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The future of functional food regulation

23 June 2014


Strict regulations on health claims have made Europe a centre for clinical trials in the functional food market. Japan, on the contrary, has become a test hub for innovation. In a new report, Canadean investigates the future market of functional foods.

In Europe, the number of approved health claims in food is extremely low. Until March 2014, the European Food Safety Authority (EFSA) has only approved 254 health claims out of the 2,242 submitted. This has made Europe a hard market for manufacturers, but also an important one as it provides a gold standard test for health claims. On the other end of the spectra there is a country like Japan. The stability of Japan’s FOSHU system, as well as its less strict demands for clinical evidence, has made Japan a popular test market for new ingredients. By early 2014, total approvals in Japan reached over 1,100 – five times higher than the number of approvals in Europe. Japan stands out among developed countries for the range of approved innovative health ingredients.

Particularly in digestive health and immune support, such as the use of probiotics, there has been a high number of claims. Where the underlying clinical evidence is seen as too poor to get the approval in EU, Japan has approved probiotics as functional foods, resulting in many new different ways of using these in foods.  

According to Canadean analyst, Ronan Stafford, Japan is the centre of functional innovation: “Both in terms of the regulatory attitude towards approval of novel ingredients but also in the willingness of consumers to embrace new and unusual functional ingredients.”

The largest number of functional food and drinks consumers is in the US – especially as a market for lifestyle health products. Emerging hubs such as China, India and Brazil are less important for now, but stand to exert significant influence over the functional food and drinks market in the future.

The future of the regulatory landscape is hard to predict. Certainly, large emerging markets such as India, China, and Brazil will adopt stricter regulation, although it is unclear how closely this will be enforced in the short term. The second key future event is the ‘rump’ of approvals in Europe – particularly the possibility of approval for probiotic health claims. “Clinical trials evidence has lagged EFSA’s approvals process by 6-10 years so within the next five years we should see more definitive outcomes on a range of ingredients,” says Stafford.

Powerful yogurt bar

The dairy sector, and particularly yogurt, remains the most closely linked with probiotics. Other categories such as savoury snacks and energy bars are starting to include probiotics. US company, Powerful Yogurt, was the first to launch a yogurt-covered protein bar with 20 grams of natural protein and premium probiotics. 



This information is based on Canadean’s report: ‘The Future of Functional Food & Drinks – successful product positioning and claims.’

For further information

Please get in contact if you have any questions to this or other Canadean reports and data. Call +44 (0) 20 3220 0818 or email


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