Since 1993, Codex has recognized the importance of identifying and labelling food allergens, with significant updates in 1999, 2001, and 2003 to the General Standard for the Labelling of Packaged Foods (GSLPF). By now, scientific understanding of food allergens has significantly advanced and there was a need to review and update the guidance on allergen labelling and management. Therefore, FAO and WHO have convened an expert meeting to provide up-to-date scientific advice on food allergens, focusing on updating the GSLPF, establishing threshold levels for allergens, and evaluating precautionary labelling practices. Since 2020, five joint expert consultations on food allergen risk assessment have been held, and the last report was published most recently (February 2024).
The first consultation aimed to validate and potentially update the list of food allergens in the GSLPF. The experts on the committee assessed the criteria for including or excluding commodities from the allergen list. The committee focused on immune-mediated hypersensitivities and recommended that only those foods and ingredients that cause such reactions be included in the GSLPF. Foods causing non-immune-mediated reactions were excluded.
The meeting resulted in the identification of priority allergens based on prevalence, severity, and potency criteria, and a watch list of foods was created for future consideration based on emerging dietary trends.
The second consultation concentrated on establishing threshold levels for priority allergens to inform risk management strategies. The expert committee deliberated on various approaches to define these thresholds, ultimately aligning with the benchmark dose/probabilistic hazard assessment approach. The objective was to minimize clinically relevant allergic responses through the establishment of reference doses (RfDs). The committee discussed the quality and availability of data necessary for determining these thresholds and proposed RfDs for priority allergens, emphasizing the need for their practical application and the standardization of analytical methods to support this implementation.
In the third consultation, precautionary allergen labelling (PAL) was focused on. The expert committee highlighted the current challenges with voluntary and inconsistent PAL practices. The meeting emphasized the importance of a clear, unambiguous advisory statement as part of a comprehensive allergen risk management program. The committee recommended a regulatory framework for PAL, suggesting that labels should indicate when unintended allergen presence exceeds the established RfD. Education for various stakeholders was also noted as essential for the effective management of PAL. The committee concluded that Codex CoP Compliance, Good Allergen Management and Allergen Control programs are prerequisites for any PAL, and a legal framework should be created that defines when PAL can be used, and when not, e.g. when the risk assessment results in a value above the action level. The committee also suggested that PAL labelling needs to be easy to understand by consumers, with simple, unambiguous phrases, e.g. “not suitable for consumers with peanut allergy“. It also recommended considering a logo to indicate if PAL is based on risk assessment.
The fourth consultation explored the process for establishing exemptions from mandatory allergen labelling. A pro forma process was developed to assess the safety of allergen derivatives, considering their source, composition, and manufacturing process. The committee recommended using multiple test methods to determine the protein content in derivatives and outlined a weight-of-evidence approach to evaluate potential changes in allergenicity. The meeting concluded that a derivative which meets the established safety criterion (RfD/30) might not require clinical studies for safety validation.
The fifth consultation addressed establishing threshold levels for specific tree nuts and other allergens not considered global priorities but of regional or national interest. The Expert Committee reviewed available data and proposed RfDs or risk management values for these allergens, acknowledging the limitations in data quality and quantity. The meeting underscored the necessity for additional research and improved analytical methods to support the recommended RfDs. The importance of standardized reporting and the need for method performance criteria were reiterated to facilitate the implementation and monitoring of these thresholds in food safety management.
The full reports can be downloaded from both, the FAO and WHO websites. Below are the download links for the reports:
Part 1: Review and validation of Codex Alimentarius priority allergen list through risk assessment.
Part 2: Review and establish threshold levels in foods for the priority allergens
Part 3: Review and establish precautionary labelling in foods of the priority allergens
Part 4: Establishing exemptions from mandatory declaration for priority food allergens
