On June 18, 2019, the Food Evaluation Center of SAMR issued the Q&As of China infant formula milk powder registration application, mainly including Q&As about the project related to the R&D capability certification materials in the application materials.

What projects are included in the R&D capability certification materials?

It should include the basis for determining the nutrient design value and/or label value of the product, the research on the attenuation of nutrients in the production process and shelf life, the research on the range of nutrient design values and/or label value detection deviation, formula composition selection basis and dosage design value, formula verification corrective process and results and determination of internal control standards for the enterprise. All of them should not be missing.

Research on raw material nutrition data

1. Submit quality inspection reports (including at least 1 batch) about that bulk raw materials (Including at least base powder, lactose, milk powder, whey powder, whey protein powder, raw milk and vegetable oil) provide protein, fat and carbohydrates. The inspection items should cover at least the requirements of raw material quality safety standards, and the base powder inspection items should simultaneously cover the requirements of GB 10765 or GB 10767. In addition, the enterprise who use the base powder should provide the quality inspection report of the base powder, while the quality inspection report for the base powder ingredients could no longer be provided.

2. Submit the content data (At least 3 batches) of the essential nutrients and optional ingredients indicated in the final product nutrient composition table in the bulk material background, statistical analysis of the coefficient of variation and control measures.

3. The quality inspection report and background content data should be issued by the applicant self-inspection or by a qualified third-party inspection agency.

Attenuation research in the production process

1. The research subjects should be 3 batches of the infant formula produced under commercial production conditions.

2. The research content can be determined according to the production experience. All process types should include at least the attenuation study of fats and fatty acids (Linoleic acid, DHA and AA, etc.), water-soluble vitamins (VC, B1, B2, B12, Folic acid and Choline, etc.), fat soluble vitamin (VE, VA, etc.) and minerals (Copper, Zinc, Iron, Selenium and Iodine, etc.).

3. The research data should be issued by the applicant self-inspection or by a qualified third party inspection agency. In the case of entrusted inspection, the principal should be the applicant for registration of the formula.

Attenuation research during shelf life

1. The research subjects should be 3 batches of the infant formula produced under commercial production conditions.

2. Long-term testing and/or accelerated testing can be used.

3. Specific test protocols which include at least the time point, temperature, and humidity should be provided. In the case of accelerated testing, the time point of investigation includes at least the time point of starting month and the end of the test, and no less than 2 time points in the middle. All the items specified in the product standard should be tested at the starting month and the end of the test. The test items in the middle of each inspection may be determined according to the production experience, and should include at least fat and fatty acids (Linoleic acid, DHA and AA, etc.), Water soluble vitamin (VC, B1, B2, B12, Folic acid and choline, etc.), fat soluble vitamin (VE, VA, etc.), minerals (Copper, Zinc, Iron, Selenium and Iodine, etc.). Finally, through the analysis of the research results to explain rationality of the shelf life.

4. The research data should be issued by the applicant self-inspection or by a qualified third party inspection agency. In the case of entrusted inspection, the principal should be the applicant for registration of the formula. The test data of each inspection time point of the same test item should be detected by the same inspection unit.

Design value and/or label value detection deviation range research

Submit the research results about range of deviations of nutrient design values and/or label values and detected values.