Commission Directive 2008/42/EC of 3 April 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: 2008-04-03
Institutions: European Commission
Subjects: chemical product, consumer information, cosmetic product, product safety, technological change

4.4.2008

EN

Official Journal of the European Union

L 93/13

DIRECTIVES

COMMISSION DIRECTIVE 2008/42/EC

of 3 April 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,

(4)

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,

Whereas:

(1)

(2)

(3)

On the basis of the IFRA (International Fragrance Asso-
ciation) Code of Practice, the Scientific Committee on
(SCCP) (2),
identified substances
Consumer Products
used as fragrance compounds in cosmetic products for
which some restrictions should be provided.

the

that whatever

function of
these
Considering
it is the exposure
substances in cosmetic products is,
to these
considered.
substances which should be
Therefore, the restrictions should not be limited to the
use of the identified substances as fragrance compounds
in cosmetic products.

exist when the
However,
sensitisation would not
in order
substance is used in oral products. Therefore,
to ensure consistency, as some of these substances are
authorised as
flavouring substances by Commission
Decision 1999/217/EC of 23 February 1999 adopting
a register of flavouring substances used in or on food-
stuffs drawn up in application of Regulation (EC) No
2232/96 of
the
the European Parliament
Council of 28 October 1996 (3),
restrictions
should not apply to substances listed under this register.

and of

these

(1) OJ L 262, 27.9.1976, p. 169. Directive as last amended by
Commission Directive 2008/14/EC (OJ L 42, 16.2.2008, p. 43).
(2) OJ L 66, 4.3.2004, p. 45. Decision as amended by Decision

2007/263/EC (OJ L 114, 1.5.2007, p. 14).

In the light of the opinions of the SCCP, it is necessary to
amend the restrictions related to the identified substances
which are already listed in Annex III
to Directive
76/768/EEC under entries 45, 72, 73, 88 and 89.
Furthermore, it is appropriate to include in that Annex
those identified substances which are not yet listed with
their respective restrictions, as well as, for consistency,
substances belonging to the same family identified in
Commission Decision 96/335/EC of 8 May 1996 estab-
lishing an inventory and a common nomenclature of
ingredients employed in cosmetic products (4).

(5)

Benzyl alcohol being listed twice in Annex III part 1,
under reference numbers 45 and 68,
the content of
entry 68 as well as the new restrictions should be
included in entry 45.

(6)

Following clarification by the SCCP regarding Peru
balsam, entry 1136 of Annex II should be amended.

(7)

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

(8)

(9)

to ensure a smooth progression from the
In order
existing formulae of cosmetic products
to formulae
which comply with the requirements laid down in this
Directive, it is necessary to provide for appropriate tran-
sitional periods.

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

the

in this Directive are in
Standing
the

of

(3) OJ L 84, 27.3.1999, p. 1. Decision as last amended by Decision

(4) OJ L 132, 1.6.1996, p. 1. Decision as amended by Decision

2006/252/EC (OJ L 91, 29.3.2006, p. 48).

2006/257/EC (OJ L 97, 5.4.2006, p. 1).

L 93/14

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Official Journal of the European Union

4.4.2008

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

Article 2

Member States shall take all necessary measures to ensure that
products which fail to comply with this Directive are not sold
or disposed of to the final consumer after 4 October 2009.

Article 4

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

Article 3

Article 5

the latest,

1. Member States shall adopt and publish, by 4 October
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 4 April 2009.

This Directive is addressed to the Member States.

Done at Brussels, 3 April 2008.

For the Commission

Günter VERHEUGEN
Vice-President

4.4.2008

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Official Journal of the European Union

L 93/15

Directive 76/768/EEC is amended as follows:

ANNEX

(1) In Annex II, reference number 1136 is replaced by the following:

(Peru balsam, crude); CAS No 8007-00-9) when used as fragrance ingredient’.

‘Exudation of Myroxylon pereirae (Royle) Klotzch

(2) Part 1 of Annex III is amended as follows:

(a) reference number 68 is deleted;

(b) reference numbers 45, 72, 73, 88 and 89 are replaced by the following:

Reference
number

Substance

Field of application and/or use

Restrictions

Maximum authorised
concentration in the finished
cosmetic product

Other limitations and requirements

Conditions of
use and
warnings which
must be
printed on the
label

a

‘45

b

c

d

e

f

Benzyl alcohol (*)

(a) Solvent

CAS No 100-51-6

(b) fragrance/aromatic

compositions/their raw
materials

(b)

the

The presence of
substance
must be indicated in the list of
ingredients
in
referred
Article 6(1)(g) when its concen-
tration exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products

to

72

Hydroxycitronellal

(a) Oral products

(a) (b)

