Allergic to bureaucracy? Regulatory allergenicity assessments of novel food: motivations, challenges, compromises, and possibilities
Open accessAbstract
New sources of proteins are essential to meet the demands of the growing world population and evolving food trends. Assessing the allergenicity of proteins in novel food (NF) poses a significant food safety regulatory challenge. The Codex Alimentarius Commission presented an allergenicity assessment protocol for genetically modified (GM) foods, which can also be adapted for NF. Since no single laboratory test can adequately predict the allergenic potential of NF, the protocol follows a weight-of-evidence approach, evaluated by experts, as part of a risk management process. Regulatory bodies worldwide have adopted this safety protocol, which, among other things, promotes global harmonization. This review unravels the reliability and various motivations, terms, concepts, and approaches of allergenicity assessments, aiming to enhance understanding among manufacturers and the public. Health Canada, Food Safety Commission JAPAN, and Food Standards Australia New Zealand were surveyed, focusing on the European Food Safety Authority and the US Food Safety Administration for examples of scientific opinions regarding allergenicity assessments for novel and GM foods, from 2019 to 2023. According to our findings, current regulatory allergenicity assessments for NF approval primarily rely on literature reviews. Only a few of the NF assessments proactively presented additional tests. We recommend conducting bioinformatic analyses on NF when a panel of experts deems that there is insufficient prior scientific research.
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Australia and New Zealand have adopted a joint system through FSANZ, in which novel food applications are assessed on a case-by-case basis, focusing on dietary exposure and allergenic risks.
“Australia and New Zealand have adopted a joint system through Food Standards Australia New Zealand (FSANZ), in which novel food applications are assessed on a case-by-case basis, focusing on dietary exposure and allergenic risks (Kedar et al., 2024).”
From Microalgae biotechnology and its role in sustainable and healthy food design (2025) · cites this paper as Kedar et al., 2024
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Flagged first, then by citations
Cited by
Sorted by citations
Microalgae biotechnology and its role in sustainable and healthy food design
Schneider, A. T., Machado, R. L. S., Dutra, D. A., Machado, E. F., Dias, R. R., Deprá, M. C., Zepka, L. Q., & Jacob-Lopes, E. (2025) · Frontiers in Bioengineering and Biotechnology · doi:10.3389/fbioe.2025.1716473 · Cited by 15 · see citing works
- Authors
- Kedar, O., Golberg, A., Obolski, U., & Confino‐Cohen, R.
- Affiliations
- Tel Aviv University (IL)
- Corresponding author
- Kedar, Odeya
- Venue
- Comprehensive Reviews in Food Science and Food Safety
- Publisher
- Wiley
- Published
- 2024-03
- Volume
- 23
- Issue
- 2
- Pages
- e13300-e13300
- ISSN
- 1541-4337 (ISSN-L)
- OpenAlex
- W4392751256
- Cited by
- 27
- References
- 147
- Citations by year
- 2026: 10 · 2025: 14 · 2024: 3
- FWCI
- 1.72
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Comprehensive Reviews in Food Science and Food Safety (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Immunology and Allergy › Food Allergy and Anaphylaxis Research
- Life Sciences › Agricultural and Biological Sciences › Plant Science › Genetically Modified Organisms Research
- Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
- Keywords
- novel foods, allergenicity assessment, genetically modified foods, Codex Alimentarius, weight-of-evidence approach, expert panel, food safety regulation, regulatory harmonization, bioinformatics analysis, scientific opinion
- MeSH terms
- Allergens, Food Hypersensitivity, Humans, Motivation, Proteins, Reproducibility of Results, Plants, Genetically Modified
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