Companies can now start to prepare for authorisation applications

Press Release

ECHA/PR/11/03
Media enquiries: ECHA Press

The European Commission has published in the Official Journal (1) the first list of six substances that are subject to authorisation. Without authorisation, their use must end after the specified "sunset date". Companies can start preparing their applications for authorisation. The publication of the Authorisation List is a major step forward in managing the risks posed to human health and the environment of substances of very high concern.

Helsinki, 21 February 2011 (Updated version: 25 February 2011) - According to the REACH regulation, the aim of the authorisation process is to ensure the good functioning of the internal market while assuring that risks from Substances of Very High Concern (SVHC's) are properly controlled and these substances are progressively replaced by suitable alternatives that are economically and technically viable.

Unless specific provisions or exemptions (2) apply, the six SVHC's now on the published Authorisation List can from a certain "sunset" date be used only if the European Commission has granted an authorisation. Companies can receive an authorisation for a substance on the List only for specific uses and for a certain period of time, that can be renewed.

When applying to ECHA for an authorisation, a company needs to include a Chemical Safety Report which addresses the risks from the use of the substance. The company also has to provide an analysis of alternatives and – if suitable alternatives are available – a plan describing when and how the substance will be substituted. The applicant can also include an analysis of the socio-economic impact of using the substance. Companies can apply individually or in group for one or more uses by a pre-set latest application date which is well before "sunset" date. Any application is subject to a fee.

Companies wishing to prepare for their future application can now find more practical information on ECHA's website: information on the application process; the actors involved; how to apply; and submission dates. This web section will be updated regularly.

New guidance

ECHA recently published two new guidance documents on authorisation applications. The first guidance document explains how to prepare an application for authorisation, the analysis of alternatives and the substitution plan. It also describes how third parties may prepare and submit information on alternatives. The second guidance document shows how to prepare a socio-economic analysis if the risks of the continued use of the substance cannot be adequately controlled. It describes how to calculate the costs of using alternatives and how the human health or environmental impacts of continued use of the substance or the alternatives can be estimated.

ECHA Seminar

ECHA will organise a seminar for potential applicants on 12 April 2011 in Helsinki. Go online for more information.