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

Transkript

1 Part A National Assessment Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Draft Registration Report Central Zone Country Germany Page 1 of 11 Art. 51 Extension of authorisation for minor uses REGISTRATION REPORT Part A Risk Management Product code: Active Substances: Fatty acids potassium salts (CAS ) 515 g/l COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT Applicant: Landwirtschaftskammer Niedersachsen - Pflanzenschutzamt FB 3.7 Date: 12/03/2015 BVL_FO_05_2422_200_V1.0 Applicant Landwirtschaftskammer Niedersachsen Pflanzenschutzamt Date: 12/03/2015

2 Part A National Assessment Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Draft Registration Report Central Zone Country Germany Page 2 of 11 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 1272/ R and S phrases under Regulation (EC) No 547/ 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 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 Landwirtschaftskammer Niedersachsen Pflanzenschutzamt Date: 12/03/2015

3 Part A National Assessment Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Draft Registration Report Central Zone Country Germany Page 3 of 11 PART A Risk Management This document describes the acceptable use conditions required for extension of the registration of containing Fatty acids C7-C18 and C18 unsaturated potassium salts (CAS ) 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 have been made using endpoints agreed in the EU reviews of Fatty acids C7-C18 and C18 unsaturated potassium salts (CAS ). 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 Registration number /02 Zonal application according to Article 51, ZRMS = DE, first application (GV1) Applicant Landwirtschaftskammer Niedersachsen - Pflanzenschutzamt FB 3.7, Wunstorfer Landstraße 9, Hannover, Deutschland Authorisation holder Function Type of formulation W. NEUDORFF GMBH KG, An der Mühle 3, Emmerthal Insecticide Expiration of authorisation Soluble concentrate (SL) BVL_FO_05_2422_200_V1.0 Applicant Landwirtschaftskammer Niedersachsen Pflanzenschutzamt Date: 12/03/2015

4 Part A National Assessment Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Draft Registration Report Central Zone Country Germany Page 4 of Annex I inclusion The active substances included in the plant protection product are approved according Regulation (EC) No 1107/2009. The present application is in line with the provisions of the approvals. Active substance (BVL Number) Fatty acids C7-C18 and C18 unsaturated potassium salts (CAS ) (0653) Content in PPP 515 g/l Approval status Approved according Regulation (EC) No 1107/2009 Approval Regulation (EC) No 540/2011 Expiration of approval 31/08/ 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 field bean sucking insects Authorise 002 field pea sucking insects Authorise 003 lupin species (field) sucking insects Authorise Public interest and minor use 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 field bean is about 8600 ha, of which approx. 860 ha need to be controlled. The cultivated area of field pea is about 9000 ha, of which approx. 900 ha need to be controlled and the cultivated area of lupin species is about 9000 ha, of which approx. 900 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 use(s) it can be stated that the applied use(s) is minor in nature and the authorisation is in the public interest. BVL_FO_05_2422_200_V Data protection claims The applicant is owner of the new studies submitted and claims data protection. Applicant Landwirtschaftskammer Niedersachsen Pflanzenschutzamt Date: 12/03/2015

5 Part A National Assessment Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Draft Registration Report Central Zone Country Germany Page 5 of Letters of Access Not necessary since a national Ordinance (Pflanzenschutzmittelverordnung) allows to use the data submitted in support of the authorisation. 2 Details of the authorisation 2.1 Product identity Product name Authorisation number Composition Fatty acids C7-C18 and C18 unsaturated potassium salts (CAS ) 515 g/l Type of formulation Function Authorisation holder Soluble concentrate (SL) Insecticide 2.2 Classification and labelling W. NEUDORFF GMBH KG, An der Mühle 3, Emmerthal Classification and labelling under Directive 99/45/EC or Regulation (EC) No 1272/2008 Xi R 38 S 2 S 36/37 S46 SP001 Irritant Irritating to skin Keep out of the reach of children. Wear suitable protective clothing and gloves. If swallowed, seek medical advice immediately and show this container or label. To avoid risks to man and the environment, comply with the instructions for use R and S phrases under Regulation (EC) No 547/2011 SPo 5 Treated areas may not be entered until spray coating has dried Other phrases Restrictions linked to the PPP The authorisation of the PPP is linked to the following conditions (mandatory labelling): BVL_FO_05_2422_200_V1.0 Human health protection SB001 SB110 SS110 Avoid any unnecessary contact with the product. Misuse can lead to health damage. The directive concerning requirements for personal protective gear in plant protection, "Personal protective gear for handling plant protection products" of the Federal Office of Consumer Protection and Food Safety must be observed. Wear standard protective gloves (plant protection) when handling the undiluted product. Applicant Landwirtschaftskammer Niedersachsen Pflanzenschutzamt Date: 12/03/2015

