Ethephon SL 120 G [ ] (PRM 12 RP) Page 1 of 56. REGISTRATION REPORT Part A. Risk Management

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1 Page 1 of 56 REGISTRATION REPORT Risk Management Product code: Product name: PRM 12 RP Active Substance: ethephon, 120 g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (Label extension)

2 Page 2 of 56 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) No 1272/ 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 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... 56

3 Page 3 of 56 PART A Risk Management The company Bayer CropScience France has requested extensions to the marketing authorisation in France for the product PRM 12 RP (formulation code: ; authorisation number ), containing 120 g/l ethephon, for use as a plant growth regulator. 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 PRM 12 RP where those data have not been considered in the EU peer review process. Otherwise assessments for the safe use of PRM 12 RP have been made using endpoints agreed in the EU peer review of ethephon. This document describes the specific conditions of use and labelling required for France for the registration of PRM 12 RP. 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 Bayer CropScience France s application to market PRM 12 RP in France as a plant growth regulator (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 Ethephon 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) 2015/415 of 12 March 2015 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances ethephon and fenamiphos. Specific provisions of Regulation (EU) No 540/2011 were as follows : PART A Only uses as plant growth regulator 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 ethephon, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 14 July 2006 shall be taken into account. Specific provisions of Regulation (EU) No 2015/415 were to extend the expiry date of the active substance s approval to 31 July An EFSA conclusion is available (EFSA Scientific Report (2008) 174, 1-65). A Review Report is available (SANCO/10037/2006 rev 3, 2 December 2008).

4 1.3 Regulatory approach Page 4 of 56 The present applications ( , , and ) were 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 4th May provides that: - unless formally stated in the product authorisation, the pre harvest interval (PHI) is at least three days; - unless formally stated in the product authorisation, the minimum buffer zone alongside a water body is five metres; - unless formally stated in the product authorisation, the minimum re-entry period is six hours for field uses and eight 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, 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 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 Arrêté du 4 mai 2017 relatif à la mise sur le marché et à l'utilisation des produits phytopharmaceutiques et de leurs adjuvants visés à l'article L du code rural et de la pêche maritime 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

5 1.4 Data protection claims Page 5 of 56 Where protection for data is being claimed for information supporting registration of PRM 12 RP, 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.

g/l ethephon Soluble concentrate (SL) High-density polyethylene (HDPE) containers holding 5 L product 2.2 Classification and labelling 2.2.1 Classification and labelling under Directive 99/45/EC Not applicable after 1st June 2015.

6 Page 6 of 56 2 DETAILS OF THE AUTHORISATION 2.1 Product identity Product name (code) PRM 12 RP () Authorisation number Function Applicant Composition Formulation type (code) Packaging Plant growth regulator Bayer CropScience France 120 g/l ethephon Soluble concentrate (SL) High-density polyethylene (HDPE) containers holding 5 L product 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) No 1272/2008 Physical hazards - Health hazards Serious eye damage/eye irritation, Hazard Category 1 Environmental hazards - Hazard pictograms Signal word Danger Hazard statements H318 Causes serious eye damage Precautionary statements For the P phrases, refer to the extant legislation 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 The authorisation of the preparation is linked for professional uses only to the following conditions: SP 1 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.

7 Page 7 of 56 SPe 3 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 : 24 hours Pre-harvest interval 11 : Pear tree F - Application must be made at growth stage BBCH 73 at the latest Other mitigation measures: - Apple tree (eating apple only), azarole Apple tree (cider apple only) Cherry tree Plum tree 14 days Application must be made at growth stage BBCH 73 at the latest Application must be made at growth stage BBCH 59 at the latest Application must be made at growth stage BBCH 75 at the latest The label must reflect the conditions of authorisation The legal basis for this is Titre III Article 12 of the French Order of 4th May 2017 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 4th May 2017 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 4th May 2017, PHI cannot be lower than 3 days unless specifically stated in the assessment and decision.

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. When a use is acceptable with GAP restrictions, the modifications of the GAP are in bold. GAP rev. 1, date: 2017-sseptember-22 PPP (product name/code) PRM 12 RP/() active substance 1 ethephon Applicant: Bayer CropScience France Zone(s): southern EU Verified by MS: yes Formulation type: Conc. of a.s. 1: professional use non-professional use soluble concentrate (SL) 120 g/l Crop and/ or situation (a) Country 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 a.s. (i) method kind (f-h) growth stage & season (j) number min max (k) interval between applications (min) kg a.s./hl min max water L/ha min max kg a.s./ha min max Pear FR Ethephon SL 120 G F Thinning- post flowering SL 120 g/l Spraying BBCH 69 to F application must be made at BBCH 73 at the latest Acceptable.

