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

Transcription

1 Part A National Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /22 Registration Report Central Zone Country Germany Page 1 of 13 Art. 51 Extension of authorisation for minor uses REGISTRATION REPORT Part A Risk Management Product code: Signum Active Substances: Boscalid 267 g/kg and Pyraclostrobin 67 g/kg COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT Applicant: BASF SE Date: 18/12/2014 BVL_FO_05_2422_200_V1.0 Applicant BASF SE E-APE/DT, Li 556 Date: 18/12/2014

2 Part A National Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /22 Registration Report Central Zone Country Germany Page 2 of 13 Table of Contents PART A Risk Management Details of the application Application background Annex I inclusion Regulatory approach Uses applied for and registration decision Public interest and minor use Data protection claims Letters of Access Details of the authorisation Product identity Classification and labelling Classification and labelling under Directive 99/45/EC R and S phrases under Directive 2003/82/EC (Annex IV and V) Other phrases Restrictions linked to the PPP Specific restrictions linked to the intended uses Product uses Risk management Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties Methods of analysis Analytical method for the formulation Analytical methods for residues Mammalian Toxicology Residues and Consumer Exposure Residues Consumer exposure Environmental fate and behaviour Ecotoxicology Efficacy Conclusions Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation Appendix 1 Copy of the product authorisation Appendix 2 Copy of the product label Appendix 3 Letter of Access BVL_FO_05_2422_200_V1.0 Applicant BASF SE E-APE/DT, Li 556 Date: 18/12/2014

3 Part A National Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /22 Registration Report Central Zone Country Germany Page 3 of 13 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 Type of application Signum Registration number /22 Applicant Authorisation holder Function Type of formulation Zonal application according to Article 51, ZRMS=DE, first application (GV1) BASF SE E-APE/DT, Li 556, Speyerer Straße 2, Limburgerhof, Deutschland BASF SE E-APE/DT, Li 556, Speyerer Straße 2, Limburgerhof, Deutschland Fungicide Expiration of authorisation Water dispersible granule (WG) BVL_FO_05_2422_200_V1.0 Applicant BASF SE E-APE/DT, Li 556 Date: 18/12/2014

4 Part A National Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /22 Registration Report Central Zone Country Germany Page 4 of Annex I inclusion The active substances included in the plant protection product are approved according Regulation (EC) No 1107/2009. The present application is in line with the provisions of the approvals. Active substance (BVL Number) Boscalid (1023) Content in PPP 267 g/kg Approval status Approved according Regulation (EC) No 1107/2009 Approval Regulation (EC) No 540/2011 Expiration of approval 31/07/2018 Pyraclostrobin (1013) Content in PPP 67 g/kg Approval status Approved according Regulation (EC) No 1107/2009 Approval Expiration of approval 31/01/2017 Regulation (EC) No 540/2011 and Regulation (EU) No 823/ Regulatory approach The PPP is already registered in Germany according to Directive 91/414/EEC taking into account the uniform principles of Annex VI. Therefore the evaluation of the current application is limited to the points not covered by the existing registration Uses applied for and registration decision Number of use Plant/commodity/object Harmful organism/purpose decision 001 rhubarb RHERH fungal leaf spot diseases No Authorisation possible 002 rhubarb RHERH fungal leaf spot diseases Authorise Public interest and minor use BVL_FO_05_2422_200_V1.0 According to Article 51 (2) a and c of the Regulation (EC) No 1107/2009 extensions of authorisation are only possible if the intended use applied for is minor in nature and in public interest. In Germany the cultivated area of rhubarb ( ) is about 881 ha, of which approx. 352 ha need to be controlled. Calculation shows that authorisation holder will not profit from an authorisation of the requested uses. 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. Applicant BASF SE E-APE/DT, Li 556 Date: 18/12/2014

5 Part A National Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /22 Registration Report Central Zone Country Germany Page 5 of Data protection claims The applicant is owner of the new studies submitted and claims data protection 1.5 Letters of Access The applicant is owner of the new studies submitted. Applicant is Authorisation holder. No letter of access necessary. 2 Details of the authorisation 2.1 Product identity Product name Signum Authorisation number Composition Type of formulation Function Authorisation holder Boscalid 267 g/kg and Pyraclostrobin 67 g/kg Water dispersible granule (WG) Fungicide 2.2 Classification and labelling BASF SE E-APE/DT, Li 556, Speyerer Straße 2, Limburgerhof, Deutschland Classification and labelling under Directive 99/45/EC or Regulation (EC) No 1272/2008 N R 50/53 S 35 S 57 SP001 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 547/2011 None Other phrases BVL_FO_05_2422_200_V Restrictions linked to the PPP The authorization of the PPP is linked to the following conditions (mandatory labelling): Applicant BASF SE E-APE/DT, Li 556 Date: 18/12/2014

6 Part A National Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /22 Registration Report Central Zone Country Germany Page 6 of 13 Operator protection SB001 SB010 Avoid any unnecessary contact with the product. Misuse can lead to health damage. Keep out of children reach. SF Treated areas/crops may not be entered until the spray coating has dried. Ecosystem protection NW262 NW264 NW468 The product is toxic for algae. The product is toxic for fish and aquatic invertebrates. Fluids left over from application and their remains, products and their remains, empty containers and packaging, and cleansing and rinsing fluids must not be dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and to rain-water and sewage canals. Integrated Pest Management (IPM) Mode of action (FRAC-Group): Pyraclostrobin C3, Boscalid C2 Active substance VH329 VH410 The content of dimethylsulfate (DMS) in the technical active substance pyraclostrobin may not exceed 1 mg/kg. 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. The authorization of the PPP is linked to the following conditions (voluntary labelling): Honeybee 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 The product is classified as harmless for populations of the species Typhlodromus pyri (predatory mite). NN1326 The product is classified as harmless for populations of the species Euseius finlandicus (predatory mite). NN1842 The product is classified as harmless for populations of the species Aphidius rhopalosiphi (braconid wasp) 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) BVL_FO_05_2422_200_V1.0 Ecosystem protection NW605-1 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 Applicant BASF SE E-APE/DT, Li 556 Date: 18/12/2014

