provided for the safety evaluations and risk assessments may be modified as
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 programme 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 (M
) below 1000 D and
those with M
above 1000 D. For those polymeric additives with a M
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.
Biocides, 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-
The petitioner should also provide evidence that the substance is not used to
reduce the normal hygienic measures required in handling foodstuffs.