Commission Directive 2007/17/EC of 22 March 2007 amending Council Directive 76/768/EEC, concerning cosmetic products, for the purposes of adapting Annexes III and VI thereto to technical progress (Text with EEA relevance )
Date: 2007-03-22
Institutions: European Commission
Subjects: analytical chemistry, approximation of laws, chemical product, consumer protection, cosmetic product, product safety, technological change

23.3.2007

EN

Official Journal of the European Union

L 82/27

DIRECTIVES

COMMISSION DIRECTIVE 2007/17/EC

of 22 March 2007

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

for the purposes of

adapting Annexes III and VI thereto to technical progress

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

symbol (*) when used in higher concentrations for other
specific purposes.

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:

(1)

(2)

(3)

in

allowed

cosmetic

products.

Annex VI to Directive 76/768/EEC establishes a list of
The
preservatives
substances listed in Annex VI marked with the symbol
(*) may be used in concentrations other than those fixed
in that Annex for non-preservative purposes,
the
specific purpose is apparent from the presentation of
the product. Nevertheless, the use of these substances
may be restricted in other Annexes to that Directive.

if

The substances listed in Annex VI without the symbol (*)
may not be used in concentrations other than those
listed in that Annex and the other restrictions set out
therein also apply when those substances are used for
other specific purposes.

The Scientific Committee on Consumer Products, here-
inafter ‘the SCCP’, has issued an opinion stating that the
restrictions for usage level and warnings in Annex VI
should also apply if the preservatives marked with the
symbol (*) are used for other specific purposes.

(5)

(6)

(7)

(8)

(9)

On the basis of those safety-files, the SCCP concluded
that the use of several of the preservative substances in
Annex VI for other specific purposes in higher concen-
trations is safe.

those preservative
The safe concentration limits
for
specific purposes
substances when used for other
in Annex
should
to Directive
III
included
should be
it
the sake of clarity,
76/768/EEC. For
indicated for the relevant entries in Annex III that the
same substance is listed in Annex VI to that Directive.

be

Substances that were not considered to be safe by the
SCCP when used in concentrations other than those laid
down in Annex VI for other specific purposes should be
subject to the restrictions laid down in that Annex for
use as preservatives. The symbol (*) should therefore be
deleted from those substances in Annex VI.

In order to ensure a coherent approach, all substances
listed in Annex VI which may also be added to cosmetic
products, for other specific purposes, in higher concen-
trations than those laid down in that Annex should be
marked with the symbol (*).

Moreover, the SCCP considered it safe to increase the
acid and its
maximum concentration of benzoic
sodium salt in rinse-off products and oral-care products
and to increase the maximum concentration of zinc
pyrithione in rinse-off hair products for preservative
therefore appropriate to amend reference
use.
to Directive
numbers 1 and 8 of Annex VI
76/768/EEC accordingly.

is

It

(4)

The Commission therefore called upon the industry
to submit safety files for substances listed with the

(1) OJ L 262, 27.9.1976, p. 169. Directive as last amended by

Commission Directive 2007/1/EC (OJ L 25, 1.2.2007. p. 9).

(10)

The SCCP is also of the opinion that methyldibromo
glutaronitrile should not be present
in any cosmetic
products, as no safe use-levels in cosmetic leave-on and
rinse-off products have been established. It is therefore
necessary to delete that substance from reference number
36 of Annex VI to Directive 76/768/EEC.

L 82/28

EN

Official Journal of the European Union

23.3.2007

(11) Directive 76/768/EEC should therefore be amended

accordingly.

(12)

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

the

in this Directive are in
Standing
the

of

HAS ADOPTED THIS DIRECTIVE:

Article 1

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

the latest. They shall
Directive by 23 September 2007 at
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.

Article 2

Article 4

Member States shall take all necessary measures to ensure that
from 23 March 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.

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.

Member States shall take all necessary measures to ensure that
those products are not
to the final
consumer after 23 June 2008.

sold or disposed of

Done at Brussels, 22 March 2007.

Article 3

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

For the Commission

Günter VERHEUGEN
Vice-President

23.3.2007

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Official Journal of the European Union

L 82/29

ANNEX

Directive 76/768/EEC is amended as follows:

(1) Annex III, Part 1, is amended as follows:

Reference numbers 98 to 101 are added as indicated below:

Reference
No

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

‘98

Salicylic acid (1)

(CAS No
69-72-7)

a) Rinse-off hair
products

b) Other products

a) 3,0 %

b) 2,0 %

Not to be used
for children under
three years of
age (2)

Not to be used in preparations for children
under three years of age, except for
shampoos.

For purposes other than inhibiting the
development of micro-organisms in the
product. This purpose has to be apparent
from the presentation of the product.

For purposes other than inhibiting the
development of micro-organisms in the
product. This purpose has to be apparent
from the presentation of the product.

Purity criteria:
3,3',4,4'-Tetrachloroazobenzene ≤ 1 ppm
3,3',4,4'-Tetrachloroazoxybenzene ≤ 1 ppm

For purposes other than inhibiting the
development of micro-organisms in the
product. This purpose has to be apparent
from the presentation of the product.

For purposes other than inhibiting the
development of micro-organisms in the
product. This purpose has to be apparent
from the presentation of the product.

99

Inorganic
sulfites and
bisulfites (3)

a) Oxidative hair dye

products

a) 0,67 % expressed
as free SO2

b) Hair straightening

b) 6,7 % expressed as

products

free SO2

c) Self tanning

products for the
face

d) Other self tanning

products

c) 0,45 % expressed
as free SO2

d) 0,40 % expressed
as free SO2

100

Triclocarban (4)

Rinse-off products

1,5 %

(CAS No
101-20-2)

101

Zinc
pyrithione (5)

(CAS No
13463-41-7)

Leave-on hair
products

0,1 %

(1) As a preservative, see Annex VI, Part 1, No 3.
(2) Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.
(3) As a preservative, see Annex VI, Part 1, No 9.
(4) As a preservative, See Annex VI, Part 1, No 23.
(5) As a preservative, see Annex VI, Part 1, No 8.’

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Official Journal of the European Union

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

a)

In column b, the symbol ‘(*)’ is deleted for the reference numbers 1, 2, 4, 7, 12, 14, 18, 19, 21, 22, 24, 25, 26, 27, 28, 29, 30, 32, 33, 35, 37,
42 and 47.

b) In column b, the symbol ‘(*)’ is added for the reference numbers 5 and 43.

c) Reference number 1 is replaced by the following:

Reference No

Substance

Maximum authorised
concentration

Limitations and requirements

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

a

‘1

1a

b

c

d

e

Benzoic acid
(CAS No 65-85-0)
and its sodium salt
(CAS No 532-32-1)

Salts of benzoic acid other
than that listed under
reference number 1 and
esters of benzoic acid

Rinse-off products, except
oral care products: 2,5 %
(acid)

Oral care products: 1,7 %
(acid)

Leave-on products: 0,5 %
(acid)

0,5 % (acid)’

d) Reference number 8 is replaced by the following:

Reference No

Substance

Maximum authorised
concentration

Limitations and requirements

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

a

‘8

b

c

d

e

Zinc pyrithione (*)

Hair products: 1,0 %

Rinse-off products only.

(CAS No 13463-41-7)

Other products: 0,5 %

No use in products for oral
hygiene.’

e) Reference number 36 is deleted.