The European Food Safety Authority’s (ESFA’s) Panel on Food Contact Materials, Enzymes, Flavorings and Processing Aids (CEF) has announced a public consultation on its draft statement on exposure assessment of food enzymes. Recognizing the difficulty in applying current exposure assessment guidelines to food enzymes, which are added during processing of food and food ingredients, the draft state- ment recommends a tiered approach based on “more realistic” exposure scenarios as opposed to methods that rely solely on upper use levels.

In particular, the CEF Panel notes that food enzyme guidance adopted in 2009 stipulates that, “Potential human exposure to the food enzyme and to any other constituent or by-product of concern should be assessed considering all proposed uses. A conservative technique such as the ‘budget method’ should be used … assuming that they (i.e. foods and beverages) always contain the food enzyme at its proposed upper use level.” This budget method apparently makes several assumptions regarding (i) food and beverage intake, (ii) the percentage of food and beverage that are processed, and (iii) the percentage of processed food and beverage containing the food additive. A margin of exposure (MoE) is then calculated “based on the estimated dietary exposure from use of the food enzyme and the no-observed-adverse-effect level (NOAEL).”

Because the budget method when applied to food enzymes “can lead to a considerable overestimation of exposure,” a tiered approach would use the budget method without the use of standard factors as an initial screening step for all food enzymes. Only in those cases “where calculated MoE according to Tier 1 is insufficient” will the exposure assessment be further refined in one of two ways. Tier 2a assessments will cover cases in which there is available information about the occurrence of the food enzyme in foods/beverages as consumed that “allows for a calculation of the exposure using specific food categories in the EFSA Comprehensive European Food Consumption Database.” All other cases will undergo Tier 2b assessment, which will use the budget method with factors specific to the respective enzymes and derived “using all available infor- mation (e.g. the use of the enzyme during food processing, the proportion of processed food and the presence of the food enzyme therein).”

“As each safety assessment is performed on a case-by-case basis requiring expert judgment of the entire toxicological database and information related to the intrinsic properties of specific food enzyme, no generally acceptable value can be established for MoE,” concludes the CEF Panel, which seeks public feedback by March 31, 2016. “As a first indication, a MoE of 300 (Factor 10 for inter-species difference, factor 10 for intra-species difference and factor 3 for the extrapolation from short- term studies to chronic studies, EFSA Scientific Committee, 2012) may be regarded as sufficient provided the data are complete and the quality of the data is acceptable.”