Commission Regulation (EU) No 344/2013Show full title

Commission Regulation (EU) No 344/2013

of 4 April 2013

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

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

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

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). 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 U.K.

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

Article 2 U.K.

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

It shall apply from 11 July 2013.

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

ANNEX U.K.

(1) Annex II to Regulation (EC) No 1223/2009 is amended as follows: U.K.

(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: U.K.

(a)

The entries concerning reference numbers 8, 9 and 10 are replaced by the following:

a 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.’
‘8	N-substituted derivatives of p-Phenylenediamine and their salts; N-substituted derivatives of o-Phenylenediaminea, 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. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Contains phenylenediamines. Do not use to dye eyelashes or eyebrows
							(b) Professional use For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3 % calculated as free base	(b) To be printed on the label: The mixing ratio. For professional use only Hair colourants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Contains phenylenediamines. Wear suitable gloves
8a	p-Phenylenediamine and its salts	p-Phenylenediamine; p-Phenylenediamine HCl; p-Phenylenediamine Sulphate	106-50-3 / 624-18-0 / 16245-77-5	203-404-7 / 210-834-9 / 240-357-1	Hair dye substance in oxidative hair dye products		(a) General use	(a) To be printed on the label: The mixing ratio. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Contains phenylenediamines. Do not use to dye eyelashes or eyebrows.
							(b) Professional use For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % calculated as free base	(b) To be printed on the label: The mixing ratio. For professional use only. Hair colourants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Contains phenylenediamines. Wear suitable gloves.
9	Methylphenylenediamines, their N-substituted derivatives and their saltsa 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. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Contains phenylenediamines (toluenediamines). Do not use to dye eyelashes or eyebrows.
							(b) Professional use For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 5 % calculated as free base	(b) To be printed on the label: The mixing ratio. For professional use only Hair colourants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Contains phenylenediamines (toluenediamines). Wear suitable gloves.
9a	Toluene-2,5-diamine and its salts	Toluene-2,5-Diamine Toluene-2,5-Diamine Sulfate	95-70-5 / 615-50-9	202-442-1 / 210-431-8	Hair dye substance in oxidative hair dye products		(a) General use	(a) To be printed on the label: The mixing ratio. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Contains phenylenediamines (toluenediamines). Do not use to dye eyelashes or eyebrows.
							(b) Professional use For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 4 % calculated as free base	(b) To be printed on the label: The mixing ratio. For professional use only Hair colourants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Contains phenylenediamines (toluenediamines). Wear suitable gloves.
10

(b)

The entry concerning reference number 12 is replaced by the following:

a OJ L 255, 30.9.2005, p. 22.’
‘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/ECa 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. ‘ 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.’’ Hair colourants can cause severe allergic reactions.’

(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. 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. 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)

[X1 The entry concerning reference number 45 is replaced by the following:

a For use as a preservative, see Annex V, No 34. ’]
‘ 45	Benzyl alcohol a	Benzyl Alcohol	100-51-6	202-859-9	(a) Solvent		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:

a This limit applies to the substance and not to the finished cosmetic product.’
‘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/La
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:

a This limit applies to the substance and not to the finished cosmetic product.
b The sum of those substances used in combination should not exceed the limits given as “Maximum concentration in ready for use preparation”.
c The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are permitted for use.
d For use as a preservative, see Annex V, No 58.’
‘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/La
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/La
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/La
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/La
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/La
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/La
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/La
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/La
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/La
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/La
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/La
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/La
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/La
117	Pinus cembra extract acetylated	Pinus Cembra Twig Leaf Extract Acetylated	94334-26-6	305-102-1			Peroxide value less than 10 mmoles/La
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/La
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/La
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/La
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/La
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/La
124	Turpentine gum (Pinus spp.)	Turpentine	9005-90-7	232-688-5			Peroxide value less than 10 mmoles/La
125	Turpentine oil and rectified oil	Turpentine	8006-64-2	232-350-7			Peroxide value less than 10 mmoles/La
126	Turpentine, steam distilled (Pinus spp.)	Turpentine	8006-64-2	232-350-7			Peroxide value less than 10 mmoles/La
127	Terpene alcohols acetates	Terpene alcohols acetates	69103-01-1	273-868-3			Peroxide value less than 10 mmoles/La
128	Terpene hydrocarbons	Terpene hydrocarbons	68956-56-9	273-309-3			Peroxide value less than 10 mmoles/La
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/La
130	Terpenes and terpenoids		68917-63-5	272-842-9			Peroxide value less than 10 mmoles/La
131	alpha-Terpinene; p-Mentha-1,3-diene	alpha-Terpinene	99-86-5	202-795-1			Peroxide value less than 10 mmoles/La
132	gamma-Terpinene; p-Mentha-1,4-diene	gamma-Terpinene	99-85-4	202-794-6			Peroxide value less than 10 mmoles/La
133	Terpinolene; p-Mentha-1,4(8)-diene	Terpinolene	586-62-9	209-578-0			Peroxide value less than 10 mmoles/La
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-1b; (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-2b; (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-5b; (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-4b; 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-3b; 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-2b; (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-1b; (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-5b; 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-3b; 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/La
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/La
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 lakec; (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 saltsc; (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-sulphonatec; (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 lakec; (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 saltc; (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. 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-sulphonatec; (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 hydrochlorided	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. 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 saltc	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. 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 saltc	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:

a The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are permitted for use.’
‘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. 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) 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. 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. 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. 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)benzenea	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. 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]benzenea	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. 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. 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. 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]a	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. 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 salta	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. 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. 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. 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. 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. 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-chlorobenzenea	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. 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. 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. 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) 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]ethanola	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. 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. 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. 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. 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. 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. 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. 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. 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. 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]bisethanola	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. 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) 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. 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. 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. 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) 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-disulphonatea; (CI 17200)	Acid Red 33	3567-66-6	222-656-9	Hair dye substance in non-oxidative hair dye products	0,5 %
255
256

Editorial Information

X1 Substituted by Corrigendum to 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 (Official Journal of the European Union L 114 of 25 April 2013).

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

(a)

The entry concerning reference number 34 is replaced by the following:

a For other uses than preservatives, see Annex III, entry No 45.’
‘34	Benzyl alcohola	Benzyl Alcohol	100-51-6	202-859-9		1,0 %

(b)

The following entry is added:

a For other uses than preservatives, see Annex III, entry No 197.’
‘58	Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloridea	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: U.K.

(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)

OJ L 342, 22.12.2009, p. 59.

(2)

OJ L 262, 27.9.1976, p. 169.