EFSA Seeks to Revise Consumer Exposure Estimates for Food Contact Materials
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).”
Issue 593
