Note for Guidance for Food Contact Materials
Page 46 of 126
material should be tested. However, if it is properly
argued, only tests with the material representing the
worst case may be acceptable.
Set out chemical composition of the test sample.
Information should be provided on the initial
concentration of the substance(s), and also on the
total composition, as this may influence the final
migration of the substance(s).
Set out physical composition of test sample, such as
homogeneous material, multi-layer material.
In case for a multi-layer material it should be
indicated in which layer the substance(s) is present.
If this is not the direct food contact side, then also
relevant information on the top-layers should be
220.127.116.11 density, melt flow
index of polymer:
Set out density and melt flow index (if relevant) of
the polymer containing the substance(s).
This information is required for mathematical
modelling. In multi-layer constructions the density
of the barrier layers should be given also.
Set out dimensions of test sample.
Test sample is the sample manufactured or used for
the study. 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 non-
homogeneous thickness, the thickness at various
places should be given. The dimensions of an article
should be set out (height, length, width and/or
Describe briefly that part or section of the test
sample from which the test specimen was taken
particularly in case of variable thickness materials
Set out spatial dimensions of test specimen (length,
height, width, diameter).
Calculate the total area of the test specimen. In case
of two-sided contact (see 18.104.22.168) also calculate the
total area of both sides. If the test specimen does not
come into contact completely with the simulant then
calculate the actual contact area.
In case of extraction, the weight of the test sample
sample prior to
Set out to what treatment the food contact material
was subjected prior to testing, e.g. cleaning, washing
etc. Treatment of a test sample should be