Regulatory Requirements for Food Supplements in the European Union and Bulgaria

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Abstract

Data provided by the European Commission show that public expenditures for food supplements have been constantly increasing over the last decade.

The aim of the present study was to analyze the major food supplements regulations in the European Union and in Bulgaria. Relevant publications were searched and found in MEDLINE/PubMed, Scopus Database, Web of Knowledge, and in Internet-based search with predefined keywords. Numerous authors support the opinion that there is a real risk that low quality products may be distributed in countries with poor production control. Bulgarian national legislation have 6 regulations with different legal force for provision of healthy and safe food supplements on the market. Currently, the European Community is concerned about food products, including FS, launched on the market because the citizens require reliable protection of their health. This concern provoked the European Parliament and the Council to undertake a number of legislative initiatives in the field of production and control of food products. It is necessary to set more precise quality and safety criteria in future strategies associated with those products.

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  • 1. http://europa.eu/legislation

  • 2. 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 (OJ L 31 1.2.2002) p. 0001-0024.

  • 3. 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 (Text with EEA relevance) (OJ L 183 12/07/2002) p. 0051-0057.

  • 4. Duleva V. [Aspects of regulation of food supplements in the European Union. National Center of Public Health and Analyses] Sofia 2013 (Article in Bulgarian).

  • 5. FDA. Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues. Retrieved January 15 2013 from http://www.fda.gov/food/guidancecomplianceregulatoryinformation/guidancedocuments/dietarysupplements/ucm257563.htm.; 2011.

  • 6. European Food Safety Authority. E. Compendium of botanicals reported to contain naturally occurring substances of possible concern for human health when used in food and food supplements. EFSA J 2012;2012:10.

  • 7. Ivanova S. [Pharmacoanalytical control of food supplements with androgenic effect] [PhD thesis]. Plovdiv: Medical University; 2016 (Bulgarian).

  • 8. 8. Bagchi D editor. Nutraceutical and functional food regulation in the United States and around the United States. 2nd ed. Elsevier Inc; 2014 ISBN: 978-0-12-405870-5.

  • 9. European Commission. Commission Regulation (EC) No 1170/2009 of 30 November 2009 amending Directive 2002/46/EC of the European Parliament and of Council and Regulation (EC) No 1925/2006 of the European Parliament and of the Council as regards the lists of vitamin and minerals and their forms that can be added to foods including food supplements. Official Journal of the European Union L 314/36 2009.

  • 10. European Commission. Novel foods and novel food ingredients. Food and Feed Safety Retrieved January 15 2013. Available from http://ec.europa.eu/food/food/biotechnology/novel-food/index_en.htm; 2012.

  • 11. European Commission. Novel Food catalogue Search. Food and Feed Safety Retrieved January 15 2013. Available from http://ec.europa.eu/food/food/biotechnology/novelfood/nfnetweb/mod_search/index.cfm

  • 12. FDA. New Dietary Ingredients in Dietary Supplements Background for Industry. Retrieved January 15 2013. Available from http://www.fda.gov/Food/DietarySupplements/ucm109764.htm; 2012.

  • 13. ANVISA. Registration of Products: Manual covering procedures for registration and exemption from registration of imported products. Retrieved January 15 2013. Available from http://www.anvisa.gov.br/eng/food/registration.htm; 2000.

  • 14. 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. Official Journal of the European Union. 18.1.2007 p. 1-16

  • 15. Asp NG Bryngelsson S. Health claims in Europe: new legislation and PASSCLAIM for substantiation. J Nutr 2008;138(6):1210S-5S.

  • 16. Getov I Grigorov E Lebanova H. Food supplements-marketing and health claims analysis. Archives of the Balkan Medical Union 2011; 46(4 Suppl.1):26-29.

  • 17. Natural Health Products Directorate. Compendium of Monographs. Drugs and Health Products. Retrieved January 15 2013. Available from http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/licen-prod/monograph/index-eng.php.; 2009.

