Commission Directive 2005/80/EC of 21 November 2005 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes II and III thereto to technical progress   (Text with EEA relevance)
Date: 2005-11-21
Institutions: European Commission
Subjects: carcinogenic substance, consumer information, cosmetic product, labelling, market approval, marketing standard, product safety, toxic substance

L 303/32

EN

Official Journal of the European Union

22.11.2005

COMMISSION DIRECTIVE 2005/80/EC

of 21 November 2005

amending Council Directive 76/768/EEC, concerning cosmetic products,

for the purposes 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 4b and Article
8(2) thereof,

consulting the Scientific Committee on Consumer

After
Products,

Whereas:

(1)

(2)

(3)

as

76/768/EEC,

amended
the European Parliament and of

by Directive
Directive
2003/15/EC of
the
Council (2), prohibits the use in cosmetic products of
substances classified as carcinogenic, mutagenic or toxic
for reproduction (CMR), of category 1, 2 and 3, under
Annex I to Council Directive 67/548/EEC of 27 June
1967 on the approximation of
laws, regulations and
administrative provisions relating to the classification,
packaging and labelling of dangerous substances (3), but
allows the use of substances classified in category 3
pursuant to Directive 67/548/EEC subject to evaluation
and approval by the Scientific Committee on Cosmetic
products and Non-Food Products intended for consumers
replaced by the Scientific Committee on
SCCNFP,
Consumer Products
(SCCP) by Commission Decision
2004/210 (4).

Directive 67/548/EEC has been amended by Directive
2004/73/EC, and it
is therefore necessary to adopt
measures so as to bring Directive 76/768/EEC in line
with the provisions of Directive 67/548/EEC.

In so far as some of the substances classified as CMR of
category 1 and 2 under Annex I to Directive 67/548/EEC
are not yet listed in Annex II to Directive 76/768/EEC, it
is necessary to include them in that Annex. Substances
to
classified as CMR of category 3 under Annex I

to Directive 76/768/EEC, except

Directive 67/548/EEC should also be included in Annex
II
if they have been
evaluated by the SCCP and found acceptable for use in
cosmetic products.

Substances classified as CMR of category 1 and 2 listed
in Annex III, Part 1 to Directive 76/768/EEC should be
deleted, since these substances are now listed in Annex II
to Directive 76/768/EEC and therefore must not form
part of the composition of cosmetic products.

Commission Directive 2004/93/EC (5) provided for the
insertion in Annex II
to Directive 76/768/EEC of
certain substances which were already listed there. That
Annex should therefore be amended for the sake of
clarity.

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

(4)

(5)

(6)

(7)

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

Article 2

Member States shall take all necessary measures to ensure that
from 22 August 2006 cosmetic products which fail to comply
with this Directive are not placed on the market by Community
manufacturers
the
importers
Community.

established within

by

or

(1) OJ L 262, 27.9.1976, p. 169. Directive as last amended by
Commission Directive 2005/52/EC (OJ L 234, 10.9.2005, p. 9).

(2) OJ L 66, 11.3.2003, p. 26.
(3) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission

Directive 2004/73/EC (OJ L 152, 30.4.2004, p. 1).

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

Member States shall take all necessary measures to ensure that
those products are not
to the final
consumer after 22 November 2006.

sold or disposed of

(5) OJ L 300, 25.9.2004, p. 13.

22.11.2005

EN

Official Journal of the European Union

L 303/33

Article 3

Article 4

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 22 May 2006 at the latest. They shall forthwith
communicate to the Commission the text of those provisions
and a correlation table between those provisions and this
Directive.

When Member States adopt those provisions, they shall contain
a 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.

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 third day following
its publication in the Official Journal of the European Union.

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 21 November 2005.

For the Commission

Günter VERHEUGEN
Vice-President

L 303/34

EN

Official Journal of the European Union

22.11.2005

ANNEX

Annexes II and III to Directive 76/768/EEC are amended as follows:

1. Annex II is amended as follows:

(a)

the entries under reference numbers 615 and 616 are deleted;

(b) the entry under reference number 687 is replaced by the following:

‘687. dinitrotoluene, technical grade (Cas No 121-14-2)’;

(c)

the following reference numbers 1137 and 1211 are added:

Ref.
No

‘1137

1138

1139

1140

1141

1142

1143

1144

1145

1146

1147

1148

1149

1150

1151

Chemical name

isobutyl nitrite

isoprene (stabilized)
(2-methyl-1,3-butadiene)

1-bromopropane
n-propyl bromide

chloroprene (stabilized)
(2-chlorobuta-1,3-diene)

1,2,3-trichloropropane

ethylene glycol dimethyl ether
(EGDME)

dinocap (ISO)

diaminotoluene,
technical product
diamine] (1) and [2-methyl-m-phenylene diamine] (2)
methyl-phenylenediamine

