CHA 1526 Page 1 of 18. REGISTRATION REPORT Part A. Risk Management

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1 Page 1 of 18 REGISTRATION REPORT Part A Risk Management Product code: Product name: NEXIDE Active Substance: Gamma-cyhalothrin, 60 g/l COUNTRY: FRANCE NATIONAL ASSESSMENT Application for label extension according to Art Minor uses

2 Page 2 of 18 Table of Contents 1 DETAILS OF THE APPLICATION APPLICATION BACKGROUND ACTIVE SUBSTANCE APPROVAL REGULATORY APPROACH DATA PROTECTION CLAIMS LETTER(S) OF ACCESS DETAILS OF THE AUTHORISATION PRODUCT IDENTITY CLASSIFICATION AND LABELLING Classification and labelling under Directive 99/45/EC Classification and labelling in accordance with Regulation (EC) No1272/ Other phrases in compliance with Regulation (EU) No 547/ Other phrases linked to the preparation PRODUCT USES RISK MANAGEMENT REASONED STATEMENT OF THE OVERALL CONCLUSIONS TAKEN IN ACCORDANCE WITH THE UNIFORM PRINCIPLES Physical and chemical properties Methods of analysis Mammalian Toxicology Residues and Consumer Exposure Environmental fate and behaviour Ecotoxicology Efficacy CONCLUSIONS ARISING FROM FRENCH ASSESSMENT 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 FRENCH DECISION APPENDIX 2 COPY OF THE DRAFT PRODUCT LABEL AS PROPOSED BY THE APPLICANT APPENDIX 3 LETTER(S) OF ACCESS... 18

3 Page 3 of 18 PART A Risk Management The company Cheminova A/S has requested a label extension according to article 51 in for the product NEXIDE (formulation code: ). This document describes the specific conditions of use and labelling required for extension of the registration of NEXIDE containing gamma-cyhalothrin in. The risk assessment conclusions are based on the already existing registration of the preparation in. Therefore, the evaluation of the current application is limited to the points not covered by the existing authorizations. The existing registration of the preparation NEXIDE (Marketing authorisation n based on application n ) was based on the assessment of the representative formulation which was evaluated during the Annex I inclusion of gamma-cyhalothrin CORELLO (GF-317), a similar formulation containing gamma-cyhalothrin 60 g/l CS. The products CORELLO (GF-317) and NEXIDE (CHA1526) are equivalent. Appendix 1 of this document provides a copy of the French decision. Appendix 2 of this document is a copy of the draft product label as proposed by the applicant. Appendix 3 of this document is a copy of the letter(s) of access. 1 DETAILS OF THE APPLICATION 1.1 Application background NEXIDE () is a capsule suspension formulation containing 60 g/l of gamma-cyhalothrin, for use as an insecticide for the control of various pests. The aim of this registration application is to gain label extension for crops for seed production. The complete GAP for the national application in is provided below, under point Active substance approval Gamma-cyhalothrin Commission Implementing Regulation (EU) No 1334/2014 of 16 December 2014 approving the active substance gamma-cyhalothrin, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 and allowing Member States to extend provisional authorisations granted for that active substance Specific provisions of regulation were as follows : For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on gamma-cyhalothrin, and in particular Appendices I and II thereof, as finalised in the Standing Committee on Plants, Animals, Food and Feed on 10 October 2014 shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the safety of operators and workers; (b) the risk to aquatic organisms. Conditions of use shall include risk mitigation measures, where appropriate. The applicant shall submit confirmatory information as regards: (1) analytical methods for the monitoring of residues in body fluids, tissues and environmental matrices;

