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Evaluation of Allergenicity of Genetically Modified Foods

Report of a Joint FAO/WHO Expert Consultation on Allergenicity of Foods Derived from Biotechnology, 22 – 25 January 2001









Last updated date 16/03/2021, see corrigendum



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    For some people, certain foods may trigger an allergic reaction - a medical condition where their immune system mistakenly responds as it would to a danger. The proteins in food that trigger allergic reactions are known as food allergens. Approximately 220 million people worldwide have food allergies. A single food item may contain more than one allergen. People may have allergies to multiple foods. Establish threshold levels for priority allergenic foods. Through risk assessment, reference doses, based on health-based guidance values for each of the priority allergens were recommended.
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    The Codex Committee on Food Labelling (CCFL) requested scientific advice as to whether certain foods and ingredients, such as highly refined foods and ingredients, that are derived from the list of foods known to cause hypersensitivity can be exempted from mandatory declaration. The objective of this fourth meeting was to expand on the recommendations from the first meeting concerning derivatives of food allergens and establish a framework for evaluating exemptions for food allergens.A pro forma process has been developed and tested against allergen derivatives previously granted exemptions in various countries or regions and found to be effective for consideration in future exemption decisions. The Expert Committee recommends that the process outlined in the pro forma process be used to guide any future development and evaluation of derivative exemptions. Establishment of safety based upon this weight of evidence approach is dependent upon consideration of data quality, outcome of the exposure assessment for all intended ingredient uses (specified for exemption) and review by competent authorities (as needed). When safety is established, exemption can be justified.
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    FAO and WHO reconvened a third meeting to review and evaluate the evidence in support of precautionary allergen labelling to address unintended allergen presence in foods. The Expert Committee at the third meeting reviewed the data on the current status and uses of the precautionary allergen labelling (PAL) and unanimously agreed that current PAL systems used in many countries needed to be improved as they were neither uniform nor informative and were not consistently risk based on amount and frequency of UAP found in food products. The Expert Committee also found that current PAL approaches led to widespread PAL that diminished information and value for consumers. The Expert Committee reviewed again the principles and basis of RfD from the second meeting and reached a consensus that the RfD for each priority allergen, as described by the HBGV and safety objectives, was a valid risk assessment endpoint for determining when sporadic or unexpected UAP posed more than appreciable risk to consumers and needed to be communicated to consumers by PAL.

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