In July (my July 16, 2010 posting), I commented on my confusion about what I termed a peculiar European public consultation on a definition for nanomaterials. (I also had a previous posting on July 6, 2010 about a proposed nanomaterial definition for Europe.) A recent news item on Nanowerk has almost clarified matters for me,
In its response to the European Parliament resolution of 24 April 2009, the Commission agreed on the need to develop a definition, preferably at global level, to serve as a basis also for EU regulation and implementing measures and instruments.
The Commission is now putting forward a draft Recommendation containing such a definition for public consultation. Stakeholders are invited to send their views on the envisaged definition of the term ‘nanomaterial’ by 19 November 2010 to ENV-NANO-CONSULTATION@ec.europa.eu. Responses will be placed on the Commission’s website unless explicitly requested otherwise by the stakeholders in their response.
The text builds notably on the work done by the Commission’s Joint Research Centre and the input of the Scientific Committee for Emerging or Newly Identified Health Risks (SCENIHR) which itself conducted a public consultation on its work earlier this year1. [emphasis mine] It takes the work of international organisations2 and third countries in this field into account.
The public consultation in July 2010 seems to have been conducted by SCENHR and this new one is being conducted by a parent (?) organization. Regardless, there is a second public consultation open from Oct. 21, 2010 to Nov. 19, 2010. You can visit this European Commission website to find more information about the consultation and to participate.
The nanomaterial definition being considered is this one,
Nanomaterial: means a material that meets at least one of the following criteria:
– consists of particles, with one or more external dimensions in the size range 1 nm – 100 nm for more than 1 % of their number size distribution;
– has internal or surface structures in one or more dimensions in the size range 1 nm – 100 nm;
– has a specific surface area by volume greater than 60 m2/cm3, excluding materials consisting of particles with a size lower than 1 nm.
2. Particle: means a minute piece of matter with defined physical boundaries (ISO 146446:2007) (p. 6 PDF, p. 5 print)
“The term ‘substance characteristic’ means, with respect to a particular chemical substance, the physical and chemical characteristics that may vary for such substance, and whose variation may bear on the toxicological properties of the chemical substance, including—
(A) chemical structure and composition
(B) size or size distribution
(D) surface structure
(E) reactivity; and
(F) other characteristics and properties that may bear on toxicological properties” (page 11)
It’s the category which gives people implementing the regulations some discretion in the event that some currently unforeseen characteristic has a toxic impact, that I think is important. Given our current uncertainty about the safety of nanoparticles and nanomaterials and the fact that we’re still in the early stages of introducing them into use, I would prefer that officials have some discretion to act in the interim without having to negotiate for whole new rules and regulations.