This page lists the certificates and credentials behind our pasteurized Akkermansia muciniphila (AKM Lab-01), with the holder of each stated. AKM Lab-01 is developed and manufactured by our strain partner Moon (Guangzhou) Biotech Co., Ltd.. Its certificates, strain deposits, GRAS conclusion and patents belong to Moon Biotech. Tianyi Health Tech supplies the ingredient and handles quotation, documentation and export. We list a document only while it is current, and copies can be provided on request for your supplier file.
Held by Moon (Guangzhou) Biotech (our strain and manufacturing partner): FSSC 22000, Halal certificate, US FDA food facility registration, the self-affirmed GRAS conclusion, strain deposits DSM 35743, CGMCC 46611 and GDMCC 63782, the granted patents and the awards below.
Held by Tianyi Health Tech: company-level research record (20+ years of research experience and 11 invention patents, see our about section) and the export, quotation and documentation service.
Certificates
Certificates for AKM Lab-01 (Held by Moon Biotech)
FSSC 22000
Food safety management system
Certificate no.
CN26/00001110
Issuer
SGS United Kingdom Ltd (UKAS accredited)
Holder
Moon (Guangzhou) Biotech Co., Ltd. (Chinese legal name 慕恩（广州）生物科技有限公司)
Standards
ISO 22000:2018, ISO/TS 22002-1:2009, FSSC 22000 additional requirements v6
Scope
Production of lactic acid bacteria powder for the food industry; main processes fermentation and freeze-drying (category K)
Validity
2026-02-11 to 2029-02-10, subject to surveillance audits
Scope wording is as printed on the certificate. It names lactic acid bacteria powder and its fermentation and freeze-drying processes; it does not name Akkermansia. Ask us for the certificate for your file.
US FDA food facility registration
Establishment registration
Registration no.
10136700232
Holder
Moon (Guangzhou) Biotech Co. Ltd, Science City, Guangzhou
Issued via
Registration service provider CCA SERVICE INC.
Issued
2025-11-07
Valid to
2026-12-31
Facility registration is not an FDA approval or endorsement of the facility, the ingredient or any product.
International Halal certificate
Halal certification
Certificate no.
SSPY-201318-34625
Issuer
ShaanXi Shang Pin Yuan Halal Food & Restaurant Management Co., Ltd (SSPY); the issuer states that it is recognized by JAKIM Malaysia
Independent GRAS expert panel convened by Tender Light Scientific US LLC
Signed
2025-04-30
Conclusion
Safe as an ingredient in conventional foods and beverages at up to 3.4×1010 cells per day, all food categories combined
This is a self-affirmed panel conclusion. It is not an FDA GRAS notice (no GRN number), not an FDA “no questions” letter and not an FDA approval. For dietary supplements, confirm new-dietary-ingredient requirements with your regulatory advisor.
Status checked 2026-10-12. Validity dates are as printed on each document.
DSMZ, Leibniz Institute DSMZ - German Collection of Microorganisms and Cell Cultures
Budapest Treaty deposit, 19 February 2026
CGMCC 46611
China General Microbiological Culture Collection Center (CGMCC)
Received 29 August 2025; deposit report dated 19 September 2025; retained for 30 years
GDMCC 63782
Guangdong Microbial Culture Collection Center (GDMCC)
Budapest Treaty receipt; original deposit 21 June 2024
DSM 35743 is also the accession quoted in our product documents. Depositor of record: Moon (Guangzhou) Biotech Co., Ltd..
Intellectual property
Granted Patents
8 granted patents (CN & HK) for strain AKM Lab-01 and Amuc_1100 methods, with further applications pending (including international filings). The patentee of all patents below is Moon (Guangzhou) Biotech Co., Ltd.. Subjects are summarized in neutral terms; refer to the patent documents for the official titles and claims.
Granted patents for strain AKM Lab-01 and Amuc_1100 methods. Patentee: Moon (Guangzhou) Biotech Co., Ltd.
Patent no.
