UK: First Six Substances Of Very High Concern Added To REACH 'Authorisation List'

Last Updated: 22 October 2010
Article by Paul Sheridan and Valentina Keys

On the 21 September 2010 a committee of EU Member States identified the first six substances to be placed on the "authorisation list" of substances of very high concern (SVHCs) under REACH (see below). This is the penultimate legislative step before the ramifications become law. The last step is for the European Commission to confirm this list. Such confirmation is expected in January 2011.

If the European Commission confirms the list, then in due course any legal entity that wishes to use these substances will have to apply for authorisation from the European Commission [which is advised by the European Chemicals Agency].


The Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals ("REACH") (EC) 1907/2006 is the main system for controlling chemicals in the EU. REACH is coordinated by the European Chemicals Agency (ECHA). It requires the registration of substances (in phases). It sets up a system under which the use and placing on the market in the EU of Substances of Very High Concern (SVHCs) will be subject to prior written authorisation. The aim of the authorisation is to ensure that risks from SVHCs are properly controlled and that these substances can be progressively replaced by suitable alternative substances or technologies.

'Authorisation list'

Annex XIV is intended to contain the list of substances which will require prior authorisation. This is the so-called 'Authorisation List'. [To date there have not been any substances placed on the list. Instead a process was adopted to determine which substances should appear on the list. It was this process which has determined these first 6 such substances (see below)].

Once a SVHC is placed on Annex XIV a 'sunset date' will also be set. After this sunset date the use of the particular SVHC will be prohibited unless a written authorisation has been granted for use or the use is exempt from authorisation. Anyone wishing to use the SVHC immediately after the sunset date will need to apply for an authorisation (and pay a substantial fee) not less than 18 months before the sunset date. Applications are to be made to the ECHA. More detailed guidance on the application process is to be published shortly.

In addition authorisations can be reviewed by the Commission at any time during the authorisation period. Each authorisation will be reviewed after a specified time (to be decided on a case-by-case basis) and may be amended or withdrawn as a result of the review. Holders of an authorisation will have to submit a review report at least 18 months before the review is carried out for use to continue. In principle the authorisations will be renewable subject to the risk assessment on renewal.

There are two grounds for grant of an authorisation:

  • The use of the SVHC is considered safe as long as the risks are adequately controlled, and the conditions of the authorisation are met; or
  • The use of the SVHC can be demonstrated to be so important on socio-economic grounds that its continued use outweighs the risks to human health and the environment.


Article 57 sets out the criteria which determines when a substance is a SVHC, namely:

  • category 1 and 2 carcinogens, mutagens, and reproductive toxicants (CMRs);
  • substances that are persistent, bioaccumulative, and toxic to the environment (PBTs);
  • substances that are very persistent and very bioaccumulative (vPvBs); and
  • substances that are of an equivalent concern (where there is scientific evidence of probable serious effects, such as endocrine disruptors).

First 6 SVHCs

These are:

  • 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene)
  • 4,4'-Diaminodiphenylmethane (MDA)
  • Hexabromocyclododecane (HBCDD)
  • Bis(2-ethylhexyl)phthalate (DEHP)
  • Benzyl butyl phthalate (BBP)
  • Dibutyl phthalate (DBP)

Sunset dates

In January 2011, the European Commission is expected to take the decision to confirm the placing of these 6 substances in the Authorisation List. The sunset dates for the various substances are not intended to be the same. These sunset dates will be a number of months following the date when the rules enter into force (which date will not be known until the European Commission makes its decision). From this (as yet unknown date) the sunset date for:

1. Musk xylene and MDA, will be 42 months later,

2. DEHP, BBP and DBP, will be 48 months later, and

3. HBCDD, will be 54 months later.

More substances are expected to be added as SVHC to the Authorisation List in the future.

This article was written for Law-Now, CMS Cameron McKenna's free online information service. To register for Law-Now, please go to

Law-Now information is for general purposes and guidance only. The information and opinions expressed in all Law-Now articles are not necessarily comprehensive and do not purport to give professional or legal advice. All Law-Now information relates to circumstances prevailing at the date of its original publication and may not have been updated to reflect subsequent developments.

The original publication date for this article was 18/10/2010.

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