FACTS reports now include
allergen threshold levels
The draft South African labelling regulations (Anon.,
2007) require the declaration of any of the "common food allergens"
contained in a food product on the product label. These common allergens
include cow’s milk, egg, fish, crustaceans and molluscs, soy,
peanuts, tree nuts and certain grains. However, the issue of cross-contamination
with these allergens, and the doses of allergens that can cause a reaction,
needs to be recognized by the food industry to prevent a possible fatal
reaction from occurring.
How have threshold levels been determined?
As individuals with food allergies differ in their degree of sensitivity
to specific allergenic foods, attempts have been made to determine threshold
doses for the major food allergens. The basic concept of establishing
allergen thresholds is that if a Lowest Observed Adverse Effect Level
(LOAEL) and No Observed Adverse Effect Level (NOAEL) are identified,
then the food industry may target their processes to achieve these levels.
There is currently limited consensus in the scientific literature regarding
thresholds for the common food allergens. For this reason, the US FDA
Threshold Working Group conducted an extensive review of the published
literature containing dose-response data from double-blind placebo controlled
food challenges (DBPCFC) from November 2004 to April 2005. In 2006,
this group summarised the threshold data for some of the common food
allergens as follows:
FACTS has included these summarised threshold levels
in all allergen test reports in order to assist the food industry in
assessing the risks of allergen cross contamination and to gauge the
need for allergen precautionary labelling. The threshold values are
a simplistic view of the problem, but FACTS is always available to put
these in perspective based on the product, the matrix, and other relevant
How can allergen thresholds be useful?
A soy drink was found to be contaminated with 20 ppm milk protein using
an ELISA detection method. According do the published threshold LOAEL
data summarised by the US FDA Threshold Working Group, consumption of
as little as 0.36 mg milk protein could elicit mild, objective symptoms
in highly sensitive individuals. Consumption of just 18 g (approximately
two sips) of this soy drink could contain 0.36 mg milk protein, and
thus be sufficient to elicit a reaction in a highly milk allergic person.
Thus, since a serving of such a drink would normally be around 200 g,
this product is likely to pose a considerable threat to milk allergic
patients. The source of the contamination should be identified and the
problem rectified, and if it cannot be, then precautionary labeling
is highly advisable.
Anonymous (2007). Foodstuffs, Cosmetics and Disinfectants Act, 1972
(Act 54 of 1972). The draft South African regulations relating to the
labelling and advertising of foodstuffs, Government notice R.642. Government
Gazette No. 30075, 69-145.
FDA (2006). Approaches to Establish Thresholds for Major Food Allergens
and for Gluten in Food. Available at: www.cfsan.fda.gov/~dms/alrgn.html