- Applications for authorisation
- Applications for authorisation process
The main actors in the authorisation application process are:
The applicant can be a manufacturer, an importer or a downstream user of a substance that requires authorisation (as listed in Annex XIV). The applicant may apply for authorisation in respect of his own use or uses for which he intends to place the substance on the market. An application may be made by one or several persons, for one or several substances that meet the definitions of a group of substances according to section 1.5 of Annex XI of the REACH Regulation, and for one or several uses.
If the Commission authorises the use of the substance the holders of authorisations must comply with the requirements of the authorisation when marketing and/or using the substance. The holders of authorisations need to update the Safety Data Sheet and include the authorisation number on the label before they place the substance or a mixture containing the substance on the market.
2.1 ECHA Committees
The Committees for Risk Assessment and Socio-economic Analysis shall give their opinions on an application for authorisation.
2.1.1 Risk Assessment Committee (RAC)
RAC shall prepare an opinion on the application including an assessment of the risk to human health and/or the environment arising from the use(s) of the substance, including the appropriateness and effectiveness of the risk management measures as described in the application and, if relevant, an assessment of the risks arising from possible alternatives.
2.1.2 Socio-Economic Analysis Committee (SEAC)
SEAC prepares an opinion on the application including an assessment of the socio-economic factors and the availability, suitability and technical feasibility of alternatives associated with the use(s) of the substance as described in the application, and of any information on alternatives submitted by interested third parties.
2.2 ECHA Secretariat
The ECHA Secretariat provides guidance and tools to applicants for the preparation of their applications. The Secretariat also supports the ECHA Committees by providing scientific, technical and regulatory services in an efficient and transparent way.
3. Interested parties
Interested parties are citizens, organisations, companies as well as authorities. They can be from the EU or elsewhere. They may provide information on alternative substances or technologies during the consultation process for applications as well as for reviews of authorisations.
4. The European Commission
The opinions of RAC and SEAC are sent to the European Commission. The Commission prepares a draft authorisation decision within three months of receipt of the opinions from the Agency. The Commission adopts the final decision granting or refusing the authorisation. Summaries of the decision will be published in the Official Journal of the European Union and made publicly available through a database maintained by ECHA.
5. Downstream users
A Downstream user may use the substance if an authorisation for that use has been granted to an actor further up his supply chain. He must comply with the conditions set out in the authorisation and notify ECHA of his use of the substance.