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(15)
The overall migration limit is a measure of the inertness
of the material and prevents an unacceptable change in
the composition of the foodstuffs, and, moreover,
reduces the need for a large number of specific migration
limits or other restrictions, thus giving effective control.
(16)
Council Directive 78/142/EEC (
1
) lays down limits for
the quantity of vinyl chloride present in plastic materials
and articles prepared with this substance and for the
quantity of vinyl chloride released by these materials and
articles, and Commission Directives 80/766/EEC (
2
) and
81/432/EEC (
3
) establish the Community methods of
analysis for controlling these limits.
(17)
In view of potential liability, there is a need for the
written declaration provided for in Article 6(5) of Direc-
tive 89/109/EEC whenever professional use is made of
plastic materials and articles which are not by their
nature clearly intended for food use.
(18)
Commission Directive 80/590/EEC (
4
) determines the
symbol that may accompany any material and article
intended to come into contact with foodstuffs.
(19)
In accordance with the principle of proportionality, it is
necessary and appropriate for the achievement of the
basic objective of ensuring the free movement of plastic
materials and articles intended to come into contact with
foodstuffs, to lay down rules on the definition of plastics
and permitted substances. This Directive confines itself
to what is necessary in order to achieve the objectives
pursued in accordance with the third paragraph of
Article 5 of the Treaty.
(20)
In accordance with Article 3 of Directive 89/109/EEC,
the Scientific Committee on Food has been consulted on
the provisions liable to affect public health.
(21)
The measures provided for in this Directive are in accor-
dance with the opinion of the Standing Committee on
the Food Chain and Animal Health.
(22)
This Directive should be without prejudice to the dead-
lines set out in Annex VII, Part B within which the
Member States are to comply with Directive 90/128/
EEC, and the acts amending it,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1.
This Directive is a specific Directive within the meaning
of Article 3 of Directive 89/109/EEC.
2.
This Directive shall apply to plastic materials and articles
and parts thereof:
(a) consisting exclusively of plastics; or
(b) composed of two or more layers of materials, each
consisting exclusively of plastics, which are bound together
by means of adhesives or by any other means,
which, in the finished product state, are intended to come into
contact or are brought into contact with foodstuffs are intended
for that purpose.
3.
For the purposes of this Directive, `plastics' shall mean the
organic macromolecular compounds obtained by polymerisa-
tion, polycondensation, polyaddition or any other similar
process from molecules with a lower molecular weight or by
chemical
alteration
of
natural
macromolecules.
Other
substances or matter may be added to such macromolecular
compounds.
However, the following shall not be regarded as `plastics':
(a) varnished or unvarnished regenerated cellulose film,
covered by Commission Directive 93/10/EEC (
5
);
(b) elastomers and natural and synthetic rubber;
(c) paper and paperboard, whether modified or not by the
addition of plastics;
(d) surface coatings obtained from:
-- paraffin waxes, including synthetic paraffin waxes, and/
or micro-crystalline waxes,
-- mixtures of the waxes listed in the first indent with each
other and/or with plastics,
(e) ion-exchange resins;
(f) silicones.
4.
This Directive shall not apply, until further action by the
Commission, to materials and articles composed of two or
more layers, one or more of which does not consist exclusively
of plastics, even if the one intended to come into direct contact
with foodstuffs does consist exclusively of plastics.
Article 2
Plastic materials and articles shall not transfer their constituents
to foodstuffs in quantities exceeding 10 milligrams per square
decimetre of surface area of material or article (mg/dm
2
) (overall
migration limit). However, this limit shall be 60 milligrams of
the constituents released per kilogram of foodstuff (mg/kg) in
the following cases:
(a) articles which are containers or are comparable to
containers or which can be filled, with a capacity of not less
than 500 millilitres (ml) and not more than 10 litres (l);
(b) articles which can be filled and for which it is impracticable
to estimate the surface area in contact with foodstuffs;
(c) caps, gaskets, stoppers or similar devices for sealing.
15.8.2002
L 220/19
Official Journal of the European Communities
EN
(
1
) OJ L 44, 15.2.1978, p. 15.
(
2
) OJ L 213, 16.8.1980, p. 42.
(
3
) OJ L 167, 24.6.1981, p. 6.
(
4
) OJ L 151, 19.6.1980, p. 21.
(
5
) OJ L 93, 17.4.1993, p. 27. Directive amended by Directive 93/111/
EC (OJ L 310, 14.12.1993, p. 41).