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Nanomaterials and the EU Cosmetics Regulation: Implications for Your Company

By: Giles Chappell
Posted: March 20, 2012

Nanomaterials are increasingly used in beauty products, but regardless of the consumer benefits, questions persist about the real and perceived risks to human health and safety. This uncertainty arises, in particular, because the chemical and physical properties of particles at the nanoscale may be significantly different from those of the same substance at a larger scale. According to the Scientific Committee of Emerging and Newly Identified Health Risks (SCENIR): “there is insufficient knowledge and data concerning nanoparticle characterisation, their detection and measurement, the fate (and especially the persistence) of nanoparticles in humans and in the environment, and all aspects of toxicology and environmental toxicology related to nanoparticles.”

Thus, an important balancing act has to be made between safety concerns and the desire to avoid constraining one of the EU’s fastest developing industries.

In the EU, the new Cosmetic Products Regulation 1223/2009 (which will fully replace Directive 76/768/EEC by July 11, 2013) attempts to go some way in addressing concerns over nanomaterials. The regulation sets out four key provisions concerning nanomaterials:

Definition: under Article 2(1)(k), “‘nanomaterial’ 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.” However, following the more general definition published by the European Commission on October 18, 2011 in recommendation 2011/696/EU, a working group is currently analyzing whether the definition of nanomaterial in the Cosmetic Products Regulation should be modified.

Labelling: under Article 19(1)(g), all ingredients present as nanomaterials must be indicated on the package, beginning July 11, 2013, with the word “nano” in brackets.