The botanical blockade: EC ponders 3 pathways

By Annie-Rose Harrison-Dunn from Brussels

- Last updated on GMT

The head of the Commission's DG SANTE food legislation unit outlines three possible solutions to the EU's botanical woes. © / JPC-PROD
The head of the Commission's DG SANTE food legislation unit outlines three possible solutions to the EU's botanical woes. © / JPC-PROD

Related tags Health claims regulation European union European food safety authority

The European Commission has mused three different solutions to the botanical extracts situation that has seen about 2000 claims stuck on hold. Yet real movement will not be seen in the immediate future, a DG SANTE head has said.  

Last Thursday (30 June) the head of the Commission's DG SANTE food legislation unit, Alexandra Nikolakopoulou, discussed work on the so-called ‘Botanical Problem’ as part of its REFIT (Regulatory Fitness and Performance Programme) mission​.

Talking at an open Brussels meeting for the European Food Safety Authority’s (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA), she said the Commission was working on a report on the issue along with another on the need for nutrient profiles​.

Once the findings are in, the Commission will come up with a proposal with three main options under consideration.

Option one would mean applying the 2006 nutrition and health claims regulation (NHCR) in its current form to botanicals.

The Botanical Problem

There are about 2000 botanical health claims on hold, within which 500 received a negative opinion from the European Food Safety Authority (EFSA).

EFSA requires human studies to prove efficacy, but the majority of botanical health claim dossiers rely on 'traditional use' evidence. This kind of evidence is allowed under medicinal laws through a simplified registration procedure.

Yet under current EU rules, it is possible for member states to classify a product as a food or as medicine on a case-by-case basis depending on its presentation and claimed effect. This has led to confusion and disparities between countries.

“But if it was that simple, we wouldn’t be here,”​ said Nikolakopoulou.

A second option would be to create rules for botanicals based on traditional use, something similar to existing rules for traditional medicines under the Traditional Herbal Medicinal Products Directive (THMPD) which kicked into life in 2011.

One EFSA panelist at the meeting quipped that traditional use did not mean efficacy.

A third option would be to take botanicals out of the health claim regulation altogether and create a new system for composition, labelling and safety.

“It is too early to say now,”​ Nikolakopoulou said. “It is a period of questions. Now what we question is the health claims regulation. Aspects, not the health claims regulation in its entirety.” 

NDA chair Dominique Turck asked if they could assume the claims would remain on hold “for a while”​, to which Nikolakopoulou replied: “This is what I understood also.”

A fresh look 

Discussing the Commission's fitness check of the General Food Law, Nikolakopoulou said a lot could be said for what the legislation had achieved, despite challenges.

“It has substantially improved the internal market and it has harmonised science in the EU, by establishing EFSA as the supreme body. Having said that, problems have been seen.”


She said stakeholder frustrations were mainly around the interpretation and implementation of the regulation, rather than the regulation itself.

Some stakeholders, for example, had criticised the extreme implementation of the precautionary principle, which meant safety concerns could be weighted disproportionately against benefits to users.

She said there had been comments on the relationship between risk managers and assessors.

“I must say EFSA has attracted attention in this exercise,”​ she told the NDA panel members.

The Commission was now “seeing”​ what the follow-up to the exercise would be, with a working document expected by the end of the year.

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