Twenty-fourth Commission Directive 2000/6/EC of 29 February 2000 adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (Text with EEA relevance)
Date: 2000-02-29
Institutions: European Commission
Subjects: approximation of laws, cosmetic product, technological change

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Official Journal of the European Communities

1. 3. 2000

TWENTY-FOURTH COMMISSION DIRECTIVE 2000/6/EC

of 29 February 2000

adapting to technical progress Annexes II, III, VI and VII to Council Directive 76/768/EEC on the
approximation of the laws of the Member States relating to cosmetic products

(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 relating to cosmetic products (1), as last amended by Commission Directive 98/62/EC (2),
and in particular Article 8(2) thereof,

After consulting the Scientific Committee on Cosmetic Products and Non-Food Products intended for
Consumers,

Whereas:

(1)

(2)

(3)

(4)

(5)

Tallow derivatives, such as fatty acids, glycerine, esters of fatty acids and soaps and fatty alcohols,
fatty amines and fatty amides derived therefrom, are considered safe for use in the manufacture of
cosmetic products with regard to the risk of contracting transmissible spongiform encephalopathies
if they are prepared in strict accordance with specific physico-chemical processes in which tempera-
ture is the decisive parameter on which the corresponding pressure conditions depend. Annex II to
the abovementioned Directive should therefore be amended accordingly.

Harmful secondary effects have been shown to arise following prolonged use of hydroquinone as
skin-lightening cream. This particular use of hydroquinone must not therefore be authorised,
meaning that Part I of Annex III to the abovementioned Directive needs to be amended. Studies also
show that the concentration of hydroquinone used in hair dyes does not have harmful effects for
health if it does not exceed 0,3 %. Part I of Annex III to the abovementioned Directive must be
amended accordingly.

On the basis of new scientific data, benzalkonium chloride, bromide and saccharinate have recently
been added to the list of substances which may be used as preservatives in the manufacture of
cosmetic products set out in Part 1 of Annex VI to the abovementioned Directive. In the light of
experience,
it is also acceptable for these benzalkonium salts to be used for other purposes in
cosmetic products, according to the length of their carbon chain, provided that the maximum
authorised concentrations are observed. These specific characteristics therefore justify their inclusion
in the list Part 1 of Annex III.

The cosmetics industry has supplied new scientific data based on studies of the percutaneous
absorption of acqueous solutions of boric acid, borates and tetraborates at various pH numbers and
at various concentrations showing that the requirement that pH should be neutral or slightly alkaline
in order to minimise the percutaneous absorption of these boron derivatives is not justified. The list
of substances which cosmetic products must not contain except subject to the restrictions and
conditions laid down, set out in Part 1 of Annex III, should therefore be amended accordingly.

In the concentrations in which it is normally used as a preservative in cosmetic products intended to
be removed by rinsing, benzylhemiformal is not likely to cause harmful effects for human health.
Therefore it should be removed from Part 2 of Annex VI to the abovementioned Directive which sets
out the list of preservatives provisionally allowed in cosmetic products and included in Part 1 of
Annex VI which contains the list of preservatives allowed in cosmetic products.

(1) OJ L 262, 27.9.1976, p. 169.
(2) OJ L 253, 15.9.1998, p. 20.

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(6)

(7)

(8)

In the concentrations in which it is normally used as a preservative in cosmetic products, 3-iodo-2-
propynyl butylcarbamate is not likely to have harmful effects on human health. Therefore, it should
be removed from the list in Part 2 of Annex VI and entered in the list in Part 1 of Annex VI.

In the concentrations in which it is normally used as a UV filter for sunscreen cream, 4-dimethyl-
amino-benzoate of ethyl-2-hexyl (octyl dimethyl PABA) is not likely to have harmful effects on the
health of users. Therefore, it should be removed from Part 2 of Annex VII to the abovementioned
Directive which sets out the list of UV filters that cosmetic products may provisionally contain and
entered in Part 1 of Annex VII which contains the list of UV filters allowed in cosmetic products.

In the concentrations in which it is normally used as a UV filter for sunscreen cream, 2-hydroxy-4-
methoxybenzophenone-5-sulfonic acid (benzophenone-5) and its sodium salt is not likely to give rise
to harmful effects for human health. Therefore, 2-hydroxy-4-methoxybenzophenone-5-sulfonic
(benzophenone-5) and its sodium salt should be removed from Part 2 of Annex VII and entered in
Part 1 of Annex VII.

(9)

4-isopropyl-benzyl salicylate is no longer used as a UV filter for sunscreen products. Consequently,
4-isopropyl-benzyl salicylate must be removed from Part 2 of Annex VII.

(10) Within the concentration limits and under the conditions adopted by the cosmetic industry for its use
products, 2,2'-methylene-bis-6-(2H-benzotriazol-2-yl)-4-tetra-
as
methyl-butyl-1,1,3,3-phenol, is not likely to produce harmful effects for the health of users. Therefore,
it may be included in the list in Part 1 of Annex VII.

a UV filter

sunscreen

for

(11) Within the concentration limits and under the conditions adopted by the cosmetic industry for
its use
the monosodium salt of 2-2'-bis-(1,4-
phenylene)1H-benzimidazole-4,6-disulfonic acid is not likely to have harmful effects on the health of
users. Therefore,

it may be included in the list in Part 1 of Annex VII.

sunscreen products,

a UV filter

for

as

(12) Within the concentration limits and under the conditions adopted by the cosmetic industry for
its use
(1,3,5)-triazine-2,4-bis-((4-(2-ethyl-hexy-
sunscreen products,
loxy)-2-hydroxy)-phenyl)-6-(4-methoxyphenyl) is not likely to have harmful effects on the health of
users. Therefore,

it may be included in the list in Part 1 of Annex VII.

a UV filter

for

as

(13)

The measures provided for in this Directive are in accordance with the opinion of the Committee on
the Adaptation to Technical Progress of the Directives on the Removal of Technical Barriers to Trade
in the Cosmetic Products Sector,

HAS ADOPTED THIS DIRECTIVE:

Directive 76/768/EEC is hereby amended as indicated in the Annex to this Directive.