7 Part A National Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /22 Registration Report Central Zone Country Germany Page 7 of 13 NW606 equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 ('Bundesanzeiger' [Federal Gazette] No 205, p. 9780) as amended. Depending on the drift reduction classes for the equipment stated below, the following buffer zones must be kept from surface waters. In addition to the minimum buffer zone from surface waters stipulated by state law, the ban on application in or in the immediate vicinity of waters must be observed at all times for drift reduction classes marked with "*". Driftreduction 90%: * Driftreduction 75%: 5 m Driftreduction 50%: 5 m 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 Euro. 5 m BVL_FO_05_2422_200_V1.0 Applicant BASF SE E-APE/DT, Li 556 Date: 18/12/2014

8 Part A National Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /22 Registration Report Central Zone Country Germany Page 8 of Product uses PPP (product name/code) Signum ( ) Formulation type: SC active substance 1 Boscalid Conc. of as 1: 267 g/kg active substance 2 Pyraclostrobin Conc. of as 2: 67 g/kg safener - synergist - Applicant: BASF SE E-APE/DT, Li 556 Conc. of safener: - Conc. of synergist: - professional use Zone(s): central EU non professional use Verified by MS: yes Use- Member Crop and/ F Pests or Group of pests Application Application rate PHI Remarks: No. state(s) or situation (crop destination / purpose of crop) G or I controlled (additionally: developmental stages of the pest or pest group) Method / Kind Timing / Growth stage of crop & season Max. number (min. interval between applications) a) per use kg, L product / ha a) max. rate per appl. b) max. total rate g, kg as/ha a) max. rate per appl. b) max. total Water L/ha min / max (days) e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures b) per crop/ per crop/season rate per season crop/season BVL_FO_05_2422_200_V DE rhubarb RHERH F fungal leaf spot diseases spraying BBCH 15-49, in case of danger of infection and/or 7-14 days a) 2 b) 2 a) 1.5 kg/ha b) 3 kg/ha as1: a) 400 g as/ha b) 800 g L/ha An acute health risk for consumers cannot be excluded. Restrictions (see ) Applicant BASF SE E-APE/DT, Li 556 Date: 18/12/2014

9 Part A National Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /22 Registration Report Central Zone Country Germany Page 9 of 13 after warning service appeal as/ha as2: a) 100 g as/ha b) 200 g as/ha NW605-1 (*,5,5 m) NW606 (5 m) No authorisation possible (consumer protection) 002 DE rhubarb RHERH F fungal leaf spot diseases spraying after harvest, in case of danger of infection and/or after warning service appeal 7-14 days a) 2 b) 2 a) 1.5 kg/ha b) 3 kg/ha as1: a) 400 g as/ha b) 800 g as/ha as2: a) 100 g as/ha b) 200 g as/ha L/ha NW605-1 (*,5,5 m) NW606 (5 m) BVL_FO_05_2422_200_V1.0 Applicant BASF SE E-APE/DT, Li 556 Date: 18/12/2014

10 Part A National Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /22 Registration Report Central Zone Country Germany Page 10 of 13 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 and high acid content such as celery and rhubarb are available and acceptable for enforcing boscalid and pyraclostrobin 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 Boscalid Field trials on celery which can be extrapolated to rhubarb show that residues of boscalid were in the range of 0.17 to 14 mg/kg. Thus, an exceedance of the current MRL of 0.5 mg/kg for boscalid in rhubarb as laid down in Reg. (EU) 396/2005 is likely and a new MRL is necessary. An adequate application for MRL modification (30 mg/kg) was already submitted by the applicant to France. Pyraclostrobin Field trials on celery which can be extrapolated to rhubarb show that residues of pyraclostrobin were in the range of 0.05 to 2.6 mg/kg. Thus, an exceedance of the current MRL of 0.02* mg/kg for pyraclostrobin in rhubarb as laid down in Reg. (EU) 396/2005 is likely and a new MRL is necessary. An adequate application for MRL modification (5 mg/kg) was already submitted by the applicant (BASF) to France. However, residues at the level of this proposed MRL are not safe for consumers! BVL_FO_05_2422_200_V Consumer exposure Boscalid Applicant BASF SE E-APE/DT, Li 556 Date: 18/12/2014

11 Part A National Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /22 Registration Report Central Zone Country Germany Page 11 of 13 Chronic risk assessment ADI 0.04 mg/kg bw TMDI (% ADI) according to EFSA PRIMo 247 % (based on NL Children) NTMDI (% ADI) according to German NVS II 246 % (based on DE children aged 2-4 years) IEDI (% ADI) according to EFSA PRIMo rev.2 58 % (based on WHO Cluster diet B) NEDI (% ADI) according to German NVS II 56 % (based on DE children aged 2-4 years) Acute risk assessment ARfD not necessary not allocated The long-term and the short-term intake of boscalid residues are unlikely to present a public health concern. Pyraclostrobin Chronic risk assessment ADI TMDI (% ADI) according to EFSA PRIMo NTMDI (% ADI) according to German NVS II Acute risk assessment ARfD IESTI (% ARfD) according to EFSA PRIMo rev mg/kg bw 77 % (based on DE children, mean body weight) 83 % (based on DE children, individual consumption/body weight ratio) 0.03 mg/kg bw Rhubarb: 322 % (based on UK toddler, mean body weight) NESTI (% ARfD) according to German NVS II Rhubarb, raw: 432 % (based on DE children, individual consumption/body weight ratio) Rhubarb, processed: 270 % (based on DE children, individual consumption/body weight ratio) Factors included in IESTI and NESTI None. It is assumed that a reduction or concentration of residues during processing does not occur (refer to results from canning of cherries, PF = 1). The long-term intake of pyraclostrobin residues is unlikely to present a public health concern. However, the estimation of the short-term dietary intake of pyraclostrobin residues results in a clear exceedance of the ARfD in rhubarb (>300 % for UK toddler according to EFSA PRIMo model and > 400 % for DE children, individual consumption/body weight ratio according to German NVS II model) and thus a health risk for consumers cannot be excluded. Based on the information on processing from the MRL review for pyraclostrobin, a reduction of residues during processing does not occur (PF = 1 for canned cherries). BVL_FO_05_2422_200_V Environmental fate and behaviour No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation /00 according the uniform principles of directive 91/414/EEC. Applicant BASF SE E-APE/DT, Li 556 Date: 18/12/2014

