Please enable JavaScript

Label bank

Regarding the labeling of "Foods with Function Claims": Current situation and Outlook

In this month's column, we are going to tackle the issue of "Foods with Function Claims". We believe that a lot of people among our readers are dealing with the production and selling of processed food. Only a few of our readers are handling "Foods with Function Claims", but since this new system has attracted lots of attention we will provide you with a general picture of the current situation.

One year has passed since the system implementation

A year has passed since the introduction of the "Food with Function Claims" system, on the first of April, 2015. At the time this article was written (April 25, 2016), it has been publicly revealed that 304 goods has been accepted.
We believe that this new system can be said to be used quite widely, though it is difficult to simply compare it with the "Foods for Specified Health Uses" (about 1,200 applications authorized). And now one year after, several modifications has been announced so we will try to sum them up.

List of the changes since April

First and as reported previously, all clinical studies that have been launched from April onward shall now be pre-registered. ("Regarding researches started (from the registering of the first entrant)within one year after the enforcement of the new "Food Labeling Standard", one shall be able to omit pre-registration" Guidelines, P26)
In addition, all documents for "Guidelines", "Checklist" and "Points to consider" were revised.

  • Guidelines on Notification of Foods with Function Claims (2016, March 31-Partial Revision)
  • Notes on How to Write Application for Foods with Function Claims (April 1, 2016-Partial Revision)
  • Checklist of How to Write Application for Foods with Function Claims (April 1, 2016-Partial Revision)

Furthermore, the method of application has been changed from a mailing system to online system. Meanwhile, the applied goods are compiled in a database so that they are easily searched on the web.
(*Last year’s data of applied goods are currently being processed)

Regarding the main modifications (Postscript) in the Guidelines

Guidelines can be said to be the most important documents when notifying "Food with Function Claims". The comparative chart of the prior and amended versions has been officially announced; therefore we will try to sum up the principal modifications (postscript).

  • It shall be ensured with regard to the corresponding food products and functional ingredients that they are not included in the "List of ingredients and components used solely as pharmaceutical drug", that they do not violate the "Food Sanitation Act", and that they are evaluated after gathering all possible information within the applicant's reach about whether the safety review for "Food for Specified Health Uses" has been performed.
  • The submitted organization chart shall clearly specify the position of the section which responds to health hazard information in the organization of the applicant.
  • And additionally, the refinement of statements related to equivalence (e.g "Equivalent" changed to "Equivalent quantity"). (This postscript has also been added in the "Checklist": "Has the equivalence between the existing information of the functional ingredients and the would-be- notified functional ingredients considered in case of the evaluations when reviewing the functional ingredients?")

Regarding future outlook

From January 18th of this year onward, the "Review meetings on the handling of functional ingredients involved in "Foods with Function Claims"" have been opened. On April 26 was held the fourth Review meeting, at the occasion of which issues such as the "handling of nutrients involved in functional ingredients" or "handling of foods whose functional ingredients are not clarified" have been considered up to now.

Regarding the parts currently defined as "Components for which quantitative and qualitative verifications are possible" / "Components published in the 1st column of the 9th Food labeling Standards annexed table*are not listed" (*nutrients such as vitamins and minerals), they are likely to be reviewed in the future: we therefore suggest people interested in that matter to regularly check information coming from the Review meetings.

Additionally and concerning an important point to consider for food products whose labeling is related to health concerns ("Regarding points to consider for the Act against Unjustified Premiums and Misleading Representations related with the so called 'health foods', and for the "Health Promotion Act""), the following proposition of amendment ("Regarding points to consider for the Act against Unjustified Premiums and Misleading Representations related with health foods, and for the "Health Promotion Act"") has been put out on April 20 - with public comments being accepted up to May 20.

Statements related to "Foods with Function Claims" and "Foods for Specified Health Uses" have been added to the proposition of amendment, with warnings such as "In regards with "Foods with Function Claims", if the content displayed by the labeling exceeds the product initial function claim, there are some concerns that this labeling may display false or exaggerated representation for instance".

In our opinion, this is how these gradual changes in the environment surrounding the "Foods with Function Claims" can be seen compared to the previous year. These points can be checked from the reference materials provided below, so we think that it is important for those of you having interest in health related labeling to double check them.

"Information pertaining to "Foods with Function Claims" (All documents for "Guidelines", "Checklists", "Points to consider")"

"Review meetings on the handling of functional substance in "Foods with Function Claims""

"Regarding the Act against Unjustified Premiums and Misleading Representation related with health foods, and points of concern for the "Health Promotion Act""

May 2016