Do you need to make sure that your raw materials for cosmetic products meet all the national and international standards?
Abich – Lifeanalytics can perform all the tests envisaged in Regulation (EC) No. 1223/2009 in compliance with ISO standards and OECD guidelines.
The safety and efficacy of a product depend mainly on the choice and quality of the cosmetic ingredients in its formulation.
The main substance categories used in the composition of cosmetic products are:
- Surfactants: specific to detergents producing foam (soaps, shower gel, shampoo),
- Emulsifiers and solubilisers: to make homogeneous formulations containing both water and oil,
- Lipids: for fat-based formulations such as lip balm sticks or lipsticks,
- Humectants: substances that prevent water loss from both the cosmetic product and our skin, once applied,
- Antioxidants: they prevent product alteration and fight the formation of free radicals,
- Pigments: insoluble substances used in make-up to determine the colour,
- Preservatives: “substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product” (from Regulation (EC) No. 1223/2009). Therefore, preservatives have the important task to preserve the cosmetic product from contamination by bacteria, fungi, and moulds. This is fundamental for cosmetic product safety, in particular if the cosmetic product is intended for contact with mucous membranes, eye contour or it is used on children.
The key tests to check that the preservative system is effective are the Challenge Test and the use test (RDV) to determine the Period After Opening (PAO), i.e. the cosmetic product’s expiry date after opening it.
In order to determine this, the finished cosmetic product is artificially inoculated to simulate the contamination it will be subject to during its life cycle. The decrease in the microbiological load will be assessed at specific intervals.
In addition to passing safety and efficacy tests individually, cosmetic raw materials must undergo further tests within the final formulation to check that they maintain their properties.
Lifeanalytics, your safest choice in cosmetics
Abich – Lifeanalytics, the Group’s Competence Center for Pharma and Cosmetic industries, offers a comprehensive range of tests for your cosmetic raw materials in compliance with national, European and international standards and guidelines currently in force.
H295R Steroidogenesis in vitro Assay – OECD 456
The in vitro test is designed to be applied to raw ingredients and finished products with the purpose of substantiating the claim “No endocrine disruption” according to OECD 456.
The purpose of the test is identifying substances that interfere with 17-ß estradiol and testosterone production.
In vitro test for the evaluation of the protective effect against air pollution
The test is designed to be applied to raw materials and finished products with the purpose of substantiating claims “Anti-pollution” and “Antioxidant” according to proprietary method.
In vitro test for the evaluation of the protective effect against air pollution. The purpose of this test is to evaluate the efficacy of the sample in reducing ROS release in response to a mix of heavy metals and atmospheric dust particulate in a skin-derived cell model.
Ocular irritation in vitro test on reconstructed corneal epithelium
The in vitro test test is designed to be applied to chemical substances or mixtures with the purpose of substantiating the claim “Non-irritant for the eyes” according to OECD 492.
Identification of chemical substances or mixtures that do not require classification as (severe) irritants through evaluation of their cytotoxic effects on an in vitro reconstructed corneal epithelium model. NOTE: if the sample qualifies as irritant, further tests are required in order to determine the degree of irritant action.
In vitro short term exposure test
The in vitro test test is designed to be applied either to raw materials or finished products, with the purpose of substantiating the claim “Non-irritant for the eyes (labelling CLP)” according to OECD 491.
Short term exposure analysis by application of each tested substance on SIRC (Statens Seruminstitut Rabbit Cornea) cells for the determination of the effect on cell viability through MTT test.
Patch test for the evaluation of the irritation potential on 3D reconstructed epidermis
The in vitro test is designed to be applied to chemical substances or mixtures with the purpose of substantiating the claim “Non-irritant for the skin” according to OECD 439.
Patch test for the evaluation of the irritation potential of chemical substances or mixtures through evaluation of their cytotoxic effect on an in vitro reconstructed model of human skin.
Antimicrobial activity test vs Propionibacterium acnes
The in vitro test is designed to be applied to cosmetics and raw cosmetic ingredients with the purpose of substantiating the claim “Anti-acne” according to proprietary method.
