Note for Guidance for Food Contact Materials
Page 64 of 126
Annex 2 to Chapter III
Components with a molecular mass above 1000 Dalton (D) are very unlikely to be absorbed by
the gastro-intestinal tract and thus are not considered to present a toxicological risk. The value of
1000 D was chosen because it takes into account the effect of the shape of the molecule, which
has an important influence on the likelihood of absorption of substances in the molecular mass
range 600-1000 D. Below 600 D most substances are absorbed and the rate of absorption is
determined by factors other than size and shape of the molecule.
Since only the fraction of the polymeric additive 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
polymeric additives with Mw above 1000 D, the fraction with molecular mass below 1000 D will
vary and a case-by-case consideration of the specification will determine whether further data are
The following data should be supplied:
Data according to "AFC-FCM-WG Explanatory Guidance to the SCF Guidelines for
Food Contact Materials on:
Genotoxicity data on the monomer(s) according to "SCF Guidelines", unless the
monomer(s) are already in SCF lists 0-4.
IIIa. For those additives with Mw less than 1000 D: migration and toxicity data on the
polymeric additive itself, according to "SCF Guidelines" with the exception that
mutagenicity studies on the polymeric additive itself are not required.
IIIb. For those additives with Mw above 1000 D: data, including migration and toxicity, may
be required on the polymeric additive itself once the AFC Panel has examined the
specification; especially for those additives containing a significant fraction with
molecular mass below 1000 D.
In deciding whether further data are needed, the AFC Panel will take into account both
the size of the fraction with molecular weights below 1000 D and the proportion of the
additive in the plastic.