Abstract: For some time, Brazil has been appointed as one of the greatest consumers of cosmetic products in the world. Although cosmetics may seem harmless, destined exclusively to enhance personal appearance or to clean and protect the skin, hair and nails, new studies and events are highlighting the need to evaluate the safety of such products. The present work interrelated the lifecycle of a cosmetic product with the safety trials and tests applicable to some cycle phases. From this information, a survey was made of accredited Conformity Assessment Bodies (CAB) and test facilities recognized by the General Coordination for Accreditation (CGCRE) which are competent respectively to carry out safety trials and tests of cosmetics. Twenty five competent laboratories were identified to carry out chemical and/or biological trials of cosmetics, according to the legislation ABNT ISO IEC 17025:2005, and 10 test facilities recognized by the Compliance Monitoring Program that can carry out tests of the development of a product for register purposes, aiming at human health and safety. It is interesting to notice that Brazil has accredited laboratories to carry out trials that are critical for the health of the population, such as the levels of heavy metals and the presence of pathogens. On the other hand, CGCRE does not have a program to recognize safety clinical trials. The importance of this kind of study is understood, considering the world history of adverse reactions and the great consumption of cosmetics in the country.
Abstract: Fragrances and fragranced formulated products are ubiquitous in society. Contact allergies to fragrance chemicals are among the most common findings when patch-testing patients with suspected allergic contact dermatitis, as well as in studies of contact allergy in the general population. The routine test materials for diagnosing fragrance allergy consist mainly of established mixes of fragrance compounds and natural extracts. The situation is more complex as several fragrance compounds have been shown to be transformed by activation inside or outside the skin via abiotic and/or biotic activation, thus increasing the risk of sensitization. For these fragrance chemicals, the parent compound is often non-allergenic or a very weak allergen, but potent sensitizers will be formed which can cause contact allergy. This review shows a series of fragrance chemicals with well-documented abiotic and/or biotic activation that are indicative and illustrative examples of the general problem. Other important aspects include new technologies such as ethosomes which may enhance both sensitization and elicitation, the effect on sensitization by the mixtures of fragrances found in commercial products and the effect of antioxidants. A contact allergy to fragrances may severely affect quality of life and many patients have multiple allergies which further impact their situation. Further experimental and clinical research is needed to increase the safety for the consumer.
Abstract: Whitening cosmetics with anti-melanogenesis activity are very popular worldwide. Many companies have tried to identify novel ingredients that show anti-melanogenesis effects for new product development. Among many plant-derived compounds, polyphenols are thought to be one of the most promising anti-melanogenesis ingredients. In order to prepare effective whitening polyphenols, 3,3,4,5,7-pentahydrosyflavone (quercetin) has been widely researched and applied to commercial products because it is present in high levels in many edible plants. Quercetin is thus a representative polyphenol and has recently gained attention in the cosmetics field. There are many controversies, however, regarding the effect of quercetin, based on in vitro studies, cell line experiments, and human trials. In this review, toxicity and efficacy data for quercetin and its derivatives in various experimental conditions (i.e., various cell lines, concentration ranges, and other parameters) were examined. Based on this analysis, quercetin itself is shown to be ineffective for hypopigmentation of human skin. However, a few types of quercetin derivatives (such as glycosides) show some activity in a concentration-dependent manner. This review provides clarity in the debate regarding the effects of quercetin.
Abstract: For several decades, the European Union (EU) has amongst its many tenets and principles the aim, enshrined in an EU Directive, that cosmetic products should not cause harm to the consumer. To a great extent, this is been successful, although it is noteworthy that the frequency of contact allergy to a number of ingredients commonly found in cosmetics has remained stubbornly high. Perhaps because of this, but certainly because of the drive by the European Commission towards better, more streamlined, regulation, the Directive was recast into a Regulation, usually referred to as the EU Cosmetics Regulation ((EC) No 1223/2009). As with the Directive, for each and every cosmetic product placed on the consumer market in the EU, a safety assessment is required. The Regulation requires that a dossier is prepared detailing the composition of the product, the safety of each of its ingredients, as well as an evaluation of overall product safety. This has to be completed by suitably trained and qualified assessors. Also relevant to cosmetic products are the general regulations pertaining to chemicals used in the EU where again many details of the toxicological profile must be ascertained and reviewed. On this basis, it should be possible to ensure that the extent of contact allergy attributed to cosmetic products declines. However, legislation is one thing, but it is also necessary to ensure that the cosmetic industry safety assessment process is completed in a rigourous manner (or even done at all) and that demands enforcement of the legislation.
Abstract: The paper provides an overview of existing Integrated Testing Strategies (ITS) for assessing hazard and potency of skin sensitization. The ITS research is active, diverse and constantly evolving as new assays are being developed and new mechanistic insights are discovered. Despite the need to assess potency, the majority of the ITS approaches developed to date assess hazard only. Reasons for this situation are analyzed and include, for example, the dynamic range of existing alternative assays versus the range of in vivo responses, but also sporadic use of kinetic information and molar units. Depending on the application, regulatory or product development, standardized and nonstandard ITS approaches will be developed. Challenges to practical applications, with focus on regulatory are discussed.
Abstract: The stratum corneum (SC), the most superficial layer of the skin, is directly responsible for the skin’s barrier function. The intercellular lipids in the SC play an important role in the regulation of the skin’s water-holding capacity. The modification of the intercellular lipid organization and composition may impair these properties. The aim of the present study is to describe a new in vitro approach of the repairing capacity evaluation of lipid formulations on skin with the use of absorption and desorption curves. The formulations were applied on lipid-extracted SC, and the possible SC reparation was assessed with the use of a thermogravimetric balance (DVS). Moisture absorption/desorption experiments proved to be adequate for the evaluation of the repairing capacity of formulations applied on damaged skin. Besides, freeze-substitution transmission electron microscopy (FSTEM) images showed some lipid bilayers, indicating a lipid bilayer reconstitution due to the applied formulations.