Parliamentary Questions | Subject: Evaluation of biocidal active substances

A recent communication from the European Chemicals Agency (ECHA) acknowledged the concerning delay to the review programme for biocidal active substances. Evaluations have only been completed for 250 out of the 700 active substance and product type combinations in the programme. Thus, a significant number of substances that are potentially highly harmful to health and the environment are on the EU market without having undergone adequate safety assessment. ECHA, the Commission and the Member States have agreed on a joint action plan to remedy the situation.

Parliamentary Questions:

(*) What the key measures of this plan will be and how they will solve the current delays and increase health and environment protection, in a context of limited capacities within the Member States and ECHA?

(*) How, in the context of the recent implementation of the endocrine disrupting chemicals criteria for biocides, this plan will guarantee that all active substances are thoroughly assessed for their potential endocrine properties within the legal time requirements, without causing further delays to the review programme?

(*) Whether, in cases of incomplete safety dossiers and in the context of limited legal deadlines, the Commission pushes for the systematic use of precautionary non-approvals until all safety data have been provided and fully assessed?

Response:

The Commission shares the concerns of the Honourable Member as regards the delays in the review programme of existing active substances under the Biocidal Products Regulation(1). The reasons for the delay are multifactorial, the main one being a lack of resources allocated by Member States and, in some, a lack of technical expertise to complete the assessments of the dossiers submitted by applicants.

(*) Therefore, the key measures in the action plan focus on providing active support from the European Chemicals Agency (ECHA) to the Member States authorities to complete their assessments and to improve the efficiency of the peer-review process at ECHA(2) by focusing on the most relevant issues.

(*) The Commission agrees that it is important to determine thoroughly whether active substances have endocrine disrupting properties in accordance with the scientific criteria set out in Commission Delegated Regulation (EU) 2017/2100(3), which entered into application on 7 June 2018. Therefore, the Delegated Regulation has become applicable to all ongoing procedures. This has inevitably caused further delays in the review programme, as it requires the generation of new data .

(*) The Commission agrees that when dossiers are found incomplete or additional data required by Member States are not submitted within the applicable deadlines, Member States should conclude that the applicants are considered to have withdrawn their support for their substance/product-type combinations in the review programme(4).

This leads to the publication of a withdrawal notice by ECHA or ultimately to a non-approval decision by the Commission. The Commission has repeatedly reminded Member States of this rule in the regulation.

Link to the Questions on the Evaluation of biocidal active substances