Commission Directive 2007/54/EC of 29 August 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annexes II and III thereto to technical progress (Text with EEA relevance )
Date: 2007-08-29
Institutions: European Commission
Subjects: chemical product, consumer information, cosmetic product, disclosure of information, product safety, technological change

30.8.2007

EN

Official Journal of the European Union

L 226/21

COMMISSION DIRECTIVE 2007/54/EC

of 29 August 2007

amending Council Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting
Annexes II and III thereto to technical progress

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

Having regard to the Treaty
Community,

establishing the European

Having regard to Council Directive 76/768/EEC of 27 July 1976
on the approximation of the laws of the Member States relating
to cosmetic products (1), and in particular Article 8(2) thereof,

consulting the Scientific Committee on Consumer

After
Products,

Whereas:

(6)

(7)

However 4,4′-Diaminodiphenylamine and its salts; 4-
Diethylamino-o-toluidine and its
salts; N,N-Diethyl-p-
phenylenediamine and its salts; N,N-Dimethyl-p-phenyle-
nediamine and its salts; and Toluene-3,4-Diamine and its
salts, are currently listed under reference numbers 8 and
9 in Annex III, Part 1, which are general entries.
Therefore they should be expressly deleted from general
entries in Annex III.
It is appropriate to list them in
Annex II
instead. Those annexes should therefore be
amended accordingly.

Directive 76/768/EEC should therefore be amended
accordingly.

The measures provided for
opinion
accordance with
Committee on Cosmetic Products,

the

in this Directive are in
Standing
the

of

(1)

(2)

(3)

Following the publication of a scientific study in 2001,
entitled ‘Use of permanent hair dyes and bladder cancer
risk’, the Scientific Committee on Cosmetic Products and
Non-Food Products intended for Consumers, replaced by
the Scientific Committee on Consumer Products (SCCP),
by Commission Decision 2004/210/EC (2), concluded
that the potential risks were of concern. It recommended
that the Commission take further steps to control the use
of hair dye substances.

The Scientific Committee on Consumer Products further
recommended an overall safety assessment strategy for
hair dye substances
for
testing substances used in hair dye products for their
potential genotoxicity/mutagenicity.

including the requirements

Following the opinions of the SCCP, the Commission
together with Member States and stakeholders agreed
on an overall strategy to regulate substances used in
hair dye products according to which the industry was
required to submit files containing the scientific data on
hair dye substances to be evaluated by the SCCP.

(4)

for which no updated safety files

Substances
are
submitted allowing an adequate risk assessment should
be included in Annex II.

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annexes II and III to Directive 76/768/EEC are amended in
accordance with the Annex to this Directive.

Article 2

the latest,

1. Member States shall adopt and publish, by 18 March
the laws, regulations and administrative
2008 at
provisions necessary to comply with this Directive. They shall
forthwith communicate to the Commission the text of those
provisions and a correlation table between those provisions and
this Directive.

They shall apply those provisions from 18 June 2008. When
they shall contain a
Member States adopt those provisions,
reference to this Directive or be accompanied by such a
reference on the occasion of their official publication. Member
States shall determine how such reference is to be made.

(1) OJ L 262, 27.9.1976, p. 169. Directive as last amended by
Commission Directive 2007/22/EC (OJ L 101, 18.4.2007, p. 11).

(2) OJ L 66, 4.3.2004, p. 45.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

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Official Journal of the European Union

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This Directive shall enter into force on the 20th day following its publication in the Official Journal of the
European Union.

Article 3

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 29 August 2007.

For the Commission

Günter VERHEUGEN
Vice-President

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Official Journal of the European Union

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ANNEX

Directive 76/768/EEC is amended as follows:

(1) In Annex II, the following reference numbers 1244 to 1328 are added:

Ref. No

‘1244

1245

1246

1247

1248

1249

1250

1251

1252

1253

1254

1255

1256

1257

1258

1259

1260

1261

1262

Chemical name/INCI-name

1-Methyl-2,4,5-trihydroxybenzene (CAS No 1124-09-0) and its salts, when used as a substance in
hair dye products

2,6-Dihydroxy-4-methylpyridine (CAS No 4664-16-8) and its salts, when used as a substance in
hair dye products

5-Hydroxy-1,4-benzodioxane (CAS No 10288-36-5) and its salts, when used as a substance in
hair dye products

3,4-Methylenedioxyphenol (CAS No 533-31-3) and its salts, when used as a substance in hair dye
products

3,4-Methylenedioxyaniline (CAS No 14268-66-7) and its salts, when used as a substance in hair
dye products

Hydroxypyridinone (CAS No 822-89-9) and its salts, when used as a substance in hair dye
products

