In your Product Information File (PIF), you are obliged to have a safety assessment report.

A safety assessment report compromises different tests.

We can offer:

  • Stability tests
  • Microbiological tests
  • Compatibility testing for your packaging
  • Heavy metals testing

Stability tests

Stability testing involves the laboratory testing of cosmetic products in different environment/storage conditions for a set period of time, in order to simulate what will happen to the product during its life cycle. At selected intervals, the samples are evaluated for various physical, chemical and performance characteristics, to see how they have changed.

For any stability test, all testing should be done in commercial packaging.

Based on the recommendations of the International Federation of Societies of Cosmetic Chemists, IFSCC Monograph, Number 2, stability testing can be done under the following conditions:

Temperature Humidity Duration
Control 4°C Shelf life
Room Temp 20 – 25° C Shelf life
Accelerated 37° C 3-6 months
Accelerated 37° C 80% 1 month
Accelerated 45° C 1-3 months

During stability testing, parameters such as colour, odour, appearance, changes in container, pH level, viscosity, weight changes and microbial quality are tested.
Meanwhile, it is very important to ensure the stability of your product under light (by mimicking the situation where your products are placed on store shelves).

  •  Microbiological tests

Skin and mucous membranes are protected from microbial attack by a natural mechanical barrier and various defence mechanisms. However, these may be damaged and slight trauma may be caused by the action of some cosmetics that may enhance microbial infection. This may be of particular concern when cosmetics are used around the eyes, on mucous membranes in general, on damaged skin, on children under 3 years, on elderly people and persons showing compromised immune responses. Consequently, two separate categories of cosmetic products are defined in the microbiological quality control limits:

Category 1: Products specifically intended for children under 3 years, to be used in the eye area and on mucous membranes.

Category 2: Other products.

Microbial contaminants usually originate from two different sources: during production and filling, and during the use of the cosmetic by the consumer. From the moment the cosmetic unit is opened until the last use of the product by the consumer(s), a permanent, variable and additive microbial contamination is introduced, caused by the domestic environment and contact with the skin on the consumer’s hands and body.

Reasons for the microbial preservation of cosmetics are:

– to ensure the microbial safety of cosmetics for the consumer,

– to maintain the quality and specifications intended for the product,

– to confirm hygienic and high-quality handling.

In order to ensure the quality of the product and safety for the consumer, it is necessary to carry out routine microbiological analyses of each batch of any finished product coming on the market. In addition of these routine microbiological tests, a Responsible Person should make sure that any preservatives used in the product are effective within the shelf life and last while consumers are using the product.
Based on the type of product and its formulation, you may need either a microbial challenge test (duration: 28 days) or a total viable count (TVC, duration: 10 days). In some justified cases (e.g. alcohol content > 20%), end product testing is not necessary.

For further information on designing your stability testing, and to receive a quotation for this service, please contact us on: info@personalcareregulatory.eu