Regulatory Developments

EC Begins Targeted Consultation on Endocrine Disruptors, Will Hold Online Focus Groups in October

September 1, 2021 PRINT

The European Commission (EC) is holding a targeted consultation on potential revisions to the Annexes to Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) to introduce information requirements to improve the identification of substances with endocrine disrupting potential. The EC has developed two different options that would amend the Annexes to include new standard tests providing information on endocrine disrupting properties. The purpose of the targeted consultation is to obtain the views of key stakeholders on the costs and benefits of including in REACH standard information requirements for endocrine disruption. Responses to the targeted consultation are due October 8, 2021.

Background

The EC announced on October 14, 2020, that it adopted the Chemicals Strategy for Sustainability. The Strategy proposes a roadmap and timeline to transform industry with the goal of attracting investment into safe and sustainable products and production methods. The Strategy states that moving to safe and sustainable-by-design chemicals, including sustainable biobased chemicals, and investing in finding alternatives to substances of concern are both critical for human health and the environment, as well as an important precondition for reaching a clean circular economy. According to the EC, flagship initiatives include phasing out from consumer products the most harmful substances, including endocrine disruptors, unless their use is proven essential for society.

On March 15, 2021, the Council of the European Union (EU) endorsed the EU Chemicals Strategy for Sustainability. The Council’s press release states that in its conclusions, the Council asks the EC to implement the actions laid down in the Strategy, including targeted amendments to streamline EU chemicals legislation, substituting and minimizing substances of concern, and phasing out the most harmful chemicals for non-essential societal uses. The Council also highlights the importance of limiting exposure to endocrine disruptors and of reducing the harmful effects of chemical mixtures.

Targeted Consultation

The EC states that to meet the “ambition” of the Chemicals Strategy for Sustainability to ensure sufficient and appropriate information for identification of endocrine disruptors, it proposes to update:

  • Annex I: General provisions for assessing substances and preparing chemical safety reports;
     
  • Annex VII: Standard information requirements for substances manufactured or imported in quantities of one tonne or more;
     
  • Annex VIII: Standard information requirements for substances manufactured or imported in quantities of ten tonnes or more;
     
  • Annex IX: Standard information requirements for substances manufactured or imported in quantities of 100 tonnes or more; and
     
  • Annex X: Standard information requirements for substances manufactured or imported in quantities of 1,000 tonnes or more.
     

The targeted consultation is divided into seven parts:

  • Part 1 asks for some information about the responder;
     
  • Part 2 aims to gather information on general awareness and views of the impacts of endocrine disruptors and the measures to manage these and existing legislation;
     
  • Part 3 contains more detailed questions about the ambitions and relevance of chemical legislation in the EU and views on the revision of REACH Annexes;
     
  • Parts 4, 5, 6, and 7 aim to gather evidence of the potential baseline direct and indirect economic, social, and environmental impacts of the proposed changes to REACH Annexes to include standard information requirements for endocrine disruption.
     

At the end of the questionnaire, there will be an option to upload one document (e.g., technical information, Position Paper) supporting and detailing the stakeholder’s views.

The EC will hold follow-on targeted stakeholder online focus groups for experts (October 11 - 29, 2021). At the end of the survey, respondents should indicate whether they wish to participate.

Commentary

Amending the REACH Annexes is just one of several actions that the EC is considering or has taken to address endocrine disruptors. As reported in our August 2021 Global Regulatory Update, the EC announced on August 9, 2021, that it launched a public consultation on a targeted revision of the Regulation (EC) No 1272/2008 on the Classification, Labeling, and Packaging of Substances and Mixtures (CLP). The questionnaire includes questions concerning new hazard classes, including endocrine disruptors. Our December 16, 2020, memorandum, “Important Changes to Annex II to REACH Come into Force January 1, 2021,” describes new safety data sheet (SDS) requirements that include the requirement to provide information on endocrine disrupting properties.

Stakeholders should carefully review and respond to the EC’s questions regarding the potential economic, social, and environmental impacts of the proposed changes to REACH Annexes. Those who wish to participate in the follow-on targeted stakeholder online focus groups should indicate their interest.


 
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