GF-1076 OD (BOA) Page 1 of 30. REGISTRATION REPORT Part A. Risk Management

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1 Page 1 of 30 REGISTRATION REPORT Part A Risk Management Product code: GF-1076 OD Product name(s): BOA Active Substance(s): penoxsulam, 20 g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (Extension of use)

2 Page 2 of 30 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 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... 30

3 Page 3 of 30 PART A Risk Management The company Dow AgroSciences S.A.S. has requested marketing authorisation in France for the product BOA (formulation code: GF-1076 OD), containing 20 g/l penoxsulam for use as a herbicide. 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 BOA where that data have not been considered in the EU peer review process. Otherwise assessments for the safe use of BOA have been made using endpoints agreed in the EU peer review of penoxsulam. This document describes the specific conditions of use and labelling required for France for the registration of BOA (GF-1076 OD). 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 Dow AgroSciences S.A.S s application to market BOA (GF-1076 OD) in France as a herbicide (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 label extension of this product in France and in other MSs of the Southern zone. 1.2 Active substance approval penoxsulam Regulations 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. Specific provisions of regulation were as follows : PART A Only uses as herbicide 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 penoxsulam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 22 January 2010 shall be taken into account. In this overall assessment, Member States must pay particular attention to: - the protection of aquatic organisms, - the dietary exposure of consumers to residues of the metabolite BSCTA in succeeding rotational crops, - the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions. Conditions of authorisation shall include risk mitigation measures, where appropriate.

4 Page 4 of 30 The Member States concerned shall ensure that the notifier submits to the Commission further information to address the off-field risk to higher aquatic plants. They shall ensure that the notifier provides such information to the Commission by 31 July The Rapporteur Member State shall inform the Commission in accordance with Article 38 of Regulation (EC) No 1107/2009 on the specification of the technical material as commercially manufactured. An EFSA conclusion is available (EFSA Scientific Report (2009) 343, 1-90). A Review Report is available (SANCO/11082/09 final - 22 January 2010). 1.3 Regulatory Approach The present application ( ) was evaluated in France by the French Agency for Food, Environmental and Occupational Health & Safety (Anses) 1 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 ) 2 the highest application rates over the. When risk mitigation measures were necessary, they are adapted to the situation in France. 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 4, 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 5, 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, 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 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 30 mainly based on the EU document on residue data extrapolation 7 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 BOA (GF-1076 OD), it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections Letter(s) of Access Not necessary: the applicant has provided sufficient data to show that access is not required. 2 DETAILS OF THE AUTHORISATION 2.1 Product Identity Product name (code) BOA (GF-1076 OD) Authorisation number Function Applicant Composition Formulation type (code) Packaging Herbicide Dow AgroSciences S.A.S. penoxsulam 20 g/l Oil dispersion (OD) Not applicable for a label extension. 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 Irrit. 2 Skin sens. Cat 1B Eye Irrit. 2 Environmental hazards Aquatic Chronic 1; Aquatic Acute 1 7 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 30 Hazard pictograms Signal word Warning Hazard statements H315 Causes skin irritation. H317 May cause an allergic skin reaction. H319 Causes serious eye irritation. H400 Very toxic to aquatic life with long lasting effects. H411 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 - 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 The authorisation of the preparation is linked for professional uses only to the following conditions: SP 1 SPe 3 Do not contaminate water with the product or its container (Do not clean application equipment near surface water/avoid contamination via drains from farmyards and roads). To protect aquatic organisms, respect an unsprayed buffer zone of 5 metres 8 to surface water bodies Other phrases linked to the preparation Wear suitable personal protective equipment 9 : refer to the Decision in Appendix 1 for the details Re-entry period 10 : 48 hours Pre-harvest interval 11 : 56 days The legal basis for this is Titre III Article 11 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] 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.

