12ELM (CICADOR JARDIN) Page 1 of 24. REGISTRATION REPORT Part A. Risk Management

Transcription

1 Page 1 of 24 REGISTRATION REPORT Part A Risk Management Product code: 12ELM Product name: CICADOR JARDIN Active Substance: pyrethrins, 10 g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (marketing authorisation)

2 Page 2 of 24 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 Specification of the active substance: Physical and chemical properties Methods of analysis Mammalian Toxicology Residues and Consumer Exposure Environmental fate and behaviour Ecotoxicology Efficacy CONCLUSIONS ARISING FROM FRENCH ASSESSMENT SUBSTANCES OF CONCERN FOR NATIONAL MONITORING FURTHER INFORMATION TO PERMIT A DECISION TO BE MADE OR TO SUPPORT A REVIEW OF THE CONDITIONS AND RESTRICTIONS ASSOCIATED WITH THE AUTHORISATION Post-authorisation monitoring Post-authorisation data requirements Label amendments (see label in Appendix 2): 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... 24

3 Page 3 of 24 PART A Risk Management The company SBM Développement has requested marketing authorisation in France for the product CICADOR JARDIN 1 (formulation code: 12ELM), containing 10 g/l pyrethrins for use as an insecticide. The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C, and where appropriate the addenda for France. The information, data and assessments provided in Registration Report, Part B include assessment of further data or information as required at national registration by the EU peer review. It also includes assessment of data and information relating to CICADOR JARDIN where those data have not been considered in the EU peer review process. Otherwise assessments for the safe use of CICADOR JARDIN (12ELM) have been made using endpoints agreed in the EU peer review of pyrethrins. This document describes the specific conditions of use and labelling required for France for the registration of CICADOR JARDIN. 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 The present registration report concerns the evaluation of SBM Développement s application to market CICADOR JARDIN (12ELM) in France as an insecticide (product uses described under point 2.3). France acted as a zonal Rapporteur Member State (zrms) for this request and assessed the application submitted for the first authorisation of this product in France and in other MSs of the Southern zone. 1.2 Active substance approval Pyrethrins Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. Commission Implementing Regulation (EU) No 798/2013 of 21 August 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance pyrethrins. Specific provisions of regulation were as follows: In Regulation (EU) No 540/2011: PART A Only uses as insecticide may be authorised. PART B 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 pyrethrins (SANCO/2627/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. Conditions of use shall include, where appropriate, risk mitigation measures. 1 CICADOR JARDIN

4 Page 4 of 24 In Regulation (EU) No 798/2013: PART A Only uses as insecticide may be authorised. PART B 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 pyrethrins (SANCO/2627/2008) and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. In this overall assessment Member States shall pay particular attention to: (a) the risk to operators and workers; (b) the risk to non-target organisms. Conditions of use shall, where appropriate, include the application of adequate personal protective equipment and other risk mitigation measures. The applicant shall submit confirmatory information as regards: (1) the specification of the technical material, as commercially manufactured including information on any relevant impurities and its equivalence with the specifications of the test material used in the toxicity studies; (2) the risk from inhalation; (3) the residue definition; (4) the representativeness of the major component pyrethrin 1 as regards the fate and behaviour in soil and water. The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) by 31 March 2014 and the information set out in points (2), (3) and (4) by 31 December An EFSA conclusion is available (EFSA Journal 2013;11(1):3032 [original] ; Technical report, 13 May 2015 [confirmatory data]). Review Reports are available (SANCO/2627/08 rev July 2008 [inclusion]; SANCO/2627/08 final 16 July [conditions of approval]). 1.3 Regulatory approach The present application ( ) was evaluated in France by the French Agency for Food, Environmental and Occupational Health & Safety (Anses) 2 in the context of the zonal procedure for all Member States of the Southern zone, taking into account the worst-case uses ( risk envelope approach ) 3 the highest application rates over the. When risk mitigation measures were necessary, they are adapted to the situation in France. 2 3 French Food Safety Agency, Afssa, before 1 July 2010 SANCO document risk envelope approach, European Commission (14 March 2011). Guidance document on the preparation and submission of dossiers for plant protection products according to the risk envelope approach ; SANCO/11244/2011 rev. 5

