REGISTRATION REPORT Part A Risk Management. Product name: LITTOVIR Active Substance: OB/L SpliNPV

Transcription

1 Page 1 of 26 REGISTRATION REPORT Part A Risk Management Product name: Active Substance: OB/L SpliNPV (Spodoptera littoralis Nucleopolyhedrovirus) COUNTRY: FRANCE Southern Zone Zonal Rapporteur Member State: France NATIONAL ASSESSMENT FRANCE (marketing authorisation) Applicant: Date: Andermatt Biocontrol GmbH 18/08/2016 (Decision)

2 Page 2 of 26 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 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... 25

3 Page 3 of 26 PART A Risk Management The company Andermatt Biocontrol GmbH has requested marketing authorisation in France for the product (formulation code: SC), containing 520 g/l Spodoptera littoralis Nucleopolyhedrovirus (corresponding to OB/L) for use as an insecticide. The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-7 and Part C, and where appropriate the addenda for France. The information, data and assessments provided in Registration Report, Part B include assessment of further data or information as required at national registration by the EU peer review. It also includes assessment of data and information relating to 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 Spodoptera littoralis Nucleopolyhedrovirus (SpliNPV). 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 Andermatt Biocontrol GmbH s application to market in France as an insecticide (product uses described under point 2.3). France acted as a zonal Rapporteur Member State (zrms) for this request and assessed the application submitted for the first authorisation of this product in France and in other MSs of the Southern zone. is the representative preparation in European evaluation process for the approbation of SpliNPV. 1.2 Active substance approval Spodoptera littoralis nucleopolyhedrovirus (SpliNPV) Commission Implementing Regulation (EU) No 367/2013 of 22 April 2013 approving the active substance Spodoptera littoralis Nucleopolyhedrovirus, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. Specific provisions of Regulation (EU) No 540/2011 were as follows : 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 Spodoptera littoralis Nucleopolyhedrovirus, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 15 March 2013 shall be taken into account. An EFSA conclusion is available (EFSA Journal 2012; 10(9): 2864). A Review Report is available (SANCO/10418/2013 rev 2, 15 March 2013).

4 Page 4 of Regulatory approach The present application ( ) was evaluated in France by the French Agency for Food, Environmental and Occupational Health & Safety (Anses) 1 in the context of the zonal procedure for all Member States of the Southern zone, taking into account the worst-case uses ( risk envelope approach ) 2 the highest application rates over the Southern Zone. When risk mitigation measures were necessary, they are adapted to the situation in France. In addition, applications ( ) for a dispensation to the mandatory ban of application of an insecticide during the flowering period or in presence of honeydew according to the French Order of 28 March have been considered. 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 5, implementing regulations, and French regulations. The data taken into account are those deemed to be valid either at European Union level or at zonal/national level. This part A of the RR presents a summary of essential scientific points upon which recommendations are based and is not intended to show the assessment in detail. The conclusions relating to the acceptability of risk are based on the criteria indicated in Regulation (EU) No 546/2011 6, and are expressed as acceptable or not acceptable / not finalised in accordance with those criteria. Finally, the French Order of 26 March provides that: - an authorisation granted for a reference crop applies also for linked crops, unless formally stated in the Decision - the reference and linked crops are defined in Appendix 1 of that French Order. Thus, at French national level, possible extrapolation of submitted data and the corresponding assessment from reference crops to linked ones are undertaken even if not clearly requested by the applicant in their drr, and a conclusion is reached on the acceptability of the intended uses on those linked crops. The aim of this Order, French Food Safety Agency, Afssa, before 1 July 2010 SANCO document risk envelope approach, European Commission (14 March 2011). Guidance document on the preparation and submission of dossiers for plant protection products according to the risk envelope approach ; SANCO/11244/2011 rev. 5 Arrêté du 28 novembre 2003 relatif aux conditions d'utilisation des insecticides et acaricides à usage agricole en vue de protéger les abeilles et autres insectes pollinisateurs. REGULATION (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC COMMISSION REGULATION (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products

