Source: EURLEX
Language: en
Format: md

|  |  |  |  |
| --- | --- | --- | --- |
| 25.4.2013 | EN | Official Journal of the European Union | L 114/1 |

---

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)](#ntr1-L_2013114EN.01000101-E0001), and in particular Article 31, paragraphs 1 and 2, thereof,

Whereas:

|  |  |
| --- | --- |
| (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)](#ntr2-L_2013114EN.01000101-E0002). 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.

Done at Brussels, 4 April 2013.

For the Commission

The President

José Manuel BARROSO

---

---

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)](#ntr1-L_2013114EN.01000301-E0001), 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.  “ Image 1  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  Image 2  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.  “ Image 3  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.  Image 4  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)](#ntr1-L_2013114EN.01000301-E0001) 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.  “ Image 5  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  Image 6  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.  “ Image 7  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  Image 8  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 |  |  |  |  |  |  |  |  | |

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (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 | |  | |  |  | | --- | --- | | (a) | Wear suitable gloves | | | |  |  | | --- | --- | | (b) | Skin products | | |  |  | | --- | --- | | (b) | 4 % of H2O2, present or released | | (a) (b) (c) (e)  Contains hydrogen peroxide  Avoid contact with eyes  Rinse immediately if product comes into contact with them. | | |  |  | | --- | --- | | (c) | Nail hardening products | | |  |  | | --- | --- | | (c) | 2 % of H2O2, present or released | | | |  |  | | --- | --- | | (d) | Oral products, including mouth rinse, tooth paste and tooth whitening or bleaching products | | |  |  | | --- | --- | | (d) | ≤ 0,1 % of H2O2, present or released | | | |  |  | | --- | --- | | (e) | Tooth whitening or bleaching products | | |  |  | | --- | --- | | (e) | > 0,1 % ≤ 6 % of H2O2, present or released | | |  |  | | --- | --- | | (e) | To be only sold to dental practitioners.  For each cycle of use, first use by dental practitioners as defined under Directive 2005/36/EC[(\*1)](#ntr*1-L_2013114EN.01000301-E0002) or under their direct supervision if an equivalent level of safety is ensured. Afterwards to be provided to the consumer to complete the cycle of use.  Not to be used on a person under 18 years of age. | | |  |  | | --- | --- | | (e) | Concentration of H2O2 present or released indicated in percentage.  Not to be used on a person under 18 years of age.  To be only sold to dental practitioners. For each cycle of use, the first use to be only done by dental practitioners or under their direct supervision if an equivalent level of safety is ensured. Afterwards to be provided to the consumer to complete the cycle of use. | | |

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (c) | The entry concerning reference number 14 is replaced by the following:   |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘14 | Hydroquinone | Hydroquinone | 123-31-9 | 204-617-8 | Artificial nail systems | 0,02 % (after mixing for use) | Professional use only | |  |  | | --- | --- | | — | For professional use only |  |  |  | | --- | --- | | — | Avoid skin contact |  |  |  | | --- | --- | | — | Read directions for use carefully’ | | |

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (d) | The entry concerning reference number 16 is replaced by the following:   |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘16 | 1-Naphthol and its salts | 1-Naphthol | 90-15-3 | 201-969-4 | Hair dye substance in oxidative hair dye products |  | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1 % calculated as free base | To be printed on the label:  The mixing ratio.  “ Image 9  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.” ’ | | |

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (e) | The entry concerning reference number 22 is replaced by the following:   |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘22 | Resorcinol | Resorcinol | 108-46-3 | 203-585-2 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  |  |  | | --- | --- | --- | --- | | (a) | |  |  | | --- | --- | | 1. | General use | | | |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | 1. | To be printed on the label:  The mixing ratio.  “Contains resorcinol.  Rinse hair well after application.  Do not use to dye eyelashes or eyebrows.  Rinse eyes immediately if product comes into contact with them.  Image 10  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.” | | | | | |  |  | | --- | --- | | 2. | Professional use |   For 1 and 2:  After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 % calculated as free base | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | 2. | To be printed on the label:  The mixing ratio.  “For professional use only. Contains resorcinol.  Rinse eyes immediately if product comes into contact with them.  Image 11  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.” | | | | |  |  | | --- | --- | | (b) | Hair lotions and shampoos | | |  |  | | --- | --- | | (b) | 0,5 % | | |  |  | | --- | --- | | (b) | Contains resorcinol’ | | |

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (f) | The entries concerning reference numbers 26 to 43 are replaced by the following:   |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘26 | Ammonium monofluorophosphate | Ammonium Monofluorophosphate | 20859-38-5 / 66115-19-3 | — / — | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains ammonium monofluorophosphate.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 27 | Disodium fluorophosphate | Sodium Monofluorophosphate | 10163-15-2 / 7631-97-2 | 233-433-0 / 231-552-2 | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains sodium monofluorophosphate.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 28 | Dipotassium fluorophosphate | Potassium Monofluorophosphate | 14104-28-0 | 237-957-0 | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains potassium monofluorophosphate.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 29 | Calcium fluorophosphate | Calcium Monofluorophosphate | 7789-74-4 | 232-187-1 | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains calcium monofluorophosphate.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 30 | Calcium fluoride | Calcium Fluoride | 7789-75-5 | 232-188-7 | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains calcium fluoride.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 31 | Sodium fluoride | Sodium Fluoride | 7681-49-4 | 231-667-8 | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains sodium fluoride.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 32 | Potassium fluoride | Potassium Fluoride | 7789-23-3 | 232-151-5 | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains potassium fluoride.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 33 | Ammonium fluoride | Ammonium Fluoride | 12125-01-8 | 235-185-9 | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains ammonium fluoride.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 34 | Aluminium fluoride | Aluminum Fluoride | 7784-18-1 | 232-051-1 | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains aluminium fluoride.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 35 | Tin difluoride | Stannous Fluoride | 7783-47-3 | 231-999-3 | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains stannous fluoride.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 36 | Hexadecyl ammonium fluoride | Cetylamine Hydrofluoride | 3151-59-5 | 221-588-7 | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains Cetylamine hydrofluoride.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 37 | 3-(N-Hexadecyl-N-2-hydroxyethylammonio)propylbis(2-hydroxyethyl) ammonium difluoride | — | — | — | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains 3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 38 | N,N′,N′-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride | — | — | — | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains N,N′,N′-tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 39 | 9-Octadecen-1-amine hydrofluoride | Octadecenyl-Ammonium Fluoride | 36505-83-6 | — | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains octadecenyl-ammonium fluoride.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 40 | Disodium hexafluorosilicate | Sodium Fluorosilicate | 16893-85-9 | 240-934-8 | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains sodium fluorosilicate.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 41 | Dipotassium hexafluorosilicate | Potassium Fluorosilicate | 16871-90-2 | 240-896-2 | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains potassium fluorosilicate.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 42 | Ammonium hexafluorosilicate | Ammonium Fluorosilicate | 16919-19-0 | 240-968-3 | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains ammonium fluorosilicate.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” | | 43 | Magnesium hexafluorosilicate | Magnesium Fluorosilicate | 16949-65-8 | 241-022-2 | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains magnesium fluorosilicate.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” ’ | |

