Special edition: Botanicals
What will it take to break the botanicals deadlock?
Reaching any kind of agreement on botanicals would be no mean feat considering the sector’s backstory of member state divergence on the classification as medicine or food, opinions on the evidence needed to establish safety and as a result around 2000 botanical health claims stuck in the backwaters of the EU food law books.
So what will it take to change the state of play?
Luca Bucchini, director of the food safety and nutrition consultancy firm Hylobates, said in the unlikely case that the two ECJ cases were successful, botanicals could see new opportunities opening up. One case was from the UK's HFMA and Italy's Federsalus seeking the cancellation of the current list of functional claims and another questioning the stalled health claims. The verdict of the first case may not be delivered until the summer.
Taking the issue to court
"If the first succeeds, it will probably mean that the way the European Food Safety Authority (EFSA) has looked at claims is at least partially wrong, and EFSA may need to look at tradition and evidence other than human intervention studies to approve claims - which would be a fresh start for botanicals," he told us.
"On the other hand, if the second lawsuit succeeds, all botanicals will be rammed through the current system of assessment, and all health claim applications will be rejected. While I am not sympathetic to this lawsuit, I accept they have a point. Regardless, the ECJ is likely to break the deadlock."
Bucchini said a unified pan-EU list of safe botanicals could also be a game changer for the sector.
Joris Geelen, who has worked for eight years as a regulatory expert for botanicals at Belgium’s department of health, food chain safety and environment, was part of the team which unified the French, Belgian and Italian lists of safe botanicals to form BELFRIT in 2013. For Belgium he said the ultimate aim was still clear: Convince member states and the Commission to agree on one pan-EU list of safe botanicals.
Commission action needed
Geelen was optimistic that the Commission would take action on the issue, citing a letter which "left the door open" to harmonisation back in 2012. Yet he conceded that there had been no firm deadline suggested. He said Croatia, Luxembourg and Romania had all expressed interest in implementing the list, yet often these smaller states did not have the same resources as Belgium to bring such plans to fruition.
Geelen said the "pragmatic" Belgian system in the making since 1997 and now using a digital notification system was already being used an unofficial reference point for other countries. "We see that in Spain - where the legislation is not that clear - we get
heaps and heaps of notifications here in Belgium and the authorities in Spain authorise the products when the notification has been done in Belgium."
Meanwhile convincing other member states held its challenges with Germany and the UK favouring medical categorisation and therefore ruling out maximum limits for certain plant extracts and Holland taking an ever liberal stance meaning it was difficult to know what was on its market.
Bucchini said the main challenge for BELFRIT was to establish a credible system for reviewing and updating the list that was scientifically and legally sound.
"If that happens, and the effort is opened up to other countries, including Germany with its own list, then the future may be brighter."
Meanwhile Geelen said current assessments under the novel food regulation did not go deep enough into the safety of the products, considering first and foremost the existence of the product on the EU market and not the complex composition of the plant and the possibility of setting upper limits as the Belgian system did.
Bucchini added: "One also wonders if the European Commission should be more proactive in this area so that we may perhaps have one day an actual single market for botanicals."
Geelen said his team would be presenting the BELFRIT list to the new Commission, as they had done with the previous Commission.