Table 1.

European legislation related to risk management of marketed chemical substances – Pieces of legislation, which contain specific provisions for endocrine disrupters.

Regulation	Reference	Comment
The REACH Regulation	EC No 1907/2006 [45]	The following substances may be included in Annex XIV in accordance with the procedure laid down in Article 58:
		[…]substances — such as those having endocrine disrupting properties or those having persistent, bioaccumulative and toxic properties or very persistent and very bioaccumulative properties, which do not fulfil the criteria of points (d) or (e) — for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern to those of other [CMR, PBT, vPvB] substances […] and which are identified on a case-by-case basis in accordance with the procedure set out in Article 59.
The Biocidal Products Regulation	EU No 528/2012 [46]	… the following active substances shall not be approved:
		(d) active substances which, […] are considered as having endocrine-disrupting properties that may cause adverse effects in humans or which are identified in accordance with Articles 57(f) and 59(1) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties;
The Regulation on Plant Protection Products	EC No 1107/2009 [47]	An active substance, safener or synergist shall only be approved if, on the basis of the assessment of Community or internationally agreed test guidelines […], it is not considered to have endocrine disrupting properties that may cause adverse effect in humans/ non-target organisms, unless the exposure […] to that active substance, […] in a plant protection product, under realistic proposed conditions of use, is negligible
The Regulation on Medical Devices	EU 2017/745 [48]	Devices, or those parts thereof or those materials used therein that:
		— are invasive and come into direct contact with the human body,
		— (re)administer medicines, body liquids or other substances, including gases, to/from the body, or
		— transport or store such medicines, body fluids or substances, including gases, to be (re)administered to the body,
		shall only contain the following substances in a concentration that is above 0,1 % weight by weight (w/w) where justified pursuant to Section 10.4.2:
		[…]
		(b) substances having endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health and which are identified either in accordance with the procedure set out in Article 59 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) or, once a delegated act has been adopted by the Commission pursuant to the first subparagraph of Article 5(3) of Regulation (EU) No 528/2012 of the European Parliament and the Council (3), in accordance with the criteria that are relevant to human health amongst the criteria established therein.
The Water Framework Directive	2000/60/EC [49]	Indicative list of the main pollutants
		4. Substances and preparations, or the breakdown products of such, which have been proved to possess carcinogenic or mutagenic properties or properties which may affect steroidogenic, thyroid, reproduction or other endocrine- related functions in or via the aquatic environment.