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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)

EU Regulation No 344/2013 · Adopted 4 April 2013 · Extends to United Kingdom

Original text. legislation.gov.uk does not revise this item, so later amendments are not shown here. Changes made to it are listed under each provision when known.

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 productsf1, 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 productsf2. 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:

Annotations to the whole text

Footnotes

f1

OJ L 342, 22.12.2009, p. 59.

f2

OJ L 262, 27.9.1976, p. 169.

Contents

  1. 1Article 1
  2. 2Article 2
  3. Signature
  4. Annex
  5. (1)Annex II to Regulation (EC) No 1223/2009 is amended as follows:
  6. (2)Annex III to Regulation (EC) No 1223/2009 is amended as follows:
  7. (3)Annex V to Regulation (EC) No 1223/2009 is amended as follows:
  8. (4)Annex VI to Regulation (EC) No 1223/2009 is amended as follows:

1

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

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.

Signature

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

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

  1. (a)

    The entry concerning reference number 167 is replaced by the following:

    ‘

    1674-Aminobenzoic acid and its esters, with the free amino group150-13-0205-753-0

    ’

  2. (b)

    The entry concerning reference number 450 is replaced by the following:

    ‘

    450Verbena essential oils (Lippia citriodora Kunth.) and derivatives other than absolute when used as a fragrance ingredient8024-12-2285-515-0

    ’

  3. (c)

    The entry concerning reference number 1136 is replaced by the following:

    ‘

    1136Exudation of Myroxylon pereirae (Royle) Klotzsch (Peru balsam, crude) when used as a fragrance ingredient8007-00-9232-352-8

    ’

  4. (d)

    Entries for the following reference numbers are added:

    ‘

    13294-[(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 products3248-93-9 / 632-99-5 (HCl)221-832-2 / 211-189-6 (HCl)
    13304-(2,4-Dihydroxyphenylazo)benzensulphonic acid and its sodium salt (Acid Orange 6; CI 14270) when used as substance in hair dye products2050-34-2 / 547-57-9 (Na)218-087-0 / 208-924-8 (Na)
    13313-Hydroxy-4-(phenylazo)-2-naphthoic acid and its calcium salt (Pigment Red 64:1; CI 15800) when used as a substance in hair dye products27757-79-5 / 6371-76-2 (Ca)248-638-0 / 228-899-7 (Ca)
    13322-(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 products2321-07-5 / 518-47-8 (Na)219-031-8 / 208-253-0 (Na)
    13334′,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 products596-03-2 / 4372-02-5 (Na)209-876-0 / 224-468-2 (Na)
    13342-(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 products15086-94-9 / 17372-87-1 (Na) / 15876-39-8 (Al)239-138-3 / 241-409-6 (Na) / 240-005-7 (Al)
    1335Xanthylium, 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 products10213-95-3 / 6252-76-2 (Na)— / 228-377-9 (Na)
    13363′,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 products38577-97-8 / 33239-19-9 (Na)254-010-7 / 251-419-2 (Na)
    13372′,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 products15905-32-5 / 16423-68-0 (Na) / 12227-78-0 (Al)240-046-0 / 240-474-8 (Na) / 235-440-4 (Al)
    13381-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) and its dihydrochloride salts (2,4-Diaminophenol HCl) when used as a substance in hair dye products95-86-3 / 137-09-7 (HCl)202-459-4 / 205-279-4 (HCl)
    13391,4-Dihydroxybenzene (Hydroquinone), with the exception of entry 14 in Annex III123-31-9204-617-8
    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 products2580-56-5219-943-6
    1341Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (Ponceau SX; CI 14700) when used as a substance in hair dye products4548-53-2224-909-9
    1342Trisodium 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 products19381-50-1243-010-2
    13434-(Phenylazo)resorcinol (Solvent Orange 1; CI 11920) and its salts when used as a substance in hair dye products2051-85-6218-131-9
    13444-[(4-Ethoxyphenyl)azo]naphthol (Solvent Red 3; CI 12010) and its salts when used as a substance in hair dye products6535-42-8229-439-8
    13451-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol (Pigment Red 4; CI 12085) and its salts when used as a substance in hair dye products2814-77-9220-562-2
    13463-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 products6535-46-2229-440-3
    1347N-(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 products6410-41-9229-107-2
    1348Disodium 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 products3564-21-4222-642-2
    1349Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate (Pigment Red 63:1; CI 15880) when used as a substance in hair dye products6417-83-0229-142-3
    1350Trisodium 3-hydroxy-4-(4′-sulphonatonaphthylazo)naphthalene-2,7-disulphonate (Acid Red 27; CI 16185) when used as a substance in hair dye products915-67-3213-022-2
    13512,2′-[(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 products5102-83-0225-822-9
    13522,2′-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] (Solvent Yellow 29; CI 21230) when used as a substance in hair dye products6706-82-7229-754-0
    13531-((4-Phenylazo)phenylazo)-2-naphthol (Solvent Red 23; CI 26100) when used as a substance in hair dye products85-86-9201-638-4
    1354Tetrasodium 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 products2118-39-0218-326-9
    1355Ethanaminium, 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 products129-17-9204-934-1
    1356Ethanaminium, 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 products3536-49-0222-573-8
    1357Benzenemethanaminium, 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 products2353-45-9219-091-5
    13581,3-Isobenzofurandione, reaction products with methylquinoline and quinoline (Solvent Yellow 33; CI 47000) when used as a substance in hair dye products8003-22-3232-318-2
    1359Nigrosine (CI 50420) when used as a substance in hair dye products8005-03-6—
    13608,18-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 products6358-30-1228-767-9
    13611,2-Dihydroxyanthraquinone (Pigment Red 83; CI 58000) when used as a substance in hair dye products72-48-0200-782-5
    1362Trisodium 8-hydroxypyrene-1,3,6-trisulphonate (Solvent Green 7; CI 59040) when used as a substance in hair dye products6358-69-6228-783-6
    13631-Hydroxy-4-(p-toluidino)anthraquinone (Solvent Violet 13; CI 60725) when used as a substance in hair dye products81-48-1201-353-5
    13641,4-bis(p-Tolylamino)anthraquinone (Solvent Green 3; CI 61565) when used as a substance in hair dye products128-80-3204-909-5
    13656-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 products2379-74-0219-163-6
    13665,12-Dihydroquino[2,3-b]acridine-7,14-dione (Pigment Violet 19; CI 73900) when used as a substance in hair dye products1047-16-1213-879-2
    1367(29H,31H-Phthalocyaninato(2-)- N29,N30,N31,N32)copper (Pigment Blue 15; CI 74160) when used as a substance in hair dye products147-14-8205-685-1
    1368Disodium [29H,31H-phthalocyaninedisulphonato(4-)- N29,N30,N31,N32]cuprate(2-) (Direct Blue 86; CI 74180) when used as a substance in hair dye products1330-38-7215-537-8
    1369Polychloro copper phthalocyanine (Pigment Green 7; CI 74260) when used as a substance in hair dye products1328-53-6215-524-7
    1370Diethylene glycol (DEG); 2,2′-oxydiethanol for traces level, see Annex III111-46-6203-872-2
    1371Phytonadione [INCI] / phytomenadione [INN]84-80-0 / 81818-54-4201-564-2 / 279-833-9
    13722-Aminophenol (o-Aminophenol; CI 76520) and its salts95-55-6 / 67845-79-8 / 51-19-4202-431-1 / 267-335-4

