In November 2009, the European Union member states agreed to recast some 55 directives relating to cosmetics into a single regulation on cosmetic products, the EU Cosmetics Regulaton (EC No 1223/2009), which has been in force since July 2013. As the first piece of national or supranational legislation to incorporate rules relating specifically to the use of nanomaterials in consumer products, this regulation was considered to be significant at the time (Bowman et al., 2010).
For the purposes of the EU Cosmetic Regulation, the following definition applies to the term 'nanomaterial': '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'.
Adaptation of this definition is currently underway, in light of the various definitions of nanomaterials published by different bodies - including the EU recommendation on the definition of a nanomaterial (2011/696/EU) - and technical and scientific progress in the nanotechnology field.
The Cosmetics Regulation also introduces conditions for the notification and safety assessment of cosmetic products containing nanomaterials. Cosmetic products containing nanomaterials must be notified to the Commission via the online Cosmetic Products Notification Portal at least six months prior to being placed on the market, including specific data relevant for risk assessment purposes (e.g. substance identification, physico-chemical properties, toxicological profile, and reasonably foreseeable exposure conditions).
The Scientific Committee on Consumer Safety (SCCS) has published guidance to help the cosmetics industry comply with these requirements, and the Cosmetic Ingredient Database (CosIng) provides access to information on notified cosmetic substances and ingredients. The Cosmetics Regulation also requires labelling of nanomaterials in the list of ingredients with the word ‘nano’ in brackets following the name of the substance (e.g. ‘titanium dioxide (nano)’).
When there are concerns over the safety of a nanomaterial, the Commission will refer it to the Scientific Committee on Consumer Safety (SCCS) for risk assessment.