The purpose of the authorisation process is to ensure that the risks from Substances of Very High Concern (SVHC) are properly controlled and that these substances are progressively replaced by suitable alternative substances or technologies where these are technically and economically viable. Thus, REACH authorisation provides a strong incentive for the substitution of hazardous substances.
Substances that may be identified as a so-called SVHC have one or several of the hazardous properties according to Art. 57 (a-f) REACH which are listed below:
- Carcinogenic, mutagenic or toxic for reproduction (CMR substances) category 1A or 1B (Art. 57(a-c));
- Persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) (Art. 57(d-e));
- Other substances, for which there is scientific evidence of probable serious effects that cause an equivalent level of concern as with CMR or PBT/vPvB substances (e.g. endocrine disruptors) (Art. 57(f)).
The authorisation procedure (see ECHA Factsheet) foresees a step-wise process with several actors involved.
The first step in this procedure is to identify those substances that may have serious effects on human health or the environment. A Member State or ECHA, at the request of the European Commission, can propose a substance to be identified as an SVHC if these substances have any of the above properties. If identified, the substance is added to the Candidate List. This list contains candidate substances for possible inclusion in the Authorisation List (Annex XIV REACH). Before adding a substance to the Candidate List, interested parties have the opportunity to comment and to provide any other relevant information.
The inclusion of a substance in the Candidate List already creates legal obligations for companies manufacturing, importing or using such substances, whether on their own, in mixtures or in articles.
ECHA prioritises substances from the Candidate List based on the available information on the intrinsic properties, conditions of use and volumes on the EU market, and normally priority should be given to PBT/vPvB substances. ECHA regularly recommends SVHCs to the European Commission, who will ultimately decide which substances should be included in the Authorisation List.
Once a substance has been added to the Authorisation list, it must not be used without an authorisation granted by the European Commission after the so called sunset date. Manufacturers, importers or downstream users can apply for an authorisation for the placing on the market or the use of an SVHC which is listed in Annex XIV.
The list of submitted applications (for public consultations) is accessible here.
After receipt of the application and the payment of the fee, ECHA's Risk Assessment Committee (RAC) and the Committee for Socio-Economic Analysis (SEAC) prepare their opinion on the application. The two opinions of RAC and SEAC are sent to the European Commission for final decision making. An authorisation shall be granted by the Commission if the risk to human health or the environment associated with the uses of a substance are adequately controlled or the socio-economic benefits of their use outweigh the risks (Authorisation decisions list of the European Commission).
An overview of the authorisation process is available on the ECHA Website.
Some uses are exempt from authorisation (Art 56(3-6)):
- Substances used in scientific research and development;
- Substances used in plant protection products or biocidal products;
- Substances used as motor fuel or fuel in mobile or fixed combustion plants;
- Substances used in mixtures below a concentration limit of 0.1 % (w/w).
For SVHC included in Annex XIV only due to human health hazards, the uses in cosmetic products and in food contact materials is also exempt.
An SVHC in Annex XIV may not be used after the sunset date unless an application has been granted. Applications need to be submitted before the “Latest Application date” (LAD) in order to allow applicants to use the substance after the sunset date until a decision has been taken by the European Commission. ECHA asks potential applicants to submit their application in defined submission windows to allow for an efficient and smooth processing.
- Thematic newsletter on REACH Authorisation (2014)
- Guidance on the preparation of an application for authorisation
- Guidance on the preparation of socio-economic analysis as part of an application for authorisation
- ECHA Webinars
- ECHA Webpage on Authorisation
- ECHA support around Application for Authorisation
- Overview on ECHA’s public consultations in the process