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Editor's note: This article was originally published on February 1, 2024, and was updated on March 25, 2024, as per the latest developments.
On March 19, 2024, the MHLW announced the official approval of the proposal, which will be implemented immediately. Besides, enterprises will be given a half-year transition period to adapt to the new regulations.
On January 19, 2024, Japan Ministry of Health, Labor and Welfare (MHLW) revealed an amendment for the Ministerial Ordinance Concerning Compositional Standards, Etc. for Milk and Milk Products (hereinafter the “Standards”). Stakeholders and the public have the opportunity to provide comments on the proposed changes until February 17, 2024. The revised standards are expected to come into effect in mid-March 2024.
Currently, among milk, adjusted milk, low-fat milk, skim milk, processed milk, liquid dairy preparations, and dairy beverages, there is a type of products whose definition falls under either of the following: "store at room temperature" or "No need to store below 10 degrees Celsius". Now, in addition to the room-temperature-storable products that are aseptically filled into containers after sterilization, the proposal also includes products sterilized after being filled into containers that can be similarly stored at room temperature. Provisions and specifications are newly established for them as part of the Standards.
Room-temperature-storable products that are aseptically filled into containers after sterilization
Ingredient standards
Dairy products | Current | Proposal |
| Milk, adjusted milk, low-fat milk, skim milk, processed milk | Bacterial count: 0 Acidity: within 0.02% Alcohol test: negative | Viable microorganisms: Negative (No growth of microorganisms) |
Dairy beverages & Liquid dairy preparations | Bacterial count: 0 | Viable microorganisms: Negative (No growth of microorganisms) |
Manufacturing requirements
Dairy products | Current | Proposal |
Milk, adjusted milk, low-fat milk, skim milk, processed milk, liquid dairy preparations, and dairy beverages | Products that have been sterilized through a continuous flow heat sterilization machine and filled aseptically into pre-sterilized packaging, as approved by the MHLW. | The food must be processed through a heat sterilization method, either by heating at a temperature of 120 degrees Celsius for 4 minutes, which is sufficient to destroy viable microorganisms derived from raw materials or other sources present in the food, or by a method with equal or greater effectiveness. Additionally, the food must be aseptically filled into appropriate pre-sterilized packaging, and this filling process must be carried out in accordance with the prescribed method. |
Record keeping provisions related to sterilization
Dairy products | Current | Proposal |
Milk, adjusted milk, low-fat milk, skim milk, processed milk, liquid dairy preparations, and dairy beverages | One year | A reasonable duration, considering the period until consumption. |
Room-temperature-storable products that are sterilized after being filled into containers
Ingredient standards
Dairy products | Current | Proposal |
Milk, adjusted milk, low-fat milk, skim milk, processed milk, and dairy beverages | / | Viable microorganisms: Negative (No growth of microorganisms) |
Manufacturing requirements
Dairy products | Current | Proposal |
Milk, adjusted milk, low-fat milk, skim milk, and processed milk | / | Except for items that have been heat sterilized by a method involving placing them in a storage-stable container and heating them at 120 degrees Celsius for 4 minutes or using a method with equal or greater sterilization effectiveness, store them at a temperature below 10 degrees Celsius. |
Record keeping provisions related to sterilization
Dairy products | Current | Proposal |
Milk, adjusted milk, low-fat milk, skim milk, processed milk, liquid dairy preparations, and dairy beverages | One year | A reasonable duration, considering the period until consumption. |
Notably
Importantly, following the revisions of the above provision, the provision "requiring a certificate from the government agency of the exporting country of milk products, excluding products approved by the MHLW as room-temperature-storable" shall be deleted simultaneously.
Current | Proposal |
The products that require a certificate from the government agency of the exporting country during importation shall be as follows:
| The products that require a certificate from the government agency of the exporting country during importation shall be as follows:
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