background image
Note for Guidance for Food Contact Materials
Page 47 of 126
representative of use in practice.
5.3.3 test
Set out foodstuff(s) or food simulant(s) or extraction
solvent(s) used in migration testing.
For quantitative determinations, the use of food
simulants selected according to Directive
82/711/EEC as amended should be followed.
Identification or characterisation of migratable
substances may be possible in aqueous food
simulants. In general, use of olive oil may not be
feasible for various reasons. The use of volatile
simulants or extraction solvents may be required to
allow identification or characterisation of the
migratable substances.
5.3.4 contact
Set out whether the sample was tested on one or on
two sides. Set out in which way contact with the
simulants was achieved, e.g.: cell, pouch, total
immersion etc. If tested on two sides set out whether
one or both sides of the test specimen are used in the
calculation of the contact area.
Set out conditions of extraction, if relevant.
5.3.5 contact time and
Set out test duration and temperature.

5.3.6 surface to volume ratio
in migration tests:
Give the actual contact area and the volume of
simulant used in the migration experiment. Calculate
their ratio expressed as dmē/kg food simulant
In principle, the ratio should be equivalent to the
ratio occurring in real use. If this ratio is not known
then the conventionally 6 dmē/kg simulant may be
used. For analytical reasons it may be necessary to
deviate from that ratio, which in principle is
acceptable. However it should be carefully
considered whether or not using a higher ratio of
area to volume, could influence the final migration
due to saturation of the simulant, which may occur
with substances poorly soluble in the simulant used.
In extraction experiments, this most likely will not
5.3.7 analytical
Set out the principle of analytical method(s) used,
and submit a full copy of the method in the technical
Identification or characterisation of migratable
substances usually require application of various
sophisticated and complementary techniques. In the
summary data sheet an outline of the analytical
approach should be given. In the technical dossier
the analytical methods applied should be described
in such detail to allow appropriate evaluation of the