1.CONTEXT OF THE DELEGATED ACT
Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products sets out regulatory consequences for active substances having endocrine-disrupting properties and biocidal products containing these substances. Article 5(3) of the Regulation provides that, by 13 December 2013 at the latest, the Commission had to adopt delegated acts specifying scientific criteria for the determination of endocrine-disrupting properties. In its judgement of 16 December 2015 on the Case T-521/14 Sweden versus the Commission, the EU General Court ruled that the European Commission breached EU law by failing to set criteria to identify endocrine disruptors within the deadline indicated in Regulation (EU) No 528/2012.
The delegated act provides scientific criteria to identify endocrine disruptors. These criteria are based on the definitions for endocrine disruptors and adverse effects developed by World Health Organisation through its International Programme for Chemical Safety. These criteria reflect the current state of scientific and technical knowledge and allow a more accurate identification of active substances having endocrine disrupting properties.
On 15 June 2016, the Commission adopted a Communication of the Commission to the European Parliament and the Council on endocrine disruptors and presented the draft Commission acts setting out scientific criteria for their determination in the context of the EU legislation on plant protection products and biocidal products (COM(2016) 350 final). This communication puts the established scientific criteria for biocidal products in a broader context, in particular the link with the setting of scientific criteria for the determination of endocrine-disrupting properties in the domain of plant protection products, the implication for other regulatory areas and other on-going activities of the Commission on endocrine disruptors.
2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
A public consultation was carried out from September 2014 till January 2015 in the context of an impact assessment. The report was published on 24 July 2015.
The Commission published a draft of the delegated act the 15 of June 2016. This draft delegated act was consulted with the general public between the 30 of June and the 28 of July 2016 via the Better Regulation Portal. A total of 120 responses were received which are publicly available 1 . This draft delegated act was also notified on the 23 June 2016 under the Agreement on Technical Barriers to Trade and comments were received from five members.
The Commission has consulted an expert group (the 'Biocides CA meeting') consisting of representatives of Member States' competent authorities for biocidal products, in meetings which took place the 22 of June 2016, the 21 of September 2016, the 18 of November 2016, the 21 of December 2016, the 28 of February 2017, the 7th of April 2017 and 12th of July 2017.
3.LEGAL ELEMENTS OF THE DELEGATED ACT
The delegated act specifies scientific criteria for the determination of endocrine-disrupting properties in accordance with Article 5(3) of Regulation (EU) No 528/2012.
COMMISSION DELEGATED REGULATION (EU) …/...
setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products 2 , and in particular the first subparagraph of Article 5(3) thereof,