because the marketability of the harvested products cannot be guaranteed. BVL_FO_5_2422_2_V1. The authorization of the PPP is linked to the following conditions (voluntary labelling): Honeybee Applicant BASF SE E-APE/DT, Li 556 Date: 4/6/214

7 Part A Core Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /2 Registration Report Central Zone Country Germany Page of 14 NB6641 The product is classified as non-hazardous to bees, even when the maximum application rate, or concentration if no application rate is stipulated, as stated for authorisation is applied. (B4) Integrated Pest Management (IPM) NN134 NN1842 The product is classified as harmless for populations of the species Typhlodromus pyri (predatory mite). The product is classified as harmless for populations of the species Aphidius rhopalosiphi (braconid wasp). NN1326 The product is classified as harmless for populations of the species Euseius finlandicus (predatory mite) 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 to /2-5 NW65-1 When applying the product on areas adjacent to surface waters - except only occasionally but including periodically water bearing surface waters - the product must be applied with equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 ('Bundesanzeiger' [Federal Gazette] No 25, p. 98) as amended. Depending on the drift reduction classes for the equipment stated below, the following buffer zones must be kept from surface waters. In addition to the minimum buffer zone from surface waters stipulated by state law, the ban on application in or in the immediate vicinity of waters must be observed at all times for drift reduction classes marked with "*". 9%: *, 5%: 5 m, 5%: 5 m to /2-5 NW66 The only case in which the product may be applied without loss reducing equipment is when at least the buffer zone stated below is kept from surface waters - except only occasionally but including periodically water bearing surface waters. Violations may be punished by fines of up to 5 Euro. 5 m BVL_FO_5_2422_2_V1. Applicant BASF SE E-APE/DT, Li 556 Date: 4/6/214

8 Part A Core Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /2 Registration Report Central Zone Country Germany Page 8 of Product uses PPP (product name/code) Signum (25483-) active substance 1 Boscalid active substance 2 Pyraclostrobin Formulation type: Conc. of as 1: Conc. of as 2: SC 26 g/kg 6 g/kg safener - synergist - Applicant: BASF SE E-APE/DT, Li 556 Zone(s): central EU Conc. of safener: - Conc. of synergist: - professional use non professional use Verified by MS: yes 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 BVL_FO_5_2422_2_V1. 1 DE Tomate G leaf mould (Fulvia fulva) spraying BBCH in case of danger of infection and/or after warning service appeal a) 2 ( to 1 days) b) 2 plant height < 5 cm: a),5 kg /ha b) 1,5 kg/ha plant height cm: a) 1,125 kg/ha b) 2,25 kg/ha plant height 125: a) 1,5 kg/ha b) 3 kg/ha as 1: plant height < 5 cm: a) 2,3 g /ha b) 4,5g/ha plant height cm: a) 3,4 g/ha b) 6,8 g/ha plant height < 5 cm: 6 L/ha plant height cm : 9 L/ha plant height > 125 cm: 12 3 Restrictions (see ) Applicant BASF SE E-APE/DT, Li 556 Date: 4/6/214

9 Part A Core Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /2 Registration Report Central Zone Country Germany Page 9 of 14 plant height 125: a) 4,5 g/ha b) 81 g/ha as 2: plant height < 5 cm: a) 5,3 g /ha b) 1,5g/ha plant height cm: a) 3,1 g/ha b) 146,3 g/ha plant height 125: a) 1,5 g/ha b) 21 g/ha L/ha BVL_FO_5_2422_2_V1. 2 DE aubergine G Sclerotinia species spraying BBCH in case of danger of infection and/or after warning service appeal a) 2 ( to 1 days) b) 2 plant height < 5 cm: a),5 kg /ha b) 1,5 kg/ha plant height cm: a) 1,125 kg/ha b) 2,25 kg/ha plant height 125: a) 1,5 kg/ha b) 3 kg/ha as 1: plant height < 5 cm: a) 2,3 g /ha b) 4,5g/ha plant height cm: a) 3,4 g/ha b) 6,8 g/ha plant height 125: a) 4,5 g/ha b) 81 g/ha as 2: plant height < 5 cm: 6 L/ha plant height cm : 9 L/ha plant height > 125 cm: 12 L/ha 3 Applicant BASF SE E-APE/DT, Li 556 Date: 4/6/214

10 Part A Core Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /2 Registration Report Central Zone Country Germany Page 1 of 14 plant height < 5 cm: a) 5,3 g /ha b) 1,5g/ha plant height cm: a) 3,1 g/ha b) 146,3 g/ha plant height 125: a) 1,5 g/ha b) 21 g/ha 3 DE rocket species G grey mould (Botrytis cinerea) spraying BBCH from 14 in case of danger of infection and/or after warning service appeal a) 2 ( to 1 days) b) 2 a) 1,5 kg/ha b) 3 kg/ha as 1: a) 4,5 g/ha b) 81 g/ha as 2: a) 1,5 g/ha b)21 g/ha 5-1 L/ha 14 No authorisation possible due to insufficient residue data (see ) BVL_FO_5_2422_2_V1. 4 DE spinach and related species turnip tops vegetable cabbage turnip (stubble turnip, early turnip etc.) radish, small radish, garden lettuce species pea swedish turnip (utilisation as baby G grey mould (Botrytis cinerea) spraying BBCH from 14 in case of danger of infection and/or after warning service appeal a) 2 ( to 1 days) b) 2 a) 1,5 kg/ha b) 3 kg/ha as 1: a) 4,5 g/ha b) 81 g/ha as 2: a) 1,5 g/ha b)21 g/ha 5-1 L/ha 14 No authorisation possible due to insufficient residue data (see ) Applicant BASF SE E-APE/DT, Li 556 Date: 4/6/214

11 Part A Core Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /2 Registration Report Central Zone Country Germany Page 11 of 14 leaf salad) 5 DE spinach and related species turnip tops vegetable cabbage turnip (stubble turnip, early turnip etc.) radish, small radish, garden lettuce species pea swedish turnip (utilisation as baby leaf salad) F grey mould (Botrytis cinerea) spraying BBCH from 14 in case of danger of infection and/or after warning service appeal a) 2 ( to 1 days) b) 2 a) 1,5 kg/ha b) 3 kg/ha as 1: a) 4,5 g/ha b) 81 g/ha as 2: a) 1,5 g/ha b)21 g/ha 5-1 L/ha 14 NW65-1 (*,5,5 m) NW66 (5 m) BVL_FO_5_2422_2_V1. Applicant BASF SE E-APE/DT, Li 556 Date: 4/6/214

12 Part A Core Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /2 Registration Report Central Zone Country Germany Page 12 of 14 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 Analytical methods for commodities of high water content such as tomatoes, aubergines and lettuce are available and acceptable for enforcing all compounds given in the residue definitions of both active substances 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 substances boscalid and pyraclostrobin have been evaluated within the EU review process. Information about metabolism is sufficient to evaluate the intended uses Residues The data available to support the indoor applications of boscalid and pyraclostrobin to tomatoes and aubergines and the field application to baby-leaf lettuce are considered sufficient for risk assessment. An exceedance of the current MRLs for boscalid (3 mg/kg for tomatoes and aubergines, 3 mg/kg for leaves and sprouts of Brassica (Mizuna, leaves of peas and radish and other babyleaf brassica crops (crops harvested up to 8 true leaf stage)) and for pyraclostrobin (.3 mg/kg for tomatoes and aubergines, 2 mg/kg for leaves and sprouts of Brassica (Mizuna, leaves of peas and radish and other babyleaf brassica crops (crops harvested up to 8 true leaf stage)) as laid down in Reg. (EU) 396/25 is not expected. The established MRLs also cover the potential uptake of residues from soil into rotational crops for both active substances. For the treatment of rucola and baby-leaf lettuce in glasshouse the data provided for boscalid is insufficient for assessment. The data available for head lettuce is no longer suitable for extrapolation since the Revision 9 of the EU Guidance for Extrapolation came into force. Additional data on lamb s lettuce were from studies with only one application, which probably results in an underestimation of the true residues after two treatments. For pyraclostrobin sufficient data for an assessment of the intended uses was submitted. BVL_FO_5_2422_2_V1. Applicant BASF SE E-APE/DT, Li 556 Date: 4/6/214

13 Part A Core Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /2 Registration Report Central Zone Country Germany Page 13 of Consumer exposure For boscalid a refined assessment of residue uptake by consumers (IEDI calculation, EFSA PRIMo) results in the following maximum ADI consumption: Boscalid (.4 mg/kg bw/d) 58 % (WHO cluster diet B) For pyraclostrobin the assessment of residue uptake by consumers (TMDI calculation, EFSA PRIMo) results in the following maximum ADI consumption: Pyraclostrobin (.3 mg/kg bw/d) 6 % (DE Children, aged 2-4 y, mean body weight basis) Long-term dietary intake of residues of pyraclostrobin and boscalid is unlikely to present a public health concern for European consumers. No acute risk is expected from the consumption of tomatoes, aubergines and baby leaf lettuce treated according to the intended use Environmental fate and behaviour No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation / according the uniform principles of directive 91/414/EEC Ecotoxicology No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation / according the uniform principles of directive 91/414/EEC. The PPP Signum and the active substance pyraclostrobin are toxic to the aquatic environment (fish, HC5 referred to LC5 von 5,9 µg a.i./l). Subsequently no additional entries as those according to the evaluated use pattern and good agricultural practise are acceptable. Therefore the safety phrases and conditions of use NW262, NW264, NW468 and NW 65-1/66 are assigned, see also 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 11/29 (see also point 2.2) Efficacy Labelling in accordance with the requirements of ANNEX III General principles of integrated pest management under directive 29/128/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 11/29. -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 11/29. According to Article 51 of the regulation (EC) No 11/29 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_5_2422_2_V1. Applicant BASF SE E-APE/DT, Li 556 Date: 4/6/214

14 Part A Core Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /2 Registration Report Central Zone Country Germany Page 14 of Conclusions PPP Signum 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(s). The indended uses in of tomatoes, aubergines and baby leaf lettuce will not result in residues above the MRLs set in Regulation (EC) No 396/25. A risk for consumers through the consumption of food with these residues of boscalid and pyraclostrobin is not expected. There is no special risk mitigation necessary which deviate from the existing registration. The residue data for the use of boscalid in rocket species and baby-leaf salad in glasshouses is insufficient and therefore an authorisation can not be given for uses no 3 and 4. Considering an application in accordance with the evaluated use pattern and good agricultural practise as well as strict observance of the conditions of use no harmful effects on groundwater or adverse effects on the ecosystem are to be apprehended. An authorisation can be granted for the uses in tomatoes, aubergines and outdoor baby-leaf salad 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 See below. 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 registration owner. BVL_FO_5_2422_2_V1. Applicant BASF SE E-APE/DT, Li 556 Date: 4/6/214

15 Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dienstsitz Braunschweig Postfach Braunschweig Dr. Birgit Schreiber Referentin BASF SE E-APE/DT, Li 556 Speyerer Straße Limburgerhof IHR ZEICHEN IHRE NACHRICHT VOM TELEFON +49 () TELEFAX +49 () birgit.schreiber@bvl.bund.de AKTENZEICHEN / (bitte bei Antwort angeben) DATUM 4. Juni 214 GV /2 Signum Verfahren zur Erweiterung einer Zulassung nach Artikel 51 Abs. 1 der Verordnung (EG) Nr. 11/29 Bescheid Die Zulassung des oben genannten Pflanzenschutzmittels mit den Wirkstoffen: 26 g/kg Boscalid 6 g/kg Pyraclostrobin Zulassungsnummer: Versuchsbezeichnung: BAS-516-F-1-WG Antrag vom:. September 212 wird wie in Anlage 1 beschrieben auf der Grundlage von Art. 51 der Verordnung (EG) Nr. 11/29 des Europäischen Parlaments und des Rates vom 21. Oktober 29 über das Inverkehrbringen von Pflanzenschutzmitteln und zur Aufhebung der Richtlinien 9/11/EWG und 91/414/EWG des Rates (Abl. L 39 vom , S. 1) um folgende Anwendungsgebiete bzw. Anwendungen erweitert: BVL_FO_5_2468_2_V1.3 Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet:

16 SEITE 2 VON 9 Anwendungsnummer Schadorganismus/ Zweckbestimmung Pflanzen/-erzeugnisse/ Objekte /2-5 Botrytis cinerea Spinat und verwandte Arten, Stielmus, Kohlgemüse, Speiserüben (Stoppelrübe, Mairübe etc.), Radieschen, Rettich, Salat-Arten, Erbse, Kohlrübe /2-1 Samtfleckenkrankheit Tomate (Fulvia fulva) /2-2 Sclerotinia-Arten Aubergine (Sclerotinia spp.) Verwendungszweck Festgesetzte Anwendungsbestimmungen Es werden folgende Anwendungsbestimmungen gemäß 36 Abs. 1 S. 1 des Gesetzes zum Schutz der Kulturpflanzen (Pflanzenschutzgesetz - PflSchG) vom 6. Februar 212 (BGBl. I S. 148, 1281), zuletzt geändert durch Artikel 4 Absatz 8 des Gesetzes vom. August 213 (BGBl. I S. 3154) 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 Für folgende Anwendungsgebiete bzw. Anwendungen lehne ich Ihren Antrag ab (siehe Anlage 2): BVL_FO_5_2468_2_V1.3 Anwendungsnummer Schadorganismus/ Pflanzen/-erzeugnisse/ Zweckbestimmung Objekte /2-3 Botrytis cinerea Rucola-Arten Verwendungszweck

