REACH Preparation of Applications for Authorisation

Applications for authorisation need to be made within the set deadlines for each use that is not exempted from the authorisation requirement and must include among others:

• a chemical safety report covering risks related to those properties that caused the substance to be included in authorisation system (unless already submitted as part of the registration);
• an analysis of possible alternative substances or technologies including, where appropriate, information on research and development foreseen or already in progress to develop such alternatives.

If the analysis of alternatives reveals that a there is a suitable alternative, you must submit a substitution plan, explaining how you intend to replace the substance by the alternative. The suitability of available alternatives is assessed taking into account all relevant aspects, including whether the alternative results in reduction of overall risks and is technically and economically feasible.

You may include a socio-economic analysis in your application, and in cases where you are not able to demonstrate adequate control of risks and where no suitable alternative exists, you must include one in your application.

Authorisations will be granted if you can demonstrate that the risk from the use of the substance is adequately controlled. The 'adequate control route' does not apply for substances for which it is not possible to determine thresholds and substances with PBT or vPvB properties.

If the risk is not adequately controlled, an authorisation may still be granted if it is proven that the socio-economic benefits outweigh the risks and there are no suitable alternative substances or technologies.

We can help you:

• Analyse alternative substances;
• Develop and document substitution plans;
• Prepare a socio-economic analysis;