title: Allergen and allergy risk assessment, allergen management, and gaps in the European Food Information Regulation (FIR): Are allergic consumers adequately protected by current statutory food safety and labelling regulations?
abstract: Individuals suffering from IgE-mediated food allergies are obliged to systematically eliminate the culprit allergen from their diet. To support allergic consumers in avoiding food allergens to make informed and safe purchasing choices, the European Union (EU) Food Information Regulation (FIR) imposes a requirement to label the 13 most common allergenic foods (food groups) as ingredients in pre-packed and non-pre-packed foods. The as yet unregulated labelling of unintended presence of allergens has lead to a widespread use of precautionary allergen labelling (PAL) - despite established allergen management in many companies. This PAL significantly hampers making a safe food choice, or renders it largely unfeasible, since it is not possible to estimate the actual extent to which allergens are present in a product. Not only food-allergic consumers, but also the food industry, physicians, dieticians/nutritionists, as well as food regulators and law enforcement officers would benefit from a standardized labelling regulation for unintended presence of allergens. The following position paper highlights the chances of such a regulation on the basis of available data and the analytical methods for detecting allergenic components in the context of effective allergen management. On the basis of evidence-based allergen and allergy-risk assessment, the use of PAL should be restricted to only those allergens that are unavoidable and which represent an unacceptable risk for allergic consumers, e. g., when allergens are present at levels that exceed a clinically meaningful reference dose or in the case of unintended presence of particulate allergens (e. g., nuts or sesame seeds).
authors.affiliation: Nutritional Counselling and Therapy, Allergology, Munich, Germany ; Ansprengerstr. 19, 80803 Munich, Germany.
authors.forename: Imke
authors.initials: I
authors.lastname: Reese
authors.affiliation: Paul-Ehrlich- Institute , Allergology Department, Langen, Germany.
authors.forename: Thomas
authors.initials: T
authors.lastname: Holzhauser
authors.affiliation: German Allergy and Asthma Association, Mönchengladbach, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Schnadt
authors.affiliation: Department of Dermatology, Venereology and Allergology, Charité Allergy Centre, Charité University Hospital, Berlin, Germany.
authors.forename: Sabine
authors.initials: S
authors.lastname: Dölle
authors.affiliation: Westend Allergy and Asthma Centre, Berlin, Germany.
authors.forename: Jörg
authors.initials: J
authors.lastname: Kleine-Tebbe
authors.affiliation: Medical Clinic 1, Gastroenterology, Interventional Endoscopy, Functional Tissue Diagnostics, Erlangen University Hospital, Erlangen, Germany.
authors.forename: Martin
authors.initials: M
authors.lastname: Raithel
authors.affiliation: Department of Dermatology, Venereology and Allergology, Charité Allergy Centre, Charité University Hospital, Berlin, Germany.
authors.forename: Margitta
authors.initials: M
authors.lastname: Worm
authors.affiliation: Department of Dermatology, Venereology and Allergology, Charité Allergy Centre, Charité University Hospital, Berlin, Germany.
authors.forename: Torsten
authors.initials: T
authors.lastname: Zuberbier
authors.affiliation: Paul-Ehrlich- Institute , Allergology Department, Langen, Germany.
authors.forename: Stefan
authors.initials: S
authors.lastname: Vieths
keywords: allergen risk assessment; food allergy; labelling; precautionary labelling; reference doses; unintended presence of allergens