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  • Writer's pictureMargarida Lindo

The importance of performing safety tests on cosmetic products


According to Regulation (EC) No 1223/2009 of the European Parliament and of the Council, a cosmetic product made available on the market shall be safe for human health when used under normal and reasonably foreseeable conditions of use. 





Safety tests are a fundamental tool for guaranteeing the safety and well-being of consumers, as they assess whether products are safe and well tolerated, using strict criteria that consider the potential risks associated with cosmetic products. Furthermore, extending beyond the realm of safety, these tests play a central role for cosmetics companies to consistently uphold and guarantee the superior quality of their products. This commitment contributes significantly to the establishment and fortification of trustful relationships with customers, thereby enhancing the overall customer experience with cosmetic products.


Also, if a safety claim is to be made, it must be supported by adequate evidence such as by performing these tests.


Examples of these claims include:

  • "Dermatologically tested”;

  • “Suitable for sensitive skin”.


There are several safety tests for cosmetic products, each designed to assess specific potential hazards.


Some of the most common tests are:

  • Human Repeated Insult Patch Test (HRIPT);

  • Patch test;

  • Dermatological/ ophthalmological/gynecological/pediatric/ dental and urological acceptability;

  • Phototoxicity and photosensitization;

  • Comedogenicity and acnegenicity;

  • Salon test;

  • Tear test (no more tears testing).


These tests must be conducted following the guidelines and standards for clinical trials, such as the ICH E6 (R2) Good Clinical Practice - Scientific guideline, an international ethical and scientific quality standard for the designing, conducting, recording and reporting trials that involves the participation of human beings, preserving the integrity of the participants. In addition, the Declaration of Helsinki by the World Medical Association (WMA) establishes ethical principles for medical research involving human beings. According to this declaration, "It is the duty of the physician to promote and safeguard the health, well-being and rights of patients, including those who are involved in medical research". Cosmetics Europe - The Personal Care Association (COLIPA) also provides various guidelines, including the "Guidelines for the assessment of skin tolerance of potentially irritant cosmetic ingredients" and "Product test guidelines for the assessment of human skin compatibility".


As such, safety tests conducted on human beings, in compliance with legal and ethical requirements, strengthen consumer confidence in cosmetic products, guarantee their safety and well-being, and substantiate safety claims. Knowing that products have undergone rigorous testing before being put on the market makes consumers feel more confident about using them. This trust is essential for maintaining the reputation of companies and protecting the health of consumers.


Are you planning on carrying out safety tests for your cosmetic products? Pharmilab has a specialized laboratory for numerous tests. Contact us to speak to an expert and get more information!


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