Regulation (EU) No 528/2012 of the European Parliament and of the Council sets out the procedures for approval of biocidal active substances and for authorisation and placing on the market of biocidal products. The vast majority of Member States’ evaluating competent authorities have not met the time limits for sending to the European Chemicals Agency the assessment reports for applications for approval of existing active substances. This has delayed the finalisation of the work programme for the examination of existing biocidal active substances set out in Article 89 of that Regulation (the review programme). As explained in the Commission report of 7 June 2021 on the implementation of Regulation (EU) No 528/2012, that was submitted to the European Parliament and to the Council, the main reasons for failing to meet the time limits are the lack of resources in Member States’ competent authorities; the quality of the initial applications and delays caused by applicants when not submitting additional data on time; the need to resolve complex technical questions in relation to certain dossiers; the evolution of technical guidance; and the adoption of Commission Delegated Regulation (EU) 2017/2100, which specifies new scientific criteria for determining endocrine disrupting properties.
Text as published in the Official Journal, reproduced verbatim (including any typographical quirks of the source). For the authentic version, see EUR-Lex.
