Market research
Foods with Function Claims
This service is a joint program with ORTHOMEDICO.
What is a Food with Function Claims?
A Food with Function Claims is a food that displays a function based on scientific evidence, on the responsibility of the business. Unlike Foods for Specified Health Uses, the function and safety are not evaluated by the government.
How we support you
We do more than refile a health claim that has already been accepted. We support companies that want to attempt a claim with no prior acceptance — a first in Japan.
The team includes attorneys and administrative scriveners, plus specialists in the Foods with Function Claims system, statistics, and medicine.
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A high-quality systematic review
A team of medical-literature specialists, biostatisticians, and clinicians prepares the review, including meta-analysis.
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Support in one place
From the dossier and systematic review to label checks, database entry, and responses when a filing is returned. The standard plan includes one year of change-notification support after acceptance, at no extra charge.
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Japanese market entry for overseas companies, in several languages
We work in Japanese, English, Chinese, and Korean. We deal directly with overseas ingredient makers and food companies, from checking ingredient information and research papers through preparation of a notification that fits the Japanese system.
Plans for different notification goals
Foods with Function Claims: from acceptance to notification
Documents required, and what you prepare
Overview of documents and data
- Basic information (notifier details and others)
- Safety information (sales history, safety studies, adverse-event reports)
- Quantitative data (the functional component, and any component needed to assure safety)
- Production and manufacturing control
- Package design
- Nutrition labelling analysis (for fresh food, estimates such as the Standard Tables of Food Composition in Japan are allowed)
- Materials showing how health-harm information is collected
What you prepare (processed foods and supplement forms)
Safety information
Sales history (the food to be notified, or a similar food)
- Who consumed it (example: adult men and women in Japan)
- Form (example: tablet, capsule, beverage)
- How it is taken (example: with water, as it is)
- How often (example: two tablets once a day)
- Daily intake of the functional component, or of a food containing it, in light of eating habits (example: 100 mg/day)
- Amount of the functional component (example: 30 mg per tablet)
- Sales period of the commercial food (example: August 2000 to the present)
- Volume sold so far (example: about 1 million bags, about 500,000 servings)
- Health-harm information (example: none in particular)
Safety studies
If you have cell studies, animal studies, toxicity studies, or clinical trials, please share them.
Adverse events
If you have information on interactions with medicines or on adverse events, please share it.
Manufacturing control
This is the information entered in Form III-1-1 or Form III-1-2.
- Name and address of the plant (and whether that plant is the notifier)
- Plant identification code, if it is displayed
- Whether GMP, HACCP, ISO 22000, or FSSC 22000 is held, and the certificate number (if not held, materials describing the control system)
Package design
- We have reference materials that summarise the displays required on a Food with Function Claims.
- We check those items.
Nutrition analysis data
- Estimates are not allowed.
- Enter the data on the package in line with the Food Labelling Standards.
Materials showing how health-harm information is collected
- We have sample organisation charts and contact flow charts.
Scope of support
This support is a joint program with ORTHOMEDICO.
1 Basic research
Finding a new substance that can be a functional component
- Target-molecule search
- Function screening
2 Non-clinical studies
Efficacy and safety of the new substance
- Safety studies
- Efficacy studies
3 Human clinical trials
Safety and efficacy in humans
- Safety studies
- Dose-response studies
- Efficacy studies
4 Papers
Submit and publish the human safety and efficacy results as a paper.
5 Foods with Function Claims
notification
Prepare and submit the documents required to become a Food with Function Claims
- Form preparation
- Filing on your behalf
- Responses to comments returned by the Consumer Affairs Agency
6 After the notification
is accepted
Work after the food is accepted as a Food with Function Claims
- Responses to consumer-group questions
- Procedures when the dossier is updated
Communications
Safety and efficacy in humans
- Safety studies
- Dose-response studies
- Efficacy studies
Agency certificate
ORTHOMEDICO Co., Ltd. appoints WORSO Inc. as its authorised overseas agent for business and services outside Japan.
