EU Nano-Regulation: Specific Nanomaterial Register under REACH and Mandatory Labeling for Consumer Products?
Ahead of the EU Commission’s nanotechnology regulatory review next year, several EU members are advocating the creation of a specific register for nanomaterials under the EU’s REACH (Registration, Evaluation, and Authorization of Chemicals) chemicals regulation. There are also calls for mandatory labeling of the presence of nanomaterials in consumer products sold in the EU.
Most recently, on September 14, 2010, the Belgian EU Presidency proposed those nanotechnology regulatory measures at the opening of an EU workshop on the traceability of nanomaterials. "Nanomaterials are increasingly present in consumer products and everyday items we use, and yet we don't know a lot about them," said Paul Magnette, the Belgian minister in charge of consumer protection and environment. He also argued that "the current development approach for nanomaterials without prior notification of their presence or labelling of their characteristics or potential toxicity is not acceptable".
Magnette seemed to strike a balance between calls for a moratorium on nanomaterials based on the precautionary principle and arguments from industry groups, which say their potential risks to human health are have not been proven. The so-called "no data, no market" principle, which would establish a de facto moratorium, would be too restrictive, Magnette said. But he also criticized a posture where only the merits of nanomaterials are currently being put forward by industry.
This week’s remarks follow a report a few months ago from the French Agency for Environmental and Occupational Health Safety (AFSSET), which called for the REACH legislation to be rewritten to specifically address manufactured nanomaterials. AFSSET's report, "Evaluation of Risks Linked to Nanomaterials for the General Population and for the Environment", recommended acting immediately to require all nanomaterials to be traceable, to require labeling of products containing nanomaterials, and to ban nanomaterials for uses in which their utility is outweighed by potential risks.
The AFSSET report identifies several hundred consumer products containing nanomaterials and says that "[N]ew studies suggest possible risks for health and the environment linked to certain of these products," particularly antibacterial socks containing nanosilver, quick dry cement and sunscreen containing titanium dioxide, and nanometric silica used in food products.
EU to Complete Regulatory Review of Nanomaterials by end 2011 ?
After a first review in June 2008, the EU Commission is committed to completing its second regulatory review of nanomaterials by the end of 2011.
The European Commission's department for enterprise and industry has stated that the 2011 review will focus on the specific inclusion of nanomaterials under the REACH regulations, and that all aspects related to exisiting environmental legislation on water, waste, and air - as well as worker safety - will be addressed.
If you do business in the EU, or have clients that do, it is critical that you watch these moves closely.