On June 12, 2019, the European Commission (EC) opened a public consultation on the roadmap “Fitness check on endocrine disruptors.” The document informs that “endocrine disruptors are chemical substances that can alter the functioning of the endocrine (hormonal) system and negatively affect the health of humans or animals,” and “the EU is today recognized as one of the global leaders in dealing with these chemicals.” A variety of EU legal measures addressing endocrine disruptors exist that collectively “aim to ensure a high level of protection of human health and the environment, while ensuring the smooth functioning of the internal market.” However, because these measures “have been developed at different points in time and have, in certain cases, different specific objectives,” currently there exist “different approaches for managing endocrine disruptors, depending on the sector being regulated.” As a consequence, “questions are regularly raised by stakeholders on the overall coherence of the EU legal framework” on endocrine disruptors.

In November 2018, the EC published a Communication updating its endocrine disruptors strategy from 1999 (FPF reported). There, the EC confirmed its “commitment to protect EU citizens and the environment from endocrine disruptors” and “outlin[ed] a number of actions to step up the EU approach in order to further progress and maintain the expected high level of protection.” The now-launched Fitness Check on endocrine disruptors aims “to address the concerns on the coherence of the EU legal framework” by performing “a systematic analysis of the coherence of relevant provisions on endocrine disruptors across the EU legal measures” in order to identify “potential gaps or inconsistencies.” In addition, the “effectiveness, efficiency, relevance and EU added-value” will be assessed.

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,” the EC informed. Furthermore, a “specific focus will be on whether the different pieces of legislation take into account the protection of vulnerable population groups that are particularly sensitive to endocrine disruptors (such as the fetus or adolescents) when assessing and regulating such substances.” This analysis will “feed into the reflection on whether legislative changes are necessary to achieve the EU’s objectives.”

The EC further informs that two points will receive “special attention.” One of them concerns the “horizontal approach to the identification of endocrine disruptors,” i.e. the possibility of applying the criteria for identification of endocrine disruptors, as recently adopted only for pesticides and biocides, across all “the relevant pieces of EU chemicals legislation for reasons of legal certainty and in order to avoid the potential risk that a substance is identified as an endocrine disruptor under one piece of legislation and not under another one.”

The second point concerns the differences in the “regulatory consequences for endocrine disruptors” currently adopted in different pieces of legislation. For example, some pieces of legislation rule that “endocrine disruptors cannot in principle be authorized for use” with “very limited derogation possibilities,” while in other pieces of legislation “endocrine disruptors can be subject to authorization requirements or restrictions,” and yet in others such chemicals are “consider[ed] like other substances and regulate[d] . . . via general provisions aimed at protecting against the risks of exposure to hazardous substances,” the EC explained.

The EC plans to “consult a broad range of stakeholder groups as well as citizens to ensure that all interested parties can provide their views,” and both “public and targeted consultations” will be carried out. More specifically, a large public consultation and “the first meeting of the Annual Forum on endocrine disruptors” will take place in the latest quarter of 2019. The results of all consultation activities will be later summarized in a synopsis report.

The current roadmap consultation is open until July 10, 2019.

Read more

EC (June 12, 2019). “Harmful chemicals – endocrine disruptors, review of EU rules.

EC (June 12, 2019). “Fitness check on endocrine disruptors.” Staff working document, Ref. Ares(20193752914) – 12/06/2019 (pdf)

Chemical Watch (June 19, 2019). “Consultation open on EU Commission’s EDC roadmap.