EU’s disapproval of methylene dithiocyanate for biocidal products

On the 15^th of June 2022, the European Commission notified its draft decision to not approve methylene dithiocyanate as an existing active substance to be used in biocidal products of product-type 12. This is in accordance with Regulation (EU) No 528/2012 of the European Parliament and the Council.

This new decision means that biocidal products of product-type 12 containing methylene dithiocyanate are not expected to meet the criteria laid down in Article 5(1) for specific points. It is quite challenging to confirm the minimum purity of the active substance and to set a reference specification for the substance considering applicants’ inability to submit data of an excellent quality to meet data requirements in points 2.7, 2.8, and 4.1.

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.

Point 4.1: Analytical methods for the determination of the pure active substance and where appropriate, for relevant degradation products, isomers, and impurities of the active substance and additives.

All these points are of Title II of Annex IIA to Directive 98/8/EC. It is also impossible to confirm that the materials used to conduct ecotoxicological studies cover the presented specifications and to conclude on the impurities’ relevance since there is no ecotoxicological data.

Additionally, an environmental risk assessment identified unacceptable risks and there is no suitable risk mitigation measure to adopt. The proposed date of adoption is September 2022 and entry into force will be 20 days from its publication in the Official Journal of the EU.