Part A Core Assessment Ridomil Gold Combi Art. 51 Extension of authorisation for minor uses BVL Registration Number: 024548-00/08 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: Ridomil Gold Combi Active Substances: Folpet 400g/kg and Metalaxyl-M 50g/kg COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/04/2012 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/04/2012
Part A Core Assessment Ridomil Gold Combi Art. 51 Extension of authorisation for minor uses BVL Registration Number: 024548-00/08 Draft Registration Report Central Zone Country Germany Page 2 of 11 Table of Contents PART A Risk Management... 3 1 Details of the application... 3 1.1 Application background... 3 1.2 Annex I inclusion... 4 1.3 Regulatory approach... 4 1.3.1 Uses applied for and registration decision... 4 1.3.2 Public interest and minor use... 4 1.4 Data protection claims... 4 1.5 Letters of Access... 4 2 Details of the authorisation... 5 2.1 Product identity... 5 2.2 Classification and labelling... 5 2.2.1 Classification and labelling under Directive 99/45/EC or Regulation (EC) No 1272/2008... 5 2.2.2 R and S phrases under Regulation (EC) No 547/2011... 5 2.2.3 Other phrases... 6 2.2.3.1 Restrictions linked to the PPP... 6 2.2.3.2 Specific restrictions linked to the intended uses... 7 2.3 Product uses... 8 3 Risk management... 9 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles... 9 3.1.1 Physical and chemical properties... 9 3.1.2 Methods of analysis... 9 3.1.2.1 Analytical method for the formulation... 9 3.1.2.2 Analytical methods for residues... 9 3.1.3 Mammalian Toxicology... 9 3.1.4 Residues and Consumer Exposure... 9 3.1.4.1 Residues... 9 3.1.4.2 Consumer exposure... 9 3.1.5 Environmental fate and behaviour... 10 3.1.6 Ecotoxicology... 10 3.1.7 Efficacy... 10 3.2 Conclusions... 10 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... 10 Appendix 1 Copy of the product authorisation... 11 Appendix 2 Copy of the product label... 11 Appendix 3 Letter of Access... 11 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/04/2012
Part A Core Assessment Ridomil Gold Combi Art. 51 Extension of authorisation for minor uses BVL Registration Number: 024548-00/08 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 Ridomil Gold Combi containing Folpet and Metalaxyl-M 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 Ridomil Gold Combi have been made using endpoints agreed in the EU reviews of Folpet and Metalaxyl-M. 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 Ridomil Gold Combi Registration number 024548-00/08 Applicant Authorisation holder Function Type of formulation Zonal application according to Article 51, ZRMS=DE, first application (GV1) Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen, Siebengebirgsstraße 200, 53229 Bonn, Deutschland Syngenta Agro GmbH, Am Technologiepark 1-5, 63477 Maintal Fungicide Expiration of authorisation 2012-12-31 Water dispersible granule BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/04/2012
Part A Core Assessment Ridomil Gold Combi Art. 51 Extension of authorisation for minor uses BVL Registration Number: 024548-00/08 Draft Registration Report Central Zone Country Germany Page 4 of 11 1.2 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) Folpet (0091) Content in PPP 400g/kg Approval status Approved according Regulation (EC) No 1107/2009 Approval Regulation (EC) No 540/2011 Expiration of approval 30/09/2017 Metalaxyl-M (0933) Content in PPP 50g/kg Approval status Approved according Regulation (EC) No 1107/2009 Approval Regulation (EC) No 540/2011 Expiration of approval 31/12/2015 1.3 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. 1.3.1 Uses applied for and registration decision Number of use Plant/commodity/object Harmful organism/purpose decision 001 black salsify white rust of salsify (Albugo tragopodonis) 1.3.2 Public interest and minor use authorise 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 cultivated area of black salsify is about 80 ha, therefrom worth to treat are 32 ha. Calculation shows that authorisation holder will not profit from authorisation in that use. Upon this calculation and the examination of available alternative measures for the applied use(s) it can be stated that the applied use(s) is minor in nature and the authorisation is in the public interest. 1.4 Data protection claims The applicant is owner of the studies submitted / evaluated in this report and claims data protection. BVL_FO_05_2422_200_V1.0 1.5 Letters of Access Not necessary. The applicant is owner of the studies submitted. Authorisation holder agrees to the current application to extend the authorisation. Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/04/2012
Part A Core Assessment Ridomil Gold Combi Art. 51 Extension of authorisation for minor uses BVL Registration Number: 024548-00/08 Draft Registration Report Central Zone Country Germany Page 5 of 11 2 Details of the authorisation 2.1 Product identity Product name Ridomil Gold Combi Authorisation number 024548-00 Composition Type of formulation Function Authorisation holder Folpet 400g/kg; Metalaxyl-M 50g/kg Water dispersible granule (WG) Fungicide 2.2 Classification and labelling Syngenta Agro GmbH, Am Technologiepark 1-5, 63477 Maintal 2.2.1 Classification and labelling under Directive 99/45/EC or Regulation (EC) No 1272/2008 N Xn RK050 RX036 RX040 RX043 SK010 SX002 SX013 SX024 SX035 SX046 SX057 SP001 Dangerous for the environment Harmful R 50/53: Very toxic to aquatic organisms, may cause long-term adverse effects in the aquatic environment R 36: Irritating to eyes R 40: Limited evidence of a carcinogenic effect R 43: May cause sensitisation by skin contact S 20/21: When using do not eat, drink or smoke S 2: Keep out of the reach of children S 13: Keep away from food, drink and animal feeding stuffs S 24: Avoid contact with skin S 35: This material and its container must be disposed of in a safe way. S 46: If swallowed, seek medical advice immediately and show this container or label S 57: Use appropriate container to avoid environmental contamination. To avoid risk to man and the environment, comply with the instructions for use. 2.2.2 R and S phrases under Regulation (EC) No 547/2011 none BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/04/2012
Part A Core Assessment Ridomil Gold Combi Art. 51 Extension of authorisation for minor uses BVL Registration Number: 024548-00/08 Draft Registration Report Central Zone Country Germany Page 6 of 11 2.2.3 Other phrases 2.2.3.1 Restrictions linked to the PPP The authorization of the PPP is linked to the following conditions (mandatory labelling): Operator protection SB001 SF1891 SS110 SS120 SS2202 SS420 Avoid any unnecessary contact with the product. Misuse can lead to health damage. 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. Wear standard protective gloves (plant protection) when handling the undiluted product. Wear standard protective gloves (plant protection) when handling/applying the product ready for application. Wear a protective suit against pesticides and sturdy shoes (e.g. rubber boots) when applying/handling the product ready for application. Wear a hat made of firm material with a wide brim when applying/handling the product ready for application. Ecosystem protection NW262 NW264 NW468 NW604 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. The direction for use which determined a certain distance to protect surface waters does not apply in areas which are specifically identified by the designated authority, as long as the authority has authorised the application there. Honeybee Integrated Pest Management (IPM) NN2844 The product is classified as slightly harmful for populations of the species Aphidius colemani (braconid wasp). Active substance VH384 The content of carbon tetrachloride in the plant protection product may not exceed 0.1 %. BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/04/2012
