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Sautebin L.; Understanding the Adverse Effects of Cosmetics. A Pilot Project in Cosmetovigilance; Drug safety 2008; 31(5): 433-436
Currently, cosmetics and toiletries are very popular and their use continues to increase because consumers consider physical appearance important and, at the same time, these products are considered to be safe. However, in spite of their safety and tolerability, during recent decades, we have become aware that adverse effects can occur. The number of adverse effects known so far is very low indeed. This is partly because such adverse effects are underestimated as a result of self diagnosis and self-medication, which are common behaviors’ in the presence of mild-to-moderate reactions, as in the case of cosmetics. Moreover, such effects are underestimated because of the absence of formal and reliable monitoring systems ('cosmetovigilance') - This requires the creation of a standard reporting form, as well as resolution concerning professional categories authorized to report and the subsequent validation/evaluation of the collected forms. All these items are of great importance, not only to investigate but also to prevent risks caused by cosmetic use. A pilot project was undertaken to test the effectiveness of a notification system by the validation of either a reporting form or the role of dermatologists and community pharmacists as reporting categories. Collection of reporting forms began in July 2006 and it is still in progress; the preliminary data reported here refer to the period July 2006-June 2007 and mainly concern the recording and validation of the collected reporting forms. During this period, we have received 40 reporting forms (32 by dermatologists and 8 by pharmacists). The validation process of the recorded forms revealed several drawbacks, such as incompleteness (19 forms), inadequacy of the description of the suspected undesirable effect and its location (2), illegible handwriting (6) and mistaken statements (3). Six forms reported a misuse of a cosmetic product: four of these were related to the site of application while two were related to time. In one case, instructions for use were not followed. In conclusion, our experience regarding the notification of adverse effects of cosmetics, although limited to a restricted geographical area, suggests that for an efficient and reliable monitoring system to be in place, which includes all the necessary measures to protect public health, an education and training programme for all stakeholders (health professionals, consumers and appropriate authorities) is required.
Moretti, U. & Velo, G.; Cosmetovigilance: The 'Beautiful' Risk ; Drug Safety 2008: 31 (5); 437-439
A cosmetic is classically defined as any preparation that is applied to the skin, eyes, mouth, hair or nails for the purpose of cleansing, enhancing appearance, giving a pleasant smell or giving protection. Unlike drugs, which are used to treat or prevent a disease in the body, cosmetics are not thought to change or affect the body's structure or functions. However, the distinction between drugs and cosmetics is sometimes not clear. Regulations for cosmetic products primarily address the safety of products that may be used by large populations of healthy consumers. However, the efficacy and safety of cosmetic products are not reviewed or approved by national authorities before they are sold to the public. The identification and analysis of adverse effects related to cosmetic products is a process that is currently still, to a large extent, industry driven. It is the responsibility of manufacturers to determine that products and ingredients are safe before they are marketed, an d then to collect reports of adverse reactions. However, although the manufacturers do their best to monitor the safety profile of their products, we should consider that there is always a potential inherent conflict of interest.
Nohynek, G.J., et al., Safety assessment of personal care products/cosmetics and their ingredients, Toxicol. Appl. Pharmacol. (2009), doi:10.1016/j.taap.2009.12.001
We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO(2) and ZnO in sunscreens. However, current evidence suggests that these particles are non-toxic, do not penetrate into or through normal or compromised human skin and, therefore, pose no risk to human health. The increasing use of natural plant ingredients in personal care products raised new safety issues that require novel approaches to their safety evaluation similar to those of plant-derived food ingredients. For example, the Threshold of Toxicological Concern (TTC) is a promising tool to assess the safety of substances present at trace levels as well as minor ingredients of plant-derived substances. The potential human systemic exposure to PCP ingredients is increasingly estimated on the basis of in vitro skin penetration data. However, new evidence suggests that the in vitro test may overestimate human systemic exposure to PCP ingredients due to the absence of metabolism in cadaver skin or misclassification of skin residues that, in vivo, remain in the stratum corneum or hair follicle openings, i.e. outside the living skin. Overall, today's safety assessment of PCP and their ingredients is not only based on science, but also on their respective regulatory status as well as other issues, such as the ethics of animal testing. Nevertheless, the record shows that today's PCP are safe and offer multiple benefits to quality of life and health of the consumer. In the interest of all stakeholders, consumers, regulatory bodies and producers, there is an urgent need for an international harmonization on the status and safety requirements of these products and their ingredients
Chua-Gocheco A., Bozzo P., Einarson A. Safety of hair products during pregnancy Canadian Family Physician Vol. 54: October 2008
QUESTION Several of my pregnant patients who are hairdressers have asked me if exposure to products they use is harmful to their unborn babies. They also want to know if their pregnant clients’ personal use of hair products should be of concern. ANSWER There is no evidence of teratogenic effects for pregnant women exposed to these products from occupational use (i.e., hairdressing); however, it is recommended that pregnant hairdressers wear gloves to minimize exposure, work for no more than 35 hours per week, avoid standing for prolonged periods of time, and ensure that the salons where they work have adequate ventilation. Evidence suggests there is minimal systemic absorption of hair products, so personal use by pregnant women 3 to 4 times throughout pregnancy is not considered to be of concern.
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