Expertise Réglementaire et Toxicologique
Regulatory and Toxicological Expertise
Our aim is to assist you in the creation of innovative and effective products which are in line with european regulation, and safe for both human health and the environment.
Test and analyzes
Various test and analyzes can be required in order to assess the safety on human health of the products :
Challenge-Test allows evaluation of the antimicrobial effectiveness of the preservative system of your product, based on the NF ISO 11930 standard or the European Pharmacopoeia (EP). This experimental technic consists in inoculating a known concentration of a microorganism in the product and to follow, by enumeration, its development.
Test for skin irritation
Test on reconstituted human tissues is an in vitro testing system which uses a reconstituted human epidermis that accurately reproduce the biochemical and physiological properties of the human skin. The product is applied locally on a three-dimensional human skin model and cell viability is measured subsequently.
Eye irritation test
Neutral Red Release Assay is an official alternative method allowing evaluation of the eye irritation potential by applying the product on corneal fibroblasts (order of December 27, 1999 relating to methods of analysis necessary for checking the composition of cosmetic products, French Official Gazette n°302 of 30 December 1990).
Agarose gel test is an alternative to animal testing allowing the evaluation of its eye irritation potential. Its principle is based on the determination of the product toxicity, 24 hours after it has been spread on the surface of the agarose gel which is covering a monolayer cell culture (French Official Gazette n°302 of 30 December 1990)
Het Cam test is an official alternative method allowing evaluation of the irritant potential of the product, performed by applying it on a membrane (order of November 29, 1996 relating to methods of analysis necessary for checking the composition of cosmetic products, French Official Gazette n°302 of 30 December 1990).
Patch test consists in a patch containing the product, which is applied on the back or the arm of a volunteer for 24 or 48 hours. Once the patch is removed, skin reactions are observed and evaluated.
Patch test and other tests
Photosensitization / phototoxicity / photoallergy tests are performed after exposure of the skin to light or radiations.
Test on reconstituted buccal or vaginal epithelium.
ERTC and partners offers testing and microbiological analyzes necessary for assessing the safety of your products with the help of in vitro alternative methods carried out in GLP certified laboratories.
ERTC SAS - RCS SEDAN SIRET : 808 049 96900013
Regulation on cosmetic products
Product Information File (PIF)
Toxicological profile of the ingredients
Safety assessment of cosmetic products
Validation of cosmetic labeling
Cosmetic Products Notification Portal (CPNP)