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

Transcription

1 Part A National Assessment Cuprozin progress Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 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: Cuprozin progress Active Substance: Copper hydroxide 383 g/l COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany NATIONAL ASSESSMENT Applicant: Spiess-Urania Chemicals GmbH Date: 29/02/2016 BVL_FO_05_2422_200_V1.0 Applicant Spiess-Urania Date: 29/02/2016

2 Part A National Assessment Cuprozin progress Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Table of Contents Registration Report Central Zone Country Germany Page 2 of 13 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/ Classification and labelling under Regulation (EC) No 1272/ 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 Spiess-Urania Date: 29/02/2016

3 Part A National Assessment Cuprozin progress Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 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 Cuprozin progress containing copper hydroxide 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 3 and Section 4. Assessments for the safe use of Cuprozin progress have been made using endpoints agreed in the EU reviews of copper hydroxide. 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 Cuprozin progress Registration number /04 Applicant Authorisation holder Function Type of formulation Zonal application according to Article 51, ZRMS=DE, first application (GV1) Spiess-Urania Chemicals GmbH, Frankenstraße 18 b, Hamburg, Deutschland Spiess-Urania Chemicals GmbH, Frankenstraße 18 b, Hamburg, Deutschland Fungicide Expiration of authorisation Suspension concentrate (SC) BVL_FO_05_2422_200_V1.0 Applicant Spiess-Urania Date: 29/02/2016

4 Part A National Assessment Cuprozin progress Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 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) Copper hydroxide (0347) Content in PPP 383 g/l Approval status Approved according to Regulation (EC) No 1107/2009 Approval Regulation (EC) No 540/2011 Expiration of approval 31/01/ 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 grape vine red fire disease of grapevine (Pseudopezicula tracheiphila) 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 grape vine is about ha, of which approx ha need to be controlled. Calculation shows that authorisation holder will not profit from an authorisation of the requested use. Upon this calculation and the examination of available alternative measures for the applied use it can be stated that the applied use is minor in nature and the authorisation is in the public interest. 1.4 Data protection claims No the new studies submitted. The authorisation holder is the applicant for this application. BVL_FO_05_2422_200_V Letters of Access Not necessary. The applicant is authorisation holder. Applicant Spiess-Urania Date: 29/02/2016

5 Part A National Assessment Cuprozin progress Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Registration Report Central Zone Country Germany Page 5 of 13 2 Details of the authorisation 2.1 Product identity Product name Cuprozin progress Authorisation number Composition Type of formulation Function Authorisation holder Copper hydroxide 383 g/l Suspension concentrate (SC) Fungicide 2.2 Classification and labelling Spiess-Urania Chemicals GmbH, Frankenstraße 18 b, Hamburg, Deutschland Classification and labelling under Directive 99/45/EC or Regulation (EC) No 1272/2008 T Toxic RX023 RX041 SK012 SX001 SX002 SX013 SX026 R 23: Toxic by inhalation R41: Risk of serious damage to eyes S36/37: Wear suitable protective clothing and gloves. S 1: Keep locked away S 2: Keep out of the reach of children S13: Keep away from food, drink and animal feeding stuffs S26: In case of contact with the eyes, rinse thoroughly and seek medical advice SX039 SX045 S39: Wear eye/face protection. S45: In case of an accident, or if you feel unwell, seek medical advice immediately (where possible, show this label) SP001 To avoid riks to man and the environment, comply with the instructions for use Classification and labelling under Regulation (EC) No 1272/2008 The following labelling is proposed in accordance with Regulation (EC) No 1272/2008: BVL_FO_05_2422_200_V1.0 Applicant Spiess-Urania Date: 29/02/2016

6 Part A National Assessment Cuprozin progress Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Registration Report Central Zone Country Germany Page 6 of 13 Hazard pictograms: GHS05 corrosion GHS07 exclamation mark GHS09 environment Signal word: Danger Hazard statements: H318 Causes serious eye damage. H332 Harmful if inhaled. H400 Very toxic to aquatic life. H410 Very toxic to aquatic life with long lasting effects. Precautionary statemtents: Not proposed for all sections by zrms Germany, to be decided by applicant P501 Dispose of contents/container to.. Special rule for labelling of PPP: EUH401 To avoid risks to man and the environment, comply with the instructions for use percent of the mixture consist of ingredient(s) of unknown inhalation toxicity. Further labelling statements under Regulation (EC) No 1272/2008: None Other phrases Restrictions linked to the PPP The authorization of the PPP is linked to the following conditions (mandatory labelling): BVL_FO_05_2422_200_V1.0 Operator protection SB001 SB110 SE110 SF194 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 tight fitting eye protection when handling the undiluted product. When re-entering the treated bush and tree cultures on the day of application the protective suit for working with plant protection products and universal protective gloves (plant protection) must be worn. Successive work on/in the crops stated above may not be carried out until 24 hours after applying the product. During the first week, the standard protective suit for working with plant protection products and universal protective gloves (plant protection) must be worn. Wear standard protective gloves (plant protection) when handling the undiluted product. Applicant Spiess-Urania Date: 29/02/2016

7 Part A National Assessment Cuprozin progress Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Registration Report Central Zone Country Germany Page 7 of 13 SS2101 SS2202 SS610 Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when handling the undiluted product. Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when applying/handling the product ready for application. Wear a rubber apron when handling the undiluted product. Ecosystem protection NW262 NW264 NW468 NH621 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. In addition to the information on the type and amount of active substance, the content of pure copper in the product must be stated on the containers and retail packaging. This information must be stated directly below the directions for use under NT620. NT620 The maximum application rate of 3000 g pure copper per hectare and year (hop growing: 4000 g pure copper per hectare and year) on the same area may not be exceeded - not even in combination with other plant protection products which contain copper. Integrated Pest Management (IPM) NN370 The product is classified as harmful for populations of the species Chrysoperla carnea (lacewing). NN3842 The product is classified as harmful for populations of the species Aphidius rhopalosiphi (braconid wasp). Mode of action (FRAC -Group): M1 Active substance None 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) 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 Applicant Spiess-Urania Date: 29/02/2016