17 SEITE 3 VON 9 Anwendungsnummer Schadorganismus/ Zweckbestimmung Pflanzen/-erzeugnisse/ Objekte /2-4 Botrytis cinerea Spinat und verwandte Arten, Stielmus, Kohlgemüse, Speiserüben (Stoppelrübe, Mairübe etc.), Radieschen, Rettich, Salat-Arten, Erbse, Kohlrübe Verwendungszweck 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, 3814 Braunschweig, schriftlich oder zur Niederschrift einzulegen. Mit freundlichen Grüßen im Auftrag gez. Dr. Hans-Gerd Nolting Abteilungsleiter Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig. Anlage BVL_FO_5_2468_2_V1.3

18 SEITE 4 VON 9 Anlage 1 zugelassene Anwendung: /2-1 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Samtfleckenkrankheit (Fulvia fulva) Pflanzen/-erzeugnisse/Objekte: Verwendungszweck: 2 Kennzeichnungsauflagen Tomate 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: Anwendung im Haus- und Kleingartenbereich: Gemüsebau Gewächshaus Nein Stadium der Kultur: 19 bis 85 Anwendungszeitpunkt: Maximale Zahl der Behandlungen - in dieser Anwendung: 2 - für die Kultur bzw. je Jahr: 2 - Abstand: bis 1 Tage Anwendungstechnik: Aufwand: Bei Infektionsgefahr bzw. ab Warndiensthinweis spritzen - Pflanzengröße bis 5 cm,5 kg/ha in 6 l Wasser/ha - Pflanzengröße 5 bis 125 cm 1,125 kg/ha in 9 l Wasser/ha - Pflanzengröße über 125 cm 1,5 kg/ha in 12 l Wasser/ha 2.2 Sonstige Kennzeichnungsauflagen - keine Wartezeiten 3 Tage Gewächshaus: Tomate 3 Anwendungsbezogene Anwendungsbestimmungen - keine - BVL_FO_5_2468_2_V1.3

19 SEITE 5 VON 9 Anlage 1 zugelassene Anwendung: /2-2 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Sclerotinia-Arten (Sclerotinia spp.) Pflanzen/-erzeugnisse/Objekte: Verwendungszweck: 2 Kennzeichnungsauflagen Aubergine 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: Anwendung im Haus- und Kleingartenbereich: Gemüsebau Gewächshaus Nein Stadium der Kultur: 19 bis 85 Anwendungszeitpunkt: Maximale Zahl der Behandlungen - in dieser Anwendung: 2 - für die Kultur bzw. je Jahr: 2 - Abstand: bis 1 Tage Anwendungstechnik: Aufwand: Bei Infektionsgefahr bzw. ab Warndiensthinweis spritzen - Pflanzengröße bis 5 cm,5 kg/ha in 6 l Wasser/ha - Pflanzengröße 5 bis 125 cm 1,125 kg/ha in 9 l Wasser/ha - Pflanzengröße über 125 cm 1,5 kg/ha in 12 l Wasser/ha 2.2 Sonstige Kennzeichnungsauflagen - keine Wartezeiten 3 Tage Gewächshaus: Aubergine 3 Anwendungsbezogene Anwendungsbestimmungen - keine - BVL_FO_5_2468_2_V1.3

20 SEITE 6 VON 9 Anlage 1 zugelassene Anwendung: /2-5 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Botrytis cinerea Pflanzen/-erzeugnisse/Objekte: Verwendungszweck: 2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: Anwendung im Haus- und Kleingartenbereich: Erläuterung zur Kultur: Spinat und verwandte Arten, Stielmus, Kohlgemüse, Speiserüben (Stoppelrübe, Mairübe etc.), Radieschen, Rettich, Salat-Arten, Erbse, Kohlrübe Gemüsebau Freiland Nein Stadium der Kultur: ab 14 Anwendungszeitpunkt: Maximale Zahl der Behandlungen - in dieser Anwendung: 2 - für die Kultur bzw. je Jahr: 2 - Abstand: bis 1 Tage Anwendungstechnik: Aufwand: Nutzung als baby leaf - Salate Bei Infektionsgefahr bzw. ab Warndiensthinweis spritzen - 1,5 kg/ha in 5 bis 1 l Wasser/ha 2.2 Sonstige Kennzeichnungsauflagen - keine Wartezeiten 14 Tage Freiland: Spinat und verwandte Arten 14 Tage Freiland: Stielmus 14 Tage Freiland: Kohlgemüse 14 Tage Freiland: Speiserüben (Stoppelrübe, Mairübe etc.) 14 Tage Freiland: Radieschen BVL_FO_5_2468_2_V Tage Freiland: Rettich 14 Tage Freiland: Salat-Arten

21 SEITE VON 9 14 Tage Freiland: Erbse 14 Tage Freiland: Kohlrübe 3 Anwendungsbezogene Anwendungsbestimmungen (NW65-1) Die Anwendung des Mittels auf Flächen in Nachbarschaft von Oberflächengewässern - ausgenommen nur gelegentlich wasserführende, aber einschließlich periodisch wasserführender Oberflächengewässer - muss mit einem Gerät erfolgen, das in das Verzeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 25, S. 98) in der jeweils geltenden Fassung eingetragen ist. Dabei sind, in Abhängigkeit von den unten aufgeführten Abdriftminderungsklassen der verwendeten Geräte, die im Folgenden genannten Abstände zu Oberflächengewässern einzuhalten. Für die mit "*" gekennzeichneten Abdriftminderungsklassen ist, neben dem gemäß Länderrecht verbindlich vorgegebenen Mindestabstand zu Oberflächengewässern, das Verbot der Anwendung in oder unmittelbar an Gewässern in jedem Fall zu beachten. reduzierte Abstände: 5% 5 m, 5% 5 m, 9% * Begründung: Der im Pflanzenschutzmittel Signum enthaltene Wirkstoff Pryraclostrobin weist ein hohes Gefährdungspotenzial für aquatische Organismen auf. Bewertungsbestimmend ist die HC5 bezogen auf LC5: 5,9 µ a.i./l. Nach dem Stand der wissenschaftlichen Erkenntnisse ist die Einhaltung der in der Anwendungsbestimmung NW65-1 festgelegten Maßgaben erforderlich, um einen ausreichenden Schutz von Gewässerorganismen vor Einträgen des Wirkstoffs in Oberflächengewässer zu gewährleisten. Bei Nichteinhaltung der in Zusammenhang mit der Anwendungsbestimmung NW 65-1/66 definierten Maßgaben führen die Einträge des Mittels "Signum" in Oberflächengewässer und die hieraus resultierenden Konzentrationen auch bei sachgerechter und bestimmungsgemäßer Anwendung zu einer Unterschreitung des erforderlichen Toxizitäts-/Expositionsverhältnisses (hier: TER = 2). Die Einhaltung der Maßgaben ist zur Herstellung der Zulassungsvoraussetzungen durchsetzbar vorzuschreiben, da andernfalls schädliche Auswirkungen auf den Naturhaushalt nicht auszuschließen sind und somit der Schutz der Gewässer nicht gewährleistet ist. Siehe hierzu auch den Bescheid vom 1. Juni 29 zum Antrag /. BVL_FO_5_2468_2_V1.3 (NW66) Ein Verzicht auf den Einsatz verlustmindernder Technik ist nur möglich, wenn bei der Anwendung des Mittels mindestens unten genannter Abstand zu Oberflächengewässern - ausgenommen nur gelegentlich wasserführende, aber einschließlich periodisch wasserführender Oberflächengewässer - eingehalten wird. Zuwiderhandlungen können mit einem Bußgeld bis zu einer Höhe von 5. Euro geahndet werden. 5 m Begründung: Siehe Anwendungsbestimmung NW65-1

22 SEITE 8 VON 9 Anlage 2 nicht zugelassene Anwendung: /2-3 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Botrytis cinerea Pflanzen/-erzeugnisse/Objekte: Rucola-Arten Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: Anwendung im Haus- und Kleingartenbereich: Gemüsebau Gewächshaus Nein Stadium der Kultur: ab 14 Anwendungszeitpunkt: Bei Infektionsgefahr bzw. ab Warndiensthinweis Maximale Zahl der Behandlungen - in dieser Anwendung: 2 - für die Kultur bzw. je Jahr: 2 - Abstand: bis 1 Tage Anwendungstechnik: spritzen Aufwand: - 1,5 kg/ha in 5 bis 1 l Wasser/ha 3 Begründung Für die Bewertung der Anwendungen von Boscalid an Rucola und Baby-Salaten im Gewächshaus liegen nicht die erforderlichen 4 Rückstandsversuche entsprechend den beantragten GAPs vor. Die bisherige Datenbasis an Kopfsalat im Gewächshaus ist nach Inkrafttreten der Revision 9 des EU Guidance Documents zur Extrapolation nicht mehr für andere Salatarten verwendbar. Vorliegende Versuche an Feldsalat im Gewächshaus, welche theoretisch extrapolierbar wären, umfassen nur einmalige Anwendungen und sind somit unterdosiert. Passende Rückstandversuche an ähnlichen Kulturen liegen nicht vor. BVL_FO_5_2468_2_V1.3

23 SEITE 9 VON 9 Anlage 2 nicht zugelassene Anwendung: /2-4 1 Anwendungsgebiet Schadorganismus/Zweckbestimmung: Botrytis cinerea Pflanzen/-erzeugnisse/Objekte: Spinat und verwandte Arten, Stielmus, Kohlgemüse, Speiserüben (Stoppelrübe, Mairübe etc.), Radieschen, Rettich, Salat-Arten, Erbse, Kohlrübe Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: Anwendung im Haus- und Kleingartenbereich: Erläuterung zur Kultur: Gemüsebau Gewächshaus Nein Nutzung als baby leaf - Salate Stadium der Kultur: ab 14 Anwendungszeitpunkt: Bei Infektionsgefahr bzw. ab Warndiensthinweis Maximale Zahl der Behandlungen - in dieser Anwendung: 2 - für die Kultur bzw. je Jahr: 2 - Abstand: bis 1 Tage Anwendungstechnik: spritzen Aufwand: - 1,5 kg/ha in 5 bis 1 l Wasser/ha 3 Begründung Für die Bewertung der Anwendungen von Boscalid an Rucola und Baby-Salaten im Gewächshaus liegen nicht die erforderlichen 4 Rückstandsversuche entsprechend den beantragten GAPs vor. Die bisherige Datenbasis an Kopfsalat im Gewächshaus ist nach Inkrafttreten der Revision 9 des EU Guidance Documents zur Extrapolation nicht mehr für andere Salatarten verwendbar. Vorliegende Versuche an Feldsalat im Gewächshaus, welche theoretisch extrapolierbar wären, umfassen nur einmalige Anwendungen und sind somit unterdosiert. Passende Rückstandversuche an ähnlichen Kulturen liegen nicht vor. BVL_FO_5_2468_2_V1.3

24 Signum /2 Part B Section 4 - Core Assessment zrms Version REGISTRATION REPORT Part B Section 4: Metabolism and Residues Detailed summary of the risk assessment Product code: Signum Active Substances: 6 g/kg Pyraclostrobin, 26 g/kg Boscalid Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: BASF Date: 4/6/214 Page 1 / 51

25 Signum /2 Part B Section 4 - Core Assessment zrms Version Table of Contents 4 METABOLISM AND RESIDUES DATA Evaluation of the active substances Boscalid Storage stability Metabolism in plants and plant residue definition(s) Metabolism in livestock and animal residue definition(s) Residues in rotational crops Residues in livestock Pyraclostrobin Storage stability Metabolism in plants and plant residue definition(s) Metabolism in livestock and animal residue definition(s) Residues in rotational crops Residues in livestock Evaluation of the intended use(s) Selection of critical use and justification Tomato and aubergine Residues in primary crops Distribution of the residue in peel/pulp Residues in processed commodities Proposed pre-harvest intervals, withholding periods Rucola species and baby-leaf lettuce (indoor) Distribution of the residue in peel/pulp Residues in processed commodities Proposed pre-harvest intervals, withholding periods Baby-leaf lettuce (outdoor) Distribution of the residue in peel/pulp Residues in processed commodities Proposed pre-harvest intervals, withholding periods Consumer intake and risk assessment Boscalid Pyraclostrobin Proposed maximum residue levels (MRLs) Conclusion...22 Appendix 1 List of data submitted in support of the evaluation...22 Page 2 / 51

