China Infant Formula Registration: Updates, Clarifications and First Batch of Registrants

On August 3rd, 2017, China CFDA released the first batch of infant formula registration, including 89 formulas from 22 enterprises (check the English Version in our F-lists here).

International manufacturing plants include Yashili (6 products), Wyeth (3), FrieslandCampina (3), Mead Johnson (6). Other famous overseas milk powder brands include Nestle, Abbott. (highlighted in yellow)

General situation of infant formula registration

At present, the review center has received 665 registration applications, 531 are from domestic enterprise and 134 from overseas enterprise. Currently 75 domestic and 26 overseas enterprises have applied for formula registration, and 42 enterprises are required to supplement materials for their 168 formulas, meaning that these formulas are in the final stage of registration.

Registration requirement: Existing products versus new entrants

Currently most of  manufacturers applying for formula registration have registered with China CNCA and had a history of retail in the Chinese market. While for new entrants with CNCA manufacturer registration, they have to submit more materials for the formula registration as they do not have sales record.

International Enterprise Infant Formula Registration Status

Currently only 40% of international enterprise exporting IF to China have submitted a registration application. Liu Xuecong, secretary general of China Nutrition and Health Food Association, pointed out that many small and medium enterprises and OEM brands have not applied for formula registration. Larger enterprise have been preparing registration materials since the release of the new policy while many small and medium enterprises have been waiting for a potential reduction in registration requirements particularly those requirements associated with stability testing and other costly and time consuming steps in dossier compilation. With the registration deadline looming and dossier requirements unchanged many smaller enterprise are now facing a crisis and a lack of professional expertise on regulation which will ultimately lead to delays in application submission and registration approval.

It is certain that the deadline will not be extended. On the 14th of July CFDA issued a statement clarifying that all infant formula and FSMP product imported prior to Jan 1st 2018 can be sold until its expiration in China. The review center also suggested that enterprises should apply for formula registration by October, and can expect a minimum of 1 month before the application review and feedback.