The 14th session of the Standing Committee of the 12th National People's Congress held a closing meeting and passed the newly revised Food Safety Law, which will come into effect on October 1, 2015. The newly revised Food Safety Law further improves the supervision of health food, special medical purpose formula food, and infant formula food. At the press conference held in the afternoon of April 24, Mr. Teng Jiacai, Deputy Director of the CFDA, explained the provisions on health food in the newly revised Food Safety Law.
The newly revised Food Safety Law further improves the supervision of health food, special medical purpose formula food, and infant formula food.
What specific provisions does the Food Safety Law make for health food?
First, it clarifies the classification management of health food registration and filing, changing the previous single product registration system.
Second, it clarifies the management system of health food raw material directory and function directory. By formulating the health food raw material directory to specify the raw material dosage and corresponding functions, filing management is implemented for products using raw materials in accordance with the health food raw material directory.
Third, it clarifies that health food enterprises should implement the main responsibility, production must comply with good manufacturing practices, and implement systems such as regular reports.
Fourth, it clarifies that the release of health food advertisements must be reviewed and approved by the provincial food and drug regulatory authorities.
Fifth, it clarifies the basis for punishment of health food violations. These specific provisions can be found in the law, which are very specific and clear, especially for the labels and advertisements of health food. Both the Food Safety Law and the newly passed Advertising Law have provisions, which are quite specific and clear, and the punishment measures are also severe.
How to understand that raw materials in the health food raw material directory can only be used for health food production and not for other food production?
In the health food directory, the name, dosage, and corresponding functions of raw material directory should be included. Some substances are both food and medicine, which can be used in ordinary food and health food. In order to clearly define the difference between health food and other food, the law clearly proposes that raw materials listed in the health food raw material directory can only be used for health food production according to the specified dosage and claimed functions in the directory. This provision further clarifies the difference between health food and other food.
Main provisions related to health food in the newly revised Food Safety Law
Article 74 The state implements strict supervision and management of special food such as health food, special medical purpose formula food, and infant formula food.
Article 75 Health food claims health functions, which should be based on scientific evidence and shall not cause acute, subacute or chronic harm to the human body.
The health food raw material directory and the health function directory allowed for health food claims shall be formulated, adjusted and published by the State Food and Drug Administration in conjunction with the State Health Administration and the State Administration of Traditional Chinese Medicine.
The health food raw material directory shall include the name, dosage and corresponding functions of the raw materials; raw materials listed in the health food raw material directory can only be used for health food production and shall not be used for other food production.
Article 76 Health food using raw materials outside the health food raw material directory and health food imported for the first time shall be registered with the State Food and Drug Administration. However, health food imported for the first time that belongs to the supplementation of vitamins, minerals and other nutrients shall be filed with the State Food and Drug Administration. Other health food shall be filed with the food and drug administration departments of the people's governments of provinces, autonomous regions, and municipalities directly under the central government. Imported health food shall be a product allowed to be marketed and sold by the competent authorities of the exporting country (region).
Article 77 Health food that is required to be registered by law shall submit research and development reports, product formulas, production processes, evaluations of safety and health functions, labels, instructions and other materials and samples, and provide relevant supporting documents when registering. The State Food and Drug Administration shall organize technical review and evaluation. For those that meet the requirements of safety and functional claims, registration shall be granted; for those that do not meet the requirements, registration shall not be granted and reasons shall be explained in writing. If the decision to grant registration is made for health food using raw materials outside the health food raw material directory, the raw material shall be promptly included in the health food raw material directory.
Health food that is required to be filed by law shall submit product formulas, production processes, labels, instructions and materials indicating the safety and health functions of the product when filing.
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