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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
Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products Text with EEA relevance
Commission Regulation (EU) No 344/2013 of 4 April 2013 amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products Text with EEA relevance
OJ L 114, 25.4.2013, p. 1–59
(BG, ES, CS, DA, DE, ET, EL, EN, FR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
This document has been published in a special edition(s)
(HR)
⏵This document has been published in a special edition(s)
(HR)
Special edition in Croatian: Chapter 13 Volume 063 P. 253 - 311
In force: This act has been changed. Current consolidated version: 15/05/2013
amending Annexes II, III, V and VI to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (1), and in particular Article 31, paragraphs 1 and 2, thereof,
Whereas:
(1)
Regulation (EC) No 1223/2009 is to apply from 11 July 2013 and will replace Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (2). However, in order to ensure a smooth transition, economic operators are allowed to place on the market cosmetic products which comply with Regulation (EC) No 1223/2009 before the date of application of that Regulation.
(2)
The Annexes to Regulation (EC) No 1223/2009 reflect the advancement of science at the time of the adoption of the proposal for that Regulation by the Commission on 5 February 2008. Since then, the Annexes to Directive 76/768/EEC have been amended several times.
(3)
Several of the amendments to the Annexes to Directive 76/768/EEC aimed to address potential risks to human health and therefore introduced the necessary measures to protect public health. Both for the sake of legal clarity and, as there is an option to comply with Regulation (EC) No 1223/2009 before 11 July 2013 as an alternative to compliance with Directive 76/768/EEC, it is therefore necessary to amend the Annexes to Regulation (EC) No 1223/2009 as well, with a view to ensuring a high level of protection of public health.
(4)
Also, a number of the amendments to the Annexes to Directive 76/768/EEC adapted those Annexes to technical and scientific progress, while protecting public health. As a result, the Annexes to Directive 76/768/EEC are now better adapted to technical and scientific progress than those of Regulation (EC) No 1223/2009. It is thus necessary to introduce those amendments in the Annexes to Regulation (EC) No 1223/2009 as well.
(5)
In some cases, the substances have not been assigned with internationally recognised nomenclatures as the International Nomenclature of Cosmetic Ingredients (INCI). However, they are identified by their perfuming names. It is therefore appropriate to indicate the perfuming names in column c of Annex III (Name of Common Ingredients Glossary).
(6)
Regulation (EC) No 1223/2009 should therefore be amended accordingly.
(7)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,
HAS ADOPTED THIS REGULATION:
Article 1
Annexes II, III, V and VI to Regulation (EC) No 1223/2009 are amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 11 July 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Annex II to Regulation (EC) No 1223/2009 is amended as follows:
(a)
The entry concerning reference number 167 is replaced by the following:
‘167
4-Aminobenzoic acid and its esters, with the free amino group
150-13-0
205-753-0’
(b)
The entry concerning reference number 450 is replaced by the following:
‘450
Verbena essential oils (Lippia citriodora Kunth.) and derivatives other than absolute when used as a fragrance ingredient
8024-12-2
285-515-0’
(c)
The entry concerning reference number 1136 is replaced by the following:
‘1136
Exudation of Myroxylon pereirae (Royle) Klotzsch (Peru balsam, crude) when used as a fragrance ingredient
8007-00-9
232-352-8’
(d)
Entries for the following reference numbers are added:
‘1329
4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine and its hydrochloride salt (Basic Violet 14; CI 42510) when used as a substance in hair dye products
3248-93-9 / 632-99-5 (HCl)
221-832-2 / 211-189-6 (HCl)
1330
4-(2,4-Dihydroxyphenylazo)benzensulphonic acid and its sodium salt (Acid Orange 6; CI 14270) when used as substance in hair dye products
