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….”
*The opinions herein are mine (Catherine Fish) and do not necessarily reflect those of Bayer Consumer Care AG or its affiliates.
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Abbreviations
- 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
AESGP (Association of the European Self-medication Industry), The European Union, Economic and Legal Framework for Non-Prescription Medicines, 2006
AESGP (Association of the European Self-medication Industry), The Regulatory Framework for Food Supplements in Europe, 2007
Altenstetter, C.: EU and Member State medical device regulation. Int. J. Technol. Assess. Health Care 19, 228–248 (2003)
Anselmann, N.: The European legislation on medical devices. In: Palikarakis, N. (ed.) Information Exchange for Medical Devices. IOS Press, Amsterdam (1996)
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)
Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, OJ L 262
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 L151
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 247
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 L121
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 311
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 183
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, 26–35
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 foodstuffs
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 136
Directive 2004/27/EC amending Directive 2001/83/EC, OJ L 136
Eberhardie, C.: Nutritional supplements and the EU: is anyone happy? Proc. Nutr. Soc. 66, 508–511 (2007)
European Advisory Services – EAS, 2005, Marketing Food Supplements, Fortified and Functional Foods in Europe
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)
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)
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)
Jefferys, D.B.: The regulation of medical devices and the role of the Medical Devices Agency. Br. J. Clin. Pharmacol. 52, 229–235 (2001)
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)
Lachout, P.: Comparative study on borderline products and borderline situations. In: CECP, Committee of Experts on Cosmetic Products (2006) Council of Europe Publishing
Li Bassi, L., Bertelle, V., Garattini, S.: European regulatory policies on medicines and public health needs. Eur. J. Public Health 13, 246–251 (2003)
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)
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. 107/1994
Pauwels, M., Rogiers, V.: EU legislations affecting safety data availability of cosmetic ingredients. Regul. Toxicol. Pharmacol. 49, 308–315 (2007)
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)
Pignatti, F., Boone, H., Moulon, I.: Overview of the European regulatory approval system. J. Ambul. Care Manage. 27, 89–97 (2004)
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 L031
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)
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Karajiannis, H., Fish, C. (2010). Legal Aspects: How Do Food Supplements Differ from Drugs, Medical Devices, and Cosmetic Products?. In: Krutmann, J., Humbert, P. (eds) Nutrition for Healthy Skin. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-12264-4_15
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