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Use authorisation


The authorisation process of REACH should allow to control risks arising from substances of very high concern (SVHC) because of their effects on health and environment and to promote their progressive replacement by suitable alternatives. So, an authorisation is compulsory to place on the market or to use a substance included in Annex XIV, on its own or contained in a mixture or in an article.

Identification of substances

The authorisation process of REACH starts with the identification of substances considered as of very high concern because of their intrinsic properties1. For each concerned substance, ECHA prepares a dossier according to Annex XV, publishes a notice that the substance has been identified for eventual inclusion in Annex XIV and then registers it in the candidate list. ECHA then sends to the European Commission a recommendation for inclusion of priority substances with PBT2 or vPvB3 properties, wide dispersive use or high volumes. Finally, the Commission decides to include or not a candidate substance in Annex XIV, i.e. in the list of substances subject to authorisation.

Content of Annexe XIV

Annex XIV comes as a table where are noted in particular the identity of the substance, the intrinsic properties having led to the inclusion and transitional arrangements. Some uses or categories of uses may also be noted as exempted from the authorisation requirement. At last, Annex XIV may indicate review periods for certain uses.

Application for authorisations and granting of authorisations

For all placing on the market or use of a substance included in the authorisation list (Annex XIV), manufacturers, importers or downstream users shall make an application for an authorisation to ECHA specifying which use is concerned and including a chemical safety report (CSR) and an analysis of the alternatives and of their possible risks. Moreover, a fee is required for all application for an authorisation.

The Committees for Risk Assessment and Socio-economic Analysis consider the application and prepare draft opinions. Then ECHA sends its final opinions to the Commission, the Member States and the applicant. The Commission finally decides to grant or not an authorisation.

An authorisation may only be granted for an use of a substance if it is demonstrated that the risks to human health and the environment is adequately controlled or that socio-economic benefits outweigh the risks and that no suitable alternative exists. The authorisation specifies in particular the person(s) to whom it is granted, the identity of the substance, the authorized use(s) and any possible condition. Each authorisation has a reference number that the holder or the downstream users must include on the label of the substance or of a mixture contenting it before their placing on the market. Each downstream user of a substance subject to a granted authorisation (cf Usable substances) must notify ECHA which keeps up to date a register of downstream users of substances subject to authorisation.


1. According to article 57, SVHC are substances with properties of carcinogenicity, mutagenicity or toxicity for the reproduction, PBT/vPvB substances (fulfilling the Annex XIII criteria or identified on a case-by-case basis) and endocrine disruptors.
2. PBT: persistant, bioaccumulable and toxic.
3. vPvB: very persistant and very bioaccumulable.



Prévention du risque chimique, France, 2007, 2011
This document is provided for information only and under no circumstances constitutes legal advice. The only authentic legal reference is the text of the REACH Regulation (Regulation (EC) no 1907/2006).