(NEU 1170 H EC) FINALSAN POLYVALENT JARDIN Page 1 of 23. REGISTRATION REPORT Part A. Risk Management

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1 Page 1 of 23 REGISTRATION REPORT Part A Risk Management Product code: NEU 1170 H EC Product name(s): Active Substance(s): Pelargonic acid, g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (marketing authorisation)

2 Page 2 of 23 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 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... 23

3 Page 3 of 23 PART A Risk Management The company Neudorff GmbH KG has requested marketing authorisation in France for the product FINALSAN POLYVALENT JARDIN for use as an 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 where those data have not been considered in the EU peer review process. Otherwise assessments for the safe use of have been made using endpoints agreed in the EU peer review of Pelargonic acid. This document describes the specific conditions of use and labelling required for France for the registration of. 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 Neudorff GmbH KG s application to market FINALSAN POLYVALENT JARDIN in France as an 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 first authorisation of this product in France and in other MSs of the Southern zone. 1.2 Active substance approval Pelargonic acid 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 (EU) No 540/2011 were as follows : PART A Only uses as insecticide, acaricide, and herbicide and 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 fatty acids (SANCO/2610/2008) 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. There is no definitive EFSA Conclusion on the peer review of the pesticide risk assessment of the active substance. A Review Report is available (SANCO/2611/08 rev. 1, 1 August 2008). 1.3 Regulatory approach The present application ( ) was evaluated in France by the French Agency for Food, Environmental and

4 Page 4 of 23 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 4 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. 1.4 Data protection claims 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 SANCO document guidance document:- Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs : SANCO/ 7525/VI/95 - rev.9

5 Page 5 of 23 Where protection for data is being claimed for information supporting registration of FINALSAN POLYVALENT JARDIN, it is indicated in the reference lists in Appendix 1 of the Registration Report, Part B Sections Letter(s) of Access Not necessary. 2 DETAILS OF THE AUTHORISATION 2.1 Product identity Product name (code) Authorisation number Function Applicant Composition Formulation type (code) Herbicide Neudorff GmbH KG g/l Pelargonic acid Emulsifiable concentrate (EC) Packaging Bottles in HDPE (250 ml, 500 ml, 750 ml, 1 L, 1.1 L, 1.2 L, 1.3 L, 1.4 L, 1.5 L, 2 L) with measuring screw cap 2.2 Classification and labelling Classification and labelling under Directive 99/45/EC Not applicable after 1st June Containers in HDPE (2.5 L, 3 L, 4 L, 5 L) with measuring screw cap Classification and labelling in accordance with Regulation (EC) No1272/2008 Physical hazards - Health hazards Eye irritation category 2 Environmental hazards Hazard pictograms - Signal word Warning Hazard statements H319 Causes serious eye irritation Precautionary statements Supplementary information (in accordance with Article 25 of Regulation (EC) No 1272/2008) For the P phrases, refer to the extant legislation

6 Page 6 of 23 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 non-professional uses only to the following conditions: To protect groundwater do not apply from September to December for the intended uses on permeable surfaces. Do not discharge into the sink, gutter or any other water hole the non-used container leftovers and the sprayer washing water. To protect aquatic organisms do not apply at least 5 meters away from any surface water bodies (well, pond, stream, river ). Avoid spray drift and runoff to nearby plants. To protect aquatic organisms do not apply in sloping gardens or impermeable surfaces located near a waterhole such as asphalt, concrete, pavements and slabs. Do not apply when beneficial organisms are present. Do not apply when bees are present Other phrases linked to the preparation The preparation is intended to be used by non-professionnals, therefore, no personal protective equipment is required. Re-entry period 8 : Wait until the treated area has completely dried before re-entry. Pre-harvest interval: N/A. Other mitigation measures: The label must reflect the conditions of authorisation. 8 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]

7 Page 7 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. GAP rev. 1, date: PPP (product name/code) Formulation type: EC active substance 1 Pelargonic acid Conc. of as 1: g/l Applicant: Zone(s): Verified by MS: yes Neudorff GmbH KG southern 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 Paths and open areas with tree growth Non cropped areas with impermeable surfaces Non cropped areas with impermeable surfaces France France France NEU 1170 H EC NEU 1170 H EC NEU 1170 H EC F F Annual and perennial monocotyledonous and dicotyledonous weeds Annual and perennial monocotyledonous and dicotyledonous weeds EC Backpack sprayer EC Backpack sprayer Professional amenity sprayer with spray shield F Mosses and algae EC Backpack sprayer Professional amenity sprayer with spray shield During the vegetation period: from January to August (independent from growth stage) During the vegetation period: from January to August (independent from growth stage) During the vegetation period: from January to August (independent from growth stage) 2 ca. 21 days Not applicable 2 ca. 21 days Not applicable 2 ca. 21 days Not applicable Acceptable 16,6 ml/m² (15) Acceptable 16,6 ml/m² (15) Acceptable 16,6 ml/m² (15)

