ILSI Europe brings together academics, food industry, and regulators and other public service experts to address timely challenges in food safety, nutrition and sustainability. Active since 1995, the ILSI Europe Food Allergy Task Force aims to improve the assessment and management of food allergen risks to protect people with food allergies. Examples of activities include facilitating Allergen Quantitative Risk Assessment (QRA), proposing improvements to allergenicity assessments, and bringing forward discussions on an acceptable level of protection for allergic consumers.

An ongoing Expert Group formed in 2024 aims to identify barriers to, and opportunities for effective implementation of Precautionary Allergen Labelling (PAL). This initiative is designed to benefit Food Business Operators, Regulatory Agencies, and, most importantly, allergic consumers.

The food industry often uses PAL to communicate the possibility of unintended presence of an allergen. Product labels display statements like “May contain traces of nuts”. Yet PAL is not regulated. This contrasts with the labelling of priority allergenic ingredients and processing aids, regulated within most jurisdictions. PAL is therefore inconsistently used (or possibly not used), with different word choices, different risk assessments, and different interpretations from consumers. Inconsistent use of PAL may result in a food safety risk. The fact that the use of PAL is voluntary is a probable factor in the lack of standardisation in analysing the risk from unintended allergen presence in a food due to cross-contact, accounting for the inconsistent application of PAL, with inappropriate presence or absence of PAL and/or a multitude of different phrases employed. This ILSI Europe project seeks to determine the barriers to, and levers for the effective regulation of PAL for both Food Business Operators and Regulatory Agencies, and ultimately for the benefit of allergic consumers.

People with a food allergy have a mixed understanding of what PAL is meant to communicate. Most do not find it helpful in deciding if a food is ‘safe to eat’. As a corollary, some effectively ignore it (1; 2). They lack trust in PAL (2) and find it confusing.

Due to the voluntary nature of PAL, the lack of a PAL statement could effectively mean two things; either the Food Business Operator (FBO) has completed a full risk assessment and determined that risk management measures are sufficient to not warrant a PAL statement; or the FBO has not completed a risk assessment and has overlooked the use of PAL (3). Conversely the FBO may be overly conservative and used a PAL statement as they believe this to be a control as consumers with given allergies would avoid these foods (4). Consumers’ lack of understanding of, and trust in PAL statements can lead to false assumptions about the risk certain PAL phrases convey and/or a heuristic (trial and error) approach to purchasing foods, which puts them at risk of an adverse reaction (5).

The available evidence indicates that some manufacturers, consumers and other stakeholders such as health care professionals do not understand current strategies to communicate precautionary messages (6). Although the use of PAL is voluntary, different regulatory jurisdictions appear to have a divergent approach to enforcement which has resulted in market action (recall / withdrawal etc.) (7). General food law however does require FBOs to provide ‘safe food’ and could apply to the presence of allergens not declared in a PAL statement rendering the food unsafe for food-allergic consumers (2). Recently published work from the Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens (Part 3: Review and establish precautionary labelling in foods of the priority allergens (8)) recommends that the decision whether to use a PAL statement should be part of a regulatory framework and quantitative risk assessment. This would require FBOs to use PAL when Unintentional Allergen Presence (UAP) may result in ingestion of an amount that exceeds the safe level which is referred to as the reference dose (RfD) (i.e. ED05-derived RfD for priority allergenic foods as recommended in the second meeting of the FAO/WHO consultation) and not to use PAL when UAP is below the relevant RfD.

Food Allergen risk assessments today tend to use a combination of both quantitative (RfDs approach) and qualitative data (9). Regardless of whether RfDs are unilaterally accepted by CODEX and ultimately the global regulatory community, there remains a pressing need to standardise allergen risk assessment as part of the food safety program and if deemed necessary, regulate PAL to maximise choice and minimise risk for the food allergic population. If regulation is the best route to achieve harmonisation, this will provide a legal framework to ensure food allergic consumers and make informed and safe choices. This project seeks to identify the barriers and gaps preventing the effective regulation of PAL as proposed by the WHO/FAO ad-hoc Expert Consultation by taking a multi-stakeholder approach (Regulators, Food Business Operators, Health Care Practitioners, Patient Support Groups) and ultimately identify work needed & levers required to remove these barriers and address gaps such that there is a more uniform approach to decisions on PAL.

The Expert Group is expected to run for 12-months, and is composed of experts from academia, regulatory agencies, patient support groups and the food industry. The results will be published in an open access journal and in ILSI’s internal publications.