5 Page 5 of 24 According to the French law and procedures, specific conditions of use are set out in the Decision letter. The French Order of 12 September provides that: - unless formally stated in the product authorisation, the pre harvest interval (PHI) is at least 3 days; - unless formally stated in the product authorisation, the minimum buffer zone alongside a water body is 5 metres; - unless formally stated in the product authorisation, the minimum re-entry period 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 France. However, drift buffer zones may be reduced under some circumstances as explained in appendix 3 of the abovementioned French Order. The current document (RR) based on Anses s assessment of the application submitted for this product is in compliance with Regulation (EC) no 1107/2009 5, implementing regulations and French regulations. The data taken into account are those deemed to be valid either at European Union level or at zonal/national level. This part A of the RR 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) No 546/2011 6, and are expressed as acceptable or not acceptable in accordance with those criteria. Finally, 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, mainly based on the EU document on residue data extrapolation 8 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 reproduced in Appendix 1, takes also into account national provisions, including national mitigation measures. 1.4 Data protection claims Where protection for data is being claimed for information supporting registration of CICADOR JARDIN (12ELM), it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections Letter(s) of Access The applicant has provided the supporting data in Document K; the ownership of the data is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections 1-7. A copy of the letter of access is reproduced in Part A, Appendix 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 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 24 2 DETAILS OF THE AUTHORISATION 2.1 Product identity Product name (code) CICADOR JARDIN (formulation code: 12ELM) Authorisation number - Function Applicant Composition Formulation type (code) Packaging insecticide SBM Développement 10 g/l pyrethrins oil-in-water emulsion (EW) Mould-blown fluorinated high-density polyethylene containers (f-hdpe): 125 and 250 ml containers with self-dispenser 2.2 Classification and labelling Classification and labelling under Directive 99/45/EC Not applicable after 1st June Classification and labelling in accordance with Regulation (EC) No1272/2008 Physical hazards - Health hazards Skin sensitisation, category 1 Environmental hazards Hazardous to the aquatic environment - acute hazard, category 1 Hazardous to the aquatic environment - chronic hazard, category 1 Hazard pictograms Signal word Warning Hazard statements H317 May cause an allergic skin reaction H400 H410 Very toxic to aquatic life Very toxic to aquatic life with long-lasting effects Precautionary statements For the P phrases, refer to the extant legislation

7 Page 7 of 24 Supplementary information (in accordance with Article 25 of Regulation (EC) No 1272/2008) - - See Part C for justifications of the classification and labelling proposals Other phrases in compliance with Regulation (EU) No 547/2011 N/A: not registered in France Other phrases linked to the preparation N/A: not registered in France

8 Page 8 of Product uses Please note: The GAP Table below reports the intended uses proposed by the applicant and evaluated by France as zrms. When the conclusion is not acceptable, the intended use is highlighted in grey and the main reason(s) reported in the remarks. GAP rev. 1, date: PPP (product name/code) active substance 1 CICADOR JARDIN (12ELM) pyrethrins Formulation type: Conc. of a.s. 1: Oil-in-water emulsion (EW) 10 g/l Applicant: Zone(s): SBM Développement southern EU professional use non-professional use Verified by MS: yes 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) Trees and shrubs * Foliar spraying* Aphids Southern 12ELM- Cicador Jardin-A Type (d-f) F aphids EW Conc. of as (i) 10 g/l method kind (f-h) Manual hand-held sprayer growth stage & season (j) BBCH01 to BBCH91 from the end of winter to autumn number min max (k) 6 applications max/year and max 3 applications successively interval between applications (min) 7 days between 2 applications and 21 days minimum between 2 series of 3 applications kg as/hl min max water L/ha min max kg as/ha min max 0.06 max Not relevant 6 ml/l Not acceptable (lack of specification data, risk to groundwater, risk to aquatic organisms, packaging not suitable to guarantee minimal exposure given the classification)

