Report from the Commission to the European Parliament, the Council and the European Economic and Social Committee in accordance with Article 138(7) of REACH to review if the scope of Article 60(3) should be extended to substances identified under Article 57(f) as having endocrine disrupting properties with an equivalent level of concern to other substances listed as substances of very high concern

The REACH Regulation entered into force on 1 June 2007. Its main objectives are to ensure a high level of protection of human health and the environment, as well as the free circulation of substances on the internal market while enhancing competitiveness and innovation. The Regulation shifts the responsibility to manage chemicals risks from public authorities to industry. Those objectives are to be achieved via four processes, namely Registration, Evaluation, Authorisation and Restriction.

The authorisation process aims at ensuring the sound functioning of the internal market while assuring that the risks from substances of very high concern (SVHCs) included in Annex XIV are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are economically and technically viable.

Article 60(2) states that "an authorisation shall be granted if the risk to human health or the environment [..] is adequately controlled". To this end, manufacturers, importers or downstream users have to apply for authorisation and to analyse the availability of alternatives, considering their risks and the technical and economic feasibility of substitution. According to Article 60(3), Article 60(2) shall not apply to substances that are carcinogenic, mutagenic or toxic to reproduction [...] or to substances meeting the criteria in Article 57(f) for which it is not possible to determine a threshold.

Substances falling under Article 57(f) are inter alia those "having endocrine disrupting properties, for which there is scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent concern" or to substances which are persistent, bioaccumulating and toxic or very persistent and very bioaccumulating. For substances identified under Article 60(3), "authorisation may only be granted if it is shown that socio-economic benefits outweigh the risk to human health or the environment" (the so-called 'Socio-Economic Route').

Article 138(7) of REACH requires that "by 1 June 2013, the Commission shall carry out a review to assess whether or not, taking into account latest developments in scientific knowledge, to extend the scope of Article 60(3) to substances identified under Article 57(f) as having endocrine disrupting properties. On the basis of that review the Commission may, if appropriate, present legislative proposals." In other words, the Commission has to review the way some SVHCs should be handled under the authorisation process and in particular whether endocrine disruptors should only be authorised through the Socio-Economic Route.

The review clause was inserted during the co-decision process, where the authorisation process was substantially changed from the Commission proposal. There was not enough time to find a detailed agreement on whether endocrine disruptors should be authorised in all circumstances through the Socio-Economic Route. Therefore this decision was postponed, as there was also an expectation that the scientific knowledge about endocrine disruptors might have evolved further to allow taking a clear position on this matter.

The purpose of this document is to review whether or not, based on the current scientific knowledge, there would be a need to change the legislative text as regards those substances, as required by Article 138(7). The Commission's conclusions build on work with Member States, input from EU regulatory agencies, independent scientific committees advising the Commission, the Commission's in-house scientific body (the Joint Research Centre), and from multilateral and bilateral scientific and regulatory cooperation with third countries, as well as extensive contacts with stakeholders over the past years.

ESO: Background information: Commission proposals on identifying endocrine disruptors http://www.europeansources.info/record/commission-proposals-on-identifying-endocrine-disruptors/

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