    ’

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

  1. (a)

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

    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.’

    ‘8N-substituted derivatives of p-Phenylenediamine and their salts; N-substituted derivatives of o-Phenylenediaminef1, with exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex IIHair 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

    8ap-Phenylenediamine and its salts

    p-Phenylenediamine;

    p-Phenylenediamine HCl;

    p-Phenylenediamine Sulphate

    106-50-3 / 624-18-0 / 16245-77-5203-404-7 / 210-834-9 / 240-357-1Hair 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.

    9Methylphenylenediamines, their N-substituted derivatives and their salts with the exception of the substance under reference number 9a in this annex and substances under reference numbers 364, 1310 and 1313 in Annex IIHair 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.

    9aToluene-2,5-diamine and its salts

    Toluene-2,5-Diamine

    Toluene-2,5-Diamine Sulfate

    95-70-5 / 615-50-9202-442-1 / 210-431-8Hair 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
  2. (b)

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

    ‘12Hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxideHydrogen peroxide7722-84-1231-765-0

    (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/ECf2 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.

  3. (c)

    The entry concerning reference number 14 is replaced by the following:

    ‘

    14HydroquinoneHydroquinone123-31-9204-617-8Artificial nail systems0,02 % (after mixing for use)Professional use only
    • For professional use only

    • Avoid skin contact

    • Read directions for use carefully

    ’

  4. (d)

    The entry concerning reference number 16 is replaced by the following:

    ‘

    161-Naphthol and its salts1-Naphthol90-15-3201-969-4Hair dye substance in oxidative hair dye productsAfter 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.’

    ’

  5. (e)

    The entry concerning reference number 22 is replaced by the following:

    ‘

    22ResorcinolResorcinol108-46-3203-585-2

    (a)

    Hair dye substance in oxidative hair dye products

    (a)

    1. 1..

      General use

    (a)

    1. 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.

    1. 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

    1. 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

    ’

  6. (f)

    The entries concerning reference numbers 26 to 43 are replaced by the following:

    ‘

    26Ammonium monofluorophosphateAmmonium Monofluorophosphate20859-38-5 / 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.

    27Disodium fluorophosphateSodium Monofluorophosphate10163-15-2 / 7631-97-2233-433-0 / 231-552-2Oral 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.

    28Dipotassium fluorophosphatePotassium Monofluorophosphate14104-28-0237-957-0Oral 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.

    29Calcium fluorophosphateCalcium Monofluorophosphate7789-74-4232-187-1Oral 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.