Part A Core Assessment Ridomil Gold Combi Art. 51 Extension of authorisation for minor uses BVL Registration Number: 024548-00/08 Draft Registration Report Central Zone Country Germany Page 7 of 11 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 NN165 NN170 The product is classified as harmless for populations of the species Typhlodromus pyri (predatory mite). The product is classified as harmless for populations of the species Poecilus cupreus (ground beetle). The product is classified as harmless for populations of the species Chrysoperla carnea (lacewing). NN1511 The product is classified as harmless for populations of the species Orius insidiosus (predatory anthocorid bug). NN160 The product is classified as harmless for populations of the species Aleochara bilineata (staphylinid beetle). 2.2.3.2 Specific restrictions linked to the intended uses Some of the authorized uses are linked to the following conditions (mandatory labelling): See 2.3 (Product uses) Ecosystem protection NW605 NW606 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 provided for by state law, 6 (2) 2nd sentence of the 'PflSchG' (German Plant Protection Act) must be observed for the drift reduction classes marked with "*". 50% - 5m ; 75 % - 5 m; 90 % - * 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 50 000 Euro. 10 m BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/04/2012
Part A Core Assessment Ridomil Gold Combi Art. 51 Extension of authorisation for minor uses BVL Registration Number: 024548-00/08 Draft Registration Report Central Zone Country Germany Page 8 of 11 2.3 Product uses PPP (product name/code) Ridomil Gold Combi (024548-00) Formulation type: active substance 1 Folpet Conc. of as 1: active substance 2 Metalaxyl-M Conc. of as 2: Zone(s): central EU professional use non professional use 400 g/kg 50 g/kg Verified by MS: yes 1 2 3 4 5 6 7 8 10 11 12 13 14 Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) F G or I Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Method / Kind Application Timing / Growth stage of crop & season Max. number (min. interval between applications) a) per use b) per crop/ season kg, L product / ha a) max. rate per appl. b) max. total rate per crop/season Application rate g, kg as/ha a) max. rate per appl. b) max. total rate per crop/season Water L/ha min / max PHI (days) Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures 001 DE black salsify (SCVHI) F white rust of salsify (Albugo tragopodonis) ( ALBUTR) spraying From BBCH 43; at beginning of infestation and/or when first symptoms become visible a) 2 (14 to 21 days) b) 2 a) 2.0 kg/ha b) 4.0 kg/ha as1: a) 0.8 kg as/ha b) 1.6 kg as/ha) as2: a) 0.1 kg/ha b) 0.2 kg/ha) 300-600 21 Restrictions (see 2.2.3.2) NW605/606 BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/04/2012
Part A Core Assessment Ridomil Gold Combi Art. 51 Extension of authorisation for minor uses BVL Registration Number: 024548-00/08 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 3.1.1 Physical and chemical properties Not relevant for extension of authorisation according article 51. 3.1.2 Methods of analysis 3.1.2.1 Analytical method for the formulation Not relevant for extension of authorisation according article 51. 3.1.2.2 Analytical methods for residues Salsify belongs to the group of high water content commodities. It is noted that sufficiently validated analytical methods using capillary gas chromatography with electron capture detection respectively mass spectrum detection are available for enforcing Folpet. Acceptable analytical methods in high water content commodities such as salsify are available for enforcing Metalaxyl(-M). 3.1.3 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. 3.1.4 Residues and Consumer Exposure The residue behaviour of the active substances Folpet and Metalaxyl-M have been evaluated within the EU review process. Information about metabolism is sufficient to evaluate the intended use in black salsify. 3.1.4.1 Residues The available residue information is sufficient to perform an adequate assessment. Residues that are expected from the intended use of the plant protection product will not exceed the MRLs set in Regulation (EC) No 396/2005 for Folpet (0.02* mg/kg) and Metalaxyl-M (0.05* mg/kg) BVL_FO_05_2422_200_V1.0 3.1.4.2 Consumer exposure An assessment of residue uptake by consumers (TMDI calculation, EFSA PRIMo) results in the following maximum ADI consumptions: Folpet (0.1 mg/kg bw/d) 81 % (DE children) Metalaxyl-M (0.08 mg/kg bw/d) 26 % (DE children) Long-term dietary intake of residues of Folpet and Metalaxyl-M is unlikely to present a public health concern for European consumers. No acute risk is expected from the consumption of radishes treated according to the intended use. Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/04/2012
Part A Core Assessment Ridomil Gold Combi Art. 51 Extension of authorisation for minor uses BVL Registration Number: 024548-00/08 Draft Registration Report Central Zone Country Germany Page 10 of 11 3.1.5 Environmental fate and behaviour No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation 024548-00/00 according the uniform principles of directive 91/414/EEC. No further data are required. 3.1.6 Ecotoxicology No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation 024548-00/00 according the uniform principles of directive 91/414/EEC. The PPP Ridomil Gold Combi is toxic to the aquatic environment (O.mykiss: Preparation LC 50 0.540 mg/l). Subsequently no additional entries as those according to the evaluated use pattern and good agricultural practise are acceptable. Therefore the safety phrases and conditions of use NW262, NW264, NW468, NW 605 and 606 are assigned, see also 2.2. 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). 3.1.7 Efficacy Labelling in accordance with the requirements of ANNEX III General principles of integrated pest management under directive 2009/128/EC (see also point 2.2): -The classification of effects on beneficial arthropods for the main application covers the use(s) in accordance with Article 51 of regulation (EC) No 1107/2009. -The categories and labelling for mode of action for the main application covers the use(s) in accordance with 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 have not to be met. 3.2 Conclusions PPP Ridomil Gold Combi is already registered in Germany according to Directive 91/414/EEC taking into account the uniform principles of Annex VI. The intended use is minor in nature and the extension of authorisation is in public interest. Effects on bees and other beneficials were evaluated in the frame of the already authorised uses. No additional effects are anticipated because of the extension of uses(s). The intended use in salsify will not result in residues above the MRLs set in Regulation (EC) No 396/2005. A risk for consumers through the consumption of food with these residues of Folpet and Metalaxyl-M 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. BVL_FO_05_2422_200_V1.0 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 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/04/2012
