European Commission Consults on Horizontal EU Rules for Endocrine Disruptors

The European Commission opened a public consultation, running until July 10, on its Roadmap on the review of EU rules, a "Fitness Check on Endocrine Disruptors."

Specific rules on Endocrine Disruptors (EDs) already exist under various EU legislative frameworks such as the REACH Regulation, Biocides, Plant Protection Products (PPPs), Water, and Medical Devices. On the other hand, legally established scientific criteria on EDs currently only exist under two of those regimes: Biocides^[1] and Plant Protection Products.^[2] As recognized by the Commission, the existing EU measures "have been developed at different points in time" and at times with "different specific objectives," which "has resulted in different approaches for managing endocrine disruptors, depending on the sector being regulated."^[3] This risk of divergence of regulatory approaches towards the same substance under different regimes (for instance chemicals subject to the REACH Regulation that are used as co-formulants in biocidal products) has been highlighted in the past.^[4]

The Commission will, in its Fitness Check, assess whether these are fit for purpose i.e. protect human health and the environment through the overall reduction of exposure to EDs. The outcome of the review of existing EU chemicals legislation will "feed into the reflection on whether legislative changes are necessary." In particular, the Commission intends to focus on:

• The coherence of the various EU chemical regimes to identify "inconsistencies" between these pieces of legislation. This includes particular attention to legislation which does currently not have specific provisions on EDs, such as toys, cosmetics and food contact materials - an indication that the Commission is addressing its mind to the question whether these legislations should equally feature ED specific rules.
• Whether the "same criteria"^[5] for EDs should be introduced horizontally, across the different EU chemicals regimes, for legal certainty and to ensure a consistent approach to the same substance under the different regimes.
• Examining the different regulatory consequences for substances having ED properties under the different legal regimes, varying from general safety provisions to ED specific bans and restrictions.

In view of the potential impacts, affected companies and interested stakeholders should consider submitting comments on the Roadmap by July 10, 2019, especially as it is the Roadmap that "sets the scene" for the entire Fitness Check on the appropriateness of the existing rules on EDs. Aside from technical considerations, inherent to EDs, the involvement of legal counsel in the preparation of the comments might be helpful to potentially strengthen their impact and effectiveness.

After the public consultation, next steps in the Commission's Fitness Check will include a more comprehensive data gathering exercise (including a general three-month public consultation and targeted consultations of key stakeholders and authorities) as well as the organization of the first, annual forum on EDs (tentatively scheduled for October this year). The Commission also plans to launch a web portal on ED substances in 2019.^[6]

The completion of the Fitness Check, which would include the detailed analysis, conclusions and recommendations of the aspects outlined in the Roadmap, is foreseen for Q2 of 2020.

[1] Commission Delegated Regulation (EU) 2017/2100 of September 4, 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 C/2017/5467 OJ L 301, 17.11.2017, p. 1–5-

[2] Commission Regulation (EU) 2018/605 of  April 19, 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties C/2018/2229 OJ L 101, 20.4.2018, p. 33–36.

[3] Commission Roadmap

[4] See: Steptoe contributions in Chemical Watch (BiocidesHub): Endocrine disruptors: confronting the new criteria, November 2017 and Endocrine criteria in practice, October 2018 as well as Guidance, i.e. CA Note "CA-March18-Doc.7.3.b-final," in particular paragraphs 31 and following.

[5] Arguably this means the two existing, but different legal criteria for biocides and PPPs, see: Commission Roadmap, page 2.

[6] See: Written answer to Parliamentary question No E-001666/19 given by Vice-President Katainen on behalf of the European Commission.