UK REACH Authorisation Overview

Authorisation under UK REACH

UK REACH authorisation aims to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where feasible alternatives exist.

Substances that have been identified as SVHCs and included in the Authorisation List (Annex XIV) cannot be used or placed on the market for a use, after the sunset date unless the use has been authorised or is exempt from authorisation.

Authorisation has no tonnage threshold, so unlike registration, you will need to be covered by an authorisation no matter what quantities you use, unless that use is exempt.

Using substances on Annex XIV

Manufacturers, importers, only representatives or downstream users can apply for an authorisation to use or place a substance that is on the Authorisation list on the market.

More information on the authorisation process.

Find out if you need to apply for authorisation

You should first check whether any of the substances of very high concern (SVHCs) you use or place on the market for a use are included in the Authorisation List.

If your substances are included in the Authorisation List, you should then check that your uses are not exempt from authorisation.

Exemptions

Exemptions for all intrinsic properties include:

• hhuman and veterinary medicinal products within the scope of the Veterinary Medicines Regulations 2013 or the Human Medicines Regulations 2012.
• use in food or feeding stuff in accordance with Regulation (EC) No. 178/2002
• use in scientific research and development
• use  in product and process orientated research and development may be exempted. (Article 56(3))
• use in plant protection products
• use in biocidal products
• use as motor fuels or as fuel in mobile or fixed combustion plants of mineral oil products and use as fuels in closed systems

Exemptions specific to certain intrinsic properties:

In the case of substances that are subject to authorisation only because they meet the criteria in Article 57(a), (b) or (c) or because they are identified in accordance with Article 57(f) only because of hazards to human health, the following uses are exempt:

• uses in cosmetic products within the scope of Regulation (EC) No 1223/2009
• uses in food contact materials within the scope of Regulation (EC) No 1935/2004

The use of substances when they are present in mixtures:

• for substances referred to in Article 57(d), (e) and (f), below a concentration limit of 0,1 % weight by weight (w/w)
• for all other substances, below the values specified in Article 11(3) of Regulation (EC) No 1272/2008 which result in the classification of the mixture as hazardous

Articles

Imported articles are not subject to authorisation. The use or sale of articles that have been made using a substance on Annex XIV of UK REACH are exempt from authorisation and can continue to be used.

Such articles may have been produced outside of Great Britain or could come from stocks produced in Great Britain before the sunset date. The authorisation requirements will apply to the use of the substance (including incorporation of the substance into an article and the use in any solution) but not to the supply and use of the finished articles.

Intermediates

If the substance is manufactured for and consumed in or used for chemical processing in order to be transformed into another substance, then that use is exempt from authorisation.

A manufacturer or importer of a substance subject to authorisation does not need to apply for an authorisation if they place a substance on the market for use as an intermediate by their customer or downstream user.

There is no requirement to demonstrate strictly controlled conditions to rely on this exemption.