Allergen LOAELs
(Lowest Observed Adverse Effect Levels)
December 2010

We would like to focus your attention to the Lowest Observed Adverse Effect Levels (LOAELs) for allergens in the guidelines of the Regulations on Labelling and Advertising of Foodstuffs (R.146/2010) (Please refer to page 15 of the Guidelines).

This LOAEL data is drawn from the findings of the USFDA Threshold Working Group and represents a summary from a collection of all published levels of reactions to low levels of allergens. LOAELs should not be confused with allowable levels of allergen contamination in food products. Since LOAEL values do not refer to No Observed Adverse Effect Levels (NOAELs), there is still a risk that individuals may react to lower levels of allergens in food products than the LOAELs. When using LOAELs rather than NOAELS to establish allergen thresholds, the selection of appropriate factors to account for uncertainty and inherent variability is critical.

The Australian/New Zealand Allergen Bureau has developed the VITAL (Voluntary Incidental Trace Allergen labelling) procedure to assist with decisions relating to allergen precautionary labelling. The VITAL grid (see below) indicates proposed action levels when assessing allergen risk. This grid is based on established LOAEL for common allergens, but has an added safety margin added to each to account for uncertainty. The levels indicated in the VITAL grid, with their added safety margins, are thus seemingly more appropriate to apply to risk assessment procedures than the FDA levels (LOAELs) in their raw format.

KEY TO TABLE:
Green: No precautionary labelling required
Yellow: “May contain” statement is recommended if action cannot reduce these levels.
Red: Ingredient labelling recommended (i.e. the levels of allergen contaimaition are so high that the allergen should be labelled as an ingredient). Immmediate action is required.