EFSA Published Draft Scientific Opinion on Toxicological Evaluations of Food-Contact Materials

July 24, 2015

The European Food Safety Authority's (EFSA) Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) published a draft scientific opinion on recent developments in the risk assessment of chemicals in food and their potential impact on the safety assessments for food-contact materials.

As a result of the availability now of EFSA's Comprehensive European Food Consumption Database, a key area that the Panel recommends revisiting is the estimation of consumer exposure to substances used in food-contact materials. The current default assumption used in estimating exposure in the European Union is that an individual may consume daily up to 1 kg of food in contact with 6 dm² of the food-contact material. The Panel is suggesting three new food consumption categories be used that would result in approximately 9, 5 and 1.2 times higher exposures than if the current model were used. Category One would cover materials and articles intended to come into contact with water and infant formula, with the age group having the highest consumption being infants. Category Two would be materials and articles intended to come into contact with milk, milk products, and other nonalcoholic drinks, and Category Three would be materials and articles intended to come in contact with all other foods and beverages. The age group with the highest consumption for both Categories Two and Three is toddlers, who have a higher food intake relative to body weight than an average adult, which is why exposures in these Categories would be higher than under the default scenario. The Panel notes that special exposure scenarios may be used under certain conditions where consumption was found to be lower.

The opinion also discusses the toxicity data that are required to ensure that exposures to food-contact materials are safe. The Panel points out that genotoxicity testing is needed to establish the safety of all substances used in food-contact materials, even where exposures are low. EFSA recommendations are that two in vitro studies fulfill the requirements—a bacterial reverse mutation assay (Ames test), and an in vitro mammalian cell micronucleus test—with additional recommendations for in vivo studies for substances that give positive results in the in vitro assays. In addition, the Panel sets out two levels of human exposure (1.5 and 80 µg/kg b.w. per day) as thresholds for requiring additional toxicity data.

Finally, the opinion notes that the same approach for evaluating food-contact materials theoretically could be applied in risk assessments for non-intentionally added substances (NIAS), since all materials migrating from food-contact articles should be subject to the same safety standard. The Panel does suggest, however, that non-testing methods may be taken into account for priority setting and for toxicological assessments of NIAS on a case-by-case basis.


Comments are due by October 7, 2015. Information on how to submit comments can be found on EFSA's website.