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (g) | The entry concerning reference number 45 is replaced by the following:   |  |  |  |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘45 | Benzyl alcohol[(7)](#ntr7-L_2013114EN.01000301-E0003) | Benzyl Alcohol | 100-51-6 | 202-859-9 | |  |  | | --- | --- | | (a) | Solvent | |  | |  |  | | --- | --- | | (a) | For purposes other than inhibiting the development of microorganisms in the product. This purpose has to be apparent from the presentation of the product. | |  | | |  |  | | --- | --- | | (b) | Fragrance/aromatic compositions/their raw materials | | |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | | (b) | The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:   |  |  | | --- | --- | | — | 0,001 % in leave-on products |  |  |  | | --- | --- | | — | 0,01 % in rinse-off products. | | | |

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (h) | The entry concerning reference number 47 is replaced by the following:   |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘47 | 3-Pyridinemethanol hydrofluoride | Nicomethanol Hydrofluoride | 62756-44-9 | — | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains nicomethanol hydrofluoride.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” ’ | |

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (i) | The entry concerning reference number 56 is replaced by the following:   |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘56 | Magnesium fluoride | Magnesium Fluoride | 7783-40-6 | 231-995-1 | Oral products | 0,15 % calculated as F.  When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |  | Contains magnesium fluoride.  For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:  “Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” ’ | |

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (j) | The entry concerning reference number 68 is replaced by the following:   |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘68’ |  |  |  |  |  |  |  |  | |

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (k) | The entries concerning reference numbers 72 and 73 are replaced by the following:   |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘72 | 7-Hydroxycitronellal | Hydroxycitronellal | 107-75-5 | 203-518-7 | |  |  | | --- | --- | | (a) | Oral products | |  | (a) (b)  The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:   |  |  | | --- | --- | | — | 0,001 % in leave-on products |  |  |  | | --- | --- | | — | 0,01 % in rinse-off products | |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 1,0 % | | | 73 | Phenol, 2-methoxy-4-(1-propenyl) | Isoeugenol | 97-54-1 / 5932-68-3 | 202-590-7 / 227-678-2 | |  |  | | --- | --- | | (a) | Oral products | |  | (a) (b)  The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:   |  |  | | --- | --- | | — | 0,001 % in leave-on products |  |  |  | | --- | --- | | — | 0,01 % in rinse-off products’ | |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,02 % | | |

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (l) | The entries concerning reference numbers 88 and 89 are replaced by the following:   |  |  |  |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘88 | d-Limonene(4R)-1-Methyl-4-(1-methylethenyl) cyclohexene | Limonene | 5989-27-5 | 227-813-5 |  |  | The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:   |  |  | | --- | --- | | — | 0,001 % in leave-on products |  |  |  | | --- | --- | | — | 0,01 % in rinse-off products |   Peroxide value less than 20 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0004) |  | | 89 | Methyl Oct-2-ynoate; Methyl heptine carbonate | Methyl 2-Octynoate | 111-12-6 | 203-836-6 | |  |  | | --- | --- | | (a) | Oral products | |  | (a) (b)  The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:   |  |  | | --- | --- | | — | 0,001 % in leave-on products |  |  |  | | --- | --- | | — | 0,01 % in rinse-off products | |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,01 % when used alone  When present in combination with methyl octine carbonate, the combined level in the finished product shall not exceed 0,01 % (of which methyl octine carbonate shall not be more than 0,002 %) | | |

