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STABILITY TESTING COSMETICS FOR SHELF LIFE

Nov 8, 2024 | Testing and Quality Assurance

Routine stability testing provides cosmetic manufacturers with critical data about their products’ safety
and shelf life and can help you align your products with the FDA’s cosmetic stability testing guidelines.
Although the US food and Drug Administration (FDA) does not yet require cosmetic manufacturers to
conduct stability testing on products before commercially marketing them, we consider it a good
manufacturing practice.

The information gained from stability testing can be useful to companies both externally and internally,
creating successful ANDAs (abbreviated new drug applications) and informing product development,
material procurement/management, and lifecycle management. This page provides an overview of the
basics manufacturers should consider when developing a stability testing protocol for cosmetic products.

ABOUT PRODUCT STABILITY TESTING

As is well-known, stability testing is essentially an experiment in which a batch of formula is created and
placed into different environmental conditions for a set period of time. These conditions vary in
temperature and humidity and are meant to simulate what happens to the product during its life cycle. The
associated stability test protocol, then, should de�ne test parameters that evaluate stability samples.

In the pharmaceuticals �eld, both the FDA and the European Medicines Agency require the stability testing
of products before they can be sold to consumers. The main purpose is to measure and document the
potency of medications up until a predicted expiration date.This data has proven important, especially
considering the FDA has cited, within the past two years, stability-related issues as key factors in
pharmaceutical recalls. And, as pharmaceutical and cosmetic manufacturers well understand, such
product recalls are not only expensive and labor intensive, but they also can seriously damage one’s brand
image.

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Similar to pharmaceuticals, cosmetics naturally degrade over time, and stability testing via the
manipulation of storage temperature and other factors can reveal the extent to which they degrade by
measuring factors such as:

The natural degradation rate of key ingredients

A product’s ability to resist microbial intrusion

The product’s reactivity to packaging materials

Impurities exacerbated by the manufacturing process

Product response to heat, humidity, and light

One objective of stability testing is to ensure that a product maintains its intended physical, chemical and
microbiological qualities—as well as functionality and aesthetics—when stored under appropriate (room
temperature) conditions. Another is to glean data by foreseeing the stability of the cosmetic product over
time within its useful life span, as well as compatibility between the formulation and the container material.

COSMETIC STABILITY TESTING GUIDELINES

As stated, there currently are no existing enforceable or uniform protocols outlined by the FDA Code of
Federal Regulations or European Commission Regulation No. 1223/2009 for the stability testing of

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cosmetics. The exception is for some OTC products, such as sunscreens, antiperspirants/deodorants, and
dandruff shampoos. As such, a well-designed internal stability protocol must test those product attributes
that are susceptible to change during storage, and that can can in�uence the quality, safety, and
performance of the product. Stability studies include the evaluation of product quality at speci�c time
intervals of a storage period under controlled conditions.

THERE ARE THREE BASIC FORMS OF STABILITY TESTS:

1. Physical and chemical integrity: These evaluate the color, odor or fragrance, pH value,
viscosity, texture, ow and emulsion stability, or signs of separation.
2. Microbiological stability: These evaluate the degree of contamination with bacteria,
mold and/or yeast.
3. Packaging stability: These evaluate the effect of packaging on the contained product.

STABILITY TESTING FOR COSMETICS IS TYPICALLY

PERFORMED WHEN:
• A new product is developed;
• An existing on-market product has been reformulated;
• The production method has been modi�ed, or production has moved to a new facility
or vendor; and/or
packaging has changed.
• Currently, little published research exists to support speci�c methods for predicting
cosmetic shelf life.

REASONS FOR THE GAP IN COSMETIC SHELF LIFE

INFORMATION:
• The wide variety and complexity of cosmetic formulas and packaging;
• The proprietary nature of most cosmetic products and their associated stability test
methods; and
• The scope of potential changes to be examined, including physical, chemical,
microbial, functional or aesthetic.

METHOD DEVELOPMENT AND THE NEED FOR ACCELERATED

STABILITY TESTING
For each formulation type, manufacturers should determine the qualities to be examined, then test them at
one or more temperature and humidity conditions. Test parameters should be evaluated and a decision
made for each criterion based on the company’s own internal procedures and experience. Evaluations
should allow for the deduction of predicted or real stability of the product.

