Can we define a level of protection for allergic consumers that everyone can accept?

• Published in: Regulatory toxicology and pharmacology 2020-11, Vol.117, p.104751, Article 104751
• Main Authors: Madsen, Charlotte B., van den Dungen, Myrthe W., Cochrane, Stella, Houben, Geert F., Knibb, Rebecca C., Knulst, André C., Ronsmans, Stefan, Yarham, Ross A.R., Schnadt, Sabine, Turner, Paul J., Baumert, Joseph, Cavandoli, Elisa, Chan, Chun-Han, Warner, Amena, Crevel, René W.R.
• Format: Article
• Language: English
• Subjects: Allergens - adverse effects; Consensus; Decision framework; European Union; Food allergy; Food Hypersensitivity - diagnosis; Food Hypersensitivity - epidemiology; Food Hypersensitivity - prevention & control; Food Labeling - methods; Food Labeling - standards; Food Safety - methods; Humans; Internationality; Risk Assessment; Risk management; Tolerable risk
• ISSN: 0273-2300; 1096-0295
• DOI: 10.1016/j.yrtph.2020.104751

Substantial progress has been made in characterising the risk associated with exposure to allergens in food. However, absence of agreement on what risk is tolerable has made it difficult to set quantitative limits to manage that risk and protect allergic consumers effectively. This paper reviews scientific progress in the area and the diverse status of allergen management approaches and lack of common standards across different jurisdictions, including within the EU. This lack of regulation largely explains why allergic consumers find Precautionary Allergen Labelling confusing and cannot rely on it. We reviewed approaches to setting quantitative limits for a broad range of food safety hazards to identify the reasoning leading to their adoption. This revealed a diversity of approaches from pragmatic to risk-based, but we could not find clear evidence of the process leading to the decision on risk acceptability. We propose a framework built around the criteria suggested by Murphy and Gardoni (2008) for approaches to defining tolerable risks. Applying these criteria to food allergy, we concluded that sufficient knowledge exists to implement the framework, including sufficient expertise across the whole range of stakeholders to allow opinions to be heard and respected, and a consensus to be achieved. •Quantitative limits for unintended allergen presence have in general not been defined across and within jurisdictions.•Inability to define what risk is tolerable is a major obstacle to defining those limits.•Diverse approaches (pragmatic to risk-based) have been adopted to define quantitative limits for other food safety hazards.•How tolerability decisions were reached in the case of those hazards is unclear.•We propose a framework for transparent decisions on risk tolerability, founded on full participation of stakeholders.