Frustration over EU regulatory framework

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

One in three industry professionals surveyed by the organisers of Vitafoods Europe said the current EU regulatory environment is unhelpful, up from 25 per cent at the start of 2017. Although 34 per cent find the framework helpful, this figure has dropped from 37 per cent.

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Experts believe dissatisfaction has 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 per cent) of respondents to the Vitafoods Europe survey said the EU policy change would help their business if there were 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,’ says Dr Elinor McCartney, president, Pen & Tec Consulting Group. ‘Once they established the Generally Accepted Science (GAS) 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, says the low number of approvals is a disincentive to research and development.  ‘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. The execution of the health claim regulation is not satisfactory, either for the industry or for the consumer.’

Botanical bottleneck

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,’ Dr McCartney explains. ‘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 per cent) of respondents to the Vitafoods Europe survey said this policy change would most benefit their business. Whatever the way forward, experts believe the current regulatory void is stifling innovation developments.

Guidance through the regulatory maze

Vitafoods Europe 2018 will be held on 15 to 17 May in Palexpo, Geneva. The show offers a range of support and advice for visitors trying to navigate the regulatory maze. Resources include the Advice & Expertise Trail. This self-guided tour leads visitors to top consultancy agencies with expertise in regulation (as well as product development, clinical research, market research and marketing). Many of the event exhibitors will offer a wealth of knowledge on regulation.

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 and insights into how the situation can be improved,’ Dr Nielsen notes.  ‘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,’ concludes Dr McCartney. ‘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.’