Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products Text with EEA relevance

COMMISSION REGULATION (EU) No 344/2013

of 4 April 2013

amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (¹), and in particular Article 31, paragraphs 1 and 2, thereof,

(1) Regulation (EC) No 1223/2009 is to apply from 11 July 2013 and will replace Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (²). However, in order to ensure a smooth transition, economic operators are allowed to place on the market cosmetic products which comply with Regulation (EC) No 1223/2009 before the date of application of that Regulation.

(2) The Annexes to Regulation (EC) No 1223/2009 reflect the advancement of science at the time of the adoption of the proposal for that Regulation by the Commission on 5 February 2008. Since then, the Annexes to Directive 76/768/EEC have been amended several times.

(3) Several of the amendments to the Annexes to Directive 76/768/EEC aimed to address potential risks to human health and therefore introduced the necessary measures to protect public health. Both for the sake of legal clarity and, as there is an option to comply with Regulation (EC) No 1223/2009 before 11 July 2013 as an alternative to compliance with Directive 76/768/EEC, it is therefore necessary to amend the Annexes to Regulation (EC) No 1223/2009 as well, with a view to ensuring a high level of protection of public health.

(4) Also, a number of the amendments to the Annexes to Directive 76/768/EEC adapted those Annexes to technical and scientific progress, while protecting public health. As a result, the Annexes to Directive 76/768/EEC are now better adapted to technical and scientific progress than those of Regulation (EC) No 1223/2009. It is thus necessary to introduce those amendments in the Annexes to Regulation (EC) No 1223/2009 as well.

(5) In some cases, the substances have not been assigned with internationally recognised nomenclatures as the International Nomenclature of Cosmetic Ingredients (INCI). However, they are identified by their perfuming names. It is therefore appropriate to indicate the perfuming names in column c of Annex III (Name of Common Ingredients Glossary).

(6) Regulation (EC) No 1223/2009 should therefore be amended accordingly.

(7) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,

HAS ADOPTED THIS REGULATION:

Article 1

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

Article 2

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

It shall apply from 11 July 2013.

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

ANNEX

(1)Annex II to Regulation (EC) No 1223/2009 is amended as follows: (a)The entry concerning reference number 167 is replaced by the following:

‘167 4-Aminobenzoic acid and its esters, with the free amino group 150-13-0 205-753-0’ (b)The entry concerning reference number 450 is replaced by the following:

‘450 Verbena essential oils (Lippia citriodora Kunth.) and derivatives other than absolute when used as a fragrance ingredient 8024-12-2 285-515-0’ (c)The entry concerning reference number 1136 is replaced by the following:

‘1136 Exudation of Myroxylon pereirae (Royle) Klotzsch (Peru balsam, crude) when used as a fragrance ingredient 8007-00-9 232-352-8’ (d)Entries for the following reference numbers are added:

‘1329 4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine and its hydrochloride salt (Basic Violet 14; CI 42510) when used as a substance in hair dye products 3248-93-9 / 632-99-5 (HCl) 221-832-2 / 211-189-6 (HCl) 1330 4-(2,4-Dihydroxyphenylazo)benzensulphonic acid and its sodium salt (Acid Orange 6; CI 14270) when used as substance in hair dye products 2050-34-2 / 547-57-9 (Na) 218-087-0 / 208-924-8 (Na) 1331 3-Hydroxy-4-(phenylazo)-2-naphthoic acid and its calcium salt (Pigment Red 64:1; CI 15800) when used as a substance in hair dye products 27757-79-5 / 6371-76-2 (Ca) 248-638-0 / 228-899-7 (Ca) 1332 2-(6-Hydroxy-3-oxo-(3H)xanthen-9-yl)benzoic acid; Fluorescein and its disodium salt (Acid Yellow 73 sodium salt; CI 45350) when used as a substance in hair dye products 2321-07-5 / 518-47-8 (Na) 219-031-8 / 208-253-0 (Na) 1333 4′,5′-Dibromo-3′,6′-dihydroxyspiro[isobenzofuran-1(3H),9′-[9H]xanthene]-3-one; 4′,5′-Dibromofluorescein; (Solvent Red 72) and its disodium salt (CI 45370) when used as a substance in hair dye products 596-03-2 / 4372-02-5 (Na) 209-876-0 / 224-468-2 (Na) 1334 2-(3,6-Dihydroxy-2,4,5,7-tetrabromoxanthen-9-yl)benzoic acid; Fluorescein, 2′,4′,5′,7′-tetrabromo-; (Solvent Red 43), its disodium salt (Acid Red 87; CI 45380) and its aluminium salt (Pigment Red 90:1 Aluminium lake) when used as a substance in hair dye products 15086-94-9 / 17372-87-1 (Na) / 15876-39-8 (Al) 239-138-3 / 241-409-6 (Na) / 240-005-7 (Al) 1335 Xanthylium, 9-(2-carboxyphenyl)-3-((2-methylphenyl)amino)-6-((2-methyl-4-sulfophenyl)amino)-, inner salt and its sodium salt (Acid Violet 9; CI 45190) when used as a substance in hair dye products 10213-95-3 / 6252-76-2 (Na) — / 228-377-9 (Na) 1336 3′,6′-Dihydroxy-4′,5′-diiodospiro(isobenzofuran-1(3H),9′-[9H]xanthene)-3-one; (Solvent Red 73) and its sodium salt (Acid Red 95; CI 45425) when used as a substance in hair dye products 38577-97-8 / 33239-19-9 (Na) 254-010-7 / 251-419-2 (Na) 1337 2′,4′,5′,7′-Tetraiodofluorescein, its disodium salt (Acid Red 51; CI 45430) and its aluminium salt (Pigment Red 172 Aluminium lake) when used as a substance in hair dye products 15905-32-5 / 16423-68-0 (Na) / 12227-78-0 (Al) 240-046-0 / 240-474-8 (Na) / 235-440-4 (Al) 1338 1-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) and its dihydrochloride salts (2,4-Diaminophenol HCl) when used as a substance in hair dye products 95-86-3 / 137-09-7 (HCl) 202-459-4 / 205-279-4 (HCl) 1339 1,4-Dihydroxybenzene (Hydroquinone), with the exception of entry 14 in Annex III 123-31-9 204-617-8 1340 [4-[[4-Anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (Basic Blue 26; CI 44045) when used as a substance in hair dye products 2580-56-5 219-943-6 1341 Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (Ponceau SX; CI 14700) when used as a substance in hair dye products 4548-53-2 224-909-9 1342 Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)- N5,O6]ferrate(3-); (Acid Green 1; CI 10020) when used as a substance in hair dye products 19381-50-1 243-010-2 1343 4-(Phenylazo)resorcinol (Solvent Orange 1; CI 11920) and its salts when used as a substance in hair dye products 2051-85-6 218-131-9 1344 4-[(4-Ethoxyphenyl)azo]naphthol (Solvent Red 3; CI 12010) and its salts when used as a substance in hair dye products 6535-42-8 229-439-8 1345 1-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol (Pigment Red 4; CI 12085) and its salts when used as a substance in hair dye products 2814-77-9 220-562-2 1346 3-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide (Pigment Red 112; CI 12370) and its salts when used as a substance in hair dye products 6535-46-2 229-440-3 1347 N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide (Pigment Red 5; CI 12490) and its salts when used as a substance in hair dye products 6410-41-9 229-107-2 1348 Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (Pigment Red 48; CI 15865) when used as a substance in hair dye products 3564-21-4 222-642-2 1349 Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate (Pigment Red 63:1; CI 15880) when used as a substance in hair dye products 6417-83-0 229-142-3 1350 Trisodium 3-hydroxy-4-(4′-sulphonatonaphthylazo)naphthalene-2,7-disulphonate (Acid Red 27; CI 16185) when used as a substance in hair dye products 915-67-3 213-022-2 1351 2,2′-[(3,3′-Dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] (Pigment Yellow 13; CI 21100) when used as a substance in hair dye products 5102-83-0 225-822-9 1352 2,2′-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] (Solvent Yellow 29; CI 21230) when used as a substance in hair dye products 6706-82-7 229-754-0 1353 1-((4-Phenylazo)phenylazo)-2-naphthol (Solvent Red 23; CI 26100) when used as a substance in hair dye products 85-86-9 201-638-4 1354 Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate (Food Black 2; CI 27755) when used as a substance in hair dye products 2118-39-0 218-326-9 1355 Ethanaminium, N-(4-((4-diethylamino)phenyl)(2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, sodium salt (Acid Blue 1; CI 42045) when used as a substance in hair dye products 129-17-9 204-934-1 1356 Ethanaminium, N-(4-((4-diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, calcium salt (2:1) (Acid Blue 3; CI 42051) when used as a substance in hair dye products 3536-49-0 222-573-8 1357 Benzenemethanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)(4-hydroxy-2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt (Fast Green FCF; CI 42053) when used as a substance in hair dye products 2353-45-9 219-091-5 1358 1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline (Solvent Yellow 33; CI 47000) when used as a substance in hair dye products 8003-22-3 232-318-2 1359 Nigrosine (CI 50420) when used as a substance in hair dye products 8005-03-6 — 1360 8,18-Dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3′,2′-m]triphenodioxazine (Pigment Violet 23; CI 51319) when used as a substance in hair dye products 6358-30-1 228-767-9 1361 1,2-Dihydroxyanthraquinone (Pigment Red 83; CI 58000) when used as a substance in hair dye products 72-48-0 200-782-5 1362 Trisodium 8-hydroxypyrene-1,3,6-trisulphonate (Solvent Green 7; CI 59040) when used as a substance in hair dye products 6358-69-6 228-783-6 1363 1-Hydroxy-4-(p-toluidino)anthraquinone (Solvent Violet 13; CI 60725) when used as a substance in hair dye products 81-48-1 201-353-5 1364 1,4-bis(p-Tolylamino)anthraquinone (Solvent Green 3; CI 61565) when used as a substance in hair dye products 128-80-3 204-909-5 1365 6-Chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one (VAT Red 1; CI 73360) when used as a substance in hair dye products 2379-74-0 219-163-6 1366 5,12-Dihydroquino[2,3-b]acridine-7,14-dione (Pigment Violet 19; CI 73900) when used as a substance in hair dye products 1047-16-1 213-879-2 1367 (29H,31H-Phthalocyaninato(2-)- N29,N30,N31,N32)copper (Pigment Blue 15; CI 74160) when used as a substance in hair dye products 147-14-8 205-685-1 1368 Disodium [29H,31H-phthalocyaninedisulphonato(4-)- N29,N30,N31,N32]cuprate(2-) (Direct Blue 86; CI 74180) when used as a substance in hair dye products 1330-38-7 215-537-8 1369 Polychloro copper phthalocyanine (Pigment Green 7; CI 74260) when used as a substance in hair dye products 1328-53-6 215-524-7 1370 Diethylene glycol (DEG); 2,2′-oxydiethanol for traces level, see Annex III 111-46-6 203-872-2 1371 Phytonadione [INCI] / phytomenadione [INN] 84-80-0 / 81818-54-4 201-564-2 / 279-833-9 1372 2-Aminophenol (o-Aminophenol; CI 76520) and its salts 95-55-6 / 67845-79-8 / 51-19-4 202-431-1 / 267-335-4’