7 Page 7 of 30 Other mitigation measures: - Do not apply in presence of root suckers in the treated surface. Resistance management: - On the same site, do not make more than one treatment per year with BOA (GF-1076 OD) or any other product containing an inhibitor of ALS (eg. sulfonylurea). The label must include the following statement: Contains 1,2-benzisothiazol-3-(2H)-one, may produce an allergic reaction. The label must reflect the conditions of authorisation.

8 Page 8 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 France as zrms. Those uses are then granted in France. PPP (product name/code) active substance 1 Applicant: Zone(s): Verified by MS: yes BOA / GF-1076 OD penoxsulam Dow AgroSciences S.A.S. Southern/EU Formulation type: Conc. of as 1: professional use non professional use GAP rev. 1, date: 15/11/2016 OD 20 g/l 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 Vines France GF-1076 OD F Annual broad leaved weeds OD 20 g as/l Tractor mounted spray directed to 50% of area (under row application) or Hand-held sprayer March to mid July (BBCH 00 to BBCH 75) 1 NA (= 0.75 L product/ha) 56 days Product to be applied under the vine row as a banded application on a maximum of 1/2 of the total vineyard. Do not apply in presence of root suckers on treated surface. Acceptable

9 Page 9 of 30 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 30 3 RISK MANAGEMENT 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties The formulation GF-1076 (BOA) is an Oil Dispersible, containing 20 g/l of penoxsulam. 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 creamy yellow liquid with paint odour. It is not explosive and has no oxidizing properties. The product is not flammable. It has a self-ignition temperature of 350 C. In aqueous solution (1%), it has a ph value at 25 C is 5. There is no effect of low and high temperature on the stability of the formulation, since after 7 days at 0 C and 14 days at 54 C, neither the active ingredient content nor the technical properties were changed. The stability data indicate a shelf life of at least 2 years at ambient temperature when stored in f-hdpe, and in PET. Its technical characteristics are acceptable for a OD formulation. The formulation is not classified for the physical-chemical aspect. Under recommended use, no particular problems should be expected due to technical characteristics or physico-chemical properties. Data required: - Report of shelf-life study in commercial packaging is required in post-authorization Methods of analysis Analytical method for the formulation Analytical methods for the determination of active substance penoxsulam in the formulation are available and validated. Analytical methods for the determination of active substance and relevant impurity bis-chymp in the formulation are available and validated. But the relevant impurity Bis-Chymp is a by-product of the manufacturing process for penoxsulam and as such cannot be formed by storage of the formulation Analytical methods for residues Analytical methods are available in the monograph/this dossier and validated for the determination of residues of penoxsulam in plants (grapes), soil, water (surface and drinking) and air. Analytical methods for the determination of residues of penoxsulam in foodstuffs of animal origin are not necessary. 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 Mammalian Toxicology Acute Toxicity Acute oral, dermal and inhalation toxicity studies used to support GF-1076 (BOA formulation, an OD formulation containing 20 g/l of penoxsulam) were generated with GF-237 essentially similar OD containing 25.2 g/l of penoxsulam. Primary eye and skin irritation and dermal sensitization studies were performed with GF-1076 (= BOA OD containing 20 g/l of penoxsulam) formulation.

