Commission Directive 2008/88/EC of 23 September 2008 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: 2008-09-23
Institutions: European Commission
Subjects: approximation of laws, cosmetic product, dyestuff, health risk, product safety, toxic substance

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Official Journal of the European Union

24.9.2008

DIRECTIVES

COMMISSION DIRECTIVE 2008/88/EC

of 23 September 2008

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,

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:

(1)

(2)

(3)

(4)

(5)

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.

for which no updated safety files

Substances
are
submitted allowing an adequate risk assessment should
be included in Annex II to Directive 76/768/EEC.

Some hair dye substances have already been banned,
either as a result of opinions by the SCCP or due to

(1) OJ L 262, 27.9.1976, p. 169.
(2) OJ L 66, 4.3.2004, p. 45.

lack of safety data. The substances currently under con­
sideration were carefully selected to be regulated together
since they are listed in Annex IV. As no safety files on
these substances for their use in hair dye products were
submitted to the SCCP for a risk assessment by the
these
agreed deadlines,
substances, when used in hair dye products, can be
considered safe for human health.

is no evidence

there

that

(Hydroquinone);

1,4-Dihydroxybenzene

Substances without safety files 1-Hydroxy-2,4-diamino­
benzene (2,4-Diaminophenol) and its dihydrochloride
salt;
[4-[[4-
anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]­
cyclohexa-2,5-dien-1-ylidene]dimethylammoniumchloride
(Basic Blue 26); Disodium 3-[(2,4-dimethyl-5-sulphonato­
phenyl)azo]-4-hydroxynaphthalene-1-sulpho-nate (Ponceau
SX) and 4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-
ylidene)methyl]-o-toluidine and its hydrochloride salt (Basic
Violet 14), currently listed as colorants in Annex IV and as
hair dye substances in Annex III, Part 1 and Part 2, shall be
deleted from Annex III and banned for use in hair dye
products in Annex II.

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

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

the

in this Directive are in
Standing
the

of

(6)

(7)

(8)

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 14 February
2009 at
the laws, regulations and administrative
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.

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They shall apply those provisions from 14 August 2009.

When Member States adopt those provisions, they shall contain a reference to this Directive or be accom­
panied by such a reference on the occasion of their official publication. Member States shall determine how
such reference is to be made.

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.

This Directive shall enter into force on the 20th day following that of 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, 23 September 2008.

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 1329 to 1369 are added:

Reference No

‘1329

1330

1331

1332

1333

1334

1335

1336

1337

1338

1339

1340

Chemical name/INCI-name

4-[(4-Aminophenyl)(4-iminocyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine (CAS 3248-93-9; EINECS
221-832-2) and its hydrochloride salt (Basic Violet 14; CI 42510) (CAS 632-99-5; EINECS 211-189-6)
when used as a substance in hair dye products

4-(2,4-Dihydroxyphenylazo)benzenesulphonic acid (CAS 2050-34-2; EINECS 218-087-0) and its
sodium salt
(CAS 547-57-9; EINECS 208-924-8) when used as a
substance in hair dye products

(Acid Orange 6; CI 14270)

3-Hydroxy-4-(phenylazo)-2-naphthoic acid (CAS 27757-79-5; EINECS 248-638-0) and its calcium salt
(Pigment Red 64:1; CI 15800) (CAS 6371-76-2; EINECS 228-899-7), when used as a substance in hair
dye products

2-(6-Hydroxy-3-oxo-(3H)-xanthen-9-yl)benzoic acid; Fluorescein (CAS 2321-07-5; EINECS 219-031-8)
and its disodium salt (Acid yellow 73 sodium salt; CI 45350) (CAS 518-47-8; EINECS 208-253-0),
when used as a substance in hair dye products

4′,5′-Dibromo-3′,6′-dihydroxyspiro[isobenzofuran-1(3H),9′-[9H]xanthene]-3-one; 4′,5′-Dibromofluo­
rescein;
(CAS 596-03-2; EINECS 209-876-0) and its disodium salt (CI 45370)
(CAS 4372-02-5; EINECS 224-468-2) when used as a substance in hair dye products

(Solvent Red 72)

