REACH includes an authorisation requirement to ensure that the risks from substances of very high concern (SVHC) are properly controlled and that those substances are progressively replaced by suitable alternative substances or technologies. Where risks cannot be adequately controlled, the use of those substances may only be authorised where there is an overall benefit for society and there are no suitable alternatives.
Substances of very high concern are identified in the REACH 'Candidate list' for their possible subsequent inclusion in Annex XIV to the REACH Regulation.
List of Commission decisions for SVHC identification (in case of non-unanimous agreement of the European Chemicals Agency (ECHA) Member State Committee)
Annex XIV lists the substances subject to authorisation obligations. Once included in that Annex, a substance cannot be placed on the market for a use or used after a given date (the so-called 'sunset date') unless the companies concerned, who cannot replace that substance, are granted an authorisation for the specific use(s).
Between 5 June - 6 August 2018, the European Chemicals Agency conducted, on behalf of the European Commission, a public consultation on the inclusion of additional intrinsic properties of the substances bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in Annex XIV to Regulation (EC) No 1907/2006 (REACH). The consultation invited interested parties to provide their views on:
Please note that ECHA is also conducting a public consultation on this issue, from 12 December 2018 until 12 March 2019. See the ECHA public consultation
The List of authorisation decisions (1 MB) includes reference to related documentation concerning all applications for authorisation on which an opinion has been adopted by the Committee for Risk Assessment and the Committee for Socio-economic Analysis of ECHA on the basis of Article 64(5) REACH. The decisions are adopted on the basis of Article 64(8) of Regulation (EC) No 1907/2006 (REACH).
The implementation of the authorisation requirement so far has shown that in certain cases it can constitute a significant administrative burden for the companies concerned. In its Communication of 18 June 2014 ‘Regulatory Fitness and Performance Programme (REFIT): State of Play and Outlook’ (COM(2014) 368 final) the Commission announced its intention to reflect on specific areas of Regulation (EC) No 1907/2006 where rules could be simplified and burdens reduced, and in particular to improve the authorisation process by, amongst others, simplifying that process for some specific low-risk cases, while maintaining the REACH goals and objectives.
In March 2015, at the 17th meeting of Competent Authorities for REACH and CLP (CARACAL), the Commission presented the results of a public consultation and a document for discussion on the simplification and streamlining of the authorisation process. This document and a preceding document on simplification and streamlining can be found here: CA/16/2015; CA/81/2014
A public Workshop on 'Streamlining applications for authorisation' was organised on 17 November 2015.