4 Page 4 of 18 (2) the toxicity profile of the metabolites CPCA, PBA and PBA(OH); (3) the long-term risk to wild mammals; (4) the potential for biomagnification in terrestrial and aquatic food chains. The applicant shall submit to the Commission, the Member States and the Authority the relevant information by 31 March An EFSA conclusion is available (EFSA Journal 2014;12(2):3560) A Review Report is available (SANCO/10606/2014 rev. 1, 10 October 2014). 1.3 Regulatory Approach The present application (n ) was evaluated in by the French Agency for Food, Environmental and Occupational Health & Safety (Anses) 1. The current document based on Anses assessment of the application submitted for this product is in compliance with Regulation (EC) no 1107/2009 2, implementing regulation and French regulation. Since the application is intended for use in only, the draft Part A was not circulated for comments. According to the French law and procedures, specific conditions of use are set in the decision letter. The French Order of 12 September provides that: - unless formaly stated in the product authorisation, the pre harvest interval (PHI) is at least 3 days; - unless formaly stated in the product authorisation, the minimum buffer zone alongside a water body is 5 m; - unless formally stated in the product authorisation, the minimum reentry delay is 6 hours for field uses and 8 hours for indoor uses. Drift reduction measures such as low-drift nozzles are not considered within the decision making process in. However, drift buffer zones may be reduced under some circumstances as explained in appendix 3 of the abovementioned French order. The data taken into account are those deemed to be valid either at European Union level or at zonal/national level. This part A presents a summary of essential scientific points upon which recommendations are based and is not intended to show the assessment in detail. The conclusions relating to the acceptability of risk are based on the criteria indicated in Regulation (EU) N 546/2011 4, and are expressed as acceptable or not acceptable in accordance with those criteria. Last, the French Order of 26 March provides that: - an authorisation granted for a reference crop applies also for linked crops, unless formally stated in the decision - the reference and linked crops are defined in Appendix 1 of that French Order. Thus, at French national level, possible extrapolation of submitted data and the corresponding assessment from reference crops to linked ones are undertaken even if not clearly requested by the applicant in their drr, and a conclusion is reached on the acceptability of the intended uses on those linked crops. The aim of this Order, French Food Safety Agency, Afssa, before 1 July 2010 REGULATION (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC COMMISSION REGULATION (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products

5 Page 5 of 18 mainly based on the EU document on residue data extrapolation 6 is to supply minor crops with registered plant protection products. Therefore the GAP table (Section 2.3) and Decision may include uses on crops not originally requested by the applicant. The decision, as duplicated in Appendix 1, takes also into account national provisions, including national mitigation measures. 1.4 Data Protection Claims There is no new data submitted with this application. The studies referred to were submitted at the EU level (representative formulation) or at the first registration of the preparation in. 6 SANCO document guidance document:- Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs : SANCO/ 7525/VI/95 - rev.9

6 Page 6 of Letter(s) of Access Not relevant for this application. 2 DETAILS OF THE AUTHORISATION 2.1 Product Identity Product name (code) NEXIDE Authorisation number Function Applicant Composition Formulation type (code) insecticide Cheminova A/S P.O. Box 9 DK-7620 Lemvig Denmark 60 g/l gamma-cyhalothrin Capsule suspension (CS) Packaging Not relevant for extension of authorisation according article Classification and Labelling Classification and labelling under Directive 99/45/EC Not applicable after 1st June For information: Xi, R38, R43, N, R50 is the current classification of the registrated product. A request for a new classification has been submitted (application n ) and assessed together with this application (refer to next point) Classification and labelling in accordance with Regulation (EC) No1272/2008 A request for a new classification has been submitted (application n ) and assessed together with this application. Physical hazards - Health hazards Skin Sensitisation category 1 Specific Target Organ Toxicity Repeat Exposure category 2 Environmental hazards Aquatic Acute 1 Aquatic Chronic 1 Hazard pictograms

7 Page 7 of 18 Signal word Warning Hazard statements H317 May cause an allergic skin reaction H373 H400 H410 May cause damage to organs through repeated exposures or a prolonged exposure Very toxic to aquatic life Very toxic to aquatic life with long lasting effects Precautionary statements Supplementary information (in accordance with Article 25 of Regulation (EC) No 1272/2008) For the P phrases, refer to the extant legislation The preparation containing gamma cyhalothrin, it may cause paresthesia. According to the french Arrêté du 9 novembre 2004, it should be mentioned on the label to avoid contact with skin. In addition, the label should contain the following statement : " Contains 1,2- benzisothiazol-3(2h)-one. May produce an allergic reaction. " See Part C for justifications of the classification and labelling proposals Other phrases in compliance with Regulation (EU) No 547/2011 SPe 3 SPe 3 To protect aquatic organisms, respect an unsprayed buffer zone of 20 metres to surface water bodies for uses at the maximum application rate of 4.5 g as /ha. To protect non-target arthropods, respect an unsprayed buffer zone of 5 metres to non-agricultural land for uses) at the maximum application rate of 4.5 g as /ha. The other mitigation measures of the decision of product authorisation are applicable to this application Other phrases linked to the preparation Wear suitable personal protective equipment 7 : refer to the decision of product authorisation Re-entry period 8 : 48 hours (based on new classification) Pre-harvest interval 9 : not applicable Other mitigation measures : refer to the decision of product authorisation The label must reflect the conditions of authorisation. It should be mentioned on the label to avoid contact with skin. The label should contain the following statements : If a tractor with cab is used, wearing gloves during application is only required when working with the spray mixture The legal basis for this is Titre I Article 3 of the French Order of 12 September 2006 concerning the marketing and use of products encompassed by article L of the rural code [that is, plant protection products/pesticides] According to the French Order of 12 September 2006, PHI cannot be lower than 3 days unless specifically stated in the assessment and decision.

