Article 2 of the Cosmetics Regulation defines a 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 revision of the definition of nanomaterial in light of the new recommendation of the European Commission is planned as part of the upcoming revision of the Cosmetics Regulation. However, the French government adheres to a different interpretation of the nanomaterial definition.
French definition
In French Decree No. 2012-232 for the French R-Nano declaration, a nanomaterial is a "substance intentionally manufactured on a nanometric scale and containing particles, unbound or as an aggregate or agglomerate, of which a minimum proportion in the number-size distribution has one or more external dimensions in the range 1 nm to 100 nm ”.
Differences in definitions between the EU and France
Threshold
The French authorities consider that the Cosmetics Regulation does not provide for any threshold above which a substance is considered a nanomaterial and arbitrarily set a tolerance threshold of around 10% in terms of the number of nano-sized particles in order to take into account the uncertainties of the measurement methods and potential environmental contaminations.
This threshold is also subject to debate since it is different from the one of 50% provided under Regulation (EU) N°1907/2006 (REACH) which is fully and directly imposed in the EU on manufacturers of raw materials intended in particular for the cosmetics sector. Likewise, the European Commission Recommendation 2011/696 gives a definition by referring to a threshold of 50%: "means a natural, incidental or manufactured material consisting of solid particles that are present, either on their own or as identifiable constituent particles in aggregates or agglomerates, and where 50% or more of these particles in the number-size distribution have one or more external dimensions in the range 1 nm to 100 nm”.
Internal structure
The Cosmetics Regulation does not provide for the automatic authorization of agglomerated, aggregated, or grafted structures on the (unproven) grounds that the nanoparticles cannot become detached from the structure. However, the French authority emphasizes that the assertion that the nanoparticles cannot become detached from the structure at any point during the lifetime of the raw material or the finished product has not been scientifically established. Therefore, the possibility of nanoparticles (e.g., Titanium Dioxide grafted onto Mica flakes (pearlescent pigments)) becoming detached from the structure cannot be precluded. Where such proof exists, the Scientific Committee on Consumer Safety (SCCS), as part of the authorization application for the use of such substances, must evaluate the possibility of nanoparticles detaching from the main structure.
The European Commission Recommendation 2011/696 as well as the French authority, specify that to be considered a ‘nanomaterial’, a material must consist of solid particles and that the nanomaterial definition is based on particle external dimensions. Nanostructured materials that are not agglomerates or aggregates are not nanomaterials. However, nanostructured materials that have nanoscale internal or surface structures are included in the definition of nanomaterials according to Article 2 of the Cosmetics Regulation. 'Nanostructured materials' are materials (either particulate or not) that have internal structures at the nanoscale (one example would be highly porous materials such as zeolites).
Intentionally manufactured
What is more, the French authority defines nanomaterials as "intentionally manufactured materials". The term "intentionally" excludes cases where nanoparticles make their way into the product by accident or occur naturally in the ingredients used. Unlike, the European Commission Recommendation 2011/696 of nanomaterials definition is broader as it covers all materials (i.e., natural, incidental, or manufactured materials).
Insoluble and biopersistant
Article 2 of the Cosmetics Regulation defines a nanomaterial as “an insoluble or biopersistant", a term not used in the definition of nanomaterial according to the French authority. The threshold of 33.3 g/L for distinguishing between soluble and insoluble materials has been set by the SCCS according to the recent Opinion on the solubility of synthetic amorphous silica (SAS). The bio-persistence is a more difficult concept to grasp because it relates to the way in which a material interacts with the body-a matter on which there is no established expert opinion or frame of reference. A responsible person asserting that a nanomaterial is not biopersistant must provide proof to support the claim.
Mandatory French notification scheme of Nanomaterials
As of January 1, 2013, French manufacturers, importers, and distributors of more than 100 grams per year of substances in nanoparticle form, from 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. The data reported in the R-Nano register managed by ANSES provide a better understanding of the nanomaterials placed on the market, the quantities handled, and the intended uses, enable traceability in the sectors using them, and bring together knowledge for risk assessment and public information purposes.
Note that the ingredient supplier must inform the responsible persons of the nano nature or particle size of the ingredients they sell, and that are subsequently incorporated into the finished products. A "non-nanomaterial" certificate without evidence of adequate analyses having been performed is not sufficient to meet regulatory requirements. A particle size distribution curve, expressed in a number of particles, must support the supplier's reasoning. If the latter is unable to provide such evidence, it is up to the person responsible for marketing the product to carry out the appropriate analyses.