8 Part A National Assessment Cuprozin progress Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Registration Report Central Zone Country Germany Page 8 of 13 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 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%: 5 m Driftreduction 75%: 10 m Driftreduction 50%: 15 m NW NT104 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. 20 m In a strip at least 20 m wide which is adjacent to other areas, the product must be applied using loss reducing equipment which is registered in the index of 'Loss Reducing Equipment' of 14 October 1993 (Federal Gazette No 205, p. 9780) as amended, and be registered in at least drift reducing class 50 % (except agriculturally or horticulturally used areas, roads, paths and public places). If it is not possible to apply the product with loss reducing equipment, a buffer zone of at least 5 m must be kept from adjacent areas (except agriculturally or horticulturally used areas, roads, paths and public places). Neither loss reducing equipment nor a buffer zone of at least 5 m are required if the product is applied with portable plant protection equipment or if adjacent areas (e.g. field boundaries, hedges, groups of woody plants) are less than 3 m wide or if the product is applied in an area which has been declared by the Biologische Bundesanstalt in the "Index of regional proportions of ecotones" of 7 February 2002 (Federal Gazette no. 70 a of 13 April 2002), as amended, as agrarian landscape with a sufficient proportion of natural and semi-natural structures. A buffer zone of at least 5 m is also not necessary if evidence can be shown that adjacent areas (e.g. field boundaries, hedges, groups of woody plants) were planted on agriculturally or horticulturally used areas. BVL_FO_05_2422_200_V1.0 Applicant Spiess-Urania Date: 29/02/2016

9 Part A National Assessment Cuprozin progress Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Registration Report Central Zone Country Germany Page 9 of Product uses PPP (product name/code) Cuprozin progress ( ) active substance Copper hydroxide Formulation type: Conc. of as 1: SC 383 g/l safener - synergist - Conc. of safener: - Conc. of synergist: - Applicant: Zone(s): Verified by MS: j Spiess-Urania Chemicals GmbH central EU professional use non professional use Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) F G or I Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Method / Kind Application 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 BVL_FO_05_2422_200_V DE grape vine VITVI (utilisation as table and wine grape) F red fire disease of grapevine (Pseudopezicula tracheiphila) PSPZTR spraying or fine spraying (low volume spraying) in case of danger of infection and/or after warning service appeal, up to before flowering days a) 3 b) 7 basic application rate: a) 2.5 L/ha b) 17.5 L/ha BBCH 61: a) 5 L/ha b) 35 L/ha basic application rate: a) kg as/ha b) kg as/ha BBCH 61: a) kg as/ha b) kg as/ha a) b) F* Restrictions (see ) for treatments with lower doses (reduced efficacy, e.g. in organic farming) the maximum number of treatments can be increased as long as the specified total application rate of 12 L/ha is not exceeded per crop and year * The PHI is covered by the conditions of use and/or the vegetation period remaining between the application of the plant protection product and the Applicant Spiess-Urania Date: 29/02/2016

10 Part A National Assessment Cuprozin progress Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Registration Report Central Zone Country Germany Page 10 of 13 use of the product (e. g. harvest) or the setting of a PHI in days is not required resp. NW605-1 (90%: 5; 75%: 10; 50%: 15 m) NW606 (20 m) NT104 BVL_FO_05_2422_200_V1.0 Applicant Spiess-Urania Date: 29/02/2016

11 Part A National Assessment Cuprozin progress Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Registration Report Central Zone Country Germany Page 11 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 content such as vine grapes are available and acceptable for enforcing all compounds given in the residue definition 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 An evaluation of the active substance copper hydroxide has not been conducted in the framework of applications according to article 51 of Regulation (EC) No 1107/2009. It is referred, however, to the data reported in the final addendum of the DAR for copper compounds and EFSA s conclusion on the peer review of the pesticide risk assessment of copper compounds Residues An exceedance of the current MRL of 50 mg/kg for copper in wine grapes as laid down in Reg. (EU) 396/2005 is not expected Consumer exposure Consumer risk assessment Chronic risk assessment ADI 0.15 mg/kg bw TMDI (% ADI) according to EFSA PRIMo 412 % (based on WHO Cluster diet B) NTMDI (% ADI) according to German NVS II 383 % (based on 2-4 years old German children, individual consumption/body weight ratio) 219 % (based on German general population, individual consumption/body weight ratio) BVL_FO_05_2422_200_V1.0 The calculation considers MRLs and the national legal limit value of 2 mg/kg copper in drinking water. Applicant Spiess-Urania Date: 29/02/2016

12 Part A National Assessment Cuprozin progress Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Registration Report Central Zone Country Germany Page 12 of 13 IEDI (% ADI) according to EFSA PRIMo rev.2 NEDI (% ADI) according to German NVS II Acute risk assessment ARfD Not possible. A significant share of the overall intake is based on drinking water. It is unknown which legal levels for copper in drinking water are established in other European member states. In addition, the EFSA PRIMo does not include consumption figures for drinking water. 91 % (based on 2-4 years old German children, individual consumption/body weight ratio) 57 % (based on German general population, individual consumption/body weight ratio) Not required The long-term and the short-term intake of copper residues are unlikely to present a public health concern 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. The uses applied for are not complete covered by already authorised uses, therefore an additional risk assessment was conducted 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 Cuprozin progress and the active substance copper-hydroxyd are toxic to the aquatic environment (Oncorhynchus mykiss: LC10 = 3,7 µg/l and natural background concentration of the testwater: 1 µg/l). Also for non-target arthropods exists a high risk potential (Chysoperla carnea: corrected mortality 72.5% at 579 g copper/ha). 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, NH621, NT620 and NW605-1, NW606 and NT104 are assigned, see also 2.2. Risk Assessment for Honeybees The honeybee risk assessment for the main application covers the use 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): BVL_FO_05_2422_200_V1.0 -The classification of effects on beneficial arthropods for the main application covers the use 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 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. Applicant Spiess-Urania Date: 29/02/2016

13 Part A National Assessment Cuprozin progress Art. 51 Extension of authorisation for minor uses BVL Registration Number: /04 Registration Report Central Zone Country Germany Page 13 of Conclusions PPP Cuprozin progress 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 use. The intended use in vine grapes will not result in residues above the MRLs set in or proposed for copper compounds in Regulation (EC) No 396/2005. A risk for consumers through the consumption of food with these residues of copper is not expected. There is no special risk mitigation necessary which deviate from the existing registration. Considering an application in accordance with the evaluated use pattern and good agricultural practise as well as strict observance of the conditions of use no harmful effects on groundwater or adverse effects on the ecosystem are to be apprehended. An authorisation can be recommended. 3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation 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. Authorisation holder is applicant. BVL_FO_05_2422_200_V1.0 Applicant Spiess-Urania Date: 29/02/2016

14 Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dienstsitz Braunschweig Postfach Braunschweig Dr. Cornelia Landsmann Referentin Spiess-Urania Chemicals GmbH Frankenstraße 18 b Hamburg IHR ZEICHEN IHRE NACHRICHT VOM TELEFON +49 (0) TELEFAX +49 (0) cornelia.landsmann@bvl.bund.de AKTENZEICHEN / (bitte bei Antwort angeben) DATUM 29. Februar 2016 GV /04 Cuprozin progress 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: 383 g/l Kupferhydroxid Zulassungsnummer: Versuchsbezeichnungen: SPU F-1-SC Antrag vom: 10. Juni 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_V1.5 Das Bundesamt für Verbraucherschutz und Lebensmittelsicherheit im Internet:

15 SEITE 2 VON 6 Anwendungsnummer Zweckbestimmung Schadorganismus/ / Roter Brenner (Pseudopezicula tracheiphila) Pflanzen/-erzeugnisse/ Objekte Weinrebe 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 375 der Verordnung vom 31. August 2015 (BGBl. I S. 1474), 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_V1.5

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. Martin Streloke Abteilungsleiter Dieses Schreiben wurde maschinell erstellt und ist daher ohne Unterschrift gültig. Anlage BVL_FO_05_2468_200_V1.5

17 SEITE 4 VON 6 Anlage 1 zugelassene Anwendung: / Anwendungsgebiet Schadorganismus/Zweckbestimmung: Roter Brenner (Pseudopezicula tracheiphila) Pflanzen/-erzeugnisse/Objekte: Verwendungszweck: 2 Kennzeichnungsauflagen Weinrebe 2.1 Angaben zur sachgerechten Anwendung Einsatzgebiet: Anwendungsbereich: Anwendung im Haus- und Kleingartenbereich: Erläuterung zur Kultur: Anwendungszeitpunkt: Maximale Zahl der Behandlungen - in dieser Anwendung: 3 - für die Kultur bzw. je Jahr: 7 Weinbau Freiland Nein - Abstand: 10 bis 14 Tage - Erläuterungen Anzahl Behandlungen: Anwendungstechnik: Aufwand: Nutzung als Tafel- und Keltertraube Bei Infektionsgefahr bzw. ab Warndiensthinweis, bis vor der Blüte bei Behandlungen mit niedrigerer Dosierung (mit verminderter Wirksamkeit, z. B. im ökologischen Pflanzenbau) kann die maximale Zahl der Behandlungen erhöht werden, solange der für die Kultur und das Jahr vorgesehene Gesamtmittelaufwand von 12 l/ha nicht überschritten wird spritzen oder sprühen - Basisaufwand: 2,5 l/ha in 200 bis 400 l Wasser/ha - ES 61: 5 l/ha in 400 bis 800 l Wasser/ha 2.2 Sonstige Kennzeichnungsauflagen - keine - BVL_FO_05_2468_200_V1.5

18 SEITE 5 VON Wartezeiten (F) Freiland: Weinrebe (Tafel- und Keltertrauben) 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_V1.5 (NT104) Die Anwendung des Mittels muss in einer Breite von mindestens 20 m zu angrenzenden Flächen (ausgenommen landwirtschaftlich oder gärtnerisch genutzte Flächen, Straßen, Wege und Plätze) mit einem verlustmindernden Gerät erfolgen, das in das Verzeichnis "Verlustmindernde Geräte" vom 14. Oktober 1993 (Bundesanzeiger Nr. 205, S. 9780) in der jeweils geltenden Fassung, mindestens in die Abdriftminderungsklasse 50 % eingetragen ist. Ist der Einsatz verlustmindernder Technik nicht möglich, muss bei der Anwendung ein Abstand von mindestens 5 m zu angrenzenden Flächen (ausgenommen landwirtschaftlich oder gärtnerisch genutzte Flächen, Straßen, Wege und Plätze) eingehalten werden. Bei der Anwendung des Mittels ist weder der Einsatz verlustmindernder Technik noch die Einhaltung eines Abstandes von mindestens 5 m erforderlich, wenn die Anwendung mit tragbaren Pflanzenschutzgeräten erfolgt oder angrenzende Flächen (z. B. Feldraine, Hecken, Gehölzinseln) weniger als 3 m breit sind oder die Anwendung des Mittels in einem Gebiet erfolgt, das von der Biologischen Bundesanstalt im "Verzeichnis der regionalisierten Kleinstrukturanteile" vom 7. Februar 2002 (Bundesanzeiger Nr. 70a vom 13. April 2002) in der jeweils geltenden Fassung, als Agrarlandschaft mit einem ausreichenden Anteil an Kleinstrukturen ausgewiesen worden ist. Bei der Anwendung des Mittels ist ferner die Einhaltung eines Abstandes von mindestens 5 m nicht erforderlich, wenn angrenzende Flächen (z. B. Feldraine, Hecken, Gehölzinseln) nachweislich auf landwirtschaftlich oder gärtnerisch genutzten Flächen angelegt worden sind. Begründung: Das Pflanzenschutzmittel "SPU F" bzw. der darin enthaltene Wirkstoff Kupferhydroxid besitzt ein hohes Gefährdungspotenzial für terrestrische Nichtzielarthropoden auf Nichtzielflächen. Im Laborversuch zeigte sich die Florfliege (Chrysoperla carnea) von den 3 untersuchten Spezies am empfindlichsten (korrigierte Mortalität 72,5 % bei 579 g Cu/ha). Zur Ermittlung der PEC-Werte wurde eine Abdriftberechnung basierend auf den aktuell geltenden Abdrifteckwerten durchgeführt. Für die Übertragung der Ergebnisse aus dem Versuch an C. carnea mit Exposition in einem 2-dimensionalen Szenario auf reale Verhältnisse wurde ein Korrekturfaktor von 5 berücksichtigt. In Abhängigkeit von der verwendeten Technik und dem Abstand zu Nichtzielflächen errechne sich für die beantragte Indikation des Pflanzenschutzmittels die im UBA-Bewertungsbericht dargestellten Einträge in an die Behandlungsfläche angrenzende Areale mit den jeweils korrespondierenden TER-Werten. Nach dem Stand der wissenschaftlichen Erkenntnisse ist die ebendort ausgewiesene indikationsspezifische Anwendungsbestimmung erforderlich, um einen ausreichenden Schutz von terrestrischen Nichtzielarthropoden in Saumbiotopen vor Auswirkungen des Mittels "SPU F"

19 SEITE 6 VON 6 zu gewährleisten. (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 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% 15 m, 75% 10 m, 90% 5 m Begründung: Der im Pflanzenschutzmittel Cuprozin progress enthaltene Wirkstoff Kupfer weist ein hohes Gefährdungspotenzial für aquatische Organismen auf. Bewertungsbestimmend ist die maximal zulässige zusätzliche Konzentration von 2,7 µg Cu/L (abgeleitet aus ELS-Test mit O. mykiss, LC10 = 3,7 µg Cu/L, natürliche Hintergrundkonzentration des Testwassers = 1 µg Cu/L). Nach dem Stand der wissenschaftlichen Erkenntnisse ist die Einhaltung der in der Anwendungsbestimmung NW605-1/606 festgelegten Maßgaben erforderlich, um einen ausreichenden Schutz von Gewässerorganismen vor Einträgen des Wirkstoffs in Oberflächengewässer zu gewährleisten. (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. 20 m Begründung: Siehe unter NW BVL_FO_05_2468_200_V1.5

