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,
Having regard to the Treaty establishing the European
Community,
Having regard to Council Directive 76/768/EEC of 27 July 1976
on the approximation of the laws of the Member States relatingto cosmetic products (
1), and in particular Article 8(2) thereof,
Whereas:
(1) On the basis of the IFRA (International Fragrance Asso-
ciation) Code of Practice, the Scientific Committee on
Consumer Products (SCCP) (2), identified substances
used as fragrance compounds in cosmetic products forwhich some restrictions should be provided.
(2) Considering that whatever the function of thesesubstances in cosmetic products is, it is the exposureto these substances which should be considered.Therefore, the restrictions should not be limited to theuse of the identified substances as fragrance compoundsin cosmetic products.
(3) However, sensitisation would not exist when thesubstance is used in oral products. Therefore, in orderto ensure consistency, as some of these substances areauthorised 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) No2232/96 of the European Parliament and of theCouncil of 28 October 1996 (
3), these restrictions
should not apply to substances listed under this register.(4) 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 Directive76/768/EEC under entries 45, 72, 73, 88 and 89.Furthermore, it is appropriate to include in that Annexthose identified substances which are not yet listed withtheir respective restrictions, as well as, for consistency,substances belonging to the same family identified inCommission Decision 96/335/EC of 8 May 1996 estab-lishing an inventory and a common nomenclature ofingredients employed in cosmetic products (
4).
(5) Benzyl alcohol being listed twice in Annex III part 1,under reference numbers 45 and 68, the content ofentry 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 amendedaccordingly.
(8) In order to ensure a smooth progression from theexisting formulae of cosmetic products to formulaewhich comply with the requirements laid down in thisDirective, it is necessary to provide for appropriate tran-sitional periods.
(9) The measures provided for in this Directive are inaccordance with the opinion of the StandingCommittee on Cosmetic Products,EN 4.4.2008 Official Journal of the European Union L 93/13
(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).
(3) OJ L 84, 27.3.1999, p. 1. Decision as last amended by Decision
2006/252/EC (OJ L 91, 29.3.2006, p. 48).(4) OJ L 132, 1.6.1996, p. 1. Decision as amended by Decision
2006/257/EC (OJ L 97, 5.4.2006, p. 1).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.
Article 2
Member States shall take all necessary measures to ensure that
products which fail to comply with this Directive are not soldor disposed of to the final consumer after 4 October 2009.
Article 3
1. Member States shall adopt and publish, by 4 October
2008 at the latest, the laws, regulations and administrativeprovisions necessary to comply with this Directive. They shallforthwith communicate to the Commission the text of thoseprovisions and a correlation table between those provisions andthis Directive.
They shall apply those provisions from 4 April 2009.When Member States adopt those provisions, they shall contain
a reference to this Directive or be accompanied by such areference on the occasion of their official publication. MemberStates 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 inthe field covered by this Directive.
Article 4
This Directive shall enter into force on the 20th 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, 3 April 2008.
For the Commission
Günter VERHEUGEN
Vice-PresidentEN L 93/14 Official Journal of the European Union 4.4.2008ANNEX
Directive 76/768/EEC is amended as follows:
(1) In Annex II, reference number 1136 is replaced by the following: ‘Exudation of Myroxylon pereirae (Royle) Klotzch
(Peru balsam, crude); CAS No 8007-00-9) when used as fragrance ingredient ’.
(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
numberSubstanceRestrictions Conditions of
use and
warnings which
must be
printed on the
labelField of application and/or useMaximum authorised
concentration in the finished
cosmetic productOther limitations and requirements
ab c d e f
‘45 Benzyl alcohol (*)
CAS No 100-51-6(a) Solvent
(b) fragrance/aromatic
compositions/their raw
materials(b)
