Substances of Very High Concern (SVHC)

What is a Substance of Very High Concern?

Substances of very high concern are substances that have hazards with severe consequences. Substances meeting the criteria may be placed on a list. The list of SVHCs was first published on 28 October 2008 and was last updated on 25 June 2011. This list is known as the Candidate List and all substances are added by the European Chemicals Agency (ECHA). SVHC may have very serious, or in some cases, irreversible affects on both people and the environment, hence the reason for their authorisation.

Authorisation

Substances of very high concern will be gradually included in Annex XIV of the Registration, Evaluation, Authorisation and restriction of CHemicals (REACH) Regulation. Once the substance has been included in this Annex, they cannot be placed on the market or used after a date to be set (the so-called “sunset date”) unless authorisation has been granted to the company.

 

How does a SVHC become selected to go on the list?

The criteria for a SVHC are given below:
 A substance may be proposed as an SVHC if it meets one or more of the following criteria, these criteria can be found in Article 57 of REACH:

  • It is carcinogenic, mutagenic or toxic for reproduction (CMR) classified in category 1 or 2;
  • It is persistent, bioaccumulative and toxic (PBT) according to the criteria set out in Annex XIII of the REACH Regulation;
  • It is very persistent and very bioaccumulative (vPvB substances) according to the criteria set out in Annex XIII to the REACH Regulation;
  • There is "scientific evidence of probable serious effects to human health or the environment which give rise to an equivalent level of concern". Such substances are identified on a case-by-case basis, for example, endocrine disrupters.

If a substance meets one or more of the criteria, it will not automatically be a SVHC. Many substances are already subject to restrictions on their use within the European Union, such as those named in Annex XVII of the REACH Regulation. SVHCs are substances for which the current restrictions on use (where these exist) might be insufficient.

There are three priority groups for review:

  • PBT substances and vPvB substances;
  • Substances which are widely dispersed during use;
  • Substances which are used in large quantities.

Proposals to include a substance on the list of SVHCs can come from the European Commission or one of the Member States of the European Union. These proposals are publically available by the European Chemicals Agency (ECHA) and are open for comment for a 60–90 day period. If the substance is thought to meet one or more of the criteria, it is then listed as an SVHC.

Once a substance has been listed as an SVHC, the Agency creates a technical report containing the analysis from national or private laboratories. The laboratory will analyse the available information on manufacture, importation, uses and substance release, as well as any other possible alternatives. On review of this technical report, the Agency decides whether to prioritise the substance and whether to make a recommendation to the European Commission to add the substance to Annex XIV of the REACH Regulation, making its use subject to authorisation. The draft recommendations must be made public and opened for comment for three months before the final recommendations are sent to the Commission. The first draft recommendations were published on 14 January 2009, and new draft recommendations must be issued at least once every two years.
What happens when a SVHC goes on the list?
The list of SVHCs is a public list of substances for which the European Chemicals Agency is considering making a requirement for authorisation for some, or even all uses. However, there are some direct consequences of including a substance on the list of SVHCs;

  • Suppliers of pure SVHCs must provide customers with a safety data sheet (SDS).
  • Suppliers of mixtures of substances which contain more than 0.1% by weight of any SVHC must provide their customers with a safety data sheet if requested. 
  • Manufacturers or importers of articles containing more than 0.1% by weight of any SVHC must provide their customers, and consumers on request, with adequate information on the safe use and disposal of the article, including the name of the SVHC(s) concerned.

From 1 June 2011, manufacturers and importers of articles will also have to notify the European Chemicals Agency of the quantities of SVHCs used in their article.

Where can I find the list?

The list can be found on the ECHA website