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Reply Letter of the Office of CFDA About Defining the Date of Transitional Administration Period Implementing Product Formula Registration for Imported Formula Food for Special Medical Purposes and Infants & Young Children Formula Milk Powder

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

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

According to the letter of CFDA replied to Shanghai Food and Drug Administration, the foods for special medical purpose and infants & young children formula powder produced overseas that had been approved to entry by related departments before January 1, 2018 (January 1, 2018 isn’t included) but had not registered, can be sold at our country till the expiry date in accordance with the related requirements of CFDA. The full text is published below.


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

According to the document at that time, the infants and young children formula milk powder produced in our country or exported to our country shall be equipped with the corresponding product formula registration certificate from January 1, 2018, and be indicated with the registration number on the label and specification. 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 from October 1, 2016. CFDA had promised to release document to grant a certain transitional period to ensure the consecutiveness of production and sale as well as the market supply of infants and young children formula milk powder.

Although it has been forecasted in the industry in advance, the statement of transitional period is reiterated today, which indicated that the formula registration enters the final state directly. But if there are enough inventories, the milk powder provided with the official approval of importation can still be sold after the “Deadline” in the next year, which ensures the stability of market. However, it is still the formula registration that plays a decisive role after the inventories are sold out.

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 before can be sold to the end of the shelf life till 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 importation enterprises are certainly to declare for entry focused on the end of the year. You can imagine the pressure on CIQ at that time. The bad result is estimated that the product can only be returned instead of importing because the certificate can’t be obtained in time due to the exceeded workload when the cargos arrived at the port.

5. It is estimated that the first batch of infants & young children milk powder registration certificate will be approved at August if it is successful. Enterprises still need to consider affairs such as production license, and import label, etc, which shall be overall planned by enterprises. In consideration of the registration period, the enterprises that have not submitted for registration need to hurry up and submit as soon as possible.

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. Now it is focused on registration, and at the same time, it can’t be ignored that the transitional period of cross-border E-commerce is also as of January 1, 2018. No matter administration or indulgence, both of them will test the wisdom and courage of administers. But the time limit is coming, while there has been no official statement yet.

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