    30Calcium fluorideCalcium Fluoride7789-75-5232-188-7Oral 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.

    31Sodium fluorideSodium Fluoride7681-49-4231-667-8Oral 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.

    32Potassium fluoridePotassium Fluoride7789-23-3232-151-5Oral 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.

    33Ammonium fluorideAmmonium Fluoride12125-01-8235-185-9Oral 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.

    34Aluminium fluorideAluminum Fluoride7784-18-1232-051-1Oral 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.

    35Tin difluorideStannous Fluoride7783-47-3231-999-3Oral 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.

    36Hexadecyl ammonium fluorideCetylamine Hydrofluoride3151-59-5221-588-7Oral 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.

    373-(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.

    38N,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.

    399-Octadecen-1-amine hydrofluorideOctadecenyl-Ammonium Fluoride36505-83-6—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.

    40Disodium hexafluorosilicateSodium Fluorosilicate16893-85-9240-934-8Oral 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.

    41Dipotassium hexafluorosilicatePotassium Fluorosilicate16871-90-2240-896-2Oral 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.

    42Ammonium hexafluorosilicateAmmonium Fluorosilicate16919-19-0240-968-3Oral 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.

    43Magnesium hexafluorosilicateMagnesium Fluorosilicate16949-65-8241-022-2Oral 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.’

    ’

  7. (g)

    X1The entry concerning reference number 45 is replaced by the following:

    For use as a preservative, see Annex V, No 34. ’

    ‘ 45 Benzyl alcohol f3 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.

  8. (h)

    The entry concerning reference number 47 is replaced by the following:

    ‘

    473-Pyridinemethanol hydrofluorideNicomethanol Hydrofluoride62756-44-9—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.’

    ’

  9. (i)

    The entry concerning reference number 56 is replaced by the following:

    ‘

    56Magnesium fluorideMagnesium Fluoride7783-40-6231-995-1Oral 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.’

    ’

  10. (j)

    The entry concerning reference number 68 is replaced by the following:

    ‘

    68

    ’

  11. (k)

    The entries concerning reference numbers 72 and 73 are replaced by the following:

    ‘

    727-HydroxycitronellalHydroxycitronellal107-75-5203-518-7

    (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 %

    73Phenol, 2-methoxy-4-(1-propenyl)Isoeugenol97-54-1 / 5932-68-3202-590-7 / 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 %

    ’

  12. (l)

    The entries concerning reference numbers 88 and 89 are replaced by the following:

    This limit applies to the substance and not to the finished cosmetic product.’

    ‘88d-Limonene(4R)-1-Methyl-4-(1-methylethenyl) cyclohexeneLimonene5989-27-5227-813-5

    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/Lf4

    89Methyl Oct-2-ynoate; Methyl heptine carbonateMethyl 2-Octynoate111-12-6203-836-6

    (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 %)

  13. (m)

    The following entries concerning reference numbers 103 to 205 are inserted:

    This limit applies to the substance and not to the finished cosmetic product.

    The sum of those substances used in combination should not exceed the limits given as “Maximum concentration in ready for use preparation”.

    The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are permitted for use.

    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

    90028-76-5289-870-2Peroxide value less than 10 mmoles/Lf5
    104
    105 Abies pectinata oil and extract

    Abies Pectinata Oil;

    Abies Pectinata Leaf Extract;

    Abies Pectinata Needle Extract

    Abies Pectinata Needle Oil

    92128-34-2295-728-0Peroxide value less than 10 mmoles/L
    106 Abies sibirica oil and extract

    Abies Sibirica Oil;

    Abies Sibirica Needle Extract

    Abies Sibirica Needle Oil

    91697-89-1294-351-9Peroxide value less than 10 mmoles/L
    107 Abies balsamea oil and extract

    Abies Balsamea Needle Oil;

    Abies Balsamea Needle Extract

    Abies Balsamea Resin;

    Abies Balsamea Extract

    Abies Balsamea Balsam Extract

    85085-34-3285-364-0Peroxide value less than 10 mmoles/L
    108 Pinus mugo pumilio oil and extract

    Pinus Mugo Pumilio Twig Leaf Extract;

    Pinus Mugo Pumilio Twig Leaf Oil

    90082-73-8290-164-1Peroxide value less than 10 mmoles/L
    109 Pinus mugo oil and extract

    Pinus Mugo Leaf Oil

    Pinus Mugo Twig Leaf Extract

    Pinus Mugo Twig Oil

    90082-72-7290-163-6Peroxide value less than 10 mmoles/L
    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

    84012-35-1281-679-2Peroxide value less than 10 mmoles/L
    111 Pinus nigra oil and extract

    Pinus Nigra Bud/Needle Extract

    Pinus Nigra Twig Leaf Extract

    Pinus Nigra Twig Leaf Oil

    90082-74-9290-165-7Peroxide value less than 10 mmoles/L
    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 / 8002-09-3306-895-7 / —Peroxide value less than 10 mmoles/L
    113 Pinus pinaster oil and extract

    Pinus Pinaster Twig Leaf Oil;

