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Proof of the efficacy of dermatological products is a prerequisite
for clinical testing and registration. Now, efficacy claims for
cosmetics must be equally substantiated. This book provides a
concise, practical but comprehensive overview of experimental
models used to screen, develop and select dermatological and
cosmetic formulations. The authors are recognized specialists in
their field and use a standardized approach to the projects
facilitating the reading for the stressed scientist, for the R+D
managers general view as well as for the beginners in the field.
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.
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