1. Is the formula registration now in accordance with the new standard?

Starting from March 18, 2021, manufacturers can start to apply for infant formula registration in accordance with the new national standard, and can produce in accordance with the new national standard in advance after the approval.

2. Is the registered formula still available during the validity period?

The currently registered formulas of infant formula milk powder products must be registered before February 22, 2023 after the conversion to the new national standard. Otherwise, even if the original registration certificate is still within the validity period, production is not allowed after this period.

3. When is the latest time to register?

As the actual situation of each enterprise is different (such as application experience, material quality), it is safe to reserve at least half a year to one year for administrative review. Which means the best to submit application materials is before February to August 2022. Therefore, the company only has about one year to carry out related research and development, trial production, testing, and material preparation. For companies that have not yet started the transition to the new national standard, Foodmate recommends that these companies seek professional teams for technical support as soon as possible. As the experience during the first round of formula registration is not feasible today. Relying on the professional reporting technical team can understand the latest requirements and policies, and improve the efficiency and success rate of reporting.

In addition, it is worth noting that products manufactured before February 22, 2023 can be sold until the end of the shelf life.

4. What should I do if the approved formula meets the new national standard?

If the currently approved formula conforms to the new national standard, but the nutritional composition table is passively changed due to factors such as changes in the energy factor of dietary fiber and the update of the inspection method, and still conforms to the new national standard after adjustment. There is no substantial change in this type of formula , deal this case with modification registration.

5. What should I do if the approved formula does not meet the new national standard?

If the currently approved formula does not meet the requirements of the new national standard nutrient composition table, the formula nutrient composition table needs to be adjusted (at the same time it will also cause the formula dosage change), and the formula raw material variety is adjusted. The product formula is deemed to have undergone substantial changes , need to be canceled and reapplied.

6. Is the process of re-registration, modification and continuation the same as the previously approved formula ?

For the approved formula, if you apply for cancellation, re-registration, change of registration, or renewal of registration, you need to check 9 items one by one like the first application for formula registration. If there is no change, you don’t need to submit it. You only need to submit the changed materials. Foodmate suggests that the unchanged and changed materials should be briefly explained or labelled. For the material 5 Product Formulation Research and Development Report, it is necessary to list and summarize the changes (list item changes, dosage changes, reasons for the changes, etc.), and explain the changes in detail in the text.

7. How to apply for formula registration, is there anything to pay attention to?

For all companies that apply for formula registration (first application for registration, cancellation and re-registration, change of registration, renewal of registration), the shelf-life stability study materials should be submitted, in accordance with the newly released "Guidelines for the Study of Stability of Infant Formula Milk Powder Products (Trial)" (hereinafter referred to as the new guidelines).

Foodmate reminds companies that have approved formulas to check the test conditions, test items, and test time in accordance with the new guidelines. At the same time, the new guidelines also adjust the seven requirements of the report content of the research materials, which should be confirmed one by one.

After comparison, the temperature and humidity range of accelerated test conditions is reduced (new guide: temperature 37℃±2℃, humidity RH75%±5%; original draft for comments: temperature not lower than 40℃, humidity not lower than RH 75%) ; The test time, the original draft for comments required the accelerated test to be at least 3 months, and now it is at least 6 months. For those with a shelf life of less than 24 months, the overall time for the accelerated test is extended. Compared with the question and answer of the original evaluation center, the key test items (sensitive items, etc.) have been added or removed. The new ones include sensory, (or) a-linolenic acid, vitamin B6, moisture, lutein, taurine, and active bacteria Kind. 

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Business Division of Food Safety and Regulatory Compliance of Global Foodmate provides food standards & regulations research, labelling compliance consulting/Chinese label design, industry public opinion monitoring and analysis, registration services (of Infant formula, FSMP, Health food, Novel Food Ingredients, Novel Food Additives, New Varieties of Food-Related Products and Overseas manufacturers of imported food) and other comprehensive food safety solutions for domestic and overseas enterprises and institutions in food industry. 

Please feel free to contact us: +86 10 68869850, E-mail: global_info@foodmate.net