“We want to sell it as a food with function claims” is a request we sometimes receive. Japan’s foods with health claims, however, comprise three separate systems, and the procedures and difficulty differ entirely. Which one you aim for changes what you need to prepare.

The three systems

Foods with health claims divide into foods with nutrient function claims, foods for specified health uses, and foods with function claims.

Foods with nutrient function claims — self-certification

Foods used to supplement specific nutrients such as vitamins, minerals and fatty acids, labelled with the function of that nutrient. No individual application for approval is required: this is a self-certification system. It has the nearest entrance of the three, while what may be written is limited to the prescribed functions of the prescribed nutrients.

Foods for specified health uses (FOSHU) — approval system

Foods containing a relevant component that affects physiological function, labelled as able to be expected to serve a specified health purpose. To sell one, national review of efficacy and safety must be undergone for each food, and approval obtained. This is the heaviest of the three.

Foods with function claims — notification system

A system begun in 2015, whose defining feature is that notification is made on the business operator’s own responsibility rather than by national approval. It moves faster than FOSHU, while the validity of the evidence rests with the operator.

In summary

  • Nutrient function claims … neither approval nor notification required (self-certification)
  • FOSHU … approval system (national review)
  • Function claims … advance notification (operator’s responsibility)

The reality for imported goods

Filing an imported product as a food with function claims straight away can be a high hurdle in practice. Notification requires scientific evidence of function and safety, and that documentation has to be assembled from the overseas manufacturer in a form meeting Japanese standards.

Rather than choosing a system, work backwards from the documentation you can actually assemble. For imported goods this order is the more realistic one.

Building a track record as an ordinary food first, then considering notification once the documentation is in place, is a perfectly viable route. Not entering a system is not the same as not selling.

Whichever system you aim for, checking the food–drug classification and food labelling comes first. Getting the order wrong makes the rework substantial.

Primary sources referenced

※ This article summarises the outline of the system. Systems are revised over time. Please confirm current primary sources when making an actual assessment.