Authorisation

It is the intention of authorisation to ensure that the ‘risks of substances of very high concern are appropriately managed or these substances are replaced by suitable alternative substances or techniques when this is economically and technically feasible’ (article 55).

The substances concerned:

• substances that were classified as carcinogenic, mutagenic or toxic to reproduction (CMR), category 1a or 1b;
• substances that may be persistent, bioaccumulating and toxic (PBT) or very persistent and very bioaccumulating (vPvB) in accordance with the criteria appended in XIII of the REACH regulation;
• substances for which there is scientific evidence of probable serious effects on human health and the environment giving rise to an equivalent level of concern as the substances mentioned above (for example substances that can disrupt the endocrine system).

The authorisation procedure comprises four steps:

• The determining of substances of very high concern: the Member States or the ECHA determine the substances subject to authorisation and make a list of high priority substances (the ‘candidate list’), that is published and regularly updated by the ECHA.
• Procedure of classification according to priority: the body then selects the high priority substances in the candidate list to determine which must be subject to authorisation (in annex XIV).
• Authorisation applications: industry must submit the authorisation applications to the ECHA and must in particular present an analysis of the alternative solutions and an alternative plan to either apply the alternatives or develop new ones.
• Allocation of authorisations: the European Commission grants authorisations if it is shown that the risk linked to use of the substance is sufficiently managed.

The authorisation does not apply to substances for which it is impossible to determine thresholds and to substances with PBT or vPvB properties. Authorisation can still be granted for such substances if the risk is not sufficiently managed when it is shown that the social-economic advantages prevail over the risks and no appropriate alternative substances or technologies are available.