5 Page 5 of 26 mainly based on the EU document on residue data extrapolation 8 is to supply minor crops with registered plant protection products. Therefore the GAP table (Section 2.3) and Decision may include uses on crops not originally requested by the applicant. The Decision, as reproduced in Appendix 1, takes also into account national provisions, including national mitigation measures. 1.4 Data protection claims Where protection for data is being claimed for information supporting registration of, 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. Letter of Access to the biological data package has been submitted (See Appendix III page 17). 8 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 26 2 DETAILS OF THE AUTHORISATION 2.1 Product identity Product name (code) Authorisation number Function Applicant Composition Formulation type (code) insecticide ANDERMATT BIOCONTROL GMBH 520 g/l of SpliNPV (corresponding to OB/L) suspension concentrate (SC) Packaging Bottle HDPE (0.1; 0.2; 0.5 ; 1 ; 5 L) 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 - Environmental hazards Hazard pictograms - Signal word - Hazard statements - - Precautionary statements Supplementary information (in accordance with Article 25 of Regulation (EC) No 1272/2008) For the P phrases, refer to the extant legislation - - 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 26 SPe 3 To protect aquatic organisms, respect an unsprayed buffer zone of 5 metres 9 to surface water bodies Other phrases linked to the preparation Wear suitable personal protective equipment 10 : refer to the Decision in Appendix 1 for the details Re-entry period 11 : - not relevant in open field - 8 hours in greenhouse or wearing a half-mask particulate filter certified according to EN 149 standard or a half mask certified EN 140 with a particle filter P3 (certified EN 143) or A2P3 (certified EN 14387) Pre-harvest interval 12 : 3 days Other mitigation measures: Authorized use during flowering and during honeydew production outside the presence of bees. (according to French Order of 28 November 2003) The label may include the following recommendations: - May be stored for a maximum of 3 years at temperature between -18 and 5 C. - "Product contains Spodoptera littoralis virus. Micro-organisms may have the potential to provoke sensitising reactions". The label must reflect the conditions of authorisation The legal basis for this is Titre III Article 11 of the French Order of 12 September 2006 concerning the marketing and use of products encompassed by article L of the rural code [that is, plant protection products/pesticides] If a tractor with cab is used, wearing gloves during application is only required when working with the spray mixture The legal basis for this is Titre I Article 3 of the French Order of 12 September 2006 concerning the marketing and use of products encompassed by article L of the rural code [that is, plant protection products/pesticides] According to the French Order of 12 September 2006, PHI cannot be lower than 3 days unless specifically justified by the applicant and stated in the 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. PPP (product name/code) Spodoptera littoralis GAP rev., date: Formulation type: < SC code> Conc. of Spodoptera littoralis: 520 g/l (Corresponding to OB/L) Applicant: Verified by MS: yes ANDERMATT BIOCONTROL GMBH Zone(s): southern professional use Use- No Member state(s) Crop and/ or situation (crop destination / purpose of crop) 1 France Fruiting vegetables (Tomatoes, peppers, chili peppers, eggplants) 2 France Leafy vegetables (lettuce and other salads, spinach, Swiss chard, purslane, watercress and fresh herbs) F G or I F, G F, G Pests or Group of pests controlled (additionally: developmental stages of the pest or pest group) Spodoptera littoralis Spodoptera littoralis Method / Kind Timing / Growth stage of crop & season Spraying (tractor drawn motor sprayer) and lance indoor Spraying (tractor drawn motor sprayer) and lance indoor Application Application rate PHI Max. number (min. kg, L product g, kg as/ha Water L/ha (days) interval between / ha a) max. rate per applications) a) max. rate appl. min / max a) per use per appl. First treatment just before first larvae hatch from eggs First treatment just before first larvae hatch from eggs b) per crop/ season a) 2 to 3 treatments per generation (8 sunny days, counting 2 partially sunny days as 1 day) b) max. total rate per crop/season a) L//ha b) 2.4 L/ha b) Max. 12 a) 2 to 3 treatments a) per generation (8 L//ha sunny days, counting 2 partially sunny days b) 2.4 L/ha as 1 day) b) Max. 12 b) max. total rate per crop/season a) 1.0 x OB/ha b) 1.2 x OB/ha a) 1.0 x OB/ha b) 1.2 x OB/ha 400 / 1000 L/ha 400 / 1000 L/ha Remarks: e.g. safener/synergist per ha e.g. recommended or mandatory tank mixtures 3 days* 0.2 L/ha maximum 3 days* 0.2 L/ha maximum 3 France Ornamentals F, G Spodoptera littoralis Spraying (tractor drawn motor sprayer) and lance indoor First treatment just before first larvae hatch from eggs a) 2 to 3 treatments per generation (8 sunny days, counting 2 partially sunny days as 1 day) a) L//ha b) 2.4 L/ha a) 1.0 x OB/ha b) 1.2 x / 1000 L/ha N/A 0.2 L/ha maximum