8 Page 8 of 23 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 Woody ornamental and ornamental, roses Paths and open areas with tree growth Decorative lawns and turf France France France NEU 1170 H EC NEU 1170 H EC NEU 1170 H EC F Annual and perennial monocotyledonous and dicotyledonous weeds EC Backpack sprayer F Mosses and algae EC Backpack sprayer During the vegetation period: from January to August (independent from growth stage) During the vegetation period: from January to August (independent from growth stage) F Mosses EC Watering can During the vegetation period: from January to August (independent from growth stage) 2 ca. 21 days Not applicable 2 ca. 21 days Not applicable 1 Not applicable Not applicable Acceptable 16,6 ml/m² (15) Acceptable 16,6 ml/m² (15) Acceptable 16,6 ml/m² (15) 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

9 Page 9 of 23 Remarks columns: 1 Numeration necessary to allow references 2 Use official codes/nomenclatures of EU Member States 3 For crops, the EU and Codex classifications (both) should be used; when relevant, the use situation should be described (e.g. fumigation of a structure) 4 F: professional field use, Fn: non-professional field use, Fpn: professional and nonprofessional field use, G: professional greenhouse use, Gn: non-professional greenhouse use, Gpn: professional and non-professional greenhouse use, I: indoor application 5 Scientific names and EPPO-Codes of target pests/diseases/ weeds or, when relevant, the common names of the pest groups (e.g. biting and sucking insects, soil born insects, foliar fungi, weeds) and the developmental stages of the pests and pest groups at the moment of application must be named. 6 Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type of equipment used must be indicated. 7 Growth stage at first and last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN ), including where relevant, information on season at time of application 8 The maximum number of application possible under practical conditions of use must be provided. 9 Minimum interval (in days) between applications of the same product 10 For specific uses other specifications might be possible, e.g.: g/m³ in case of fumigation of empty rooms. See also EPPO-Guideline PP 1/239 Dose expression for plant protection products. 11 The dimension (g, kg) must be clearly specified. (Maximum) dose of a.s. per treatment (usually g, kg or L product / ha). 12 If water volume range depends on application equipments (e.g. ULVA or LVA) it should be mentioned under application: method/kind. 13 PHI - minimum pre-harvest interval 14 Remarks may include: Extent of use/economic importance/restrictions 15 dose expression adapted to amateur uses

10 Page 10 of 23 3 RISK MANAGEMENT 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties is an emulsifiable contentrate (EC). 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 a colourless, opaque liquid. It is not explosive and has no oxidising properties. The product has a flash point of 95 C. It has a self-ignition temperature higher than 320 C. In 1 % aqueous solution, it has a ph value of 6.15 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 14 days at 54 C, neither the active ingredient content nor the technical properties were changed. However, the formulation should be protected from frost and shaken during the application. The stability data indicate a shelf life of at least 2.5 years at ambient temperature when stored in HDPE. Its technical characteristics are acceptable for an EC formulation. The formulation is not classified for the physico-chemical aspect Methods of analysis Analytical method for the formulation Analytical method for the determination of the active substance in the formulation is available and validated. As the active substance Pelargonic Acid does not contain relevant impurity, no analytical method is required Analytical methods for residues Analytical methods for the determination of residues of Pelargonic Acid in plants, foodstuff of animal origin and soil are not necessary. The active substance is neither toxic nor very toxic hence no analytical method is required for the determination of residues in biological fluids and tissues Mammalian Toxicology Endpoints used in risk assessment Active Substance: pelargonic acid (nonanoic acid) ADI ARfD AOEL Dermal absorption not relevant. Not relevant. Not relevant. EU However, an AOEL of 821 mg/kg bw/d has been set in the Draft Assessment Report Fatty acides (C7-C20) in 2008 according to the UK National Diet & Nutrition Survey based on the average daily intake of fatty acid. Based on default values according to guidance on dermal absorption (Efsa 2012): Concentrate (used in formulation) g/l (pure content) Spray dilution (used in formulation) 3.1 g/l Dermal absorption endpoints % 25% 75%

