Under draft legislation, published by the China Food and Drug Administration (CFDA) on September 2, Chinese infant formula manufacturers will be permitted to produce a maximum of 15 products.
The difference in formulation between each product must also be "obvious," says Chinese regulatory consultancy, REACH24H.
The draft regulation, Administration Measures for Registration of Infant Formula Formulations, which is open for public comment until October 1, will prevent Chinese manufacturers using a single formulation to produce numerous products.
“It would raise the barriers and limit the number of infant formula brands in China,” Raymond Ng, food regulatory consultant, REACH24H, told DairyReporter.
“In my opinion, revision will have big impacts on the industry, reducing the number of brands in the market.”
“I think the intention is so that only the biggest and best will stay; with the objective to reduce the risk of safety problems from smaller domestic manufacturers and brands," said Ng.
Applicants must be among the 92 domestic manufacturers approved by the CFDA to produce infant formula in China.
In time, Ng added, the draft regulation published by the CFDA this month could be extended to manufacturers of imported infant formula.
“[There is a] high chance that some of those policies (not all) will be imposed on international companies," said Ng.
If extended, manufacturers of imported infant formula face a lengthy and potentially expensive registration process, he said.
“The time taken to register is uncertain, but [would be] at least several months."