Part A of the cosmetic product safety report includes the following:
- Microbiological quality, evidenced by the results of a preservation challenge test.
- Physical and chemical properties of the product and proof of its stability in foreseeable storage conditions.
- The purity of the product, including information on any traces of prohibited substances or other impurities.
- The purity and stability of the packaging material.
In order to provide this information, there are essential testing for cosmetic products.
Each Cosmetic product sold in EU should have a:
Microbiological Test
All cosmetic products sold in the EU have to be produced according to the good manufacturing practice (GMP). GMP requires that very batch of cosmetic products is tested for microbiological, physical and chemical properties in order to ensure safety and quality of each batch.
Microbiological specifications of the finished cosmetic product have to include the total count of aerobic mesophilic microorganisms, which covers bacteria as well as yeast and moulds. There are two kinds of maximum limits allowed, depending on the type of cosmetic product.
Preservative Efficacy (Challenge) Test
Preservation of cosmetic products is necessary in order to ensure the microbial safety of the product and to maintain the quality and safety of the product during its shelf life.The purpose of challenge testing is to test whether microorganism introduced during normal and reasonably foreseeable use will not negatively affect the quality or safety of the product.
ISO 11930 provides standardized guidelines for evaluating the preservative effectiveness of cosmetic products. This method is crucial for testing preservation systems by inoculating products with 5 specific strains of microbes (Pseudomonas aeruginosa, Staphylococcus aureus, E. coli, Candida albicans, Aspergillus Brasiliense) and monitoring their growth over time. It ensures that the products remain microbiologically safe throughout their shelf life.
In some cases, cosmetic products are exempt from the challenge test. For more information, see our article titled “Which Products are Exempt from the Challenge Test?”.
Stability and Compatibility Test
It is important to predict and avoid changes to the physical state of the finished product that may occur during transport, storage or handling of the product.
By exposing the product to various conditions such as changing temperatures, humidity, UV light, mechanical stress, we can predict conditions, which a product may be subjected to during its shelf life and see if these conditions have a negative impact on the product’s quality and safety.
Another important reason for performing a stability test is the determination of the minimum durability of the product and its period after opening (PAO).
In addition to the physical stability of the product formulation, compatibility between the formulation and the primary packaging is also checked during stability testing.
The type of packaging can affect the finished product stability, e.g. leaching of substances of the packaging into the product formulation. Stability testing should, therefore, be performed in an inert packaging (e.g. glass containers) as well as in the final product packaging in which the product will be sold.
In case you use different packaging types, it is advisable to test the product in every type of packaging.
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