2050-34-2 / 547-57-9 (Na)
218-087-0 / 208-924-8 (Na)
1331
3-Hydroxy-4-(phenylazo)-2-naphthoic acid and its calcium salt (Pigment Red 64:1; CI 15800) when used as a substance in hair dye products
27757-79-5 / 6371-76-2 (Ca)
248-638-0 / 228-899-7 (Ca)
1332
2-(6-Hydroxy-3-oxo-(3H)xanthen-9-yl)benzoic acid; Fluorescein and its disodium salt (Acid Yellow 73 sodium salt; CI 45350) when used as a substance in hair dye products
2321-07-5 / 518-47-8 (Na)
219-031-8 / 208-253-0 (Na)
1333
4′,5′-Dibromo-3′,6′-dihydroxyspiro[isobenzofuran-1(3H),9′-[9H]xanthene]-3-one; 4′,5′-Dibromofluorescein; (Solvent Red 72) and its disodium salt (CI 45370) when used as a substance in hair dye products
596-03-2 / 4372-02-5 (Na)
209-876-0 / 224-468-2 (Na)
1334
2-(3,6-Dihydroxy-2,4,5,7-tetrabromoxanthen-9-yl)benzoic acid; Fluorescein, 2′,4′,5′,7′-tetrabromo-; (Solvent Red 43), its disodium salt (Acid Red 87; CI 45380) and its aluminium salt (Pigment Red 90:1 Aluminium lake) when used as a substance in hair dye products
15086-94-9 / 17372-87-1 (Na) / 15876-39-8 (Al)
239-138-3 / 241-409-6 (Na) / 240-005-7 (Al)
1335
Xanthylium, 9-(2-carboxyphenyl)-3-((2-methylphenyl)amino)-6-((2-methyl-4-sulfophenyl)amino)-, inner salt and its sodium salt (Acid Violet 9; CI 45190) when used as a substance in hair dye products
10213-95-3 / 6252-76-2 (Na)
— / 228-377-9 (Na)
1336
3′,6′-Dihydroxy-4′,5′-diiodospiro(isobenzofuran-1(3H),9′-[9H]xanthene)-3-one; (Solvent Red 73) and its sodium salt (Acid Red 95; CI 45425) when used as a substance in hair dye products
38577-97-8 / 33239-19-9 (Na)
254-010-7 / 251-419-2 (Na)
1337
2′,4′,5′,7′-Tetraiodofluorescein, its disodium salt (Acid Red 51; CI 45430) and its aluminium salt (Pigment Red 172 Aluminium lake) when used as a substance in hair dye products
15905-32-5 / 16423-68-0 (Na) / 12227-78-0 (Al)
240-046-0 / 240-474-8 (Na) / 235-440-4 (Al)
1338
1-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) and its dihydrochloride salts (2,4-Diaminophenol HCl) when used as a substance in hair dye products
95-86-3 / 137-09-7 (HCl)
202-459-4 / 205-279-4 (HCl)
1339
1,4-Dihydroxybenzene (Hydroquinone), with the exception of entry 14 in Annex III
123-31-9
204-617-8
1340
[4-[[4-Anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (Basic Blue 26; CI 44045) when used as a substance in hair dye products
2580-56-5
219-943-6
1341
Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (Ponceau SX; CI 14700) when used as a substance in hair dye products
4548-53-2
224-909-9
1342
Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)- N5,O6]ferrate(3-); (Acid Green 1; CI 10020) when used as a substance in hair dye products
19381-50-1
243-010-2
1343
4-(Phenylazo)resorcinol (Solvent Orange 1; CI 11920) and its salts when used as a substance in hair dye products
2051-85-6
218-131-9
1344
4-[(4-Ethoxyphenyl)azo]naphthol (Solvent Red 3; CI 12010) and its salts when used as a substance in hair dye products
6535-42-8
229-439-8
1345
1-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol (Pigment Red 4; CI 12085) and its salts when used as a substance in hair dye products
2814-77-9
220-562-2
1346
3-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide (Pigment Red 112; CI 12370) and its salts when used as a substance in hair dye products
6535-46-2
229-440-3
1347
N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide (Pigment Red 5; CI 12490) and its salts when used as a substance in hair dye products
6410-41-9
229-107-2
1348
Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (Pigment Red 48; CI 15865) when used as a substance in hair dye products
3564-21-4
222-642-2
1349
Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate (Pigment Red 63:1; CI 15880) when used as a substance in hair dye products
6417-83-0
229-142-3
1350
Trisodium 3-hydroxy-4-(4′-sulphonatonaphthylazo)naphthalene-2,7-disulphonate (Acid Red 27; CI 16185) when used as a substance in hair dye products
915-67-3
213-022-2
1351
2,2′-[(3,3′-Dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] (Pigment Yellow 13; CI 21100) when used as a substance in hair dye products
5102-83-0
225-822-9
1352
