Detailed Rules for Infant Formula Processor Approval in 2013 Released

Tag: Grain & food processors; General Administration of Customs of China; local food safety

standards; dairy farming; UHT milks; infant formula product; the State Council

Summary: On 25 December, the China Food and Drug Administration holds a press

conference to announce the Detailed Rules for Infant Formula Processor Approval in 2013,

and also outlines its work reviewing processors' production licenses.

According to Dairy Products China News issued by CCM in January 2014, on 25 December,

the China Food and Drug Administration (CFDA) held a press conference attended by a

range of media and industry personnel from processors such as Mengniu, Dumex and Nestlé.

The event saw it announce the release of the Detailed Rules for Infant Formula Processor

Approval in 2013 (the Rules) and outline its review of processors’ production licenses.

The Rules were finalised after soliciting opinions from the dairy industry and the public in

August last year. They set new requirements for infant formula producers in nine aspects,

including purchasing of raw materials, infant formula inspection, manufacturing processes and

product traceability.

Compared with the initial draft, the final version saw some specific stipulations added. For

example, infant formula are divided into 3 stages to avoid confusion: 1st stage for infants from

0-6 months; 2nd stage for 6 months to 1 year old; and 3rd stage for 1-3 years old. Moreover, it

requires that production of infant formula with dry and wet mixing processes should be

completed at a single site. Most of the main factories in China are wet-blending, however

some processors produce a base formula at a plant in the North by wet process, and then

transport the base product to another factory in the South where additional nutrients are

added by dry process – this practice will be forbidden.

Mr. Ma Chunliang, an official at the CFDA, explained the stipulations with regard to imported

infant formula in the press conference, the area where the public is most concerned. For

example, he explained that production of infant formula through dry process or wet process

with imported base powder is allowed, but that importing the base powder and then simply

adding a few ingredients or sub-packaging are not permitted.

In order to urge all the processors to implement these Rules, the CFDA issued a notice on 24

December indicating that it will review all infant formula processors’ production licenses; the

following aspects are notable:

The review must be completed by 31 May 2014, otherwise the processors will have to halt

production and will be offered a 2 years transition period to rectify their production processes

Processors who pass the review should send the products’ formulations along with samples

of packaging and labels to the provincial CFDA offices to be kept on file; those who want to

change formulations, or product names, packaging, labels etc should comply with the

requirements for 1st/2nd/3rd stages (for 1st stage formula, demineralised whey powder’s ash

content must be ≤15% and WPC ash content ≤5.5%), and will be offered a 1 year transition

period to rectify processes as required

Processors whose base powder and infant formula production are in different factories will

be offered a 3 years’ transition period for rectification

Mr. Teng Jiacai, Deputy Director of the CFDA, said that the infant formula processors who

want to exit this sector can diversify into other products and will get support from the

government to do so. As a next step the Ministry of Industry and Information Technology and

other authorities will issue a policy to support the development of infant formula industry and

those companies seeking to diversify in this way.

The Rules involve stricter standards for domestic infant formula production, taking production

standards in the pharmaceutical sector as a reference point, in order to guarantee better

safety and quality. They also require processors to take primary responsibility for quality

problems, to strengthen inspection of raw materials, to review their suppliers and to set up

records systems to monitor and control every step of the production process, as the potential

Fonterra food incident last year underlined the risks which could theoretically be caused by

upstream suppliers.

As the standards for the industry are raised, processors will be under great pressure and

some small and mid-sized processors may be eliminated, but the changes seem beneficial for

the industry’s long term development and the Rules are unlikely to disturb the supply and

pricing of infant formula in China. They constituted the 3rd announcement made by the CFDA

about infant formula in December, but many consumers will still doubt whether the quality of

domestic products is as good as imported products – this concept is so ingrained will take a

long time to change.

Table of Contents of Dairy Products China News 1401:

Guangzhou Cancels School Milk Guide Price

Biostime Acquisition Brings Local Production Capability

Government Focuses on Infant Formula Safety

Import Tariff Cut for Infant Formula

China Tightens Supervision on Infant Formula Sales

Government Concerns over Milk Safety and Quality

Detailed Rules for Infant Formula Processor Approval in 2013 Released

Rebornne Focuses on E-commerce

Fonterra’s Challenge in China’s Dairy Market

Ausnutria’s Profitability Challenged

Milk Price Rises in Heilongjiang

Abbott’s Similac Launched Online

Dairy Products China News, a monthly publication issued by CCM on 15th, offers you the

latest information on new market dynamics, company development, new products,

technology, packaging and raw material supply, etc. It also focuses on the government’s

direction and polices, helping you get the whole picture of the industry.

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