The Commission is bending over backwards in an effort to obtain the necessary support at the next experts’ meeting on 28 February from the member states on the criteria for identifying endocrine disruptors. In an effort to satisfy the countries calling for stricter criteria, it is proposing a return to a hazard-based approach, whilst introducing (in an effort to satisfy pro-industry appeals) an exception for concept-based disruptors.
It should be pointed out that in the middle of 2016, the Commission presented three criteria for identifying and ultimately banning chemical substances that dangerously impacted on the hormonal system: (1) provoking unwanted side effects; (2) the endocrine mode of action (helping to explain the effect at a cellular and molecular level); (3) a correlation between the two previous criteria (see EUROPE 11573). It did, however, propose the introduction of an exception to this principle for chemical substances –Pesticides and biocides – that contain a “negligible risk” following exposure and which could therefore continue to be marketed. These proposals immediately provoked a hostile response from a number of member states, with some of them calling for more protective criteria for human health. These countries included Denmark, Sweden and France. Others, such as Poland, were more concerned about the economic impact of such criteria.
Two major changes
In this context, the Commission revised its proposals on several different occasions. It will present a fifth version during the meeting of member state experts on 28 February next. At a general level, the new casting abandons the idea of authorising the marketing of pesticides that contain a “negligible risk”. The status quo is therefore maintained: active substances that are endocrine disruptors are not approved, except in cases of negligible exposure (in the use of phytopharmaceutical products, for example) or in cases of negligible risk (in the case of biocides). The new casting, however, returns to the idea suggested by the German delegation of authorising pesticides and biocides intentionally devised to disrupt the endocrine system, Such as the 2,4-D herbicide.
Health organisations concerned
The Endocrine Society was unable to conceal its disappointment. It denounced the “narrow criteria for identifying EDCs that will make it nearly impossible for regulatory agencies to meet the unrealistically high burden of proof and protect the public from dangerous chemicals”. The Society opposes these recent proposals because they “include broad exemptions that ignore the ability of a chemical to interfere with the endocrine system”. The Endocrine Society supports the creation of multiple categories based on the amount of existing evidence that shows how specific chemicals (proven, supposed or suspected disruptors) act as EDCs. PAN-Europe defends more or less the same position, but welcome the abandonment of the risk-based approach. The NGO explained that, “In a recent letter to PAN Europe (attached), DG SANTE claimed that not only proven endocrines but also ' presumed' endocrines will be identified (“the concept is fully integrated”). We didn't see this (very important) option coming back in the text and this makes the provision unclear”.
At a more general level, the Centre for International Environmental Law (CIEL) and ClientEarth, and endorsed by MEPs from five parties (EPP, S&D, Greens/EFA, EFDD and the GUE/NGL) published a report demanding horizontal criteria to identify endocrine disruptors. They believe that this should span the Cosmetics Regulation, the Water Framework Directive, the Toys Directive, the Medical Devices Regulations, and the Food Contact Materials Regulation. The revised Commission text is available at: https://ec.europa.eu/health/endocrine_disruptors/next_steps_en. (Original version in French by Sophie Petitjean)