Microbiological purity
Microbiological purity testing is a key element in assessing the safety of cosmetics. Its purpose is to confirm that the product does not contain microorganisms in quantities that pose a threat to the health of the user and that it meets the requirements of applicable standards and legal regulations.
What does the test involve?
The research includes:
- determination of the Total Aerobic Microbial Count (TAMC),
- determination of the Total Yeast and Mold Count (TYMC).
Detection of the presence of specific pathogens, such as:
- Staphylococcus aureus,
- Pseudomonas aeruginosa,
- Candida albicans,
- bacteria from the group Enterobacteriaceae.
What standard is it manufactured to?
The tests are performed in accordance with the requirements:
- ISO 17516 – „Cosmetics – Microbiology – Microbiological limits”,
- ISO 21149, ISO 16212, ISO 18416, ISO 22717, ISO 22718 (methods for determining and identifying microorganisms).
Why is testing necessary?
- Confirms the microbiological safety of the product before it is placed on the market.
- Protects consumers from the risk of skin and mucous membrane infections.
- Forms part of the documentation for the Cosmetic Product Safety Report (CPSR).
- Minimizes the risk of complaints and market withdrawals.
When should the test be performed?
- Before the product is first placed on the market.
- After a significant change in composition or raw material.
- When changing the place of production.
- As part of stability and quality control of production batches.
Challenge Test
Challenge Test is a specialized microbiological test designed to assess the effectiveness of a cosmetic product’s preservative system. It checks whether the product is adequately protected against microbial growth during storage and use by the consumer.
What is the Challenge Test?
The procedure consists of:
- Deliberate contamination of the product sample with specific strains of microorganisms (bacteria, yeast, and mold).
- Storage of the product under controlled conditions.
- Determination of the number of microorganisms at specific intervals (e.g., 7, 14, 28 days).
- Assessment of the reduction in the number of microorganisms in accordance with acceptance criteria.
The test allows you to determine whether the preservation system effectively eliminates microorganisms and prevents their regrowth.
What microorganisms are used in the test?
In accordance with ISO 11930, the test uses, among other things:
- Aspergillus brasiliensis,
- Staphylococcus aureus,
- Pseudomonas aeruginosa,
- Escherichia coli,
- Candida albicans.
When should the maintenance test be performed?
A Challenge Test is required:
- in the event of a significant change in the technological process,
- before launching a new product on the market,
- when changing the composition (especially preservatives or raw materials with a high microbiological risk),
- when changing packaging (e.g., switching from airless to jar).
Why is the Challenge Test so important?
- Confirms the effectiveness of maintenance in real-world conditions.
- Reduces the risk of product contamination during use.
- Protects the brand from product withdrawal from the market.
- Is part of the documentation required in the Cosmetic Product Safety Report (CPSR).
Stability and compatibility of the mass with the packaging
Testing the stability and compatibility of the substance with the packaging allows us to assess whether the cosmetic product retains its physicochemical, microbiological, and functional properties over time and whether it interacts undesirably with the packaging material.
What does the test involve?
The purpose of the study is to confirm that, during the declared shelf life, the product:
- does not change the color, smell, or texture,
- does not separate or form sediment,
- maintains the correct pH and viscosity,
- maintains the effectiveness of its claimed properties,
- meets microbiological purity requirements.
The scope of the research may include:
- accelerated testing (e.g., elevated temperature, freeze-thaw cycles),
- tests at room temperature,
- exposure to light,
- monitoring of physicochemical parameters at specified intervals.
Based on the results, it is possible to determine the best-before date and/or the PAO (Period After Opening).
Compatibility—why is it so important?
The cosmetic product may interact with the packaging material (plastic, glass, aluminum, airless systems), which may lead to:
- migration of substances from packaging to the product,
- absorption of active ingredients by the packaging,
- changes in color or smell,
- deformation, cracking, or leakage of the packaging,
- corrosion of metal components.
Compatibility testing allows these risks to be eliminated before mass production begins.
When should the test be performed?
- Before the product is first placed on the market,
- When changing packaging or component suppliers.
- When modifying the recipe.
- In the case of products containing ingredients with high reactivity potential (e.g., essential oils, acids, alcohol).
What are the benefits?
- Confirmation of product safety and quality.
