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Jan 04, 2019

Letter No. 466, 2017 of the Department of Special Food Registration under the Office of CFDA

The CFDA has released the “Reply Letter of the Office of CFDA about Defining the Date of the Transitional Administration Period Implementing Product Formula Registration for imported Formula Food for Special Medical Purposes and Infants & Young Children Formula Milk Powder” on the official website on July 14, 2017. The letter specifies the transition period for “Overseas milk powder” not registered at formula again.

According to the letter of the CFDA, the foods for special medical purposes and infant & young children formula powder produced overseas that has been approved for entry before January 1, 2018 but not yet registered, may be sold until the expiry date in accordance with the related requirements of the CFDA.

This statement is consistent with the “Announcement of the CFDA on the transitional period for product formula registration management of infants & young children formula milk powder (No. 160, 2016)” as published by CFDA on the official website on June 29, 2016.

According to the latter document, the infants and young children formula milk powder produced in our country or exported to our country need to be accompanied by the corresponding product formula registration certificate from January 1, 2018. The label and specification documents should include the registration number. The infants and young children formula milk approved to be produced and sold in our country or exported to our country can be sold till the expiry date before January 1, 2018.

The infants and young children formula milk powder registration system has been implemented since October 1, 2016. CFDA had promised to release document to grant a certain transition period in the market supply of infants and young children formula milk powder.

The transitional period had been foreseen by manufacturers and distributors, and is finally published indicating that the formula registration enters the final state directly. But if product suppl are still left, the milk powder provided with the official approval of importation can still be sold after the deadline in the following year, which ensures the stability of market. However, the registration will be mandatory for newly produced products.

Analysis on the transitional period of infants & young children formula milk power and foods for special medical purposes

1. All the products that have been approved to be produced in domestic and imported by the related departments can be sold until their provided expiry dates and ultimately until January 1, 2018.

2. The infants & young children formula milk power and foods for special medical purposes approved after January 1, 2018 must obtain the formula registration certificate approved by CFDA. The domestic enterprise that has not obtained the certificate needs to suspend production, and the product of its overseas enterprise can’t be imported.

3. “January 1, 2018” refers to the date calculated according to the date of manufacture for domestic enterprises, and the date issuing certificate according to CIQ for imported enterprises, which explained that the declaration date need to be brought forward one month to November, 2017. It needs a shorter time if it is declared by air transportation, while the date of declaration has to be brought forward if it is by sea transportation or others.

4. In face of the above provisions specified by CFDA, the importating enterprises have to declare for entry before the end of the year. The consequence is that the product can only be returned instead of importing.

5. It is estimated that the first batch of infants & young children milk powder registration certificate will be approved in August if it is successful. Enterprises still need to consider affairs such as production license, and import label. In consideration of the registration period, the enterprises that have not submitted for registration need should do so soon.

6. For the current situation, the enterprises without certificate may take into consideration of stocking up. The several following factors shall be comprehensively considered for the amount of inventory: transitional time limit, plant capacity, inventory of dealer and rentable warehouse. However, there is certain risk for stocking up. When the first batch of products with certificate is put into market, the ones without certificate will be disadvantaged.

7. The focus is on registration, and at the same time, it can’t be ignored that the transitional period for cross-border E-commerce is also as on January 1, 2018.


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