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

On March 26, 2025, China issued a notice titled “Announcement by the State Administration for Market Regulation on Further Strengthening the Management of Raw and Auxiliary Materials for Infant & Young Children Formula Milk Powder”. The notice took effect on the release date.

Key Content

The notice outlines seven critical measures for ingredient management, impacting the following stakeholders regarding infant & young children formula milk powder (hereinafter infant formula):

1. Requirements for all infant formula manufacturers

At the begining of the Notice, the authority emphasizes the current effective requirements stipulated in “Administrative Measures for Recipe Registration of Infants and Young Children Formula Milk Powder”. It is emphasized that

• 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.

• Compound ingredients that have already met the nutritional component requirements of the national food safety standards for infant formula shall not be used as raw materials to produce infant formula.

Additionally, to encourage enterprises to use raw cow/goat milk to produce infant formula, the notice allows that:

For formula milk powder intended for babies over 1 year old, the ingredient list may include the statement "processed from raw cow’s milk” or “processed from raw goat’s milk” in the same font size (with other ingredient information).

When label adjustments have been made accordingly, enterprises shall file with provincial market regulatory authorities before product launch, without applying for recipe registration alteration. [ChemLinked notes: Overseas infant formula manufacturers are encouraged to follow the filing requirements outlined in this guideline. Before placing products on the market, overseas manufacturers can file information regarding food ingredients, food additives, product recipes, and labels with the provincial market supervision authorities where their agent, importer, or distributor is located.]

2. Requirements for raw and auxiliary material suppliers

Manufacturers producing raw and auxiliary materials that will be used directly in the dry blending process of infant formula production shall take measures to ensure their products:

• Comply with relevant food safety standards;

• Meet microbial requirements specified in national food safety standards for infant formula;

• Implement strict storage and transportation management.

Notes: The dry blending process involves the dry process, and the dry process part of the dry-wet composite process.

3. Requirements for enterprises using base powder

Lastly, Point 7 of this Notice 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.

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