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EU Definition of Nanomaterial a Step on the Path to Further Regulation
December 14, 2011 | By GILES CHAPPELL
by Giles Chappell, attorney in the Brussels office of McKenna Long & Aldridge
On 18 October 2011, the European Commission published its much-awaited definition of nanomaterials. According to this recommendation, a “Nanomaterial” is:
“A natural, incidental or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm - 100 nm.
In specific cases and where warranted by concerns for the environment, health, safety or competitiveness, the number size distribution threshold of 50% may be replaced by a threshold between 1 and 50%.
By derogation from the above, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.”
The definition will be reviewed in 2014 in the light of technical and scientific progress, particularly whether the number size distribution of 50% should be increased or decreased.
Following the commission’s decision to choose particle number (i.e., the number of particles) rather than weight concentration (mass) as a measuring unit for size distribution of a nanomaterial product in order to determine the cut-off criterion for nanomaterials, many in industry are concerned that such an approach will lead to administrative and financial burdens. As such, companies should carefully inventorize and review their products to determine whether or not they fall within the definition and therefore would be caught by the scope of existing or future requirements.
In fact, now the definition has been published, it is likely that certain Member States and Members of the European Parliament as well as NGOs will place increasing pressure on the commission to introduce requirements, such as:
• obligatory chemicals risk assessment to assess toxicological risk from a regulatory perspective, and risk management measures;
• mandatory reporting to the authorities (similar to recent legislation introduced in France);
• mandatory labeling for all products (e.g., already under the Cosmetic Regulation 1223/2009, cosmetic ingredients present in the form of nanomaterials must be clearly indicated in the list of ingredients. The names of such ingredients must be followed by the word “nano” in brackets). However, there is the risk that consumers may interpret such labeling as warnings, whether or not the nanomaterials consist of dangerous properties;
• pre-market notifications to the authorities (e.g., under the Cosmetics Regulation, products containing nanomaterials require notification six months prior to placing on the market);
• rules on traceability of nanomaterials; and
• rules on liability of nanomaterials if workers or consumers are exposed to any harmful effects.
Such requirements are likely to be applied to all EU legislation concerned by nanomaterials, such as biocides, detergents, cosmetics, food, food contact materials, electrical equipment and chemicals in general, i.e., Reach, although the recommendation specifies that the definition may not be readily usable in pharmaceutical and medical devices legislation.
Thus, companies are advised to already prepare in advance of future requirements, and also to actively engage with the authorities to ensure that any new requirements do not end up blocking the potential of an increasingly developing industry.
About the author: Giles Chappell is an attorney in the Brussels office of McKenna Long & Aldridge LLP. His practice focuses on chemicals (REACH and the CLP Regulation), electronic waste and disposal legislation (WEEE, RoHS), biocides and pesticides legislation, and the developing legal and regulatory framework for nanomaterials.