    Pinus Pinaster Twig Leaf Extract

    90082-75-0290-166-2Peroxide value less than 10 mmoles/L
    114 Pinus pumila oil and extract

    Pinus Pumila Twig Leaf Extract

    Pinus Pumila Twig Leaf Oil

    97676-05-6307-681-6Peroxide value less than 10 mmoles/L
    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

    94266-48-5304-455-9Peroxide value less than 10 mmoles/L
    116 Pinus cembra oil and extract

    Pinus Cembra Twig Leaf Oil

    Pinus Cembra Twig Leaf Extract

    92202-04-5296-036-1Peroxide value less than 10 mmoles/L
    117 Pinus cembra extract acetylatedPinus Cembra Twig Leaf Extract Acetylated94334-26-6305-102-1Peroxide value less than 10 mmoles/L
    118 Picea mariana oil and extract

    Picea Mariana Leaf Extract;

    Picea Mariana Leaf Oil

    91722-19-9294-420-3Peroxide value less than 10 mmoles/L
    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

    90131-58-1290-370-1Peroxide value less than 10 mmoles/L
    120
    1213-Carene; 3,7,7-Trimethylbicyclo[4.1.0]hept-3-ene (isodiprene)13466-78-9236-719-3Peroxide value less than 10 mmoles/L
    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

    92201-55-3295-985-9Peroxide value less than 10 mmoles/L
    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

    84696-07-1283-626-9Peroxide value less than 10 mmoles/L
    124Turpentine gum (Pinus spp.)Turpentine9005-90-7232-688-5Peroxide value less than 10 mmoles/L
    125Turpentine oil and rectified oilTurpentine8006-64-2232-350-7Peroxide value less than 10 mmoles/L
    126Turpentine, steam distilled (Pinus spp.)Turpentine8006-64-2232-350-7Peroxide value less than 10 mmoles/L
    127Terpene alcohols acetatesTerpene alcohols acetates69103-01-1273-868-3Peroxide value less than 10 mmoles/L
    128Terpene hydrocarbonsTerpene hydrocarbons68956-56-9273-309-3Peroxide value less than 10 mmoles/L
    129Terpenes and terpenoids with the exception of limonene (d-, l-, and dl-isomers) listed under reference numbers 88, 167 and 168 of this Annex IIITerpenes and terpenoids65996-98-7266-034-5Peroxide value less than 10 mmoles/L
    130Terpenes and terpenoids68917-63-5272-842-9Peroxide value less than 10 mmoles/L
    131alpha-Terpinene; p-Mentha-1,3-dienealpha-Terpinene99-86-5202-795-1Peroxide value less than 10 mmoles/L
    132gamma-Terpinene; p-Mentha-1,4-dienegamma-Terpinene99-85-4202-794-6Peroxide value less than 10 mmoles/L
    133Terpinolene; p-Mentha-1,4(8)-dieneTerpinolene586-62-9209-578-0Peroxide value less than 10 mmoles/L
    1341,1,2,3,3,6-Hexamethylindan-5-yl methyl ketoneAcetyl Hexamethyl indan15323-35-0239-360-0

    (a)

    Leave-on products

    (b)

    Rinse-off products

    (a)

