The European Commission (EC) is organizing a targeted consultation on potential revisions of the annexes of Regulation (EC) No. 1907/2006 on Registration, Evaluation, Authorization and Restriction of Chemical Substances (REACH) in order to introduce information requirements in order to ” improve the identification of substances potentially disrupting the endocrine system. The EC has developed two different options which would modify the annexes to include new standard tests providing information on endocrine disrupting properties. The objective of the targeted consultation is to obtain the views of key stakeholders on the costs and benefits of inclusion in the REACH standard information requirements for endocrine disruption. Responses to the targeted consultation are awaited October 8, 2021.
CE announcement on October 14, 2020, that it adopted the Chemicals strategy for sustainability. The strategy proposes a roadmap and a timetable for transforming the industry with the aim of attracting investment in safe and sustainable products and production methods. The strategy states that switching to chemicals that are safe and sustainable by design, including sustainable bio-based chemicals, and investing in finding alternatives to substances of concern are both essential for human health and the environment, as well as an important prerequisite for achieving a circular clean economy. Flagship initiatives include the phasing out of consumer products of the most harmful substances, including endocrine disruptors, unless their use is essential for society, according to the EC.
On March 15, 2021, the Council of the European Union (EU) approved the EU Strategy on Chemicals for Sustainable Development. The board Press release declares that in its conclusions the Council calls on the EC to implement the actions foreseen in the strategy, including targeted changes aimed at streamlining EU legislation on chemicals, replacing and minimizing substances of concern, and phase out the most harmful chemicals for non-essential societal uses. The Council also stresses the importance of limiting exposure to endocrine disruptors and of reducing the harmful effects of chemical mixtures.
The EC states that in order to meet the “ambition” of the Chemicals Strategy for Sustainability to ensure sufficient and appropriate information for the identification of endocrine disruptors, it proposes to update:
- Annex I: General provisions for the evaluation of substances and the preparation of 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 1000 tonnes or more.
The targeted consultation is divided into seven parts:
- Part 1 asks for information about the respondent;
- Part 2 aims to collect information on awareness and general opinions on the impacts of endocrine disruptors and measures to manage these and existing legislation;
- Part 3 contains more detailed questions on the ambitions and relevance of chemical legislation in the EU and views on the revision of the REACH annexes;
- Parts 4, 5, 6 and 7 aim to collect evidence of the potential direct and indirect economic, social and environmental impacts of the proposed changes to the REACH annexes to include standard information requirements for endocrine disruption.
At the end of the questionnaire, there will be an option to upload a document (for example., technical information, position statement) supporting and detailing the views of stakeholders.
The EC will organize online focused stakeholder discussion groups for experts (October 11 – 29, 2021). At the end of the survey, respondents must indicate whether they wish to participate.
Changing the REACH annexes is just one of the many actions the EC is considering or has taken to tackle endocrine disruptors. As reported in our August 2021 Global regulatory update, the EC announcement on August 9, 2021, that it launched a public consultation on a targeted revision of Regulation (EC) No 1272/2008 on the classification, labeling and packaging of substances and mixtures (CLP). The questionnaire includes questions regarding new hazard classes, including endocrine disruptors. Our memorandum of December 16, 2020, “Important changes to REACH Annex II enter into force on January 1, 2021Describes the new safety data sheet (SDS) requirements which include the obligation to provide information on endocrine disrupting properties.
Stakeholders should carefully consider and respond to questions from the EC regarding the potential economic, social and environmental impacts of proposed changes to the REACH annexes. Those wishing to participate in the targeted online stakeholder follow-up focus groups should indicate their interest.