12 Part A National Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /22 Registration Report Central Zone Country Germany Page 12 of Ecotoxicology No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation /00 according the uniform principles of directive 91/414/EEC. The PPP Signum and the active substances pyraclostrobin and boscalid are toxic to the aquatic environment (fish: HC5 concerned to LC50 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 NW605-1/606 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 1107/2009 (see also point 2.2) Efficacy Labelling in accordance with the requirements of ANNEX III General principles of integrated pest management under directive 2009/128/EC (see also point 2.2): -The classification of effects on beneficial arthropods for the main application covers the use(s) applied for under the terms of Article 51 of regulation (EC) No 1107/ The categories and labelling for mode of action for the main application cover the use(s) applied for under the terms of Article 51 of regulation (EC) No 1107/2009. According to Article 51 of the regulation (EC) No 1107/2009 the requirements for approval concerning the sufficient effect and any unacceptable effects on plants and plant products not need to be checked. 3.2 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. The indended use in rhubarb after harvest (002) will not result in residues above the MRLs set in Regulation (EC) No 396/2005. A risk for consumers through the consumption of food with these residues of boscalid and pyraclostrobin is not expected. There is no special risk mitigation necessary which deviate from the existing registration. For the use 001 (rhubarb at BBCH 15-49) is no authorisation possible because an acute health risk for consumers cannot be excluded. 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. BVL_FO_05_2422_200_V Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation None Applicant BASF SE E-APE/DT, Li 556 Date: 18/12/2014

13 Part A National Assessment Signum Art. 51 Extension of authorisation for minor uses BVL Registration Number: /22 Registration Report Central Zone Country Germany Page 13 of 13 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 authorisation holder. BVL_FO_05_2422_200_V1.0 Applicant BASF SE E-APE/DT, Li 556 Date: 18/12/2014

14 Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dienstsitz Braunschweig Postfach Braunschweig Dr. Cornelia Landsmann Referentin BASF SE E-APE/DT, Li 556 Speyerer Straße Limburgerhof IHR ZEICHEN IHRE NACHRICHT VOM TELEFON +49 (0) TELEFAX +49 (0) cornelia.landsmann@bvl.bund.de AKTENZEICHEN / (bitte bei Antwort angeben) DATUM 18. Dezember 2014 GV /22 Signum Verfahren zur Erweiterung einer Zulassung nach Artikel 51 Abs. 1 der Verordnung (EG) Nr. 1107/2009 Bescheid Die Zulassung des oben genannten Pflanzenschutzmittels mit den Wirkstoffen: 267 g/kg Boscalid 67 g/kg Pyraclostrobin Zulassungsnummer: Versuchsbezeichnungen: BAS F-1-WG Antrag vom: 3. Mai 2013 wird wie in Anlage 1 beschrieben auf der Grundlage von Art. 51 der Verordnung (EG) Nr. 1107/2009 des Europäischen Parlaments und des Rates vom 21. Oktober 2009 über das Inverkehrbringen von Pflanzenschutzmitteln und zur Aufhebung der Richtlinien 79/117/EWG und 91/414/EWG des Rates (Abl. L 309 vom , S. 1) um folgende Anwendungsgebiete bzw. Anwendungen erweitert: BVL_FO_05_2468_200_V1.3 Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet:

15 SEITE 2 VON 6 Anwendungsnummer Zweckbestimmung Schadorganismus/ / Pilzliche Blattfleckenerreger Pflanzen/-erzeugnisse/ Objekte Rhabarber Verwendungszweck Festgesetzte Anwendungsbestimmungen Es werden folgende Anwendungsbestimmungen gemäß 36 Abs. 1 S. 1 des Gesetzes zum Schutz der Kulturpflanzen (Pflanzenschutzgesetz- PflSchG) vom 6. Februar 2012 (BGBl. I S. 148, 1281), zuletzt geändert durch Artikel 4 Absatz 87 des Gesetzes vom 7. August 2013 (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): Anwendungsnummer Zweckbestimmung Schadorganismus/ / Pilzliche Blattfleckenerreger Pflanzen/-erzeugnisse/ Objekte Rhabarber Verwendungszweck BVL_FO_05_2468_200_V1.3

16 SEITE 3 VON 6 Rechtsbehelfsbelehrung Gegen diesen Bescheid kann innerhalb eines Monats nach Bekanntgabe Widerspruch erhoben werden. Der Widerspruch ist bei dem Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Messeweg 11/12, Braunschweig, schriftlich oder zur Niederschrift einzulegen. Mit freundlichen Grüßen im Auftrag gez. Dr. Karsten Hohgardt stellvertretender Abteilungsleiter Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig. Anlage BVL_FO_05_2468_200_V1.3

