The European Commission has presented criteria to identify endocrine disruptors in the field of plant protection products and biocides, including:
- A Communication providing an overview of the scientific and regulatory context;
- an Impact Assessment Report which presents the state of science regarding different criteria to identify endocrine disruptors, and provides information on possible consequences;
- and two draft legal acts – one under the Biocidal Products legislation, the other under the Plant Protection Products legislation – which set the criteria to identify endocrine disruptors.
It has chosen to base the criteria solely on UN WHO definition of EDs: having an adverse effect on human health; an endocrine mode of action; and a causal link between the adverse effect and the mode of action. The proposals specify that identification of an ED should be carried out by making use of all relevant scientific evidence; using a weight of evidence-based approach; and applying a “robust” systemic review. The European Crop Protection Association (ECPA) has criticised the Commission’s decision as it doesnot include consideration of potency or socio-economic impacts.
In the Communication, the Commission explains the reasoning behind its decisions, which were also based on an impact assessment. For identification ofcriteria, it decided against the roadmap option to combine the WHO definition with additional categories, such as “suspected” EDs. Establishing a category of what “may” be an ED does not help define what “is” an ED and would decrease legal certainty for industry and regulators, the Commission says. It also decided against considering potency, arguing that it is not necessary for identification. The scientific consensus is that potency should only be considered after an active substance has been identified as an ED, to evaluate the actual risk posed, it points out. Health, environmental and consumer NGOs had supported the use of categories, while the industry had supported the use of potency.
Based on a screening exercise of approved active substances, carried out as part of the impact assessment, the Commission estimates that the proposed use of the WHO definition would identify 26 agrochemical and five biocide active substances as EDs. This compares with 42 and 16 active substances, respectively, under the interim ED criteria currently being used. Adding the categories option would have identified 45-82 agrochemical active substances and eight to 26 biocide active substances. Using the potency option would have identified 11 and two active substances, respectively.
For advice on how the new ED criteria might affect your actives and for further information on the registration of plant protection products, biocides or general chemicals, or any other regulatory issues, please contact JSC on +44 (0)1423 520245, firstname.lastname@example.org
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