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5.
AUTHORISATION OF THE SUBSTANCE
Information concerning authorisation for use of the substance in EU Member
States and other countries, e.g. USA, Japan.
6.
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
7.
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.
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 tk assay)
iii)
A test for induction of chromosomal aberrations in mammalian
cells in vitro