Cosmetics: Controlled Efficacy Studies and RegulationP. Elsner, Hans F. Merk, Howard I. Maibach th Together with the 6 Amendment - Council Directive 93/35 EEC - to the Cosmetic Directive 76/768 EEC it was the first time that, according to Article 7b, special claims of efficacy could be legally attributed to cosmetic products but under the obligation to make evidence of the claimed effects; also an entirely new "controller" was introduced - the independent "safety assessor", This indeed means not only progress in reliable and honest marketing arguments but above all transparency as to the respective proof and thus protection of consumer's health. Such claims demand high standards in scientifi cally based methodology and their results in order to prove such demands evidently. There are also within the 6" Amendment to the Cosmetic Directive in Article 4a strict restrictions as to the further use of conventional animal testing for cosmetic pro ducts and their ingredients and especially for finished products. Without doubt there is a competition between the necessity and expectations on consumer health on the one hand and the requirements of acknowledged protection of animals as done in Council Directive 86/609 EEC on the other. But at least, based on the present state of knowledge, tests in human beings cannot replace animal testing in all instances. Not only ethical reasons alone prohibit or impede testing in humans but also very often the lack of knowledge on functional and/or biological processes underlaying observed effects with the consequence that suitable experimental methodologies are missing. |
Contents
Legal Aspects | 43 |
Ethical Aspects for Conducting Human Studies | 50 |
Methods for Antiperspirant and Deodorant Efficacy Evaluations | 107 |
Copyright | |
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Other editions - View all
Cosmetics: Controlled Efficacy Studies and Regulation P. Elsner,Hans F. Merk,Howard I. Maibach Limited preview - 2012 |
Cosmetics: Controlled Efficacy Studies and Regulation P. Elsner,Hans F. Merk,Howard I. Maibach No preview available - 2013 |
Common terms and phrases
Acad Dermatol acid acne active advertising agents allergens allergic antiperspirant application Arch Dermatol assay assessment barrier creams Berardesca bioengineering Boca Raton cells chemical cleansing clinical comedogenic consumer Contact Dermatitis contact urticaria cosmetic cosmetic claims cosmetic products CRC Press cutaneous dandruff Dermatology developed drugs dry skin effect efficacy Elsner epidermis erythema European evaluation experimental exposure factor fiber formulation fragrances furfur genotoxicity guidelines hair horny layer human skin hydration hypoallergenic increased induced ingredients Invest Dermatol irritation ketoconazole Kligman lipids Malassezia measurements mechanical micronucleus moisturizers mutagenicity parameters patch test photoallergic photomutagenicity phototoxic Piérard potential procedure properties protection quasi-drugs reactions regulatory safety seborrhoeic dermatitis sebum sensitive Serup shampoo skin gloss skin surface Soc Cosmet Chem sodium lauryl sulfate standard stratum corneum subjects substance sunscreens surfactants T-cell Table techniques TEWL topical toxicity treatment vitro vivo washing