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limits of the analytical methods would require the use of assumptions about the biological response thresholds. In that case, the thresholds are actually based on using another approach and should not be considered an analytical methods-based threshold.

Advantages. When accurate, validated methods are available to measure food allergens, determining a threshold based on these methods can be a straightforward way to establish that products are in compliance with this defined level.

Limitations. There are several disadvantages to using this approach in determining thresholds for food allergens:

  • 1.

    The approach is not risk-based and it is likely that the appropriateness of any thresholds established using this approach will be questioned as existing methods are improved or new methods are developed. Further, in the absence of information on biological response thresholds, it is difficult to assess how well thresholds established using this approach protect public health.

  • 2.

    Validated analytical methods are currently not available for all of the major food allergens. However, this is likely to change rapidly if there is a need for such analytical capability.

  • 3.

    There is uncertainty as to the performance of the available analytical methods in the wide variety of food matrices that are likely to be encountered. Theoretically, the test methods should be validated for all foods and food matrices, but this is not practical.

  • 4.

    Current methods, which are based on a food’s total protein content, will not be sufficient in the future if techniques and technologies for reducing the levels of specific allergenic proteins are developed.

Presumably, the analytical methods used to establish thresholds in this approach could also be used to evaluate compliance with any applicable legal requirements. However, the ability to use these methods to help prevent the introduction of unlawful product into the market place would require that the methods be applied in a scientifically supportable manner. This would require the establishment of a statistically supportable sampling plan. The cost of the sampling to a degree sufficient to provide reasonable statistical confidence is potentially an issue.

Finding 2. The analytical methods-based approach could be used to establish thresholds for those food allergens for which validated analytical methods are available. However, if this approach is used, the thresholds should be replaced by thresholds established using another approach as quickly as possible.

b. Safety Assessment-Based Approach. The safety assessment-based approach could be used to establish thresholds based on NOAELs or LOAELs reported in the literature in combination with appropriate uncertainty factors. Because very few publications report NOAELs or present results in a form that allows NOAELs to be calculated, this type of analysis would, for most food allergens, be based on LOAELs. NOAELs should be used when they are available or can be calculated (see Appendix 2).

Revised Threshold Report Page 53 of 108

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