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (m) | The following entries concerning reference numbers 103 to 205 are inserted:   |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘103 | Abies alba oil and extract | Abies Alba Cone Oil;  Abies Alba Cone Extract;  Abies Alba Leaf Oil;  Abies Alba Leaf Cera;  Abies Alba Needle Extract;  Abies Alba Needle Oil | 90028-76-5 | 289-870-2 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 104 |  |  |  |  |  |  |  |  | | 105 | Abies pectinata oil and extract | Abies Pectinata Oil;  Abies Pectinata Leaf Extract;  Abies Pectinata Needle Extract  Abies Pectinata Needle Oil | 92128-34-2 | 295-728-0 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 106 | Abies sibirica oil and extract | Abies Sibirica Oil;  Abies Sibirica Needle Extract  Abies Sibirica Needle Oil | 91697-89-1 | 294-351-9 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 107 | Abies balsamea oil and extract | Abies Balsamea Needle Oil;  Abies Balsamea Needle Extract  Abies Balsamea Resin;  Abies Balsamea Extract  Abies Balsamea Balsam Extract | 85085-34-3 | 285-364-0 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 108 | Pinus mugo pumilio oil and extract | Pinus Mugo Pumilio Twig Leaf Extract;  Pinus Mugo Pumilio Twig Leaf Oil | 90082-73-8 | 290-164-1 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 109 | Pinus mugo oil and extract | Pinus Mugo Leaf Oil  Pinus Mugo Twig Leaf Extract  Pinus Mugo Twig Oil | 90082-72-7 | 290-163-6 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 110 | Pinus sylvestris oil and extract | Pinus Sylvestris Oil;  Pinus Sylvestris Leaf extract;  Pinus Sylvestris Leaf Oil;  Pinus Sylvestris Leaf Water;  Pinus Sylvestris Cone Extract;  Pinus Sylvestris Bark Extract;  Pinus Sylvestris Bud Extract  Pinus Sylvestris Twig Leaf Extract  Pinus Sylvestris twig Leaf Oil | 84012-35-1 | 281-679-2 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 111 | Pinus nigra oil and extract | Pinus Nigra Bud/Needle Extract  Pinus Nigra Twig Leaf Extract  Pinus Nigra Twig Leaf Oil | 90082-74-9 | 290-165-7 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 112 | Pinus palustris oil and extract | Pinus Palustris Leaf Extract;  Pinus Palustris Oil  Pinus Palustris Twig Leaf Extract  Pinus Palustris Twig Leaf Oil | 97435-14-8 / 8002-09-3 | 306-895-7 / — |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 113 | Pinus pinaster oil and extract | Pinus Pinaster Twig Leaf Oil;  Pinus Pinaster Twig Leaf Extract | 90082-75-0 | 290-166-2 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 114 | Pinus pumila oil and extract | Pinus Pumila Twig Leaf Extract  Pinus Pumila Twig Leaf Oil | 97676-05-6 | 307-681-6 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 115 | Pinus species oil and extract | Pinus Strobus Bark Extract;  Pinus Strobus Cone Extract;  Pinus Strobus Twig Oil  Pinus Species Twig Leaf Extract  Pinus Species Twig Leaf Oil | 94266-48-5 | 304-455-9 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 116 | Pinus cembra oil and extract | Pinus Cembra Twig Leaf Oil  Pinus Cembra Twig Leaf Extract | 92202-04-5 | 296-036-1 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 117 | Pinus cembra extract acetylated | Pinus Cembra Twig Leaf Extract Acetylated | 94334-26-6 | 305-102-1 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 118 | Picea mariana oil and extract | Picea Mariana Leaf Extract;  Picea Mariana Leaf Oil | 91722-19-9 | 294-420-3 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 119 | Thuja occidentalis oil and extract | Thuja Occidentalis Bark Extract;  Thuja Occidentalis Leaf;  Thuja Occidentalis Leaf Extract;  Thuja Occidentalis Leaf Oil;  Thuja Occidentalis Stem Extract;  Thuja Occidentalis Stem Oil;  Thuja Occidentalis Root Extract | 90131-58-1 | 290-370-1 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 120 |  |  |  |  |  |  |  |  | | 121 | 3-Carene; 3,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene) |  | 13466-78-9 | 236-719-3 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 122 | Cedrus atlantica oil and extract | Cedrus Atlantica Bark Extract;  Cedrus Atlantica Bark Oil;  Cedrus Atlantica Bark Water;  Cedrus Atlantica Leaf Extract;  Cedrus Atlantica Wood Extract;  Cedrus Atlantica Wood Oil | 92201-55-3 | 295-985-9 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 123 | Cupressus sempervirens oil and extract | Cupressus Sempervirens Leaf Oil;  Cupressus Sempervirens Bark Extract;  Cupressus Sempervirens Cone Extract;  Cupressus Sempervirens Fruit Extract;  Cupressus Sempervirens Leaf Extract;  Cupressus Sempervirens Leaf/Nut/Stem Oil;  Cupressus Sempervirens Leaf/Stem Extract;  Cupressus Sempervirens Leaf Water;  Cupressus Sempervirens Seed Extract;  Cupressus Sempervirens Oil | 84696-07-1 | 283-626-9 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 124 | Turpentine gum (Pinus spp.) | Turpentine | 9005-90-7 | 232-688-5 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 125 | Turpentine oil and rectified oil | Turpentine | 8006-64-2 | 232-350-7 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 126 | Turpentine, steam distilled (Pinus spp.) | Turpentine | 8006-64-2 | 232-350-7 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 127 | Terpene alcohols acetates | Terpene alcohols acetates | 69103-01-1 | 273-868-3 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 128 | Terpene hydrocarbons | Terpene hydrocarbons | 68956-56-9 | 273-309-3 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 129 | Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 88, 167 and 168 of this Annex III | Terpenes and terpenoids | 65996-98-7 | 266-034-5 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 130 | Terpenes and terpenoids |  | 68917-63-5 | 272-842-9 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 131 | alpha-Terpinene; p-Mentha-1,3-diene | alpha-Terpinene | 99-86-5 | 202-795-1 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 132 | gamma-Terpinene; p-Mentha-1,4-diene | gamma-Terpinene | 99-85-4 | 202-794-6 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 133 | Terpinolene; p-Mentha-1,4(8)-diene | Terpinolene | 586-62-9 | 209-578-0 |  |  | Peroxide value less than 10 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 134 | 1,1,2,3,3,6-Hexamethylindan-5-yl methyl ketone | Acetyl Hexamethyl indan | 15323-35-0 | 239-360-0 | |  |  | | --- | --- | | (a) | Leave-on products |  |  |  | | --- | --- | | (b) | Rinse-off products | | |  |  | | --- | --- | | (a) | 2 % | |  |  | | 135 | Allyl butyrate; 2-Propenyl Butanoate | Allyl butyrate | 2051-78-7 | 218-129-8 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 136 | Allyl cinnamate; 2-Propenyl 3-Phenyl-2-propenoate | Allyl cinnamate | 1866-31-5 | 217-477-8 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 137 | Allyl cyclohexylacetate; 2-Propenyl Cyclohexane acetate | Allyl cyclohexylacetate | 4728-82-9 | 225-230-0 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 138 | Allyl cyclohexylpropionate; 2-Propenyl 3-Cyclohexanepropanoate | Allyl cyclohexylpropionate | 2705-87-5 | 220-292-5 