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Note for Guidance for Food Contact Materials
Page 25 of 126
8.4.1 Hydrolysable
substances
If the chemical structure suggests ready hydrolysis of the substance in food and/or the
gastrointestinal tract into components which already have been toxicologically evaluated,
the rate of hydrolysis and its degree of completeness will determine the extent of
toxicological testing necessary for an evaluation. In particular, it will depend on these
parameters. Whether the unhydrolysed substance needs also to be included in the testing
program depends on the outcome of the hydrolysis studies.

8.4.2 Polymeric
additives
Because only the fraction with molecular mass below 1000 D is regarded as
toxicologically relevant, a distinction has been made between polymeric additives with a
weight averaged molecular mass (MW) below 1000 D and those with MW above 1000 D.
For those polymeric additives with a MW > 1000 D only a reduced set of data may be
required. In deciding which data are needed, the data available on the monomers
involved, the size of the fraction with molecular masses below 1000 D, and the
proportion of the additive in the plastic will be taken into account.

8.4.3 Foodstuffs/Food
ingredients
These can be used as monomers, as starting substances or as additives and will require
only the data requested in sections 1 and 3.

8.4.4 Food
additives
Those already evaluated by the SCF will, in the first instance, only require the data
requested in sections 1, 3 and 6.

8.4.5 Antimicrobial
Substances
Antimicrobial substances, intended to be present in food contact materials, require
additional considerations to those applied to microbiologically inert substances of food
contact materials. The petitioner should provide evidence that any migration into food is
not intentional but only incidental; that its use does not exert any preservative effect on
the food; that it does not allow the selection of non-sensitive organisms on the surface of
the food contact materials; and that it does not allow the development of biocide
resistance in sensitive micro-organisms.
The petitioner should also provide evidence that the substance is not used to reduce the
normal hygienic measures required in handling foodstuffs.