The formulator’s guide to safe cosmetic preservation

This list is filled with a wide range of substances that have been raised with respect to antimicrobial efficacy and beyond that had little influence on the physical parameters of the cosmetic product. This comfortable situation has fundamentally changed in recent years. Today, the application of a growing number of listed preservatives has been restricted, due to their skin irritating or sensitising potentials. In some cases preservatives were first restricted and then finally even banned and deleted from the list. Because of an animal testing ban anchored in the Cosmetic Regulation, the development and listing of new preservatives has become extremely difficult. These circumstances are limiting the selection of approved preservatives and are complicating the development of new cosmetic products. This article tries to provide an overview of the present situation and to offer formulators a guidance for future decisions.

Cosmetic products in general, especially oil and water emulsions, offer microorganisms ideal growth conditions and therefore need to be preserved. Preservation is achieved by antimicrobial ingredients, whose properties also bear a potential for undesired skin side effects. This is why, years ago, legislators in Europe started to regulate the application of preservatives in cosmetic products. Preservatives, whose safety was evaluated in toxicological tests, have been listed since 1982 in the respective current version of the Cosmetic Directive/ Regulation, together with restrictions regarding the application, if necessary. The actual version of the positive list is Annex V of the 1223/2009/EG Cosmetic Regulation. Many Asian countries, like China, Korea, New Zealand and the ten ASEAN countries have adopted the Cosmetic Regulation together with Annex V for the establishment of their own regulatory system. Moreover, for many cosmetic companies in countries, e.g. Australia, the European Annex V serves as a regulatory guideline.

The approval of new preservatives in Annex V is a complex procedure, including extensive toxicological studies. Once approved, preservatives are subject to supervision by local authorities. They collect data about observed side effects and hand in this information to the ‘Scientific Committee on Consumer Safety’ (SCCS) of the European Commission. The SCCS consists of experts in the field. They evaluate the existing data and, if necessary, recommend to restrict the application of a preservative or even to delete it completely from Annex V.