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On March 14, 2024, the European Union revised the list of prohibited substances (Appendix II) and restricted substances (Appendix III) for cosmetics in the EU Cosmetics Regulation (EC) No 1223/2009. This revision is mainly aimed at the use of some nanomaterials in cosmetics and setting the limit of hydroxyapatite (nano).

EU,Cosmetic,Prohibition,Restriction,Substance,List

1. The following entry will be added to Annex II:

Name	CAS Number	EC Number
Styrene/Acrylates copolymer (nano) [INCI] Sodium Styrene/Acrylates copolymer (nano) [INCI]	9010-92-8	927-710-1
Copper (nano) [INCI], Colloidal Copper (nano) [INCI]	7440-50-8	231-159-6
Colloidal silver (nano) [INCI]	7440-22-4	231-131-3
Gold (nano) [INCI], Colloidal Gold (nano) [INCI] Gold Thioethylamino Hyaluronic Acid (nano) [INCI] Acetyl heptapeptide-9 Colloidal gold (nano) [INCI]	7440-57-5 [1] 1360157-34-1 [2] -[3]	231-165-9 [1] -[2] -[3]
Platinum (nano) [INCI], Colloidal Platinum (nano) [INCI] [1] Acetyl tetrapeptide-17 Colloidal Platinum (nano) [INCI] [2]	7440-06-4 [1] -[2]	231-1161-1 [1] - [2]

From February 1, 2025, cosmetic products containing that substance shall not be placed on the Union market. From November 1, 2025, cosmetic products containing that substance shall not be made available on the Union market.

2. The following entry will be added to Annex III

Substance identification

Restrictions

Name

CAS number

EC number

Product type

Maximum concentration

Other

Hydroxyapatite (nano)

1306-06-5

215-145-7

(a) Toothpaste

(b) Mouthwash

(a) 10 %

(b) 0.465 %

For (a) and (b):

Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation.

Only nanomaterials having the following characteristics are allowed:

— [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;

— the particles are not coated or surface modified

From February 1, 2025, cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From November 1, 2025, cosmetic products containing that substance shall not be made available on the Union market.

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Further Information

(EU) 2024/858

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European Union Revised List of Prohibited and Restricted Substances in Cosmetics