Spotlight on Nanomaterials: Exploring new Regulation (EU) 2024/858
Nano-based ingredients have been in use in the cosmetic industry for more than three decades, providing enhanced and novel functions and creating opportunities to produce products that are more effective, more agreeable to use, more attractive and longer lasting. One of the primary benefits of nano-based ingredients in cosmetics is their ability to penetrate the skin more effectively, delivering active ingredients deeper into the skin.
However, despite their widespread use and benefits, concerns regarding the safety of nanomaterials in consumer products persist as they may penetrate the skin barrier and potentially accumulate in the body, raising questions about their long-term effects on human health and the environment. In the European Union (EU) stringent regulations and guidelines are continuously being reviewed and improved to ensure the safety of nanomaterials in cosmetic products.
What is a nanomaterial?
In cosmetic products, “nanomaterial” refers to an insoluble or biopersistent and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm.
Health concerns
Many ingredients that are safe can become potentially problematic when in nano form as the size and shape, as well as solubility, may affect their functions, both chemically and physically, and potentially biologically.
Some nanomaterials may indeed pose a health risk to consumers because of their ability to penetrate biological membrane barriers and reach those parts of the body that are otherwise protected from exposure to (larger) particles, potentially interacting with biological entities close to the molecular level.
SCCS Opinions on nanomaterials
If the European Commission has concerns regarding the safety of a nanomaterial, it may request the Scientific Committee on Consumer Safety (SCCS) to perform a risk assessment.
During 2021, the Scientific Committee on Consumer Safety (SCCS) assessed the safety of several nanomaterials in cosmetics, including Styrene/Acrylates Copolymer (nano), Sodium Styrene/Acrylates Copolymer (nano), Colloidal Silver (nano), Copper (nano) and Colloidal Copper (nano), Gold (nano), Colloidal Gold (nano), Gold Thioethylamino Hyaluronic Acid (nano) and Acetyl heptapeptide-9 Colloidal gold (nano), Platinum (nano), Colloidal Platinum (nano) and Acetyl tetrapeptide-17 Colloidal Platinum (nano), concluding in general that such nanomaterials can pose a health risk to the consumer when used in cosmetic products.
Regulation (EU) 2024/858
In light of the Opinions of the SCCS, on 14 March 2024, the European Commission published Regulation (EU) 2024/858 which amends Regulation (EC) No 1223/2009 as regards the use of the nanomaterials Styrene/Acrylates copolymer, Sodium Styrene/Acrylates copolymer, Copper, Colloidal Copper, Hydroxyapatite, Gold, Colloidal Gold, Gold Thioethylamino Hyaluronic Acid, Acetyl heptapeptide-9 Colloidal gold, Platinum, Colloidal Platinum, Acetyl tetrapeptide-17 Colloidal Platinum and Colloidal Silver in cosmetics products.
Accordingly, Styrene/Acrylates copolymer (nano), Sodium Styrene/Acrylates copolymer (nano), Copper (nano), Colloidal Copper (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) and Colloidal Silver (nano) are added to Annex II to Regulation (EC) No 1223/2009 and Hydroxyapatite (nano) is restricted to a maximum concentration of 10% in toothpaste and of 0.465 % in mouthwash with the respective characteristics, while the use of Hydroxyapatite (nano) in applications that may lead to exposure of the end user’s lungs by inhalation should not be allowed.
This Regulation comes into effect on 4 April 2024.
References:
European Commission. Cosmetic products - specific topics: Nanomaterials
European Chemicals Agency (ECHA). European Union Observatory for nanomaterials (EUON) - Safety
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