PAL: Empowering consumers OR Encouraging risk-taking behaviour?

24 November 2021. By FACTS in Allergen Management

The risks associated with food allergens are well-studied and documented. Most countries therefore mandate the declaration of intentionally added allergenic ingredients on product labels, to empower consumers to make safe purchasing decisions. But what about allergens that are present in products due to cross-contact? Cross-contact allergens are allergens that are not deliberately added to a product, but are sporadically present due to cross-contamination along the manufacturing chain. Most countries do not directly mandate the use of precautionary allergen labelling; neither do they require that it is applied based on risk to the allergic consumer.

Precautionary allergen labelling (PAL) aims to inform allergenic consumers that a product may be contaminated with a specific allergen at levels that are unsafe for them. Internationally, and to a reasonable extent locally, there has been a proliferation in the number of products that carry PAL statements and the number of different versions of PAL statements used. This may be due to a lack of knowledge in the food industry on how to perform quantitative allergen risk assessments, and/or to undefined international guidance and consensus on how to approach PAL.

The proliferation of PAL has left consumers with two questions:

  1. Why are manufacturers applying an array of different PAL statements instead of one standardised form? Do some statements communicate an increased risk compared to others?
  2. Are food manufacturers making use of a PAL statement to protect themselves against any possible litigation, rather than controlling allergens and applying a risk-based approach?

The arbitrary use of PAL statements and the inconsistency in wording cause ‘label fatigue’ among consumers. This phenomenon increases the tendency for people to disregard label information, and may lead to either unnecessary avoidance of products, or risk-taking behaviour.

Why is a harmonised allergen information guideline necessary?

South Africa is one of only a few countries globally that actually regulates the use of PAL; in most other countries, its use is voluntary. In the absence of enforcement by authorities and/or clear allergy information guidelines on the use of a PAL statement, the industry has come up with an array of different versions of PAL to convey allergen information to the allergic consumer. Evidence shows that consumers associate different levels of risk with the different statements used (See ‘5 ways of saying “may contain soy”’, alongside). We can all agree that it may seem that the statement ‘processed in a factory that handles soy’ may not communicate the same level of risk as the phrase ‘made on a line that also handles soy’; although, in essence, they may mean the same thing. How well allergen labelling information is understood can impact life-or-death decisions.

5 ways of saying “may contain soy”:

  • “Made in a factory that uses soy.”
  • “Processed on the same line that also handles soy.”
  • “Not suitable for people who suffer from soy allergies.”
  • “This product contains no soy. However, we cannot guarantee the ingredients used are soy-free.”
  • “Before being prepared for manufacture of this product, the equipment was previously used to make products containing soy.”

How do South African regulations mandate the use of PAL?

No limits for common allergens are set in South Africa. The Regulations Relating to the Labelling and Advertising of Foodstuffs (R. 146/2010, as amended) state that if a product contains a specific common allergen as an inherent ingredient, it must be declared in the product’s ingredient list or after the word ‘Contains:’, close to the ingredient list. If a common allergen is not intentionally added to a product, but a risk for cross-contamination exists, the same regulations require manufacturers to complete a risk assessment to determine whether precautionary allergen labelling (PAL) is required. If a risk assessment indicates that the level of allergen cross-contamination holds significant risk for allergic consumers, then PAL should be applied. The appropriate PAL statement will be added to the product labelling as a ‘may contain:…’ statement.

When is a PAL statement allowed on a product label?

The decision to use a PAL statement should be based on a thorough process assessment and the implementation of an effective Allergen Control Plan (including good manufacturing procedures, sanitation and training). Only after it is concluded that inadvertent cross-contamination cannot be eliminated is the PAL appropriate. The regulations are clear in saying that precautionary labelling may not be used to circumvent the implementation of allergen controls. Hence, PAL is never to be used as a substitute for good manufacturing practices and an implemented Allergen Control Plan.

How is the risk profile of an allergen assessed?

A comprehensive quantitative risk assessment often considers known allergen threshold values to determine the need for PAL, based on real risk and not perceived risk. It is important not to regard threshold levels as acceptable levels. The VITAL® Program (https://vital.allergenbureau.net/), which is based on allergen threshold values, is a risk-based methodology that provides a common approach to due diligence for identification, reduction, and control of cross-contact allergens and the process to determine the appropriate use of PAL.

Definitions

Threshold level: The maximum amount of an allergenic food that can be tolerated by the majority of allergic individuals without producing severe adverse reactions.

The VITAL® Program offers the capability of calculating the concentration of allergenic protein from cross-contact allergens in the food product. The protein concentration is compared with scientifically determined threshold levels that decide the required action level and whether a ‘may contain’ statement is recommended.

Because PAL is not regulated in all countries – and where it is regulated, there is little equivalence – the food industry uses various forms of ‘may contain’ statements. Firstly, this approach is often inconsistent; and secondly, it may diminish the value of such advisory statements as a communication tool over time. Given the existence of a strong mandated regulation, South African manufacturers should ensure that they are not contributing to label fatigue, but rather setting the scene for striving for a globally harmonised PAL approach.

PAL should be used as a trusted tool, with standardised wording that empowers the allergenic consumer to make informed decisions. Implementation of a quantitative, risk-based approach to managing allergens will build confidence with consumers, ensuring PAL consistently communicates the same level of risk to them. It will mean reduced confusion and risk-taking behaviours for the allergenic consumer. Food producers hold the power in their hands to present consumers with credible risk-based allergen information in a purposeful manner.

The FACTS Allergen Management Department is here to assist you in your journey to managing allergens more effectively. FACTS is a registered VITAL® trainer; we offer training on site and in a workshop format.

To get more information on how to use the VITAL® quantitative risk assessment tool practically, feel free to contact us, review the Allergen Bureau website, and/or attend a training session hosted by FACTS. We also offer label reviews to ensure compliance with South African regulations. Contact us for more information.

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