
Article 1 
The scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 are set out in the Annex to this Regulation.
Article 2 
The criteria laid down in the Annex to this Regulation shall apply as of 7 June 2018, except for procedures where the Committee referred to in Article 82 of Regulation (EU) No 528/2012 has voted on a draft Regulation by 7 June 2018.
Article 3 
By 7 June 2025, the Commission shall present to the expert group (the ‘Biocides CA meeting’) consisting of representatives of Member States' competent authorities for biocidal products an assessment of the experience gained from the application of the scientific criteria for the determination of endocrine-disrupting properties introduced by the present Regulation.
Article 4 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 7 June 2018.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 4 September 2017.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX

A substance shall be considered as having endocrine-disrupting properties with respect to humans or non-target organisms, where it meets the criteria set out in section A or section B.

Section A — Endocrine-disrupting properties with respect to humans
(1) 

((a)) it shows an adverse effect in an intact organism or its progeny, 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;
((b)) it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;
((c)) the adverse effect is a consequence of the endocrine mode of action.

(2) 

((a)) all available relevant scientific data (in vivo studies or adequately validated alternative test systems predictive of adverse effects in humans or animals; as well as in vivo, in vitro, or, if applicable, in silico studies informing about endocrine modes of action):

((i)) scientific data generated in accordance with internationally agreed study protocols, in particular those referred to in Annexes II and III of Regulation (EU) No 528/2012;
((ii)) other scientific data selected applying a systematic review methodology;
((b)) an assessment of the available relevant scientific data based on a weight of evidence approach in order to establish whether the criteria set out in point (1) are fulfilled; in applying the weight of evidence determination, the assessment of the scientific evidence shall, in particular, consider all of the following factors:

((i)) both positive and negative results;
((ii)) the relevance of the study designs for the assessment of adverse effects and of the endocrine mode of action;
((iii)) the quality and consistency of the data, considering the pattern and coherence of the results within and between studies of a similar design and across different species;
((iv)) the route of exposure, toxicokinetic and metabolism studies;
((v)) the concept of the limit dose, and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity;
((c)) using a weight of evidence approach, the link between the adverse effect(s) and the endocrine mode of action shall be established based on biological plausibility, which shall be determined in the light of current scientific knowledge and under consideration of internationally agreed guidelines;
((d)) adverse effects that are non-specific secondary consequences of other toxic effects shall not be considered for the identification of the substance as endocrine disruptor.

Section B — Endocrine-disrupting properties with respect to non-target organisms
(1) 

((a)) 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;
((b)) it has an endocrine mode of action, i.e. it alters the function(s) of the endocrine system;
((c)) the adverse effect is a consequence of the endocrine mode of action.

(2) 

((a)) all available relevant scientific data (in vivo studies or adequately validated alternative test systems predictive of adverse effects in humans or animals; as well as in vivo, in vitro or, if applicable, in silico studies informing about endocrine modes of action):

((i)) scientific data generated in accordance with internationally agreed study protocols, in particular those referred to in Annexes II and III of Regulation (EU) No 528/2012;
((ii)) other scientific data selected applying a systematic review methodology;
((b)) an assessment of the available relevant scientific data based on a weight of evidence approach in order to establish whether the criteria set out in point 1 are fulfilled; in applying the weight of evidence determination, the assessment of the scientific evidence shall consider all of the following factors:

((i)) both positive and negative results, discriminating between taxonomic groups (e.g. mammals, birds, fish, amphibians) where relevant;
((ii)) the relevance of the study design for the assessment of the adverse effects and its relevance at the (sub)population level, and for the assessment of the endocrine mode of action;
((iii)) the adverse effects on reproduction, growth/development, and other relevant adverse effects which are likely to impact on (sub)populations. Adequate, reliable and representative field or monitoring data and/or results from population models shall as well be considered where available;
((iv)) the quality and consistency of the data, considering the pattern and coherence of the results within and between studies of a similar design and across different taxonomic groups;
((v)) the concept of the limit dose and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity;
((c)) using a weight of evidence approach, the link between the adverse effect(s) and the endocrine mode of action shall be established based on biological plausibility, which shall be determined in the light of current scientific knowledge and under consideration of internationally agreed guidelines;
((d)) adverse effects that are non-specific secondary consequences of other toxic effects shall not be considered for the identification of the substance as endocrine disruptor with respect to non-target organisms.

(3) If the intended biocidal mode of action of the active substance being assessed consists of controlling target organisms other than vertebrates via their endocrine systems, the effects on organisms of the same taxonomic phylum as the targeted one shall not be considered for the identification of the substance as having endocrine-disrupting properties with respect to non-target organisms.
