ECHA Designates 15 Substances of Very High Concern under REACH

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October 30, 2008

On October 28, 2008, the European Chemicals Agency (ECHA) published on its website a Candidate List of 15 Substances of Very High Concern (SVHC). The Candidate List generates immediate new legal obligations for suppliers of a listed substance on its own, in preparations and in articles.

In general, substances of very high concern include substances which are:

• Carcinogenic, Mutagenic or toxic to Reproduction (CMR) classified in category 1 or 2,
• Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) according to the criteria in Annex XIII of the REACH Regulation, and/or
• identified, on a case-by-case basis, from scientific evidence as causing probable serious effects to humans or the environment of an equivalent level of concern as those above e.g. endocrine disrupters

The October 28, 2008 list is available here, and ECHA will be updating the list periodically to cover more substances that have hazardous properties.

Substances on the List will be gradually included in Annex XIV of the European Union’s regulation for Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH). Once included in the Annex, they cannot be placed on the market or used after a date to be set unless the company is granted an authorization.

However, inclusion in the list may entail immediate responsibilities for all companies. Effective from the date of inclusion in the Candidate List (October 28, 2008), EU and EEA suppliers of articles which contain SVHCs in a concentration above 0.1% (w/w) must provide, at the consumer’s request, sufficient information to ensure the safe use of the article within 45 days of the receipt of such a request. At a minimum, this information must include the name of the substance.

Those supplying a substance on the Candidate List in itself must provide a safety data sheet to their customers immediately. If a SVHC is included in a preparation not classified as dangerous according to Directive 1999/45/EC in a concentration of at least 0.1%(w/w) for non-gaseous preparations and at least 0.2% by volume for gaseous preparations, the supplier must provide the recipients, at their request, with a safety data sheet.

Beginning December 1, 2011, EU and EEA producers or imports of articles with a presence of a SVHC above 0.1% (w/w) will be required to notify ECHA. Companies must also notify ECHA if SVHC quantities in produced/imported articles exceed 1 ton per year.

While these obligations most obviously affect chemical companies, suppliers to the EU should note that REACH applies to all sectors using chemicals; i.e. not only companies engaged in industrial processes, but also those supplying day-to-day items such as cleaning products, paints, clothing, cosmetics, furniture, electronics, etc.