On June 13, 2016 Anna Federica Castoldi, toxicologist from the European Food Safety Authority (EFSA), spoke at the 2nd International Conference on Food & Beverage Packaging in Rome, Italy. In her talk entitled “Scientific facts for developing a new EFSA guidance for the safety assessment of a substance to be used in food contact materials,” Ms. Castoldi explained EFSA’s scientific opinion on food contact materials (FCMs) that was published in January 2016 (FPF reported).
Notably, the scientific opinion proposes a change in the toxicological data requirements for authorization of food contact substances (FCS). Toxicological data requirements are based on a tiered approach, where low exposure estimates trigger basic toxicological testing (in vitro mutagenicity and genotoxicity), intermediate exposure estimates call for more advanced toxicological testing (e.g. subchronic in vivo), and highest exposure estimates make full toxicological testing mandatory (chronic in vivo, as well as developmental and reproductive tests). In EFSA’s new proposal, these tiers remain the same, however the way how exposure estimates are derived is different: Currently, exposure estimates are based on migration from FCMs, while the new approach foresees using actual food consumption data for deriving exposure estimates using the EFSA Comprehensive European Food Consumption Database (FPF reported). As such, EFSA’s proposal is similar to the approach currently taken by the U.S. Food and Drug Administration (FDA).
EFSA’s proposal will see an increase in the lowest exposure tier: For exposures below 1.5 µg/kg bodyweight (bw)/day (corresponding to a migration of 90 µg/kg food in the present scheme), two genotoxicity in vitro tests are required. In the present scheme, these tests are triggered by migration below 50 µg/kg food. If the FCS, based on its chemical structure, is considered to have low toxicity according to the Threshold of Toxicological Concern (TTC) Cramer Class I, then exposures may be up to 30 µg/kg bw/day (or 1800 µg per person and day, for a 60 kg person).
Exposures above 1.5 µg/kg bw/day (or 30 µg/kg bw/day respectively), but below 80 µg/kg bw/day require additional subchronic in vivo data, as well as information on accumulation, distribution, metabolism and excretion in vivo for substances with potential accumulation in humans.
Highest exposures above 80 µg/kg bw/day (corresponding to migration of 4800 µg/kg food in the present scheme) call for additional data on chronic toxicity (carcinogenicity), as well as data from reproductive and developmental toxicity studies. This tier is similar to the present scheme.
In her talk, Ms. Castoldi mentioned that the EFSA scientific opinion suggests “more focus on the finished articles rather than starting materials or additives,” because “reaction and degradation products can be formed during manufacturing and use.” In this context she noted that the “same degree of safety should be warranted for all migrating substances” from FCMs, regardless of whether they are intentionally or non-intentionally added substances (NIAS). For risk assessment of NIAS, EFSA recommends use of the TTC, whereby for exposures below 0.0025 µg/kg bw/day (0.15 µg/kg food) no genotoxicity data may be needed, if the substance does “not belong to any of the TTC exclusion chemical categories.” This threshold is about two orders of magnitude lower than the migration threshold of 10 µg/kg food for unauthorized substances used in plastic FCMs (“functional barrier,” (EU) No 10/2011).
As a next step, Ms. Castoldi explained that EFSA’s scientific opinion and its suggestions for change would now be assessed by the European Commission for their impact on risk management, and that a level of protection for consumers would need to be set. EFSA would then prepare draft guidance for submitting an application for a novel FCS, followed by a public consultation. A timeline for these two steps was not given.
EFSA (December 2015). The EFSA comprehensive European food consumption database.