9 Page 9 of 56 Crop and/ or situation (a) Country 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 a.s. (i) method kind (f-h) growth stage & season (j) number min max (k) interval between applications (min) kg a.s./hl min max water L/ha min max kg a.s./ha min max Apple (eating), azarole FR Ethephon SL 120 G F Thinning - pre flowering SL 120 g/l Spraying BBCH 57 to F - application must be made at BBCH 69 at the latest Acceptable 3 applications per year and per crop considering all actions. Apple (cider) FR Ethephon SL 120 G F Thinning - pre flowering SL 120 g/l Spraying BBCH 57 to F - application must be made at BBCH 69 at the latest Acceptable 2 applications per year and per crop considering all actions. Apple (eating), azarole FR Ethephon SL 120 G F Thinning- post flowering SL 120 g/l Spraying BBCH 69 to F - application must be made at BBCH 73 at the latest Acceptable 3 applications per year and per crop considering all actions. Apple (cider) FR Ethephon SL 120 G F Thinning- post flowering SL 120 g/l Spraying BBCH 69 to F - application must be made at BBCH 73 at the latest Acceptable 2 applications per year and per crop considering all actions.

10 Page 10 of 56 Crop and/ or situation (a) Country 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 a.s. (i) method kind (f-h) growth stage & season (j) number min max (k) interval between applications (min) kg a.s./hl min max water L/ha min max kg a.s./ha min max Apple (eating), azarole FR Ethephon SL 120 G F Coloration SL 120 g/l Spraying BBCH days Acceptable 3 applications per year and per crop considering all actions. Cherry FR Ethephon SL 120 G F Thinning SL 120 g/l Spraying BBCH 53 to F - application must be made at BBCH 59 at the latest Acceptable Plum, jujube FR Ethephon SL 120 G F Thinning SL 120 g/l Spraying BBCH F - application must be made at BBCH 75 at the latest Acceptable 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

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12 Page 12 of 56 3 RISK MANAGEMENT 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties PRM 12 RP () is a soluble concentrate formulation (SL). All studies have been performed in accordance with the current requirements and the results are deemed acceptable. The appearance of the product is that of a transparent colourless liquid, with weak musty odour. It is not explosive and has no oxidising properties. The product is not flammable. It has a self-ignition temperature of 600 C. In aqueous solution (1 %), its ph is 2.1 at ambient temperature. There is no effect of low and high temperatures on the stability of the formulation, since after 14 days at 54 C and eight 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 two years at ambient temperature when stored in HDPE cans. Its technical characteristics are acceptable for an SL formulation. The formulation is not classified for the physico-chemical aspect Methods of analysis Analytical method for the formulation Analytical methods for the determination of the active substance in the formulation are available and validated Analytical methods for residues As relevant impurities 1,2-dichloroethane and mono 2-chloroethyl ester, 2-chloroethyl phosphonic acid (MEPHA) are by-products of the manufacturing process and as such cannot be formed by storage of the formulation, an analytical method for their determination in the formulation is not necessary. Analytical methods are available in the Draft Assessment Report/this dossier and validated for the determination of residues of ethephon in plants (high water-content commodities), foodstuffs of animal origin, soil, water (surface and drinking) and air. The active substance is neither toxic nor very toxic, hence no analytical method is required for the determination of residues in biological fluids Mammalian Toxicology Endpoints used in risk assessment Active Substance: ethephon ADI ARfD 0.03 mg kg bw/d 0.05 mg kg bw/d EU agreed endpoints AOEL Dermal absorption 0.03 mg/kg bw/d Values obtained based on a study with a similar formulation Concentrate (tested) 120 g/l Diluted formulation (tested) 0.48 g/l In vivo (rat) % 3 3 Concentrate (plant protection product to be evaluated) 120 g/l Diluted (plant protection product to be evaluated) 0.48 g/l