2,2′-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] (Solvent Yellow 29; CI 21230) when used as a substance in hair dye products
6706-82-7
229-754-0
1353
1-((4-Phenylazo)phenylazo)-2-naphthol (Solvent Red 23; CI 26100) when used as a substance in hair dye products
85-86-9
201-638-4
1354
Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate (Food Black 2; CI 27755) when used as a substance in hair dye products
2118-39-0
218-326-9
1355
Ethanaminium, N-(4-((4-diethylamino)phenyl)(2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, sodium salt (Acid Blue 1; CI 42045) when used as a substance in hair dye products
129-17-9
204-934-1
1356
Ethanaminium, N-(4-((4-diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, calcium salt (2:1) (Acid Blue 3; CI 42051) when used as a substance in hair dye products
3536-49-0
222-573-8
1357
Benzenemethanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)(4-hydroxy-2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt (Fast Green FCF; CI 42053) when used as a substance in hair dye products
2353-45-9
219-091-5
1358
1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline (Solvent Yellow 33; CI 47000) when used as a substance in hair dye products
8003-22-3
232-318-2
1359
Nigrosine (CI 50420) when used as a substance in hair dye products
8005-03-6
—
1360
8,18-Dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3′,2′-m]triphenodioxazine (Pigment Violet 23; CI 51319) when used as a substance in hair dye products
6358-30-1
228-767-9
1361
1,2-Dihydroxyanthraquinone (Pigment Red 83; CI 58000) when used as a substance in hair dye products
72-48-0
200-782-5
1362
Trisodium 8-hydroxypyrene-1,3,6-trisulphonate (Solvent Green 7; CI 59040) when used as a substance in hair dye products
6358-69-6
228-783-6
1363
1-Hydroxy-4-(p-toluidino)anthraquinone (Solvent Violet 13; CI 60725) when used as a substance in hair dye products
81-48-1
201-353-5
1364
1,4-bis(p-Tolylamino)anthraquinone (Solvent Green 3; CI 61565) when used as a substance in hair dye products
128-80-3
204-909-5
1365
6-Chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one (VAT Red 1; CI 73360) when used as a substance in hair dye products
2379-74-0
219-163-6
1366
5,12-Dihydroquino[2,3-b]acridine-7,14-dione (Pigment Violet 19; CI 73900) when used as a substance in hair dye products
1047-16-1
213-879-2
1367
(29H,31H-Phthalocyaninato(2-)- N29,N30,N31,N32)copper (Pigment Blue 15; CI 74160) when used as a substance in hair dye products
147-14-8
205-685-1
1368
Disodium [29H,31H-phthalocyaninedisulphonato(4-)- N29,N30,N31,N32]cuprate(2-) (Direct Blue 86; CI 74180) when used as a substance in hair dye products
1330-38-7
215-537-8
1369
Polychloro copper phthalocyanine (Pigment Green 7; CI 74260) when used as a substance in hair dye products
1328-53-6
215-524-7
1370
Diethylene glycol (DEG); 2,2′-oxydiethanol for traces level, see Annex III
111-46-6
203-872-2
1371
Phytonadione [INCI] / phytomenadione [INN]
84-80-0 / 81818-54-4
201-564-2 / 279-833-9
1372
2-Aminophenol (o-Aminophenol; CI 76520) and its salts
95-55-6 / 67845-79-8 / 51-19-4
202-431-1 / 267-335-4’
(2)
Annex III to Regulation (EC) No 1223/2009 is amended as follows:
(a)
The entries concerning reference numbers 8, 9 and 10 are replaced by the following:
‘8
N-substituted derivatives of p-Phenylenediamine and their salts; N-substituted derivatives of o-Phenylenediamine (1), with exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II
Hair dye substance in oxidative hair dye products
(a)
General use
(a)
To be printed on the label:
The mixing ratio.
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.
Contains phenylenediamines.
Do not use to dye eyelashes or eyebrows”
(b)
Professional use
For (a) and (b):
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3 % calculated as free base
(b)
To be printed on the label:
The mixing ratio.
“For professional use only
Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.
Contains phenylenediamines.
Wear suitable gloves”
8a
p-Phenylenediamine and its salts
p-Phenylenediamine;
p-Phenylenediamine HCl;
p-Phenylenediamine Sulphate
106-50-3 / 624-18-0 / 16245-77-5
203-404-7 / 210-834-9 / 240-357-1
Hair dye substance in oxidative hair dye products
(a)
General use
(a)
To be printed on the label:
The mixing ratio.
