Food supplements have a huge market in China, but they are under strict supervision and administration to protect the health of consumers. This article is a translation of the regulations on food supplements from the Food Safety Law of the People’s Republic of China.
Article 74 The state implements strict supervision and administration on special food such as food supplements, formula for special medical purposes, formula for infants and young children, etc.
Article 75 Food supplements claiming to have the efficacy of maintaining health shall be adequately substantiated and pose no acute, subchronic or chronic risk to human health.
The list of raw materials for food supplements and the list of health functions allowed to be claimed are drafted, modified, and promulgated by the Food and Drug Safety Supervision and Administration Department of the State Council in conjunction with the Health Administrative Department of the State Council and National Traditional Medicine Management Department.
The list of raw materials for food supplements specifies the name, dosage, and corresponding efficacy. The raw materials listed can only be applied to food supplements, not other food products.
Article 76 Food supplements not listed in the list of raw materials for food supplements or imported into China for the first time are subject to registration with the Food and Drug Safety Supervision and Administration Department of the State Council. However, if the food supplements imported into China for the first time fall into the nutrition category of vitamins or minerals, they are subject to notification with the Food and Drug Safety Supervision and Administration Department of the State Council. Other food supplements shall be notified with the Food and Drug Safety Supervision and Administration Department of the province, autonomous region, or municipality directly under the central government where they import their products.
Food supplements imported into China shall be products that are legally permitted by competent authority to be sold on the market of the exporting country (region).
Article 77 Research and development report, product formula, manufacturing procedure, product safety and efficacy evaluation, label, instructions, samples, and relevant substantiation shall be provided for the registration of food supplements. Under the technical review of the Food and Drug Safety Supervision and Administration Department of the State Council, registration is approved if products comply with the requirements of safety standards and efficacy claims. For products failing to comply with requirements, the registration will be rejected with a written report of reasons. When a supplement with a new ingredient obtains registration, this ingredient shall be listed in the list of raw materials for food supplements.
In notification, formula, manufacturing procedure, label, instructions, and other substantiation that proves the safety and efficacy of products shall be submitted.
Article 78 The label and instructions of food supplements shall not indicate any function of preventing or treating diseases. Additionally, the label and instructions shall be truthful and align with the content submitted for registration or notification. Furthermore, the label and instructions shall bear conditions for use, active ingredients, or ingredients characterizing the products along with the recommended dosage. A statement that ‘food supplements should not be used as a substitute for medicine’ shall also be bored in the label and instructions.
Article 79 The advertisement of food supplements shall comply with Item 1 Article 73 of this regulation and state that ‘this food supplement should not be used as a substitute for medicine’. The content of the advertisement shall obtain approval and a certificate from the competent authority of the province, autonomous region, or municipality directly under the central government where the products are manufactured. Additionally, the competent authority of the province, autonomous region, or municipality directly under the central government shall promptly publish and update the approved advertisement catalog and content.
Article 80 Formula for special medical purposes shall register with the Food and Drug Safety Supervision and Administration Department of the State Council. In registration, product formula, manufacturing procedure, label, and instructions along with substantiation that proves the safety, nutrition, and special clinic efficacy of the products shall be submitted.
The formula for special medical purposes is subject to the Advertisement Law of the People’s Republic of China and other laws and regulations on drug advertisements.
Article 81 Manufacturers of formula for infants and young children shall implement quality control throughout the entire process from the raw materials entering into the factory to the final products leaving the factory. They shall also inspect each batch of the products to ensure their safety.
Food additives and ingredients such as milk, and nutritional supplements used in formula for infants and young children shall comply with regulations and laws on food safety. They shall provide the nutrition necessary for the healthy growth of infants and young children.
Manufacturers of formula for infants and young children shall notify the raw materials, food additives, formula, label, etc. with the Food and Drug Safety Supervision and Administration Department of the local province, autonomous region, or municipality directly under the central government.
The product formula of the formula for infants and young children is subject to notification with the Food and Drug Safety Supervision and Administration Department of the State Council. In registration, the research and development report and other substantiation that proves the safety and efficacy of the products shall be submitted.
Repackaging of the formula for infants and young children is not allowed and one formula cannot be used for different brands.
Article 82 Registration and notification persons shall be responsible for the authenticity of submitted dossiers in the registration and notification of food supplements, formula for special medical purposes, and formula for infants and young children.
The Food and Drug Safety Supervision and Administration Department above the provincial level shall promptly publish the catalog of the registered or notified food supplements, the formula for special medical purposes, and the formula for infants and young children. The business secrets from the process of registration and notification shall be kept confidential.
Manufacturers of food supplements, formula for special medical purposes and formula for infants and young children shall organize production under technical requirements such as product formula, manufacturing procedure, etc.
Article 83 Enterprises that produce food supplements, formula for special medical products, formula for infants and young children, and other supplementary food for specific groups shall establish a quality management system in accordance with the good manufacturing practice. They shall conduct self-inspection regularly to ensure that the system operates properly and submit a report on self-inspection to the local county-level Food and Drug Safety Supervision and Administration Department.
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