The Current Situation of Herbal Products in Europe
The markets of herbal preparations are currently being harmonized in the European Community. Basically, there are four different categories of legislation into which a herbal product may fall: Products can be
- Food (including food supplements and Novel Food),
- Drug (registered as a traditional herbal medicinal product or with a marketing authorisation)
- Cosmetic
Each of these fields is separately regulated by EU Directives.
A potential manufacturer will therefore have to decide which category will fit best to his intentions.
Is the preparation food or drug?
The differentiation is often rather difficult, as with herbal preparations the situation arises that a plant may have a dual use, both as a drug and a food item. E.g., turmeric (Curcuma longa) would usually be considered food when marketed in the typical form of a spice, but not necessarily when it comes in capsules.
The decision whether a given preparation is food or drug is not self-evident, and the criteria for acceptability in either category are constantly shifting. The most important parameter in the past was not so much the actual presentation of a given plant or herbal preparation, but rather the health claim made for the preparation. Consequently we are facing the situation that exactly the same product with the same recommended posology and application form may be food supplement in some EU member states, and registered or even authorized drug in others.
If food, is it “novel”?
Herbal preparations are being marketed as food supplements in most EU member states. Whether a given preparation may be freely marketed depends on its composition. In the food sector it must be made clear that the plants in the preparation or the application form as such, respectively its method of preparation, are not “novel”, i.e., they must have been available on the EU markets prior to May 15, 1997. This date marks the inauguration of the Novel Food Directive (258/1997/EG), a directive originally created to protect EU consumers from genetically manipulated food. Genetic manipulation has meanwhile been regulated in a separate directive, but the Novel Food Directive stayed and is increasingly used as an argument to prevent plants from non-EU sources from being marketed within the EU. There are plenty of examples of Indian/Ayurvedic herbs such as Phyllantus emblica (Amla), or Terminalia chebula, just to mention two. Especially in the case of Phyllantus emblica the recurrent classification by certain national authorities as “Novel Food” is clearly wrong.
When a plant/preparation is considered “novel” an application must be made to the EU, demonstrating the safety of the product with corresponding toxicological data. Not only is the process itself rather costly, but also time consuming, as it may take a practically indefinite number of years. In addition, there is no guarantee that a product will be accepted, even when the toxicological data is presented. For small and medium size enterprises this approach is in practice not viable for economic reasons.
In the recent past some changes have been applied to the Novel Food Directive in order to streamline the process, but in fact nothing substantial seems to have come out of these changes. In addition one should be aware that even permission to market a “novel” preparation is obtained, this does not include an authorization of a health claim.