The integration of nanotechnology in various industries has extended to the cosmetic sector, where nanomaterials are gaining prominence. These nanoscale particles possess unique properties due to their size, promising groundbreaking advancements, such as improved product efficacy and targeted delivery systems. Nevertheless, with the increasing prevalence of nanomaterials in cosmetic products, apprehensions concerning safety and potential environmental repercussions demand careful consideration.
According to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products: “‘nanomaterial’ means 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”.
At this scale, they exhibit distinctive physical and chemical attributes, setting them apart from their bulk counterparts. In the realm of cosmetics, nanomaterials are employed to formulate innovative products capable of:
enhancing efficacy;
precise ingredient delivery;
creating superior UV protection and more transparent formulations;
improving formulation stability, leading to prolonged shelf life and consistent performance;
developing lightweight and non-greasy cosmetic products.
However, there are also concerns surrounding nanomaterials in cosmetics, such as:
Potential of Skin Penetration, leading to systemic absorption and potential accumulation in organs;
Toxicity: Several studies indicate that specific nanoparticles may possess toxic properties;
Environmental Impact due to lack of biodegradability.
Based on this information, new standardized regulations governing the incorporation of nanomaterials in cosmetic products were needed.
On 10th June 2022, the European Commission published a recommendation about the definition of nanomaterial. This new definition replaces the 2011 definition and is intended to apply to all EU regulations including cosmetics.
It is stated that “’Nanomaterial’ 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-based size distribution fulfill at least one of the following conditions:
(a)one or more external dimensions of the particle are in the size range 1 nm to 100 nm;
(b)the particle has an elongated shape, such as a rod, fiber or tube, where two external dimensions are smaller than 1 nm and the other dimension is larger than 100 nm;
(c)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.
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 < 6 m2/cm3 shall not be considered a nanomaterial."
On 23 May 2023, the European Union transmitted an update to the proposal previously announced in February 2022 that sought to include in Annex II (prohibited substances) 12 ingredients used in cosmetics in the form of nanomaterials for which the SCCS identified reasons for concern and issued negative opinions.
Accordingly, Annex II will be updated to include the following substances:
Styrene/Acrylates copolymer (nano)
Sodium Styrene/Acrylates copolymer (nano)
Copper (nano)*, Colloidal Copper (nano=
Colloidal Silver (nano)
Gold (nano)*, Colloidal Gold (nano)
Gold Thioethylamino Hyaluronic Acid (nano)
Acetyl heptapeptide-9 Colloidal gold (nano)
Platinum (nano)*, Colloidal Platinum (nano)
Acetyl tetrapeptide-17 Colloidal Platinum (nano)
Inclusion of the following entry in Annex III:
Hydroxyapatite (nano)
As the scientific community continues to expand its knowledge of nanomaterials, brands and manufacturers are encouraged to remain well-informed and make conscientious choices when placing on the market cosmetic products that incorporate these innovative elements.
Want to know if you are using nanomaterials in your cosmetic products and how to proceed? Contact us!