Chemical name: 1-ethynyl-2-methylpent-2-enyl 2,2-dimethyl-3-(2- methylprop-1-enyl) cyclopropanecarboxylate methylprop-1-enyl) cyclopropanecarboxylate Final regulatory action has been taken for the category: Pesticide Final regulatory action: The chemical is Banned Use or uses prohibited by the final regulatory action: Applications as a biocidal product for product-type 18 (insecticides, acaricides and products to control other arthropods). Pesticide use or uses that remain allowed: Not relevant The final regulatory action was based on a risk or hazard evaluation: Yes Summary of the final regulatory action: It is prohibited to place on the market or use biocidal products containing empenthrin because empenthrin is not approved as an active substance for use in biocidal products of product- type 18 under Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products. EU Member States had to withdraw authorisations for biocidal products containing empenthrin as active substance by 7 April 2019 at the latest. Disposal, storage, placing on the market and use of existing stocks of biocidal products containing empenthrin is prohibited as of 4 October 2019 at the latest. The reasons for the final regulatory action were relevant to: Human health and environment Summary of known hazards and risks to human health: In conclusion from the evaluation made on the basis of the submitted information, it is concluded that biocidal products containing empenthrin as an active substance for the use as insecticide may not be expected to meet the criteria laid down in point (b)(iii), (b)(iv) and (c) of Article 19(1) of Regulation (EU) No 528/2012. Consequently, empenthrin shall not be approved and included in the Union list of approved active substances in product type 18. The scenarios evaluated in the human health assessment identified unacceptable risks for primary exposure (via inhalation) and for secondary exposure scenarios (via dermal and oral route) to the biocidal product for adults, children and toddlers. No safe use of empenthrin could be identified. In addition, it was not possible to assess whether empenthrin meets the exclusion criteria laid down in Article 5(1)(a) of Regulation (EU) No 528/2012 due to lack of data relevant for carcinogenicity assessment. The lack of carcinogenicity data results in an unacceptable data gap. Expected effect of the final regulatory action in relation to human health: Reduction of risk for human health from the use of biocidal products containing empenthrin. Summary of known hazards and risks to the environment: In conclusion from the evaluation made on the basis of the submitted information, it is concluded that biocidal products containing empenthrin as an active substance for the use as insecticide may not be expected to meet the criteria laid down in point (b)(iii), (b)(iv) and (c) of Article 19(1) of Regulation (EU) No 528/2012. Consequently, empenthrin shall not be approved and included in the Union list of approved active substances in product type 18. The scenarios evaluated in the environmental assessment identified unacceptable risks in surface water and soil, and more particularly for soil organisms based on available data and the proposed use pattern of empenthrin. Expected effect of the final regulatory action in relation to the environment: Reduction of risk for the environment from the use of biocidal products containing empenthrin. Date of entry into force of the final regulatory action: 09/10/2018 Complete entry into force of all provisions of Commission Implementing Decision (EU) 2018/1251 of 18 September 2018 not approving empenthrin as an existing active substance for use in biocidal products of product- type 18 was on 9 October 2018. |