- Reducing the risk of complaints and market withdrawals.
- Support in determining the actual shelf life.
- Strengthening brand credibility.
Water activity testing
Water activity testing (wa) allows the amount of “free water” available in a cosmetic product to be determined and confirms that the product has a low microbiological risk, as the limited availability of free water hinders the growth of bacteria, yeast, and mold. A low wa value is an important factor supporting the microbiological safety of the product and may justify a limited scope of additional microbiological testing, depending on the type of formulation.
What does the test involve?
The measurement is performed using a specialized water activity analyzer, which:
- Places the sample in a sealed measuring chamber.
- It means the equilibrium of water vapor pressure above the sample.
- Calculates the value of wa with high accuracy.
The test is rapid, reproducible, and does not require prolonged microbiological incubation.
Why is the WA test important?
- It enables microbiological risk assessment already at the recipe development stage.
- It helps you choose the optimal maintenance system.
- In some cases, it may justify a limited scope of microbiological testing.
- Supports the safety assessment process in accordance with Regulation (EC) No. 1223/2009.
When is it worth getting tested?
- When developing new formulations.
- In the case of products with reduced water content (e.g., lotions, oils, water-free products).
- When modifying the composition affecting the water management of the product.
Dermatological Tests
Dermatological tests confirm the product’s good skin tolerance and allow its irritant and sensitizing potential to be assessed under test conditions. The aim of the test is to demonstrate that, when used correctly, the cosmetic does not cause any significant adverse reactions in the test group. The tests are carried out under the supervision of a dermatologist.
General dermatology
The purpose of the test is to confirm that the product:
- is well tolerated by the skin,
- does not exhibit irritant properties,
- does not cause allergic reactions under test conditions.
It is most often performed in the form of a patch test – the product is applied to the skin (usually the back or forearm) and evaluated after a specified period of time (e.g., 24–48 hours).
Test result: possibility of using messages such as
“Dermatologically tested.”
Advanced dermatology
The extended form of the examination may include:
- tests on a larger group of subjects,
- extended application time,
- multiple applications (e.g., HRIPT – Human Repeat Insult Patch Test),
- evaluation on sensitive skin or in a specific target group.
This test allows for a more in-depth analysis of irritant and allergenic potential and increases the credibility of marketing claims. It can be used as a basis for statements such as: “Suitable for sensitive skin.”
When is it worth having dermatological tests done?
- Before launching a new product on the market.
- When introducing a line for sensitive, atopic, or children’s skin.
- When using active ingredients with irritating potential (e.g., acids, retinoids).
- To support marketing claims.
Application tests
Application testing under the supervision of a specialist doctor is an advanced form of assessing the safety and effectiveness of a cosmetic product in conditions similar to actual use. The test is conducted with the participation of test subjects and supervised by a doctor of the appropriate specialty (e.g., dermatologist, pediatrician, gynecologist, depending on the intended use of the product).
What does the application test involve?
The application test includes:
- regular use of the product for a specified period of time (e.g., 2–4 weeks),
- application in accordance with the declared method of use,
- assessment of the skin before and after the examination,
- monitoring of possible adverse reactions.
A specialist doctor assesses the condition of the skin, product tolerance, and observed effects.
What can the assessment cover?
The assessment may include, among other things:
- skin tolerance during prolonged use,
- occurrence of irritation or hypersensitivity symptoms,
- improvement of specific skin parameters (e.g., hydration, smoothing),
- confirmation of safety for use in a specific target group.
The scope of the study is always tailored to the type of cosmetic product and the planned marketing claims.
When is it worth getting tested?
- For products containing active ingredients with a pronounced biological effect.
- When introducing specialized products (e.g., for sensitive or problematic skin).
- For cosmetics intended for specific areas (eye area, intimate area).
- In order to support the declaration of effectiveness.
Instrumental tests – equipment-based
Instrumental (apparatus) tests are an objective assessment of a cosmetic’s effectiveness using specialized measuring equipment. They allow for a quantitative determination of changes occurring in the skin under the influence of the product’s use. Unlike survey or declarative tests, the results of apparatus tests are based on measurable physiological parameters of the skin.
What can we measure?
