Substances with properties of very high concern may be subject to a separate authorisation requirement. According to current estimates, some 1,500 different substances could be affected. Substances with the following properties fall under the authorisation procedure:
- substances classified as carcinogenic, mutagenic or toxic for reproduction category 1A and 1B (so-called "CMR substances"),
- persistent or bioaccumulative substances with toxic properties or very persistent or very bioaccumulative substances (so-called PBT or vPvB substances) or
- substances with properties of very high concern (e.g. endocrine disruptors) identified on a case-by-case basis.
Substances subject to authorisation are included in a list that is gradually expanded and provided with an "expiry date" (Annex XIV of the REACH Regulation, which is still blank even though the REACH Regulation has entered into force). To this end, the European Chemicals Agency (ECHA) first publishes, on its website, a list of substances that are candidates for inclusion in Annex XIV (the so-called "Candidate List").
The first six substances subject to authorisation in Annex XIV were added in May 2011. Once the aforementioned "expiry date" has lapsed, the substance in question may neither be brought to market nor used without an authorisation. It is possible for certain uses of the substance in question to be excluded from the authorisation requirement.
The application for authorisation is submitted to ECHA. Manufacturers, importers and downstream users alike may submit the application. The decision on whether to approve the authorisation applications rests with the EU Commission. The bar for obtaining authorisation is high: the applicant must demonstrate that the risks related to the substance are adequately controlled when it is used. Where applicable, the applicant must also provide evidence that the socio-economic benefits outweigh the risks and that no suitable alternative substances or technologies exist. If suitable alternatives are available, the application for authorisation must additionally include a substitution plan outlining the measures that will, in the long term, replace the substance subject to authorisation.
A granted authorisation relates exclusively to one or more uses. Where appropriate, the authorisation may be tied to additional requirements concerning how the substance in question is to be monitored. A review period is also set for each authorisation on a case-by-case basis. In order to preserve the authorisation, a review report must be resubmitted no later than 18 months before expiry of this period. Notwithstanding this, the EU Commission may – e.g. where new information on substitutes comes to light – request that the authorisation be reviewed, which may result in the authorisation being revoked under the relevant framework conditions.
Approved substances, along with their permitted uses, are given an authorisation number and published in a database. If substances subject to authorisation are brought to market in a mixture, the authorisation number must be printed on the label. Downstream users employing substances in an application that has already been authorised are required to notify ECHA.
Exemptions from the authorisation requirement apply in the case of intermediate products, the use of substances in the context of scientific research and development, use in plant protection products and biocidal products, use as a motor fuel, and the use of mineral oil products as fuel. Under certain conditions, cosmetics, food contact materials and the use of substances in mixtures below certain concentration limits are also exempted.