    2 %

    135Allyl butyrate; 2-Propenyl ButanoateAllyl butyrate2051-78-7218-129-8Level of free allyl alcohol in the ester shall be less than 0,1 %
    136Allyl cinnamate; 2-Propenyl 3-Phenyl-2-propenoateAllyl cinnamate1866-31-5217-477-8Level of free allyl alcohol in the ester shall be less than 0,1 %
    137Allyl cyclohexylacetate; 2-Propenyl Cyclohexane acetateAllyl cyclohexylacetate4728-82-9225-230-0Level of free allyl alcohol in the ester shall be less than 0,1 %
    138Allyl cyclohexylpropionate; 2-Propenyl 3-CyclohexanepropanoateAllyl cyclohexylpropionate2705-87-5220-292-5Level of free allyl alcohol in the ester shall be less than 0,1 %
    139Allyl heptanoate; 2-Propenyl heptanoateAllyl heptanoate142-19-8205-527-1Level of free allyl alcohol in the ester shall be less than 0,1 %
    140Allyl hexanoateAllyl Caproate123-68-2204-642-4Level of free allyl alcohol in the ester shall be less than 0,1 %
    141Allyl isovalerate; 2-Propenyl 3-MethylbutanoateAllyl isovalerate2835-39-4220-609-7Level of free allyl alcohol in the ester shall be less than 0,1 %
    142Allyl octanoate; 2-Allyl caprylateAllyl octanoate4230-97-1224-184-9Level of free allyl alcohol in the ester shall be less than 0,1 %
    143Allyl phenoxyacetate; 2-Propenyl PhenoxyacetateAllyl phenoxyacetate7493-74-5231-335-2Level of free allyl alcohol in the ester shall be less than 0,1 %
    144Allyl phenylacetate; 2-Propenyl BenzeneacetateAllyl phenylacetate1797-74-6217-281-2Level of free allyl alcohol in the ester shall be less than 0,1 %
    145Allyl 3,5,5-trimethylhexanoateAllyl 3,5,5-trimethylhexanoate71500-37-3275-536-3Level of free allyl alcohol in the ester shall be less than 0,1 %
    146Allyl cyclohexyloxyacetateAllyl cyclohexyloxyacetate68901-15-5272-657-3Level of free allyl alcohol in the ester shall be less than 0,1 %
    147Allyl isoamyloxyacetateIsoamyl Allylglycolate67634-00-8266-803-5Level of free allyl alcohol in the ester shall be less than 0,1 %
    148Allyl 2-methylbutoxyacetateAllyl 2-methylbutoxyacetate67634-01-9266-804-0Level of free allyl alcohol in the ester shall be less than 0,1 %
    149Allyl nonanoateAllyl nonanoate7493-72-3231-334-7Level of free allyl alcohol in the ester shall be less than 0,1 %
    150Allyl propionateAllyl propionate2408-20-0219-307-8Level of free allyl alcohol in the ester shall be less than 0,1 %
    151Allyl trimethylhexanoateAllyl trimethylhexanoate68132-80-9268-648-9Level of free allyl alcohol in the ester shall be less than 0,1 %
    151aAllyl phenethyl etherAllyl phenethyl ether14289-65-7238-212-2Level of free allyl alcohol in the ether shall be less than 0,1 %
    152Allyl heptine carbonate (allyl oct-2-ynoate)Allyl heptine carbonate73157-43-4277-303-10,002 %This material shall not be used in combination with any other 2-alkynoic acid ester (e.g. methyl heptine carbonate)
    153Amylcyclopentenone; 2-Pentylcyclopent-2-en-1-oneAmylcyclopentenone25564-22-1247-104-40,1 %
    154 Myroxylon balsamum var. pereirae; extracts and distillates; Balsam Peru oil, absolute and anhydrol (Balsam Oil Peru)8007-00-9232-352-80,4 %
    1554-tert.-Butyldihydrocinnamaldehyde; 3-(4-tert-Butylphenyl)propionaldehyde4-tert.-Butyldihydrocinnamaldehyde18127-01-0242-016-20,6 %
    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

    84775-51-9283-881-6

    (a)

    Leave-on products

    (a)

    0,4 % of Cumin oil

    (b)

    Rinse-off products

    157cis-Rose ketone-1f6; (Z)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one (cis-alpha-Damascone)Alpha-Damascone23726-94-5 / 43052-87-5245-845-8 / —

    (a)

    Oral products

    (b)

    Other products

    (b)

    0,02 %

    158trans-Rose ketone-2; (E)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one (trans-beta-Damascone)trans-Rose ketone-223726-91-2245-842-1

    (a)

    Oral products

    (b)

    Other products

    (b)

    0,02 %

    159trans-Rose ketone-5; (E)-1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one (Isodamascone)trans-Rose ketone-539872-57-6254-663-80,02 %
    160Rose ketone-4; 1-(2,6,6-Trimethylcyclohexa-1,3-dien-1-yl)-2-buten-1-one (Damascenone)Rose ketone-423696-85-7245-833-2

    (a)

    Oral products

    (b)

    Other products

    (b)

    0,02 %

    161Rose ketone-3; 1-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-1-one (Delta-Damascone)Delta-Damascone57378-68-4260-709-8

    (a)

    Oral products

    (b)

    Other products

    (b)

    0,02 %

    162cis-Rose ketone-2; (Z)-1-(2,6,6-Trimethyl-1-cyclohexen-1-yl)-2-buten-1-one (cis-beta-Damascone)cis-Rose ketone-223726-92-3245-843-7

    (a)

    Oral products

    (b)

    Other products

    (b)

    0,02 %

    163trans-Rose ketone-1; (E)-1-(2,6,6-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-one (trans-alpha-Damascone)trans-Rose ketone-124720-09-0246-430-4

    (a)

    Oral products

    (b)

    Other products

    (b)

    0,02 %

    164Rose ketone-5; 1-(2,4,4-Trimethyl-2-cyclohexen-1-yl)-2-buten-1-oneRose ketone-533673-71-1251-632-00,02 %
    165trans-Rose ketone-3; 1-(2,6,6-Trimethyl-3-cyclohexen-1-yl)-2-buten-1-one (trans-delta-Damascone)trans-Rose ketone-371048-82-3275-156-8

    (a)

    Oral products

    (b)

    Other products

    (b)

    0,02 %

    166trans-2-hexenaltrans-2-hexenal6728-26-3229-778-1

    (a)

    Oral products

    (b)

    Other products

    (b)

    0,002 %

    167l-Limonene; (S)-p-Mentha-1,8-dieneLimonene5989-54-8227-815-6Peroxide value less than 20 mmoles/L
    168dl-Limonene (racemic); 1,8(9)-p-Menthadiene; p-Mentha-1,8-diene (Dipentene)Limonene138-86-3205-341-0Peroxide value less than 20 mmoles/L
    169p-Mentha-1,8-dien-7-alPerillaldehyde2111-75-3218-302-8

