Safety Testing

SHAPYPRO carries out studies and clinical evaluations of safety testing on cosmetics within the framework of the requirements of the European Regulation on Cosmetics CE 1223/2009 of November 30, 2009 and the European Regulation EU 655/2013 of the Commission, of July 10, 2013, which establishes the common criteria to which claims relating to cosmetic products must respond, respectively.

Why conduct a In vivo safety test?

1. Validated or innovative efficacy assays to support your cosmetic claims.
2. Screening active ingredients, and characterize the efficacy of your cosmetic formulations.
3. Customized service for special requirements on your efficacy or safety tests.

Types In Vivo Safety Testing

1. PATCH TEST (Skin Compatibility Test):
   • Purpose: To assess skin compatibility and potential allergic reactions.
   • Method: A small amount of the cosmetic product is applied to a patch, which is then placed on the skin (usually on the back). The patch remains in place for 48 hours, and any skin reactions are observed.
   • Use: Identifies contact dermatitis or skin irritation caused by the product.
2. OPEN TEST (Skin Compatibility Test):
   • Purpose: Similar to the patch test, but the product is applied directly to a small area of the skin (such as the inner forearm).
   • Method: The product is applied, and any skin reactions are monitored.
   • Use: Evaluates immediate skin reactions.
3. ROAT (Repeat Open Application Test) (Skin Compatibility Test):
   • Purpose: To assess cumulative skin irritation.
   • Method: The product is applied repeatedly to a specific area (usually the forearm) for several weeks.
   • Use: Determines if prolonged use leads to skin irritation.
4. USAGE TEST (Skin Acceptability Test):
   • Purpose: To evaluate overall acceptability of a cosmetic product during regular use.
   • Method: Participants use the product as intended, and any adverse effects are recorded.
   • Use: Assesses real-world safety and acceptability.
5. NON-COMEDOGENICITY TEST:
   • Purpose: Determines if a product causes comedones (blackheads or whiteheads).
   • Method: Participants apply the product to their face, and comedone formation is assessed.
   • Use: Relevant for skincare products, especially those labeled as non-comedogenic.
6. FINAL CLINICAL SAFETY TEST (TCFS):
   • Purpose: Comprehensive safety evaluation of the finished cosmetic product.
   • Method: Involves various tests, including skin compatibility, eye irritation, and other relevant assessments.
   • Use: Ensures overall safety before market release.
7. SKIN SENSITIZATION TEST (Formerly HRIPT):
   • Purpose: Identifies potential allergens in a product.
   • Method: A group of volunteers is exposed to the test substance under controlled conditions.
   • Use: Determines if the product causes allergic reactions.
8. PHOTO IRRITATION AND/OR PHOTO SENSITIZATION:
   • Purpose: Assesses whether a product causes adverse reactions when exposed to sunlight or UV radiation.
   • Method: Volunteers are exposed to UV light after applying the product.
   • Use: Relevant for sunscreens and other sun-exposed products.

If you are interested in evaluating the safety testing of your products, ask us without obligation.