Codex Expert panel recommendations on food allergen labelling

• Review the current Codex priority allergen list to establish whether any foods and ingredients need to be added or removed.
• Provide clarity on the grouping of foods and ingredients included on the list.
• Provide guidance on whether certain foods and ingredients, e.g. highly refined ingredients derived from priority allergens, can be exempted from mandatory declaration.

Criteria

The criteria below were established and applied to select priority allergens:

• Prevalence – How many people experience immune-mediated hypersensitivity reactions when they are exposed to the food in question?
• Severity – How severe are resulting hypersensitivity reactions likely to be, and how many individuals are likely to have severe objective reactions such as anaphylaxis?
• Potency – How much of the offending food or ingredient is required to cause an objective reaction?

Conclusions

• Only foods that cause immune-mediated hypersensitivity reactions (IgE-mediated food allergies & coeliac disease) should be included on the Codex priority allergen list.
• The global priority allergen list should include:
  • Cereals containing gluten – wheat and other Triticum species, rye and other Secale species, barley and other Hordeum species and their hybridised strains
  • Crustaceans
  • Eggs
  • Fish
  • Milk
  • Peanut
  • Sesame
  • Tree nuts – almond, cashew, hazelnut, pecan, pistachio, walnut
• Based on prevalence data, the foods below can be considered to be included on individual countries’ priority allergen lists:
  • Buckwheat
  • Celery
  • Lupin
  • Mustard
  • Oats
  • Soybean
  • Tree nuts – Brazil nut, macadamia, pine nut.
• The foods below were highlighted and placed on a ‘watch list’. Based on future prevalence, severity and potency data they will be evaluated for inclusion on the priority list.
  • Pulses
  • Insects
  • Kiwi
• Foods and ingredients derived from priority allergens should be evaluated for labelling exemption on a case-by-case basis.

• Establish threshold levels for priority allergens below which most consumers will not suffer an adverse food reaction.
• Recommend appropriate analytical methods to test food and surfaces for the presence of priority allergens.
• Make recommendations on what the minimum performance criteria for analytical methods should be.

Conclusions

• The recommended reference doses were based on ED05* values and expressed in mg/kg protein from the allergenic source.
• It was advised that analytical capability does exist to some degree to implement and monitor the recommended reference doses, but that there are limitations in method performance.
• It was recommended that the expression of analytical results be standardised to mg/kg protein from the allergenic source.
• It was advocated to address deficiencies in analytical methodology, to develop method performance criteria, and to improve accessibility to reference materials.
• The panel expressed that there is a need to better understand assay performance in different matrices, and for transparency regarding assay-specific reagents such as antibodies used in ELISA.

* See considerations in full report. ** Provisional.

• Analyse and evaluate the evidence supporting precautionary labelling (PAL).
• Provide support for the CCFL’s current efforts to formulate guidance on the use of PAL.

Conclusions

• Currently the use of PAL is voluntary in most countries, and its application is typically not based on the outcomes of a standardised risk assessment process.
  • The arbitrary use of PAL and/or inappropriate absence of PAL results in consumers misinterpreting the risks posed by UAP. 
  • Currently, consumers find PAL to be confusing, leading to an erosion in consumer trust and effective communication, which increases the health risk to allergic consumers.

• Several manufacturers, consumers and other stakeholders do not understand the current strategies used to communicate the risk associated with UAP in products. 
• An effective strategy to protect consumers from unintended allergen exposure is to have a PAL statement based on a comprehensive allergen risk management programme, and implemented using a single, clear, unambiguous advisory statement that conveys that the particular food is ‘not suitable for’ consumers with a particular allergy.
• Allergic consumers and other stakeholders must be educated on the principles and meaning of PAL to ensure its correct interpretation.
• The recommended reference doses are not to be used for claiming that a food is free from specified allergens. 
• The panel will consider ingredient exemptions from priority allergen labelling in the future. 
• Education of allergic consumers (or those providing food for them, including FBOs) and other relevant stakeholders (e.g., risk assessors, risk managers, healthcare providers) is critical, to ensure understanding of the applied principles and the implications of the chosen phraseology.
• Under the proposed framework the committee concluded/recommended that:
  • PAL based on the proposed reference doses (see phase 2 conclusions) will protect the vast majority of food-allergic individuals from severe reactions.
  • Individuals with food allergies avoid products that carry a PAL for the allergens of concern to them. However, the panel recognises that such foods may not pose a risk to less sensitive individuals.

• To develop an approach or framework that can guide decision making on whether an ingredient or product can be exempted from mandatory declaration. This is applicable when an ingredient is derived from or contains a food that causes hypersensitivity, but the food is highly refined and may not cause a reaction.

Conclusions

• A guidance process in the form of a flow diagram was created, tested (using already exempted ingredients as case studies) and found to be fit for purpose.
• The process comprises 10 steps, each asking for key information that will help to determine whether the ingredient can be exempted.
• Among other requirements, the process asks:
  • For a clear description of the ingredient or product.
  • For documentation describing how it has been used in the past, its safety data, and whether it has ever triggered an allergic reaction.
  • For a description of the ingredient/product, including process parameters, composition and purity, and how much total protein from the priority allergen, it contains.
  • Whether it is equivalent to a product that has already been granted an exemption.
  • If necessary, for information on the maximum amount of protein, from the allergen, that consumers are likely to consume, based on the typical use of the ingredient/product.
  • If necessary, for information on how the allergenicity of the ingredient/product is reduced due to processing.
  • If necessary, for a clinical evaluation of the ingredient/product.
• The flow-chart was found to be effective, and proposed for use in the consideration of future exemption decisions.