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Published on 29/07/2016
ANSES issues its conclusions regarding criteria for the identification of endocrine disruptors
In May 2016, ANSES received a formal request to propose criteria for defining endocrine disruptors (EDs). On 15 June 2016, while this request was being examined, the European Commission (EC) published a proposal for criteria for identifying EDs, which had been expected since late 2013. Today ANSES issues the results of its expert assessment, whose scope had to be modified to take into account the draft proposed by the Commission. In its conclusions, the Agency recommends retaining the definition and criteria for identifying EDs from Option 3 of the European Commission's 2014 roadmap, which enables EDs to be distinguished into three categories: "known", "presumed" and "suspected". In addition, the Agency recommends that classification of EDs be conducted by a single European body, to avoid any risk of divergence of classification for a given substance.
On 15 June, the European Commission (EC) published its proposal for criteria for identifying endocrine disruptors (EDs), accompanied by several texts proposing amendments to the regulations in force concerning biocidal products and plant protection products. In this context, the Minister of the Environment, Energy and the Sea, responsible for international climate relations, asked the Agency to propose criteria for defining EDs that could be used to clarify the French contribution to current European Union discussions on this issue.
The Agency therefore set up an Emergency Collective Expert Assessment Group to examine the EC's 2014 roadmap, submitted for public consultation, which proposed four options for criteria for identifying EDs and three options relating to approaches to regulatory decision-making. The experts also examined the EC's communication of 15 June 2015 and its proposed amendments to the regulations on biocidal products and plant protection products.
The Agency's recommendations
After analysing the four options proposed by the EC, the Agency recommends retaining the definition and criteria for identifying EDs from Option 3 of the 2014 roadmap, based on the WHO/IPCS definition of 2002, on which there is consensus. This option suggests distinguishing EDs into three categories: "known" EDs, "suspected" EDs and "endocrine active substances". The Agency proposes making the distinction, as stated in the National Endocrine Disruptor Strategy (SNPE), by classifying EDs into three categories: "known", "presumed" and "suspected". This distinction, which is similar to the European classification system defined by Regulation (EC) No 1272/2008 (CLP), would mean that its application could be rapidly made operational.
Moreover, according to the experts, this option offers a better guarantee that all the available data on a substance at a given time are taken into account. As with the current procedure for carcinogenic, mutagenic and reprotoxic (CMR) substances, a graduated approach would make it possible to more effectively take uncertainties into account and facilitate the experts' judgment.
In addition, this categorisation would allow tailored regulatory implementation. Different levels of management could thus be introduced depending on the uses and exposed populations (for example, stricter regulations for toys, with a ban on "known", "presumed" and "suspected" EDs).
The EC proposal is based on a single category, rejecting the concept of suspected ED (potential endocrine disruptor) present in the WHO/IPCS's definition of EDs. Nevertheless, it takes into account the effects on humans and non-target organisms in the environment, which is essential for a comprehensive assessment of the effects of EDs. However, the Agency considers that the concept of target organism should be defined and applied by each of the regulations concerned. ANSES therefore recommends not distinguishing between the identification of an ED for humans or for the environment.
In addition, the Agency recommends that harmonised classification of EDs be performed by a single European body, which could be the European Chemicals Agency (ECHA), to avoid any risk of divergence in the classification for a given substance. This classification would be decided independently of any specific implementation which would be covered by a specific regulation.
Lastly, a technical guide, which would be amended according to scientific advances, could be developed to clarify the criteria for assessing and classifying EDs (level of evidence required for inclusion in each of the categories, type of study that can be used to assess the level of evidence, etc.).
Regulation on classification, labelling and packaging of chemicals and their mixtures. The CLP Regulation is intended to ensure that the hazards presented by chemicals are clearly communicated to workers and consumers in the European Union through the classification and labelling of chemical products., would mean that its application could be rapidly made operational.