2026-07-02
The new version of the "Detailed Rules for the Review of Production Licenses for Infant and Toddler Complementary Foods (Draft Comments)" has begun public solicitation of comments. The new regulations further tighten licensing requirements and enhance product quality. Infant and toddler complementary foods refer to infant and toddler cereal-based foods, canned complementary foods, and nutritional supplements for infants and toddlers aged 6 to 36 months. The new draft rules impose stricter control requirements on the raw and auxiliary of infant and toddler complementary foods. Ma Chaohui, Director of the Infant Formula Registration Division, Special Food Department of the State Administration for Market Regulation: Focus on the risks by raw materials, strictly implement the new national standards, prohibit the use of honey, and prevent risks such as botulism poisoning. Conduct on-site audits of major raw material and perform necessary testing for potential adulterants. The draft for comments requires production enterprises to establish an audit system for raw and auxiliary material suppliers and a procurement and acceptance management system: on-site quality and safety audits of major raw and auxiliary material suppliers or manufacturers, including rice, millet, wheat, fruits and vegetables, livestock and poultry, aquatic products, and dairy products, vitamins, and trace elements; additionally, inspect the full-item inspection reports of raw materials before they are entered into the warehouse; livestock and poultry must come from-built or self-controlled large-scale centralized farms, and the use of raw materials sourced from small-scale farmers is strictly prohibited. Strengthen management of allergenic raw and requirements for co-line production In addition to the stricter requirements for the raw and auxiliary materials of infant and toddler complementary foods, the newly released draft rules also feature many new changes to current production licensing requirements in terms of allergenic raw material management, food production processes, and production technologies. The draft for comments formulates storage management requirements for raw materials that cause allergies for the first time, requiring that raw materials for products with special requirements for allergenic substances be stored separately from or in a dedicated area from raw materials containing that specific aller substance, and be clearly labeled; when produced on the same production line, if the previous batch of products contains allergenic substances that need to be controlled in subsequent products, effective cleaning be performed. Enterprises must also, based on actual conditions, conduct validation of key production processes and process parameters and form validation reports. Meanwhile, it is clearly stated that production should be equipped with food safety management personnel, food safety technical personnel, and production operators suitable for production, define their job responsibilities, and comply with relevant requirements.
Clarify the division of responsibilities in the contract manufacturing model
In addition, the new draft for public comments on detailed rules puts forward detailed requirements the current contract manufacturing model of some infant and toddler complementary food products.
Ma Chaohui, Director of the Infant Formula Registration Division of the Special Food Department of the State for Market Regulation: The entrusting and entrusted parties must sign a written contract, clarify their respective responsibilities, and carry out labeling as required. The entrusting party bears overall responsibility, the entrusted party is responsible for production and ensuring product quality and safety.
The draft for public comments clearly stipulates that the entrusting and entrusted parties shall carry out contract manufacturing activities in accordance laws and regulations, food safety standards, and contract agreements, and shall report to their respective county-level market supervision and administration departments within 10 working days after the conclusion the contract manufacturing agreement. The entrusting party shall supervise the production activities of the entrusted party and be responsible for the food safety of the contract-manufactured food.
The draft public comments also specifically emphasizes that infant and toddler complementary food production enterprises shall conduct full-item self-inspections on every batch of products leaving the factory in accordance with the national safety standards and relevant regulations applicable to the products. Each batch of products shall have batch production records, enabling effective traceability of the production process and the quality and safety status of the. (Outlook New Era)
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