They say the latest adoption, that follows a similar although broader adoption that actually expanded on BELFRIT in Italy in April, will boost the drive toward European Union botanical harmony, along with the principle of mutual recognition.
"This marks indeed an important step toward a comprehensive regulatory framework for botanicals,” said Patrick Coppens, director of scientific and regulatory affairs at Brussels-based industry group, Food Supplements Europe (FSE).
“The requirements for notification now included in the signed French law are a good basis for making sure that the safety and quality of such products are ensured is a way that FSE and its members think is essential.”
Mutual recognition is the idea that something accepted in one member state, should be accepted in others, “unless very specific conditions are met.”
BELFRIT was a joint project between Belgian, French and Italian researchers that compiled about 1000 botanicals into a positive list based on available safety and efficacy data, including traditional use data.
Coppens said he hoped the BELFRIT work and the actions of the French and Italian governments would be, “taken as the basis by other EU Member States and the European Commission to further harmonise this category of products, taking into consideration its specificities and in particular the long tradition of use.”
Thomas Pauquai, PhD, head of health claims and food safety at French consultancy, Nutraveris, said the list was important for France and elsewhere as it superseded the confusing situation of multiple positive and negative lists.
“However many botanicals or preparations often present in food supplements can not be found on any list...” Pauquai said of the new list that was drafted at the end of 2012 and is open to modification as new data and market entries comes to light.
“The specific conditions are particular to each plant and consist of usable parts of plants, potential substances to be monitored or maximum levels of metabolites, and possible warnings and precautions addressed to populations at risk,” Pauquai said.
“The restrictions are, for the most part, the result of regulations from other Member States.”
Pauquai added: “While for some manufacturers of non-traditional preparations it is quite clear that they will be affected, for others it will be the result of a case by case analysis…”
The French regulation was careful to prohibit botanicals that could be classed as medicines, he relayed.