2-(3,6-Dihydroxy-2,4,5,7-tetrabromoxanthen-9-yl)-benzoic acid; Fluorescein, 2′,4′,5′,7′-tetrabromo-;
(Solvent Red 43) (CAS 15086-94-9; EINECS 239-138-3), its disodium salt (Acid Red 87; CI 45380)
(CAS 17372-87-1; EINECS 241-409-6) and its aluminium salt (Pigment Red 90:1 Aluminium lake)
(CAS 15876-39-8; EINECS 240-005-7) when used as a substance in hair dye products

Xanthylium, 9-(2-carboxyphenyl)-3-(2-methylphenyl)amino)-6-((2-methyl-4-sulfophenyl)amino)-,
salt (CAS 10213-95-3); and its sodium salt (Acid Violet 9; CI 45190)
228-377-9) when used as a substance in hair dye products

inner
(CAS 6252-76-2; EINECS

3′,6′-Dihydroxy-4′,5′-diiodospiro(isobenzofuran-1(3H),9′-[9H]xanthene)-3-one; (Solvent Red 73) (CAS
38577-97-8; EINECS 254-010-7) and its sodium salt (Acid Red 95; CI 45425) (CAS 33239-19-9;
EINECS 251-419-2) when used as a substance in hair dye products

2′,4′,5′,7′-Tetraiodofluorescein (CAS 15905-32-5; EINECS 240-046-0), its disodium salt (Acid Red 51;
CI 45430)
(Pigment Red 172
Aluminium lake)(CAS 12227-78-0; EINECS 235-440-4) when used as a substance in hair dye products

(CAS 16423-68-0; EINECS 240-474-8) and its aluminium salt

1-Hydroxy-2,4-diaminobenzene (2,4-Diaminophenol) (CAS 95-86-3; EINECS 202-459-4) and its di­
hydrochloride salt (2,4-Diaminophenol HCl) (CAS 137-09-7; EINECS 205-279-4) when used as a
substance in hair dye products

1,4-Dihydroxybenzene (Hydroquinone) (CAS 123-31-9; EINECS 204-617-8) when used as a substance
in hair dye products

[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethy­
lammonium chloride (Basic Blue 26; CI 44045) (CAS 2580-56-5; EINECS 219-943-6) when used as a
substance in hair dye products

1341

Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (Ponceau SX;
CI 14700) (CAS 4548-53-2; EINECS 224-909-9) when used as a substance in hair dye products

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Reference No

Chemical name/INCI-name

1342

1343

1344

1345

1346

1347

1348

1349

1350

1351

1352

1353

1354

1355

1356

1357

Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-)
(Acid Green 1; CI 10020) (CAS 19381-50-1; EINECS 243-010-2) when used as a substance in hair dye
products

4-(Phenylazo)resorcinol (Solvent Orange 1; CI 11920) (CAS 2051-85-6; EINECS 218-131-9) and its
salts, when used as a substance in hair dye products

4-[(4-Ethoxyphenyl)azo]naphthol (Solvent Red 3; CI 12010) (CAS 6535-42-8; EINECS 229-439-8) and
its salts, when used as a substance in hair dye products

1-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol (Pigment Red 4; CI 12085) (CAS 2814-77-9; EINECS 220-
562-2) and its salts when used as a substance in hair dye products

3-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide (Pigment Red 112; CI
12370) (CAS 6535-46-2; EINECS 229-440-3) and its salts when used as a substance in hair dye
products

N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxy­
naphthalene-2-carboxamide (Pigment Red 5; CI 12490) (CAS 6410-41-9; EINECS 229-107-2) and its
salts when used as a substance in hair dye products

Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (Pigment Red 48;
CI 15865) (CAS 3564-21-4; EINECS 222-642-2) when used as a substance in hair dye products

Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate (Pigment Red 63:1; CI 15880)
(CAS 6417-83-0; EINECS 229-142-3) when used as a substance in hair dye products

Trisodium 3-hydroxy-4-(4′-sulphonatonaphthylazo)naphthalene-2,7-disulphonate (Acid Red 27; CI
16185) (CAS 915-67-3; EINECS 213-022-2) when used as a substance in hair dye products

