Risk assessment

The purpose of an allergen risk assessment is to determine the risks due to unintentional presence of allergens. Based on the result of the risk assessment you can decide whether or not allergen advisory labelling is appropriate.

Risk management matrix chart with pen and keyboardImportant factors to cover in the risk assessment are:

  • Which allergenic foods or ingredients that unintentionally could get into contact with your food products.
  • The amount of the allergenic food generally needed to provoke a reaction in allergic people.
  • How common adverse reactions are to a particular food.
  • Whether subgroups of the population have an increased risk.
  • The relative allergenicity of your ingredient and whether processing changes the allergenicity. In general there is no effective way to process out allergens, but if no or very little protein is present as could be the case for e.g. refined nut oils, the risk of an allergic reaction is very low.
  • The physical form of the ingredient e.g. whether air-borne cross-contact is a possibility
  • How cross-contact could happen and how likely it is to happen.


Recent research has concluded that there arelower limits below which food allergens will not cause any symptoms (called a threshold).

Researchers use data from the diagnostic method double blind placebo controlled food challenge to obtain knowledge on thresholds for individuals with food allergies. 

The amount of allergen that may trigger reactions ranges from a tenth of a milligram (in rare cases) up to several grams, and sometimes tens of grams, with considerable variation between individuals, as well as allergens.

For example, 10% of people with peanut allergy will react to 40 mg (a mg being 1/1000th of a gram) of peanut seed, but people with allergy to shrimp usually have to eat several grams of shrimp to have a reaction.

The Voluntary Incidental Trace Allergen Labelling initiative (VITAL) expert panel has reviewed the threshold data and identified doses that can be used for allergen risk management.

However, current available data does not permit estimation of population thresholds with adequate certainty by risk assessors such as EFSA.

So, it still remains a matter of debate how to use the individual threshold data to predict the amount of food safe to eat for most allergic patients.

However, if food business operators can decrease the likelihood of allergen cross-contact on their premises, they will achieve one of the major objectives of food allergen risk management.

You can find more detailed information on thresholds found in clinical studies for each allergenic food on our InformAll database.

Reducing risk

Sufficient data does likely exist for cows’ milk, eggs and peanuts to be able to make a statistical evaluation to predict a dose of those foods that it will be safe for the majority of allergic individuals to eat. However, it is only recently that scientists and regulatory authorities have started discussions on what is the best way to make statistical evaluations of the individual data.

So it still remains a matter of debate how to use the individual threshold data to predict the amount of food safe to eat for most allergic patients. The Australian Food and Grocery Council is to our knowledge the first organisation to develop and recommend the use of an allergen risk assessment tool to harmonise the application of allergen precautionary labelling.

Even though the risk is difficult to assess you can decrease it if you decrease how likely it is for allergen cross-contact to happen on your premises. That is one of the major objectives of allergen risk management.

Further reading