EU - SVHC List
Substances of Very High Concern for REACH Annex XIV Authorisation (Article 59)
*This list contains the SVHC Candidate list, Prioritization list, and Authorisation list.
REACH: Registration, Evaluation, Authorisation and restriction of CHemicals
It entered into force on 1st June 2007 to streamline and improve the former legislative framework on chemicals of the European Union (EU). REACH places greater responsibility on industry to manage the risks that chemicals may pose to the health and the environment.
In principle REACH applies to all chemicals: not only chemicals used in industrial processes but also in our day-to-day life, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances.
The aims of REACH are to:
- Improve the protection of human health and the environment from the risks that can be posed by chemicals
- Enhance the competitiveness of the EU chemicals industry, a key sector for the economy of the EU
- Promote alternative methods for the assessment of hazards of substances
- Ensure the free circulation of substances on the internal market of the European Union
Substances of very high concern (SVHC) are defined in Article 57 of Regulation (EC) No 1907/2006 and include substances which are:
* Carcinogenic, Mutagenic or toxic to Reproduction (CMR) classified in category 1 or 2,
* Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, and/or
* identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to humans or the environment of an equivalent level of concern as those above e.g. endocrine disrupters
Steps to authorisation: Article 59 defines procedures for moving SVHC substances through prioritization procedures to determine if and when they need to be subjected to the authorisation process through listing in Annex XIV which can enforce allowable uses and sunset dates as needed.
Candidate list: Member state authorities or the Agency prepare a dossier on identified as SVHCs for potential listing in Annex XIV, interested parties comment and the Agency identifies which should be included on the Candidate List. There are immediate obligations for companies (such as notification of users) for substances on the Candidate List.
Prioritization: Substances on the Candidate List are prioritized and assessed for whether sufficient legislative controls are already in place for the substance. If not, and the chemical is determined to need authorization, a sunset date is set by which time a substance can no longer be used without authorization
Authorisation: List of substances included in Annex XIV of REACH ("Authorisation List"). Once included in that Annex, they cannot be placed on the market or used after a date to be set (the so-called “sunset date”) unless the company is granted authorization. Authorisations will be granted if the applicant can demonstrate that the risk from the use of the substance is adequately controlled. The “adequate control route” does not apply to substances for which it is not possible to determine thresholds and substances with PBT or vPvB properties. If the risk is not adequately controlled, authorization may still be granted if it is proven that the socio-economic benefits outweigh the risks and there are no suitable alternative substances or technologies.
More information on the authorisation process is available at: http://guidance.echa.europa.eu/authorisation_en.htm and http://echa.europa.eu/web/guest/addressing-chemicals-of-concern/authorisation/substances-of-very-high-concern-identification/candidate-list-of-substances-of-very-high-concern-for-authorisation