Cosmetics
From microbiological quality control to in vitro safety testing, Renolab supports cosmetic companies in assessing product safety and meeting regulatory and quality requirements.
For the cosmetic industry, Renolab performs microbiological quality control and in vitro safety testing on raw materials and finished cosmetic products.
These studies support product safety evaluation and quality control activities carried out in accordance with internationally recognised testing standards.
Microbiological Quality Control for Cosmetics
Renolab performs microbiological testing on cosmetic raw materials and finished products to assess microbial contamination and verify compliance with microbiological quality requirements.
1. Routine Microbiological Testing
- Total aerobic mesophilic count (ISO 21149:2017)
- Enumeration of yeasts and molds (ISO 16212:2017)
Detection of key pathogens:
- S. aureus (ISO 22718:2016)
- C. albicans (ISO 18416:2016)
- E. coli (ISO 21150:2016)
- P. aeruginosa (ISO 22717:2016)
2. Preservative Efficacy Testing
Renolab performs preservative efficacy testing to evaluate the effectiveness of antimicrobial preservative systems in cosmetic formulations. Tests include:
- Challenge Test (ISO 11930:2019 / Ph. Eur. 5.1.3)
- Method development and validation (neutralization, recovery, interference)
3. Microorganism Identification
Microbial isolates can be identified using advanced analytical techniques, including:
- MALDI-TOF MS
- PCR
4. Culture Media Quality Control
Quality control of microbiological culture media includes:
- Growth promotion testing (Ph. Eur. 2.6.12)
In vitro Testing
Cosmetics must undergo a human safety assessment which is described in the Product Information File. This is focused on an in vitro testing strategy in accordance with the Cosmetics Products Regulation (EC) No 1223/2009.
Renolab can test individual ingredients, mixtures or final products using a broad range of in vitro methods that meet both testing and compliance requirements.
Cytotoxicity Tests
Cytotoxicity assays evaluate the effect of substances on cell viability and cellular integrity.
- MTT Test (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium) to measure cell viability.
- LDH Test (Lactate Dehydrogenase) to measure cellular damage.
- Cell Morphology Test to examine the integrity and shape of the cells.
Skin Corrosion and Skin Irritation
In vitro tests used to evaluate potential skin damage include:
- 3D tissue model testing for skin corrosion (OECD 431)
- 3D tissue model testing for skin irritation (OECD 439)
- In chemico skin corrosion testing with Corrositex™ (OECD 435)
Serious Eye Damage and Eye Irritation
Ocular safety is evaluated using internationally recognised in vitro methods:
- Bovine corneal opacity and permeability test (OECD437) for eye damage
- Reconstructed human cornea-like epithelium test (OECD 492) for ocular irritation (EpiOcular)
- SkinEthic™ RhCE test method for eye hazard identification (OECD 492B)
- Ocular Irritection® – Eye Irritation Test (OECD 496)
Skin Sensitization
Skin sensitization potential is assessed using alternative in vitro methods including:
- DPRA and kinetic DPRA (OECD 442C)
- KeratinoSens (OECD 442D)
- U-SENS, h-CLAT (OECD 442E)
Mutagenicity/Genotoxicity
- Bacterial reverse mutation (Ames) test (OECD 471)
Regulatory framework
Cosmetic products in the European Union are regulated under:
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 is a recast of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products.
FAQ
What microbiological tests are required for cosmetic products?
Microbiological testing of cosmetic products typically includes total aerobic microbial count, enumeration of yeasts and molds and detection of specific pathogens such as Staphylococcus aureus, Candida albicans, Escherichia coli and Pseudomonas aeruginosa.
What is a preservative efficacy test for cosmetics?
A preservative efficacy test, often called a challenge test, evaluates the effectiveness of preservatives in preventing microbial growth in cosmetic formulations. The test can be performed according to ISO 11930 and the European Pharmacopoeia.
What methods are used to identify microorganisms in cosmetic testing?
Microorganisms isolated during testing can be identified using techniques such as MALDI-TOF mass spectrometry or PCR.
What in vitro tests are used to evaluate cosmetic safety?
In vitro safety testing for cosmetics may include cytotoxicity tests, skin irritation and corrosion studies, eye irritation tests, skin sensitization assays and mutagenicity testing using methods described in OECD guidelines.
What is the Ames test used for in cosmetic testing?
The Ames test is a bacterial reverse mutation test used to evaluate the mutagenic potential of a substance according to OECD Test Guideline 471.
Which regulation governs cosmetic products in the EU?
Cosmetic products in the European Union are regulated by Regulation (EC) No. 1223/2009, which establishes safety requirements and responsibilities for cosmetic products placed on the market.