Source

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)

Regulation (EU) 2019/1966 · Regulation · 5 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Article 1

Open ↗

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

Article 2

Open ↗

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

Article 3

Open ↗

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.

Supplementary provisions

ANNEX ISupplementary provisions

Open ↗

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 IISupplementary provisions

Open ↗

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)’

Other acts of the same type

Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

What to look at next

Browse all EU Legal ActsEvery instrument by type and year, full text free to read section by sectionEuropean Union legislation EU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and year European Union: what this database coversWhich datasets are here, which official source they come from, and how current they areEuropean Union overview