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The "Guidelines on notification of foods with function claims" were amended

The Consumer Affairs Agency (CAA) partly amended the “guidelines on notification of foods with function claims” (hereinafter referred to as the “guidelines”) and “Q&A about foods with function claims.” on March 28, 2018.

There were several changes in this new version. However, “available carbohydrates, sugars (from March 28, 2018)” and “plant extract and secretion (after the notification database was improved) “ were added as a part of the widening of target functional ingredients/substances, and as this specific topic should attract more interests, we will feature it here.

Key amendments

The amendments are to deal with issues related to the operation of foods with function claims system, widening of target functional ingredients/substances and how to provide the information to consumers. We will try to summarize each issue and its related amendments separately as below.

(1) Notification documents
Issue: Required notification documents can be cumbersome
Amendment: Simplification of the documents required for the notification
- About 30% less items to fill in the notification documents

(2) Confirmation of the notification
Issue: Delay in the notification confirmation
Amendment: Speed up the notification confirmation (process)
- Notification of pre-confirmation by trade associations, etc.
- Notification ensuring that the target product is (mostly) similar to products that have already been publicly announced

(3) Fresh foods
Issue: The number of notified fresh foods remains very low
Amendment: Management based on the characteristics of fresh foods
- Addition of a labeling mention to state that the product provides part of the recommended daily intake
- Extension of the Q&A section concerning fresh foods

(4) Target ingredients/substance
Issue: Management of food products whose nutrients components and functional substances/ingredients are not specified
Amendment: Widening of the target functional substances/ingredients
- Clarification regarding the treatment of available carbohydrates and sugars
- Clarification regarding the treatment of plant extract and secretion

(5) Verification by a third party
Issue: Inability of third parties to analyze components/ingredients
Amendment: Disclosure of documents showing the analysis method (masking can be used if needed)

(6) Provision of information to consumers
Issue: Inability to check the current sales status of the products
Amendment: Notification of sales situation by food business operators after their FFC notification is complete

Improvement of the notification database and planned operation starting date

Some of the amendments this time require improvement of the notification database. Therefore, the timing to start its operation depends on the items to be amended. The differences in starting dates between before and after the improvement are listed as follows.

  Before improvement of the notification database
(Operate based on the amended guidelines)
Start the operation from March 28, 2018
After improvement of notification database
(Operate based on the attachment of the amended guidelines)
Operation starting date to be notified separately
Simplification of the documents required for the notification (Partial changes in the form) Reduce the number of items to be filled in the notification documents before the amendment by about 30%
Speed up the notification confirmation (process)
(Re-submit the notification)
(Trial operation) Start full-fledged operation
Speed up the notification confirmation (process)
Notification of pre-confirmation by trade associations, etc.
Start the operation
Notify fresh foods
(Labeling stating that the product provides a part of recommended daily consumption)
Start the operation
Notify available carbohydrates and sugars Start the operation
Notify plant extract and secretion   Start the operation
Disclose the analysis method Start the operation
Notify the sale situation   Start the operation

The timing to improve the database has not been announced yet. Thus, it is said that it may be at the end of this fiscal year (end of March, 2019).

Available carbohydrates, sugars

Among the contents for which operation has already started (from March 28, 2018), the addition of available carbohydrates and sugars should attracts people’s attention the most. We excerpted the relevant parts from the amended guidelines. (The underlined part is the added information)

Amended guidelines: “Basic guideline regarding functional ingredients/substances and related scientific evidence” (P3)

(1) Functional ingredients/substances (snip)
② The components listed in the 1st column of the 9th appended table of the food labeling standard are not targeted (including the nutrients whose consumption criteria are defined in the Health Promotion Act (snip)). However, regarding the constituents of the nutrients listed in the table below, and taking into consideration their different actions/functions (compared to said nutrients), they can be the target of the FFC system. Regarding the available carbohydrates and sugars, and excluding components (glucose, fructose, galactose, sucrose, lactose, maltose and starch) that are supposed to be the main nutrient source (energy source), are considered to be part of the target ingredients/substances.

Table Constituents of potential target ingredients/substances

Nutrients for which consumption criteria are defined in Dietary Reference Intakes for Japanese Constituents as mentioned left which can be the target ingredients/substances (for example)
Protein Various amino acids, various peptides
n-6 fatty acid γ-linolenic acid, arachidonic acid
n-3 fatty acid α-linolenic acid, EPA (eicosapentaenoic acid), DHA (docosahexaenoic acid)
Available carbohydrates Xylitol, erythritol, fructo‐oligosaccharide, xylooligosaccharide, galactooligosaccharide, oligosaccharide of lactose (lactosucrose)
Sugars L-arabinose, palatinose, lactulose
Dietary fiber Indigestible dextrin, guar gum hydrolyzate
Vitamin A Provitamin A, carotenoid (β-carotene, α-carotene, β-cryptoxanthin, etc.)

As for Available carbohydrates and sugars, besides above mentioned changes, the “Precautions regarding consumption (P4, 40)”, “safety evaluation (P7)” and “analysis method (P22)” are also added to the guideline. Therefore, please check the amendment amended guidelines if you are interested.

Future schedule

At the time of writing (April 13, 2018), 1,338 food products have been approved as foods with function claims after notification. The number of foods with function claims will likely increase thanks to the simplification of notification documents and speeding up confirmation of notification, as well as after the improvements of the database to start to consider “plant extract and secretion” as system targets (scheduled around the end of this fiscal year). Also, since the disclosure of analysis methods has started, disclosed analysis methods are also required when making a notification of changes of already notified products, a move that will be likely help to improve transparency.

Since this was a big amendment, we hope this will be a good chance for you to review the system for foods with function claims.

About the partial amendment of “the guidelines about notification of foods with function claims” (CAA)
The guidelines about notification of foods with function claims (amended on March 28, 2018 (CAA food labeling standard the 156th issue) CAA)

June 2018