Art. 51 extension. Risk Management

Transkript

1 Part A Core Assessment Centium 36 CS Art. 51 extension BVL Registration Number: /18 Draft Registration Report Central Zone Country Germany Page 1 of 11 Art. 51 extension REGISTRATION REPORT Part A Risk Management Product code: Centium 36 CS Active Substance: Clomazone 360 g/l COUNTRY: Germany Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Bayerische Landesanstalt für Landwirtschaft - Institut für Pflanzenschutz - Date: 20/09/2012 BVL_FO_05_2422_200_V1.0 Applicant Bayerische Landesanstalt für Landwirtschaft Institut für Pflanzenschutz Date: 20/09/2012

2 Part A Core Assessment Centium 36 CS Art. 51 extension BVL Registration Number: /18 Draft Registration Report Central Zone Country Germany Page 2 of 11 Table of Contents PART A Risk Management Details of the application Application background Annex I inclusion Regulatory approach Uses applied for and registration decision Public interest and minor use Data protection claims Letters of Access Details of the authorisation Product identity Classification and labelling Classification and labelling under Directive 99/45/EC R and S phrases under Directive 2003/82/EC (Annex IV and V) Other phrases Restrictions linked to the PPP Specific restrictions linked to the intended uses Product uses Risk management Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties Methods of analysis Analytical method for the formulation Analytical methods for residues Mammalian Toxicology Residues and Consumer Exposure Residues Consumer exposure Environmental fate and behaviour Ecotoxicology Efficacy Conclusions Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation Appendix 1 Copy of the product authorisation Appendix 2 Copy of the product label Appendix 3 Letter of Access BVL_FO_05_2422_200_V1.0 Applicant Bayerische Landesanstalt für Landwirtschaft Institut für Pflanzenschutz Date: 20/09/2012

3 Part A Core Assessment Centium 36 CS Art. 51 extension BVL Registration Number: /18 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 Centium 36 CS containing clomazone in Germany. The risk assessment conclusions are based on the already existing registration of the PPP. The following section of Registration Report, Part B is prepared: Section 4. Assessments for the safe use of Centium 36 CS have been made using endpoints agreed in the EU reviews of clomazone. 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 Centium 36 CS Type of application Zonal application according to Article 51, ZRMS=DE, first application (GV1) Registration number /18 Applicant Bayerische Landesanstalt für Landwirtschaft - Institut für Pflanzenschutz -, Lange Point 10, Freising-Weihenstephan, Deutschland Authorisation holder FMC Chemical,sprl,Agricultural Products Group Boulevard de la Plaine 3, 1050 BRÜSSEL BELGIEN Function Herbicide Type of formulation Capsule suspension Expiration of authorisation BVL_FO_05_2422_200_V1.0 Applicant Bayerische Landesanstalt für Landwirtschaft Institut für Pflanzenschutz Date: 20/09/2012

4 Part A Core Assessment Centium 36 CS Art. 51 extension BVL Registration Number: /18 Draft Registration Report Central Zone Country Germany Page 4 of Annex I inclusion The active substance included in the plant protection product is approved according Regulation (EC) No 1107/2009. The present application is in line with the provisions of the approvals. Active substance (BVL Number) Clomazone (0864) Content in PPP 360 g/l Approval status Approved according Regulation (EC) No 1107/2009 Approval Regulation (EC) No 540/2011 Expiration of approval 31/10/ Regulatory approach The PPP is already registered in Germany according to Directive 91/414/EEC taking into account the uniform principles of Annex IV. Therefore the evaluation of the actual application is limited to the points not covered by the existing registration Uses applied for and registration decision Number of Plant/commodity/object Harmful organism/purpose decision use 1 Soya bean Catchweed bedstraw, Deadnettle species, Knotweed species, Common chickweed 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 soya bean is about 3500 ha, thereof 2800 ha need to be controlled. 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 No new studies were submitted. BVL_FO_05_2422_200_V Letters of Access Authorisation holder agrees to the current application to extend the authorisation. 2 Details of the authorisation Applicant Bayerische Landesanstalt für Landwirtschaft Institut für Pflanzenschutz Date: 20/09/2012