26 Signum /2 Part B Section 4 - Core Assessment zrms Version Appendix 2 Detailed evaluation of the additional studies relied upon...2 A 2.1 Storage stability...2 A 2.2 Residues in primary crops...2 A Nature of residues...2 A Magnitude of residues in tomato...28 A Magnitude of residues in spinach...4 A 2.3 Residues in processed commodities...5 A 2.4 Residues in rotational crops...5 A 2.5 Residues in livestock...5 A 2.6 Other studies/information...5 Appendix 3 Pesticide Residue Intake Model (PRIMo)...5 Page 3 / 51

27 Signum /2 Part B Section 4 - Core Assessment zrms Version 4 METABOLISM AND RESIDUES DATA 4.1 Evaluation of the active substances Boscalid Table IIIA 4.1-1: Identity of the active substance Structural formula Common Name Boscalid CAS number Storage stability The results of storage stability studies of boscalid residues in various matrices of plant and animal origin were evaluated and reported in the framework of the peer review (DAR, DE 22, ASB ). A short conclusion of the findings is provided in the following table. Table IIIA 4.1-2: Stability of residues (Annex IIA, point 6.1) Stability of boscalid Plant matrices (RIP22-192): The deep freeze stability of boscalid in dry commodities (wheat grain, wheat straw), matrices with high oil content (oilseed rape seed) and matrices with high water content (wheat plant, white cabbages, peaches, peas) was investigated over a period of two years at 2 C. Samples taken after 1, 3, 6, 12 and 24 months indicated that residue concentrations in the various plant matrices had not changed considerably. Animal matrices (RIP21-354): Residues in frozen (-18 C) animal matrices proved being stable over a period of at least 5 months Metabolism in plants and plant residue definition(s) Primary plant metabolism of boscalid was studied in representatives of various crop groups. The results were evaluated and reported in the framework of the peer review. A short conclusion of the findings is provided in the following table. For more details it is referred to section B..1 of the DAR (RMS DE ASB ). Plant metabolism of boscalid was also studied in rotational crops. The results were summarized in the table below. For more details it is referred to section B..9.1 of the DAR (DE, 22, ASB ). Page 4 / 51

28 Signum /2 Part B Section 4 - Core Assessment zrms Version Table IIIA 4.1-3: Metabolism in plants (Annex IIA, point 6.2.1; 6.5.1, 6.5.2, and 6..1) foliar application of [diphenyl-u- 14 C]-boscalid and [pyridine-3-14 C]-boscalid, respectively, on grapes (3 x.8 kg a.s./ha, RIP21-32), lettuce (3 x. kg a.s./ha, RIP21-328)and beans (3 x.5 kg a.s./ha, RIP21-329). Plant groups covered Rotational crops In grape berries 93 % of the TRR was unchanged parent boscalid; in stalks and leaves parent boscalid amounted to % of the TRR. When lettuce plants were treated with 14 C-boscalid, parent compound represented more than 9 % of the TRR in the samples taken 18 days after the last application. The residues in beans (edible part) were much lower compared to the rest of the plant. When separating green beans into pods and seeds, the major part of radioactivity was found in pods rather than in seeds. Boscalid was identified as the major compound of the TRR in bean leaves and forage (>98 %), in green beans and green pods (9 %), in bean straw ( 94 %), in dry pods (8 95 %) and in dry seeds (2 %). In green beans and seeds the metabolites M51F62 (chlorophenylamin obenzene) and M51F4 (chloronicotinic acid) were identified in small amounts. 2.1 kg as/ha of [pyridine-3-14 C]- and [diphenyl-u- 14 C], lettuce, radish (leaves, roots), wheat (forage, grain, straw) (RIP21-33, ASB29-453). 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) Studies indicate that generally higher residues are identified with pyridine labelled boscalid. Apart from the parent compound, which was the major component of the TRR in all crops except wheat grain, metabolite M51F61 (sugar conjugate of boscalid) was identified at levels exceeding the trigger value of 1 % in radish leaf (11 % 16 % 365 DAT and 21 % (diphenyl label) 2 DAT) and in wheat forage (18 % (diphenyl label) 2 DAT). The proposed metabolic pathway in succeeding crops involves hydroxylation and conjugation reactions. Part of residues was also incorporated and/or associated with natural products such as starch, cellulose and lignin. No metabolites of concern were identified in soil. yes Not applicable Boscalid was stable under standard processing conditions representing pasteurisation (ph 4, 9 C), baking, boiling, brewing (ph 5, 1 C) or sterilisation (ph 6, 12 C) (RIP21-355) Plant residue definition for monitoring boscalid (Reg. (EC) No 396/25) Plant residue definition for risk assessment yes boscalid Conversion factor(s) (monitoring to risk assessment) none Metabolism in livestock and animal residue definition(s) The metabolism of boscalid was studied in ruminants and poultry. The results were evaluated and Page 5 / 51

29 Signum /2 Part B Section 4 - Core Assessment zrms Version reported in the framework of the peer review. A short conclusion of the findings is provided in the following table. For more details it is referred to section B..2 of the DAR (DE 22, ASB ). Table IIIA 4.1-4: Metabolism in livestock (Annex IIA, point to and 6..1) Lactating goats; [diphenyl-u- 14 C]-labelled boscalid (RIP21-33, RIP21-331); Laying hens, [diphenyl-u- 14 C]-labelled boscalid (RIP21-332); Animals covered Time needed to reach a plateau concentration in milk and eggs Animal residue definition for monitoring Animal residue definition for risk assessment Conversion factor(s) (monitoring to risk assessment) none Metabolism in rat and ruminant similar (yes/no) The metabolic pathways in rats, goats and hens were qualitatively similar. In ruminants, the majority of the administered radioactivity was excreted via faeces (46 % and 64 %) and urine (23 % and 44 %). Milk and goat tissues contained.6 %.15 % and.46 %.66 % of the administered dose, respecttively. Boscalid and its hydroxylated metabolite M51F1, including the conjugate M51F2, formed the major residues in milk and all tissues. When laying hens were orally dosed with radiolabelled boscalid, most of the administered 14 C was excreted (98 %). Eggs and tissues contained.115 % and.46 % of the administered dose, respectively. In hens the residues in eggs, fat, and muscle mainly consisted of unchanged parent. Besides boscalid also the hydroxy metabolite M51F1 (including conjugates) was seen in eggs. Bound residues in goat and hen liver mainly resulted from a substitution of the chlorine at the pyridine ring by thiole groups of liver proteins, which were only released after solvolytic cleavage of the amide bond. Milk = 14 days Eggs = 6 days Sum of boscalid and M51F1 (including its conjugates), calculated as boscalid Sum of boscalid and M51F1 (including its conjugates), calculated as boscalid Additionally, metabolite M51F53 (expressed as boscalid) has to be considered for liver and milk. yes Fat soluble residue: (yes/no) Yes, due to findings in feeding study (despite of log P OW = 2.96 at ph ) Residues in rotational crops Field rotational crop studies were evaluated and reported in the framework of the peer review and the evaluation according to Article 12(2) of Reg. (EC) No 396/25 (EFSA Reasoned opinion not yet available). A short conclusion of the findings is provided in the following table. For more details it is referred to section B..2 of the DAR (DE 22, ASB ) and the information on the EFSA extranet. Page 6 / 51

30 Signum /2 Part B Section 4 - Core Assessment zrms Version Table IIIA 4.1-5: Residues in rotational crops (Annex IIA, point 6.6.3) Field studies Field studies demonstrate uptake of boscalid residues via roots into succeeding crops. Elevated concentrations were found particularly in vegetative parts of wheat plants. In order to take account of such inadvertant contamination and to comply with residue legislation, a general default MRL of.5 mg/kg has been proposed in Addendum 1 to the DAR (RMS DE, 26) for all rotational crop commodities, unless it could be shown that there was no need to do so. In the context of article 12 (2) of Regulation (EC) No 396/25 the RMS suggested a more adjusted approach for different crop groups. (RIP21-34, ASB29-458, RIP , ASB , RIP24-18, ASB , ASB , RIP , ASB ) Residues in livestock An actual calculation of the dietary burden (based on all relevant uses authorized in Germany) is provided in Table IIIA Table IIIA 4.1-6: Calculation of the dietary burden (based on all relevant uses authorized in Germany) Feedstuff % DM Percent of daily livestock diet (dry feed basis) Chicken 1.9 kg bw daily maximum feed (DM) 12 g Dairy cattle 55 kg bw daily maximum feed (DM) 2 kg Beef cattle 35 kg bw daily maximum feed (DM) 15 kg Pig 5 kg bw daily maximum feed (DM) 3 kg Residue (mg/kg) Intake (mg/kg, dry feed basis) Chicken Dairy cattle Beef cattle kale a apple pomace cereals (grain) cereals (straw) b c d carrots e rape seed f.3 Intake (mg/kg dry weight feed) Intake (mg/kg bw/d) Intake (mg/animal/d) a HR, based on the following cgap: 3 x.26 kg as/ha, PHI: 14 d b STMR-P, based on the following cgap: 4 x.6 kg as/ha, PHI: d, PF for wet pomace = 6. c STMR, based on the following cgap: 2 x.35 kg as/ha, PHI: XF (.45 mg/kg) + STMR from field studies on rotational crops (.5 mg/kg) d HR, based on the following cgap: 2 x.35 kg as/ha, PHI: XF (16 mg/kg) + HR from field studies on rotational crops (2. mg/kg) e HR, based on the following cgap: 2 x.2 kg as/ha, PHI: 14 d Pig Page / 51

31 Signum /2 Part B Section 4 - Core Assessment zrms Version Table IIIA 4.1-: Conditions of requirement of livestock feeding studies Expected intakes by livestock.1 mg/kg diet (dry weight basis) (yes/no If yes, specify the level) Ruminant: Poultry: Pig: Yes 12.5 (dairy cow); 18. (beef) Potential for accumulation (yes/no): No No No Metabolism studies indicate potential level of residues.1 mg/kg in edible tissues (yes/no) Yes 1.9 Yes 4.5 Yes Yes n.a. A brief summary of the available livestock feeding studies on dairy cows and laying hens is given in the following table. Data were evaluated in the DAR (DE 22, ASB ). Table IIIA 4.1-8: Results of livestock feeding studies (Annex IIA, point 6.4) Feeding levels (mg/kg feed dry matter) in feeding studies Ruminant: Poultry: Pig: dairy cows: 1.8, 5.9, 2 ASB laying hens 1., 5.3, 2 RIP26-46 Relevant dosing levels in feeding study: extrapolation from ruminant study Expected residue levels in animal matrices (mg/kg): Muscle <. (MRL) <.5* (MRL) <. (MRL) Liver <.2 (MRL) <.1* (MRL) <.2 (MRL) Kidney <.3 (MRL) <.5 (MRL) <.3 (MRL) Fat <. (MRL) <.1* (MRL) <. (MRL) Milk <.1 (MRL) Eggs -- <.5* (MRL) Pyraclostrobin Table IIIA 4.1-9: Identity of the active substance Structural formula Common Name Pyraclostrobin CAS number Storage stability A brief summary of the storage stability data on pyraclostrobin is given in the following table. Data has been previously evaluated at EU level and is described in detail in the DAR (DE, 21, ASB21-156) and in EFSA s Reasoned Opinion on the review of the existing maximum residue levels for pyraclostrobin according to Article 12 of Regulation (EC) No 396/25 (EFSA, ASB ). Page 8 / 51

32 Signum /2 Part B Section 4 - Core Assessment zrms Version Table IIIA 4.1-1: Stability of residues (Annex IIA, point 6.1) Stability of pyraclostrobin, BF 5-3 and BF 5-1 (animal matrices only) Storage stability of pyraclostrobin and its metabolite BF 5-3 was investigated in peanut matrices (oil, nutmeat), wheat matrices (grain, straw), sugar beet tops and roots, tomatoes and grape juice (interim reports RIP2-243 and RIP2-14, final report ASB28-498). Residues of pyraclostrobin and BF 5-3 were stable over a period of 19 (peanut nutmeat and oil) or 25 months (other commodities). Pyraclostrobin residues were stable in bovine liver, muscle and milk for at least 24 days when stored at <-18 C (interim report RIP2-1; final report RIP2-242). Losses of the metabolite B5-1 (2- hydroxyphenyl metabolite), which was used as a model for hydroxylated metabolites, were 29% (liver), 12% (muscle) and 36% (milk) after that period Metabolism in plants and plant residue definition(s) A brief summary of the metabolism of pyraclostrobin in plants is given in the following table. Data has been previously evaluated at EU level and is described in detail in the DAR (ASB21-156) and in EFSA s Reasoned Opinion on the review of the existing maximum residue levels for pyraclostrobin according to Article 12 of Regulation (EC) No 396/25 (EFSA, ASB ). Table IIIA : Metabolism in plants (Annex IIA, point 6.2.1; 6.5.1, 6.5.2, and 6..1) Grapes (fruit, RIP2-15, RIP2-125), wheat (cereals, RIP2-19) and potatoes (root and tuber vegetables, RIP2-151, RIP2-141), all as foliar application with [tolyl-u- 14 C]-and [chlorophenyl-u- 14 C]- pyraclostrobin Plant groups covered The relevant residue in grapes consisted of parent pyraclostrobin (56 66% TRR) and its desmethoxy metabolite BF 5-3 (11 15 % TRR). Pyraclostrobin was also the main component in forage and potato tubers in the chlorophenyl study, amounting to 55 % and 29 % of the TRR, respectively. In forage, metabolite BF 5-3 was identified at a level of 2 % TRR in both studies. In the tolyl study the major component of the residue in potato tubers was the natural amino acid L-tryptophan (29% TRR). In cereal grain, residues ranged from.98 mg/kg (chlorophenyl label) to.441 mg/kg (tolyl label). The cereal matrix with highest residues was wheat straw, amounting to 4 mg/kg in both studies. The major component of residues in straw and grain in the chlorophenyl study was parent pyraclostrobin and its metabolite BF 5-3. In the tolyl study the major component in grain was L-tryptophan (23 % TRR). All other metabolites were clearly below 1 % TRR. Page 9 / 51

