A food and drinks manufacturer.
Food-Contact Materials (FCMs) encompass all materials and articles that come into contact with food as it is produced, packaged, stored and consumed. Experts from the European Food Safety Authority (EFSA) have stated that the safety of FCMs must be evaluated to ensure that their potential transfer to foods would not have any adverse effects on consumers. Under EU regulation (EC) 1935/2004, FCMs must not transfer their components into the foods in unacceptable quantities.
Bibra was asked to identify toxicity data relevant to the chemical of interest, derive an appropriate TDI which could be used to assess the health risks posed to consumers exposed to FCMs containing this chemical.
Approach and outcome
Toxicity and ADME data searches were undertaken using bibra’s in-house TRACE database, which includes reports from Expert Groups such as the European Food Safety Authority (EFSA) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA), and a range of external data sources including REACH dossiers, PubMed, and the Registry of Toxic Effects of Chemical Substances (RTECS). All relevant endpoints (including sensitisation, acute and repeated-dose toxicity, reproductive and developmental toxicity, genotoxicity and carcinogenicity) were considered. A structurally similar read-across analogue was also identified and used to inform on several critical toxicological endpoints.
The overall dataset supported the evaluation of the chemical as a threshold toxin. A significant risk of sensitisation was also not anticipated; while the structures of the chemical of interest and read-across analogue both contain the same structural alert for sensitisation, reliable in vivo
data on the read-across compound are reassuring. Points of Departure (PoDs) such as No-Observed-Adverse-Effect Levels (NOAELs) and Lowest-Observed-Adverse-Effect Levels (LOAELs) were considered from each available dataset, and a critical LOAEL was chosen. Suitable Uncertainty Factors (UFs) were applied to account for inter and intraspecies differences and the use of an effect level as a PoD. This value was found to be just below the Expert Group-derived tolerable exposures to the read-across analogue.
 Absorption, Distribution, Metabolism and Excretion.