Japan Revises Labeling Requirements for Foods for Specified Health Uses

On August 31, 2022, the Consumer Affairs Agency of Japan issued No. 343 notification, stating that contents in Regarding Labeling Permission for Foods for Specified Health Uses were revised. According to the comparative table of the prior and amended article provisions, the application scope of re-permitted FOSHU, the marking requirement for mandatory labeling, and the application documents of FOSHU have been modified. The details of the revisions are as follows:

Revisions

Re-permitted FOSHU

Re-permitted FOSHU refers to FOSHU that has been approved but now applies for a slight change on the product name, flavour, etc. Conventionally, it is required to perform separate procedures for re-permitted applications and change notification. However, in practice, it is allowed to apply for a re-permitted FOSHU with the content of the change notification included.

Foods for specific health uses (FOSHU) include functional health ingredients with physiological functions and can improve the biological activity of the human body. There are five subcategories for FOSHU foods: Ordinary FOSHU, Qualified FOSHU, Standardized FOSHU, FOSHU to reduce disease risk, and Re-permitted FOSHU. Under the FOSHU approval system, CAA evaluates documents submitted by applicants to check the product's safety and efficacy in improving individual physiological and specified health functions. Enterprises must obtain a label approval from CAA to sell FOSHU products.

According to the revision, an application for re-permitted FOSHU is now allowed if the applicant is changed.

Application for Re-permitted FOSHU
Classification	Items	Remark
Re-permitted FOSHU	Applicant	Newly added;
	Product name	/
	Flavour	Additives such as fragrances and coloring agents.
	Others	/
Re-permitted FOSHU with change notification	Best before date	Expiration date or freshness date.
	Manufacturing	Manufacturers' name and address.
	Ingredient	Blending ratio of raw materials, manufacturing method, amount of nutritional ingredients (limited to ingredients other than those with function), and calorific value within the condition that the identity of the product is not lost and the health effect is not changed.
	Net weight	Content without changing the recommended daily intake.
	Precautions	Addition of precautions regarding ingestion precautions, or method of ingestion, preparation or storage.
	Labeling item	Labeling items other than mandatory items.
	Labeling sample	/

When apply for FOSHU's labeling license, enterprises need to submit documents according to their categories, as shown in the table below. It is worth noting that this update makes it clear that labeling sample needs to be submitted. Besides, for re-permitted FOSHU, if the applicant is different from the applicant for the permitted FOSHU, it is necessary to provide materials such as an OEM contract that indicates the relationship between the two applicants.

No.	Documents on recommended daily intake and precautions for taking			Ordinary	Qualified¹	Standardized²	Risk-reduction³	Re-permitted
1	Labeling sample			√	√	√	√	√
2	Document on why this food contributes to the improvement of eating habits, and why people's health is maintained through the consumption of such food			√	√	√	√	√
3	Documents on recommended daily intake and precautions for taking			√	√	×	√	×
4	Documents medically and nutritionally clarifying the health function and recommended daily intake of foods and nutritional ingredients that contribute to specific health purposes		Food	√	√	×	√	×*
4			Ingredients that serve specific health purposes	√	√	×	√	×
5	Documents on the safety and stability of food and nutritional ingredients for specific health purposes	Safety	Food	√	√	√	√	×*
		Safety	Ingredients that serve specific health purposes	√	√	×	√	×
		Stability	Food	√	√	√	√	√
		Stability	Ingredients that serve specific health purposes	√	√	×	√	×
6	Documents related to the physical, chemical and biological properties of nutrients that contribute to specific health purposes, and their test methods			√	√	×	√	×
7	Test result and inspections for the amount of nutrients and calorie			√	√	√	√	√
8	Qualitative and quantitative test results of nutrient ingredients in food that contribute to specific health purposes, and documents describing the methods of the tests and inspections			√	√	√	√	√
9	Documents on quality control methods			√	√	√	√	√
1. Qualified FOSHU refers to products with ingredients showing certain health effects but not reaching the established standards for FOSHU approval. 2. Standardized FOSHU refers to FOSHU with established standards and specifications for their ingredients, supported by sufficient scientific evidence. 3. Risk-reduction FOSHU refers to products whose ingredients are clinically and nutritional-based to reduce the risk of certain diseases. *Information about products with different flavors (additives such as fragrances and colorings) shall be provided as needed.

Labeling

The amendment also added some additional requirements for obligatory labeling items.

No.	Obligatory Labeling Items	Amendment
1	Preservation method	Excluding indication that the product should be stored at room temperature.
2	Ingestion method	Newly added; It must be displayed as described in the application form; It may be displayed together with the recommended daily intake.
3	Slogan for FOSHU	Slogan: "Please maintain a good and well-balanced diet, which consists of staple food, main dish, and side dish." The label shall be displayed on the front of the container or packaging to ensure that it can gain consumer's attention. Due consideration should be given to the size and placement of characters and the design of the entire package.
4	Ingestion, cooking or preservation methods that require special attention	The labeling item can be abbreviated according to the content, but the content must be displayed as described in the application form; Examples for labeling items (they are allowed to be described briefly): Precautions for eating, cooking or preserving methods Precautions for eating method Precautions for cooking methods Precautions for preserving methods

Frequently Asked Questions

Q1: Regarding the "methods for testing and inspection of involved ingredients", if the reagents used are changed, is it necessary to notify for the changed items even if the method itself has not changed?

A1: If standard products, medium, reagents, columns, etc. specified in the analytical method of the involved ingredient are changed from those described in the application form and attached documents, notification of the change is required.

Q2: What does "changes to labeling samples do not require notification of changes" refer to?

A2: Products whose changes are not related to health use, safety or other emphasis on food functionality, and only related to the labeling sample, are not required for the notification.

For example, the following cases belong to this situation:

Change, addition or deletion of text color/size, background color or design;
Change, addition or deletion of arbitrary labeling items or catchphrases;

Notably, these matters may also relate to health use, safety, or other emphasis on food functionality in some cases. It is recommended to consult CAA in advance to check if the change needs to be notified. But the submission of a notification of change or new application is definitely required when the mandatory labeling items are changed.

Q3: What items should be paid attention to when preparing a test report at a testing laboratory other than a research institute or a registered testing laboratory?

A3: The following items shall be described in the test report:

Name of the food subject to the testing
Lot, manufacturing or control number
Manufacturing or processing plant of the food to be tested, and the location of the plant
Test method and results (including description of the detection limit)
Date of test and inspection
Date of the issuance of the test report
Name and address of the testing facility
Name of the person who conducted the test
Details of the investigation on the suitability of test and inspection results