Commission Regulation (EU) 2021/850 of 26 May 2021 amending and correcting Annex II and amending Annexes III, IV and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)

• CELEX: Regulation (EU) 2021/850
• Articles: 4

Article 1

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

Article 2

In Annex II to Regulation (EC) No 1223/2009, the entry 1427, corresponding to the substance nickel bis(tetrafluoroborate) (CAS number: 14708-14-6), is deleted.

Article 3

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

Article 1 shall apply from 1 October 2021 with respect to points (1), (2) (b), (3) and (4) of the Annex.

Schedules & Appendices

ANNEX

ANNEX

Regulation (EC) No 1223/2009 is 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

‘x

Cobalt

7440-48-4

231-158-0

x

Metaldehyde (ISO); 2,4,6,8-tetramethyl- 1,3,5,7-tetraoxacyclooctane

108-62-3

203-600-2

x

Methylmercuric chloride

115-09-3

204-064-2

x

Benzo[rst]pentaphene

189-55-9

205-877-5

x

Dibenzo[b,def]chrysene; dibenzo[a,h]pyrene

189-64-0

205-878-0

x

Ethanol, 2,2'-iminobis-, N- (C13-15-branched and linear alkyl) derivs.

97925-95-6

308-208-6

x

Cyflumetofen (ISO); 2-methoxyethyl (RS)-2- (4-tert-butylphenyl)-2-cyano-3-oxo-3-(α,α,α-trifluoro-o-tolyl)propionate

400882-07-7

-

x

Diisohexyl phthalate

71850-09-4

276-090-2

x

halosulfuron-methyl (ISO); methyl 3-chloro-5-{[(4,6- dimethoxypyrimidin-2-yl) carbamoyl]sulfamoyl}-1- methyl-1H-pyrazole-4- carboxylate

100784-20-1

-

x

2-methylimidazole

693-98-1

211-765-7

x

Metaflumizone (ISO);

(EZ)-2'-[2-(4-cyanophenyl)-1-(α,α,α -trifluoro-m- tolyl)ethylidene]-[4-(trifluoromethoxy)phenyl] carbanilohydrazide [E-isomer ≥ 90 %, Z-isomer ≤ 10 % relative content]; [1]

(E)-2'-[2-(4-cyanophenyl)- 1-(α,α,α -trifluoro-m-tolyl) ethylidene]-[4-(trifluoromethoxy)phenyl]carbanilohydrazide [2]

139968-49-3 [1]

852403-68-0 [2]

-

x

Dibutylbis(pentane-2,4- dionato-O,O’)tin

22673-19-4

245-152-0’;

(2)

Annex III is amended as follows:

(a)

entry 98 is replaced by the following:

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 for use preparation

Other

a

b

c

d

e

f

g

h

i

‘98

Benzoic acid, 2-hydroxy-  ( 1 )

Salicylic acid

69-72-7

200-712-3

(a)

Rinse-off hair products

(b)

Other products except body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant

(c)

Body lotion, eye shadow, mascara, eyeliner, lipstick, roll-on deodorant

(a)

3,0 %

(b)

2,0 %

(c)

0,5 %

(a) (b) (c)

Not to be used in preparations for children under 3 years of age. Not to be used in applications that may lead to exposure of the end-user’s lungs by inhalation. Not to be used in oral products. For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product.

These levels are inclusive of any use of salicylic acid.

(a) (b) (c)

Not to be used for children under 3 years of age  ( 2 )

(b)

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 for use preparation

Other

a

b

c

d

e

f

g

h

i

‘x

Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm

Titanium Dioxide

13463-67-7/1317-70-0/1317-80-2

236-675-5/215-280-1/215-282-2

(a)

face products in loose powder form

(b)

hair aerosol spray products

(c)

other products

(a)

25 %;

(b)

1,4 % for general consumers, and 1.1

% for professional use.

(a) (b)

Only in the pigmentary form

(c)

Not to be used in

applications that may lead to exposure of the end-user’s lungs by inhalation’;

(3)

in Annex IV 143 is replaced by the following:

Reference number

Substance identification

Conditions

Wording of conditions of use and warnings

Chemical Name

Colour index Number/Name of Common Ingredients Glossary

CAS number

EC number

Colour

Product type, Body parts

Maximum concentration in ready for use preparation

Other

a

b

c

d

e

f

g

h

i

j

‘143

Titanium dioxide  ( 3 )

77891

236-675-5

White

—

Purity criteria as set out in Commission Directive 95/45/E (E 171)

—

Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm, to be used in compliance with Annex III, No [321]

(4)

in Annex VI entry 27 is replaced by the following:

Reference number

Substance identification

Conditions

Wording of conditions of use and warnings

Chemical name/INN/XAN

Name of Common Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration in ready for use preparation

Other

a

b

c

d

e

f

g

h

i

‘27

Titanium dioxide  ( (2) )

Titanium Dioxide

13463-67-7/1317-70-0/1317-80-2

236-675-5/215-280-1/215-282-2

25 % ( 4 )

Titanium dioxide in powder form containing 1 % or more of particles with aerodynamic diameter ≤ 10 μm, to be used in compliance with Annex III, No [321]. For the product types under letter (c) of column (f) in Annex III, No [321], the maximum concentration in ready for use preparation provided in column (g) of this entry applies.

( 1 )   For use as a preservative see Annex V, No 3.

( 2 )   Solely for products which might be used for children under 3 years of age.’;

( 3 )   For use as a UV filter, see Annex VI, No 27.’;

( (2) )   For use as a colorant, see Annex IV, No 143.’.