Health Foods, Scientific and Regulatory Environment

Fac. Health, Medicine and Life Sciences

Health Foods, Scientific and Regulatory Environment

Full course description

This course covers both the regulatory and scientific framework of health and nutrition claims. In the first half of the 20th century, political and socio-economic developments in developed countries have resulted in a more secure and abundant food supply than ever before. It has become clear that food safety is an inherent aspect associated with nutrition; an aspect that in the aftermath of the BSE crisis of 1996, has highly ranked on the political and legislative agenda of the EU and other countries. We can also observe a trend of industry to add vitamins and minerals to foods in order to enhance its nutrition value. It is not surprising that in this context we may observe an increasing number of foods labelled and advertised in the EU bear nutrition and health claims. In order to ensure a high level of protection for consumers and to facilitate their choice, products put on the market, including imported products and to ensure their safety, the EU and other countries have set a variety of requirements that health and nutrition claims and food fortification and food supplements need to fulfil. This course deals with this variety of requirements and will provide in- depth knowledge and critical understanding of both the theoretical and practical aspects of health and nutrition aspects of foods. It will hereby focus on the EU regime, but also give an insight into the global setting. It will give an appraisal of role of risk assessor and risk manager in risk assessment and risk-benefit assessment, qualitative assessment and quantitative assessment. At the same time the course will introduce you to the definition of law and the legal terminology. It will subsequently give in-depth insights in the whole set of regulatory requirements set by the EU. The course ultimately will give a critical understanding of the complex relationship of science and the law. This course will be given in collaboration with the Faculty of Law and the National Institute for Public Health and the Environment (RIVM).

Course objectives

• Insights in Public Health Care and the Environmental and Regulatory Influences that impact on it; • Appreciation of food and consumer regulatory environment: functional foods, novel foods, health claims, nutrition content claims, regulations and requirements for approval submissions in EU, US, Japan and China; • Understanding environmental and socio-economical influences on food consumption; • Critical evaluation of scientific literature in terms of drawing conclusions that are supported by "the weight of the evidence" and that can survive the challenge of critics; • Critical assessment of the chance of success of desired benefit claims in the light of the regulatory environment in the area of planned product launch; • Critical overall early assessment of the potential chance of success of innovative ideas in the light of technical, business and regulatory feasibility;