11 Page 11 of 30 Available toxicological data relating to non active substances The non-active ingredient in the formulation does not modify the toxicological classification of the formulation, based on the acute toxicity studies and the classification of the penoxsulam Operator Exposure Dermal absorption Study Study Method GLP Acceptable y/n Results LD 50 oral GF-237 (OD, 25.2 g/l penoxsulam) Batch n : TSN102516, 2.7% LD 50 dermal GF-237 (OD, 25.2 g/l penoxsulam) Batch n : TSN102516, 2.7% CL 50 inhalation (nose only) GF-237 (OD, 25.2 g/l penoxsulam) Batch n : TSN102683, 2.7% Skin irritation GF-1076 (OD, 20 g/l penoxsulam) Batch n : TSN106089, 2.14% Eye irritation GF-1076 (OD, 20 g/l penoxsulam Batch n : TSN106089, 2.14% Skin Sensitization GF-1076 (OD, 20 g/l penoxsulam Batch n : HI , 2.07% OECD 401, Rat Fischer 344 M + F OECD 402, Rat Fischer 344 M + F OECD 402, Rat Fischer 344 M + F OECD 404, Rabbit NZ OECD 405, Rabbit NZ LLNA, CBA/J Classification Labelling Y Y > 5000 mg/kg bw Not required Y Y > 5000 mg/kg bw Not required Y The in vitro dermal absorption of penoxsulam was investigated in human skin membranes using flow-through diffusion cells. The test preparation GF-1076 was tested at three target concentrations: 20 g.l-1 (concentrate), 0.1 g.l-1 (dilution I, 1:200) and 0.01 g.l-1 (dilution II, 1:2000). For the purposes of the risk assessment the most relevant dermal absorption value to use would be 0.3% for the concentrate, 6% from dilution I (1:200) and 9% from dilution II (1:2000) as this dilution is most closely representative of the worst case dilution stated in the GAP. Y > 2.1 mg/l (maximum attainable concentration) Not required Y Y Irritant H315 Y Y Irritant H315 Y N Sensitiser H317

12 Page 12 of 30 Parameters used in operator exposure assessment Crop Equipment Application rate g/l product/ha (g a.s./ha) Open field Spray dilution (L/ha) Model used %AOEL (AOEL of penoxsulam: 0.18mg/kg bw/day) Vine Tractor boom sprayer 20g/L product/ha 15g a.s./ha BBA 0,1% With a coverall Vine Hand-held sprayer 20g/L product/ha 15g a.s./ha UK POEM 6.0% With a coverall According to the model calculations, it can be concluded that the risk for the operator using BOA (GF-1076 OD) on field crops is acceptable without the use of personal protective equipment and with a coverall (90% protection factor). The following personal protective equipment is recommended by applicant: Tractor-mounted boom sprayer for mixing/loading - Nitrile gloves certified EN 374-3; - Working coveralls 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; - Long-sleeved aprons, Category III Type PB3 worn over the coverall proposed above; during application: Downward spraying If application with tractor with cab - Working coveralls 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; - Disposable nitrile gloves certified EN in the case of an intervention on application equipment, but not inside the cab. In the case of an intervention on application equipment, it should be noted that gloves should be worn only outside the tractor cab and stored after use outside the cab If application with tractor without cab - Working coveralls 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; - Disposable nitrile gloves certified EN in the case of an intervention on application equipment; for equipment cleaning - Nitrile gloves certified EN 374-3; - Working coveralls 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; - Long-sleeved aprons, Category III Type PB3 worn over the coverall proposed above. Hand-held sprayer outdoor: herbicide for mixing/loading - Nitrile gloves certified EN 374-3; - Protective coveralls category III Type 4; during application - Nitrile gloves certified EN 374-3; - Protective coveralls category III Type 4 with hood; - Rubber boots certified EN ; for equipment cleaning - Nitrile gloves certified EN 374-3; - Protective coveralls category III Type 4.

