On 20 April 2018 was published the Commission Regulation (EU) 2018/605 setting out the scientific criteria to identify the substances used in plant protection which are endocrine disruptors (EDs).
After the rejection of the initial regulation project by the European Parliament in October 2017, the new project taking into consideration the claims of the European Parliament (i.e. the deletion of the exemption for substances that have an ‘intended endocrine mode of action’), was voted at the PAFF meeting in December 2017.
According to the Regulation, an active substance, safener or synergist is considered as ED if (i) it shows an adverse effect in an intact organism or its progeny, (ii) it alters the function(s) of the endocrine system, and (iii) the adverse effect is a consequence of the endocrine mode of action.
The new criteria will apply from 20 October 2018 onwards, including the substances for which an assessment or a re-evaluation is ongoing. A feedback regarding the experience gained from the application of these criteria will be presented by the Commission by 20 October 2025.
As a reminder, very similar criteria will apply to biocide substances from 7 June 2018. The European Union is now the first worldwide to have strict legally binding criteria to identify EDs.
Besides, the draft technical guidance document for identifying EDs of ECHA and EFSA is currently being updated with the new criteria set. The guidance document will be available by June 2018.
To download: Commission Regulation (EU) 2018/605 of 19 April 2018 amending Annex II to Regulation (EC) No 1107/2009 by setting out scientific criteria for the determination of endocrine disrupting properties.
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