Regulatory Developments

EC Begins Public Consultation on Fitness Check Roadmap on Endocrine Disruptors

June 20, 2019

The European Commission (EC) began a public consultation on June 12, 2019, on the Fitness Check Roadmap on Endocrine Disruptors. According to the EC, the Fitness Check will contribute to the assessment of whether chemicals legislation in the European Union (EU) delivers its objective to protect human health and the environment by minimizing the overall exposure to endocrine disruptors. The Fitness Check will include an analysis of how different provisions in the broad spectrum of EC legal instruments interact, identifying potential gaps or inconsistencies. It will also assess, to the extent possible, EU legislation’s effectiveness, efficiency, relevance, and EU added-value. The EC will take comments into account for further development and fine tuning of the initiative. Comments are due July 10, 2019.

The Fitness Check will pay particular attention to legislation that does not contain specific provisions for endocrine disruptors, such as the legislation on toys, cosmetics, and food contact materials. A particular focus of the Fitness Check will be on whether the different pieces of legislation take into account the protection of vulnerable population groups that may be particularly sensitive to endocrine disruptors when assessing and regulating such substances. It is intended to help assess whether legislation is fit for purpose and analyze whether there is potential to improve regulatory efficiency. According to the EC, two points deserve special attention:

  • Horizontal approach to the identification of endocrine disruptors: The EC recently established criteria for identifying endocrine disruptors under the legislation on plant protection products and biocides. EU legislation in other fields does not contain such criteria, however, leaving substances demonstrating endocrine disrupting properties subject to case-specific regulatory action. It has been argued that uniform criteria for the identification of endocrine disruptors should be included in and apply across the relevant pieces of EU chemicals legislation for reasons of legal certainty and to avoid the potential risk that a substance is identified as an endocrine disruptor under one piece of legislation and not under another one; and
     
  • Regulatory consequences for endocrine disruptors: Different regulatory approaches exist in different pieces of legislation for substances that have endocrine disrupting effects. In some pieces of legislation, endocrine disruptors cannot, in principle, be authorized for use. In other pieces of legislation, endocrine disruptors can be subject to authorization requirements or restrictions. Certain pieces of legislation do not mention endocrine disruptors specifically but consider them like other substances and regulate them via general provisions aimed at protecting against the risks of exposure to hazardous substances.
     

The Fitness Check will assess the current situation in the EU and compare it with the situation in 1999, when the EC adopted its first Strategy on endocrine disruptors. It will also assess the international dimension, taking into account the impact of EU provisions on products imported into the EU.

The EC will consult a broad range of stakeholder groups to ensure that all interested parties can provide their views. The different consultation activities will aim to contribute to the analysis of the coherence of the EU framework, as well as, to the extent possible, its effectiveness, efficiency, relevance, and EU added-value. The main stakeholders identified are: public authorities (within and outside the EU); economic operators (within and outside the EU) in both the chemicals industry and downstream industries (with a focus on small- and medium-sized enterprises (SME)); workers; industry associations; trade unions; farmers; non-governmental organizations (NGO); consumer associations; international organizations; academia/research institutes/think tanks; consumers; and, more generally, citizens.

The Fitness Check will build on scientific evidence and the data already collected and analyzed by the EC on the topic, in particular in the context of relevant final and ongoing evaluations. Findings from the impact assessment on the criteria to identify endocrine disruptors in the areas of pesticides and biocides will also be taken into account. These sources of evidence will be complemented with findings from the scientific literature, reports from EU agencies and Scientific Committees, and the consultation activities.

What Is Next

The EC plans a public consultation in the fourth quarter of 2019. It will be accessible on the EC’s central consultation web page, Have your Say, for 12 weeks. The EC also plans to consult key stakeholders and public authorities through targeted consultations, as appropriate. In addition, it will organize the first meeting of the annual forum on endocrine disruptors, announced in the Communication “Towards a comprehensive EU framework on endocrine disruptors,” in the fourth quarter of 2019. The EC will publish a synopsis report, summarizing the results of all consultation activities once the activities are closed.

Commentary

The Fitness Check Roadmap on Endocrine Disruptors aspires to provide an open and transparent forum to bring all interested parties together in a comprehensive effort to protect human health and the environment while preserving a thriving EU market. The detailed examination, both vertically within each applicable regulatory framework, and horizontally across regulatory frameworks, is an important step forward in the development of coherent, consistent EU regulatory policy with respect to the identification and evaluation of chemicals that may have endocrine disrupting effects. The scientific criteria for determining endocrine disrupting properties set forth in the plant protection and biocides regulations provide reasonable foundations for developing criteria that are appropriate within the context of each regulatory framework. As noted in other of our firm memoranda, on June 7, 2018, the European Chemicals Agency and the European Food Safety Authority published Guidance for the identification of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009. Under the Biocidal Products Regulation, active substances believed to possess endocrine disrupting properties will not be approved for use unless the registrant demonstrates potential risk from exposure to the active substance is negligible or, alternatively, use of the active substance is essential to address a serious danger. The new guidance reflects the EU’s growing interest in and focus on endocrine disruptors.

Achieving the stated goals of the consultation also requires significant financial support for the development of new validated methods, particularly non-animal methods that can identify endocrine disruptors reliably and cost effectively. Interested stakeholders are urged to comment on and monitor this important initiative. It seems clear that what is evolving in the EU is destined to have a significant impact globally on the identification and regulation of endocrine disruptors.


 
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