9 Page 9 of 26 b) Max. 12 OB/ha 4 France Strawberry F, G Spodoptera littoralis Spraying (tractor drawn motor sprayer) and lance indoor First treatment just before first larvae hatch from eggs a) 2 to 3 treatments per generation (8 sunny days, counting 2 partially sunny days as 1 day) b) Max. 12 a) L//ha b) 2.4 L/ha a) 1.0 x OB/ha b) 1.2 x OB/ha 400 / 1000 L/ha 3 days* 0.2 L/ha maximum Remarks table heading: (a) (b) (c) e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) Catalogue of pesticide formulation types and international coding system CropLife International Technical Monograph n 2, 6th Edition Revised May 2008 g/kg or g/l (d) (e) (f) Select relevant Use number(s) in accordance with the list of all intended GAPs in Part B, Section 0 should be given in column 1 No authorization possible for uses where the line is highlighted in grey, Use should be crossed out when the notifier no longer supports this use. 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 * The restriction of the PHI from 1 to 3 days come from the French Order of 12 September 2006, PHI cannot be lower than 3 days unless specifically justified by the applicant and stated in the decision.

10 Page 10 of 26 3 RISK MANAGEMENT 3.1 Reasoned statement of the overall conclusions taken in accordance with the Uniform Principles Physical and chemical properties The formulation is suspension concentrate (SC). All studies have been performed in accordance with the current requirements and the results are deemed to be acceptable. The appearance of the product is that of greybrown liquid with a typical organic odour. It is not explosive and has no oxidising properties. The formulation is not flammable and not auto-flammable. In aqueous solution, it has a ph value around 6.65 at ambient temperature. There is no effect of low and high temperature on the stability of the formulation, since after 7 days at 0 C, 3 years at 5 C and 3 years at -18 C, neither the active ingredient content nor the technical properties were changed. Its technical characteristics are acceptable for a suspension concentrate formulation. The formulation is not classified for the physical-chemical part. The formulation must be stored at a temperature between -18 and 5 C for a maximum of 3 years Methods of analysis Analytical method for the formulation Analytical methods used for the determination of microbial contaminants in the formulation are international standard methods and are in accordance with the document OECD 65 (Oct. 2011) Analytical methods for residues As there is no residue definition in plants, food of animal origin, soil, water and in air, analytical methods for the determination of residues are not necessary Mammalian Toxicology Endpoints used in risk assessment Active substance ADI mg/kg.bw/d ArfD mg/kg.bw AOEL mg/kg.bw/d Classification Spodoptera littoralis nucleopolyhedrovirus Not relevant for microorganisms Micro-organisms may have the potential to provoke sensitising reactions The derivation or reference values were not needed based on the absence of toxicity, infectivity and pathogenicity indications of the micro-organism Acute Toxicity has a content of the active substance Spodoptera littoralis nucleopolyhedrovirus (SpliNPV) of 5 x Occlusion Bodies (OB)/L (5 x viable polyhedra of SpliNPV in 1 L product). has a low toxicity in respect to acute oral, inhalation and dermal toxicity and is not irritating to the rabbit skin or eye and is not a skin sensitizer Operator Exposure Neither the UK Predictive Operator Exposure Model (POEM) nor the German BBA model is suitable for calculating a risk assessment for operators on the base of a not existing dose-effect relation.

