China CFDA Revises Requirements for Infant Formula Recipe Registration Application Dossiers

Takehome:

• The requirements for application dossiers of infant formula recipe registration have been greatly simplified.

On May 25, 2017, China CFDA announced the revision of “Items and Requirements of Application Materials for Registration of Infants and Young Children Milk Powder Formula Recipes (Trial)” (see revised version from here). The revision this time has greatly simplified the requirements for the application dossiers, which will facilitate the application of receipt registration for both domestic and overseas infant formula enterprises.

Product R&D report:

Market research and investigation result, breast milk research result, as well as relevant demonstration report are no longer required.

Manufacturing technique description:

The information for manufacturing technique verification is no longer required.

Other materials demonstrating the scientificity and safety of product formula:

The following materials will not be required as well:

• The documents for proving the origin of food raw materials and food additives
• The analysis report on production, sale, human feeding and evaluation on tracking, as well as sampling inspection carried out by supervision department and type inspection report
• The research and control situation of hazardous contents potentially contained in food raw materials, food additives and packing materials directly contacting with the products

Reference link

China CFDA No. 65 Announcement