5 Part A Core Assessment Centium 36 CS Art. 51 extension BVL Registration Number: /18 Draft Registration Report Central Zone Country Germany Page 5 of Product identity Product name Centium 36 CS Authorisation number Composition Type of formulation Function Authorisation holder Clomazone 360 g/l Capsule suspension (CS) Herbicide FMC Chemical,sprl,Agricultural Products Group Boulevard de la Plaine 3, 1050 BRÜSSEL BELGIEN 2.2 Classification and labelling Classification and labelling under Directive 99/45/EC or Regulation (EC) No 1272/2008 SP001 To avoid riks to man and the environment, comply with the instructions for use R and S phrases under Regulation (EC) No 547/2011 None Other phrases Restrictions linked to the PPP The authorization of the PPP is linked to the following conditions (mandatory labelling): Operator protection SB001 SB010 SB110 Avoid any unnecessary contact with the product. Misuse can lead to health damage. Keep out of children s reach. 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. SF Treated areas/crops may not be entered until the spray coating has dried. SS110 Wear standard protective gloves (plant protection) when handling the undiluted product. Ecosystem protection NW 262 NW 264 The product is toxic for algae. The product is toxic for fish and aquatic invertebrates BVL_FO_05_2422_200_V1.0 NW468 Fluids left over from application and their remains, products and their remains, empty containers and packaging, and cleansing and rinsing fluids must not be dumped in water. This also applies to indirect entry via the urban or agrarian drainage system and to rain- Applicant Bayerische Landesanstalt für Landwirtschaft Institut für Pflanzenschutz Date: 20/09/2012

6 Part A Core Assessment Centium 36 CS Art. 51 extension BVL Registration Number: /18 Draft Registration Report Central Zone Country Germany Page 6 of 11 water and sewage canals. NW NT 127 NT 149 The product may not be applied in or in the immediate vicinity of surface or coastal waters. Irrespective of this, the minimum buffer zone from surface waters stipulated by state law must be observed. Violations may be punished by fines of up to EUR. The product may only be applied between 6 p.m. and 9 a.m. if the forecasted maximum day temperatures are higher than 20 C. If forecasted maximum day temperatures are higher than 25 C, the product must not be applied. The operator must check the plants once a week for one month after application and within a radius of 100 m around the application area for paling. Cases of paling must be reported immediately to the official plant protection service and the authorisation holder. Integrated Pest Management (IPM) Mode of action (HRAC-Group): F3 Active substance None. The authorization of the PPP is linked to the following conditions (voluntary labelling): Honeybee NB663 Due to the manner in which authorisation governs application of the product, bees are not endangered.(b3) Integrated Pest Management (IPM) NN160 NN130 NN165 The product is classified as harmless for populations of the species Aleochara bilineata (rove beetle). The product is classified as harmless for populations of the species Pardosa amentata und palustris (wolf spiders). The product is classified as harmless for populations of the species Poecilus cupreus (carabid beetle) 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 BVL_FO_05_2422_200_V1.0 NT 101 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). Loss reducing equipment is not required if the product is applied with portable plant protection equipment or if adjacent areas (field boundaries, hedges, groups of woody plants) are less than 3 m wide or 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. Applicant Bayerische Landesanstalt für Landwirtschaft Institut für Pflanzenschutz Date: 20/09/2012

7 Part A Core Assessment Centium 36 CS Art. 51 extension BVL Registration Number: /18 Draft Registration Report Central Zone Country Germany Page 7 of 11 BVL_FO_05_2422_200_V1.0 Applicant Bayerische Landesanstalt für Landwirtschaft Institut für Pflanzenschutz Date: 20/09/2012

8 Part A Core Assessment Centium 36 CS Art. 51 extension BVL Registration Number: /18 Draft Registration Report Central Zone Country Germany Page 8 of Product uses PPP (product name/code) Centium 36 CS ( ) active substance 1 Clomazone Formulation type: Capsule suspension Conc. of as 1: 360 g/l safener - synergist - Applicant: Zone(s): Verified by MS: j Bayerische Landesanstalt 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 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 1 DE Soya bean GLXMA F Catchweed bedstraw GALAP, Deadnettle species LAMSS, Knotweed species POLSS, Common chickweed STEME spraying BBCH 00-05, before emergence until 5 days after seeding a) 1 b) ditto a) 0.25 L/ha b) ditto a) 0.09 g/ha b) ditto F Restrictions (see ) NT 101 BVL_FO_05_2422_200_V1.0 Applicant Bayerische Landesanstalt für Landwirtschaft Institut für Pflanzenschutz Date: 20/09/2012