13 Page 13 of 56 Dermal absorption endpoints % 3 % 3 % Acute Toxicity PRM 12 RP (), containing 120 g/l ethephon, has a low acute oral, inhalational and dermal toxicity, is not irritating or sensitising to the rabbit skin but is irritating to the rabbit eye Operator Exposure Summary of critical use patterns (worst cases): Crop F/G 12 Equipment Fruit trees F Tractormounted/trailed broadcast airassisted sprayer Application rate kg/l product/ha (g a.s./ha) 4 L PPP/ha (480 g a.s./ha) Model BBA Considering the proposed uses, operator systemic exposure was estimated using the German BBA model: Crop Equipment PPE and/or working coverall % AOEL ethephon Fruit trees Tractormounted/trailed boom sprayer : Working coverall and gloves during mixing/loading and application 32 According to the model calculations, it can be concluded that the risk for the operator using PRM 12 RP is acceptable with a working coverall (90 % protection factor) and gloves during mixing/loading and application. For details of personal protective equipment for operators, refer to the Decision in Appendix Bystander Exposure Bystander exposure was assessed according to EUROPOEM II. Exposure is estimated to be 7 % of the AOEL of ethephon. It may be concluded that there is no unacceptable risk to the bystander after incidental short-term exposure to PRM 12 RP (). Resident Exposure Residential exposure was assessed according to Martin et al (2008). Exposure is estimated to be 6 % of the AOEL of ethephon for adults and 2 % of the AOEL for children. It may be concluded that there is no unacceptable risk to the resident exposed to PRM 12 RP () Worker Exposure Worker exposure was assessed according to EUROPOEM II. Exposure is estimated to be 19 % of the AOEL of ethephon for a worker wearing working coverall and gloves. 12 Open field or glasshouse

14 Page 14 of 56 For details of personal protective equipment for operators, refer to the Decision in Appendix Residues and Consumer Exposure Residues PRM 12 RP () contains ethephon. Summary for ethephon Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL compliance Reg. (EU) 2015/846 Chronic risk for consumers identified? Acute risk for consumers identified? Comments Pear Yes Yes (9 NEU and 8 SEU) Yes Yes Yes No No Apple ( eating apple) Yes Yes (7 NEU and 8 SEU) + 9 NEU & 9 SEU from reregistration dossier Yes Yes Yes No No Use evaluated: thinning + colouring Cherry Yes Yes (9 SEU) Yes Yes Yes No No NEU trials were submitted but not required Plum Yes Yes (2 NEU and 4 SEU) Yes Yes Yes No The number of residue trials was sufficient, as they confirm a noresidue situation Apple (cider apple only) Yes Yes (2 N EU trials at the intended GAP requested postauthorisation) Yes Yes Yes No No 2 N EU trials at the intended GAP requested postauthorisation The effects of processing on the nature of ethephon residues have been investigated. Data on effects of processing on the amount of residue have been submitted. These data were not considered for risk assessment purposes. Residues in succeeding crops were not assessed as pear, apple, plum and cherry trees are perennial crops. Considering dietary burden and based on the intended uses, no significant modification of the intake was calculated for livestock. Further investigation of residues as well as the modification of MRLs in commodities of animal origin is therefore not necessary.

15 Page 15 of 56 Information on PRM 12 RP Crop PHI for PRM 12 RP proposed by applicant PHI/withholding period* sufficiently supported for ethephon PHI for PRM 12 RP proposed by zrms zrms Comments (if different PHI proposed) Pear F** BBCH Yes F** BBCH Apple (for dessert/eating apple only) 14 days Yes 14 days Cherry F** - BBCH Yes F** - BBCH Plum F** - BBCH Yes F** - BBCH Apple (cider apple only) F** - BBCH Yes F** - BBCH 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 The data available are considered sufficient for risk assessment. Any exceedence of the current MRL for ethephon as laid down in Reg. (EU) 396/2005 is not expected for the intended use on apple for thinning + colouring, nor on cider apple, pear, plum and cherry. The chronic and the short-term intakes of ethephon residues resulting from the uses proposed in the framework of this application are unlikely to present a public health concern. As far as consumer health protection is concerned, France agrees with the authorisation of the intended uses. Data gaps None. Data required post-authorisation 2 N EU trials on cider apple at the intended GAP of 4 x 480 g a.s./ha, PHI F (thinning use) Mitigation measures According to the available data, no specific mitigation measures should apply Environmental fate and behaviour The fate and behaviour in the environment have been evaluated according to the requirements of Regulation (EC) No 1107/2009. Appropriate endpoints from the EU conclusions were used to calculate predicted environmental concentration (PEC) values 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.

