The European Food Safety Authority’s (EFSA’s) Panel on Food Contact Materials, Enzymes, Flavorings and Processing Aids (CEF Panel) has issued a scientific opinion recommending revisions to the safety assessments conducted for food contact materials (FCM). After considering scientific comments received during public consultation, the CEF Panel advocates new standards for estimating food intake and calculating the level of FCM migration into food. The scientific opinion also finds that genotoxicity testing for FCM substances should be mandatory even in low-exposure scenarios, and that nanomaterials used in FCM should be evaluated on a “case by case” basis.
To address different consumption scenarios, the CEF Panel divided foods into four categories based on exposure data extrapolated from EFSA’s Comprehensive European Food Consumption Database as well as “default water consumption figures set by the World Health Organization (WHO) for infants.” For each of these food categories, the panel identified the “critical” age group with the highest consumption by body weight and set consumption figures accordingly.
Replacing Scientific Committee on Food guidelines that use a default consumption figure of 17 grams per kilogram body weight per day (g/ kg bw per day), this system would establish consumption estimates for packaging substances in contact with the following food categories: (i) water and foodstuffs such as reconstituted infant milk, (ii) milk, milk products and other non-alcoholic drinks, (iii) foods specifically intended for infants and toddlers, and (iv) foods other than those covered by categories one, two or three. According to the opinion, infants have the highest consumption by body weight of water and reconstituted infant milk, with a consumption figure estimated at 150 g/kg bw per day, while toddlers have the highest consumption by body weight of foods in the other three categories, with consumption figures estimated at 80, 50 and 20 g/kg bw per day, respectively.
Intended for use in estimating FCM exposures, these consumption figures are “approximately 9, 5, 3 and 1.2 times higher than the current default for consumption.” In addition, the CEF Panel advocates “a tiered approach to toxicity testing of substances migrating” from FCM, proposing three thresholds—1.5, 30 and 80 μg/kg bw per day—that would trigger the need for additional toxicity data. The opinion adds that the migration of FCM substances resulting in exposures exceeding 80 μg/ kg bw per day would approach those seen with food additives and require a corresponding toxicological data set.
“The first level, 1.5 μg/kg bw per day, is intended to be a general threshold for the investigation of potential toxic effects other than genotoxicity,” explains the CEF Panel in January 26, 2016, press release. “In case a substance can be classified in Cramer class I (the less toxic class, i.e. the substance has a simple chemical structure and can be anticipated to be metabolized to innocuous products, suggesting low oral toxicity), a second level of 30 µg/kg bw per day could be set instead of 1.5 μg/kg bw per day as the threshold for the investigation of repeated-dose toxicity. A third exposure threshold [80 μg/kg bw per day] is proposed as a trigger for additional toxicity studies beyond the core set of general toxicity data.”
After the European Commission and member state authorities review these recommendations and provide direction “on the necessary levels of protection for consumers,” EFSA will issue detailed guidance on applications for the safety assessment of FCM substances. As CEF Panel member Laurence Castle notes, “This opinion reflects both advances in science and our experience over the last decade in applying existing EU guidelines… [The scientific opinion] presents recent scientific developments that impact on the estimation of consumer exposure to substances migrating from food contact materials, the tiered approach to their safety assessment, toxicological data requirements and consideration of the migration of non-intentionally added substances (NIAS).”