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 139 | Allyl heptanoate; 2-Propenyl heptanoate | Allyl heptanoate | 142-19-8 | 205-527-1 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 140 | Allyl hexanoate | Allyl Caproate | 123-68-2 | 204-642-4 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 141 | Allyl isovalerate; 2-Propenyl 3-Methylbutanoate | Allyl isovalerate | 2835-39-4 | 220-609-7 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 142 | Allyl octanoate; 2-Allyl caprylate | Allyl octanoate | 4230-97-1 | 224-184-9 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 143 | Allyl phenoxyacetate; 2-Propenyl Phenoxyacetate | Allyl phenoxyacetate | 7493-74-5 | 231-335-2 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 144 | Allyl phenylacetate; 2-Propenyl Benzeneacetate | Allyl phenylacetate | 1797-74-6 | 217-281-2 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 145 | Allyl 3,5,5-trimethylhexanoate | Allyl 3,5,5-trimethylhexanoate | 71500-37-3 | 275-536-3 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 146 | Allyl cyclohexyloxyacetate | Allyl cyclohexyloxyacetate | 68901-15-5 | 272-657-3 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 147 | Allyl isoamyloxyacetate | Isoamyl Allylglycolate | 67634-00-8 | 266-803-5 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 148 | Allyl 2-methylbutoxyacetate | Allyl 2-methylbutoxyacetate | 67634-01-9 | 266-804-0 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 149 | Allyl nonanoate | Allyl nonanoate | 7493-72-3 | 231-334-7 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 150 | Allyl propionate | Allyl propionate | 2408-20-0 | 219-307-8 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 151 | Allyl trimethylhexanoate | Allyl trimethylhexanoate | 68132-80-9 | 268-648-9 |  |  | Level of free allyl alcohol in the ester shall be less than 0,1 % |  | | 151a | Allyl phenethyl ether | Allyl phenethyl ether | 14289-65-7 | 238-212-2 |  |  | Level of free allyl alcohol in the ether shall be less than 0,1 % |  | | 152 | Allyl heptine carbonate (allyl oct-2-ynoate) | Allyl heptine carbonate | 73157-43-4 | 277-303-1 |  | 0,002  % | This material shall not be used in combination with any other 2-alkynoic acid ester (e.g. methyl heptine carbonate) |  | | 153 | Amylcyclopentenone; 2-Pentylcyclopent-2-en-1-one | Amylcyclopentenone | 25564-22-1 | 247-104-4 |  | 0,1  % |  |  | | 154 | Myroxylon balsamum var. pereirae; extracts and distillates; Balsam Peru oil, absolute and anhydrol (Balsam Oil Peru) |  | 8007-00-9 | 232-352-8 |  | 0,4  % |  |  | | 155 | 4-tert.-Butyldihydrocinnamaldehyde; 3-(4-tert-Butylphenyl)propionaldehyde | 4-tert.-Butyldihydrocinnamaldehyde | 18127-01-0 | 242-016-2 |  | 0,6  % |  |  | | 156 | Cuminum cyminum oil and extract | Cuminum Cyminum Fruit Oil;  Cuminum Cyminum Fruit Extract;  Cuminum Cyminum Seed Oil;  Cuminum Cyminum Seed Extract;  Cuminum Cyminum Seed Powder | 84775-51-9 | 283-881-6 | |  |  | | --- | --- | | (a) | Leave-on products | | |  |  | | --- | --- | | (a) | 0,4 % of Cumin oil | |  |  | | |  |  | | --- | --- | | (b) | Rinse-off products | |  | | 157 | cis-Rose ketone-1[(16)](#ntr16-L_2013114EN.01000301-E0006); (Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one (cis-alpha-Damascone) | Alpha-Damascone | 23726-94-5 / 43052-87-5 | 245-845-8 / — | |  |  | | --- | --- | | (a) | Oral products | |  |  |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,02 % | | | 158 | trans-Rose ketone-2[(16)](#ntr16-L_2013114EN.01000301-E0006); (E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one (trans-beta-Damascone) | trans-Rose ketone-2 | 23726-91-2 | 245-842-1 | |  |  | | --- | --- | | (a) | Oral products | |  |  |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,02 % | | | 159 | trans-Rose ketone-5[(16)](#ntr16-L_2013114EN.01000301-E0006); (E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one (Isodamascone) | trans-Rose ketone-5 | 39872-57-6 | 254-663-8 |  | 0,02  % |  |  | | 160 | Rose ketone-4[(16)](#ntr16-L_2013114EN.01000301-E0006); 1-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone) | Rose ketone-4 | 23696-85-7 | 245-833-2 | |  |  | | --- | --- | | (a) | Oral products | |  |  |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,02 % | | | 161 | Rose ketone-3[(16)](#ntr16-L_2013114EN.01000301-E0006); 1-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-1-one (Delta-Damascone) | Delta-Damascone | 57378-68-4 | 260-709-8 | |  |  | | --- | --- | | (a) | Oral products | |  |  |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,02 % | | | 162 | cis-Rose ketone-2[(16)](#ntr16-L_2013114EN.01000301-E0006); (Z)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one (cis-beta-Damascone) | cis-Rose ketone-2 | 23726-92-3 | 245-843-7 | |  |  | | --- | --- | | (a) | Oral products | |  |  |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,02 % | | | 163 | trans-Rose ketone-1[(16)](#ntr16-L_2013114EN.01000301-E0006); (E)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one (trans-alpha-Damascone) | trans-Rose ketone-1 | 24720-09-0 | 246-430-4 | |  |  | | --- | --- | | (a) | Oral products | |  |  |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,02 % | | | 164 | Rose ketone-5[(16)](#ntr16-L_2013114EN.01000301-E0006); 1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one | Rose ketone-5 | 33673-71-1 | 251-632-0 |  | 0,02  % |  |  | | 165 | trans-Rose ketone-3[(16)](#ntr16-L_2013114EN.01000301-E0006); 1-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-1-one (trans-delta-Damascone) | trans-Rose ketone-3 | 71048-82-3 | 275-156-8 | |  |  | | --- | --- | | (a) | Oral products | |  |  |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,02 % | | | 166 | trans-2-hexenal | trans-2-hexenal | 6728-26-3 | 229-778-1 | |  |  | | --- | --- | | (a) | Oral products | |  |  |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,002 % | | | 167 | l-Limonene; (S)-p-Mentha-1,8-diene | Limonene | 5989-54-8 | 227-815-6 |  |  | Peroxide value less than 20 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 168 | dl-Limonene (racemic); 1,8(9)-p-Menthadiene; p-Mentha-1,8-diene (Dipentene) | Limonene | 138-86-3 | 205-341-0 |  |  | Peroxide value less than 20 mmoles/L[(15)](#ntr15-L_2013114EN.01000301-E0005) |  | | 169 | p-Mentha-1,8-dien-7-al | Perillaldehyde | 2111-75-3 | 218-302-8 | |  |  | | --- | --- | | (a) | Oral products | |  |  |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,1 % | | | 170 | Isobergamate; Menthadiene-7-methyl formate | Isobergamate | 68683-20-5 | 272-066-0 |  | 0,1  % |  |  | | 171 | Methoxy dicyclopentadiene carboxaldehyde; Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehyde | Scentenal | 86803-90-9 | — |  | 0,5  % |  |  | | 172 | 3-Methylnon-2-enenitrile | 3-Methylnon-2-enenitrile | 53153-66-5 | 258-398-9 |  | 0,2  % |  |  | | 173 | Methyl octine carbonate; Methyl non-2-ynoate | Methyl octine carbonate | 111-80-8 | 203-909-2 | |  |  | | --- | --- | | (a) | Oral products | |  |  |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,002 % when used alone.  