Following the first batch of approvals on 3 August, this development brings the total number of approved products to 98 and companies to 25, of which 20 are domestic and five foreign (Nestlé, Wyeth, Abbott, Friesland Campina and Mead Johnson).
The new approvals consist of nine products across three product lines, from three domestic manufacturers; no overseas manufacturers were included.
More to come
The CFDA has confirmed that more approvals will soon be announced, and that unapproved formulas on the shelves can be sold until their expiry dates, to ensure a lower risk of supply shortage after the 1 January 2018 registration deadline for manufacturers.
Currently, there are still 80 infant formula manufactures that have not submitted their formula registration dossiers, of which about 50 are overseas manufacturers.
Major market share
Regulations expert Rong Liu, from Yantai FoodMate Information Technology, said, “Currently, large domestic and overseas infant formula manufactures have already been approved, and these companies already have more than 70% share of the China market.”
She added that the already approved manufacturers and their products have a “competitive advantage, since they have more time to organise production and marketing activities”, thus making it easier for them to win the trust of distributors and consumers.
Chinese regulation dictates that unregistered imported formulas can be sold in China only after inspection and with a quarantine certificate issued before 1 January 2018.
Typically, the period between production and inspection and certification in China is approximately three months.
As such, Liu advised manufacturers that had already registered but had not yet received approval to “suspend or slow down production plans for existing products”.
She also said it was “very critical” to ensure that registered products were fully compliant with Chinese regulations, “since any non-compliance during the next few months will have a negative impact on the approval of the submitted dossiers”.
The CFDA revealed that during its infant formula registration forum in Shanghai on 31 July, 665 dossiers were received, (531 domestic and 134 foreign), involving 101 companies (75 domestic and 26 foreign).