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Review of the regulation and safety assessment of food substances in various countries and jurisdictions
Open accessAbstract
This review compares the regulations, definitions and approval processes for substances intentionally added to or unintentionally present in human food in the following specific countries/jurisdictions: Argentina, Australia, Brazil, Canada, China, the European Union, Japan, Mexico, New Zealand, and the United States. This includes direct food additives, food ingredients, flavouring agents, food enzymes and/or processing aids, food contact materials, novel foods, and nanoscale materials for food applications. The regulatory authority of each target jurisdiction/country uses its own regulatory framework and although the definitions, regulations and approval processes may vary among all target countries, in general there are many similarities. In all cases, the main purpose of each authority is to establish a regulatory framework and maintain/enforce regulations to ensure that food consumed and sold within its respective countries is safe. There is a move towards harmonisation of food regulations, as illustrated by Australia and New Zealand and by Mercosur. The European Union has also established regulations, which are applicable for all member states, to establish a common authorisation procedure for direct food additives, flavourings and enzymes. Although the path for approval of different categories of food additives varies from jurisdiction to jurisdiction, there are many commonalities in terms of the data requirements and considerations for assessment of the safety of use of food additives, including the use of positive lists of approved substances, pre-market approval, and a separation between science and policy decisions. The principles applied are largely reflective of the early work by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) committees and JECFA assessments of the safety of food additives for human and animal foods.
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“there is a lack of universal guidelines specifically developed for the safety and environmental assessment of nanotechnology food applications”
From Emerging trends in European food, diets and food industry (2018) · cites this paper as Magnuson et al., 2013
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“Recent evidence do not allow to build a sounds science-based regulatory framework”
From Emerging trends in European food, diets and food industry (2018) · cites this paper as Magnuson et al., 2013
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“there are currently no specific regulations on nanotechnology food applications either in EU, USA or elsewhere”
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Biswas, R., Alam, M., Sarkar, A., Haque, M. I., Hasan, M. M., & Hoque, M. (2022) · Heliyon · doi:10.1016/j.heliyon.2022.e11795 · Cited by 221
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Handford, C. E., Dean, M., Henchion, M., Spence, M., Elliott, C. T., & Campbell, K. (2014) · Trends in Food Science & Technology · doi:10.1016/j.tifs.2014.09.007 · Cited by 215
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“Regarding risk assessment (Renwick et al., 2003; Goga and Clementi, 2010; van der Fels-Klerx et al., 2010; Worm et al., 2010; Magnuson et al., 2013; Barlow et al., 2015; Steffensen et al., 2018; Verhoeckx et al., 2020), some authors studied this theme by linking it to different profiles as follows: food safety managem…”
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“Upon receipt of the GRAS notification, the USFDA will provide an indication of whether or not the basis of the GRAS decision appears appropriate (Magnuson et al., 2013; Food and Drug Administration, 2020; Overview of International Regulatory Approaches – Proposal P1024, 2020).”
MethodMicroencapsulation in food industry – an overview
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Gentès, M., Caron, A., & Champagne, C. P. (2022) · International Journal of Dairy Technology · doi:10.1111/1471-0307.12854 · Cited by 14
Anticaking Additives for Food Powders
Yapıcı, E., İkizler, B. K., & Yücel, S. (2020) · Food engineering series · doi:10.1007/978-3-030-48908-3_6 · Cited by 14
Gite, S. S., Karmakar, M., Mokashi, S., Dalbhagat, C. G., Vivek, K., Raigar, R. K., & Shukla, R. M. (2025) · Trends in Food Science & Technology · doi:10.1016/j.tifs.2025.104977 · Cited by 13
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Fernandes, A. S., Nass, P. P., Oliveira, A. S., & Zepka, L. Q. (2020) · Springer eBooks · doi:10.1007/978-3-030-50971-2_16 · Cited by 12
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Aphibanthammakit, C., & Kasemwong, K. (2021) · Elsevier eBooks · doi:10.1016/b978-0-12-821506-7.00015-6 · Cited by 11
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Mycotoxins in Children’s Food: Problem and Halal Management
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“In exposed populations in Asia and West Africa, hepatitis B virus infection (and also hepatitis C virus infection) may confound the relationship between aflatoxin ingestion and liver cancer (Wogan, 1999; Magnuson et al., 2013).”
