02018R0605 — EN — 20.04.2018 — 000.001

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►B 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 (Text with EEA relevance) (OJ L 101 20.4.2018, p. 33)





Corrected by:









▼B

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

(Text with EEA relevance)







Article 1

Annex II to Regulation (EC) No 1107/2009 is amended in accordance with the Annex to this Regulation.

Article 2

Points 3.6.5 and 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by this Regulation, shall apply as of ►C1 10 November 2018 ◄ , except for procedures where the Committee has voted on a draft Regulation by ►C1 10 November 2018 ◄ .

Article 3

By ►C1 10 November 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.

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 ►C1 10 November 2018 ◄ .

This Regulation shall be binding in its entirety and directly applicable in all Member States.









ANNEX

Annex II to Regulation (EC) No 1107/2009 is amended as follows:

(1) in point 3.6.5 the following paragraphs are added after the fourth paragraph:

‘From ►C1 10 November 2018 ◄ , an active substance, safener or synergist shall be considered as having endocrine disrupting properties that may cause adverse effect in humans if, based on points (1) to (4) of the sixth paragraph, 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, 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.

The identification of an active substance, safener or synergist as having endocrine disrupting properties that may cause adverse effect in humans in accordance with the fifth paragraph shall be based on all of the following points:

(1) 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):

(a) scientific data generated in accordance with internationally agreed study protocols, in particular those listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation;

(b) other scientific data selected applying a systematic review methodology, in particular following guidance on literature data which is listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation;

(2) 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 the fifth paragraph are fulfilled; in applying the weight of evidence determination, the assessment of the scientific evidence shall, in particular, consider all of the following factors:

(a) both positive and negative results;

(b) the relevance of the study designs, for the assessment of adverse effects and of the endocrine mode of action;

(c) 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;

(d) the route of exposure, toxicokinetic and metabolism studies;

(e) the concept of the limit dose, and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity;

(3) 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;

(4) 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.’;

(2) in point 3.8.2 the following paragraphs are added after the sole paragraph:

‘From ►C1 10 November 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, based on points (1) to (4) of the third paragraph, 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.

The identification of an active substance, safener or synergist as having endocrine disrupting properties that may cause adverse effects on non-target organisms in accordance with the second paragraph shall be based on all of the following points:

(1) 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):

(a) scientific data generated in accordance with internationally agreed study protocols, in particular, those listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation;

(b) other scientific data selected applying a systematic review methodology, in particular following guidance on literature data listed in the Commission Communications in the framework of setting out the data requirements for active substances and plant protection products, in accordance with this Regulation;

(2) 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 the second paragraph are fulfilled; in applying the weight of evidence determination, the assessment of the scientific evidence shall consider all of the following factors:

(a) both positive and negative results, discriminating between taxonomic groups (e.g. mammals, birds, fish, amphibians) where relevant;

(b) 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;

(c) 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;

(d) 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;

(e) the concept of the limit dose and international guidelines on maximum recommended doses and for assessing confounding effects of excessive toxicity.

(3) 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;