    (a)

    Oral products

    (b)

    Other products

    (b)

    0,1 %

    170Isobergamate; Menthadiene-7-methyl formateIsobergamate68683-20-5272-066-00,1 %
    171Methoxy dicyclopentadiene carboxaldehyde; Octahydro-5-methoxy-4,7-Methano-1H-indene-2-carboxaldehydeScentenal86803-90-9—0,5 %
    1723-Methylnon-2-enenitrile3-Methylnon-2-enenitrile53153-66-5258-398-90,2 %
    173Methyl octine carbonate; Methyl non-2-ynoateMethyl octine carbonate111-80-8203-909-2

    (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 %)

    174Amylvinylcarbinyl acetate; 1-Octen-3-yl acetateAmylvinylcarbinyl acetate2442-10-6219-474-7

    (a)

    Oral products

    (b)

    Other products

    (b)

    0,3 %

    175Propylidenephthalide; 3-PropylidenephthalidePropylidenephthalide17369-59-4241-402-8

    (a)

    Oral products

    (b)

    Other products

    (b)

    0,01 %

    176Isocyclogeraniol; 2,4,6-Trimethyl-3-cyclohexene-1-methanolIsocyclogeraniol68527-77-5271-282-20,5 %
    1772-Hexylidene cyclopentanone2-Hexylidene cyclopentanone17373-89-6241-411-7

    (a)

    Oral products

    (b)

    Other products

    (b)

    0,06 %

    178Methyl heptadienone; 6-Methyl-3,5-heptadien-2-oneMethyl heptadienone1604-28-0216-507-7

    (a)

    Oral products

    (b)

    Other products

    (b)

    0,002 %

    179p-methylhydrocinnamic aldehyde; Cresylpropionaldehyde; p-Methyldihydrocinnamaldehydep-methylhydrocinnamic aldehyde5406-12-2226-460-40,2 %
    180 Liquidambar orientalis oil and extract (styrax)

    Liquidambar Orientalis Resin Extract;

    Liquidambar Orientalis Balsam Extract;

    Liquidambar Orientalis Balsam Oil

    94891-27-7305-627-60,6 %
    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 %
    1821-(5,6,7,8-Tetrahydro-3,5,5,6,8,8,-hexamethyl-2-naphthyl)ethan-1-one (AHTN)Acetyl hexamethyl tetralin21145-77-7 / 1506-02-1244-240-6 / 216-133-4All 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 oilOpoponax oil93686-00-1297-649-70,6 %
    184 Opopanax chironium resin93384-32-80,6 %
    185Benzene, methyl-Toluene108-88-3203-625-9Nail products25 %

    Keep out of reach of children

    To be used by adults only

    186

    2,2′-oxydiethanol

    Diethylene glycol (DEG)

    Diethylene glycol111-46-6203-872-2As traces in ingredients0,1 %
    187Diethylene glycol monobutyl ether (DEGBE)Butoxydiglycol112-34-5203-961-6Solvent in hair dye products9 %No use in aerosol dispensers (sprays)
    188Ethylene glycol monobutyl ether (EGBE)Butoxyethanol111-76-2203-905-0

    (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 lakef7;

    (CI 19140)

    Acid Yellow 23;

    Acid Yellow 23 Aluminum lake

    1934-21-0 / 12225-21-7217-699-5 / 235-428-9Hair dye substance in non-oxidative hair dye products0,5 %
    190Benzenemethanaminium, 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; (CI 42090)

    Acid Blue 9;

    Acid Blue 9 Ammonium Salt;

    Acid Blue 9 Aluminum Lake

    3844-45-9 / 2650-18-2 / 68921-42-6223-339-8 / 220-168-0 / 272-939-6Hair dye substance in non-oxidative hair dye products0,5 %
    191Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate; (CI 16035)Curry Red25956-17-6247-368-0Hair dye substance in non-oxidative hair dye products0,4 %
    192Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4′,6,8-trisulphonate and aluminium lake; (CI 16255)

    Acid Red 18;

    Acid Red 18 Aluminum Lake

    2611-82-7 / 12227-64-4220-036-2 / 235-438-3Hair dye substance in non-oxidative hair dye products0,5 %
    193Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium salt; (CI 45100)Acid Red 523520-42-1222-529-8

    (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 %

    194GlyoxalGlyoxal107-22-2203-474-9100 mg/kg
    195Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate; (CI 62045)Acid Blue 624368-56-3224-460-9;Hair dye substance in non-oxidative hair dye products0,5 %
    • Do not use with nitrosating agents

    • Maximum nitrosamine content: 50 μg /kg

    • Keep in nitrite-free containers

    196Verbena absolute (Lippia citriodora Kunth.)8024-12-2—0,2 %
    197Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloridef8 Ethyl Lauroyl Arginate HCl60372-77-2434-630-6

