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Label bank

Functional Claim Food - Sales Started in June

It's been two months since a new health food category, functional claim food, was introduced under new labeling system, and those foods with proven health benefits are now appearing on the selves of stores.

However concerns have been raised over the new system; some consumers complain that the information on those products released by each company is too technical and difficult to understand. For those people involved in developing and selling functional claim foods, we provide general information on the topic.

Supplement: 24
Processed food: 19 (beverages: 19)
Fresh produce: 0
(Information as of June 25, 2015)

Of those registered as functional claim food products, more than half are supplements (tablets, capsules, powder and drink), and the processed food is made up of beverages only (including vinegar).

It appears that so far the products sold with functional claims are similar to those sold under the "food for specified health uses". Fresh foods or food specialties from each region of Japan sold as functional foods are not yet available on the market, but the number is expected to increase in the near future.

"Functional Claim": It is required to provide specific information on claims
× "Eating fish makes you smart"
○ "DHA contributes to the maintenance of normal brain function: 250 mg DHA/day"
 (An example of health claim approved in EU)

In order to claim a product as "functional food", scientific evidence for the claimed health benefit must be submitted. Functional claims must be made based on test results or relevant research papers. I provide two sample function claims the CAA received for your reference below: One is based on the results obtained from clinical trials of the final product, and the other one uses a research review of functional components as scientific evidence.

"This product includes lutein, astaxanthin, cyanidin-3-glucoside and DHA, which adjust the eye's focus and alleviate shoulder and neck pain caused by eye strain"

"This product includes L-Theanine, which is reported to improve sleep quality"

This new health food category covers wider variety of health benefits and includes more detailed descriptions compared to "Food for Specified Health Uses" (FOSHU). This is to say that qualifying for the functional claim foods requires scientific papers such as test results on functional components, intake levels and efficacy.

When you prepare papers offering scientific evidence, "equivalence" with regard to efficacy and safety must be ensured. The ingredient and its dosage tested and included in the final product must demonstrate the same efficacy and safety.

It is often more difficult to demonstrate equivalence of the ingredient than of the dosage, and therefore the guidelines for pre-marketing notification discusses the "equivalence". The equivalence can be determined using different methods, and the main points on "equivalence" discussed in the guidelines are as follows:

  • Are they identical in form (disintegrability/dissolution)?
  • Are they identical in source ingredients?
  • Are they identical in ingredients and compounds (recipe)?
  • Are they identical in manufacturing process?
  • Is there any change in functional ingredient resulting from the recipe used in the final product?
  • Can the method for ingredient analysis used in the test applied to final product?
  • Does the functional ingredient in the tested product provide the same efficacy in the final product (a decrease in efficacy with time won’t be observed)?

Although the "equivalence" between papers offering scientific evidence and the final product has been focused, the "equivalence" between the final product and time of intake will also have to be considered when the number of notifications for fresh foods and the processed foods that require cooking before eating is increased in the future. Let's say if functional components lose their effectiveness depending on preparation methods, cautions may be given in the guidelines for the general public.

This new category of health foods, functional claim foods, will enter a new phase when the number is increased in the future.

Source: CCA, "Information concerning functional claim food"

July 2015