6 Part A National Assessment Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Draft Registration Report Central Zone Country Germany Page 6 of 11 SS2101 Wear a protective suit against pesticides and sturdy shoes (e. g. rubber boots) when handling the undiluted product. Ecosystem protection NW263 NW468 Honeybee The product is toxic for aquatic invertebrates. Fluids left over from application and their remains, products and their remains, empty containers and packaging, and cleansing and rinsing fluids must not be dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and to rain-water and sewage canals. Integrated Pest Management (IPM) NN280 The product is classified as slightly harmful for populations of the species Trichogramma cacoeciae (chalcid wasp). NN3323 The product is classified as harmful for populations of the species Amblyseius andersoni (predatory mite). NN390 The product is classified as harmful for populations of the species Syrphus corollae (hover fly). Mode of action (FRAC/HRAC/IRAC-Group): unknown Active substance none The authorisation 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) Specific restrictions linked to the intended uses Some of the authorised uses are linked to the following conditions (mandatory labelling): See 2.3 (Product uses) BVL_FO_05_2422_200_V1.0 Ecosystem protection NW609-1 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 observing the minimum buffer zone stated below. It is not necessary to observe this buffer zone if the product is applied using equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette No 205, p. 9780) as amended. Irrespective of this, 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. Violations may be punished by fines of up to EUR. 5 m Uses: Applicant Landwirtschaftskammer Niedersachsen Pflanzenschutzamt Date: 12/03/2015

7 Part A National Assessment Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Draft Registration Report Central Zone Country Germany Page 7 of Product uses PPP (product name/code) ( ) active substance 1 Fatty acids C7-C18 and C18 unsaturated potassium salts (CAS ) Formulation type: Conc. of as 1: SL 515 g/l Applicant: Landwirtschaftskammer Niedersachsen - Pflanzenschutzamt - Fachbereich Zone(s): central EU Verified by MS: j professional use non professional use Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) F G or I Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Method / Kind Application Application rate PHI Max. number kg, L product / g, kg as/ha Water L/ha (days) (min. interval ha between a) max. rate per a) max. rate min / max applications) appl. per appl. a) per use Timing / Growth stage of crop & season b) per crop/ season b) max. total rate per crop/season b) max. total rate per crop/season Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures 001 DE field bean (VICFM) F sucking insects (ISXXXX) spraying after reaching thresholds or after warning service appeal a) 2 (treatments must be at least 7 days apart) b) 2 (treatments must be at least 7 days apart) a) 18 L/ha b) 36 L/ha a) 9,2 kg as/ha b) 18,54 kg as/ha 800 F Restrictions (see ) NW609-1 (5 m) According to the comment of the JKI a reduced application rate of a) 18 L/ha and b) 36 L/ha (both in at least 800 L water) is also effective BVL_FO_05_2422_200_V DE field pea (PIBSA) F sucking insects (ISXXXX) spraying after reaching thresholds or after warning a) 2 (treatments must be at a) 18 L/ha b) 36 L/ha a) 9,2 kg as/ha 800 F NW609-1 (5 m) According to the comment of the JKI a reduced application Applicant Landwirtschaftskammer Niedersachsen Pflanzenschutzamt Date: 12/03/2015

8 Part A National Assessment Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Draft Registration Report Central Zone Country Germany Page 8 of 11 service appeal least 7 days apart) b) 2 b) 18,54 kg as/ha rate of a) 18 L/ha and b) 36 L/ha (both in at least 800 L water) is also effective (treatments must be at least 7 days apart) 003 DE lupin species (LUPSS) F sucking insects (ISXXXX) spraying after reaching thresholds or after warning service appeal a) 2 (treatments must be at least 7 days apart) b) 2 a) 18 L/ha b) 36 L/ha a) 9,2 kg as/ha b) 18,54 kg as/ha 800 F NW609-1 (5 m) According to the comment of the JKI a reduced application rate of a) 18 L/ha and b) 36 L/ha (both in at least 800 L water) is also effective (treatments must be at least 7 days apart) BVL_FO_05_2422_200_V1.0 Applicant Landwirtschaftskammer Niedersachsen Pflanzenschutzamt Date: 12/03/2015

