Safety, of cosmetic products

The history of cosmetology, past experience with the safety of cosmetic products, and in particular statistics published by poisoning advisory centers show that the cosmetic industry in general has met these criteria [55], This is achieved by continuously evolving safety assessment strategies which take into account the actual state of the art in safety and toxicity testing. 

The efficacy of a cosmetic product can be defined as the capacity to provide the desired effect. The safety of cosmetic products is of great importance because these products are used without medical supervision, on sensitive areas of the body and/or for long periods of time. The safety relates to composition, packaging, and information and responsibility... 

The way in which advanced research in pharmaceutical, nutraceutical and chemical products has influenced the cosmetics industry is increasingly significant and will continue to grow. This brief review of just a few of the many examples of innovative active ingredients used in cosmetics is only the tip of the iceberg as this exciting research will lead to huge advances in the effectiveness and safety of cosmetic products. 

In the last 50 years, skin sensitisation potential assessment has been of paramount importance for ensuring the safety of cosmetic products. Different human sensitisation tests, such as Schwartz-Peck test (Schwartz, 1969), human repeated insult patch tests (Marzulli and Maibach, 1973 Griffith and Buehler, 1976) and human maximisation test (Kligman and Epstein, 1975), have been used but standardised test guideUnes are not available and the tests have not undergone an official validation process. 

Vicki Barwick obtained a first degree in Chemistry from the University of Nottingham. She then joined the Laboratory of the Government Chemist (which became LGC in 1996) as an analyst in the Consumer Safety Group. Vicki was involved with a number of projects to assess the safety of consumer products, including developing test methods for the identification of colourants in cosmetics and the quantitation of phthalate plasticizers in child-care items. 

The Food Drug Administration has the responsibility for the premarket clearance of all animal drugs. The 1958 food additive amendment to the Federal Food, Drug Cosmetic Act requires sponsors to demonstrate the safety of their products. The Kefauver-Harris amendment of 1962 requires the sponsors to demonstrate, in addition to safety, the efficacy of their drugs. Safety implies safety to the animal as well as to the consumers of animal products. The role of the Center for Veterinary Medicine in the premarket approval process is to establish conditions of drug use and to establish the allowable tolerances for drug residues in animal-derived food products. 

The Scientific Committee on Consumer Products (SCCP) handles questions concerning the safety of consumer products (nonfood products intended for the consumer). In particular, the Committee addresses questions in relation to the safety and allergenic properties of cosmetic products and ingredients with respect to their impact on consumer health, toys, textiles, clothing, personal care products, domestic products such as detergents, and consumer services such as tattooing (EU 2006f). 

Cosmetic ingredients are natural or synthesized chemicals entering in the preparation/formulation of cosmetic products. According to the Cosmetics Directive 76/768/EEC (1), cosmetic products placed on the market must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use. The cosmetics manufacturers have to ensure the safety of their cosmetic products prior to marketing. However, the European Commission can adopt, on the basis of advice of the Scientific Committee on Consumer Products (SCCP), measures to limit or to forbid the commercialization of cosmetic products containing ingredients with safety concerns. 

Besides their utilization in the production of many compounds with therapeutic, diagnostic, and immunizing applications, animal cell cultures have undoubted utility in the performance of in vitro cytotoxicity tests. They can be used for the evaluation of potential anti-neoplastic agents and assessment of the safety of various products, such as pharmaceuticals, cosmetics, alimentary additives, pesticides, and industrial chemical products. Cell culture systems are frequently employed in the cancer chemotherapy field, in which their potential value for viability and cytotoxicity tests is largely accepted. Animal models play an important role in toxicity testing, but the pressure to adopt in vitro tests is growing since they present considerable economical advantages over in vivo tests. The use of animal models is limited to human metabolism studies, and there are... 

The pH-values of cosmetic products are often stated on the packaging or mentioned in advertisements. Expressions like pH neutral or skin friendly pH are used, and their role is usually to convince customers about mildness and safety of the product, or its suitability for intended use, for example, low pH of a product for intimate hygiene or sensitive skin. 

In most cases, skin moisturizers are intended to keep the skin in a good condition, and are therefore considered as cosmetic/hygienic products and must comply with the legislation for these products. The manufacturer is in principle responsible for the safety of each product. However, in addition, the legislation in many countries may restrict the use of certain ingredients, and demand specific documentation of ingredients and the final product. 

Rogier V, Balls M, Basketter D, et al. (1999) The Potential Use of Non-invasive Methods in the Safety Assessment of Cosmetic Products. The Report and Recommendations of ECVAM/EEMCO (The European Group for Efficacy Measurements on Cosmetics and Other Topical Products) Workshop 36. European Commission, Institute for Health and Consumer Protection, European Centre for Validation of Alternative Methods (ECVAM). 

ANVISA (2012) Guide for the safety evaluation of cosmetic products, 2nd ed. Brasilia, 74 pp... 

Collaboration between academia and the pharmaceutical industry on basic research diminished steadily between 1940 and the 1970s as alternative sources of support for university research (mainly the government) increased and as the growth in industrial research laboratories reduced firms reliance on academia (415). Yet, the amount of clinical research sponsored by the industry and conducted by academia grew significantly over this period, particularly after the 1962 amendments to the Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.) required drug sponsors to establish effectiveness as well as safety of new products. 

In summary, although there is considerable evidence that parabens can penetrate into the skin, permeation and systemic availability of intact compounds are likely to be considerably reduced by transcutaneous and systemic metabolism. Furthermore, since these preservatives are present at concentrations of 0.1-0.2 percent w/w in topical pharmaceutical formulations, in-use dermal exposure to these compounds will be relatively low. In the cosmetic industry, there is a trend toward preservative-free and self-preserving formulations (Kabara and Orth 1997). However, before starting down this road, the pharmaceutical formulator must consider the potential implications on the efficacy and safety of the product. 

The analytes of main interest in cosmetic formulations are those related to the efficacy and safety of the products. 

Micro-organism limits (see Table 4) are listed in guidelines published in Annex VIII of the SCCNFP/031/00 Final (The Scientific Committee on Cosmetic Products and Non-Food Products Intended for Consumers). They also reflect the dermatological and toxicological safety of cosmetic materials. 

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