REACH – Substances of Very High Concern – Annex XIV

REACH Annex XIV has introduced controls on Substances of Very High Concern (SVHC) because of their potential harm to human health or the environment. From 1 Jun 2011, ECHA must be informed of the presence of SVHCs in a wide range of products if the total quantity used is > 1 tonne per annum and the SVHC is > 0.1% of the product by weight.

The minimum criteria for SVHCs are explained in Article 57 of the REACH Regulations:

  • carcinogenic, mutagenic or toxic to reproduction (CMRs);
  • persistent, bio-accumulative and toxic (PBTs);
  • very persistent and bio-accumulative (vPvBs);
  • seriously and / or irreversibly damaging the environment or human health, such as substances damaging the hormone system;

The first ‘Candidate List’ of SVHCs was published by ECHA in October 2008, and the latest in June 2011. They will be gradually included in Annex XIV of the REACH Regulations. Priority will be given to PBT and vPvBs, substances that end up in a lot of products, and those used in large quantities.

Currently there are 73 substances declared on the SVHC candidate list published by ECHA, latest additions December 2011. This list will be regularly updated as member states suggest more substances for inclusion. Here is the link to ECHA website:

Impact on the tyre industry:

Tyres belong to the “article” category under REACH. Suppliers of tyres must fulfil the following obligations when a SVHC on the candidate list is present:

  • Communication Requirement: Suppliers of tyres which contain substances on the Candidate List in a concentration above 0.1% (w/w) have to provide sufficient information (such as SDS, substance declaration) to allow safe use of the article to their customers or upon request, to a consumer within 45 days of the receipt of the request. This information must contain as a minimum the name of the substance.
  • Notification : EU producers or importers of tyres have to notify ECHA if their article contains a substance on the Candidate List. This obligation applies if the substance is present in those articles in quantities over one tonne per producer or importer per year and if the substance is present in those articles.

PAHs are most likely to be present in rubber oil, carbon black, rubber additives, reclaimed rubber and these can all be components of tyres. Some SVHCs might also be present in tyres. Both PAHs and SVHCs apply to tyres due to the complexities of manufacturing process and the possibility of non-compliant raw materials being used.

To protect consumers and avoid possible product recall, sales ban or penalties, tyre companies shall take PAHs and SVHCs seriously in their products. Laboratory testing is the most reliable way to identify PAHs and SVHCs in products and ensure compliance.

Tyre manufacturers, importers and distributors need to know whether toxic chemicals such as PAHs and SVHCs exist in their tyres to meet their REACH obligations. Tyre manufactures also need to make sure all raw materials have been registered and their uses have been covered in the registration.

Rubber Consultants Testing Services for the Tyre or General Rubber/Polymer Goods Industry

Testing for SVHCs x 73 – according to the current ECHA list

This is a limit test – Pass or Fail the REACH SVHCs limit of 0.1%.

For further information please contact us.

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