粮农组织-世界卫生组织食品过敏原风险评估特设联合专家协商——风险评估指南

1and Conclusionsand Recommendations•Food allergens are a distinct category of food safety hazards, with uniquecharacteristicsdifferentfromthose ofchemical, microbiological, and physical hazards.Differentiating foodallergens from other hazardsinriskassessment andriskmanagementwill improve food safety.oThe panel recommends thatrelevant documentsbe updated accordingly.•Food allergens should be controlled through appropriate food safety managementsystems.oThis includes compliance with existing Codexdocuments(e.g.codes of practice), goodallergen management,andotherqualitysystems.oBy adhering toexistingfood allergen labellingand informationrequirements,foodbusinessoperators (FBOs)already hold much of the information needed to conductfood allergen risk assessment.oUnintended allergen presence (UAP) of priority allergenic foods1(including ingredients,food additives and processing aids) due to cross-contact should be eliminated ormitigated/controlled to a level as low as reasonably possible through good hygienepractices (GHPs), good agricultural practices (GAP), good manufacturing practices(GMP), and procedures based on HACCP principles (e.g., General Principles of FoodHygiene CXC 1-1969; Code of Practice on Food Allergen Management CXC 80-2020).•The goal of food allergen risk assessment is to support informed decisions,e.g., on labelling orprocess control,andcommunicationthrough the supply chain.•The risk assessment process for food allergens is applicable and achievable for all FBOs,including primary producers.oTherefore, it is recommended that the definition of small and/or less developedbusinesses (SLDBs) and documents providing guidance to them (e.g., "FAO/WHOguidance to governments on the application of HACCP in small and/or less-developedfood businesses2") should be reviewed and updated.•Risk assessment of food allergens is interconnected with risk communication and riskmanagement within the overall risk analysisframework.•Food allergenrisk assessment ispart of astepwiseanditerativeprocesswithinformationrequirementsthatmay differdepending on theapplication.•Thisiterative processallows forimprovementofthe supply of safe foodthrough theinvestigation andpotentialimplementationofrisk mitigationpractices.1Priority allergenic foods refer to the global priority allergenic foods and those relevant to the applicable nationalor regional jurisdictions2FAO and WHO.2006. FAO/WHO guidance to governments on the application of HACCP in small and less-developed food businesses. https://www.fao.org/4/a0799e/a0799e00.htm andhttps://iris.who.int/handle/10665/43598 2 3oImprovements infood allergen managementmayalso have an overallpositive impactonother food safety and quality aspects.•Irrespective ofthesize of business,risk assessment for foodallergensshould beevidence-based,andinformationshould be collected andbeable tosupport a decision.oThe initial steps of any food allergen risk assessment are commonfor all FBOs andprimary producers,typesof products, and manufacturing processes.oInformation required for such risk assessmentisqualitative and,depending on thesituation,mayneed tobesupplemented withquantitativeinformation.oOften,a completed risk assessment may solely rely on qualitative informationobtainedin the initial steps.oWhen needed, quantitative information mainly concerns estimation of the possible leveloramount of UAP.Suchestimationmay be based onproduct formulation,volumes orsizes of observed allergenic material,volumes or sizes of production equipment,and/orappropriateanalytical results.oVery often,risk assessment can be completed withoutanalytical data.▪When needed, analytical data can include, for example, results of total proteinestimation (e.g., based on nitrogen determination), gravimetric analysis (e.g.,weighing of particulates), and allergen-specific methodology (e.g., immunoassayresults).▪Analytical data in isolation is insufficient to complete a risk assessment.•Conducting a food allergen risk assessment is required to justify precautionary allergen labelling(PAL) decisions3.•A food allergen risk assessment framework was developed to enable risk communication andinformed risk management decision-making. Figure 1 is a summary representation of thisframework.oThe detailedframeworkwith explanatory notes willbeincluded in the full report.▪It is recommended thatthisdetailedframeworkisused by FBOs, competentauthorities,andotherstakeholdersto conductfoodallergen risk assessment.oThe proposed framework does not differentiate between exclusively qualitative andquantitative approaches, rather it utilizes qualitativeinformation and, where required,the combination of qualitative and quantitative information.oThe potential combination of qualitative and quantitative information within a riskassessment is not unique to food allergens and is common in other fields of riskassessment for food.3For more information, refer toFAO and WHO.2023. Risk assessment of food allergens–Part 3:Review andestablish precautionary labelling