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Parliamentary questions
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16 April 2020
E-001040/2020(ASW)
Answer given by Ms Kyriakides
on behalf of the European Commission
Question reference: E-001040/2020

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not submitted within the applicable deadlines, Member States should conclude that the applicants are considered to have withdrawn their support for their substance/product-type combinations in the review programme(4).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.

(1)Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market of biocidal products (OJ L 167, 27.6.2012, p. 1).
(2)In addition, the Commission, ECHA and the Member States have agreed several other actions since 2018 in order to accelerate the review programme (https://circabc.europa.eu/w/browse/f5b309a8-abef-4550-a4c7-fe14a67f2c13 and https://circabc.europa.eu/w/browse/9b8a5c0c-9d25-4373-b89f-8ddfeeabe2e8)
(3)Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (OJ L 301, 17.11.2017, p.1).
(4)This provision is set in Article 11(1)(c) and (d) of Commission Delegated Regulation No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council .
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