    (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
    201Phenol, 2-Chloro-6-(ethylamino)-4-nitro-2-Chloro-6-ethylamino-4-nitrophenol131657-78-8411-440-1

    (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

    202See 226
    2036-Methoxy-N2-methyl-2,3-pyridinediamine hydrochloride and dihydrochloride salt 6-Methoxy-2-methylamino-3-aminopyridine HCl90817-34-8 / 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

    2042,3-Dihydro-1H-indole-5,6-diol and its hydrobromide salt

    Dihydroxy indoline

    Dihydroxy indoline HBr

    29539-03-5 / 138937-28-7— / 421-170-6Hair dye substance in non-oxidative hair dye products2,0 %Can cause allergic reaction
    205See 219
  14. (n)

    The entries concerning reference numbers 215 to 256 are replaced by the following:

    The free base and salts of this hair colouring ingredient, unless prohibited under Annex II, are permitted for use.’

    ‘2154-Amino-3-nitrophenol4-Amino-3-nitrophenol610-81-1210-236-8

    (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.

    216Naphthalene-2,7-diol2,7-Naphthalenediol582-17-2209-478-7

    (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 %

    217m-Aminophenol and its salts

    m-Aminophenol

    m-Aminophenol HCl

    m-Aminophenol sulfate

    591-27-5 / 51-81-0 / 68239-81-6 /38171-54-9209-711-2 / 200-125-2 / 269-475-1Hair dye substance in oxidative hair dye productsAfter 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.

    2186-Hydroxy-3,4-dimethyl-2-pyridone2,6-Dihydroxy-3,4-dimethylpyridine84540-47-6283-141-2Hair dye substance in oxidative hair dye productsAfter 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.

    2191-Hydroxy-3-nitro-4-(3-hydroxypropylamino)benzenef9 4-Hydroxypropylamino-3-nitrophenol92952-81-3406-305-9

    (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 %

    2201-[(2′-Methoxyethyl)amino]-2-nitro-4-[di-(2′-hydroxyethyl)amino]benzene HC Blue No 1123920-15-2459-980-7Hair dye substance in non-oxidative hair dye products2,0 %
    • Do not use with nitrosating agents

    • Maximum nitrosamine content: 50 μg /kg

    • Keep in nitrite-free containers

    2211-Methyl-3-nitro-4-(beta-hydroxyethyl)aminobenzene and its saltsHydroxyethyl-2-nitro-p-toluidine100418-33-5408-090-7

    (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 %

    2221-Hydroxy-2-beta-hydroxyethylamino-4,6-dinitrobenzene2-Hydroxyethylpicramic acid99610-72-7412-520-9

    (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 %

    223p-Methylaminophenol and its sulphate

    p-Methylaminophenol

    p-Methylaminophenol sulphate

    150-75-4 / 55-55-0 /1936-57-8205-768-2 / 200-237-1 /217-706-1Hair 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.

    2241-Propanol, 3-[[4-[bis(2-hydroxyethyl)amino]-2-nitrophenyl]amino] HC Violet No 2104226-19-9410-910-3Hair dye substance in non-oxidative hair dye products2,0 %
    • Do not use with nitrosating agents

    • Maximum nitrosamine content: 50 μg /kg

    • Keep in nitrite-free containers

    Can cause allergic reaction
    2251-(beta-Hydroxyethyl)amino-2-nitro-4-N-ethyl-N-(.beta.-hydroxyethyl)aminobenzene and its hydrochlorideHC Blue No 12104516-93-0 / 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)

    2264,4′-[1,3-Propanediylbis(oxy)]bisbenzene-1,3-diamine and its tetrahydrochloride salt

    1,3-bis-(2,4-Diaminophenoxy)propane

    1,3-bis-(2,4-Diaminophenoxy)propane HCl

    81892-72-0 / 74918-21-1279-845-4 / 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

    2273-Amino-2,4-dichlorophenol and its hydrochloride

    3-Amino-2,4-dichlorophenol

    3-Amino-2,4-dichlorophenol HCl

    61693-42-3 / 61693-43-4262-909-0 / —

    (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)

    2283-Methyl -1- phenyl -5-pyrazolonePhenyl methyl pyrazolone89-25-8201-891-0Hair dye substance in oxidative hair dye productsAfter 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.

    2295-[(2-Hydroxyethyl)amino]-o-cresol2-Methyl-5-hydroxyethylaminophenol55302-96-0259-583-7Hair 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.

    2303,4-Dihydro-2H-1,4-benzoxazin-6-olHydroxybenzomorpholine26021-57-8247-415-5Hair 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.

    2311,5-Di-(beta-hydroxyethylamino)-2-nitro-4-chlorobenzene HC Yellow No 10109023-83-8416-940-3Hair dye substance in non-oxidative hair dyes products0,1 %
    • Do not use with nitrosating agents

    • Maximum nitrosamine content: 50 μg /kg

    • Keep in nitrite-free containers

    2322,6-Dimethoxy-3,5-pyridinediamine and its hydrochloride

    2,6-Dimethoxy-3,5-pyridinediamine

    2,6-Dimethoxy-3,5-pyridinediamine HCl

    56216-28-5 / 85679-78-3260-062-1 / —Hair dye substance in oxidative hair dye productsAfter 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.

