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China's Domestic Infant Formula Falls Short Again

On 4 Aug 2015, CFDA released the results from a campaign of random inspections conducted on infant formula products sold on the Chinese market during May to June. 42 batches all made by domestic SMEs were found to be non-complaint with national standards. Later on the 6th Aug, CFDA reported another two local brands detected with enterobacter sakazakii, a substance which poses a high risk to infant health and is not permitted in IF products. The companies in question have been ordered to recall unqualified products and cease production until problems are resolved. However these revelations are particularly concerning given the fact these manufacturers have recently been audited and approved under series of Chinese infant formula manufacturing standard reforms.

Last year, CFDA implemented a new production specification with greatly enhanced regulatory requirements for IF manufacturers, namely Detailed Rules for Examination on Production Licensing for Baby Formula Manufacturers (2013) (see CL food news on 27 Dec 2013). After a first round screening, 92 out of 128 IF manufacturers were approved. Recently, CFDA organized food safety panels to re-audit 6 of the problematic manufacturers identified during the random inspection campaign. The following problems were highlighted:

  • Failure to sustain production conditions required in the Detailed Rules;

  • Food safety management system not implemented well;

  • Improper disposal of defective products;

  • Inadequate testing capacity;

  • Incomplete production record;

  • Manipulation of production volume data, production and operation data, etc.

It was reported that CFDA will release the draft of Administrative Measures on Registration of Product Formulations of Infant Formula for public consultation soon (see CL food news on 10 Aug 2015). At present the Chinese IF market is in chaos with around 2000 IF brands circulating on the market which directly opposes the Chinese government’s primary goal of a domestic IF supply consolidated in the hands of far fewer manufacturers and brands. As “one brand , one formula” will be adopted under the new IF regulations the key focus is to produce clearly differentiated products with unique formulas e.g. a certain number of nutritional substances should be different and the applicant should provide scientific reference and testing data to prove product safety and its nutritional advantages. After 2008, a lot of SMEs created hundreds of “me-too” brands to seize market share in less developed cities. The new regulation is designed to force copycat IF products out of the market and compel real R&D and innovation within the industry.

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