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

• CELEX: Regulation (EU) 2024/858
• Articles: 3

Article 1

Annexes II and III to Regulation (EC) No 1223/2009 are amended in accordance with the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

ANNEX

Annexes II and III to Regulation (EC) No 1223/2009 are amended as follows:

(1)

in Annex II, the following entries are added:

Reference number

Substance identification

Chemical name/INN

CAS number

EC number

a

b

c

d

‘1725

Styrene/Acrylates copolymer (nano) [INCI]  ( *1 )

Sodium Styrene/Acrylates copolymer (nano) [INCI]  ( *1 )

9010-92-8

927-710-1

1726

Copper (nano) [INCI]  ( *1 ) , Colloidal Copper (nano) [INCI]  ( *1 )

7440-50-8

231-159-6

1727

Colloidal silver (nano) [INCI]  ( *1 )

7440-22-4

231-131-3

1728

Gold (nano) [INCI]  ( *1 ) , Colloidal Gold (nano) [INCI] [1]  ( *1 )

Gold Thioethylamino Hyaluronic Acid (nano) [INCI] [2]  ( *1 )

Acetyl heptapeptide-9 Colloidal gold (nano) [INCI] [3]  ( *1 )

7440-57-5 [1]

1360157-34-1 [2]

—

[3]

231-165-9 [1]

—

[2]

—

[3]

1729

Platinum (nano) [INCI]  ( *1 ) , Colloidal Platinum (nano) [INCI] [1]  ( *1 )

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

7440-06-4 [1]

—

[2]

231-116-1 [1]

—

[2]

(2)

in Annex III, the following entry is added:

Reference number

Substance identification

Restrictions

Wording of conditions of use and warnings

Chemical name/INN

Name of Common Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration in ready use preparation

Other

a

b

c

d

e

f

g

h

i

‘372

Hydroxyapatite  ( *2 )

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

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

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