When present in combination with methyl heptine carbonate, the combined level in the finished product shall not exceed 0,01 % (of which methyl octine carbonate shall not be more than 0,002 %) | | | 174 | Amylvinylcarbinyl acetate; 1-Octen-3-yl acetate | Amylvinylcarbinyl acetate | 2442-10-6 | 219-474-7 | |  |  | | --- | --- | | (a) | Oral products | |  |  |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,3 % | | | 175 | Propylidenephthalide; 3-Propylidenephthalide | Propylidenephthalide | 17369-59-4 | 241-402-8 | |  |  | | --- | --- | | (a) | Oral products | |  |  |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,01 % | | | 176 | Isocyclogeraniol; 2,4,6-Trimethyl-3-cyclohexene-1-methanol | Isocyclogeraniol | 68527-77-5 | 271-282-2 |  | 0,5  % |  |  | | 177 | 2-Hexylidene cyclopentanone | 2-Hexylidene cyclopentanone | 17373-89-6 | 241-411-7 | |  |  | | --- | --- | | (a) | Oral products | |  |  |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,06 % | | | 178 | Methyl heptadienone; 6-Methyl-3,5-heptadien-2-one | Methyl heptadienone | 1604-28-0 | 216-507-7 | |  |  | | --- | --- | | (a) | Oral products | |  |  |  | | |  |  | | --- | --- | | (b) | Other products | | |  |  | | --- | --- | | (b) | 0,002 % | | | 179 | p-methylhydrocinnamic aldehyde; Cresylpropionaldehyde; p-Methyldihydrocinnamaldehyde | p-methylhydrocinnamic aldehyde | 5406-12-2 | 226-460-4 |  | 0,2  % |  |  | | 180 | Liquidambar orientalis oil and extract (styrax) | Liquidambar Orientalis Resin Extract;  Liquidambar Orientalis Balsam Extract;  Liquidambar Orientalis Balsam Oil | 94891-27-7 | 305-627-6 |  | 0,6  % |  |  | | 181 | Liquidambar styraciflua oil and extract (styrax) | Liquidambar Styraciflua Oil;  Liquidambar Styraciflua Balsam Extract;  Liquidambar Styraciflua Balsam Oil | 8046-19-3  94891-28-8 | 232-458-4  305-628-1 |  | 0,6  % |  |  | | 182 | 1-(5,6,7,8-Tetrahydro-3,5,5,6,8,8,-hexamethyl-2-naphthyl)ethan-1-one (AHTN) | Acetyl hexamethyl tetralin | 21145-77-7 / 1506-02-1 | 244-240-6 / 216-133-4 | All cosmetic products with the exception of oral products | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | leave-on products: 0,1 %  except:   |  |  | | --- | --- | |  | hydroalcoholic products: 1 % |  |  |  | | --- | --- | |  | fine fragrance: 2,5 % |  |  |  | | --- | --- | |  | fragrance cream: 0,5 % | |  |  |  | | --- | --- | | (b) | rinse-off products: 0,2 % | |  |  | | 183 | Commiphora erythrea Engler var. glabrescens Engler gum extract and oil | Opoponax oil | 93686-00-1 | 297-649-7 |  | 0,6  % |  |  | | 184 | Opopanax chironium resin |  | 93384-32-8 |  |  | 0,6  % |  |  | | 185 | Benzene, methyl- | Toluene | 108-88-3 | 203-625-9 | Nail products | 25  % |  | Keep out of reach of children  To be used by adults only | | 186 | 2,2′-oxydiethanol  Diethylene glycol (DEG) | Diethylene glycol | 111-46-6 | 203-872-2 | As traces in ingredients | 0,1  % |  |  | | 187 | Diethylene glycol monobutyl ether (DEGBE) | Butoxydiglycol | 112-34-5 | 203-961-6 | Solvent in hair dye products | 9  % | No use in aerosol dispensers (sprays) |  | | 188 | Ethylene glycol monobutyl ether (EGBE) | Butoxyethanol | 111-76-2 | 203-905-0 | |  |  | | --- | --- | | (a) | Solvent in oxidative hair dye products | | |  |  | | --- | --- | | (a) | 4,0 % | | (a) (b)  No use in aerosol dispensers (sprays) |  | | |  |  | | --- | --- | | (b) | Solvent in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 2,0 % | | | 189 | Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate and aluminium lake[(17)](#ntr17-L_2013114EN.01000301-E0007);  (CI 19140) | Acid Yellow 23;  Acid Yellow 23 Aluminum lake | 1934-21-0 / 12225-21-7 | 217-699-5 / 235-428-9 | Hair dye substance in non-oxidative hair dye products | 0,5  % |  |  | | 190 | Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl-[(3-sulfophenyl)-methyl]-amino]-phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo, inner salts, disodium salt and its ammonium and aluminium salts[(17)](#ntr17-L_2013114EN.01000301-E0007); (CI 42090) | Acid Blue 9;  Acid Blue 9 Ammonium Salt;  Acid Blue 9 Aluminum Lake | 3844-45-9 / 2650-18-2 / 68921-42-6 | 223-339-8 / 220-168-0 / 272-939-6 | Hair dye substance in non-oxidative hair dye products | 0,5  % |  |  | | 191 | Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate[(17)](#ntr17-L_2013114EN.01000301-E0007); (CI 16035) | Curry Red | 25956-17-6 | 247-368-0 | Hair dye substance in non-oxidative hair dye products | 0,4  % |  |  | | 192 | Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4′,6,8-trisulphonate and aluminium lake[(17)](#ntr17-L_2013114EN.01000301-E0007); (CI 16255) | Acid Red 18;  Acid Red 18 Aluminum Lake | 2611-82-7 / 12227-64-4 | 220-036-2 / 235-438-3 | Hair dye substance in non-oxidative hair dye products | 0,5  % |  |  | | 193 | Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium salt[(17)](#ntr17-L_2013114EN.01000301-E0007); (CI 45100) | Acid Red 52 | 3520-42-1 | 222-529-8 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %. | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 12  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 0,6 % | | | 194 | Glyoxal | Glyoxal | 107-22-2 | 203-474-9 |  | 100  mg/kg |  |  | | 195 | Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate[(17)](#ntr17-L_2013114EN.01000301-E0007); (CI 62045) | Acid Blue 62 | 4368-56-3 | 224-460-9; | Hair dye substance in non-oxidative hair dye products | 0,5  % | |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | |  | | 196 | Verbena absolute (Lippia citriodora Kunth.) |  | 8024-12-2 | — |  | 0,2  % |  |  | | 197 | Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride[(18)](#ntr18-L_2013114EN.01000301-E0008) | Ethyl Lauroyl Arginate HCl | 60372-77-2 | 434-630-6 | |  |  | | --- | --- | | (a) | soap |  |  |  | | --- | --- | | (b) | anti-dandruff shampoos |  |  |  | | --- | --- | | (c) | deodorants, not in form of spray | | 0,8  % | 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 |  | | 201 | Phenol, 2-Chloro-6-(ethylamino)-4-nitro- | 2-Chloro-6-ethylamino-4-nitrophenol | 131657-78-8 | 411-440-1 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 13  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 3,0 % | | (a) and (b):   |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | | | 202 | See 226 |  |  |  |  |  |  |  | | 203 | 6-Methoxy-N2-methyl-2,3-pyridinediamine hydrochloride and dihydrochloride salt[(17)](#ntr17-L_2013114EN.01000301-E0007) | 6-Methoxy-2-methylamino-3-aminopyridine HCl | 90817-34-8 / 83732-72-3 | — / 280-622-9 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,68 % calculated as free base (1,0 % as dihydrochloride). |   For (a) and (b):   |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 14  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 0,68 % as free base (1,0 % as dihydrochloride) | | |  |  | | --- | --- | | (b) | Can cause allergic reaction | | | 204 | 2,3-Dihydro-1H-indole-5,6-diol and its hydrobromide salt[(17)](#ntr17-L_2013114EN.01000301-E0007) | Dihydroxy indoline  Dihydroxy indoline HBr | 29539-03-5 / 138937-28-7 | — / 421-170-6 | Hair dye substance in non-oxidative hair dye products | 2,0  % |  | Can cause allergic reaction | | 205 | See 219 |  |  |  |  |  |  |  | |