Part A Core Assessment Ridomil Gold Combi Art. 51 Extension of authorisation for minor uses BVL Registration Number: 024548-00/08 Draft Registration Report Central Zone Country Germany Page 11 of 11 Appendix 1 Copy of the product authorisation Will be inserted in final registration report Appendix 2 Copy of the product label No product label available. Not mandatory according to Article 51 (5) Appendix 3 Letter of Access No letter of access necessary. The applicant is owner of the new studies submitted. Authorisation holder agrees to the current application to extend the authorisation. BVL_FO_05_2422_200_V1.0 Applicant Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Date: 04/04/2012
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dienstsitz Braunschweig Postfach 15 64 38005 Braunschweig mit Zustellungsurkunde Pflanzenschutzdienst der Landwirtschaftskammer Nordrhein-Westfalen Siebengebirgsstraße 200 53229 BONN Dr. Yasmine Bernhards Referentin TELEFON +49 (0)531 299-3457 TELEFAX +49 (0)531 299-3002 E-MAIL yasmine.bernhards@bvl.bund.de INTERNET www.bvl.bund.de IHR ZEICHEN IHRE NACHRICHT VOM AKTENZEICHEN 200.22200.024548-00/08.54033 (bitte bei Antwort angeben) DATUM 3. April 2012 GV1 024548-00/08 Ridomil Gold Combi Verfahren zur Erweiterung einer Zulassung nach Art. 51 der Verordnung (EG) Nr. 1107/2009 Bescheid mit den Wirkstoffen: 400 g/kg Folpet; 50 g/kg Metalaxyl-M Zulassungsnummer 024548-00 in weiteren Anwendungsgebieten Versuchsbezeichnung: SYD-21010-F-1-WG Ihr Antrag vom 20. Juni 2011 Die Zulassung des oben genannten Pflanzenschutzmittels wird wie in Anlage 1 beschrieben auf der Grundlage von Art. 51 der Verordnung (EG) Nr. 1107/2009 um folgende Anwendungsgebiete erweitert: Dienstsitz Braunschweig Bundesallee 50, Geb. 247 38116 Braunschweig Tel: +49 (0)531 21497-0 Fax: +49 (0)531 21497-299 Abt. Pflanzenschutzmittel Messeweg 11/12 38104 Braunschweig Tel: +49 (0)531 299-5 Fax: +49 (0)531 299-3002 Dienstsitz Berlin Mauerstraße 39-42 10117 Berlin Tel: +49 (0)30 18444-000 Fax: +49 (0)30 18444-89999 Referatsgr. Untersuchungen Diedersdorfer Weg 1 12277 Berlin Tel: +49 (0)30 18412-0 Fax: +49 (0)30 18412-2955
SEITE 2 VON 6 Schadorganismus/ Zweckbestimmung Pflanzen/ -erzeugnisse/objekte Anwendungsnummer Weißer Rost (Albugo tragopodonis) Schwarzwurzel 024548-00/08-001 Es werden folgende Anwendungsbestimmungen gemäß 36 Abs. 1 S. 1 PflSchG festgesetzt: Für die Anwendung 024548-00/08-001: (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% 5 m, 75% 5 m, 90% * Begründung: Unter Berücksichtigung der aktuell geltenden Abdrifteckwerte errechnen sich für die beantragten Anwendungen des Pflanzenschutzmittels Ridomil Gold Combi wegen der akuten Toxizität des Mittels gegenüber Fischen (Oncorhynchus mykiss: LC50 (4d, stat., nom.) = 540 µg Pr./L) folgende maximale Initialkonzentrationen in Oberflächengewässer mit den jeweils korrespondierenden TER-Werten: Ackerbau/Gemüsebau - Applikation 2 x 2 kg Pr./ha mit 7 Tagen Abstand Szenarium: Feldbau 82. Percentil Die Berechnung der PEC init. max. bei Mehrfachanwendung erfolgte unter Einstellung einer Halbwertzeit im Wasser von 37 Tagen (Halbwertzeit für Metalaxyl) TER-Werte bezogen auf die akute Toxizität des Mittels gegenüber Fische Abstand Driftrate PEC init Einsatz verlustmindernder Technik mit einer Driftreduktion von
in m in % in µg Pr./L konv.t. 50 % 75 % 90 % 0 100,00 1219,44 0,4 - - - 1 2,38 29,02 19 37 74 186 5 0,47 5,73 94 188 377 10 0,24 2,93 185 SEITE 3 VON 6 Bei Nichteinhaltung der in Zusammenhang mit den o. g. Anwendungsbestimmungen definierten Maßgaben führen die Einträge des Mittels in Oberflächengewässer und die hieraus resultierenden Konzentrationen auch bei sachgerechter und bestimmungsgemäßer Anwendung zu einer Unterschreitung des erforderlichen TER von 100. Die Einhaltung der Maßgaben ist zur Herstellung der Zulassungsvoraussetzungen durchsetzbar vorzuschreiben, da andernfalls schädliche Auswirkungen auf den Naturhaushalt nicht auszuschließen sind und somit der Schutz der Gewässer nicht gewährleistet ist. Für die Anwendung 024548-00/08-001: (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 50.000 Euro geahndet werden. 10 m Begründung: Siehe Anwendungsbestimmung NW605-1 Folgende Auflage wird gemäß 36 Abs. 3 S. 1 PflSchG erteilt: Siehe anwendungsbezogene Auflage in Anlage 1, unter 3. Dieser Bescheid wird mit dem Vorbehalt der nachträglichen Aufnahme, Änderung oder Ergänzung von Auflagen verbunden.
SEITE 4 VON 6 Für folgende Anwendung ist die Bearbeitung noch nicht abgeschlossen: 024548-00/07-001 Hinsichtlich der Gebühren erhalten Sie einen gesonderten Bescheid. 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, 38104 Braunschweig, schriftlich oder zur Niederschrift einzulegen. Im Auftrag gez. Dr. Karsten Hohgardt stellvertretender Abteilungsleiter Anlage Dieses Schreiben ist maschinell gefertigt und daher ohne Unterschrift gültig.
SEITE 5 VON 6 Anlage 1 genehmigte Anwendung: 024548-00/08-001 1 Anwendungsgebiet: Schadorganismus/Zweckbestimmung Pflanzen/-erzeugnisse/Objekte Weißer Rost (Albugo tragopodonis) Schwarzwurzel 2 Einsatzgebiet: Gemüsebau 3 Kennzeichnungsauflagen: 3.1 Angaben zur sachgerechten Anwendung: Anwendungsbereich Freiland Stadium der Kultur ab 43 Anwendungszeitpunkt Bei Befallsbeginn bzw. bei Sichtbarwerden der ersten Symptome Maximale Zahl der Behandlungen - in dieser Anwendung 2 - für die Kultur bzw. je Jahr 2 - Abstand 14 bis 21 Tage Anwendungstechnik spritzen Aufwand 2 kg/ha in 300 bis 600 l Wasser/ha 3.2 Sonstige Kennzeichnungsauflagen: - keine - 3.3 Wartezeiten: 21 Tage Freiland: Schwarzwurzel 4 Anwendungsbezogene Anwendungsbestimmungen:
NW605-1 NW606 SEITE 6 VON 6 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% 5 m, 75% 5 m, 90% * 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 50.000 Euro geahndet werden. 10 m
REGISTRATION REPORT Part B Section 4: Metabolism and Residues Detailed summary of the risk assessment Product code: Ridomil Gold Combi Active Substances: 400 g/l Folpet 50 g/l Metalaxyl-M Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Landwirtschaftskammer NRW Date: 17/10/2011 Page 1 / 26
