Latest revised draft criteria published

Revised draft criteria published

Decision making process

In seeking agreement on the two drafts setting scientific criteria to identify endocrine disruptors, the Commission engaged in parallel with experts and representatives of EU countries responsible for biocidal (BP) and plant protection products (PPP) via the foreseen adoption procedures.

At the Standing Committee on Plants Animals Food and Feed (PAFF) Pesticides legislation meeting on 12/13 December 2017, EU national representatives voted in favour of a new draft Regulation setting criteria for the identification of endocrine disruptors in the context of the pesticides legislation. Neither the Council nor the European Parliament objected to the draft criteria during the scrutiny period which ended on 9 April 2018. The Commission adopted the criteria on 19 April 2018.

The criteria for plant protection products are published and entered into force on 10 May 2018. They will apply from 10 November 2018 to all new and ongoing applications for plant protection products.

• Commission Regulation (EU) 2018/605 of 19 April 2018
• Corrigendum to Commission Regulation (EU) 2018/605
• Decision-making process on the PPP criteria

On 4 September 2017, the Commission adopted a Delegated Regulation on scientific criteria to identify endocrine disruptors for biocidal products. Neither the Council nor the European Parliament objected to the Delegated Regulation during the scrutiny period which ended on 4 November 2017.

The criteria for biocidal products are published and entered into force on 7 December 2017. They will apply from 7 June 2018 to all new and ongoing applications for biocides.

• Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017
• Decision-making process on the BP criteria

Commissioner Andriukaitis and the Chair of the EP ENVI Committee exchanged letters on the criteria on 18th October 2016, and 26th October 2017.

Implementation of the criteria

A guidance document for the identification of substances with endocrine disrupting properties in pesticides and biocides is now available (7 June 2018).

The Guidance document has been developed by the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECHA) with the support of the European Commission Joint Research Centre (JRC).

• Commission Notice on the availability and applicability of the guidance document
• Guidance document (7 June 2018)
• Mandate
• Addendum to the mandate
• EFSA and ECHA outline of the Guidance (20 December 2016)
• Public consultation on the draft Guidance (open from 7 December 2017 to 31 January 2018)

Impact assessment

Before putting forward criteria to identify endocrine disruptors in the context of the plant protection products and biocidal products regulations, the European Commission carried out a comprehensive impact assessment to analyse different options for defining the criteria for the identification of endocrine disruptors.

• The roadmap of the impact assessment was published in June 2014.
• A public consultation between 26 September 2014 and 16 January 2015 received 27,000 responses. All non-confidential responses were published on 2 February 2015. The report on the consultation was published on 24 July 2015.
• The impact assessment was published in June 2016, together with its executive summary
• A study assessing which chemicals would be identified as endocrine disruptors under the different options for the criteria was used as a first input into the impact assessment. An external independent contractor applied a methodology developed by the Joint Research Centre (JRC) of the Commission to screen the available evidence of approximately 600 chemicals.

Dialogue with interested parties

In the context of the impact assessment, the European Commission engaged with interested parties and other policy makers in an open and transparent dialogue throughout the process of identifying the criteria. Events included:

• An ad hoc Working Group of the Advisory Group on the Food Chain and Animal and Plant Health, presenting the draft acts setting scientific criteria to identify endocrine disruptors
• A technical meeting on the JRC methodology for evidence screening of chemicals.
• A one-day conference on criteria to identify endocrine disruptors
• Three roundtables between interested parties, EU countries and Members of Parliament.