I. Revision background

“Items and requirements of application materials for product formula registration of infants and young children formula milk powder (trial)” (Announcement No. 175, 2016 of the China Food and Drug Administration) was published and put into effect on October 29, 2016 (hereinafter referred to as the old edition). After a period of trial operation, it is found that it is hard to be implemented. China Food and Drug Administration released the 2017 Revision (hereinafter referred to as the Revision) on May 25, 2017 after repeated research and demonstration.

II. Main changes

Highlight interpretation: After carefully studying the “Items and requirements of application materials for product formula registration of infants and young children formula milk powder (trial)” (2017 Revision), Foodmate has found that the Revision is changed as follows compared with the old edition:

① The materials of “stability study and confirmation status of products in various package specifications” is no longer required to submit; ② The “information on tracking assessment of nutrition and safety of product” is no longer required to submit at the first application for registration, which is modified to submit at renewal of formula registration; ③ The process validation report does not have to be submitted for 3 batches, while it must be for commercialized production process; ④ The requirement of “market survey research situation and relevant breast milk research situation, as well as test materials, nutrition guide or monograph, nutrition data materials, other relevant research literatures and historical materials of consumption in the market for a long time” in Material V has been deleted; ⑤ The basic situation of R & D and production personnel as well as their research and development work and achievements is no longer needed to provide; ⑥ The evidentiary materials showing the legal origin of food raw materials and food additives are not needed to submit.

The Revision also focuses on adjusting the order of the contents of each part of the application materials, moves the core of the application materials to Material VIII from the original Material V. For example, the content of Material V (1) Formula research and development ③ validation report is adjusted to Material VIII (2) ① Evidentiary materials on R&D ability.

As a result of the simplification on the test process and research materials, etc., the previous preparation time for application materials is greatly shortened, and the cost of product test and material translation is reduced. On the whole, this revision is good news for the enterprise, but for the enterprises that have prepared the related materials, this part of cost may become the “silent cost”, which is a little pity.