Towards a new nano definition in the future Cosmetics Regulation… yes, but which one?

What is the definition of the term “nanomaterial” in the future Cosmetics Regulation?

Le European Cosmetics Regulation, in force since 2009, is currently being revised. One of the objectives of this revision is to improve the text in order to “ensuring human health and the functioning of the internal market”', and this, in particular in line with chemicals strategy for sustainability published in 2020 and the Zero Pollution Action Plan of the European Union adopted in 2021. The European Commission, which had already organized a written consultation between March and June, brought together the stakeholders on June 28 during a exchange workshop (organized both face-to-face in Brussels and online) aimed at collecting possible contributions and opinions from industry, Member States and NGOs. 

The definition of nanomaterials was among the five topics on the agenda, identified as the main issues to be addressed in the future regulation. AVICENN took part, via video, in the meeting moderated by Hans Ingels, Head of Unit at the Directorate General for the Internal Market (DG Grow) of the European Commission, supported by a Ricardo consulting firm.

Harmonizing definitions: an objective in itself?

One of the major problems of the current Cosmetics Regulation – and which the current revision proposes to remedy, is the coexistence of different definitions of the term “nanomaterial” in European texts. The definition of the term “nanomaterial” is indeed different depending on the sector: that of the Cosmetics Regulation* is different from that of the Regulation governing nanos in food for example, which is also different from that of the Biocides regulation.

Chemical manufacturers have long denounced this heterogeneity of definitions, which they accuse of being a source of confusion and complexity: supply and processing chains being sometimes long, some manufacturers claim to be unaware, at least partially, of the uses of the substances (nano or not) that they sell, in particular to intermediary companies which mix or transform them before then selling them, in turn, to other companies. The same given substance can indeed be used in very different sectors (recently banned in food, titanium dioxide is, for example, still widely used in paint, in pharmaceuticals, in cosmetics, etc.). Manufacturers may therefore find it difficult to provide the correct information to their customers on the "nano" qualification or not, of the substances they market, since the labeling or declaration criteria (in REACH, in r-nano, in the portal of notification of cosmetics CPNP, etc.) are not the same from one sector to another (with or without a threshold in the particle size distribution, whether or not solubility is taken into account, etc.). 

* As a reminder, the definition in the current Cosmetics Regulation is as follows:

“an insoluble or bio-persistent material, intentionally made and characterized by one or more external dimensions, or internal structure, on a scale of 1 to 100 nm”.

Two different options were presented by a consultant from the Ricardo agency:

• la first option would be to replace this definition with the very recent European Commission definition recommendation (itself adopted to replace the previous initial version of 2011) without any particular adjustments,  
• la second option would consist of also copying and pasting this definition recommendation in the future Cosmetics Regulation, but adding specific adaptations to the cosmetics sector allowing the integration of materials with nanoscale characteristics¹“materials with features in the nanoscale”.

More than legal consistency and security, it is health security that must prevail

If no details have been provided as to the exact accommodation arrangements, AVICENN intervened to express concern that Option 1 would cause large numbers of engineered nanoparticles to disappear from the authorities' radar. Indeed, the inclusion of a fixed threshold of 50% would exempt labeling and notification thousands of cosmetics containing nanoparticles potentially dangerous for consumers. Already last February, AVICENN and 14 other NGOs called on the European Commission questioning the scientific legitimacy of this threshold. AVICENN also expressed concern about the exclusion of nanocomposites from the new definition recommendation: some brands could use it to escape regulatory constraints on the grounds that their ingredients are complex compounds, in which several substances are present ( for example titanium dioxide nanoparticles coated with silica or grafted onto mica plates).

« French authorities have used a 10% threshold so far and people living in other member states should benefit from the same level of protection. Legal consistency and certainty should not be used to impose the 50% threshold of the new recommendation, nor to exclude nanocomposite materials at the expense of health safety, which must prevail. –AVICENN

The French authorities also defended this position during the meeting. And although the question concerning the definition of nanomaterials generated fewer reactions from stakeholders, three industrial federations, for their part, expressed their support for harmonization without adapting the definition: this option 1 is indeed less costly and more advantageous for the cosmetics industry, whereas option 2 would have the disadvantage, from the point of view of European Cosmetics, to make it necessary for the European Scientific Committee for Consumer Safety (CSSC) to re-assess a large number of colorants used in cosmetics. The latter indeed almost all contain a more or less significant fraction of nanoparticles – often between 10 and 50%. Note: insofar as the current definition of the Cosmetics Regulation does not include a threshold, these colorants are not currently authorized, even if they are in fact very widely present in our cosmetics.

Harmonization of definitions should not be at the expense of consumer safety. The problems related to the coexistence of different definitions is a problem that ultimately mainly concerns ingredient suppliers. Indeed, when substance characterization is done in a complete and adequate manner upstream and transmitted correctly to downstream actors, the latter can apply the appropriate definition to their sector and apply the necessary measures: labeling and notification(s), if applicable. 

What to expect in the next few months?  

Once the impact assessment procedure²(“impact assessment”) finalized, the European Commission will submit a draft revision of the Cosmetics Regulation in September to the “Regulatory Scrutiny Board”, before a presentation to the Council and Parliament, for adoption expected in 2024, followed by a transition period one to two years – coming into force in 2025-2026. 

The suspense therefore remains today on the outcome of this process:

• if option 1 is finally the one chosen by the Commission, management measures will have to be introduced in order to minimize the health risks for consumers concerning materials “presenting nano-scale properties” but not covered by the definition recommendation
• if option 2 was to be chosen, the nature and number of adaptations made are still extremely vague at this stage, no leads having been presented on June 28.

To be continued!