20 Part B - Section 3 - Core Assessment REGISTRATION REPORT Part B Section 3: Mammalian Toxicology Detailed summary of the risk assessment Product code/name: SPU F-1-SC / Cuprozin progress Active Substance: Copper hydroxide 383 g/l (Copper 250 g/l) Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Spiess-Urania Chemicals GmbH Date: 29/02/2016 Page 1 / 8

21 Part B - Section 3 - Core Assessment Table of Contents 3 Mammalian Toxicology Summary Toxicological Evaluation of Plant Protection Product Exposure Assessment of Plant Protection Product Selection of critical use and justification Worker exposure Estimation of worker exposure Measurement of worker exposure Statement on combined exposure... 7 Appendix 1 Exposure calculations... 8 A 1.1 Worker exposure calculations... 8 A Calculations for copper... 8 Page 2 / 8

22 Part B - Section 3 - Core Assessment 3 Mammalian Toxicology 3.1 Summary Table 3.1-1: Product name and code Formulation type Information on SPU F-1-SC / Cuprozin progress Cuprozin progress SC (Suspension concentrate (= flowable concentrate)) Active substance(s) (incl. content) copper hydroxide 383 g/l (Cu 250 g/l ) Function Product already evaluated as the representative formulation during the Annex I inclusion Fungicide No Product previously evaluated in an other MS according to Uniform Principles No * Information on the detailed composition of SPU F-1-SC / Cuprozin progress can be found in the confidential drr Part C. Justified proposals for classification and labelling In accordance with Directives 67/548/EEC and 1999/45/EC and according to the criteria given in Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 the following classification and labelling with regard to toxicological data is proposed for the preparation: Table 3.1-2: Justified proposals for classification and labelling C&L according to Directives 67/548/EEC and 1999/45/EC Hazard symbol(s): Indication(s) of danger: T Toxic Risk phrases: R23-41 Safety phrases: Additional labelling phrases: S To avoid risks to man and the environment, comply with the instructions for use. C&L according to Regulation (EC) No 1272/2008 Hazard class(es), categories: Eye Dam. 1, Acute Tox. 4 Signal word: Danger Hazard statement(s): H Precautionary statement(s): Additional labelling phrases: P To avoid risks to man and the environment, comply with the instructions for use. [EUH401] '10.4 percent of the mixture consist of ingredient(s) of unknown inhalation toxicity.' Page 3 / 8

23 Part B - Section 3 - Core Assessment Table 3.1-3: Summary of risk assessment for operators, workers, bystanders and residents for SPU F-1-SC / Cuprozin progress The risk assessment for operators, bystanders and residents regarding the intended uses in /04 is already considered in approved applications of this product. Therefore, risk assessment is conducted for workers only. Result PPE / Risk mitigation measures Workers Acceptable Re-entering the treated areas/crops is only possible on the day of application wearing personal protective equipment which is specified for applying the particular product. Successive work on/in treated areas/crops may fundamentally not be carried out until 24 hours after applying the product. Within the first 48 hours, protective suits against pesticides and standard protective gloves (plant protection) are to be worn (SF1891). No unacceptable risk for workers was identified when the product is used as intended and provided that the PPE/ risk mitigation measures stated in Table are applied. A summary of the critical uses and the overall conclusion regarding exposure for operators, workers and bystanders/residents is presented in Table Table Critical uses and overall conclusion of exposure assessment Crops 1) and situation (e.g. growth stage of crop) F/G or I 2) Application Application rate kg as/ha Remarks: (e.g. surfactant (L /ha)) Method / Kind (incl. application technique 3) ) Grape vine F HCHH HCTM Max. number (min. interval between applications) a) per use b) per crop/ season a) 3 b) 7 a) max. rate per appl. b) max. total rate per crop/season a) 1.25 b) 3 4) Water L/ha min / max critical gap for operator, worker, bystander or resident exposure based on [Exposure model] Critical GAP for worker, exposure based on German re-entry model. Acceptability of exposure assessment Operator Worker Bystander Residents Exposure acceptable without PPE / risk mitigation measures Further refinement and/or risk mitigation measures required Exposure not acceptable/ Evaluation not possible 1) Pooled critical GAPS with the same max. application rate per application and using the same application technique 2) F: field or outdoor application, G: greenhouse application, I: indoor application 3) LC: low crops, HC: high crop, TM: tractor-mounted, HH: hand-held 4) maximum application rate: 3 kg Cu per year 3.2 Toxicological Evaluation of Plant Protection Product A summary of the toxicological evaluation for SPU F-1-SC / Cuprozin progress is given in Table Page 4 / 8

24 Part B - Section 3 - Core Assessment Table 3.2-1: Summary of evaluation of the studies on acute toxicity including irritancy and skin sensitisation for SPU F-1-SC / Cuprozin progress Type of test, model system (Guideline) LD 50 oral, rat (OECD 425) LD 50 dermal, rat (OECD 402) LC 50 inhalation, rat (waiving) Skin irritation, rabbit (OECD 404) Eye irritation, rabbit (OECD 405) Skin sensitisation, (OECD 406, M&K) Supplementary studies for combinations of plant protection products Result Acceptability Classification (acc. to the criteria in Dir. 67/548/EEC) Classification (acc. to the criteria in Reg. 1272/2008) Reference >2,000 mg/kg bw Yes None None Haferkorn, J. (2007); final report: ASB ; Amendment, ASB ) >2,000 mg/kg bw Yes None None Haferkorn, J. (2008); ASB ) LC 50 Cu(OH) 2: 0.50 mg/l air (males), 0.61 mg/l air (females) 2) Not submitted, not necessary, vapour pressure of active substance is negligible, no generation of particles < 50 µm, not shown, None None Anon., ASB Non-irritant Yes None None Leuschner, J. (2008); ASB ) Non-irritant / Irritant Yes None H319 Haferkorn, J. (2008); ASB ) Non-sensitising Yes None None Haferkorn, J. (2008); ASB ) No data not required 1) Previous formulation of Cuprozin progress was tested, i.e. SPU F-0-SC; study results listed above can be applied 2) A study using a different active substance preparation (containing 85.9 % copper hydroxide) was submitted in the EU-procedure for Annex I inclusion of copper compounds (TOX ) 3) Previous formulation of Cuprozin progress was tested, i.e. SPU F-0-SC; study result given above can be applied, in the new preparation (SPU F-1-SC) two additional co-formulants have not been tested, therefore please see additional toxicological information relevant for classification and labelling in the table below Page 5 / 8

