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Note for Guidance for Food Contact Materials
Page 42 of 126
temperature (
100°C), describe in acceptable manner
or demonstrate maintenance of the temperature over
the test period.
5.1.7 surface
Set out dmē test sample per kg food or per L
simulant. Give the actual contact area and the
volume of simulant. Calculate from these data the
actual surface to volume ratio applied in the
migration test. Conventionally the ratio is 6 dmē/kg
simulant. For analytical reasons it is often necessary
to deviate from that ratio, which in principle is
acceptable. However it should be carefully
considered whether or not the migration, using a
higher ratio of area to volume, could influence the
final migration due to saturation of the simulant.
5.1.8 analytical
Set out principle of analytical method used, and
submit a copy of the method in standard format.
Guidance for the description of a method in standard
format is given in the document "Commission
Explanatory Guidance for Migration Testing"
(Chapter IV). In addition, the technical dossier shall
contain e.g. actual data concerning the preparation of
calibration solutions, typical chromatograms,
calibration curves, correlation coefficients and all
relevant data needed for a proper evaluation of the
method and the migration data provided. It should be
realised that the method of determination may be
used by enforcement laboratories in order to enforce
any restriction established to the substance.
Therefore the method should use generally available
equipment. Use of very sophisticated methods
should be justified.
5.1.9 detection/
determination limit:
Give detection and/or determination limit of method,
and set out the way the detection limit was
established. Detection limits are particularly
important when migration is not detectable or at the
level of the detection limit. Where relevant, visual
information such as typical chromatograms,
calibration curve, blank values should be provided.
5.1.10 precision of test
Give repeatability (r) of method at migration level.
For example, repeatability of the method can be
obtained from the standard deviation of the triplicate
migration experiments or from recovery
5.1.11 recovery:
Set out percentage recovery of substance as
determined in recovery experiments under time-
temperature conditions of migration test. To obtain