BAS H (TANARIS) Page 1 of 31. REGISTRATION REPORT Part A. Risk Management

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1 Page 1 of 31 REGISTRATION REPORT Part A Risk Management Product code: BAS H Product name: TANARIS Active Substances: dimethenamid-p, 333 g/l quinmerac, 167 g/l COUNTRY: FRANCE Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (marketing authorisation) Applicant: BASF Date: 16/03/2017

2 Page 2 of 31 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... 31

3 Page 3 of 31 PART A Risk Management The company BASF has requested marketing authorisation in France for the product TANARIS (BAS H), containing 333 g/l dimethenamid-p and 167 g/l quinmerac 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 TANARIS (BAS H) where those data have not been considered in the EU peer review process. Otherwise assessments for the safe use of TANARIS (BAS H) have been made using endpoints agreed in the EU peer review of both dimethenamid-p and quinmerac. This document describes the specific conditions of use and labelling required for France for the registration of TANARIS (BAS H). 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 BASF s application to market TANARIS (BAS H) 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 first authorisation of this product in France and in other MSs of the Southern zone. 1.2 Active substance approval Dimethenamid-P 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 Regulation (EU) No 823/2012 of 14 September 2012 derogating from Implementing Regulation (EU) No 540/2011 as regards the expiry dates of the approval of the active substances 2,4-DB, benzoic acid, betacyfluthrin, carfentrazone ethyl, Coniothyrium minitans Strain CON/M/91-08 (DSM 9660), cyazofamid, cyfluthrin, deltamethrin, dimethenamid-p, ethofumesate, ethoxysulfuron, fenamidone, flazasulfuron, flufenacet, flurtamone, foramsulfuron, fosthiazate, imazamox, iodosulfuron, iprodione, isoxaflutole, linuron, maleic hydrazide, mecoprop, mecoprop-p, mesosulfuron, mesotrione, oxadiargyl, oxasulfuron, pendimethalin, picoxystrobin, propiconazole, propineb, propoxycarbazone, propyzamide, pyraclostrobin, silthiofam, trifloxystrobin, warfarin and zoxamide. Commission Implementing Regulation (EU) 2016/950 of 15 June 2016 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 2,4-DB, beta-cyfluthrin, carfentrazone ethyl, Coniothyrium minitans Strain CON/M/91-08 (DSM 9660), cyazofamid, deltamethrin, dimethenamid-p, ethofumesate, fenamidone, flufenacet, flurtamone, foramsulfuron, fosthiazate, imazamox, iodosulfuron, iprodione, isoxaflutole, linuron, maleic hydrazide, mesotrione, oxasulfuron, pendimethalin, picoxystrobin, silthiofam and trifloxystrobin. Specific provisions of Regulation (EU) No 540/2011 were as follows:

4 Page 4 of 31 Only uses as herbicide may be authorised. 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 dimethenamid-p, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 4 July 2003 shall be taken into account. In this overall assessment Member States: should pay particular attention to the potential of the metabolites of dimethenamid-p for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climate conditions, should pay particular attention to the protection of aquatic ecosystems, especially of aquatic plants. Risk mitigation measures should be applied where appropriate. The Member States 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. Specific provisions of Regulation (EU) No 823/2012 were to extend the approval s expiry date to 31 October Specific provisions of Regulation (EU) No 2016/950 were to further extend the approval s expiry date to 31 October 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/1402/2001-Final, 3 July 2003). Quinmerac 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 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 quinmerac, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2010 shall be taken into account. In this overall assessment Member States shall pay particular attention to: the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions; the dietary exposure of consumers to residues of quinmerac (and its metabolites) in succeeding rotational crops the risk to aquatic organisms and the long term risk for earthworms. Conditions of use shall include risk mitigation measures, where appropriate. The Member States concerned shall request the submission of information as regards: the potential of plant metabolism to result in an opening of the quinoline ring; residues in rotational crops and the long term risk for earthworms due to the metabolite BH

5 Page 5 of 31 They shall ensure that the applicant provides such confirmatory data and information to the Commission by 30 April 2013 An EFSA conclusion is available (EFSA Journal 2010; 8(3): 1523) [approval] and EFSA supporting publication 2015:EN-767 [confirmatory data]. A Review Report is available (SANCO/12192/2010 final, 7 December 2010). 1.3 Regulatory approach The present applications ( for authorisation, plus for an addition of commercial second name) 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 12 September 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 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

6 Page 6 of 31 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 TANARIS, 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.

