18 October 2011 13:00 [Source: ICIS news]
LONDON (ICIS)--The European Commission has adopted the recommendation for a common definition of the term “nanomaterials” that is broadly applicable to all EU legislation and can be used for regulatory purposes, it said on Tuesday.
Nanomaterials have now been defined as “materials whose main constituents have a dimension of between 1 [billionth] and 100 billionth of a metre”.
The Commission said the announcement marks an important step towards greater protection for citizens, clearly defining which materials need special treatment in specific legislation, in order to ensure that appropriate chemical safety rules apply.
Nanomaterials are governed by a variety of legislative instruments at EU and national level. However, definitions have been developed on a case-by-case basis and vary across sectors, which the Commission said created unnecessary burdens for industry and hampered public debate about the risks and benefits of these substances.
The definition adopted is based on an approach that considers the size of the constituent particles of a material, rather than hazard or risk, the Commission said.
The wording describes a nanomaterial as “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 [nanometre] – 100 nm”, it added.
“We have come up with a solid definition based on scientific input and a broad consultation,” said European environment commissioner Janez Potocnik.
“Industry needs a clear coherent regulatory framework in this important economic sector, and consumers deserve accurate information about these substances. It is an important step towards addressing any possible risks for the environment and human health, while ensuring that this new technology can live up to its potential,” he added.
The Commission said the definition, based on scientific advice from the Scientific Committee on Emerging and Newly Identified Health Risks and the Joint Research Centre, will help stakeholders, including industry associations, as it brings coherence to the variety of definitions in use in different sectors.
The definition will be reviewed in 2014 in the light of technical and scientific progress, it added.
Cefic, the European chemical industry council, despite welcoming the Commission’s regulatory definition for nanomaterials, said it is concerned that the recommendation is too broad in scope and will be difficult to integrate into existing legislation in a meaningful way.
The trade group fears implementing the proposed definition will add unnecessary burden for companies, leading to added costs and less efficient use of resources, it said.
“In addition, its current form would define as nanomaterials some decades-old substances such as mineral pigments used in paints and other everyday products,” it added.
The chemical industry is also concerned by the lack of standardised measurement techniques, which are important for legal certainty, Cefic said.
“A common definition for nanomaterials is important to help research and innovation make the next great breakthroughs to meet societal needs and ensure the right level of safety,” said Cefic director general Hubert Mandery.
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