Table of Contents IIIA 8 METABOLISM AND RESIDUES DATA... 4 IIIA 8.1 Evaluation of the active substances... 4 IIIA 8.1.1 Folpet... 4 IIIA 8.1.1.1 Storage stability... 4 IIIA 8.1.1.2 Metabolism in plants and plant residue definition(s)... 4 IIIA 8.1.1.3 Metabolism in livestock and animal residue definition(s)... 6 IIIA 8.1.1.4 Residues in rotational crops... 6 IIIA 8.1.1.5 Residues in livestock... 6 IIIA 8.1.2 Metalaxyl-M... 7 IIIA 8.1.2.1 Storage stability... 7 IIIA 8.1.2.2 Metabolism in plants and plant residue definition(s)... 7 IIIA 8.1.2.3 Metabolism in livestock and animal residue definition(s)... 9 IIIA 8.1.2.4 Residues in rotational crops... 9 IIIA 8.1.2.5 Residues in livestock... 9 IIIA 8.2 Evaluation of the intended use(s)... 10 IIIA 8.2.1 Salsify... 10 IIIA 8.2.1.1 Selection of critical use and justification... 10 IIIA 8.2.1.2 Residues in primary crops... 12 IIIA 8.2.1.3 Distribution of the residue in peel/pulp... 12 IIIA 8.2.1.4 Residues in processed commodities... 12 IIIA 8.2.1.5 Proposed Pre-Harvest Intervals, Withholding Periods... 12 IIIA 8.3 Consumer intake and risk assessment... 13 IIIA 8.4 Maximum residue levels (MRLs)... 14 IIIA 8.5 Conclusion... 15 Appendix 1: List of data submitted in support of the evaluation... 16 Page 2 / 26
Appendix 2: Detailed evaluation of the additional studies relied upon... 16 Appendix 3: Pesticide Residue Intake Modell (PRIMo)... 25 Page 3 / 26
IIIA 8 METABOLISM AND RESIDUES DATA IIIA 8.1 IIIA 8.1.1 Evaluation of the active substances Folpet Table 8.1.1-1 Information on the active substance folpet Structural formula Common Name folpet IIIA 8.1.1.1 Storage stability The storage stability of folpet in primary crops was reported in the DAR (Italy, 2004). Additional data were evaluated in the framework of an evaluation prepared to modify existing MRLs for folpet in wine grapes, garlic and tomatoes (EFSA Journal 2011; 9(9):2391). A brief summary of the storage stability data on folpet and its metabolite phthalimide is given in the following table. Table 8.1.1.1-1 Stability of residues (Annex IIA, point 6 Introduction, Annex IIIA, point 8 Introduction) Folpet Phthalimide Tomatoes: 18 months at -18 C Grapes: 15 months at -18 C Wheat grain, straw: 12 months at -20 C Onions: 12 months at -18 C Apples: 5 months at -21 C Processed tomatoes: 2 months at -21 C Processed apples: 1 month at -21 C Grape juice: 1 month at -21 C Onions: 12 months at -18 C Tomatoes: 12 months at -18 C Grapes: 6 months at -18 C IIIA 8.1.1.2 Metabolism in plants and plant residue definition(s) Data evaluated on EU level are described in detail in the DAR (Italy, 2004) and in EFSA s Reasoned opinion which was prepared within the framework of the modification of existing MRLs for the active substance folpet in wine grapes, garlic and tomatoes ((EFSA Journal 2011; 9(9):2391). A brief summary of the metabolism of folpet in plants is given in the following table. Page 4 / 26
Table 8.1.1.2-1 Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6) 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 Fruits and fruiting vegetables - Grapes, foliar application of [U-phenyl- 14 C]-folpet, outdoor, 3 x 1.4-1-6 kg as/ha; PHI 23-25 d - Avocados with [U-phenyl- 14 C]-folpet, outdoor, 3 x 3.4 kg as/ha; PHI 21, 97 d - Tomatoes with [carbonyl- 14 C]-folpet, indoor, root treatment, 1 x 0.1 mg/plant, PHI 1, 4, 7 and 11 d Cereals - Wheat, foliar application of [U-phenyl- 14 C]-folpet, outdoor, 2 x 1.1 1.6 kg as/ha; PHI 1, 28 and 39 d Root and tuber vegetables - Potatoes, foliar application of [U-phenyl- 14 C]-folpet, outdoor, 5 x 2 kg as/ha; PHI 1, 3 and 7 d and after each treatment The metabolism of folpet was similar in all investigated crops, though the individual metabolic pattern appeared to be dependent on the mode of application and on the time elapsed between treatment and sampling. In crops having received a foliar application, the majority of the terminal residue was generally present as folpet, phthalimide (through release of the trichloromethylthio side) and phthalic acid. The findings in potato tubers and root-treated tomato plants indicate that the most important residues translocated between underground plant parts and upper plant parts were the secondary metabolites phthalic acid and phthalamic acid. The soil degradation studies demonstrated that the degradation rate of folpet and its main metabolites in soil is rapid; the maximum DT 90 in laboratory studies was 53.8 days for folpet, 93.7 days for phthalimide, 13.7 days for phthalic acid and 2.7 days for phthalamic acid, all below the trigger value of 100 days. Thus, no further studies investigating the nature and magnitude of residues in rotational crops are required. Not concluded. No information available. The studies investigating the effect of processing on the nature of folpet residues demonstrated that under standard processing conditions (ph 4, 90 C, 20 min; ph 5, 100 C, 60 min; ph 6, 120 C, 20 min) the compound is completely converted into phthalimide and phthalic acid. yes Reg. (EC) No 396/2005: Folpet EFSA proposal: Sum of folpet and phthalimide, expressed as folpet Sum of folpet and phthalimide, expressed as folpet Page 5 / 26
Conversion factor(s) (monitoring to risk assessment) Phthalimide is mainly formed during processing. A proposal for a general conversion factor was not possible on European level, since most of the supervised field trials were conducted without measurement of phthalimide. IIIA 8.1.1.3 Metabolism in livestock and animal residue definition(s) A brief summary of the metabolism of folpet in livestock is given in the following table. Data, which has been previously evaluated on EU level is described in detail in the DAR (Italy, 2004). Table 8.1.1.3-1 Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6) Animals covered Time needed to reach a plateau concentration in milk and eggs Animal residue definition for monitoring Animal residue definition for risk assessment Conversion factor(s) (monitoring to risk assessment) Metabolism in rat and ruminant similar (yes/no) Lactating goats The substance is extensively metabolised and excreted and was not found in any edible tissue. After oral administration, residues in animal tissues were very low and no accumulation was observed. Only in liver and kidney total radioactive residues were above 0.01 mg as-eq/kg (0.02 and 0.05 mg as-eq/kg respectively). The metabolism was found to be similar to that observed in rats proceeding via hydrolysis of the nitrogen-sulphur bond leading to thiophosgen and phthalimide which is then further metabolised to phthalamic acid and phthalic acid. 4-5 days Reg. (EC) No 396/2005: residue not defined EFSA proposal: phthalimide, expressed as folpet Phthalimide, expressed as folpet Not applicable Fat soluble residue: (yes/no) no (log P ow >2) yes IIIA 8.1.1.4 Residues in rotational crops The persistence of folpet and its metabolite phthalimide is low. Therefore, residues of folpet are not expected to occur in crops grown in normal rotation after those treated with folpet. Rotational crop studies are not required. IIIA 8.1.1.5 Residues in livestock Residues of folpet in commodities of animal origin were not assessed, since salsify is normally not fed to livestock. Page 6 / 26
