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Note for Guidance for Food Contact Materials
Page 23 of 126
5.
MIGRATION DATA ON THE SUBSTANCE
To permit estimation of the likely maximum daily intake of the substance, its impurities,
its breakdown and reaction products give, where practicable, information on their
concentrations in the food itself. Alternatively, information on migration into food
simulants under standard conditions of migration testing or applying the worst case
scenario. If known, include exposure estimates from other non-food contact material
sources

6.
DATA ON THE RESIDUAL CONTENT OF THE SUBSTANCE IN THE FOOD
CONTACT MATERIAL
All relevant information concerning the residual content of the substance in the food
contact material.

7.
MICROBIOLOGICAL PROPERTIES OF THE SUBSTANCE
All relevant information on microbiological properties of substance


8. TOXICOLOGICAL
DATA

8.1 General
requirements
The general requirements for toxicological studies that have to be supplied for substances
in food contact materials are set out below. It should be recognised that not all chemicals
used in the manufacture of a food contact material will migrate into food. Many will
form a stable part of a polymer, some will migrate only in minute quantities, if at all,
others will disappear during production, while yet others will decompose completely to
yield either no or vanishingly small residues. While many substances migrate in the same
chemical form in which they were incorporated into food contact materials, others will
migrate partially or totally in another chemical form. In such cases the toxicological
requirements may also apply to the transformation or reaction products.

8.2 Core
set
The core set of tests comprises:
- 3
mutagenicity
studies
in vitro:
i)
A test for induction of gene mutations in bacteria
ii) A test for induction of gene mutations in mammalian cells in vitro
(preferably the mouse lymphoma to assay)
iii) A test for induction of chromosomal aberrations in mammalian cells in vitro
-
90-day oral toxicity studies, normally in two species
-
Studies on absorption, distribution, metabolism and excretion

-
Studies on reproduction in one species, and developmental toxicity, normally in
two species