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Antimicrobial Stabiliser

The topic of preservation is always of importance to formulators and finished good marketers. Formulators are aware of the necessity to adequately preserve their products in order to ensure product safety and be in compliance with the respective legislations. This task is made much more difficult when marketing requirements are added to the factors influencing the preservative choice. Demands such as global approval, soft preservation, „free of“ …, etc. have limited the number of acceptable actives.

Increasing marketing pressure has resulted in an interest in reducing the amount of traditional preservatives in cosmetic formulations or in finding novel ways to keep cosmetic products microbiologically stable. It is now more important than ever that preservation or microbiological stability is an integral part of new formulation concepts. At an early stage of product development, formulators must consider all possible methods of enhancing the efficacy of traditional preservative actives, e.g. using chelating agents or multifunctional materials. 

Microbial stabilisation of formulations

The regulatory framework for preservatives varies in different regions. According to the EC Regulation (EC) No 1223/2009 on cosmetic products “preservatives means substances which are exclusively or mainly intended to inhibit the development of microorganisms in the cosmetic product”. These substances are listed in Annex V of the EC Regulation [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].

Based on the definition of preservatives in the regulation on cosmetic products the application of multifunctional additives is possible. The prevailing purpose of these substances is not the inhibition of the development of microorganisms but have still certain effectiveness. E.g. ethanol can be used as a solvent, resulting in microbiologically low-risk product according to ISO 29621 [4], if used in a concentration ≥20%.

References

[1] Regulation (EC) No 1223/2009 on cosmetic products
[2] Japan - Standards for Cosmetics (Ministry of Health and Welfare Notification No.331 of 2000)
[3] USA - Cosmetic Ingredients
[4] ISO 29621:2010, Cosmetics - Microbiology - Guidelines for the risk assessment and identification of microbiologically low-risk products