7 Page 7 of 31 2 DETAILS OF THE AUTHORISATION 2.1 Product identity Product name (code) TANARIS (BAS H) Authorisation number Function Applicant Composition Formulation type (code) Packaging herbicide BASF 333 g/l dimethenamid-p 167 g/l quinmerac suspo-emulsion (SE) High-density polyethylene (HDPE) bottles holding 0.15, 0.25, 0.5 or 1L product High-density polyethylene (HDPE) containers holding 3, 5 or 10 L product High-density polyethylene (HDPE) barrels holding 50 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) No1272/2008 Physical hazards - Health hazards Serious eye damage/eye irritation, Category 2 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 Hazard statements Precautionary statements Warning H319 Causes serious eye irritation. H317 May cause an allergic skin reaction. H400 Very toxic to aquatic life H410 Very toxic to aquatic life with long lasting effects. For the P phrases, refer to the extant legislation

8 Page 8 of 31 Supplementary information (in accordance with Article 25 of Regulation (EC) No 1272/2008) Contains 1,2-benzisothiazol-3(2H)-one (CAS No ) and 2-methyl-4-isothiazolin- 3-one (CAS No ). 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 1 SPe 2 SPe 3 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 groundwater, following an application on winter rapeseed, do not apply this or any other product containing dimethenamid-p or quinmerac more than every other year. To protect aquatic organisms do not apply to artificially drained soils with clay content greater than or equal to 45 % To protect aquatic organisms, respect an unsprayed buffer zone of 5 metres to surface water bodies. To protect non-target plants, respect an unsprayed buffer zone of 5 metres to non-agricultural land Other phrases linked to the preparation Wear suitable personal protective equipment 8 : refer to the Decision in Appendix 1 for the details Re-entry period 9 : 48 hours Pre-harvest interval 10 : Oilseed brassicas (winter rapeseed, turnip rape, mustard, gold of pleasure, ): F (BBCH 18) Other mitigation measures: - The label must include the following recommendations: Contains 1,2-benzisothiazol-3(2H)-one and 2-methyl-4-isothiazolin-3-one ' The label must reflect the conditions of authorisation 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.

9 Page 9 of Product uses Please note: The GAP Table below reports the intended uses proposed by the applicant, and possible extrapolation according to French Order of 26 March 2014 (highlighted in green), evaluated and concluded as safe uses by 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. PPP (product name/code) TANARIS (BAS H) active substance 1 dimethenamid-p active substance 2 quinmerac Formulation type: Conc. of a.s. 1: Conc. of a.s. 2: GAP, date: SE 333 g/l 167 g/l Applicant: Zone(s): Verified by MS: BASF southern yes 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 Type (d-f) Conc. of as (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 max PHI (days) (l) Remarks: (m) 1 FR, Oilseed brassicas [winter oilseed rape, mustard, turnip rape, mustard, gold-of-pleasure] F Weeds (general) SE 333d + 167q Spraying BBCH d 0.25q F Acceptable except for spring rapeseed [(MRL not respected) 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 31 3 RISK MANAGEMENT 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties The formulation TANARIS (BAS H) is a suspo-emulsion. All studies have been performed in accordance with the current requirements and the results are deemed acceptable. The appearance of the product is a light brown free-flowing homogeneous liquid of medium viscosity and free from foreign matter, with slightly aromatic odour. It is not explosive and has no oxidising properties. The product has no flash point. It has a self-ignition temperature of 454 C. In 1 % aqueous solution, it has a ph value 3.6 at 22 C. There is no effect of low and high temperatures on the stability of the formulation, since after seven days at 0 C and 14 days at 54 C, neither the active substances 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 packaging. Its technical characteristics are acceptable for a suspoemulsion. The formulation is not classified for the physico-chemical aspect Methods of analysis Analytical method for the formulation Analytical methods for the determination of active substances in the formulation are available and validated. As the active substances quinmerac and dimethenamid-p do not contain relevant impurities, no analytical methods are required Analytical methods for residues Analytical methods are available in the Draft Assessment Report (DAR) and in this dossier and validated for the determination of residues of dimethenamid-p in plants (high-oil-content commodities), soil, water (surface and drinking) and air. Analytical methods for the determination of residues of dimethenamid-p in foodstuffs of animal origin are not necessary. Nevertheless, when the active substance is re-registered, an ILV for the determination of dimethenamid in high-oil-content commodities must be submitted. Analytical methods are available in the DARs and in another dossier of this applicant, validated for the determination of residues of quinmerac in plants (high-oil-content matrices), foodstuffs of animal origin, soil, water (surface and drinking) and air. The active substances are 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: Dimethenamid-P ADI 0.02 mg kg bw/d EU agreed endpoint ARfD 0.25 mg/kg bw/d EU agreed endpoint AOEL 0.04 mg/kg bw/d EU agreed endpoint Dermal absorption Based on an in vitro human study performed on the formulation : Concentrate (tested) 333 g/l Spray dilution (tested) 1.25 g/l In vitro (human) % 1.09 ± 0.79 % ± %