9 Part A National Assessment Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Draft Registration Report Central Zone Country Germany Page 9 of 11 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 Not relevant with regards to consumer health protection Mammalian Toxicology If the product is 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 No specific MRLs are listed and required for the active ingredient. The intended uses are not relevant regarding consumer health protection Consumer exposure If the technical material complies with food grade specification no unacceptable risk is to be expected for consumers. The fatty acids to which consumers may be exposed as a result of the use in plant protection products is considered negligible compared to normal dietary intake of fatty acids Environmental fate and behaviour No new studies were presented; all data were reviewed within the EU review for the active substance potassium salts of fatty acids and the national authorisation procedure for the product Neudosan Neu Blattlausfrei ( /00) and assessed according to the uniform principles of directive 91/414/EEC. The environmental risk due to the minor use extensions applied for (spray application in field beans, field peas and lupins) is covered by the risk assessment for the uses included in the original authorisation (amongst others: spray application in vegetable and fruit crops). Neither accumulation in soil nor leaching to groundwater of the active substance or relevant metabolites in concentrations above 0.1 µg/l has to be expected. Additional risk mitigation measures are not required. BVL_FO_05_2422_200_V Ecotoxicology No new studies were presented; all data were reviewed within the EU review for the active substance potassium salts of fatty acids and the national authorisation procedure for the product Neudosan Neu Blattlausfrei ( /00) and assessed according to the uniform principles of directive 91/414/EEC. Applicant Landwirtschaftskammer Niedersachsen Pflanzenschutzamt Date: 12/03/2015

10 Part A National Assessment Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Draft Registration Report Central Zone Country Germany Page 10 of 11 The environmental risk due to the minor use extensions applied for (spray application in field beans, field peas and lupins) is covered by the risk assessment for the uses included in the original authorisation (amongst others: spray application in vegetable and fruit crops). Toxicity exposure ratios (TER) calculated for the exposure of aquatic organisms via spray drift show for the field spray uses in orchards an acceptable risk only considering specific additional risk mitigation measures. For the intended uses with 2 x 18 L product/ha drift reducing technique or untreated buffer zones have to be considered for the protection of aquatic organisms (conventional application technique: 5 m; with drift reduction: 1 m label restriction NW609-1) to achieve the required TER of 10 (relevant ecotoxicological endpoint: NOEC Daphnia magna = 500 µg a.i./l). Additional specific risk mitigation measures for the protection of other groups of non-target organisms are not required. The product as well as the active substance potassium salts of fatty acids is toxic to the aquatic environment. Therefore, additional labelling with risk phrases (NW263) and safety phrases (NW468) is assigned, particularly to encourage prevention of any point source entry into surface waters; see also 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 uses 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 uses 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. BVL_FO_05_2422_200_V Conclusions PPP 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). If used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected. There is no special risk mitigation necessary, which deviates from the existing registration. With regards to residue behaviour the extension of the uses does not represent an additional consumer or animal health risk. Considering the minor use extensions applied for neither harmful effects on groundwater nor unacceptable effects on the environment have to be apprehended as a consequence of proper use Applicant Landwirtschaftskammer Niedersachsen Pflanzenschutzamt Date: 12/03/2015

11 Part A National Assessment Art. 51 Extension of authorisation for minor uses BVL Registration Number: /02 Draft Registration Report Central Zone Country Germany Page 11 of 11 consistent with good plant protection practice. For the protection of aquatic organisms specific additional risk mitigation measures are required. An authorisation has been recommended for all uses. 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 owner of the new studies submitted. BVL_FO_05_2422_200_V1.0 Applicant Landwirtschaftskammer Niedersachsen Pflanzenschutzamt Date: 12/03/2015