BackgroundNanohybrid Active Fillers in Food Contact Bio-based Materials
Gorrasi, G., Bugatti, V., & Sorrentino, A. (2017) · Springer eBooks · doi:10.1007/978-3-319-67319-6_4 · Cited by 10
The application of dietary fibre as microcapsule wall material in food processing
Zhang, Y., Amin, K., Zhang, Q., Yu, Z., Jing, W., Wang, Z., Lyu, B., & Yu, H. (2024) · Food Chemistry · doi:10.1016/j.foodchem.2024.141195 · Cited by 9
Food additives for the central nervous system, useful or harmful? An evidence-based review
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“Propolis can be used as an active ingredient which is included in the ‘Food for Specified Health Uses’ (FOSHU) in Japan Magnuson et al. (2013).”
InfluentialMafe, A. N., Obumneme, O. S., Edo, G. I., Akpoghelie, P. O., Gaaz, T. S., Yousif, E., Isoje, E. F., Igbuku, U. A., Ismael, S. A., Essaghah, A. E. A., et al. (2025) · Probiotics and Antimicrobial Proteins · doi:10.1007/s12602-025-10756-3 · Cited by 9
“By focusing on personalized approaches that consider unique microbiome profiles Inconsistent enforcement [150] and health goals, probiotics can play a significant role in enhancing well-being and preventing disease.”
Regulatory principles on food nanoparticles legislated by Asian and Oceanian countries
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“The EU adopted the ADI methodology as part of its regulatory framework for food additives, aligning with the global standards set by JECFA (Magnuson et al., 2013).”
InfluentialPRELIMINARY ASSESSMENT OF HEAVY METALS CONTENT OF VEGETABLES GROWN IN INDUSTRIAL AREAS IN ROMANIA
Nedelescu, M. M., Bălălău, D., Baconi, D. L., Jula, M., & Gligor, A. M. (2015) · Cited by 7
Metadata
- Authors
- Magnuson, B., Munro, I., Abbot, P., Baldwin, N., Lopez-Garcia, R., Ly, K., McGirr, L., Roberts, A., & Socolovsky, S.
- Affiliations
- University of Toronto (CA)
- Intertek (Canada) (CA)
- Corresponding author
- Magnuson, Bernadene
- ORCID
- Roberts, Ashley
- Venue
- Food Additives & Contaminants: Part A
- Publisher
- Informa UK Limited
- Published
- 2013-07
- Volume
- 30
- Issue
- 7
- Pages
- 1147-1220
- ISSN
- 1944-0049 (ISSN-L)
- 1944-0057
- PMC
- PMC3725665
- OpenAlex
- W2113403465
- Cited by
- 200
- References
- 16
- Citations by year
- 2026: 19 · 2025: 30 · 2024: 20 · 2023: 16 · 2022: 17 · 2021: 13 · 2020: 16 · 2019: 13 · 2018: 8 · 2017: 17 · 2016: 16 · 2015: 11 · 2014: 4
- FWCI
- 15.39
- Type
- journal article
- Language
- en
- Open access
- green
- europepmc.org
- Locations
- Food Additives & Contaminants Part A (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Pew Charitable Trusts
- European Food Safety Authority
- European Commission
- Health Canada
- Topics
- Life Sciences › Agricultural and Biological Sciences › Food Science › Agricultural safety and regulations
- Life Sciences › Agricultural and Biological Sciences › Food Science › Food Safety and Hygiene
- Physical Sciences › Chemistry › Analytical Chemistry › Dye analysis and toxicity
- Keywords
- food additive regulation, food safety assessment, food additives, food ingredients, flavouring agents, food enzymes, processing aids, food contact materials, novel foods, regulatory harmonisation, premarket approval, JECFA, international regulatory comparison
- MeSH terms
- Legislation, Food, Safety, Internationality
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