Toxicological assessment of a food-contact material migrant and derivation of an oral TDI


A global food manufacturer


Foods come into contact with many different materials during preparation, processing, packing and transportation. Under European legislation, these materials must be “sufficiently inert”, such that any migration into food would not be a human health risk. An application for the authorisation of a food-contact material must be accompanied by a detailed technical dossier containing a safety assessment.

Project Goals

One substance identified as a potential migrant was suspected of being a genotoxic carcinogen. Bibra was asked to review the available toxicological data (specifically for oral use) and to derive a tolerable daily intake (TDI) for long-term oral exposure.


Searches were made of the bibra TRACE database to identify recently published expert group reviews likely to provide overviews of the available data on the substance. Additional searches of a closely structurally-related substance (which had been considered in more detail by several expert groups) were also performed. We considered the expert group findings alongside the primary literature to establish tolerable long-term values for a range of exposure scenarios.

Project Outcome

Bibra concluded that the weight-of-evidence of the mutagenicity and carcinogenicity information suggested that the compound of interest was not an in vivo mutagen. We provided the client with a detailed report summarising the available data for the key toxicological endpoints and suggesting a number of potentially defensible TDI values.

Project Team

Chris Waine
Pete Watts


Food and Food-contact

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