Applications for authorisation explained
Manufacturers, importers, only representatives or downstream users can apply for an authorisation to use or place a substance that is on the Authorisation List (Annex XIV to REACH) on the market.
Authorisation may be granted under two circumstances:
- Adequate control: applicants must show that the risk from using the substance is adequately controlled, i.e. the exposure is below the derived no-effect level (DNEL) or the predicted no–effect concentration (PNEC).
- Socio-economic benefits outweigh the risks and there are no suitable alternatives: applications must show that the socio-economic benefits of using the substance outweigh the risks and that there are no suitable alternative substances or technologies. These are the conditions under which the use of a ‘non-threshold’ substance may be authorised (i.e. substances for which a no-effect level, and thus a DNEL or PNEC, cannot be established). Uses of threshold substances that result in exposures above the DNEL or PNEC may also be authorised under these circumstances.
Applications are always made for specific uses. The application always needs to include a chemical safety report and an analysis of alternatives. It may also include a socio-economic analysis. For threshold substances, a substitution plan needs to be included if suitable alternatives are available.
ECHA publishes the applications on its website for consultation. This allows European and other third parties to provide information on possible alternative substances or technologies.
ECHA’s Committees for Risk Assessment (RAC) and Socio-economic Analysis (SEAC) prepare their draft opinions to the European Commission within 10 months based on the application. The comments received during the public consultation and the collected information on alternatives will help in this opinion making.
RAC and SEAC often request additional information from the applicants, which is also taken into account. RAC and SEAC sometimes ask additional questions to those who provide comments during the public consultation.
RAC evaluates the risks to human health and the environment arising from the use of the substance. It assesses the appropriateness and effectiveness of the risk management measures and operating conditions described in the application. It also assesses – to a limited extent -- the possible risks of alternatives.
SEAC assesses the socio-economic factors and the suitability and availability of the alternatives to the use of the substance described in the application. It also assesses information on alternatives submitted by third parties.
In their opinions, RAC and SEAC often recommend to the Commission conditions or monitoring arrangements to further reduce risks or make the authorisation decision more precise. They also make a recommendation for the length of the review period.
RAC and SEAC may, alternatively, recommend to the Commission that an authorisation should not be granted.
The applicant can comment on the draft opinions within two months before the committees adopt their final opinions. ECHA will send the opinions to the Commission, Member States and the applicants and publishes them on its website.
The Commission makes the decisions, with Member States, on whether or not to grant an authorisation. It prepares a draft authorisation decision within three months of receiving the opinions. All-in–all, it takes over six months before the decision is adopted and published in the Official Journal. In some cases, the decision can take much longer.
Authorisation holders must comply with the conditions of the decision. If they place the substance or a mixture containing the substance on the market, they must include the authorisation number on the label and pass on information about the authorisation.
They also need to identify and analyse suitable alternatives after an authorisation has been granted for a use.
Downstream users relying on an upstream authorisation must naturally also comply with the decision. In addition, they need to notify to ECHA their use of the substance within three months of the first supply of the substance. Downstream users should also keep in touch with their suppliers and provide them with information required for a review report.
ECHA keeps a register of the notifications and shares it with the Member State competent authorities. ECHA also publishes the summaries of the notifications on its website.
All authorisation decisions are always subject to a review. This takes place between four and 12 years. If an authorisation holder wants to continue the review, it must submit a review report to ECHA at least 18 months before the review period ends.
The Commission may review the authorisation at any time. The review could be triggered if the circumstances of the authorised use change so as to affect the risks or the socio-economic impact, or if new information on alternatives becomes available.