CEFIC Comments on EU Endocrine Disruptors Plan

09.08.2016 -

Joining other stakeholders who initially commented on the draft legislation defining criteria for identifying endocrine disrupting chemicals (EDCs) in biocidal and plant protection products, published by the EU Commission on Jun. 15, the European Chemical Industry Council (CEFIC) has now formally presented its own views.

For the association representing European chemical producers, the Commission’s proposals “do not form a sufficiently solid basis for defining endocrine disruptors. For industry to ensure that people and the environment are properly protected, it is essential that the criteria enable the identification of harmful substances, while allowing harmless substances, to continue contributing to the economy.”

While CEFIC said it supports using the EU proposal to use the WHO/IPCS definition as a starting point for the endocrine disruptors (ED) criteria, it disagrees with the position that potency should not be included. This a key omission, it said, as “potency is a fundamental principle of toxicology and of hazard characterization specifically. Without potency built-in, substances present in everyday food and drinks which are safe for consumption such as caffeine or soy bean proteins could be identified as endocrine disruptors.”

The association called on the Commission and Member States Competent Authorities to use the impact assessment conclusions and amend the proposals to make the criteria fit for their regulatory purpose. “Priority must be on having the right criteria in place to make clear, predictable and unequivocal decisions,” it said.

In amending the proposals, CEFIC said, the authorities should include all elements of hazard characterization to make the criteria properly operational. Along with using the WHO/IPCS definition with clear reference to all three elements of adverse effects, mode of action and causality and its definition of adverse effects, it said it supports reviewing of all the relevant scientific evidence and making a weight of evidence assessment before coming to conclusions about a substance.

While there are some good aspects to the proposals, at this stage they are not sufficient to make the criteria operational,” the association said.

Earlier, the German chemical industry association, Verband der Chemischen Industrie, called on the Commission to “limit the regime for endocrine disruptors to substances that trigger a harmful effect in humans or in the environment already in low quantities or doses. In its own statement, European Crop Protection, the trade body representing the agrochemicals industry, said its members were “extremely disappointed” that after six years of hard work with input from EFSA, scientific experts and various stakeholders, the criteria were no more than the WHO/IPCS definition, developed over a decade ago.

In parallel to the public consultation relating to the regulatory aspects, the EU Commission has made two notifications to the World Trade Organization (WTO) covering, respectively, the Plant Protection Products and the Biocidal Products Regulation with an ongoing consultation for input until 31 August 2016.