Delegated regulation 2017/2100 - Scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation 528/2012 Council - Main contents
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official title
Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council (Text with EEA relevance. )| Legal instrument | delegated regulation |
|---|---|
| Number legal act | Delegated regulation 2017/2100 |
| CELEX number i | 32017R2100 |
| Document | 04-09-2017; Date of adoption |
|---|---|
| Publication in Official Journal | 17-11-2017; OJ L 301 p. 1-5 |
| Effect | 07-12-2017; Entry into force Date pub. +20 See Art 4 07-06-2018; Application See Art 4 |
| Deadline | 07-06-2025; See Art 3 |
| End of validity | 31-12-9999 |
17.11.2017 |
EN |
Official Journal of the European Union |
L 301/1 |
COMMISSION DELEGATED REGULATION (EU) 2017/2100
of 4 September 2017
setting out scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 of the European Parliament and Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products (1), and in particular the first subparagraph of Article 5(3) thereof,
Whereas:
(1) |
Scientific criteria for the determination of endocrine-disrupting properties pursuant to Regulation (EU) No 528/2012 should be developed taking into account the purpose of that Regulation to improve the free movement of biocidal products within the Union while ensuring a high level of protection of both human and animal health and the environment. |
(2) |
In 2002, the World Health Organisation (WHO) through its International Programme for Chemical Safety, proposed a definition for endocrine disruptors (2) and in 2009 a definition of adverse effects (3). Those definitions have by now reached the widest consensus among scientists. The European Food Safety Authority endorsed those definitions in its Scientific Opinion on endocrine disruptors adopted on 28 February 2013 (4). Such is also the view of the Scientific Committee on Consumer Safety (5). It is therefore appropriate to base the criteria for the determination of endocrine-disrupting properties on those WHO definitions. |
(3) |
In order to implement those criteria, weight of evidence should be applied considering in particular the approach provided for in Regulation (EU) No 528/2012 and in Regulation (EC) No 1272/2008 of the European Parliament and Council (6) on the weight of evidence. Previous experience with the application of the Guidance documenton standardised test guidelines for evaluating chemicals for endocrine disruption of OECD (7) should also beconsidered. In addition, the implementation of the criteria should be based on all relevant scientific evidence, including studies submitted in accordance with the current regulatory data requirements of Regulation (EU) No 528/2012. These studies are mostly based on international agreed study protocols. |
(4) |
The determination of endocrine-disrupting properties with respect to human health should be based on human and/or animal evidence, therefore allowing for the identification of both known and presumed endocrine-disrupting substances. |
(5) |
One of the characteristics of endocrine-disrupting substances is their endocrine mode of action. Several endocrine modes of action exist. Organisms belonging to different taxonomic phyla differ biologically on essential traits, involving different endocrine modes of action. Therefore, a certain endocrine mode of action relevant for a specific phylum may not be biologically plausible for organisms of a different phylum. Substances whose intended biocidal mode of action, within the meaning of point 6.5, Title 1 of Annex II of Regulation (EU) No 528/2012, is to control target organisms other than vertebrates via their endocrine system, therefore present a mode of action which is not expected to be relevant for vertebrates. These substances consequently do not generally pose a risk via this intended mode of action to humans and vertebrates in the environment and are therefore particularly effective and useful in integrated pest management. When setting the criteria for the determination of endocrine-disrupting properties that may cause adverse effects on non-target organisms, it is appropriate, in view of the objectives of Regulation (EU) No 528/2012, and the... |
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