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This draft Commission Implementing Decision does not approve empenthrin as an active substance for use in biocidal products of product-type 18.

Insufficient data has been provided by the applicant making it impossible to assess the exclusion criterion set out in Article 5(1)(a) of that Regulation, as requested by the Biocidal Product Regulation (EU) No 528/2012. In addition, the scenarios evaluated in the human health and environmental risk assessments identified unacceptable risks.

This draft Commission Implementing Regulation approves cyphenothrin an active substance for use in biocidal products of product-type 18

This draft Commission Implementing Regulation approves acetamiprid an active substance for use in biocidal products of product-type 18

This draft Commission Implementing Regulation approves penflufen an active substance for use in biocidal products of product-type 18

This draft Commission Implementing Regulation provides that the approval of the active substance fenamidone is not renewed in accordance with Regulation (EC) No 1107/2009. Existing authorised plant protection products containing fenamidone will be withdrawn from the market. The non-approval is based on the first evaluation of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009. The substance was formerly approved under Directive 91/414/ EEC.

In particular it was not possible to conclude on the genotoxic potential of fenamidone and no health-based reference values could be set. Consequently, the consumer and non-dietary risk asessements could not be conducted. Furthermore, a high potential for groundwater contamination above the parametric drinking water limit of 0.1 μg/L by a toxicologically relevant metabolite (RPA 412708) was indicated in all pertinent scenarios for crops grown in soil s of predominantly pH 7 or above.

In addition, the consumer risk assessment for exposure to another groundwater metabolite (RPA 412636) which is also found in food of plant and animal origin could not be finalised. Furtermore, the residue definitions for risk assessment in plant and livestock commodities are not finalised in terms of the inclusion of potentially relevant metabolites.

Finally, the risk assessment for wild mammals could not be concluded and a high risk to aquatic organisms from exposure to the metabolite acetophone could not be excluded based on the available information.

These concerns mean that fenamidone does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and cannot be approved currently.

This decision only concerns the placing on the market of this substance and does not affect the Maximum Residue Levels (MRLs) for residues of the concerned pesticide. However, following non-approval, separate action may be taken on MRLs. Any subsequent action on MRLs will be subject to notification under the SPS procedure.

This draft Commission Implementing Regulation approves cypermethrin an active substance for use in biocidal products of product-type 18

This draft Commission Implementing Regulation provides that the approval of the active substance chlorpropham is not renewed in accordance with Regulation (EC) No 1107/2009. Existing authorised plant protection products containing chlorpropham will be withdrawn from the market. The non-approval is based on the first evaluation of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009. The substance was formerly approved under Directive 91/414/ EEC.

The Authority could not finalise the consumer risk assessment through dietary intake due to several data gaps. Moreover, a critical area of concern was identified regarding the results of an indicative consumer risk assessment where severe acute and chronic risks have been identified both for chlorpropham and for its major metabolite 3-chloroaniline.

Furthermore, the information available is also insufficient to satisfy the requirements set out in Article 4(1) to (3) of Regulation (EC) No 1107/2009, in particular further scientific assessment is needed to conclude on the potential endocrine disrupting properties of chlorpropham and it was not possible to finalise the risk assessment to non-target arthropods for the field uses.

These concerns mean that chlorpropham does not meet the approval criteria as outlined in Regulation (EC) No 1107/2009 and cannot be approved currently.

This decision only concerns the placing on the market of this substance and does not affect the Maximum Residue Levels (MRLs) for residues of the concerned pesticide. However, following non-approval, separate action may be taken on MRLs and if so a separate notification will be made in accordance with SPS procedures.

This draft Commission Implementing Regulation provides that the conditions of approval of the active substance dithianon are amended. Existing authorisations for plant protection products containing dithianon will be amended or withdrawn from the market. The amendment is based on evaluation of confirmatory information submitted following the approval of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009.

During the evaluation and peer-review of the confirmatory data provided on dithianon following its approval (Commission Implementing Directive 2011/41/EU), it was identified that the consumer exposure assessment could not be concluded given the data gaps identified for storage stability data on dithianon residues in grape wine, and for the magnitude of the metabolites Reg. No. 4107273, Reg. No. 31062, Reg. No. 4005234 (Phthalic acid) and Reg. No. 4110933 in apple and grapes processed commodities. This is indicated as a critical area of concern in the conclusion of the European Food Safety Authority (EFSA) published in August 2015.

In order to ensure the protection of consumers it is necessary to amend the approval to include a restriction of use. Dithianon will be restricted to use on non-edible crops only.

This decision only concerns the placing on the market of this substance and does not affect the Maximum Residue Levels (MRLs) for residues of the concerned pesticide.

This draft Commission Implementing Regulation provides that the approval of the active substance flurtamone is not renewed in accordance with Regulation (EC) No 1107/2009. Existing authorised plant protection products containing flurtamone will be withdrawn from the market. The non-approval is based on the first evaluation of the substance for use as a pesticide active substance in the EU under Regulation (EC) No 1107/2009. The substance was formerly approved under Directive 91/414/ EEC.

During the evaluation and peer-review of flurtamone, a number of concerns and areas that could not be finalised were identified. These are detailed in the conclusion of the European Food Safety Authority (EFSA) .

In particular, it was not possible to fully exclude the mutagenic potential of flurtamone and no final health-based reference values could be set. Consequently, the consumer and non-dietary risk asessements could not be conducted.

In addition, the Authority concluded that the overall consumer risk assessment for exposure to metabolite trifluoroacetic acid, predicted to occur in groundwater in all pertinent scenarios and as a residue in plants, could not be finalised due to a number of deficiencies in the dossier.

Furthermore, the assessment of endocrine disrupting properties could not be completed based on the available studies.

This decision only concerns the placing on the market of this substance and does not affect the Maximum Residue Levels (MRLs) for residues of the concerned pesticide. However, following non-approval, separate action may be taken on MRLs. Any subsequent action on MRLs will be subject to notification under the SPS procedure.

This draft Commission Implementing Decision states that i) the bacteria Wolbachia (or any preparation containing the bacteria) used to infect the mosquitos meets the definition of a biocidal product and ii) the infected mosquitos do not meet the definition of either a biocidal product or a treated Article.