European safety assessment of nanomaterials in cosmetics
The European Commission's Scientific Committee on Consumer Safety (SCCS) has published the 2nd revision of Guidance on the Safety Assessment of Nanomaterials in Cosmetics. The new guidance introduces the new European Commission (EC) recommendation for a definition of nanomaterials, although this recommendation has not yet been applied to the definition of nanomaterials under Cosmetic Regulation (EC) No 1223/2009. New sections in the guidance document cover solubility and dissolution rate, solubility in non-aqueous media, evidence for the absence of nanoparticles, dispersion, aspect ratio, uptake into blood cells, reproductive toxicity, and endocrine disruption.
The new European Commission (EC) recommendation for a definition of nanomaterials is based on particle size distribution. If more than 50% of the particles in a material have external dimensions between 1nm-100nm, it is considered a nanomaterial (the flexibility in this threshold “in specific cases” is removed). The updated definition includes elongated shapes (rods, fibres, tubes) if two external dimensions are smaller than 1 nm and plate-like structures where one external dimension is smaller than 1 nm. However, particles that are significantly larger overall - with at least two orthogonal external dimensions greater than 100 µm, or materials with a volume-specific surface area less than 6 m2/cm3 are not considered nanomaterials. Nor are large solid materials such as coatings, nanoporous and nanocomposite materials, even when they have an internal structure or a surface structure at the nanoscale.
The new guidance on solubility assessment is important. Any nano-specific risk may change (even diminish) when a nanomaterial is dissolved, but it is the time over which the dissolution happens that determines the considerations for risk assessment.
The document also highlights ongoing developments in vitro and ex vivo methods, in silico models, grouping and read-across, physiologically-based pharmacokinetic and toxicokinetic modelling, used to obtain toxicological data (animal testing data obtained before March 2013, or obtained to meet requirements under a different regulatory framework, not for cosmetics, can also be used).
Vireo’s team of experts creates strategies to demonstrate technical performance and safety of nanomaterials in a wide range of products, including cosmetics. We conduct risk assessments, including physicochemical, exposure and hazard characterization, across the product life-cycle. Our mission is to support innovative organizations bringing better, more-sustainable materials to market while protecting their employees, customers and the environment.