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Active ingredients used in cosmetics: safety survey

Active ingredients used in cosmetics: safety survey

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Published by Council of Europe
Ingredients are used in cosmetics to give them specific properties. Certain ingredients, so called active ingredients, may produce pharmacological or toxic effects under certain conditions. Cosmetic products containing such ingredients may pose a health risk both because of their potential toxicity and because they may mask underlying serious diseases and consequently cause a dangerous delay in diagnosis and treatment.
The objective of this study is to give safety information on certain active ingredients which give raise to toxicological concerns and for which restrictions of use in cosmetics should be considered.
Monographs were prepared for 45 active ingredients for which no specific regulations exist including, inter alia, information about uses, properties, a risk evaluation of the use in cosmetic products considering as toxicological endpoints both systemic and local effects. Each monograph includes a bibliography, conclusions and recommendations.
The study complements a series of three volumes containing monographs about the safety of certain natural ingredients used in cosmetics and will serve as a useful reference in the field, for health authorities, manufacturers and health professionals in particular.
Ingredients are used in cosmetics to give them specific properties. Certain ingredients, so called active ingredients, may produce pharmacological or toxic effects under certain conditions. Cosmetic products containing such ingredients may pose a health risk both because of their potential toxicity and because they may mask underlying serious diseases and consequently cause a dangerous delay in diagnosis and treatment.
The objective of this study is to give safety information on certain active ingredients which give raise to toxicological concerns and for which restrictions of use in cosmetics should be considered.
Monographs were prepared for 45 active ingredients for which no specific regulations exist including, inter alia, information about uses, properties, a risk evaluation of the use in cosmetic products considering as toxicological endpoints both systemic and local effects. Each monograph includes a bibliography, conclusions and recommendations.
The study complements a series of three volumes containing monographs about the safety of certain natural ingredients used in cosmetics and will serve as a useful reference in the field, for health authorities, manufacturers and health professionals in particular.

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Published by: Council of Europe on Oct 27, 2010
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10/27/2010

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General background
The Council of Europe’s Committee of Experts on Cosmetic Products (the Committee) has observedthat many ingredients used in cosmetics have potential pharmacological effects. Of these ingredients,some are used in all the partial agreement states and some are used in only some of these states.Typically these ingredients are used to confer a specific cosmetic property on the product.Examples of conditions that the products are intended to be used for include dry skin, unclean skin,photo-aged skin, “fine lines” (wrinkles), “orange-peel” skin (so called from its surface resemblanceto orange peel), age spots, blotches, freckles, brittle nails, hair loss, dandruff, plaque, sensitive teeth,discoloured teeth, unpleasant odours, sweating, unpleasant conditions of the skin after sunbathing,and hygiene in the outer genital region (intimate products) or the feet.There is a consensus that cosmetic products containing certain active ingredients may pose a healthrisk both because of their potential toxicity and because they can mask underlying serious diseases inan early phase and consequently cause a dangerous delay in diagnosis.Some of these ingredients, when present in sufficient quantities, are capable of exerting pharmaco-logical and toxicological effects – for instance, they may eliminate or reduce:pain (camphor, menthol, methylsalicylate, ibuprofen),symptoms such as bulging veins, varicose veins, “spider” veins, swollen legs (escin, esculin, rutin),symptoms of immune system deficiency being manifested in the form of various fungus infections(the azoles discussed below),inflammatory symptoms (glycyrrhetinic acid and various xanthines, used to counteract orange-peelskin),slight gum bleeding, which may be a precursor of serious gingivitis (tranexamic acid).The substances in question could rightly be called active ingredients, by analogy with active principlesin medicinal products. Nearly all of them are, or have been, used for medical purposes also. In thosecases, their evaluation takes into account their medicinal properties as well as their toxicological pro-files. The evaluation of the benefit/risk ratio is not acceptable for cosmetics. Moreover the completesafety assessments as regards their use in cosmetics use may be missing.In this survey the Committee has only considered these active ingredients for which no specific regula-tions regarding their cosmetic use exist in any partial agreement member state.The Committee therefore thought it worthwhile to identify these ingredients and any potential safetyconcerns.Definition of an active ingredient (AI)In the context of this publication, “active ingredient” is defined as:“a substance used in cosmetic products with the aim of conferring specific cosmetic properties onthem. Certain of these active ingredients may have pharmacological and/or toxic effects under certainconditions of use (e.g. concentration, formulation, frequency of use, site and mode of application).”Included under this definition are not only ingredients conferring properties relating to some phar-macological potential, as mentioned, but also ingredients used for biocidal purposes in cosmeticsmaking secondary claim.Other sorts of “active” ingredients used in cosmetic products include ultraviolet (UV) absorbers, col-ourants for external parts of the body, and odorant molecules meant to provide a pleasant bodilyodour. The active ingredients in question are either rigorously regulated (UV filters, colourants), arethe subject of EU programmes to introduce their stricter regulation (hair dyes) or are being actively

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