Herbals directive will not include substances regulated as food
medicinal products directive (THMPD) that will prevent it from
regulating herbal products sold under food law.
In a second reading by the European Parliament's Environment Committee, a new paragraph has been added under article 16c to guarantee that herbal substances used in foods, and below pharmacological levels, will continue to be regulated under food legislation. It also clarifies the difference between herbal preparations sold in food supplements, not targeted under this directive.
"We are very happy with the amendment. We will monitor compromises between the MEPs to ensure this reaches the best outcome," said Pedro Azua Vicente, director of the European Herbal Products Manufacturers (EHPM) association .
A second amendment altered the wording referring to the list of approved substances to be drawn up by the new herbal medicinal products committee.
The amendments are expected to be voted through by ministers at a codecision procedure next week. The directive will then go back to the Council in preparation for its introduction by member states.
The new directive is designed to safeguard the growing number of consumers using herbal medicinal products throughout the EU. It will, however, present a significant rise in costs for the herbal industry. The proposal sets high standards for medicinal herbs and stipulates the inclusion, on labelling and in package leaflets, of rigorously scientific, simple and clear indications regarding the potential toxicity and possible interactions with food or drugs.
The European Council has already adopted key amendments from Parliament's first reading including the tasks and the composition of a new herbal medicines committee, to be set up to assess the safety of herbs, as well as the possibility of registering herbal medicinal products that contain non-herbal ingredients like minerals and vitamins, and the acceptance of non-European tradition when deciding on the status of traditional herbal medicines.
The directive still requires ingredients to have been in medicinal use for at least 30 years before approval, 15 of which must be in Europe. It is feared that a number of products will not be able to demonstrate the recognised efficacy and acceptable level of safety.
