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'Borderline' Products

SpecialChem / Marie-Claude Martini – Nov 24, 2006

Legislation in the field of so-called 'borderline' products is completely different in Europe than in the USA. In Europe there is no OTC category for cosmetics. Only two categories of product exist for topical applications: cosmetics and drugs. It is for this reason that certain cosmetics can be very close to being drugs, depending on the ingredients used or the advertising claims made for them. To give a brief summary: a drug is linked to a marketing authorization given by the Ministry of Health and claims only a physiological action. If applied topically, it can act solely locally, but can also pass into general circulation to cause systemic action (be active on the whole organism). A cosmetic must have a detailed dossier but does not require a marketing authorization application. A simple manufacturing declaration suffices. It can claim only a physiological action on the skin or its structural components. It is applied topically and can have cutaneous action to varying depths but cannot be absorbed transcutaneously or pass into general circulation.

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