3-Nitro-4-aminophenoxyethanol (CAS No 50982-74-6) and its salts, when used as a substance in
hair dye products

2-methoxy-4-nitrophenol (CAS No 3251-56-7) (4-Nitroguaiacol) and its salts, when used as a
substance in hair dye products

C.I. Acid Black 131 (CAS No 12219-01-1) and its salts, when used as a substance in hair dye
products

1,3,5-Trihydroxybenzene (CAS No 108-73-6)
substance in hair dye products

(Phloroglucinol) and its salts, when used as a

1,2,4-Benzenetriacetate (CAS No 613-03-6) and its salts, when used as a substance in hair dye
products

Ethanol, 2,2'-iminobis-, reaction products with epichlorohydrin and 2-nitro-1,4-benzenediamine
(HC Blue No 5) and its salts, when used as a
(CAS No 68478-64-8)
substance in hair dye products

(CAS 158571-58-5)

N-Methyl-1,4-diaminoanthraquinone, reaction products with epichlorohydrin and monoethano-
lamine (CAS No 158571-57-4) (HC Blue No 4) and its salts, when used as a substance in hair
dye products

4-Aminobenzenesulfonic acid (CAS No 121-57-3) and its salts, when used as a substance in hair
dye products

3,3'-(Sulfonylbis(2-nitro-4,1-phenylene)imino)bis(6-(phenylamino)) benzenesulfonic acid and its
salts, when used as a substance in hair dye products

3(or5)-((4-(Benzylmethylamino)phenyl)azo)-1,2-(or1,4)-dimethyl-1H-1,2,4-triazolium and its salts,
when used as a substance in hair dye products

2,2'-((3-Chloro-4-((2,6-dichloro-4-nitrophenyl)azo)phenyl)imino)bisethanol (CAS No 23355-64-8)
(Disperse Brown 1) and its salts, when used as a substance in hair dye products

Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methyl- and its
salts, when used as a substance in hair dye products

2-[(4-Chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutanamide (CAS No 13515-40-7)
(Pigment Yellow 73) and its salts, when used as a substance in hair dye products

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Ref. No

1263

1264

1265

1266

1267

1268

1269

1270

1271

1272

1273

1274

1275

1276

1277

1278

1279

1280

1281

1282

1283

Chemical name/INCI-name

2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutanamide]
(CAS No
6358-85-6) (Pigment Yellow 12) and its salts, when used as a substance in hair dye products

2,2'-(1,2-Ethenediyl)bis[5-((4-ethoxyphenyl)azo]benzenesulfonic acid) and its salts, when used as a
substance in hair dye products

2,3-Dihydro-2,2-dimethyl-6-[(4-(phenylazo)-1-naphthalenyl)azo]-1H-pyrimidine (CAS No 4197-
25-5) (Solvent Black 3) and its salts, when used as a substance in hair dye products

3(or5)-[[4-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-1-naphthyl]azo]salicylic acid and
its salts, when used as a substance in hair dye products

2-Naphthalenesulfonic acid, 7-(benzoylamino)-4-hydroxy-3-[[4-[(4-sulfophenyl)azo]phenyl]azo]-
and its salts, when used as a substance in hair dye products

(μ-((7,7'-Iminobis(4-hydroxy-3-((2-hydroxy-5-(N-methylsulphamoyl)phenyl)azo)naphthalene-2-
sulphonato))(6-)))dicuprate(2-) and its salts, when used as a substance in hair dye products

3-[(4-(Acetylamino)phenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulfo-2-naphthalenyl]
amino]carbonyl]amino]-2-naphthalenesulfonic acid and its salts, when used as a substance in hair
dye products

2-Naphthalenesulfonic acid, 7,7'-(carbonyldiimino)bis(4-hydroxy-3-[[2-sulfo-4-[(4-sulfophenyl)a-
zo]phenyl]azo]-,
(CAS No 25188-41-4) and its salts, when used as a substance in hair dye
products

Ethanaminium, N-(4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene)-N-
ethyl- and its salts, when used as a substance in hair dye products

3H-Indolium, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-
when used as a substance in hair dye products

and its

salts,

3H-Indolium, 2-(2-((2,4-dimethoxyphenyl)amino)ethenyl)-1,3,3-trimethyl- and its
used as a substance in hair dye products

salts, when

Nigrosine spirit soluble (CAS No 11099-03-9) (Solvent Black 5), when used as a substance in
hair dye products

Phenoxazin-5-ium, 3,7-bis(diethylamino)-, (CAS No 47367-75-9) and its salts, when used as a
substance in hair dye products

Benzo[a]phenoxazin-7-ium, 9-(dimethylamino)-, and its salts, when used as a substance in hair
dye products

