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Note for Guidance for Food Contact Materials
Page 51 of 126
diameter) or weight of the test specimen. If a sub-
sample is taken from in-homogeneous materials (e.g.
bottle), then set out which part was taken.
6.4 treatment
of
sample:
Set out treatment of the test sample, if not included
in the test method.
6.5 test
method:
If relevant, the technical dossier shall contain the
following information 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 data related to the
residual content. Guidance for the description of a
method in standard format is given in the document
"Commission Explanatory Guidance for Migration
Testing". The method of determination may be used
by enforcement laboratories in order to enforce
restriction set for the substance. Therefore the
method should use generally available equipment.
Use of very sophisticated methods should be
justified.
Where relevant, visual information such as typical
chromatograms, calibration lines, etc. should be
included.
Ref:
6.5.1 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 a substance 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.
Ref:
6.5.2
precision of test
method:
Give repeatability (r) of method at residual content
level. For example, repeatability of the method can
be obtained from the standard deviation of the
triplicate determination or from recovery
experiments.
Ref:
6.5.3 recovery:
Set out percentage recovery of substance as
determined in recovery experiments. To obtain data
on the suitability of the analytical method, recovery
experiments (triplicate) shall be performed by
standard addition of the substance to the polymer
sample at a level of interest or at the level of the
actual content. Also the use of similar test material
not containing the substance may be allowed. The
spiked samples shall be treated in the same way as
the test samples itself. Where relevant, visual
information should be provided. If low recovery
values are obtained, reasons for this should be