INSIGHT: Counting the legal costs of nanomaterials

19 October 2011 16:31  [Source: ICIS news]

By Nigel Davis

European Commission headquarters, BrusselsLONDON (ICIS)--Size may be important when it comes to defining nanomaterials, but weight is even more so for the chemical industry.

The sector is far from pleased that the European Commission has listened to its own scientific experts and recommended a legal definition for nanomaterials based on particle number distribution.

The industry has advocated internationally through the International Council of Chemical Associations (ICCA) the use of weight concentration to help decide what is and what is not a nanomaterial.

The definitions are vitally important because they will be used by the Commission to decide what legislation applies to materials of this type.

“A practical definition for nanomaterials is essential for balancing the risk and benefit discussion,” said Hubert Mandery, director general of the European Chemical Industry Council (Cefic), on Tuesday.

“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.”

But the newly defined materials, as the Commission definition stands, will sweep many more substances – including certain pigments and products that have been widely used for years – into the nanomaterials net.

And when defined as such, they will require special treatment under the Registration, Evaluation and Authorisation of Chemicals (Reach), the EU’s chemicals policy, and any future legislation that might specifically target the hazards and risks posed by nanomaterials.

The chemical industry says it supports the need for a definition to allow a consistency of approach to legislation from regulators and the industry. But differences on the definition are clearly set to cause problems.

“We are concerned that we lack the standardised measurement techniques [that] will be important for establishing the legal certainty that particular substances are or are not nanomaterials, and that the proposed definition will add unnecessary burden for companies, leading to added costs and less efficient use of resources,” said Dr Anne-Gaelle Collot, head of environment at the UK’s Chemical Industries Association (CIA), following the Commission’s decision.  

Cefic said in a statement that the Commission’s recommended definition “is too broad in scope, and therefore difficult to integrate into existing legislation in a meaningful way”.

But the Commission says its definition takes into account advice from the Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and other scientific bodies, as well as the size range of nanoparticles used in the International Organization for Standardization (ISO) term “nanomaterial”.

“The amount of nanoparticles in a material can be determined based on mass (weight of nanoparticles to total weight of material) or based on the numbers (number of nanoparticles to total number of particles, ‘number size distribution’),” the Commission explained this week.

“There is a correspondence between the two measures for every material, but size and mass distribution are not directly convertible.”

The SCENIHR’s argument was that, in its opinion, “a low mass concentration of nanoparticles in a product may still represent a high number of particles and a mass based distribution can be skewed by the presence of relatively few large and thus heavy particles”, the Commission explained.

“Therefore it considered number size distribution as a more relevant metric for possible effects of nanoparticles than mass concentration,” it added.

The Commission acknowledges that it will have to give practical guidance on how measurements might be made. A detailed review of the metrics and other aspects of the Commission’s proposals is planned for 2014.

“The experience of the first registration deadline [30 November 2010] under Reach, the Commission’s overarching chemicals policy, showed that companies needed more clarity about their obligations with regard to nanomaterials,” the Commission said.

“Reach has a key role to play in generating information about the properties of nanomaterials as chemical substances. With the adopted definition, it will be easier for companies to assess their registration dossiers and determine exactly when they should consider their products as nanomaterials.”

The Commission’s definition does not imply that nanomaterials are intrinsically hazardous: “The breadth of the definition is a deliberate choice flowing from its exclusive focus on size.

“It is imperative to underline that materials covered by the definition are not more hazardous as such than larger but otherwise identical materials. Whether a nanomaterial is hazardous will only be determined as part of a risk assessment.”

It also plays down the economic impact of the definition – the key argument of the chemical industry – saying that “it is simply a categorisation of certain materials based on their size”.

But Cefic says it offers industrial experience to “illustrate the practical consequences of the definition proposals under discussion based on real materials”.

According to Mandery: “Nanomaterials offer real potential to improve quality of life in many areas, from climate change to health care. A practical definition for nanomaterials is essential for balancing the risk and benefit discussion.”

By: Nigel Davis
+44 20 8652 3214

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