12 Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dienstsitz Braunschweig Postfach Braunschweig Dr. Susanne Luttmann Referentin Landwirtschaftskammer Niedersachsen - Pflanzenschutzamt - Fachbereich Wunstorfer Landstraße Hannover IHR ZEICHEN IHRE NACHRICHT VOM TELEFON +49 (0) TELEFAX +49 (0) susanne.luttmann@bvl.bund.de AKTENZEICHEN / (bitte bei Antwort angeben) DATUM 10. März 2015 GV /02 Verfahren zur Erweiterung einer Zulassung nach Artikel 51 Abs. 1 der Verordnung (EG) Nr. 1107/2009 Bescheid Die Zulassung des oben genannten Pflanzenschutzmittels mit dem Wirkstoff: 515 g/l Fettsäuren, Kaliumsalze (Kali-Seife) Zulassungsnummer: Versuchsbezeichnungen: NEU AI-0-SL Antrag vom: 6. Dezember 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 Anwendungsnummer Zweckbestimmung Objekte Schadorganismus/ Pflanzen/-erzeugnisse/ / Saugende Insekten Ackerbohne Verwendungszweck Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet:

13 SEITE 2 VON 9 Anwendungsnummer Zweckbestimmung Objekte Schadorganismus/ Pflanzen/-erzeugnisse/ / Saugende Insekten Futtererbse / Saugende Insekten Lupine-Arten 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): - keine - BVL_FO_05_2468_200_V1.3

14 SEITE 3 VON 9 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 kommissarischer Abteilungsleiter Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig. Anlage BVL_FO_05_2468_200_V1.3

15 SEITE 4 VON 9 Anlage 1 zugelassene Anwendung: / Anwendungsgebiet Schadorganismus/Zweckbestimmung: Saugende Insekten Pflanzen/-erzeugnisse/Objekte: Ackerbohne Verwendungszweck: 2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: Anwendung im Haus- und Kleingartenbereich: Anwendungszeitpunkt: Ackerbau Freiland Nein Nach Erreichen von Schwellenwerten oder nach Warndienstaufruf Maximale Zahl der Behandlungen - in dieser Anwendung: 2 - für die Kultur bzw. je Jahr: 2 - Erläuterungen Anzahl Behandlungen: zeitlicher Abstand der Behandlungen mindestens 7 Tage Anwendungstechnik: spritzen Aufwand: - 18 l/ha in 800 l Wasser/ha 2.2 Sonstige Kennzeichnungsauflagen - keine Wartezeiten (F) Freiland: Ackerbohne 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 (NW609-1) Die Anwendung des Mittels auf Flächen in Nachbarschaft von Oberflächengewässern - ausgenommen nur gelegentlich wasserführende, aber einschließlich periodisch wasserführender Oberflächengewässer - muss mindestens mit unten genanntem Abstand erfolgen. Dieser Abstand muss nicht eingehalten werden, wenn die Anwendung mit einem Gerät erfolgt, das

16 SEITE 5 VON 9 in das Verzeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung eingetragen ist. Unabhängig davon ist, neben dem gemäß Länderrecht verbindlich vorgegebenen Mindestabstand zu Oberflächengewässern, das Verbot der Anwendung in oder unmittelbar an Gewässern in jedem Fall zu beachten. Zuwiderhandlungen können mit einem Bußgeld bis zu Euro geahndet werden. 5 m Begründung: Unter Berücksichtigung der geltenden Abdrifteckwerte und der bewertungsrelevanten Toxizität des Mittels "" (Daphnia magna NOEC = 0,5 mg a.i./l) errechnen sich für die beantragten Indikationen des Pflanzenschutzmittels im Ackerbau Initialkonzentrationen im Oberflächengewässer, die nur unter Berücksichtigung risikomindernder Maßnahmen zu akzeptablen TER-Werten führen. Bei Nichteinhaltung der mit der Anwendungsbestimmung NW609-1 definierten Maßgaben führen die Einträge des Mittels "Neudosan Neu Blattlausfrei" in Oberflächengewässer und die hieraus resultierenden Konzentrationen auch bei sachgerechter und bestimmungsgemäßer Anwendung zu einer Unterschreitung des erforderlichen Toxizitäts-Expositions-Verhältnisses (hier TER = 10). Die Einhaltung der Maßgaben ist zur Herstellung der Zulassungsvoraussetzungen durchsetzbar vorzuschreiben, da andernfalls unvertretbare Auswirkungen auf den Naturhaushalt nicht auszuschließen sind und somit der Schutz der Gewässer nicht gewährleistet ist. BVL_FO_05_2468_200_V1.3

