Cosmetic Testing FAQ – Everything You’ve Always Wanted To Know About Cosmetic Testing
What counts as a cosmetic product?
Anything that is intended to be put on the hair, skin, nails, lips, teeth or gums to improve, change their appearance or smell is considered a cosmetic product.
Why do products need to be tested?
In order to sell a product in Europe or the UK, a product information file (PIF) must be held. This contains information and data related to the product including its safety, efficacy and regulatory compliance. This is mandatory in order to comply with the EU's Cosmetic Regulations 1223/2009. The PIF contains the product formulation, manufacturing process, packaging, labelling and stability testing data as well as the microbiological report and toxicological report. PIFs must be kept for 10 years after the last batch of product was made.
What are the safety implications relating to products?
Cosmetic products can, (if not compliant with the regulations) cause any of the following issues: Infections of the eye, irritation and scratches to the eye. Spread microorganisms onto the skin which may cause acne, infection or itching. Chemicals present could cause phototoxic effects, photosensitivity or even anaphylactic shock. There is also a fire risk with some products such as aerosols as used with hairsprays. So, 'safe' means that the product is not injurious to users under the conditions of use prescribed in the labelling thereof or under such conditions of use as are customary or usual.
What microbiological tests are required?
A Preservative Efficiency Test (PET). This is also known as a challenge test which is used to evaluate the effectiveness of a preservative system in preventing the growth of microorganisms. In the UK, the PET should conform to the European Pharmacopoeia which uses the most stringent of test methods. Known numbers of five standard organisms; E. coli, S. aureus, Ps. aeruginosa (bacteria) Candida albicans (yeast) and Aspergillus brasiliensis (mould) are added to product and assessed over a 28-day period. To pass the test the reduction in numbers of these organisms must meet specified criteria at certain time points. Other factors such as packaging, usage, and storage instructions should be taken into account when assessing a challenge test result.
Routine microbiological analysis of raw materials, intermediate, bulk and final product, typically this will include the organisms listed above but many other microorganisms can be bespoke tested for if required. Analysis will of course establish whether there is absolute sterility if that is the requirement.
Shelf-life testing. This will ensure that an appropriate shelf life is given to a product having established that microbiological and chemical analyses are still acceptable at particular time points during storage.
What about chemical testing?
The chemical composition of a cosmetic product is of course also of great importance. Techniques most commonly used are chromatographic (gas and liquid) and spectroscopic and parameters tested for can include, for example, colour, odour, appearance, pH, viscosity, melting/slip point, specific gravity, refractive index, water activity, acid value, saponification value, iodine value, peroxide value plus individual elements including heavy metals.
The article was written by one of our experts at Southern Microbiological Services, Steve Wilde.
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