33 Signum /2 Part B Section 4 - Core Assessment zrms Version Rotational crops Treatment of bare soil with [tolyl-u- 14 C] and [chlorophenyl-u- 14 C] pyraclostrobin at an application rate of.9 kg as/ha, planting of rotational crops lettuce (leafy vegetables), wheat (cereals) and radish (root and tuber vegetables) after PBIs of 3, 12 and 365 days (RIP2-185) TRR in edible parts of succeeding crops were very low for all PBIs: radish roots, lettuce.4 mg/kg and wheat grain.89 mg/kg. After a PBI of 3 days, TRR was highest in wheat straw:.11 mg/kg (both labels). In all crop samples the residue levels decreased with longer PBI except for lettuce where residue levels remained the same throughout various plant back intervals. No accumulation of parent compound or its metabolites was observed. No metabolites were found in significant amounts in addition to those already found in primary crop metabolism studies. Metabolism in rotational crops similar to metabolism in primary crops? (yes/no) yes 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 Plant residue definition for risk assessment No information Pyraclostrobin is stable under standard conditions representing pasteurisation, baking, brewing, boiling and sterilisation (RIP2-18). yes Conversion factor(s) (monitoring to risk assessment) none Pyraclostrobin This is in line with Reg. (EC) No. 396/25. Pyraclostrobin Metabolism in livestock and animal residue definition(s) A brief summary of the metabolism of pyraclostrobin in livestock is given in the following table. Data has been previously evaluated at EU level and is described in detail in the DAR (ASB21-156) and in EFSA s Reasoned Opinion on the review of the existing maximum residue levels for pyraclostrobin according to Article 12 of Regulation (EC) No 396/25 (EFSA, ASB ). Table IIIA : Metabolism in livestock (Annex IIA, point to and 6..1) Lactating goats (RIP2-118, RIP2-12): tolyl and chlorophenyl label, 12 and 5 mg/kg feed DM, 5 days Animals covered Pyraclostrobin was extensively metabolised, with the majority of the administered radioactivity being excreted via the faeces..1.5 % of the applied dose was recovered in milk. No accumulation of pyraclostrobin was seen in tissues. Pyraclostrobin was present in all tissues and in milk and was the main residue component in muscle and in fat. Metabolites are formed (mainly in liver and kidney) by oxidation of the aromatic rings to several hydroxylated compounds and by cleavage of the molecule which led to further metabolites. As these transformations occurred in matrices with small amounts of parent or little extractability, it was suggested to apply a total residue method to obtain residue data representting reasonable worst case estimates for risk assessment. Page 1 / 51

34 Signum /2 Part B Section 4 - Core Assessment zrms Version Time needed to reach a plateau concentration in milk and eggs Animal residue definition for monitoring Animal residue definition for risk assessment Laying hens (RIP2-121, RIP2-122): tolyl and chlorophenyl label, 12 and 13 mg/kg feed DM, days Only.5 and.19 % of the applied dose were recovered in eggs and poultry tissues. Residues were low in all matrices. The parent compound was found in fat and eggs but not in liver. BF 5-3 was also present in fat and eggs (main residue; 3 4 % of the extractable residue in fat). The main metabolite in liver was the glucuronic acid conjugate which was bound to the tolyl ring of the demethoxylated parent structure. Milk: days Eggs: not concluded Pyraclostrobin This is in line with Reg. (EC) No. 396/25. Conversion factor(s) (monitoring to risk assessment) Ruminant liver: 4 Other commodities: 1 Metabolism in rat and ruminant similar (yes/no) Fat soluble residue: (yes/no) Yes (log P O/W = 3.9) Sum of pyraclostrobin and its metabolites containing the 1-(4-chlorophenyl)-1H-pyrazole moiety or the 1-(4- chloro-2-hydroxyphenyl)-1h-pyrazole moiety, expressed as pyraclostrobin (see EFSA Journal 211;9(8):2344, ASB ). yes Residues in rotational crops No respective studies are available. This is commented on in the following table. Table IIIA : Residues in rotational crops (Annex IIA, point 6.6.3) Field studies No data available. From the outcome of a confined study, no significant residues of parent compound or its metabolites are expected to occur in rotational crops Residues in livestock An actual calculation of the dietary burden (based on all relevant uses authorized in Germany) is provided in Table IIIA Table IIIA : Calculation of the dietary burden (based on all relevant uses authorized in the Germany Feedstuff % DM Percent of daily livestock diet (dry feed basis) Chicken 1.9 kg bw daily maximum feed (DM) 12 g Dairy cattle 55 kg bw daily maximum feed (DM) 2 kg Beef cattle 35 kg bw daily maximum feed (DM) 15 kg Pig 5 kg bw daily maximum feed (DM) 3 kg Residue (mg/kg) Intake (mg/kg, dry feed basis) Chicken Dairy cattle Beef cattle Kale a Sugar Beet leaves + tops b Silage (maize) c Pig Page 11 / 51

35 Signum /2 Part B Section 4 - Core Assessment zrms Version 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) 12 g Dairy cattle 55 kg bw daily maximum feed (DM) 2 kg Beef cattle 35 kg bw daily maximum feed (DM) 15 kg Pig 5 kg bw daily maximum feed (DM) 3 kg Residue (mg/kg) Chicken Dairy cattle Beef cattle Pig Fruit Pomace d Grains except Maize Straw (Cereals) e f Carrots g a HR, based on the following cgap: 3x.6 kg as/ha, BBCH>41, PHI: 14 b HR, based on the following cgap: 2x.13 kg as/ha, PHI: 28 d c HR, based on the following cgap: 1x.2 kg as/ha, PHI: 28 d, without PF d STMR, based on the following cgap: 4x.34 kg as/ha, PHI: d, PF 8.5 e STMR, based on the following cgap: 2x.23 kg as/ha, BBCH 25-61, PHI: 35 d f HR, based on the following cgap: 2x.23 kg as/ha, BBCH 25-61, PHI: 35 d g HR, based on the following cgap: 2x.5 kg as/ha, PHI: 14 d Intake (mg/kg dry weight feed) Intake (mg/kg bw/d) Intake (mg/animal/d) Table IIIA : Conditions of requirement of livestock feeding studies on pyraclostrobin Ruminant: Poultry: Pig: Expected intakes by livestock.1 mg/kg diet (dry weight basis) (yes/no If yes, specify the level) yes 3.3 (dairy) 5.3 (beef) yes.39 yes 1. Potential for accumulation (yes/no): yes no yes Metabolism studies indicate potential level of residues.1 mg/kg in edible tissues (yes/no) yes no see ruminant A brief summary of the available livestock feeding study is given in the following table. Data has been previously evaluated at EU level and is described in detail in the DAR (ASB21-156) and in EFSA s Reasoned Opinion on the review of the existing maximum residue levels for pyraclostrobin according to Article 12 of Regulation (EC) No 396/25 (EFSA, ASB ). Table IIIA : Results of livestock feeding studies (Annex IIA, point 6.4) Ruminant: Poultry: Pig: Feeding levels (mg/kg feed dry matter) in feeding studies Dairy cattle:, 21, (RIP2-15, RIP2-16) No data; metabolism studies indicate residues <.1 mg/kg in edible tissues see ruminant Relevant dosing levels in feeding study: -- (ruminant) Page 12 / 51

36 Signum /2 Part B Section 4 - Core Assessment zrms Version Expected residue levels in animal matrices (mg/kg), parent only/total residue: Muscle <.5/<.1 <.1 <.5/<.1 Liver <.5/.2 <.1 <.5/.2 Kidney <.5/<.1 <.1 <.5/<.1 Fat <.5/<.1 <.1 <.5/<.1 Milk <.1/ Eggs < Evaluation of the intended use(s) Selection of critical use and justification The GAP reported for the zone/eu (which at the same time is the critical GAP), is presented in Table It has been used for consumer intake and risk assessment. Page 13 / 51

37 Signum /2 Part B Section 4 - Core Assessment zrms Version Table 4.2-1: 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 kg product / ha a) max. rate per appl. b) max. total rate per crop/season kg 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 tomato G leaf mould, Fulvia fulva spraying BBCH a) 2 b) 2 ( to 1 days) a) see below b) a) see below b) 6 / DE aubergine G Sclerotinia species spraying BBCH a) 2 b) 2 ( to 1 days) a) see below b) a) see below b) 6 / DE rocket species G Grey mould, Botrytis cinerea spraying from BBCH 14 a) 2 b) 2 ( to 1 days) a) 1.5 b) 3. a) pyraclostrobin.4 boscalid b).2 pyraclostrobin.8 boscalid 5 / DE spinach and related species, turnip tops, brassica vegetables, turnip (stubble turnip, early turnip etc.), radish, small, radish, lettuce species, pea, swedes G Grey mould, Botrytis cinerea spraying from BBCH 14 a) 2 b) 2 ( to 1 days) a) 1.5 b) 3. a) pyraclostrobin.4 boscalid b).2 pyraclostrobin.8 boscalid 5 / 1 14 utilisation as baby leaf lettuce 5 DE spinach and related species, turnip tops, brassica vegetables, turnip (stubble turnip, early turnip etc.), radish, small, radish, lettuce species, pea, swedes F Grey mould, Botrytis cinerea spraying from BBCH 14 a) 2 b) 2 ( to 1 days) a) 1.5 b) 3. a) pyraclostrobin.4 boscalid b).2 pyraclostrobin.8 boscalid 5 / 1 14 utilisation as baby leaf lettuce Page 14 / 51

38 Signum /2 Part B Section 4 - Core Assessment zrms Version 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, 199, 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 uses no 1 and 2 kg product / ha a) max. rate per appl. plant height up to 5 cm.5 kg product / ha in 6 L water/ha plant height 5 up to 125 cm kg product / ha in 9 L water/ha plant height more than 125 cm 1.5 kg product / ha in 12 L water/ha b) max. total rate per crop/season plant height up to 5 cm 1.5 kg product / ha in 6 L water/ha plant height 5 up to 125 cm 2.25 kg product / ha in 9 L water/ha plant height more than 125 cm 3. kg product / ha in 12 L water/ha kg as/ha a) max. rate per appl. plant height up to 5 cm.5 kg as/ha pyraclostrobin,.2 kg as/ha boscalid plant height 5 up to 125 cm.5 kg as/ha pyraclostrobin,.3 kg as/ha boscalid plant height more than 125 cm.1 kg as/ha pyraclostrobin,.4 kg as/ha boscalid b) max. total rate per crop/season plant height up to 5 cm.1 kg as/ha pyraclostrobin,.4 kg as/ha boscalid plant height 5 up to 125 cm.15 kg as/ha pyraclostrobin,.6 kg as/ha boscalid plant height more than 125 cm.2 kg as/ha pyraclostrobin,.8 kg as/ha boscalid Page 15 / 51

