Microbial quality is a crucial factor in determining the safety of cosmetic products. It must be guaranteed that the product does not contain any harmful microorganisms at the time of production or during normal use of the product, safeguarding both the health of the consumer and the integrity of the product.
There are, however, cosmetic products in which the likelihood of microbiological contamination is extremely low or non-existent, due to the characteristics of the product that create a hostile environment for microorganisms.
The ISO 29261: 2017 Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products helps to identify products that present a low risk of microbial contamination during manufacture and/or intended use. This assessment is based on the characteristics of the product and includes: composition, production conditions, packaging and a combination of these factors. These products are consequently exempt from the application of microbiological standards for cosmetics.
Factors that should be considered to determine whether the product is of low microbiological risk or not:
Composition
Water activity - The water available in the formulation is one of the most important factors controlling the growth rate of a microorganism. The easiest and most useful way to assess the presence of water in the formulation is by carrying out a water activity test.
pH of the formulation - Products with extreme pH (pH ≤ 3 and pH ≥ 10) do not require microbiological testing because at these pH values the environment becomes unfavorable for the growth of microorganisms.
Specific raw materials - The use of certain raw materials, in certain concentrations, in cosmetic formulations helps to create a hostile environment for microbial growth. These raw materials include alcohol, ammonia and monoethanolamine, polar organic solvents, strong oxidizing or reducing agents, aluminium hydrochloride and its salts.
Production conditions
Manufacturing conditions can reduce the microbiological risk for a cosmetic product. High temperatures will inhibit growth and kill microorganisms. Therefore, high temperatures during manufacturing (above 65ºC for at least 10 minutes) can effectively eliminate microorganisms.
Packaging
Another factor that has a direct impact on microbiological risk is the final packaging. Some components of the packaging provide physical protection against possible contamination by the consumer and help to preserve the formulation. Other aspects, such as size, can limit the number of uses. In the case of pressurized packaging, they also provide total protection of the formulation against contamination during use.
Given that these formulations effectively eliminate the potential for microbial growth, there is no need to carry out a Challenge test.
Are you unsure whether your cosmetic product is considered to be a low microbiological risk? Contact us and we can help!
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