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Selling infant formula and baby food in Japan

In Japan, infant formula meets the Ministerial Ordinance on Milk as powdered or liquid infant formula, and labelling it as a breast-milk alternative needs permission from the Consumer Affairs Agency as a Food for Special Dietary Uses. It must meet a nutrient table and carry set statements. Other baby food follows the general food rules.

Updated · Each section links to the official source it comes from

Composition
Ministerial Ordinance on Milk and Milk Products (乳等省令)
Special-use labelling
Permission from the CAA, Health Promotion Act Article 43
Forms permitted
Infant formula in powdered and liquid form
Energy
60 to 70 kcal per 100 ml at standard concentration
Label
Breast milk is best, and use on a physician's and dietitian's advice
Import
Notification to an MHLW quarantine station

Before a product goes on sale

The questions to answer, in the order they usually come up.

  1. 1Is the formula approved as powdered or liquid infant formula under the Milk Ordinance? Read more
  2. 2Does it meet the nutrient table for infant formula? Read more
  3. 3Does the label say it is suitable for infants, and so need special-use permission? Read more
  4. 4Does the label carry the statements the permission requires? Read more
  5. 5Who files the import notification, and does it need a health certificate? Read more

The rules, by area

What each area covers, the texts that set it, and what the official pages say.

Special-use permission

Permission to label a food as suitable for infants.

  • A person who wants to represent that a food is for infants, young children, expectant mothers or sick persons, or suitable for another special use, must obtain the Prime Minister's permission (Health Promotion Act, Article 43(1)).
  • Foods for Special Dietary Uses (特別用途食品) cover foods for medical uses, formulas for pregnant or lactating women, infant formulas and foods for people with dysphagia.
  • Infant formula in powdered form and in liquid form are the two infant formula groups that can be permitted.
  • Permission applies to labels stating that a food is suitable as an alternative to breast milk, using medical and nutritional expressions.
  • A person abroad may obtain the Prime Minister's approval for special-use labelling of a food for sale in Japan (Article 63); importing a food that carries such labelling without permission or approval is treated as making the representation (Article 64).

How we help: Compliant Always keeps the permission and the test evidence behind it with the product, so the label can be checked against what was permitted. Ask about this

Composition

What infant formula is made of and must meet.

  • Permission needs the food to be approved as powdered or liquid infant formula under the Ministerial Ordinance on Milk (乳及び乳製品の成分規格等に関する省令), and to meet the CAA's nutrient table.
  • The table sets energy at 60 to 70 kcal per 100 ml at standard concentration, and ranges per 100 kcal for protein (1.8 to 3.0 g), fat (4.4 to 6.0 g), carbohydrates (9.0 to 14.0 g), and vitamins and minerals.
  • The Ordinance defines formulated milk powder as milk-based food with the nutrients infants need added, reduced to powder, with at least 50.0% milk solids, at most 5.0% moisture and negative coliforms.
  • Only milk, milk products, or ingredients whose types and mixing ratios have been approved may be used in formulated milk powder.

How we help: Compliant Always reads your specification and lab reports against the nutrient table, line by line, with the source beside each value. Ask about this

Labelling

What a permitted infant formula label must say.

  • The label of a permitted formula states 'powdered infant formula' or 'liquid infant formula'.
  • It states that the food can be used as an alternative to breast milk, with a note that breast milk is best for infants.
  • It states that it is appropriate to use the food on the advice and instructions of a physician and registered dietitian, gives the standard preparation, and asks that differences between infants be considered.
  • Infant formulas are also labelled under the Food Labelling Standards, in Japanese.

How we help: Compliant Always sets the label beside the statements the permission requires and the Food Labelling Standards, so a missing statement is visible before print. Ask about this

Import and baby food

How formula and other baby food come into Japan.

  • Each import of food for sale is notified to an MHLW quarantine station (Food Sanitation Act, Article 27).
  • Milk and milk products need a health certificate issued by the exporting country's government.
  • Food for babies and young children that makes no special-use claim follows the general food rules: Food Sanitation Act standards and additives, and the Food Labelling Standards.

How we help: Compliant Always keeps the health certificates and specifications each shipment needs with the product, and shows what expires before the next one. Ask about this

Who answers for what

WhoWhat they answer forHow we help
Permit holderThe special-use permission and a product that stays within it.The permission and its evidence kept with the product.
ManufacturerComposition under the Milk Ordinance and the nutrient table, and its approval.Specifications and lab reports kept by product and lot.
ImporterThe import notification, the health certificate, and not importing special-use labelled food without permission.Certificates read and dated before the goods ship.
BrandThe label statements and the Japanese food label.Label checked against both sets of requirements.

National law, prefectural enforcement

Product law in Japan is national. Ministries and the Consumer Affairs Agency set the standards; prefectural governors and cities with public health centres license food businesses, receive food recall notifications and carry out inspections.

Imports are checked at the border: food and food contact articles at MHLW quarantine stations, and liquor licences are granted by the tax office for each place of sale.

Questions businesses ask

Does infant formula need approval in Japan?
To be labelled as suitable for infants it needs permission as a Food for Special Dietary Uses under Article 43 of the Health Promotion Act, and must be approved as powdered or liquid infant formula under the Milk Ordinance.
Who grants permission for infant formula in Japan?
The Prime Minister under the Health Promotion Act; the CAA's pages describe it as permission from the Commissioner of the Consumer Affairs Agency, after a review of conformity with the criteria.
Is liquid infant formula allowed in Japan?
Yes. Infant formula in liquid form is one of the two infant formula groups, with powdered formula, that can be permitted as a Food for Special Dietary Uses.
What energy content must infant formula have in Japan?
60 to 70 kcal per 100 ml at standard concentration, with protein, fat, carbohydrate, vitamin and mineral ranges set per 100 kcal in the CAA's criteria.
What must an infant formula label say in Japan?
That it is powdered or liquid infant formula; that it can replace breast milk, noting breast milk is best; that it is used on a physician's and dietitian's advice; the standard preparation; and to consider differences between infants.
Can a foreign manufacturer get special-use permission?
A person abroad may obtain the Prime Minister's approval for special-use labelling of a food for sale in Japan under Article 63 of the Health Promotion Act.
Does imported infant formula need a health certificate?
Milk and milk products need a health certificate issued by the exporting country's government, alongside the import notification to an MHLW quarantine station.
What rules apply to baby food that is not formula?
The general food rules: Food Sanitation Act standards and additives, the import notification, and the Food Labelling Standards. Labelling it as suitable for infants is a special-use representation under Article 43.
How does Compliant Always help with selling in Japan?
Our team reads the rules for the markets you sell in, including the Japanese-language sources. Compliant Always shows which apply to your product, keeps the documents behind each one ready, and watches the sources for changes. It shows what the requirements say and what your documents show; you decide.

Sources

Compliant Always is a product of Lettuce Labs LLC. It shows what requirements say and what your documents show. It is not legal advice, and you decide.

Tell us what you make, and we will show you the rules for it.

Name the product and the markets you sell in. We will come back to you with what applies in Japan and what your paperwork needs to show.

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