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Note for Guidance for Food Contact Materials
Page 43 of 126
data both on the suitability of the analytical method
as well as the stability of the substance in the food
simulants, recovery experiments (triplicate) shall be
performed with food simulants spiked with the
substance at a level of interest (e.g. 50
g/kg) or at
the actual level of the migration values. The spiked
food simulants shall be stored under the same
conditions of time and temperature, in the same or
equivalent containers as used in the migration
experiments. Provide all actual data, to allow proper
evaluation of the results presented, such as method
of standard addition (solvent used, volume added)
amount of substance added to a known volume of
simulant (x
g/y ml), storage condition, etc.
If low recovery values are obtained, reasons for this
should be explained.
Results of the recovery test may influence the type of
restriction to be established.
Ref:
5.1.12 other
information:
Set out any other information that may be relevant for
evaluation.
Ref:
5.1.13 results:
Give all individual migration data obtained, blank
and recovery data inclusive. Preferably the data
should be presented in a table, which should contain
sufficient details to follow the way the final results
are obtained. For example it should contain:
- test conditions of time and temperature
- simulant
- contact area
- volume of food simulant used in the test
- actual concentration of the substance in the
simulant as obtained from the migration
experiment
- migration in the food simulant expressed in
mg/dm
- migration in the food simulant using the
conventional factor of 6 dm/kg or any other
relevant ratio
- amount of substance added in the recovery tests.
Ref:
5.2 overall
migration
(OM):
Answer 'determined', 'not determined'
In general the determination of the OM as described
in CEN methods EN 1186 is not required for
petitioning of an additive or a monomer. The overall
migration may be used as a replacement for specific
migration in those cases where the specific migration
is impossible to measure because of the properties of
the substance, e.g. polymeric additives. The overall
migration may be used to demonstrate worst case
migration of the substance.