13 Page 13 of Bystander Exposure The exposure of bystanders present at the time of spraying was calculated using data presented in the report on EURO-POEM II 12. Exposure is calculated less than 0.1% of the AOEL of penoxsulam for a 60 kg person situated five meters away from the spraying operation and exposed for five minutes. It is concluded that there is no unacceptable risk to the bystander after incidental short-term exposure to BOA (GF-1076 OD) Worker Exposure BOA (GF-1076 OD) is used as herbicidal treatment on several crops where there is no need to re-enter the treated area after application. Worker exposure is considered not relevant. The following personal protective equipment is recommended by applicant: - Nitrile gloves certified EN 374-3; - Working coverall 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment Residues and Consumer Exposure Residues The data available are considered sufficient for risk assessment. An exceedance of the current MRL of 0.01* mg/kg for penoxsulam as laid down in Reg. (EU) 396/2005 is not expected. According to available data, the following specific mitigation measure is recommended: - the application must not be achieved if grape shoots are present on the treated area Summary for penoxsulam Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL compliance Chronic risk for consumers identified? Acute risk for consumers identified? grapes Yes Yes (3 NEU + 3 SEU) Yes Yes Yes No No Six trials have been performed according to the intended GAPs. According to the metabolism study achieved with last application at GS BBCH 55, and to residue trials rating penoxsulam metabolites produced in soil after a later application (BBCH 75), no residue of penoxsulam or its metabolites are expected in grapes at maturity. As more than 2 trials in each zone confirm this, no further data are required. As residues of penoxsulam do not exceed the trigger values defined in Reg (EU) No 283/2013, there is no need to investigate the effect of industrial and/or household processing. As grapes are perennial crops and are not fed to livestock, further investigation of residues in succeeding crops as well as the modification of MRLs in commodities of animal origin are therefore not necessary. Summary for BOA (GF-1076 OD) Crop PHI for GF 1076 OD proposed by applicant PHI sufficiently supported for penoxsulam PHI for GF 1076 OD proposed by zrms zrms Comments (if different PHI proposed) wine and table grape 56 days Yes 56 days The application must not be achieved if grape shoots are present. 12 EURO-POEM II - Bystander Working group Report.

14 Page 14 of 30 NR: not relevant * Purpose of withholding period to be specified ** F: PHI is defined by the application stage at last treatment (time elapsing between last treatment and harvest of the crop) Consumer exposure No ARfd has been considered necessary for penoxsulam so no short term risk is awaited for consumers. The chronic intake of penoxsulam residues is unlikely to present a public health concern. As far as consumer health protection is concerned, France agrees with the authorization of the intended use(s) Environmental fate and behaviour The fate and behaviour in the environment of the formulation have 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 substance and its 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. The PEC of penoxsulam and its metabolites in soil, surface water and groundwater have been assessed according to FOCUS guidance documents, with standard FOCUS scenarios to obtain outputs from the FOCUS models, and the endpoints established in the EU review or agreed in the assessment based on new data provided. PEC soil and PECsw derived for the active substances and its metabolites are used for the eco-toxicological risk assessment, and mitigation measures are proposed. PECsw were calculated for an application on 50% of the treated area. PECgw were calculated for an application on 50% of the area. In these application conditions, PECgw for penoxsulam and its metabolites do not occur at levels exceeding those mentioned in regulation EC 1107/2009 and guidance document SANCO/221/ Based on vapour pressure, information on volatilisation from plants and soil, and DT 50 calculation, no significant contamination of the air compartment is expected for the intended uses Ecotoxicology The ecotoxicological risk assessment of the formulation was performed according to the requirements of Regulation (EC) No 1107/2009. Appropriate endpoints from the EU review for active substances and their metabolites were used 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. Based on the guidance documents, the risks for birds, mammals, aquatic organisms, bees and other non-target arthropods, earthworms and other soil macro-organisms, micro-organisms and terrestrial non-target plants are acceptable for the intended uses without any buffer zone according to the GAP Efficacy The efficacy of BOA (GF-1076 OD) is considered satisfactory. The selectivity of BOA (GF-1076 OD) is considered satisfactory. The risk of negative impact (yield, quality, transformation processes, adjacent crops) is considered negligible. 13 Guidance document on the assessment of the relevance of metabolites in groundwater of substances regulated under Council directive 91/414/EEC. Sanco/221/2000-rev10-final, 25 February 2003.

15 Page 15 of 30 The risk of resistance development is considered medium. The resistance management proposed by the applicant is considered satisfactory. 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 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 No further information is required Post-authorisation data requirements No information stated Label amendments (see label in Appendix 2): The draft label proposed by the applicant in appendix 2 may be corrected with consideration of any new element under points (or 2.2.2), and The label shall reflect the detailed conditions stipulated in the Decision.

16 Page 16 of 30 Appendix 1 Copy of the French decision

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23 Page 23 of 30 Appendix 2 Copy of the draft product label as proposed by the applicant

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30 Page 30 of 30 Appendix 3 Letter(s) of Access Not applicable.