    2331-(beta-Aminoethyl)amino-4-(beta-hydroxyethyl)oxy-2-nitrobenzene and its saltsHC Orange No 285765-48-6416-410-1Hair dye substance in non-oxidative hair dye products1,0 %
    • 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.

    234Ethanol, 2-[(4-amino-2-methyl-5-nitrophenyl)amino]- and its saltsHC Violet No 182576-75-8417-600-7

    (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.

    2352-[3-(methylamino)-4-nitrophenoxy]ethanol 3-Methylamino-4-nitrophenoxyethanol59820-63-2261-940-7Hair dye substance in non-oxidative hair dye products0,15 %
    • Do not use with nitrosating agents

    • Maximum nitrosamine content: 50 μg /kg

    • Keep in nitrite-free containers

    2362-[(2-methoxy-4-nitrophenyl)amino]ethanol and its salts2-Hydroxyethylamino-5-nitroanisole66095-81-6266-138-0Hair dye substance in non-oxidative hair dye products0,2 %
    • Do not use with nitrosating agents

    • Maximum nitrosamine content: 50 μg /kg

    • Keep in nitrite-free containers

    2372,2′-[(4-Amino-3-nitrophenyl)imino]bisethanol and its hydrochlorideHC Red No 1329705-39-3/94158-13-1-/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)

    238Naphthalene-1,5-diol1,5-Naphthalenediol83-56-7201-487-4

    (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 %

    239Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) and its tetrahydro-chlorideHydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) HCl128729-30-6 / 128729-28-2— / 416-320-2Hair dye substance in oxidative hair dye productsAfter 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
    2415-Amino-o-cresol4-Amino-2-hydroxytoluene2835-95-2220-618-6Hair dye substance in oxidative hair dye productsAfter 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.

    2422,4-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 / 274-713-2Hair dye substance in oxidative hair dye productsAfter 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.

    2431,3-benzenediol, 2-methyl2-Methylresorcinol608-25-3210-155-8

    (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 %

    2444-Amino-m-cresol4-Amino-m-cresol2835-99-6220-621-2Hair dye substance in oxidative hair dye productsAfter 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.

    2452-[(3amino-4-methoxyphenyl)amino]ethanol and its sulphate

    2-Amino-4-hydroxyethylaminoanisole

    2-Amino-4-hydroxyethylaminoanisole sulfate

    83763-47-7 /83763-48-8280-733-2 /280-734-8Hair 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.

    246Hydroxyethyl-3,4-methylenedioxyaniline and its hydrochlorideHydroxyethyl-3,4-methylenedioxyaniline HCl94158-14-2303-085-5Hair 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.

    2472,2′-[[4-[(2-Hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol HC Blue No 233229-34-4251-410-3Hair dye substance in non-oxidative hair dye products2,8 %
    • Do not use with nitrosating agents

    • Maximum nitrosamine content: 50 μg /kg

    • Keep in nitrite-free containers

    Can cause allergic reaction
    2484-[(2-Hydroxyethyl)amino]-3-nitrophenol3-Nitro-p-hydroxyethylaminophenol65235-31-6265-648-0

    (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.

    2491-(beta-Ureidoethyl)amino-4-nitrobenzene4-Nitrophenyl aminoethylurea27080-42-8410-700-1

    (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 %

    2501-Amino-2-nitro-4-(2′,3′-dihydroxypropyl)amino-5-chlorobenzene and 1,4-bis-(2′,3′-dihydroxypropyl)amino-2-nitro-5-chlorobenzene and its saltsHC Red No 10 and HC Red No 1195576-89-9 / 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
    2522-Amino-6-chloro-4-nitrophenol2-Amino-6-chloro-4-nitrophenol6358-09-4228-762-1

    (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
    254Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate; (CI 17200)Acid Red 333567-66-6222-656-9Hair dye substance in non-oxidative hair dye products0,5 %
    255
    256

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

  1. (a)

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

    For other uses than preservatives, see Annex III, entry No 45.’

    ‘34Benzyl alcoholf1 Benzyl Alcohol100-51-6202-859-91,0 %
  2. (b)

    The following entry is added:

    For other uses than preservatives, see Annex III, entry No 197.’

    ‘58Ethyl-N-alpha-dodecanoyl-L-arginate hydrochloridef2 Ethyl Lauroyl Arginate HCl60372-77-2434-630-60,4 %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:

  1. (a)

    The entry concerning reference number 1 is replaced by the following:

    ‘

    1

    ’

  2. (b)

    The entry concerning reference number 28 is replaced by the following:

    ‘

    28Benzoic acid, 2-[-4-(diethylamino)-2-hydroxybenzoyl]-. HexylesterDiethylamino Hydroxy benzoyl Hexyl Benzoate302776-68-7443-860-610 %

    ’