China is currently drafting new regulations that when promulgated will effectively implement a “one brand, one formula” rule. The “registration of infant formula product guideferrous gluconate 27 mg vs 325 mglines” is currently being compiled by the CFDA. In addition domestic manufacturers are likely to be limited to producing no more than 5 IF brands. The regulation is likely to be released in Oct this year and will bring about tremendous changes to China’s domestic market which currently has over 2000 individual IF brands vying for market share and credibility. China’s new Food Safety Law (effective from 1 Oct) articulates the new registration rferrous fumarate every other dayequirement and briefly mentions applicants should provide the CFDA with R & D report and other supporting materials ferrous sulfate 90 18 feable to prove the formulation is both scientifically and nutritionally sound and above all safe. The pending &nbsiron (ii) acetate tetrahydratep;guidance is a subsequent implementation document for FSL. Moreover, the new FSL emphasizes the “one brand, one formula rule” and reiterates the ban on OEM production models. In contrast to the domestically manufactured infant ferrous gluconate on empty stomachformula market, there are only about 300 imported IF brands sold in China.
China Making Infant Formula Registration Rules