39 Signum /2 Part B Section 4 - Core Assessment zrms Version Tomato and aubergine Residues in primary crops The following tables give a brief overview of the supervised residue trials selected for the assessment of boscalid and pyraclostrobin in tomatoes and aubergines. According to the current Guidance for extrapolation used in the EU, data on tomatoes following application close to harvest can be extrapolated to aubergines. For the detailed evaluation of new/additional residue trials, it is referred to Appendix 2. Table 4.2-2: Overview of the selected supervised residue trials for boscalid in tomatoes Commodity Region (a) Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (boscalid) Tomato - Indoor <.5,.1,.2,.25,.2,.2,.32,.35,.38,.41,.4,.6,.1 Risk assessment (boscalid) <.5,.1,.2,.25,.2,.2,.32,.35,.38,.41,.4,.6,.1 STMR (mg/kg) (b) HR (mg/kg) (c) Median CF (d).32.1 not applicable (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. Table 4.2-3: Overview of the selected supervised residue trials for pyraclostrobin in tomatoes Commodity Region (a) Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (pyraclostrobin) Tomato - Indoor,.2,.3,.4(4),.5,.5,.6(5),.(4),.8,.88,.9,.9,.11,.11,.12,.12,.14,.15,.26 Risk assessment (pyraclostrobin),.2,.3,.4(4),.5,.5,.6(5),.(4),.8,.88,.9,.9,.11,.11,.12,.12,.14,.15,.26 STMR (mg/kg) (b) HR (mg/kg) (c) Median CF (d)..26 not applicable (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 tomatoes and aubergines are available and acceptable for enforcing all compounds given in the residue definition Distribution of the residue in peel/pulp Not relevant Residues in processed commodities Not relevant Proposed pre-harvest intervals, withholding periods See GAP table. A PHI of 3 days was proposed for the intended uses Rucola species and baby-leaf lettuce (indoor) For the indoor use of boscalid in rucola and baby-leaf lettuce, two crops qualifying for extrapolation are Page 16 / 51

40 Signum /2 Part B Section 4 - Core Assessment zrms Version covered by supervised field trials. The first set of data involves treatment of head lettuce according to the GAP intended for rucola and baby-leaf lettuce. However, based on the latest revision of the EU Guidance for Extrapolation (rev.9), the extrapolation would only be possible from open-head varieties, so the data cannot be used for the current assessment. The second set of data was conducted on lamb s lettuce, but with only one application at.4 kg as/ha instead of two (as intended). In view of the very slow degradation of boscalid in plants and the significant uptake of the active substance from soil, it is likely that one additional application results in much higher residues. For evaluation of the intended use, these trials on lamb s lettuce are underdosed and cannot be taken into account. No data suitable for extrapolation according to the current EU Guidance for Extrapolation (rev.9) are available to assess the residue situation after treatment according to the intended GAP in glasshouse for boscalid in rucola and baby-leaf lettuce. For pyraclostrobin the intended uses on rucola species and baby-leaf lettuce correspond to the critical GAPs evaluated in EFSA s Reasoned Opinion for the Review of existing MRLs according to Art. 12 of Reg. (EC) 396/25 (EFSA, ASB ). In the following table the residue data for the indoor use are reported for pyraclostrobin. Table 4.2-4: Overview of the selected supervised residue trials for pyraclostrobin in rucola Commodity Region (a) Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (pyraclostrobin) Rucola. - Indoor.5,.88,.89, 2.5, 2.5, 4.1, 4.3, 5.1,.2 Risk assessment (pyraclostrobin).5,.88,.89, 2.5, 2.5, 4.1, 4.3, 5.1,.2 STMR (mg/kg) (b) HR (mg/kg) (c) Median CF (d) not applicable (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 rucola and baby-leaf lettuce are available and acceptable for enforcing all compounds given in the residue definition Distribution of the residue in peel/pulp Not relevant Residues in processed commodities Not relevant Proposed pre-harvest intervals, withholding periods See GAP table. A PHI of 14 days was proposed for the intended uses Baby-leaf lettuce (outdoor) The following tables give a brief overview of the supervised residue trials selected for the assessment of boscalid and pyraclostrobin in baby-leaf lettuce. For baby-leaf lettuce, supervised field trials on spinach are taken into account with treatment according to the intended use. Although this extrapolation is currently not foreseen in the EU Guidance for Extrapolation, the early point of application in combination with the intended PHI suggests a comparable residue situation as in baby-leaf lettuce. For the detailed evaluation of new/additional residue trials, it is referred to Appendix 2. Page 1 / 51

41 Signum /2 Part B Section 4 - Core Assessment zrms Version Table 4.2-5: Overview of the selected supervised residue trials for boscalid in spinach Commodity Region (a) Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (boscalid) Spinach NEU outdoor.15,.1,.28,.63, 2.8 Risk assessment (boscalid).15,.1,.28,.63, 2.8 STMR (mg/kg) (b) HR (mg/kg) (c) Median CF (d) not applicable (a): NEU, SEU, EU or Import (country code). (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. For pyraclostrobin the intended uses on baby-leaf lettuce in the field correspond to the critical GAP for spinach evaluated in EFSA s Reasoned Opinion for the Review of existing MRLs according to Art. 12 of Reg. (EC) 396/25 (EFSA, ASB ). In the following table the residue data for the outdoor use are reported for pyraclostrobin. Table 4.2-6: Overview of the selected supervised residue trials for pyraclostrobin in spinach Commodity Region (a) Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (pyraclostrobin) Spinach NEU outdoor.2,.4,.5,.13,.31 Risk assessment (pyraclostrobin).2,.4,.5,.13,.31 STMR (mg/kg) (b) HR (mg/kg) (c) Median CF (d).5.31 not applicable (a): NEU, SEU, EU or Import (country code). (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 lettuce are available and acceptable for enforcing all compounds given in the residue definition Distribution of the residue in peel/pulp Not relevant Residues in processed commodities Not relevant Proposed pre-harvest intervals, withholding periods See GAP table. A PHI of 14 days was proposed for the intended uses. 4.3 Consumer intake and risk assessment Boscalid The consumer intake and risk assessment is based on the appropriate input values given in Table and the toxicological reference values stated in Table For the detailed calculation results it is referred to Appendix 3. Page 18 / 51

42 Signum /2 Part B Section 4 - Core Assessment zrms Version Table 4.3-1: Residue input values for the consumer risk assessment Commodity Chronic risk assessment Input value (mg/kg) Comment Pome fruit.42 STMR (EFSA, ASB ) Pistachios.2 STMR (EFSA, ASB ) other tree nuts.5 STMR (EFSA, ASB ) Cherries 1.51 STMR (EFSA, ASB ) other stone fruits 1.21 STMR (EFSA, ASB ) Canefruit 2.53 STMR (EFSA, ASB ) Strawberries.56 STMR (EFSA, ASB ) other small fruits and berries 2.6 STMR (EFSA, ASB ) Banana.5 STMR (EFSA, ASB ) Root and tuber vegetables.35 STMR (EFSA, ASB ) Bulb onions 2.2 STMR (EFSA, ASB ) Acute risk assessment Input value (mg/kg) Comment - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated Tomato, aubergine.32 STMR - no ARfD allocated other solanacea.565 STMR (EFSA, ASB ) Gherkin and courgette.4 STMR (EFSA, ASB ) other cucurbits.565 STMR (EFSA, ASB ) Flowering brassica 1.52 STMR (EFSA, ASB ) Leafy brassica 2.95 STMR (EFSA, ASB ) Kohlrabi 1.52 STMR (EFSA, ASB ) Lambs lettuce 14 STMR (EFSA, ASB ) other lettuce and salad plants, spinach, vine leaves, watercress (incl. baby-leaf lettuce) 2.95 STMR leafy brassica (JMPR Report boscalid 21) - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated Fresh herbs 1 STMR (EFSA, - no ARfD allocated Page 19 / 51

43 Signum /2 Part B Section 4 - Core Assessment zrms Version ASB ) Legume vegetables.5 STMR (EFSA, ASB ) Celery 8.45 STMR (EFSA, ASB ) Leek 2.2 STMR (EFSA, ASB ) Dry beans.55 STMR (EFSA, ASB ) Dry peas.21 STMR (EFSA, ASB ) Oilseeds.145 STMR (EFSA, ASB ) Barley, oats.92 STMR (EFSA, ASB ) Wheat, rye.5 STMR (EFSA, ASB ) Sugar beet, chicory roots.35 Swine and ruminant meat STMR (EFSA, ASB ).4 STMR (EFSA, ASB ) Swine and ruminant fat.18 STMR (EFSA, ASB ) Swine and ruminant liver.12 Swine and ruminant kidney Swine and ruminant edible offal, other than liver and kidney STMR (EFSA, ASB ).16 STMR (EFSA, ASB ).12 STMR (EFSA, ASB ) Milks.66 STMR (EFSA, ASB ) - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated - no ARfD allocated all other commodities various MRL - no ARfD allocated Table 4.3-2: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8) ADI TMDI (% ADI) according to EFSA PRIMo NTMDI (% ADI) according to NVS II model.4 mg/kg bw 24 % (based on NL Children) 246 % (based on DE children aged 2-4 years) IEDI (EFSA PRIMo) (% ADI) 58 % (based on WHO Cluster diet B) NEDI (NVS II model) (% ADI) Factors included in IEDI and NEDI ARfD IESTI (EFSA PRIMo) (% ARfD) - NESTI (NVS II model) (% ARfD) - 56 % (based on DE children aged 2-4 years) none not necessary not allocated Page 2 / 51

44 Signum /2 Part B Section 4 - Core Assessment zrms Version Factors included in IESTI and NESTI none Pyraclostrobin The consumer intake and risk assessment is based on the appropriate input values given in Table and the toxicological reference values stated in Table For the detailed calculation results it is referred to Appendix 3. Table 4.3-3: Commodity Residue input values for the consumer risk assessment Chronic risk assessment Acute risk assessment Input value (mg/kg) Comment Input value (mg/kg) Tomato, aubergine.3 MRL.26 HR Lettuce group, spinach various MRL, other uses for pyraclostrobin result in higher residues, thus MRL is taken into account as Tier 1 assessment. Comment.31 HR for baby-leaf lettuce other commodities various MRL - not relevant Table 4.3-4: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8) ADI TMDI (% ADI) according to EFSA PRIMo NTMDI (% ADI) according to NVS II model IEDI (EFSA PRIMo) (% ADI) NEDI (NVS II model) (% ADI) Factors included in IEDI and NEDI ARfD IESTI (EFSA PRIMo) (% ARfD).3 mg/kg bw 6 % (based on DE children aged 2-4 y, mean body weight basis) 66 % (based on DE children aged 2-4 y, individual consumption/body weight ratio) not necessary not necessary none.3 mg/kg bw Tomato: 5.4 % (based on BE children) Aubergine: 21. % (based on UK 4-6 y.) Scarole (most critical salad commodity selected for babyleaf lettuce): 9.3% (based on NL children) NESTI (NVS II model) (% ARfD) Tomato: 42 % (based on children aged 2-4 y) Aubergines: 21. % (based on children aged 2-4 y) Lettuce (most critical salad commodity selected for babyleaf lettuce): 15% (based on children aged 2-4 y) Factors included in IESTI and NESTI none 4.4 Proposed maximum residue levels (MRLs) No new MRLs are required. For rotational crops the expected residues of boscalid and pyraclostrobin following uptake from soil are covered by the MRLs currently established. Page 21 / 51

45 Signum /2 Part B Section 4 - Core Assessment zrms Version 4.5 Conclusion The data available to support the indoor applications of boscalid and pyraclostrobin to tomatoes and aubergines and the field application to baby-leaf lettuce are considered sufficient for risk assessment. An exceedance of the current MRLs for boscalid (3 mg/kg for tomatoes and aubergines, 3 mg/kg for leaves and sprouts of Brassica (Mizuna, leaves of peas and radish and other babyleaf brassica crops (crops harvested up to 8 true leaf stage)) and for pyraclostrobin (.3 mg/kg for tomatoes and aubergines, 2 mg/kg for leaves and sprouts of Brassica (Mizuna, leaves of peas and radish and other babyleaf brassica crops (crops harvested up to 8 true leaf stage)) as laid down in Reg. (EU) 396/25 is not expected. The established MRLs also cover the potential uptake of residues from soil into rotational crops for both active substances. For the treatment of rucola and baby-leaf lettuce in glasshouse the data provided for boscalid is insufficient for assessment. The data available for head lettuce is no longer suitable for extrapolation since the Revision 9 of the EU Guidance for Extrapolation came into force. Additional data on lamb s lettuce were from studies with only one application, which probably results in an underestimation of the true residues after two treatments. For pyraclostrobin sufficient data for an assessment of the intended uses was submitted. The chronic and the short-term intake of boscalid and pyraclostrobin residues is unlikely to present a public health concern. As far as consumer health protection is concerned, DE agrees with the authorization of the intended uses on tomatoes and aubergines in glasshouse and with the authorization of the intended use on baby-leaf lettuce in the field. DE does not agree with the authorization of the intended uses on rucola and baby-leaf lettuce in glasshouse. Appendix 1 List of data submitted in support of the evaluation Table A 1: Annex point/ reference No OECD: KIIA 6.1 List of data submitted in support of the evaluation Author(s) Year Title Source (where different from company) Report-No. GLP or GEP status (where relevant), Published or not Authority registration No DE Boscalid (Monograph) ASB DE Pyraclostrobin (Monograph) ASB EFSA 211 Reasoned opinion - Review of the existing maximum residue levels (MRLs) for Pyraclostrobin according to Article 12 of Regulation (EC) No 396/25 EFSA Journal 211;9(8):2344! EFSA- Q ASB Abdel-Baky, S. 2 Storage stability of BAS 5 F and BF 5-3 in various plant matrices including processed commodities for up to 19 months of frozen storage 2/5248! RIP2-243 Data protection claimed Owner N COM Y N COM Y N EFSA Y How considered in drr Study-Status / Usage * Page 22 / 51

