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"Liquid infant formula" was added to food for special dietary use.

On August 8, 2018, the regulation "About license of labeling for food for special dietary use" (March 31, 2017 No. 188) was partly amended and "liquid infant formula" was added to the list of foods for special dietary use.
In this month's newsletter we will feature the outline of the "food for special dietary use" system as well as the content of its amendment, providing a new opportunity to analyze it.

Background of the amendment

The background of the amendment and some important related points are written in the press release material of the Consumer Affairs Agency (CAA). We have decided to provide an excerpt bellow:

August 8, 2018
About setting approval standards of liquid infant formula regarding "food for special dietary use"

When selling food for special dietary use, based on the Health Promotion Act, it is required to obtain a labeling approval issued by the national government. However, regarding liquid infant formula, such approval standards (confirming that the product is appropriate to be used as a breast milk substitute) have not been set so far.
Today, to encourage the diffusion of liquid infant formula products, the "classifications, items and price determined by the Prime Minister based on a provision of item 2, Article 3 of Order for Enforcement of the Health Promotion Act (Notification of CAA)" and "About license of labeling for food for special dietary use" (Notice of Deputy Director of CAA)"texts were amended, and approval standards for liquid infant formula regarding food for special dietary use were set and their enforcement started. Therefore, we announce it here.

Points amended

  • A classification of "infant formula" shall be added regarding "food for special dietary use"
    After changing the name of liquid infant formula (JP: 乳児用液体ミルク) to "modified infant formula liquid milk" (JP: 乳児用調製液状乳), a new classification ("modified infant formula milk", JP: 乳児用調製乳) shall be newly added, together with two sub-classifications: "modified infant formula liquid milk" and "modified infant formula milk powder.
  • Labeling items required for infant formula liquid state milk shall be prescribed
    An indication that the food can be used as a breast milk substitute (with, however, a mandatory indication that breast milk is the best for infants) and required labeling items such as standard Instructions of use shall be newly prescribed.
  • Selenium shall be added to the standards of permitted substances for infant formula milk (Enforcement starting on April 1, 2022)
    Considering the current state of discussion about the amendment of standards and criteria for food additives based on the Food Sanitation Act, selenium shall be newly added to the compositional standards.

What is a "food for special dietary use"?

It is a food mentioning a special use on its label, among the foods used for patients, milk powder for pregnant women and breastfeeding women, infant formula milk or foods for people with dysphagia.
This labeling is allowed by a licensing system, and after getting the license, you can attach this mark.

From the document "What isa "food for special dietary use"? (CAA)", we understood that:

  • It is a food which should have a labeling mentioning its special use and showing that it contributes to children growth and to the maintenance/recovery of health for pregnant women, breastfeeding women, persons with dysphagia and patients.
  • In order to sell a food as food for special dietary use, the license for its labeling must be obtained from the Secretary-General of the CAA.
  • When licensing a labeling, the compatibility with the criteria/requirements must be examined and then the license shall be given.

Since this is a labeling based on an approval system, it is required to apply to CAA.
There are 51 approved products currently.* The breakdown table is an easier way to understand the system of food for special dietary use. Therefore, we are providing it here (from "Breakdown of numbers of licensed labeling for food for special dietary use (CAA)").
"Liquid infant formula", which is in the amendment this time, is added to the column "infant formula milk powder" in the below table.

"Breakdown of numbers of licensed labeling for food for special dietary use" as of August 6, 2018

Food group Number of licensed labeling
Food for patients Licensing standards type Low protein foods 11
Allergen-free (removed) foods 6
Lactose free foods 4
Total nutritional foods 5
Individual evaluation type 8
Milk powder for pregnant and breastfeeding women 0
Infant formula milk powder 8
Food for people with dysphagia Food for people with dysphagia 12
Food used to adjust thickness 0

*The 3 products which are licensed under allergen-free(removed) foods and lactose free foods are counted in each food group. Therefore, the number of licensed products is 51.

You can see these press release materials on "Licensing system for food for special dietary use", CAA website.
This can be a good chance to review the needs for such food classifications through the system, so if you are interested, we recommend to have a look at these details.

Reference:
Licensing system for foods for special dietary use (CAA)
About setting the licensing standards for liquid infant formula regarding ood for special dietary use

October 2018