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.
Contains phenylenediamines.
Do not use to dye eyelashes or eyebrows.”
(b)
Professional use
For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % calculated as free base
(b)
To be printed on the label:
The mixing ratio.
“For professional use only.
Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.
Contains phenylenediamines.
Wear suitable gloves.”
9
Methylphenylenediamines, their N-substituted derivatives and their salts (1) with the exception of the substance under reference number 9a in this annex and substances under reference numbers 364, 1310 and 1313 in Annex II
Hair dye substance in oxidative hair dye products
(a)
General use
(a)
To be printed on the label:
The mixing ratio.
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.
Contains phenylenediamines (toluenediamines).
Do not use to dye eyelashes or eyebrows.”
(b)
Professional use
For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 5 % calculated as free base
(b)
To be printed on the label:
The mixing ratio.
“For professional use only
Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.
Contains phenylenediamines (toluenediamines).
Wear suitable gloves.”
9a
Toluene-2,5-diamine and its salts
Toluene-2,5-Diamine
Toluene-2,5-Diamine Sulfate
95-70-5 / 615-50-9
202-442-1 / 210-431-8
Hair dye substance in oxidative hair dye products
(a)
General use
(a)
To be printed on the label:
The mixing ratio.
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.
Contains phenylenediamines (toluenediamines).
Do not use to dye eyelashes or eyebrows.”
(b)
Professional use
For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 4 % calculated as free base
(b)
To be printed on the label:
The mixing ratio.
“For professional use only
Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.
Contains phenylenediamines (toluenediamines).
Wear suitable gloves.”
10
(b)
The entry concerning reference number 12 is replaced by the following:
‘12
Hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide
Hydrogen peroxide
7722-84-1
231-765-0
(a)
Hair products
(a)
12 % of H2O2 (40 volumes), present or released
(a)
Wear suitable gloves
(b)
Skin products
(b)
4 % of H2O2, present or released
(a) (b) (c) (e)
Contains hydrogen peroxide
Avoid contact with eyes
Rinse immediately if product comes into contact with them.
(c)
Nail hardening products
(c)
2 % of H2O2, present or released
(d)
Oral products, including mouth rinse, tooth paste and tooth whitening or bleaching products
(d)
≤ 0,1 % of H2O2, present or released
(e)
Tooth whitening or bleaching products
(e)
> 0,1 % ≤ 6 % of H2O2, present or released
(e)
To be only sold to dental practitioners.
For each cycle of use, first use by dental practitioners as defined under Directive 2005/36/EC (*1) or under their direct supervision if an equivalent level of safety is ensured. Afterwards to be provided to the consumer to complete the cycle of use.
Not to be used on a person under 18 years of age.
(e)
Concentration of H2O2 present or released indicated in percentage.
Not to be used on a person under 18 years of age.
To be only sold to dental practitioners. For each cycle of use, the first use to be only done by dental practitioners or under their direct supervision if an equivalent level of safety is ensured. Afterwards to be provided to the consumer to complete the cycle of use.
(c)
The entry concerning reference number 14 is replaced by the following:
‘14
Hydroquinone
Hydroquinone
123-31-9
204-617-8
Artificial nail systems
0,02 % (after mixing for use)
Professional use only
—
For professional use only
—
Avoid skin contact
—
Read directions for use carefully’
(d)
The entry concerning reference number 16 is replaced by the following:
‘16
1-Naphthol and its salts
1-Naphthol
90-15-3
201-969-4
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1 % calculated as free base
To be printed on the label:
The mixing ratio.
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.” ’
(e)
The entry concerning reference number 22 is replaced by the following:
‘22
Resorcinol
Resorcinol
108-46-3
203-585-2
(a)
Hair dye substance in oxidative hair dye products
(a)
1.
General use
(a)
1.
To be printed on the label:
The mixing ratio.
“Contains resorcinol.
Rinse hair well after application.
Do not use to dye eyelashes or eyebrows.
Rinse eyes immediately if product comes into contact with them.
Hair colourants can cause severe allergic reactions. Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.”
2.
Professional use
For 1 and 2:
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,5 % calculated as free base
2.
To be printed on the label:
The mixing ratio.
“For professional use only. Contains resorcinol.
Rinse eyes immediately if product comes into contact with them.
Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.”
