Commission Directive 2007/22/EC of 17 April 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes IV and VI thereto to technical progress (Text with EEA relevance)
Date: 2007-04-17
Institutions: European Commission
Subjects: chemical product, cosmetic product, dyestuff, health control, market approval, product safety

18.4.2007

EN

Official Journal of the European Union

L 101/11

DIRECTIVES

COMMISSION DIRECTIVE 2007/22/EC

of 17 April 2007

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

for the purposes of

adapting Annexes IV and VI 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,

(4)

(5)

consulting the Scientific Committee on Consumer

After
Products,

authorised colorant. In view of the absence of interest
from stakeholders to defend the use of these substances
and the opinion of the SCCP regarding the necessity to
reduce the exposure to iodine from cosmetic products,
the authorisations should be withdrawn.

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

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

the

in this Directive are in
Standing
the

of

consumers,

intended for

The Scientific Committee on Cosmetic and Non-Food
Products
replaced by the
Scientific Committee on Consumer Products, (SCCP), by
Commission Decision 2004/210/EC (2), delivered an
opinion regarding the safe use of the preservative iodo-
propynyl butylcarbamate (IPBC)
in cosmetic products
concluding that the daily bioavailable intake of iodine
from cosmetic products should not exceed 20 % of the
recommended daily intake of 150 μg and that
IPBC
should not be used in oral hygiene and lip care products.

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annexes IV and VI to 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
from 18 October 2008 no cosmetic products which fail to
comply with this Directive are placed on the market by
Community manufacturers or by importers established within
the Community.

Considering that the list of preservatives authorised in
cosmetic products should not be too limited, but that
the exposure to iodine from IPBC should not be too
high,
the existing entry 56 to Annex VI should be
amended accordingly.

Member States shall take all necessary measures to ensure that
those products are not
to the final
consumer after 18 April 2009.

sold or disposed of

Sodium iodate and colorant CI 45425 contain iodine and
are currently respectively listed under Annex VI as
IV as
and
authorised

under Annex

preservative

(1) OJ L 262, 27.9.1976, p. 169. Directive as last amended by
Commission Directive 2007/17/EC (OJ L 82, 23.3.2007, p. 27).

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

Article 3

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 18 January 2008 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.

Whereas:

(1)

(2)

(3)

L 101/12

EN

Official Journal of the European Union

18.4.2007

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 its publication in the Official Journal of the
European Union.

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 17 April 2007.

For the Commission

Günter VERHEUGEN
Vice-President

18.4.2007

EN

Official Journal of the European Union

L 101/13

ANNEX

Directive 76/768/EEC is amended as follows:

(1) In part 1 of Annex IV, colouring agent CI 45425 is deleted.

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

(a) reference number 10 is deleted;

(b) reference number 56 is replaced by the following:

Reference
number

Substance

Maximum authorised
concentration

Limitations and
requirements

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

a

b

c

d

e

‘56

iodopropynyl butyl-
carbamate

(a) rinse-off

products: 0,02 %

(IPBC)

3-iodo-2-propynyl-
butylcarbamate

CAS No:
55406-53-6

(b) leave-on
products:
0,01 %, except in
deodorants/anti-
perspirants:
0,0075 %

(a) “Not to be used for
children under three
years of age” (**)
(b) “Not to be used for
children under three
years of age” (***)

Not to be used in oral
hygiene and lip care
products

(a) Not to be used in
preparations for
children under
three years of age,
except in bath
products/shower
gels and shampoo
(b) — Not to be used

in body lotion
and body
cream (*)

— Not to be used
in preparations
for children
under three
years of age

(*) Concerns any products aimed to be applied on a large part of the body.
(**) Solely for products, other than bath products/shower gels and shampoo, which might be used for children under three years

of age.

(***) Solely for products which might be used for children under three years of age.’