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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 productsText with EEA relevance.

32019R1966

Den Europæiske UnionForordning2019

European Union

§ Article 1

Article 1 shall apply from 1 May 2020.

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 27 November 2019.

For the Commission

The President

Jean-Claude Juncker

Annex

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 numberEC numberabcd1612

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

O,O-dimethyl-S-phthalimidomethyl phosphorodithioate

732-11-6211-987-41613

Potassium permanganate

7722-64-7231-760-316142-Benzyl-2-dimethylamino-4′- morpholinobutyrophenone119313-12-1404-360-31615

Quizalofop-p-tefuryl (ISO);

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

yloxy)phenyloxy]propionate

200509-41-7414-200-41616Propiconazole (ISO); (2RS,4RS;2RS,4SR)-1-{[2-(2,4- dichlorophenyl)-4-propyl-1,3- dioxolan-2-yl]methyl}-1H- 1,2,4-triazole60207-90-1262-104-41617Pinoxaden (ISO); 8-(2,6-diethyl-4-methylphenyl)-7-oxo-1,2,4,5-tetrahydro-7H-pyrazolo[1,2-d][1,4,5]oxadiazepin-9-yl 2,2-dimethylpropanoate243973-20-8635-361-91618

Tetramethrin (ISO);

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

7696-12-0231-711-61619(1,3,4,5,6,7-Hexahydro-1,3-dioxo-2H-isoindol-2-yl)methyl (1R-trans)-2,2-dimethyl-3-(2- methylprop-1-enyl)cyclopropanecarboxylate1166-46-7214-619-01620

Spirodiclofen (ISO);

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

148477-71-8604-636-51621Reaction mass of 1-[2-(2-aminobutoxy)ethoxy]but-2-ylamine and 1-({[2-(2-aminobutoxy)ethoxy]methyl}propoxy) but-2-ylamine897393-42-9447-920-216221-Vinylimidazole1072-63-5214-012-01623Amisulbrom (ISO)3-(3-bromo-6-fluoro-2-methylindol-1-ylsulfonyl)-N,N-dimethyl-1H-1,2,4-triazole-1-sulfonamide348635-87-0672-776-4

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

Entry 98 is replaced by the following:

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

Solely for products which might be used for children under 3 years of age.

98Benzoic acid, 2-hydroxy- Salicylic acid69-72-7200-712-3

(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

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

Entry 3 is replaced by the following:

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

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

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

Reference number

Substance IdentificationConditionsWording of conditions of use and warningsChemical name/INNName of Common Ingredients GlossaryCAS numberEC numberProduct type, Body partsMaximum concentration in ready for use preparationOtherabcdefghi3

Salicylic acid 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

Not to be used for children under 3 years of age

Annex

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 numberEC number395Hydroxy-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 numberEC numberabcd1396

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 numberEC number1507Diaminotoluene, 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 numberEC numberabcd1624Pirimicarb (ISO); 2-(dimethylamino)-5,6-dimethylpyrimidin-4-yl dimethylcarbamate23103-98-2245-430-116251,2-Dichloropropane; propylene dichloride78-87-5201-152-21626

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]

1627Coumatetralyl (ISO); 4- hydroxy-3-(1,2,3,4-tetrahydro-1-naphthyl) coumarin5836-29-3227-424-01628Difenacoum (ISO); 3-(3- biphenyl-4-yl-1,2,3,4- tetrahydro-1-naphthyl)- 4-hydroxycoumarin56073-07-5259-978-41629Brodifacoum (ISO); 4-hydroxy-3-(3-(4′-bromo-4-biphenylyl)-1,2,3,4-tetrahydro-1-naphthyl)coumarin56073-10-0259-980-51630Flocoumafen (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)coumarin90035-08-8421-960-01631Acetochlor (ISO); 2- chloro-N-(ethoxymethyl)-N-(2-ethyl-6- methylphenyl)acetamide34256-82-1251-899-3

1632e-Glass microfibres of representative composition--1633Glass microfibres of representative composition--1634Bromadiolone (ISO); 3- [3-(4′-bromobiphenyl- 4-yl)-3-hydroxy-1-phenylpropyl]-4-hydroxy- 2H-chromen-2-one28772-56-7249-205-91635Difethialone (ISO); 3-[3-(4′-bromobiphenyl-4-yl)-1,2,3,4-tetrahydronaphthalen-1-yl]- 4-hydroxy-2H-1-benzothiopyran-2-one104653-34-1600-594-71636

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]

1637Dicyclohexyl phthalate84-61-7201-545-916383,7-Dimethylocta-2,6- dienenitrile5146-66-7225-918-01639Bupirimate (ISO); 5-butyl-2-ethylamino-6- methylpyrimidin-4-yl dimethylsulfamate41483-43-6255-391-21640Triflumizole (ISO); (1E)-N-[4-chloro-2-(trifluoromethyl)phenyl]-1- (1H-imidazol-1-yl)-2- propoxyethanimine68694-11-1604-708-81641tert-Butyl hydroperoxide75-91-2200-915-7

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

(a) entry 9 is replaced by the following:

Ref

No.

Substance identificationRestrictionsWording of conditions of use and warnings

Chemical name/

INN

Name of Common Ingredients GlossaryCAS numberEC numberProduct type, body partsMaximum concentration in ready for use preparationOtherabcdefghi‘9Methylphenylenediamines, 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 IIHair 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 numberSubstance identificationRestrictionsWording of conditions of use and warningsChemical name/INNName of Common Ingredients GlossaryCAS numberEC numberProduct type, body partsMaximum concentration in ready for use preparationOtherabcdefghi51Bis(8-hydroxyquinolinium) sulphateOxyqui-noline sulphate134-31-6205-137-1

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)

Metadata

Type
Forordning
År
2019
Ikrafttrædelsesdato
1. januar 1970
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 productsText with EEA relevance. | TheLawyer.sh