Botanical barrier adds to ‘unhelpful’ regulatory arena, say one in three

By Will Chu

- Last updated on GMT


Related tags Health claim European union European commission Nutrition

The difficulty in getting a probiotic health claim approved and the botanical stand-off may explain why one in three industry professionals find the current EU framework unhelpful and difficult to navigate.

Despite this figure—an increase from 25% in 2017—the survey of 208 nutrition industry representatives revealed  34% find the framework helpful, although this figure had dropped from 37% compared to last year.

“The increasing frustration is not surprising,”​ said Dr Annegret Nielsen, senior consultant at analyze & realize.

“Despite progress in some areas, the regulatory challenges for the industry have remained, or even increased, over the past year. It is currently very hard for companies to develop innovative products that comply.”

Probi woes

Only last week the European Commission denied the claim​ Probi’s probiotic Lactobacillus plantarum 299v​ could increase non-haem iron absorption.

The decision​​ follows a string of disappointments, which began in 2009 with an unsuccessful application to the European Food and Safety Authority (EFSA) and again in 2016.

CEO Peter Nählstedt revealed plans for another dossier re-submission for the same claim, currently with EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) panel.

Nählstedt said the European regulatory landscape would remain highly complex if EFSA continued to require proof beyond any ​doubt, not only beyond reasonable​ doubt, to publish a positive opinion on a health claim application on probiotics.

“We do however believe that the system has gradually become more ‘user-friendly’ as the guidelines for beneficial health effects, study designs etc. are becoming more and more detailed,”​ he added.

Nählstedt also said that with the expense and time involved in trying to gain a probiotic health claim, further efforts would be ‘questionable’ if he did not get a positive opinion on the present health claim application.

This consideration was also reflected in the Vitafoods Europe survey, which revealed that over a quarter (28%) of respondents thought the EU policy change that would most help their business was an overhaul of health claims regulations.

‘Mission Impossible’

“I think many in the food and supplement industry are frustrated with EFSA’s tough stance on the Nutrition & Health Claim Regulation,”​ said Dr Elinor McCartney, president, Pen & Tec Consulting Group.

“Once they established the GAS (Generally Accepted Science) claims list, companies found it extremely hard – and very expensive – to achieve new claims. The industry has worked hard to comply but many feel the compliance pendulum has swung too far towards ‘mission impossible.’”

The difficulty in applying and succeeding in getting a health claim is one thing, but the botanical debacle has been hugely frustrating as EFSA continue to place thousands of botanical health claims on hold as it considers how best to evaluate them.

The botanical category in question—Nutrition and Health Claims Regulation (NHCR) (EC) 1924/2006—currently has around 2,000 claim applications that need much more scientific evidence than is needed for traditional herbal medicinal products (THMPs).

“The EC and member states seem unable to agree on how to sort out the anomaly that health claims are allowed on traditional herbal remedies, but the same claims are prohibited on food botanicals unless a dossier passes EFSA,”​ said Dr McCartney.

Sector-specific laws needed

A fifth (19%) of respondents to the survey said sector-specific regulation for botanicals was the policy change that would most benefit their business.

The industry is in no doubt that current regulatory barriers are stifling innovation at a time when new approaches are urgently needed in evaluating standard health claims and those that require specific appraisals such as those for probiotics.

“Not only are botanical claims applications on hold, but the situation also discourages new developments.”​ said Dr Iris Hardewig, head of consulting & strategic innovation at analyze & realize.

“EFSA plays a key role in the evaluation of existing and new food components” ​added Dr McCartney. “But it would be even better if they looked at reducing bureaucratic delays.

“They should listen to stakeholders then do what needs to be done, focusing on maximum effect for minimum investment while preserving the EU’s excellent food safety record.

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