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International Food Laws and Regulations
FOOD 528
Instructor: Dr. Jerzy Zawistowski
Office: FNH 100c
Office Hours:
Class Schedule:


The objective of this course is to provide students with an overview of the regulatory systems in different jurisdictions such as the US, Canada, and European Union. The course enables students to study similarities and differences between regulatory jurisdictions. Students will also understand how to find relevant information and documentation using Internet and other governmental resources. The focus of this course is also to teach students how to interpret the content of regulations and use them to support the professional needs in the food industry.

Upon completion of this course, the student should be able to:

  • Find relevant regulatory information using various resources
  • Know how to interpret food regulations
  • Know how to use knowledge of regulation while developing new food products or seeking the approval of new food products
  • Understand the process of making law and regulations in various jurisdictions
  • Learn about specific laws and understand differences between law, regulations and guidelines
  • Learn about current changes in the international regulations as well as new regulations such as Bioterrorism Act, novel foods and natural health products
  • Understand the impact of regulations on the safety of food supply

Course Design

The course will be taught in the four major sections. Each section will focus on the US law and regulations, Canadian regulations, European Union regulations, and Codex Alimentarius. Students will be involved in problem solving and will be expected to prepare a submission to regulatory authorities. There will be assignments during the course. Students will be participating in groups to prepare and present them in the class.


  1. Introduction to Food Law and Regulations
    Historical perspectives
    Reason for food law and regulations
  2. Food Law and Regulation in USA
    History of Food and Drug Administration (FDA)
    Role of the US federal government
    Legislation process
    Code of federal regulations
    The US federal agencies and their jurisdiction
    Significant food acts in USA
    Prohibited acts
    FDA acts, actions and responsibilities
    US Department of Agriculture food acts and responsibilities
    Standard of identity for food products
    Substances and additives used in foods
    The importation process and regulations
    Bioterrorism Act of 2002
    Food Safety Modernization Act 2011
    Basic labeling of food products
    Allergen and organic food declaration
    Nutrition labeling
    Serving sizes and calculations
    Nutrient content claims
    Health claims
    Nutrition Labeling and Education Act
    US FDA Modernization Act
    Dietary Supplement Health and Education Act
  3. Canadian Food Laws and Regulations
    Federal, Provincial/Territorial and Municipal governments and their responsibilities
    Health Canada – scope of roles, organizational chart and responsibilities
    Food Directorate, Natural Health Product Directorate and other offices
    Canadian Food Inspection Agency – responsibilities and authorities
    Agriculture and Agri-Food Canada – responsibilities and authorities
    The process of making law and regulations (legislation process)
    Canada Gazette
    Acts and regulations
    Food and Drugs Act and Regulations
    Canada Agriculture Products Act and Regulations
    Meat and Fish Inspection Acts and Regulations
    Consumer Packaging and Labelling Act and Regulations
    Safety Food for Canadians Act
    Administration and enforcement
    Standardized foods
    Adulterated foods
    Foods for special dietary use
    Novel foods
    Vitamins, minerals and amino acids
    Basic labeling of foods
    Allergen and organic food declaration
    Nutritional labelling
    Label formats, reference amounts, and regulatory descriptive terms
    Nutrient content claims
    Canada versus USA
    Health claims
    Function, and nutrient function claims
    Disease risk reduction claims
    Therapeutic claims
    Natural health products
    Health claims
    Approval process
    Food-like natural health products
  4. Food Law and Regulations in European Union
    European treaties
    Member states of the EU
    EU regulatory institutions
    European Commission
    Council of the EU
    European Parliament
    White paper 2000
    European food safety authority
    Legislative process
    Forms of legislations
    Official journal of the European Communities
    Food additives
    Labelling requirements for additives
    2% rule and QUID
    Allergen, organic, and GMO food declaration
    Nutrition labelling
    Nutrition claims
    Current health claims
    Approval process
    Articles 13 and 14 (Regulation (EC) No 1924/2006) and approved health claims
    The Codex standards process – approval procedure
    Case Study – developing standards for genetically modified foods
  5. Functional foods regulations in selective countries (Optional)
    Asia (Japan, China), USA, Canada. EU


Assignments and Presentations 25%
Term Paper 30%
Final Exam 45%


Internet Websites



European Union:

Codex Alimentarius:

Suggested Books

Vetter, J.L. 1996. “Food Laws and Regulations” American Institute of Baking, Manhattan, Kansas.
Vetter, J.L. 1993. “Food Labeling – Requirements for FDA Regulated Products” American Institute of Baking, Manhattan, Kansas.
Graham, J., Babinski, M., Collard, C., Loh, A., Patry, M., Prince, V. and Wise, J. 2007. “Canadian Food and Drug Legislation and Commentary” Lexis Nexis Canada (available in September 2007)
Goodburn, K (Ed.) 2005. “EU Food Law: A Practical Guide” CRC Press. Boca Raton, Boston, New York, Washington D.C., Woodhead Publishing Limited, Cambridge, England
“Understanding the Codex Alimentarius”
Bagchi, D (Ed.) 2014. “Nutraceuticals and Functional Foods Regulations in the United States and Around the World” 2nd edition. Elsevier.
Asian Regulations of Functional Foods
Zawistowski, J. 2011. Legislation of functional foods in Asia. In: Functional foods: concept to profit: 2e. M. Saarela (Ed) Woodhead Publishing Ltd.
Zawistowski, J. 2014. Regulation of functional foods in selected Asian countries in the Pacific Rim. In: Nutraceuticals and Functional Foods Regulations in the United States and Around the World. 2nd edition. D. Bagchi (Ed.) Elsevier.
Zawistowski, J and Jones, P. 2015. Regulatory aspects related to plant sterol and stanol supplemental foods. J AOAC International, 98:1-7.

Policy on Plagiarism (quote from University calendar)

“Plagiarism, which is intellectual theft, occurs where an individual submits or presents the oral or written work of another person as his or her own. Scholarship quite properly rests upon examining and referring to the thoughts and writings of others. However, when another person's words (i.e. phrases, sentences, or paragraphs), ideas, or entire works are used, the author must be acknowledged in the text, in footnotes, in endnotes, or in another accepted form of academic citation. Where direct quotations are made, they must be clearly delineated (for example, within quotation marks or separately indented). Failure to provide proper attribution is plagiarism because it represents someone else's work as one's own. Plagiarism should not occur in submitted drafts or final works. A student who seeks assistance from a tutor or other scholastic aids must ensure that the work submitted is the student's own. Students are responsible for ensuring that any work submitted does not constitute plagiarism. Students who are in any doubt as to what constitutes plagiarism should consult their instructor before handing in any assignments.”