Japan FFC Food Regulation Assurance Service Items

Evershine Japan, together with its foreign affiliates, provides comprehensive “Foods with Function Claims (FFC)” Regulatory Affairs application services to support your Japan subsidiary.
Email：tyo4ww.food@evershinecpa.com

Food Project Management Services (PRA-F-PM)

*Service Scope
Evershine shall act as the Project Manager and the Client’s single point of contact throughout the Japan food market entry project. Our services include, but are not limited to:
Coordination with Japanese regulatory consultants.
Coordination with the Administrative Scrivener.
Coordination with FFC consultants.
Coordination with laboratories.
Coordination with customs brokers (if required).
Coordination with freight forwarders (if required).
Coordination with warehouses (if required).
Coordination with the Japan Quarantine Station through the appointed service providers.
Client communication and meeting coordination.
*Deliverables
Vendor Coordination Record
Client Communication Record
Project Status Report
*Throughout the entire project
(Estimated 3–12 months depending on the selected market entry route)
*Exclusions
Evershine does not act as: Importer of Record (IOR) ; Customs Broker; Freight Forwarder;Warehouse Operator;Laboratory. *Any third-party professional services shall be contracted directly between the Client and the relevant service provider unless otherwise agreed.
*Evershine will charge client by hourly rate multiplying spending-hours, when signing engagement. *Estimated Spending-hours will be 20 man-hours.
*If over 20 man hours will inform you to get your written approval in advance.
*Payment Terms Client will need to pay us PRA-F-PM when sign this quotation and engagement document.

Pre-check if Imported as General Food or FFC in Japan (PRA-F-CR)

Pre-check of whether the products can be imported into Japan as “General Food” or “Foods with Function Claims (FFC)”. **Service Scope:
1. Review of ingredients
2. Review of food additives
3. Food / drug classification assessment
4. Japan regulatory risk analysis
5. Recommendations for improvement or adjustment
*Deliverables
-Ingredient Review Report
-Additive Review Report
-Food / Drug Classification Opinion
-Japan Regulatory Risk Assessment
-Go / No-Go Recommendation
-Food Import Feasibility Report
*Estimated Timeline
Around 2~3 Weeks
* If you choose to be imported by “Foods with Function Claims (FFC)”, you must firstly take FFC seriral services like PRA-FFC-FD & PRA-FFC-SR & PRA-FFC-CAA1 & PRA-FFC-CAA2 & PRA-FFC-PN. Then go to PRA-F-LCR & PRA-F-Test & PRA-INPS. * If you choose to be imported by “General Food”, you can neglect FFC Serial Services , directly go to PRA-F-LCR & PRA-F-Test & PRA-INPS.
*Payment Terms Client will need to pay us PRA-F-CR when sign this quotation and engagement document.

Japan Company Incorporation (PRA-JP-Inc)

* Regarding with your Japan subsidiary setup, we will provide quotation after you passing FRA-F-CR Pre-check if Imported as General Food or FFC in Japan.
* we will provide Quotation separately.

FFC Feasibility Diagnosis Services (PRA-FFC-FD)

*Service Scope:
1. Function claim feasibility review
2. Scientific evidence review
3. SR feasibility analysis
4. Regulatory risk analysis
5. Go / No-Go recommendation
*Deliverables
-FFC Feasibility Report
-Claim Feasibility Assessment
-Scientific Evidence Gap Analysis
-Risk Assessment
-Go / No-Go Recommendation
*Estimated Timeline
Around 2~4 Weeks
*The quotation is provided by 株式会社機能食品研究所, client will directly pay to 株式会社機能食品研究所 not being paid to us.
*Evershine will help you communicate with 株式会社機能食品研究所, like sign-contract help, execution help etc. Evershine charge client by hourly rate multiplying spending-hours as shown in the PRA-FFC-PM

FFC Systematic Review Services (PRA-FFC-SR)

*Service Scope:
1. Literature search
2. Literature review and assessment
3. Mechanism of action review
4. Scientific evidence summary
5. SR report preparation (PRISMA)
*Deliverables
-Systematic Review Report
-PRISMA Checklist
-Literature Search Strategy
-Evidence Matrix
-Scientific Evidence Summary
-Reference List
*Estimated Timeline
Around 4~8 Weeks
*The quotation is provided by 株式会社機能食品研究所, client will directly pay to 株式会社機能食品研究所 not being paid to us.
*Evershine will help you communicate with 株式会社機能食品研究所, like sign-contract help, execution help etc. Evershine charge client by hourly rate multiplying spending-hours as shown in the PRA-FFC-PM

