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[Updated] EU Amends the Use Requirements for 13 Nanomaterials in Cosmetics

Mar 15, 2024
Jarius Ji
The EU is to ban the use of 12 nanomaterials, and restrict the use of Hydroxyapatite (nano) in cosmetics.

Editor's note: This article was originally published on May 26, 2023, and was updated on March 15, 2024, as per the latest developments. The updated contents are marked in red below.

On May 23, 2023, EU notified WTO of a draft Commission Regulation which proposed to revise the ingredient lists in Regulation (EC) No 1223/2009 (Cosmetics Regulation) regarding the use of nanomaterials.1 On March 15, 2024, EU published the finalized regulation in its Official Journal, which will come into effect on April 4, 2024.2 

The Cosmetics Regulation places particular emphasis on the safe use of cosmetics containing nanomaterials. If the European Commission has concerns regarding the safety of a nanomaterial, the Scientific Committee on Consumer Safety (SCCS) will be requested to give an opinion on its safety. In light of recent opinions from SCCS on nanomaterials, the Commission prepared this regulation. 

1. List of Prohibited Ingredients: 12 added

SCCS has conducted safety assessments on the nanomaterials listed in the table below, and concluded that currently available data is not sufficient enough to assess their safety in cosmetics. However, based on the available information in the scientific literature, SCCS indicates that there is a concern that these nanomaterials can pose a health risk to consumers when used in cosmetics. In response to SCCS's opinions, the regulation bans the use of these nanomaterials in cosmetics. 

Ref. No.

Substance Identification

Chemical Name / INN

CAS No.

EC No.

1725

Styrene / Acrylates copolymer (nano) [INCI]
Sodium Styrene / Acrylates copolymer (nano) [INCI]

9010-92-8

927-710-1

1726

Copper (nano) [INCI], Colloidal Copper (nano) [INCI]

7440-50-8

231-159-6

1727

Colloidal silver (nano) [INCI]

7440-22-4

231-131-3

1728

Gold (nano) [INCI], Colloidal Gold (nano) [INCI] [1]
Gold Thioethylamino Hyaluronic Acid (nano) [INCI] [2]
Acetyl heptapeptide-9 Colloidal gold (nano) [INCI] [3]

7440-57-5 [1]
1360157-34-1 [2]
/ [3]

231-165-9 [1]
/ [2]
/ [3]

1729

Platinum (nano) [INCI], Colloidal Platinum (nano) [INCI] [1]
Acetyl tetrapeptide-17 Colloidal Platinum (nano) [INCI] [2]

7440-06-4 [1]
/ [2]

231-116-1 [1]
/ [2]

Notes:
From February 1, 2025, cosmetic products containing these substances shall not be placed on the Union market. From November 1, 2025, cosmetic products containing these substances shall not be made available on the Union market.

2. List of Restricted Ingredients: 1 added

Hydroxyapatite (nano) is currently not included in the ingredient lists in the Cosmetics Regulation. On March 22, 2023, SCCS adopted an opinion on it, concluding that it could be used safely in cosmetics under certain restrictions. In view of SCCS's opinion, it is newly included into the restricted ingredients list. 

Ref. No.

Substance Identification

Restrictions

Chemical name / INN

Name of Common Ingredients Glossary

CAS No.

EC No.

Product Type

Maximum concentration

Other

372

Hydroxyapatite

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.

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

Further Reading

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Tags : IngredientsEU
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