Japan moves beyond Foshu: Over 400 products approved under new health claims regime in last year

The regulatory shift was a landmark change in the country.

More than 400 foods have been approved under Japan’s 2015 Foods with Function Claims (FFC) regulation, with the market already estimated to be worth US$70bn.

The FFC rules came into force last year as an additional regulation alongside the country’s more stringent Food For Specified Health Uses (Foshu) system.

But while the latter restricts claims to 14 health benefits and requires clinical trials, the new system permits systematic literary reviews as suitable evidence and allows any health benefit to be claimed.

Industry experts at last week’s HI Japan show in Tokyo said the new rules had made the claims environment less complex, while also widening the market and creating healthy competition.

They added the regulatory shift was a landmark change in the country that is considered the home of healthy food innovation – a tradition that dates back to Yakult’s entry into the market in the mid-1930’s.

Hisaaki Kato, former executive president of DSM in Japan and now president of consultancy Smooth Link, said manufacturers now had more control over the claims process.

Like the DSHEA in the US, food manufacturers can now make a claim for function based on their own evidence for both safety and effectiveness.

So far, 441 FFC claims have been approved in just over a year.

This is in contrast to the Foshu scheme where only 1271 products have been given the green light since 1991.

New product areas

According to Viator Yasumoto from Japan’s Health Industry News, 63% of the FFC-approved products are for health claims that are covered by Foshu, such as items for blood sugar management and cholesterol.

The remaining 37% come under new areas such as products to help with sleep, stress, eye health and joint health.

“These health claims are not new in many places, but they are new for us," he said.

“Eye, skin, sleep and joint products are the biggest FFC claims so far."

Japan market experts now predict that 1000 FFC products will be on the market within the next two years, and say it has been a game-changer for the marketing potential of products.

Yasumoto said some products had seen 450% sales growth after they were permitted to make FFC claims.

Meanwhile Smooth Link’s Kato added: “It has had a big impact on marketing strategy and its potential. It is especially providing a new business chance for international players and SMEs.”

The regulation change was broadly welcomed by the biggest multinational players with the likes of Naturex, DSM, Lonza, Rousselet at the time of their introduction.

It also received support from local outfits like Taiyo Kagaku, the Yokohama Oils and Fats Industry (Linda) and Morinaga Milk Industry, which welcomed the impact they had on marketing practices.

Speaking to NutraIngredients in 2014, Yuji Matsushita, president at Japanese distributor Tradepia Corporation (TPC), called the proposals, "a great change."

Experts at HI Japan last week said they now expected more international firms to try and enter the market, alongside the Japanese manufacturers and global powerhouses which have made the early running.

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