The European Commission’s proposals on endocrine disruptors have provoked strong reactions among both stakeholders and member states. The divisions are clear, including within the Council where some member states, such as Sweden, Denmark and France, want tougher rules while others, like the United Kingdom, are calling for potency to be among the criteria.
In mid-June, the Commission proposed using the definition in the World Health Organisation’s international programme on chemical safety (IPCS) to identify substances that have a harmful effect on the hormonal system – the said “endocrine disruptors”. It did not, however, propose establishing categories of disruptors based on the level of evidence (active substances, suspected disruptors and proven disruptors) even though this was the option backed by endocrinologists.
Since then, the Commission has received over 380 responses from stakeholders under its new feed-back mechanism (one of the new “smart regulation” instruments): 260 contributions on its proposal on plant protection products (amendment of Regulation 1107/2009) and 126 on its proposal on biocides (amendment of Regulation 528/2012). It also held initial discussions with the member states at a meeting of the standing committee on plants, animals, food and feed on 22 June.
Generally, reactions are somewhat mixed, though for reasons which vary from stakeholder to stakeholder. On the one hand, a number of stakeholders accuse the Commission of not doing enough to protect human health. France, Denmark and Sweden, for example, have written to the Commission calling for the proposed criteria to be toughened (EUROPE 11576). The three countries, backed by Austria and Finland in the working group, have said that, in their view, the criteria did not offer sufficient protection to human health or the environment. They believe the Commission has exceeded its powers in altering the WHO’s IPCS definition, only including those endocrine disruptors which may have secondary effects on humans rather than those known to produce secondary effects relevant to human health. This, they argue, would mean that suspected disruptors (those identified from animal data) would no longer be covered. Responses to the consultation are also critical of the evidence required. The criteria proposed require a level of evidence such that it will be practically impossible to identify more than a small number of substances that effect hormonal disruption on human health and on the environment, yet current lists of potential endocrine disruptors contain over 800 substances, argue a number of anonymous respondents.
On the other hand, several stakeholders have criticised the Commission proposals as being too restrictive. They argue that the criteria as proposed could result in harmless substances, such as caffeine, being banned. At the meeting of member states, the United Kingdom expressed its disappointment that potency (i.e. the correlation between the dose and the effect) is not one of the criteria. Canada, which took part in the consultation, urged the EU to adopt a hazard-based approach rather than one that assesses risk “in line with its international obligations”.
The many documents published on the Commission website provide a good idea of the line of defence adopted by the Commission. It says that differences with the WHO’s IPCS definition (notably, with regard to the replacement of the term “supposed disruptor” by “known disruptor”) are the result of aligning the proposals with classification, packaging and labelling legislation. It states, too, that the reason why it did not propose categories is that it did not have a mandate to do so. In the face of criticism from the member states, the Commission says, further, that it was within its rights to extend the exemptions to the principle of banning endocrine disruptors: at present, exemptions apply in cases of negligible exposure to plant protection products and in cases of negligible risk of exposure to biocides; the Commission proposed, however, that the two regulations be harmonised and that “negligible exposure” be used for both types of product.
The discussions are expected to continue over the coming months, with the Commission hoping to have everything wrapped up before the end of the year. The proposal on biocides is a delegated act: it will, therefore, be discussed within the expert group before adoption by the Commission, after which the Parliament and the Council will have two months to make any opposition known. The proposal on plant protection products falls within the regulatory procedure with scrutiny: the standing committee on plants, animals, food and feed will be required to come to a decision by qualified majority. In the event of a vote to approve, the Council and Parliament will have three months to react; if the proposal is rejected, the Council will have two months to respond and the Parliament four months to use its right of veto.
The next meeting of the standing committee will take place on 21 September. (Original version in French by Sophie Petitjean)