8 Page 8 of 18 Contains 1,2-benzisothiazol-3(2H)-one. May produce an allergic skin reaction. Contains gamma-cyhalothrin, avoid contact with skin.

9 Page 9 of Product uses Please note: The GAP Table below reports the intended uses proposed by the applicant, and possible extrapolation according to French Order of 26 march 2014 (highlighted in green), evaluated and concluded as safe uses by. Those uses are then granted in. Use should be crossed out when the applicant no longer supports this use. PPP (product name/code) NEXIDE () active substance Gamma-cyhalothrin Formulation type: Conc. of as: Capsule suspension 60 g/l Applicant: Zone(s): Cheminova A/S professional use non professional use Crop and/ or situation (a) Zone Product code F G or I (b) Pests or Group of pests controlled (c) Formulation Application Application rate per treatment PHI (days) (l) Remarks: (m) Type (d-f) Conc. of as (i) method kind (f-h) growth stage & season (j) number min max (k) interval between applications (min) kg as/hl min max water L/ha min max kg as/ha min max Vegetable plants, MAPP and flowers seed production Fodder legume seed production FR FR CHA 1526 (15F) CHA 1526 (15F) F F Phytophagous beetles Flower insect pests CS 60 g/l Overall spraying with tractor mounted sprayer CS 60 g/l Overall spraying with tractor mounted sprayer 1) Cotyledons to rosettes 2) flower buds Cotyledons toflower buds 2 10 days Not relevant 1 Not relevant Not relevant 0.05 L PPP/ha L PPP/ha

10 Page 10 of 18 Crop and/ or situation (a) Zone Product code F G or I (b) Pests or Group of pests controlled (c) Formulation Application Application rate per treatment PHI (days) (l) Remarks: (m) Type (d-f) Conc. of as (i) method kind (f-h) growth stage & season (j) number min max (k) interval between applications (min) kg as/hl min max water L/ha min max kg as/ha min max Fodder legume seed production FR CHA 1526 (15F) F Foliar eating insects CS 60 g/l Overall spraying with tractor mounted sprayer Cotyledons to flower buds 1 Not relevant Not relevant L PPP/ha 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) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (f) All abbreviations used must be explained (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated (i) g/kg or g/l (j) Growth stage at last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application (k) The minimum and maximum number of application possible under practical conditions of use must be provided (l) PHI - minimum pre-harvest interval (m) Remarks may include: Extent of use/economic importance/restrictions

11 Page 11 of 18 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 Further data for this application are not necessary Mammalian Toxicology The preparation is already registered in. 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 use claimed in the seed-bearing plants for the preparation NEXIDE does not lead to a human exposure through residues in food. The evaluation of consumer exposure is therefore not necessary Residues Not relevant for this application Consumer exposure Not relevant for this application Environmental fate and behaviour The preparation is already registered in. There is no mitigation measure to protect groundwater Ecotoxicology The preparation is already registered in. To protect aquatic organisms, respect an unsprayed buffer zone of 20 metres to surface water bodies. To protect non-target arthropods, respect an unsprayed buffer zone of 5 metres to non-agricultural land. Mitigation measures to protect bees are applicable Efficacy According to Article 51 of Regulation (EC) No 1107/2009, the efficacy assessment and the absence of any phytotoxicity risk on the crop is not necessary. 3.2 Conclusions arising from French assessment Taking into account the above assessment, an authorisation can be granted as proposed in Appendix 1 Copy of the product decision. 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 No further information is required.

12 Page 12 of 18 Appendix 1 Copy of the French decision

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17 Page 17 of 18 Appendix 2 Copy of the draft product label as proposed by the french growers organisation

18 Page 18 of 18 Appendix 3 Letter(s) of Access Not applicable