At ANMAR Clinical Services, we conduct clinical studies on healthy volunteers to evaluate the safety and efficacy of cosmetic products.
Guidance and compliance with European cosmetic product regulations
Our activity is carried out in accordance with the regulatory framework applicable to cosmetic products in the European Union. According to Regulation (EC) No. 1223/2009 of the European Parliament and of the Council, dated 30 November 2009, a cosmetic product is any substance or mixture intended to be placed in contact with the external parts of the human body —such as the epidermis, hair system, nails, lips and external genital organs— or with the teeth and the mucous membranes of the oral cavity, with the exclusive or main purpose of cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odors.
Certain parameters such as irritation potential, sensitizing potential, phototoxicity and other evaluations can be studied in humans using minimally invasive techniques with a high degree of reliability.
This regulation prohibits animal testing with ingredients or finished products and requires that any cosmetic product marketed within the European Union be safe for human health. For this reason, alternative methods to animal testing have been developed and validated, such as in vitro tests, enabling consumers to receive an equivalent level of protection.
European and national authorities are responsible for ensuring that cosmetic products available on the market comply with the established safety requirements. Their ingredients must be safe and low in toxicity, and the product’s sensitizing and irritating potential must be low and controlled.
To verify these parameters, at ANMAR Clinical Services we design and conduct clinical studies in healthy volunteers, tailored to the product type, its area of application and the objectives of each study.