9 Part A Core Assessment Centium 36 CS Art. 51 extension BVL Registration Number: /18 Draft Registration Report Central Zone Country Germany Page 9 of 11 3 Risk management 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties Not relevant for extension of authorisation according article Methods of analysis Analytical method for the formulation Not relevant for extension of authorisation according article Analytical methods for residues Soya beans belong to the group of oil content commodities. Sufficiently validated analytical methods based on HPLC-MS/MS are available for enforcing clomazone in soya beans Mammalian Toxicology The PPP is already registered in Germany according to Directive 91/414/EEC. If used properly and according to the intended conditions of use, adverse health effects for operators, workers, bystanders and residents will not be expected Residues and Consumer Exposure The residue behaviour of the active substance clomazone has been evaluated within the EU review process. Information about metabolism is sufficient to evaluate the intended use in soya beans Residues The available residue information is sufficient to perform an adequate consumer risk assessment after transfer of residues of clomazone from RAC to food of plant and animal origin and to animal feed as well. Residues that are expected from the intended use of the plant protection product will not exceed the MRL of 0.01* mg/kg set in Regulation (EC) No 396/2005 for clomazone Consumer exposure An assessment of residue uptake by consumers (TMDI calculation: EFSA PRIMo and NTMDI: German NVS II model) results in the following maximum ADI consumptions: Clomazone (0.133 mg/kg bw/d) < 1 % (UK toddlers and DE children) Long-term dietary intake of residues of clomazone is unlikely to present a public health concern for European consumers. Based on the low acute toxicity of clomazone no ARfD has been allocated. Therefore, no acute risk is expected from the consumption of soya beans treated according to the intended use. BVL_FO_05_2422_200_V Environmental fate and behaviour No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation /00 according the uniform principles of directive 91/414/EEC. No effect on groundwater and the environment are to be expected. Applicant Bayerische Landesanstalt für Landwirtschaft Institut für Pflanzenschutz Date: 20/09/2012

10 Part A Core Assessment Centium 36 CS Art. 51 extension BVL Registration Number: /18 Draft Registration Report Central Zone Country Germany Page 10 of Ecotoxicology No new studies are presented; all data were reviewed within the EU review and approval of the national authorisation /00 according the uniform principles of directive 91/414/EEC. Considering use patterns as laid down in 2.3 entries of the product Centium 36 CS on terrestrial nontarget areas cannot be excluded. The ER50 for the non-target plant Stellaria media amounts to 2,07 g as/ha. Risk mitigation (see NT 101, NT 127, NT 149) is therefore necessary to avoid harmful effects on terrestrial non-target plants. The product Centium 36 CS and the active substance clomazone is toxic to the aquatic environment (Menidia menidia LC 50 (4d,dur.,real.) = 6.26 mg as/l; Daphnia magna EC 50 (2d,sta.,nom.) = 5.2 mg as/l; Selenastrum capricornutum NOEC (5d,sta.,real) = 0,99 mg as/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 642) are assigned, see also and Honeybee risk assessment The honeybee risk assessment for the main application covers the use(s) in accordance with Article 51 of regulation (EC) No 1107/2009 (see also point 2.2) Efficacy 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. Labelling in accordance with the requirements of ANNEX III General principles of integrated pest management under directive 2009/128/EC (see also point 2.2): -The classification of effects on beneficial arthropods for the main application covers the use(s) applied for under the terms of Article 51 of regulation (EC) No 1107/ The categories and labelling for mode of action for the main application cover the use(s) applied for under the terms of Article 51 of regulation (EC) No 1107/ Conclusions PPP Centium 36 CS 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 beyond these are anticipated because of the extension of uses(s). The indended use in soya beans will not result in residues of clomazone above the MRL set in Regulation (EC) No 396/2005. A risk for consumers through the consumption of food with these residues of 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_V Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation Applicant Bayerische Landesanstalt für Landwirtschaft Institut für Pflanzenschutz Date: 20/09/2012

11 Part A Core Assessment None Centium 36 CS Art. 51 extension BVL Registration Number: /18 Draft Registration Report Central Zone Country Germany Page 11 of 11 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 agrees to the current application to extend the authorisation. BVL_FO_05_2422_200_V1.0 Applicant Bayerische Landesanstalt für Landwirtschaft Institut für Pflanzenschutz Date: 20/09/2012

12 Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Dienstsitz Braunschweig Postfach Braunschweig mit Zustellungsurkunde Bayerische Landesanstalt für Landwirtschaft - Institut für Pflanzenschutz - Lange Point FREISING-WEIHENSTEPHAN Dr. Axel Wilkening Referatsleiter TELEFON +49 (0) TELEFAX +49 (0) axel.wilkening@bvl.bund.de INTERNET IHR ZEICHEN IHRE NACHRICHT VOM AKTENZEICHEN / (bitte bei Antwort angeben) DATUM 18. September 2012 GV /18 Centium 36 CS Verfahren zur Erweiterung einer Zulassung nach Art. 51 der Verordnung (EG) Nr. 1107/2009 Bescheid Änderung mit dem Wirkstoff: 360 g/l Clomazone Zulassungsnummer Versuchsbezeichnung: FMC H-2-CS Genehmigung GV vom 16. April 2004 in der Fassung der Änderungsbescheide vom 15. Juni 2004, 30. Dezember 2011, 28. Februar 2012, 24. August 2012 Ihr Antrag vom 04. August 2011 Meine oben näher bezeichneten Bescheide ändere ich wie folgt: Dienstsitz Braunschweig Bundesallee 50, Geb Braunschweig Tel: +49 (0) Fax: +49 (0) Abt. Pflanzenschutzmittel Messeweg 11/ Braunschweig Tel: +49 (0) Fax: +49 (0) Dienstsitz Berlin Mauerstraße Berlin Tel: +49 (0) Fax: +49 (0) Referatsgr. Untersuchungen Diedersdorfer Weg Berlin Tel: +49 (0) Fax: +49 (0)

