粮农组织世界卫生组织关于食品过敏原风险评估的特设联合专家协商——含谷蛋白或谷蛋白谷物的参考剂量

Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens–reference dose(s)for cereals containing gluten or gluten FAO HQ, Rome, Italy:3–7November2025 SUMMARY AND CONCLUSIONS IssuedinNovember2025 In response to the request from CodexCommittee on Food Labelling (CCFL)for scientific advice onreference dose(s) (RfDs) and concentration forgluten andcereals containing gluten, FAO and WHO FAO and WHORisk Assessment of Food Allergens. Part 1–Review and validation of Codex Alimentariuspriority allergen list through risk assessment1,contains details aboutcoeliac disease andIgE-mediated allergies to cereals containing gluten. Thiscurrentdocument summarizes the conclusions of thismeeting andis made availableto facilitate thedeliberations of theCCFLand Codex Committee on Food Hygiene(CCFH). Thefullreport of the meeting Themeetingparticipants are listed in Annex 1ofthis summary report.Melanie Downsserved as More information on this work is available at:http://www.fao.org/food-safety/en/andhttps://www.who.int/foodsafety/en/ The issuance of this document does not constitute formal publication. The document may, however,be freely reviewed, abstracted, reproduced or translated, in whole or in part, but not for sale or use in Coeliac disease •Coeliac disease is a chronic,immune-mediated(non-IgE)intestinal and systemicdisease ingenetically predisposed individuals induced by exposure to dietary glutenproteinsthat come oForindividuals withcoeliac disease, sustained ingestion of gluten is associated withsmall intestinal mucosaldamage and anincreasedrisk ofa range ofadversehealthoutcomes.oIn addition to chronicintestinalinjury, gluten can also trigger acute symptoms inindividualswith coeliac diseaseotherwiseadhering to a gluten-free diet,thatadverselyimpact their quality of life. •Individuals with coeliacdiseasecan be exposed to gluten througha variety of sources includingundeclared ingredients in packaged foodsor food service operations, cross-contactinpackaged oAccess to affordable, available,and safe food optionsis importantforindividuals withcoeliac disease.oOne of the concerns with current labelling practices is the confusing use of gluten-free •In 2008, CodexAlimentarius Commissionestablished thatgluten-freefoodsshould containlevels of glutennohigherthan20 mg/kg[CXS-118]2.Witha daily intake of 500 g offoodwithlevels of gluten no higher than 20 mg/kg, this would equate toan intake ofno more than 10 mg oThis level was primarily informed by a single,double-blind randomisedcontrolled trialwhich showed that 50 mgof glutendaily forthreemonths causedmucosal damageinmost, but the effect at 10 mgglutenwasnotstatistically significant. The experts notedthis wasastudy witha smallnumber of participants.oAsdatacontinue to belimited,more robust data on the chronic exposure threshold •While the data forestablishinga tolerable daily intake of 10 mgglutenarelimited,they remainrelevant andthe implementation of a definition of gluten-freeatlevels of gluten no higher than20mg/kghas been successfulinimprovingthe availability and safety of foods for individuals oThe expertsagreedthatRfDsfor glutenforthe PAL frameworkshould not be used asthe basis fordefining gluten-freelabelling. •Individualswithcoeliacdiseasemayreact totheingestion ofoats due toeitherwheat, barley orryecross-contact(common) oroatavenin sensitivity (rare).Avenin sensitivity isoutside thescope of thismeeting,andthe issue ofgluten cross-contact in oats has been addressed in priorFAO/WHO expert consultations3,4. Reference dose(s)for glutenandcereals containing gluten •Establishing areference dose (RfD)for gluten is importantfor precautionarylabelling ofproducts that do not have a gluten-free label. •EstablishingRfD(s)for glutenin coeliac diseaserequiresa different basis than thatused for IgE- oThe nature of data relevant for establishing a protective reference dose for individualswith coeliac disease must reflect longer-term exposure risks. This differs from IgE-mediated food allergy, where acute exposures cause reactions.Consequently, themethodologyappropriateforrisk assessmentis different from that for IgE-mediated •The expertsthereforeconducted risk assessmentsto evaluate a RfD for gluten based on chronicgluten exposure, rather than making decisions based on single exposures, as has been done forIgE-mediatedfood allergy. The goal was to ensure the cumulative daily dose does not exceed 10mg gluten based on a consideration of daily intake of food from multiple individual eating •Modelling reflective of chronic or cumulativedailyexposure was conducted for potential gluten RfDs (1to10 mg of gluten).oThe gluten RfD represents the maximum acute gluten dose ingested from a single foodper eating occasion.oThe model was used to investigatethe impact of various RfDvalueson the potentialchronic daily intake of gluten.▪In this model single-eating occasion assumptions were used to derive actionlevels and the impact of these action levels on chron