9 Page 9 of 24 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) * Rosebush*Foliar spraying* Aphids Southern 12ELM- Cicador Jardin-A Type (d-f) F aphids EW Conc. of as (i) 10 g/l method kind (f-h) Manual hand-held sprayer growth stage & season (j) BBCH01 to BBCH91 from the end of winter to autumn number min max (k) 6 applications max/year and max 3 applications successively interval between applications (min) 7 days between 2 applications and 21 days minimum between 2 series of 3 applications kg as/hl min max water L/ha min max kg as/ha min max 0.06 max Not relevant 6 ml/l Not acceptable (lack of specification data, risk to groundwater, risk to aquatic organisms, packaging not suitable to guarantee minimal exposure given the classification) 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

10 Page 10 of 24 3 RISK MANAGEMENT 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Specification of the active substance: According to the conclusions of EFSA 9 : The specification is not acceptable for any of the applicants; a specification for a TK (technical concentrate) has to give a purity range, an upper and lower limit. As stated in the EFSA conclusion (EFSA Journal 2013;11(1):3032), this should be given for each component of the pyrethrins and not for total pyrethrins. This also needs to be supported by batch data. It should be noted that the RMS is of the opinion that a reasonable compromise was achieved by setting a limit to the amount of Pyrethrins I/Pyrethrins II. With regard to the impact on human and animal health, including non-target organisms, it still cannot be concluded that the test material used in the toxicity studies was representative of the proposed technical product. Similarly it cannot be concluded on the toxicological relevance of the impurity represented by a complex range of natural plant products co-extracted with the pyrethrins. The impurity hydrocarbon solvent is considered as toxicologically relevant on the basis of its hazardous properties, with a proposed level triggering the classification Asp. Tox. 1 (H304) for the technical product Physical and chemical properties The formulation CICADOR JARDIN (12ELM) is an oil-in-water emulsion (EW). All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. The appearance of the product is that of a white liquid, with a characteristic odour. It is not explosive and has no oxidising properties. The product is not flammable (no flash point). It has a self-ignition temperature of 463 C. In aqueous solution (1 %), it has a ph value 5.3 at 20 C. There is no effect of low and high temperature on the stability of the formulation, since after 7 days at 0 C and 8 weeks at 40 C, neither the active substance content nor the technical properties were changed. The stability data indicate a shelf life of at least 1 year at ambient temperature when stored in HDPE. The F-HDPE packaging is considered acceptable too as the storage stability was performed on HDPE. Its technical characteristics are acceptable for a EW formulation. The shelf life stability 2 years at ambient temperature is ongoing and is required. The formulation is not classified for the physical-chemical aspect. The formulation must be stored at temperatures below 40 C Methods of analysis Analytical method for the formulation Analytical methods for the determination of active substance in the formulation are available and validated Analytical methods for residues According to the EFSA conclusions, analytical methods for the determination of residues of pyrethrins in soil, water (surface and drinking) and air are required post-authorisation. The active substance is neither toxic nor very toxic, hence no analytical method is required for the determination of resides in biological fluids and tissues. 9 EFSA, technical report. Outcome of the consultation with Member States, the applicants and EFSA on the pesticide risk assessment for pyrethrins in light of confirmatory data European Food Safety Authority (EFSA). Mai 2015