17 SEITE 4 VON 6 Anlage 1 zugelassene Anwendung: / Anwendungsgebiet Schadorganismus/Zweckbestimmung: Pilzliche Blattfleckenerreger Pflanzen/-erzeugnisse/Objekte: Rhabarber Verwendungszweck: 2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: Anwendung im Haus- und Kleingartenbereich: Anwendungszeitpunkt: Gemüsebau Freiland Nein Nach der Ernte bei Infektionsgefahr bzw. ab Warndiensthinweis Maximale Zahl der Behandlungen - in dieser Anwendung: 2 - für die Kultur bzw. je Jahr: 2 - Abstand: 7 bis 14 Tage Anwendungstechnik: spritzen Aufwand: - 1,5 kg/ha in 400 bis 1000 l Wasser/ha 2.2 Sonstige Kennzeichnungsauflagen - keine Wartezeiten (F) Freiland: Rhabarber Die Wartezeit ist durch die Anwendungsbedingungen und/oder die Vegetationszeit abgedeckt, die zwischen Anwendung und Nutzung (z. B. Ernte) verbleibt bzw. die Festsetzung einer Wartezeit in Tagen ist nicht erforderlich. 3 Anwendungsbezogene Anwendungsbestimmungen BVL_FO_05_2468_200_V1.3 (NW605-1) Die Anwendung des Mittels auf Flächen in Nachbarschaft von Oberflächengewässern - ausgenommen nur gelegentlich wasserführende, aber einschließlich periodisch wasserführender Oberflächengewässer - muss mit einem Gerät erfolgen, das in das Verzeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung eingetragen ist. Dabei sind, in Abhängigkeit von den unten aufgeführten Abdriftminderungsklassen der verwendeten Geräte, die im Folgenden genannten Abstände

18 SEITE 5 VON 6 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: 50% 5 m, 75% 5 m, 90% * Begründung: Siehe Bescheid vom 10. Juni 2009 zum Antrag /00. (NW606) 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 Euro geahndet werden. 5 m Begründung: Siehe Bescheid vom 10. Juni 2009 zum Antrag /00. BVL_FO_05_2468_200_V1.3

19 SEITE 6 VON 6 Anlage 2 nicht zugelassene Anwendung: / Anwendungsgebiet Schadorganismus/Zweckbestimmung: Pilzliche Blattfleckenerreger Pflanzen/-erzeugnisse/Objekte: Rhabarber Verwendungszweck: 2 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: Anwendung im Haus- und Kleingartenbereich: Gemüsebau Freiland Nein Stadium der Kultur: 15 bis 49 Anwendungszeitpunkt: Bei Infektionsgefahr bzw. ab Warndiensthinweis Maximale Zahl der Behandlungen - in dieser Anwendung: 2 - für die Kultur bzw. je Jahr: 2 - Abstand: 7 bis 14 Tage Anwendungstechnik: spritzen Aufwand: - 1,5 kg/ha in 400 bis 1000 l Wasser/ha 3 Begründung Rückstandsverhalten und Toxikologie: Gemäß Punkt 6.9 im Anhang der Verordnung (EU) Nr. 283/2013 muss eine Abschätzung der Exposition über die Nahrung und andere Quellen erfolgen. Die IESTI-Berechnung für Pyraclostrobin (drr Part B.4 Seite 9) ergibt auf Basis der vorliegenden Rückstandsdaten eine Ausschöpfung der ARfD von über 300 % für britische Kleinkinder (EFSA PRiMo-Modell) und die NESTI-Berechnung von über 400 % für deutsche Kinder (NVS II-Modell). Ein akutes Risiko für Verbraucher durch Rückstände aus der beantragten Anwendung an Rhabarber (BBCH 15-49) kann demzufolge nicht ausgeschlossen werden. Aus Gründen des gesundheitlichen Verbraucherschutzes kann diese Anwendung nicht bei der Zulassung vorgesehen werden. BVL_FO_05_2468_200_V1.3

20 Signum /22 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: 267 g/kg Boscalid 67 g/kg Pyraclostrobin Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: BASF SE Date: 18/12/2014 Page 1 / 20

21 Signum /22 Part B - Section 4 - Core Assessment zrms version Table of Contents 4 METABOLISM AND RESIDUES DATA Evaluation of the active substances Evaluation of the intended use(s) Selection of critical use and justification Rhubarb Residues in primary crops 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 Appendix 1 List of data submitted in support of the evaluation Appendix 2 Detailed evaluation of the additional studies relied upon A 2.1 Storage stability A 2.2 Residues in primary crops A Nature of residues A Magnitude of residues in rhubarb A 2.3 Residues in processed commodities A 2.4 Residues in rotational crops A 2.5 Residues in livestock A 2.6 Other studies/information Appendix 3 Pesticide Residue Intake Model (PRIMo rev.2) A 3.1 IEDI calculation for boscalid A 3.2 TMDI and NESTI calculation for pyraclostrobin Page 2 / 20

22 Signum /22 Part B - Section 4 - Core Assessment zrms version 4 METABOLISM AND RESIDUES DATA 4.1 Evaluation of the active substances Not conducted in the framework of the current application. 4.2 Evaluation of the intended use(s) Selection of critical use and justification The critical GAP used for consumer intake and risk assessment is presented in Table Page 3 / 20