-mixture of

[4-methyl-m-phenylene

p-chlorobenzotrichloride

diphenylether; octabromo derivate

1,2-bis(2-methoxyethoxy)ethane
triethylene glycol dimethyl ether (TEGDME)

tetrahydrothiopyran-3-carboxaldehyde

4,4′-bis(dimethylamino)benzophenone
(Michler's ketone)

oxiranemethanol, 4-methylbenzene-sulfonate, (S)-

CAS No
EC No

542-56-3

78-79-5

106-94-5

126-99-8

96-18-4

110-71-4

39300-45-3

25376-45-8

5216-25-1

32536-52-0

112-49-2

61571-06-0

90-94-8

70987-78-9

1,2-benzenedicarboxylic acid, dipentylester, branched and linear [1]

84777-06-0 [1]

n-pentyl-isopentylphthalate [2]

di-n-pentyl phthalate [3]

diisopentylphthalate [4]

1152

benzyl butyl phthalate
(BBP)

-[2]

131-18-0 [3]

605-50-5 [4]

85-68-7

1153

1,2-benzenedicarboxylic acid di-C 7-11, branched and linear alkylesters

68515-42-4

22.11.2005

EN

Official Journal of the European Union

L 303/35

Ref.
No

1154

1155

1156

1157

1158

1159

1160

1161

1162

1163

1164

1165

1166

1167

1168

1169

1170

1171

1172

1173

1174

1175

1176

1177

Chemical name

CAS No
EC No

a mixture of: disodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-
hydroxy-1-(4-sulfonatophenyl)
pyrazol-4-yl)penta-2,4-dienylidene)-4,5-
dihydro-5-oxopyrazol-1-yl)benzenesulfonate and trisodium 4-(3-ethoxy-
carbonyl-4-(5-(3-ethoxycarbonyl-5-oxido-1-(4-sulfonatophenyl)pyrazol-4-
yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate

EC No 402-660-9

(methylenebis(4,1-phenylenazo(1-(3-(dimethylamino)propyl)-1,2-dihydro-
6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))-1,1′-dipyridinium dichloride
dihydrochloride

EC No 401-500-5

2-[2-hydroxy-3-(2-chlorophenyl) carbamoyl-1-naphthylazo]-7-[2-hydroxy-
3-(3-methylphenyl)-2-[2-hydroxy-3-(3-methylphenyl)-carbamoyl-1-
naphthylazo]-7-[2-hydroxy-3-(3-methylphenyl)-carbamoyl-1-naphthyla-
zo]fluoren-9-one

azafenidin

2,4,5-trimethylaniline [1]

2,4,5-trimethylaniline hydrochloride [2]

4,4′-thiodianiline and its salts

4,4′-oxydianiline (p-aminophenyl ether) and its salts

N,N,N′,N′-tetramethyl-4,4′-methylendianiline

6-methoxy-m-toluidine
(p-cresidine)

EC No 420-580-2

68049-83-2

137-17-7 [1]

21436-97-5 [2]

139-65-1

101-80-4

101-61-1

120-71-8

3-ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine

143860-04-2

a mixture of: 1,3,5-tris(3-aminomethylphenyl)-1,3,5-(1H,3H,5H)-triazine-
2,4,6-trione and a mixture of oligomers of 3,5-bis(3-aminomethylphenyl)-
1-poly[3,5-bis(3-aminomethylphenyl)-2,4,6-trioxo-1,3,5-(1H,3H,5H)-
triazin-1-yl]-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione

2-nitrotoluene

tributyl phosphate

naphthalene

nonylphenol [1]

4-nonylphenol, branched [2]

1,1,2-trichloroethane

pentachloroethane

vinylidene chloride
(1,1-dichloroethylene)

allyl chloride
(3-chloropropene)

1,4-dichlorobenzene
(p-dichlorobenzene)

bis(2-chloroethyl) ether

phenol

bisphenol A
(4,4′-isopropylidenediphenol)

trioxymethylene
(1,3,5-trioxan)

EC No 421-550-1

88-72-2

126-73-8

91-20-3

25154-52-3 [1]

84852-15-3 [2]

79-00-5

76-01-7

75-35-4

107-05-1

106-46-7

111-44-4

108-95-2

80-05-7

110-88-3

2312-35-8

1178

propargite (ISO)

L 303/36

EN

Official Journal of the European Union

22.11.2005

Ref.
No

Chemical name

1-chloro-4-nitrobenzene

molinate (ISO)

fenpropimorph

epoxiconazole

methyl isocyanate

N,N-dimethylanilinium tetrakis(pentafluorophenyl)borate

CAS No
EC No

100-00-5

2212-67-1

67564-91-4

133855-98-8

624-83-9

118612-00-3

O,O′-(ethenylmethylsilylene) di[(4-methylpentan-2-one) oxime]

