Commission Directive 2009/6/EC of 4 February 2009 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: 2009-02-04
Institutions: European Commission
Subjects: aerosol, allergy, approximation of laws, consumer protection, cosmetic product, dyestuff, product safety

5.2.2009

EN

Official Journal of the European Union

L 36/15

DIRECTIVES

COMMISSION DIRECTIVE 2009/6/EC

of 4 February 2009

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:

Following restrictive measures taken by one Member
State on the
basis of Article 12 of Directive
76/768/EEC regarding the use of diethylene glycol
in cosmetic products, the SCCP was consulted.
(DEG)
Considering that
the
opinion that DEG should not be used as an ingredient
in cosmetic products, but that a maximum concentration
of up to 0,1 % of DEG from impurities in the finished
this
cosmetic products can be considered to be safe,
substance
in cosmetic
should be banned for use
products and its traces limit should be fixed at 0,1 %.

scientific committee is of

this

Following restrictive measures taken by one Member
basis of Article 12 of Directive
State on the
76/768/EEC regarding the use of phytonadione
in
cosmetic products, the SCCP was consulted. The scientific
committee is of the opinion that use of phytonadione in
cosmetic products
since it may cause
cutaneous allergy and individuals so affected may be
denied an important
therapeutic agent. Therefore the
substance should be banned.

is not

safe,

(1)

(2)

(3)

provisions relating to the classification, packaging and
labelling of dangerous substances (2). However, the use
to
substances classified in category 3 pursuant
of
Directive 67/548/EEC may be
to
allowed subject
evaluation and approval by the Scientific Committee on
Consumer Products (SCCP).

The SCCP considers that toluene, a substance classified as
to
a CMR substance of category 3 under Annex I
Directive 67/548/EEC,
is safe from the general toxico­
logical point of view when present up to 25 % in nail
products; however its inhalation by children should be
avoided.

and

(EGBE)

ethylene

(DEGBE)

in cosmetic products,

Following restrictive measures decided by one Member
State on the
basis of Article 12 of Directive
76/768/EEC regarding the use of diethylene glycol
glycol
monobutyl
ether
monobutyl ether
the
SCCP was consulted. This scientific committee is of the
opinion that the use of DEGBE as a solvent in hair dye
products at a concentration up to 9,0 % does not pose a
risk to the health of consumer. Moreover, the committee
considers that the use EGBE as a solvent at a concen­
tration up to 4,0 % in oxidative hair dye products and up
to 2,0 % in non-oxidative hair dye products does not
pose a risk to the health of the consumer. However,
the SCCP did not consider the use of these substances
safe when the product is presented in aerosol/spray; this
potential use should therefore be banned.

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)

of

substances

the use in cosmetic
Directive 76/768/EEC prohibits
products
carcinogenic,
mutagenic or toxic for reproduction (hereinafter, CMR
substances), of category 1, 2 and 3, under Annex I to
Council Directive 67/548/EEC of 27 June 1967 on the
laws, regulations and administrative
approximation of

classified

as

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.

(1) OJ L 262, 27.9.1976, p. 169.

(2) OJ 196, 16.8.1967, p. 1.

L 36/16

EN

Official Journal of the European Union

5.2.2009

Article 2

1. Member States shall adopt and publish, by 5 August 2009
at the latest, the laws, regulations and administrative provisions
necessary to comply with this Directive. They shall forthwith
communicate to the Commission the text of those provisions.

They shall apply those provisions from 5 November 2009.

However,
they shall apply the provisions concerning the
substance toluene as set out in point 2 of the Annex under
reference number 185 from 5 February 2010.

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 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 4 February 2009.

subparagraph,

When Member States adopt the provisions referred to in the
first
they shall contain a reference to this
Directive or be accompanied by such a reference on the
shall
occasion of
determine how such reference is to be made.

their official publication. Member States

For the Commission

Günter VERHEUGEN
Vice-President

5.2.2009

EN

Official Journal of the European Union

L 36/17

ANNEX

Directive 76/768/EEC is amended as follows:

1. In Annex II, the following reference numbers are added:

Reference number

Chemical name

CAS number
EC number

‘1370

Diethylene glycol
Annex III
2,2′-oxydiethanol

(DEG),

for traces level see

CAS No 111-46-6

EC No 203-872-2

1371

Phytonadione [INCI], phytomenadione [INN]

CAS No 84-80-0/81818-54-4;
EC No 201-564-2’

2. In Part 1 of Annex III, the following reference numbers 185 to 188 are added:

Reference
number

Substance

Restrictions

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

Field of application
and/or use

Maximum authorised
concentration in the
finished cosmetic
product

Other limitations and
requirements

a

‘185

b

c

Toluene

Nail products

CAS No 108-88-3

EC No 203-625-9

186

Diethylene
(DEG)

glycol

Traces in ingre­
dients

d

25 %

0,1 %

e

f

Keep out of reach of
children

To
be
adults only

used

by

CAS No 111-46-6

EC No 203-872-2
2,2′-oxydiethanol

187

Butoxydiglycol

CAS No 112-34-5

EC No 203-961-6

diethylene
monobutyl
(DEGBE)

glycol
ether

188

Butoxyethanol

CAS No 111-76-2

EC No 203-905-0

ethylene
monobutyl
(EGBE)

glycol
ether

Solvent in hair dye
products

9 %

No use in aerosol
dispensers (sprays)

Solvent in
oxidative hair dye
products

Solvent in non-
oxidative hair dye
products

4,0 %

2,0 %

No use in aerosol
dispensers (sprays)

No use in aerosol
dispensers (sprays)’