Passage CL Sp. z o.o.represents years of experience and scientific expertise in conducting tests and analysis for cosmetic products. Acting in accordance with the prevailing regulations, we are capable of preparing all necessary documents required for the product to be introduced to the market.
A well-equipped laboratory which is at our disposal offers a whole variety of tests.We specialize in preparation of the Cosmetic Product Safety Report (CPSR)from the performed Safety Assessment for human health and offer assistance in the process of cosmetic product registration in CPNP.
Since 2013 Passage CL has assembled a strong team of experienced people who are experts in cosmetology, dermatology, chemistry and pharmacy.In Passage CL we live by the statement that a company’s success is determined by its staff. This is why at the core of our company are people who are truly passionate about what they do. Our mission is to always strive to meet and exceed our clients’ expectations, provide them with professional services and, with our many years of experience working within the industry, deliver professional support.
Cosmetic Product Safety Asesor (since 2003),
Quality and Safety Consultant for cosmetics usage,
Lead Auditor of Quality Management System according to PN-EN ISO 9001,
Specialist in Good Manufacturing Practices in cosmetic industry,
Member of Polish Society of Allergology,
Author of a number of publications, reports and patents in cosmetology.
Offer
MICROBIOLOGICAL TESTS
The microbiological quality test is one of the basic tests from which the process of introduction of a new product to the market should start. It allows cosmetics manufacturers to control their products and raw materials in terms of microbiological quality. The analysis is based on the quantitative test of bacteria, yeast and mould in a product, and also on identification of pathogens and detection of their presence. The source of microbiological infections can be found in raw materials, packaging or production environment, but it can also result from the direct contact of the end product with microbes during the consumer use, which in turn may lead to serious and dangerous consequences for human health.
Microbiological purity tests are conducted in accordance with the below testing standards:
PN-EN ISO 21149 – enumeration and detection of aerobic mesophilic bacteria
PN-EN ISO 16212 – enumeration of yeast and mould
PN-EN ISO 22718 – detection of Staphylococcus aureus
PN-EN ISO 22717 – detection of Pseudomonas aeruginosa
PN-EN ISO 21150 – detection of Escherichia coli
PN-EN ISO 18416 – detection of Candida albicans
CHALLENGE TESTS
The cosmetics challenge test, also known as the preservative efficacy test (PET), ensures that the used preservatives protect the cosmetic product from microbial growth and secondary infection during the consumer use. This test is performed by inoculating selected microorganisms into the cosmetic mass and then evaluated based on the reduction in the contamination levels over time. Technological processes, storage and usage might affect the stability of the conservative system, and thus it is advised to confirm the preservative efficacy.
Challenge tests are carried out in accordance with the relevant standards:
The EN ISO 11930
The Pharmacopoeial Method
The Schülke Koko Test
PHYSICO-CHEMICAL TESTS
The aim of the physico-chemical tests is to determine the basic properties of a cosmetic product. The appearance, color, fragrance, density or pH are the most frequent parameters marked in cosmetic products. The appropriate physico-chemical form ensures the appropriate properties of a product. The tests are conducted for all types of cosmetics in order to confirm or establish their properties. These tests are one of the most crucial ones as they allow to control the quality of the cosmetic mass.
Specific parameters such as the acid value or peroxide value, the presence of contamination or heavy metals are assayed depending on the type of a product and on the requirements set for each product category.
STABILITY AND COMPATIBILITY TESTS
The specific types of physico-chemical tests are stability and compatibility tests. The results of these tests are one of the crucial elements taken into consideration while deciding on the shelf life of a cosmetic product and on the right choice of the packaging.
The stability test is performed by exposing the cosmetic mass to extreme storage conditions. The purpose of the test is to assess whether the cosmetic formulation will be stable over time. The test is performed at both elevated and reduced temperatures which usually causes the cosmetic mass to undergo an accelerated aging compared to normal storage conditions. Stability, therefore, means there are no adverse changes which could be connected with the deterioration of the product quality.
The compatibility test verifies the reaction between the cosmetic mass and its packaging during the storage period and during the exposition to the specific temperature. Inappropriately chosen packaging can cause deterioration of the product quality over time, as well as the cosmetic mass can affect the deterioration of the quality of the packaging.
DERMATOLOGICAL TESTS
Dermatological tests are carried out in order to assess how a cosmetic product affects the skin i.e. to assess whether the product is safe to use and also to detect any of its potential sensitizing or irritating properties. The tests are run under the supervision of a specialist in dermatology and allergology on a group of carefully selected subjects with the usage of patch tests. A sample of the tested cosmetic product is placed inside original aluminium chambers attached to a hypoallergenic adhesive surgical tape which stays on the direct contact with the skin for 48 hours. The assessment of the result is done by the doctor in compliance with the scoring system of the International Contact Dermatitis Research Group (ICDRG).
All dermatological tests are carried out based on principals included in the Declaration of Helsinki and also in accordance with the COLIPA and Good Clinical Practice (GCP) standards.
APPLICATION TESTS
The aim of the application tests is:
evaluation of efficacy and functional qualities of a tested product,
confirmation of the marketing declarations,
assessment of skin tolerance to the tested product i.e. the exclusion of any adverse reactions – contact dermatitis or irritation during the reapplication of the cosmetic product,
confirmation of the safety use of a cosmetic product and of the lack of any harmful effects on the skin.
The selection of the subjects is conducted by the specialist in dermatology and allergology according to the precisely defined criteria. A group of at least 20 subjects is asked to test the cosmetic product in real conditions during a specific period of time and in accordance with the directions for use provided by the manufacturer. The subjects are obliged to fill in the prepared questionnaires thoroughly and to discuss the test with a specialist in application tests, a cosmetologist and a dermatologist. All the information collected from the subjects are extremely essential while assessing the application and functional value of the product and are the basis for the confirmation of the marketing declarations stated by the manufacturer.
Our company owns an extensive subject database which helps to correctly choose and match the subject group to each type of a cosmetic product.
All dermatological tests including application tests are carried out in compliance with:
the principals described in the Declaration of Helsinki,
the Cosmetics Europe (formerly COLIPA) Guidelines - Guidelines for the Assessment of Human Skin Compatibility 1997 and Guidelines for the Evaluation of the Efficacy of Cosmetic Products 2008
the Good Clinical Practice (GCP) standards.
COSMETIC PRODUCT SAFETY REPORT
Before the cosmetic product is introduced into the market within the European Union, it has to undergo the cosmetic product safety report.
The Cosmetic Product Safety Report is an obligatory document described in the Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. The Safety Assessment is conducted based on the conformity of the product ingredients with the current law regulations, toxicological analysis, test results and also on the calculated safety margin (MoS – Margin of Safety) for particular ingredients of the product. The safety assessment is carried out by the Safety Assessor in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognized as equivalent by an EU member state as stated in article 10 of the Regulation (EC) No 1223/2009.
Read more: www.raportbezpieczenstwa.pl
OTHER SERVICES
We also offer other services and tests:
Assay of heavy metal contents,
Water activity test,
Assay of antimicrobial activity,
Instrumental tests: measuring skin moisture and sebum (lubrication),
Verification of ingredients and labels,
Other (To find out more, please check out our current offer).
The highest quality, years of experience, individual approach and complex cosmetics tests in one laboratory
Articles