46 Signum /2 Part B Section 4 - Core Assessment zrms Version Annex point/ reference No OECD: KIIA 6.1 OECD: KIIA 6.1 OECD: KIIA 6.1 Author(s) Year Title Source (where different from company) Report-No. GLP or GEP status (where relevant), Published or not Authority registration No Abdel-Baky, S. Abdel-Baky, S.; Riley M. E. Funk, H.; Mackenroth, C. 21 Freezer storage stability of BAS 5 F and BF 5-3 in plant matrices including processed commodities 21/5232! ASB Freezer storage stability of BAS 5 F and BF 5-3 in various plant matrices including processed commodities 1999/564! RIP Investigation of the stability of residues of BAS 51 F in plant matrices under storage conditions 21/11528! RIP OECD: KIIA 6.1 Grosshans, F. 21 Investigation of the stability of residues of BAS 51 F and M51F1 in sample materials of animal origin under usual storage conditions 2/11229! 4243 RIP OECD: KIIA 6.1 Tilting, N. 2 Investigation of the stability of residues of BAS 5 F (Reg. No ) in sample materials of animal origin under usual storage conditions 2/11116! RIP2-242 OECD: KIIA 6.1 Tilting, N.; Knoell, H.-E. 2 Investigation of the stability of residues of BAS 5 F (Reg. No ) in sample materials of animal origin under usual storage conditions 2/12! RIP2-1 OECD: KIIA 6.11 Anon. 212 Boscalid + Pyraclostrobin / Signum: Zusammenfassung der Rückstandsdaten aus überwachten Feldversuchen - Tomate im Gewächshaus, 23 und 25 ASB OECD: KIIA 6.11 Anon. 212 Boscalid + Pyraclostrobin / Signum: Zusammenfassung der Rückstandsdaten aus überwachten Feldversuchen - Tomate im Gewächshaus, 23 und 25 ASB OECD: KIIA OECD: KIIA Bross, M.; Mackenroth, C. Bross, M.; Mackenroth, C The metabolism of 14C-BAS 5 F (14C-Reg.No.34428) in potato 1999/11419! 3551 RIP The metabolism of 14C-BAS 5 F (14C-Reg.No ) in potato - Report amendment no. 1 2/148! 3551 RIP2-141 OECD: KIIA Hamm, R. T Metabolism of BAS 5 F in grapes BASF 98/1988! 355 RIP2-15 OECD: KIIA Hamm, R. T Metabolism of BAS 51 F in lettuce 1999/1124! 4435 RIP OECD: KIIA Hamm, R. T. 2 Metabolism of BAS 5 F in grapes - Report amendment no. 1 BASF 2/121! 355 RIP2-125 Data protection claimed Owner How considered in drr Study-Status / Usage * Page 23 / 51

47 Signum /2 Part B Section 4 - Core Assessment zrms Version Annex point/ reference No OECD: KIIA Author(s) Year Title Source (where different from company) Report-No. GLP or GEP status (where relevant), Published or not Authority registration No Rabe, U.; Schlüter, H. 21 Metabolism of BAS 51 F in grapevine 2/11486! 4183 RIP21-32 OECD: KIIA Reinhard, K Metabolism of 14C-BAS 5 F in wheat 1999/1113! 3823 RIP2-19 OECD: KIIA Veit, P. 21 Metabolism of 14C-BAS 51 F in beans 2/114861! 4256 RIP OECD: KIIA OECD: KIIA OECD: KIIA OECD: KIIA OECD: KIIA OECD: KIIA OECD: KIIA Hafemann, C.; Knoell, H.-E. Leibold, E.; Hoffmann, H. D.; Hildebrand, B. Nietschmann, D. A.; Lam, W. W. Bross, M.; Tilting, T. Fabian, E.; Grosshans, F. Leibold, E.; Hoffmann, H. D. Leibold, E.; Hoffmann, H. D.; Hildebrand, B Metabolism of (14C) BAS 5 F in laying hens BASF 99/1148! RIP C-BAS 5 F - Study of the absorption, distribution and excretion after repeated oral administration to laying hens BASF 98/163! 1b14 RIP Nature of residues of 14C-BAS 51 F in laying hens 2/5154! 9884 RIP Investigation of the metabolism of 14C- BAS 5 F in the goat 2/14! RIP The metabolism of 14C-BAS 51F in lactating Goat 2/11221! RIP C-BAS 51 F - Absorption, distribution and excretion after repeated oral administration in lactating goats 2/112353! 2B426/9639! 1b158 RIP C-BAS 5 F - Absorbtion, distribution and excretion after repeated oral adminstration in lactating goats BASF 98/1636! 1b94 RIP2-118 OECD: KIIA 6.3 Balluff, M. 2 Field residue study for the determination of residues of the active ingredients after the maximum number of applications in spring (2 locations) and fall (2 locations) with BAS 516 GA F in tomato cultivated under greenhouse conditions in Spain, /196! 9913/S1-FGTO RIP OECD: KIIA 6.3 Funk, H.; Mackenroth C. 2 Determination of the residues of BAS 51 F in wheat obtained from the trial year 2 2/114853! 55 RIP21-34 OECD: KIIA 6.3 Leonard, R. C. 26 Study on the residue behavior of BAS 5 F and BAS 51 F (BAS 516 F) in tomatoes after treatment with BAS 516 F under greenhouse conditions in the Netherlands and Spain 25 25/4269 ASB Data protection claimed Owner Y BAS N How considered in drr Study-Status / Usage * Page 24 / 51

48 Signum /2 Part B Section 4 - Core Assessment zrms Version Annex point/ reference No Author(s) Year Title Source (where different from company) Report-No. GLP or GEP status (where relevant), Published or not Authority registration No OECD: KIIA 6.3 Perny, A. 26 Study on the residue behaviour of dimethomorph and pyraclostrobin in tomato after treatment with BAS F under field conditions in Italy, Spain, Greece and Southern France, 25 26/13825! 234 ASB OECD: KIIA 6.3 Schroth, E. 25 Study on the residue behaviour of pyraclostrobin and dimethomorph (BAS 536 F) in tomato after application of BAS 536 F under greenhouse conditions in Spain and Italy, 24 25/11664! 26959! 4/PF/1 ASB OECD: KIIA 6.3 Schroth, E. 25 Study on the residue behaviour of pyraclostrobin and dimethomorph in tomato after the application of BAS 536 F and BAS F under greenhouse conditions in Spain, Italy and Greece, 25 25/1263! 24! 5/PF/2 ASB OECD: KIIA 6.3 Schulz, H. 24 Determination of the residues of BAS 5 F and BAS 51 F in tomatoes and peppers following treatment with BAS 516 F under field/greenhouse conditions in Greece, 22 24/12444! IPMIS 11531! IF- 2/48 RIP OECD: KIIA 6.3 Schulz, H. 24 Study on the residue behaviour of BAS 51 F and BAS 5 F in tomatoes (greenhouse) after application of BAS 516 F under field conditions in France North and South, 23 24/ RIP OECD: KIIA 6.3 OECD: KIIA 6.3 Treiber, S.; Funk, H.; Mackenroth, Ch. Veit, P.; Weber, S. 21 Study on the residue behavior of BAS 5 F and BAS 51 F in tomatoes and pepper after treatment with BAS 516 GA F under greenhouse conditions in Spain, 2 21/16129! ES/FR/2/ RIP Investigation of the residue behaviour of BAS 516 F (Signum) in lamb's lettuce, kohlrabi, parsley, radish, celeriac, celery, spinach and welsh onion 25/12658! 212 RIP OECD: KIIA 6.3 Weber, S. 26 Investigation of the residue behaviour of BAS 516 F (Signum) in lamb's lettuce, kohlrabi, parsley, radish, celeriac, celery, spinach and welsh onion, onion, common cabbage, raspberries and currants 26/115882! RIP OECD: KIIA Stewart, J. 22 A meat and egg magnitude of the residue study with BAS 51 F in laying hens 22/52466! 1319 RIP26-46 Data protection claimed Owner How considered in drr Study-Status / Usage * Page 25 / 51

49 Signum /2 Part B Section 4 - Core Assessment zrms Version Annex point/ reference No OECD: KIIA Malinsky, D. S.; Pryadun, R. OECD: KIIA Author(s) Year Title Source (where different from company) Report-No. GLP or GEP status (where relevant), Published or not Authority registration No Schat, B.; Beelen, G. M. 29 A meat and milk magnitude of the residue study with BAS 51 F in lactating dairy cows 28/1533! ASB Feeding study with BAS 5 F (Reg. no ) in lactating dairy cows 1999/11895! V99.3! 86 RIP2-15 OECD: KIIA Tilting, N. 2 Investigation of residues of BAS 5 F (Reg. No ) in tissues and milk of dairy cows 2/13! RIP2-16 OECD: KIIA Scharf, J Hydrolysis of BAS 51 F at 9 C, 1 C, and 12 C 98/188! 4555 RIP OECD: KIIA Scharf, J Hydrolysis of BAS 5 F at 9 C, 1 C, and 12 C BASF 98/184! 4212 RIP2-18 OECD: KIIA OECD: KIIA Hamm, R. T.; Veit, P. Hamm, R. T.; Veit, P. 21 Confined rotational crop study with 14C-BAS 51 F 2/114862! RIP Confined rotational crop study with 14C-BAS 51 F (Report amendment No. 1) 22/14122! 41838! 2/ ASB OECD: KIIA Veit, P. 2 Confined rotational crop study with 14C-BAS 5 F 1999/11829! 3551 RIP2-185 OECD: KIIA Beck, J.; Lehmann, A.; Grote, C.; Mackenroth, C. 23 Study on the residue behavior of Boscalid (BAS 51 F) on succeeding crops after application of BAS 51 1 F on bare soil and cultivation of potatoes under field conditions in Denmark, France, Germany and Great Britain, 22 23/11358! RIP24-18 OECD: KIIA Jordan, J. M. 22 Cereal grains and soybean field rotational crop study for BAS 51 F 22/51341! 64382! 23/513 ASB OECD: KIIA Jordan, J. M. 22 Field rotational study for BAS 51 F on grasses, alfalfa, and clover as livestock feed crops 22/5263! ASB OECD: KIIA Jordan, J. M. 22 Cereal grains and soybean field rotational crop study for BAS 51 F (Amendeded final report) 23/513! 64382! 22/51341 RIP OECD: KIIA Leonard, R. C. 23 Sugar beet, garden beet and turnip field rotational crop study for BAS 51 2 F residues 22/5423! 132 ASB Data protection claimed Owner How considered in drr Study-Status / Usage * Page 26 / 51

50 Signum /2 Part B Section 4 - Core Assessment zrms Version Annex point/ reference No OECD: KIIA OECD: KIIA OECD: KIIA Author(s) Year Title Source (where different from company) Report-No. GLP or GEP status (where relevant), Published or not Authority registration No Schroth, E.; Martin, T. Schweda, Z.; Mackenroth, C. Versoi, P. L.; Abdel-Baky, S. 28 Study on the residue behavior of BAS 51 F on the rotational crop: Carrots after the application to the soil of BAS 51 1 F under field conditions in France (South), Germany, Netherlands and Spain, 2 28/136949! 25296! /PF/1 ASB Study on the residue behaviour of BAS 51 F in the rotational crops: Wheat, spinach, and radish after growing on the soil with different aged Boscalid 29/16915! ASB Magnitude of the residue of BAS 51 F in peas and beans planted as rotational crops and of BAS 5 F in peas and beans when applied as a foliar spray 21/53311! 131 RIP * Y: Yes, relied on N: No, not relied on Add: Relied on, study not submitted by applicant but necessary for evaluation Data protection claimed Owner How considered in drr Study-Status / Usage * Appendix 2 Detailed evaluation of the additional studies relied upon A 2.1 Storage stability No further study on storage stability submitted/needed. A 2.2 Residues in primary crops A Nature of residues No further study on nature of residues submitted/needed. Page 2 / 51

51 A Magnitude of residues in tomato Reference: OECD KIIA 6.3 Report RIP23-526, RIP23-528, RIP25-164, ASB , RIP Guideline(s): EU Guidance to Dir. 91/414/EEC Deviations: No GLP: Yes Acceptability: Yes Table A 2: Residues of boscalid in tomatoes RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Boscalid (BAS 51 F) (Application on agricultural and horticultural crops) Crop / crop group : Tomato Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : February 24 : Content of a.i. (g/kg or g/l) : 26 g/kg Indoors / outdoors : Indoors Formulation (e.g. WP) : WG Other a. i. in formulation Commercial product (name) : Signum (common name and content) : 6g/kg Pyraclostrobin (BAS 5 F) Applicant : BASF Aktiengesellschaft Residues calculated as : Boscalid (BAS 51 F) Report-No. Commodity / Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i. / ha l / ha a.i. / hl and last date or date 21/196 ES Mareny de les Barraquetes (S9914R) (a) (b) (c) (a) (d) (e) Rollesta 1.) BBCH fruit.26 RIP ) ) from

