Q&A Infant Formula Milk Powder Product Formula Registration (Quality and Technology II)_News & Articles

Q&A Infant Formula Milk Powder Product Formula Registration (Quality and Technology II)

Ellie WangGlobal Foodmate12 Jan 2022

What are the prevent and control measures for product miscellaneous bacteria contamination caused by the use of active bacteria?

The prevent and control measures for the possible contamination of products by miscellaneous bacteria caused by the use of active bacteria should at least include the following:

(1) Provide quality specifications, sanitary indicators and corresponding test reports of active bacteria raw materials, including but not limited to bacterial composition, counting, chemical and microbial contamination indicators.

(2) Clear requirements on supplier selection, incoming inspection procedures (including but not limited to various quality specifications and hygiene indicators), storage and transportation conditions of raw materials, inbound and outbound storage management, etc.

(3) Ensure the consistency of strains in the production process, and provide control measures for the key processes of active bacteria raw materials using and site cleaning up.

(4) Batch test of active bacteria count and microbial contamination index in finished products.

How should I submit the application materials for adding the active strain formula?

For the formula of adding active strains, relevant materials such as strain traceability and miscellaneous bacteria pollution prevent and control measures should be submitted. It includes source description of strain raw materials, identification report of strain, and prevent and control measures that may cause product miscellaneous bacteria contamination due to use of strain (such as quality specification and test report of active strain raw materials, management of active strain raw materials, control of production process related to finished products, testing of related items in finished products, etc.).

What are the requirements for strain identification report?

Strain identification report should meet the following requirements:

(1) The identification report may be provided by the applicant or the supplier;

(2) Identification report should be identified to strain level;

(3) Strain identification should be completed within two years prior to the application date.

How should the quality and safety standards of base powder and manufacturing process materials be provided?

If base powder is used, the actual quality and safety standards of base powder and raw materials used in the production of base powder shall be submitted. At the same time, a commercial production process flow chart of base powder should be submitted, indicating the main production processes, environmental conditions and critical control points.

Can the quality and safety standards for food additives be pharmacopoeia standards? How to submit materials?

The pharmacopoeia standards of the People's Republic of China may be applied to food additives for which there is no corresponding national food safety standard and whose product standards are stipulated in the relevant announcement of the National Health Commission and/or the former Ministry of Health in accordance with the Pharmacopoeia of the People's Republic of China. Applicant could only submit the name of the announcement as application materials.

Can the quality and safety standards for food additives be pharmacopoeia standards? How to submit materials?

How should the quality and safety standards for compound ingredients, compound food additives and food additive preparations be provided?

The executive standards for compound ingredients, compound food additives, food additive preparations and their components shall be provided. Where there are national food safety standards, they shall conform to the current and effective national food safety standards.

For the implementation of GB 26687, it shall meet the requirements of the standard for compound food additives: consisting of two or more single varieties of food additives, having the same range of use, etc.

For food additive preparations, the quality standard text of the preparations, such as the acceptance standard of the applicant, the supplier's enterprise standard or the product quality specification shall be provided. The quality standards for food additive preparations should at least include the control of the active ingredients and safety indicators of the preparations.

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