(b)
Hair lotions and shampoos
(b)
0,5 %
(b)
Contains resorcinol’
(f)
The entries concerning reference numbers 26 to 43 are replaced by the following:
‘26
Ammonium monofluorophosphate
Ammonium Monofluorophosphate
20859-38-5 / 66115-19-3
— / —
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains ammonium monofluorophosphate.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
27
Disodium fluorophosphate
Sodium Monofluorophosphate
10163-15-2 / 7631-97-2
233-433-0 / 231-552-2
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains sodium monofluorophosphate.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
28
Dipotassium fluorophosphate
Potassium Monofluorophosphate
14104-28-0
237-957-0
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains potassium monofluorophosphate.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
29
Calcium fluorophosphate
Calcium Monofluorophosphate
7789-74-4
232-187-1
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains calcium monofluorophosphate.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
30
Calcium fluoride
Calcium Fluoride
7789-75-5
232-188-7
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains calcium fluoride.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
31
Sodium fluoride
Sodium Fluoride
7681-49-4
231-667-8
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains sodium fluoride.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
32
Potassium fluoride
Potassium Fluoride
7789-23-3
232-151-5
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains potassium fluoride.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
33
Ammonium fluoride
Ammonium Fluoride
12125-01-8
235-185-9
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains ammonium fluoride.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
34
Aluminium fluoride
Aluminum Fluoride
7784-18-1
232-051-1
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains aluminium fluoride.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
35
Tin difluoride
Stannous Fluoride
7783-47-3
231-999-3
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains stannous fluoride.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
36
Hexadecyl ammonium fluoride
Cetylamine Hydrofluoride
3151-59-5
221-588-7
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains Cetylamine hydrofluoride.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
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.”
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
39
9-Octadecen-1-amine hydrofluoride
Octadecenyl-Ammonium Fluoride
36505-83-6
—
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains octadecenyl-ammonium fluoride.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
40
Disodium hexafluorosilicate
Sodium Fluorosilicate
16893-85-9
240-934-8
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains sodium fluorosilicate.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
41
Dipotassium hexafluorosilicate
Potassium Fluorosilicate
16871-90-2
240-896-2
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains potassium fluorosilicate.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
42
Ammonium hexafluorosilicate
Ammonium Fluorosilicate
16919-19-0
240-968-3
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains ammonium fluorosilicate.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.”
43
Magnesium hexafluorosilicate
Magnesium Fluorosilicate
16949-65-8
241-022-2
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains magnesium fluorosilicate.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” ’
(g)
The entry concerning reference number 45 is replaced by the following:
For purposes other than inhibiting the development of microorganisms in the product. This purpose has to be apparent from the presentation of the product.
(b)
Fragrance/aromatic compositions/their raw materials
(b)
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products.
(h)
The entry concerning reference number 47 is replaced by the following:
‘47
3-Pyridinemethanol hydrofluoride
Nicomethanol Hydrofluoride
62756-44-9
—
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains nicomethanol hydrofluoride.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” ’
(i)
The entry concerning reference number 56 is replaced by the following:
‘56
Magnesium fluoride
Magnesium Fluoride
7783-40-6
231-995-1
Oral products
0,15 % calculated as F.
When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %
Contains magnesium fluoride.