23 Signum /22 Part B - Section 4 - Core Assessment zrms version Table 4.2-1: Critical Uses (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 Application rate PHI 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) Rhubarb ( ) F fungal leaf spot diseases spraying BBCH a) 2 b) days Rhubarb ( ) F fungal leaf spot diseases spraying after harvest a) 2 b) days kg product / ha a) max. rate per appl. b) max. total rate per crop/season a) 1.5 b) 3.0 a) 1.5 b) 3.0 g as/ha a) max. rate per appl. b) max. total rate per crop/season a) 405 (boscalid) 102 (pyraclostrobin) b) 810 (boscalid) 204 (pyraclostrobin) a) 405 (boscalid) 102 (pyraclostrobin) b) 810 (boscalid) 204 (pyraclostrobin) Water L/ha min / max (days) (i) n/a Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures (j) Remarks: (a) For crops, the EU and Codex classifications (both) should be used; where relevant, the use situation should be described (e.g. fumigation of a structure) (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) e.g. biting and suckling insects, soil born insects, foliar fungi, weeds (d) All abbreviations used must be explained (e) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (f) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated (g) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application (h) The minimum and maximum number of application possible under practical conditions of use must be provided (i) PHI - minimum pre-harvest interval (j) Remarks may include: Extent of use/economic importance/restrictions Page 4 / 20

24 Signum /22 Part B - Section 4 - Core Assessment zrms version Rhubarb 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 celery. According to the current Guidance for extrapolation used in the EU, data on celery following application close to harvest can be extrapolated to rhubarb. For the detailed evaluation of the residue trials it is referred to Appendix 2. Table 4.2-2: Overview of the selected supervised residue trials for boscalid Commodity Celery Rhubarb Region (a) Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (boscalid) NEU Outdoor 0.17; 0.21; 0.51, 2 x 1.2; 2.8; 14.0 Risk assessment (boscalid) 0.17; 0.21; 0.51, 2 x 1.2; 2.8; 14.0 STMR (mg/kg) (b) HR (mg/kg) (c) Existing MRL (mg/kg) (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. Median CF (d) Table 4.2-3: Overview of the selected supervised residue trials for pyraclostrobin Commodity Celery Rhubarb Region (a) Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (pyraclostrobin) NEU Outdoor 0.050; 0.090; 0.11; 0.12; 0.21; 0.24; 2.6 Risk assessment (pyraclostrobin) 0.050; 0.090; 0.11; 0.12; 0.21; 0.24; 2.6 STMR (mg/kg) (b) HR (mg/kg) (c) Existing MRL (mg/kg) * (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. Median CF (d) Analytical methods for commodities of high water and high acid content such as celery and rhubarb are available and acceptable for enforcing Boscalid and pyraclostrobin Distribution of the residue in peel/pulp Not relevant Residues in processed commodities Boscalid Under the peer review of Directive 91/414/EEC the effects of processing on the nature of boscalid residues were investigated in a hydrolysis study by simulating pasteurization, baking, brewing, boiling and sterilisation processes (ASB ). The studies demonstrate that boscalid was not degraded during processing. Specific studies to assess the magnitude of residues during processing of the crops under consideration were not provided. Pyraclostrobin The effect of processing on the nature of pyraclostrobin residues was investigated in the framework of the peer review (ASB ). A study was conducted simulating representative hydrolytic conditions for pasteurisation (20 minutes at 90C, ph 4), boiling/brewing/baking (60 minutes at 100C ph 5) and sterilisation (20 minutes at 120C, ph 6). This study demonstrates that processes such as brewing, cooking, sterilisation or pasteurisation have no impact on the nature of pyraclostrobin residues. Page 5 / 20

25 Signum /22 Part B - Section 4 - Core Assessment zrms version Specific studies to assess the magnitude of pyraclostrobin residues during processing of the crops under consideration were not provided but reliable processing factors for beer, peeled melons, several commodities derived from cherries (canned, juice), plums (prunes, jam) and wine grapes (juice, wet pomace, must, white wine) were derived in the framework of the MRL review according to Article 12 of Reg. 396/2005 (ASB ). The following table gives a brief overview of reliable processing factors for pyraclostrobin. Canning of cherries can be considered a process also representative of cooking of rhubarb. Table 4.2-3: Overview of the available processing studies for pyraclostrobin Processed commodity Number of studies Median PF (a) Citrus fruits, peeled Cherries, canned Cherry juice Plums, dried Plums, jam Wine grapes, juice Wine grapes, wet pomace Wine grapes, white wine Wine grapes, must Melons, peeled Barley, beer (a): The median processing factor (PF) is obtained by calculating the median of the individual PFs of each processing study Proposed pre-harvest intervals, withholding periods See GAP table. 4.3 Consumer intake and risk assessment Boscalid The key data for consumer intake assessment, which have been derived from residue and/or processing studies for the intended uses, are summarized in Table Table 4.3-1: Key data for consumer intake assessment derived for the intended uses Commodity Chronic risk assessment Input value (mg/kg) Comment Pome fruit 0.42 STMR (EFSA, Pistachios 0.27 STMR (EFSA, other tree nuts 0.05 STMR (EFSA, Cherries 1.51 STMR (EFSA, Acute risk assessment Input value (mg/kg) Comment Page 6 / 20

26 Signum /22 Part B - Section 4 - Core Assessment zrms version other stone fruits 1.21 STMR (EFSA, Canefruit 2.53 STMR (EFSA, Strawberries 0.56 STMR (EFSA, other small fruits and berries 2.6 STMR (EFSA, Banana STMR (EFSA, Root and tuber vegetables STMR (EFSA, Bulb onions 2.2 STMR (EFSA, Tomato, aubergine 0.32 STMR other solanacea STMR (EFSA, Gherkin and courgette 0.74 STMR (EFSA, other cucurbits STMR (EFSA, Flowering brassica 1.52 STMR (EFSA, Leafy brassica 2.95 STMR (EFSA, Kohlrabi 1.52 STMR (EFSA, Lambs lettuce 14 STMR (EFSA, other lettuce and salad plants, spinach, vine leaves, watercress (incl. baby-leaf lettuce) 2.95 STMR leafy brassica (JMPR Report boscalid 2010) Fresh herbs 10 STMR (EFSA, Legume vegetables (except rhubarb) 0.5 STMR (EFSA, Rhubarb 1.2 STRM (intended use) Celery 8.45 STMR (EFSA, Leek 2.2 STMR (EFSA, Dry beans STMR (EFSA, Dry peas 0.21 STMR (EFSA, Page 7 / 20

