Long awaited action
A range of EU chemicals regimes focus on endocrine-disrupting properties as a trigger for legal and regulatory action. Today the European Commission issued criteria to define endocrine disruptors (ED), notwithstanding the scientific uncertainty which surrounds them. In December 2015 the Court of Justice of the EU condemned the Commission’s failure to adopt criteria, which was mandatory under the Biocidal Products Regulation (BPR). Such criteria also had to be proposed under the plant protection products (agrochemicals) regime. The European Commission has now:
- Adopted a non-legislative Communication on endocrine disruptors;
- Proposed a draft Commission Regulation setting out scientific criteria for the determination of endocrine disrupting properties and amending Annex II to Plant Protection Regulation (PPPR);
- Proposed a draft Commission Delegated regulation setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to the Biocides Products Regulation.
Points of influence
The two draft Commission Regulations will be considered through so-called “comitology” procedures: the regulatory procedure with scrutiny (for PPPs) and the delegated act procedure (for biocides). These different adoption procedures provide distinct opportunities for stakeholder interaction with representatives of member states and the European parliament, who may oppose or object.
The ED criteria are based on the existing WHO definitions of endocrine disruptors and adverse effects. A PPP or biocidal active substance, or a safener or synergist (in a PPP) is identified as having ED properties for humans if the substance meets all of the following criteria:
- It is known to cause an adverse effect relevant for human health, which is a change in the morphology, physiology, growth, development, reproduction, or, life span of an organism, system, or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress, or an increase in susceptibility to other influences;
- It has an endocrine mode of action;
- the adverse effect relevant for human health is a consequence of the endocrine mode of action.
A similar definition is set out for ED properties with respect to non-target organisms. The focus is not on potency or risk but on intrinsic properties alone. It remains to be seen whether these criteria really provide sufficient clarity to inform regulatory decision making.
The ED criteria will be implemented by two authorities in charge of the safety assessment of products, the European Food Safety Authority (EFSA) for PPPs and the European Chemicals Agency (ECHA) for biocides, using a weight of evidence approach.
- The presence of endocrine disrupting properties has been a possible basis for non-approval of active substances under both the PPPR and the BPR. If the Regulations are adopted, the criteria they establish would become the new reference point for non-approvals of endocrine disruptors. Derogations would remain, under specific circumstances, as today, where there is “negligible exposure” (for PPPs) or “negligible risk”, a socio-economic case, or an essential need (for biocides).
- The ED criteria would apply formally only as of their date of entry into force. Specific transitional measures would apply for active substance approvals which have not yet been adopted but member states (in a “standing committee”) have already voted. Informally, the Commission has asked EFSA and ECHA to start applying the proposed criteria immediately, in preparation for a review of already approved active substances for which there are indications that they may meet the criteria.
- The Commission has expressly affirmed that today’s action should have no direct legal consequences for other areas of EU law, many of which currently refer to endocrine disrupting properties. However, we anticipate that the criteria could have an indirect and very real influence on the application of EU regimes including REACH, workers safety, food and feed, and consumer goods (such as toys and cosmetics). The EU’s independent scientific committees, the Commission and member states may find it hard to place the criteria in a silo for PPPs and biocides alone.