Report on the implementation of the Union authorisation of biocidal products in accordance with Article 42(3) of Regulation (EU) No 528/2012

Regulation (EU) 528/2012, which is applicable since 1 September 2013, lays down the rules for the placing on the market and use of biocidal products. This Regulation aims at improving the functioning of the biocidal products market in the EU, while ensuring a high level of protection for humans and the environment.

Article 42 (3) of the Regulation introduced an obligation for the Commission to report on Union authorisation of biocidal products by 31 December 2017. However, by that date, no Union authorisation had been granted as the regulatory process for the first applications requesting authorisation had not been completed. Therefore, the Commission is not in a position to make a comprehensive analysis of the functioning of current provisions in the Regulation on Union authorisation.

Gaining further experience is needed before any firm conclusions can be drawn and any relevant proposals for changes can be considered. Consequently, this report provides a factual overview of the applications for Union authorisation submitted until 1 October 2017 and some preliminary conclusions based on the limited experience gained so far with the existing applications.