The presence of the substance
must be indicated in the list of
ingredients referred to inArticle 6(1)(g) when its concen-tration exceeds:
—0,001 % in leave-on products
—0,01 % in rinse-off products
72 Hydroxycitronellal
CAS No 107-75-5(a) Oral products (a) (b)
The presence of the substance
must be indicated in the list of
ingredients referred to inArticle 6(1)(g) when its concen-tration exceeds:
—0,001 % in leave-on products
—0,01 % in rinse-off products(b) Other products (b) 1,0 %
73 Isoeugenol
CAS No 97-54-1(a) Oral products (a) (b)
The presence of the substance
must be indicated in the list of
ingredients referred to in
Article 6(1)(g) when its concen-tration exceeds:
—0,001 % in leave-on products
—0,01 % in rinse-off products(b) Other products (b) 0,02 %
88 d-Limonene
CAS No 5989-27-5The presence of the substance
must be indicated in the list ofingredients referred to inArticle 6(1)(g) when its concen-
tration exceeds:
—0,001 % in leave-on products
—0,01 % in rinse-off products
Peroxide value less than
20 mmoles/L (**)EN 4.4.2008 Official Journal of the European Union L 93/15ab c d e f
89 Methyl 2-octynoate
CAS No 111-12-6(a) Oral products (a) (b)
The presence of the substance
must be indicated in the list of
ingredients referred to in
Article 6(1)(g) when its concen-tration exceeds:
—0,001 % in leave-on products
—0,01 % in rinse-off productsMethyl heptine
carbonate(b) Other products (b) 0,01 % when used alone
When present in combi-
nation with methyloctine carbonate, the
combined level in the
finished product shouldnot exceed 0,01 % (ofwhich 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:
Reference
numberSubstanceRestrictions Conditions of use
and warnings
which must be
printed on the
labelField of application and/or
useMaximum authorised
concentration in the
finished cosmetic productOther limitations and requirements
ab c d e f
‘103 Abies alba cone oil and
extract
CAS No 90028-76-5Peroxide value less than
10 mmoles/L (*)
104 Abies alba needle oil and
extract
CAS No 90028-76-5Peroxide value less than
10 mmoles/L (*)
105 Abies pectinata needle oil and
extract
CAS No 92128-34-2Peroxide value less than
10 mmoles/L (*)
106 Abies sibirica needle oil and
extract
CAS No 91697-89-1Peroxide value less than
10 mmoles/L (*)
107 Abies balsamea needle oil and
extract
CAS No 85085-34-3Peroxide value less than
10 mmoles/L (*)
108 Pinus mugo pumilio leaf and
twig oil and extract
CAS No 90082-73-8Peroxide value less than
10 mmoles/L (*)
109 Pinus mugo leaf and twig oil
and extract
CAS No 90082-72-7Peroxide value less than
10 mmoles/L (*)
110 Pinus sylvestris leaf and twig
oil and extract
CAS No 84012-35-1Peroxide value less than
10 mmoles/L (*)EN L 93/16 Official Journal of the European Union 4.4.2008ab c d e f
111 Pinus nigra leaf and twig oil
and extract
CAS No 90082-74-9Peroxide value less than
10 mmoles/L (*)
112 Pinus palustris leaf and twig
oil and extract
CAS No 97435-14-8Peroxide value less than
10 mmoles/L (*)
113 Pinus pinaster leaf and twig
oil and extract
CAS No 90082-75-0Peroxide value less than
10 mmoles/L (*)
114 Pinus pumila leaf and twig oil
and extract
CAS No 97676-05-6Peroxide value less than
10 mmoles/L (*)
115 Pinus species leaf and twig oil
and extract
CAS No 94266-48-5Peroxide value less than
10 mmoles/L (*)
116 Pinus cembra leaf and twig oil
and extract
CAS No 92202-04-5Peroxide value less than
10 mmoles/L (*)
117 Pinus cembra leaf and twig
extract acetylated
CAS No 94334-26-6Peroxide value less than
10 mmoles/L (*)
118 Picea Mariana Leaf Oil and
Extract
CAS No 91722-19-9Peroxide value less than
10 mmoles/L (*)
119 Thuja Occidentalis Leaf Oil
and Extract
CAS No 90131-58-1Peroxide value less than
10 mmoles/L (*)
120 Thuja Occidentalis Stem Oil
CAS No 90131-58-1Peroxide value less than
10 mmoles/L (*)
121 3-Carene
CAS No 13466-78-9
3,7,7-Trimethyl-
bicyclo[4.1.0]hept-3-ene(isodiprene)Peroxide value less than
10 mmoles/L (*)
122 Cedrus atlantica wood oil and
extract
CAS No 92201-55-3Peroxide value less than
10 mmoles/L (*)
123 Cupressus sempervirens leaf
oil and extract
CAS No 84696-07-1Peroxide value less than
10 mmoles/L (*)
124 Turpentine gum ( Pinus spp.)
CAS No 9005-90-7Peroxide value less than
10 mmoles/L (*)EN 4.4.2008 Official Journal of the European Union L 93/17ab c d e f
125 Turpentine oil and rectified
oil
CAS No 8006-64-2Peroxide value less than
10 mmoles/L (*)
126 Turpentine, steam distilled
(Pinus spp.)
