Nutrition for Healthy Skin pp 167-180 | Cite as
Legal Aspects: How Do Food Supplements Differ from Drugs, Medical Devices, and Cosmetic Products?
Abstract
About 2500 years ago, Hippocrates, the father of modern medicine, shaped the relationship between the use of appropriate foods for health and their therapeutic potential and quoted “…let food be the medicine….”
Keywords
Member State Medical Device Medicinal Product Product Category Food SupplementAbbreviations
- AESGP
Association of the European Self-medication Industry
- BGH
Bundesgerichtshof (German Federal Higher Court)
- CECP
Committee of Expert on Cosmetic Products
- CHMP
Committee on Human Medicinal Products
- EAS
European Advisory Services
- EC
European Commission
- EFSA
European Food Safety Authority
- EMEA
European Medicines Evaluation Agency
- ERNA
European Responsible Nutrition Alliance
- EU
European Union
- GCP
Good Clinical Practice
- GMOS
Genetically Modified Organism
- ILSI
International Life Sciences Institute
- INCI
International Nomenclature of Cosmetic Ingredients
- MEDDEV
Medical Device
- MRP
Mutual Recognition Procedure
- OTC
Over The Counter
- QUID
Quantitative Ingredient Declaration
- SCC-NFP
Scientific Committee on Cosmetic Products & Non Food Products
- SCCP
Scientific Committee on Cosmetic Products
- UV
UltraViolet
References
- 1.AESGP (Association of the European Self-medication Industry), The European Union, Economic and Legal Framework for Non-Prescription Medicines, 2006Google Scholar
- 2.AESGP (Association of the European Self-medication Industry), The Regulatory Framework for Food Supplements in Europe, 2007Google Scholar
- 3.Altenstetter, C.: EU and Member State medical device regulation. Int. J. Technol. Assess. Health Care 19, 228–248 (2003)CrossRefPubMedGoogle Scholar
- 4.Anselmann, N.: The European legislation on medical devices. In: Palikarakis, N. (ed.) Information Exchange for Medical Devices. IOS Press, Amsterdam (1996)Google Scholar
- 5.Coppens, P., Fernandes de Silva, M., Pettman, S.: European regulations on nutraceuticals, dietary supplements and functional foods: a framework based on safety. Toxicology 221, 59–74 (2006)CrossRefPubMedGoogle Scholar
- 6.Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, OJ L 262Google Scholar
- 7.Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products. OJ L151Google Scholar
- 8.Directive 93/42/EEC of the Council of 14 June 1993 on medical devices, OJL 169 1-43; last amended by Directive 2007/47/EC, OJ L 247Google Scholar
- 9.Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, OJ L121Google Scholar
- 10.Directive 2001/83/EC of the European Parliament and the Council of 6 November 2001 on the Community code relating to medicinal products for human use, OJ L 311Google Scholar
- 11.Directive 2002/46/EC of the European Parliament and the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements, OJ L 183Google Scholar
- 12.Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003 amending for the seventh time Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products, OJ L066, 26–35Google Scholar
- 13.Directive 2003/89/EC of the European Parliament and of the Council of 10 November 2003 amending Directive 2000/13/EC as regards indication of the ingredients present in foodstuffsGoogle Scholar
- 14.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, OJ L 136Google Scholar
- 15.Directive 2004/27/EC amending Directive 2001/83/EC, OJ L 136Google Scholar
- 16.Eberhardie, C.: Nutritional supplements and the EU: is anyone happy? Proc. Nutr. Soc. 66, 508–511 (2007)CrossRefPubMedGoogle Scholar
- 17.European Advisory Services – EAS, 2005, Marketing Food Supplements, Fortified and Functional Foods in EuropeGoogle Scholar
- 18.German Medicinal Products Act (Arzneimittelgesetz, AMG) 1976, last amended by Act of 29. August 2005 (BGBI.I 2555,2570), revised by announcement of 12. December 2005 (BGBI. I 3394)Google Scholar
- 19.Gulati, O.P., Ottaway, P.B.: Legislation relating to nutraceuticals in the European Union with a particular focus on botanical-sourced products. Toxicology 221, 75–87 (2006)CrossRefPubMedGoogle Scholar
- 20.Hanekamp, J.C., Bast, A.: Food supplements and European Regulation within a precautionary context: a critique and implications for nutritional, toxicological and regulatory consistency. Crit. Rev. Food Sci. Nutr. 47, 267–285 (2007)CrossRefPubMedGoogle Scholar
- 21.Jefferys, D.B.: The regulation of medical devices and the role of the Medical Devices Agency. Br. J. Clin. Pharmacol. 52, 229–235 (2001)CrossRefPubMedGoogle Scholar
- 22.Kramer, A., Kremer, J., Assadian, O., et al.: The classification of antiseptic products to be administered to wounds – another borderline case between medicinal products and medical devices? Int. J. Clin. Pharmacol. Therap. 44, 677–692 (2006)Google Scholar
- 23.Lachout, P.: Comparative study on borderline products and borderline situations. In: CECP, Committee of Experts on Cosmetic Products (2006) Council of Europe PublishingGoogle Scholar
- 24.Li Bassi, L., Bertelle, V., Garattini, S.: European regulatory policies on medicines and public health needs. Eur. J. Public Health 13, 246–251 (2003)CrossRefPubMedGoogle Scholar
- 25.Loden, M., Ungerth, L., Serup, J.: Changes in European legislation make it timely to introduce a transparent market surveillance system for cosmetics. Acta Dermato-Venerologica 87, 485–492 (2007)CrossRefGoogle Scholar
- 26.Medicinal Products Act of 2. March 1983 on the production and marketing of medicinal products, BGBI. No. 185/1983 in the version in BGBI. No. 748/1988, BGBI. No. 107/1994Google Scholar
- 27.Pauwels, M., Rogiers, V.: EU legislations affecting safety data availability of cosmetic ingredients. Regul. Toxicol. Pharmacol. 49, 308–315 (2007)CrossRefPubMedGoogle Scholar
- 28.Permanand, G., Mossialos, E., McKee, M.: Regulating medicines in Europe: the European Medicines Agency, marketing authorisation, transparency and pharmacovigilance. Clin. Med. 6, 87–90 (2006)PubMedGoogle Scholar
- 29.Pignatti, F., Boone, H., Moulon, I.: Overview of the European regulatory approval system. J. Ambul. Care Manage. 27, 89–97 (2004)PubMedGoogle Scholar
- 30.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 L031Google Scholar
- 31.Richardson, D.: 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. 4, 51–66 (2007)CrossRefGoogle Scholar