Applications for authorisation

Manufacturers, importers or downstream users can apply for an authorisation for the placing on the market or the use of a substance on the Authorisation List.

Authorisations will be granted if the applicant can demonstrate that the risk from the use of the substance is adequately controlled. If not, an authorisation may still be granted when it is proven that the socio-economic benefits of using the substance outweigh the risks and there are no suitable alternative substances or technologies.

The application will include a chemical safety report, an analysis of the possible alternatives and a plan to substitute the substance if suitable alternatives are available. It may also include a socio-economic analysis.

Upon receiving the application and the fee payment, ECHA's Risk Assessment Committee (RAC) and the Committee for Socio-Economic Analysis (SEAC) prepare their opinions on the application. They first check whether the application conforms to the information requirements of REACH (Article 62). If it does not, the Committees may request additional information.

ECHA will publish information on the uses of the substance related to the application so anyone can provide information on possible alternative substances or technologies. Those most likely to be interested are companies, organisations representing industry or civil society, individual citizens, as well as public authorities. Comments are welcomed from the EU or beyond.

SEAC can also ask the applicant or those who provided comments during the public consultation to submit additional information on the possible alternatives.

Committees opinions

RAC and SEAC will prepare their draft opinions within ten months based on the application, the comments received during the public consultation and the collected information on alternatives.

RAC will evaluate the risks to human health and the environment arising from the use of the substance. The committee will also assess the appropriateness and effectiveness of the risk management measures described in the application, as well as the possible alternatives.

SEAC will assess the socio-economic factors and the availability, suitability and technical feasibility of the alternatives to the use of the substance described in the application and any information on alternatives submitted by third parties.

The applicant can comment on the draft opinions within two months before the Committees adopt their final opinions, which will be provided to Member States and the applicant. ECHA will publish non-confidential versions of the final opinions.

Decision

The two opinions of the ECHA Committees are sent to the European Commission, who will take the decision whether to grant the authorisation and under which conditions.

Holders of an authorisation must comply with the requirements of the decision and include the authorisation number on the label before they place the substance or the mixture containing the substance on the market.

Downstream users of an authorised substance must also comply with the decision and notify to ECHA the use of the substance within three months of the first supply of the substance. ECHA will keep a register of these notifications and give access to the Competent Authorities of the Member States.

Review

All authorisation decisions will define a time-limited review period. Holders of authorisations must submit a review report at least 18 months before this review period ends.

In addition, an authorisation may be reviewed at any time 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.

 

 

Application for authorisation procedure steps

  • Notification of intention to submit an application for authorisation
  • Submission of the application and fee payment
  • Checking of application's conformity
  • Public consultation on the uses applied for
  • Draft opinions by RAC and SEAC
  • Comments on the draft opinions
  • Adoption of final opinions by RAC and SEAC
  • EU Decision
  • Downstream users notifications
  • Review