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Botanical sabbaticals, special cases, and the EU's legal Eldorado

By Shane Starling+

23-Jan-2013

The ongoing imbroglio around botanical health claim regulation in the EU saw no sign of resolution in Brussels yesterday as the EC’s Basil Mathioudakis said any new regulatory framework could take “5-6 years” to become reality. Quite a sabbatical before meaningful changes may apply.

That is if that avenue is pursued at all; the major alternative being to keep the status quo and force 2078 ‘on-hold’ botanical submissions through the EU nutrition and health claims regulation (NHCR) wringer that Mathioudakis himself conceded would almost certainly condemn them all to a claimless existence.

“If the European Food Safety Authority (EFSA) proceeds with its evaluations there would be few claims subject to positive evaluation,” he told the EU Regulations for Food Supplements 2013 conference, before highlighting the core misfit between herbal product efficacy data and NHCR requirements.

“Effects based on traditional use are not generally sufficient for [the NHCR] as it is laid down today.”

The rub, right there.

Mathioudakis cryptically said if he was speaking at the end of this week, he may have more concrete developments to report, a statement attendees said referenced meetings with new health commissioner, Tonio Borg, where the status quo with botanicals would be discussed.

“It could be a chance to know where we are going with this,” Mathioudakis said.

So what to do?

Member states have begun the discussion and it seems some kind of new regulation or amendment to the NHCR to allow for the ‘special case’ of botanical food and food supplement products is gaining force as an alternative, but it is a long route, fraught with hazards.

There are the impending legal cases (four and counting) to be heard before EU law courts complaining about the unfairness of the ‘on-hold’ situation if it continues to offer potential amnesty for 2000+ herbal claims while 1500+ others have been rejected and are banned in the EU since last December.

There is the interaction with the EU Traditional Herbal Medicinal Products Directive (THMPD) and broader medicines law and how the protocols used there relate to, and may or may not be utilised and incorporated into any new botanicals framework.

Perhaps the framework could combine elements of the NHCR and THMPD to bring all herbal food products and medicines under one banner, suggested EU law expert Jean Savigny of Keller and Heckman.

There is the confusion felt by member states forced to do things their own way in lieu of harmonisation.

Indeed so complex is the task that Steve Mann, a long time botanicals legal expert with Nelsons in London, observed this morning that 5-6 years was actually an optimistic forecast to put any new framework in place for herbals.

Especially, he added, when the timeframe for the implementation of the EU THMPD, is considered.

Look to Belgium

In the meantime, member state food and health agencies are applying their own laws and interpretation of the EU laws that do exist, with Belgium’s system widely regarded as being the best-functioning in terms of transparency of what is required in safety, quality and efficacy data, the pragmatism of that criteria, and the innovation-promoting efficiency of the system.

As event chair Sebastian Romero Melchor, from K&L Gates observed: “The Belgian system is the marquee system in the EU. It offers solid science-based solutions.”

The Belgians are working to improve their system with a digital notification system that should go live this year, said Joris Geelen from Belgium’s Directorate for Animals, Plants and Food.

With speakers from Dutch, Austrian, Swedish, Belgian and Danish ministries outlining their approach to herbal and other supplements, harmonised or otherwise, the call for greater community and communication between member states came often at the conference.

As Soren Langkilde from the Danish Veterinary and Food Administration observed in a presentation about the Scandinavian nation’s hyper-strict approach to botanical products: “It is important that national authorities collaborate more closely – more closely than we do now.”

Could this map hold the key to harmonised botanical rules in the EU?

Calling Joris Geelen in Belgium may be a start on that…

...especially given, as Romero Melchor quipped, the EU harmonisation project around supplements appears sometimes like a search for Eldorado, that highly sought, but ultimately mythical lake into which Spanish folklore said a Muisca tribal chief dived after covering himself in gold dust.

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