Allergens as ingredients have been regulated in the EU since 2005. Due to the realities of agricultural and food production, there are situations where it is not possible to avoid the unintended presence of allergens, which in some cases might pose a risk to susceptible people. Precautionary allergen labelling (PAL) has evolved as a tool to communicate, and therefore help manage, this risk.

Currently PAL is not formally regulated in the EU, although the general principles of food safety law arguably apply to it. However, Article 36 of Regulation (EU) 1169/2011 (hereafter: the “FIC Regulation”) sets out a framework which can be used to implement a comprehensive, consistent, and science-based approach.

New methodologies as well as growing volumes of good quality data now exist that can be applied to assess the risk from unintended allergen presence. In addition to these advancements, this version of the paper also incorporates recent Codex and related developments, including the findings of an Ad hoc Joint FAO/WHO Expert Committee, which was tasked with establishing reference doses (RfDs) for priority allergens, and making other recommendations on PAL.

A science-based approach to PAL, based on a QRA would greatly strengthen the protection of allergic consumers by making PAL meaningful and transparent. It would also benefit the European food industry by providing an important element of a comprehensive framework (“level playing field”), which would also strengthen the single market. However, it needs to be recognised that PAL should be based on a multipronged approach utilising a range of risk management tools that may, when appropriate, include QRA.