Note for Guidance for Food Contact Materials
Page 35 of 126
If available, solubility in organic solvents should be
presented as well as in food simulants.
If in migration tests a fatty food simulant is replaced
by a substitute volatile simulant then both solubility
in the oil and in the substitute simulants is required.
At least a semi-quantitative estimate of solubility
should be presented to make the use of substitute
solvents acceptable. The solubility may be given in
g/l, or it may be indicated e.g. miscible, good,
moderate, poor or insoluble etc. The intention here
is that comparative information on solubility, which
is one of the parameters that may influence
migration, is obtained.
Set out partition coefficient, if available.
Information is obligatory in the following cases:
- Migration is > 0.05 mg/kg of food/food simulant
- Substance is requested to be subject to the Fat
(consumption) Reduction Factor (FRF).
If the migration is > 0.05 mg/kg then information on
accumulation in man is requested (see Annex 4).
The log Po/w could be a tool to decide for the need
of additional data.
Lipophilic substances may be marked as appropriate
to apply the FRF. Proper evidence should be
provided to demonstrate the lipophilic properties of
a substance. A log Po/w may be one of the three
criteria established to classify the substance as
lipohilic. The other 2 are the following:
1. Migration into non-fatty simulants should not
exceed 1/10 of the SML of the substance or
2 Solubility in the non-fatty simulants should be
less than 10% of the SML
Give any other relevant information.
Answer 'acidic', basic' or 'neutral'.
Give information on reactivity of subject substance.
Give information on stability of subject substance in
the polymer towards light, heat, moisture, air,
ionising radiation, oxidative treatment, etc.
Provide a thermogravimetric analysis (for