17 SEITE 6 VON 9 Anlage 1 zugelassene Anwendung: / Anwendungsgebiet Schadorganismus/Zweckbestimmung: Saugende Insekten Pflanzen/-erzeugnisse/Objekte: Futtererbse Verwendungszweck: 2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: Anwendung im Haus- und Kleingartenbereich: Anwendungszeitpunkt: Ackerbau Freiland Nein Nach Erreichen von Schwellenwerten oder nach Warndienstaufruf Maximale Zahl der Behandlungen - in dieser Anwendung: 2 - für die Kultur bzw. je Jahr: 2 - Erläuterungen Anzahl Behandlungen: zeitlicher Abstand der Behandlungen mindestens 7 Tage Anwendungstechnik: spritzen Aufwand: - 18 l/ha in 800 l Wasser/ha 2.2 Sonstige Kennzeichnungsauflagen - keine Wartezeiten (F) Freiland: Futtererbse 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 (NW609-1) Die Anwendung des Mittels auf Flächen in Nachbarschaft von Oberflächengewässern - ausgenommen nur gelegentlich wasserführende, aber einschließlich periodisch wasserführender Oberflächengewässer - muss mindestens mit unten genanntem Abstand erfolgen. Dieser Abstand muss nicht eingehalten werden, wenn die Anwendung mit einem Gerät erfolgt, das

18 SEITE 7 VON 9 in das Verzeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung eingetragen ist. Unabhängig davon ist, neben dem gemäß Länderrecht verbindlich vorgegebenen Mindestabstand zu Oberflächengewässern, das Verbot der Anwendung in oder unmittelbar an Gewässern in jedem Fall zu beachten. Zuwiderhandlungen können mit einem Bußgeld bis zu Euro geahndet werden. 5 m Begründung: Unter Berücksichtigung der geltenden Abdrifteckwerte und der bewertungsrelevanten Toxizität des Mittels "" (Daphnia magna NOEC = 0,5 mg a.i./l) errechnen sich für die beantragten Indikationen des Pflanzenschutzmittels im Ackerbau Initialkonzentrationen im Oberflächengewässer, die nur unter Berücksichtigung risikomindernder Maßnahmen zu akzeptablen TER-Werten führen. Bei Nichteinhaltung der mit der Anwendungsbestimmung NW609-1 definierten Maßgaben führen die Einträge des Mittels "Neudosan Neu Blattlausfrei" in Oberflächengewässer und die hieraus resultierenden Konzentrationen auch bei sachgerechter und bestimmungsgemäßer Anwendung zu einer Unterschreitung des erforderlichen Toxizitäts-Expositions-Verhältnisses (hier TER = 10). Die Einhaltung der Maßgaben ist zur Herstellung der Zulassungsvoraussetzungen durchsetzbar vorzuschreiben, da andernfalls unvertretbare Auswirkungen auf den Naturhaushalt nicht auszuschließen sind und somit der Schutz der Gewässer nicht gewährleistet ist. BVL_FO_05_2468_200_V1.3

19 SEITE 8 VON 9 Anlage 1 zugelassene Anwendung: / Anwendungsgebiet Schadorganismus/Zweckbestimmung: Saugende Insekten Pflanzen/-erzeugnisse/Objekte: Lupine-Arten Verwendungszweck: 2 Kennzeichnungsauflagen 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: Anwendung im Haus- und Kleingartenbereich: Anwendungszeitpunkt: Ackerbau Freiland Nein Nach Erreichen von Schwellenwerten oder nach Warndienstaufruf Maximale Zahl der Behandlungen - in dieser Anwendung: 2 - für die Kultur bzw. je Jahr: 2 - Erläuterungen Anzahl Behandlungen: zeitlicher Abstand der Behandlungen mindestens 7 Tage Anwendungstechnik: spritzen Aufwand: - 18 l/ha in 800 l Wasser/ha 2.2 Sonstige Kennzeichnungsauflagen - keine Wartezeiten (F) Freiland: Lupine-Arten 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 (NW609-1) Die Anwendung des Mittels auf Flächen in Nachbarschaft von Oberflächengewässern - ausgenommen nur gelegentlich wasserführende, aber einschließlich periodisch wasserführender Oberflächengewässer - muss mindestens mit unten genanntem Abstand erfolgen. Dieser Abstand muss nicht eingehalten werden, wenn die Anwendung mit einem Gerät erfolgt, das