6-Amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No 2478-20-8)
(Solvent Yellow 44) and its salts, when used as a substance in hair dye products

1-Amino-4-[[4-[(dimethylamino)methyl]phenyl]amino]anthraquinone (CAS No 12217-43-5) and
its salts, when used as a substance in hair dye products

Laccaic Acid (CI Natural Red 25) (CAS No 60687-93-6) and its salts, when used as a substance in
hair dye products

Benzenesulfonic acid, 5-[(2,4-dinitrophenyl)amino]-2-(phenylamino)-, (CAS No 15347-52-1) and
its salts, when used as a substance in hair dye products

4-[(4-Nitrophenyl)azo]aniline (CAS No 730-40-5) (Disperse Orange 3) and its salts, when used as
a substance in hair dye products

4-Nitro-m-phenylenediamine (CAS No 5131-58-8) and its salts, when used as a substance in hair
dye products

1-Amino-4-(methylamino)-9,10-anthracenedione (CAS No 1220-94-6) (Disperse Violet 4) and its
salts, when used as a substance in hair dye products

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Ref. No

1284

1285

1286

1287

1288

1289

1290

1291

1292

1293

1294

1295

1296

1297

1298

1299

1300

1301

1302

1303

1304

Chemical name/INCI-name

N-Methyl-3-nitro-p-phenylenediamine (CAS No 2973-21-9) and its salts, when used as a
substance in hair dye products

N1-(2-Hydroxyethyl)-4-nitro-o-phenylenediamine (CAS No 56932-44-6) (HC Yellow No 5) and
its salts, when used as a substance in hair dye products

N1-(Tris(hydroxymethyl))methyl-4-nitro-1,2-phenylenediamine (CAS No 56932-45-7) (HC Yellow
No 3) and its salts, when used as a substance in hair dye products

2-Nitro-N-hydroxyethyl-p-anisidine (CAS No 57524-53-5) and its salts, when used as a substance
in hair dye products

N,N'-Dimethyl-N-Hydroxyethyl-3-nitro-p-phenylenediamine (CAS No 10228-03-2) and its salts,
when used as a substance in hair dye products

3-(N-Methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol (CAS No 93633-79-5) and
its salts, when used as a substance in hair dye products

4-Ethylamino-3-nitrobenzoic acid (CAS No 2788-74-1)
when used as a substance in hair dye products

(N-Ethyl-3-Nitro PABA) and its salts,

(8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-2-naphthyl)trimethylammonium and its salts, except
Basic Red 118 (CAS 71134-97-9) as impurity in Basic Brown 17), when used as a substance in
hair dye products

5-((4-(Dimethylamino)phenyl)azo)-1,4-dimethyl-1H-1,2,4-triazolium and its salts, when used as a
substance in hair dye products

m-Phenylenediamine, 4-(phenylazo)-, (CAS No 495-54-5) and its salts, when used as a substance
in hair dye products

1,3-Benzenediamine, 4-methyl-6-(phenylazo)- and its salts, when used as a substance in hair dye
products

2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)- and its salts,
when used as a substance in hair dye products

4,4'-[(4-Methyl-1,3-phenylene)bis(azo)]bis[6-methyl-1,3-benzenediamine]
(Basic Brown 4) and its salts, when used as a substance in hair dye products

(CAS No 4482-25-1)

Benzenaminium,
and its salts, when used as a substance in hair dye products

3-[[4-[[diamino(phenylazo)phenyl]azo]-2-methylphenyl]azo]-N,N,N-trimethyl-

Benzenaminium,
and its salts, when used as a substance in hair dye products

3-[[4-[[diamino(phenylazo)phenyl]azo]-1-naphthalenyl]azo]-N,N,N-trimethyl-

Ethanaminium, N-[4-[(4-(diethylamino)phenyl)phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-
ethyl- and its salts, when used as a substance in hair dye products

9,10-Anthracenedione, 1-[(2-hydroxyethyl)amino]-4-(methylamino)- (CAS No 86722-66-9) and
its derivatives and salts, when used as a substance in hair dye products

1,4-Diamino-2-methoxy-9,10-anthracenedione (CAS No 2872-48-2) (Disperse Red 11) and its
salts, when used as a substance in hair dye products

1,4-Dihydroxy-5,8-bis[(2-hydroxyethyl)amino]anthraquinone (CAS No 3179-90-6) (Disperse Blue
7) and its salts, when used as a substance in hair dye products

1-[(3-Aminopropyl)amino]-4-(methylamino)anthraquinone and its salts, when used as a substance
in hair dye products