IIIA 8.1.2 Metalaxyl-M Table 8.1.2-1 Information on the active substance Metalaxyl-M Structural formula Me Me N H R CO 2 Me Me O OMe Common Name Metalaxyl-M IIIA 8.1.2.1 Storage stability A brief summary of the storage stability data on Metalaxyl-M is given in the following table. Data which had been previously evaluated on EU level are described in detail in the DAR (Belgium, 1999). Table 8.1.2.1-1 Stability of residues (Annex IIA, point 6 Introduction, Annex IIIA, point 8 Introduction) Cranberries: 38 months at -20 C Peppers, potatoes, spinach: 39 months at -20 C Lettuce: 12 months at -20 C IIIA 8.1.2.2 Metabolism in plants and plant residue definition(s) A brief summary of the metabolism of metalaxyl(-m) in plants is given in the following table. Data evaluated on EU level are described in detail in the DAR (Belgium, 1999) and the Draft Reasoned Opinion on the Review of existing MRLs for metalaxyl-m according to Article 12 of Reg. (EC) No 396/2005. All plant metabolism studies (primary and rotational crop studies) were conducted with [ 14 C- phenyl]-labelled metalaxyl. One study comparing the metabolism of metalaxyl-m and metalaxyl was performed on lettuce and showed a similar pattern for the R-enantiomer and the racemic mixture. Table 8.1.2.2-1 Metabolism in plants (Annex IIA, point 6.1 and 6.7, Annex IIIA, point 8.1 and 8.6) Plant groups covered Fruits and fruiting vegetables - Grapes, outdoor, foliar application, 7 x 0.05 kg as/hl; PHI 52 d Leafy vegetables - lettuce, outdoor, foliar, 2 x 0.25 kg as/ha; PHI 14 d - tobacco, indoor, soil treatment at transplanting and preplanting soil incorporation treatment, application rates between 0.28 and 7.1 kg as/ha, sampling 3 to 20 weeks after transplanting Root and tuber vegetables - potatoes, outdoor, foliar application, 4 x 0.0625 kg as/ha, PHI 47 d; 6 x 0.43 resp. 1.3 kg as/ha, PHI: 7 d Metalaxyl(-M) is intensively metabolised in all investigated crops with up to 8 identified metabolites. At harvest the parent metalaxyl accounted for 64 % Page 7 / 26
TRR in grapes, 20 % TRR in lettuce, and 3 % TRR in potato leaves. Metabolite CGA 94689, free and conjugated, accounted for 20 % TRR in grapes and 25 % TRR in lettuce. In potato leaves CGA 108905 amounted to 47 % TRR. All other metabolites were <10 % TRR. Metabolites mainly consisted of hydroxylated or demethylated parent, which are considered as less toxic than the parent. Uptake following root, stem or leaf application is fast, translocation primarily occurs acropetally. Rotational crops Leafy vegetables - Lettuce, outdoor, seed treatment, 1 x 3.4 kg as/ha - Lettuce, outdoor, foliar treatment on potatoes, 6 x 0.45 kg as/ha Root and tuber vegetables - Sugar beet, outdoor, seed treatment, 1 x 3.4 kg as/ha - Sugar beet, outdoor, foliar treatment on potatoes, 6 x 0.45 kg as/ha Cereals - Wheat, outdoor, seed treatment, 1 x 3.4 kg as/ha - Wheat, outdoor, foliar treatment on potatoes, 6 x 0.45 kg as/ha - Oats, outdoor, foliar treatment on potatoes, 6 x 0.45 kg as/ha - Corn, outdoor, foliar treatment on potatoes, 6 x 0.45 kg as/ha 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) Pulses and oilseeds - Soya bean, outdoor, seed treatment, 1 x 3.4 kg as/ha - Soya bean, outddor, foliar treatment on potatoes, 6 x 0.45 kg as/ha In crops planted immediately after harvest of treated potatoes, TRR levels were higher than 0.1 mg/kg in wheat (0.11 mg/kg in grain, 0.56 in straw), soybean (0.17 mg/kg in beans, 0.59 in leaves), lettuce (0.11 mg/kg) and oats (0.19 mg/kg in straw). In corn, oat grain and sugar beet, TRR was below 0.1 mg/kg. In crops planted after tobacco which had received a soil treatment, 79 % TRR in mature wheat stalks, 57 % TRR in 50 % mature lettuce and 57 % TRR in mature sugar beet root had been charactewrised and/or identified. Seven glycosides were isolated and identified. Parent was extensively metabolized but still remained an important compound of the residue in the 50 % mature lettuce foliage (15 % TRR). The metabolite CGA 6786813 present in wheat stalks (6.8 % TRR) and lettuce foliage (15.5 % TRR) was neither detected in plants nor in the rat metabolism. yes No information available. The studies investigating the effect of processing on the nature of metalaxyl residues demonstrated that under standard processing conditions (ph 4, 90 C, 20 min; ph 5, 100 C, 60 min; ph 6, 120 C, 20 min) the compound is hydrolytically stable. yes Page 8 / 26
Plant residue definition for monitoring Plant residue definition for risk assessment Conversion factor(s) (monitoring to risk assessment) Metalaxyl and metalaxyl-m, sum of isomers Metalaxyl and metalaxyl-m, sum of isomers Not applicable IIIA 8.1.2.3 Metabolism in livestock and animal residue definition(s) A brief summary of the metabolism of metalaxyl(-m) in livestock is given in the following table. Data evaluated on EU level are described in detail in the DAR (Belgium, 1999) and the Draft Reasoned Opinion on the Review of existing MRLs for metalaxyl-m according to Article 12 of Reg. (EC) No 396/2005. Table 8.1.2.3-1 Metabolism in livestock (Annex IIA, point 6.2 and 6.7, Annex IIIA, point 8.1 and 8.6) Animals covered Time needed to reach a plateau concentration in milk and eggs Animal residue definition for monitoring Animal residue definition for risk assessment Conversion factor(s) (monitoring to risk assessment) Metabolism in rat and ruminant similar (yes/no) Lactating goats, phenyl label, 77 mg/kg diet Laying hens, phenyl label, 100 mg/kg diet Lactating goats excreted 67 % of the administered dose via urine. In laying hens 91 % of the administered dose were found in excreta. Metalaxyl was intensively metabolised in both species. Unchanged parent was not found or only at low levels (<10 % of the TRR). Identified metabolites were normally conjugated with sugars, glucuronic acid or lipids. An accumulation has not been observed in any tissue. 1 day Metalaxyl and metalaxyl-m, sum of isomers Metalaxyl and metalaxyl-m, sum of isomers Not applicable Fat soluble residue: (yes/no) no (log P OW = 1.71) yes IIIA 8.1.2.4 Residues in rotational crops The persistence of metalaxyl-m is relatively low. Therefore, residues of metalaxyl-m are not expected to occur in crops grown in normal rotation after those treated with metalaxyl-m. Rotational crop studies are not required. IIIA 8.1.2.5 Residues in livestock Residues of metalaxyl-m in commodities of animal origin were not assessed, since salsify is normally not fed to livestock. Page 9 / 26
IIIA 8.2 IIIA 8.2.1 Evaluation of the intended use(s) Salsify IIIA 8.2.1.1 Selection of critical use and justification The critical GAP used for the consumer intake and risk assessment is presented in Table 8.2.1.1-1. Page 10 / 26
Table 8.2.1.1-1 Critical Use (worst case) on which consumer intake and risk assessment was based 1 2 3 4 5 6 7 8 10 11 12 13 14 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) 1 Germany Salsify F White rust of salsify (Albugo tragopodonis) (c) Application Method / Kind (d-f) spraying Timing / Growth stage of crop & season (g) At beginning of infestation and/or when first symptoms become visible, BBCH > 43 Max. number (min. interval between applications) a) per use b) per crop/ season (h) a) 2 (14-21 days) b) 2 Application rate kg, L product / ha a) max. rate per appl. b) max. total rate per crop/season a) 2.0 b) 4.0 g, kg as/ha a) max. rate per appl. b) max. total rate per crop/season a) 0.8 kg folpet/ha; 0.10 kg metalaxyl- M/ha b) 1.6 kg folpet/ha; 0.20 kg metalaxyl- M/ha Water L/ha min / max PHI (days) (i) 300-600 21 - 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 3-8263-3152-4), 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 11 / 26