11 Page 11 of Mammalian Toxicology Acute Toxicity CICADOR JARDIN (12ELM) has a low acute oral, dermal and inhalational toxicity. It is not irritating to the rabbit skin and eye but it is a skin sensitiser. On the basis of these experimental results and the classification of the active substance and co-formulants, the Anses Opinion concluded that the formulation should be classified as shown in Section Operator Exposure Dermal absorption No dermal absorption study of pyrethrins has been made with the product CICADOR JARDIN (12ELM) or similar products. In the absence of dermal absorption data on the formulation, the default value of 75 % for undiluted and diluted product is used because it contains less than 5 % active substance. Operator exposure The acceptable operator exposure level (AOEL) of pyrethrins in the context of its evaluation for approval, is 0.07 mg/kg bw/d (pending the conclusion of assessment of confirmatory information). This is based on the no observed adverse effect level in a 1-year oral rat toxicity study and a 100-fold assessment factor. (SANCO/2627/08 final 16 July 2013) Estimate of operator [i.e., non-professional user] exposure to pyrethrins according to the French UPJ model (Gardener Exposure Model v3-6, based on a study conducted by UPJ (French Amenities Protection Union) in French gardens 10 ) (manual spreading) revealed that the risk is considered as acceptable on home garden without personal protective equipment Bystander Exposure Bystander exposure is considered to be negligible for products used in the home garden Worker Exposure CICADOR JARDIN (12ELM) is used as insecticidal treatment on several crops where there is no need to re-enter the treated area after application. Worker exposure is considered to be negligible and is thus not calculated Acceptability criteria (French legal basis 11 ) The proposed container with auto-dose device will allow exposure to be reduced; however, it cannot be considered that exposure will be minimal. In this context, ANSES notes that the applicant recommends wearing gloves. In addition, the example container with auto-dose device which the applicant has supplied does not have the same volume as the requested containers. As this type of packaging does not guarantee minimal exposure of amateur (home) gardeners, CICADOR JARDIN must not be used by non-professionals. Furthermore, it should be noted that in the Anses Opinion of 16 February , it is recommended that a product classified R43 (H317) must not be used by non-professionals. 10 Thouvenin I. (2004) Détermination de l'exposition des opérateurs utilisant du matériel d'application pour jardins amateurs; ADME Bioanalyses for UPJ. Report No. UPJ/CAR/ La conformité fait référence aux dispositions du décret n du 30 décembre 2010 et des arrêtés du 30 décembre 2010 relatifs à l emploi de certains produits phytopharmaceutiques par des utilisateurs non professionnels et à la saisine Anses 2013-SA Avis de l Anses du 16 février 2015 relatif à la «modification ou à l apport de précision de l'arrêté du 30 décembre 2010 relatif aux conditions d'emballage des produits phytopharmaceutiques pouvant être employés par des utilisateurs non professionnels» (saisine 2013-SA- 0128).

12 Page 12 of Residues and Consumer Exposure Not relevant use on non-comestible crops only Environmental fate and behaviour The fate and behaviour in the environment of the formulation has been evaluated according to the requirements of Regulation (EC) No 1107/2009. Appropriate endpoints from the EU review were used to calculate PECs for the active substances and their metabolites for the intended use patterns. In cases where deviations from the EU agreed endpoints were considered appropriate (for example when additional studies are provided), such deviations were highlighted and justified accordingly. Pyrethrin I is one of the reported six active components that are claimed to constitute up to 50 % of the active substance pyrethrins (pyrethrin I, cinerin I, jasmolin I, pyrethrin II, cinerin II and jasmolin II). Pyrethrin I is stated to amount to about 18 % of the technical material (36 % of the active components identified, relatively major active component). Fate and behaviour studies are only available for pyrethrin I. A data gap has been identified in the EFSA Journal for scientific information or data to demonstrate the representativeness of pyrethrin I with respect to the environmental assessment of all the pyrethrin components. This data gap is listed as a confirmatory data in Regulation 798/2013 (Commission Implementing Regulation (EU) No 798/2013 of 21 August 2013 amending Implementing Regulation (EU) No 540/2011 as regards the conditions of approval of the active substance pyrethrins). Data to address this point should be submitted by 31/12/2015. For pyrethrin I, studies are only available with material labelled in the cyclopropane ring. Therefore, a data gap has been identified to address the fate and behaviour of the cyclopentelone moiety after the rupture of the ester bridge in the pyrethrins (normally first degradation step). Despite the RMS s request, this data gap has not been addressed in the current submission. Therefore, in agreement with the EFSA conclusions, the zrms considers that the environmental risk assessment cannot be finalised on the basis of the available data. Implications for labelling resulting from environmental fate assessment: None Ecotoxicology Effects on Terrestrial Vertebrates The TER A and TER LT are above the trigger value indicating an acceptable risk for birds for exposure via dietary, drinking water and secondary poisoning. Considering the home and garden uses on ornamentals (sprayed product) intended for CICADOR JARDIN (12ELM), a risk assessment for mammals is not considered necessary Effects on Aquatic Species For pyrethrins, the PECsw are available only for pyrethrin I but no values could be estimated for the 5 other active components that are claimed to constitute the active substance pyrethrins (cinerin I, jasmolin I, pyrethrin II, cinerin II and jasmolin II). In this condition, the zrms has corrected the toxicity endpoints of pyrethrum extract by the amount of pyrethrin I (18 %) in the technical material for the TER value estimations. Pyrethrin I poses acceptable risk to aquatic organisms only for the uses on ornamental plants < 50 cm tall with a buffer zone of 5 m. For the other uses (ornamental plants > 50 cm tall and trees) it is not possible to conclude to an acceptable risk with the maximum acceptable mitigation measure (10 m buffer zone) for home-garden (amateur) use.

