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7
Factor (DRF)
(3)
assumed to be equal to 5. According to industry it is not correct to
replace in migration testing 1 kg of fatty foodstuffs composed by semisolids and
solids foodstuffs having in the majority of the cases a limited % of fat by 1 kg of olive
oil, which is liquid and contains 100% of fat. By so doing the exposure of the
consumer is largely overestimated because the realistic maximum intake by the
consumers has been shown to be up to 200 grams of fat (i.e. olive oil). Therefore a
reduction factor of 5 is requested to correct the experimental values of the migration.
This new factor will replace, in the industry proposal, the reduction factors (RF)
provided in Directive 85/572/EEC, which were introduced to take into account the
different values obtained in fatty food and in fatty food simulants (M
fat)
.
In conclusion the industry requested that migration value to be compared with the
SML (M
corr
) in the enforcement of the legislation is the value obtained by applying the
following formula:
M
corr
= (M
fat
/DRF) = (M
fat
X
0.2).= M
fat
/5
This correction does not take into account any contribution to the exposure that may
come from migration into the non-fatty simulants. Therefore the industry proposes to
add to 1/5 of the migration into simulant D the highest of the three migration values in
1 kg of the other simulants (A, B and C):
Therefore the corrected migration into food simulants is calculated by applying the
following formula:
M
corr
= (M
max
in simulants A or B or C)+ (M
sim.D/
DRF)
M
corr
= (M
max
in simulants A or B or C)+ (M
sim.D
X
0.2)
1.3.
A
NALYSIS BY THE
C
OMMISSION TASK FORCE OF THE TWO PROPOSALS
1.3.1. F
IRST CASE
: Correction of the specific migration
(4)
values obtained in foodstuffs
themselves.
The Commission task force recognises that the exposure from fatty foodstuffs derives
only from the 200 grams of fat dispersed in the fatty foodstuffs and, therefore this
quantity of fat is a limiting factor in the ingestion of fatty foodstuffs. But inserting this
correction in a system where the contribution to the exposure derived from the other
aqueous sources is not considered adequately (1 kg of aqueous beverage is not a
conservative value) may increase exposure. Therefore it proposes that this correction
can be acceptable only if the substance does not migrate into non-fatty foodstuffs. In
this respect the Commission task force proposes that these substances are identified
on the basis of the value of their migration into non-fatty simulants which should not
exceed 1/10 of their SML. If this value is not available it can be replaced by either the
3
In the industrial document the abbreviation used was TMRF = Type (Specific) Migration Reduction
Factor.
4
It has to be noted that the FRF and DRF do not apply to overall migration as well as QM (Maximal
quantity in finished material) values.