China tightens regulation on infant formula makers

BEIJING - China's food and drug watchdog on Wednesday unveiled a revised regulation that will significantly increase standards for domestic infant formula producers and lead to a shake-up of China's infant formula industry.

The revised regulation sets new rules and raises requirements for infant formula producers in nine areas, including product safety control, purchase of raw materials, formula product inspection, manufacturing process and product traceability.

The regulation, called Detailed Rules on Examination of Production License for Infant-formula Milk Powder Producers (Version 2013), was drafted with participation of 30 experts and food and drug supervisors, said the State Food and Drug Administration (SFDA).

The SFDA said that in July of this year, experts started revising the old regulation, which was issued in November of 2010. A draft new regulation was published on Aug 6 to solicit public opinions. A total of 8,970 opinions and suggestions were collected during 10 days of public consultations, it said.

To implement the new regulation, the SFDA said it would start a nationwide campaign to review and examine the production licenses currently held by the infant formula producers. The campaign will be finished before May 31, 2014, it said.

Producers who fail to meet new requirements or fail to obtain new licenses in the campaign will be granted a grace period of two years by provincial food and drug administrations to improve and rectify their manufacturing.

According to the new regulation, an infant formula producer should register its product formula, product packages and labels with provincial food and drug administrations.

The regulation demands that the producers assume primary liability for product safety. Producers should ensure the traceability of their products and establish and implement a product recall system, it said.

The new regulation also includes a series of sanitation and quality control standards, which employ pharmaceutical production standards as reference.

In a notice to provincial food and drug administrations, the SFDA said the new regulation was an important measure to implement the arrangements of the State Council, China's cabinet, on strengthening quality control of infant formula products.

The SFDA asked provincial authorities to strictly enforce the new regulation and ensure smooth work in reviewing and examining the production licenses.

Chinese authorities have been making continuous efforts to restore consumer confidence in Chinese dairy products, the reputation of which was seriously undermined by a tainted milk scandal in 2008.

In that incident, unscrupulous Chinese milk producers were found to have mixed melamine with their dairy products in order to cheat protein content tests. The practice caused the deaths of at least six Chinese babies and left another 300,000 ill.

On May 31, 2013, Chinese Premier Li Keqiang chaired an executive meeting of the State Council and unveiled detailed plans aiming to improve the quality of domestic baby milk powder.

At that time, Li said that supervision of baby formula should be as strict as it is for medicine.