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Alternative preservation: options and developments

Ensuring that products remain stable, safe and suitable for use on skin is a highly important consideration for cosmetics manufacturers and the decision on how to preserve a product now requires searching through an increasingly wide range of ingredients. Key to this are ingredients that support claims within new trends for milder cosmetics. Richard Scott spoke to Daniel Winn, business director of Philadelphia-based specialty chemical company, Inolex, to discover more about alternative preservation.
PC: Inolex produces Preservation Systems. Could you explain how these ingredients work as a system? DW:: We start with the hurdle technology, which is a concept developed by the food industry in the 1960s, or perhaps even earlier, whereby we use multiple hurdles to make it difficult for microorganisms to live. We have various microorganisms in the cosmetics microbial challenge criteria that need to be addressed. There are four or more microorganisms that are important: Gram-positive and Gram-negative bacteria, yeast, and fungus. There are different hurdles that exist for each microorganism to thrive. In a sense, that is why a system is necessary to create the right hurdles for each of the specific microorganisms. PC: The supposed link between parabens and cancer made headlines in the middle of the last decade. How has your preservative offering changed since then? DW: It really hasnt at all. Weve been focused for over ten years on bringing hurdle technology into cosmetics, independent of regulatory concerns or consumer scares. Weve been reading the works of Jon Kabara and Don Orth who are leaders in cosmetic microbiology going back 25 or 30 years, and they simply said that it makes sense to reduce levels of biocide. Why? Because biocides, for the most part, were originally designed for water treatment, paints, coatings, home care applications, etc. They werent designed, per se, for the human skin. So those at the forefront of innovation have wanted to reduce and, if possible, eliminate 2 their use in cosmetics. It just makes good consumer sense, and good scientific sense to try to develop hurdle technologies that cost-effectively eliminate the need for biocides. The fact that the paraben scare comes along, or a new regulation comes along, certainly helps our sales but it doesnt change the good sense that we originally set out with. PC: You were quite ahead of the curve there, but the reason behind that was that you were trying to make your ingredients as skin-friendly as possible? DW: Yes but just in case. There is a risk to everything. Note that our position is that approved biocides are safe. Im not here, or we as a Company, are not here to attack biocides, or specific chemicals, or the biocides companies. I think those companies do a great job of designing molecules that are highly suitable for those types of applications. But for the consumer, the whole idea behind cosmetics is experiential. For example, there may be a physical benefit to moisturising your skin, or having shinier hair, but a good portion of consumer benefit is the repeating of the experience, the sensation of the fragrance, the overall sensory experience. So if the customer is fearful about what they are putting on their skin, it damages the experience. And were here to provide ingredients that help with the experience. Mild or alternative preservation help by reducing or allaying their fears. On the subject of whether or not it is friendlier to the skin, we do not over-sell the advantages to the skin. Some alternative systems have their own potential irritations to the skin. They are certainly highly non-toxic materials, and in general they are much milder than biocides in their inherent biochemical nature. But they can still irritate when used in high levels. So were not claiming a fully-fledged panacea. What we proposed is the use of low-level, non-biocidal materials that can, perhaps, reduce the risk of irritation and sensitisation, but that will almost certainly reduce the fear and anxiety of the consumer about applying biocides to their skin every day. PC: How big is the desire for paraben-free cosmetics and do you see this changing? DW: It is huge, and we do not see it changing. Obviously the paraben-free issue is good for our business, but the concept goes beyond this current trend. We have offerings that will help people who are concerned about meeting any kind of regulation or pseudo-regulation. For example, in markets such as Germany, cosmetic companies avoid isothiazolinones because of historical negative perception. So whether its a perception issue, or whether its an actual EU ban, we have alternatives that can help. PC: Do these ingredients work well in all types of formulations? DW: The first and second generation of alternative systems relied primarily on medium chain glycols, and these had difficulty against Aspergillus niger. Thus they were not effective in every type of formulation. In the first and second generation of technologies you always had this issue with Aspergillus niger and

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the formulator was always forced to try to address it. There are some strategies to overcome this, for example, by adding a biocide to the medium chain glycol. We proposed an Aspergillus niger strategy that involved formulating at lower pHs. And that was a good strategy for lotions and creams, but it was a relatively restrictive strategy for toiletries, such as shampoos and body washes. Thus the first and second generation products with alternative systems based on medium chain glycols were often not able to handle toiletries, or neutral pH systems in general. Inolex has a third generation technology called CHA (caprylhydroxamic acid), which is a chelating agent that chelates specifically the nutrient iron, and iron is the most important nutrient for Aspergillus niger. So by making an iron-deficient cosmetic were able to inhibit the ability of the fungus to grow. CHA creates a fungistatic environment. With our third generation of systems and the use of CHA were able to really tackle neutral pHs, toiletries and those types of formulas that were harder to approach with the early generations of medium chain glycols. PC: Is Inolex continuing to work on new non-paraben preservative systems? DW: Absolutely. I think that now we have the third generation systems that are robust in all different types of formulas we need to look at even gentler, more consumer-friendly products. Some consumers, particularly with regard to baby products, are starting to have a negative view of the word glycol or glycol-type materials, that could impact the barrier of baby skin. So were always looking to produce the mildest, most consumer-friendly systems possible. PC: With ever-growing scrutiny of formulations and claims, how is Inolex classifying and justifying the primary function of its preservative free systems? DW: Well, its very simple when Inolex suggest such a claim, we are proposing multi-functional ingredients that are not biocides. If you look at medium chain glycols, they are not historically used as biocides in any other application. Also if you look at chelating agents, they are not normally used as biocides in food, pharma or industrial applications. By anyones definition, these materials are not biocides. Again, our philosophy involves using a whole-formulation approach, using certain multifunctional ingredients that

