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Monday, March 18, 2024European Commission

Regulation 2024/858: 12 nanos banned, Hydroxyapatite subject to restrictions

Règlement 2024/858 : 12 nanos interdits, l'Hydroxyapatite soumise à restrictions

Regulation 2024/858 of 14 March 2024, published in the Official Journal of the European Union on 15 March, amends Annexes II (prohibited substances) and III (restricted ingredients) of European Cosmetics Regulation 1223/2009. It provides for a ban on 12 ingredients in nano form and new restrictions on Hydroxyapatite, applicable from February 2025.

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The key points of Regulation 2024/858

12 ingredients in nano form are banned :
-> 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 added to Annex III of the Cosmetics Regulation with the following restrictions :
-> Authorised only in toothpastes (maximum 10%) and mouthwashes (maximum 0.465%)
-> Authorised only in the form 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, not coated or surface modified
-> Prohibited in applications that may lead to exposure of the end-user’s lungs by inhalation
These provisions apply :
-> From 1st February 2025 for products placed on the market
-> From 1st November 2025 for products made available on the market

The “Whereas” of Regulation 2024/858

(1) Regulation (EC) No.1223/2009 provides that for every cosmetic product that contains nanomaterials, a high level of …

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