16 Page 16 of 56 The PEC values of ethephon 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 conclusions or agreed in the assessment based on new data provided. PECsoil and PECsw values derived for ethephon and its metabolites are used for the ecotoxicological risk assessment, and mitigation measures are proposed. PECgw values for ethephon and its metabolites do not occur at levels exceeding those mentioned in Regulation EC 1107/2009 and guidance document SANCO 221/2000 on the relevance of metabolites in groundwater. Therefore, no unacceptable risk of groundwater contamination is expected for the intended uses. 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 conclusions for the active substances and its 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, bees and other non-target arthropods, earthworms, other soil macro-organisms and micro-organisms are acceptable for the intended uses Effects on Terrestrial Vertebrates The risk assessment showed that all toxicity-to-exposure-ratios (TERs) for birds meet the a priori acceptability criteria of the EU Regulation. An unacceptable risk to birds from dietary exposure after use of the product as described in this dossier is therefore unlikely. The acute and long-term risks to herbivorous mammals exposed to the product are considered to be low. No unacceptable risk to birds and mammals resulted from exposure via drinking water Effects on Aquatic Species The TER values for all aquatic species were above the regulatory trigger values, on the basis of worst-case laboratory studies and considering worst-case PEC sw calculations Effects on Bees and Other Arthropod Species The tier 1 risk assessment showed that the hazard quotients (oral and contact) were below the EU trigger value. This indicates that the use of the product according to the proposed use pattern does not constitute an unacceptable risk towards bees. The higher-tier risk assessment indicated that no unacceptable adverse effects on non-target arthropods are to be expected for the in- or off-field habitats following the use of the product according to the proposed use pattern. No mitigation measures are needed.

17 Page 17 of Effects on Earthworms and Other Soil Macro-organisms As has been demonstrated by acute and chronic studies, no unacceptable effects on earthworms are to be expected from the application of the product according to the proposed use pattern Effects on organic matter breakdown A study on the organic matter breakdown is not required based on the DT 90f value of the active substance and acceptable TER values for earthworms and soil micro-organisms Effects on Soil Non-target Micro-organisms The risk assessment indicates that no adverse effects on soil micro-organisms are to be expected when the product is applied according to the proposed use pattern Assessment of Potential for Effects on Other Non-target Organisms (Flora and Fauna) The tier 1 risk assessment indicated that no unacceptable adverse effects on non-target arthropods are to be expected for the in- or off-field habitats following the use of the product according to the proposed use pattern. No mitigation measures are needed Efficacy Introduction PRM 12 RP () is a growth regulator product containing ethephon (120 g/l). The activity of ethephon is based on the release of ethylene. This naturally occurring phyto-hormone is associated with various physiological processes, most commonly ripening, senescence and abscission. PRM 12 RP () is already registered in France for action on fruit-ripening and flowering processes (apple, cherry, peach, tomato). Bayer CropScience France has applied to extend use to pear, cherry and plum tree thinning, and GAP modification on apple trees (the possibility to cumulate pre-flowering and post-flowering applications for thinning, thus increasing the application number from one to two), with PRM 12 RP () applied at 3 L/ha, except for cider apple (4 L/ha). On eating apple trees, a third application is possible for an action on fruits quality. Considering the data submitted : The efficacy of PRM 12 RP () is considered satisfactory in the requested conditions; The selectivity of PRM 12 RP () is considered acceptable in the requested conditions; The risk of negative impact on yield, quality, transformation processes (cider making), propagation, or adjacent crops is considered negligible. The risk of resistance developing or appearing is not relevant for this kind of product.

18 Page 18 of 56 Crop Use Thinning preflowering Method of application Rate of use (product/ha) Max no. of appl. per use 3 L/ha 1 Max no. of appl. per crop Conclusion of France for efficacy section Comments (e.g. monitoring ) / additional requests Apple tree Thinning postflowering 3 L/ha 1 3 Colouration 3 L/ha 1 Cider-apple tree Pear tree Cherry tree Plum tree Thinning preflowering Thinning postflowering Thinning postflowering Thinning preflowering Thinning postflowering Foliar and fruit spraying 4 L/ha 1 4 L/ha 1 3 L/ha 3 L/ha 3 L/ha Acceptable

19 Page 19 of 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 The French Decision requests the submission of post-authorisation confirmatory pieces of information within 24 months regarding: - Two Northern EU trials on cider apple at the intended GAP of 4 x 480 g a.s./ha, with PHI F (thinning use). - Suitable data or a detailed argued case to justify the absence of phytotoxicity when PRM 12 RP is applied twice at 4 L/ha (as requested) for the thinning use in cider-apple trees Label amendments 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.

20 Page 20 of 56 Appendix 1 Copy of the French Decision

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26 Page 26 of 56 Appendix 2 Copy of the draft product label as proposed by the applicant

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