Major Changes in the GMP for Infant Formula (Draft for Comment)
2021-11-04 14:14 Click:760
On October 25, the Secretariat of the National Food Safety Standards Review Committee publicly solicited opinions on 34 national food safety standards, including "National Food Safety Standards Good Manufacturing Practices for infant formula". FoodMate will take you briefly to the solicitation of opinions on the major changes in the draft compared with GB 23790-2010 for industry reference.
1. Add technical requirements for liquid infant formula
Because GB 10765 infant formula and GB 10767 Older Infant and Young Child Formula cover liquid and powdered products. The imported liquid infant formula has been sold in China, and domestic companies are already developing related products, thus this revision will change the standard name into "Good Manufacturing Practices for infant formula" and add technical requirements for liquid infant formula.
2. Revise terms and definitions
Add liquid (production) process definition. The liquid (production) process refers to the process of the ingredients of infant formula food in a liquid state to make the final liquid product. This process usually includes batching, homogenization, sterilization, filling, sealing and other processes (also including the sterilization process after filling and sealing).
Delete the terms and definitions of "clean operation area", "quasi-clean operation area" and "general operation area". In Chapter 4, the basic scope of different operating areas is explained.
The general operation area includes milk acceptance room, raw material warehouse, packaging material warehouse, outer packaging room and finished product warehouse, and the sterilization area after filling and sealing of liquid products.
The quasi-clean operation area includes the raw material preprocessing workshop, the raw material inner packaging cleaning or packaging material disinfection or tunnel sterilization area, the wet processing area of powdered products (such as weighing, batching, concentration, etc.), the weighing, batching of liquid products, heat treatment, sterilization or sterilization area, filling area of liquid product post-sterilization semi-product, etc.
The cleaning operation area includes the workshop where the food is in contact with the air and there is no subsequent sterilization or sterilization operation (such as weighing, ingredients, mixing, etc.), the filling area of liquid aseptic filling products, and the auxiliary area with special cleaning requirements (such as the temporary storage room for the inner packaging after cleaning and disinfection), the storage area of the semi-finished product to be packaged, the filling and inner packaging workshop, etc.
3. Add standard static/dynamic control requirements for clean operation area
For facilities and workshops, the relevant regulations of GB 14881 are required. The draft gave more detailed examples of different operation areas. According to product characteristics, production technology, production characteristics, and the cleanliness requirements of the production process, the facilities and workshops should be divided into general operation areas, quasi-clean operation areas and clean operation areas. The static/dynamic standard control requirements of the clean operation area were added for the production of powdered and liquid infant foods, respectively stipulate the maximum allowable number of floating bacteria, settling bacteria, and surface microorganisms in the clean operation area of the production of powdered and liquid products; the number of settled bacteria in the air of quasi-clean operation area should be controlled below 50CFU/dish (determined in accordance with GB/T 16294 for 5 min, static).
4. Clarify the basic requirements of sterilization equipment
For facilities and equipment, the general requirements are in accordance with GB 14881. The draft emphasizes on increasing the various sterilization equipment in the production process that should meet the basic requirements of the sterilization process and the aseptic filling and thermal sterilization evaluation requirements of liquid infant formula food. Sterilization process is the basic general process for the production of dairy products, which mainly includes mature sterilization processes such as pasteurization, maintenance sterilization, and ultra-high temperature sterilization. However, the evaluation and recording of sterilization effectiveness when using equipment varies among factories, thus the basic requirements for sterilization equipment are clearly defined in the draft.
5. Revise the food safety requirements of production process
In the draft, the food safety requirements of the production process are divided into three parts: basic requirements, special technical requirements for the production process of powdered infant formula, and special technical requirements for the production process of liquid infant formula. The first part of the basic requirements meets the relevant regulations of GB 14881, and puts forward requirements for important processing parameters, such as: critical control points, cross-contamination, etc. Environmental monitoring measures for Salmonella, Kronobacter and other Enterobacteria in powdered infant formula clean operation areas should be established. The monitoring guidelines should meet the requirements of Appendix A. The second part stipulates the special requirements of the powdered infant formula food production process. The third part stipulates the special requirements of the liquid infant formula food production process.
6. Summary
This revision focuses on adding content related to liquid formula for infants, older infants and young children; clarifying the implementation of provisions of GB 14881 for the general requirements of production specifications; revising the requirements for key control measures for microbiological, chemical, and physical contamination, etc. The solicitation of opinions ends on November 20, during which relevant industry practitioners can put forward valuable opinions and suggestions on the revised content, and FoodMate will continue to pay close attention to the progress of the standard revision.