Bacillus subtilis and the EFSA QPS Status

Bacillus subtilis and the EFSA QPS Status

Scientific Classification for Food Supplements

Summary

The QPS status (“Qualified Presumption of Safety”) of the European Food Safety Authority (EFSA) is a central instrument for the safety assessment of microorganisms. This article explains what QPS means, why Bacillus subtilis has been granted this status, and what relevance this classification has for its use in food supplements.

What does QPS (Qualified Presumption of Safety) mean?

QPS is an assessment approach developed by the EFSA for a simplified yet scientifically robust safety evaluation of microorganisms that are deliberately introduced into the food or feed chain.

This approach is based on the recognition that certain microorganisms:

• have been used for decades or even centuries,

• are very well documented in the scientific literature,

• and do not raise relevant safety concerns.

Instead of reassessing each individual strain in full, the safety assessment is carried out at species or genus level, provided that certain prerequisites are met.

Further information on the QPS concept is provided by the European Food Safety Authority (EFSA) here:
https://www.efsa.europa.eu/en/topics/topic/qualified-presumption-safety-qps

The four criteria of the QPS approach

The EFSA grants QPS status only if all of the following criteria are fulfilled:

Clear identity
The microorganism must be taxonomically well defined.

Sufficient body of scientific knowledge
A robust history of use and scientific documentation must be available.

Absence of relevant pathogenicity
No known disease-causing properties may be present.

Assessed intended use
The intended application must not give rise to additional safety concerns.

The QPS status is “qualified”, meaning that it may be subject to specific conditions.

Why Bacillus subtilis has QPS status

Within the genus Bacillus, the EFSA makes a clear distinction between suitable and unsuitable species. While certain representatives (e.g. from the Bacillus cereus group) are excluded due to their toxin-producing potential, Bacillus subtilis is classified as fundamentally safe.

The QPS status for Bacillus subtilis applies under the condition that:

• no enterotoxic activity is present,

• no emetic (vomiting-inducing) toxins are produced,

• the strain used is clearly and unequivocally identified.

This differentiation is essential, as it shows that not the genus alone, but the specific species and the individual strain are decisive.

Importance of strain identity (e.g. DSM numbers)

A central aspect of QPS evaluation is the clear and unambiguous identification of a strain.
Reference strains with documented origin – such as those carrying a DSM number – enable:

• traceability,

• comparability with scientific data,

• regulatory classification within the QPS framework.

Merely stating “Bacillus subtilis” is therefore scientifically insufficient. Only precise strain identification ensures transparency and proper assessment.

What the QPS status explicitly does not mean

The QPS status is often misunderstood. Clear distinction is essential:

• QPS is not an authorisation,

• QPS is not a statement of efficacy,

• QPS is not a health recommendation.

It exclusively describes the safety assessment of a microorganism under defined conditions. Statements regarding health effects remain subject to the European Health Claims Regulation.

Relevance for food supplements containing Bacillus subtilis

For manufacturers and users, QPS status means:

• a high level of regulatory safety,

• clear differentiation from non-assessed microorganisms,

• a focus on quality, identity, and documentation.

Especially for spore-forming bacteria such as Bacillus subtilis, this scientific classification is of central importance.

Further information

Products containing clearly identified Bacillus subtilis strains can be found here:
Bacillus subtilis DSM 21097 – high dose
https://bacillus-subtilis.eu/en/collections/all

This article is intended for scientific information only and does not constitute a health-related claim.

Author Andreas Kraus
Owner and Managing Director Professional Lead

Editorial and Research Selina Kraus
Journalist BA Master studies in management and leadership of online marketing