China CFDA: Both Domestic and Imported Infant Formula Manufacturers are Limited to Produce 3 Brands

1. Both domestic and imported infant formula will be subject to registration with China Food and Drug Administration. 2. Both domestic and overseas IF manufacturers will be limited to 3 product lines (3 brands) for the Chinese market.

Take home:

Both domestic and imported infant formula will be subject to registration with China Food and Drug Administration.
Both domestic and overseas IF manufacturers will be limited to 3 product lines (3 brands) for the Chinese market.

On 7 Jan 2015, China CFDA notified WTO of the much-anticipated “Administrative Measures for Registration of Infant Formula Formulations”. The draft strongly indicates the Chinese government’s determination to reshuffle the IF industry by applying the same criteria for both domestic and imported IF products and their manufacturers at home and abroad.

Compared to the previous draft version (see CL Food news on 2 Sep 2015), the WTO version specifies the following important amendments:

Competent authority	CFDA
Affected product	Domestic and imported IF products
Applicant	Domestic and overseas IF manufacturers
Maximum number of brands to produce for the Chinese market	3 sets totaling 9 formulae There must be significant difference between formulae for the same stage used by one company, supported by solid scientific evidence.
Registration dossier	Application form; R&D report and description of production process; Test report; Supporting materials regarding production management system, R&D ability and testing ability; Other materials that manifest the science and safety of formulae
CFDA officials conduct factory on-site inspection?	Yes
Registration timeframe	Domestic	around half a year
	Imported	depend on the actual condition of overseas manufacturers and CFDA’s on-site inspection

If one company has several subsidiary IF factories, these manufacturers can jointly apply for the same formula but there must be significant difference between the formula and any other formulae for the same stages.

The pending regulation also contains a number of new labeling requirements, such as:

If the IF product is made of goat milk powder, the proportion of goat milk (powder) in every 100g product and the source of the whey protein powder should be labeled in the ingredient list.
The nutrients in the nutrition information table on the label should be listed in the order appeared in the national standards GB 10765-2010 and GB 10767-2010, categorized by vitamin, mineral, optional ingredients, etc.
The name, address and contact information of the actual manufacturer should be labeled.
Potential misleading terms like “imported milk source (进口奶源)”, “from foreign ranch (源自国外牧场)”, “no additives (零添加)”, etc. shall not appear on the label.
The product label should not indicate:

the functions of disease prevention and treatment;
the functions of improving intelligence, strengthening immunity, protecting intestine and health care;
information like recommended or supervised by industry associations, consumer organizations, testing institutions, etc.

It will take 60 days for seeking comments among WTO members. It's expected that CFDA will publish the final version within the first half year of 2016.