13 SEITE 2 VON 6 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 Schadorganismus/ Zweckbestimmung Kletten-Labkraut, Vogel-Sternmiere, Knöterich-Arten, Taubnessel-Arten Pflanzen/ -erzeugnisse/objekte Anwendungsnummer Sojabohne / Es werden folgende Anwendungsbestimmungen gemäß 36 Abs. 1 S. 1 PflSchG festgesetzt.: Folgende Anwendungsbestimmung wird zusätzlich festgesetzt: Für die Anwendung /18-001: (NT101) 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. Bei der Anwendung des Mittels ist der Einsatz verlustmindernder Technik nicht 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. Begründung: Aus allen zum Wirkstoff Clomazone und zu den Clomazone-haltigen Formulierungen vorliegenden Versuchsergebnissen wurde eine ER 50 von 2,07 g a.i./ha an Stellaria media als bewertungsrelevant für die Beurteilung von Auswirkungen auf Pflanzen abgeleitet (Wachstumstest, Report No. SYD HUH vom , vorgelegt von der Firma Syngenta Agro GmbH zu ZA ; EVE liegt vor). Ausgehend von dem aktuellen Abdriftmodell errechnen sich aufgrund der Toxizität des Wirkstoffes gegenüber Pflanzen

14 folgende Einträge in an die Behandlungsfläche angrenzende Areale mit den jeweils korrespondierenden TER-Werten: SEITE 3 VON 6 TER-Werte zum Wirkst. Clomazone unter Beachtung von Abdrift und Verflüchtigung Applikation: 90 g Clomazone/ha TER-Werte bezogen auf Stellaria media ER 50: 2,07 g a.i./ha Abdrift konv. Tech. Driftred. 50 % Driftred. 75 % Driftred. 90 % Abstand Driftrate PEC PEC * TER PEC * TER PEC * TER PEC * TER in m in % in g ai/ha in g ai/ha in g ai/ha in g ai/ha in g ai/ha 1 2,77 2,49 2,82 0,7 1,58 1,3 0,95 2,2 0,58 3,6 5 0,57 0,51 * Summe aus Abdrift und Verflüchtigung Eintrag über Verflüchtigung berechnet mit EVA hier für mikroverkapselte Formulierungen mit einer Reduktion der Verflüchtigung um 80 % aufgrund der vergleichenden Untersuchungen mit Command 48 EC und Centium 36 CS (Reduktion der Verflüchtigung nach 24 h auf 18,8 % und nach 48 h auf 24 %) Abstand in m Eintrag in % 0,38 0,37 0,33 Eintrag in g a.i./ha 0,34 0,33 0,30 Die Einhaltung der in Zusammenhang mit der NT101 definierten Maßgaben führen zu Einträgen des Mittels Centium 36 CS in angrenzende Flächen, die eine Unterschreitung des unter Berücksichtigung der in den Prüfungen an Pflanzen mitbetrachteten subletalen Endpunkte einzustellenden Toxizitäts-/Expositionsverhältnisses von 10 bedingen. Im zu betrachtenden Fall wird jedoch eine Reduzierung des Toxizitäts-/Expositions- Verhältnisses aus folgenden Gründen als vertretbar erachtet: bei der Bewertung der Auswirkungen von Clomazone auf Pflanzen konnte auf Ergebnisse aus Freilandbeobachtungen zurückgegriffen werden, die als Grundlage der Bewertung verwendete Art Stellaria media weist sich durch die aufgrund der Vielzahl der geprüften Arten ermittelbaren Sensitivitäts-Verteilung als zugehörig zu den gegenüber Clomazone empfindlichsten Pflanzenarten aus. Unter Einstellung dieser entscheidungsrelevanten Umstände wird ein Toxizitäts- /Expositionsverhältnisses von 1,0 als ausreichend zur Berücksichtigung bleibender

15 SEITE 4 VON 6 Unsicherheiten und somit Gewährleistung eines hinreichenden Schutzes von Pflanzen außerhalb der Behandlungsfläche beurteilt. Folgende Auflagen werden gemäß 36 Abs. 3 S. 1 PflSchG erteilt: Siehe anwendungsbezogene Auflage in Anlage 1, unter 3. 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. Im Auftrag gez. Dr. Hans-Gerd Nolting Abteilungsleiter Anlage Dieses Schreiben ist maschinell gefertigt und daher ohne Unterschrift gültig.

