Italy Decree on Botanical Supplements May Foster Harmonization

BRUSSELS, BelgiumThe European Federation of Associations of Health Product Manufacturers (EHPM) issued enthusiastic support for the recent Italian Ministry decree on the use of plant ingredients in food supplements, saying the move validates the need for harmonization on this subject.  The decree, which includes a list of approved plants as well as conditions of use and labeling requirements, was published in the Gazzetta Ufficiale on July 21, 2012. It also includes an official statement on mutual recognition to ensure free movement of botanical supplements between European Union countries and legality of the products.

According to EHPM, the situation with plants in supplements has been a matter of lengthy discussion, but was never adopted as national law until the decree was adopted this summer.  This is a major development for the regulatory climate for botanicals in Europe, said Keith Legge, chairman of EHPM. This is an instrument that can be used to foster harmonization. Consumers want to have access to products of their choice and be sure of the safety of the botanicals used in supplements. The business sector also needs clarification on borderline issues.

The decree, which EHPM explained paired with guidelines on the physiological effects that can be claimed on product labels, resembles a similar model developed by Belgian authorities, who also included an approved list of substances and conditions for their use. EHPM said it is hopeful serve as a basis for the development of "an appropriate framework offering a coherent approach and tailored solutions to botanicals." In fact, Legge argued the lack of current harmonization directly impacts the market and limits consumer choice, challenging the very existence of botanical supplements.  "We hope that these two models will encourage other Member States to start a reflection on the harmonization of practice," he said. "Such a reflection would be welcomed by the food supplement industry.