China to Tighten Management of Raw and Auxiliary Materials for Infant Formula Milk Powder

China’s State Administration for Market Regulation (SAMR) issued a notice on October 18, 2024, consulting on a draft to further strengthen the management of raw and auxiliary materials for formula milk powder for infants and young children (hereinafter infant formula or infant formula milk powder).

Any feedback can be submitted to [email protected] prior to November 17, 2024.

Key Content

The draft mainly outlines the following requirements for infant formula manufacturers.

1. For all infant formula milk powder manufacturers

Type	Details of the Requirements
General requirements	Manufacturers shall establish a production quality management system in accordance with laws and regulations, set up raw and auxiliary material quality and safety control requirements, and optimize the raw and auxiliary material procurement and acceptance management system.
Prohibited	Compound ingredients that have already met the nutritive index requirements of the national standards for infant formula food safety shall not be used as raw materials to produce infant formula milk powder.
Encouraged	Enterprises are encouraged to use cow's milk or sheep/goat's milk as raw materials for the direct processing of infant formula. The words "cow's milk processing" or "goat's milk processing" can be marked under the product name on the main page of the label of infant formula for children over 1 year old, and the total font area shall not exceed one-half of the total font area used for the product name. After the label adjustment, the product should be filed with the provincial market supervision authority as required before the product is put on the market; there is no need to apply for product recipe alteration registration. For new registrations of infant formula recipes using base powder, the base powder should be directly processed with cow's milk or goat's milk.

2. For enterprises using dry process to produce infant formula milk powder

Enterprises that use a dry process to produce infant formula shall take measures to ensure that the raw and auxiliary materials, such as whole milk powder, skim milk powder, whey powder, whey protein powder, vegetable oil (fat powder), vitamins, and trace elements, not only meet the corresponding food safety standards but also satisfy the requirements of microbiological indicators as specified in the product standards for infant formula.

3. For enterprises using base powder to produce infant formula milk powder

Such enterprises shall gradually use base powder produced by enterprises with infant formula milk powder production qualifications within two years from the date of this announcement.
Such enterprises should conduct on-site quality and safety audits on base powder production enterprises to ensure that they implement the Hazard Analysis and Critical Control Point (HACCP) system in accordance with the requirements of the "National Food Safety Standard Good Manufacturing Practice for Dairy Products" (GB 12693) and the "National Food Safety Standard Good Manufacturing Practice for Infant Formula Foods" (GB 23790), comply with the corresponding content of the base powder in the recipe registration certificate, and conduct batch-by-batch inspection of the base powder before it leaves the factory.
Such enterprises should formulate base powder quality control documents and implement full inspections on batches of base powder entering the factory, strictly manage storage and use, and shorten the service life of base powder.

Lastly, point 7 of this draft emphasizes the responsibilities of the market supervision authority at the provincial level. For example, the authorities must strictly implement the production license mechanism and manage the filing of issues regarding ingredients, etc.

Read the full text here. For further translation or consultation services, please email [email protected].