Two draft legal acts setting out the criteria to identify endocrine disruptors for biocidal and plant protection products (BP and PPP, respectively) were presented by the EU Commission on 15 June 2016. Following discussion and various revisions the criteria to identify endocrine disruptors for PPPs were agreed by Member States on 4 July 2017.
The criteria will apply after a 6 month transition period during which EFSA and ECHA will develop joint guidance that will enable applicants and regulatory authorities to identify ED properties among chemical substances proposed as pesticides and biocides under EU legislation. It is expected that a draft guidance document will be available for public consultation in the autumn. However, the Commission have indicated that they will not delay any action and will apply the criteria to substances for which assessment or re-evaluation is undergoing or for which confirmatory data concerning endocrine properties have been requested.
In order to facilitate the scientific review process a proposed amendment to grounds for derogation from bans resulting from classification as an EDC was separated from the ED criteria proposals. Therefore the anticipated exemption when negligible risk/exposure can be demonstrated for PPPs is not included in the new criteria at present. This and the proposed ED criteria for biocides are now the focus of ongoing discussions within the EU Commission. There is also a requirement for the EU Commission to assess the experience gained in using the ED criteria within 7 years of the implementation date.
The finalised criteria are based on the World Health Organisation (WHO) definition. They identify known and presumed endocrine disruptors. They also specify that the identification of an endocrine disruptor should be carried out by taking into account all relevant scientific evidence including animal, in-vitro or in-silico studies, and using a weight of evidence-based approach.
Further information is available at: http://www.efsa.europa.eu/en/topics/topic/endocrine-active-substances
For advice on risk assessment and 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, email@example.com.
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