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WHO developed guidance on procedures for exemptions from mandatory declarations of allergens

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On February 26, 2024, the World Health Organization (WHO) and the Food and Agriculture Organization of the United Nations (FAO) released the "Food Allergens Risk Assessment Report: Part IV Establishing Exemptions from Mandatory Declarations for Priority Food Allergens", which includes:

 

(1) The Codex Committee on Food Labeling (CCFL) has established a scientific framework for guidance on whether certain foods and ingredients, such as highly refined foods, are exempt from mandatory declarations when there are autogenic food ingredients that can cause allergic reactions;

 

(2) The flow chart of the risk assessment model was established, including the characteristics of the allergenic derivative, analysis of the allergenic protein, safety verification and exposure assessment for the proposed exemption labeling, and the effectiveness of the model was verified by testing the allergenic derivative that had previously been exempted from labeling in various countries (regions);

 

(3) The exemption proposal should assess the equivalence of any new derivative with existing ingredients from similar sources, taking into account factors such as type of source, total protein content, other key ingredient characteristics, safety and cases of existing adverse reactions, and estimate exposure by assessing consumer food consumption data and the maximum level of intended use of the derivative;

 

(4) For the currently accepted exemption designation, there is an established history of safe consumption, and based on currently approved scientific data, 1/30 of the relevant reference dose (RfD) in a reasonable and worst-case consumption scenario appears to provide an adequate exposure margin for safety assessment of the allergenic derivative, Those assessed by this procedure and meeting the threshold criteria (RfD/30) may not undergo clinical testing to determine safety.


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