20 SEITE 9 VON 9 in das Verzeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung eingetragen ist. Unabhängig davon ist, neben dem gemäß Länderrecht verbindlich vorgegebenen Mindestabstand zu Oberflächengewässern, das Verbot der Anwendung in oder unmittelbar an Gewässern in jedem Fall zu beachten. Zuwiderhandlungen können mit einem Bußgeld bis zu Euro geahndet werden. 5 m Begründung: Unter Berücksichtigung der geltenden Abdrifteckwerte und der bewertungsrelevanten Toxizität des Mittels "" (Daphnia magna NOEC = 0,5 mg a.i./l) errechnen sich für die beantragten Indikationen des Pflanzenschutzmittels im Ackerbau Initialkonzentrationen im Oberflächengewässer, die nur unter Berücksichtigung risikomindernder Maßnahmen zu akzeptablen TER-Werten führen. Bei Nichteinhaltung der mit der Anwendungsbestimmung NW609-1 definierten Maßgaben führen die Einträge des Mittels "Neudosan Neu Blattlausfrei" in Oberflächengewässer und die hieraus resultierenden Konzentrationen auch bei sachgerechter und bestimmungsgemäßer Anwendung zu einer Unterschreitung des erforderlichen Toxizitäts-Expositions-Verhältnisses (hier TER = 10). Die Einhaltung der Maßgaben ist zur Herstellung der Zulassungsvoraussetzungen durchsetzbar vorzuschreiben, da andernfalls unvertretbare Auswirkungen auf den Naturhaushalt nicht auszuschließen sind und somit der Schutz der Gewässer nicht gewährleistet ist. BVL_FO_05_2468_200_V1.3

21 /02 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: Active Substance: 515 g/l Fatty acids potassium salts Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Landwirtschaftskammer Niedersachsen Date: March 2015 Page 1 / 6

22 /02 Part B Section 4 - Core Assessment zrms version Table of Contents 4 METABOLISM AND RESIDUES DATA Evaluation of the active substances Fatty acids, potassium salts 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 Residues in primary crops Proposed pre-harvest intervals, withholding periods Consumer intake and risk assessment Proposed maximum residue levels (MRLs) Conclusion... 6 Appendix 1 List of data submitted in support of the evaluation... 6 Page 2 / 6

23 /02 Part B Section 4 - Core Assessment zrms version 4 METABOLISM AND RESIDUES DATA 4.1 Evaluation of the active substances Fatty acids, potassium salts Table 4.1-1: Identity of the active substance Structural formula Common Name CAS number CH 3(CH 2) ncooh where n= 6-18 (including unsaturated linoleic and linolenic acids) Fatty acids, potassium salts (Synonym: Fatty acids C 7 to C 18 and C 18 unsaturated potassium salts) Storage stability No studies are available and none are required (see also DAR by Ireland, ASB ) Metabolism in plants and plant residue definition(s) No studies are available and none are required (see also DAR by Ireland, ASB ). Table 4.1-2: Metabolism in plants (Annex IIA, point 6.2.1; 6.5.1, 6.5.2, and 6.7.1) Plant groups covered Rotational crops Metabolism in rotational crops similar to metabolism in primary crops? (yes/no) Distribution of the residue in peel/ pulp Processed commodities (nature of residue) Residue pattern in raw and processed commodities similar? (yes/no) Plant residue definition for monitoring Plant residue definition for risk assessment Fatty acids occur naturally and are ubiquitous in plant matrices. The metabolism in plants is well understood. Application of 14 C fatty acids would result in the incorporation of radioactivity into the carbon pool and all intermediary metabolites would become labelled to some extent. A metabolism study with 14 C fatty acids would therefore provide no useful information. No studies available and none required. Not applicable. Not applicable. No studies available and none required. Not applicable. Not required. Since fatty acids (potassium salts) are listed in Annex IV of Regulation (EC) No 396/2005, neither a residue definition nor MRLs were established. Not required Conversion factor(s) (monitoring to risk assessment) Not applicable Metabolism in livestock and animal residue definition(s) No studies are available and none are required (see also DAR by Ireland, ASB ). Page 3 / 6

