An increasing number of member states are unhappy with the definition of endocrine disruptors proposed by the European Commission on 15 June 2016 and are taking action at ministerial level to get the Commission to change tack (see EUROPE 11632, 11571).
The environment ministers of Denmark, the Netherlands and Sweden, backed by their Luxembourg colleague, spoke up at the Environmental Council on 17 October to make it clear that they were not intending to be deprived of their prerogatives on an issue of such enormous general interest. Among other health issues, these chemical pollutants cause cancer, infertility and foetus malformations.
In a written memorandum, the ministers explain that the Commission’s draft regulation is subject to the comitology procedure, but the criteria defining endocrine disruptors are the focus of public and political interest and therefore deserve attention at Council level.
At a time when the European Commission is considering adjusting the margins of the proposal, the ministers say the criteria for identifying endocrine disruptors with a view to banning them should be in-phase with the basic regulations in force – the regulation on marketing and using biocides (EU 528/2012) and the pesticide regulation on authorising the sale of phytopharma products (EC 1107/2009). The criteria should therefore take account of the precautionary principle as laid down in EU law, rather than being based on proven health damage for human beings alone, they explain. This was raised under ‘any other business’ as a joint initiative. The French minister spoke to back this approach, although the question was not debated in any depth.
"The biocidal products regulation and the regulation for placing plant protection products on the market both refer to substances that are considered as having endocrine-disrupting properties that may cause adverse effects in humans. This includes both substances that lead to and are presumed to lead to adverse effects due to endocrine disruption", the memorandum states. It adds that the criteria need to be in line with the above two regulations and with the approach accepted at global level for identifying dangerous substances, and also with the REFIT initiative that aims to ensure coherence across legislation.
The ministers add: "The European Union's 7th Environmental Action Programme (7the EAP) provides a long-term vision to achieve a non-toxic environment. Developing harmonised criteria for the identification of endocrine disruptors is one of the key points of the 7th EAP to meet that objective" (see EUROPE 10966).
"Clear scientific criteria for the determination of endocrine disrupting properties, combined with adequate information requirements, are the prerequisite for proper identification of endocrine disrupting substances. They also form the basis for the subsequent assessment of the risk that may be associated with the uses of such substances", says the memorandum, adding that the establishment of scientific criteria should facilitate "clarity and predictability for industry, promoting responsible behaviour, investments and sustainable growth, improved basis for regulation of endocrine disrupting substances, better protection of consumers, workers and the environment, and consistency in the approach to chemicals across relevant regulation".
Environment Commissioner Karmenu Vella said that the European Commission was currently assessing the member states’ remarks and also the comments by the European Parliament’s legal department with a view to making a number of adjustments, but the decision would be taken in comitology. Unlike the European Parliament’s legal department, the Commission is convinced that it has not overstepped its implementation powers, a European source told EUROPE on Thursday 20 October.
The definition laid down in the WHO/IPCS report of 2002, which the Commission says it used, says that an endocrine disruptor is a substance of exogenous mixture altering the functioning of the endocrine system and thus causing a negative impact on the health of an intact organism, its progeny or (sub-)populations. A potential endocrine disruptor is a substance of exogenous mixture possessing qualities likely to cause endocrine disruption in an intact organism, its progeny or (sub-)populations. (http://www.who.int/ipcs/publications/en/ch1.pdf ). (Original version in French by Aminata Niang)