Regulatory Developments

EC Begins Public Consultations on Fitness Check of EU Legislation Regarding Endocrine Disruptors

December 18, 2019

As part of its Fitness Check of European Union (EU) legislation regarding endocrine disruptors, the European Commission (EC) has begun two public consultations: a public consultation (designed from a citizen’s perspective), and a stakeholder consultation (designed for stakeholders and experts). The public consultation will close March 9, 2020, and targets the general public. The stakeholder survey will close on January 31, 2020, and targets stakeholder organizations such as businesses, public authorities, academic research and non-governmental organizations (NGO), and experts working in such areas responding in their professional capacity.

Public Consultation

The EC states that it is holding the public consultation to:

  • Assess public concerns and needs with respect to endocrine disruptors in the European Union (EU);
     
  • Evaluate the extent to which current EU legislation meets the concerns and needs of citizens; and
     
  • Identify opportunities for improvement in the way endocrine disruptors are assessed and managed and how potential risks are communicated.
     

The public consultation asks whether the EU should have the same approach across regulatory sectors (e.g., industrial chemicals, cosmetics, plant protection products, biocides, food) to identify endocrine disruptors and manage the risks of exposure to endocrine disruptors. It also asks the extent to which EU laws allow for the identification and management of the risks of endocrine disruptors in a number of different sectors. Other topics addressed include regulatory testing and animal welfare, efficiency of EU laws, and relevance of EU laws.

Stakeholder Consultation

The aims of the stakeholder consultation are to:

  • Collect views on possible legislative inconsistencies and assess their impact on stakeholders;
     
  • Collect information from stakeholders on the effectiveness of the current EU legislation for the identification and risk management of endocrine disruptors; and
     
  • Collect information on the efficiency of procedures for the identification and risk management of endocrine disruptors (e.g., duplication of efforts) and to identify opportunities for improvement.
     

The stakeholder consultation lists more than 30 pieces of legislation and asks how familiar respondents are with them. The EC notes that the Biocidal Products Regulation and the Plant Protection Products Regulation include similar criteria to identify endocrine disruptors that are based on the World Health Organization (WHO) definition. The EC notes that other pieces of EU legislation related to human health and environmental protection from manufactured chemicals do not contain such criteria, and asks whether the absence of harmonized criteria poses a problem to a coherent approach for the identification of endocrine disruptors. The stakeholder consultation includes questions about how hazard-based criteria for identifying endocrine disruptors affect certain objectives when used in combination with hazard-based and risk-based approaches to decision making. Regarding the effectiveness in achieving policy objectives, the stakeholder consultation includes specific questions about identifying and controlling substances with endocrine disrupting properties in biocidal products, in plant protection products, under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation, in cosmetics, in medical devices, and under the Water Framework Directive. Other topics addressed include vulnerable groups, data requirements and available regulatory test methods, regulatory testing and animal welfare, effectiveness of regulatory procedures, adequacy of legislation to address needs and concerns on endocrine disruptors, and added value of EU-level intervention.

Commentary

According to the EC, the goal is to complete the Fitness Check in 2020. The EC held its first annual forum on endocrine disruptors on November 8, 2019, and the program and video of the event are available. As reported in our June 20, 2019, memorandum, “EC Begins Public Consultation on Fitness Check Roadmap on Endocrine Disruptors,” the EC held a public consultation this summer on the Fitness Check Roadmap on Endocrine Disruptors.


 
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