To all certified clients for Good Manufacturing Practices (GMP) for dairy products and infant formula applicants,
The two standards GB 12693-2023 "National Food Safety Standard - Good Manufacturing Practices for Dairy Products" and GB 23790-2023 "National Food Safety Standard - Good Manufacturing Practices for Infant Formula" (hereinafter referred to as the new version certification standards) were officially published on September 6, 2023, and will be formally implemented starting from September 6, 2024.
On April 24, 2024, the China National Accreditation Service for Conformity Assessment (CNAS) posted the "Guidance on Accreditation Conversion for the Revision of Certification Standards GB 12693-2023 and GB 23790-2023" (CNAS-EC-068: 2024) on its official website (https://www.cnas.org.cn), stipulating arrangements and requirements for the accreditation conversion of certification bodies. In order to ensure a smooth transition to the new certification standards, CQC hereby issues the following announcement regarding the revision of the certification standards:
1. Key Changes in the New Version of Certification Standards
(1) A comparison between the "National Food Safety Standard - Good Manufacturing Practices for Dairy Products" (GB 12693-2023) and its predecessor, GB 12693-2010 (hereinafter referred to as the old version certification standard), revealed the following main changes:
a. The deletion of terminologies and definitions related to "clean operating areas," "semiclean operating areas," and "general operating areas."
b. The inclusion of technical requirements and monitoring specifications for sterilization equipment.
c. The addition of technical measures for reliable control of automated storage systems for equipment and facilities.
d. The incorporation of control requirements for the storage temperature of raw milk upon arrival.
e. The inclusion of "Specific Technical Requirements for Different Dairy Processing Procedures," outlining refined microbial monitoring recommendations for various dairy production processes.
f. The addition of training requirements for sterilization operators, liquid product packaging and sealing operators, as well as cleaning and disinfection staff.
(2) A comparison of the "National Food Safety Standard - Good Manufacturing Practices for Infant Formula Foods" (GB 23790-2023) with GB 23790-2010 (hereinafter referred to as the old version certification standard) reveals the following major changes:
a. Deletion of the terminologies and definitions for "clean operating areas," "semi-clean operating areas," and "general operating areas."
b. Revision of the dynamic standard control requirements for clean operating areas in the production of powdered infant formula foods and addition of dynamic standard control requirements for clean operating areas in the production of liquid infant formula foods.
c. Replacement of "Enterobacter sakazakii" with "Cronobacter genera (Enterobacter sakazakii)."
d. Inclusion of technical requirements for sterilization equipment.
e. Addition of technical requirements for the production specifications of liquid infant formula foods.
f. Inclusion of the requirement for "liquid infant formula foods to undergo commercial aseptic testing in accordance with GB 4789.26."
g. Introduction of training requirements for sterilization operators, operators involved in the filling and sealing of liquid products, as well as cleaning and disinfection staff.
2. Transition Arrangements for Certification Standards
(1) The transition period to the new version of certification standards is from May 20, 2024, to September 6, 2024.
(2) All certificates of GMP for dairy products based on standards GB 12693-2010 and GB 23790-2010 should be transitioned to the new version of certification standards by September 6, 2024. Certificates issued based on the old version of the standards after September 6, 2024, will automatically become invalid, and CQC will process the invalid certificates according to relevant regulations.
(3) Customers submitting certification applications after May 20, 2024, will undergo certification in accordance with the new version of certification standards.
(4) For first-time certification applicants, organizations that have completed on-site audits before May 20, 2024, and meet the certification decision requirements, may still be granted certificates based on the old version of the standards. However, the certificate's validity period should not exceed September 6, 2024.
(5) First-time certification applicants who submitted applications based on the old version of certification standards before May 20, 2024, not having completed on-site audits by that date, must reapply for certification under the new version of standards.
(6) For existing certificate holders, it is encouraged to transit by combined supervision audits or recertification audits. If necessary, standalone transition audits should be carried out. Certificate holders should submit certificate modification applications, and transition audits will be conducted in accordance with the new version of certification standards.
(7) We urge all certificate holders to plan for the transition and promptly implement the standard transition for the GMP certification system for dairy products.
China Quality Certification Centre
May 9, 2024