Food for special medical purpose refers to foods that are specially processed and prepared to meet the special requirements of nutrition or meals for people with restricted eating, disorder of digestion and absorption, metabolic disorder or special disease status, including infant formula for special medical purpose suitable for 0 months to 12 months old and food for special medical purpose suitable for people over 1 year old.

Qualification Requirements

The sale of food for special medical purpose should be in accordance with the relevant regulations, and obtain the license or filing before the sale.

Specific whole-nutrition formula in food for special medical purpose should be sold to consumers through medical institutions or drug retailers that do not need to obtain a food business license, but should comply with the Food Safety Law and its regulations on the sale of food.

Medical institutions and drug retailers which sell specific whole-nutrition formula in food for special medical purpose do not need to be filed, but business enterprises which sell specific whole-nutrition formula to medical institutions and drug retailers, should obtain a food business license or make a filing.

Requirements for process management

01 When purchasing food for special medical purpose, food operators should check whether the license, the food factory inspection certificate and the registration certificate of the supplier are in conformity with the actual commodities and within the validity period. Establish a system for food purchase inspection records, and keep the records and vouchers for a period of not less than six months after the expiration date of the product; if there is no clear shelf life, the retention period should not be less than two years.

02 Where a food operator finds that the operated food does not meet food safety standards or there is evidence that it may be harmful to human health, the business operation should be immediately stopped, the relevant manufacturers, operators and consumers should be notified, and the business cessation and notification should be recorded. If a food manufacturer considers that a recall should be made, it should be made immediately. Where the food sold by the food operator falls under the circumstances specified in the preceding paragraph due to the reasons of the food operator, the food operator should recall it. The food manufacturer and operator should report the food recall and disposal to the food safety supervision department of the local People's government at the county level; where the recalled food needs to be treated harmlessly or destroyed, the time and place should be reported in advance.

03 Special food should not be mixed with general food or medicines for sale.

04 The sale of food for special medical purpose should be placed at a special area, counter or shelves display in the business premises.

05 The sale of food for special medical purpose should be set up separately prompt plate, indicating "**** sale area (or counter)", which is green background, white letters, font for bold, and font size can be based on the size of the established special cabinet or special area.

Requirements for advertising and publicity

Business operators should not make false or misleading commercial publicity about the performance, function, quality, sales status, user evaluation or previous honors of their commodities to deceive or mislead consumers. Business operators should not, by organizing false transactions or other means, help other business operators to carry out false or misleading commercial publicity.

The content of advertisements should be true and legal, should not contain false content, and should not involve the function of disease prevention and treatment. Food manufacturers and operators should be responsible for the authenticity and legality of the contents of food advertisements.

Requirements for providers of third-party platforms for online food transactions

Establish systems of examination and registration of food manufacturers and operators entering, food safety self-check, stop and report of food safety violations, stop of the platform service for serious violations, handling of food safety complaints and reports, and open on the internet platform.

Set up a special network food safety management organization or designate full-time food safety management personnel, to check the food business behaviors and information on the platform.

Carry out real-name registration for food operators entering, clear their responsibilities for food safety management, and establish files for food manufacturers and operators entering.

Review materials such as food production and operation licenses or filing vouchers for food manufacturers and operators entering, truthfully record and update in a timely manner.

Where illegal acts of food operators are found, they should be promptly stopped and immediately reported to the food safety supervision department of the local People's government at county level; if serious violations are found, they should immediately stop providing online trading platform services.

Record and preserve food transaction information, and the preservation time should not be less than 6 months after the expiration date of the product; if there is no clear shelf life, the preservation time should not be less than 2 years.

Requirements for online special food manufacturers and operators

Food manufacturers and operators of food for special medical purpose entering, in addition to publicizing the above information in accordance with laws, should also publicize the certificate of registration of the product in accordance with laws. Those holding an advertising review and approval number should also publicize it, and link to the data query page corresponding to the market supervision department's website.

Specific whole-nutrition formula in food for special medical purpose cannot be sold online.

Source: SAMR

Note: This article is compiled by Antion. Please indicate the source for reprint.