Abstract:

Food contact materials contain many chemical agents including intentionally added substances (IAS) and
non-intentionally added substances (NIAS). It is impractical to obtain all toxicological data for IAS and NIAS, and also
unnecessary to assess the substances of low exposure level in food contact materials for less risk to human health. The
threshold of toxicological concern (TTC) concept, as a novel safety assessment strategy, can be used to assess the substances
with insufficient toxicological data and lower exposure level. This paper discusses the application of TTC to assess
substances (known and unknown) in food contact materials. Our research is conducted in compliance with TTC decision tree
proposed by the European International Life Sciences Institute specialists for the assessment of substances. For unknown
substances, a stepwise analytic method is applied to reach a conclusion whether safety concerns are required or not.
Difficulties in using TTC and problems to be solved are pointed out. This paper can provide the basis for risk assessment of
substances in food contact materials complete toxicological data about which is lacking.

Key words: threshold of toxicological concern, food contact materials, food safety, risk assessment