Regulatory Developments

EU Council Adopts Updated Cosmetics Regulation Requiring Labeling of Nanoscale Ingredients

November 30, 2009 PRINT

On November 20, 2009, the European Union (EU) Council approved an updated cosmetics regulation that would require cosmetic products that contain nanoscale ingredients to be labeled as such.  The regulation would also require the manufacturers of new cosmetic products containing nanomaterials to notify the European Commission (EC) and provide certain information six months before the product is placed on the European market.  If the EC has concerns regarding the safety of the nanomaterial, it would ask the Scientific Committee for Consumer Safety (SCCS) to give its opinion.  Manufacturers of products containing nanoscale ingredients already being sold in the EU also would have to notify the EC and submit safety data.  The regulation is expected to be published soon in the Official Journal of the European Union, and is available at http://register.consilium.europa.eu/pdf/en/09/st03/st03623.en09.pdf.

The regulation defines nanomaterial as “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.”  The regulation requires that all nanomaterial ingredients “be clearly indicated in the list of ingredients,” and the names of such ingredients shall be followed by the word “nano” in brackets.  The regulation states:

The use of nanomaterials in cosmetic products may increase with the further development of technology.  In order to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials at international level.  The Community should endeavour to reach an agreement on a definition in appropriate international fora.  Should such an agreement be reached, the definition of nanomaterials in this Regulation should be adapted accordingly.

 

At present, there is inadequate information on the risks associated with nanomaterials.  In order to better assess their safety the SCCS should provide guidance in cooperation with relevant bodies on test methodologies which take into account specific characteristics of nanomaterials.

 

The Commission should regularly review the provisions on nanomaterials in the light of scientific progress.

The regulation directs the EC to “make available a catalogue of all nanomaterials used in cosmetic products placed on the market, including those used as colorants, UV-filters and preservatives in a separate section, indicating the categories of cosmetic products and the reasonably foreseeable exposure conditions.  This catalogue shall be regularly updated thereafter and be made publicly available.”  The EC will also prepare an annual state report for the European Parliament and EU Council on developments in the use of nanomaterials in cosmetic products.  The regulation will replace the current EU Cosmetics Directive 76/768/EEC.  Within the EU, regulations automatically apply to all 27 member states, unlike directives, which must be implemented through legislation within each member state.

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