54 TESTING
with plant extracts. It was essential that the performance of the vegan media should be comparable to that of traditional media. This process involved many months
of validation work comparing recovery of organism numbers, colour changes for specific organisms, selectivity to allow the isolation of the target organism from mixed cultures containing many other organisms and the recovery of damaged organisms, etc. The lab worked closely with UKAS
assessors to ensure that the data provided was sufficient for the assessors to be confident in the performance of the culture media before moving on to then carry out comparative trials using both vegan and standard culture media in both the QC and PET methods. All stakeholders – Melbec itself, UKAS and customers - needed to have complete confidence that test results would be comparable, regardless of the media used. After almost two years of trials, and investment of both money and resources during the busiest year ever for microbiology labs, in September 2021 the accreditation was granted.
Three key tests All cosmetic products placed on the market in the UK must comply with Schedule 34 of the Product Safety & Metrology Statutory Instrument Regulation which details the amendments to the EU Cosmetic Regulation (EC) No. 1223/2009. Three main laboratory tests are required to ensure your product is safe and hence complies with the Regulation: PET; stability and compatibility testing; and, QC/batch release tests. PET is carried out at the product
development stage and is used to demonstrate that the preservative is effective in the cosmetic formulation. There are a number of PET methods notably BS EN ISO 11930, and European, British and US Pharmacopeia. Only the first is written specifically for cosmetic products and Melbec is UKAS-accredited to carry out this test by both traditional and vegan methodologies. All PET methods follow the same principles.
The first stage is to add microorganisms to the cosmetic product and then the numbers of surviving microorganisms are determined at defined timepoints. The reduction in organism numbers required at each time point is specified in the standard being followed and are termed the acceptance criteria. The differences between the different standards are the test timepoints, the culture media used, the starting inocula and the acceptance criteria. Stability and compatibility testing are carried out at the product development stage. They are used to demonstrate that a formulation is stable over time and that there are no interactions between product and packaging. Stability testing assesses the formulation
only and is carried out in glass jars, whereas compatibility testing assesses the product in the final packaging. The data obtained from the testing is used to determine the date of minimum durability of the product. The date of minimum durability is expressed as a ‘best
PERSONAL CARE November 2021
of temperature, humidity, simulated light and freeze-thaw. Products are assessed at each time point and assessment includes organoleptic properties, viscosity, specific gravity, weight loss, functionality and pH. Standards used for stability and compatibility include CIPAC, PD ISO/TR 18811, IFSCC and ‘in- house’ customer-specific methods. After manufacturing, cosmetic products
used before end of’ date and uses the ‘egg timer’ symbol. If a product has a minimum durability greater than 30 months, a ‘period after opening’ is used and the symbol for this is the ‘open jar’. Stability tests involves incubating products
at a variety of temperatures and light conditions to mimic transportation and storage conditions which may be encountered during warehousing, retail and with the consumer. These tests ensure that the characteristics of the products, including the fragrance, colour, texture, appearance and formulation, do not change when subjected to these conditions. Compatibility testing is similar to stability
but would also include an assessment of packaging functionality and stability, label stability . It also determines whether there are any interactions between product and packaging. Most stability and compatibility tests are
carried out at elevated temperatures as an accelerated shelf life study. The incubation conditions chosen for the test will depend upon several factors including how the product is to be warehoused, how it is to be transported and where in the world it will be marketed, etc. Melbec has a range of ambient humidity
incubators, environmental chambers and simulated light chambers and hence can cover most testing requirements with respect
should be assessed by QC/batch release testing for microbial levels prior to release to market. Microbial contamination in cosmetic products may enter during the manufacturing procedure, from the process water or from raw materials/components. QC/batch release testing should include
enumeration of aerobic mesophilic bacteria, yeasts and moulds. In addition, the presence or absence of specified organisms should be determined. Batch release testing ensures you are confident that your product is of the highest quality, free from contamination and compliant with the requirements for microbial limits in cosmetics when it reaches your customer. Melbec Microbiology is UKAS
17025-accredited for QC/batch release testing by both traditional and vegan methodologies. The standards we use to test cosmetics for batch release include: ■ BS EN ISO 21149 Cosmetics – Microbiology - Enumeration and Detection of Aerobic Mesophilic Bacteria ■ BS EN ISO 16212 Cosmetics – Microbiology – Enumeration of Yeasts and Moulds ■ BS EN ISO 18415 Cosmetics – Microbiology – Detection of Specified and Non-specified Organisms ■ BS EN ISO 22718 Cosmetics – Microbiology – Detection of Staphylococcus aureus ■ BS EN ISO 22717 Cosmetics – Microbiology – Detection of Pseudomonas aeruginosa ■ BS EN ISO 21150 Cosmetics – Microbiology – Detection of Escherichia coli ■ BS EN ISO 18416 Cosmetics – Microbiology – Detection of Candida albicans ■ BS EN ISO 17516 Cosmetics – Microbiology – Microbiological Limits
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