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FDA issues guidance for assessing public health impact of food allergens other than major food allergens listed in FDCA

USA

Jan 10, 2025

The Food and Drug Administration (FDA) has published Guidance for FDA Staff and Interested Parties: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the Federal Food, Drug, and Cosmetic Act. This guidance addresses substances that are currently consumed in food or have previously been consumed in food, within or outside the United States, such that there is a body of information about adverse reactions experienced by consumers who ingest the substance.   This guidance does not address the potential that a substance that would be new to the food supply might be a food allergen.  This guidance also does not address scientific research regarding potential cross-reactivity to a known food allergen and how this research could help determine whether a substance in food could be a food allergen.

This guidance describes the approach we generally intend to take when we evaluate the public health importance of a non-listed food allergen by specifying:

  • The scientific factors that we generally intend to consider when evaluating the public health importance of a non-listed food allergen.
  • Other information, relevant to the labeling and production of food containing the food allergen, that we generally intend to consider when evaluating the public health importance of a non-listed food allergen.
  • Recommendations for how to identify and evaluate the body of evidence applicable to an evaluation of the public health importance of a non-listed food allergen.

 

 

For further information (in English), click on the Link

Check the full text of the documents (in English), click on the Link

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