Endocrine disruptors

Next steps

The two draft legal acts setting the criteria to identify endocrine disruptors that were presented by the Commission on 15 June 2016 now need to be adopted according to their relevant procedures, which in both cases involve Parliament and Council.

The first discussions with experts and Member States took place on 22 June 2016:

A second round of discussions with experts and Member States took place on 21 September 2016:

A third meeting with experts and Member States took place on 18 November 2016, with the aim to discuss a revised version of the draft criteria which consider the comments received during the previous meetings. The revised criteria clarify the scope of the WHO definition, the burden of proof, and the kind of scientific evidence that can be used to identify endocrine disruptors.

A fourth meeting with experts and Member States took place on 21 December 2016. The aim was to discuss on a revised version of the texts which considered the latest comments received from Member States. The revised criteria addressed comments as regards the burden of proof and the scope of the criteria.

The original text concerning plant protection products has been split into two: one text containing the criteria and another one, containing the technical amendment to the clause on negligible exposure. This was done in order to offer Member States the possibility to express their opinion on each one of them separately. This split was also done to allow Council and European Parliament to consider each draft act separately during the scrutiny period.

A fifth meeting with experts and Member States took place on 28 February 2017. The draft criteria were amended based on the discussions of the meeting the 21 of December 2016.

As a follow up of the fifth meetings, a sixth meeting with experts from Member States Competent Authorities for the implementation of Regulation (EU) No 528/2012 took place on 7 April 2017 to discuss point 3 of section B of the Annex (growth regulators) of the draft Commission delegated regulation setting out scientific criteria for the determination of on endocrine-disrupting properties.

A SC PAFF Pesticides legislation meeting took place on 17/18 May 2017.

A SC PAFF Pesticides legislation meeting took place on 30 May 2017.

At the SC PAFF Pesticides legislation meeting on the 4 July 2017, Member States representatives voted in favour of the European Commission's proposal on scientific criteria to identify endocrine disruptors for plant protection products. During the scrutiny period, the Council did not oppose to the text (25 September 2017), while the European Parliament adopted a resolution to oppose to the text (4 October 2017). This vote means that the scientific criteria presented to Parliament cannot be adopted by the Commission. The Commission  is now reflecting on the next steps.

A meeting with experts from Member States Competent Authorities for the implementation of Regulation (EU) No 528/2012 took place on the 12 July 2017. The Commission, having taken into account the discussions and views of the experts, views of stakeholders, and comments received during these consultations, adopted a Delegated Regulation on scientific criteria to identify endocrine disruptors for biocidal products on the 4 September 2017. The scrutiny of the Council and the European Parliament on the Delegated Regulation finished the 4 November 2017. The criteria are now published, will enter into force on 7 December and will apply from 7 June 2018 to all new and on-going applications for biocides.

At the SC PAFF Pesticide legislation meeting the 12/13 December 2017 a new draft Regulation for setting criteria for the identification of endocrine disruptors used in pesticides will be discussed.

 


A reply letter from Commissioner Andriukaitis to the Chair of the Committee on the Environment, Public Health and Food Safety, Ms Adina-Ioana Vălean, confirmed that any biocidal product that has endocrine-disrupting properties cannot be authorised for making available on the market for use by the general public.
The scrutiny of the Council and the European Parliament on the Delegated Regulation ended on 4 November 2017, as neither of them requested an extension for a further two months. Neither the Council nor the European Parliament objected to the Delegated Regulation.

A reply letter from Commissioner Andriukaitis to MEP La Via, chair of the EP ENVI Committee, explains the legal mandate of the Commission to amend the first paragraph of point 3.6.5 of annex II to Regulation (EC) No 1107/2009.

Work of the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) towards the development of a guidance document for the implementation of the criteria to identify substances with endocrine disrupting properties in pesticides and biocides has been initiated.