Here we go again on endocrine disruptors. The European Commission has amended its proposals for a second time. The documents, of which EUROPE has had sight, began to be circulated on Wednesday 7 December. The Commission could call for a vote on the section devoted to pesticides on 21 December.
In mid-June, the Commission presented three criteria that would enable chemicals which have harmful effects on the hormonal system (the said “endocrine disruptors”) to be identified (and, ultimately, banned): (1) the appearance of adverse effects (2) the endocrine mode of action (which makes it possible to explain the effect at cellular and molecular level); (3) causality or correlation between the two preceding criteria (see EUROPE 11573). It then made some marginal changes to its proposals to address member states’ concerns. Yet, at the last meeting of experts in November, only five member states clearly backed the proposals (with five unequivocally opposing them).
Marginal changes … yet again. The Commission has therefore reworked its proposals in the hope of winning the support of a qualified majority of member states at the next meeting, scheduled for 21 December. Once again, the changes are minor: they relate mainly to the burden of proof, which endocrinologists have hitherto felt to be too restrictive compared to international protocols. The new version refers to data generated according to international protocols (including in vitro, in vivo and, where applicable, in silico investigations) and other scientific data selected through systematic review. As for the rest, the Commission continues to apply a risk-based approach towards derogations. Thus, it suggests that chemicals – pesticides and biocides – presenting a negligible risk after exposure should not be “considered” (rather than “identified” as in the previous version) to be disruptors and should be able to be marketed. This provision, however, is widely criticised by several member states and MEPs.
Next stage. The Commission has convened a further meeting of its expert committees on 21 December. It is expected to propose that the member states vote on the pesticides section. This is somewhat surprising in view of the reluctance it has so far met, a source close to the issue said. The regulation on pesticides will be subject to the regulatory procedure with scrutiny, and thus will be put to the vote in the permanent committee before it is adopted by the College of Commissioners, while the delegated regulation on biocidal products will only be discussed. Thereafter, the European Parliament and the Council will each be able, if they so wish, to raise objections. (Original version in French by Sophie Petitjean)