Industry needs to act on EC nano regulation

Dr Anna Gergely, Director EHS Regulatory in the Brussels offices of international law firm Steptoe & Johnson, says that SCENIHR’s scientific opinion, together with the policy paper published recently by the EC’s Joint Research Centre (JRC), indicate that regulators are likely to adopt a fairly broad size-based definition of nanomaterials, backed up by a series of case-by-case exclusion criteria.

“Industry may consider commenting on the approach of a generic definition in combination with exclusions as a whole,” says Gergely.

“If industry supports the proposed approach, companies should be prepared to get involved in the discussion on the exclusion criteria’s scope and nature as well as the conditions under which such criteria could be amended<" she told European Plaastics News this week.

JRC and SCENIHR both agree there should be an overarching basic definition of the term nanomaterial. SCENIHR proposes such generic definition in combination with case-by-case exclusion criteria, while the JRC concludes that specific inclusion or exclusion of certain nanomaterials needs to be considered.

Both conclude that size should be the “predominant feature” of the overarching definition, but because special nano-size related characteristics vary neither the JRC or SCENIHR believe it is possible to identify a specific size limit at which a new specific property would change or appear.

SCENIHR says that because of this the use of a single upper value might be too restrictive. So it proposes a tiered approach to the risk assessment of nanomaterials, suggesting 500 nm as the high upper threshold and 100 nm as low upper threshold: If the median size of the material is above 500nm, a classical risk assessment can be performed. If the median size is below 500 nm, a material is considered to be a nanomaterial and a nanospecific risk assessment is necessary. The JRC uses a size definition of between 1nm and 100nm.

Both JRC and SCENIHR size-based definitions would ‘catch’ a very broad range of materials, says Gergely. So to avoid frequent revisions of the definition in the light of scientific/technical progress, they recommend development of case-by-case criteria that would exclude certain areas of application and specific structures. However, neither specify the recommended exclusion criteria in more detail.

“It is important that this ambiguity is resolved, in order to make sure that potential sector specific modifications are of practical relevance,” says Gergely.

“Companies should be prepared to adopt positions on characteristic parameters (size, size distribution, specific surface area (VSSA), surface modification, other physico-chemical characteristics such as crystallinity, redox potential, zeta potential, photocatalytic activity, solubility etc).”

SCENIHR’s consultation period runs up to 15 September. Comments can be registered here.