16 Anlage 1 genehmigte Anwendung: / SEITE 5 VON 6 1 Anwendungsgebiet: Schadorganismus/Zweckbestimmung Pflanzen/-erzeugnisse/Objekte Kletten-Labkraut, Vogel-Sternmiere, Knöterich- Arten, Taubnessel-Arten Sojabohne 2 Einsatzgebiet: Ackerbau 3 Kennzeichnungsauflagen: 3.1 Angaben zur sachgerechten Anwendung: Anwendungsbereich Freiland Erläuterung zur Kultur ausgenommen zur Saatguterzeugung Stadium der Kultur 00 bis 05 Anwendungszeitpunkt Vor dem Auflaufen, bis 5 Tage nach der Saat Maximale Zahl der Behandlungen - in dieser Anwendung 1 - für die Kultur bzw. je Jahr 1 Anwendungstechnik spritzen Aufwand 0,25 l/ha in 200 bis 400 l Wasser/ha 3.2 Sonstige Kennzeichnungsauflagen: - keine Wartezeiten: (F) Freiland: Sojabohne 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.

17 SEITE 6 VON 6 4 Anwendungsbezogene Anwendungsbestimmungen: NT101 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. Bei der Anwendung des Mittels ist der Einsatz verlustmindernder Technik nicht 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.

18 Centium 36 CS /18 Part B Section 4 - Core Assessment REGISTRATION REPORT Part B Section 4: Metabolism and Residues Detailed summary of the risk assessment Product code: Centium 36 CS Active Substance: Clomazone 360 g/l Central Zone Zonal Rapporteur Member State: Germany CORE ASSESSMENT Applicant: Bayerische Landesanstalt für Landwirtschaft Date: 20/09/2012 Page 1 / 9

19 Centium 36 CS /18 Part B Section 4 - Core Assessment Table of Contents IIIA 8 METABOLISM AND RESIDUES DATA...3 IIIA 8.1 Evaluation of the active substances...3 IIIA Clomazone...3 IIIA Storage stability...3 IIIA Metabolism in plants and plant residue definition(s)...3 IIIA Metabolism in livestock and animal residue definition(s)...4 IIIA Residues in rotational crops...5 IIIA Residues in livestock...5 IIIA 8.2 Evaluation of the intended use(s)...5 IIIA Selection of critical use and justification...5 IIIA Soya bean...7 IIIA Residues in primary crops...7 IIIA Distribution of the residue in peel/pulp...7 IIIA Residues in processed commodities...7 IIIA Proposed pre-harvest intervals, withholding periods...7 IIIA 8.3 Consumer intake and risk assessment...7 IIIA 8.4 Proposed maximum residue levels (MRLs)...8 IIIA 8.5 Conclusion...8 Appendix 1 List of data submitted in support of the evaluation...8 Appendix 2 Detailed evaluation of the additional studies relied upon...8 Appendix 3 Pesticide Residue Intake Model (PRIMo)...9 Page 2 / 9

20 Centium 36 CS /18 Part B Section 4 - Core Assessment IIIA 8 IIIA 8.1 METABOLISM AND RESIDUES DATA Evaluation of the active substances IIIA Clomazone Table IIIA 8.1-1: Identity of the active substance Structural formula Common Name clomazone CAS number IIIA Storage stability A brief summary of the storage stability data on clomazone is given in the following table. Data, which has been previously evaluated at EU level is described in detail in the DAR (DK, 2005, ASB ), the conclusion on the peer review regarding the risk assessment of the active substance clomazone (EFSA Scientific Report (2007) 109, 1-73, ASB ) and EFSA`s Reasoned opinion in the review of the MRLs for clomazone according to Article 12 of Regulation (EC) No 396/2005 (EFSA Journal 2011;9(8):2345, ASB ). Table IIIA 8.1-2: Stability of residues (Annex IIA, point 6.1) Stability of clomazone Tobacco: 40 months at -20 C Cotton seed, corn: 12 months at -18 C Soyabean: 6 months at -18 C IIIA Metabolism in plants and plant residue definition(s) A brief summary of the metabolism of clomazone in plants is given in the following table. Data, which has been previously evaluated at EU level is described in detail in the DAR (DK, 2005, ASB ), the conclusion on the peer review regarding the risk assessment of the active substance clomazone (EFSA Scientific Report (2007) 109, 1-73 ASB ) and EFSA`s Reasoned opinion in the review of the MRLs for clomazone according to Article 12 of Regulation (EC) No 396/2005 (EFSA Journal 2011;9(8):2345, ASB ). Table IIIA 8.1-3: Metabolism in plants (Annex IIA, point 6.2.1; 6.5.1, 6.5.2, and 6.7.1) Plant groups covered Pre-emergence treatment of tobacco, sweet potatoes and soybeans, post-emergence treatment of cotton and alfalfa, with [phenyl- 14 C], [carbonyl- 14 C] and [methylene- 14 C] labelled clomazone An additional study on maize was reported in the DAR, but not further considered because the study was not considered valid. The metabolism was considered to be similar for the different crops and timings of application. The most abundant plant metabolite is 2-chlorobenzyl alcohol (10 48 % TRR). Parent compound was almost completely degraded and, if present, only at low levels (0.3 4 % TRR). Page 3 / 9