25 Part B - Section 3 - Core Assessment Table 3.2-2: Additional toxicological information relevant for classification/labelling of SPU F-1-SC / Cuprozin progress Substance (Concentration in product, % w/w) Classification of the substance (acc. to the criteria in Dir. 67/548/EEC and/or in Reg. 1272/2008) Reference Classification of product (acc. to the criteria in Dir. 67/548/EEC, in Dir. 1999/45/EC and/or in Reg. 1272/2008) Short-term toxicity studies No data not required Toxicological properties of active substance(s) (relevant for classification of product) Toxicological properties of non-active substance(s) (relevant for classification of product) Further toxicological information Copper hydroxide (28.73 % (w/w)) AG 6202 (3.6 % (w/w)) Berol 175 (0.2 % (w/w)) T; R23 1) ( 25 %) 2) Xi; R41 1) (covered by the studies on the previous formulation of Cuprozin progress) Xi; R41 No data not required 4), 5) Reg. EFSA Sc. Report (2008) 187,1-101 (EC) No 1272/2008 / MSDS 4) H332 Danger; H318 Xi; R41 4), 5) Danger; H318 1) based on BfR proposal in accordance with EFSA-conclusion, up to now no legal classification but unequivocally based on study results, therefore considered for the classification of the preparation 2) based on Dir. 1999/45/EC 3) based on Reg. (EC) No 1272/2008 4) according to the safety data sheet of the manufacturer 5) Since this co-formulant enhances the total eye irritation potential of the current formulation and since it was not tested with the above cited studies, R41 is allocated to Cuprozin progress for precautionary reasons. 4), 5) 4), 5) 3.3 Exposure Assessment of Plant Protection Product Table 3.3-1: Product information and toxicological reference values used for exposure assessment Product name and code Cuprozin progress Formulation type SC (Suspension concentrate (= flowable concentrate)) Category Fungicide Active substance (incl. content) copper hydroxide 383 g/l (Cu 250 g/l) AOEL systemic mg/kg bw/d Inhalative absorption 100 % Oral absorption 36 % Dermal absorption Concentrate: 10 % Dilution: 10 % (Based on varoius formulations; EFSA Scientific Report (2008) 187, 1-101) Selection of critical use and justification The critical GAP used for the exposure assessment of the plant protection product is shown in Table Page 6 / 8

26 Part B - Section 3 - Core Assessment Worker exposure Estimation of worker exposure Table shows the exposure model used for estimation of worker exposure after entry into a previously treated area or handling a crop treated with SPU F-1-SC / Cuprozin progress according to the critical use. Outcome of the estimation is presented in Table Detailed calculations are in Appendix 1. Table 3.3-2: Exposure models for intended uses Critical use(s) Grape vine (max. 7 x 5 L / kg product/ha) Model German re-entry model, Krebs et al. (2000) [Uniform Principles for Safeguarding the Health of Workers Re-entering Crop Growing Areas after Application of Plant Protection Products, Nachrichtenbl. Deut. Pflanzenschutzdienst., 52(1), p. 5-9] Table 3.3-3: Estimated worker exposure Copper hydroxide (250 g / L copper) Model data Level of PPE Total absorbed dose (mg/kg/day) % of systemic AOEL Number of applications and application rate: 7 x 1.25 kg a.s./ha 8 hours/day 1), TC: 10,000 cm 2 /person/h 2) Body weight: 60 kg no PPE 3) with PPE 4) ) 8 h/day for professional applications for harvesting, pruning, tying, thinning or weeding activities etc 2) US-EPA policy paper [EPA, Science Advisory Council for Exposure; 2000; Agricultural Default Transfer Coefficients, Policy # 003.1, May revised 7 August 2000]. 3) no PPE: Worker wearing long sleeved shirt, long trousers ( permeable ) but no gloves 4) with PPE: see 'Instructions for use' Measurement of worker exposure Since the worker exposure estimations carried out indicated that the acceptable operator exposure level (AOEL) will not be exceeded under conditions of intended uses, a study to provide measurements of worker exposure was not necessary and was therefore not performed Statement on combined exposure Not relevant. The product contains only one active substance. Page 7 / 8

27 Part B - Section 3 - Core Assessment Appendix 1 Exposure calculations A 1.1 A Worker exposure calculations Calculations for copper Table A 1: Input parameters considered for the estimation of worker exposure Intended use(s): grape vine Dislodgeable foliar residues (DFR): 1 µg/cm 2 /kg a.s. Application rate (AR): 3 kg a.s./ha Transfer coefficient (TC): cm 2 /person/h Number of applications (NA): 1 Work rate per day (WR): 8 h/d Body weight (BW): 60 kg/person PPE 5 % Dermal absorption (DA): 10 % ('worst case') AOEL mg/kg bw/d Table A 2: Estimation of worker exposure towards copper using the German re-entry model Without PPE 1) With PPE 2) Worker (re-entry): Systemic dermal exposure after application in grape vine grape vine SDE W = (DFR x TC x WR x AR x NA x DA) / BW SDE W = (DFR x TC x WR x AR x NA x PPE x DA) / BW (1 x x 8 x 3 x 1 x 10%) / 60 (1 x x 8 x 3 x 1 x 5% x 10%) / 60 External dermal exposure 240 mg/person External dermal exposure 12 mg/person External dermal exposure 4 mg/kg bw/d External dermal exposure 0.2 mg/kg bw/d Total systemic exposure 24 mg/person Total systemic exposure 1.2 mg/person Total systemic exposure 0.4 mg/kg bw/d Total systemic exposure 0.02 mg/kg bw/d % of AOEL % % of AOEL 27.8 % 1) without PPE: Worker wearing long sleeved shirt, long trousers ( permeable ) but no gloves 2) with PPE: see 'Instructions for use' Page 8 / 8

28 Part B - Section 4 - Core Assessment REGISTRATION REPORT Part B Section 4: Metabolism and Residues Detailed summary of the risk assessment Product code: SPU F-1-SC / Cuprozin progress Active Substance: Copper hydroxide 383 g/l (Copper 250 g/l) Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Spiess-Urania Chemicals GmbH Date: 29/02/2016 Page 1 / 16

29 Part B - Section 4 - Core Assessment 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 Wine grapes 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 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 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) Page 2 / 16

30 Part B - Section 4 - Core Assessment 4 METABOLISM AND RESIDUES DATA 4.1 Evaluation of the active substances An evaluation of the active substance copper hydroxide is not conducted in the framework of applications according to article 51 of Regulation (EC) No 1107/2009. It is referred to the data reported in the final addendum of the DAR for copper compounds (ASB ) and EFSA s conclusion on the peer review of the pesticide risk assessment of copper compounds (ASB ). 4.2 Evaluation of the intended use(s) Selection of critical use and justification The GAP reported for the central zone is presented in Table It has been used for consumer intake and risk assessment. Page 3 / 16

