Bacillus subtilis DSM - Product Data Sheet

Bacillus subtilis DSM 21097 · Product Data Sheet

Product Data Sheet

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Technical product information, composition, dosage, manufacturing and quality characteristics of our products containing Bacillus subtilis DSM 21097.

Last updated: August 2026

Microorganism
Bacillus subtilis
Strain
DSM 21097
Dosage form
HPMC capsules
Spore form
stable spores

Strain identity

The name Bacillus subtilis describes a bacterial species. Different strains exist within this species.

For this reason, the specific strain used in our products is clearly identified:

Bacillus subtilis DSM 21097

The DSM number enables unambiguous assignment to a reference strain deposited in an international culture collection.

For our high-dose products containing 10 billion spores per capsule, the identity of the strain used and the defined strain enrichment are documented by the strain manufacturer.

Product variants

Variant Contents Spores per capsule Total amount Daily dose
High dose 30 capsules 10 billion CFU 300 billion CFU 1 capsule
High dose 90 capsules 10 billion CFU 900 billion CFU 1 capsule
Lower dose 60 capsules 1 billion CFU 60 billion CFU 2 capsules
Lower dose 180 capsules 1 billion CFU 180 billion CFU 2 capsules

CFU = colony-forming units.

Composition

Moringa variant

Moringa oleifera
Bacillus subtilis DSM 21097
plant-based HPMC capsule shell

OPC variant

Grape seed extract (OPC)
Bacillus subtilis DSM 21097
plant-based HPMC capsule shell

Quality characteristics:
Vegan · Gluten-free · Lactose-free · Non-GMO · No artificial fillers · No synthetic flow agents

Stable natural spore form

Bacillus subtilis is a spore-forming bacterium. DSM 21097 is present in the product in a stable spore form.

This allows the products to be stored without refrigeration when stored appropriately.

Manufacturing & filling

The strain enrichment with Bacillus subtilis DSM 21097 for our high-dose products is carried out in Germany.

Subsequent processing and filling take place in Western Europe at an FSSC 22000-certified food production facility.

FSSC 22000
FSSC 22000 is an internationally recognised certification scheme for food safety management systems.

Bacillus subtilis in the EFSA QPS framework

The European Food Safety Authority EFSA uses the Qualified Presumption of Safety (QPS) framework for the safety assessment of certain microorganisms.

Bacillus subtilis is included as a taxonomic unit within this QPS framework.

For Bacillus strains, EFSA considers in particular the absence of emetic toxigenic activity and enterotoxigenic activity.

Important: The QPS framework is not a product authorisation and does not constitute individual EFSA certification of DSM 21097. It is a scientific assessment framework for microbiological taxonomic units and the relevant qualifications that must be considered.

Documented quality and safety testing

For DSM 21097 starting material, tests relating to various microbiological and chemical quality parameters are available. The underlying tests refer to the respective samples examined and form part of our internal quality documentation.

Parameter tested Documented result
B. cereus enterotoxin NHE negative
B. cereus enterotoxin HBL negative
Emetic Bacillus cereus characteristics (PCR) negative
Salmonella spp. negative
Coagulase-positive staphylococci negative
Coliform bacteria < 10 CFU/g
Yeasts < 10 CFU/g
Moulds < 10 CFU/g

Biogenic amines

In a separate analysis, five biogenic amines were determined in the DSM 21097 material examined.

Histamine
< 5 mg/kg
Agmatine
< 5 mg/kg
Cadaverine
< 5 mg/kg
Putrescine
< 5 mg/kg
Tyramine
< 5 mg/kg

Additional quality documentation

In addition, documentation and testing relating to further strain-specific quality parameters are available, including:

• Antibiotic susceptibility
• Concentration of viable units
• Microbiological purity
• Heavy metals
• Strain identity and traceability

The underlying original documents form part of our internal quality documentation and are not generally made publicly available on the internet.

More about our quality documentation More detailed information on strain identity, safety testing and traceability can be found on our quality page. Analyses & Quality Documentation

Recommended use

Products containing 10 billion spores per capsule:
Take 1 capsule daily with sufficient liquid.

Products containing 1 billion spores per capsule:
Take 2 capsules daily with sufficient liquid.

Capsules may be opened if required.

Storage

Store in a dry, cool place protected from light. Refrigeration is not required.

Keep out of reach of young children.

 

Bacillus subtilis DSM 21097 products

Discover our different Bacillus subtilis DSM 21097 variants with different dosages and plant-based carrier ingredients.

View all Bacillus subtilis products

 

Responsible company

MoringaGarden B.V.
The Netherlands

Legal notice

Food supplements should not be used as a substitute for a balanced and varied diet and a healthy lifestyle. Do not exceed the recommended daily intake. Keep out of reach of young children.

The laboratory results stated on this page refer to the respective DSM 21097 samples examined. They should not be understood as a blanket batch-specific analysis of every finished product currently offered for sale.

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