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Summarization on the Memorabilia for Registration of Infants and Young Children Formula Milk Powder

In the evening of August 3, the China Food and Drug Administration published the list of the first batch of enterprises and formula passed the formula registration application, including 89 infants and young children formula milk powder product formula of 22 companies, which indicates that the new policy is finally launched. The publicity of the first batch of list encouraged the registered milk industry greatly, and it is also believed that the second and the third batch of list will soon be announced. Foodmate.net summarized the memorabilia of infants and young children formula milk powder registration, to review the ages on registration of the infants and young children formula milk powder in joint endeavors with everyone together.

(1) On April 24, 2015: “Food Safety Law of the People’s Republic of China” was issued, and implemented from October 1, 2015. The Article 81 of it clearly defined that: The product formula of infants and young children formula milk powder shall be registered by the food and drug administration departments under the State Council. The formula R & D report and other materials indicating the scientificity and safety of the formula shall be submitted at registration. This clearly specified at the first time that the infants and young children formula milk powder needs to be registered.

(2) On June 6, 2016: China Food and Drug Administration (hereinafter referred to as CFDA) published the “Administrative measures for product formula registration of infants and young children formula milk powder” (Decree No. 26 of CFDA), and implemented from October 1, 2016.

(3) On June 13, 2016: CFDA released the interpretation document for “Administrative measures for product formula registration of infants and young children formula milk powder”.

(4) On September 30, 2016: CFDA released the “Announcement about implementing transition period on the product formula registration for infants and young children formula milk powder formula” (No. 160, 2016), which made it clear that the infants and young children formula milk powder approved to be produced and sold within the territory of our country or exported to the territory of our country before January 1, 2018can be sold till the end of shelf life. However, the infants and young children formula milk powder produced within the territory of our country or exported to the territory of our country must obtain the product formula registration certificate of infants and young children formula milk powder according to law from January 1, 2018.

(5) On October 29, 2016: CFDA released the “Items and requirements of application materials for product formula registration of infants and young children formula milk powder (trial)” and “Key points and judgment principle of on-site inspection for product formula registration of infants and young children formula milk powder (trial)”, which stipulated the key points and judgment principle of on-site inspection for formula registration application materials at the first time in details. In addition, CFDA also released the interpretation on the two auxiliary documents.

(6) On January 26, 2017: After the auxiliary document of formula registration (trial) is released, in order to carry out the registration work in a sequential, reasonable and scientific manner, CFDA solicited public opinions on the related auxiliary documents including the “Technical guidelines on labeling normalization for product formula registration of infants and young children formula milk powder (trial) (exposure draft)” and “Technical guidelines on stability study for product formula registration of infants and young children formula milk powder (trial) (exposure draft)” of “Administrative measures for product formula registration of infants and young children formula milk powder”.

(7) On May 23, 2017: In order to further promote the registration work of infants and young children formula milk powder, CFDA released the “Items and requirements of application materials for product formula registration of infants and young children formula milk powder (trial) (revised edition of 2017)” on the basis of soliciting public opinions, and released the interpretation on the trial document (revised edition of 2017) at the same time, to further make a detailed description on the requirements of materials.

(8) On May 24, 2017: CFDA released the “Technical guidelines on stability study for product formula registration of infants and young children formula milk powder (trial)” to further strengthen the management on the product formula registration label of infants and young children formula milk powder, so as to better carry out the registration work of infants and young children formula milk powder.

(9) On May 25, 2017: CFDA released the interpretation on the “Technical guidelines on labeling normalization for product formula registration of infants and young children formula milk powder (trial) (exposure draft)”.

(10) On July 31, 2017: Health Food Review Center held the infants and young children formula milk powder import business forum in Shanghai, answered to the “Frequently asked questions” on registration, and reminded enterprises to submit materials as soon as possible before the end of September at the latest. It was pointed out at the meeting that the Review Center will receive 20 to 30 pieces of materials every day that are all from domestic enterprises, while the overseas enterprises submitting materials still remain at 26, so the overseas enterprises shall speed up.

(11) On August 3, 2017: CFDA has approved the registration application on the product formula of 89 infants and young children formula milk powder for 22 enterprises, and issued the first batch of approved list of enterprises accordingly. There are 17 domestic enterprises in the 22 companies including Beingmate, Yashili, Mengniu, Feihe, Yili, Biostime, Junlebao, Sujia, Red Star and CHF, etc., and the other five companies are from overseas, i.e. Nestle, Wyeth , Abbott, FrieslandCampina and Mead Johnson.

The first batch of “Published” enterprises can relieve temporarily, while more dairy companies still need to continue to make efforts. According to the Review Center, about 665 registration applications have been received at present, of which domestic milk enterprises account for 79%. Foodmate.net reminds that small & medium-sized milk enterprises and imported milk enterprises need to apply for registration as soon as possible, abandon the wait-and-see attitude by luck or placing hope on transitional period, and pay close attention to complete registration work before September so as to make it before January 1, 2018.

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