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
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