COMMISSION DIRECTIVE 2004/19/EC
of 1 March 2004
amending Directive 2002/72/EC relating to plastic materials and articles intended to come into
contact with foodstuffs
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European
Having regard to Council Directive 89/109/EEC of 21
December 1988 on the approximation of the laws of the
Member States relating to materials and articles intended to
come into contact with foodstuffs (
), and in particular Article
After consulting the European Food Safety Authority,
Commission Directive 2002/72/EC (
) sets out rules for
plastic materials and articles which are intended to come
into contact with foodstuffs.
Directive 2002/72/EC establishes a list of monomers and
other starting substances, which may be used for the
manufacture of plastic materials and articles. On the
basis of new information, certain monomers provision-
ally admitted at national level as well as new monomers
should be included in the Community list of permitted
substances in that Directive.
Directive 2002/72/EC also contains an incomplete list of
additives which may be used in the manufacture of
plastic materials and articles. That list should be
amended so as to include other additives evaluated by
the European Food Safety Authority (the Authority).
For certain substances, the restrictions already estab-
lished at Community level should be amended on the
basis of the new information available.
The current list of additives is incomplete inasmuch as it
does not contain all substances currently accepted in one
or more Member States. Those additives continue to be
regulated by national laws pending a decision on inclu-
sion into the Community list.
The current list of additives should become a positive
list in order to harmonise the use of these additives in
the Community. For additives which are already placed
on the market in one or more of the Member States,
sufficient time should be allowed for the submission of
the data necessary for the Authority to carry out an
evaluation of their safety. Therefore, the deadline for the
submission of the data should be set as 31 December
If the data are in compliance with the Authority require-
ments, it should be possible to continue to use those
additives in accordance with national law until their
evaluation is completed. If the data are not in compli-
ance with the Authority requirements or are submitted
later than 31 December 2006 those additives should not
be included in the first positive list.
The date when the list of additives is to become a posi-
tive list should be established no later than 31 December
2007 as it is impossible to know the number of addi-
tives for which the data required by the Authority will
be supplied. That date should be fixed taking into
account the time needed for the Authority to evaluate all
the applications supplied on time.
Some substances used to manufacture plastic materials
and articles intended to come into contact with food are
also added directly to foodstuffs. These substances
should not migrate from the materials or articles into
the foodstuffs in quantities that could exceed the limits
set in the relevant food legislation or in this Directive
whichever provides the lower restriction. In any case,
these substances should not migrate from the materials
or articles into the foodstuffs in quantities having a tech-
nological function in the final food. The users of mate-
rials and articles which may release these substances into
foodstuffs should be appropriately informed in order to
be able to comply with other relevant food legislation.
Member States should retain the right to lay down rules
concerning substances used as active components in
active food contact materials and articles until Com-
munity provisions are adopted.
Directive 2002/72/EC should therefore be amended
Official Journal of the European Union
) 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).
) OJ L 220, 15.8.2002, p. 18. Directive as amended by Directive
2004/1/EC (OJ L 7, 13.1.2004, p. 45).