Precautionary Allergen Labelling (PAL) - eHandbook

 “Education of consumers, healthcare providers, food business operators, risk assessors and risk managers is critical to PAL management” (FAO/WHO 2021)            

Introduction    

What is PAL?  
PAL means precautionary allergen labelling. It is sometimes also referred to as the “may contain” statement on the food product, or other times as “advisory labelling”. “A food allergen precautionary statement is a declaration on the label of a prepackaged food of the possible inadvertent presence of an allergen in the food” (Health Canada 2012). So, PAL is a way to inform consumers that a certain allergen could be present in the product even though it is not an ingredient and thus not listed on the label. It is aimed to reduce the risk posed by the unintended presence of small amounts of allergens.    

Why did the food industry introduce PAL?  
PAL was introduced in the 80s when allergen risk was very poorly characterized to warn people with allergies of the possible unintentional and unavoidable presence of an allergen in the product. This occurrence of an allergen is called Unintended Allergen Presence (UAP).

Is PAL used in a proper way?  
Several studies have demonstrated that often the allergen reported in the PAL was not present (or, more accurately, not detectable by state-of-the-art analytical methods). On the other side, several food products on the market, without the PAL, did contain one or more allergens, which were not ingredients, mostly through cross-contamination even at relatively high concentrations (Manny et al. 2021a; Manny et al. 2021b). For many years ago it  has been evident that the lack of rules about PAL and generally the lack of harmonization of allergen regulations across the world are a big problem both for allergic consumers and for the food industries (Allen 2014).

Regulatory framework        

What does Codex say about PAL?

In 2021, the Codex Alimentarius Commission (jointly run by FAO/WHO) was requested to evaluate its existing labelling recommendation for food allergens, threshold levels and also precautionary food allergen labelling. The Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens, in its third meeting in October 2021 evaluated the current precautionary allergen labelling (PAL) practises.  
Already in 2017, Soon and Manning compiled a list of labels used as precautionary statements (Soon and Manning 2017). The collection includes statements such as “Contains: milk. Recipe: No nuts. Ingredients: Cannot guarantee nut-free. Factory: Before being prepared for manufacture of this product, the equipment was previously used to make products containing nuts. Product may contain traces of soy” and “I contain celery. I have been known to hang around near nuts, peanuts, and sesame seeds and I may contain them as well. Do not munch if you are allergic to soy beans and sesame seeds”, and a recent manuscript published by Linders et al. (2023) shows that even less convoluted PAL can be confusing for consumers. Evaluating current practices, the Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens nonetheless came to the conclusion that PAL was useful, but only if