European trade association EHPM has hailed Italy’s recently adopted Decree on the use of plant substances and preparations in food supplements as recognition of sector and consumer needs.
The decree, which was published in the official gazette on July 21, had long been discussed, but until now never been adopted in Italian national law.
It contains a long list of plants approved for use in food supplements, with conditions of use and labeling requirements. The Decree also contains an official clause on the principle of mutual recognition that will support the free movement of botanical food supplements and provide legal certainty on the status of these products.
The decree comes together with guidelines on indications and/or references to physiological effects that can be claimed on the product labels.
“This is a major development for the regulatory climate for botanicals in Europe,” said EHPM Chairman Keith Legge. “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.”
Italy’s Decree is in line with a similar model created by Belgium, which also established a list of permitted plants with specific conditions of use to ensure safe use of these products.
EHPM said that both models could be of value in the development of an appropriate framework offering a coherent approach and tailored solutions to botanicals.
Legge said: “The lack of harmonization in the current system has a direct impact on the sector and consumer choice, making the continued existence of botanical food supplements increasingly challenging. We hope that these two models will encourage other Member States to start a reflection on the harmonization of practice. Such a reflection would be welcomed by the food supplement industry.”