According to the survey, conducted by the organisers of trade show Vitafoods Europe, one in three nutrition industry professionals find the current EU regulatory environment “unhelpful”. This is up from 25% at the start of 2017. And while 34% of respondents stated that the framework is helpful, this figure has dropped from 37%.
Experts believe dissatisfaction has risen because of the EU’s stance on health claims and the continuing regulatory deadlock on botanicals.
“The increasing frustration is not surprising,” said Dr Annegret Nielsen, a consultant with 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.”
New health claims ‘mission impossible’?
European regulations make it particularly challenging for companies to get health claims approved, with 28% of professionals surveyed suggesting that an overhaul of the framework would “most help” their businesses.
“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 reduced number of health claim approvals can put companies off investing in health related R&D, Dr Iris Hardewig, head of strategic innovation at Analyze & Realize, added.
“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,” Dr Hardewig argued.
Botanical bottleneck
A particularly problematic area is the question of botanical ingredients, with thousands of botanical health claims on hold while EFSA considers how to evaluate them.
Dr McCartney described the issue as a “legal disaster area”.
“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.”
One solution that has been proposed is sector-specific regulation for botanicals. Nineteen percent of respondents to the Vitafoods survey identified this policy change as most beneficial.
The EU is currently reviewing nutrition regulation through the Commission’s Regulatory Fitness and Performance (REFIT) programme.
This presents an opportunity to “bring a sense of proportion” to existing regulations, Dr Nielsen suggested.
Dr McCartney added: “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.”