Introduction of Japanese Special Purpose Foods (1)

Food Partner Network News Japan's special-purpose foods refer to foods that are specially processed and labeled for their specific purposes for four categories of people, including infants, pregnant and lactating women, people with dysphagia, and patients
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When it is sold as a special-purpose food in Japan, the content of the label must be approved by the Consumer Affairs Agency
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The Consumer Affairs Agency, the Expert Committee, the Ministry of Health, Labour and Welfare and other departments jointly review whether the content of the label is appropriate and whether the product meets the specifications and specific requirements
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FoodPartners.
com conducts a summary and analysis of Japanese special-purpose food issues that netizens and customers are interested in.
It will share the declaration process of Japanese special-purpose food that everyone pays attention to, approve relevant testing items, and allow labelling items to be shared in 3 phases
.
In this issue, I will share with you the first part: the application process part
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(1) Number of approvals

 

Since the implementation of the special-purpose food labeling system in 1947, as of March 25, 2022, Japan has approved a total of 89 types of special-purpose foods.
The specific product types and quantities are shown in the following table:

 

 

　　(2) Application process

 

　　What is the process for reporting special-purpose foods in Japan? How much does it cost to apply? How long does it take to get approved?

 

　　First, the applicant prepares the documents required for the application and submits a license application to the Consumer Affairs Agency, and at the same time entrusts a designated testing and testing agency to test the production samples
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The Consumer Affairs Agency charges an application acceptance fee of 9,800 yen, and the designated testing and testing agency charges the corresponding testing and testing fees according to the testing items stipulated by various products
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　　For products whose product specifications and benchmarks have been announced, the Consumer Affairs Agency will review whether the labelling content is compliant, and whether the product indicators meet the specifications and benchmark requirements, based on the license application documents submitted by the applicant and the test results of the testing and testing institutions
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For individual evaluation-type products for which no standard has been established, the Consumer Affairs Agency organizes an expert committee to evaluate the suitability and safety of the product, and conduct an audit based on relevant opinions
.

 

　　When a product is declared for special use, and its function and efficacy on patients may violate the relevant laws and regulations of the "Medicine and Medical Devices Act", the Consumer Affairs Agency should consult the relevant department in charge of drugs and medical devices of the Ministry of Health, Labour and Welfare
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If the safety of food is at risk, consult the competent food hygiene department of the Ministry of Health, Labour and Welfare
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　　It takes at least half a year for a product labeled for special purpose to take at least half a year from application to final approval
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It does not include the time required for consultation before application, supplementation and correction of application materials, and testing and testing
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Please refer to the following figure (Figure 1) for the specific application process
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　　When food produced in Japan is exported abroad as special-purpose food, it is possible to apply for certification by the Consumer Affairs Agency
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Imported foods must also be licensed by the Consumer Affairs Agency when they are sold as special-purpose foods in Japan
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Unauthorized products sold as special-purpose foods are considered illegal
.

 

　　When applying for individual evaluation-type products in food for patients, in order to verify their effectiveness and safety, food trials can be conducted on patients
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Japan's "Clinical Research Law" and "Clinical Research Law Implementation Rules" related Q&A stipulates that the above-mentioned experiments on the efficacy and safety of diseases through dietary therapy research are not regarded as clinical trials
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　　The specific application process for special-purpose food is as follows:

　　Summary: Through sharing, we can see that Japan's special-purpose food labeling system has a relatively long history, a comprehensive product range, and a clear related approval process
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Therefore, it has great reference significance for relevant parties to carry out research and development, application and approval of similar products
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So what items need to be tested in the approval process of food labeled for special use? What is the focus of each project testing? Please pay attention to the analysis of the follow-up articles of Food Partner Network
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Related reports: Introduction to special-purpose foods in Japan (2)


This article is an original article by the Food Safety Compliance Division of FoodPartners.
com, please contact us for reprints
.
The Food Safety Compliance Division provides domestic and foreign food standards and regulations management and consulting, food safety information monitoring and analysis and early warning, product registration and filing services, label review and compliance consulting, conference training services, etc.
Details: 0535-2129301, E-mail : vip@foodmate.
net
.