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REGULATION (EC) No 1935/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 27 October 2004
on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC
and 89/109/EEC
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,
Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and
Social Committee (
1
),
Acting in accordance with the procedure laid down in Article 251
of the Treaty (
2
),
Whereas:
(1)
Council Directive 89/109/EEC of 21 December 1988 on
the approximation of the laws of the Member States relat-
ing to materials and articles intended to come into contact
with foodstuffs (
3
) established general principles for elimi-
nating the differences between the laws of the Member
States as regards those materials and articles and provided
for the adoption of implementing directives concerning
specific groups of materials and articles (specific directives).
This approach was successful and should be continued.
(2)
The
specific
directives
adopted
under
Directive 89/109/EEC in general contain provisions which
leave little room for the exercise of discretion by the Mem-
ber States in their transposition besides being subject to
frequent amendments required to adapt them rapidly to
technological progress. It should therefore be possible for
such measures to take the form of regulations or decisions.
At the same time it is appropriate to include a number of
additional subjects. Directive 89/109/EEC should therefore
be replaced.
(3)
The principle underlying this Regulation is that any mate-
rial or article intended to come into contact directly or
indirectly with food must be sufficiently inert to preclude
substances from being transferred to food in quantities
large enough to endanger human health or to bring about
an unacceptable change in the composition of the food or
a deterioration in its organoleptic properties.
(4)
New types of materials and articles designed to actively
maintain or improve the condition of the food (active food
contact materials and articles) are not inert by their design,
unlike traditional materials and articles intended to come
into contact with food. Other types of new materials and
articles are designed to monitor the condition of the food
(intelligent food contact materials and articles). Both these
types of materials and articles may be brought into con-
tact with food. It is therefore necessary, for reasons of clar-
ity and legal certainty, for active and intelligent food con-
tact materials and articles to be included in the scope of
this Regulation and the main requirements for their use to
be established. Further requirements should be stated in
specific measures, to include positive lists of authorised
substances and/or materials and articles, which should be
adopted as soon as possible.
(5)
Active food contact materials and articles are designed to
deliberately incorporate `active' components intended to be
released into the food or to absorb substances from the
food. They should be distinguished from materials and
articles which are traditionally used to release their natural
ingredients into specific types of food during the process
of their manufacture, such as wooden barrels.
(6)
Active food contact materials and articles may change the
composition or the organoleptic properties of the food
only if the changes comply with the Community provi-
sions applicable to food, such as the provisions of
Directive 89/107/EEC (
4
) on food additives. In particular,
substances such as food additives deliberately incorporated
into certain active food contact materials and articles for
release into packaged foods or the environment surround-
ing such foods, should be authorised under the relevant
Community provisions applicable to food and also be sub-
ject to other rules which will be established in a specific
measure.
(
1
) OJ C 117, 30.4.2004, p. 1.
(
2
) Opinion of the European Parliament of 31 March 2004 (not yet pub-
lished in the Official Journal) and Council Decision of 14 October
2004.
(
3
) OJ L 40, 11.2.1989, p. 38. Directive as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).
(
4
) Council Directive 89/107/EEC of 21 December 1988 on the approxi-
mation of the laws of the Member States concerning food additives
authorised for use in foodstuffs intended for human consumption
(OJ L 40, 11.2.1989, p. 27). Directive as last amended by Regula-
tion (EC) No 1882/2003.
L 338/4
EN
Official Journal of the European Union
13.11.2004