CAS No 8006-64-2Peroxide value less than
10 mmoles/L (*)
127 Terpene alcohols acetates
CAS No 69103-01-1Peroxide value less than
10 mmoles/L (*)
128 Terpene hydrocarbons
CAS No 68956-56-9Peroxide value less than
10 mmoles/L (*)
129 Terpenes and terpenoids with
the exception of limonene (d-,
l-, and dl-isomers) listed under
reference numbers 167, 168and 88 of this Annex III,part 1
CAS No 65996-98-7Peroxide value less than
10 mmoles/L (*)
130 Terpene terpenoids sinpine
CAS No 68917-63-5Peroxide value less than
10 mmoles/L (*)
131 α-Terpinene
CAS No 99-86-5
p-Mentha-1,3-dienePeroxide value less than
10 mmoles/L (*)
132 γ-Terpinene
CAS No 99-85-4
p-Mentha-1,4-dienePeroxide value less than
10 mmoles/L (*)
133 Terpinolene
CAS No 586-62-9
p-Mentha-1,4(8)-dienePeroxide value less than
10 mmoles/L (*)
134 Acetyl hexamethyl indan
CAS No 15323-35-0(a) Leave-on products (a) 2 %
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 ButanoateLevel of free allyl alcohol in the
ester should be less than 0,1 %
136 Allyl cinnamate
CAS No 1866-31-5
2-Propenyl 3-Phenyl-2-
propenoateLevel of free allyl alcohol in the
ester should be less than 0,1 %
137 Allyl cyclohexylacetate
CAS No 4728-82-9
2-Propenyl Cyclohexanea-
cetateLevel of free allyl alcohol in the
ester should be less than 0,1 %EN L 93/18 Official Journal of the European Union 4.4.2008ab c d e f
138 Allyl cyclohexylpropionate
CAS No 2705-87-5
2-Propenyl 3-Cyclohexane-
propanoateLevel of free allyl alcohol in the
ester should be less than 0,1 %
139 Allyl heptanoate
CAS No 142-19-8
2-Propenyl heptanoateLevel of free allyl alcohol in the
ester should be less than 0,1 %
140 Allyl caproate
CAS No 123-68-2
Allyl hexanoateLevel of free allyl alcohol in the
ester should be less than 0,1 %
141 Allyl isovalerate
CAS No 2835-39-4
2-Propenyl 3-Methyl-
butanoateLevel of free allyl alcohol in the
ester should be less than 0,1 %
142 Allyl octanoate
CAS No 4230-97-1
2-Allyl caprylateLevel of free allyl alcohol in the
ester should be less than 0,1 %
143 Allyl phenoxyacetate
CAS No 7493-74-5
2-Propenyl PhenoxyacetateLevel of free allyl alcohol in the
ester should be less than 0,1 %
144 Allyl phenylacetate
CAS No 1797-74-6
2-Propenyl BenzeneacetateLevel of free allyl alcohol in the
ester should be less than 0,1 %
145 Allyl 3,5,5-trimethylhexanoate
CAS No 71500-37-3Level of free allyl alcohol in the
ester should be less than 0,1 %
146 Allyl cyclohexyloxyacetate
CAS No 68901-15-5Level of free allyl alcohol in the
ester should be less than 0,1 %
147 Allyl isoamyloxyacetate
CAS No 67634-00-8Level of free allyl alcohol in the
ester should be less than 0,1 %
148 Allyl 2-methylbutoxyacetate
CAS No 67634-01-9Level of free allyl alcohol in the
ester should be less than 0,1 %
149 Allyl nonanoate
CAS No 7493-72-3Level of free allyl alcohol in the
ester should be less than 0,1 %
150 Allyl propionate
CAS No 2408-20-0Level of free allyl alcohol in the
ester should be less than 0,1 %
151 Allyl trimethylhexanoate
CAS No 68132-80-9Level of free allyl alcohol in the
ester should be less than 0,1 %EN 4.4.2008 Official Journal of the European Union L 93/19ab c d e f
152 Allyl heptine carbonate
CAS No 73157-43-4
(allyl oct-2-ynoate)0,002 % This material should not be used in
combination with any other2-alkynoic acid ester (e.g methylheptine carbonate)
153 Amylcyclopentenone
CAS No 25564-22-1
2-Pentylcyclopent-2-en-1-one0,1 %
154 Myroxylon balsamum var
pereirae. extracts and distillates
CAS No 8007-00-9
Balsam Peru oil, absolute and
anhydrol
(Balsam Oil Peru)0,4 %
155 4- tert.-Butyldihydrocinnamal-
dehyde
CAS No 18127-01-0
3-(4-tert-Butylphenyl)propion-
aldehyde0,6 %
156 Cuminum cyminum fruit oil
and extract
CAS No 84775-51-9(a) Leave-on products
(b) Rinse-off products(a) 0,4 % of Cumin oil
157 cis-Rose ketone-1 (**)
