The proposal comes as the EC prepares to align two different definitions for the term ‘nano-material’, one contained in the EU regulation on cosmetic products and the other in the EU Commission recommendation for the term ‘nano-material’.
The Commission’s aim is to apply the updated definition to cosmetic products as soon as the nano-specific requirements enter into force in 2013.
“In this paper we make concrete proposals on the scope and elements which a definition for the term ‘nano-material’ for cosmetics should comprise,” a BEUC spokesperson told CosmeticsDesign-Europe.com.
“The most important aspects will be setting the right threshold for percentage in particle distribution and to interpret the meaning of ‘intentionally manufactured’. In addition, we have to look into solubility and bio-persistence very carefully too,” they added.
Regulation
The proposal comes after BEUC argued that the definition of nanomaterials in terms of regulation was too narrow and that many escape the safety evaluation process because the definition only covers biopersistent and insoluble particles back in 2009.
That same year the EU adopted a new regulation for cosmetic products (EC/ 1229/2009)2 which featured for the first time specific requirements for nano-materials including a technical definition of this term.
As there was a need for a horizontal definition which could be applied across sectors, the EU then adopted a general definition for the term ‘nano-material’ in a Commission recommendation in 2011.
Proposal
Outlined in the paper, BEUC says that the new definition of nanomaterials in cosmetics needs to include all materials in which more than 15 per cent of the number of particles are present in the nano-size range.
It further advises that products which are not intentionally manufactured but which are present in the nano-range, including soluble nanoparticles and nanostructures add a criteria on volume-specific surface area because particle size distribution alone is insufficient to give information about the surface area which has an impact on the reactivity of the particles.
"As cosmetic products are directly applied to the skin, we are of the opinion that the 50 per cent threshold is far too high to ensure safety based on the precautionary principle. We argue that even the 1 per cent threshold is too high because the Commission's definition covers all materials including naturally occurring ones whereas the cosmetics regulation only covers intentionally manufactured materials."
Thus, the NGO recommends that 0.15 per cent of particles, in an unbound state or as aggregate or as agglomerate or an internal structure with a size below 100 nm should be introduced as deciding threshold for the size distribution of nano-materials.
"This number is recommended by SCENHIR 2009. This value is derived from the mean plus/minus three times the Standard Deviation (indicating 99.7 per cent of the data set of measured nano-particles."