On September 14, 2021, the State Administration of Market Supervision issued the 2021 draft of the Detailed Rules for the Examination of Infant Formula Milk Powder Production License (Hereinafter referred to as The Draft). The 2021 draft has seven chapters and 42 articles, including production sites, equipment and facilities, equipment layout and technology, personnel management, management system, etc. The overall structure is more reasonable and the content is more rigorous. The draft, combined with the current General Principles for the Examination of Food Production Licenses and the requirements for formula registration, requires the implementation of the whole process management from raw and auxiliary materials to products. Foodmate compares and analyzes the 2021 version of the exposure draft with the 2013 version, and shares it in two phases. The main contents of the second phase are as follows:


6. Improve the equipment layout and process of production technology

The Draft stipulates strict control of the storage and transportation requirements of the wet process, combined with the relevant requirements of GMP and HACCP systems for dairy product manufacturers, and increases the storage requirements for raw milk before pasteurization.

The Draft proposes the ingredients requirements for the digital production process. Regardless of the process, the new batching process can realize automatic batching, and manual review may not be performed, but the system must have a corresponding error-proof design.

In the dry process, the facilities for dust removal and sterilization between the material preparation area and the feeding area are no longer limited to air shower and sterilization systems; the types of sterilization facilities are no longer limited to sterilization tunnels before the materials are removed from the outer packaging and enter the cleaning operation area. In the process of inputting materials, when the materials are input into the delivery system, other screening equipment except the vibrating screen is allowed to remove foreign objects.

The Draft added an illustration of the general production process of the dry-wet composite process. If an enterprise adopts a production process that is different from the prescribed production process, it shall submit a process rationality statement.


7. Scientific personnel management

The Draft revised the classification and requirements of relevant production personnel. The personnel are divided into three categories: food safety management personnel, food safety technical personnel, and production operators. Each category is subdivided separately and the names of personnel are modified.

The requirements of "R&D personnel" has been added to the "Food Safety Technicians". As for the personnel engaged in testing in the laboratory, the requirements for the corresponding qualification certificate have been deleted in the draft because the license and accreditation of the professional qualification of food inspection have been cancelled. However, the draft requires professional theoretical and practical training, the ability to test and operate instruments and equipment, and the inspection work will be carried out after passing the assessment. It can be seen that the actual requirements have not been relaxed. At the same time, the draft changed the requirements for laboratory testing personnel and production operators. Those who perform testing in the laboratory only need to pass the examination to carry out the inspection work, without having to obtain a food inspection professional qualification certificate. Production operators have added new requirements for taking up their posts after passing the training and assessment.

The Draft added the training time requirements for relevant personnel. It is stipulated that the training time shall not be less than 40 hours/year. D

8. Revise various system requirements

The Draft added the specific requirements for the purchase inspection record system. It includes the recognition, inspection, recording, reporting, acceptance or rejection treatment opinions and approval procedures for the raw and auxiliary materials.

The Draft added audit requirements for raw material suppliers. The supplier or manufacturer of base powder needs to conduct on-site quality and safety audit. If using the bacterial strain can be used in infant formula milk powder, the identification report (identified strains) provided by the supplier shall be reviewed and traceable.

The Draft revised the material requisition control requirements and detailed the content of material distribution and requisition records. The record contents include the corresponding material name, material code (if any), batch number, quantity, shelf life and other information. The Draft added material management requirements for the use of the computer management system and added the requirement of "Establishing a Cleaning and Disinfection System".

The specific requirements for sampling and sample sealing are deleted from the finished product inspection in the exposure draft; the requirements for the use of non-national standards for inspections with national standard inspection methods were added; the factory release requirements of qualified products are detailed; the requirements for product storage and transportation were added.

In addition, the draft also puts forward the following requirements in terms of system formulation. The Draft added production water control requirements, including the requirements for monitoring the content of chlorate risk substances in production water, which is consistent with the Standards for Drinking Water Quality(Exposure Draft). To prevent the occurrence of pollution events, the requirements of production process control requirements and air cleanliness and humidity are added in the production process management.


9. Summary

According to the current draft, with the reasonable adjustment of the structure, the content requirements are more detailed. It will take some time from the draft of the official release. It is recommended that infant formula milk powder manufacturers make corresponding preparations in advance according to their conditions. At the same time, considering the upcoming opening of the second round of formula registration and the implementation of the new national standard for infant formula food, the enterprise will face greater challenges and opportunities. Foodmate will continue to follow the revision progress and release of the detailed rules for the review of production license of infant formula milk powder, and timely remind relevant infant formula food manufacturers to keep abreast of the latest news. Foodmate also provides infant formula milk powder formula registration services for enterprises in need. Please feel free to consult us.