Since time is such a crucial parameter in the development of a new cosmetic product, real-time cosmetic
stability testing is not always feasible. In such situations, accelerated stability testing represents a good
alternative. In accelerated stability testing, samples are stored in different elevated temperature and
humidity conditions, as determined by product type and market demands.

Given the absence of o�cial guidance from regulatory authorities concerning stability testing for cosmetic
products, manufacturers should take into account these considerations:

• Conditions that might accelerate or predict the effects of stress on product consistency, including
varying temperatures;

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• Changes to a product’s aesthetic properties, such as color, fragrance or texture, under varying
conditions;
• Variations in the manufacturing process that might affect a product; and
• Packaging and its effect on formulation, and vice versa.

STEPS FOR COSMETIC SHELF LIFE AND STABILITY TESTING

Following is a basic format for conducting a cosmetic formula stability test:

1. BATCH PRODUCTION

Calculate how much to produce based on the number of samples being used for testing. Stability
guidelines from the International Conference on
Harmonization (ICH) state that three batches at a certain scale must be placed on stability; these
batches should be representative of the quality of the material to be made on a production scale.

2. PRODUCT CONTAINER FILLING

The product should be �lled in proper intermediate and �nal packaging, as it is best practice to test
both the container and �nal packaging during stability testing. Samples should be representative of
the batch size as well as the range of shades, fragrances and formulations to properly test stability
extremes of the product. The closure system should be the same as the packaging proposed for
storage and distribution.

3. INITIAL TEST (TIME POINT ZERO)

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Once samples are �lled, one should test for all characteristics to be evaluated later. Exact tests
depend on the speci�c product, but minimally, one should record appearance, color, pH, viscosity
readings and fragrance. For aerosol products, spray patterns should be tested.

4. PRODUCT STORAGE

Stability testing cosmetics requires different temperature and humidity conditions. Some standard
temperatures include: 40°C/75% RH; 30°C/65% RH; 25°C/60% RH; and 5°C/no RH.

5. PRODUCT EVALUATION

For long-term studies, the frequency of testing should be su�cient to establish the stability pro�le for
the formulation. The frequency of testing at long-term storage conditions normally is three months
during the �rst year; every six months during the second year; and once annually thereafter through
the proposed re-test period. At the accelerated storage condition, a minimum of three points,
including the initial and �nal time points (e.g. 0, 3 and 6 months), from a six-month study is
recommended.

Where an expectation exists that data from accelerated stability studies for cosmetics is likely to
approach signi�cant change criteria, one should conduct increased testing, either by adding samples
at the �nal time point or by including a fourth-time point in the study design. When testing at the

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intermediate storage condition is called for, due to a signi�cant change under accelerated storage
conditions, a minimum of four time points, including the initial and �nal time points (e.g. 0, 6, 9 and
12 months), from a 12-month study is recommended.

6. DETERMINE THE COSMETIC’S STABILITY

After the de ned stability study period, one should have a high level of certainty whether the formula
is stable or not. If test results yield unsatisfactory or questionable results, additional testing should
be performed. Nearly all products will exhibit some change, so it will be up to the manufacturer to
determine whether the product passes.

7. CONCLUSION REPORT

Once testing has been completed, a conclusion report on stability should be compiled, including:
• Identi�cation of the lab conducting the testing (if a third-party contractor is used);
• Identi�cation of the product;
• Samples of primary packaging material used in the test;
• Description of the methodology used to determine the product’s minimum durability, study
conditions and results of the study; and
• The signature of the person responsible for the study.

CONCLUSION
It can bene�t cosmetic manufacturers to incorporate routine stability testing into the lifecycle of their
products. By obtaining this critical data about a product, manufacturers can create better products while
improving e�ciencies in terms of material management. Furthermore, while the largest global regulatory
authorities do not currently require cosmetic stability testing, they do require such testing for
pharmaceuticals. This indicates at least some potential that the same expectation could be levied on
cosmetic manufacturers eventually. In that event, early-adopter cosmetic manufacturers with routine

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stability testing processes in place would be well positioned to respond.

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