August 23, 2022 – On June 10, 2022, the European Commission issued a recommendation on the definition of nanomaterial for legislative purposes. The document aims at updating the previous definition included in the Recommendation 2011/696/EU considering the scientific progress. Recommendations are non-binding acts by the European Union institutions. They usually serve as an indication for future legislative acts and concern scientific topics.
The text is of great importance for the cosmetics regulatory framework because the EU Cosmetics Regulation is under revision process; among the proposed changes, there is the introduction of a new horizontal definition of nanomaterial to align with the other sectors. The topic was one of the objects of the public consultation held between March 29, 2022, and June 21, 2022.
Definition of nanomaterial in the EU Cosmetics Regulation
Currently, Article 2(k) of the EU Cosmetics Regulation defines a nanomaterial as “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).
Conversely, according to Recommendation 2011/696/EU, a nanomaterial is “a natural, incidental, or manufactured material containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50% or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness, the number size distribution threshold of 50% may be replaced by a threshold between 1 and 50%” (EC, 2011).
The coexistence of different definitions may cause discrepancies between sectors. Therefore, the adoption of a cross-sectorial definition is much needed.
The updated definition
In light of the new scientific findings and the regulatory experience, the European Commission adopted an updated definition of nanomaterial.
Below is a table with the major elements of the definition of nanomaterial comparing the recommendations of 2011 and 2022.
2011 EC Recommendation
2022 EC Recommendation
|Natural, incidental or manufactured material in an unbound state or as an aggregate or as an agglomerate||Natural, incidental or manufactured material consisting of solid particles present, either on their own or as identifiable constituent particles in aggregates or agglomerates|
|where 50% or more of the particles in the number size distribution, one or more external dimensions are in the size range 1 nm-100 nm. In specific cases and where warranted by concerns for the environment, health, safety or competitiveness the number size distribution threshold of 50% may be replaced by a threshold between 1 and 50%.||where 50% or more of these particles in the number-based size distribution fulfils at least one of the following conditions:|
|(1) one or more external dimensions of the particle are in the size range 1 nm to 100 nm;|
|By derogation, fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm should be considered as nanomaterials.||(2) the particle has an elongated shape, such as a rod, fibre or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm;|
|(3) the particle has a plate-like shape, where one external dimension is smaller than 1 nm and the other dimensions are larger than 100 nm.|
|Where technically feasible and requested in specific legislation, compliance with the definition may be determined on the basis of the specific surface area by volume. A material should be considered as falling under the definition where the specific surface area by volume of the material is greater than 60 m²/cm³. However, a material which, based on its number size distribution, is a nanomaterial should be considered as complying with the definition even if the material has a specific surface area lower than 60 m²/cm³.||In the determination of the particle number-based size distribution, particles with at least two orthogonal external dimensions larger than 100 μm need not be considered. However, a material with a specific surface area by volume of <6m²/cm³ shall not be considered a nanomaterial.|
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- European Commission. (2022). Commission Recommendation of 10.06.2022 on the definition of nanomaterial. Retrieved on 12.07.2022 from https://ec.europa.eu/environment/chemicals/nanotech/pdf/C_2022_3689_1_EN_ACT_part1_v6.pdf
- European Commission. (2011). Commission Recommendation of 18 October 2011 on the definition of nanomaterial. Retrieved on 12.07.2022 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32011H0696
- European Commission. (2009). Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Retrieved on 12.07.2022 from https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20190813