The European Consumer Organisation (BEUC) has published a proposal to align the definition of nanomaterials used in cosmetic products with the recommendation published by the European Commission last year. Indeed, the definition provided in the Regulation for Cosmetic Products (EC/ 1229/2009), which will enter into force in July 2013, differs significantly from the definition recommended by the Commission.
|COSMETICS REGULATION||COMMISSION RECOMMENDATION|
|‘Nano-material’ (NM) means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm||2. ‘Nano-material’ (NM) means 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-100 nm. |
In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50 % may be replaced by a threshold between 1 and 50 %.
3. By derogation from point 2, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nano-materials.
In 2012 the EU Commission has set up a small working group which is mandated to work out first ideas of how these two definitions can be aligned and finally made applicable to cosmetic products before the new legal requirements for cosmetics containing nanomaterials will enter into force.
In its proposal, BEUC outlines which elements such a new definition should contain “in order to effectively protect consumers from unknown hazards that may be related to cosmetic products which use new materials at an infinite small scale.”
According to BEUC, a definition of nano-materials in cosmetic products needs to:
include all materials in which more than 0.15 % of the number of particles are present in the nano-size range;
cover by-products which are not intentionally manufactured but which are present in the nano-range;
include soluble nano-particles and nano-structures which have specifically been designed to carry encapsulated substances that will be released to the systemic circulation;
include nano-particles below 1nm such as fullerenes;
add a criterion on volume specific surface area as particle size distribution alone is insufficient to give information about the surface area which has an impact on the reactivity of the particles.
In practice, the proposal of BEUC is mainly intended to make more restrictive the definition applicable to cosmetics, in particular regarding the distribution threshold of nanomaterials. “As cosmetic products are directly applied to the skin, we are of the opinion that the 50% threshold is far too high to ensure safety based on the precautionary principle. We argue that even the 1% threshold is too high for cosmetic products because the Commission definition covers all materials including naturally occurring ones whereas the Cosmetics Regulation only covers intentionally manufactured materials,” says BEUC.