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Note for Guidance for Food Contact Materials
Page 39 of 126

4.1.3 other
information:
Give any other relevant information.
4.2 non-EU
countries
4.2.1 in
USA:
Answer 'yes' or 'no'. If 'yes' give relevant
regulation(s) or other and give further details like
restrictions and conditions.
4.2.2 in
Japan:
Answer 'yes' or 'no'. If 'yes' give relevant
regulation(s) or other and give further details like
restrictions and conditions.
4.2.3
in other countries:
Answer 'yes' or 'no'. If 'yes' set out other countries,
give relevant regulation(s) or other and give further
details like restrictions and conditions.
4.2.4 other
information:
Set out any other information that may be relevant
for evaluation.
4.3 other
information:
Set out any other information that may be relevant for
evaluation, e.g. authorisation on other uses or
environmental regulations.

5.
DATA ON MIGRATION OF SUBSTANCE

If food simulants are used, the provisions concerning the specific and overall migration set
out in the EU Directives6 and in the document "Commission Explanatory Guidance for
Migration Testing" should be followed.

5.1 specific
migration
(SM):
Answer 'SM determined' or 'SM not determined'. If
SM is not determined give reasons. In general the
determination of the specific migration will be
requested to demonstrate worst case migration.
Based on the level of migration the number of
toxicity tests can be established. However there are a
number of exceptions where specific migration can
be replaced by the determination of the actual
content of the substance followed by worst case
calculation. In cases where it is impossible to
measure specific migration because of the properties
of the substance, e.g. polymeric additives, the overall
migration can be used to demonstrate worst case
migration of the substance.
All experiments required in specific migration
testing should be performed in triplicate.
Ref:
5.1.1 substance:
Set out substance(s) determined.

6
See the document "Eu and national Legislations" appearing in the homepage of EC-JRC website