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Note for Guidance for Food Contact Materials
Page 89 of 126
Research project No 33 revision 1 entitled "Migration testing with conventional and
alternative fatty-food simulants" an overview is presented of all comparative data,
available at that time (Feb. 1996), using a fat simulant or a volatile test medium. The
compilation can be used to indicate suitability of the chosen volatile test medium.

However it should be noted that some special types of polyolefins may give migration
values with iso-octane higher of those expected in the real use. Also polystyrene
containing more than 6.5% of polybutadiene and/or mineral oil may give high results,
while polyamides may give low results.

Data on specific migration into iso-octane are scarcer and use of iso-octane in specific
migration testing should therefore be considered on a case by case basis.
As regards the analytical procedure consult the document "Methods of Analysis".

2.8.3.2 Ethanol 95%
The previously mentioned EC study (EC Research project No 33, revision 1) also
contains useful data about the use of 95% ethanol as a volatile test medium in substitute
tests. Also in that case mainly overall migration data are available.
Usually it is found that a good comparison is obtained between olive oil and 95% ethanol.
It is found that 95% ethanol is more suitable for testing polystyrene/butadiene blends than
iso-octane. However, it is also the case that values obtained with 95% ethanol tend to give
slightly lower results compared to olive oil for most polyolefins.

Data on specific migration into 95% ethanol are relatively scarce and use of 95% ethanol
in specific migration testing should therefore be considered on a case by case basis.

As regards the analytical procedure consult the document "Methods of Analysis".


2.8.3.3 Modified polyphenylene oxide (MPPO)
In order to circumvent a number of analytical difficulties caused by the overall migration
determination with food simulant D at high temperatures, another test has been developed
using MPPO as an absorption test medium. The draft Directive specifies the conditions to
be fulfilled before applying this test i.e.:
a)
the contact temperature in worst foreseeable use is higher than 70C;

b)
the results obtained in a "comparison test" are equal to or greater than those
obtained in the test or with the abovementioned substitute tests or with
representative foodstuffs;

c)
the migration limits are not exceeded.
Comparative studies with 14C-labelled HB307 have shown that, in experiments with a
polypropylene and a polyetherimid tray at test conditions of 2 hours/100C and 2
hours/175C, respectively, the MPPO adsorbed amount is equivalent to overall migration
in fat simulant D. In addition, further studies with a number of organic substances have