Article 1

Article 2

Member States shall adopt the necessary measures to ensure that cosmetic products containing the
substances listed in Annexes II, III, VI and VII to Directive 76/768/EEC, as set out in the Annex to this
Directive, which are supplied to the final consumer after 1 January 2001, comply with the provisions of
this Directive.

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Article 3

Member States shall bring into force the laws, regulations and administrative provisions necessary to
comply with this Directive by 1 July 2000 at the latest. They shall forthwith inform the Commission
thereof.

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.

This Directive shall enter into force on the third day following that of its publication in the Official Journal of
the European Communities.

Article 4

This Directive is addressed to the Member States.

Article 5

Done at Brussels, 29 February 2000.

For the Commission

Erkki LIIKANEN

Member of the Commission

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The Annexes to Directive 76/768/EEC are hereby amended as follows:

ANNEX

1. In Annex II

The first indent of paragraph (b) of reference number 419 reads as follows:

‘— transesterification or hydrolysis at at least 200 °C and at an appropriate corresponding pressure, for 20 minutes

(glycerol, fatty acids and fatty acid esters),’

2. In Part 1 of Annex III

(i) Reference number 1 is amended as shown in the following table:

a

‘1a

b

c

d

e

f

Boric acid,
borates and tetra-
borates

(a) Talc

(a) 5 % (by mass/mass as

(a) 1. Not to be used in

(a) 1. Not to be used for

boric acid)

products for children
under 3 years of age

children under 3 years
of age

2. Not to be used on
peeling or irritated
skin

2. Not to be used on
peeling or irritated
skin if the concentra-
tion of free soluble
borates exceeds 1,5 %
(by mass/mass as
boric acid)

(b) Products for all hygiène

(b) 0,1 % (by mass/mass as

(b) 1. Not to be used in

(b) 1. Not to be swallowed

boric acid)

products for children
under 3 years of age

2. Not to be used for

children under 3 years
of age

(c) Other products

(c) 3 % (by mass/mass as

(c) 1. Not to be used in

(c) 1. Not to be used for

(excluding bath products
and hair waving prod-
ucts)

boric acid)

products for children
under 3 years of age

children under 3 years
of age

2. Not to be used on
peeling or irritated
skin

2. Not to be used on
peeling or irritated
skin if the concentra-
tion of free soluble
borates exceeds 1,5 %
(by mass/mass as
boric acid)

1b

Tetraborates

(a) Bath products

(a) 18 % (by mass/mass as

boric acid)

(a) Not to be used in prod-
ucts for children under
3 years of age

(a) Not to be used of bathing
children under 3 years of
age

(b) Hair waving products

(b) 8 % (by mass/mass as

(b) Rinse well’

boric acid)

(ii) Reference number 14 is hereby amended as follows:

— the second occurrence of ‘Hydroquinone’ in column b, item ‘(b)’ in column c, the second occurrence of ‘2 %’

in column (d) and item ‘(b)’

in column f are deleted,

— ‘2 %’

in column d is replaced by ‘0,3 %’.

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a

‘65

(iii) Reference number 65 is added in accordance with the following table:

b

c

d

e

f

Benzalkonium
Chloride,
bromide and
saccharinate

(a) Rinse-off hair (head)

(a) 3 % (as benzalkonium

(a)

care products

chloride)

(a) Avoid contact with the

eyes

In the final products the
concentrations of
benzalkonium chloride,
bromide and sacchari-
nate with an alkyl chain
of C
, or less must not
exceed 0,1 % (as
benzalkonium chloride)

14

(b) Other products

(b) 0,1 % (as benzalkonium

chloride)

(b) Avoid contact with the

eyes’

3. In Annex VI

(i) The following reference numbers are added in Part 1:

a

b

‘55

Benzylhemiformal

c

0,15 %

d

e

Only for products to be
removed by rinsing

56

3-Iodo-2-propynylbutylcarba-
mate

0,05 %

1. Not to be used for oral

hygiene and lipcare products

2. If the concentration in prod-
ucts intended to remain on
the skin exceeds 0,02 % add
the phrase: Contains iodine

Contains iodine’

(ii) Reference numbers 21 and 29 in Part 2 are deleted.

4. In Annex VII

(i) The following reference numbers are added in Part 1:

a

‘21

22

23

b

4-Dimethyl-amino-benzoate of ethyl-2-hexyl
(octyl dimethyl PABA)

d

e

c

8 %

2-Hydroxy-4-methoxybenzophenone-5-sulfonic
acid (Benzophenone-5) and its sodium salt

5 % (of acid)

2,2'-Methylene-bis-6-(2H-benzotriazol-
2yl)-4-(tetramethyl-butyl)-1,1,3,3-phenol

10 %

24 Monosodium salt of 2-2'-bis-(1,4-

10 % (of acid)

phenylene)1H-benzimidazole-4,6-disulphonic
acid)

25

(1,3,5)-Triazine-2,4-bis((4-(2-ethyl-hexyloxy)-
2-hydroxy)-phenyl)-6-(4-methoxyphenyl)

10 %’

(ii) Reference numbers 5, 17 and 29 in Part 2 are deleted.