Skip to main content
Log in

European Legislation on Herbal Medicines

A Look into the Future

  • Conference Paper
  • Published:
Drug Safety Aims and scope Submit manuscript

Abstract

Harmonization of the market for herbal medicines is a fundamental requirement for European industries and health professionals and it will also be useful for consumers. Herbal medicines are generally sold as food supplements, but a common regulatory status in the various European countries does not exist. As a consequence, information on clinical indications for use, efficacy and safety are influenced by different opinions, according to the clinical or traditional experience of various folk medicines available in each European country. The European Directive 2004/24/EC released in 2004 by the European Parliament and by the Council of Europe provides the basis for the use of herbal medicines in Europe going forward. The Directive establishes that herbal medicines released in the market need authorization by the national regulatory authorities of each European country and that these products must have a recognized level of safety and efficacy. The safety of herbal medicinal products will be evaluated on the basis of existing scientific literature (data from clinical studies, case reports, pre-clinical studies). When data on safety are not sufficient, it will be communicated to consumers. According to the criteria of safety and efficacy, we will have two kinds of herbal medicinal products in the future: (i) ‘well established use herbal medicinal products’ (medicinal herbs with a recognized level of safety and efficacy); and (ii) ‘traditional use herbal medicinal products’. The later category will include those medicinal herbs that do not have a recognized level of efficacy but are acceptably safe. Even though the fundamental objective of the new European herbal legislation is the harmonization of the market of herbal medicines, important regulations have been introduced, which will contribute to safer use of herbal substances if adopted by the whole of the European community.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  1. Mazzanti G. Pharmacological considerations on herbal medicine use. Ann Ist Super Sanita 2005; 41 (1): 23–6

    PubMed  Google Scholar 

  2. Calapai G. Herbal medicines: the european future scene. Evid Based Complement Alternat Med 2007; 4(S1): 69–70

    Article  Google Scholar 

  3. Tyler VE. Herbal medicine: from the past to the future. Public Health Nutr 2000 Dec; 3(4A): 447–52

    Article  PubMed  CAS  Google Scholar 

  4. Mahady GB. Global harmonization of herbal health claims. J Nutr 2001 Mar; 131 (3 Suppl.): 1120–1123S

    Google Scholar 

  5. Directive 2004/24/EC of the European Parliament and of the Council 31 March 2004 [online]. Available from URL: http://www.emea.europa.eu/pdfs/human/pmf/2001-83-EC.pdf [Accessed 2008 Mar 6]

  6. Silano M, De Vincenzi M, De Vincenzi A, et al. The new European legislation on traditional herbal medicines: main features and perspectives. Fitoterapia 2004 Mar; 75(2): 107–16

    Article  PubMed  Google Scholar 

  7. Directive 2001/83/EC of the European Parliament and of the Council 6 November 2001 [online]. Available from URL: http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol-1/dir_2004_24/dir_2004_24_en.pdf [Accessed 2008 Mar 6]

  8. Calixto JB. Efficacy, safety, quality control, marketing and regulatory guidelines for herbal medicines (phytotherapeutic agents). Braz J Med Biol Res 2000 Feb; 33(2): 179–89

    Article  PubMed  CAS  Google Scholar 

  9. Ernst E. Herbal medicines: they are popular, but are they also safe? Eur J Clin Pharmacol 2006 Jan; 62 (1): 1–2

    Article  PubMed  Google Scholar 

  10. Calapai G, Caputi AP. Herbal medicines: can we do without pharmacologist? Evid Based Complement Alternat Med 2007; 4 (Suppl. 1): 41–3

    Article  PubMed  Google Scholar 

  11. Ernst E. Herbal medicines: balancing benefits and risks. Novartis Found Symp 2007; 282: 154–67

    Article  PubMed  Google Scholar 

Download references

Acknowledgements

No sources of funding were used to assist in the preparation of this conference paper. The author has no conflicts of interest that are directly relevant to the content of this conference paper.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Gioacchino Calapai.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Calapai, G. European Legislation on Herbal Medicines. Drug-Safety 31, 428–431 (2008). https://doi.org/10.2165/00002018-200831050-00009

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/00002018-200831050-00009

Keywords

Navigation