Brussels, 15/06/2016 (Agence Europe) - The European Commission has chosen the middle way in the sensitive dossier on endocrine disruptors and will be using the World Health Organisation (WHO) definition. This scenario was described on 13 June by EUROPE (EUROPE 11571) and confirmed by the Commission on 15 June. It is a position that can be located somewhere between that sought by the industry and that aimed for by endocrinologists. According to the criteria, 25 pesticides could be prohibited.
Vytenis Andriukaitis, the Commissioner for Health and Food Safety, informed journalists that "The criteria retained will help increase safety standards and will provide more protection than the current provisional criteria. They will allow us to respond immediately by calling on the support of EU agencies".
The raft of measures is based around a general communication, two legislative documents, an impact analysis and an evaluation of individual substances. It seeks to identify the chemical substances that effectively and dangerously disrupt the hormonal system (substances known as "endocrine disruptors"). It effectively responds (after two years of delay) to the requirements set out by the regulations on biocide (EU 528/2012) and phytosanitary products (CE 1107/2009).
Overall, the Commission is proposing to maintain a hazard-based approach: it considers that chemical substances that resemble endocrine disruptors are banned. It is, however, proposing to review possible derogations: therefore, these derogations are valid in cases of negligible exposure for phyto-pharmaceutical products and negligible exposure risks for biocides. The Commission is proposing to harmonise the two regulations and just retain the "negligible exposure" for the two types of products. In reply to a question from EUROPE, which wanted to know whether this involved a way of introducing further derogations, we were informed as follows "No. This just involves a better way of working because this approach takes into account certain elements for characterising danger and risk. But our focus on danger has not changed". Another novelty involves the fact that the Commission is proposing to take into account ways of taking action to determine whether a substance is in an endocrine disruptor. One European source explained "Whereas before, we simply observed the effects, now, we are observing the whole process in an effort to undertake action".
The two legislative proposals both result from the former comitology procedure. The regulation relating to phyto-pharmaceutical products will be subject to a regulatory and control procedure (therefore, a vote by the standing committee) before its adoption by the College, while the delegated regulation on biocide products will simply be discussed. Afterwards, the European Parliament and Council will, if they wish, issue an objection. It is currently too early to say what substances will be banned and which ones will be authorised. According to our information, 25 to 26 pesticides (out of the 400 evaluated by the Joint Research Centre) could be affected by the new criteria. The European Chemicals Agency (ECHA) and the European Food Safety Agency (EFSA) will have to proceed to a meticulous analysis in light of the new criteria. If they have any doubts, they will have two share them with the committee of member states responsible, which will be in charge of making a decision on the matter.
Avalanche of criticism
The proposals created an avalanche of criticism from both the industry and health organisations. The European Crop Protection Agency (ECPA) deplores the lack of a potency criterion (the relationship between dose and exposure). It is not pleased with the new provisions on derogations either. The organisation added that "The regulation by derogation is neither acceptable or easy to foresee. The extension of derogations highlights the weakness of the criteria". The ECPA also affirms that these new criteria could lead to a ban on products that contain the same properties as daily products such as coffee.
The environmental defence, public health and consumer organisations that were arguing for an approach based on different categories including potential disrupters are not any happier either. The Health and Environmental Alliance (HEAL) said that Europe had missed its chance to put a stop to endocrine disruptors. It also said that the law included criteria identifying and banning endocrine disruptors that can "provoke side-effects" not only those that have a link with a proven cause and effect. The organisation said that it is "astounded" by the new criteria. PAN-Europe, the organisation that fights against the over use of pesticides asserted that the new proposals may fail to lead to any ban on current pesticides. The European Consumers Office (BEUC) indicated that the new criteria went against the precautionary principle on possible protective action being taken in the event of scientific uncertainty.
At the European Parliament, Françoise Grossetête MEP (EPP, Frenche) said that the proposals were a "good starting point", whilst pointing out that the application of a system of derogations based on risk should be monitored. The Greens/EFA MEP from France Michèle Rivasi said that she would oppose such criteria. (Original version in French by Sophie Petitjean)