Evaluation of the anti-acne efficacy by testing the inhibition of the proliferation of Propionibacterium acnes by an ingredient or finished product.
Quantification of trace substances and impurities
The chemical test is designed to be applied to cosmetics and medical devices with the purpose of substantiating the claim “Titer of substances” according to UE Regulation.
Analysis of trace substances, residues and impurities for quality control purposes through UPLC or GC-MS. Includes sample preparation.
Quantification of trace substances and impurities
The chemical test is designed to be applied to preservatives, dyes, sunscreen filters with the purpose of substantiating claims “Titer of substances” and “Limit of preservatives” according to Regulation 1223/2009.
Quantification method for the measurement of the titer of substances by HPLC, UPLC, GC-MS after preparative steps.
OECD 442D in vitro sensitization test
The in vitro test is designed to be applied to substances or mixtures with the purpose of substantiating claims “No skin sensitizing” and “Hypoallergenic” according to OECD 442D.
The ARE-Nrf2 method employs cytofluorometry to quantify the antioxidant response in a culture of human keratinocytes after exposure to the product.
OECD 442E in vitro sensitization test
The in vitro test is designed to be applied to substances or mixtures with the purpose of substantiating claims “No skin sensitizing” and “Hypoallergenic” according to OECD 442E.
H-CLAT cytometry method to evaluate possible changes in the expression of cell surface markers (CD86 e CD54) in cultures of THP-1 human monocytes to exclude the related sensitization pathway.
Ames Test
The in vitro test is designed to be applied to raw ingredients for medical devices or cosmetics with the purpose of substantiating the claim “Non mutagenic” according to OECD 471.
Analysis of genotoxicity of a substance according to OECD 471.
DPRA: Direct Peptide Reactivity Assay test
The in vitro test is designed to be applied to substances or mixtures without metal compounds with the purpose of substantiating claims “No skin sensitizing” and “Hypoallergenic” according to OECD 442C.
The DPRA is proposed to address the molecular initiating event of the skin sensitisation AOP (Adverse Outcome Pathway), namely protein reactivity, by quantifying the reactivity of test chemicals towards model synthetic peptides containing either lysine or cysteine. Cysteine and Lysine percent peptide depletion values are then used to categorise a substance in one of four classes of reactivity for supporting the discrimination between skin sensitisers and non-sensitisers.
Cytotoxicity test for the identification of substances with acute oral toxicity LD50>2000 mg/kg
The in vitro test is designed to be applied to chemical substances or mixtures without metal compounds with the purpose of substantiating claims “Biocompatible” and “Non citotoxic” according to OECD 129 (on using cytotoxicity tests to estimate starting doses for acute oral systemic toxicity tests) and EURL-ECVAM 2011 (follow-up study on the predictive capacity of the 3T3 Neutral Red Uptake cytotoxicity assay to correctly identify substances not classified for acute oral toxicity under the EU CLP system).
The in vitro LD50 prediction test is designed to test chemicals or mixtures by evaluating their cytotoxic effect on an in vitro model of BALB/c 3T3 murine fibroblasts.
Usage test – Required D-Value (RDV)
The in vitro microbiological test is designed to be applied to cosmetic products with the purpose of substantiating the claim “Efficacy of preservatives” according to proprietary method.
In vitro and in vivo evaluation RDV for the determination of the PAO (Period After Opening).
Evaluation of the microbial contamination risk and water activity
The test is designed to be applied to cosmetic products with the purpose of substantiating claims “Low microbial contamination risk” and “Free water percentage calculation” according to ISO 29621.
Evaluation of the risk of microbial contamination in a cosmetic product by ISO 29621 method for the determination of water activity (Aw) parameter.
Challenge Test
The in vitro microbiological test is designed to be applied to finished products with the purpose of substantiating the claim “Efficacy of preservatives” according to ISO 11930.
Challenge test for the evaluation of the efficacy of preservative systems according to ISO guidelines (for cosmetics).
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