At the beginning of the New Year in 2020, Washington time on January 15, China and the U.S. signed the first phase of economic and trade agreement (hereinafter referred to as âThe Agreementâ) (full text of The Agreement), once released quickly on to the front page of major websites.
At present, the imported infant formula allowed to be sold in China through general trade must finish the registration of facilities in General Administration of Custom (GACC) and the registration of product formulation in State Administration for Market Regulation (SAMR), which are two independent registration systems. However, signing of this Agreement will change the current situation.
After thorough study and comparison, the registration department of FOODMATE highlighted and interpreted few key points appeared in The Agreement, for your reference.
1. U.S. dairy imports only need to meet the following two requirements:
(a) The facility is on the list of USFDA;
(b) with a dairy sanitary certificate of AMS.
2. The difficulty and duration of facility registration are greatly reduced
China will register the facilities within 20 working days after receiving the updated list from USFDA. The required materials and the difficulty of auditing for facility registration will be significantly reduced when compared. In addition, the time limit is also clearly stated sa 20 working days.
3. Cut the time duration of infant formula registration by half
(a) China will take into full consideration section 412 of 21 U.S.C. Â§ 350a, when reviewing the registration of US infant formula;
b) upon entry into force of the Agreement, the time duration of infant formula registration set out in the Administrative Measures for Product Formulation Registration of Infants and Young Children Formula Milk Powder (hereinafter referred to as the âRegistration Measuresâ) will be greatly shortened to 105 working days.
(c) In The Agreement, the time duration is clearly listed step by step. And during technical review, inspecting, sampling and testing, China will consider the USFDAâ decisions on product compliance. While, in Registration Measures, the time duration between the correction of information and on-site verification is not clearly stated, which depends on the actual situation of overseas manufacturers.
4. Infant formula product registration helps facility registration
After the infant formula is registered, USFDA provides the list of the facility producing the corresponding infant formula to China, and the facility registration will be approved within 20 working days. Within a week of the agreement's entry into force, China will grant facility registration to a factory whose products have been approved in China.
Prior to The Agreement, the overseas facility registration is completely independent of infant formula product registration, the approval time of facility registration is relatively long and uncontrollable.
5. No longer require renewal of registration
The validity period of the U.S. facility registration and infant formula product registration will not be subject to the relevant Registration Measures.
6. On-site inspecting is not a pre-requisite for facility registration
The Agreement makes it clear that on-site verification is not a must when U.S. infant milk manufacturers or and dairy products manufacturers are going to be registered in China. This is consistent with the relevant contents of the Regulations on the Registration and Administration of Overseas manufacturers of imported Food (Draft) recently issued by the GACC.
If China needs to conduct audits and inspections for dairy products and infant formula, China will notify the USFDA, the USDA and the facility at least 20 working days in advance.
Currently, 6 U.S. infant formula plants are registered in China (including 4 milk powder plants and 2 liquid milk plants), of which only Maple Island Inc. (approval number: 2122612) obtained the formulation approval of infant formula (brand: Baby's Only).
In conclusion, this Agreement will facilitate the import of U.S. dairy products to China, not only greatly shortening the time for U.S. facility registration and product registration, but also linking the two independently managed systems. With respect to infant formula, Infant formula product registration supports the facility registration and will speed up the registration process in China.
Regulations on Registration Administration of Overseas Manufacturers of imported Food (General Order No. 145) (2012-03-22) (revised in 2018)
Administrative Measures for Product Formulation Registration of Infants and Young Children Formula Milk Powder (Order No. 26 of China Food and Drug Administration)
Annex 2. Dairy and Infant Formula, Economic and Trade Agreement between the Government of the Peopleâs Republic of China and the Government of the United States of America (page 3-4)