Authorisation is one of the REACH processes for managing the risks of hazardous substances.
Substances that are subject to authorisation may not be used in the EU, unless a company (and their registered users) have been authorised to do so. This will mean that eventually these substances are phased out of all non-essential uses.
The substances that qualify for consideration for authorisation are known as ‘Substances of Very High Concern’ (SVHC).
Substances to which authorisation will apply are listed in Annex XIV of REACH [Corrigendum 24 Feb. 2011]. For each substance included on Annex XIV, a deadline will be set after which use of that substance in the EU must stop (known as the ‘sunset date’),unless Authorised. Some substances may be accompanied by a list of specific-uses that do not require authorisation.
Once the sunset date has passed for an Annex XIV substance, only uses which have been specifically ‘authorised’ (or which do not require authorisation) will be allowed.
2- How are substances added to the Authorisation list (Annex XIV)?
Before a substance can be included on Annex XIV it must be identified as an SVHC and placed on the Candidate List. Member States or the European Commission can prepare a dossier to identify a substance as a SVHC. These dossiers are subject to a formal procedure for addition to the Candidate List which includes public consultation. Periodically, ECHA will look at the substances on the Candidate List and will identify and recommend priority substances to add to Annex XIV. The European Commission, in collaboration with Member States and the European Parliament, will then decide which of these recommendations to take forward for addition to Annex XIV.
A number of other lists have been created – for instance by industry groups or Non-Government Organisations. These other lists have no legal status under REACH, and should not be confused with the official Candidate List or Annex XIV.
3- Who will be affected?
Businesses may be affected in a number of ways when a substance is placed on Annex XIV.
Those businesses who use a substance (or a mixture containing a substance) that is listed on Annex XIV will no longer be allowed to use it after the sunset date unless they are covered by an authorisation (or the uses are exempt from authorisation).This could lead to changes in the way you handle the substance in a different way.
Some businesses may choose to discontinue manufacture and/or use rather than apply for authorisation and those that do apply may have their applications rejected. This could mean that a substance or preparation you use is no longer available.
Even if you do not use a substance listed on Annex XIV you may still be affected if the substance is used further up your supply chain. Goods used by your business may be manufactured using a substance on Annex XIV. If authorisation is not granted for that use, you may no longer be able to obtain these goods. If an authorisation is granted, then the cost of the goods could increase.
Identification as an SVHC and inclusion on the Candidate List also leads to other duties.
4- What are the institutional fees for applications for an authorisation under Article 62 of Regulation (EC) No 1907/2006?
Commission Regulation (EU) No 340/2008 of 16 April 2008 on the fees and charges payable to the European Chemicals Agency pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) .