21 Centium 36 CS /18 Part B Section 4 - Core Assessment 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) Though the DT 90 value of clomazone in soil is in the range of 86 to 297 days in field studies, no study dealing with residues in rotational crops has been submitted. However, a couple of metabolism studies with pre-emergence applications were available. Possible uptake of clomazone residues from soil into plants is covered by these investigations. It is concluded that no further studies were necessary to support the use of clomazone as pre-emergence herbicide on potatoes and oilseed rape. Not applicable Not applicable Not required due to low residues at harvest (<0.01 mg/kg). Not applicable Plant residue definition for monitoring Clomazone 1 In Reg (EC) No 396/2005, the DoR currently is clomazone for all commodities of plant origin. Plant residue definition for risk assessment Clomazone 1 Conversion factor(s) (monitoring to risk assessment) None IIIA Metabolism in livestock and animal residue definition(s) A brief summary of the metabolism of clomazone in livestock is given in the following table. Data, which has been previously evaluated at EU level is described in detail in the DAR (DK, 2005, ASB ), the conclusion on the peer review regarding the risk assessment of the active substance clomazone (EFSA Scientific Report (2007) 109, 1-73, ASB and EFSA`s Reasoned opinion in the review of the MRLs for clomazone according to Article 12 of Regulation (EC) No 396/2005 (EFSA Journal 2011;9(8):2345, ASB ). Table IIIA 8.1-4: Metabolism in livestock (Annex IIA, point to and 6.7.1) Animals covered Time needed to reach a plateau concentration in milk and eggs Animal residue definition for monitoring Lactating goats, laying hens In the goat metabolism study, only the total radioactive residues were determined, in poultry, the metabolism was only investigated with material radio-labelled in the phenyl ring. The available data is considered insufficient to reach a conclusion about the metabolism in livestock and to propose a residue definition for products of animal origin. Ambiguous results Not required as intake by livestock is < 0.1 mg/kg. No detectable residues are expected. In Reg (EC) No 396/2005, no MRLs have been established for clomazone in commodities of animal origin. 1 Currently restricted to representative uses of EU evaluation (potatoes and oilseed rape); EFSA proposed in its RO for Art. 12 (1) to extend this definition to all crops Page 4 / 9

22 Centium 36 CS /18 Part B Section 4 - Core Assessment Animal residue definition for risk assessment Conversion factor(s) (monitoring to risk assessment) Not applicable Metabolism in rat and ruminant similar (yes/no) Fat soluble residue: (yes/no) No (log Pow = 2.54) Not required as intake by livestock is < 0.1 mg/kg. No detectable residues are expected. Due to limited quality of studies no clear results. IIIA Residues in rotational crops Field studies are not required; residues 0.01 mg/kg are not expected (reference is made to metabolism in rotational crops. IIIA Residues in livestock An actual calculation of the dietary burden (based on all relevant uses authorized in Germany) is provided in the following table. Table IIIA 8.1-5: Calculation of the dietary burden (based on all relevant uses authorized in DE) Feedstuff % DM Percent of daily livestock diet (dry feed basis) Residue Intake (mg/kg, dry feed basis) Chicken 1.9 kg bw daily Dairy cattle 550 kg bw daily Beef cattle 350 kg bw daily Pig 75 kg bw daily (mg/kg) Chicken Dairy cattle Beef cattle Pig maximum feed maximum feed maximum feed maximum feed (DM) 120 g (DM) 20 kg (DM) 15 kg (DM) 3 kg Kale/ a Cabbage Pulses b Potatoes c Rape seed d Intake (mg/kg dry weight feed) Intake (mg/kg bw/d) Intake (mg/animal/d) a STMR, based on the following cgap: 1 x 90 g as/ha, pre-emergence, PHI: F b STMR, based on the following cgap: 1 x 90 g as/ha, pre-emergence, for seed production, PHI: F c STMR, based on the following cgap: 1 x 90 g as/ha, pre-emergence, for seed production, PHI: F d STMR, based on the following cgap: 1 x 120 g as/ha, pre-emergence, PHI: F Table IIIA 8.1-6: Conditions of requirement of livestock feeding studies on clomazone Expected intakes by livestock 0.1 mg/kg diet (dry weight basis) (yes/no If yes, specify the level) Ruminant: Poultry: Pig: no no no Potential for accumulation (yes/no): no no no Metabolism studies indicate potential level of residues 0.01 mg/kg in edible tissues (yes/no) no no no Feeding studies are not available. Residues in products of animal origin are not expected. IIIA 8.2 Evaluation of the intended use(s) IIIA Selection of critical use and justification The critical GAP used for consumer intake and risk assessment is presented in Table IIIA It is the only GAP reported for soya bean in the framework of this application. Page 5 / 9

