In early 2024, significant amendments to Annex II and Annex III of the EU Cosmetics Regulation (EC) No. 1223/2009 introduced new restrictions on certain substances in cosmetic products.
Two of the deadlines outlined in these amendments are set for February 2025
Annex III: restricted substances and compliance deadlines
From 1 February 2025, cosmetic products containing the following substances and not complying with the conditions specified in Annex III shall not be placed on the Union market:
- Genistein – CAS 446-72-0: Maximum concentration allowed is 0,007% in ready-to-use products.
- Daidzein – CAS 486-66-8: Restricted to a maximum concentration of 0.02% in ready-to-use products.
- Kojic Acid – CAS 501-30-4: Permitted at a concentration of up to 1% in face and hand products.
- Alpha-Arbutin – CAS 84380-01-8: Allowed in face creams up to a maximum concentration of 2% and body lotions up to a maximum of 0.5%. Hydroquinone levels shall remain as low as possible in formulations containing alpha-arbutin and shall not be higher than the unavoidable trace level.
- Arbutin – CAS 497-76-7: Permitted in face creams up to a maximum concentration of 7%. Hydroquinone levels shall remain as low as possible in formulations containing Arbutin and shall not be higher than the unavoidable trace level.
By 1 November 2025, such products must also be removed from the market entirely.
These updates were published last year in Commission Regulation (EU) 2024/996, officially adopted on 4 April 2024.
Nanomaterials and Annex II Updates
In a related development, the EU has tightened its stance on the use of certain nanomaterials in cosmetics following the opinions issued by the Scientific Committee on Consumer Safety (SCCS) on their safety.
From February 2025, manufacturers of cosmetics containing the following substances added to Annex II can no longer place their products on the Union market:
- Styrene/Acrylates copolymer (nano) – CAS 9010-92-7
- Sodium Styrene/Acrylates copolymer (nano) – CAS 9010-92-7
- Copper (nano), Colloidal Copper (nano) – CAS 7440-50-8
- Colloidal silver (nano) – CAS 7440-22-4
- Gold (nano) – CAS 7440-57-5
- Colloidal Gold (nano) – CAS 7440-57-5
- Gold Thioethylamino Hyaluronic Acid (nano) – CAS 1360157-34-1
- Acetyl heptapeptide-9 Colloidal gold (nano)
- Platinum (nano), Colloidal Platinum (nano) – CAS 7440-06-4
- Acetyl tetrapeptide-17 Colloidal Platinum (nano)
Additionally, from 1 February 2025, cosmetic products containing the following susbtance and not complying with the conditions specified in Annex III shall not be placed on the Union market:
Hydroxyapatite (nano) – CAS 1306-06-5:
- Maximum concentration: 10% in toothpaste and 0.465% in mouthwash.
- Must not be used in applications that may lead to exposure of the end-user’s lungs by inhalation.
- Nanomaterial must consist of rod-shaped particles, with at least 95.8% (by particle number) having an aspect ratio less than 3, and the remaining 4.2% not exceeding an aspect ratio of 4.9.
- Particles must not be coated or surface modified
By 1 November 2025, products with these prohibited nanomaterials must be removed entirely from the Union market.
The regulation on nanomaterials, Commission Regulation (EU) 2024/858, was published on 15 March 2024.
Do you have any questions on compliance of labels in cosmetic products in the EU?
References:
European Commission (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 02/01/2025.
European Commission. (2024). Commission Regulation (EU) 2024/996 of 3 April 2024 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Vitamin A, Alpha-Arbutin and Arbutin and certain substances with potential endocrine disrupting properties in cosmetic products. Retrieved on 02/01/2025.
Chiara Lai
Regulatory Intelligence & Innovation
19.01.2025
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