European Regulations on Food Supplements, Fortified Foods, Dietetic Foods, and Health Claims

Nutraceutical and Functional Food Regulations in the United States and Around the World: Second Edition

Volumn , Issue , 2014, Pages 201-219

  Coppens, Patrick ^a   Pettman, Simon ^a  

^a EAS Strategic Advice   (Belgium)

Author keywords

Benefit assessment; Borderline issues; Dietetic foods; Food supplements; Fortified foods; Health claims, botanicals; Legislation, european union; Minerals; Novel foods; Risk assessment; Risk management; Vitamins

Indexed keywords

EID: 84902234674     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1016/B978-0-12-405870-5.00013-X     Document Type: Chapter

References (47)

1. Regulation (EC) no 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. 01/02/2002. Official Journal of the European Union: L31/1.
2. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. 12/06/2002. Official Journal of the European Union: L136/85.
3. Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods. 30/12/2006. Official Journal of the European Union: L404/26.
4. Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses. 20/05/2009. Official Journal of the European Union: L124/21.
5. Corrigendum to Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. 18/01/2007. Official Journal of the European Union: L12/3.
6. The General principles of food law in the European Union. Commission Green Paper. 30/04/1997. Com(97) 176 final.
7. White paper on food safety (COM (1999) 719 final; 12/01/2000).
8. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. 28/11/2001. Official Journal of the European Union: L311/67.
9. Commission of the European Communities. White Paper on the Completion of the Internal Market. 14/06/1985 COM(85) 310 final.
10. Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC. 13/08/08. Official Journal of the European Union: L218/21.
11. EAS Strategic Advice. How to apply mutual recognition for the free trade of food products across the EU, 2009. http://www.eas.eu.
12. Commission of the European Communities. Report from the Commission to the Council and the European Parliament on the use of substances other than vitamins and minerals in food supplements. 05/12/2008. COM(2008) 824 final.
13. Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients. 14/02/1997. Official Journal of the European Union: L043/1.
14. European Commission: Discussion paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs; 2006.
15. European Commission: Orientation paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs. July 2007.
16. European Food Safety Authority: Compilation of the Scientific Opinions on Tolerable Upper Intake Levels for Vitamins and Minerals; 2006.
17. European Responsible Nutrition Alliance (ERNA): Vitamin and Mineral Supplements: a risk management model; 2005.
18. Richardson David P. Risk management of vitamins and minerals: a risk categorization model for the setting of maximum levels in food supplements and fortified foods. Food Sci Technol Bull Funct Foods 2007, 4(6):51-66.
19. Richardson David P. Risk management of vitamins and minerals in Europe: quantitative and qualitative approaches for setting maximum levels in food supplements for children. Food Sci Technol Bull Funct Foods 2010, 7(6):77-101.
20. Flynn A., Moreiras O., Stehle P., Fletcher R.J., Müller D.J., Rolland V. Vitamins and minerals: a model for safe addition to foods. Eur J Nutr 2003, 42(2):118-130.
21. Bundesinstituts für Risikobewertung (Federal Institute for Risk assessment - BfR): Verwendung von Vitaminen in Lebensmitteln (Use of Vitamins in Foods); 2005.
22. Bundesinstituts für Risikobewertung (Federal Institute for Risk assessment - BfR): Verwendung von Mineralstoffen in Lebensmitteln; 2005.
23. Danmarks Fødevareforskning (Danish Institute for Food and Veterinary Research-DFVF) A safe strategy for addition of vitamins and minerals to foods. Eur J Nutr 2005, doi:10.1007/s00394-005-0580-9.
24. Kloosterman J., Fransen H.P., de Stoppelaar J., Verhagen H., Rompelberg C. Safe addition of vitamins and minerals to foods: setting maximum levels for fortification in the Netherlands. Eur J Nutr 2007.
25. Commission Directive 2001/15/EC of 15 February 2001 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses. 22/02/2001. Official Journal of the European Union: L52/19.
26. Court of Justice of the European Union. Joined Cases C-154/04 and C-155/04. Judgment of the Court of 12 July 2005.
27. Guidance on the implementation of regulation no 1924/2006 on nutrition and health claims made on foods conclusions of the standing committee on the food chain and animal health. 14/12/2007.
28. European Commission. Working document on the setting of nutrient profiles. 02/06/2008.
29. European Food Safety Authority The setting of nutrient profiles for foods bearing nutrition and health claims pursuant to article 4 of the regulation (EC) No 1924/2006. EFSA J 2008, 644:1-44.
30. Commission Regulation (EU) No 432/2012 of 16 May 2012 establishing a list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children's development and health. 25/05/2012. Official Journal of the European Union: L136/1.
31. Richardson David P. The scientific substantiation of health claims with particular reference to the grading of evidence. Eur J Nutr 2005, 44:319-324.
32. European Responsible Nutrition Alliance (ERNA), Nutrition and Health Claims in the EU. Regulation (EC) No 1924/2006. A review of the consequences of implementation.
33. EAS Strategic Advice. How to apply the Nutrition and Health Claims Regulation, 2010. http://www.eas.eu.
34. Food Supplements Europe. The application of the Nutrition and Health Claims Regulation 1924/2006. Guidance for food operators, 2013.
35. Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings. 31/12/2008. Official Journal of the European Union L354/1.
36. EAS Strategic Advice. Novel Foods in the European Union: Developing Regulatory Strategies; 2003.
37. European Commission. Human Consumption to a Significant Degree. Information and Guidance Document; 2012.
38. European Commission. EU Guidelines for the presentation of data to demonstrate substantial equivalence between a novel food or food ingredient and an existing counterpart; 2013.
39. Commission of the European Communities. Proposal for a Regulation of the European Parliament and of the Council on novel foods and amending Regulation (EC) No XXX/XXXX [common procedure]. 14/01/2008. COM(2007) 872 final.
40. Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC. 30/12/2006. Official Journal of the European Union: L401/1.
41. Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children. 06/12/2006. Official Journal of the European Union: L339/16.
42. Commission Directive 96/8/EC of 26 February 1996 on foods intended for use in energy-restricted diets for weight reduction. 06/03/1996. Official Journal of the European Union: L55/22.
43. Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes. 07/04/1999. Official Journal of the European Union: L91/29.
44. Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control [...]. Official Journal of the European Union: L181/35.
45. Commission of the European Communities. Report from the Commission to the European Parliament and the Council on the implementation of Article 9 of Council Directive 89/398/EEC on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses. 27/06/2008. COM(2008) 393 final.
46. Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use. 30/04/2004. Official Journal of the European Union: L136/85.
47. European Commission. Discussion paper on Health Claims on Botanicals in Food; 2013.