For any toothpaste with compounds containing fluorine in a concentration of 0,1 to 0,15 % calculated as F unless it is already labelled as contra-indicated for children (e.g. “for adult use only”) the following labelling is obligatory:
“Children of 6 years and younger: use a pea-sized amount for supervised brushing to minimise swallowing. In case of intake of fluoride from other sources consult a dentist or doctor.” ’
(j)
The entry concerning reference number 68 is replaced by the following:
‘68’
(k)
The entries concerning reference numbers 72 and 73 are replaced by the following:
‘72
7-Hydroxycitronellal
Hydroxycitronellal
107-75-5
203-518-7
(a)
Oral products
(a) (b)
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
(b)
Other products
(b)
1,0 %
73
Phenol, 2-methoxy-4-(1-propenyl)
Isoeugenol
97-54-1 / 5932-68-3
202-590-7 / 227-678-2
(a)
Oral products
(a) (b)
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products’
(b)
Other products
(b)
0,02 %
(l)
The entries concerning reference numbers 88 and 89 are replaced by the following:
The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:
—
0,001 % in leave-on products
—
0,01 % in rinse-off products
(b)
Other products
(b)
0,01 % when used alone
When present in combination with methyl octine carbonate, the combined level in the finished product shall not exceed 0,01 % (of which methyl octine carbonate shall not be more than 0,002 %)
(m)
The following entries concerning reference numbers 103 to 205 are inserted:
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 %)
All cosmetic products with the exception of oral products
(a)
leave-on products: 0,1 %
except:
hydroalcoholic products: 1 %
fine fragrance: 2,5 %
fragrance cream: 0,5 %
(b)
rinse-off products: 0,2 %
183
Commiphora erythrea Engler var. glabrescens Engler gum extract and oil
Opoponax oil
93686-00-1
297-649-7
0,6 %
184
Opopanax chironium resin
93384-32-8
0,6 %
185
Benzene, methyl-
Toluene
108-88-3
203-625-9
Nail products
25 %
Keep out of reach of children
To be used by adults only
186
2,2′-oxydiethanol
Diethylene glycol (DEG)
Diethylene glycol
111-46-6
203-872-2
As traces in ingredients
0,1 %
187
Diethylene glycol monobutyl ether (DEGBE)
Butoxydiglycol
112-34-5
203-961-6
Solvent in hair dye products
9 %
No use in aerosol dispensers (sprays)
188
Ethylene glycol monobutyl ether (EGBE)
Butoxyethanol
111-76-2
203-905-0
(a)
Solvent in oxidative hair dye products
(a)
4,0 %
(a) (b)
No use in aerosol dispensers (sprays)
(b)
Solvent in non-oxidative hair dye products
(b)
2,0 %
189
Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate and aluminium lake (17);
(CI 19140)
Acid Yellow 23;
Acid Yellow 23 Aluminum lake
1934-21-0 / 12225-21-7
217-699-5 / 235-428-9
Hair dye substance in non-oxidative hair dye products
0,5 %
190
Benzenemethanaminium, N-ethyl-N-[4-[[4-[ethyl-[(3-sulfophenyl)-methyl]-amino]-phenyl](2-sulfophenyl)methylene]-2,5-cyclohexadien-1-ylidene]-3-sulfo, inner salts, disodium salt and its ammonium and aluminium salts (17); (CI 42090)
Acid Blue 9;
Acid Blue 9 Ammonium Salt;
Acid Blue 9 Aluminum Lake
3844-45-9 / 2650-18-2 / 68921-42-6
223-339-8 / 220-168-0 / 272-939-6
Hair dye substance in non-oxidative hair dye products
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product
201
Phenol, 2-Chloro-6-(ethylamino)-4-nitro-
2-Chloro-6-ethylamino-4-nitrophenol
131657-78-8
411-440-1
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %
(a)
To be printed on the label:
The mixing ratio.
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.”
(b)
Hair dye substance in non-oxidative hair dye products
(b)
3,0 %
(a) and (b):
—
Do not use with nitrosating agents
—
Maximum nitrosamine content: 50 μg /kg
—
Keep in nitrite-free containers
202
See 226
203
6-Methoxy-N2-methyl-2,3-pyridinediamine hydrochloride and dihydrochloride salt (17)
6-Methoxy-2-methylamino-3-aminopyridine HCl
90817-34-8 / 83732-72-3
— / 280-622-9
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,68 % calculated as free base (1,0 % as dihydrochloride).
For (a) and (b):
—
Do not use with nitrosating agents
—
Maximum nitrosamine content: 50 μg /kg
—
Keep in nitrite-free containers
(a)
To be printed on the label:
The mixing ratio.
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.”
(b)
Hair dye substance in non-oxidative hair dye products
(b)
0,68 % as free base (1,0 % as dihydrochloride)
(b)
Can cause allergic reaction
204
2,3-Dihydro-1H-indole-5,6-diol and its hydrobromide salt (17)
Dihydroxy indoline
Dihydroxy indoline HBr
29539-03-5 / 138937-28-7
— / 421-170-6
Hair dye substance in non-oxidative hair dye products
2,0 %
Can cause allergic reaction
205
See 219
(n)
The entries concerning reference numbers 215 to 256 are replaced by the following:
‘215
4-Amino-3-nitrophenol
4-Amino-3-nitrophenol
610-81-1
210-236-8
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %
(a)
To be printed on the label:
The mixing ratio.
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.”