  • 18. New function health claims under Article 13.5 of the EU Regulation. Available from http://www.efsa.europa.eu/en/topics/topic/article13-5.htm

  • 19. Claims regarding disease risk reduction and child development or health under Article 14 of the EU Regulation. Available from http://www.efsa.europa.eu/en/topics/topic/article14.htm

  • 20. Aggett PJ Antoine JM Asp N-G et al. PASSCLAIM Process for the assessment of scientific support for claims on foods. Consensus on criteria. Eur J Nutr 2005;44 Suppl 1:I/1-I/30.

  • 21. TGA. Australian Guidelines for Complementary Medicines (ARGCM) Part II: Listed Complementary Medicines 2011.

  • 22. Asp NG Cummings JH Mensink RP et al editors. PASSCLAIM. Process for the assessment of scientific support for claims on foods. Phase 1: Preparing the way. Eur J Nutr 2003;42 Suppl 1:I/1-I/119.

  • 23. Asp NG Cummings JH Howlett J et al editors. PASSCLAIM. Process for the assessment of scientific support for claims on foods. Phase 2: Preparing the way. Eur J Nutr 2004;43 Suppl 2:II/1-II/183.

  • 24. Asp NG Bryngelsson S. Health claims in Europe: new legislation and PASSCLAIM for substantiation. J Nutr 2008;138(6):1210S-5S.

  • 25. Food Law Bulgaria State Gazette No. 70 of 10 August 2004 [in Bulgarian].

  • 26. Law for medicinal products in human medicine Bulgaria SG No. 31 of 13 April 2007 [in Bulgarian].

  • 27. Health Law Bulgaria SG No. 70 of 10 August 2004 [in Bulgarian].

  • 28. Ordinance No. 47 of the Bulgarian Ministry of Health on requirements for food supplements SG No. 5/2005 [in Bulgarian].

  • 29. Ordinance No. 23/2001 of the Bulgarian Ministry of Health on conditions and requirements for presenting nutritional information on food labels SG 53/2001 [in Bulgarian]./

  • 30. Ordinance No 5 of the Bulgarian Ministry of Health on food hygiene SG 55/07.07.2005 [in Bulgarian].

  • 31. European Commission “Food Supplements” European Commission Food Safety. Available from https://ec.europa.eu/food/safety/labelling_nutrition/supplements_en

  • 32. TGA. The regulation of complementary medicines in Australia an overview: Pre-market assessment. Retrieved January 15 2013. Available from http://www.tga.gov.au/industry/cm-basics-regulationoverview.htm#pre.; 2012

  • 33. TGA. Australian Guidelines for Complementary Medicines (ARGCM) Part II: Listed Complementary Medicines 2011.

  • 34. Dietary Supplement Quality: The Meaning of the USP Verified Mark. Available from http://www.pharmacytimes.com/publications/issue/2014/april2014/r636_april2014

  • 35. Global Dietary Supplements Market will reach USD 220.3 Billion in 2022: Zion Market Research. Available from https://globenewswire.com/news-release/2017/01/11/905073/0/en/Global-Dietary-Supplements-Market-will-reach-USD-220-3-Billion-in-2022-Zion-Market-Research.html

  • 36. Halsted CH. Dietary Supplements. Am J Clin Nutr 2000;71(2):399-400.

  • 37. Mason P. Handbook of Dietary Supplements. USA: Blackwell Science Ltd; 1998.

  • 38. ASEAN. Harmonization of Standards and Technical Requirements in ASEAN. Retrieved January 15 2013. Available from http://www.asean.org/news/item/harmonizationof-standards-and-technical-requirements-in-asean. 2012.

  • 39. ASEAN. Profile of Definition Terminology and Technical Requirement of Traditional Medicines and Health Supplements among ASEAN Member Countries. 2006.

  • 40. ASEAN. Guiding Principles for Inclusion of Active Substances into the Restricted List for Traditional Medicines and Health Supplements (TMHS). 2010.

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