23rd Commission Directive 98/62/EC of 3 September 1998 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: 1998-09-03
Institutions: European Commission
Subjects: approximation of laws, cosmetic product, marketing, product safety, technological change

L 253/20

EN

Official Journal of the European Communities

15. 9. 98

23rd COMMISSION DIRECTIVE 98/62/EC

of 3 September 1998

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
the
July 1976 on the approximation of
Member States relating to cosmetic products (1), as last
amended by Commission Directive 98/16/EC (2) and in
particular Article 8(2) thereof,

the laws of

After consulting the Scientific Committee on Cos-
metology,

as

regards

long-term toxicity,

Whereas, in the absence of fresh scientific data, in par-
ticular
the Scientific
Committee on Cosmetology recommends that the use of
moskene and musk tibetene should be prohibited in
cosmetic products as they may present a risk to the health
of consumers;

Whereas a further toxicological evaluation of strontium
chloride, based on new data submitted by industry, shows
that the use of this substance may be extended, without
any safety risk,
to shampoos and face care products
provided a maximum concentration is not exceeded;

Whereas, on the basis of the latest scientific data, the use
may be permitted of benzalkonium chloride, bromide and
saccharinate as preservatives in cosmetic products subject
to the requirements of the Directive;

Whereas, on the basis of the latest scientific research and
data, 3-iodo-2-propynyl butylcarbamate (iodopropynyl
butylcarbamate) may be provisionally used as a preserva-
tive in cosmetic products subject to certain conditions on
concentrations and use;

Whereas, on the basis of the latest scientific data, phenol
2-(2H-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3-
tetramethyl-1-(trimethylsilyl)oxy)-disiloxanyl)propyl) may
be used as a UV filter in cosmetic products subject to the
requirements of the Directive;

(1) OJ L 262, 27. 9. 1976, p. 169.
(2) OJ L 77, 14. 3. 1998, p. 44.

Whereas, on the basis of the latest scientific data, benzoic
acid,4,4-((6-(((1,1-dimethylethyl)amino)carbonyl)phenyl)
amino) 1,3,5-triazine-2,4-diyl)diamino)bis-,bis(2-ethylhexyl)
ester may be used as a UV filter in cosmetic products;

ethoxylated ethyl-4-aminobenzoate,

Whereas, on the basis of the latest scientific research and
data,
isopentyl-4-
2,4,6-trianilino-(p-carbo-2Y-ethyl-
methoxycinnamate,
hexyl-1Yoxy)-1,3,5-triazine
salicylate
may be used as UV filters in cosmetic products subject to
the requirements of the Directive;

and 2-Ethylhexyl

Whereas, on the basis of the latest scientific research and
data, 3-(4Y-methylbenzylidene)-d-1camphor and 3-benzyl-
idene camphor may be used as UV filters in cosmetic
products;

Whereas the measures laid down 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:

Article 1

Directive 76/768/EEC is hereby amended as shown in the
Annex.

Article 2

1. Member States shall take the necessary measures to
ensure that, as from 1 July 1999, for the substances set
out in the Annex, neither manufacturers nor importers
established in the Community place on the market prod-
ucts which do not comply with the requirements of this
Directive.

2. Member States shall take the necessary measures to
the products referred to in paragraph 1
ensure that
containing the substances set out in the Annex are not
sold or otherwise supplied to the final consumer after 30
June 2000.

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EN

Official Journal of the European Communities

L 253/21

Article 3

Article 4

1. Member States shall bring into force the laws, regula-
tions and administrative provisions necessary to comply
with this Directive no later than 30 June 1999. They shall
forthwith inform the Commission thereof. When Member
States adopt these provisions, these shall contain a refer-
ence to this Directive or shall be accompanied by such
reference at the time of their official publication. The
procedure for such reference shall be adopted by the
Member States.

2. Member States shall communicate to the Commis-
sion the provisions of national law which they adopt in
the field covered by this Directive.

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

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 3 September 1998.

For the Commission

Martin BANGEMANN

Member of the Commission

L 253/22

EN

Official Journal of the European Communities

15. 9. 98

ANNEX

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

1. In Annex II

The following reference numbers are added:

‘421. 1,1,3,3,5,-Pentamethyl-4,6-dinitroindane (moskene)

422. 5-tert-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (musk tibetene)'.

2. In Annex III

Reference number 57 is amended as follows:

‘57

Strontium chloride
hexahydrate

(a) Toothpaste

(b) Shampoo

and face care
products

3. In Annex VI

(a) P a r t o n e

The following reference number is added

as

3,5 % calculated
strontium.
When mixed with other permitted
strontium compounds
total
strontium content must not exceed
3,5 %.

the

Contains
strontium
Frequent
chloride.
use by children is
not advisable.'

as

2,1 % calculated
strontium.
When mixed with other permitted
strontium compounds
total
strontium content must not exceed
2,1 %.

the

a

‘54

b

c

d

e

Benzalkonium chloride, bromide
and saccharinate (+)

0,1 % calculated as benzalkonium
chloride

Avoid contact with the
eyes'

(b) P a r t

t w o

Reference number 16 is deleted.

‘30.6.1998' is replaced by ‘30.6.1999' for reference number 21 and 29.

Reference number 29 is also modified:

a

‘29

b

c

d

e

3-Iodo-2-propynyl butylcarbamate
(iodopropynyl butylcarbamate)

0,05 %

Not for oral hygiene and lip products'

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Official Journal of the European Communities

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4. In Annex VII

(a) P a r t o n e

The following reference numbers are added

a

b

c

d

e

‘13

Ethoxylated Ethyl-4-Aminobenzoate (PEG-25 PABA)

Isopentyl-4-methoxycinnamate (Isoamyl p-Methoxycinnamate)

10 %

10 %

2,4,6-Trianilino-(p-Carbo-2’-Ethylhexyl-1’Oxy)-1,3,5-Triazine (Octyl Triazone)

5 %

Phenol,2-(2H-Benzotriazol-2-yl)-4-Methyl-6-(2-Methyl-3-(1,3,3,3-Tetramethyl-l-
(Trimethylsilyl)Oxy)-Disiloxanyl)Propyl)

(Drometrizole Trisiloxane)

Benzoic
1,3,5-triazine-2,4-diyl)diimino)bis-,bis(2-ethylhexyl)ester)

4,4-((6-(((1,1-dimethylethyl)amino)carbonyl)phenyl)amino)

acid,

3-(4’-Methylbenzylidene)-d-l camphor (4-Methylbenzylidene Camphor)

3-Benzylidene camphor (3-Benzylidene Camphor)

2-Ethylhexyl salicylate (Octyl-salicylate)

15 %

10 %

4 %

2 %

5 %'

14

15

16

17

18

19

20

(b) P a r t

t w o

Reference numbers 2, 6, 12, 25, 26 and 32 are deleted.
‘30.6.1998' is replaced by ‘30.6.1999' for reference numbers 5, 17 and 29.