SAMR Releases Q&A Guidance for Infant Formula Recipe Registration During the Grace Period

For products that intended to add choline into stage 1 infant formula recipes based on the new IF standard, applicants can apply for registration alteration. For products that intended to add or remove certain optional ingredients, applicants should cancel the old recipe registration first and then apply for new recipe registration. For products that adjust the recipe according to new standards, product stability research material should be submitted whether to apply for alteration or new recipe registration.

Background:

On March 18, 2021, three new national food safety standards¹ for infants formula (IF) were published by China’s NHC authority, which will be effective starting from Feb 22, 2023. During the 2-year grace period, it is voluntary and encouraged to follow the new requirements, and products produced before the implementation date are still allowed to be sold within its shelf life. On March 24, 2021, SAMR released a following-up notice² regulating the infant formula recipe registration under the new GB standards.

To better help stakeholders get through the grace period, another notice³ was released by SAMR on June 15, 2021, further addressing 20 most frequently asked questions. The 20 questions involve different situations to apply for alteration/new recipe registration, application materials needed for recipe registration/alteration, materials related to bacterial strain traceability, others related to commercial manufacturing process verification report, manufacturing procedure, product stability research, etc.

Details of some key points are listed below.

Registration alteration or new recipe registration?

Applicants can apply for registration alteration if they adjust the old recipe (recipes have already got the recipe registration approval) based on the new GB standard. The adjustments here include:

a. Addition of choline in stage 1 IF recipes;

b. Addition of choline, selenium, manganese in stage 2 IF recipes;

c. Adjustment of compound sources of vitamins and minerals;

d. Adjustment of active ingredient content in food additive preparations, etc..

For old recipes that intended to add or remove certain optional ingredients, applicants should withdraw the old recipe registration first and then apply for new recipe registration. However, to optional ingredients like nucleotide, bacterial culture for infants and dietary fiber (including fructo oligosaccharide, galactooligosaccharides, polyfructose, raffinose, polydextrose, yeast beta-glucan, etc.), only when the whole type of ingredient is removed or added, applicants should apply for new recipe registration.

Materials need to be submitted when products with old recipe registration approval apply for the recipe registration/alteration based on the new standards

a. Application form for IF recipe registration/alteration

b. Research and development argument material for recipe adjustment

c. Product recipe

d. Explanation of manufacturing process (only when the manufacturing process is changed)

e. Product test report

f. Materials related to product stability research

g. Product label sample

What should a commercial manufacturing process verification report consist of?

It should include the feeding information related to the raw and auxiliary material of three batches of products during the pilot production, and the analysis of sample homogeneity, process stability and nutrition fact compliance.

Is it necessary to submit product stability research material when apply for registration alteration?

For old recipes that adjust the recipe according to new standards, product stability research materials should be submitted whether to apply for alteration or new recipe registration.

For further translation of this notice and regulatory consultation, please email [email protected].