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Label bank

Released report of New Functional Labeling System Review Committee

Concerning new measures to describe functionalities based on scientific evidence under not government but corporate responsibility, on July 30th 2014, the Consumer Affairs Agency has released a discussion report on the "New Functional Labeling System", which consolidates policies such as "report before sale" or "public disclosure".
Public comment will be invited for more opinions.

Outline of the new system

Under the new system, function claims based on scientific evidence can be labeled on each corporate's own responsibility.
However, references for scientific evidence must be submitted to the Consumer Affairs Agency before sale.
Furthermore, this is the system with premise that the Consumer Affairs Agency should disclose the scientific evidence provided to the public.
Functional foods are not controlled by the ex-ante regulations, unlike "food for specified health use(FOSHU)".
So they will be regulated by the "food labeling standards" and after putting in a store, they will be observed and sampling inspection will be conducted.

  1. Target food: Overall food ( Except for alcoholic beverage, food with excessive sugar )
  2. Target ingredients: Ingredients whose "action mechanism" is known, and it can be measured directly or indirectly.
    - Further review should be required as for nutritional values, such as vitamins and certain minerals, whose reference intakes are formulated in the Dietary Reference Intakes.
    - Handling of foods whose functional ingredients are not clarified will be reviewed based on the implement situation of the system.
  3. Target people: Those who are likely to contract lifestyle-related diseases or who are on the borderline of these diseases.
    (Except for those who have already contracted them, minors, expectant (including planning pregnancy) and nursing mothers).
  4. Possible range of function claims: Claims about maintenance and improvement of health, totally or partly.(Except for claims which include disease names)

Reference: the Consumer Affairs Agency "A report of New Functional Labeling Review Committee"

"Scientific evidences required for new labeling"

First of all, scientific evidence is required.
As for the safety, following are required:

- Information about assessed experiences of "foods with functional ingredients".(everyday intake amount, sales period of the food, sales quantity,
 content of functional ingredients, group of intake, form of intake, manner of intake, frequency of intake, etc.) or information about safety trial.

- As for the function claims, there are two main conditions: "Clinical trials using final products (based on testing manners for "food for specified health use"(FOSHU)) or "systematic review of studies with peer review on the functional ingredients" will be required.
 In case of clinical trials, reports by "pre-registration of study plan with transitional period" and studies with peer review will be required.

- Systematic review will require that studies with peer review should approve labeling contents.
 It is important to keep in mind that information above-mentioned will be "disclosed" by the Consumer Affairs Agency.

Features of the new system and impact on labeling business operation

There are three main features of the new system as follows:
- Consumers' knowledge about scientific evidence will improve because of the high transparency due to the information disclosure.
- Quality-assurance operation against function claims will be clarified by being regularized in the food labeling standards.
- Each food form will need different scientific evidence, which will have some impacts on product development plans.

For example:
In case that clinical trials using final products are not conducted, it should be informed and disclosed.
As the result, it is expected that registration of products which can have clinical trials will be preferred more.
It is also expected that companies who conducted clinical trials using final products will disclose more information on their websites, as long as it is about function claims.
This is because the Consumer Affairs Agency announced at the end of last year that "It is preferable for companies to upload appropriately on the website the data and experiment results, which show reasonable grounds of effect and efficacy.

Supposing that only one time clinical trial might not assure full objectivity, other studies or systematic reviews will be taken into consideration.
As the result, information disclosure will be expanded and consumers' knowledge of scientific evidence will improve, which will bring severe product choice.

Same things can be said as to business operation of quality assurance. For companies, inspection and confirmation will become easier compared to current situation. This is because they will have certain standards against scientific evidence of products from suppliers, in the daily quality assurance operations, since function claims are regulated by food labeling standards.

Some health foods are sold with unclear function claims because currently it is prohibited to label clear function claims.
In the future, however, there might be a possibility that they will be inspected under same conditions of the new system.
Taking this possibility into consideration, regardless if products will be registered or not, it is required that development of new products or renewal of products should be planned on the base of scientific evidence.

Future plans

New system will be officially announced within this fiscal year, after inviting public comment and being reviewed again.
We hope the new system will help increase knowledge of scientific evidence and that it will become the milestone of better product manufacture.

* Systematic review: a review with various studies and data, and summarized results concerning functions of target ingredients

August 2014