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Note for Guidance for Food Contact Materials
Page 49 of 126
actual or residual content of the substance in the test
material depends on the type of substance and the data
provided in the specific migration determination. For
guidance the following examples are given:

- monomer (case 1)
Full data on specific migration are provided.
Determination of residual content is not required.

- monomer (case 2)
Specific migration is not determined, but calculation of
migration based on residual content and assuming
100% migration is provided. Determination of residual
content is required. Full details concerning the method
and results shall be provided.

- monomer (case 3)
Worst case migration is based on the amount of
monomer initially added to the polymerisation process,
while assuming 100% migration
Determination of residual content is not required.
However, a properly described method for the
determination of the residual content shall be provided
for enforcement purposes.

- additive
Migration of additive is determined by specific and/or
overall migration. Presence of the additive at the
intended level in the actual test material used in
migration experiments (5) should be demonstrated by
means of analytical data. In general it is sufficient to
demonstrate by analytical experiments the presence of
the additive at the intended level. In this situation
validation of the analytical method and extensive
description of the analytical method is of less
importance. Nevertheless sufficient information should
be provided to make the data provided transparent and
acceptable.

- monomer or additive
Determination of the specific migration of monomer or
additive is not possible because of e.g. instability of the
substance in food simulants, or because a QM limit is
more appropriate. The determination of the actual
content should be described in full detail according to
standard format. In addition the method should be
validated, and, where relevant, visual information (e.g.
chromatograms) should be added.
Ref:
6.2 substance:
Set out substance.
6.3 test
sample:
Where relevant, the test sample shall be equivalent to