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of 6 August 2002
relating to plastic materials and articles intended to come into contact with foodstuffs
(Text with EEA relevance)
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 3
After consulting the Scientific Committee on Food,
Commission Directive 90/128/EEC of 23 February 1990
relating to plastic materials and articles intended to come
into contact with foodstuffs (
), as last amended by Direc-
tive 2002/17/EC (
), has been frequently and substantially
amended; for reasons of clarity and rationality, it should
therefore be consolidated.
Article 2 of Directive 89/109/EEC lays down that mate-
rials and articles, in their finished state, must not transfer
their constituents to foodstuffs in quantities which could
endanger human health or bring about an unacceptable
change in the composition of the foodstuffs.
In order to achieve this objective in the case of plastic
materials and articles, a suitable instrument is a specific
Directive within the meaning of Article 3 of Directive
89/109/EEC, the general provisions of which are also
applicable to the case in question.
The scope of this Directive must coincide with that of
Council Directive 82/711/EEC (
Since the rules established in this Directive are not
suitable for ion-exchange resins, these materials and arti-
cles will be covered by a subsequent specific Directive.
Silicones should be regarded as elastomeric materials
rather than plastic materials and therefore should be
excluded from the definition of plastic.
The establishment of a list of approved substances
accompanied by a limit on overall migration and, where
necessary, by other specific restrictions will be sufficient
to achieve the objective laid down in Article 2 of Direc-
tive 89/109/EEC.
Besides the monomers and other starting substances fully
evaluated and authorised at Community level, there are
also monomers and starting substances evaluated and
authorised in at least one Member State which may
continue to be used pending their evaluation by the
Scientific Committee on Food and the decision on their
inclusion in the Community list; this Directive will
accordingly be extended in due course to the substances
and sectors provisionally excluded.
The current list of additives is an incomplete list inas-
much as it does not contain all the substances which are
currently accepted in one or more Member States;
accordingly, these substances continue to be regulated by
national laws pending a decision on inclusion in the
Community list.
This Directive establishes specifications for only a few
substances. The other substances, which may require
specifications, therefore remain regulated in this respect
by national laws pending a decision at Community level.
For certain additives the restrictions established in this
Directive cannot yet be applied in all situations pending
the collection and evaluation of all the data needed for a
better estimation of the exposure of the consumer in
some specific situations; therefore, these additives appear
in a list other than that of the additives fully regulated at
Community level.
Directive 82/711/EEC lays down the basic rules neces-
sary for testing migration of the constituents of plastic
materials and articles and Council Directive 85/572/
) establishes the list of simulants to be used in the
migration tests.
The determination of a quantity of a substance in a
finished material or article is simpler than the determina-
tion of its specific migration level. The verification of
compliance through the determination of quantity rather
than specific migration level should therefore be
permitted under certain conditions.
For certain types of plastics the availability of generally
recognised diffusion models based on experimental data
allows the estimation of the migration level of a
substance under certain conditions, therefore avoiding
complex, costly and time-consuming testing.
L 220/18
Official Journal of the European Communities
) OJ L 40, 11.2.1989, p. 38.
) OJ L 75, 21.3.1990, corrected by OJ L 349, 13.12.1990, p. 26.
) OJ L 58, 28.2.2002, p. 19.
) OJ L 297, 23.10.1982, p. 26. Directive as last amended by Directive
97/48/EC (OJ L 222, 12.8.1997, p. 10).
) OJ L 372, 31.12.1985, p. 14.