11 Page 11 of 31 Concentrate (used in the formulation) 333 g/l Spray dilution (used in the formulation) 1.25 g/l Dermal absorption endpoints % 2 % 43 % Active Substance: Quinmerac ADI 0.08 mg kg bw/d EU agreed endpoint ARfD 0.3 mg/kg bw/d EU agreed endpoint AOEL 0.08 mg/kg bw/d EU agreed endpoint Dermal absorption Based on an in vitro human study performed on a similar formulation (using a pro rata correction) according to guidance on dermal absorption (Efsa 2012): Concentrate (tested) 100 g/l In vitro (human) % 0.5 % 2.47 % Concentrate (used in the formulation) 167 g/l Dermal absorption endpoints % 0.5 % 4 % Spray dilution (tested) 0.5 g/l (1:200) Spray dilution (used in the formulation) 0.63 g/l (1:265) Acute Toxicity TANARIS (BAS H), containing 333 g/l dimethenamid-p and 167 g/l quinmerac, has low acute oral, inhalational and dermal toxicity, is not irritating to the rabbit skin but is irritating to eyes and is a skin sensitiser Operator Exposure Summary of critical use patterns (worst cases): Crop F/G 11 Equipment Application rate L product/ha (g a.s./ha) Spray dilution (L/ha) Model Rapeseed F Tractor-mounted sprayer boom 1.5 (500 g dimethenamid-p/ha 250 g quinmerac/ha) BBA model Considering proposed use, operator systemic exposure was estimated using the German BBA model: Crop Equipment PPE and/or working coverall % AOEL Dimethenamid-P % AOEL Quinmerac Rapeseed Tractor-mounted boom sprayer Working coverall and gloves during mixing/loading and application % 11 Open field or glasshouse

12 Page 12 of 31 According to the model calculations, it may be concluded that the risk for the operator using TANARIS (BAS H)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 4.2 % of the AOEL of dimethenamid-p and 1.1 % of the AOEL of quinmerac. It may be concluded that there is no unacceptable risk to the bystander after incidental short-term exposure to TANARIS (BAS H). Resident Exposure Residential exposure was assessed according to the German guidance paper (Martin et al., 2008). Exposure is estimated to be as follows: % AOEL - Adults % AOEL - Children dimethenamid-p quinmerac It may be concluded that there is no unacceptable risk to the resident exposed to TANARIS (BAS H) Worker Exposure TANARIS (BAS H) is used as herbicidal treatment on crops where there is no need to re-enter the treated area after application. Worker exposure is considered to be not relevant Residues and Consumer Exposure Overall conclusion The data available are considered sufficient for risk assessment purposes. Any exceedance of the current MRLs of 0.1* mg/kg for quinmerac and 0.01* mg/kg for dimethenamid-p as laid down in Reg. (EU) 396/2005 is not expected, except for spring rapeseed. The chronic and the short-term intakes of quinmerac and dimethenamid-p residues are unlikely to present a public health concern. As far as consumer health protection is concerned, France agrees with authorisation of the intended use(s). According to the available data, no specific mitigation measures should apply. Data gaps Noticed data gaps are: Quinmerac: Appropriate storage stability data are necessary to demonstrate the validity of the results generated in the rotational crop residue trials with regard to rotational cereals (notably for cereal straw). Dimethenamid-P: The final report of BASF DocID 2013/ must be submitted post authorisation, to confirm the a.s. s stability in high-oil-content matrices.

