October 16, 2020 — The symptoms of food allergies can span from a mild itchy mouth to full blown anaphylaxis resulting in death (although fatalities are relatively rare). Some food allergies are so severe that even small amounts of allergens of less than 1 mg protein can trigger an allergic reaction in the most sensitive of allergic individuals. It is in addition important to not consume foods that have been cross contaminated with an allergen, because the amount of allergen present is currently not defined and might be high enough to cause severe allergic reactions.
A series of interesting findings on the importance of correct measures for allergy labelling were presented at FAAM 2020 by experts in the field. Sessions “Precautionary Allergen Labelling: the patient perspective” by Sabine Schnadt and “The pitfalls of Allergy Testing and electronic allergen information provision” by Michael Walker, emphasise the current challenges in precautionary allergen labelling, also known as PAL. One of the key aspects required to make the application of PAL more transparent are commonly agreed amounts of allergens which trigger the use of PAL. Delivering such data is a key aspect of the ThRAll project, and the topic of an oral poster presentation “Compiling a consensus database for ThRAll” by Chloe French from the group of Clare Mills.
Precautionary Allergen Labelling: voluntary and volatile
Since food allergies can be dangerous, food manufacturers must label their foods accordingly. While mandatory labelling of allergenic ingredients informs about the deliberate use of 14 major allergens in the EU (Regulation (EU) No 1169/2011), Precautionary Allergen Labelling (PAL) statements indicate that an allergen might unintentionally be present in a food product, and they are provided on a voluntary basis. There is currently no official framework which informs food manufacturers on when and how to use PAL.
“PAL remains problematic for many – while the “may contain” was initially an honest attempt by manufacturers to label their products, and provide information on cross contamination arising from contact in the supply chain or the manufacturing process, it developed into a plethora of formats. With now over 25 ways of saying “may contain”, people with food allergies tend to not trust it or ignore it – it is not useful for them, nor to manufacturers themselves.” Says Prof. Michael Walker, Laboratory of the Government Chemist, UK.
Research shows that PAL is used appropriately by some food business operators (FBO), reflecting the real risk of unintended allergen presence. On the other hand, some FBOs use PAL with improper risk assessments that do not take into consideration whether there is a threat to the health of food allergic consumers.
Unfortunately, patients cannot distinguish one from the other by just looking at the label. The same applies to a missing PAL: it could mean that the FBO did allergen management and applied a quantitative risk assessment concluding that PAL is not needed and that these food products are safe for allergic consumers to eat. But they cannot be discriminated from those products where FBOs did not choose to use a PAL or did not apply a proper risk assessment.
These issues cause a lot of confusion and can put patients with food allergies at risk of experiencing allergic reactions on one hand, and restricting their food choice and limiting their quality of life on the other hand.
“Legislation around PAL is desperately needed to make it meaningful. PAL should only be applied, when there is an actual risk to health, and the absence of PAL must imply a clear level of safety. PAL should be the result of a quantitative risk assessment based on agreed reference doses that are relevant to protect patients with food allergies from severe allergic reactions. The wording of PAL must be easy to understand, uniform and consistent,” says Sabine Schnadt, German Allergy and Asthma Association.
The Codex Alimentarius Commission is currently evaluating scientific evidence regarding food allergens through an Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens. The purpose of this project is to (i) validate and update the priority list of allergenic foods and ingredients based on risk assessment, (ii) establish threshold levels in foods of the priority allergens, and (iii) evaluate the evidence in support of PAL. Most patient organisations within the EAACI Patient Organisation Committee, European Federation of Allergy and Airway Diseases (EFA) and the iFAAA support regulation of PAL to give patients the opportunity to make informed and safe food choices that will reduce anxiety and increase quality of life.
“Allergen information in prepacked and non-prepacked food products should always be accurate and available to consumers. The EU Regulation on Food Information to Consumers (FIC) represents a good progress in providing food allergen information, yet EU and national authorities should ensure a proper implementation of the law, the harmonisation of Precautionary Allergen Labelling and the development of educational trainings on food allergen management for FBOs. These measures will allow consumers with food allergies to make informed choices, preventing potential life-threatening events and improving their and their caregivers Quality of Life,” says Sofia Ramagosa, European Federation of Allergy and Airway Diseases (EFA).
