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Mandatory laboratory testing of cosmetic products

List of mandatory laboratory tests offered by the laboratory

CoLab is a modern testing laboratory in Kyiv that specializes in the testing of cosmetic products and raw materials, medical devices, and cosmetic products for animals.

The CoLab laboratory carries out all mandatory tests (stability, challenge test and packaging compatibility), as well as additional tests to confirm the PAO (period after opening) and to substantiate claims (efficacy) of cosmetic products.

Our test reports form the basis for regulatory documentation, safety assessment and substantiation of a product's claimed properties. We carry out laboratory tests whose results are used to confirm that products comply with the requirements of the technical regulations of Ukraine, the European Union, the United Kingdom and other international markets.

Legislation

Regulatory requirements

The Technical Regulation on Cosmetic Products, approved by Cabinet of Ministers of Ukraine Resolution No. 65 of 20.01.2021, and Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products specify in Annex 1 the list of mandatory laboratory tests, in particular:

01

Stability of the cosmetic product

Section 2 of Part A of the Cosmetic Product Safety Report (CPSR)

02

Preservation efficacy test results — Challenge test

Section 3 of Part A of the CPSR

03

Packaging compatibility

Section 4 of Part A of the CPSR

All of the listed tests build a scientifically sound evidence base on which the safety expert (assessor):

Assesses potential risks to the consumer's health
Analyses the impact of composition, stability and microbiological factors
Draws a conclusion on the safety of the cosmetic product under normal or reasonably foreseeable use

Regulatory documents

  • Cabinet of Ministers of Ukraine Resolution No. 65 Technical Regulation on Cosmetic Products (20.01.2021)
  • EU Regulation 1223/2009 On cosmetic products (30.11.2009)
  • ДСТУ ISO/TR 18811:2019 Guidelines on testing the stability
Mandatory tests

Stability testing

Stability testing of cosmetic products is carried out in accordance with ДСТУ ISO/TR 18811:2019 "Cosmetics. Guidelines on testing the stability of cosmetic products" (ISO/TR 18811:2018, IDT).

The testing is comprehensive in nature and includes a systematic assessment of:

Organoleptic characteristics

Appearance, colour, odour, and taste for products intended for the oral cavity

Physicochemical characteristics

pH, viscosity or rheological properties, mass or volume, content of volatile components

Microbiological characteristics

Total microbial load and the absence of pathogenic microorganisms

Packaging compatibility

Maintenance of a tight seal and the absence of deformation or functional failures of the packaging

Microbiological testing

Microbiological testing during the stability study checks for the following pathogens:

Indicator
Standard
Enumeration of mesophilic aerobic bacteria
ДСТУ ISO 21149:2010, ISO 21149:2017/Amd 1:2022
Enumeration of yeasts and moulds
ДСТУ EN ISO 16212:2022
Detection of Escherichia coli
ДСТУ ISO 21150:2010, ДСТУ EN ISO 21150:2022
Detection of Pseudomonas aeruginosa
ДСТУ ISO 22717:2010, ДСТУ EN ISO 22717:2022
Detection of Staphylococcus aureus
ДСТУ ISO 22718:2010, ДСТУ EN ISO 22718:2022
Detection of Candida albicans
ДСТУ ISO 18416:2017, ДСТУ EN ISO 18416:2022

Accelerated testing is carried out at elevated temperatures and/or altered storage conditions.

Mandatory tests

Preservation efficacy test — Challenge test

The challenge test is carried out in accordance with ДСТУ EN ISO 11930:2016, ДСТУ EN ISO 11930:2022, ISO 11930:2019/Amd 1:2022 and is a standardised laboratory test whose purpose is to assess the ability of a cosmetic product's preservation system to prevent the growth and survival of microorganisms during its normal and reasonably foreseeable use.

During the challenge test, the cosmetic product is deliberately inoculated with specified strains of microorganisms, after which the reduction in their numbers is assessed at set time intervals.

What does the challenge test simulate?

In this way, real-world conditions of product use are simulated, in particular:

Repeated opening of the packaging

Simulation of real-world use by the consumer

Contact with the surrounding environment

Exposure to air, humidity and temperature

Potential transfer of microorganisms

Contact with the skin or mucous membranes

Main purpose of the test

Confirmation that the preservation system provides reliable and consistent microbiological protection throughout the entire declared period after opening or shelf life.

Mandatory tests

Compatibility of cosmetic products with packaging

Assessing the compatibility of cosmetic products with packaging in accordance with ДСТУ ISO/TR 18811:2019 is an integral part of the stability and safety testing of a cosmetic product.

The purpose of such testing is to confirm that the interaction between the cosmetic product and the packaging materials does not lead to changes that could affect the quality, stability or safety of the product throughout its entire shelf life.

The standard treats packaging not as a neutral container but as an active element of the "product–packaging" system that can influence the characteristics of the cosmetic product.

Purpose of the testing

The main purpose of the testing is to identify possible physical, chemical and sensory changes that may arise as a result of prolonged contact between the cosmetic product and the packaging materials.

ISO/TR 18811:2019 recommends carrying out a compatibility assessment for:

1 The final product formula
2 In the final type of packaging
3 Under conditions that simulate real-world storage and use

Order testing

The CoLab laboratory carries out the testing required to demonstrate compliance with the Technical Regulation on Cosmetic Products and EU Regulation 1223/2009. The tests are performed according to approved protocols with full documentation of all stages.