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 EU and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the EU Courts in Luxembourg and in…

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

Chambers Global notes that a client said: “He is an extremely experienced professional with broad expertise and provides sensible and well-balanced solutions.” He is consistently ranked by PLC as one of the leading life sciences lawyers globally and Legal 500 EMEA and Chambers Europe note Peter’s prominent regulatory pharmaceutical and environmental practice. Legal 500 EME noted that he is “a superb lawyer who is very pleasant to work with.” Peter regularly writes and speaks on life sciences issues. He is a founding member of the Brussels Pharma Law Group and also served for fifteen years as Managing Partner of the firm’s Brussels office.

Photo of Cándido García Molyneux Cándido García Molyneux

Cándido García Molyneux provides clients with regulatory, policy and strategic advice on EU environmental and product safety legislation. He helps clients influence EU legislation and guidance and comply with requirements in an efficient manner, representing them before the EU Courts and institutions.

Cándido…

Cándido García Molyneux provides clients with regulatory, policy and strategic advice on EU environmental and product safety legislation. He helps clients influence EU legislation and guidance and comply with requirements in an efficient manner, representing them before the EU Courts and institutions.

Cándido co-chairs the firm’s Environmental Practice Group.

Cándido has a deep knowledge of EU requirements on chemicals, circular economy and waste management, climate change, energy efficiency, renewable energies as well as their interrelationship with specific product categories and industries, such as electronics, cosmetics, healthcare products, and more general consumer products. He has worked on energy consumption and energy efficiency requirements of AI models under the EU AI Act.

In addition, Cándido has particular expertise on EU institutional and trade law, and the import of food products into the EU. Cándido also regularly advises clients on Spanish food and drug law.

Cándido is described by Chambers Europe as being “creative and frighteningly smart.” His clients note that “he has a very measured, considered, deliberative manner,” and that “he has superb analytical and writing skills.”