|  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (n) | The entries concerning reference numbers 215 to 256 are replaced by the following:   |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘215 | 4-Amino-3-nitrophenol | 4-Amino-3-nitrophenol | 610-81-1 | 210-236-8 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 15  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 1,0 % | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (b) | “ Image 16  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.” | | | | 216 | Naphthalene-2,7-diol | 2,7-Naphthalenediol | 582-17-2 | 209-478-7 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 % | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 17  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 1,0 % | | | 217 | m-Aminophenol and its salts | m-Aminophenol  m-Aminophenol HCl  m-Aminophenol sulfate | 591-27-5 / 51-81-0 / 68239-81-6 /38171-54-9 | 209-711-2 / 200-125-2 / 269-475-1 | Hair dye substance in oxidative hair dye products |  | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,2 % | To be printed on the label:  The mixing ratio.  “ Image 18  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.” | | | 218 | 6-Hydroxy-3,4-dimethyl-2-pyridone | 2,6-Dihydroxy-3,4-dimethylpyridine | 84540-47-6 | 283-141-2 | Hair dye substance in oxidative hair dye products |  | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 % | To be printed on the label:  The mixing ratio.  “ Image 19  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.” | | | 219 | 1-Hydroxy-3-nitro-4-(3-hydroxypropylamino)benzene[(17)](#ntr17-L_2013114EN.01000301-E0009) | 4-Hydroxypropylamino-3-nitrophenol | 92952-81-3 | 406-305-9 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,6 % calculated as free base. |   For (a) and (b):   |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 20  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 2,6 % | | | 220 | 1-[(2′-Methoxyethyl)amino]-2-nitro-4-[di-(2′-hydroxyethyl)amino]benzene[(17)](#ntr17-L_2013114EN.01000301-E0009) | HC Blue No 11 | 23920-15-2 | 459-980-7 | Hair dye substance in non-oxidative hair dye products | 2,0  % | |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | |  | | 221 | 1-Methyl-3-nitro-4-(beta-hydroxyethyl)aminobenzene and its salts | Hydroxyethyl-2-nitro-p-toluidine | 100418-33-5 | 408-090-7 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 % | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 21  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 1,0 % | | | 222 | 1-Hydroxy-2-beta-hydroxyethylamino-4,6-dinitrobenzene | 2-Hydroxyethylpicramic acid | 99610-72-7 | 412-520-9 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % |   For (a) and (b):   |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg m/kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 22  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 2,0 % | | | 223 | p-Methylaminophenol and its sulphate | p-Methylaminophenol  p-Methylaminophenol sulphate | 150-75-4 / 55-55-0 /1936-57-8 | 205-768-2 / 200-237-1 /217-706-1 | Hair dye substance in oxidative hair dye products |  | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,68 % (as sulphate)   |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | | To be printed on the label:  The mixing ratio.  “ Image 23  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.” | | | 224 | 1-Propanol, 3-[[4-[bis(2-hydroxyethyl)amino]-2-nitrophenyl]amino][(17)](#ntr17-L_2013114EN.01000301-E0009) | HC Violet No 2 | 104226-19-9 | 410-910-3 | Hair dye substance in non-oxidative hair dye products | 2,0  % | |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | | Can cause allergic reaction | | 225 | 1-(beta-Hydroxyethyl)amino-2-nitro-4-N-ethyl-N-(.beta.-hydroxyethyl)aminobenzene and its hydrochloride | HC Blue No 12 | 104516-93-0 / 132885-85-9 (HCl) | — / 407-020-2 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,75 % (as hydrochloride) |   For (a) and (b):   |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 24  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 1,5 % (as hydrochloride) | | | 226 | 4,4′-[1,3-Propanediylbis(oxy)]bisbenzene-1,3-diamine and its tetrahydrochloride salt[(17)](#ntr17-L_2013114EN.01000301-E0009) | 1,3-bis-(2,4-Diaminophenoxy)propane  1,3-bis-(2,4-Diaminophenoxy)propane HCl | 81892-72-0 / 74918-21-1 | 279-845-4 / 278-022-7 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,2 % calculated as free base (1,8 % as tetrahydrochloride salt). | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 25  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 1,2 % as free base (1,8 % as tetrahydrochloride salt) | | |  |  | | --- | --- | | (b) | Can cause allergic reaction | | | 227 | 3-Amino-2,4-dichlorophenol and its hydrochloride | 3-Amino-2,4-dichlorophenol  3-Amino-2,4-dichlorophenol HCl | 61693-42-3 / 61693-43-4 | 262-909-0 / — | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (as hydrochloride) | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 26  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 1,5 % (as hydrochloride) | | | 228 | 3-Methyl -1- phenyl -5-pyrazolone | Phenyl methyl pyrazolone | 89-25-8 | 201-891-0 | Hair dye substance in oxidative hair dye products |  | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 % | To be printed on the label:  The mixing ratio.  “ Image 27  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.” | | | 229 | 5-[(2-Hydroxyethyl)amino]-o-cresol | 2-Methyl-5-hydroxyethylaminophenol | 55302-96-0 | 259-583-7 | Hair dye substance in oxidative hair dye products |  | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %   |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | | To be printed on the label:  The mixing ratio.  “ Image 28  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.” | | | 230 | 3,4-Dihydro-2H-1,4-benzoxazin-6-ol | Hydroxybenzomorpholine | 26021-57-8 | 247-415-5 | Hair dye substance in oxidative hair dye products |  | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %   |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | | To be printed on the label:  The mixing ratio.  “ Image 29  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.” | | | 231 | 1,5-Di-(beta-hydroxyethylamino)-2-nitro-4-chlorobenzene[(17)](#ntr17-L_2013114EN.01000301-E0009) | HC Yellow No 10 | 109023-83-8 | 416-940-3 | Hair dye substance in non-oxidative hair dyes products | 0,1  % | |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | |  | | 232 | 2,6-Dimethoxy-3,5-pyridinediamine and its hydrochloride | 2,6-Dimethoxy-3,5-pyridinediamine  2,6-Dimethoxy-3,5-pyridinediamine HCl | 56216-28-5 / 85679-78-3 | 260-062-1 / — | Hair dye substance in oxidative hair dye products |  | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 % (as hydrochloride) | To be printed on the label:  The mixing ratio.  “ Image 30  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.” | | | 233 | 1-(beta-Aminoethyl)amino-4-(beta-hydroxyethyl)oxy-2-nitrobenzene and its salts | HC Orange No 2 | 85765-48-6 | 416-410-1 | Hair dye substance in non-oxidative hair dye products | 1,0  % | |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitritefree containers | | To be printed on the label:  The mixing ratio.  “ Image 31  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.” | | | 234 | Ethanol, 2-[(4-amino-2-methyl-5-nitrophenyl)amino]- and its salts | HC Violet No 1 | 82576-75-8 | 417-600-7 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 % |   For (a) and (b)   |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 32  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 0,28 % | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (b) | “ Image 33  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.” | | | | 235 | 2-[3-(methylamino)-4-nitrophenoxy]ethanol[(17)](#ntr17-L_2013114EN.01000301-E0009) | 3-Methylamino-4-nitrophenoxyethanol | 59820-63-2 | 261-940-7 | Hair dye substance in non-oxidative hair dye products | 0,15  % | |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | |  | | 236 | 2-[(2-methoxy-4-nitrophenyl)amino]ethanol and its salts | 2-Hydroxyethylamino-5-nitroanisole | 66095-81-6 | 266-138-0 | Hair dye substance in non-oxidative hair dye products | 0,2  % | |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | |  | | 237 | 2,2′-[(4-Amino-3-nitrophenyl)imino]bisethanol and its hydrochloride | HC Red No 13 | 29705-39-3/94158-13-1 | -/303-083-4 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,25 % (as hydrochloride) | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 34  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 2,5 % (as hydrochloride) | | | 238 | Naphthalene-1,5-diol | 1,5-Naphthalenediol | 83-56-7 | 201-487-4 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 % | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 35  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 1,0 % | | | 239 | Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) and its tetrahydro-chloride | Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) HCl | 128729-30-6 / 128729-28-2 | — / 416-320-2 | Hair dye substance in oxidative hair dye products |  | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,4 % (as tetrahydrochloride) | To be printed on the label:  The mixing ratio.  “ Image 36  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.” | | | 240 |  |  |  |  |  |  |  |  | | 241 | 5-Amino-o-cresol | 4-Amino-2-hydroxytoluene | 2835-95-2 | 220-618-6 | Hair dye substance in oxidative hair dye products |  | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % | To be printed on the label:  The mixing ratio.  “ Image 37  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.” | | | 242 | 2,4-Diaminophenoxyethanol, its hydrochloride and its sulphate | 2,4-Diaminophenoxyethanol HCl  2,4-Diaminophenoxyethanol sulphate | 70643-19-5/ 66422-95-5 / 70643-20-8 | — / 266-357-1 / 274-713-2 | Hair dye substance in oxidative hair dye products |  | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (as hydrochloride) | To be printed on the label:  The mixing ratio.  “ Image 38  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.” | | | 243 | 1,3-benzenediol, 2-methyl | 2-Methylresorcinol | 608-25-3 | 210-155-8 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,8 % | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 39  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 1,8 % | | | 244 | 4-Amino-m-cresol | 4-Amino-m-cresol | 2835-99-6 | 220-621-2 | Hair dye substance in oxidative hair dye products |  | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % | To be printed on the label:  The mixing ratio.  “ Image 40  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.” | | | 245 | 2-[(3amino-4-methoxyphenyl)amino]ethanol and its sulphate | 2-Amino-4-hydroxyethylaminoanisole  2-Amino-4-hydroxyethylaminoanisole sulfate | 83763-47-7 /83763-48-8 | 280-733-2 /280-734-8 | Hair dye substance in oxidative hair dye products |  | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (as sulphate)   |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | | To be printed on the label:  The mixing ratio.  “ Image 41  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.” | | | 246 | Hydroxyethyl-3,4-methylenedioxyaniline and its hydrochloride | Hydroxyethyl-3,4-methylenedioxyaniline HCl | 94158-14-2 | 303-085-5 | Hair dye substance in oxidative hair dye products |  | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %   |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | | To be printed on the label:  The mixing ratio.  “ Image 42  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.” | | | 247 | 2,2′-[[4-[(2-Hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol[(17)](#ntr17-L_2013114EN.01000301-E0009) | HC Blue No 2 | 33229-34-4 | 251-410-3 | Hair dye substance in non-oxidative hair dye products | 2,8  % | |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | | Can cause allergic reaction | | 248 | 4-[(2-Hydroxyethyl)amino]-3-nitrophenol | 3-Nitro-p-hydroxyethylaminophenol | 65235-31-6 | 265-648-0 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3,0 % |   For (a) and (b):   |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 43  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 1,85 % | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (b) | “ Image 44  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.” | | | | 249 | 1-(beta-Ureidoethyl)amino-4-nitrobenzene | 4-Nitrophenyl aminoethylurea | 27080-42-8 | 410-700-1 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 % |   For (a) and (b):   |  |  | | --- | --- | | — | Do not use with nitrosating agents |  |  |  | | --- | --- | | — | Maximum nitrosamine content: 50 μg /kg |  |  |  | | --- | --- | | — | Keep in nitrite-free containers | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 45  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 0,5 % | | | 250 | 1-Amino-2-nitro-4-(2′,3′-dihydroxypropyl)amino-5-chlorobenzene and 1,4-bis-(2′,3′-dihydroxypropyl)amino-2-nitro-5-chlorobenzene and its salts | HC Red No 10 and HC Red No 11 | 95576-89-9 / 95576-92-4 | — / — | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1 % | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 46  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 1,0 % | | | 251 |  |  |  |  |  |  |  |  | | 252 | 2-Amino-6-chloro-4-nitrophenol | 2-Amino-6-chloro-4-nitrophenol | 6358-09-4 | 228-762-1 | |  |  | | --- | --- | | (a) | Hair dye substance in oxidative hair dye products | |  | |  |  | | --- | --- | | (a) | After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (a) | To be printed on the label:  The mixing ratio.  “ Image 47  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.” | | | | |  |  | | --- | --- | | (b) | Hair dye substance in non-oxidative hair dye products | | |  |  | | --- | --- | | (b) | 2,0 % | | |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | | (b) | “ Image 48  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.” | | | | 253 |  |  |  |  |  |  |  |  | | 254 | Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate[(17)](#ntr17-L_2013114EN.01000301-E0009); (CI 17200) | Acid Red 33 | 3567-66-6 | 222-656-9 | Hair dye substance in non-oxidative hair dye products | 0,5  % |  |  | | 255 |  |  |  |  |  |  |  |  | | 256 |  |  |  |  |  |  |  |  | |

