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Shelf Life: The Future of Preservatives

By: Nancy Jeffries
Posted: September 5, 2008, from the August 2006 issue of GCI Magazine.

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Another aspect of the equation is the potential for the use of parabens and other preservatives outside of the United States. Right now, says Steinberg, unlike the EU and Japan, the U.S. doesn’t have a pre-approval process for preservatives. This is an area that can be quite costly, and in order to satisfy the criteria of the EU and Japan, companies may be faced with the prospect of spending a quarter of a million dollars for safety testing, costs that may not be supported by actual sales. “How do you justify spending one quarter of a million dollars for safety testing for $50,000 worth of sales?” asks Steinberg. Thus, the task of formulators is made more difficult when it is suggested they use universally acceptable ingredients (those permitted in Japan, the EU and Canada) or that the ingredients be natural or preservative-free.

Approval data varies, depending on the regulatory bodies in different areas. In the U.S., the FDA does not approve preservatives. It does, however, restrict or prohibit certain preservatives, which are noted on its negative list. The Cosmetic Ingredient Review has evaluated many preservatives, and currently rates them as safe up to a maximum concentration. The EU, which pre-approves preservatives, works on a positive list known as Annex VI of Preservatives Which Cosmetic Products May Contain—its Cosmetic Directive. There are currently 56 permitted preservatives. However, Steinberg notes that while the EU is looking at the safety of parabens, it is possible that it may de-list the longer C-3 and C-4 chain lengths, largely because it might be “too expensive to do the testing in relation to the business available.”

Steinberg believes that negative pre-conceptions about preservatives will translate into more pressure for cosmetic pre-approval and, ultimately, have a negative impact on the preservative industry. “How can you keep cosmetics without preservatives?” he asks. “You’ll have mold and bacteria.”

Ideal Antimicrobial Agents

According to Steinberg in his recent book Preservatives for Cosmetics, the ideal preservative does not exist and probably cannot exist, which is why combinations of preservatives are used. However, the ideal preservative or system will have broad-spectrum activity, enabling it to:

  • kill all types of micro-organisms,
  • be effective at low concentrations,
  • be water- or oil-insoluble,
  • be stable under all temperature and pH conditions,
  • be colorless and odorless, and not react with other ingredients to form colors or odor,
  • be compatible with other ingredients and not alter ingredient effectiveness,
  • retain shelf life activity for the intended life of the cosmetic, and
  • be safe to use.

In addition, preservatives should be easy to analyze for antimicrobial activity, easy-to-handle and inactivate, which could then be incorporated into the plates to prevent further activity or carry over. Ultimately, the preservative should be affordable and effective.