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solubility in the non-fatty simulants which should be less than 10% of the SML or by
the log Po/w which should be no less than 3
(5).
Moreover the Commission task force agrees on the other conditions proposed by the
industry for the application of the FRF.
a)
it is applied only to substances which cannot migrate into non-fatty foodstuffs.
b)
it is not applied to substances of SCF List 4 (substances which should not be
detectable in food simulants)
c)
the application of the FRF shall not lead to a specific migration exceeding the
OML
1.3.2 Second case: Correction of the specific migration values
5
obtained in food
simulants.
The correction proposed by industry M
corr
= M
sim.D
/5 is not generally acceptable.
However the Commission task force agreed that a new reduction factor related to the
% of fat present in the foodstuffs (FRF) could be introduced provided that the
following conditions are respected:
d)
the specific migration (SM) into simulant D is less than 80% of the initial
content of the substance in the plastic material or article .
c)
the total reduction factor (TRF) should not exceed 5
The Commission task force recognised that replacing 1 kg of fatty food by 1 kg of fat
(olive oil) overestimates the exposure from fatty foodstuffs taking into account that a
realistic maximum intake for consumers is up to 200 grams of fat. However it stressed
the existence of certain specific situations such as the contact at high temperatures or
with thin films where the migration is almost complete and then the assumption of the
industrial proposal that the exposure is proportional to the quantity of the oil is not
longer valid. For example, the substance migrating in 200 grams of olive oil could be
just the same as the quantity migrating in 1 kg of oil if the migration is quite extensive
and it is regulated only by the solubility of the migrant in the oil.
5
If log Po/w is >3 then the solubility in the non-fatty simulants is expected to be low and the substance,
even at equilibrium, will not have migrated to a significant extent from the (non-polar) plastic.