FAO/WHO take on precautionary allergen labeling (PAL)

The third in a series of meetings of a Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens took place from 18 to 29 October 2021.

The first meeting was held in December 2020, following a request from the Codex Committee on Food Labelling (CCFL) to verify and, if necessary, update the priority allergen list, which groups the most relevant allergens at a global level. The meeting led to an identification of the criteria for assessing additions and exclusions from such a list, which, in turn, led to soy being removed from it, replaced by sesame (see Bert Popping’s first-hand report from the meeting here).

The second meeting stemmed from a CoP developed by the Codex Committee on Food Hygiene (CCFH) related to the handling of allergens throughout the supply chain. CCFH asked FAO and WTO to provide scientific advice on allergen thresholds. In March 2021, it resulted in preliminary threshold levels being established by the Expert Consultation for priority allergenic foods, as well as analytical methods being recommended for the detection of allergens in food and food processing environments (see Bert’s again and the report).

The aim of the third meeting was to review and evaluate the evidence in support of precautionary allergen labelling (normally referred to as PAL).

The experts agreed on considering PAL an effective way to protect consumers against unintended allergen presence (UAP). A PAL system based on risk-based reference doses (RfDs) would be protective for most of the allergic consumers. Under the current situation, however, the system could be overprotective for some people. Also, a PAL system should necessarily be supported by proper allergen management and use a single, clear and not ambiguous statement.

The experts also noted that PAL is currently voluntary in most legislations, which leads to information related to it being presented in an inconsistent way or being completely absent in cases where it should be provided. Based on the findings of the experts, consumers regard PAL as confusing. This results in a misinterpretation of the risks related to unintended allergen presence. It has also been found that there is a general lack of understanding of the appropriate strategies to communicate precautionary allergen-related messages.

Based on those conclusions, the Joint FAO/WHO Expert Consultation released some recommendations.

First of all, the experts recommend that PAL is embedded in a regulatory framework that makes it mandatory for FBOs to make use of it when the unintended allergen presence exceeds the RfDs, but which also bans its use when the allergen presence is below the threshold. When no threshold exists for a given allergen, an estimated RfD should be used. According to the experts, PAL should be accompanied by a symbol highlighting that an appropriate risk assessment has been performed with regard to the need for such a system.

Not by chance, the expert group also highlights the importance of having appropriate allergen management and control systems in place, which are regarded as a “prerequisite” for every FBO. PAL should not be seen as a way to handle a potential deviation from such systems. Its use should be based on hazard identification and risk characterization and restricted to situations where unintended allergen presence above the RfDs for priority allergens cannot be avoided despite an appropriate and coordinated use of the FAO/WHO Code of Practice on Allergen Management for FBOs, GMPs, HACCP and UAP risk assessment systems. In this regard, the experts also developed a diagram, which can help determine when PAL should be included and when it should be omitted.

The expert group also recommends that PAL is presented in a way that is “simple, clear, unambiguous and not false or misleading”. Precise and harmonized warnings should be used. Furthermore, appropriate training for consumers and FBOs alike is desirable, too.

This diagram is attached to the summary of the meeting, freely available here. Such papers and guidelines are not of course mandatory as law, but are a huge first step in the right direction for correct allergen management.

(by Simone Volpe and Cesare Varallo)


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