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- Practical Guide -
Page 27 of 153
an unacceptable contamination of a food. The choice of the units reflects the evaluation of
the testing conditions and assessment of the risk connected to exposure.
10.2 Purity, extent of migration control and 'GMP'
The question may arise as to what extent migration must be reduced in order to comply with
the 'principle of inertness' ascertained in Article 2 of Directive 89/109/EEC. Is the
manufacturer required to lower the migration into foodstuffs to the lowest level technically
possible, or is he only expected to comply with the migration limits established by the
specific Directives?
The relevant directives do not oblige to reduce the migration to the lowest possible level, but
manufacturers must comply with the concept of GMP ('Good Manufacturing Practice' -
Art. 2 of Dir. 89/109/EEC) even when the ensuing obligations are more stringent than the
migration limits. A more specific definition of 'GMP' should be prepared to enforce
adequately this obligation.
As example of 'GMP' see (a) the Documentedited by British Plastic Federation entitled
"Plastic in contact with food": a Guide" (publication N 341/3 November 1999)
(b) -
Document edited by Flexible Packaging Europe and CITPA "
Code for good
manufacturing practices for flexible and fibre-based packaging for food
10.3 Multi-layer articles
A problem of interpretation has recently been raised on the materials and articles composed
by two or more layers, e.g. paper/plastic/food or paper/aluminium/plastics/food. Do directive
89/109/EEC and its specific Directives also apply to the layers not in direct contact with
foodstuffs, or only to the layer in direct contact with foodstuffs?
Although the interpretation of a Directive belongs to the competence of the Court of Justice,
an analysis of the wording of Directive 89/109/EEC is attempted here. The sentences to be
analysed are the following:
Article 1
This Directive shall apply to materials and articles which, in their finished state, are intended to be brought into contact
with foodstuffs or which are brought into contact with foodstuffs and are intended for that purpose hereinafter referred to
as 'materials and articles'.
Sixth whereas
Whereas the principle underlying this Directive should be that any material or article intended to come into contact or
which is intentionally in contact either directly or indirectly with foodstuffs, must be sufficiently stable not to transfer.....
In the case of a multi-layer structure, Directive 89/109/EEC and its specific Directives
(unless providing other specific rules) apply to all layers, whether in direct or indirect contact
with the foodstuffs. Indirect contact may be relevant because of possible migration into food
through the layer in direct food contact. Therefore, at first for the legislator the layers in
direct or indirect contact are subject to the same rules.
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