Japan Revises Approval Process for Dairy Products

Japan’s Consumer Affairs Agency (CAA) has revised approval procedures for condensed and powdered milk, effective February 28, 2025. Approved products will be publicly disclosed on the CAA website. Existing approvals will remain valid beyond February 28, 2025.

On February 28, 2025, Japan's Consumer Affairs Agency (CAA) issued Notification No.148, announcing a revised approval process for condensed and powdered milk products. This update follows the transfer of food safety regulatory authority from the Ministry of Health, Labour and Welfare (MHLW) to the CAA in April 2024.

The new approval process took effect immediately upon publication, replacing the previous procedure established in 1997. Approvals granted before this date will remain valid. Additionally, approved products will now be publicly disclosed on the CAA's website, and approved applicants must report to local authorities.

Background:

Under the Ministerial Ordinance on Milk and Milk Products Concerning Compositional Standards, etc., the following products require Prime Ministerial approval:

The use of additives in unsweetened condensed milk, unsweetened skimmed condensed milk, condensed milk, sweetened skimmed condensed milk, whole milk powder, skimmed milk powder, and sweetened milk powder (hereinafter referred to as "condensed and powdered milk").
The types and mixing ratios of non-milk ingredients used in modified powdered milk and modified liquid milk.

Approval for New Applications:

1. Additives in Condensed and Powdered Milk

To obtain approval for the types and mixing ratios of additives used in condensed and powdered milk products, applicants must submit the following documents:

Name and location of the manufacturing facility
Type of condensed or powdered milk products
Product name
Reason for seeking approval
Name, ingredients, and mixing ratio of the additives to be used, along with the supplier information
Manufacturing process
Other relevant information

2. Non-Milk Ingredients in Modified Powdered and Modified Liquid Milk

Enterprises seeking approval for the types and mixing ratios of non-milk ingredients used in modified powdered and liquid milk must submit the following documents:

Name and location of the manufacturing facility: if multiple manufacturing sites are involved, list all locations.
Product name
Reason for approval request
Ingredient and mixing ratio information
Safety documentation for novel ingredients: if using non-milk ingredients that have no prior use in modified powdered or liquid milk, provide relevant safety data.
Contract manufacturing agreement: if the applicant is not the manufacturer, submit a copy of the contract manufacturing agreement.
Additional Documentation for Probiotic-Added Products: if the product contains probiotic, submit the required supporting documents as specified in the Annex.

Summary

The revised approval process aims to ensure transparency and compliance in the dairy industry.
Approved products will be listed on the CAA’s website, increasing accessibility for consumers and stakeholders.
Enterprises with existing approvals do not need to reapply but must comply with the new reporting requirements.