2,2′-[(3,3′-Dichloro[1,1′-biphenyl]-4,4′-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide] (Pig-
ment Yellow 13; CI 21100) (CAS 5102-83-0; EINECS 225-822-9) when used as a substance in hair
dye products

2,2′-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol] (Solvent Yellow 29; CI
21230) (CAS 6706-82-7; EINECS 229-754-0) when used as a substance in hair dye products

1-((4-Phenylazo)phenylazo)-2-naphthol (Solvent Red 23; CI 26100) (CAS 85-86-9; EINECS 201-638-4)
when used as a substance in hair dye products

Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naph-
thalene-2,7-disulphonate (Food Black 2; CI 27755)
(CAS 2118-39-0; EINECS 218-326-9) when
used as a substance in hair dye products

Ethanaminium, N-(4-((4-(diethylamino)phenyl)(2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylide-
ne)-N-ethyl-, hydroxide,
(CAS 129-17-9; EINECS
inner salt, sodium salt (Acid Blue 1; CI 42045)
204-934-1) when used as a substance in hair dye products

Ethanaminium,
xadien-1-ylidene)-N-ethyl-, hydroxide,
3536-49-0; EINECS 222-573-8) when used as a substance in hair dye products

N-(4-((4-(diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)-2,5-cyclohe-
(CAS

inner salt, calcium salt (2:1)

(Acid Blue 3; CI 42051)

Benzenemethanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino)phenyl)(4-hydroxy-2-sul-
fophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide,
inner salt, disodium salt (Fast
Green FCF; CI 42053) (CAS 2353-45-9; EINECS 219-091-5) when used as a substance in hair dye
products

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Reference No

Chemical name/INCI-name

1358

1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline (Solvent Yellow 33; CI
47000) (CAS 8003-22-3; EINECS 232-318-2) when used as a substance in hair dye products

1359

Nigrosine (CI 50420) (CAS 8005-03-6) when used as a substance in hair dye products

1360

1361

1362

1363

1364

1365

1366

1367

1368

1369

8,18-Dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3′,2′-m]triphenodioxazine (Pigment Violet 23;
CI 51319) (CAS 6358-30-1; EINECS 228-767-9) when used as a substance in hair dye products

1,2-Dihydroxyanthraquinone (Pigment Red 83; CI 58000) (CAS 72-48-0; EINECS 200-782-5) when
used as a substance in hair dye products

Trisodium 8-hydroxypyrene-1,3,6-trisulphonate (Solvent Green 7; CI 59040) (CAS 6358-69-6; EINECS
228-783-6) when used as a substance in hair dye products

1-Hydroxy-4-(p-toluidino)anthraquinone (Solvent Violet 13; CI 60725) (CAS 81-48-1; EINECS 201-
353-5), when used as a substance in hair dye products

1,4-bis(p-Tolylamino)anthraquinone (Solvent Green 3; CI 61565) (CAS 128-80-3; EINECS 204-909-5)
when used as a substance in hair dye products

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) (CAS 2379-74-0; EINECS 219-163-6) when used as a substance in hair
dye products

5,12-Dihydroquino[2,3-b]acridine-7,14-dione (Pigment Violet 19; CI 73900) (CAS 1047-16-1; EINECS
213-879-2) when used as a substance in hair dye products

(29H,31H-Phthalocyaninato(2-)-N29,N30,N31,N32)copper (Pigment Blue 15; CI 74160) (CAS 147-14-
8; EINECS 205-685-1) when used as a substance in hair dye products

(Direct Blue 86;
Disodium [29H,31H-phthalocyaninedisulphonato(4-)-N29,N30,N31,N32]cuprate(2-)
CI 74180) (CAS 1330-38-7; EINECS 215-537-8) when used as a substance in hair dye products

Polychloro copper phthalocyanine (Pigment Green 7; CI 74260) (CAS 1328-53-6; EINECS 215-524-7)
when used as a substance in hair dye products’

2. Annex III is amended as follows:

(a)

in Part 1, reference number 10 is deleted;

(b) in Part 1, column c of reference number 14, item (a) is deleted;

(c)

in Part 2, reference numbers 57, 59 and 60 are deleted.