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Note for Guidance for Food Contact Materials
Page 90 of 126
shown that MPPO provides stronger adsorption capacities than real foodstuffs such as
pizza, pastry etc.

2.8.3.4 Other substitute media
The cases in which both substitute tests are recognised to be unfeasible for technical
reasons connected with the method of analysis should be very rare. However in order to
give legal guidance in every possible situation, the text offers the possibility to use other
media e.g. MPPO or isopropanol (this last should be used at the same conditions of
ethanol 95%).

2.9 Alternative
tests

2.9.1 Directive 97/48/EC in Chapter 4, point 1, provides the following clause:
"It is permissible to use the result of alternative tests as specified in this Chapter
provided that both the following conditions are fulfilled:
a)
the results obtained in a "comparison test" show that the value are equal to or
greater than those obtained in the test with simulant D;

b)
the migration in alternative test does not exceed the migration limits, after
application of appropriate reduction factors provided in Directive 85/572/EEC.
If either or both conditions are not fulfilled, then the migration tests must be performed."
Regarding tests with fatty food simulant, if certain specified conditions are satisfied, the
Directive allows the possibility of replacing the tests described in Chapter 1, 2 and 3
either by alternative tests using volatile media, for example iso-octane or ethanol 95%, or
by "extraction tests" which are tests with very aggressive volatile solvents used at high
temperature.
The Directive does not specify how equivalency or greater severity of the alternative tests
should be demonstrated in practice. In practice the frequency will depend on the
particular situation under examination. If the alternative tests give the values of the
released substances higher than those obtained by simulant D, it is not necessary to
frequently repeat the comparison tests (check), provided the process of manufacture
ensures a high probability that the reproducibility of the characteristics of the final article
are constant. In this situation a check once each year could be sufficient. The check
should be repeated more frequently if these conditions are not satisfied.

It should be emphasised that as the alternative tests are conventionally deemed equivalent
to or giving higher values than the tests using simulants D, the reduction factors also
apply to the alternative tests.

2.9.2 "Alternative test with volatile media"
The Directive does not specify the type of volatile test medium to be used as an
alternative to the simulant D and the test conditions to be used. In fact it is impossible to
establish a general relationship between the test conditions of simulant D and the
alternative volatile test medium.