On July 11, 2013, European Cosmetics Regulation EC No. 1223/2009 will be fully enforced across the Member States of the European Union (EU). This regulation is directly applicable and does not require national implementation, unlike the Cosmetics Directive 76/768/EEC that it replaces. As explained in the March 2013 edition of this column, the main purpose of the regulation is unchanged: to provide high level protection to human health and a single-functioning internal European market for goods and services.
Although originally presented as a consolidation and simplification of the Cosmetics Directive and its complex amendments, the recasting of the directive into a regulation for cosmetic products was used as an opportunity to extend the scope in several areas. One of these concerned the use of nanomaterial in cosmetic products, now defined in Article 2(k) of the regulation. It states, “‘Nanomaterial’ means an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.”
Although this definition sounds useful in the context of cosmetic ingredients, in practice, almost all of the elements need further clarification and agreement, including: insoluble, biopersistent, intentional, manufactured and internal structure. There are also difficulties for ingredient suppliers, product manufacturers and enforcement authorities in measuring materials in a consistent fashion when some of the particles have one or more dimensions, whether internal or external, on the 1 to 100 nm scale. Nevertheless, manufacturers or, more accurately, Responsible Persons (RP), are required to comply with specific requirements as laid out in Article 16 for nanomaterials and for cosmetic products containing nanomaterials. There are three nano-related requirements for industry: notification to the European Commission (EC) six months prior to placing the product on the market; safety assessment of the cosmetic product with particular attention to nanomaterials; and the labeling of ingredients that are nanomaterials.
This content is adapted from an article in GCI Magazine. The original version can be found here.