Joris Geelen has worked for eight years as a regulatory expert for the Belgian department of health, food chain safety and environment and was part of the team which unified the French, Belgian and Italian lists of safe botanicals to form BELFRIT in 2013.
He told us Belgium hoped to have the support of the majority of other EU member states on the decree.
“On an EU level our intention is of course to convince other member states to implement the same list in their legislation and start harmonisation that way.”
EU member states are obliged to notify the Commission of new technical rules to ensure compatibility with EU law and internal market principles but Geelen added: “In a way we’re also making a point of course.”
The Commission and member states are now able to comment on the draft and possibly raise objections. Only after this process will it be written into the official Belgian journal.
France is in the process of adding 500 plants from the list to its own legislature while the Italian Ministry of Health implemented a transition period for those herbals that did not make its list to sell through, and that the 1000-strong BELRIT list was not definitive.
The amended Royal Decree of 29 August 1997 included a list of prohibited plants, a list of edible mushrooms and a list of plants permitted in food supplements specifying in some cases conditions of use.
The draft decree factored in a transition period, allowing food supplements that do not comply to sell through up to two years after the decree comes into force.
Harmonisation still in sight
Geelen, a long-time proponent of EU harmonisation on botanicals, said wildly differing national regulations meant both over and under regulation and unfair competition.
Differences included classification as medicine or food and the legitimacy of ‘traditional use’ evidence of efficacy and safety.
“To guarantee the safety, quality and legal security of these products with such heterogeneous ingredients coherent science-based legislation should be the answer to address the different and particular challenges.”
He said Belgium had been working toward this for the better part of two decades. “We want to ‘extrapolate’ our legislation, procedures and notification system to the other member states, to the EU. We need more coherent policies based on scientific advice. We need better quality dossiers and products for food supplements with botanicals. The firms need a push and guidance to assure safety and quality.”
His team has requested a meeting with the new European Commission headed by Lithuanian Vytenis Andriukaitis to discuss this.
In Europe, botanicals are typically classified as either food supplements, medicines or under the EU Traditional Herbal Medicinal Products Directive (THMPD) depending on the country.