Today, March 15, 2024, the Official Journal of the European Union published Commission Regulation (EU) 2024/858 on the use of several nanomaterials, amending the EU Cosmetics Regulation. Following the opinions issued by the Scientific Committee on Consumer Safety (SCCS) on the safety for use in cosmetics, the use of certain nanomaterials poses a potential risk to human health. The draft regulation was published in May 2024.
Updated Annex II and Annex III of the EU Cosmetics Regulation
Annexes II and III to Regulation (EC) No 1223/2009 are amended as follows:
The following nanomaterials are added to Annex II (list of substances prohibited in cosmetics):
- 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)
Annex III (list of substances that cosmetic products must not contain except subject to the restrictions laid down) is amended to include:
- Hydroxyapatite (nano) to a maximum concentration of 10% in toothpaste and 0.465% in mouthwash (not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation), when the nanomaterial is composed of rod-shaped particles of which at least 95.8% (in particle number) have an aspect ratio less than 3, and the remaining 4.2% have an aspect ratio not exceeding 4.9, and when the particles are not coated or surface modified.
Timelines to comply
This Regulation will enter into force on April 4, 2024 (20 days after its publication).
For the new entries in Annex II:
- From February 1, 2025, manufacturers of cosmetics containing that substance can no longer place their products on the Union market.
- From November 1, 2025, cosmetic products containing that substance shall not be made available on the Union market.
For the new restrictions in Annex III:
- From February 1, 2025, manufacturers of cosmetics containing that substance and not complying with the restrictions can no longer place their products on the European market.
- From November 1, 2025 cosmetic products containing that substance shall not be made available on the European market.
As a cosmetic manufacturer, you should check your formulations and take the necessary steps to ensure their compliance.
Subscribe for free to our membership to access our Library of Documents, which collects all available public documents to understand the cosmetics regulations divided into several categories. There is also a section dedicated to nanomaterials.
References:
- EUR-Lex. (2024). Commission Regulation (EU) 2024/858 of 14 March 2024 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council 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. Retrieved on 15/03/2024.
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