CAS No 107-75-5

(b) Other products

(b) 1,0 %

the

The presence of
substance
must be indicated in the list of
ingredients
in
referred
Article 6(1)(g) when its concen-
tration exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products

to

73

Isoeugenol

(a) Oral products

(a) (b)

CAS No 97-54-1

(b) Other products

(b) 0,02 %

88

d-Limonene

CAS No 5989-27-5

the

The presence of
substance
must be indicated in the list of
ingredients
in
referred
Article 6(1)(g) when its concen-
tration exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products

to

to

the

substance
The presence of
must be indicated in the list of
ingredients
in
referred
Article 6(1)(g) when its concen-
tration exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
Peroxide
value
20 mmoles/L (**)

than

less

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a

89

EN

b

Official Journal of the European Union

4.4.2008

c

d

e

f

Methyl 2-octynoate

(a) Oral products

(a) (b)

CAS No 111-12-6

Methyl heptine
carbonate

(b) Other products

(b) 0,01 % when used alone

When present in combi-
with methyl
nation
the
octine
carbonate,
in the
combined level
finished product should
not exceed 0,01 % (of
which methyl
octine
carbonate should not be
more than 0,002 %)

(*) As a preservative, see Annex VI, Part 1, No 34.
(**) This limit applies to the substance and not to the finished cosmetic product.’

(c) The following reference numbers 103 to 184 are added:

the

The presence of
substance
must be indicated in the list of
ingredients
in
referred
Article 6(1)(g) when its concen-
tration exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products

to

Reference
number

Substance

Field of application and/or
use

Maximum authorised
concentration in the
finished cosmetic product

Other limitations and requirements

Restrictions

Conditions of use
and warnings
which must be
printed on the
label

b

c

d

e

f

a

‘103

Abies alba cone oil and
extract

CAS No 90028-76-5

104

Abies alba needle oil and
extract

CAS No 90028-76-5

105

Abies pectinata needle oil and
extract

CAS No 92128-34-2

106

Abies sibirica needle oil and
extract

CAS No 91697-89-1

107

Abies balsamea needle oil and
extract

CAS No 85085-34-3

108

Pinus mugo pumilio leaf and
twig oil and extract

CAS No 90082-73-8

109

Pinus mugo leaf and twig oil
and extract

CAS No 90082-72-7

110

Pinus sylvestris leaf and twig
oil and extract

CAS No 84012-35-1

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

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b

c

d

e

f

a

111

Pinus nigra leaf and twig oil
and extract

CAS No 90082-74-9

112

Pinus palustris leaf and twig
oil and extract

CAS No 97435-14-8

113

Pinus pinaster leaf and twig
oil and extract

CAS No 90082-75-0

114

Pinus pumila leaf and twig oil
and extract

CAS No 97676-05-6

115

Pinus species leaf and twig oil
and extract

CAS No 94266-48-5

116

Pinus cembra leaf and twig oil
and extract

CAS No 92202-04-5

117

Pinus cembra leaf and twig
extract acetylated

CAS No 94334-26-6

118

Picea Mariana Leaf Oil and
Extract

CAS No 91722-19-9

119

Thuja Occidentalis Leaf Oil
and Extract

CAS No 90131-58-1

120

Thuja Occidentalis Stem Oil

CAS No 90131-58-1

121

3-Carene

CAS No 13466-78-9

3,7,7-Trimethyl-
bicyclo[4.1.0]hept-3-ene
(isodiprene)

122

Cedrus atlantica wood oil and
extract

CAS No 92201-55-3

123

Cupressus sempervirens leaf
oil and extract

CAS No 84696-07-1

124

Turpentine gum (Pinus spp.)

CAS No 9005-90-7

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

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Official Journal of the European Union

4.4.2008

b

c

d

e

f

a

125

Turpentine oil and rectified
oil

CAS No 8006-64-2

126

Turpentine, steam distilled
(Pinus spp.)

CAS No 8006-64-2

127

Terpene alcohols acetates

CAS No 69103-01-1

128

Terpene hydrocarbons

CAS No 68956-56-9

129

Terpenes and terpenoids with
the exception of limonene (d-,
l-, and dl-isomers) listed under
reference numbers 167, 168
and 88 of this Annex III,
part 1

CAS No 65996-98-7

130

Terpene terpenoids sinpine

CAS No 68917-63-5

131

α-Terpinene
CAS No 99-86-5

p-Mentha-1,3-diene

132

γ-Terpinene

CAS No 99-85-4

p-Mentha-1,4-diene

133

Terpinolene

CAS No 586-62-9

p-Mentha-1,4(8)-diene

134

Acetyl hexamethyl indan

(a) Leave-on products

(a) 2 %

CAS No 15323-35-0

1,1,2,3,3,6-Hexamethylindan-
5-yl methyl ketone

(b) Rinse-off products

135

Allyl butyrate

CAS No 2051-78-7

2-Propenyl Butanoate

136

Allyl cinnamate

CAS No 1866-31-5

2-Propenyl 3-Phenyl-2-
propenoate

137

Allyl cyclohexylacetate

CAS No 4728-82-9

2-Propenyl Cyclohexanea-
cetate

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Peroxide value less than
10 mmoles/L (*)

