Navigating the Claim Substantiation Maze in Cosmetic Industry The Perspective of the Contract Laboratory Specialized in Animal-Free Testing

The skin is the largest organ that provides not only the unique, wide palette of color tones distinctive to human race, but also the critical protection needed against potentially harmful chemical, biological and environmental agents. Besides the natural process of ageing affecting the entire body as a complex biological system, skin additionally undergoes photo-ageing due to its continuous exposure to ultraviolet (UV) radiation. Signs of the biological ageing affecting the skin usually encompass changes in the texture (fine lines, deep wrinkles), firmness of cutaneous tissue (collagen destruction, tissue atrophy), vascular disorders (spider veins) and pigmentation heterogeneities (age spots, uneven skin tone) (Flament et al., 2013). While the natural ageing process depends on time and genetics and is unavoidable, the photoageing can be prevented by reducing the exposure to the damaging effects of the UV (from sun or artificial sources) that aggravate the other signs of natural ageing. Short and long term protection of the skin against the action of potentially harmful agents can be achieved by repeated applications of cosmetic products that provide mostly superficial effects intended primarily to cleanse and beautify the skin (Saraf and Kaur, 2010). Weather from natural sources or synthetic, the ingredients included in the composition of finished cosmetic products are selected for their demonstrated capacity to nourish the health, texture and integrity of the skin and to confer photo-protection (Draelos, 2010). In response to the increasing demand from consumers, cosmetic industry is continuously searching for novel, multifunctional, safe and efficacious ingredients formulated into products claiming benefits appealing to the consumer and preferably tested without the need of animals (Secchi et al., 2016). Both European and U.S. authorities require claims substantiation although the processes differ in several practical aspects. In the European Union, the cosmetic standards are set by the European Commission which then enforces their use by regulatory authorities of member countries that require manufacturers to register cosmetic products and provide proof of claims before the products reach the consumers (OJ EU L342, 2009). In the U.S., the Federal Drug Administration (FDA) and Federal Trade Commission have jurisdiction over cosmetic claims and individual states also have regulatory authority. Pre-market clearance of safety/ efficacy is not required (except for color additives), however manufacturers are expected to supply scientific support of the claims when requested by authorities. The safety and/or efficacy claims accompanying the cosmetic products may be based on the collective weight of evidence supplied by peer-reviewed scientific literature, patents, expert opinions, suppliers’ data, as well as by reliable, reproducible and statistically relevant scientific results of pre-clinical or clinical studies. Highlighting the biological effect of a unique ingredient or desirable benefit often provides the much needed fine-tuned market margin that successfully promotes new products to consumers.