Food Allergen Precautionary Labelling: A Risk-Based Approach. Overview for Food Business Operators.

Precautionary allergen labelling (PAL), such as statements that a food ‘may contain’ an allergen, are used to alert consumers who are sensitive to this risk. However, currently, these statements often do not reflect the real risk that would be experienced by an allergic consumer if they ate the food in question. There are two reasons for this:

1. Precautionary allergen labelling is often used based on a theoretical assumption that an allergen that is not an intended ingredient could physically contaminate a food, rather than through proper consideration of whether (and to what extent) this can and does ever happen.
2. Even if it has been deemed that allergen contamination of a given food could occur (and PAL has consequently been applied), it may be that the concentration of the unintended allergen in that food would be so low that the amount consumed would not present an appreciable health risk to the food allergic population if they ate the food.

The process of understanding the health risk posed by unintentional allergen presence (UAP), is known as ‘Quantitative Risk Assessment’ (QRA). Quantitative risk assessment essentially involves comparison of the amount of UAP that a consumer may be exposed to, with a pre-established allergen Reference Dose (RfD). Allergen RfDs for major food allergens have been established by various scientific organisations and authoritative bodies. Implementation of food allergen QRA within a food business necessitates knowledge of situations that could result in UAP and quantification of the subsequent allergen exposure that may result.

Food allergen QRA is a methodology that can be used in addition to established practices as a part of decision-making on whether PAL should be applied to a finished food. When used as such, this decision-making should follow a consistent set of principles. A Food allergen QRA tools are available[1] to be used by food business operators (FBOs) on top of existing methods of allergen risk assessment, to better inform decisions about allergen management.

This short document is intended to provide an overview of  food allergen QRA and how it can help decision making by FBOs, especially regarding PAL. It will also serve to raise awareness and uptake of QRA as an approach to food allergen risk assessment. Subsequent documents will provide information on how food allergen QRA can be applied effectively by FBOs located at specific points along the supply chain.