have the added benefit of making the formula biostatic and fungistatic. This is what is meant by preservative free. Some people question the semantics behind the words, but we think the semantics are quite clear. Most of the traditional preservatives are industrial biocides in origin, and most of the new, gentle, mild systems that are preservation aids are multifunctional ingredients that are not industrial biocides. We feel the argument is strong and fair. Certainly Inolex is transparent to our customers, and ultimately to the consumer, about these materials and what they do. PC: Overall, in terms of preservative use, would you say that choosing the right preservative system for a product is about balance? Balancing the need for microbial safety with protecting the users skin. DW: Thats a reasonable statement, but I actually disagree with it. I think our

industry should be unreasonable when it comes to demanding that consumer products be safe. Safety is paramount, and we should use all scientific methods possible to make sure that your product is rigorously microbially controlled. Inolexs position, and those of visionaries like Kabara & Orth, is that use of biocides is only one aspect. And it is perhaps the easy out. If you dont have clean manufacturing, if you dont have good packaging, using large amounts of a biocide is a safety mechanism. We stand with those experts who say that it need not be more expensive, and it makes a lot more sense philosophically and commercially, to have clean manufacturing, great packaging and use very clean ingredients, and in addition use multifunctional ingredients that can reduce or eliminate the need for biocides. From a preservation perspective, making a safe cosmetic product involves multiple strategies. 3

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Only one of them is the option of using a biocide, and this should perhaps be the last option considered. PC: How rigorously do you test the efficacy of your blends? Do you perform long-term preservation studies on formulations containing them? DW: We perform a large number of challenge tests: the 28 day challenge test that is standard in our industry. We also do whats known as the double challenge test which runs up to six weeks. And also we perform free challenge tests for our customers when theyre trying these blends out for the first time. We havent done long-term consumer studies, as thats really up to our customers, the finished goods companies. However we are very much in touch with the microbiological community and those who have been involved in the European pharmacopeia and PCPC micro standards. All the experts feel that the standard 28 day challenge test is a very rigorous measure. Were very comfortable with the results of the hundreds of challenge tests weve done for our customers. Our first generation products have been on the market for many years; our third generation CHA products have been on the market since 2007. The CHA based blends have an excellent track record, and have passed over 99% of the challenge tests that we have done for our customers. PC: The issue of nitrosamines caused a move away from 2-bromo-2nitropropane-1,3-diol a few years ago, but this material is clearly returning to be a preservative of choice for many cosmetic companies. Is it a case of an over-reaction at the time, or that the industry has reacted and formulates to avoid such problems arising? DW: I think the industry is very sophisticated and can deal with the issues around Bronopol in terms of the formulation and avoiding nitrosamine formation. I think the whole issue of carcinogens in cosmetics has been blown vastly out of proportion. From an epidemiological perspective, all the questions of toxicity and carcinogenicity of these small amounts of materials in cosmetics are exaggerated. Thats my personal opinion. But going back again to consumer experience, it must be recognised that consumer psyche is fickle: a consumer is perfectly willing to drive a car in a traffic jam and inhale exhaust fumes for two hours a day and thats fine, but when they apply a cream or a lotion directly to their skin, and hear some questionable media reports, it is the cosmetic product that triggers their health fears. The ingredient suppliers are not in a position to challenge consumers on the standards and the logic behind their actions. Were only in a position to alleviate their fears as reasonably and economically as possible. PC: Inolex is proud of its market-based approach, and the need for alternative preservative systems resulted from market pressure. Do you view these trends as initiators of innovation rather than obstacles to innovation? DW: Yes absolutely, you cannot force consumers towards any particular chemical whether its a preservative or any kind of other chemical. Consumers can develop a strong fear and negative outlook against any one chemistry that our industry might produce. Or they can develop a negativity towards other characteristics such as animal-derivatives or animal testing. Inolexs perspective is that if something is impinging on the consumer experience, we will try to develop a better ingredient PC that avoids this.

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P E R S O N A L C A R E Reprinted from November 2011