Legislation fails to assess allergen risk-benefits in novel food

By Nathan Gray

- Last updated on GMT

Related tags Novel foods Allergen Assessment

Novel hypoallergenic foods that could benefit consumers with serious allergies are being overlooked by current legislation warn researchers from Wageningen University in the Netherlands. Further risk-benefit studies are needed to remedy that problem, according to a study published in the journal Food Control.

Researchers report that legislation is inadequate in many countries as it does not specify how risk assessments should be performed, and does not legislate for any form of benefit evaluation.

“The end result of the current risk assessment procedures isa conclusion as tothe likelihood of the novel food having allergenic potential. This implies that for approved novel foods, some uncertainty remains regarding the allergenicity,” ​wrote the researchers.

Current regulations

All novel foods require safety assessment before they enter the market, but current regulation does not specify how such assessments should be done.

EU regulations specify the information needed for a novel food application, but not how allergenicity assessment should be performed. They state only that allergenicity information is required.

Regulations are similar in the USA, Canada, Australia, and New Zealand, where allergenicity assessment is part of the approval procedure, but no specifications are given on how these assessments should be performed.

The new study reviews existing legislation on the introduction of novel foods, focusing specifically on considerations and assessments for allergy risk and benefits.


The review found that benefit assessment is not part of any pre-market safety analysis for novel foods, and suggest that when hypoallergenic novel foods are being assessed, testing for potential benefits should also be taken into consideration.

Japanese food regulations were reported to be well developed in this area. But the legislation could not be considered in detail due to the limited data available in English, the report said.

Regulation of food in Japan was seen to be split into several categories, including foods for specified health issues (FOSHU), and foods for special dietary issues (FOSDU). Legislation for FOSDU referred to hypoallergenic foods as part of the medical foods subcategory, whereas allergy was not mentioned in FOSHU regulation.


​The study found that information on both the risks and benefits is key to the risk-benefit assessment of novel foods.

“In order to reach a decision on appropriate risk-mitigating measures, anintegrated risk-benefit assessment to be provided by the risk-benefit assessor would be particularly valuable,”​ stated the researchers.

Novel hypoallergenic foods could be regarded as functional foods, though a separate category for such foods does not currently exist within legislations, suggested the authors.

The study concluded that potential benefits of hypoallergenic novel foods could be assessed under parallel legislation in different circumstances. For example, with health claims made on advertisements and labels, or when foods are used for specific dietary purposes.

Source: Food Control

Published online ahead of print, doi: 10.1016/j.foodcont.2010.08.002

“Novel foods and allergy: regulations and risk-benefit assessment”

Authors: M.C. van Putten, G.A. Kleter, L.J.W.J. Gilissen, B. Gremmen, H.J. Wichers, L.J. Frewer

Related topics Policy Packaging & labelling

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