To check the compliance of a plastic food contact material with the existing European
Union (EU) regulations, overall and specific migration tests shall be
carried out using the food simulants and the test conditions specified in EU
Directive 97/48/EC. However, the experimental determination of a
specific migration into a food simulant is often a complex analytical task,
which requires a considerable amount of work, time, and expertise and hence costs
for the petitioner. Moreover, in a certain number of cases it is even
impossible to obtain reliable experimental migration data because of
technical/analytical problems, chemical degradation/volatilisation of the
migrant, or non-availability of an appropriate analytical method.
Therefore, Directive 97/48/EC foresees the possibility of carrying out
substitute or alternative fast migration tests if it is generally recognised on
the basis of scientific evidence that the results obtained are equal to or
higher than those obtained in the test with olive oil, which represents the "WORST
CASE" test.
In the last decades, numerous scientific investigations have
demonstrated that migration of small organic molecules from a plastic
material into a liquid substance is a theoretically
predictable physical process. But the challenge was to prove
that the migration estimation could become a recognized method by EU legislation.
Eventually, the combined effort of a number of experts from a series of EU
member states led to the conclusion that, based on the scientific evidence
which is nowadays available, the migration estimation is, for certain types of
polymers and migrants, a validated method to check for compliance with the
existing EU consumer protection regulations(1).
(1) K. Hinrichs and O. Piringer
(editors), 2002, "Evaluation of migration models to used under Directive 90/128/EEC",
Final report contract SMT4-CT98-7513, European Commission, Directorate General
for Research, Report-EUR 20604EN, Brussels.
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