13 Page 13 of 24 A risk assessment is considered required for chrysanthemic acid and is based on the worst-case assumption that this compound is 10 times more toxic than the parent, as no toxicity data are available for chrysanthemic acid. Chrysanthemic acid poses acceptable acute risk to aquatic invertebrates only for the uses on ornamental plants < 50 cm with a buffer zone of 5 m. For the other uses (ornamental plants > 50 cm and trees) it is not possible to conclude to an acceptable risk since all the TER values are below the trigger of 100 with the maximum acceptable mitigation measure (10 m buffer zone) for home and garden uses (amateur). No PEC values are available for the other components of the active substance pyrethrins (cinerin I, jasmolin I, pyrethrin II, cinerin II and jasmolin II) and it is not possible to finalise the surface water exposure assessment and hence it is not possible to conclude whether the risk assessment for pyrethrin I could cover the other component. Therefore, in accordance with the EFSA conclusion for pyrethrins, since the surface water exposure assessment has not been finalised, it is not possible to finalise the risk assessment for aquatic organisms from pyrethrins, their metabolites and the product CICADOR JARDIN (12ELM) Effects on Bees and Other Arthropod Species Considering the home-garden uses on ornamentals intended for CICADOR JARDIN (12ELM) a risk assessment for bees is not considered necessary. However, as CICADOR JARDIN (12ELM) is an insecticide, the following safety phrase is recommended to be added on the label: Do not treat when bees are visiting the area. Considering the home and garden uses on ornamentals intended for CICADOR JARDIN (12ELM) a risk assessment for non-target arthropods is not considered required. However, as CICADOR JARDIN (12ELM) is an insecticide, the following safety phrase is recommended to be added on the label: Do not treat when beneficial organisms are visiting the area Effects on Earthworms and Other Soil Macro-organisms Considering the home and garden uses on ornamentals intended for CICADOR JARDIN (12ELM) a risk assessment for soil micro-organisms is not considered required. However, due to the toxicity of pyrethrins for earthworms (LC 50 below 100 mg/kg soil), the following safety phrase is recommended to be added to the label: Harmful to earthworms and other soil organisms Effects on organic matter breakdown No information stated Effects on Soil Non-target Micro-organisms No information stated Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) Considering the home-garden uses on ornamentals intended for CICADOR JARDIN (12ELM), a risk assessment for non-target plants is not considered necessary Efficacy The levels of efficacy and selectivity of the product have been demonstrated and are satisfactory for the uses requested (trees, shrubs and rose bushes against aphids).

14 Page 14 of 24 In some case, aphids can be more resilient to the treatment. It is recommended to change of mode of action of insecticides used, to avoid resistance. As the product is not safe for beneficial insects and sensitive to solar ultraviolet radiation, it is recommended to spray either at the beginning or at the end of the day. 3.2 Conclusions arising from French assessment The assessment could not be finalised with regard to specification of the technical active substance, the risk to groundwater and the risk to aquatic organisms (exposure side not finalised). Furthermore, the packaging and the classification are not considered acceptable at national level for a nonprofessional use of the preparation. Taking into account the above assessment, an authorisation cannot be granted in France. A copy of the decision can be found in Appendix 1 Copy of the product Decision. 3.3 Substances of concern for national monitoring No information stated. 3.4 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation Post-authorisation monitoring Not applicable Post-authorisation data requirements Not applicable Label amendments (see label in Appendix 2): N/A: product not registered in France

15 Page 15 of 24 Appendix 1 Copy of the French Decision

16 Page 16 of 24

17 Page 17 of 24

18 Page 18 of 24

19 Page 19 of 24 Appendix 2 Copy of the draft product label as proposed by the applicant

20 Page 20 of 24

21 Page 21 of 24

22 Page 22 of 24

23 Page 23 of 24

24 Page 24 of 24 Appendix 3 Letter(s) of Access