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Note for Guidance for Food Contact Materials
Page 50 of 126
the test sample used in the migration experiments. In
other situations the sample shall represent a worst
case situation. If the test sample is intended to
represent a range of materials of different brands or
grades, then it should be assured that a material is
selected that will represent the worst case situation.
If the substance is used in different kinds of
polymers then, in principle, each type of polymer
should be examined for the residual content of the
substance. However if it is properly argued only
determination of the residual content in a polymer
representing the worst case can be acceptable.
Criteria of selection will depend on the substance
and the manufacturing process.
6.3.1 chemical
Set out chemical composition of the test sample.
Information should be provided particularly on the
initial concentration of the substance, but also
information on the total composition is required as
the composition of the test specimen may influence
the applicability of the analytical method and/or the
residual content.
6.3.2 physical
Set out physical composition of test sample, such as
homogeneous material, multi-layer material. In case
of multi-layer material it should be indicated in
which layer the substance is present. If this is not the
direct food contact side, then also relevant
information on the top-layers shall be given.
density, melt flow
index of polymer
Set out density and melt flow index (if relevant) of
the polymer containing the substance. This
information is required for mathematic modelling. In
multi-layer constructions also the density of the
barrier layers shall be given.
dimensions of test
Set out dimensions of test sample.
The test sample is the sample manufactured for the
purpose of the determination of the residual or actual
content of substance. Provide information on shape,
e.g.: bottle, film, sheet, etc. and thickness. For
laminates the total thickness and the thickness of
each relevant layer should be indicated. For articles
with in-homogeneous thickness the thickness at
various places should given. The dimensions of an
article should be set out (height, length, width,
dimensions of test
Set out dimensions or weight of test specimen.
The test specimen is the actual part of material
submitted to the residual content determination. Set
out actual dimensions (height, length, width,