Identifying levels of unintended allergens that trigger the use of PAL
A crucial aspect of the food allergen risk assessment process is identifying the amount of an unintended allergen that is safe for allergic consumers and above which PAL is applied. These levels can be based on the doses of allergens that can elicit an allergic reaction and come from oral food challenges used to diagnose food allergies. However, these data are generated during oral food challenges, which are typically conducted independently using a small sample with different populations, protocols and food matrices and can be difficult to harmonise. The ThRAll project, funded by the European Food Safety Authority, the Belgian Authority and the Food Standards Agency, is working with clinical collaborators across Europe to develop strategies for collating such data into a publicly available repository. This harmonised database will be used to define threshold and minimum eliciting doses for foods in which there are currently knowledge gaps. It also provides a publicly available which can support the identification of reference doses for allergens to assist with effective allergen risk assessment and management in future.
EFSA Disclaimer: The ThRAll project has received financial support from the European Food Safety Authority (EFSA), Grant GP/EFSA/AFSCO/2017/03. The present article, however, is under the sole responsibility of the authors. The positions and opinions presented in this article are those of the authors alone and do not necessarily represent the views/any official position or scientific works of EFSA. EFSA guidance documents and other scientific outputs of EFSA, can be found in the EFSA website: http://www.efsa.europa.eu.
“Quantitative risk assessment could generate critical allergen protein concentrations which we can test against, and testing against them will enable decisions to be made about whether PAL should be applied or not. If we fail to realise the promise of current risk assessment and risk management of food allergens through lack of the ability to measure food allergens reproducibly and with traceability to an international unit of measurement, the analytical community will have failed a significant challenge. We need an international programme for the production of properly characterized, clinically relevant reference materials; a bioinformatics programme; more than one reference method; and cooperation between institutes expert in measurement science and in protein chemistry. Only through these
measures we can protect the food allergic people in our community,” says Prof. Michael Walker, Laboratory of the Government Chemist, UK.
Vital information that catches the eye
In addition to PAL, an allergen information section, icons, and allergenic ingredients are also displayed on the package. The problem is that in today’s global market an allergic consumer may be confronted with various presentations of each of these. Marty Blom, from TNO in The Netherlands presents a qualitative evaluation was undergone by TNO, the University of Utrecht and the University Medical Centre Utrecht in her Oral Abstract Session “Allergen labeling: current practice and improvement from a communication perspective”. The study looks at the effectiveness of labeling practices using basic design principles, cognitive load and Gestalt theories, for people tracing relevant information on allergens to decide if the product is safe to consume.
The findings suggest several discrepancies between the 288 labels that were analysed, including lack of contrast by background and wrongful use of colours; diversity in how the allergen is displayed on the label; unrelated information interfering with allergen information, diversity in location of allergen information and topic order.
“Allergic consumers and people buying food for allergic patients will encounter a wide variety of ways in which allergen information is communicated on the labels currently. We recommend a good readable label, grouping of related allergen topics, and a uniform topic order, a single type of PAL statement and an allergen information section enabling the consumer to ask any relevant questions to protect their health and get the answers they need,” says Marty Blom, TNO, The Netherlands.
While the 2011 European food labelling legislation was a very helpful step forward for consumers with food allergies, and the welcome Natasha’s Law – set to strengthen the allergy labelling regulations for foods prepared and packaged on site- will enter force in the UK in October 2021, EAACI now considers that it is time to revisit the current legislation, to provide the most accurate information to safeguard food allergic patients and facilitate their daily choices.
In this respect, EAACI has convened an Expert Taskforce to review the evidence base for Food Allergen Thresholds and produce a position paper to describe how this evidence base can be used to deliver personalised patient care: improve diagnosis, optimise immunotherapy and better inform dietary management in the consumers with food allergy. We are also planning to undertake a major, panEuropean iterative stakeholder consultation with patient representative organisations to (i) define what patients understand by “acceptable risk” in terms of the trade-off between PAL and appropriate dietary restrictions (ii) better understand what patients want from PAL, and in a meaningful and trustworthy way.
About the EAACI
The European Academy of Allergy and Clinical Immunology (EAACI) is an association of clinicians, researchers and allied health professionals founded in 1956. EAACI is dedicated to improving the health of people affected by allergic diseases. With more 12,000 members from 124 countries and over 75 National Allergy Societies, EAACI is the primary source of expertise in Europe for all aspects of allergy.
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