Commission Directive 2004/96/EC of 27 September 2004 amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of nickel for piercing post assemblies for the purpose of adapting its Annex I to technical progress(Text with EEA relevance)
Date: 2004-09-27
Institutions: European Commission
Subjects: dangerous substance, health legislation, jewellery and goldsmith's articles, nickel

28.9.2004

EN

Official Journal of the European Union

L 301/51

COMMISSION DIRECTIVE 2004/96/EC

of 27 September 2004

amending Council Directive 76/769/EEC as regards restrictions on the marketing and use of nickel
for piercing post assemblies for the purpose of adapting its Annex I to technical progress

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

that a nickel migration limit may induce lower risks of
sensitisation than a nickel content limit.

Having regard to the Treaty
Community, and

establishing the European

Having regard to Council Directive 76/769/EEC of 27 July 1976
on the approximation of the laws, regulations and adminis-
trative provisions of the Member States relating to restrictions
on the marketing and use of dangerous
substances and
preparations (1), and in particular Article 2a thereof,

(5)

(6)

Whereas:

(1)

(2)

(3)

According to Directive 76/769/EEC as amended by
Directive 94/27/EC of the European Parliament and the
Council (2), nickel and its compounds are not to be used
in certain post assemblies for piercing and certain other
products unless they conform to the requirements set out
in Directive 76/769/EEC.

The risk of sensitisation of humans to nickel by piercing
post assemblies has been newly assessed in a targeted risk
a
assessment;
migration limit for piercing post assemblies would be
more appropriate than a content limit.

risk assessment

concluded that

the

The new rate of nickel release (migration limit) should be
adjusted with the multiplication factor specified in EN
1811 to compensate inter-laboratory variations and
measuring inaccuracies. The European Committee of
Standardisation (CEN) is invited to review EN 1811 in
particular regarding the adjustment factor and to prepare
a revised standard without adjustment factor, or with a
smaller adjustment factor, if appropriate.

(4)

The risk assessment was
referred to the Scientific
Committee on Toxicity, Ecotoxicity and the Environment
(CSTEE) for peer review and the CSTEE has confirmed

The provisions laid down by this Directive take into
account the current state of knowledge, science and tech-
niques.

laying

legislation

should apply without prejudice

to
This Directive
Community
down minimum
requirements for the protection of workers, in particular
Council Directive 89/391/EEC of 12 June 1989 on the
introduction of measures to encourage improvements in
the safety and health of workers at work (3), and Directive
2004/37/EC of
the
Council of 29 April 2004 on the protection of
workers from the risks related to exposure to carcinogens
or mutagens at work (Sixth individual Directive within
the meaning of Article 16(1) of Directive 89/391/EEC) (4).

the European Parliament and of

(7)

The measures provided for
in this Directive are in
accordance with the opinion of the Committee for the
adaptation to technical progress of the Directives on the
technical barriers to trade in dangerous
removal of
substances and preparations,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Annex I to Directive 76/769/EEC is amended as set out in the
Annex to this Directive.

Article 2

1. Member States shall adopt and publish, by 1 August 2005
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
and a correlation table between those provisions and this
Directive.

(1) OJ L 262, 27.9.1976, p. 201. Directive as last amended by
Commission Directive 2004/21/EC (OJ L 57, 25.2.2004, p. 4).

(2) OJ L 188, 22.7.1994, p. 1.

(3) OJ L 183, 29.6.1989, p. 1. Directive as last amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

(4) OJ L 158, 30.4.2004, p. 50.

L 301/52

EN

Official Journal of the European Union

28.9.2004

They shall apply those provisions from 1 September 2005.

Article 3

those provisions,

When Member States adopt
these 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 twentieth day
following that of its publication in the Official
Journal of the
European Union.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 27 September 2004.

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.

For the Commission

Olli REHN
Member of the Commission

ANNEX

In Annex I to Directive 76/769/EEC, in point 28, Nickel, in the second column point 1 is replaced by the following:

in all post assemblies which are inserted into pierced ears and other pierced parts of the human body unless the rate

‘1.
of nickel release from such post assemblies is less than 0,2 μg/cm2/week (migration limit);’.