(2)Annex III to Regulation (EC) No 1223/2009 is amended as follows: (a)The entries concerning reference numbers 8, 9 and 10 are replaced by the following:

‘8 N-substituted derivatives of p-Phenylenediamine and their salts; N-substituted derivatives of o-Phenylenediamine (¹), with exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II

Hair dye substance in oxidative hair dye products

(a) General use (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.Do not use to dye eyelashes or eyebrows” (b) Professional use For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3 % calculated as free base (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.Wear suitable gloves” 8a p-Phenylenediamine and its salts p-Phenylenediamine; p-Phenylenediamine HCl; p-Phenylenediamine Sulphate 106-50-3 / 624-18-0 / 16245-77-5 203-404-7 / 210-834-9 / 240-357-1 Hair dye substance in oxidative hair dye products

(a) General use (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.Do not use to dye eyelashes or eyebrows.” (b) Professional use For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % calculated as free base (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.Wear suitable gloves.” 9 Methylphenylenediamines, their N-substituted derivatives and their salts (¹) with the exception of the substance under reference number 9a in this annex and substances under reference numbers 364, 1310 and 1313 in Annex II

Hair dye substance in oxidative hair dye products

(a) General use (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) 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 (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.” 9a Toluene-2,5-diamine and its salts Toluene-2,5-Diamine Toluene-2,5-Diamine Sulfate 95-70-5 / 615-50-9 202-442-1 / 210-431-8 Hair dye substance in oxidative hair dye products

(a) General use (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) Professional use For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 4 % calculated as free base (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.” 10 (¹)These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.’ (b)The entry concerning reference number 12 is replaced by the following:

‘12 Hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide Hydrogen peroxide 7722-84-1 231-765-0 (a) Hair products (a) 12 % of H2O2 (40 volumes), present or released