There are two mechanisms in REACH to control unacceptable risks of substances: Authorisation and Restriction.
Authorisation is effectively an EU ban on using and supplying the substance in question unless special permission to use it has been granted by the European Commission, or an exemption applies. However, it does not apply to imported articles.
Only substances meeting certain criteria may be subject to Authorisation. Commonly known as the Authorisation List, the list of substances subject to Authorisation is found in Annex XIV to REACH. They are a subset of the list of SVHCs known as the Candidate List.
Any substance can be subject to Restriction if it poses an unacceptable risk. A restriction may apply to the use and supply of a substance in specific products or to particular markets. It can apply to imported and EEA-produced articles as well as to the substance on its own or in mixtures.
The list of restrictions under REACH is found in Annex XVII. Each entry sets out the scope of the restriction for that substance; if a particular use, product type or market is not included it is allowed (unless subject to other control measures).
An example of a restriction under REACH is for toluene: adhesives and spray paints intended for supply to the general public must not contain this substance at 0.1% or more by weight.
In general terms any substance posing an unacceptable risk might be regarded as a substance of very high concern. For the purposes of REACH, however, the term “SVHC” is intended to indicate those substances which have been included on the Candidate List of Substances of Very High Concern for Authorisation.
Only substances meeting specific criteria may be subject to Authorisation and therefore included in the Candidate List. These criteria are laid down in Article 57 of REACH:
Category 1A or 1B carcinogens, mutagens, or reprotoxic substances according to the criteria in the CLP Regulation
Substances which are Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria of REACH Annex XIII
Substances giving rise to equivalent levels of concern, such as endocrine disruptors. These substances are identified on a case-by-case basis from scientific evidence as causing probable serious effects. The first such substance to be included in the Candidate List was4-tert-octylphenol (EC number 205-426-2).
To be identified as an SVHC a substance must first be proposed for inclusion in the Candidate List. This nomination can be submitted by a national Competent Authority for REACH, or by ECHA at the request of the European Commission. A consultation period of 45 days from the date the proposal is published on the ECHA website allows interested parties to submit comments.
Prior to submitting a proposal Member States and ECHA may indicate their intention to do so at the Registry of Intentions. The aim of this public inventory is to allow interested parties to be aware of the substances of interest to the authorities for Authorisation, Restriction and for Harmonised Classification and Labelling.
2020 SVHC Roadmap
2020 SVHC Roadmap and ECHA’s Integrated Regulatory Strategy
In 2013, the European Commission made a political commitment to include ‘all relevant known’ SVHCs in the Candidate List by 2020. In this context, authorities started to systematically screen registered substances and carry out a regulatory management option analysis (RMOA) to decide whether regulatory measures were needed and identify the most appropriate ways to manage risks. All relevant known carcinogenic, mutagenic and reprotoxic and persistent, bioaccumulative and environmentally toxic substances as well as endocrine disruptors (EDs) were included in the Candidate List, identified for other regulatory risk management measures, or considered to not require further regulatory risk management at that time. More SVHCs are expected to be identified from substances that did not have adequate information to be able to conclude on their hazard properties. The work that started under the 2020 Roadmap continues under the ECHA’s Integrated Regulatory Strategy, which aims to speed up data generation, identification of groups of substances of concern, and regulatory action.
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