On November 30, 2021, the State Administration for Market Regulation publicly solicited opinions on the Regulations on the List of Non-edible Substances that May Be Added to Foods (Draft for Comments). The deadline for comments is December 30, 2021.

In fact, China has supervised non-edible substances for a long time, such as the common Sudan Red, Melamine, Boric Acid and Borax and Poppy Shells. The food categories where additives may be easily abused include moon cakes, noodles, dumpling wrappers, pastries and steamed buns. Among them, the substances that may be illegally added to health food include Ephedrine, Reddenafil and Barbiturate.

Therefore, in order to regulate the non-edible substances that may be added to foods, the Draft for Comments are as follows.

Article 1 To regulate the formulation and publication of the list of non-food chemical substances and other substances that are added or may be added to food and may harm human health (referred to as non-edible substances), the Regulations were formulated according to the Regulation on the Implementation of the Food Safety Law of the People's Republic of China.

Article 2 For the purpose of ensuring food safety and maintaining public health, in accordance with the principles of law, science and openness, formulate and publish the list of non-edible substances that may be added to food, and update it dynamically.

Article 3 For non-edible substances that may be added to food discovered, the State Administration for Market Regulation, in conjunction with the National Health Commission and other departments, formulate and publish the list of non-edible substances and their test methods.

Article 4 The State Administration for Market Regulation organizes the establishment of an expert committee of the list of non-edible substances to be responsible for the review of the non-edible substance list and corresponding test methods. The Office of the Expert Committee is located in the Chinese Academy of Inspection and Quarantine.

Article 5 The substances included in the list of non-edible substances that may be added to food shall meet the following requirements at the same time:

(1) It has clear scientific data to prove that the substance is toxic and harmful and may harm human health;

(2) It is illegally added to food due to economic interests.

Article 6 The substances falling into the following circumstances are not included in the list of non-edible substances:

(1) Chinese laws and regulations have clearly prohibited the addition or use in food, including but not limited to pesticides, veterinary drugs and other toxic and harmful substances;

(2) Substances specified in food safety standards or related regulatory documents;

(3) Substances naturally brought in due to environmental pollution or food raw materials.

Article 7 Independent legal entities established in accordance with laws in China, based on food-borne disease information, food safety risk monitoring information and supervision and management information, propose to the local provincial market supervision department suggestions for supplements and revisions of non-edible substances and their test methods. The suggestions can also be proposed by the National Health Commission and other related departments and units. If a non-edible substance and its test method are proposed at the same time, it shall be reviewed first. The related suggestions should be submitted to the Office of the Expert Committee.

Article 8 The unit that proposes non-edible substances shall provide the following documents:

(1) Basic information of the substance (such as Chinese name, main ingredients and substance composition);

(2) The main toxicity of the substance and supporting documents that harm human health (including but not limited to publicly published scientific literature or test reports);

(3) The category of food that the substance may be added, the use link and supporting documents;

(4) The text or draft of the test method of the substance;

(5) The necessity and feasibility of the substance being included in the list;

(6) Other supporting documents.

The non-edible substance proposer shall be responsible for the authenticity, legality and integrity of the documents submitted.

Article 9 The Expert Committee shall review the necessity, scientificity, and feasibility of the non-edible substance list and test methods formulation and revision recommendations, and form comprehensive review opinions.

Article 10 The State Administration for Market Regulation, in conjunction with the National Health Commission and other departments, shall review the experts’ comprehensive review opinions, and include the substances that meet the requirements of these Regulations into the list of non-edible substances and publish them.

The published list of non-edible substances shall include the Chinese names of non-edible substances, the categories of foods that may be added, the main links and the test methods and other information.

Article 11 In any of the following circumstances, the list of non-edible substances shall be revised in time:

(1) There is new scientific evidence in food-borne disease information, food safety risk monitoring, and supervision and management, indicating that the non-edible substance may harm human health;

(2) The basic information of non-edible substance needs to be adjusted;

(3) The test methods for non-edible substances need to be revised;

(4) Other situations that need to be revised.

Article 12 If national food safety standards or related regulatory documents have provisions on certain non-edible substance listed in the list, it shall be withdrawn from the list after review.

Article 13 The list of non-edible substances is published on the website of the State Administration for Market Regulation and is available for free browse by the public.

Article 14 The Regulation will be implemented from the publication date.

Source: SAMR

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