31 Part B - Section 4 - Core Assessment Table 4.2-1: Critical Use (worst case) used for consumer intake and risk assessment Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) (a) 001 DE Wine grapes ( ) (utilisation as table and wine grapes) F G or I (b) F Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) (c) Red fire disease of grapevine (Pseudopezicula tracheiphila) Application Application rate PHI Method / Kind (d-f) spraying or low volume spraying Timing / Growth stage of crop & season (g) in case of danger of infection and/or after warning service appeal, up to before flowering Max. number (min. interval between applications) a) per use b) per crop/ season (h) a) 3 b) 7 (10-14 days) L product / ha a) max. rate per appl. b) max. total rate per crop/season a) b) max. 12 L/ha kg as/ha a) max. rate per appl. b) max. total rate per crop/season a) see below b) copper hydroxide: 4.6 kg as/ha copper: 3 kg as/ha Water L/ha min / max (days) (i) Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures (j) see below F number of applications can be increased as long as the max. intended application amount of 12 L/ha product is not exceeded for year and crop Application rate Application concentration Formulation copper hydroxide (copper) Water L/ha kg as/ha L/ha g as/hl Basic application (0.625) BBCH (1.25) 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 / 16

32 Part B - Section 4 - Core Assessment Wine grapes Residues in primary crops The intended uses are not relevant in terms of consumer health protection, since the product is applied before flowering (up to BBCH 60). Any residues of treatments in harvested grapes are anticipated not to be distinguishable from background concentrations. The submission of supervised residue trials in support of the intended use is not necessary. Analytical methods for commodities of high acid content such as grapes are available and acceptable for enforcing all compounds given in the residue definition, particularly to adequately enforce the existing EU MRLS established at 50 mg/kg Distribution of the residue in peel/pulp Not relevant Residues in processed commodities Not relevant Proposed pre-harvest intervals, withholding periods The pre-harvest interval (PHI) is covered by the time elapsing between application and commercial harvest. Setting of a specific PHI in days is not required. 4.3 Consumer intake and risk assessment Perennial crops such as wine grapes are not grown in rotation therefore residue levels in succeeding commodities from subsequent crops do not have to be considered. For reasons of application(s) before formation of consumable parts of the crop, the envisaged use is not relevant in terms of consumer health protection. Thus risk assessment is made for long-term exposure only. The MRLs currently established in EU residue legislation for copper are based on empirical data or results from literature for natural contents. As these levels frequently span broad ranges, MRLs were fixed at the upper bound of the ranges in order to avoid false positive results from enforcement. These MRLs account for a dietary intake in excess of the ADI for a number of EU consumer diets contained in EFSA PRIMo (see TMDI calculation in Table 4.3-1). As the existing copper MRLs were not yet subject to a peer review according to article 12 of Regulation (EC) No396/2005 no refinement could be done. Moreover, since copper is not only a natural component in food but also occurs in drinking water, the complete intake from different sources beyond the use as pesticide active substance has to be considered. The dietary risk assessment was based on the German VELS/NVS II model ( supplemented by the consumption of copper in tap water as derived from the underlying consumption surveys. No such data were available for other diets in revision 2 of EFSA PRIMo and calculations with this model therefore were not conducted. The consumer intake and risk assessment is based on the appropriate input values given in Table and the ADI stated in Table To illustrate the results of the chronic risk assessment, a screenshot of the NTMDI and NEDI results obtained with the German NVS II model is displayed in Appendix 3. No acute reference dose was allocated to copper compounds; hence no acute risk assessment has been performed for the commodities on which authorization of the product is sought. Page 5 / 16

33 Part B - Section 4 - Core Assessment Table 4.3-2: Key data for consumer intake assessment derived for the intended uses Commodity Chronic risk assessment Input value (mg/kg) Comment Grapefruit 0.41 Mean, German food monitoring 2010 (ASB ) Other citrus fruits 0.39 Mean, German food monitoring (ASB ) Grapefruit juice 0.25 Mean, German food monitoring 2005 (ASB ) All other citrus juices (except grapefruit) 0.34 Mean, German food monitoring 2009, based on orange juice (ASB ) Almonds 10 Mean, German food monitoring 2004 (ASB ) Chestnuts 22 Mean, German food monitoring 2007 (ASB ) Chestnuts, processed 3.65 Mean, German food monitoring 2007 (ASB ) Coconuts 5.04 Mean, German food monitoring 2008 (ASB ) Hazelnuts 16 Mean, German food monitoring 2008 (ASB ) Macadamia nuts 4.74 Mean, German food monitoring 2008 (ASB ) Pine nuts 16 Mean, German food monitoring 2012 (ASB ) Pistachio nuts 11.8 Mean, German food monitoring 2007 (ASB ) Brazil nuts, pecan, walnuts, other tree nuts 13.9 Mean, German food monitoring 2004, based on walnuts (ASB ) Pome fruit 2.1 STMR value for the application of Cuprozin progress Pome fruit juice 0.23 Mean, German food monitoring 2005, based on apple juice (ASB ) Stone fruit, except plums 0.88 Mean, German food monitoring (ASB ) Plums 0.61 Mean, German food monitoring 2010 (ASB ) Apricots, dried 3.77 Mean, German food monitoring 2007 (ASB ) Cherry juice 0.16 Mean, German food monitoring 2011 (ASB ) All juices (except citrus, pome fruit, cherry, pineapple): 0.31 Mean, German food monitoring (ASB ) Acute risk assessment Input value (mg/kg) Comment - No ARfD necessary Page 6 / 16

