“The impact of this longer-term erosion of the relationship with consumers will be profound.”

Appraised: 12 months in the life of the world’s toughest health claims regime


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FSE: “What we have not observed is how the NHCR is stimulating innovation in the sector..."
FSE: “What we have not observed is how the NHCR is stimulating innovation in the sector..."

Related tags Member states European union

Widely despised and foreseen as an innovation crusher and healthy foods/supplements market wet blanket, we asked how life under the controversial EU nutrition and health claims regulation (NHCR) is panning out.

In the 12 months since full implementation the sector sees inconsistent enforcement procedures and phenomena like the shift of claims into the social media sphere, and remains highly wary and concerned about the regulation’s effects. But there have been victories...

The EU trade group: Botanicals win, stimulation kicked

Patrick Coppens, director of scientific and regulatory affairs, Brussels-based Food Supplements Europe (FSE)

I think it is fair to say we have seen positive and less positive evolutions. A positive is that our efforts have resulted in the European Commission putting botanicals on hold and recognising that a specific approach may be needed.”

“Also positive is the recognition of the beneficial effects of vitamins and minerals that is now recognised by the approval of many claims.”

“Unfortunately the same has not happened for many other substances that also play a role in health, mainly because many of the benefits are difficult to demonstrate with intervention trials in healthy people and we believe efforts should be undertaken to clarify ways of demonstrating such effects by the consideration of the totality of the evidence available and not only on intervention trials.”

patrick coppens-FSE

What is positive also is that companies have been able to benefit from the necessary transition periods to adapt their products to the new situation and that transitions have been smooth and guided by national authorities in many member states and this is what matters to small and medium sized companies.”

“What we have not observed is how the NHCR is stimulating innovation in the sector, given the lack of clarity that still exists in relation to the scientific justification that would be sufficient.”

The UK trade group: “Massive restrictions”
Graham Keen, executive director, UK Health Food Manufacturers' Association (HFMA)

“Our members have been coming to terms over the last year with the massive restrictions imposed by the NHCR, which goes to the heart of how this industry communicates with its consumers not just now, but for years to come. The impact of this longer-term erosion of the relationship with consumers will be profound. But the immediate impact of this legislation was never going to be felt in year one.”

“The sad fact is that the regulation is banning many hundreds of claims on products that have been well understood and accepted by the average consumer here in the UK for decades – such as ‘dietary fibre helps maintain a healthy digestive system’ and ‘glucosamine helps maintain healthy joints’.”

“As a result the legislation is, unfortunately, counterproductive as it denies consumers the very information that they increasingly want about how and why these products might be used, and what reasonable expectations they might have for their effectiveness.”


“If the intention of this regulation was to have health claims that are scientifically substantiated and ‘easily understood’ by the average consumer, where is the sense in one of the few approved claims being ‘Pantothenic Acid contributes to the normal synthesis and metabolism of steroid hormones, vitamin D and some neurotransmitters’!”

“At the end of the day, consumers will lose out not just by being denied information or being provided with confusing information, but also as a result of the reduced product innovation that will result from companies not being prepared to risk the huge investment now required to meet the requirements of this aggressive and divisive regulation.”

The consultant: “…we see self-regulation as the primary means of enforcement…”

Mark J. Tallon, PhD​, managing director, UK-based Legal Foods

For some companies the risk of using unauthorised claims outweigh the risks of non-compliance. In the UK, it is relatively weak due to government cutbacks from enforcement authorities in what is still a time of austerity.”

“Companies are aware of this and are willing to fly closer to the fringe of non-compliance. However, we see self-regulation as the primary means of enforcement in this market and risk to brand damage or competitor complaints.”

The biggest impact has been in the movement of non-compliant claims from on-pack to social media. On pack-claims must be closer to 100% compliance as the risk or removal from shelf of non-compliant products is a costly proposition.”

“Similarly, some member states such as Italy are willing to issue significant fines for non-compliance. By making claims on social media compliance when required from competent authorities can be addressed instantly, with little impact on resources or sales. This is unlike reprinting a label or removal of stock.”


One aim of the regulation is harmonisation and this has failed. Interpretation of claims regarding use of flexible wording, generic descriptor use, and technical issues such as what constitutes a ‘contains’ nutrition claim can and are viewed differently across the EU and even within member states.”

“The result is an increased risk to those companies selling products across the EU unless they make claims that are not 100% in line with official wording and related conditions of use.” 

“Generic descriptors and the implementing regulation for this aspect of the regulation will cause significant issues for industry. The ability for member states to ‘choose’ to see consumer data to prove a descriptor does not imply a health benefit is a significant burden for industry. Descriptors such as 'low-carb', 'probiotic', 'antioxidant' will no doubt be considered by the consumer as a health benefit.” 

“However, in the regulation's own wording, descriptors such as ‘digestive' and 'cough drop' should be excluded from the scope of the regulation. However, the application process required to have a descriptor approved would have the Commission's own descriptor examples (i.e. Digestive) rejected as they would be considered a health claim.” 

“In our view enforcement is fragmented across the 28 member states as is the interpretation of the regulation. As we get more court judgements over the use of claims many issues will be come clearer, but whilst we wait for such issues to be concluded industry will be restricted in the free movement of products across the EU.”

Related topics Regulation & safety

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