Commission Regulation (EU) 2019/1966 of 27 November 2019 amending and correcting Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance)

• CELEX: Regulation (EU) 2019/1966
• Articles: 5

Article 1

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

Article 2

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

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 May 2020.

Points (1)(a) and (2)(b) of Annex II shall apply from 11 June 2019.

Schedules & Appendices

ANNEX I

ANNEX I

(1)

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

The following entries are added:

Reference number

Substance identification

Chemical name/INN

CAS number

EC number

a

b

c

d

‘1612

Phosmet (ISO); S -[(1,3-dioxo-1,3-dihydro-2 H - isoindol-2-yl)methyl]- O , O -dimethyl phosphorodithioate;

O , O -dimethyl- S -phthalimidomethyl phosphorodithioate

732-11-6

211-987-4

1613

Potassium permanganate

7722-64-7

231-760-3

1614

2-Benzyl-2-dimethylamino-4′- morpholinobutyrophenone

119313-12-1

404-360-3

1615

Quizalofop- p -tefuryl (ISO);

(+/–) tetrahydrofurfuryl ( R )-2-[4-(6- chloroquinoxalin-2-

yloxy)phenyloxy]propionate

200509-41-7

414-200-4

1616

Propiconazole (ISO); (2RS,4RS;2RS,4SR)-1-{[2-(2,4- dichlorophenyl)-4-propyl-1,3- dioxolan-2-yl]methyl}-1 H - 1,2,4-triazole

60207-90-1

262-104-4

1617

Pinoxaden (ISO); 8-(2,6-diethyl-4-methylphenyl)-7-oxo-1,2,4,5-tetrahydro-7 H -pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropanoate

243973-20-8

635-361-9

1618

Tetramethrin (ISO);

(1,3-dioxo-1,3,4,5,6,7-hexahydro-2 H -isoindol-2-yl)methyl 2,2-dimethyl-3-(2-methylprop-1-en-1-yl)cyclopropanecarboxylate

7696-12-0

231-711-6

1619

(1,3,4,5,6,7-Hexahydro-1,3-dioxo-2 H -isoindol-2-yl)methyl (1 R -trans)-2,2-dimethyl-3-(2- methylprop-1-enyl)cyclopropanecarboxylate

1166-46-7

214-619-0

1620

Spirodiclofen (ISO);

3-(2,4-dichlorophenyl)-2-oxo- 1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutyrate

148477-71-8

604-636-5

1621

Reaction mass of 1-[2-(2-aminobutoxy)ethoxy]but-2-ylamine and 1-({[2-(2-aminobutoxy)ethoxy]methyl}propoxy) but-2-ylamine

897393-42-9

447-920-2

1622

1-Vinylimidazole

1072-63-5

214-012-0

1623

Amisulbrom (ISO)3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)- N , N -dimethyl-1 H -1,2,4-triazole-1-sulfonamide

348635-87-0

672-776-4’

(2)

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

Entry 98 is replaced by the following:

‘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

(a) 3,0 %

(b) 2,0 %

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.

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

(3)

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

Entry 3 is replaced by the following:

Reference number

Substance Identification

Conditions

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

‘3

Salicylic acid  ( 3 ) and its salts

Salicylic acid

Calcium salicylate, magnesium salicylate, MEA- salicylate, sodium salicylate, potassium salicylate, TEA- salicylate

69-72-7

824-35-1, 18917-89-0, 59866- 70-5, 54-21-7, 578-36-9, 2174-16-5

200-712-3

212-525-4, 242-669-3, 261-963-2, 200-198-0, 209-421-6, 218-531-3

0,5 % (acid)

0,5 % (acid)

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

Not to be used in oral products.

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

Not to be used in products for children under 3 years of age, except for shampoos.

Not to be used for children under 3 years of age  ( 4 )

Not to be used for children under 3 years of age  ( 5 )

( 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 uses other than preservative, see Annex III, No 98.

( 4 )   Solely for products which might be used for children under 3 years of age

( 5 )   Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.’

ANNEX II

ANNEX II

(1)

Annex II to Regulation (EC) No 1223/2009 is corrected as follows:

(a)

entry 395 is replaced by the following:

Reference number

Substance identification

Chemical name/INN

CAS number

EC number

‘395

Hydroxy-8-quinoline and its sulphate bis(8-hydroxyquinolinium) sulphate, except for the uses of the sulphate provided for in entry 51 of Annex III

148-24-3

134-31-6

205-711-1

205-137-1’

(b)

entry 1396 is replaced by the following:

Reference number

Substance identification

Chemical name/INN

CAS number

EC number

a

b

c

d

‘1396

Borates, tetraborates, octaborates and boric acid salts and esters, including:

Disodium octaborate anhydrous [1]

Disodium octaborate tetrahydrate [2]

2-Aminoethanol, monoester with boric acid [3]

2-Hydroxypropyl ammonium dihydrogen orthoborate [4]

Potassium borate, boric acid potassium salt [5]

Trioctyldodecyl borate [6]

Zinc borate [7]

Sodium borate, disodium tetraborate anhydrous; boric acid, sodium salt [8]

Tetraboron disodium heptaoxide, hydrate [9]

Orthoboric acid, sodium salt [10]

Disodium tetraborate decahydrate; borax decahydrate [11]

Disodium tetraborate pentahydrate; borax pentahydrate [12]

12008-41-2 [1]

12280-03-4 [2]

10377-81-8 [3]

68003-13-4 [4]

12712-38-8 [5]

- [6]

1332-07-6 [7]

1330-43-4 [8]

12267-73-1 [9]

13840-56-7 [10]

1303-96-4 [11]

12179-04-3 [12]

234-541-0 [1]

