Divergences in regulatory framework with regards to nanomaterials in cosmetics between France and the EU

Inconsistencies and incongruencies regarding accepted definition of nanomaterials for use in cosmetics has becoming a contentious issue these days.

According to the EU Cosmetics Regulation, a nanomaterial is "an insoluble or bio-persistent material with one or more external dimensions or internal structure on the scale of 1 to 100 nm." This definition applies exclusively to cosmetics.

The French government adheres to a strict interpretation of the nanomaterial definition. Specifically, during post-market controls, a 10% nanoparticle tolerance threshold is applied to cosmetic products. In addition, French authorities emphasise that approval of agglomerated, aggregated, or grafted structures is not automatic. Therefore, the Scientific Committee on Consumer Safety (SCCS) must evaluate these instances and give special consideration to the possibility of nanoparticles detaching from the main structure.

As of January 1, 2013, French manufacturers, importers, and distributors of nanomaterials in all sectors, including cosmetics, must provide an annual declaration about those substances and their main characteristics. Article L523-1 of the French Environmental Code establishes the mandatory national notification scheme. Data are incorporated in the R-Nano register under the responsibility of ANSES (French Agency for Food, Environmental and Occupational Health and Safety), which aims to track the nanomaterials in France and gather knowledge about their use and properties.