CAS No 23726-94-5
(Z)-1-(2,6,6-Trimethyl-
2-cyclohexen-1-yl)-2-
buten-1-one
(cis-α-Damascone)(a) Oral products
(b) Other products (b) 0,02 %
158 trans-Rose ketone-2 (**)
CAS No 23726-91-2
(E)-1-(2,6,6-Trimethyl-
1-cyclohexen-1-yl)-2-buten-1-one
(trans- β-Damascone)(a) Oral products
(b) Other products (b) 0,02 %
159 trans-Rose ketone-5 (**)
CAS No 39872-57-6
(E)-1-(2,4,4-Trimethyl-
2-cyclohexen-1-yl)-2-
buten-1-one
(Isodamascone)0,02 %
160 Rose ketone-4 (**)
CAS No 23696-85-7
1-(2,6,6-Trimethylcyclohexa-
1,3-dien-1-yl)-2-buten-1-one(Damascenone)(a) Oral products
(b) Other products (b) 0,02 %EN L 93/20 Official Journal of the European Union 4.4.2008ab c d e f
161 Rose ketone-3 (**)
CAS No 57378-68-4
1-(2,6,6-Trimethyl-3-
cyclohexen-1-yl)-2-buten-l-one
(Delta-Damascone)(a) Oral products
(b) Other products (b) 0,02 %
162 cis-Rose ketone-2 (**)
CAS No 23726-92-3
1-(2,6,6-Trimethyl-l-
cyclohexen-1-yl)-2-
buten-l-one
(cis-β-Damascone)(a) Oral products
(b) Other products (b) 0,02 %
163 trans -Rose ketone-1 (**)
CAS No 24720-09-01-(2,6,6-Trimethyl-2-
cyclohexen-1-yl)-2-
buten-l-one
(trans- α-Damascone)(a) Oral products
(b) Other products (b) 0,02 %
164 Rose ketone-5 (**)
CAS No 33673-71-1
1-(2,4,4-Trimethyl-2-
cyclohexen-1-yl)-2-buten-l-one(b) 0,02 %
165 trans-Rose ketone-3 (**)
CAS No 71048-82-3
1-(2,6,6-Trimethyl-3-
cyclohexen-1-yl)-2-buten-l-one
(trans-delta-Damascone)(a) Oral products
(b) Other products (b) 0,02 %
166 trans -2-hexenal
CAS No 6728-26-3(a) Oral products
(b) Other products (b) 0,002 %
167 l-Limonene
CAS No 5989-54-8
(S)-p-Mentha-1,8-dienePeroxide value less than
20 mmoles/L (*)
168 dl-Limonene (racemic)
CAS No 138-86-3
1,8(9)- p-Menthadiene;
p-Mentha-1,8-diene
(Dipentene)Peroxide value less than
20 mmoles/L (*)
169 Perillaldehyde
CAS No 2111-75-3
p-Mentha-1,8-dien-7-al(a) Oral products
(b) Other products (b) 0,1 %
170 Isobergamate
CAS No 68683-20-5
Menthadiene-7-methyl
formate0,1 %EN 4.4.2008 Official Journal of the European Union L 93/21ab c d e f
171 Methoxy dicyclopentadiene
carboxaldehyde
CAS No 86803-90-9
Octahydro-5-methoxy-
4,7-Methano-1H-indene-2-carboxaldehyde0,5 %
172 3-methylnon-2-enenitrile
CAS No 53153-66-50,2 %
173 Methyl octine carbonate
CAS No 111-80-8
Methyl non-2-ynoate(a) Oral products
(b) Other products (b) 0,002 % when
used alone
When present in
combination withmethyl heptinecarbonate, the
combined level
in the finishedproduct shouldnot exceed 0,01 %
(of which methyl
octine carbonateshould not bemore than
0,002 %)
174 Amylvinylcarbinyl acetate
CAS No 2442-10-6
1-Octen-3-yl acetate(a) Oral products
(b) Other products (b) 0,3 %
175 Propylidenephthalide
CAS No 17369-59-4
3-Propylidenephthalide(a) Oral products
(b) Other products (b) 0,01 %
176 Isocyclogeraniol
CAS No 68527-77-5
2,4,6-Trimethyl-3-
cyclohexene-1-methanol0,5 %
177 2-Hexylidene cyclopentanone
CAS No 17373-89-6(a) Oral products
(b) Other products (b) 0,06 %
178 Methyl heptadienone
CAS No 1604-28-0
6-Methyl-3,5-heptadien-2-one(a) Oral products
(b) Other products (b) 0,002 %
179 p-methylhydrocinnamic
aldehyde
CAS No 5406-12-2
Cresylpropionalde-hyde
p-Methyldihydrocinnamal-
dehyde0,2 %
180 Liquidambar orientalis
Balsam oil and extract
CAS No 94891-27-7
(styrax)0,6 %EN L 93/22 Official Journal of the European Union 4.4.2008ab c d e f
181 Liquidambar styraciflua
balsam oil and extract
CAS No 8046-19-3
(styrax)0,6 %
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)All cosmetic products,
with the exception of
oral products(a) leave-on products:
0,1 %
except:
hydro
alcoholic 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
CAS No 93686-00-10,6 %
184 Opopanax chironium resin
CAS No 93384-32-80,6 %
(*) 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. ’EN 4.4.2008 Official Journal of the European Union L 93/23