Note for Guidance for Food Contact Materials
Page 36 of 126
substances other than monomers) of the compound.
For chemicals which are not deemed to react in the
polymer, the onset of degradation should in general
be 10% above the max. process temperature. If this
is not met an explanation should be given why the
substance can be used above or near the
decomposition temperature. If any of the other
parameters are relevant for authorization of the
substance, then sufficient detailed information shall
be provided for a proper evaluation.
Hydrolysis may simplify the petition if already
evaluated chemicals are formed in high yield in
body fluid simulants. If relevant, give results of
hydrolysis tests carried out according to the
guidelines of chapter III annex 1. If hydrolysis tests
are carried out then full details shall be provided,
including the analytical method.
Give information on intentional decomposition or
transformation of substance, if any, during
manufacture of a food contact material or article.
If there might be some concern about decomposition
products, migration and/or toxicity data on these
products might be requested, and specifications or
restrictions may be set.
In this respect a monomer is considered to be
transformed into a polymer Additives like
scavengers will be transformed and anti-oxidants
will be decomposed according to the intention of
use. Other substances may be decomposed e.g. by
oxidation or due to high temperature etc.
Where relevant, set out unintentional decomposition
or transformation products
of the pure substance (see 2.2.3)
formed in the material during the
manufacture of a final article
formed during various treatments likely to
be applied to the finished material or article
(e.g. ionising treatments)
Give information on reaction of substance with food
substances, if any.
This item is very important for making decisions on
the type of restriction to be established (SML, QM
or QMA). If migration tests, including recovery
tests (see 5.1.11), have been carried out then
reference could be made to item 5.1. In any other
situation stability of the substance in food simulants