27 Signum /22 Part B - Section 4 - Core Assessment zrms version Oilseeds STMR (EFSA, Barley, oats 0.92 STMR (EFSA, Wheat, rye 0.05 STMR (EFSA, Sugar beet, chicory roots Swine and ruminant meat STMR (EFSA, 0.04 STMR (EFSA, Swine and ruminant fat 0.18 STMR (EFSA, Swine and ruminant liver 0.12 Swine and ruminant kidney Swine and ruminant edible offal, other than liver and kidney STMR (EFSA, 0.16 STMR (EFSA, 0.12 STMR (EFSA, Milk STMR (EFSA, all other commodities various MRL The toxicological reference values and all input values used for consumer risk assessment are stated in Table To illustrate the results of the chronic risk assessment, a screenshot of the IEDI results obtained with EFSA PRIMO is displayed in Appendix 3. Table 4.3-2: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8) Chronic risk assessment ADI TMDI (% ADI) according to EFSA PRIMo NTMDI (% ADI) according to German NVS II 0.04 mg/kg bw 247 % (based on NL Children) 246 % (based on DE children aged 2-4 years) IEDI (% ADI) according to EFSA PRIMo rev.2 58 % (based on WHO Cluster diet B) NEDI (% ADI) according to German NVS II Factors included in IEDI and NEDI See table Acute risk assessment 56 % (based on DE children aged 2-4 years) ARfD IESTI (% ARfD) according to EFSA PRIMo rev.2 NESTI (% ARfD) according to German NVS II Factors included in IESTI and NESTI not necessary not allocated not applicable not applicable not applicable Pyraclostrobin The key data for consumer intake assessment, which have been derived from residue and/or processing studies for the intended uses, are summarized in Table Page 8 / 20

28 Signum /22 Part B - Section 4 - Core Assessment zrms version Table 4.3-3: Key data for consumer intake assessment derived for the intended uses Commodity Long-term intake Input value (mg/kg) Comment Short-term intake Input value (mg/kg) Rhubarb 0.12 STMR 2.6 HR Comment other commodities various MRL - not relevant The toxicological reference values and all input values used for consumer risk assessment are stated in Table To illustrate the results of the chronic risk assessment, a screenshot of the TMDI and NESTI results obtained with EFSA PRIMo is displayed in Appendix 3. Table 4.3-4: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8) Chronic risk assessment ADI TMDI (% ADI) according to EFSA PRIMo NTMDI (% ADI) according to German NVS II IEDI (% ADI) according to EFSA PRIMo rev.2 NEDI (% ADI) according to German NVS II Factors included in IEDI and NEDI Acute risk assessment ARfD IESTI (% ARfD) according to EFSA PRIMo rev.2 NESTI (% ARfD) according to German NVS II Factors included in IESTI and NESTI 0.03 mg/kg bw 77 % (based on DE children, mean body weight) 83 % (based on DE children, individual consumption/body weight ratio) Not conducted Not conducted n/a 0.03 mg/kg bw Rhubarb: 322 % (based on UK toddler, mean body weight) Rhubarb, raw: 432 % (based on DE children, individual consumption/body weight ratio) Rhubarb, processed: 270 % (based on DE children, individual consumption/body weight ratio) None. It is assumed that a reduction or concentration of residues during processing does not occur (refer to results from canning of cherries, PF = 1). 4.4 Proposed maximum residue levels (MRLs) The existing EU MRLs and proposals for new MRLs for the crops applied for in this dossier are summarized in Table Table 4.4-1: Overview of the existing EC MRLs and new MRL proposals for boscalid in rhubarb Commodity (Code) Boscalid Existing EC MRL (mg/kg) Proposed EC MRL (mg/kg) Result of OECD calculator (mg/kg) Justification for the proposal/ Comments Rhubarb The MRL proposal is sufficiently supported by data and no risk for consumers was identified. Extrapolation from celery trials. Page 9 / 20

29 Signum /22 Part B - Section 4 - Core Assessment zrms version Commodity (Code) Pyraclostrobin Existing EC MRL (mg/kg) Proposed EC MRL (mg/kg) Result of OECD calculator (mg/kg) Justification for the proposal/ Comments Rhubarb 0.02* - - An acute risk for consumers cannot be excluded, therefore no proposal was made. 4.5 Conclusion Boscalid Field trials on celery which can be extrapolated to rhubarb show that residues of boscalid were in the range of 0.17 to 14 mg/kg. Thus, an exceedance of the current MRL of 0.5 mg/kg for boscalid in rhubarb as laid down in Reg. (EU) 396/2005 is likely and a new MRL is necessary. An adequate application for MRL modification (30 mg/kg) was already submitted by the applicant to France. The long-term and the short-term intake of boscalid residues are unlikely to present a public health concern. Pyraclostrobin Field trials on celery which can be extrapolated to rhubarb show that residues of pyraclostrobin were in the range of 0.05 to 2.6 mg/kg. Thus, an exceedance of the current MRL of 0.02* mg/kg for pyraclostrobin in rhubarb as laid down in Reg. (EU) 396/2005 is likely and a new MRL is necessary. An adequate application for MRL modification (5 mg/kg) was already submitted by the applicant (BASF) to France. However, residues at the level of this proposed MRL are not safe for consumers! The long-term intake of pyraclostrobin residues is unlikely to present a public health concern. However, the estimation of the short-term dietary intake of pyraclostrobin residues results in a clear exceedance of the ARfD in rhubarb (>300 % for UK toddler according to EFSA PRIMo model and > 400% for DE children, individual consumption/body weight ratio according to German NVS II model) and thus a health risk for consumers cannot be excluded. Based on the information on processing from the MRL review for pyraclostrobin, a reduction of residues during processing does not occur (PF = 1 for canned cherries). As far as consumer health protection is concerned, BfR/Germany agrees with the authorization of the intended use 002 on rhubarb after harvest since this use is not relevant in terms of residues, but does not agree with the authorization of the intended use 001, because an acute health risk for consumers cannot be excluded for this use. Appendix 1 List of data submitted in support of the evaluation Table A 1: List of data submitted in support of the evaluation Annex point/ reference No Author(s) Year Title Report-No. Authority registration No All EFSA 2010 Reasoned Opinion - Modification of the existing MRLs for Boscalid in various crops EFSA Journal 2010;8(9):1780 ASB Data protection claimed Owner How considered in drr * Add Page 10 / 20