34 Part B - Section 4 - Core Assessment Commodity Chronic risk assessment Input value (mg/kg) Comment Table grapes 7.1 STMR EFSA Conclusion (EFSA, 2008, ASB ) Wine grapes 7.0 STMR EFSA Conclusion (EFSA, 2008, ASB ) Strawberries 0.38 Mean, German food monitoring 2004 (ASB ) Blackberries 0.90 Mean, German food monitoring 2011 (ASB ) Raspberries 0.71 Mean, German food monitoring 2010 (ASB ) Currants 0.95 Mean, German food monitoring 2008 (ASB ) Gooseberries 0.79 Mean, German food monitoring 2008 (ASB ) Other small fruits and berries 1.3 Mean, German food monitoring (ASB ) Dates, processed 2.3 Mean, German food monitoring 2012 (ASB ) Kaki/Persimmon 0.2 Mean, German food monitoring 2007 (ASB ) Kiwi fruit 1.5 Mean, German food monitoring 2010 (ASB ) Banana 1.01 Mean, German food monitoring 2009 (edible portion) (ASB ) Mango Mean, German food monitoring 2007 (ASB ) Pineapple 0.80 Mean, German food monitoring 2004 (ASB ) Pineapple juice 0.36 Mean, German food monitoring 2005 (ASB ) Dried fruit 4.22 Mean, German food monitoring 2007, based on raisins (ASB ) Other miscellaneous fruit 0.5 Potato and tropical root and vegetables Mean, German food monitoring (ASB ) 1.1 Mean, German food monitoring 2007 (ASB ) Beetroot, juice 0.23 Mean, German food monitoring 2010 (ASB ) Other root and tuber vegetables (e.g. carrots, beetroot, radish, 0.83 STMR value for the application of Cuprozin progress Garlic, shallots, onions STMR value for the application of Cuprozin progress Acute risk assessment Input value (mg/kg) Comment Page 7 / 16

35 Part B - Section 4 - Core Assessment Commodity Chronic risk assessment Input value (mg/kg) Comment Spring onion 0.49 Mean, German food monitoring 2011 (ASB ) Tomato 2.0 STMR value for the application of Cuprozin progress (= STMR EFSA Conclusion (EFSA, 2008, ASB ) Tomato processed 4.9 Mean, German food monitoring 2000 for tomato paste (ASB ) Peppers Mean, German food monitoring 2009 (ASB ) Curcubits, edible peel STMR value for the application of Cuprozin progress Squash/pumpkins 0.74 Mean, German food monitoring 2011 (ASB ) Watermelon 0.43 Mean, German food monitoring 2012 (ASB ) Sweet corn 0.86 Mean, German food monitoring 2012 (ASB ) Other fruiting vegetables 0.47 Mean, German food monitoring (ASB ) Broccoli 0.45 Mean, German food monitoring 2005 (ASB ) Cauliflower 0.33 Mean, German food monitoring 2003 (ASB ) Head brassica 5.0 STMR value for the application of Cuprozin progress Chinese cabbage 0.31 Mean, German food monitoring 2003 (ASB ) Kale 0.60 Mean, German food monitoring 2012 (ASB ) Kohlrabi Mean, German food monitoring 2010 (ASB ) Lamb s lettuce 1.06 Mean, German food monitoring 2004 (ASB ) Endive 0.75 Mean, German food monitoring 2011 (ASB ) Rucola 1.23 Mean, German food monitoring 2012 (ASB ) Other lettuce and other salad plants including brassicacea Vine leaves, watercress, witloof and fresh herbs 0.59 Mean, German food monitoring 2006 (ASB ) 0.54 Mean, German food monitoring (ASB ) Acute risk assessment Input value (mg/kg) Comment Page 8 / 16

36 Part B - Section 4 - Core Assessment Commodity Chronic risk assessment Input value (mg/kg) Comment Spinach and similar 5 STMR value for the application of Cuprozin progress Beans and peas, seeds with pods Beans and peas, seeds without pods Lentils, chickpeas (fresh) Mean, German food monitoring 2005 (ASB ) 1.66 Mean, German food monitoring 2007 (ASB ) Mean, German food monitoring 2009 (ASB ) Asparagus Mean, German food monitoring 2010 (ASB ) Other stem vegetables 0.56 Mean, German food monitoring (ASB ) Cultivated fungi 2.7 Mean, German food monitoring (ASB ) Wild fungi 3.67 Mean, German food monitoring 2011 (ASB ) Pulses 8.3 Mean, German food monitoring (ASB ) Peanuts, raw 7.6 Mean, German food monitoring 2004 (ASB ) Peanuts, processed 8.1 Mean, German food monitoring 2011 (ASB ) Sesame seeds 15.9 Mean, German food monitoring 2011 (ASB ) Sunflower seeds 19.4 Mean, German food monitoring 2008 (ASB ) Sunflower oil Mean, German food monitoring 2010 (ASB ) Soybeans 11.3 Mean, German food monitoring 2011 (ASB ) Pumpkin seeds 12.4 Mean, German food monitoring 2011 (ASB ) Other oilseeds 15 Mean, German food monitoring (ASB ) Oil olives, oil 0.08 Mean, German food monitoring 2012 (ASB ) Barley, oats, rye 3.8 Mean, German food monitoring 2004 (ASB ) Barley processed Mean, German food monitoring 2007 for beer (ASB ) Buckwheat 4.65 Mean, German food monitoring 2011 (ASB ) Rice 2.1 Mean, German food monitoring (ASB ) Acute risk assessment Input value (mg/kg) Comment Page 9 / 16

37 Part B - Section 4 - Core Assessment Commodity Chronic risk assessment Input value (mg/kg) Comment Wheat 3.7 Mean, German food monitoring 2006 (ASB ) Spelt, processed 5.2 Mean, German food monitoring 2012 (ASB ) Tea 2.9 Mean, German food monitoring (ASB ) Coffee beans 14.0 Mean, German food monitoring 2012 (ASB ) Rooibos leaves 0.84 Mean, German food monitoring 2008 (ASB ) Cacao, processed 41.9 Mean, German food monitoring 2008 (ASB ) Hops 238 STMR value for the application of Cuprozin progress Cumin seed 7.77 Mean, German food monitoring 2007 (ASB ) Fennel seed 9.6 STMR value for the application of Cuprozid flüssig Nutmeg 11.8 Mean, German food monitoring 2007 (ASB ) Pepper 11.0 Mean, German food monitoring 2011 (ASB ) Liquorice, processed 1.43 Mean, German food monitoring 2008 (ASB ) Other spices 5.6 Mean, German food monitoring (ASB ) Pork, meat 0.70 Mean, German food monitoring 2010 (ASB ) Swine liver 11.1 Mean, German food monitoring 2006 (ASB ) Swine kidney 6.5 Mean, German food monitoring 2001 (ASB ) Other meat products (all species) 2.8 Mean, German food monitoring for sausages (ASB ) Beef 1.57 Mean, German food monitoring 2012 (ASB ) Bovine liver 135 Mean, German food monitoring 2012 (ASB ) Bovine kidney 11.8 Mean, German food monitoring 2006 (ASB ) Poultry meat 1.2 Mean, German food monitoring (ASB ) Acute risk assessment Input value (mg/kg) Comment Page 10 / 16

