On July 10, 2023, the State Administration for Market Regulation revised and issued the Administration Measures on Formula Registration of Infant and Young Children Formula Milk Powder Products (hereinafter referred to as the Measures), which will come into force on October 1, 2023.

The Measures implement the "four strictest" requirements, combined with industry development and registration management practices, further strict product formula registration requirements, ensure product quality and safety, and encourage enterprises research and development and innovation, and constantly improve the quality of infant and young children formula milk powder.

The Measures, with a total of 6 chapters and 52 articles, stipulated the application and registration procedures, labels and instructions, supervision and management and legal responsibilities for enterprises that intend to produce, sell and import infant and young children formula milk powder in China.

First, strict formula registration and detailed verification requirements. Clarify the situations and requirements for on-site verification, and emphasize that on-site verification requires sampling of dynamically produced samples for inspection; clearly prohibit disguised sub-packaging and 8 cases of deny of registration.

Secondly, further standardize the label identification and safeguard the rights and interests of consumers. Clarify that if the product name has the words of animal origin, the milk protein sources such as raw milk, milk powder and whey powder should all come from the specie, and further refine the contents prohibited in the label.

Thirdly, encourage research and development and innovation to improve the business environment. Encourage research and development of enterprise groups, and allow holding subsidiaries to share part of the Group’s research and development capabilities if enterprise groups have independent research and development institutions; implement the main responsibilities of enterprises, after full evaluation of enterprise groups, the Group parent company and its holding subsidiaries can use formula; shorten the time limit for handling, compress the inspection time from 30 working days to 20 working days, and the time limit for reissuing certificates from 20 working days to 10 working days; increase the legal effect of the e-certificate and cancel the "legal representative" item in the registration certificate.

Fourthly, combine leniency with severity in punishment and guide enterprises to consciously abide by the law. The regulation amendment has adjusted the legal liabilities for the formula registration of infant and young children formula milk powder. The Measures increased the severity of penalties for acts of bad nature that caused harmful consequences, adhered to the "combination of punishment and education", and reduced the severity of penalties for minor violations.

Source: SAMR and Antion

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