13 Page 13 of Summary The preparation TANARIS (BAS H) contains quinmerac and dimethenamid-p. Summary for quinmerac Use- No.* Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL compliance Reg. (EC) No 149/2008 Chronic risk for consumers identified? Acute risk for consumers identified? Comments / / Oilseed brassicas (1), preemergence Y Y Y Y Y** No No Oilseed brassicas (1), postemergence Y Y Y Y Y** No No * Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 (1) Rapeseed, turnip rape, gold of pleasure, mustard. Acceptable **Except for spring rapeseed Acceptable **Except for spring rapeseed The effects of processing on the nature of quinmerac residues have been investigated. Data on effects of processing on the amount of residue have been submitted in the initial DAR. These data were not considered for this risk assessment. Residues in succeeding crops have been sufficiently investigated taking into account the specific circumstances of the cgap uses being considered here. It is very unlikely that residues will be present in wheat grain, carrots and radish roots, cauliflower and broccoli. Foliar crops (lettuce and spinach) present a high probability of residues being present at measurable levels whatever the plant-back interval (PBI). Nevertheless, residue levels measured at all PBIs are always below the extant MRL of 0.1* mg/kg (Reg. (EC) No.149/2008). Therefore no restriction has to be set but residues levels from rotational crops have still been considered in the dietary burden calculation. However, EFSA considers, contrary to the RMS evaluation, that adequate storage stability data are necessary to demonstrate the validity of the results generated in the rotational crop residue trials with regard to rotational cereals (data gap for the a.s.). Considering dietary burden and based on the intended uses and residue levels in rotational crops, the trigger for investigation of the nature and magnitude of residues in livestock is exceeded. However, no agreed peer-reviewed livestock residue definition is available. EFSA considers that future assessments would benefit from EU peer reviewed livestock studies and an agreed livestock residue definition, established in an experts consultation. The non-finalisation of the assessment is however not considered a critical area of concern, since the consumer exposure is expected to still be below the toxicological reference values.

14 Page 14 of 31 Summary for dimethenamid-p Use- No.* Crop Plant metabolism covered? Sufficient residue trials? PHI sufficiently supported? Sample storage covered by stability data? MRL compliance Reg.(EU) 2015/552 Chronic risk for consumers identified? Acute risk for consumers identified? Comments / / Oilseed brassicas (1), preemergence Y Y Y Y Y No No Oilseed brassicas (1), postemergence Y Y Y Y Y No No * Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 (1) Rapeseed, turnip rape seed, gold of pleasure seed, mustard seed. For oilseed brassicas, additional data are required post-authorisation to confirm the stability of dimethenamid-p residues. As residues of dimethenamid-p 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. Residues in succeeding crops have been sufficiently investigated taking into account the specific circumstances of the cgap uses being considered here. It is very unlikely that residues will be present in succeeding crops. Considering dietary burden and based on the intended uses, no significant modification of the intake was calculated for livestock. Further investigations of residues, as well as the modification of MRLs in commodities of animal origin, are therefore not necessary. Summary for TANARIS (BAS H) Crop PHI for TANARIS (BAS H) proposed by applicant PHI/Withholding period* sufficiently supported for Quinmerac Dimethenamid-P PHI for TANARIS (BAS H) proposed by zrms zrms Comments (if PHI proposed) different Oilseed brassicas (1) (except spring rapeseed) Oilseed brassicas (1) (except spring rapeseed) F** (BBCH 00-09) F** (BBCH 10-18) Yes Yes F** (BBCH 00-09) Yes Yes F** (BBCH 10-18) 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). (1) Rapeseed, turnip rape, gold of pleasure, mustard.

