Interested in this topic? Watch our webinar
At a recent live webinar, Dr. Emma Saunders provided an expert deep dive into safety considerations and risk management and the regulatory landscape surrounding microbial-based cleaning products in Europe.
Hosted in conjunction with our European distributors, IMCD, we’re giving customers who missed the live event the chance to watch the webinar recording now.
Watch the webinar View as PDFMicrobial-based cleaning products (MBCPs) are becoming an increasingly popular alternative to traditional chemical cleaners.
As pioneers in this field, we at Genesis Biosciences welcome this industry shift. Having long championed the use of beneficial bacteria in cleaning, we see the growing adoption of MBCPs as a testament to their effectiveness and sustainability.
But as their use expands, so too does the need for regulatory oversight. With new EU regulations set to shape the future of these products, businesses must stay informed to remain compliant while continuing to benefit from their sustainable and effective cleaning properties.
In this article, we will explore the key safety considerations, risk management strategies, and the evolving regulatory landscape that will impact MBCPs in 2025 and beyond.
What are microbial-based cleaning products?
MBCPs contain live microorganisms as active ingredients. Unlike chemical cleaners, which rely on harsh surfactants and disinfectants, these products use beneficial bacteria to clean surfaces naturally. Common Bacillus strains used in MBCPs include Bacillus amyloliquefaciens, Bacillus licheniformis, Bacillus megaterium and Bacillus subtilis.
When applied to a surface, these microbes germinate and begin secreting enzymes and secondary metabolites that break down organic matter. This enables deep cleaning, even in hard-to-reach areas, while also offering long-lasting cleaning effects beyond the initial application. As a result, MBCPs are highly effective for odour control, biofilm prevention and the removal of fats, oils and grease (FOG) deposits.
Safety considerations: Ensuring microbial-based products are safe to use
A key priority for any cleaning product is safety, particularly when live microorganisms are involved. Manufacturers of MBCPs must ensure that the strains they use meet safety standards:
- Non-pathogenic strains – All bacteria used in MBCPs must be classified as Risk Group 1 (RG1) under EU Directive 2000/54/EC, meaning they do not pose a risk to human health.
- No toxic by-products – Strains must be evaluated to confirm they do not produce harmful toxins or antimicrobial resistance genes.
- Minimal environmental impact – MBCPs should be biodegradable and must not negatively affect ecosystems when released into wastewater systems.
- Respiratory safety – Inhalation risks are an important consideration, especially for spray formulations. The level of free protein in microbial preparations should be analysed to reduce any potential for respiratory sensitisation.
Studies have demonstrated that Bacillus-based cleaners pose minimal risks to human health and the environment. They have also been shown to reduce the presence of pathogens such as E. coli and Staphylococcus aureus.
Managing risks in microbial-based cleaning products
To ensure safety, manufacturers undertake comprehensive risk assessments. Including:
- Exposure assessment – Understanding how users may be exposed to the microorganisms, whether through inhalation, skin contact or ingestion of residues left on surfaces.
- Hazard identification – Analysing the microbial strains for any potential harmful effects, including assessing their ability to produce toxins or contribute to antimicrobial resistance.
- Risk characterisation – Combining data from exposure assessments and hazard identification to determine the overall safety profile of the product.
For spray formulations, additional safety measures include air sampling during use to confirm that bacterial spore exposure remains below safe thresholds.
A quick summary: What’s changing in the regulations?
The EU Detergents Regulation is currently undergoing revision to formally integrate microbial-based cleaning products (MBCPs) into its framework. These changes aim to ensure safety, efficacy, and compliance while recognising the growing market for microbial cleaning solutions.
Key proposed changes in regulations:
- Microbial strain identification – All microorganisms used must be identified down to the species and strain level.
- Risk classification – Only Risk Group 1 (RG1) microorganisms, which are non-pathogenic and pose minimal health risks, will be permitted.
- No antibiotic resistance – Strains must be free from resistance to major antibiotic classes to prevent any contribution to antimicrobial resistance (AMR).
- Efficacy validation – All claims regarding the effectiveness of microbial action must be supported by third-party testing.
- Microbial stability requirements –
- A minimum microbial count of 1×10⁵ CFU/ml must be maintained throughout the product’s shelf life.
- A minimum shelf life of 24 months is required.
- Prohibition of refill formats – MBCPs cannot be sold in refill packaging to prevent contamination risks.
- Additional testing for sprays – Products in spray format must pass acute inhalation toxicity tests to assess potential respiratory risks.
- Workplace safety compliance – MBCPs fall under EU Directive 2000/54/EC to ensure occupational safety for workers handling microbial agents.
The evolving regulatory landscape for MBCPs
While these regulatory updates provide greater clarity, there are ongoing discussions within the industry to ensure that requirements are both practical and supportive of innovation. For example, organisations and biotechnology companies, including Genesis Biosciences, have been advocating for amendments to allow greater flexibility in testing methods and stability assessments. The goal is to eliminate the need for animal testing and to develop standardised methodologies that are fit for purpose and more accurately reflect real-world use conditions.
Looking ahead: What businesses need to do next
As regulations continue to evolve, microbial cleaning products are set to play a key role in the future of sustainable cleaning. Their ability to offer effective, long-lasting cleaning while reducing reliance on harsh chemicals makes them a compelling choice for businesses and consumers alike.
To stay ahead of regulatory changes, businesses using or manufacturing MBCPs must ensure they are aware of upcoming compliance requirements. This includes engaging with industry updates, reviewing product formulations to align with new safety guidelines, and ensuring microbial cleaning claims are backed by scientific evidence.
By proactively adapting to these regulatory shifts, businesses can continue to innovate while maintaining the highest safety and compliance standards in 2025 and beyond.
Find out more from the experts – webinar VIDEO NOW AVAILABLE
Dr. Emma Saunders (General Manager – Europe) presented on this very topic on Wednesday 19th March 2025 in conjunction with our distribution partner, IMCD.
The webinar went deeper into:
- What are microbial based cleaning products and how do they work?
- The science behind bacillus-based cleaning solutions
- Key safety considerations & risk management
- European regulatory frameworks and compliance requirements
- The future of microbial cleaning and its role as a sustainable solution
Missed the live event? You can watch the webinar recorded video or view the presentation as a PDF.