Depending on the type of cosmetic product, tests may include, among others:
- skin moisture level,
- trans epidermal water loss (TEWL),
- skin elasticity and firmness,
- protection of the hydrolipid barrier,
- pore size measurement, sebum/sebum regulation,
- wrinkle reduction or skin smoothing,
- skin tone/discoloration/skin lightening,
- scalp sensitivity, hair thickness, hair density, thermal protection.
The selection of measurement methods is always tailored to the declared function of the product.
How is the test conducted?
- Qualification and preliminary assessment of probationers.
- Measurement of output parameters (baseline).
- Regular use of the product for a specified period of time.
- Control measurements at fixed points in time.
- Statistical analysis of results.
Studies may be short-term (immediate effect) or long-term (e.g., 2–8 weeks of use).
Why is it worth performing equipment tests?
- Enable the creation of precise messages such as: “Increases skin hydration by 32% after 4 weeks of use”.
- Provide hard data for marketing communications.
- Increase the credibility of efficacy claims.
- Support product documentation in accordance with Regulation (EC) No. 1223/2009.
Sun protection tests
Sun protection testing allows us to determine the level of protection a product provides against UVB and UVA radiation and to confirm that marketing claims comply with regulatory requirements. Testing is conducted in accordance with European Commission guidelines and ISO standards for sunscreen products.
SPF – UVB protection
SPF determines the level of protection against UVB radiation, which is mainly responsible for erythema (sunburn).
The test can be performed:
- in vivo – on the skin of test subjects,
- in vitro – using special plates and spectrophotometric analyses.
The SPF result forms the basis for product labeling (e.g., SPF 15, 30, 50, 50+).
UVAPF – UVA protection
UVAPF determines the level of protection against UVA radiation, which is responsible for:
- photoaging,
- discoloration,
- collagen degradation,
- indirect DNA damage.
According to EU recommendations, the level of UVA protection should be at least 1/3 of the declared SPF.
Critical Wavelength
The critical wavelength allows you to assess whether the product provides broad spectrum protection.
For a cosmetic product to be considered broad spectrum, the critical wavelength should be ≥ 370 nm.
This parameter confirms that the product protects against both UVB and a significant portion of UVA radiation.
Why is tests crucial?
- Minimize the risk of declarations being challenged by control authorities.
- Enable legal labeling of SPF levels.
- Form the basis of documentation in accordance with Regulation (EC) No. 1223/2009.
water resistance test
Water resistance testing confirms whether a sunscreen product maintains its declared level of protection after contact with water. This is crucial for cosmetics labeled as “water resistant” or “very water resistant.”
What does the test involve?
The procedure includes:
- Determination of SPF value before contact with water.
- Controlled immersion of test subjects in water (specific temperature and duration).
- Repeated SPF marking after immersion cycles.
- Comparison of the obtained results with the initial value.
During the test, factors such as water temperature, intervals between cycles, and skin drying methods are monitored.
What does the test confirm?
- Credibility of marketing claims.
- Maintaining an adequate SPF level after exposure to water.
- Stability of the protective film on the skin.
Why is the test important?
- Enables the legal use of waterproof markings.
- Increases user safety during bathing and physical activity.
- Minimizes the risk of messages being challenged by regulatory authorities.
- Is part of the product documentation in accordance with Regulation (EC) No. 1223/2009.
IR protection test, Blue light
Research into protection against IR (infrared) radiation and Blue Light (HEV – High Energy Visible Light) allows us to assess a cosmetic’s ability to reduce the negative impact of environmental radiation on the skin.
IR protection (Infrared Radiation)
Infrared radiation (mainly IR-A) penetrates deep layers of the skin and can induce the formation of free radicals.
The tests may include:
- assessment of the reduction of oxidative stress markers,
- analysis of the impact on metalloproteinase (MMP) expression,
- measurement of changes in skin structure after IR exposure,
- evaluation of the antioxidant activity of the formulation.
The ability to absorb radiation is determined using a spectrophotometric method.
Blue Light protection (HEV)
Blue Light (400–500 nm), emitted by the sun and electronic devices, can:
- contribute to photoaging,
- intensify the formation of discoloration,
- generate free radicals.
What does the tests confirm?
It allows you to assess the ability of a cosmetic product to reduce the negative impact of environmental radiation on the skin, including oxidative stress and photoaging processes.
