Tolerability of a Cosmetic Product: How Is It Evaluated?

It is essential that a cosmetic product does not pose a hazard to the consumer under normal or unusual but foreseeable conditions of use. To ensure this, there are safety tests performed by experts (doctor, toxicologist or holder of one of the diplomas specified in the regulations).

It should be noted that the ANSM (Agence nationale de sécurité du médicament et des produits de santé) can order a product to be withdrawn from the market at any time if it appears to it to be dangerous to human health.

Below are several safety tests that are usually performed before a cosmetic product is placed on the market. As a reminder, the performance of animal tests on the territory of the European Union has been prohibited for cosmetic products since September 2004 and for cosmetic ingredients since March 2009.

• The skin irritation test or patch test

  Before a skincare product is launched on the market, patch tests are performed on human volunteers at the final product stage. This involves applying the cosmetic product to the arm or back under an occlusive or semi-occlusive patch for a one-time period of 24 or 48 hours on several volunteers. Afterwards, it is assessed whether skin reactions occur when the patch is removed (under medical or dermatological supervision).

• The eye irritation test

  As the name suggests, this is the eye irritation test, which usually uses in vitro techniques (alternative methods to animal testing) such as HET-CAM (chicken egg chorio-allantoic membrane). The eye irritation test is performed on formulations intended for use on the eye contour area and/or eyelashes. It is also suitable for skin care products whose application provides for possible contact with the eyes. Cosmetological treatments include facial cleansers, shampoos and facial masks.

• The "use test"

  This involves testing the tolerance of repeated applications under normal conditions of use of the cosmetic product (2 to 3 weeks, 10 to 20 volunteers, sometimes testing is done in the crook of the elbow).

• The sensitization test

  These sensitization tests are called HRIPT (“Human Repeat Insult Patch Test”) or RIPT (“Repeat Insult Patch Test”). They are usually performed on a test field of 50, 100 or 200 volunteers who repeatedly apply patches containing the product of interest to the skin of the back over a period of six weeks. If reactions occur, they are observed, noted and interpreted by a dermatologist to confirm that the product is or is not an allergen. Incidentally, these tests allow a skin care product to be labeled "hypoallergenic" or not.

• The test for phototoxicity

  This test involves treating cells in vitro with the cosmetic product and then comparing the reactions obtained after the cells have or have not been exposed to UVA light.

The results of these various tests must be included in the documentation accompanying the launch of each cosmetic product. This documentation is called a DIP (Dossier d'Information Produit) and includes a section titled "Cosmetic Product Safety Report".