EC No 421-870-1

a 2:1 mixture of: 4-(7-hydroxy-2,4,4-trimethyl-2-chromanyl)resorcinol-4-
4-(7-
yl-tris(6-diazo-5,6-dihydro-5-oxonaphthalen-1-sulfonate)
hydroxy-2,4,4-trimethyl-2-chromanyl)resorcinolbis(6-diazo-5,6-dihydro-5-
oxonaphthalen-1-sulfonate)

and

140698-96-0

1179

1180

1181

1182

1183

1184

1185

1186

1187

a mixture of: reaction product of 4,4′-methylenebis[2-(4-hydroxybenzyl)-
3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxo-naphthalenesulfonate
(1:2) and reaction product of 4,4′-methylenebis[2-(4-hydroxybenzyl)-3,6-
dimethylphenol]
6-diazo-5,6-dihydro-5-oxonaphthalenesulfonate
(1:3)

and

1188

malachite green hydrochloride [1]

malachite green oxalate [2]

EC No 417-980-4

569-64-2 [1]

18015-76-4 [2]

1189

1190

1191

1192

1193

1194

1-(4-chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol

107534-96-3

5-(3-butyryl-2,4,6-trimethylphenyl)-2-[1-(ethoxyimino)propyl]-3-hydroxy-
cyclohex-2-en-1-one

138164-12-2

trans-4-phenyl-L-proline

bromoxynil heptanoate (ISO)

a mixture of: 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl) azo]-2,5-
diethoxyphenyl)azo]-2-[(3-phosphonophenyl)azo]benzoic acid and 5-[(4-
[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)azo]-2,5-diethoxyphenyl)azo]-3-
[(3-phosphonophenyl) azo]benzoic acid

96314-26-0

56634-95-8

163879-69-4

2-{4-(2-ammoniopropylamino)-6-[4-hydroxy-3-(5-methyl-2-methoxy-4-
sulfamoylphenylazo)-2-sulfonatonaphth-7-ylamino]-1,3,5-triazin-2-
ylamino}-2-aminopropyl formate

EC No 424-260-3

1195

5-nitro-o-toluidine [1]

1196

1197

1198

1199

1200

5-nitro-o-toluidine hydrochloride [2]

1-(1-naphthylmethyl)quinolinium

(R)-5-bromo-3-(1-methyl-2-pyrrolidinyl
methyl)-1H-indole

pymetrozine (ISO)

oxadiargyl (ISO)

chlorotoluron
(3-(3-chloro-p-tolyl)-1,1-dimethylurea)

99-55-8 [1]

51085-52-0 [2]

65322-65-8

143322-57-0

123312-89-0

39807-15-3

15545-48-9

1201

N-[2-(3-acetyl-5-nitrothiophen-2-ylazo)-5-diethylaminophenyl] acetamide

EC No 416-860-9

22.11.2005

EN

Official Journal of the European Union

L 303/37

Ref.
No

Chemical name

1,3-bis(vinylsulfonylacetamido)-propane

p-phenetidine (4-ethoxyaniline)

m-phenylenediamine and its salts

residues (coal
benzo[a]pyrene

tar), creosote oil distn.,

if

it contains > 0,005 % w/w

creosote oil, acenaphthene fraction, wash oil, if it contains > 0,005 % w/w
benzo[a]pyrene

creosote oil, if it contains > 0,005 % w/w benzo[a]pyrene

creosote, if it contains > 0,005 % w/w benzo[a]pyrene

creosote oil, high-boiling distillate, wash oil, if it contains > 0,005 % w/w
benzo[a]pyrene

CAS No
EC No

93629-90-4

156-43-4

108-45-2

92061-93-3

90640-84-9

61789-28-4

8001-58-9

70321-79-8

extract residues (coal), creosote oil acid, wash oil extract residue,
contains > 0,005 % w/w benzo[a]pyrene

if it

122384-77-4

creosote oil, low-boiling distillate, wash oil, if it contains > 0,005 % w/w
benzo[a]pyrene

70321-80-1

1202

1203

1204

1205

1206

1207

1208

1209

1210

1211

(1)
(2)

for the individual ingredient see reference number 364 in Annex II.
for the individual ingredient see reference number 413 in Annex II.’

2. Annex III, part one, is amended as follows:

(a)

the entry under reference number 19 is deleted;

(b) under reference number 1a, column b the words ‘Boric acid, borates and tetraborates’ are replaced by ‘Boric acid,

borates and tetraborates with the exception of substance No in Annex II’;

(c) under reference number 8, column b the words ‘m-and p-Phenylenediamine, their N-substituted derivatives and their
salts; N-substituted derivatives of o-Phenylenediamine (5), with exception of those derivatives listed elsewhere in this Annex’ are
replaced by ‘p-Phenylenediamine,
its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenedia-
mine (5), with exception of those derivatives listed elsewhere in this Annex’.