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Antioxidant properties tests
Antioxidant testing allows us to assess a cosmetic product’s ability to neutralize free radicals and reduce oxidative stress in the skin. Oxidative stress is one of the main factors accelerating the aging process, the formation of discoloration, and the degradation of collagen and elastin.
What does the research involve?
Antioxidant testing involves assessing a product’s ability to neutralize free radicals and reduce oxidation processes that can lead to cell damage and accelerated skin aging.
Under review:
- the product is subjected to controlled exposure to factors causing oxidative stress,
- the degree of reduction in reactive oxygen species or other markers of oxidation is measured,
- the ability of the formulation to protect biological components from degradation is assessed,
- the intensity of the oxidation reaction is analyzed before and after application of the product.
The test results are quantitative and allow the antioxidant activity level of the formulation to be determined. On this basis, it is possible to confirm the validity of claims regarding protection against oxidative stress.
Most commonly used research methods
Most commonly used research methods:
- Test DPPH – assessment of free radical neutralization capacity,
- ABTS – analysis of antioxidant potential,
- FRAP – measurement of reduction capacity,
- determining the level of ROS (Reactive Oxygen Species),
- assessment of the impact on oxidative stress markers.
The choice of method depends on the type of formulation and the planned declarations.
What does the tests confirm?
- The product’s ability to neutralize free radicals.
- Supporting skin protection against oxidative stress.
- The validity of statements such as: “Antioxidant effect confirmed by research” “Protects the skin against oxidative stress”
When is it worth getting tested?
- On city lines (“anti-pollution”).
- In anti-aging products.
- In cosmetics containing vitamin C, E, polyphenols, coenzyme Q10.
- In protective products (UV, Blue Light, IR).
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Microbiome test
Microbiome testing allows us to assess the impact of cosmetics on the skin’s natural microflora and its biological balance. The skin microbiome plays a key role in maintaining the protective barrier, immunity, and proper functioning of the epidermis.
What does microbiome testing involve?
The procedure includes:
- taking skin samples before starting to use the product,
- regular use of the cosmetic product for a specified period of time,
- resampling after completion of the application,
- analysis of changes in the composition and diversity of microorganisms.
The following are subject to assessment:
- microbiological diversity (biodiversity),
- the proportion of selected groups of microorganisms,
- stability of the skin ecosystem.
What does the tests confirm?
These analyses are an advanced tool confirming statements such as:
- the product does not disturb the skin microbiota,
- the product does not disturb the natural balance of the skin’s microbiota,
- the tested product had a protective effect on the skin microbiota,
- the product supports the development of healthy skin microbiota.
The studies support the documentation of the product’s effectiveness in accordance with Regulation (EC) No. 1223/2009 regarding the reliability of marketing claims.
When is it worth testing your microbiome?
- in dermocosmetics with soothing and regenerating properties,
- for cosmetics for sensitive, atopic, and acne-prone skin,
- in “microbiome-friendly” lines,
- in prebiotic and postbiotic products.
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Heavy metal labeling
Heavy metal testing is a specialized analytical test designed to detect and quantify trace amounts of metals that may be present in raw materials or finished cosmetic products.
Which elements are most commonly analyzed?
The examination may include, among other things:
- lead (Pb),
- cadmium (Cd),
- mercury (Hg),
- arsenic (As),
- nickel (Ni),
- chromium (Cr),
- antimony (Sb).
The scope of the analysis is selected depending on the type of product and the raw materials used.
How is the test performed?
In the case of metals, inductively coupled plasma mass spectrometry (ICP-MS) is most commonly used, which can be coupled with liquid chromatography (LC) when it is necessary to distinguish between different chemical forms of a given element (speciation). The procedure includes:
- Sample preparation (e.g., mineralization under controlled conditions).
- Introduction of the sample into the analytical system.
- Ionization of elements in high-temperature plasma.
- Analysis of ions in a mass spectrometer.
- Quantitative determination of trace metal content (ppm/ppb).
When is it worth getting tested?
- In order to confirm compliance with the requirements of export markets.
- In mineral products (e.g., with inorganic pigments).
- In cosmetics for children, pregnant women, and people with sensitive skin.
- With natural raw materials (clay, plant extracts).
