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On October 9, 2024, China’s State Administration for Market Regulation (SAMR) issued a notification, publishing a document titled “Guidelines for Filing Ingredients and Other Matters of Formula Foods for Infants and Young Children”. This document aims to ensure that companies adhere to food safety responsibilities throughout the product lifecycle, allowing all products—from raw and auxiliary materials to finished goods—to be monitored and tracked effectively.
Key Content
According to the Guidelines, any manufacturing facility intending to manufacture and sell formula foods for infants and children (hereinafter infant formula) within China must file relevant information with the provincial administrations for market regulation (AMRs) after obtaining the infant formula recipe registration approval and production permits, but before the commencing production.
Notably, overseas infant formula manufacturers are encouraged to follow the filing requirements outlined in the guidelines. Before placing their 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. Please note that “agent, importer, or distributor” refers to the parties indicated on the product label.
Documents needed during the filing process are listed below:
No. | Item | Information needed to provide |
1 | A registration form for filing (Check the template in Annex 1 of this Guideline) |
|
2 | Information sheet of food ingredient (Annex 2) | The name of used food ingredient/food additive, its brand, place of origin, packaging specification, standards used to ensure the ingredient/additive compliance, suppliers’ name, manufacturers’ name, the recipe registration number of products that have used corresponding ingredients/additives, etc. |
3 | Information sheet regarding food additive (Annex 3) | |
4 | Information sheet regarding product recipe (Annex 4) |
|
5 | Information sheet regarding product label (Annex 5) |
|
Impact Analysis
The requirement for filing ingredients and other information is not new. Article 81 of China’s Food Safety Law has mandated that infant formula producers file their raw materials, additives, product recipe, and labels with the provincial food safety authorities. In practice, many provincial market regulatory bodies, such as those in Shaanxi, Shanghai, Heilongjiang and Hebei, have already carried out similar filing processes. Thus, the release of the new guidelines by the SAMR primarily serves to unify and clarify existing regulations nationwide rather than to introduce substantial changes.
Moreover, the SAMR stated that there is no transition period for compliance as this document is a guideline. For those that have already been filed, provincial authorities may clarify re-filing requirements depending on the situation.
Read the full text here. For translation and consulting services, please email [email protected].
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