In the European Common Market antiperspirants are considered to be cosmetic products and are therefore subject to the European Cosmetic Directive. The definition of a cosmetic product is “any substance or preparation intended to come in contact with the various surface areas of the body (epidermis, hair, and capillaries, nails, lips, and external genital organs) or with the teeth and buccal mucosae, solely or principally for cleansing, perfuming, or protective purposes in order to maintain them in good condition, modify their appearance, and/or improve body odor, and/or protect or maintain them in good order” (5).
The European Cosmetic Directive has three essential objectives: (i) to ensure consumer safety, (ii) to harmonize legislation between the different Member States of the European Union, and (iii) to respond to the consumer’s need for information (5).
The overall impact of the Cosmetics Directive is to deliver safe products to the consumer. There is also the implication that the manufacturers should possess data that supports the product’s efficacy. However, unlike the OTC monograph for antiperspirants which sets a minimum standard of 20% reduction in axillary perspiration for an antiperspirant, there is no minimum level of efficacy stipulated.
Japan
In Japan antiperspirant products are controlled under the system of the Ministry of Health and Welfare (MHW). The regulation governing them is Japan’s Pharmaceutical Affairs Law (PAL). Antiperspirant products in Japan are regulated and classified as quasi-drugs. A quasi-drug is an article used only for certain purposes that are specifically designated by the MHW. Antiperspirants are categorized under body deodorant quasi-drugs based upon their indication of effects against body odor, perspiration odor, and suppression of
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Table 1 Data Required in Applications for Approval of Cosmetics and Quasi-Drugs
a May not be required under certain conditions. Abbreviations: X, required; NA, not applicable. |
perspiration (6). Quasi-drugs and cosmetics are clearly stipulated to be articles whose biological activities are gentle and mild. Table 1 presents a tabular summary of the data required in an application for approval of cosmetics and quasi-drugs.
The practical result of the U. S., EU, and Japanese regulatory control of antiperspirants is that to be in a global market place, such products require a high level of formulation and manufacturing expertise to ensure safety and efficacy.