Recommended reading

The preparation for the lectures and tutorials will involve (to a varying degree depending on each subject) a thorough analysis of both primary sources (EU Treaties, secondary EU legislation and case-law of the European Court of Justice and scientific dossiers) and literature. Materials for most lectures and tutorials are indicated for each subject separately. In some cases no material is indicated. In these instances a large part of preparing for the session is to identify the relevant literature, documents, legislation and case law as well as other material of relevance. Literature and legal sources: 1. John Fairhurst, Law of the European Union, Longman, 8th edition, 2010: Chapters 1-5 2. Vos and F. Wendler (eds.), Food Safety Regulation in Europe. A Comparative Institutional Analysis, Intersentia Publishing, 2006 (Chapter 3 on the EU) 3. Chalmers, Damian (2003) ‘Food for thought’: reconciling European risks and traditional ways of life. Modern law review, 66 (4). pp. 532- 562 4. EP and Council Regulation 178/2002 laying down the general principles and requirements on Food Law, establishing the European Food Safety Authority and laying down procedures of food safety (2002) OJ L 031/1 5. A. Meisterernst, "A Learning Process? - Three years of regulation (EC) 1924/2006 on Nutrition and Health Claims Made on Foods," European Food and Feed Law 2/2010, pp. 59- ff 6. Hans Verhagen, Ellen Vos, Sheila Francl, Marina Heinonen and Henk van Loveren ‘Status of nutrition and health claims in Europe’, in: Archives of Biochemistry and Biophysics, 2010 (available in the UM Catalogue) 7. Jose Luis Valverde, 'Regulation of Nutritional and Health Claims made on food in the European Union', Pharmaceuticals Policy and Law Vol. 11 (2009), pp. 187-199 (available in the UM Catalogue) 8. Regulation (EC) 1924/2006 of the European Parliament and of the Council on nutrition and health claims made of foods, OJ L 404/9 (2006) (Consolidated text) 9. EurActiv, "EU scientists vet food marketing’s health claims," from 29 July 2011 available at http://www.euractiv.com/en/cap/eu-scientists- vet-food-marketings-health-claims-news-506826 10. Please also browse through the website of the European Commission on Health Claims including the EU register on health claims, http://ec.europa.eu/food/food/labellingnutrition/claims/index_en.htm 11. P. Vanden Bossche and D. Prevost, WTO in a Nutshell, 66 pages 12. B. Scarpa & S. Dalfra, "Regulating the Novel Foods Sector: Moving Forward" European Food and Feed Law Review 5/2008, pp. 292- ff 13. G. van Caalster, "Simply Swallow? The Application of Nanotechnologies in European Food Law" European Food and Feed Law Review 3/2009, pp. 167 14. M. Weimer, "EU Risk Governance of ‘Cloned Food’ – Regulatory Uncertainty Between Trade and Non-Trade" In: Marjolein Van Asselt, Esther Versluis and Ellen Vos (eds) Science and Politics in EU Risk Governance: Integrating Legal and Social Science Perspectives, (Taylor & Francis/Routledge, forthcoming 2012) 15. EurActiv, "Novel Foods Review Stumbles over Cloning" from 29 March 2011 available at http://www.euractiv.com/en/cap/novel-foods-review- stumbles-cloning-news-503610 16. Regulation (EC) No 257/97 on novel foods and novel foods ingredients (consolidated text) 17. A. Alemanno, the european food import safety regime under a ‘stress test’: the melamine contamination of the global food supply chain, Erasmus Law Review, Volume 3, Issue 4 (2010) 18. James Lawless, Conflicting Notifications in the EU's Rapid Alert System for Food and Feed in European Journal of Risk Regulation Vol. 1 (2010), Issue 4, p. 451 -ff 19. T. Christoforou, "The Regulation of Genetically Modified Organisms in the European Union: The Interplay of Science, Law and Politics"Common Market Law Review Vol. 41 (2004) pp. 637 20. E. Vos & M. Van Asselt, The Precautionary Principle and the Uncertainty Paradox, Journal of Risk Research Vol 9:4, p. 313 (see attached) 21. J. Scott, European Regulation of GMOs and WTO (2003) Columbia Journal of European Law Vol 9, p. 213 22. Regulation (EC) 1829/2003 on genetically modified food and feed, OJ L 268/1 (2003) (consolidated text) 23. Commission Communication on the Precautionary Principle COM (2000) 1 24. Jeljer Hoekstra a, Andy Hart b, Alan Boobis c, Erika Claupein d, Andrew Cockburn e, Alistair Hunt f, Ib Knudsen g, David Richardson h, Benoît Schilter i, Katrin Schütte j, Paul R. Torgerson k, Hans Verhagen a, Bernhard Watzl d, Alessandro Chiodini, BRAFO tiered approach for benefit–risk assessment of foods, Food and Chemical Toxicology xxx (2010) xxx–xxx 25. Hans Verhagen a,h, Rikke Andersen b, Jean-Michel Antoine c, Paul Finglas d, Jeljer Hoekstra a, Alwine Kardinaal e, Hervé Nordmann f, Gülden Pekcan g, Kristina Pentieva h, Tom A. Sanders i, Henk van den Berg j, Henk van Kranen a, Alessandro Chiodini k,⇑, Application of the BRAFO tiered approach for benefit–risk assessment to case studies on dietary interventions, Food and Chemical Toxicology xxx (2011) xxx–xxx 26. C.F. van Kreijl | A.G.A.C. Knaap | J.M.A. van Raaij (Editors-in- Chief), Our food, our health, Healthy diet and safe food in the Netherlands, RIVM 2006 27. ERNA, Vitamin and mineral supplements:a risk management model, November 2004 28. Janneke Kloosterman, Heidi P. Fransen, Joyce de Stoppelaar, Hans Verhagen, Cathy Rompelberg, Safe addition of vitamins and minerals to foods: setting maximum levels for fortification in the Netherlands, Eur J Nutr (2007) DOI 10.1007/s00394-007-0654-y 29. Hans Verhagen1*, Janneke te Boekhorst2, Lisette Kamps2, Marten J. van Lieshout2, Hilko Ploeger2, Daphne Verreth2, Seppo Salminen3 and Henk van Loveren1, Review Article. Novel foods: an explorative study into their grey area, British Journal of Nutrition (2009), 101, 1270–1277 30. Janneke Verkaik-Kloosterman1*, Mary T. McCann2,Jeljer Hoekstra1 and Hans Verhagen1,2, Vitamins and minerals: issues associated with too low and too high population intakes, Food & Nutrition Research 2012, 56: 5728 - DOI: 10.3402/fnr.v56i0.5728 31. Albert Flynn, Olga Moreiras, Peter Stehle, Reginald J. Fletcher, Detlef J. G. Müller, Valérie Rolland, Vitamins and minerals: A model for safe addition to foods, Eur J Nutr 42 : 118–130 (2003)
HFI2001
Period 1
2 Sep 2024
25 Oct 2024
Print course description
ECTS credits: 
10.0
Instruction language: 
English
Coordinator:
Teaching methods: 
Assignment(s), PBL, Lecture(s)
Assessment methods: 
Final paper, Written exam
Keywords: 
Regulatory environment, health claims, food law, Food Safety, EU, risk assessment