30 Signum /22 Part B - Section 4 - Core Assessment zrms version Annex point/ reference No Author(s) Year Title Report-No. Authority registration No All EFSA 2011 Reasoned opinion - Review of the existing MRLs for Pyraclostrobin according to Article 12 of Regulation (EC) No 396/2005 EFSA Journal 2011;9(8):2344 ASB All Germany 2001 Pyraclostrobin (Monograph) GLP: Open Published: Yes ASB All Germany 2002 Boscalid (Monograph) GLP: Open Published: Yes ASB OECD KIIA 6.3 Anon Residue behaviour af Boscalid and Pyraclostrobin in/on celery and celeriac after outdoor application of Signum, BAS 516 F (WG 33,4, 267 g/kg Boscalid, 67 g/kg Pyraclostrobin) in Germany, / ! RU-F HE WE 1/1! R-WZ ! RU-F BY FS 1/1! RU-F TH EF 1/1! RU-F HE WE 2/1! R-WZ ! RU-F RP NW 2/1! RU-F TH EF 2/1! AP 07/07 GLP: Yes Published: No BVL , BVL , BVL , BVL , BVL , BVL , ASB OECD KIIA 6.3 Anon Boscalid + Pyraclostrobin / Signum: Residue summary from supervised field trials GLP: No Published: No BVL , ASB OECD KIIA 6.3 Schulz, H.; Ziske, J Study on the residue behaviour of Boscalid and Pyraclostrobin in bleached celery after treatment with BAS F under field conditions in Germany, Denmark, Italy and Spain, ! 2010/ GLP: Yes Published: No BVL , ASB OECD KIIA 6.3 Weber, S Investigation of the residue behaviour of BAS F (Signum) in lamb's lettuce, kohlrabi, parsley, radish, celeriac, celery, spinach and welsh onion, onion, common cabbage, raspberries and currants 2006/ ! GLP: Yes Published: No BVL , BVL , 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 Open Open Owner Yes BAS Y Yes BAS Y Yes BAS Y Yes BAS Y How considered in drr * Add Add Add 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 11 / 20

31 A Magnitude of residues in rhubarb Reference: OECD KIIA 6.3 Report Guideline(s): Deviations: GLP: Acceptability: Table A 2: Residues of boscalid in celery see authority registration numbers cited in the remarks columns of the tables below (and study identification as laid down in the reference list) in accordance with agreed guidance unless stated otherwise in the commenting box no relevant deviations unless stated otherwise in the commenting box see reference list acceptable unless stated otherwise in the commenting box RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Boscalid (Application on agricultural and horticultural crops) Crop / crop group : Celery Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 267 g/kg Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : WG (Water dispersible granule) Other a.i. in formulation Commercial product (name) : Signum (content and common name) : 67 g/kg Pyraclostrobin Applicant : BASF SE Residues calculated as : Boscalid Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date 2006/ ; , RU-F RP NW 1/1 Germany (DE) Schifferstadt Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) Tango 1) ) n/a stem ) spraying (planting) ) ) 3) analytical method: BASF No. 445/0 (HPLC-MS/MS), LOQ(s): 0.05 mg/kg (stem), max. sample storage time in month(s): 5 RIP ASB ASB Page 12 / 20

32 Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date 2006/ ; , RU-F RP NW 1/2 Germany (DE) Schifferstadt Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) Tango 1) ) n/a stem ) spraying (planting) ) ) 3) analytical method: BASF No. 445/0 (HPLC-MS/MS), LOQ(s): 0.05 mg/kg (stem), max. sample storage time in month(s): 5 RIP ASB ASB Comments of zrms: Acceptable. Page 13 / 20

33 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Boscalid (Application on agricultural and horticultural crops) Crop / crop group : Celery Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 267 g/kg Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : WG (Water dispersible granule) Other a.i. in formulation Commercial product (name) : Signum (content and common name) : 67 g/kg Pyraclostrobin Applicant : BASF SE Residues calculated as : Boscalid Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date 2008/ , RU-F HE WE 2/1 Germany (DE) Butzbach / , RU-F RP NW 2/1 Germany (DE) Schifferstadt / , RU-F TH EF 2/1 Germany (DE) Erfurt Comments of zrms: Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) Tango 1) ) BBCH stem ) spraying (planting) ) ) ) Tango 1) (planting) 2) 3) no data 1) (sowing) (planting) 2) 3) Acceptable ) ) ) ) n/a stem leaf-stage stem RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Boscalid Page 14 / analytical method: SOP 5502 (HPLC-MS/MS), LOQ(s): 0.05 mg/kg (stem), max. sample storage time in month(s): 4 ASB ASB ) spraying analytical method: SOP 5502 (HPLC-MS/MS), LOQ(s): 0.05 mg/kg (stem), max. sample storage time in month(s): 5 ASB ASB ) spraying analytical method: SOP 5502 (HPLC-MS/MS), LOQ(s): 0.05 mg/kg (stem), max. sample storage time in month(s): 4 ASB ASB

