"Pharmaplast began to work with CE.way almost one year ago. CE.way is our cosmetics consultant who look after compilation of PIF, safety assessments and CPNP notifications. Working with CE.way has been a joy so far. Their replies are very swift and Mr Tadej is very cooperative, helpful and with a deep knowledge about the cosmetics regulations."
Cosmetics testing
Microbiology testing.
Microbiology testing verifies that cosmetic products meet the required microbiological quality standards and are free from harmful microorganisms that could compromise product safety, quality or stability. It is an essential part of cosmetic quality control and helps manufacturers ensure that products remain safe throughout their intended shelf life.
Our laboratory performs microbiological testing according to internationally recognised ISO standards, providing reliable data to support product quality, safety assessments and regulatory documentation.
Specifications
What we test.
Specifications
What we test.
- Total aerobic plate count (ISO 21149)
- Yeast & mould count (ISO 16212)
- Pathogens test. Consist of:
- Staphylococcus aureus (ISO 22718)
- Pseudomonas aeruginosa (ISO 22717)
- Candida albicans (ISO 18416)
- Escherichia coli (ISO 21150)
Recommendations
When is microbiology testing recommended?
Recommendations
When is microbiology testing recommended?
- Before releasing a production batch
- During product development
- After reformulation
- Following manufacturing changes
- As part of routine quality control
- During stability studies
Comparison
The difference between microbiology testing and a challenge test
Microbiology testing
- evaluates the microbial quality of the finished product;
- confirms that microbial counts are within acceptable limits;
- verifies the absence of specified microorganisms.
Challenge Test
- evaluates the effectiveness of the preservative system;
- deliberately introduces microorganisms;
- measures whether preservatives can control microbial growth over time.
Microbiology testing for cosmetics
FAQ
Microbiology testing for cosmetics is a laboratory analysis used to detect and measure the presence of microorganisms in a cosmetic product. It ensures that the product is free from harmful bacteria, yeasts, and moulds, and that it meets required safety standards before being placed on the EU and UK markets.
Microbiological testing is essential to guarantee product safety and consumer health. Contaminated products can lead to skin irritation, infections, or product spoilage. This testing ensures that the cosmetic product remains safe throughout its shelf life and complies with EU Cosmetics Regulation 1223/2009.
Yes, microbiology testing is required for cosmetic products sold in the EU and UK. Manufacturers must provide microbiological specifications as part of the Product Information File (PIF) to demonstrate that the product meets regulatory safety requirements.
The Total Aerobic Plate Count (ISO 21149) measures the total number of aerobic microorganisms present in a product. It provides an overall indication of the product's microbial quality and helps determine whether contamination levels are within acceptable limits.
The Yeast & Mould Count (ISO 16212) evaluates the presence of fungi, including yeasts and moulds, in a cosmetic product. This is important because fungal contamination can affect both the stability and safety of the product.
Pathogen tests are used to detect specific harmful microorganisms that must not be present in cosmetic products. These include bacteria and fungi that can pose serious risks to consumer health, even in small quantities.
Standard microbiology testing includes detection of key pathogens such as:
- Staphylococcus aureus (ISO 22718)
- Pseudomonas aeruginosa (ISO 22717)
- Candida albicans (ISO 18416)
- Escherichia coli (ISO 21150)
These microorganisms are selected because they are commonly associated with product contamination and potential health risks.
Microbiological testing involves collecting samples of the cosmetic product and analyzing them in a controlled laboratory environment. The samples are cultured to detect and quantify microbial growth, following standardized methods such as ISO testing protocols.
If a product fails microbiology testing, it indicates contamination or inadequate preservation. The formulation may need to be adjusted, the manufacturing process reviewed, or the preservative system improved. The product must be retested before it can be legally placed on the market.
Microbiology testing provides documented evidence that a cosmetic product meets required microbiological safety standards. It is a key part of the PIF and supports the Cosmetic Product Safety Report (CPSR), ensuring compliance with EU and UK regulations and enabling safe market placement.
Related services
Related services
CE.way can offer various services related to microbiology testing. We can offer:
Client reviews
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"We were looking for a stand-alone service, not too sure what to expect... The professionalism, the assistance and the responsiveness were very much appreciated, amongst the best we have ever experienced."
"We are a small manufacturing company located in the US. We recently used CE.way Regulatory Consultants to help guide us through the Cosmetic regulatory changes that have taken place in the EU. They were instrumental in helping us understand the new laws and streamline the entire process. I would highly recommend their services."
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