REACH Update: Substances of Very High Concern

Nov 18, 2008 | Contact Author | By: Annelie Struessmann, PhD, CONUSBAT
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Title: REACH Update: Substances of Very High Concern
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On Oct. 28 2008, the European Chemicals Agency (ECHA) published the first Candidate List of Substances of Very High Concern (SVHC). The list includes 15 substances and will be regularly updated when further SVHCs are identified. Within REACH it is considered essential to regulate these substances, as the effects on humans and the environment can be serious and often irreversible.

The publication of the ECHA candidate list is the first step in the REACH procedures towards authorization. Further authorization mechanisms include in-depth assessments and thorough evaluations before decisions are made and a substance is included in Annex XIV’s List of Substances Subject to Authorization. If listed in Annex XIV, substances cannot be placed on the market or used after a set date, known as a sunset date, unless an authorization is granted. The tonnage threshold does not apply for authorization. The process towards authorization consists of four steps with obligations for the industry in step three. The first step, as previously mentioned, is the SVHC candidate list. The second step is the prioritization process of Annex XIV by the authorities. Applications for authorization are then submitted, and finally, authorization is granted by the European Commission.

For a chemical to be identified as being of very high concern it must be: Carcinogenic, mutagenic or toxic to reproduction (CMR) of categories 1 or 2; persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) according to the criteria of Annex XIII (REACH Regulation); be 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.

As a consequence of the publication of the candidate list, new legal obligations result for companies and for communication in the supply chains. These obligations are linked to the listed substances on their own, in preparations and also to their presence in articles.

As of Oct. 28, 2008: suppliers of articles which contain substances on the candidate list in a concentration above 0.1% w/w must provide sufficient information to their customers and upon request to consumers; suppliers of a substance have to provide a safety data sheet to their customers when the substance is on the candidate list; suppliers of preparations not classified as dangerous according to Directive 1999/45/EC have to provide the recipients, at their request, with a safety data sheet if the preparation contains at least one substance on the candidate list and its individual concentration is at least 0.1% w/w for non-gaseous preparations and at least 0.2% w/w by volume for gaseous preparations.

On Dec. 1, 2011, EU and EEA producers or importers of articles will have to notify ECHA when their article contains a substance on the candidate list. This obligation applies if the substance is present above 0.1% w/w and its quantities in the produced/imported articles are above 1 ton per year per company. Cosmetics ingredients may become subject to authorization processes. However, if the substances are included in Annex XIV (REACH) because they are considered as being carcinogenic, mutagenic or toxic for reproduction, or because an ‘equivalent level of concern’ was identified, the use in personal care products will not be authorized due to the CMR prohibition of the Cosmetics Directive (76/768/EEC). If the substance is included in Annex XIV for environmental reasons, companies may obtain authorization for use in personal care products.

Further questions? Visit C&T magazine's REACH Round Table.

Readers are reminded that the text of the REACH Regulation (EC) No 1907/2006 is the only authentic legal reference. The information in this document does not constitute legal advice.