Endocrine disruptors criteria will apply in EU from October

On April 20th, 2018 the Official Journal of the European Union has published 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, according to Staphyt.
 

This Regulation shall apply as of 20 October 2018, except for procedures where the Committee has voted on a draft Regulation by 20 October 2018.
 

By 20 October 2025, the Commission shall present to the Committee referred to in Article 79 of Regulation (EC) No 1107/2009 an assessment of the experience gained from the application of the scientific criteria for the determination of endocrine disrupting properties introduced by this Regulation.
 

From 20 October 2018, an active substance, safener or synergist shall be considered as having endocrine disrupting properties that may cause adverse effect in humans if it is a substance that meets all of the following criteria, unless there is evidence demonstrating that the adverse effects identified are not relevant to humans:
 

• 1/ it shows an adverse effect in an intact organism or its progeny

• 2/ it alters the function(s) of the endocrine system

• 3/ the adverse effect is a consequence of the endocrine mode of action

From 20 October 2018, an active substance, safener or synergist shall be considered as having endocrine disrupting properties that may cause adverse effects on non-target organisms if it is a substance that meets all of the following criteria, unless there is evidence demonstrating that the adverse effects identified are not relevant at the (sub)population level for non-target organisms:
 

• 1/ it shows an adverse effect in non-target organisms, which is a change in the morphology, physiology, growth, development, reproduction or life span of an organism, system or (sub)population that results in an impairment of functional capacity, an impairment of the capacity to compensate for additional stress or an increase in susceptibility to other influences;

• 2/ it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system

• 3/ the adverse effect is a consequence of the endocrine mode of action

If you need support from STAPHYT REGULATORY on this subject, do not hesitate to contact our expert toxicologist Romain Galy.