11 Page 11 of Acute Toxicity FINALISAN POLYVALENT JARDIN containing (pure content) g/l pelargonic acid (= nonanoic acid) has a low toxicity in respect to acute oral, inhalation and dermal toxicity and is not irritating to the rabbit skin but is irritating to the rabbit eye and is not a skin sensitiser Operator Exposure Summary of critical use patterns (worst cases): Crop F/G 9 Equipment Application rate kg/l product/ha (kg as/ha) Spray dilution (L/ha) Model Risk envelop F Pre pressure sprayer 16.6 ml/m² equivalent to 166 L/ha (31 kg a.s./ha) 1000 L/ha (=0.1L/m² ) Modèle Expo jardin v3_6 UPJ Considering proposed uses, operator systemic exposure was estimated using the French study from UPJ dedicated to non-agricultural areas Crop Equipment PPE and/or working coverall % AOEL nonanoic acid Risk envelop Pre pressure sprayer Without PPE (amateur use) 0.15% According to the model calculations, it can be concluded that the risk for the operator using FINALSAN POLYVALENT JARDIN is acceptable without any personal protective equipment (amateur use) Bystander Exposure In the context of use by non-professionals, it is considered that the evaluation for bystanders is covered by that of the operator Resident Exposure Residential exposure was assessed according to BREAM model. Exposure is estimated to % of the AOEL of pelargonic acid (= nonanoic acid). It is concluded that there is no unacceptable risk to the resident exposed to FINALISAN POLYVALENT JARDIN Worker Exposure FINALISAN POLYVALENT JARDIN is intended to be used by amateurs during home garden application. In this case, the worker is also the operator and, it is concluded that the worker exposure is not exceeding operator exposure. To conclude, worker exposure is covered by operator exposure Residues and Consumer Exposure Not applicable Environmental fate and behaviour 9 10 Open field or glasshouse Studies and models that can be used to estimate operator exposure during the use of plant protection products in nonagricultural areas. Report from expert group «produits phytosanitaires : substances et préparations chimiques» Working group "évaluation de l exposition des utilisateurs de produits phytopharmaceutiques en zones non agricoles" - June 2011

12 Page 12 of 23 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 PEC values for the active substance 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. Given the home and garden use of the preparation, PECsoil are not needed for the eco-toxicological risk assessment. The PEC of pelargonic acid in 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. PECsw (from spray drift only) derived for the active substance is used for the ecotoxicological risk assessment. PECgw for pelargonic acid do not occur at levels exceeding those mentioned in regulation EC 1107/2009 and guidance document SANCO 221/ only for spring and summer applications. Therefore, no unacceptable risk of groundwater contamination is expected for the intended uses in amateur gardens for spring and summer applications. The following precaution sentence will be applied: To protect groundwater do not apply from September to December for the intended uses on permeable surfaces. 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 For home and garden uses, only birds and aquatic assessment is considered relevant for ecotoxicologic evaluation. The risk to birds is considered acceptable for the intended uses. For aquatic organisms, the risk to pelargonic acid following the intended uses of the formulation NEU 1170 H EC () can be considered as acceptable, with the following mitigation: To protect aquatic organisms do not apply at least 5 meters away from any surface water bodies (well, pond, stream, river, ). Moreover, the risk for aquatic organisms cannot be performed for applications on impermeable surface. The following safety phrase might be added on the label: To protect aquatic organisms do not apply in sloping gardens or impermeable surfaces located near a waterhole such as asphalt, concrete, pavements and slabs. For other non-target organisms, the following precaution sentences will be applied: - Do not treat when beneficial organisms are visiting the area. - Avoid spray drift and runoff to nearby plants. - Do not treat when bees are visiting the area Efficacy Considering the data submitted: The efficacy of is considered as satisfying on claimed uses. The risk of negative impact on yield, quality, propagation, succeeding crops is considered as acceptable. Avoid spray drift and runoff to nearby plants. Risk of pathogens to develop resistance to pelargonic acid is considered as low on claimed uses. 11 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.

13 Page 13 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 No further information is required 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.

14 Page 14 of 23 Appendix 1 Copy of the French Decision

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20 Page 20 of 23 Appendix 2 Copy of the draft product label as proposed by the applicant

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23 Page 23 of 23 Appendix 3 Letter(s) of Access Not applicable.