15 Page 15 of 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 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. The PEC values of dimethenamid-p, quinmerac and their respective 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. PEC soil and PECsw values derived for the active substances and their metabolites are used for the ecotoxicological risk assessment, and mitigation measures are proposed. PECgw values for dimethenamid-p, quinmerac and their respective metabolites do not occur at levels exceeding those mentioned in Regulation EC 1107/2009 and guidance document SANCO 221/2000 on the assessment of the relevance of metabolites in groundwater for an application of the preparation TANARIS (BAS H) every other year. Therefore, no unacceptable risk of groundwater contamination is expected for the intended uses for one application every other year. 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 Effects on birds Under the conservative assumptions of a tier 1 assessment, all TER A values and all TER LT values for dimethenamid- P and quinmerac exceed the triggers of 10 and 5 respectively, indicating an acceptable risk to birds. Effects on Terrestrial Vertebrates Other Than Birds Under the conservative assumptions of a tier 1 assessment, all TER A values and all TER LT for dimethenamid-p and quinmerac exceed the triggers of 10 and 5 respectively, indicating an acceptable risk to mammals. Effects on Aquatic Organisms The acute and long-term TER values for fish and daphnids exposed to dimethenamid-p exceed the required trigger values based on standard assumptions. TER values for algae and the aquatic plant Lemna gibba, however, do not meet the required trigger value for applications close to sensitive surface water bodies according to the standard worst-case assumptions. A range of additional and higher-tier studies on aquatic primary producers were conducted, including testing a large number of different algae and aquatic macrophytes species as well as a time-to-effect study simulating different exposure routes and different exposure durations. With all the available higher-tier data, the refined risk assessment for dimethenamid-p demonstrates that pre- and post-emergence application of TANARIS (BAS H) in winter rapeseed according to good agricultural practice will be of an acceptable risk to aquatic ecosystems without the need for additional mitigation measures, except for the D2 ditch scenario for pre-emergence application and the D2 ditch and stream scenarios for post-emergence application where no safe uses can be demonstrated.

16 Page 16 of 31 All acute and long-term TER values of the formulated product TANARIS (BAS H), the active substance quinmerac and metabolites of both active substances exceed the required trigger values based on standard assumptions and the mitigation measures proposed in 2.2.3, demonstrating an acceptable risk to aquatic organisms following the proposed uses of TANARIS (BAS H). Effects on Bees The calculated HQs for acute oral and acute contact exposure of honeybees to quinmerac, dimethenamid-p and TANARIS (BAS H) are below the trigger value of 50, indicating an acceptable risk. Effects on Arthropods Other Than Bees The calculated hazard quotient of the tier II risk assessment indicated no in-field and off-field risk for Typhlodromus pyri, Aphidius rhopalosiphi and A. bilineata. Therefore, acceptable risks for in- and off-field habitats are anticipated. Effects on Earthworms and Other Soil Non-target Macro-organisms Acute studies on earthworms were performed with dimethenamid-p, quinmerac and the metabolites M23, M27, M31, BH and BH In the risk assessment, the acute TER values exceeded the trigger value of 10, indicating an acceptable risk. Chronic studies on earthworms were carried out with TANARIS (BAS H) and the metabolites M23, M27, M31 and BH All TER values exceeded the trigger value of 5 for chronic exposure. Furthermore, chronic studies on collembolans were carried out with TANARIS (BAS H), dimethenamid-p and the metabolites M23, M27, M31 and BH Chronic studies on soil mites were carried out with TANARIS (BAS H), dimethenamid-p and the metabolites M23 and M27. All TER values exceeded the trigger value of 5 for chronic exposure, indicating an acceptable risk. Effects on Soil Microbial Activity The NOEC values of TANARIS (BAS H), dimethenamid-p metabolites M23, M27 and M31 and for quinmerac metabolites BH and BH are higher than the respective worst-case PEC values. Effects on Non-Target Plants The TER values for non-target plants exposed to TANARIS (BAS H) are above the trigger value of 5 if a 5 m buffer zone is considered, i.e., indicating an acceptable risk Efficacy Considering the data submitted: the efficacy of TANARIS (BAS H) is considered satisfactory; the selectivity of TANARIS (BAS H) is considered satisfactory; the risk of negative impact (on yield, quality, propagation, succeeding and adjacent crops) is considered negligible; the risk of resistance developing or appearing is considered to be low.

17 Page 17 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: - Adequate storage stability data are necessary to demonstrate the validity of the results generated in the quinmerac rotational crop residue trials with regard to rotational cereals. - A study to confirm the stability of dimethamid-p residues in high oil content matrices 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.

18 Page 18 of 31 Appendix 1 Copy of the French Decision

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24 Page 24 of 31 Appendix 2 Copy of the draft product label as proposed by the applicant

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31 Page 31 of 31 Appendix 3 Letter(s) of Access Not applicable.