Regulation frustration: One in three industry professionals finds EU framework unhelpful

Posted: 15 February 2018 | | No comments yet

The number of nutrition industry professionals who find the EU regulatory framework unhelpful has risen sharply over the past year, research shows.


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One in three (33%) industry professionals surveyed by the organisers of Vitafoods Europe said the current EU regulatory environment is unhelpful, up from 25% at the start of 2017.1 Although 34% find the framework helpful, this figure has dropped from 37%.1

Experts believe dissatisfaction has risen because of the EU’s tough stance on health claims and the continuing regulatory deadlock on botanicals.

Call for overhaul of health claims regulations

Over a quarter (28%) of respondents to the Vitafoods Europe survey said the EU policy change that would most help their business was an overhaul of health claims regulations.

This may be because it has become too difficult to get a health claim approved.

“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.’”

Dr Iris Hardewig, Head of Consulting & Strategic Innovation at analyze & realize, said the low number of approvals is a disincentive to research and development. “The frustration is high because clinical trials are a major investment for food companies. If it doesn’t lead to any competitive advantage, they refrain from investing in science. In that sense, the execution of the health claim regulation is not satisfactory, either for the industry or for the consumer.”

Botanical bottleneck

A particular area of concern is the current deadlock on the regulation of botanicals. Thousands of botanical health claims have been on hold for several years while EFSA considers how to evaluate them.

“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.

One solution that has been proposed is sector-specific regulation for botanicals. A fifth (19%) of respondents to the Vitafoods Europe survey said this was the policy change that would most benefit their business.

Whatever the way forward, experts believe the current regulatory void is stifling innovation.

Hope for the future

The EU is currently reviewing nutrition regulation through the Commission’s Regulatory Fitness and Performance (REFIT) programme, which aims to keep EU law simple. Experts hope it will reduce the burden on the industry: “REFIT will hopefully bring a sense of proportion as well as insights into how the situation can be improved,” said Dr Nielsen. “There are useful products between conventional food and drugs that might evaporate due to the current regulations.”

“EFSA plays a key role in the evaluation of existing and new food components,” said 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.”


  1. Vitafoods Europe surveyed 208 nutrition industry representatives between 14 November and 4 December 2017. The same questions about regulation were previously asked in a survey of 190 nutrition industry professionals between 6 December 2016 and 3 February 2017.

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