Jurisdiction
Subject (summarized)
Grant / registration date
CN 119915943 B (ZL 2025 1 0322906.3)
China
Method and kit for quantitative detection of Amuc_1100 protein
2025-07-29
CN 119842570 B (ZL 2025 1 0323230.X)
China
Method for increasing yield of Amuc_1100 protein
2025-08-26
CN 119913080 B (ZL 2025 1 0322834.2)
China
Isolated A. muciniphila strain and composition (use claims)
2025-09-05
CN 119875893 B (ZL 2024 1 1990153.5)
China
Isolated A. muciniphila strain, composition and use; deposit GDMCC 63782
2026-05-05
HK40123773
Hong Kong
Method for increasing yield of Amuc_1100 protein
2026-02-20
HK40123774
Hong Kong
Method and kit for quantitative detection of Amuc_1100 protein
2026-01-30
HK40123775
Hong Kong
Isolated A. muciniphila strain and composition (use claims)
2026-01-30
HK40123771
Hong Kong
Isolated A. muciniphila strain, composition and use
Certificate dated 2026-07-24
Regulatory context
Regulatory Position in Brief
United States: self-affirmed GRAS conclusion by an independent expert panel (2025) for conventional foods and beverages. No FDA GRAS notice has been filed, and the FDA registration above is a facility registration only.
European Union: pasteurized A. muciniphila as a category has an EFSA safety opinion (2021) and an EU novel food authorization (Commission Implementing Regulation (EU) 2022/168). That authorization was granted on another applicant’s dossier. We do not claim AKM Lab-01 itself is EU-authorized; conformity with the authorized specification must be confirmed by your regulatory advisor.
Other markets: status varies by market and use. Final specifications and regulatory status are confirmed per commercial agreement.
Batch quality
Batch Release Testing
Each batch of AKM Lab-01 is released against specification SP-FP-104 (v04, effective 2026-02-15): sensory, moisture, total cells, culturable count, aerobic plate count, mold, yeast, 16S rRNA identity and Amuc_1100 content, with a type test each year. Heavy metals and pathogen limits are listed in the bulk Akkermansia powder specification. A batch COA is supplied with every order. For DHM and vine tea, see the specification tables on the dihydromyricetin (DHM) and vine tea extract pages
Research
Publications and Registered Studies
Huang B, Xian Y, Xue W, et al. Probiotic attributes and safety profile of the A. muciniphila strain AKM Lab-01 in diet-induced obese mice (title abridged). Front Microbiol. 2026;16:1627870 (published 6 January 2026). doi:10.3389/fmicb.2025.1627870. Preclinical (mouse) study; includes a 90-day mouse safety study. Most authors are employees of the strain developer.
Huang B, Chen Z, Xue W, et al. A. muciniphila AKM Lab-01 combined with Garcinia cambogia extract in diet-induced obese mice (title abridged). Food Sci Nutr. 2026;14:e72140 (accepted 10 July 2026). doi:10.1002/fsn3.72140. Preclinical (mouse) study with Tsinghua University co-authors.
Category background (a different strain, not AKM Lab-01): Depommier C, Everard A, Druart C, et al. Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study. Nat Med. 2019;25:1096–1103. doi:10.1038/s41591-019-0495-2.
Human research: an internal 3-month pilot study (n=16, single-arm, no placebo, report dated 2024-12-05) has been completed, and two clinical trials are registered as ongoing research: NCT06974266 and NCT07331974. We make no efficacy claims from these studies.
Recognition
Awards
Awards received by our strain partner Moon Biotech for AKM Lab-01 and related work, named as listed in the partner’s materials:
2023–2025 Strong Probiotic Enterprise
2025 DaJK Huakang Award
2025 WIPO Global Awards, Top 30 (seven Chinese enterprises shortlisted)
2025 Guangdong-Hong Kong-Macao Greater Bay Area High-Value IP Cultivation and Layout Competition, Silver Award
2026 Nutrition Box Selected (Yingyanghezi Jiaxuan), New Lifestyle Hit Product Award
FFC2025 Functional Food Conference, Ingredient Award
Fi China Innovation Awards 2026, Food Health Innovation Award
Very Good Annual “Gut Health” Award
Global Food Makers Top 20
8th China “Healthy Good Technology” Slim-Guard Award
FFC2025 Functional Food Conference, Ingredient AwardFi China Innovation Awards 2026, Food Health Innovation Award
Research and clinical information is provided for R&D and B2B reference only. These statements have not been evaluated by the Food and Drug Administration. Our ingredients are not intended to diagnose, treat, cure or prevent any disease. Final specifications and regulatory status are confirmed per commercial agreement.
