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Editor's note: This article was originally published on July 24, 2024, and was updated on August 30, 2024, as per the latest developments. The updated contents are marked in red below.
On July 12, 2024, Japan’s Consumer Affairs Agency (CAA) released the Draft of Manufacturing or Processing Standards for Food with Function Claims Containing Natural Extracts in the Form of Tablets, Capsules, etc. (hereinafter the “Standards”), and planned to implement it starting September 1, 2024. However, stakeholders can still submit comments through the e-GOV website until August 16, 2024. The draft was finalized on August 30, 2024, and came into effect on September 1, 2024.
Background
After the recent incident involving Kobayashi Pharmaceutical's red yeast rice products, CAA approved the amendment to the Food Labeling Standards on August 23, 2024. The key changes focus on Food with Function Claims (FFC), involving labeling requirements and detailed provisions for the notification process.
Building on these changes, the CAA is now considering establishing new manufacturing standards for FFC products in the form of tablets, capsules, etc., which contain natural extracts. This Standards provides a comprehensive framework covering all stages of the manufacturing and distribution process, with a focus on ensuring quality, traceability and compliance.
Main Content
1. Product quality
Manufacturers shall follow the Standards and prepare the "Product Specification Document", "Manufacturing Control Manual", "Quality Control Manual", and "Procedure Documents" for FFC notification.
Required documents | Contents |
Product Specification Document | 1. Product name 2. Product ingredients and quantities 3. Product specifications and test/inspection methods 4. Product manufacturing methods and procedures 5. Standard input amounts for raw materials and intermediates, and the rationale behind them 6. Storage conditions for intermediates 7. Storage conditions for products and their expiration dates or best-by dates 8. Recommended daily intake and precautions for use or handling 9. If any part of the product manufacturing, etc. is outsourced, documents showing the details of the agreement with the contracted party |
Manufacturing Control Manual | 1. Precautions for the receipt, storage, and inventory management of raw materials and packaging materials 2. Precautions for the receipt, storage, inventory management, and shipment of products and intermediates 3. Matters related to the control of the manufacturing process 4. Matters related to the inspection and maintenance of manufacturing equipment and tools 5. Matters related to changes in raw materials, packaging, manufacturing methods, and manufacturing equipment 6. Matters related to the work management of production personnel |
Manufacturing Control Manual | 1. Matters related to the sampling, etc. for product testing and inspection 2. Matters related to the quality control of raw materials, packaging materials, and intermediates 3. Matters related to the implementation and result determination of product testing and inspection 4. Matters related to the reporting and communication from the quality control manager to the overall responsible person and the manufacturing control responsible person regarding the results of testing and inspection 5. Matters related to the sampling and management of product storage samples 6. Matters related to the handling of long-term inventory 7. Matters related to the inspection and maintenance of equipment and tools used for testing and inspection 8. Matters related to the handling of cases requiring re-testing and re-inspection |
Quality Control Manual | 1. Procedures for the control of shipments from the product manufacturing facilities 2. Procedures for the validation of manufacturing processes and procedures 3. Procedures for the management of changes to manufacturing processes and procedures 4. Procedures for the management of deviations from manufacturing processes and procedures 5. Procedures for the handling of product quality information and quality defects 6. Procedures for self-inspections 7. Procedures for the creation and management of documents and records (manufacturing control and quality control of raw materials) |
2. Record tracking
Records related to the manufacturing, and storage of products must be retained for either 3 years from the creation date, or 1 year from the expiration date.
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