An additional obstacle that botanical brands face is the regulatory framework. In Europe, this is highly fragmented, with each EU member state applying its own rules to botanical supplements.
“[...] The same botanical may be permitted in Italy, but not in France, for example,” says Luca Bucchini, managing director of Hylobates, an Italian regulatory and scientific consultancy.
“France may require data that Spain does not require, and Belgium may require a label warning at odds with the French requirement. As for Germany, the same product incorporating botanicals may be [regulated as] either a medicine or a food supplement.”
For instance, the European Court of Justice recognised that a garlic food supplement may legally be a food supplement in Italy but must be registered as a medicine in Germany if the German authorities can prove that the garlic in the supplement has medicinal effects.
Different rules also apply regarding health claims. National regulators in Italy, for instance, have issued warnings about turmeric supplements and banned all health claims, but have not set maximum limits. France and Belgium have issued different warnings but have set their own maximum limit.
Many stakeholders probably feel that harmonisation that is acceptable to Germany would be worse than the current fragmentation
Despite this disjointed situation, which can be difficult for botanical brands to navigate, there may not be significant support for EU-wide harmonisation of the rules, according to Bucchini. “Many stakeholders probably feel that harmonisation that is acceptable to Germany would be worse than the current fragmentation,” he says.
Various botanical extracts, including green tea and curcumin, have come under scrutiny in recent years for suspected adverse effects among specific groups of consumers.
Most recently, France’s Agency for Food Health and Safety (ANSES) conducted an extended safety review of curcumin and its derivatives.12
“The safety questions raised by ANSES and other agencies on curcumin derivatives are not completely new, and are actually valid for all botanicals,” says Dudek, of A&R.
EFSA’s recent statement on the “safety gaps” for CBD13 also suggests that, in Europe at least, testing and regulation could become more demanding in future. “Data provided must be valid for the specific product,” she says, and should not be reliant on synthetic or highly purified forms of the ingredient.
“Last, but not least,” says Dudek, “modified bioavailability potentially affects the safety profile of a botanical constituent, impacting maximum safe doses.”
Nutrition businesses around the world, and not only those with markets inside the EU, will understand the importance of protecting their consumers – as well as their brand reputations – by updating their safety evaluations appropriately.