IIIA 8.2.1.2 Residues in primary crops The following tables give a brief overview of the supervised residue trials selected for the assessment of folpet and metalaxyl-m in salsify. For the detailed evaluation of the available studies it is referred to Appendix 2. Folpet Table 8.2.1.2-1 Overview of supervised residue trials for folpet and its metabolite phthalimide in salsify Region (a) Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (Folpet) Risk assessment (Sum of folpet and phthalimide, expr. as folpet) STMR (mg/kg) (b) HR (mg/kg) (c) Salsify DE Outdoor <0.02 (5) <0.06 (2) 0.06 0.06 - (a): NEU, SEU, EU or Import (country code). In the case of indoor uses there is no necessity to differentiate between NEU and SEU (b): Median value of the individual trial results according to the enforcement residue definition (c): Highest value of the individual trial results according to the enforcement residue definition (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residue trial Median CF (d) Salsify belongs to the group of high water content commodities. It is noted that sufficiently validated analytical methods using capillary gas chromatography with electron capture detection respectively mass spectrum detection are available for enforcing folpet. Metalaxyl-M Table 8.2.1.2-1 Overview of supervised residue trials for metalaxyl-m in salsify Commodity Commodity Region (a) Outdoor/ Indoor Individual trial results (mg/kg) Enforcement (Metalaxyl-M) Risk assessment (Metalaxyl-M) STMR (mg/kg) (b) HR (mg/kg) (c) Salsify DE Outdoor <0.05 (3) <0.05 (3) 0.05 0.05 1 (a): NEU, SEU, EU or Import (country code). In the case of indoor uses there is no necessity to differentiate between NEU and SEU (b): Median value of the individual trial results according to the enforcement residue definition (c): Highest value of the individual trial results according to the enforcement residue definition (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residue trial Median CF (d) Acceptable analytical methods in high water content commodities such as salsify are available for enforcing metalaxyl(-m). IIIA 8.2.1.3 Not applicable. Distribution of the residue in peel/pulp IIIA 8.2.1.4 Residues in processed commodities Processing information are neither available nor required (<0.1 mg/kg in RAC). IIIA 8.2.1.5 Proposed Pre-Harvest Intervals, Withholding Periods The proposed PHI according to GAP (see Table 8.2.1.1-1) is 21 days for salsify. Page 12 / 26
IIIA 8.3 Consumer intake and risk assessment Folpet For the calculation of the chronic exposure the STMR from residue trials on salsify according to the DoR for risk assessment (sum of folpet and phthalimide, expressed as folpet) was used and for the remaining commodities the existing MRLs as established in Regulation (EC) No 396/2005. In accordance with the approach by EFSA in its reasoned opinion on the modification of the existing MRLs for folpet in wine grapes, garlic and tomatoes (EFSA Scientific Reports (2011);9(9):2391), a conversion factor of 1.5 was used for crops for which a real MRL had been set (i.e. > LOQ): pome fruit, cherries, wine grapes, strawberries, blackberries, raspberries, gooseberries, currants, potatoes, onions, tomatoes, cucurbits with inedible peel, kohlrabi, lettuce, spinach, beans with/without pods, barley, wheat and hops). This factor represents the highest median CF derived from the available residue data on plants. The consumer intake and risk assessment is based on the appropriate input values given in Table 8.3-1 and the toxicological reference values stated in Table 8.3-2. Results are also summarized in Table 8.3-2. For the detailed calculation results it is referred to Appendix 3. Table 8.3-1 Residue input values for the consumer risk assessment Commodity Input value (mg/kg) Chronic risk assessment Comment Input value (mg/kg) Acute risk assessment Comment Pome fruit 4.5 MRL x CF na not calculated Cherries 3.0 MRL x CF na not calculated Wine grapes 7.5 MRL x CF na not calculated Strawberries 4.5 MRL x CF na not calculated Blackberries 4.5 MRL x CF na not calculated Raspberries 4.5 MRL x CF na not calculated Currants 4.5 MRL x CF na not calculated Gooseberries 4.5 MRL x CF na not calculated Potatoes 0.15 MRL x CF na not calculated Salsify 0.06 STMR (sum of folpet and phthalimide) 0.06 HR (sum of folpet and phthalimide) Onions 0.15 MRL x CF na not calculated Tomatoes 3.0 MRL x CF na not calculated Cucurbits (inedible peel) 1.5 MRL x CF na not calculated Kohlrabi 0.075 MRL x CF na not calculated Lettuce 3.0 MRL x CF na not calculated Spinach 15 MRL x CF na not calculated beans with or w/o pods 3.0 MRL x CF na not calculated Barley 3.0 MRL x CF na not calculated Wheat 3.0 MRL x CF na not calculated Hops 225 MRL x CF na not calculated Other commodities of plant and animal origin 0.02 MRL (LOQ) na not calculated Page 13 / 26
Table 8.3-2 Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8) ADI 0.1 mg/kg bw TMDI (% ADI) according to EFSA PRIMo 81 % (based on DE child) NTMDI (% ADI) according to VELS model 81 % IEDI (EFSA PRIMo) (% ADI) Not calculated NEDI (% ADI) Not calculated Factors included in IEDI and NEDI Not applicable ARfD 0.2 mg/kg bw IESTI (EFSA PRIMo) (% ARfD) Salsify: 1.2 % (based on Belgian children) NESTI (German VELS model) (% ARfD) Salsify: < 1 % Factors included in IESTI and NESTI None Metalaxyl-M The consumer intake and risk assessment is based on the appropriate input values given in Table 8.3-3 and the toxicological reference values stated in Table 8.3-4. Results are also summarized in Table 8.3-4. For the detailed calculation results it is referred to Appendix 3. Table 8.3-3 Residue input values for the consumer risk assessment Commodity Chronic risk assessment Input value (mg/kg) Comment Input value (mg/kg) Acute risk assessment Comment Salsify 0.05 STMR 0.05 HR Other commodities of plant and animal origin various MRLs see Reg. (EC) No. 396/2005 na not calculated Table 8.3-4 Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8) ADI TMDI (% ADI) according to EFSA PRIMo NTMDI (% ADI) according to VELS model 27 % IEDI (EFSA PRIMo) (% ADI) NEDI (VELS model) (% ADI) Factors included in IEDI and NEDI ARfD IESTI (EFSA PRIMo) (% ARfD) 0.08 mg/kg bw 26 % (based on DE children) slight differences of TMDI and NTMDI (though both are related to DE children) are due to different data aggregations in both models Not calculated Not calculated Not applicable 0.5 mg/kg bw NESTI (German VELS model) (% ARfD) Salsify: < 1 % Factors included in IESTI and NESTI Salsify: < 1 % (based on Belgian children) None IIIA 8.4 Maximum residue levels (MRLs) Page 14 / 26