23 Centium 36 CS /18 Part B Section 4 - Core Assessment Table IIIA 8.2-1: Critical Use (worst case) used for consumer intake and risk assessment Use- No. Member state(s) Crop and/ or situation (crop destination / purpose of crop) (a) F G or I (b) Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) (c) Application Method / Kind (d-f) Timing / Growth stage of crop & season (g) Max. number (min. interval between applications) a) per use b) per crop/ season (h) Application rate L product / ha a) max. rate per appl. b) max. total rate per crop/season kg as/ha a) max. rate per appl. b) max. total rate per crop/season Water L/ha min / max PHI (days) (i) Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures (j) 1 DE soya bean F catchweed bedstraw, common chickweed, knotweed spec., deadnettle spec. spraying BBCH 00-05, before emergence, up to 5 days after sowing a) 1 b) 1 a) 0.25 L/ha b) 0.25 L/ha a) kg as/ha b) kg as/ha 200 / 400 L/ha F 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 6 / 9

24 Centium 36 CS /18 Part B Section 4 - Core Assessment IIIA Soya bean IIIA Residues in primary crops Supervised field trials on soya bean from Northern Europe are not available, but extrapolation of field trial results from rape seed to soya bean is considered acceptable for the evaluation of the intended cgap. Acceptable residue trials in oilseed rape were evaluated during the review of the existing maximum residue levels for clomazone according to Article 12 of Regulation (EC) No 396/2005 (EFSA Journal 2011;9(8):2345, ASB ). The critical EU GAP for rape seed (1 x 0.12 kg as/ha, PHI: F) is slightly more critical than the GAP envisaged for Centium 36 CS in soya beans (1 x 0.09 kg as/ha, PHI: F). Nevertheless, no clomazone residues above the LOQ of 0.01 mg/kg were seen in mature rape seed. The following table gives a brief overview of the supervised residue trials on rape seed selected for the assessment of clomazone in soya bean. Table IIIA 8.2-2: Overview of the selected supervised residue trials for clomazone in rape seed Commodity Region (a) Outdoor/ Indoor Rape seed Soya bean Individual trial results (mg/kg) Enforcement (clomazone) Risk assessment (clomazone) STMR (mg/kg) (b) HR (mg/kg) (c) NEU Outdoor <0.01 (12) <0.01 (12) Median CF (d) (a): NEU, SEU, EU or Import (country code). In the case of indoor uses there is no necessity to differentiate between NEU and SEU. (b): Median value of the individual trial results according to the risk assessment residue definition. (c): Highest value of the individual trial results according to the risk assessment residue definition. (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residues trial. A validated analytical method for enforcement of this residue definition with an LOQ of 0.01 mg/kg in all plant commodities is available. IIIA Not relevant. Distribution of the residue in peel/pulp IIIA Residues in processed commodities Not relevant. Due to low residues at harvest, no processing studies are required. IIIA Proposed pre-harvest intervals, withholding periods The time from treatment to maturity of soya bean is deemed sufficient; no specific PHI needs to be set. IIIA 8.3 Consumer intake and risk assessment The consumer intake and risk assessment is based on the appropriate input values given in Table IIIA and the toxicological reference values stated in Table IIIA For the detailed calculation results it is referred to Appendix 3. Table IIIA 8.3-1: Residue input values for the consumer risk assessment Commodity Chronic risk assessment Input value (mg/kg) Comment Acute risk assessment Input value (mg/kg) Comment Page 7 / 9

25 Centium 36 CS /18 Part B Section 4 - Core Assessment All Products of plant origin MRL MRLs according to Reg. (EC) No 396/2005 Not applicable. Table IIIA 8.3-2: Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8) ADI TMDI (% ADI) according to EFSA PRIMo NTMDI (% ADI) according to German NVS II model IEDI (EFSA PRIMo) (% ADI) NEDI (German NVS II model) (% ADI) Factors included in IEDI and NEDI ARfD IESTI (EFSA PRIMo) (% ARfD) NESTI (German NVS II model) (% ARfD) Factors included in IESTI and NESTI mg/kg bw < 1 % (UK toddlers, mean bw kg) < 1 % (2-4 years old DE children) Not required Not required Not applicable Not allocated Not applicable Not applicable Not applicable IIIA 8.4 Proposed maximum residue levels (MRLs) No new MRLs are required. IIIA 8.5 Conclusion The residue trials data on rape seed which were evaluated in the framework of the review of existing MRLs according to Article 12 of Reg. (EC) No 396/2005 are considered sufficient for risk assessment of the intended use on soya bean. At harvest, no clomazone residues above the LOQ were determined in seed. An exceedance of the current MRL of 0.01* mg/kg for clomazone as laid down in Reg. (EC) No 396/2005 is therefore not expected. The chronic and the short-term intake of clomazone residues is 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 on soya bean. Appendix 1 List of data submitted in support of the evaluation No studies were submitted in support of the evaluation. Appendix 2 Detailed evaluation of the additional studies relied upon No further studies submitted Page 8 / 9

