Details of the Announcements
CIRS Assists Maiggic in Rapid Approval of PQQ Disodium Salt for Substantial Equivalence
China
Food Ingredients
Food and Food Related Products
2025-02-21

On January 7, 2025, China's National Health Commission updated the termination review list for new food ingredients. The PQQ disodium salt, produced by fermentation using the Hyphomicrobium denitrificans MQ004-2 strain by Hubei Magic Health Technology Co., Ltd. (hereinafter referred to as “Maiggic”), was included in the list. The review concluded that it is substantially equivalent to the PQQ disodium salt announced in the 2023 No. 8 notice. Except for the production process, other requirements align with those of the already announced PQQ disodium salt.

From application acceptance to final approval, the process took less than eight months. CIRS provided comprehensive support to Maiggic throughout the application process, including material and production strain testing, dossier preparation, supplementary materials, and communication, enabling rapid approval.

Characteristics of Maiggic’s PQQ disodium salt production and application:

  1. The substance is produced through microbial fermentation. Maiggic has optimized the fermentation and purification processes to ensure product quality and stability through multi-layer separation and purification techniques.
  2. The production strain, Hyphomicrobium denitrificans MQ004-2, was independently screened and cultivated by Maiggic from natural sources. It features high synthesis and expression efficiency with a clean fermentation supernatant.
  3. The PQQ disodium salt from Maiggic has undergone quality testing in three batches, meeting the announcement standards. Microbial indicators were undetected (or below detection limits), and its application has minimal impact on the content of other nutrients, facilitating quality control in beverage products.

Recent research published in authoritative journals has highlighted PQQ’s outstanding performance in areas such as: antioxidation, mitochondrial protection and repair, organ and tissue protection and repair, promotion of growth, development, and reproduction, prevention of Alzheimer’s disease, anti-aging, skin protection and repair. PQQ disodium salt is a stable form of PQQ and exhibits physiological functions as PQQ in biological systems, acting as a coenzyme in mammals with vitamin-like properties.

About Maiggic

Founded in December 2021, Maiggic is a joint venture of Huadong Medicine Co., Ltd., Angel Yeast Co., Ltd., and Zhejiang Huinda Biotechnology Co., Ltd. A full-service health industry company specializing in R&D, incubation, industrialization, and commercialization of health and medical beauty products.

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Located in the Xiaoting Biotechnology Industrial Park in Yichang, Hubei Province, the company covers an area of 219 acres. Maiggic focuses on developing nutritional food ingredients and personal care functional materials with a dual strategic approach of “technological competitiveness + international industrial competitiveness.” By leveraging technological innovation and professional services, the company aims to become a leader in the functional raw materials sector for health products domestically and internationally.

About CIRS

Established in 2012, the Food Division of CIRS Group has assisted over 1,000 food and related enterprises in achieving comprehensive compliance solutions. CIRS has numerous successful cases in new food ingredients, synthetic biology foods, US GRAS notifications, EU Novel Food applications, and health food registration.

With expertise, extensive resources, and a global network, CIRS offers services including:

  • New food ingredient applications (e.g., new food raw materials, food additives, and food contact materials);
  • US GRAS notification;
  • EU Novel Food applications;
  • China health food registration and filing;
  • China food for special medical purposes registration;
  • China infant formula registration; and
  • General food compliance support.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

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