52 Report-No. Commodity / Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i. / ha l / ha a.i. / hl and last date or date 21/196 ES 332 Torrellano (S9915R) (a) (b) (c) (a) (d) (e) Victorio 1.) BBCH fruit 1. RIP ) ) from /196 ES Torrellano (S9916R) Rollesta 1.) ) ) Jan BBCH 3-81 fruit RIP /196 ES 4683 Beniganim (S991R) Daniela 1.) ) March 2 3.) March BBCH 66 3 fruit RIP /16129 ES Los Palacios (AC//) Bonne 1.) )from )from BBCH 3 fruit RIP /16129 ES 412 Los Palacios (AC/8/) Genaro 1.) )from )from BBCH 5 fruit RIP

53 Report-No. Commodity / Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last Postal code 2) Flowering kg Water kg treatments treatment and date 3) Harvest a.i. / ha l / ha a.i. / hl and last date or date 21/16129 ES Los Palacios (AC/9/) (a) (b) (c) (a) (d) (e) Bomd 1.) BBCH 5 fruit.18 RIP ) ) /16129 ES Los Palacios (AC/1/) Genaro 1.) ) ) BBCH 4 fruit RIP

54 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Boscalid (BAS 51 F) (Application on agricultural and horticultural crops) Crop / crop group : Tomato Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 26 g/kg Indoors / outdoors : Indoors Formulation (e.g. WP) : WG Other a.i. in formulation Commercial product (name) : BAS 516 F (content and common name) : 6 g/kg Pyraclostrobin (BAS 5 F) treated with formulation BAS 516 F (6 g/kg Pyraclostrobin and 26 g/kg Boscalid) Applicant : BASF Aktiengesellschaft Residues calculated as : Boscalid (BAS 51 F) Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date BASF24/115938, 1582, FAN/13/3 France 623 Alsace Date of 1) Sowing or planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Dates of treatments or no. of treatments and last date Growth stage at last treatment or date (a) (b) (c) (a) (d) (e) 4) spraying Grapella 1) (planting) 2) ) ) BBCH 88 fruit analytical method: BASF 445/ (HPLC-MS/MS) RIP BASF24/115938, 1582, FTL//3 France 3166 Midi-Pyrenées Brenda 1) (planting) 2) ) ) BBCH 8 fruit ) spraying analytical method: BASF 445/ (HPLC-MS/MS) RIP25-164

55 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Boscalid (BAS 51 F) (Application on agricultural and horticultural crops) Crop / crop group : Tomato Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 26 g/kg Indoors / outdoors : Indoors Formulation (e.g. WP) : WG Other a.i. in formulation Commercial product (name) : BAS 516 F (content and common name) : 6 g/kg Pyraclostrobin (BAS 5 F) treated with formulation BAS 516 F (6 g/kg Pyraclostrobin and 26 g/kg Boscalid) Applicant : BASF Aktiengesellschaft Residues calculated as : Boscalid (BAS 51 F) Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date BASF25/4269, 2196, AGR/16/5 Netherlands 5856 Limburg BASF25/4269, 2196, ALO/24/5 Spain 411 Utrera, Sevilla Date of 1) Sowing or planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Dates of treatments or no. of treatments and last date Growth stage at last treatment or date (a) (b) (c) (a) (d) (e) 4) spraying Relaxx 1) (planting) 2) ) Bond 1) (planting) 2) ) ) ) BBCH 8 fruit BBCH 83 fruit analytical method: BASF 445/ (HPLC-MS/MS) ASB ) spraying analytical method: BASF 445/ (HPLC-MS/MS) ASB

56 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Boscalid (BAS 51 F) (Application on agricultural and horticultural crops) Crop / crop group : Tomato Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 26 g/kg Indoors / outdoors : Indoors Formulation (e.g. WP) : WG Other a.i. in formulation Commercial product (name) : BAS 516 F (content and common name) : 6 g/kg Pyraclostrobin (BAS 5 F) treated with BAS 516 F, WG (6 g/kg Pyraclostrobin + 26 g/kg Boscalid) Applicant : BASF Aktiengesellschaft Residues calculated as : Boscalid (BAS 51 F) Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date BASF24/12444, IF-2/48, 2RF3/2 Greece 52 Thessaloniki Date of 1) Sowing or planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Dates of treatments or no. of treatments and last date Growth stage at last treatment or date (a) (b) (c) (a) (d) (e) 4) spraying Galli F1 1) (planting) 2) ) ) BBCH 86 fruit <.5 <.5 <.5 <.5 Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included Note: All entries to be filled in as appropriate 3 14 analytical method: 445/ (HPLC/MS/MS) RIP Comments of zrms: Acceptable.

57 Reference: OECD KIIA 6.3 Report RIP23-526, RIP23-528, ASB2-3229, ASB2-3228, ASB2-3226, ASB , RIP25-164, RIP Guideline(s): EU Guidance to Dir. 91/414/EEC Deviations: No GLP: Yes Acceptability: Yes Table A 3: Residues of pyraclostrobin in tomatoes RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Pyraclostrobin (BAS 5 F) (Application on agricultural and horticultural crops) Crop / crop group : Tomato Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : February 24 Content of a.i. (g/kg or g/l) : 6 g/kg Indoors / outdoors : Indoors Formulation (e.g. WP) : WG Other a. i. in formulation Commercial product (name) : Signum (common name and content) : 26 g/kg Boscalid (BAS 51 F) Applicant : BASF AG Residues calculated as : Pyraclostrobin (BAS 5 F) Metabolite BF 5-3 calculated as Pyraclostrobin Report-No. Commodity / Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last BAS BF TOTAL Postal code 2) Flowering kg Water kg treatments treatment 5 5 and date 3) Harvest a.i. / ha l / ha a.i. / hl and last date or date F -3 (a) (b) (c) (a) (d) (e) 21/196 Rollesta 1.) BBCH 2.) ) from ES Mareny de les Barraquetes (S9914R) (EU South) fruit < WRueck 13 (Boscalid), WRueck 236 (Pyraclostrobin) RIP23-526

58 Report-No. Commodity / Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last BAS BF TOTAL Postal code 2) Flowering kg Water kg treatments treatment 5 5 and date 3) Harvest a.i. / ha l / ha a.i. / hl and last date or date F -3 (a) (b) (c) (a) (d) (e) 21/196 ES 332 Torrellano (S9915R) (EU South) Victorio 1.) ) ) from BBCH fruit WRueck 13 (Boscalid), WRueck 236 (Pyraclostrobin) RIP /196 ES Torrellano (S9916R) (EU South) Rollesta 1.) ) ) Jan BBCH 3-81 fruit < WRueck 13 (Boscalid), WRueck 236 (Pyraclostrobin) RIP /196 ES 4683 Beniganim (S991R) (EU South) Daniela 1.) ) March 2 3.) March BBCH 66 3 fruit WRueck 13 (Boscalid), WRueck 236 (Pyraclostrobin) RIP /16129 ES Los Palacios (AC//) (EU South) Bonne 1.) ) from ) from BBCH 3 fruit WRueck 139 (Boscalid), WRueck 238 (Pyraclostrobin) RIP23-528

59 Report-No. Commodity / Date of Application Dates of Growth Portion Residues PHI Remarks Location Variety 1) Sowing or rate per treatment treatments stage analysed (mg/kg) (days) incl. planting or no. of at last BAS BF TOTAL Postal code 2) Flowering kg Water kg treatments treatment 5 5 and date 3) Harvest a.i. / ha l / ha a.i. / hl and last date or date F -3 (a) (b) (c) (a) (d) (e) 21/16129 ES 412 Los Palacios (AC/8/) (EU South) Genaro 1.) ) from ) from BBCH 5 fruit WRueck 139 (Boscalid), WRueck 238 (Pyraclostrobin) RIP /16129 ES Los Palacios (AC/9/) (EU South) Bond 1.) ) ) BBCH 5 fruit WRueck 139 (Boscalid), WRueck 238 (Pyraclostrobin) RIP /16129 ES Los Palacios (AC/1/) (EU South) Genaro 1.) ) ) BBCH 4 fruit WRueck 139 (Boscalid), WRueck 238 (Pyraclostrobin) RIP

60 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Pyraclostrobin (BAS 5 F) (Application on agricultural and horticultural crops) Crop / crop group : Tomato Federal Institute for Risk Assessment, Berlin Submission date : Federal Republic of Germany Content of a.i. (g/kg or g/l) : 4 g/l Indoors / outdoors : Indoors Formulation (e.g. WP) : EC Other a. i. in formulation Commercial product (name) : submitted to Dimethomorph W2L (common name and content) : 2 g/l Dimethomorph treated with formulation BAS F, EC (2 g/l Dimethomorph + 4 g/l Pyraclostrobin) Applicant : BASF AG Residues calculated as : 8.1 Pyraclostrobin (BAS 5 F) 8.2 BF 5-3, Methyl N-(2-[[1-(4- chlorophenyl)-1h-pyrazol-3- yl]oxomethyl]phenyl)carbamat Commodity/ Application Portion Residues Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (mg/kg) (days) Report-No. Location incl. Postal code and date BAS25/126 3, 24, trial 5ES/1R Spain 411 Utrera, Sevilla (Andalucia) BAS25/126 3, 24, trial 5GR/3R Greece 632 Moudania (Macedonia) Date of 1) Sowing or planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Dates of treatments or no. of treatments and last date Growth stage at last treatment or date (a) (b) (c) (a) (d) (e) 4) spraying Bond 1) (planting) 2) ) Beladona F1 1) (planting) 2) ) ) ) BBCH 83 fruit BBCH 2 fruit...4 <.1 <.1 <.1 <.1 <.1 < analytical method: 535/ (HPLC-MS/MS) WRueck 48 (Dimethomorph), ASB ) spraying analytical method: 535/ (HPLC-MS/MS) WRueck 48 (Dimethomorph), ASB2-3229

61 Commodity/ Application Portion Residues Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (mg/kg) (days) Report-No. Location incl. Postal code and date BAS25/126 3, 24, trial 5GR/4R Greece 56 Vasilika, Thessaloniki (Macedonia) Date of 1) Sowing or planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Dates of treatments or no. of treatments and last date Growth stage at last treatment or date (a) (b) (c) (a) (d) (e) 4) spraying Formula F1 1) (planting) 2) ) ) BBCH 2 fruit <.1 <.1 <.1 3 analytical method: 535/ (HPLC-MS/MS) WRueck 48 (Dimethomorph), ASB BAS25/126 3, 24, trial 5IT/2R Italy 641 Colonnella (Abruzzo) Optima 1) (planting) 2) ) ) BBCH 9 fruit <.1 <.1 <.1 3 4) spraying analytical method: 535/ (HPLC-MS/MS) WRueck 48 (Dimethomorph), ASB2-3229

62 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Pyraclostrobin (BAS 5 F) (Application on agricultural and horticultural crops) Crop / crop group : Tomato Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 6 g/kg Indoors / outdoors : Indoors Formulation (e.g. WP) : WG Other a. i. in formulation Commercial product (name) : submitted to Dimethomorph W2L (common name and content) : 12 g/kg Dimethomorph treated with formulation BAS 536 F, WG (12 g/kg Dimethomorph + 6 g/kg Pyraclostrobin) Applicant : BASF AG Residues calculated as : 8.1 Pyraclostrobin (BAS 5 F) 8.2 BF 5-3, Methyl N-(2-[[1-(4- chlorophenyl)-1h-pyrazol-3- yl]oxomethyl]phenyl)carbamat Commodity/ Application Portion Residues Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (mg/kg) (days) Report-No. Location incl. Postal code and date BAS25/1166 4, 26959, trial 4ES/1R Spain 412 Los Palacios, Sevilla (Andalucia) BAS25/1166 4, 26959, trial 4ES/2R Spain 411 Utrera, Sevilla (Andalucia) Date of 1) Sowing or planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Dates of treatments or no. of treatments and last date Growth stage at last treatment or date (a) (b) (c) (a) (d) (e) 4) spraying Caro 1) (planting) 2) ) Antilla 1) (planting) 2) ) ) ) BBCH 84 fruit.8..5 BBCH 82 fruit <.1 <.1 <.1 <.1 <.1 < analytical method: 535/ (HPLC-MS/MS) WRueck 4 (Dimethomorph), ASB ) spraying analytical method: 535/ (HPLC-MS/MS) WRueck 4 (Dimethomorph), ASB2-3228