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Labeling 82 fragrance allergens
The labeling of 82 fragrance allergens is a specialized analytical test that enables the identification and quantitative determination of fragrance substances subject to mandatory declaration in the European Union. The scope of the analysis is based on the requirements of Regulation (EC) No. 1223/2009 and its amendment extending the list of fragrance allergens subject to labeling on product labels.
What does the test involve?
The procedure includes:
- Proper preparation of the cosmetic sample.
- Separation of fragrance mixture components using chromatography.
- Identification of compounds based on their mass spectrum.
- Quantitative determination of the concentration of individual allergens.
- Comparison of results with reporting thresholds.
The analysis allows allergens to be detected in both fragrance raw materials and the finished product, even at very low concentrations.
Why is the test important?
- Supports the safety assessment in the Cosmetic Product Safety Report (CPSR).
- Enables correct INCI labeling on the label.
- Helps avoid errors in the composition declaration.
- Minimizes the risk of regulatory sanctions.
When should the labeling be performed?
The test is particularly relevant in situations where:
- there is no complete quantitative data from the supplier of the fragrance composition,
- the raw material documentation does not contain a detailed list of all allergens subject to declaration,
- the manufacturer launches its own fragrance composition,
- the product contains natural plant extracts or essential oils, which may be a source of allergens,
- the product is intended for the EU market and requires full compliance with Regulation (EC) No. 1223/2009.
In practice, labeling is particularly important when the manufacturer cannot unequivocally confirm the concentrations of individual allergens based on the supplier’s documentation.
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Specialist opinions
Specialist opinions provide additional, expert confirmation of the safety of using a cosmetic product in a specific target group or in a specific area of application. The document is prepared by a doctor of the relevant specialty based on an analysis of the product’s composition, its intended use and, if necessary, the results of application and dermatological tests. These opinions support the product documentation in accordance with Regulation (EC) No. 1223/2009 and increase the credibility of marketing communications.
The pediatrician’s opinion?
The pediatrician’s opinion concerns products intended for:
- infants and children,
- pregnant and breastfeeding women (in terms of safety for the child),
- sensitive and immature skin.
The opinion analyzes, among other things:
- qualitative and quantitative composition of the product,
- irritant and allergenic potential,
- compliance of intended use with safety profile.
The opinion may form the basis for statements such as: “Product suitable for children from 1 day old.”
Opinion of an ophthalmologist?
The ophthalmologist’s opinion concerns products used in the eye area, such as:
- eye creams,
- mascara, eyeliner, eyeshadow,
- makeup removers,
- eyelash and eyebrow care products.
The specialist assesses:
- safe for use around the conjunctiva and eyelids,
- risk of irritation of the mucous membranes,
- adequacy of the formulation for the declared use,
- tolerance test results.
The opinion may support statements such as: “Suitable for use around the eyes” “Tested under ophthalmological supervision”
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Hypoallergenic Package
The Hypoallergenic Package is a comprehensive procedure for assessing the safety and skin tolerance of a product, developed to reliably verify claims regarding the minimization of allergic reactions. The scope of the package has been prepared based on the requirements of Regulation (EC) No. 1223/2009 and the rules regarding the accuracy of marketing claims.
What does the package include?
1. Composition assessment by a Safety Assessor
Detailed qualitative and quantitative analysis of the product composition for the presence of substances with known sensitizing potential, including fragrance allergens and ingredients with an increased risk of hypersensitivity.
2. Dermatological study on sensitive skin
Assessment of product tolerance in a group of people declaring sensitive skin, conducted under the supervision of a dermatologist.
3. Application study involving 20 test subjects
Regular use of the product in conditions similar to actual use, with monitoring for any adverse reactions.
4. Final opinion of a dermatologist
Expert analysis of test results with confirmation or exclusion of the validity of the planned marketing claim (e.g., “minimizes the risk of allergic reactions,” “suitable for sensitive skin”).
What does the opinion contain?
The opinion on the validity of hypoallergenic claims is prepared in accordance with the current guidelines of the Scientific Committee on Consumer Safety (SCCS) on the use of the term “hypoallergenic.” The opinion does not confirm the complete absence of risk of an allergic reaction, but assesses whether the use of the claim “hypoallergenic” is justified in the context of the available data and studies conducted.