FAO/WHO Recommend Uniform Precautionary Allergen Labeling as Codex Develops Guidance
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The Food and Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO) have released a report summarizing the third meeting in a series on allergens requested by the Codex Alimentarius Commission. The work completed in the third meeting specifically relates to precautionary allergen labeling (PAL) and will support the Codex Committee on Food Labeling (CCFL) in the development of guidance on the use of PAL.
The report states that, although PAL based on a comprehensive allergen risk management program and implemented using a single unambiguous advisory statement is an effective strategy to protect consumers from unintended allergens, current use of PAL is voluntary and often not part of a standardized risk assessment process, leading to non-uniform and indiscriminate application of PAL, including a multitude of different phrases, and the inappropriate absence of PAL.
Evidence indicates that some manufacturers, consumers, and other stakeholders do not understand strategies to communicate precautionary messages relating to risks posed by unintended allergens in products. Additionally, consumers find the information provided by PAL to be confusing.
FAO/WHO suggest that the use of PAL considering risk-based reference doses (RfDs) would be protective for the vast majority of food-allergic individuals. In such a PAL, all individuals with a particular food allergy would be advised to avoid foods when PAL for that food is present on a food package. However, a small proportion of individuals with a particular food allergy who react to smaller amounts of an allergen (at or below the RfD) might not be fully protected by this PAL system, although they would be informed as to potential unintended allergen exposure above the RfD (which might cause more severe reactions). Further work may be required to determine how best to ensure hyper-allergic individuals can receive appropriate information to make informed safe food choices.
The report recommends that the decision whether or not to use a PAL statement be part of a regulatory framework that requires food business operators (FBOs) to indicate PAL when unintended allergens exceed the relevant RfD and not to use PAL when unintended allergens do not exceed the relevant RfD. FBOs should include a symbol on food labels indicating that a qualified risk assessment to inform the need for PAL has been undertaken, irrespective of whether the risk assessment outcome indicates that a PAL should be used.
Recommended RfDs are not intended to be used for making a claim that a food is free from specified allergens. The report proposes conducting a risk assessment considering ingredient exemptions from priority allergen labeling in a future meeting. If an RfD is not established for a particular priority allergenic food, an estimated RfD can be used provided it is determined following the guiding principles elaborated by the second meeting of the FAO/WHO consultation.
FAO/WHO stress that compliance with existing Codex codes of practice, good allergen management, and allergen control programs are a prerequisite for FBOs, and that the use of PAL is not a reason to deviate from adequate production practices. Adherence to the Code of Practice on Allergen Management for Food Business Operators, Good Manufacturing Practices (GMPs), and Hazard Analysis and Critical Control Points (HACCP) combined with an appropriate unintended allergen presence risk assessment should ensure that the level and frequency of unintended allergen precautions is minimized, consistent with the principles for PAL. The use of PAL should be restricted and applied to situations where unintended allergens cannot be prevented and may result in an exposure above the RfD for a priority allergenic food.
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FBOs should retain documented evidence of compliance with the Code of Practice, HACCP and the unintended allergen presence risk assessment process if an indicator that risk assessment has been conducted is on a label. Analytical methods used to inform the risk assessment process and validate or verify cleaning processes should have a demonstrated fitness-for-purpose and report in units of milligrams of total protein from the allergenic source per kilograms of food analyzed (parts-per-million of total protein from the allergenic source).
Regarding the messaging of PAL, the report states that communication should be simple, clear, unambiguous, and not false or misleading, through the use of a consistent and harmonized approach. For example, a single, unified phrase, which conveys to consumers that the product with PAL poses a health risk to individuals that have an allergy to that particular food and is not suitable for their consumption. The precise wording of the single phrase for PAL needs to be decided by CCFL in conjunction with all relevant stakeholders and should consider local linguistic nuances. Education of allergic consumers, food providers, and other relevant stakeholders (e.g., risk assessors, risk managers, and healthcare providers) is important to ensure understanding of the applied principles and the implications of the chosen phraseology.