63 Commodity/ Application Portion Residues Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (mg/kg) (days) Report-No. Location incl. Postal code and date BAS25/1166 4, 26959, trial 4IT/3R Italy 35 Santa Maria di Zevio (Veneto) BAS25/1166 4, 26959, trial 4IT/4R Italy 631 Campofilome (Marche) BAS25/126 3, 24, trial 5ES/1R Spain 411 Utrera, Sevilla (Andalucia) Date of 1) Sowing or planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Dates of treatments or no. of treatments and last date Growth stage at last treatment or date (a) (b) (c) (a) (d) (e) 4) spraying Secolo 1) (planting) 2) ) Optima 1) (planting) 2) ) Bond 1) (planting) 2) ) ) ) ) BBCH 6 fruit.15 BBCH 8 fruit BBCH 83 fruit.8..4 <.1 <.1 <.1 <.1 <.1 <.1 <.1 <.1 < analytical method: 535/ (HPLC-MS/MS) WRueck 4 (Dimethomorph), ASB ) spraying analytical method: 535/ (HPLC-MS/MS) WRueck 4 (Dimethomorph), ASB ) spraying analytical method: 535/ (HPLC-MS/MS) WRueck 48 (Dimethomorph), ASB2-3229

64 Commodity/ Application Portion Residues Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (mg/kg) (days) Report-No. Location incl. Postal code and date BAS25/126 3, 24, trial 5GR/3R Greece 632 Moudania (Macedonia) BAS25/126 3, 24, trial 5GR/4R Greece 56 Vasilika, Thessaloniki (Macedonia) BAS25/126 3, 24, trial 5IT/2R Italy 641 Colonnella (Abruzzo) Date of 1) Sowing or planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Dates of treatments or no. of treatments and last date Growth stage at last treatment or date (a) (b) (c) (a) (d) (e) 4) spraying Beladona F1 1) (planting) 2) ) Formula F1 1) (planting) 2) ) Optima 1) (planting) 2) ) ) ) ) BBCH 2 fruit BBCH 2 fruit BBCH 9 fruit <.1 <.1 <.1 <.1 <.1 <.1 <.1 <.1 < analytical method: 535/ (HPLC-MS/MS) WRueck 48 (Dimethomorph), ASB ) spraying analytical method: 535/ (HPLC-MS/MS) WRueck 48 (Dimethomorph), ASB ) spraying analytical method: 535/ (HPLC-MS/MS) WRueck 48 (Dimethomorph), ASB2-3229

65 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Pyraclostrobin (BAS 5 F) (Application on agricultural and horticultural crops) Crop / crop group : Tomato Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 4 g/l Indoors / outdoors : Indoors Formulation (e.g. WP) : EC Other a. i. in formulation Commercial product (name) : submitted to Dimethomorph W2L (common name and content) : 2 g/l Dimethomorph treated with formulation BAS F, EC (2 g/l Dimethomorph + 4 g/l Pyraclostrobin) Applicant : BASF AG Residues calculated as : 8.1 Pyraclostrobin (BAS 5 F) 8.2 BF 5-3, Methyl N-(2-[[1-(4- chlorophenyl)-1h-pyrazol-3- yl]oxomethyl]phenyl)carbamat Commodity/ Application Portion Residues Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (mg/kg) (days) Report-No. Location incl. Postal code and date BASF26/13 825, 234, trial ALO/1/5 Spain Palomares (Sevilla) Date of 1) Sowing or planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Dates of treatments or no. of treatments and last date Growth stage at last treatment or date (a) (b) (c) (a) (d) (e) 4) spraying Don Benito 1) (planting) 2) ) ) BBCH 84 fruit analytical method: Pyraclostrobin + metabolite 445/ (HPLC- MS/MS) WRueck 45 (Dimethomorph), ASB2-3226

66 Commodity/ Application Portion Residues Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (mg/kg) (days) Report-No. Location incl. Postal code and date BASF26/13 825, 234, trial FBD/8/5 France 265 St Paul les Romans BASF26/13 825, 234, trial GRE/8/5 Greece 591 Veria BASF26/13 825, 234, trial ITA/1/5 Italy 155 Tortona Date of 1) Sowing or planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Dates of treatments or no. of treatments and last date Growth stage at last treatment or date (a) (b) (c) (a) (d) (e) 4) spraying Perfect Peel 1) (planting) 2) ) Frisco 1) (planting) 2) ) Perfect Peel 1) (planting) 2) ) ) ) ) BBCH 8 fruit BBCH 85 fruit BBCH 88 fruit analytical method: Pyraclostrobin + metabolite 445/ (HPLC- MS/MS) WRueck 45 (Dimethomorph), ASB ) spraying analytical method: Pyraclostrobin + metabolite 445/ (HPLC- MS/MS) WRueck 45 (Dimethomorph), ASB ) spraying analytical method: Pyraclostrobin + metabolite 445/ (HPLC- MS/MS) WRueck 45 (Dimethomorph), ASB2-3226

67 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Pyraclostrobin (Application on agricultural and horticultural crops) Crop / crop group : Tomato Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 6 g/kg Indoors / outdoors : Indoors Formulation (e.g. WP) : WG Other a.i. in formulation Commercial product (name) : BAS 516 F (content and common name) : 26 g/kg Boscalid treated with formulation BAS 516 F (6 g/kg Pyraclostrobin and 26 g/kg Boscalid) Applicant : BASF Aktiengesellschaft Residues calculated as : 8.1 Pyraclostrobin 8.2 BF 5-3, Methyl N-(2-[[1-(4- chlorophenyl)-1h-pyrazol-3- yl]oxomethyl]phenyl)carbamat, calculated as Pyraclostrobin Commodity/ Application Portion Residues Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (mg/kg) (days) Report-No. Location incl. Postal code and date BASF25/4 269, 2196, AGR/16/5 Netherlands 5856 Limburg BASF25/4 269, 2196, ALO/24/5 Spain 411 Utrera, Sevilla Date of 1) Sowing or planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Dates of treatments or no. of treatments and last date Growth stage at last treatment or date (a) (b) (c) (a) (d) (e) 4) spraying Relaxx 1) (planting) 2) ) Bond 1) (planting) 2) ) ) ) BBCH 8 fruit BBCH 83 fruit analytical method: BASF 445/ (HPLC- MS/MS) ASB ) spraying analytical method: BASF 445/ (HPLC- MS/MS) ASB

68 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Pyraclostrobin (Application on agricultural and horticultural crops) Crop / crop group : Tomato Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 6 g/kg Indoors / outdoors : Indoors Formulation (e.g. WP) : WG Other a.i. in formulation Commercial product (name) : BAS 516 F (content and common name) : 26 g/kg Boscalid treated with formulation BAS 516 F (6 g/kg Pyraclostrobin and 26 g/kg Boscalid) Applicant : BASF Aktiengesellschaft Residues calculated as : 8.1 Pyraclostrobin 8.2 BF 5-3, Methyl N-(2-[[1-(4- chlorophenyl)-1h-pyrazol-3- yl]oxomethyl]phenyl)carbamat, calculated as Pyraclostrobin Report-No. Location incl. Postal code and date BASF24/ , 1582, FAN/13/3 France 623 Alsace BASF24/ , 1582, FTL//3 France 3166 Midi-Pyrenées Commodity/ Variety Date of 1) Sowing or Application rate per treatment Dates of treatments Growth stage Portion analysed Residues (mg/kg) Residues (mg/kg) PHI (days) planting or no. of at last 2) Flowering kg Water kg treatments treatment 3) Harvest a.i./ha l/ha a.i./hl and last date or date (a) (b) (c) (a) (d) (e) 4) spraying Grapella 1) (planting) 2) ) Brenda 1) (planting) 2) ) ) ) BBCH 88 fruit BBCH 8 fruit Remarks analytical method: BASF 445/ (HPLC-MS/MS) WRueck 239 (Pyraclostrobin) RIP ) spraying analytical method: BASF 445/ (HPLC-MS/MS) WRueck 239 (Pyraclostrobin) RIP25-164

69 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Pyraclostrobin (Application on agricultural and horticultural crops) Crop / crop group : Tomato Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 6 g/kg Indoors / outdoors : Indoors Formulation (e.g. WP) : WG Other a.i. in formulation Commercial product (name) : BAS 516 F (content and common name) : 26 g/kg Boscalid (BAS 51 F) treated with BAS 516 F, WG (6 g/kg Pyraclostrobin + 26 g/kg Boscalid) Applicant : BASF Aktiengesellschaft Residues calculated as : 8.1 Pyraclostrobin (BAS 5 F) 8.2 BF 5-3, Methyl N-(2-[[1-(4- chlorophenyl)-1h-pyrazol-3- yl]oxomethyl]phenyl)carbamat, calculated as Pyraclostrobin Commodity/ Application Portion Residues Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (mg/kg) (days) Report-No. Location incl. Postal code and date BASF24/124 44, IF- 2/48, 2RF3/2 Greece 52 Thessaloniki Date of 1) Sowing or planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Dates of treatments or no. of treatments and last date Growth stage at last treatment or date (a) (b) (c) (a) (d) (e) 4) spraying Galli F1 1) (planting) 2) ) ) BBCH 86 fruit 3 14 analytical method: 445/ (HPLC/MS/MS), WRueck 235 (Pyraclostrobin), Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included RIP Comments of zrms: Acceptable.

70 A Magnitude of residues in spinach Reference: OECD KIIA 6.3 Report RIP , RIP Guideline(s): EU Guidance to Dir. 91/414/EEC Deviations: No GLP: Yes Acceptability: Yes Table A 4: Residues of boscalid in spinach RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Boscalid (BAS 51 F) (Application on agricultural and horticultural crops) Crop / crop group : Spinach Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 26 g/kg Indoors / outdoors : Outdoors (European North) Formulation (e.g. WP) : WG Other a. i. in formulation Commercial product (name) : Signum (common name and content) : 6 g/kg Pyraclostrobin (BAS 5 F) Applicant : BASF Aktiengesellschaft Residues calculated as : Boscalid (BAS 51 F) Application Portion Residues PHI Remarks rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date BASF26/115882, study , RU-F-14 5 BB 11/1 D Neu Tucheband Date of 1) Sowing or planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Dates of treatments or no. of treatments and last date Growth stage at last treatment or date (a) (b) (c) (a) (d) (e) 4) spraying Commodit y/ Variety Mig 1) (sowing) 2) 3) BBCH ) leaf method: HPLC-MS/MS (BASF-method: 455/1), WRueck 292 [Boscalid] RIP

71 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Boscalid (BAS 51 F) (Application on agricultural and horticultural crops) Crop / crop group : Spinach Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 26 g/kg Indoors / outdoors : Outdoors (European North) Formulation (e.g. WP) : WG Other a. i. in formulation Commercial product (name) : Signum (common name and content) : 6 g/kg Pyraclostrobin (BAS 5 F) Applicant : BASF Aktiengesellschaft Residues calculated as : Boscalid (BAS 51 F) Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date BAS25/12658, study 212, RU-F-1 4 BE B 1/1, B/FG 56/4 D-1234 Berlin BAS25/12658, study 212, RU-F-1 4 BE B 1/2, B/FG 69/4 D-1234 Berlin Date of 1) Sowing or planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Dates of treatments or no. of treatments and last date Growth stage at last treatment or date (a) (b) (c) (a) (d) (e) 4) spraying Gamma 1) (sowing) 2) 3) Gamma 1) (sowing) 2) 3) ) BBCH 18 leaf ) BBCH 16 leaf analytical method: HPLC-MS/MS (BASFmethod: 445/), WRueck 288 [Boscalid], RIP ) spraying analytical method: HPLC- MS/MS (BASF-method: 445/), WRueck 288 [Boscalid], RIP26-161

72 Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date BAS25/12658, study 212, RU-F-1 4 BE B 1/3, B/FG /4 D-1234 Berlin BAS25/12658, study 212, RU-F-1 4 BE B 1/4, B/FG 1/4 D-1234 Berlin Date of 1) Sowing or planting 2) Flowering 3) Harvest kg a.i./ha Water l/ha kg a.i./hl Dates of treatments or no. of treatments and last date Growth stage at last treatment or date (a) (b) (c) (a) (d) (e) 4) spraying Gamma 1) (sowing) 2) 3) Gamma 1) (sowing) 2) 3) ) BBCH 16 leaf < ) BBCH 14 leaf Remarks: (a) According to CODEX Classification / Guide (b) Only if relevant (c) Year must be indicated (d) Days after last application (Label pre-harvest interval, PHI, underline) (e) Remarks may include: Climatic conditions; Reference to analytical method and information which metabolites are included Note: All entries to be filled in as appropriate analytical method: HPLC- MS/MS (BASF-method: 445/), WRueck 288 [Boscalid], RIP ) spraying analytical method: HPLC- MS/MS (BASF-method: 445/), WRueck 288 [Boscalid], RIP Comments of zrms: Acceptable.

73 A 2.3 Residues in processed commodities No new study on residues in processed commodities has been submitted. A 2.4 Residues in rotational crops No new study on residues in rotational crops has been submitted. A 2.5 Residues in livestock No new study on residues in livestock has been submitted. A 2.6 Other studies/information None Appendix 3 Pesticide Residue Intake Model (PRIMo)

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