Analysis of Japan's Health Functional Food Application

In 1962, Japan first proposed the concept of "functional" food. In 1991, the "Nutrition Improvement Law" was amended to include functional food in the category of special food, called "food for specific health use"; in 2001, the Japanese Ministry of Health, Labour and Welfare formulated and implemented The "Health Functional Food System" was established, which mainly classified nutritional supplements and products claiming to have health effects and health benefits into specific health food and nutritional functional food. In 2015, Japan established a functional labeling food system, and included all food with functional claims under the management of "health functional food", thus kicking off the prelude to global health food similar products. In 4 2015, the "Japan Food Labeling Law" was formally implemented, and the functional food labeling system was formally established. How to apply for the Japanese health functional food declaration. The editor summarizes the Japanese health functional food declaration management system, declaration process, time and material preparation , In order to provide valuable information guidance to enterprises with declaration needs.

1. Classification of Japanese health functional foods

According to the current Japanese classification of health functional food, health functional food include specific health food ,functional labelled food and nutritional functional food. Specific health food refer to food that contain health-care functional ingredients that affect the body's physiology, help maintain normal blood pressure, cholesterol, and regulate gastrointestinal, etc., and are labeled for specific health-care purposes; functional labeled foods refer to food that are produced based on scientific evidence. Not targeting patients, by taking in the "active ingredients" in such food, it helps to maintain or promote physical health; nutritional functional food refer to health functional food for the purpose of supplementing specific nutrients, such as cryptoxanthin in oranges It is good for bone health. The difference from specific health food is that the threshold for approval is low, and it is only necessary for the enterprise to provide evidence for the Consumer Agency to review in accordance with the corresponding rules.

2. Application for specific health food

Specific health food need to be tested and confirmed by an accredited testing agency and reviewed by the Consumer Agency of Japan, the Consumer Council, and the Food Safety Commission. The regulations do not include list management of substances that are permitted to be used in specific health food. According to the "Guide and Supervision of Unapproved and Unlicensed Drugs" promulgated by the Ministry of Health, Labour and Welfare of Japan, a distinction is made between medicines and food. At the same time, a list of pharmaceutical raw materials and a list of non-pharmaceutical raw materials have been formulated to require the use of drugs in food. The raw materials shall not use the substance components in the list of pharmaceutical raw materials. The ingredients in the list of non-pharmaceutical ingredients need to pass the safety assessment before they can be used as food ingredients. For ingredients that have not been included in the above list, the scientific name, location of use, pharmacological or physiological effects, toxicity and toxicity of the substance (raw material) must be provided. If there are any precedents for medicines approved abroad or whether there are food habits and other materials, after submitting an application to the Ministry of Health, Labour and Welfare of Japan, it is further judged whether it is a pharmaceutical raw material or a non-pharmaceutical raw material.

Specific health food and functionally labeled food must be declared to the competent authority, the Japan Consumer Agency. The declared product ingredients need to be from food ingredients known or approved in Japan. The current edible basis for Japanese food ingredients includes the "Japanese Food Ingredient Database" ", "Specified Health Food Ingredients Database", "Functional Ingredients Database", "As long as the efficacy of pharmaceuticals can be judged as non-medicinal raw materials list", "List of Japanese Designated Additives", "List of Existing Additives in Japan" ”, “List of Natural Flavors in Japan” and “List of General Dietary Additives”, if the health ingredients used are not included in the above lists, you need to apply to the Ministry of Health, Labour and Welfare of Japan to include the raw materials in the “As long as they do not declare the functional efficacy of the drug, it can be judged For non-medicinal raw materials, then apply for specific health foods or functionally labeled food.

 

specific application process is as follows:

 

Products can be listed as health functional foods for products

Declare functional labelled food for products

Declaration of health food for specific use for products

Preparation of new ingredients (raw materials) and functional materials for products

The product can be marketed as a so-called health food, such as nutritionally assisted food

to submit the safety information of the new town branch (raw material)

Not listed

to submit the safety information of the new town branch (raw material)

 

 

 

 

 

 

 

 

 

3.nutritional function claim food declaration

According to the nutritional requirements of Japanese people, refer to the Food and Agriculture Organization of the United Nations and the World Health Organization of the United Nations .The standard of Codex Commission establishes the standard of nutritional functional food. The type and content of nutritional ingredients must meet the standard set by the Ministry of Health, Labour and Welfare of Japan.  Nutritional functional food components include 1 unsaturated fatty acid, 6 minerals and 13 vitamins.  According to the "Relevant Implementation Regulations on Nutrition Labeling Benchmark", the product label shall indicate "nutritionally functional food (a nutrient)". If there are 3 kinds of nutrients or less, all the nutrients shall be listed in brackets; if there are 4 kinds or more, 3 kinds shall be listed. 

The nutritional ingredients in the daily consumption of nutritional functional food must be within the prescribed upper and lower limits. In addition to the nutritional function labeling, the nutritional ingredients must be marked with precautions, etc. If they meet the standards and requirements, they only need to be put on record in the consumer hall, without the need for permission and declaration in advance, the market supervision and testing are adopted for management.

4. Application of functional labeled food

In 2015, the functional labeling food system was implemented in the food labeling standards, targeting all food, mainly divided into dietary supplement-type processed food (tablets, capsules, powders, oral liquids, etc.), other processed food, and fresh food. There are three categories of food. The functional labeling food system stipulates that functional labeling food are in principle only for people other than patients, minors, pregnant women and breastfeeding women. The packaging of their products shall not indicate terms for the purpose of treating diseases. The scientific basis information for food safety and functionality must be published in time on the website of the Consumer Agency of Japan. The difference from specific health food is that the threshold for approval is low, and the consumer agency can provide evidence for the company to review in accordance with the corresponding rules. In principle, the Consumer Agency only records and manages the information provided by customers and makes the information public, and does not organize experts to review the information, but the reporting enterprise must be responsible for the authenticity of the information provided, and establish a health hazard information collection system to collect it at any time Information on the health hazards that consumers may have after eating. The specific application process is as follows:

 

Consumer hall confirms declare material

Submit materials to the Japan Consumer Agency 60 days before the scheduled sales date

The applicant receives the application number

The applicant sells the product

The consumer office website discloses product safety and functional information

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Compared with the declaration of specific health food, the administrative approval process for the declaration of functionally-labeled food is shorter and cheaper. The preparation of declaration materials does not require the provision of product stability test reports and clinical test data, and the choice of clinical test methods is more flexible. The time requirements for the declaration process are also more flexible and convenient. You only need to submit the declaration materials 60 days before the sale; and in terms of the content of the function declaration, the Consumer Department does not have any restrictions on the functional labeling of food. As of May 24, 2021, a total of 4,036 products have been successfully registered in the Consumer Agency of Japan.

Beijing OCI specializes in the declaration of "three noval food" and the declaration and registration of special food such as health food, formula food for special medical purposes, and infant formula food. In the food compliance consulting work, it has accumulated a wealth of successful cases. Beijing OCI will uphold the 5A service promise and continue to serve customers.