There has been a sharp rise in the number of health and nutrition professionals who believe that EU regulation of natural health products is stifling innovation and investment and harming consumers’ interests.
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.* Although 34% find the framework helpful, this figure has dropped from 37%.*
Dissatisfaction is thought to have risen because of the EU’s tough stance on health claims and the continuing regulatory deadlock on botanicals. “The increasing frustration is not surprising,” says 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.”
Call for overhaul of health claims regulations
Over a quarter (28%) of respondents 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 and 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 regulation of botanicals is a hot topic and a legal disaster area” said Dr McCartney. “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. A fifth (19%) of respondents to the 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. “For large companies who invest strongly into product development, legal certainty is absolutely necessary,” said Dr Hardewig. “Not only are botanical claims applications on hold, but the situation also discourages new developments.”
• Vitafoods Europe (15-17 May, Geneva, Switzerland) 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.