234-541-0 [2]

233-829-3 [3]

268-109-8 [4]

603-184-6 [5]

- [6]

215-566-6 [7]

215-540-4 [8]

235-541-3 [9]

237-560-2 [10]

215-540-4 [11]

215-540-4 [12]’

(c)

entry 1507 is replaced by the following:

Reference number

Substance identification

Chemical name/INN

CAS number

EC number

‘1507

Diaminotoluene, methyl-phenylenediamine, technical product-reaction mass of [4-methyl-m-phenylenediamine and 2-methyl-m-phenylenediamine]

–

–’

(d)

the following entries are added:

Reference number

Substance identification

Chemical name/INN

CAS number

EC number

a

b

c

d

‘1624

Pirimicarb (ISO); 2-(dimethylamino)-5,6-dimethylpyrimidin-4-yl dimethylcarbamate

23103-98-2

245-430-1

1625

1,2-Dichloropropane; propylene dichloride

78-87-5

201-152-2

1626

Phenol, dodecyl-, branched [1]

Phenol, 2-dodecyl-, branched [2]

Phenol, 3-dodecyl-, branched [3]

Phenol, 4-dodecyl-, branched [4]

Phenol, (tetrapropenyl) derivatives [5]

121158-58-5 [1]

1801269-80-6 [2]

1801269-77-1 [3]

210555-94-5 [4]

74499-35-7 [5]

310-154-3 [1]

— [2]

— [3]

640-104-9 [4]

616-100-8 [5]

1627

Coumatetralyl (ISO); 4- hydroxy-3-(1,2,3,4-tetrahydro-1-naphthyl) coumarin

5836-29-3

227-424-0

1628

Difenacoum (ISO); 3-(3- biphenyl-4-yl-1,2,3,4- tetrahydro-1-naphthyl)- 4-hydroxycoumarin

56073-07-5

259-978-4

1629

Brodifacoum (ISO); 4-hydroxy-3-(3-(4′-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin

56073-10-0

259-980-5

1630

Flocoumafen (ISO); reaction mass of: cis-4- hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin and trans-4-hydroxy-3-(1,2,3,4-tetrahydro-3-(4-(4-trifluoromethylbenzyloxy)phenyl)-1-naphthyl)coumarin

90035-08-8

421-960-0

1631

Acetochlor (ISO); 2- chloro- N -(ethoxymethyl)- N -(2-ethyl-6- methylphenyl)acetamide

34256-82-1

251-899-3

1632

e-Glass microfibres of representative composition

-

-

1633

Glass microfibres of representative composition

-

-

1634

Bromadiolone (ISO); 3- [3-(4′-bromobiphenyl- 4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy- 2 H -chromen-2-one

28772-56-7

249-205-9

1635

Difethialone (ISO); 3-[3-(4′-bromobiphenyl-4-yl)-1,2,3,4-tetrahydronaphthalen-1-yl]- 4-hydroxy-2 H -1-benzothiopyran-2-one

104653-34-1

600-594-7

1636

Perfluorononan-1-oic acid [1]

and its sodium [2]

and ammonium [3] salts

375-95-1 [1]

21049-39-8 [2]

4149-60-4 [3]

206-801-3 [1]

- [2]

- [3]

1637

Dicyclohexyl phthalate

84-61-7

201-545-9

1638

3,7-Dimethylocta-2,6- dienenitrile

5146-66-7

225-918-0

1639

Bupirimate (ISO); 5-butyl-2-ethylamino-6- methylpyrimidin-4-yl dimethylsulfamate

41483-43-6

255-391-2

1640

Triflumizole (ISO); (1 E )- N -[4-chloro-2-(trifluoromethyl)phenyl]-1- (1 H -imidazol-1-yl)-2- propoxyethanimine

68694-11-1

604-708-8

1641

tert -Butyl hydroperoxide

75-91-2

200-915-7’

(2)

Annex III to Regulation (EC) No 1223/2009 is corrected as follows:

(a)

entry 9 is replaced by the following:

Ref

No.

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

‘9

Methylphenylenediamines, their N- substituted derivatives and their salts (1), with the exception of the substance listed under reference numbers 9 a and 9 b of this Annex and the substances listed under reference numbers 364, 413, 1144, 1310, 1313 and 1507 of Annex II

Hair dye substance in oxidative hair dye products

(a) General use

(b) Professional use

For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 5 % calculated as free base

(a) To be printed on the label:

The mixing ratio.

‘

Hair colourants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on persons under the age of 16.

Temporary ‘black henna’ tattoos may increase your risk of allergy.

Do not colour your hair if: — you have a rash on your face or sensitive, irritated and damaged scalp, — you have ever experienced any reaction after colouring your hair, — you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.

Contains phenylenediamines (toluenediamines).

Do not use to dye eyelashes or eyebrows.’

(b) To be printed on the label:

The mixing ratio.

‘For professional use only. Hair colourants can cause severe allergic reactions.

Read and follow instructions.

This product is not intended for use on persons under the age of 16.

Temporary “black henna” tattoos may increase your risk of allergy.

Do not colour your hair if:

—

you have a rash on your face or sensitive, irritated and damaged scalp,

—

you have ever experienced any reaction after colouring your hair,

—

you have experienced a reaction to a temporary “black henna” tattoo in the past.

Contains phenylenediamines (toluenediamines).

Wear suitable gloves.’

(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

‘51

Bis(8-hydroxyquinolinium) sulphate

Oxyqui-noline sulphate

134-31-6

205-137-1

Stabilizer for hydrogen peroxide in rinse-off hair products

Stabilizer for hydrogen peroxide in leave-on hair products

(0,3 % as base)

(0,03 % as base)’