26 Centium 36 CS /18 Part B Section 4 - Core Assessment Appendix 3 Pesticide Residue Intake Model (PRIMo) Clomazone Status of the active substance: in Code no. LOQ (mg/kg bw): proposed LOQ: Toxicological end points ADI (mg/kg bw/day): 0,133 ARfD (mg/kg bw): n.n. Source of ADI: EFSA Source of ARfD: EFSA Year of evaluation: 2007 Year of evaluation: 2007 Explain choice of toxicological reference values. The risk assessment has been performed on the basis of the MRLs collected from Member States in April For each pesticide/commodity the highest national MRL was identified (proposed temporary MRL = ptmrl). The ptmrls have been submitted to EFSA in September Chronic risk assessment TMDI (range) in % of ADI minimum - maximum 0 No of diets exceeding ADI: --- Highest calculated TMDI values in % of ADI MS Diet Highest contributor to MS diet (in % of ADI) Commodity / group of commodities 2nd contributor to MS diet (in % of ADI) Commodity / group of commodities 3rd contributor to MS diet (in % of ADI) Commodity / group of commodities 0,3 UK Toddler 0,2 SUGAR PLANTS 0,0 FRUIT (FRESH OR FROZEN) 0,3 WHO Cluster diet B 0,1 CEREALS 0,1 FRUIT (FRESH OR FROZEN) 0,0 Fruiting vegetables 0,3 DE child 0,2 FRUIT (FRESH OR FROZEN) 0,2 NL child 0,1 FRUIT (FRESH OR FROZEN) 0,2 IE adult 0,1 FRUIT (FRESH OR FROZEN) 0,2 FR toddler 0,1 FRUIT (FRESH OR FROZEN) 0,1 Root and tuber vegetables 0,2 UK Infant 0,1 SUGAR PLANTS 0,0 FRUIT (FRESH OR FROZEN) 0,2 FR infant 0,1 FRUIT (FRESH OR FROZEN) 0,1 Root and tuber vegetables 0,0 Legume vegetables (fresh) 0,2 WHO cluster diet E 0,0 FRUIT (FRESH OR FROZEN) 0,2 WHO cluster diet D 0,1 CEREALS 0,0 FRUIT (FRESH OR FROZEN) 0,2 DK child 0,1 CEREALS 0,0 FRUIT (FRESH OR FROZEN) 0,2 SE general population 90th percentile 0,0 FRUIT (FRESH OR FROZEN) 0,1 WHO Cluster diet F 0,0 FRUIT (FRESH OR FROZEN) 0,1 WHO regional European diet 0,0 FRUIT (FRESH OR FROZEN) 0,1 PT General population 0,0 FRUIT (FRESH OR FROZEN) 0,0 Brassica vegetables 0,1 ES child 0,0 FRUIT (FRESH OR FROZEN) 0,1 IT kids/toddler 0,1 CEREALS 0,0 FRUIT (FRESH OR FROZEN) 0,0 Fruiting vegetables 0,1 UK vegetarian 0,0 SUGAR PLANTS 0,0 FRUIT (FRESH OR FROZEN) 0,1 FR all population 0,0 FRUIT (FRESH OR FROZEN) 0,1 NL general 0,0 FRUIT (FRESH OR FROZEN) 0,1 IT adult 0,0 FRUIT (FRESH OR FROZEN) 0,0 Fruiting vegetables 0,1 UK Adult 0,0 SUGAR PLANTS 0,0 FRUIT (FRESH OR FROZEN) 0,1 ES adult 0,0 FRUIT (FRESH OR FROZEN) 0,0 Fruiting vegetables 0,1 LT adult 0,0 FRUIT (FRESH OR FROZEN) 0,1 PL general population 0,0 FRUIT (FRESH OR FROZEN) 0,0 Fruiting vegetables 0,1 DK adult 0,0 FRUIT (FRESH OR FROZEN) 0,1 FI adult 0,0 FRUIT (FRESH OR FROZEN) ptmrls at LOQ (in % of ADI) Conclusion: The estimated Theoretical Maximum Daily Intakes (TMDI), based on ptmrls were below the ADI. A long-term intake of residues of Clomazone is unlikely to present a public health concern. Page 9 / 9