34 (Application on agricultural and horticultural crops) Crop / crop group : Celery Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 267 g/l Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : WG (Water dispersible granule) Other a.i. in formulation Commercial product (name) : BAS F (content and common name) : 67 g/l Pyraclostrobin Applicant : BASF SE Residues calculated as : Boscalid Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date BASF 2010/ , L Germany (DE) Düsseldorf BASF 2010/ , L Denmark (DK) 4930 Maribo Lolland, Sjaelland Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) Viktoria 1) ) BBCH 45 stalk (with ) spraying (sowing) ) foliage) ) ) Imperial 1) (sowing) 2) 3) ) ) BBCH 48 stalk (with foliage) analytical method: BASF No. 535/1 (HPLC-MS/MS), LOQ(s): 0.01 mg/kg (stalk), max. sample storage time in month(s): 7 ASB ASB ) spraying analytical method: BASF No. 535/1 (HPLC-MS/MS), LOQ(s): 0.01 mg/kg (stalk), max. sample storage time in month(s): 9 ASB ASB Comments of zrms: Acceptable. Page 15 / 20

35 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Pyraclostrobin (Application on agricultural and horticultural crops) Crop / crop group : Celery Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 67 g/kg Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : WG (Water dispersible granule) Other a.i. in formulation Commercial product (name) : Signum (content and common name) : 267 g/kg Poscalid Applicant : BASF SE Residues calculated as : 8.1 Pyraclostrobin 8.2 BF 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 2006/ ; , RU-F RP NW 1/1 Germany (DE) Schifferstadt Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) Tango 1) ) n/a stem ) spraying (planting) ) ) 3) analytical method: BASF No. 445/0 (HPLC- MS/MS), LOQ(s): 0.02 mg/kg, max. sample storage time in month(s): RIP ASB ASB / ; , RU-F RP NW 1/2 Germany (DE) Schifferstadt Tango 1) (planting) 2) 3) ) ) n/a stem ) spraying analytical method: BASF No. 445/0 (HPLC- MS/MS), LOQ(s): 0.02 mg/kg, max. sample storage time in month(s): RIP ASB ASB Comments of zrms: Acceptable. Page 16 / 20

36 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Pyraclostrobin (Application on agricultural and horticultural crops) Crop / crop group : Celery Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 67 g/kg Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : WG (Water dispersible granule) Other a.i. in formulation Commercial product (name) : Signum (content and common name) : 267 g/kg Boscalid Applicant : BASF SE Residues calculated as : Pyraclostrobin Commodity/ Application Portion Residues PHI Remarks Variety rate per treatment analysed (mg/kg) (days) Report-No. Location incl. Postal code and date 2008/ , RU-F HE WE 2/1 Harvest trial Germany (DE) Butzbach / , RU-F RP NW 2/1 Harvest trial Germany (DE) Schifferstadt / , RU-F TH EF 2/1 Harvest trial Germany (DE) Erfurt Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) Tango 1) ) BBCH stem ) spraying (planting) ) ) ) Tango 1) (planting) 2) 3) no data 1) (sowing) (planting) 2) 3) ) ) ) ) n/a stem leaf-stage stem analytical method: SOP 5502 (HPLC-MS/MS), LOQ(s): 0.01 mg/kg (stem), max. sample storage time in month(s): 4 ASB ASB ) spraying analytical method: SOP 5502 (HPLC-MS/MS), LOQ(s): 0.01 mg/kg (stem), max. sample storage time in month(s): 5 ASB ASB ) spraying analytical method: SOP 5502 (HPLC-MS/MS), LOQ(s): 0.01 mg/kg (stem), max. sample storage time in month(s): 6 ASB ASB Comments of zrms: Acceptable. Page 17 / 20

37 RESIDUES DATA SUMMARY FROM SUPERVISED TRIALS (SUMMARY) Active ingredient : Pyraclostrobin (Application on agricultural and horticultural crops) Crop / crop group : Celery Federal Institute for Risk Assessment, Berlin Federal Republic of Germany Submission date : Content of a.i. (g/kg or g/l) : 67 g/l Indoors / Outdoors : Outdoors (European North) Formulation (e.g. WP) : WG (Water dispersible granule) Other a.i. in formulation Commercial product (name) : BAS F (content and common name) : 267 g/l Boscalid Applicant : BASF SE Residues calculated as : 8.1 Pyraclostrobin 8.2 BF 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 BASF 2010/ , L Germany (DE) Düsseldorf BASF 2010/ , L Denmark (DK) 4930 Maribo Lolland, Sjaelland Date of 1) Sowing or planting 2) Flowering 3) Harvest Dates of treatments or no. of treatments and last date Growth stage at last treatment or date kg a.i./ha Water l/ha kg a.i./hl (a) (b) (c) (a) (d) (e) Viktoria 1) ) BBCH 45 stalk (with (sowing) ) foliage) 0.24 < ) 0.10 < ) < Imperial 1) (sowing) 2) 3) ) ) BBCH 48 stalk (with foliage) 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 Comments of zrms: Acceptable ) spraying analytical method: BASF No. 535/1 (HPLC- MS/MS), LOQ: 0.01 mg/kg max. sample storage time in month(s): 7 ASB ASB ) spraying analytical method: BASF No. 535/1 (HPLC- MS/MS), LOQ: 0.01 mg/kg max. sample storage time in month(s): 9 ASB ASB Page 18 / 20

38 A 2.3 Residues in processed commodities No new study on residues in processed commodities has been submitted and none is needed due to low residues at harvest. A 2.4 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 None Other studies/information Appendix 3 Pesticide Residue Intake Model (PRIMo rev.2) A 3.1 IEDI calculation for boscalid Page 19 / 20

39 A 3.2 TMDI and NESTI calculation for pyraclostrobin Page 20 / 20