24 /02 Part B Section 4 - Core Assessment zrms version Table 4.1-3: Metabolism in livestock (Annex IIA, point to and 6.7.1) Animals covered Time needed to reach a plateau concentration in milk and eggs Animal residue definition for monitoring Animal residue definition for risk assessment Fatty acids occur naturally and are ubiquitous in animal matrices. The metabolism in animals is well understood. Ingestion of 14 C fatty acids would result in the incorporation of radioactivity into the carbon pool and all intermediary metabolites would become labelled to some extent. A metabolism study with 14 C fatty acids would therefore provide no useful information. Not applicable. Not required. Since fatty acids (potassium salts) are listed in Annex IV of Regulation (EC) No 396/2005, neither a residue definition nor MRLs were established. Not required Conversion factor(s) (monitoring to risk assessment) Not applicable. Metabolism in rat and ruminant similar (yes/no) Not applicable. Fat soluble residue: (yes/no) Yes, log P ow = Residues in rotational crops No studies are available and none are required (see also DAR by Ireland, ASB ). Table 4.1-4: Residues in rotational crops (Annex IIA, point 6.6.3) Field studies Not required Residues in livestock Fatty acids occur naturally and are ubiquitous in animal matrices. Significant additional residues in livestock feed resulting from pesticide uses of fatty acids are not expected. 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 4 / 6

25 /02 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 001 DE field beans F sucking insects spraying after reaching thresholds or after warning service appeal 002 DE field pea F sucking insects spraying after reaching thresholds or after warning service appeal 003 DE lupin species F sucking insects spraying after reaching thresholds or after warning service appeal (g) Max. number (min. interval between applications) a) per use b) per crop/ season (h) a) 2 b) 2 (interval between applications: 7 d) a) 2 b) 2 (interval between applications: 7 d) a) 2 b) 2 (interval between applications: 7 d) L product / ha a) max. rate per appl. b) max. total rate per crop/season a) 27 b) 54 a) 27 b) 54 a) 27 b) 54 kg as/ha a) max. rate per appl. b) max. total rate per crop/season a)13.9 b)27.8 a)13.9 b)27.8 a)13.9 b)27.8 Water L/ha min / max 1350 N 1350 N 1350 N (days) (i) 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 5 / 6

26 /02 Part B Section 4 - Core Assessment zrms version Residues in primary crops The intended uses are not relevant in terms of consumer health protection. The submission of supervised residue trials is not necessary Proposed pre-harvest intervals, withholding periods A pre-harvest interval is not required. 4.3 Consumer intake and risk assessment Fatty acid salts will dissociate in an aqueous environment. The fatty acids to which consumers may be exposed as a result of the use in plant protection products is considered negligible compared to the normal dietary intake of fatty acids. However, the technical material needs to comply with the food grade specification. Otherwise potential toxicological issues might be raised, a complete residue data package might be needed and the consumer risk assessment through dietary intake would have to be reconsidered. 4.4 Proposed maximum residue levels (MRLs) Since fatty acids are common in physiology of living organisms, setting of MRLs is not deemed necessary. 4.5 Conclusion The data available is considered sufficient for risk assessment. The assessment was performed based on the assumption that the fatty acid salts used are of food grade quality and therefore exposure from the use as plant protection products is of low toxicological concern and no quantitative consumer risk assessment is needed. As far as consumer health protection is concerned, the BfR/Germany agrees with the authorization of the intended uses under the provision of using fatty acids of food-grade quality only. Appendix 1 List of data submitted in support of the evaluation Table A 1: Annex point/ reference No List of data submitted in support of the evaluation Author(s) Year Title Report-No. Authority registration No Anonym 2013 Fettsäuren, Kaliumsalze (Kali-Seife) / : Zusammenfassung der Guten Landwirtschaftlichen Praxis nach Anwendung von Pflanzenschutzmitteln - Ackerbohne, Futtererbse, Lupine-Arten Doc. D ASB OECD: KIIA 6.3 Anonym 2013 Übersicht Rückstandsversuche - Futterleguminosen Ackerbohne 2013 ASB OECD:KIIA 6.3 Anonym 2013 Analysenberichte für erbrachte Rückstandsuntersuchungen ASB * 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 HR1 HR1 HR1 How considered in drr * Y N N Page 6 / 6