(3)

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

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (a) | The entry concerning reference number 34 is replaced by the following:   |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘34 | Benzyl alcohol[(7)](#ntr7-L_2013114EN.01000301-E0010) | Benzyl Alcohol | 100-51-6 | 202-859-9 |  | 1,0  % |  |  | |

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (b) | The following entry is added:   |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘58 | Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloride[(14)](#ntr14-L_2013114EN.01000301-E0011) | Ethyl Lauroyl Arginate HCl | 60372-77-2 | 434-630-6 |  | 0,4  % | Not to be used in lip products, oral products and spray products |  | |

(4)

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

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (a) | The entry concerning reference number 1 is replaced by the following:   |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘1’ |  |  |  |  |  |  |  |  | |

|  |  |  |  |  |  |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| (b) | The entry concerning reference number 28 is replaced by the following:   |  |  |  |  |  |  |  |  |  | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | ‘28 | Benzoic acid, 2-[-4-(diethylamino)-2-hydroxybenzoyl]-. Hexylester | Diethylamino Hydroxy benzoyl Hexyl Benzoate | 302776-68-7 | 443-860-6 |  | 10  %’ |  |  | |

---

[(1)](#ntc1-L_2013114EN.01000301-E0001)  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.’

[(\*1)](#ntc*1-L_2013114EN.01000301-E0002)  
[OJ L 255, 30.9.2005, p. 22](./../../../legal-content/EN/AUTO/?uri=OJ:L:2005:255:TOC).’

[(7)](#ntc7-L_2013114EN.01000301-E0003)  For use as a preservative, see Annex V, No 34.’

[(15)](#ntc15-L_2013114EN.01000301-E0004)  This limit applies to the substance and not to the finished cosmetic product.’

[(15)](#ntc15-L_2013114EN.01000301-E0005)  This limit applies to the substance and not to the finished cosmetic product.

[(16)](#ntc16-L_2013114EN.01000301-E0006)  The sum of those substances used in combination should not exceed the limits given as “Maximum concentration in ready for use preparation”.

[(17)](#ntc17-L_2013114EN.01000301-E0007)  The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are permitted for use.

[(18)](#ntc18-L_2013114EN.01000301-E0008)  For use as a preservative, see Annex V, No 58.’

[(17)](#ntc17-L_2013114EN.01000301-E0009)  The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are permitted for use.’

[(7)](#ntc7-L_2013114EN.01000301-E0010)  For other uses than preservatives, see Annex III, entry No 45.’

[(14)](#ntc14-L_2013114EN.01000301-E0011)  For other uses than preservatives, see Annex III, entry No 197.’

---

[Top](#document1)