11 Page 11 of 26 When the potential sensitising properties are considered and appropriate protection equipment is worn (gloves, coverall and respiratory mask), the preparation is considered safe for operators based on the low toxicity profile and the application. The applicant recommends the following PPE: Tractor-mounted boom sprayer, tractor-mounted broadcast air assisted sprayer, atomiser For mixing/loading - Nitrile gloves certified EN 374-3; - Working coverall 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; - Long-sleeved apron, Category III Type PB3 worn over the coverall proposed above; - Respiratory protection: half-mask particulate filter certified according to EN 149 standard or a half mask certified EN 140 with a particle filter P3 (certified EN 143) or A2P3 (certified EN 14387); For application - Downward spraying If application with tractor with cab - Working coverall 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; - Disposable nitrile gloves certified EN in the case of an intervention on application equipment, but not inside the cab. In the case of an intervention on application equipment, it should be noted that gloves should be worn only outside the tractor cab and stored after use outside the cab If application with tractor without cab - Working coverall 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; - Disposable nitrile gloves certified EN in the case of an intervention on application equipment; For equipment cleaning - Nitrile gloves certified EN 374-3; - Working coverall 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; - Long-sleeved apron, Category III Type PB3 worn over the coverall proposed above; - Respiratory protection: half-mask particulate filter certified according to EN 149 standard or a half mask certified EN 140 with a particle filter P3 (certified EN 143) or A2P3 (certified EN 14387). Lance indoor For mix/loading - Gloves (nitrile, EN 374-3) - Protective coverall category III Type 3 or 4 (according to the protection level recommendation during spraying); - Respiratory protection: half-mask particulate filter certified according to EN 149 standard or a half mask certified EN 140 with a particle filter P3 (certified EN 143) or A2P3 (certified EN 14387). OR - Gloves (nitrile, EN 374-3) - Working coverall 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; - Long-sleeved apron, Category III Type PB3 worn over the coverall proposed above - Respiratory protection: half-mask particulate filter certified according to EN 149 standard or a half mask certified EN 140 with a particle filter P3 (certified EN 143) or A2P3 (certified EN 14387). For application without intense contact with crops Low crops < 50 cm - Nitrile gloves certified EN 374-3; - Working coverall 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; - Rubber boots certified EN Respiratory protection: half-mask particulate filter certified according to EN 149 standard or a half mask certified EN 140 with a particle filter P3 (certified EN 143) or A2P3 (certified EN 14387). High crops > 50 cm - Nitrile gloves certified EN 374-3; - Protective coverall category III Type 4 with hood; - Rubber boots certified EN ;

12 Page 12 of 26 - Respiratory protection: half-mask particulate filter certified according to EN 149 standard or a half mask certified EN 140 with a particle filter P3 (certified EN 143) or A2P3 (certified EN 14387). For application: with intense contact with crops, low and high crops - Nitrile gloves certified EN 374-3; - Protective coverall category III Type 3 with hood; - Rubber boots certified EN standard; - Respiratory protection: half-mask particulate filter certified according to EN 149 standard or a half mask certified EN 140 with a particle filter P3 (certified EN 143) or A2P3 (certified EN 14387) For equipment cleaning - Gloves (nitrile, EN 374-3) - Protective coverall category III Type 3 or 4 (according to the protection level recommendation during spraying) - Respiratory protection: half-mask particulate filter certified according to EN 149 standard or a half mask certified EN 140 with a particle filter P3 (certified EN 143) or A2P3 (certified EN 14387). OR - Gloves (nitrile, EN 374-3) - Working coverall 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; - Long-sleeved apron, Category III Type PB3 worn over the coverall proposed above - Respiratory protection: half-mask particulate filter certified according to EN 149 standard or a half mask certified EN 140 with a particle filter P3 (certified EN 143) or A2P3 (certified EN 14387) Bystander Exposure Following the above given reasons for abstaining from an estimation of operator risk assessment, this also applies with regard to bystanders. As regard the application method, bystander exposure is supposed to be negligible Worker Exposure The micro-organism is neither toxic or infectious or pathogenic in mammals, it is not expected an unacceptable risk for the worker. Nature of protective clothing and PPE for the worker: If the worker would have performed different tasks on the treated crops (field crops): - Nitrile gloves certified EN 374-3; - Working coverall 65% polyester / 35% cotton; minimum 230 g/m²; with water repellent treatment; If the worker would have performed different tasks in greenhouse: - Nitrile gloves certified EN 374-3; In case of early re-entry after treatment: - Respiratory protection: half-mask particulate filter certified according to EN 149 standard or a half mask certified EN 140 with a particle filter P3 (certified EN 143) or A2P3 (certified EN 14387) Residues and Consumer Exposure SpliNPV belongs to the family of baculoviruses which are naturally present in our environment. Therefore, their application in pest control means only a fluctuation of the virus titer in the biotope of the pest insect. Baculoviruses are highly arthropod-specific viruses which are not harmful to non-arthropods, including domestic animals and man. The experience that contact of baculoviruses with man or animals does not involve any risk for their health has been confirmed by numerous studies. Baculoviruses do not produce toxins or secondary metabolites of toxicological concern. Baculoviruses are unable to enter plant tissues and are unable to multiply on plant surfaces. On the contrary, baculoviruses are rapidly inactivated by the UV-portion of sunlight. Therefore, stable virus deposits are considered unlikely and residue data are not considered necessary.