38 Part B - Section 4 - Core Assessment Commodity Chronic risk assessment Input value (mg/kg) Comment Poultry liver 3.26 Mean, German food monitoring 2011 (ASB ) Hare 2.83 Mean, German food monitoring 2012 (ASB ) Rabbit 0.56 Mean, German food monitoring 2003 (ASB ) Deer 1.61 Mean, German food monitoring 2010 (ASB ) Wild boar 1.8 Mean, German food monitoring 1998 (ASB ) Other meat (mammalian) 1.1 Mean, German food monitoring (ASB ) Milks, up to 4% fat 0.32 Mean, German food monitoring (ASB ) Milk, 4-10% fat 0.56 Mean, German food monitoring 2012 based on cheese (<10% fat) (ASB ) Milk >10% fat 0.44 Mean, German food monitoring 2006 based on cheese (ASB ) Eggs 0.59 Mean, German food monitoring 2006 (ASB ) Honey 0.62 Mean, German food monitoring (ASB ) Freshwater fish 0.48 Mean, German food monitoring (ASB ) Sea fish 0.71 Mean, German food monitoring 2012 (ASB ) Molluscs 2.1 Mean, German food monitoring (ASB ) Other fish products roe 8.29 Mean, German food monitoring 2012 (ASB ) Drinking water 2 Legal limit value in Germany Acute risk assessment Input value (mg/kg) Comment Chronic risk assessment ADI 0.15 mg/kg bw TMDI (% ADI) according to EFSA PRIMo 412 % (based on WHO Cluster diet B) NTMDI (% ADI) according to German NVS II 383 % (based on 2-4 years old German children, individual consumption/body weight ratio) 219 % (based on German general population, individual consumption/body weight ratio) The calculation considers MRLs and the national legal limit value of 2 mg/kg copper in drinking water. Page 11 / 16

39 Part B - Section 4 - Core Assessment 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 Not possible. A significant share of the overall intake is based on drinking water. It is unknown, which legal levels for copper in drinking water are established in other European member states. In addition the EFSA PRIMo does not include consumption figures for drinking water. 91 % (based on 2-4 years old German children, individual consumption/body weight ratio) 57 % (based on German general population, individual consumption/body weight ratio) See Table 4.3-1: STMR values or monitoring data for copper in food, concentration in drinking water according to the legal limit value of 2 mg/kg, information on water consumption obtained from VELS/NVS II consumption. Not required Not applicable Not applicable Not applicable 4.4 Proposed maximum residue levels (MRLs) No new MRLs are required. The existing EU MRL for the crops applied for in this dossier are summarized in Table Table 4.4-1: Overview of the existing EC MRL for copper Commodity (Code) Existing EC MRL (mg/kg) Proposed EC MRL (mg/kg) Result of OECD calculator (mg/kg) Wine grapes 50 / / / Justification for the proposal/ Comments 4.5 Conclusion The available data are sufficient for dietary risk assessment. An exceedance of the current MRL of 50 mg/kg for copper in wine grapes as laid down in Reg. (EU) 396/2005 is not expected. The long-term and the short-term intake of copper residues are unlikely to present a public health concern. As far as consumer health protection is concerned, BfR/Germany agrees with the authorization of the intended use. Appendix 1 List of data submitted in support of the evaluation Page 12 / 16

40 Part B - Section 4 - Core Assessment 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 2008 Conclusion regarding the peer review of the pesticide risk assessment of the active substance Copper (I), Copper (II) variants namely Copper hydroxide, Copper oxychloride, tribasic Copper sulfate, Copper (I) oxide, Bordeaux mixture EFSA Scientific Report (2008) 187, EFSA Scientific Report (2008) 187, ASB all France 2008 Copper compounds: (Draft Assessment Report, final addendum) Data protection claimed Owner N open Add N open Add How considered in drr * ASB KIIA 6.10 BgVV 2000 Lebensmittel-Monitoring 2000 ASB KIIA 6.10 BVL 2001 Lebensmittel-Monitoring 2001 ASB KIIA 6.10 BVL 2004 Lebensmittel-Monitoring; Ergebnisse des bundesweiten Lebensmittel-Monitorings der Jahre 1995 bis 2002 ASB KIIA 6.10 BVL 2004 Lebensmittel-Monitoring 2003; Ergebnisse des bundesweiten Lebensmittel-Monitorings ASB KIIA 6.10 BVL 2005 Lebensmittel-Monitoring 2004; Ergebnisse des bundesweiten Lebensmittel-Monitorings ASB KIIA 6.10 BVL 2005 Berichte zur Lebensmittelsicherheit 2005; Lebensmittelmonitoring ASB KIIA 6.10 BVL 2006 Berichte zur Lebensmittelsicherheit 2006; Lebensmittel-Monitoring ASB KIIA 6.10 BVL 2007 Berichte zur Lebensmittelsicherheit 2007; Lebensmittel-Monitoring ASB KIIA 6.10 BVL 2008 Berichte zur Lebensmittelsicherheit 2008; Lebensmittel-Monitoring ASB KIIA 6.10 BVL 2009 Berichte zur Lebensmittelsicherheit 2009; Lebensmittel-Monitoring ASB KIIA 6.10 BVL 2010 Berichte zur Lebensmittelsicherheit 2010; Lebensmittel-Monitoring ASB KIIA 6.10 BVL 2011 Berichte zur Lebensmittelsicherheit 2011; Monitoring ASB KIIA 6.10 BVL 2012 BVL-Report - 8.3; Berichte zur Lebensmittelsicherheit; Monitoring 2012 ASB * Y: Yes, relied on N: No, not relied on Add: Relied on, study not submitted by applicant but necessary for evaluation N N N N N N N N N N N N N Y Y Y Y Y Y Y Y Y Y Y Y Y Page 13 / 16

41 Part B - Section 4 - Core Assessment Appendix 2 Detailed evaluation of the additional studies relied upon A 2.1 Storage stability No further study on storage stability is needed for copper compounds. A 2.2 Residues in primary crops No further study on primary crops submitted/needed. 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 Page 14 / 16

42 Part B - Section 4 - Core Assessment Appendix 3 Pesticide Residue Intake Model (PRIMo rev.2) The EFSA PRIMo does not contain consumption data for water, which is a significant intake pathway. Therefore only the German NVS II model was used for NTMDI and NEDI calculations. Moreover no data on background contents were available for the EFSA PRIMo diets, except that from Germany. Screenshot of NTMDI calculation based on the German NVS II model (To account for intake of copper from water consumption a chronic intake of mg/kg bw (36% of ADI) is added to the results for children and a chronic intake of mg/kg bw (21.6% of ADI) is added to the results for adults.) Page 15 / 16

43 Part B - Section 4 - Core Assessment Screenshot of NEDI calculation based on the German NVS II model (To account for intake of copper from water consumption a chronic intake of mg/kg bw (36% of ADI) is added to the results for children and a chronic intake of mg/kg bw (21.6% of ADI) is added to the results for adults.) Page 16 / 16