Note for Guidance for Food Contact Materials
Page 41 of 126
18.104.22.168 dimensions of test
Describe briefly that part or section of the test
sample from which the test specimen was taken
particularly in case of inhomogeneous materials (e.g.
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 5.1.5) also calculate the
total area of both sides. If the test specimen does not
come into contact completely with the simulant (with
use of one side migration cells) then calculate the
actual contact area.
sample prior to
Set out to what treatment food contact material was
subjected prior to testing. E.g. cleaning, washing etc.
Treatment of a test sample should be representative
of use in practice.
Set out foodstuff(s) or food simulant(s) used in
migration testing. For the selection of the food
simulant Directive 82/711/EEC as amended should
be followed. The "Commission Explanatory
Guidance for Migration Testing" (see Chapter IV)
should be taken into account. Especially when olive
oil is replaced by substitute food simulants this
document should be studied carefully. Also data on
solubility as requested in item 2.1.4 shall be provided
in those cases. Replacement of olive oil by substitute
simulants is only allowed in case of technical
problems. Therefore the necessity of the use of
substitute simulants should be clarified, preferably
supported by some analytical data. Olive oil should
not be replaced for convenience only. Arguments
will be considered for validity. Poor analytical
chemistry or lack of facilities may not appear
acceptable arguments for replacement of olive oil by
In the special case of migration of metal ions where
ion exchange is the driving force, migration
experiments should also be performed in the
following simulants: 40 mM sodium acetate buffer at
pH 5 and 50 mM sodium phosphate buffer at pH 7.
Set out whether 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.
contact time and
Set out duration of test and test temperature.
In case of short contact times (
2 hours) at high