N-[6-[(2-Chloro-4-hydroxyphenyl)imino]-4-methoxy-3-oxo-1,4-cyclohexadien-1-yl]acetamide
(CAS No 66612-11-1) (HC Yellow No 8) and its salts, when used as a substance in hair dye
products

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Ref. No

1305

1306

1307

1308

1309

1310

1311

1312

1313

1314

1315

1316

1317

1318

1319

1320

1321

1322

1323

1324

1325

1326

Chemical name/INCI-name

[6-[[3-Chloro-4-(methylamino)phenyl]imino]-4-methyl-3-oxocyclohexa-1,4-dien-1-yl]urea
(CAS
No 56330-88-2) (HC Red No 9) and its salts, when used as a substance in hair dye products

Phenothiazin-5-ium, 3,7-bis(dimethylamino)- and its salts, when used as a substance in hair dye
products

4,6-Bis(2-Hydroxyethoxy)-m-Phenylenediamine and its salts, when used as a substance in hair dye
products

5-Amino-2,6-Dimethoxy-3-Hydroxypyridine (CAS No 104333-03-1) and its salts, when used as a
substance in hair dye products

4,4'-Diaminodiphenylamine (CAS No 537-65-5) and its salts, when used as a substance in hair
dye products

4-Diethylamino-o-toluidine (CAS No 148-71-0) and its salts, when used as a substance in hair
dye products

N,N-Diethyl-p-phenylenediamine (CAS No 93-05-0) and its salts, when used as a substance in
hair dye products

N,N-Dimethyl-p-phenylenediamine (CAS No 99-98-9) and its salts, when used as a substance in
hair dye products

Toluene-3,4-Diamine (CAS No 496-72-0) and its salts, when used as a substance in hair dye
products

2,4-Diamino-5-methylphenoxyethanol
substance in hair dye products

(CAS No 141614-05-3) and its salts, when used as a

6-Amino-o-cresol (CAS No 17672-22-9) and its salts, when used as a substance in hair dye
products

Hydroxyethylaminomethyl-p-aminophenol (CAS No 110952-46-0) and its salts, when used as a
substance in hair dye products

2-Amino-3-nitrophenol (CAS No 603-85-0) and its salts, when used as a substance in hair dye
products

2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS No 50610-28-1) and its salts, when
used as a substance in hair dye products

2-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts, when used as a substance in hair
dye products

Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No 122252-11-3) and its salts, when used as a
substance in hair dye products

6-Nitro-2,5-pyridinediamine (CAS No 69825-83-8) and its salts, when used as a substance in hair
dye products

Phenazinium, 3,7-diamino-2,8-dimethyl-5-phenyl- and its salts, when used as a substance in hair
dye products

3-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-nitronaphthalene-1-sulphonic acid (CAS No 16279-54-
2) and its salts, when used as a substance in hair dye products

3-[(2-nitro-4-(trifluoromethyl)phenyl)amino]propane-1,2-diol (CAS No 104333-00-8) (HC Yellow
No 6) and its salts, when used as a substance in hair dye products

2-[(4-chloro-2-nitrophenyl)amino]ethanol (CAS No 59320-13-7) (HC Yellow No 12) and its salts,
when used as a substance in hair dye products

3-[[4-[(2-Hydroxyethyl)Methylamino]-2-Nitrophenyl]Amino]-1,2-Propanediol
75-7) and its salts, when used as a substance in hair dye products

(CAS No 173994-

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Ref. No

1327

1328

Chemical name/INCI-name

3-[[4-[Ethyl(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-1,2-Propanediol
41-1) and its salts, when used as a substance in hair dye products

(CAS No 114087-

N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-
Ethanaminium,
cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products’

(2) Annex III is amended as follows:

(a) Part 1 is amended as follows:

(i) in column b of reference number 8, the words ‘p-Phenylenediamine, its N-substituted derivatives and its salts;
N-substituted derivatives of o-Phenylenediamine, with exception of those derivatives listed elsewhere in this
Annex’ are replaced by the following ‘p-Phenylenediamine,
its N-substituted derivatives and its salts; N-
substituted derivatives of o-Phenylenediamine, with the exception of those derivatives listed elsewhere in
this Annex and under reference numbers 1309, 1311, and 1312 in Annex II’.

(ii) in column b of reference number 9, the words ‘Methylphenylenediamines, their N-substituted derivatives and
their salts with the exception of substance No 364 in Annex II’ are replaced by the following ‘Methylphe-
nylenediamines, their N-substituted derivatives and their salts with the exception of substances under reference
numbers 364, 1310 and 1313 in Annex II’.

(b) In Part 2, reference numbers 1, 2, 8, 13, 15, 30, 41, 43, 45, 46, 51, 52, 53, and 54 are deleted.