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

• CELEX: Regulation (EU) 2024/996
• Articles: 3

Article 1

Annexes II, III, V and VI 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.

Point (4) of the Annex shall apply from 1 May 2025.

Schedules & Appendices

ANNEX

ANNEX

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

(1)

In Annex II, the following entry is added:

Reference number

Substance identification

Chemical name/INN

CAS number

EC number

a

b

c

d

‘1730

3-(4'-methylbenzylidene)-camphor  ( *1 ) ;

[INCI: 4-Methylbenzylidene Camphor]

36861-47-9/38102-62-4

253-242-6/-

(2)

In Annex III, the following entries are added:

Reference number

Substance identification

Restrictions

Wordings 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

‘373

Genisteol; 4',5,7-Trihydroxyisoflavone; 5,7-dihydroxy-3-(4-hydroxyphenyl)-4-benzopyrone  ( *2 )

Genistein

446-72-0

207-174-9

0,007 %

374

Daidzeol; 4',7-Dihydroxyisoflavone; 7-hydroxy-3-(4-hydroxyphenyl)-4-benzopyrone  ( *2 )

Daidzein

486-66-8

207-635-4

0,02 %

375

5-Hydroxy-2-(hydroxymethyl)-4H-pyrane-4-one  ( *2 )

Kojic Acid

501-30-4

207-922-4

Face and hand products

1 %

376

(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraen-1-ol  ( *3 )

Retinol

11103-57-4/

68-26-8

234-328-2/

200-683-7

(a)

Body lotion

(b)

other leave-on and rinse-off products

(a)

0,05 % Retinol Equivalent (RE)

(b)

0,3 % RE

For any cosmetic product containing Retinol, Retinyl Acetate or

Retinyl Palmitate the following, labelling is obligatory: ‘ Contains Vitamin A. Consider your daily intake before use’.

[(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenyl] acetate  ( *3 )

Retinyl Acetate

127-47-9

204-844-2

[(2E,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenyl] hexadecanoate  ( *3 )

Retinyl Palmitate

79-81-2

201-228-5

377

4-Hydroxyphenyl-alpha-D-glucopyranoside  ( *2 )

Alpha-Arbutin

84380-01-8

617-561-8

(a)

Face cream

(b)

Body lotion

(a)

2 %

(b)

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.

378

4-Hydroxyphenyl-beta-D-glucopyranoside  ( *2 )

Arbutin

497-76-7

207-850-3

Face cream

7 %

Hydroquinone levels shall remain as low as possible in formulations containing Arbutin and shall not be higher than the unavoidable trace level.

(3)

In Annex V, entries 23 and 25 are replaced by the following:

Reference number

Substance identification

Conditions

Wordings 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

‘23

1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl)urea  ( *4 )

( *5 )

Triclocarban

101-20-2

202-924-1

All cosmetic products, with the exception of mouthwash.

0,2 %

Purity criteria:

3,3',4,4'-Tetrachloroazobenzene ≤ 1 ppm

3,3',4,4'-Tetrachloroazoxybenzene ≤ 1 ppm

Not to be used in toothpaste intended for children under 6 years of age.

For toothpaste containing Triclocarban the following labelling is obligatory: ‘ Not to be used for children under 6 years of age’.

25

5-Chloro-2- (2,4- dichlorophenoxy) phenol  ( *4 )

Triclosan

3380-34-5

222-182-2

Toothpastes; Hand soaps; Body soaps/Shower gels; Deodorants (non-spray); Face powders and blemish concealers; Nail products for cleaning the fingernails and toenails before the application of artificial nail systems;

0,3 %

Not to be used in toothpaste intended for children under 3 years of age.

For toothpaste containing Triclosan the following labelling is obligatory: ‘ Not to be used for children under 3 years of age’.

(4)

In Annex VI, entry 18 is deleted.

( *1 )   From 1 May 2025 products containing that substance shall not be placed on the Union market. From 1 May 2026 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 conditions shall not be placed on the Union market. From 1 November 2025 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market.’

( *3 )   From 1 November 2025 cosmetic products containing that substance and not complying with the conditions shall not be placed on the Union market. From 1 May 2027 cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market.’

( *4 )   Cosmetic products containing that substance that do not comply with the conditions may, provided that they comply with the conditions applicable on 23 April 2024, be placed on the Union market until 31 December 2024 and, if they have already been placed on the market before that date, continue to be made available on the Union market until 31 October 2025.

( *5 )   For uses other than preservative, see Annex III, No 100.’