FFC Notification CAA Filing Services (PRA-FFC-CAA1)

*Preparation and filing of FFC notification documents through the Consumer Affairs Agency of Japan (“CAA”) notification system.
*Service Scope:
1. Safety descriptions
2. Functionality-related documents
3. Manufacturing and quality control information
4. Organization chart
5. Adverse event response method
6. Package and labeling content review
7. Arrangement of ingredient analysis
8. Product specification documents arrangement
9. Filing through the CAA notification system
*Deliverables
-CAA Notification Package
-Safety Documents
-Scientific Documents
-Product Specification Documents
-Filing Record
-Submission Confirmation
*Estimated Timeline
-Document Preparation around 3~5 Weeks
-CAA Review around 5~9 Months
*The quotation is provided by 株式会社機能食品研究所, client will directly pay to 株式会社機能食品研究所 not being paid to us.
*Evershine will help you communicate with 株式会社機能食品研究所, like sign-contract help, execution help etc. Evershine charge client by hourly rate multiplying spending-hours as shown in the PRA-FFC-PM

FFC CAA Correction Response Services (PRA-FFC-CAA2)

*Service Scope:
1. Response support for CAA returns, comments, indications, or correction requests
2. Preparation of response explanations and supplementary documents
3. Revision of FFC notification documents
4. Communication and coordination support during the review process
*Deliverables
-Correction Response
-Revised Notification
-Revised Label
-Supplementary Documents
-Communication Record
*Estimated Timeline
According to CAA, generally,2~8 Weeks.
*The quotation is provided by 株式会社機能食品研究所, client will directly pay to 株式会社機能食品研究所 not being paid to us.
*Evershine will help you communicate with 株式会社機能食品研究所, like sign-contract help, execution help etc. Evershine charge client by hourly rate multiplying spending-hours as shown in the PRA-FFC-PM

FFC Post-notification Annual Services (PRA-FFC-PN)

*Service Scope:
1. Annual self-check report
2. Literature update review
3. Adverse event (AE) & health damage information review
4. Sales status update support
5. Annual compliance support
*Deliverables
-Annual Self-check Report
-Literature Update Report
-AE Review
-Sales Status Report
-Annual Compliance Checklist
* Estimated Timeline Once a year *Fee will be separately quoted by hourly rate multiplying spending man-hours.
*The quotation is provided by 株式会社機能食品研究所, client will directly pay to 株式会社機能食品研究所 not being paid to us.
*Evershine will help you communicate with 株式会社機能食品研究所, like sign-contract help, execution help etc. Evershine charge client by hourly rate multiplying spending-hours as shown in the PRA-FFC-PM

FFC Project Management Services (PRA-FFC-PM)

*WE will provide FFC Project Management Services to help you communicate with 株式会社機能食品研究所 like sign-contract, execution FFC etc.
*Evershine will charge client by hourly rate multiplying spending-hours, when starting FFC project *Estimated Spending-hours will be 100 man-hours.
*If over 100 man-hours will inform you to get your written approval in advance.

Food Labeling Preparation and Filing (PRA-F-LCR)

*Service Scope:
1. Review under the Japanese Food Labeling Act
2. Ingredient labeling review
3. Nutrition labeling review
4. Allergen labeling review
5. Package and labeling content review
6. Japanese label wording preparation
*Deliverables
-Japanese Label
-Nutrition Panel
-Ingredient Label
-Allergen Label
-Package Review Report
-Label Compliance Report
*Estimated Timeline
Around 1~2 Weeks
* Fee Charge General Food Label：JPY 80,000 / SKU FFC Food Label：150,000 / SKU We assume you adopt General FOOD Label If Change to be FFC Food label , fee will be changed following.

Food Import Notification under the Food Sanitation Act (PRA-INPS)

*Service Scope:
1. Food import document preparation
2. Food import notification filing
3. Liaison with Japan Quarantine Station
4. Supplementary document support
*Deliverables
-Food Import Notification
-Submission Record
-Quarantine Communication Record
-Supplementary Documents
-Import Notification Completion
*Estimated Timeline
Around 1~3 Weeks

Government Fee (PRA-F-GF)

Any government fees, official fees, customs duty, import consumption tax, testing fees required by authorities, or other official payments, if incurred during the project, shall be borne separately by the Client based on actual costs.

