Stability testing of cosmetics - Part 3: Evaluation of results and examples

Special Newsletter Cosmetics Part 20 / 01.2019

Dear Mr. Mustermann,

The two previous newsletters on stability testing of cosmetic products dealt with the topics of regulations, requirements, influencing variables, conception, selection of suitable test parameters and storage conditions.

In this third and final newsletter on the subject of stability, we focus on the evaluation of results and present examples for the performance of stability tests.

NEWS:

A summary of all BAV newsletters on stability tests of cosmetics was recently published in the magazine EURO COSMETICS as a journal article of the BAV Institute.

You will find the article "Stability Testing of Cosmetic Products" in the current issue of the journal EURO COSMETICS November/December 2018 (Volume No. 26), pages 29-32.

The journal can be obtained under the following link www.eurocosmetics.de

We wish you an informative reading and will be happy to answer any questions you may have.

Friendly greetings

Dr. Bernhard Fellenberg
Customer consulting cosmetics/pharmaceuticals

Evaluation of results

The results of the tests are evaluated during and after completion of all analytical tests. The results of all test points are fully documented, summarized and compared with previously defined specification values (see section Conception of stability tests). Analytical ranges of variation shall be taken into account in the evaluation. It must be defined in advance which deviation(s) are to be assessed as acceptable and which are to be regarded as "knockout criteria". As an example, you can define a valuation procedure as follows:

0 = no abnormalities
1 = minimum change
2 = deviation
3 = significant change, not acceptable

In the sum of the evaluation of all results, the product manager must decide whether existing deviations with regard to durability and stability are acceptable and whether the product can be placed on the market in the respective formulation.

Examples of stability tests

In the following three products with possible test plans are given as examples:

Table 1: Test plans for cosmetic products (exemplary)

Test times: t₀ = before storage (initial value), t₁ = after storage 1 month, t₂ = after storage 2 months, t₃ = after storage 3 months
*t₀ one-time check of parameters before storage
** depending on product additional test time after 2 weeks
*** daily change between 4°C and 40°C temperatures

Summary

The planning, implementation and evaluation of stability tests for cosmetics is always product-specific and takes into account all relevant information (product composition, packaging, consumer use, etc.).

ISO standards and guidelines provide information on the planning and execution of such tests; the final implementation is the responsibility of the persons responsible for the product.
Stability tests are required as part of the safety report by the European Cosmetics Regulation (EC) No. 1223/2009.
Only with carefully planned and carried out stability tests can microbiologically and chemically-physically stable products be brought onto the market over the entire shelf life and application.

BAV INSTITUT
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