Commission Regulation (EU) 2022/2195 of 10 November 2022 amending Regulation (EC) No 1223/2009 of the European Parliament and of the Council as regards the use of Butylated Hydroxytoluene, Acid Yellow 3, Homosalate and HAA299 in cosmetic products and correcting that Regulation as regards the use of Resorcinol in cosmetic products (Text with EEA relevance)

• CELEX: Regulation (EU) 2022/2195
• Articles: 4

Article 1 Amendments

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

Article 2 Correction

In Annex III to Regulation (EC) No 1223/2009, in the row for entry 22, column i, point (a), the last sentence is replaced by the following:

‘Do not use to dye eyelashes.’.

Article 3 Entry into force

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

Regulation (EC) No 1223/2009 is amended as follows:

(1)

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

‘325

2,6-Di-Tert-Butyl-4-Methylphenol  ( * )

Butylated Hydroxytoluene

128-37-0

204-881-4

a)

Mouthwash

b)

Toothpaste

c)

Other leave-on and rinse-off products

a)

0,001 %

b)

0,1 %

c)

0,8 %

326

1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts (CI 47005)  ( ** ) ,  ( *** )

Acid Yellow 3

8004-92-0

305-897-5

Non-oxidative hair dye products

0,5 %

(2)

Annex VI is amended as follows:

(a)

entry 3 is 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

‘3

Benzoic acid, 2- hydroxy-, 3,3,5- trimethylcyclohexyl ester/Homosalate  ( * )

Homosalate

118-56-9

204-260-8

Face products with the exception of propellent spray products

7,34 %

(b)

the following entries are added:

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

‘33

1,1'-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone

Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine

919803-06-8

485-100-6

10 %  ( * )

34

1,1'-(1,4-piperazinediyl)bis[1-[2-[4-(diethylamino)-2-hydroxybenzoyl]phenyl]-methanone

Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano)

919803-06-8

485-100-6

10 %  ( * )

Only nanomaterials having the following characteristics are allowed:

—

Purity ≥ 97 %

—

Median particle size D50 (50 % of the number below this diameter): ≥ 50 nm of number size distribution.

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

( * )   From 1 July 2023 cosmetic products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 January 2024 cosmetic products containing that substance and not complying with the restrictions shall not be made available on the Union market.

( ** )   From 1 July 2023 non-oxidative hair dye products containing that substance and not complying with the restrictions shall not be placed on the Union market. From 1 January 2024 non-oxidative hair dye products containing that substance and not complying with the restrictions shall not be made available on the Union market.

( *** )   For use as a colorant, see Annex IV, entry No 82.’;

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

( * )   In case of combined use of Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine (nano), the sum shall not exceed 10 %.’.