Publication of Regulation (EU) No. 2024/858 amending Regulation (EC) No. 1223/2009 concerning the use of nanomaterials.
The regulation (EU) No. 2024/858 was enacted on March 15, 2024, resulting in the inclusion of 12 substances in Annex II of the cosmetic regulation, thereby prohibiting their use in nano form. The substances concerned are:
- 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)
Hydroxyapatite (nano) is the only substance subject to restrictions with its entry into Annex III.
The person responsible must comply with this amendment before February 1, 2025 for the marketing of new products, and before November 1, 2025 for products already on the market.
[Reference : RÈGLEMENT (UE) 2024/858 DE LA COMMISSION du 14 mars 2024 modifiant le règlement (CE) no 1223/2009 du Parlement européen et du Conseil en ce qui concerne l’utilisation des nanomatériaux 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 et Colloidal Silver dans les produits cosmétiques 15/03/2024].
The European Parliament votes to ban hazardous substances in toys :
In July 2023, the European Commission adopted a proposal to revise Directive 2009/48/EC governing children’s toys [1]. In particular, this proposed regulation aimed to extend the ban on substances classified as CMR to endocrine disruptors and chemical substances that are toxic to a specific organ or affect the immune, neurological or respiratory systems. It also envisaged requiring proof of compliance with safety rules through the introduction of a digital product passport.
On March 13th, 2024, the European Parliament adopted its stance on this regulation proposal. [2]. For greater safety, MEPs overwhelmingly backed a ban on chemical substances. They also introduced a ban on nitrosamines and nitrosable substances, PFAS, chrome VI, cadmium, mercury and lead in toys.
Work on toys safety will continue after the European elections in June 2024.
[Reference: [1] Proposal for a regulation of the European Parliament and of the Council on the safety of toys and repealing Directive 2009/48/EC, 28/07/2023], [2] European Parliament legislative resolution of 13 March 2024 on the proposal for a regulation of the European Parliament and of the Council on the safety of toys and repealing Directive 2009/48/EC].
Final Opinion of the SCCS on Hexyl Salicylate
The Scientific Committee on Consumer Safety (SCCS), responsible for evaluating the safety of cosmetic ingredients, recently published its opinion on the safety of Hexyl Salicylate (Opinion SCCS/1658/23).
The use of this ingredient in cosmetics is currently not regulated. In its opinion, the SCCS is of the view that:
- The use of Hexyl Salicylate is safe up to a maximum concentration of 2% in hydroalcoholic-based perfumes, 0.5% in all rinse-off cosmetic products, 0.3% in all leave-on cosmetic products, and 0.001% in oral care products (toothpaste and mouthwashes).
- No specific scenario has been provided for children applying cosmetic products to their skin (dermal exposure), and neither have the differences between age categories been taken into consideration for certain exposure parameters. However, the SCCS notes that given the high Margin of Safety (MoS) for adults, significantly exceeding 100, the MoS will also be higher than 100 for children aged 3 to 10 years considering the product categories used by children of these ages.
[Reference : Final opinion SCCS Hexyl Salicylate (CAS/EC No. 6259-76-3/228-408-6) 11/03/2024].