Expert briefing: What have we learned from three years of in-depth active substance EDC assessments?
knoell expert regulatory toxicologist Daniela Fruth looks back at three years of in-depth active substance endocrine disruptor assessments for Biocides and Plant Protection Products within the EU.
The Echa/Efsa guidance document on the identification of endocrine disruptors published in June 2018, was made immediately applicable, leading to a steep learning curve for applicants and authorities. To date, the guidance document is only applicable to biocides and plant protection products (PPPs) covering the oestrogen (E), androgen (A), thyroid (T) and steroidogenesis (S) modalities; their mechanism is well understood and accepted, so standardised test guidelines are available. Authorisation of active substances identified as endocrine disrupting compounds under the PPPR and BPR (professional uses) may only be granted if one of the derogation criteria defined under the respective regulation is met.
It is clear from experience gained over the past three years of active substance EDC assessments under the BPR and PPPR, that adhering to the guidance document’s in-depth five-step process incurs an extensive workload for applicants and authorities. Since harmonisation across EU legislation is one of the goals of the EU chemicals strategy for sustainability, as per ‘one substance, one assessment’, the existing guidance document on the identification of endocrine disruptors, and criteria, are being used as a reference for other EU regulations.
Download the full article, published by Chemical Watch, below.