Level of free allyl alcohol in the
ester should be less than 0,1 %

Level of free allyl alcohol in the
ester should be less than 0,1 %

Level of free allyl alcohol in the
ester should be less than 0,1 %

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a

b

c

d

e

f

138

Allyl cyclohexylpropionate

CAS No 2705-87-5

2-Propenyl 3-Cyclohexane-
propanoate

139

Allyl heptanoate

CAS No 142-19-8

2-Propenyl heptanoate

140

Allyl caproate

CAS No 123-68-2

Allyl hexanoate

141

Allyl isovalerate

CAS No 2835-39-4

2-Propenyl 3-Methyl-
butanoate

142

Allyl octanoate

CAS No 4230-97-1

2-Allyl caprylate

143

Allyl phenoxyacetate

CAS No 7493-74-5

2-Propenyl Phenoxyacetate

144

Allyl phenylacetate

CAS No 1797-74-6

2-Propenyl Benzeneacetate

145

Allyl 3,5,5-trimethylhexanoate

CAS No 71500-37-3

146

Allyl cyclohexyloxyacetate

CAS No 68901-15-5

147

Allyl isoamyloxyacetate

CAS No 67634-00-8

148

Allyl 2-methylbutoxyacetate

CAS No 67634-01-9

149

Allyl nonanoate

CAS No 7493-72-3

150

Allyl propionate

CAS No 2408-20-0

151

Allyl trimethylhexanoate

CAS No 68132-80-9

Level of free allyl alcohol in the
ester should be less than 0,1 %

Level of free allyl alcohol in the
ester should be less than 0,1 %

Level of free allyl alcohol in the
ester should be less than 0,1 %

Level of free allyl alcohol in the
ester should be less than 0,1 %

Level of free allyl alcohol in the
ester should be less than 0,1 %

Level of free allyl alcohol in the
ester should be less than 0,1 %

Level of free allyl alcohol in the
ester should be less than 0,1 %

Level of free allyl alcohol in the
ester should be less than 0,1 %

Level of free allyl alcohol in the
ester should be less than 0,1 %

Level of free allyl alcohol in the
ester should be less than 0,1 %

Level of free allyl alcohol in the
ester should be less than 0,1 %

Level of free allyl alcohol in the
ester should be less than 0,1 %

Level of free allyl alcohol in the
ester should be less than 0,1 %

Level of free allyl alcohol in the
ester should be less than 0,1 %

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Official Journal of the European Union

4.4.2008

a

b

c

d

e

f

This material should not be used in
combination with any other
2-alkynoic acid ester (e.g methyl
heptine carbonate)

152

Allyl heptine carbonate

0,002 %

CAS No 73157-43-4

(allyl oct-2-ynoate)

153

Amylcyclopentenone

CAS No 25564-22-1

2-Pentylcyclopent-2-en-1-one

154

Myroxylon balsamum var
pereirae. extracts and distillates

CAS No 8007-00-9

Balsam Peru oil, absolute and
anhydrol

(Balsam Oil Peru)

155

4-tert.-Butyldihydrocinnamal-
dehyde

CAS No 18127-01-0

3-(4-tert-Butylphenyl)propion-
aldehyde

0,1 %

0,4 %

0,6 %

156

Cuminum cyminum fruit oil
and extract

CAS No 84775-51-9

(a) Leave-on products

(a) 0,4 % of Cumin oil

(b) Rinse-off products

157

cis-Rose ketone-1 (**)

(a) Oral products

(b) Other products

(b) 0,02 %

CAS No 23726-94-5

(Z)-1-(2,6,6-Trimethyl-
2-cyclohexen-1-yl)-2-
buten-1-one
(cis-α-Damascone)

158

trans-Rose ketone-2 (**)

(a) Oral products

(b) Other products

(b) 0,02 %

CAS No 23726-91-2

(E)-1-(2,6,6-Trimethyl-
1-cyclohexen-1-yl)-2-
buten-1-one
(trans-β-Damascone)

159

trans-Rose ketone-5 (**)

0,02 %

CAS No 39872-57-6

(E)-1-(2,4,4-Trimethyl-
2-cyclohexen-1-yl)-2-
buten-1-one

(Isodamascone)

160

Rose ketone-4 (**)

(a) Oral products

CAS No 23696-85-7

1-(2,6,6-Trimethylcyclohexa-
1,3-dien-1-yl)-2-buten-1-one
(Damascenone)

(b) Other products

(b) 0,02 %

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a

b

c

d

e

f

161

Rose ketone-3 (**)

