Portal site for Food-related Business Operators » Amendment of the Food Sanitation Act » Foods Containing Designated Ingredients, etc.
Foods Containing Designated Ingredients, etc.
Specified Ingredients, etc.
Covered by the revised Food Sanitation Act that went into effect June 1, 2020 requiring special attention from the standpoint of preventing risk related to food sanitation, foods containing ingredients specified by the Minister of Health, Labor and Welfare following a hearing of opinions of the Pharmaceutical Affairs and Food Sanitation Council (hereinafter referred to as "specified ingredients") were established as “Foods Containing Designated Ingredients, etc.”
In the past, the Food Sanitation Act did not specify a system for collection of information concerning harmful effects of health foods (dietary supplements), and there have been cases where there have been suspected harmful effects on health that could be related to the consumption of health foods containing certain ingredients or substances because of inadequate manufacturing controls and non-uniform content and so on, or because the consumption reference is not based on scientific grounds (for example, more than two hundred cases of harmful effects on health have been reported to the National Consumer Affairs Center of Japan and others during the five years through July of 2017 for food products containing White Kwao Krua (pueraria mirifica)), but it was difficult to gather enough information to take legal action.
The revised Food Sanitation Act makes it possible to take necessary measures to prevent risk of harmful effects to health such as making it mandatory for businesses engaged with such products to ensure proper production, implement strict quality control and report incidents where their products have had any harmful effects on health.
The following ingredients or substances have been specified as ingredients or substances that require special attention from the standpoint of preventing harmful effects on health due to improper food sanitation as specified in Article 8, paragraph 1 of the Food Sanitation Act.
1. Coleus Forskolin
2. Celandine
3. White Kwao Krua
4. Black Cohosh
As of June 1, 2020
The specified ingredients, etc., may be distributed under other names, so please check the notice.
Notification of harmful effect on health
If, after obtaining information concerning harmful effect on health involving foods containing the specified ingredients, etc., a business operator who handles said foods (hereinafter referred to as "business operator") shall be obligated to report the information without delay to the prefectural governor, the mayor of the city or leader of special district where the health center is located (notification obligation).
If the business operator is not the person responsible for labeling of food containing the specified ingredients (hereinafter referred to as the "person in charge of labeling") and receives information concerning harmful effects of said food may report said information through the person in charge of said labeling.
Range of notification of harmful effect on health
1. Case where food containing specified ingredients, etc., is suspected of having harmful effect on health, regardless of the severity of the symptoms
* Includes all phenomena related to effect on health and/or changes in physical condition of people who ingest the foods containing designated Ingredients, etc., including those with unknown cause-and-effect relationships.
2. Research reports, etc., on the risk of harmful effect on health
Notification item
Please complete the “Harmful Event Following Intake Health Food (Dietary Supplement) Information Provision Form."
* Cases where consent to use personal information of the person such as their name and contacts who has been injured cannot be obtained may be omitted.
* Please attach reference materials and additional information as needed.
Guideline for when notification should be submitted
Please report the information within approximately 30 days from the date of receipt of the information (or 15 days in the case of severe cases, including death).
However, if there is a possibility that measures must be taken immediately to prevent further harm, such as a rapid increase in the number of occurrences or a wide range of occurrences, it should be reported without delay.
Where to submit notification
Please submit notification to the local health center (Japanese) for the location of the office or factory of the business or manufacturer.
Good Manufacturing Practice (GMP)
Standards for the manufacture or processing of the foods containing designated ingredients, etc., have been established along with so-called Good Manufacturing Practice (GMP) which served as the proper manufacturing standard for manufacturing business operators.
Standards set by the Minister of Health, Labor and Welfare must be strictly observed when manufacturing or processing the foods containing designated ingredients, etc.
Food labeling
In addition to the matters previously specified in the Food Labeling Standard, the following items must be displayed on the container or packaging for the foods containing designated ingredients, etc., manufactured, processed or imported after June 1, 2020.
|
Labeling items |
Display method |
|
The fact that the product is a food containing designated ingredients, etc.* |
Should be labeled as “Food Containing Designated Ingredients (XXXXX)” (The ingredient specified in Article 8, paragraph 1 of the Food Sanitation Act goes inside the parentheses) |
|
Contact information for the food-related business operator |
Displays the phone number of the food-related business operator who is responsible for the content indicated. |
|
The fact that the designated ingredients are ingredients or substances that require special attention from the standpoint of preventing harmful effects on food sanitation* |
Include “the designated ingredients are ingredients or substances that require special attention from the standpoint of preventing harmful effects on food sanitation.” on the label. |
|
The fact that you should stop eating immediately, consult a physician and contact a food-related company if you notice a change in your physical condition. |
"If you experience a change in your physical condition, stop eating immediately and consult a physician.” Also include “Please contact the business given on the label and inform them of the change in physical condition you have experienced." on the label. |
* “The fact that the product is a food containing specified ingredients, etc,” and “the designated ingredients are ingredients or substances that require special attention from the standpoint of preventing harmful effects on food sanitation.” must be labeled in uniform font at least 14 points in size in compliance with Japan Industrial Standards (JIS) Z8305.
For healthcare organizations
When you examine a person who suspected of illness caused by a food containing designated ingredients, etc., please contact the local health center (Japanese) where your medical institution is located. In addition, if the health center inquiries about people who have suffered harm from the foods containing designated ingredients, etc., please cooperate with the survey.
For those who eat health foods or dietary supplements
If you ingest a health food or dietary supplement and you experience an abnormal physical reaction, stop taking it immediately and seek medical assistance immediately. Inform your doctor that you have ingested health foods or dietary supplement.
Also, contact the manufacturer or other food-related company labeled on the food containing designated ingredients, etc. You can also consult with your local health center (Japanese).
▼ Related sites |
・Ministry of Health, Labour and Welfare Foods Containing Designated Ingredients, etc.(Pertinent Laws and Regulations)
・Ministry of Health, Labor and Welfare "Health Food" Website
・Ministry of Health, Labor and Welfare Information on Safety of Health Foods (Notification, Etc.)
・National Institute of Health and Nutrition Safety and Effectiveness of “Health Foods (dietary supplements)”
・Bureau of Public Health, Tokyo Metropolitan Government Food Labeling System (Japanese)
・Tokyo Metropolitan Institute of Public HealthHealth Foods Guide