13 Page 13 of 26 Baculoviruses appear on the EFSA QPS (Qualified Presumption of Safety) list 13. On the basis of the data presented, used according to the proposed GAP does not expose the consumer to viable or non-viable virus. Chronic and acute consumer risks are considered acceptable Environmental fate and behaviour The fate and behaviour in the environment of the formulation have been evaluated according to the requirements of Regulation (EC) No 1107/2009. Appropriate endpoints from the EU review were used to calculate PECs for the active substance 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. Soil Baculoviruses have a high sensitivity to UV light. Baculoviruses are characterised by a rapid adsorption to soil particles. Further down in the soil layers baculoviruses can be persistent and accumulative after both natural epizootic events (should these ever occur) and anthropogenic application. Since viruses do not have metabolic activity outside host cells and they are not able to proliferate themselves, the multiplication of Spodoptera littoralis NPV depends on the population density of their host. Water Baculoviruses given into an aquatic system precipitate quickly at similar rates as soil particles. According to the given information transport into the sediment phase is likely. Activity in sediment remaining for a length of time similar to that in soil cannot be excluded. Mineralisation could be hampered by the resistance of inclusion bodies to environmental conditions. Air Baculoviruses are inactivated by sunlight. Occlusion bodies of baculoviruses can be considered as suspended solid particles that are non-volatile. Therefore a distribution of SpliNPV via air can be excluded. Risk assessment The PEC of the active substance in soil, and surface water have been assessed according to FOCUS guidance documents, and the endpoints established in the EU review or agreed in the assessment based on new data provided. PEC soil and PECsw derived for the active substance are used for the eco-toxicological risk assessment, and mitigation measures are proposed. Baculoviruses including nucleopolyhedroviruses are able to leach through a column of sieved soil to some degree (the nucleopolyhedrovirus Helicoverpa armigera NPV was detected down to 35 cm soil depth). Even though baculoviruses and hence also Spodoptera littoralis NPV display leaching potential in soil, no groundwater risk assessment is necessary since Spodoptera littoralis NPV is neither pathogenic nor toxic to humans (EFSA, 2012). Therefore, no unacceptable risk of groundwater contamination is expected for the intended uses Ecotoxicology There is no unacceptable risk to birds and mammals, due to the specific mode of action of SpliNPV. This was confirmed by the absence of toxicity upon oral administration in rats and TER values exceeding the trigger for all generic focal species considered for these two vertebrate groups. The risk for aquatic organisms, soil organisms or terrestrial plants is considered acceptable according to the intended Good Agricultural Practice. 13 EFSA Panel on Biological Hazards (BIOHAZ); Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2012 update). EFSA Journal 2012;10(12):3020.

14 Page 14 of 26 No unacceptable risk for adult bees and non-target arthropods is expected, since SpliNPV is highly specific and only has an effect on very few species of the Noctuidae family (Lepidoptera). A risk to bee brood is not expected due to the high host specificity of NPV virus (Revised Review Report, ) Efficacy Considering the data submitted: The efficacy of is variable and partial for the claimed uses on peppers, lettuce, spinach and strawberry. However it is considered as acceptable for this kind of products based on a micro-organism. The results obtained in peppers, lettuce, spinach and strawberry can be extrapolated to tomatoes, eggplants, peppergrass, fresh herbs and ornamentals. The risk of phytotoxicity can be considered negligible for the claimed uses. The risks of negative impact on the yield, the quality, the propagation, the succeeding crops and the adjacent crops are considered negligible. Considering the claimed number of applications the risk of resistance development or appearance is considered as moderate. The setting up of a monitoring is necessary. 14 Review report for the active substance Spodoptera littoralis nucleopolyhedrovirus ( SANCO/10418/2013 rev 2, 15 March 2013)

15 Page 15 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 A monitoring of resistance to SpliNPV should be set up for Spodoptera littoralis. Any new information that may modify the resistance risk analysis should be provided to the competent authorities for all claimed uses Post-authorisation data requirements The French Decision requests the submission of post-authorisation confirmatory pieces of information within 24 months regarding: - The determination of salmonella in 25 g of the formulation before and after 3 years storage at -20 C according to the OECD 65 document - The determination of microbial contaminants before and after 3 year storage at 5 C in the preparation according to the OECD 65 document. - A new test of pourability after 2 rinsing (or more) in order to obtain acceptable results. - A new test of spontaneity of dispersion at the minimum and at the maximum use concentration ( % (v/v)). - The validation data of the analytical method used for the determination of the biopotency of the microbial active substance in the formulation 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.

16 Page 16 of 26 Appendix 1 Copy of the French Decision

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25 Page 25 of 26 Appendix 2 Copy of the draft product label as proposed by the applicant

26 Page 26 of 26 Appendix 3 Letter(s) of Access