Out-of-Pocket Expenses (PRA-F-OPE)

The ordinary out-of-pocket and administrative expenses, including photocopying, ordinary transportation, domestic postage, domestic courier charges, ordinary international document courier charges, and other necessary administrative handling expenses.
Testing fees, laboratory analysis fees, translation fees, special document handling fees, official fees, system fees, sample handling fees, sample shipment costs, and other non-routine third-party expenses are not included.
Any excess amount shall be charged separately at actual cost with supporting receipts or vouchers.

Non-standard or Out-of-scope Services (PRA-Non-SOP)

If the Client requests services outside the agreed scope shall be separately quoted and agreed in writing before commencement.

General Food Import Route and FFC Import Route

The client may first establish a company in Japan and use that Japanese company as the importer and sales entity to import and sell its products in the Japanese market.

Before formal importation, the first step is to conduct a product regulatory assessment to confirm whether the product can be imported and sold in Japan as a “food product,” and then determine whether the product should be marketed as a general food product or as a Foods with Function Claims product (FFC).

If the product is marketed as a general food product, FFC notification to Japan’s Consumer Affairs Agency (CAA) is not required. However, the product must still complete the relevant Japanese food import procedures, including ingredient and additive review, food/pharmaceutical classification confirmation, Japanese labeling and package marking review, product testing if required, Food Import Notification, quarantine station handling, and customs clearance. After these procedures are completed, the product may be formally imported and sold in Japan.

If the product is intended to be marketed as a Foods with Function Claims product (FFC), then in addition to the general food import procedures above, an FFC notification must also be submitted to Japan’s Consumer Affairs Agency (CAA). FFC is not a government “certification” or “approval”; it is a notification system. The company must prepare safety information, scientific evidence for the function claim, a Systematic Review (SR) or clinical trial data, labeling content, and related filing documents, and remains responsible for the function claims made.

Therefore, an FFC product cannot be sold immediately just because the CAA notification has been completed. After FFC notification, the Japanese labeling and package marking must still be reviewed to ensure that the function claims on the package are consistent with the CAA notification. At the same time, the product must still complete Food Import Notification under the Food Sanitation Act, product testing if required, quarantine procedures, and customs clearance before it can be formally imported and sold in the Japanese market.

In Summary as below:

*General Food Import Route :
Step A1. Japan Company Incorporation
Step A2. Food Import Feasibility Assessment (pre-import regulatory review)
Step A3. Japanese Food Labeling & Package Marking Compliance Review (label compliance)
Step A4. Product Testing (if required)(testing may not always be mandatory)
Step A5. Food Import Notification
Step A6. Quarantine Inspection & Customs Clearance(inspection and import clearance)
Step A7. Commercial Launch in Japan

*FFC Import Route:
Step A1. Japan Company Incorporation
Step A2. Food Import Feasibility Assessment
Step B1. FFC Feasibility Assessment
STEP B2 Systematic Review / Scientific Evidence Preparation
Step B3. CAA1 FFC Notification
Step B4. CAA2 Correction Response
Step B5. FFC Annual Mantainance
Step A3. Japanese Food Labeling & Package Marking Compliance Review
Step A4. Product Testing (if required)
Step A5. Food Import Notification
Step A6. Quarantine Inspection & Customs Clearance
Step A7. Commercial Launch in Japan

That means If you Choose FFC Food route, will add Step B1 to B5 in addition to Step A1 to A7 of “General Food Import Route”.

Suggestions to land your food products in Japan

We usually suggest client firstly launch the products in Japan as general food products, and then gradually consider upgrading them to Foods with Function Claims (FFC), because the FFC notification process usually requires a longer preparation period and a more detailed scientific evidence review.
Regarding with client’s Japan subsidiary setup, we always provide quotation after you passing FRA-F-CR Pre-check if feasible to be Imported as General Food or FFC in Japan.

Please be aware of below Warning:

The above contents are digested by Evershine R&D and Education Center in July 2026.
Regulations might be changed as time goes forward and different scenarios will adopt different options.
Before choosing options, please contact us or consult with your trusted professionals in this area.

Contact Us

Tokyo Evershine BPO Service Limited Corp.

Email：tyo4ww.food@evershinecpa.com
Contact : Andrea Kyu, speak both Japanese and Mandarin and English
Onarimon Yusen Building 7F,Nishi-Shinbashi 3-23-5,Minato-ku, Tokyo 105-0003, Japan

or
For investment structure relevant with multi-national tax planning and Financial & Legal Due Diligence for M&A (Merge and Acquisition), send an email to HQ4tyo@evershinecpa.com
Dale Chen, Principal Partner/CPA in Taiwan+China+UK will be accountable to your case.
Email address:dalechen@evershinecpa.com
Linkedin address: Dale Chen    

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(version: 2026/07)

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