New Updates on the Formula Registration of Infant Milk Powder

24^th April 2015, the Food Safety Law was published by the National People’s Congress Standing Committee with a new stipulation that the formula of infant formula milk powder should be registered in China. It has been greatly focused by domestic and overseas dairy enterprises, and it is also a new opportunity and challenge for infant formula milk powder industry.

Regulation updates of domestic infant formula milk powder

On 2^nd September 2015, CFDA released a Notice for public comments on the Administrative Measures for the Registration of Formula of Infant Formula Milk Powder (exposure draft), and 3 months later, a new draft for examination and approval on the administrative measures for the formula registration of infant milk powder was widely spread in dairy industry.

Compared with the previous draft published on 2^nd September 2015 which allowed each manufacturer keep 5 series of infant formula milk powder with 15 kinds of formulas, the new draft may decrease it to 3 series of products with 9 kinds of formulas. It is obviously that the allowed formula quantity of a manufacturer is reduced and it is confirmed by the Food Safety Law Implementation Regulation (exposure draft) which was released by CFDA on 9th December 2015.There is every reason to believe that this rule with higher requirement will come into force in near future, maybe in December.

Regulation updates of imported infant formula milk powder

At the end of September, an unofficial draft of imported infant formula milk powder formula registration published by AQSIQ was exposed by industry association. Based on the draft, a same formula cannot be used for the production of different brand by one manufacturer and the same formula means that there is no nutrient content change in different brands with using any same raw material, food additive, nutrition enhancer and their sources. This rule is looser than the requirements of domestic infant formula milk powder. Besides, it is said that the responsible authority will be changed from AQSIQ to CFDA, and the allowed formula quantity of imported product may be similar to domestic products.

CIRS comments

Currently, the final version of regulation on domestic infant formula milk powder formula registration and the draft regulation on overseas infant formula milk powder formula registration haven’t been published, but related enterprises should be ready to register the formula early enough as the supervision tendency is very clear.

Highlights

1. For domestic manufacturers, please clean up all formulas which have been recorded under CFDA before and choose 3-5 formulas for later registration first and please prepare required documents according to the draft. Then you could complete the registration and get into the market as early as possible once the official regulation issued.

2. Meanwhile, for overseas manufacturers, please refer to the draft regulation on domestic products and unofficial draft on overseas products, checking if the formulas quantity or the difference between different brands is qualified temporarily.

Any progress on the regulations, CIRS will update continually for you to response in time.

For more information of CIRS regulatory compliance service on infant formula milk powder, please click here.

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