Data Delivery: Status of Infant Formula Milk Powder Registration in China

Updated on 15 Jul. 2020

On 1 October, 2016, the Administrative Measures on Product Formula Registration of Infant Formula Milk Powder came into force. After more than three years of development, most infant formula milk powder manufacturers have completed the registration work in China. In order to give you a better understanding of the registration status, CIRS has made a detailed analysis on the registered products.

1. The Number of Registered Products

Up to now, State Administration for Market Regulation (SAMR) has approved the registration of 1311 infant formula milk powder products from 166 manufacturers, including 998 products produced by 115 domestic manufacturers and 313 products produced by 51 overseas manufacturers.

As can be seen from Fig 1, 2017 is the peaking period of formula registration because the registration transitional period was up to the end of 2017, and a large number of enterprises submitted the application and got registration approval during this period. In that year, 952 products were approved, accounting for 73% of the approved products.

In principle, at most 3 series and 9 kinds of formulas can be registered by one manufacturer, therefore, since 2019, the number of new product registrations has been greatly reduced compared with that in 2017. On the contrary, the applications for changes of registered products are getting more and more.

Fig1. Number of Registered Infant Formula Milk Powder Products in Each Year

In general, one manufacturer applies for the registration for 1 series, 3 age groups at the same time. As a result, the number of products registered at different age groups is similar (see Fig 2).

Fig 2. Number of Registered Infant Formula Milk Powder Products at Different Age Groups

2. Top 10 Enterprises in Obtaining Registration Certificates

In accordance with the Administrative Measures on Product Formula Registration of Infant Formula Milk Powder, at most 3 series and 9 kinds of formulas can be registered by one manufacturer in principle. Therefore, products belonging to the same enterprise are generally registered by different factories. According to our statistics, the top 10 enterprises obtaining the registration certificates are shown in Fig 3.

Fig 3. Top 10 Enterprises in Obtaining Registration Certificates

3. Registration Status of Imported Products

Up to now, a total of 313 imported products from 15 overseas countries have obtained the formula registration approval in China. New Zealand, Netherlands, South Korea, France, Australia, Denmark and Ireland are the leading countries in product registration. Compared with the registration list of overseas infant formula manufacturers published by the General Administration of Customs, P.R. China, formula approval information related to the registered manufacturers in Italy, Austria, Argentina, Estonia, etc., have not been released yet.

Fig 4. Number of Registered Imported Products in Different Countries

4. The Number of Registered Goat Milk Powder Products

In recent years, goat milk powder products have received more and more attention. Up to now, 270 goat milk formulas have been approved for registration (including 237 domestic products and 33 imported products), accounting for 21% of the total.

Fig 5. Number of Registered Goat M ilk Powder VS Cow Milk Powder

5. The Number of Registered Organic Products

According to the product label, until now, a total of 22 series, 66 approved formulas are certified organic products (including 36 domestic products and 30 imported products), and all of them are cow milk powder.

Fig 6 Number of Registered Organic Products

Table1 Details of the Registered Organic Products

S.N.	Domestic/Imported	Trade Name	Applicant
1	Domestic organic products	Rui’bu’en	Inner Mongolia Ou Shi Mengniu Dairy Products Co., Ltd.
2		AusNuotore	Meilu Biotechnology Co., Ltd.
3		Zhen’zhi	Heilongjiang Fir Mus Dairy Co., Ltd
4		Ou’bei’xing	Heilongjiang Red Star Group Food Co., Ltd.
5		Zhi’zhen	Heilongjiang YeePer Dairy Co., Ltd.
6		MoraPure	Wissun Dairy (Qiqihar) Co., Ltd
7		Ai’ni’ke	Bei'an Yipin Nuka Dairy Co., Ltd.
8		You’jia’en	Heilongjiang Nongken Longwang Food Co., Ltd.
9		Jing’bo	Heilongjiang Nongken Longwang Food Co., Ltd.
10		Chun’rui	Fir Mus (Tai Lai) Dairy Co., Ltd.
11		You’cui	Hebei JunLeBao Junheng Dairy Co., Ltd.
12		Jin’ling’guan Sai’na’mu	Duerbote Yili Dairy Co., Ltd.
13	Imported organic products	Healthy Times	COOPERATIVE ISIGNY-SAINTE MERE
14		Baby & Me	Arla Foods amba Arinco
15		Eleva	Arla Foods amba Arinco
16		Wyeth illuma purie	Wyeth Nutritionals Ireland Ltd.
17		Baby's Only	Maple Island Inc.
18		Neolac	Lypack Leeuwarden B.V.
19		ExtraPure	AUSTRALIAN DAIRY PARK PTY LTD
20		Kendamil Ou’rui’er	Kendal Nutricare Ltd
21		Euland	HAM Co.,Ltd
22		babybio	LAITERIE DE MONTAIGU SAS SABOURIN

CIRS Comments

China government pays great attention to the quality and safety of infant formula, and ensuring the quality of infant formula milk powder is a long-term work for every infant milk powder manufacturer. With the goal of promoting the establishment of a scientific and complete market supervision system, strengthening legislation in key areas, the Administrative Measures for the Registration of Infant Formula Milk Powder and the food safety national standards of infant formula in China are under revision for the moment. It is believed that they will be issued and implemented in the near future. Therefore, enterprises that intend to enter Chinese market may grasp the opportunity, preparing in advance no matter on developing products or on the understanding of new Chinese standards and regulations.

Author:

Ms. Wing Yu, Technical Manager of Food Business Division, CIRS Group

Ms. Wing Yu graduated from Zhejiang University with Master Degree of Food Engineering. She has abundant experience in food technology, food testing and food regulation. After joining CIRS, she focuses on food regulatory compliance field, and is professional in food technical and regulatory support for oversea enterprises.

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