The existing EU MRLs for the crop applied for in this dossier (salsify) are summarized in Table 8.4-1. Table 8.4-1 Overview of the existing EC MRLs Active Substance Commodity (Code) Existing EC MRL (mg/kg) Proposed EC MRL (mg/kg) Result of OECD calculator Justification for the proposal / Comments Folpet Salsify 0.02* 0.02* -- No new proposal required Metalaxyl-M Salsify 0.05* 0.05* -- No new proposal required IIIA 8.5 Conclusion For the proposed GAP on salsify in Germany (2 x 0.8 kg folpet/ha, 2 x 0.1 kg metalaxyl-m/ha, BBCH > 43, PHI 21 days), 5 supervised field residue trials with folpet and 3 residue trials with metalaxyl-m on salsify were submitted. All trials were conducted in accordance with the critical GAP. In none of the submitted trials residues of folpet or metalaxyl-m above the respective LOQ occurred. Therefore the number of trials is sufficient for the evaluation of the intended use. Two of the folpet trials also investigated residues of its metabolite phthalimide. Further information on phthalimide residues in salsify is not considered necessary since no different results would be expected from additional trials. It can be concluded that the MRLs as established for salsify under the framework of Reg. (EC) No 396/2005 are sufficient to cover residues arising after treatment according to the intended use. A risk for consumers was not identified. Page 15 / 26
Appendix 1: List of data submitted in support of the evaluation Table A.1-1 List of data submitted in support of the evaluation Annex point Author(s) Year Title Testing Facility OECD: 6.3 OECD: 6.3 OECD: 6.3 OECD: 6.3 OECD: 6.3 OECD: 6.3 OECD: 6.3 OECD: 6.3 KIIA KIIA KIIA KIIA KIIA KIIA KIIA KIIA GLP or GEP Status Published or not Report-No. Frosch, M. 2010 Bericht zum Versuch zur Ermittlung der Rückstandsmenge bei der Anwendung von Ridomil Gold Combi (Wirkstoff: Metalaxyl-M + Folpet) in Schwarzwurzel (Erntewert - Feldteil) R-WZ-2009-15 Frosch 2009 Berichtsbogen für Rückstandsuntersuchungen mit Pflanzenschutzmitteln - Schwarzwurzel RU-F-11 09 HEWE 1/1 Witte, A. 2010 Determination of residues of Folpet and Metalaxyl-M after two applications of formulation Ridomil Gold Combi in Salsify, three field trials in 2009 10D02251-01-RASA Wichura, A. 2009 Berichtsbogen für Rückstandsuntersuchungen mit Pflanzenschutzmitteln Schwarzwurzel RU-F-11 09 NIH 1/1 Claus 2009 Berichtsbogen für Rückstandsuntersuchungen mit Pflanzenschutzmitteln Schwarzwurzel RU-F-11 09 RPNW 1/1 Wichura, A. 2010 Berichtsbogen für Rückstandsuntersuchungen mit Pflanzenschutzmitteln Schwarzwurzel RU-F-11 10 NIH 1/1 Witte, A. 2011 Determination of residue of Folpet and Phthalimide after two applications of formulation Ridomil Gold Combi in salsify and radish, seven field trials in 2009 and 2010 10D02270-01-RAPL Wichura, A. 2010 Berichtsbogen für Rückstandsuntersuchungen mit Pflanzenschutzmitteln Schwarzwurzel RU-F-11 10 NIH 1/2 Reference ASB2011-9823 ASB2011-9826 ASB2011-9813 ASB2011-9824 ASB2011-9825 ASB2011-9828 ASB2011-9829 ASB2011-9827 Owner/ Submitter of the Study DLR Rheinpfalz DLR Rheinpfalz DLR Rheinpfalz DLR Rheinpfalz DLR Rheinpfalz DLR Rheinpfalz DLR Rheinpfalz DLR Rheinpfalz Appendix 2: Detailed evaluation of the additional studies relied upon A 2.2 Residues in primary crops A 2.2.1 Nature of residues Page 16 / 26
A 2.2.2 Magnitude of residues A 2.2.2-1 Study 1 - Folpet Reference: Bericht zum Versuch zur Ermittlung der Rückstandsmenge bei der Anwendung von Ridomil Gold Combi (Wirkstoff: Metalaxyl-M + Folpet) in Schwarzwurzel (Erntewert - Feldteil), Frosch, M., 2010, R-WZ-2009-15 Berichtsbogen für Rückstandsuntersuchungen mit Pflanzenschutzmitteln Schwarzwurzel, Frosch, 2009, RU-F-11 09 HEWE 1/ Determination of residues of Folpet and Metalaxyl-M after two applications of formulation Ridomil Gold Combi in Salsify, three field trials in 2009, Witte, A., 2010, 10D02251-01-RASA GLP: Yes Sample storage conditions: 8 months, deep frozen Crop/crop group: Salsify Analytical method: GC-MS Indoor/Outdoor: Outdoor Limit of Quantification (mg/kg): 0.02 mg/kg Formulation: Ridomil Gold Combi Limit of Detection (mg/kg): 0.006 mg/kg Content of active substance (g/kg or g/l): 400 g/kg Folpet Residues calculated as: Folpet Table A.2.2.2-1. Residue trial summary for folpet Trial No./ Location/ Year Commodity/ Variety Date of 1.Sowing or planting 2.Flowering 3. Harvest g a.s./ ha Application rate per treatment Water (l/ha) g a.s./hl Dates of treatment or no. of treatments and last date Growth stage at last treatment or date Portion analyzed Residues (mg/kg) PHI (days) Remarks RU-F-11 09 HEWE 1/1 Germany 35510 Butzbach Hoffmans schwarzer Pfahl 1) 2009-04-15 (planting) 2) 3) 2009-10-08 832 832 600 600 130 140 2009-08-27 2009-09-17 BBCH 45-47 root <0.02 21 ASB2011-9823 ASB2011-9826 ASB2011-9813 2010-09-15 Comments of zrms: Study is acceptable. Page 17 / 26
Study 2- Folpet Reference: Berichtsbogen für Rückstandsuntersuchungen mit Pflanzenschutzmitteln Schwarzwurzel, Wichura, A., 2009, RU-F-11 09 NIH 1/1 Determination of residues of Folpet and Metalaxyl-M after two applications of formulation Ridomil Gold Combi in Salsify, three field trials in 2009, Witte, A., 2010, 10D02251-01-RASA GLP: Yes Sample storage conditions: 8 months, deep frozen Crop/crop group: Salsify Analytical method: GC-MS Indoor/Outdoor: Outdoor Limit of Quantification (mg/kg): 0.02 mg/kg Formulation: Ridomil Gold Combi Limit of Detection (mg/kg): 0.006 mg/kg Content of active substance (g/kg or g/l): 400 g/kg Folpet Residues calculated as: Folpet Table A.2.2.2-1. Trial No./ Location/ Year RU-F-11 09 NIH 1/1 Germany 29352 Dasselsbruch 2011-05-12 Residue trial summary for folpet Commodity/ Variety Date of 1.Sowing or planting 2.Flowering 3. Harvest Meres 1) 2009-04-08 planting) 2) 3) 2009-10-07 g a.s./ ha 800 800 Application rate per treatment Water (l/ha) 600 600 130 130 g a.s./hl Dates of treatment or no. of treatments and last date 2009-09-02 2009-09-16 Growth stage at last treatment or date Portion analyzed Residues (mg/kg) PHI (days) Remarks BBCH 48 root <0.02 21 ASB2011-9824 ASB2011-9813 Comments of zrms: Study is acceptable. Page 18 / 26
Study 3- Folpet Reference: Berichtsbogen für Rückstandsuntersuchungen mit Pflanzenschutzmitteln Schwarzwurzel, Claus, 2009, RU-F-11 09 RPNW 1/1 Determination of residues of Folpet and Metalaxyl-M after two applications of formulation Ridomil Gold Combi in Salsify, three field trials in 2009, Witte, A., 2010, 10D02251-01-RASA GLP: Yes Sample storage conditions: 7 months, deep frozen Crop/crop group: Salsify Analytical method: GC-MS Indoor/Outdoor: Outdoor Limit of Quantification (mg/kg): 0.02 mg/kg Formulation: Ridomil Gold Combi Limit of Detection (mg/kg): 0.006 mg/kg Content of active substance (g/kg or g/l): 400 g/kg Folpet Residues calculated as: Folpet Table A.2.2.2-1. Trial No./ Location/ Year RU-F-11 09 RPNW 1/1 Germany 67105 Schifferstadt 2011-05-12 Residue trial summary for folpet Commodity/ Variety Hoffmans schwarzer Pfahl Date of 1.Sowing or planting 2.Flowering 3. Harvest 1) 2009-05-13 planting) 2) 3) 2009-11-09 g a.s./ ha 832 832 Application rate per treatment Water (l/ha) 416 416 200 200 g a.s./hl Dates of treatment or no. of treatments and last date 2009-10-12 2009-10-19 Growth stage at last treatment or date Portion analyzed Residues (mg/kg) PHI (days) Remarks BBCH 47-48 root <0.02 21 ASB2011-9825 ASB2011-9813 Comments of zrms: Study is acceptable. Page 19 / 26
