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Allergen Working Group Topics for Discussion
1. Nature of Analyte
The precise nature of the analyte has not been resolved. Working Group members have discussed
peptides, proteins, and commodities.
Allergens are regulated by the FDA and EU as the whole allergen (i.e., peanuts) and products
thereof.
The draft SMPR specifies mass spectrometry as the analytical technique, and presumably methods
will detect/measure the peaks associated with certain peptides. However, the exact peptide is left
up to the method developer. Methods may differ as to the peptide and fragmentation methods.
Therefore the exact ratio of peptide to whole commodity may differ. It should be left up to the
method develop to: 1) decide which peptide and fragmentation method; and 2) determine the
appropriate conversion factor. The AOAC Expert Review Panel will review the method developer’s
proposed conversion factors as part of the method review.
RECOMMENDATION: PPM OF ALLERGEN PER COMMODITY.
WORKING GROUP DECISION:
AGREED.
2. Commutability
It was suggested that reference materials should be commutable. The term “commutability” was
first used to describe the ability of a reference or control material to have interassay properties
comparable to the properties demonstrated by authentic clinical samples when measured by more
than one analytical method.
Commutability is not an AOAC requirement for evaluation of methods.
While commutability would seem ideal, it may not be practical. A commutable allergen reference
material would require that a reference material provider demonstrate that equivalent results are
obtained using a variety of techniques, or example ELISA. Lateral flow, LC-MS, MALDI-TOF-MS, and
PCR. It would seem unlikely that many, if any, reference materials would be characterized by
multiple techniques, and just as unlikely that equivalent results would be demonstrated.
RECOMMENDATION: DO NOT REQUIRE COMMUTABILITY OF REFERENCE MATERIALS.
WORKING GROUP DECISION:
AGREED.
ADDITIONAL: COATES TO REACH OUT TO DAIRY COMMUNITY TO IDENTIFY ADDITIONAL REFERENCE
MATERIALS USED BY THE INDUSTRY.
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3. VITAL reference doses
3.1 Voluntary Incidental Trace Allergen Labeling (VITAL) is a project of the Allergen Bureau based in
Australia/New Zealand. There is also an EU-VITAL. VITAL is a voluntary consensus project to
establish maximum levels of allergens for safe consumption by individuals with food allergies.
The maximum allergen concentrations are calculated using the specification provided by the
commenter for a 200 g serving size of food.
serving
size (g)
converted
to kg
mg/kg
hazel nut
200
0.2
3.2
milk
200
0.2
15.2
peanut
200
0.2
4
whole
egg
200
0.2
1.2
As the commenter noted, the maximum permissible concentration of allergens are all below the
proposed LOQ in the SMPR.
While the VITAL concentrations are not binding, they are based on scientific studies.
RECOMMENDATION: LOQ AND RANGES CONSISTENT WITH THE VITAL WOULD SEEM TO BE A
BENEFIT FOR INTERNATIONAL TRADE, AND THEREFORE A GOOD REASON TO REVISE THE SMPR.
WORKING GROUP DECISION: VITAL IS NOT AN INTERNATIONALLY RECOGNIZED STANDARD.
AGREED NOT REVISE THE SMPR.
3.2 VITAL values are based on amount of protein per service size. Therefore, the definition of the
food allergens as “food commodities” without mentioning the protein content will establish a
non-comparability between results obtained by an LC-MS/MS method and VITAL values.
Method developers can provide conversion factors in their methods for peptide to protein to
“whole” allergen.
RECOMMENDATION: NO CHANGE RECOMMENDED.
WORKING GROUP DECISION: AGREED WITH RECIMMENDATION.
NO CHANGE RECOMMENDED.
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