09 March 2023 – According to the EU Cosmetics Regulation, a nanomaterial is “an insoluble or bio-persistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm” (EC, 2009). This definition applies only to cosmetic products.
Last year, the European Commission issued a recommendation on a new definition of nanomaterial for legislative purposes. In light of this, adopting the same definition for cosmetic products is under discussion in the context of the revision of the EU Cosmetics Regulation.
French definition
French authorities follow a strict interpretation of the definition of nanomaterial. In particular, during in-market controls, they apply a 10% tolerance threshold for the number of nanoparticles in a cosmetic product.
Moreover, French authorities highlight that the authorisation of agglomerated, aggregated, or grafted structures is not automatic. Therefore, the Scientific Committee on Consumer Safety (SCCS) must evaluate those cases and it should consider with special attention the possibility of nanoparticles separating from the main structure.
Finally, according to the French manufacturers, the wording “intentionally manufactured” in the definition also includes nanoparticles obtained in the manufacturing process, even if the nano form was not specifically searched for. Only nanomaterials that entered the product by accident or occured naturally are excluded.
Notification to R-Nano register
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.
The results of post-market surveillance activities
In December 2022, the French authority responsible for the in-market controls of cosmetic products published a report on the activities conducted in 2021. The authority found several non-conformities related to the use of nanomaterials. Specifically, laboratory analysis identified the following:
- Several non-authorised nanomaterials;
- Permitted nanomaterials that were not labelled correctly (with the wording nano between brackets);
- Nanomaterials that did not respect the minimum median particle size.
Lastly, the competent authority informed that also in 2023, the controls will focus on the use of nanomaterials in cosmetic products, and in particular on sunscreens.
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References:
- European Commission. (2009). Regulation (EC) 1223/2009 on cosmetic products. Retrieved on 14/02/2023
- Ministère de la transition écologique. (2023). R-Nano.fr — Déclaration des substances à l’état nanoparticulaire. Retrieved on 14/02/2023
- Ministère de l’économie des finances et de la souveraineté industrielle numériquque. (2022). Contrôles 2021 sur les substances réglementées dans les cosmétiques : trop d’anomalies. Retrieved on 14/02/2023
- Ministère de l’économie des finances et de la souveraineté industrielle numériquque. (2021). Briefing note on the definition of nanomaterials within the meaning of Regulation (EC) No 1223/2009 on cosmetic products. Retrieved on 14/02/2023
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