Study 4- Folpet Reference: Berichtsbogen für Rückstandsuntersuchungen mit Pflanzenschutzmitteln Schwarzwurzel, Wichura, A., 2010, RU-F-11 10 NIH 1/1 Determination of residue of Folpet and Phthalimide after two applications of formulation Ridomil Gold Combi in salsify and radish, seven field trials in 2009 and 2010, Witte, A., 2011, 10D02270-01-RAPL GLP: Yes Sample storage conditions: 8 months, - 18 C Crop/crop group: Salsify Analytical method: GC-MS Indoor/Outdoor: Outdoor Limit of Quantification (mg/kg): 0.02 mg/kg for both substances Formulation: Ridomil Gold Combi Limit of Detection (mg/kg): 0.006 mg/kg for both substances Content of active substance (g/kg or g/l): 400 g/kg Folpet Residues calculated as: Folpet / Phthalimide Table A.2.2.2-1. Trial No./ Location/ Year RU-F-11 10 NIH 1/1 Germany 29352 Dasselbruch 2011-05-12 Residue trial summary for folpet Commodity/ Variety Date of 1.Sowing or planting 2.Flowering 3. Harvest Duplex 1) 2010-04-14 planting) 2) 3) 2010-10-06 g a.s./ ha 800 800 Application rate per treatment Water (l/ha) 600 600 130 130 g a.s./hl Dates of treatment or no. of treatments and last date 2010-08-31 2010-09-15 Growth stage at last treatment or date Portion analyzed Folpet (mg/kg) Phthali mide (mg/kg) PHI (days) Remarks BBCH 47-48 root <0.02 <0.02 21 ASB2011-9828 ASB2011-9829 Comments of zrms: Study is acceptable. Page 20 / 26
Study 5- Folpet Reference: Berichtsbogen für Rückstandsuntersuchungen mit Pflanzenschutzmitteln Schwarzwurzel, Wichura, A., 2010, RU-F-11 10 NIH 1/2 Determination of residue of Folpet and Phthalimide after two applications of formulation Ridomil Gold Combi in salsify and radish, seven field trials in 2009 and 2010, Witte, A., 2011, 10D02270-01-RAPL GLP: Yes Sample storage conditions: 9 months, - 18 C Crop/crop group: Salsify Analytical method: GC-MS Indoor/Outdoor: Outdoor Limit of Quantification (mg/kg): 0.02 mg/kg for both substances Formulation: Ridomil Gold Combi Limit of Detection (mg/kg): 0.006 mg/kg for both substances Content of active substance (g/kg or g/l): 400 g/kg Folpet Residues calculated as: Folpet / Phthalimide Table A.2.2.2-1. Trial No./ Location/ Year RU-F-11 10 NIH 1/2 Germany 21357 Bardowick 2011-05-12 Residue trial summary for folpet Commodity/ Variety Date of 1.Sowing or planting 2.Flowering 3. Harvest Meres 1) 2010-04-12 planting) 2) 3) 2010-09-28 g a.s./ ha 800 800 Application rate per treatment Water (l/ha) 300 300 270 270 g a.s./hl Dates of treatment or no. of treatments and last date 2010-08-24 2010-09-07 Growth stage at last treatment or date Portion analyzed Folpet (mg/kg) Phthali mide (mg/kg) PHI (days) Remarks BBCH 46-47 root <0.02 <0.02 21 ASB2011-9827 ASB2011-9829 Comments of zrms: Study is acceptable. Page 21 / 26
Study 1 Metalaxyl-M Reference: Bericht zum Versuch zur Ermittlung der Rückstandsmenge bei der Anwendung von Ridomil Gold Combi (Wirkstoff: Metalaxyl-M + Folpet) in Schwarzwurzel (Erntewert - Feldteil), Frosch, M., 2010, R-WZ-2009-15 Berichtsbogen für Rückstandsuntersuchungen mit Pflanzenschutzmitteln Schwarzwurzel, Frosch, 2009, RU-F-11 09 HEWE 1/1 Determination of residues of Folpet and Metalaxyl-M after two applications of formulation Ridomil Gold Combi in Salsify, three field trials in 2009, Witte, A., 2010, 10D02251-01-RASA GLP: Yes Sample storage conditions: 8 months, deep frozen Crop/crop group: Salsify Analytical method: HPLC-MS/MS Indoor/Outdoor: Outdoor Limit of Quantification (mg/kg): 0.05 mg/kg Formulation: Ridomil Gold Combi Limit of Detection (mg/kg): 0.015 mg/kg Content of active substance (g/kg or g/l): 50 g/kg Metalaxyl-M Residues calculated as: Metalaxyl-M Table A.2.2.2-1. Trial No./ Location/ Year RU-F-11 09 HEWE 1/1 Germany 35510 Butzbach 2010-09-15 Residue trial summary for metalaxyl-m Commodity/ Variety Hoffmans schwarzer Pfahl Date of 1.Sowing or planting 2.Flowering 3. Harvest 1) 2009-04-15 (planting) 2) 3) 2009-10-08 g a.s./ ha 100 104 Application rate per treatment Water (l/ha) 600 600 17 17 g a.s./hl Dates of treatment or no. of treatments and last date 2009-08-27 2009-09-17 Growth stage at last treatment or date Portion analyzed Residues (mg/kg) PHI (days) Remarks BBCH 45-47 root <0.05 21 ASB2011-9823 ASB2011-9826 ASB2011-9813 Comments of zrms: Study is acceptable. Page 22 / 26
Study 2- Metalaxyl-M Reference: Berichtsbogen für Rückstandsuntersuchungen mit Pflanzenschutzmitteln Schwarzwurzel, Wichura, A., 2009, RU-F-11 09 NIH 1/1 Determination of residues of Folpet and Metalaxyl-M after two applications of formulation Ridomil Gold Combi in Salsify, three field trials in 2009, Witte, A., 2010, 10D02251-01-RASA GLP: Yes Sample storage conditions: 8 months, deep frozen Crop/crop group: Salsify Analytical method: HPLC-MS/MS Indoor/Outdoor: Outdoor Limit of Quantification (mg/kg): 0.05 mg/kg Formulation: Ridomil Gold Combi Limit of Detection (mg/kg): 0.015 mg/kg Content of active substance (g/kg or g/l): 50 g/kg Metalaxyl-M Residues calculated as: Metalaxyl-M Table A.2.2.2-1. Trial No./ Location/ Year RU-F-11 09 NIH 1/1 Germany 29352 Dasselsbruch 2011-05-12 Residue trial summary for folpet Commodity/ Variety Date of 1.Sowing or planting 2.Flowering 3. Harvest Meres 1) 2009-04-08 planting) 2) 3) 2009-10-07 g a.s./ ha 100 100 Application rate per treatment Water (l/ha) 600 600 17 17 g a.s./hl Dates of treatment or no. of treatments and last date 2009-09-02 2009-09-16 Growth stage at last treatment or date Portion analyzed Residues (mg/kg) PHI (days) Remarks BBCH 48 root <0.05 21 ASB2011-9824 ASB2011-9813 Comments of zrms: Study is acceptable. Page 23 / 26
Study 3- Metalaxyl-M Reference: Berichtsbogen für Rückstandsuntersuchungen mit Pflanzenschutzmitteln Schwarzwurzel, Claus, 2009, RU-F-11 09 RPNW 1/1 Determination of residues of Folpet and Metalaxyl-M after two applications of formulation Ridomil Gold Combi in Salsify, three field trials in 2009, Witte, A., 2010, 10D02251-01-RASA GLP: Yes Sample storage conditions: 7 months, deep frozen Crop/crop group: Salsify Analytical method: HPLC-MS/MS Indoor/Outdoor: Outdoor Limit of Quantification (mg/kg): 0.05 mg/kg Formulation: Ridomil Gold Combi Limit of Detection (mg/kg): 0.015 mg/kg Content of active substance (g/kg or g/l): 50 g/kg Metalaxyl-M Residues calculated as: Metalaxyl-M Table A.2.2.2-1. Trial No./ Location/ Year RU-F-11 09 RPNW 1/1 Germany 67105 Schifferstadt 2011-05-12 Residue trial summary for metalaxyl-m Commodity/ Variety Hoffmans schwarzer Pfahl Date of 1.Sowing or planting 2.Flowering 3. Harvest 1) 2009-05-13 planting) 2) 3) 2009-11-09 g a.s./ ha 104 104 Application rate per treatment Water (l/ha) 416 416 25 25 g a.s./hl Dates of treatment or no. of treatments and last date 2009-10-12 2009-10-19 Growth stage at last treatment or date Portion analyzed Residues (mg/kg) PHI (days) Remarks BBCH 47-48 root <0.05 21 ASB2011-9825 ASB2011-9813 Comments of zrms: Study is acceptable. Page 24 / 26
Appendix 3: Pesticide Residue Intake Modell (PRIMo) Page 25 / 26
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