KARIN M. STOFFELS

Schülke & Mayr GmbH Robert-Koch-Strasse 2 Norderstedt, 22851, Germany

Abstract

The microbial safety of cosmetic products is an important consideration. It is integral to ensuring the stability of the products for the entire shelf- life and to preventing damage to health of the consumers. Currently, the number of accepted substances for microbial stabilization is limited due to legal restrictions or public discussion. Hurdle technology and the intelligent combination of multifunctional additives help to design microbiologically stable products. The synergistic blend of phenethyl alcohol and ethylhexylglycerin is an effective stabilization system, while consisting of 90 percent nature-identical material.

INTRODUCTION

The regulatory framework for preservatives varies in different regions. According to the EU Cosmetics Directive 76/768/EEC preservatives are substances “for the primary purpose of inhibiting the development of microorganisms” in cosmetic products. These substances are listed in Annex VI of the EU Cosmetics Directive (1). Japan lists preservatives in Annex III of the Japanese “Standard of Cosmetics” (2). Under the Federal Food, Drug, and Cosmetic Act in the USA, cosmetic ingredients, with the exception of colour additives, “do not require FDA approval before they go on the market. Companies who market cosmetics have the legal responsibility to ensure the safety of their products” (3).
In addition to legal requirements, the options for microbial stabilization are restricted by marketing demands. The movement to preservative-free or natural products and restrictions on certain actives, i.e. formaldehyde-releasers, isothiazolinones, etc., are increasing.
The desire to avoid cosmetic preservatives extends to all categories of traditional preservatives, leading to a limited number of accepted actives. Parabens, for exam ...