Draft Commission Implementing Decision not approving methylene dithiocyanate as an existing active substance for use in biocidal products of product-type 12 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council; (3 page(s), in English)
This draft Commission Implementing Decision does not approve methylene dithiocyanate as an active substance for use in biocidal products of product-type 12.
According to the opinion of the Agency, biocidal products of product-type 12 containing methylene dithiocyanate cannot be expected to meet the criteria laid down in Article 5(1), points (b) (iii) and (iv), and (c), read in conjunction with Article 10(1) of Directive 98/8/EC. The applicant did not submit data of sufficient quality to meet the data requirements set out in point 2.7 (specification of purity of the active substance in g/kg or g/l, as appropriate), point 2.8 (identity of impurities and additives together with the structural formula and the possible range expressed as g/kg or g/l, as appropriate), and point 4.1 (analytical methods for the determination of pure active substance and, where appropriate, for relevant degradation products, isomers and impurities of the active substance and additives) of Title II of Annex IIA to Directive 98/8/EC. As a result, it was impossible to confirm the minimum purity of the active substance and to set a reference specification for methylene dithiocyanate. Moreover, it was not possible to confirm that the material used to conduct (eco)toxicological studies cover the presented specifications and to conclude on the relevance of the impurities due to the lack of (eco)toxicological data. Lastly, the environmental risk assessment identified unacceptable risks, and no suitable risk mitigation measure could be identified. The opinion of the European Chemicals Agency can be found on its website (http://echa.europa.eu/regulations/biocidal-products-regulation/approval-of-active-substances/bpc-opinions-on-active-substance-approval).