Nanomaterials in cosmetics: the hope of an update of the definition

The revision of the Cosmetic Products Regulation: the opportunity to clarify the definition of nanomaterials at EU and French level

From 28 March to 20 June 2022, the European Commission is organising a public consultation in view of the revision of the Regulation (EC) N°1223/2009 on cosmetic products (Cosmetic Products Regulation) including the definition of nanomaterial.

The consultation follows the publication of the roadmap of the Cosmetic Products Regulation revision. In this consultation, the European Commission enquires if the definition of nanomaterial should be updated, and, if it should become a cross-sectoral definition.

Indeed, despite a common definition adopted by the European Commission (EC Recommendation 2011/696/EU), several sectorial definitions of the nanomaterial currently coexist at EU and French level (Regulation (EC) N°1907/2006 (REACH), Cosmetic Products Regulation, Article R. 523-12 of the French Environmental Code) and their applicability depend on the sector concerned (ie raw materials / chemical substances, finished cosmetic products).

All these definitions greatly increase difference of interpretations between operators and authorities, leading to legal uncertainty whereas the stakes are high. Indeed, for example, if it turns out that some finished cosmetic products contain substances in the form of nanomaterials (eg dyes, UV filters), they would have to be withdrawn from the market and, more globally, this would increase the number of legal requirements or would even be likely to characterise previous breaches.

Thus, this consultation follows a series of recent debates conducted at EU and French level related to the definition of nanomaterial and the diverging interpretation of the criteria qualifying a material as a nanomaterial from the French / European authorities and the cosmetic industry.

• Under Cosmetic Products Regulation, a material can qualify as a “nanomaterial” if three cumulative criteria are met: the material is (i) insoluble and bio-persistent, (ii) composed of one or more external dimensions on a scale of 1 to 100 nm and (iii) intentionally manufactured.

These three criteria are subject to debates and diverging interpretations sometimes leading to different positions on the qualification of products between operators and control authorities and the associated consequences with such a divergence of views.

Indeed, while the first two scientific criteria are notably difficult to apprehend depending on the nature of the material and the measurement techniques to be used (ex : pearlescent pigment) , the third one is subjective (intentional criterion) which also leads to diverging interpretations from authorities and economic operators.

Regarding specifically this last criterion, it is worth noticing that trade unions and federations in the cosmetics sector consider that the substance is intentionally manufactured when it is intended to achieve a specific purpose / with a view to intentionally producing nanometric scale materials.

This interpretation seems to be in line with the European Commission and the International Cooperation on Cosmetics Regulation (ICCR) (a voluntary international group composed of cosmetics regulatory authorities from Brazil, Canada, the European Union, Japan and the United States). Indeed, in a report published on 22 July 2021 related to nanomaterials in cosmetics, the European Commission indicates:

“Similarly to the Cosmetics Regulation, the ICCR also does not include the nanoparticles emerging naturally or incidentally in the nanomaterial definition” .

However, French authorities (ANSM and DGCCRF) exposed a different position in a controversial briefing note dated 5 July 2021:

“the [cosmetic] Regulation (…) covers ingredients with a proportion of nanoparticles at the end of the manufacturing process, even if the nano nature of the ingredient was no specifically searched for” .

This interpretation of the intentional criterion is significantly broader than the one from the cosmetic industry and the European Commission which leads to difficulties of implementation to operators and drastically reduces hypotheses in which a substance would not be considered as a nanomaterial.

In addition, one could wonder whether, with regard to this interpretation, the authorities did not completely removed the criterion related to the intention.

• This position from the French authorities may be considered as a very strict application of the precautionary principle, even though, at present, we know the difficulties of the scientific community to take a position on the existence of a public health risk on certain nanomaterials. Besides the debates on the intentional criterion, it is also worth noticing that 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 around 10% in terms of 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 debates 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.

France authorities have therefore distinguished themselves from the EU by adopting a broader interpretation of nanomaterials – which may have legitimately confused the economic operators.

That may explain some feedbacks provided by some operators in the public consultation of the Cosmetic Products Regulation revision roadmap, and some propositions for the revision of the definition of nanomaterial.

In any case, there is a need for clarification of the interpretation which should be retained of the criteria to apply and classify a substance as nanomaterial – all the more so from 1st January 2023, suppliers of substances / raw materials for cosmetic use will be required to provide safety data sheets including the nanometric dimension of the manufactured substances.

Hopefully, the current debates at European level on the definition of nanomaterial may enable to shed light on this topic.