Herbal medicines in Europe - Italy shows way out of impasse
In 2004, the European Community has published a directive regarding traditional herbal medicinal products which requires a pharmaceutical registration of medicinal herbs. After a period of transition, which finished in May of 2011, it is now forbidden to sell such traditional herbal medicinal products or - as they are called in the UK - herbal remedies, without the necessary registration.
But there is a problem. The registration of medicinal herbs under the directive is extremely difficult.
Entire medicinal traditions like the Indian Ayurveda and Chinese Traditional Medicine, not to mention lesser herbal traditions of South America or Africa, are excluded from registration because they have not been officially used in Europe for 15 to 30 years. Consequently, very few of those medicinal herbs have been registered during the transition period from 2004 to now, which means the directive, in its present form, is unworkable.
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This is the background against which to see an Italian initiative which seeks to save those herbal traditions, not only in Italy but in the rest of Europe as well. The Italians are proposing a way out of this impasse.
It should be made clear in this context that the registration mandated by the EU does not regard all herbs but only those herbs that are sold as medicines.
For that reason there is no danger for products sold as food supplements, even if they contain or even consist only of herbs. Italy has firmly established this position in its national legislation that transforms the food supplements directive into Italian law.
Of course not all countries treat herbal products in the same way. France, for instance is much more restrictive and allows few herbs to be sold. Germany has always had a tradition of herbal products which were called 'Naturheilmittel' or natural medicines. The situation is similar in England, where herbal remedies have existed for years before the EU directive came into force. The difference is that now, those remedies have lost their status of exemption from pharmaceutical laws.
Herbal practitioners and healers who use those remedies are saying that their work is being made more difficult. It is the representatives of age-old herbal medicinal traditions from India and China however, who are complaining most bitterly from being unceremoniously pushed out of Europe.
The EU Commission washes its hands of the matter, saying it is up to the member states to interpret and apply the directive. In this way, instead of promoting a single market of medicinal herbs, the new European law has entirely excluded the major non-european herbal traditions and has, inside Europe, created a great confusion. National health authorities are confused - no one really knows what to do with herbs any more.
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Enter the Italian initiative
In order to get out of this impasse, the Italian associations Assoerbe and SISTE have been promoting a project to support the use of aromatic and healthy herbs in foods.
On 23 June, a meeting was organized in Milan, "Botanicals in health products: state of the art, developments and the role of industry", which brought herbal experts and both Italian and European health regulators together at the same table.
After a review of the current legislative situation of the non-pharmaceutical use of aromatic and healthy herbs by Prof. Vittorio Silano, the president of the European Food Safety Authority's scientific committee and Dr. Bruno Scarpa of the Italian Ministry of health, the research proposal of ASSOERBE was presented.
The absence of a widely accepted and consolidated list of herbs that may be used in non-pharmaceutical applications has created a climate of deep uncertainty among producers of herbs and herbal products. There are numerous lists that have been or are being elaborated in different EU countries, but certainly they are all different one from the other. The same herb could therefore be considered a supplement in one country and a herbal medicine in another, but all according to quite arbitrary criteria.
This is the situation the Italian proposal would like to address. According to ASSOERBE, there should be a role of industry in support of the regulatory authorities. The safety of plants should be evaluated with a view to the whole plant, not just some isolated chemical substance.
The proposal is to define a list of plants and to provide scientific information in the form of monographs and - where necessary - a series of toxicological tests on actual products.
Fourteen plants have been chosen as a first batch to be evaluated.
1. Cynara cardunculus L. ssp. scolymus (L.) Hegi, foglie (Artichoke, leaves)2. Ipericum perforatum (St. John's Wort)
3. Cassia senna, foglie (Cassia Senna, Senna leaf)
4. Echinacea pallida (Echinacea pallida or Pale-Purple Coneflower)
5. Aloe ferox, succo (Aloe Ferox juice)
6. Passiflora incarnata, foglia/fiore (Passion Flower, leaf and flowers)
7. Centella asiatica (Gotu Kola)
8. Serenoa repens, frutti (Saw Palmetto, fruit)
9. Valeriana officinalis, radice (Valerian root)
10. Ginko biloba, foglie (Ginkgo Biloba, leaf)
11. Tamarindus indica, succo (Tamarind juice)
12. Panax ginseng, radice (Panax Ginseng root)
13. Mentha piperita, foglie (Peppermint leaf)
14. Foeniculum vulgare Miller var. dulce (Sweet Fennel)
Scientific monographs will be provided to evaluate the feasibility of establishing, for plants to be used in foods, a process that is already quite well established for use in other types of production, to show that sufficient scientific documentation exists to attest the long term use of those plants in health promoting products, and to start a risk evaluation while considering the whole product as used.
A high level technical committee will be established to coordinate the program, to be headed by prof. Solimene, the Italian representative at the World Health Organization's Collaborating center for traditional medicine. Europe will be represented through the European Botanical Forum and the project PlantLIBRA, which deals in risk/benefit evaluations of plant-based food supplements.
Mr. Basil Mathioudakis of the European Commission, who had previously asked industry to given this type of support, expressed his satisfaction with the initiative, as did Dr. Scarpa of the Italian Ministry of health and, in a personal capacity, Prof. Silano who believes this initiative to be a pointer to a future function of EFSA, the European Food Safety Agency.
More details and the presentations (some in Italian, some in English) are available at the website www.assoerbe.eu