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Regarding the outline of the guideline for "new functional labelling system"

"New functional labelling system" allows all categories of foods ranging from perishables, processed foods to the supplements to have "functional labelling" provided that scientific evidence is submitted.

Last summer, a report of the review meeting was published. The flow since then is as follows:

Dec.2014: Draft report with some conditions was released.
Jan.2015: The outline of guideline was published by a working group.
Currently: Publication of whole guideline has been waited for.

(As the related matter, revised documents about "Points to note when making application for Food for Specified Health Use (FOSHU)" have been released. It can be used to double check the concept of methods of clinical trials).

In the "Outline" version, there are notable points as follows:

- As for food experience, even though one's experience was only of eating "food which is not exactly the identical but similar to those concerned" , his/her evaluation can be admitted.

- As for participants in clinical trials, only those who are not affected with any disease are eligible.

Among all, the most characteristic point is that "possible areas of functional labelling" are presented, which became easier to understand.

For example, descriptions regarding following areas are permitted.


1. The product is helpful to the maintenance/improvement of Index of the physical condition, which is easy to measure.
2. The product is helpful to the maintenance/improvement of physiology/ tissue function of the human body.
3. The product is helpful to the improvement of deteriorated physical condition, which is not chronicle or continuous but temporary, and can be recognized by oneself.

It is possible to use:

* Expressions which refer to certain parts of the body.
* Expressions allowed to use for FOSHU.(Reduction of Disease risk is excluded)


The outline defines the contents above mentioned at most, however, when complete contents of the guideline are released, more concrete examples might be presented.

It is a big change as deregulation, we re-realized, that the expressions of "specified body parts" and "expressions permitted to use for FOSHU" are to be accepted.

On the contrary, there are descriptions about expressions which are not permitted (prohibition of the expressions such as treatment/prevention of disease, intentional health enhancement).

Asfor those, conventional understanding will be enough. Furthermore, the collateral conditions of the draft reports say that "Elimination of products without scientific evidence is highly expected" and that "Administrative actions against misleading advertisement without scientific evidence should be strengthened".

Therefore, labelling and advertisement are to be self-checked after preparing scientific evidence, even if the functional food labelling system is not used. It costs a lot and takes much time to introduce in-house inspection facilities even though the scientific evidence is required.

However, there is a movement to help such a situation. In January of this year, the Ministry of Agriculture, Forestry and Fisheries announced that they would implement systematic review for agricultural products, and make them possible to be used by manufacturers.

There are four target items and four components.

Target items are the following four items/components:
rice (γ‐aminobutyric acid)
mandarin orange or unshu-mikan (β-Krypto xanthine)
green tea (methylated catechin)
chicken ( Imidazolepeptide )

While products vary in forms from perishables, processed foods to supplements, the policy like above will be put to practical use gradually, depending on the product form. One of the biggest characteristics of the system is that scientific evidence submitted is to be disclosed. As the media can gather information and verify it easily, more and more clear-cut information for consumers would be supplied. From the consumers' point of view, we might have the impression that the number of FOSHU products has been increased. I'd like to mention this topic again as this is a system which will draw much attention for the time being.

Source: http://www.cao.go.jp/consumer/kabusoshiki/syokuhinhyouji/doc/141210_sankou3.pdf
http://www8.cao.go.jp/kisei-kaikaku/kaigi/meeting/2013/wg3/kenko/150114/item2.pdf

February 2015