(a) Oral products

(b) Other products

(b) 0,02 %

CAS No 57378-68-4

1-(2,6,6-Trimethyl-3-
cyclohexen-1-yl)-2-
buten-l-one

(Delta-Damascone)

162

cis-Rose ketone-2 (**)

(a) Oral products

(b) Other products

(b) 0,02 %

CAS No 23726-92-3

1-(2,6,6-Trimethyl-l-
cyclohexen-1-yl)-2-
buten-l-one
(cis-β-Damascone)

163

trans-Rose ketone-1 (**)

(a) Oral products

(b) Other products

(b) 0,02 %

CAS No 24720-09-0

1-(2,6,6-Trimethyl-2-
cyclohexen-1-yl)-2-
buten-l-one
(trans-α-Damascone)

164

Rose ketone-5 (**)

(b) 0,02 %

CAS No 33673-71-1

1-(2,4,4-Trimethyl-2-
cyclohexen-1-yl)-2-
buten-l-one

165

trans-Rose ketone-3 (**)

(a) Oral products

(b) Other products

(b) 0,02 %

CAS No 71048-82-3

1-(2,6,6-Trimethyl-3-
cyclohexen-1-yl)-2-
buten-l-one

(trans-delta-Damascone)

166

trans-2-hexenal

(a) Oral products

CAS No 6728-26-3

(b) Other products

(b) 0,002 %

167

l-Limonene

CAS No 5989-54-8

(S)-p-Mentha-1,8-diene

168

dl-Limonene (racemic)

CAS No 138-86-3

1,8(9)-p-Menthadiene;
p-Mentha-1,8-diene

(Dipentene)

169

Perillaldehyde

(a) Oral products

CAS No 2111-75-3

p-Mentha-1,8-dien-7-al

(b) Other products

(b) 0,1 %

170

Isobergamate

0,1 %

CAS No 68683-20-5

Menthadiene-7-methyl
formate

Peroxide value less than
20 mmoles/L (*)

Peroxide value less than
20 mmoles/L (*)

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4.4.2008

a

171

b

c

d

e

f

Methoxy dicyclopentadiene
carboxaldehyde

CAS No 86803-90-9

Octahydro-5-methoxy-
4,7-Methano-1H-indene-
2-carboxaldehyde

0,5 %

172

3-methylnon-2-enenitrile

0,2 %

CAS No 53153-66-5

173

Methyl octine carbonate

(a) Oral products

CAS No 111-80-8

Methyl non-2-ynoate

(b) Other products

(b) 0,002 % when
used alone

When present
in
combination with
heptine
methyl
the
carbonate,
combined
level
finished
in
the
product
should
not exceed 0,01 %
(of which methyl
carbonate
octine
be
should
not
more
than
0,002 %)

174

Amylvinylcarbinyl acetate

(a) Oral products

CAS No 2442-10-6

1-Octen-3-yl acetate

(b) Other products

(b) 0,3 %

175

Propylidenephthalide

(a) Oral products

CAS No 17369-59-4

3-Propylidenephthalide

(b) Other products

(b) 0,01 %

176

Isocyclogeraniol

0,5 %

CAS No 68527-77-5

2,4,6-Trimethyl-3-
cyclohexene-1-methanol

177

2-Hexylidene cyclopentanone

(a) Oral products

CAS No 17373-89-6

(b) Other products

(b) 0,06 %

178

Methyl heptadienone

(a) Oral products

CAS No 1604-28-0

6-Methyl-3,5-heptadien-2-one

(b) Other products

(b) 0,002 %

179

180

p-methylhydrocinnamic
aldehyde

CAS No 5406-12-2

Cresylpropionalde-hyde

p-Methyldihydrocinnamal-
dehyde

Liquidambar orientalis
Balsam oil and extract

CAS No 94891-27-7

(styrax)

0,2 %

0,6 %

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b

c

d

e

f

a

181

Liquidambar styraciflua
balsam oil and extract

CAS No 8046-19-3

(styrax)

All cosmetic products,
with the exception of
oral products

182

Acetyl hexamethyl tetralin

CAS No 21145-77-7

CAS No 1506-02-1

1-(5,6,7,8-Tetrahydro-
3,5,5,6,8,8-hexamethyl-
2-naphthyl)ethan-1-one

(AHTN)

183

Commiphora erythrea engler
var. glabrescens engler gum
extract and oil

CAS No 93686-00-1

184

Opopanax chironium resin

CAS No 93384-32-8

0,6 %

(a) leave-on products:

0,1 %

except:

hydro

alcoholic products:
1 %

fine
2,5 %

fragrance:

fragrance cream:

0,5 %

(b) rinse-off products:

0,2 %

0,6 %

0,6 %

(*) This limit applies to the substance and not to the finished cosmetic product.
(**) The sum of those substances used in combination should not exceed the limits given in column d.’