(b)
Hair dye substance in non-oxidative hair dye products
(b)
1,0 %
(b)
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.”
216
Naphthalene-2,7-diol
2,7-Naphthalenediol
582-17-2
209-478-7
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %
(a)
To be printed on the label:
The mixing ratio.
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.”
(b)
Hair dye substance in non-oxidative hair dye products
(b)
1,0 %
217
m-Aminophenol and its salts
m-Aminophenol
m-Aminophenol HCl
m-Aminophenol sulfate
591-27-5 / 51-81-0 / 68239-81-6 /38171-54-9
209-711-2 / 200-125-2 / 269-475-1
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,2 %
To be printed on the label:
The mixing ratio.
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.”
218
6-Hydroxy-3,4-dimethyl-2-pyridone
2,6-Dihydroxy-3,4-dimethylpyridine
84540-47-6
283-141-2
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %
To be printed on the label:
The mixing ratio.
“ 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.”
Hair dye substance in non-oxidative hair dye products
2,0 %
—
Do not use with nitrosating agents
—
Maximum nitrosamine content: 50 μg /kg
—
Keep in nitrite-free containers
Can cause allergic reaction
225
1-(beta-Hydroxyethyl)amino-2-nitro-4-N-ethyl-N-(.beta.-hydroxyethyl)aminobenzene and its hydrochloride
HC Blue No 12
104516-93-0 / 132885-85-9 (HCl)
— / 407-020-2
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,75 % (as hydrochloride)
For (a) and (b):
—
Do not use with nitrosating agents
—
Maximum nitrosamine content: 50 μg /kg
—
Keep in nitrite-free containers
(a)
To be printed on the label:
The mixing ratio.
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.”
(b)
Hair dye substance in non-oxidative hair dye products
(b)
1,5 % (as hydrochloride)
226
4,4′-[1,3-Propanediylbis(oxy)]bisbenzene-1,3-diamine and its tetrahydrochloride salt (17)
1,3-bis-(2,4-Diaminophenoxy)propane
1,3-bis-(2,4-Diaminophenoxy)propane HCl
81892-72-0 / 74918-21-1
279-845-4 / 278-022-7
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,2 % calculated as free base (1,8 % as tetrahydrochloride salt).
(a)
To be printed on the label:
The mixing ratio.
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.”
(b)
Hair dye substance in non-oxidative hair dye products
(b)
1,2 % as free base (1,8 % as tetrahydrochloride salt)
(b)
Can cause allergic reaction
227
3-Amino-2,4-dichlorophenol and its hydrochloride
3-Amino-2,4-dichlorophenol
3-Amino-2,4-dichlorophenol HCl
61693-42-3 / 61693-43-4
262-909-0 / —
(a)
Hair dye substance in oxidative hair dye products
(a)
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 % (as hydrochloride)
(a)
To be printed on the label:
The mixing ratio.
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.”
(b)
Hair dye substance in non-oxidative hair dye products
(b)
1,5 % (as hydrochloride)
228
3-Methyl -1- phenyl -5-pyrazolone
Phenyl methyl pyrazolone
89-25-8
201-891-0
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,25 %
To be printed on the label:
The mixing ratio.
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.”
229
5-[(2-Hydroxyethyl)amino]-o-cresol
2-Methyl-5-hydroxyethylaminophenol
55302-96-0
259-583-7
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,5 %
—
Do not use with nitrosating agents
—
Maximum nitrosamine content: 50 μg /kg
—
Keep in nitrite-free containers
To be printed on the label:
The mixing ratio.
“ Hair colourants can cause severe allergic reactions.
Read and follow instructions.
This product is not intended for use on persons under the age of 16.
Temporary ‘black henna’ tattoos may increase your risk of allergy.
Do not colour your hair if:
—
you have a rash on your face or sensitive, irritated and damaged scalp,
—
you have ever experienced any reaction after colouring your hair,
—
you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.”
230
3,4-Dihydro-2H-1,4-benzoxazin-6-ol
Hydroxybenzomorpholine
26021-57-8
247-415-5
Hair dye substance in oxidative hair dye products
After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %
—
Do not use with nitrosating agents
—
Maximum nitrosamine content: 50 μg /kg
—
Keep in nitrite-free containers
To be printed on the label:
The mixing ratio.
“ 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) 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.’
In force: This act has been changed. Current consolidated version: 15/05/2013
