ECHA extends The SVHC Candidate List with 13 new substances
The European Chemicals Agency (ECHA) added 13 further substances to the Candidate List for Authorization of Substances of Very High Concern (SVHC) on June 18, 2012. Several additional entries to the list made in January 2010 and December 2011 are now consolidated, effectively combining several aluminosilicate refractory ceramic fibers (Al-RCF) and several zirconia aluminosilicate refractory ceramic fibers (ZrAl-RCF). This means the list consists of 84 substances now, after merging the two Al-RCF and ZrAl-RCF entries. The ECHA published its draft multi-annual work program in April 2012 and future consultations and discussion should result in the SVHC Candidate List growing steadily during 2013-2015. The future focus is expected to be placed on substances considered to have persistent, bioaccumulative and toxic (PBT) properties and very persistent and very bioaccumulative (vPvB) properties in addition to substances of equivalent concern arising from emerging processes, such as endocrine disruptors and nanoparticles.
Action required of manufacturers and importers in the EU
REACH states that European Union (EU) and European Economic Area (EEA) producers and importers must provide information on the safe use of articles to consumers and users when supplying, and within 45 days on request by consumers, when articles contain a concentration of more than 0.1% (w/w) of a substance on the SVHC list (article 33). Furthermore, REACH requires notification when SVHC in articles exceeds a concentration of 0.1% (w/w) of an article and the total in all articles per producer or importer exceeds 1 tonne per year (article 7). The Center for Research and Information for Organizations of Consumers (Crioc) in Belgium published a report in March 2012 that identified companies that failed to respond to requests for information about the substances in certain articles, which they are obliged to provide under article 33 of REACH (EC No. 1907/2006).
Since December 2010, any SVHC candidates published require the submission of notifications within 6 months following their inclusion on the list. The ECHA has issued reminders to producers and importers of articles about the deadlines for notifying the presence of an SVHC in their products. For example, a reminder was sent on June 6, 2012, about the twenty Candidate List substances published on Dec 19, 2011 whose notification deadline was June 19 2012. For the two refractory ceramic fibers consolidated in December 2011 their scope is wider, but they cover the previous entries from January 2010 fully. Companies who already notified the presence in articles of refractory ceramic fibers according to their January 2010 addition to the Candidate List are not required to notify them again.
The notification deadline is December 18 2012 for the 13 new substances added to Candidate List for SVHC on June 18, 2012.
Qualifications of some SVHC candidates
Four of the 13 newly added SVHCs of June 18, 2012 are only classified as SVHC if they contain a specific concentration of carcinogenic constituents. Namely, C.I. Basic Violet 3, C.I. Basic Blue 26, C.I. Solvent Blue 4 and 4,4'-bis(dimethylamino)-4''- (methylamino)trityl alcohol. These are classified as SVHC only when Michler's ketone or Michler's base ≥ 0.1 % w/w.
All of the new substances proposed are classified as carcinogenic, mutagenic or toxic for reproduction (CMR) and so pose a serious threat to the health of human beings. A table summarizing their potential uses can be retrieved from the SGS news bulletin.
About SGS REACH Services
SGS provides a range of services throughout its global network to ensure and certify compliance with REACH. These include consultancy on the legislation, providing suggestions for alternative manufacturing processes and substitute chemicals. In addition, SGS provides independent analytical laboratory testing for the presence of CMR substances, other substances of very high concern (SVHC) and restricted substances in consumer products for the EU and international markets.
If you would like to learn more about how SGS can support your REACH compliance activities please contact the SGS experts.
SGS Consumer Testing Services
Dr. Udo Krischke
Global Technical Manager RSTS
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