Originally published as Covington E-Alert in April 2011

THE REACH REGULATION AND SUBSTANCES OF VERY HIGH CONCERN

The European Union’s Regulation (EC) No. 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (“REACH Regulation”) requires the European Chemicals Agency (“ECHA”) to identify so-called Substances of Very High Concern (“SVHCs”) and to list them in the Candidate List of Substances of Very High Concern (“Candidate List”).1

  •  SVHCs listed in the Candidate List are subject to stringent information and notification requirements that apply to the substances on their own as well as to products containing them. For example, starting as of 1 June 2011, manufacturers and importers of objects, such as textiles, paper, electronic components (so-called “articles”), containing a Candidate List substance in concentrations of more than 0,1% may be required to submit a notification to the ECHA. Similarly, since October 2008, as soon as a substance is listed in the Candidate List, suppliers of articles containing such substance in concentrations of more than 0,1% are required to inform their customers. Suppliers of Candidate List substances and mixtures containing them may also be required to supply safety data sheets to their customers. Furthermore, products containing Candidate List substances may also be subject to the REACH prior authorization requirement and to marketing and use restrictions, and may also be restricted under other EU environmental legislation.
  • SVHCs may include Category 1 and 2 carcinogens, mutagens and toxic to reproduction substances (“CMRs”); persistent, bioaccumulative and toxic substances (“PBTs”); very persistent and very bioaccumulative substances (“vPvBs”); and substances raising an equivalent level of concern.

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Photo of Peter Bogaert Peter Bogaert

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in…

Peter Bogaert has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he presents numerous innovative life sciences companies, including start-ups, as well as several industry associations.

Photo of Cándido García Molyneux Cándido García Molyneux

Cándido García Molyneux is a Spanish of counsel in the Brussels office of Covington & Burling.  His practice focuses on EU environmental law, renewable energies, and international trade law.  He advises clients on legal issues concerning environmental product regulation, emissions trading, renewable energies…

Cándido García Molyneux is a Spanish of counsel in the Brussels office of Covington & Burling.  His practice focuses on EU environmental law, renewable energies, and international trade law.  He advises clients on legal issues concerning environmental product regulation, emissions trading, renewable energies, energy efficiency, shale gas, chemical law, product safety, waste management, and international trade law and non-tariff trade barriers.  Mr. García Molyneux was very much involved in the legislative process that led to the revision and amendment of the ETS Directive and Renewable Energies Directive.  He is an external professor of environmental law and policy at the College of Europe.