5D Health Protection Group Ltd - Cosmetics and Personal Care

Cosmetic, Skin and Personal Care Testing

At the 5D Health Protection Group we have extensive expertise in claim support and product release for the skin care, cosmetics and personal care industries. In particular we carry out testing for companies to assist them with compliance with the Cosmetic Regulation (EC) 1223/2009. This regulation includes preservative sfficacy testing, stability and batch release testing. We also support our customers and at all the stages involved in the product development process.

The cosmetics Regulations (EC) 1223/2009 governs the quality and safety of cosmetics and personal care products in reference to microbial contamination. Microbial contamination is considered a fundamental issue in the whole supply chain from raw material testing to the final product. 5D are able to undertake an array of different microbiological tests including:

Total viable counts (TVCs)
Challenge testing (preservative efficacy testing)
Anti-inflammatory ability
Stability and compatibility testing
Microbial contamination monitoring
Microbial identification and microbiome studies.

Cosmetic and Personal Care Methodologies

Examples of testing we carry out in the cosmetics and personal care industries include:

Preservative Efficacy Test (PET)

All cosmetic products may deteriorate over the and therefore represents a risk to consumers. The preservation of cosmetic products ensures the microbiological safety of a product during its shelf life. A challenge test is undertaken to find out if microorganisms that contaminate a cosmetic during a normal use will not affect both the safety and the quality of the cosmetic or product.

ISO 11930 is the challenge test or the preservative efficacy test. It is a test which assesses the ability of the product to reduce and prevent growth of micro-organisms. In this test samples of the cosmetic product are inoculated with known numbers of micro-organisms. The testing is then carried out for up to 28 days and during this 28 days the growth in microbial reduction is monitored.

If a cosmetic is reformulated this challenge test has to be repeated for the new formulation. The microorganisms used in the challenge test are Pseudomonas aeruginosa, Staphylococcus aureus and Aspergillus brasiliensis.

Stability Assessment and Batch Release Testing

Each cosmetic product has to be tested for stability so that it meets all chemical, microbiological and physical standards. The stability of products is assessed over a 12 week period at different temperatures.

BS EN ISO 21149 provides guidelines that are used for the detection and enumeration of mesophilic bacteria in a cosmetic product. For products that are considered to have a low microbiological risk ISO 29621 can be undertaken. For the enumeration of yeasts and mould BS EN ISO 16212 is utilised. Alternative, tests can be carried out in accordance with USP 61.

Further Cosmetic and Personal Care Tests and Methods

ISO 22717 - This test is designed to detect Pseudomonas aeruginosa. Method adaptations are possible depending on the required level of detection. ISO 18416:2015 - This standard is for the detection of Candida albicans within cosmetic products. ISO 21150:2015 - This standard is used for the detection/identification of Escherichia coli. We carry out adaptations on this standard depending on the required level of detection requested by the customer. ISO 21149:2006 - This standard provides the general guidelines for the enumeration and detection of mesophilic aerobic bacteria.

Presence/Absence of Specified Microorganism Testing

In addition to the examples of microbiological tests above we also undertake other microbiological testing services which are customised for our customers. For example, these could include validating microbiology tests undertaken in scientific publications or comparing different products in bespoke models or validating different methods.

We also offer a microbial identification service. we utilise rapid identification methods for the identification of microorganisms which may be encountered in environmental, pharmaceutical or medical devices industries using different techniques. At present we utilise API systems, traditional microbiological identification techniques, matrix-assisted laser desorption/ionisation-Time OF Flight (MALDI-TOF) mass spectrometry (MS) and quantitative polymerase chain reaction (qPCR). The use of MALDI-ToF enables us to identify microorganisms within minutes due to microorganisms producing a unique protein fingerprint. This fingerprint profile is correlated to a database of already identified microbes. As MALDI-TOF sometimes has limited reproducibility, which can therefore increase variability between laboratories, we routinely employ the use of PCR for the identification of microbes.

To discuss your scientific testing needs please contact us at info@5Dhpg.com or call on +44 (0) 151 794 9279.