China CFDA Opens Infant Formula Filing Administrative Measures to Public Feedback

On Jan. 30, 2018, China CFDA opened public feedback on Infant Formula Food Filing Administrative Measures (Exposure Draft). The deadline for this consultation is Mar. 1, 2018.

In order to strengthen supervision and obtain more comprehensive product information on infant formula, both the Food Safety Law (2015) and Inspection Requirements on Infant Formula Milk Powder Production Permit (2014) have stipulated that infant formula manufacturers must file certain information with local food and drug regulatory department, and this requirement applies to all infant formula manufactured domestically.

More specifically, domestic infant formula manufacturers are mandatorily required to report the raw materials, food additives, product formula and labels to provincial food and drug regulatory department for filing before production. Filing became somewhat redundant when the infant formula registration policy was released in 2016. The latest exposure draft of Infant Formula Food Filing Administrative Measures clarifies that enterprises that have already been granted formula registration approval are not required to submit filing materials again. The formula registration number is regarded as a filing number.

Infant formula registration is designed to standardize the scientificness of product formula, while product filing is designed to standardize food production conditions. Filing focuses on the source of raw materials, food additives, labels, and other safety issues associated with food production. With this information competent authorities can more comprehensively control food production safety. When recorded product information or related standards change, manufacturers shall update the product filing as well. In addition, the latest exposure draft also suggests that product filing may also be extended to the infant formula milk liquid (ready to consume packaged product) .

Filing procedures

Prior to producing infant formula milk powder (liquid), manufacturers shall submit relevant materials to food and drug departments. Filing approval will be obtained if materials submitted are all compliant. The following chart shows the details.

Materials required for filing

1. Information sheet for infant formula food filing

2. Manufacturers’ qualification certification

3. Quality and safety standard of raw and auxiliary materials (food raw materials, food additives)

4. Product’s R&D report

5. Label and product specification samples

Products are not allowed to be filed in following situations:

1. The product is sub-packaged or OEM

2. An enterprise produces different infant formula brands with the same formula

3. Bovine colostrum is used, or flavoring is added in product for infant at 0-6 months.

4. Other prohibited situations.