EFSA Seeks Input on Exposure Assessments for Food Enzymes
The European Food Safety Authority’s (EFSA’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 statement
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 information
(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.”
Issue 594
