Preservative Market Update

April 27, 2007

Consumer groups, rather than knowledgeable cosmetic chemists, are dictating how products are preserved. And that has some industry experts worried.

Preservative Market Update

Consumer groups, rather than knowledgeable cosmetic chemists, are dictating how products are preserved. And that has some industry experts worried.

Tom Branna
Editorial Director

What’s worse, being regulated by a misinformed politician or a scientifically-challenged blogger? Unfortunately for household and personal product companies, both have a say in consumer product preservation these days and the troubling trend is having an impact on the industry.

In recent years, a host of non-government organizations (NGOs) have targeted parabens and other preservative systems. At the same time, some marketers and suppliers are hyping the launch of “natural” preservatives at the expense of traditional materials. All the confusion and inherent bad press has led some cosmetic companies to search for paraben alternatives and has left some industry experts to wonder if any preservative is safe in this hostile environment.
“The critical issue facing cosmetics companies today is the consumer’s perception about the safety of preservatives,” said David Steinberg, president, Steinberg & Associates. “Preservatives have been under attack for years and marketers are responding by taking some preservatives out of their formulas. In this climate, we won’t have any preservatives left!”

Mr. Steinberg, who formed the Cosmetic Preservative Council last year to defend this category of ingredients, criticized cosmetic companies for caving in to these non-informed NGOs.

Product contamination could lead to ocular damage.
“How long are companies going to wait before they speak up?” he asked. “Do we have to wait until someone is injured by a poorly-preserved product? We frequently hear of food recalls due to bacteria contamination. Will we start to hear more about cosmetic recalls as preservatives are hastily removed (from the market)?”

Executives at The Cosmetic, Toiletry and Fragrance Association (CTFA) note that while many activists focus on parabens, all the data remains very supportive of their safety and efficacy.

“Preservatives, especially the parabens, have been studied and shown to be safe,” explained John Bailey of CTFA. “The Cosmetic Ingredient Review has looked at them and determined that they are safe and provide an important function for the product.”

Mr. Bailey noted that while U.S. regulators have remained quiet on the subject of preservatives, hardly a week goes by without someone questioning their safety.

“They have absolutely no science to back up their claims, but the internet makes it very easy for misinformation to be disseminated and that only perpetuates misconceptions,” he charged.

Ironically, presently regulators in Japan seem to be the most level-headed when it comes to preservatives. For years, Japan was the most difficult country in the world to market a preservative and get it formulated into finished products. But in recent years, Japan has taken a back seat to the U.S. and Europe when it comes to causing headaches for suppliers and their customers. In fact, the Japanese have approved iodopropynyl butylcarbamate (IPBC) for use, but European regulators have questioned its safety and may restrict its use in leave-on body lotions. These agencies are concerned about the levels of iodine found in IPBC and regulators claim that iodine may be absorbed in the bloodstream.

EU Scrutinizes Preservatives

The latest EU Commission ATP on preservatives, which was released on March 22, amended the Cosmetic Directive's Annexes III (restricted substances) and VI (list of permitted preservatives). According to Lambros Kromidas, vice president of product integrity, Coty, the directive was amended to make it more clear regarding the use of preservatives with an asterisk.  He noted that in the list of preservatives there were several that could be used in concentrations other than those fixed in Annex VI for non-preservative purposes, provided the use purpose was apparent. 

“One could understand using a preservative for other purposes but how can it be used at higher levels than those specified in Annex VI?” he queried. “If it is not safe to use it at higher levels as a preservative, why would it be safe to use it at higher levels as something else? That did not make sense.”

As a result, the asterisk was deleted for several preservatives and added to a couple of others. Moreover, preservatives with an asterisk that may be added in higher concentrations (for other than preservation purposes) than those specified in Annex VI, would be listed in Annex III with their safe concentration limits. At the same time, the SCCP continues to study preservatives and is in the process of finalizing its conclusions, according to Mr. Bailey, who also noted that CTFA is working with Colipa, a European industry group, to defend and support the safety of these materials.   

The Impact of REACH

But tighter restrictions on preservatives aren’t the only troubling news coming out of Europe. During the past year, much has been written about the impact that the Registration, Evaluation and Authorization of Chemicals (REACH) will have on the industry. REACH was formally adopted on Dec. 30, 2006 by the Council of Environment Ministers and becomes effective on June 1.

While REACH will impact many categories in the global household and personal products industry, it could have dire implications for preservative suppliers and their customers, according to Mr. Steinberg, who told Happi preservative costs could quadruple. That’s because no chief executive officer will be willing to go through the high costs necessary to get a product registered under REACH when the long-term growth outlook has been declining about 10% a year.

An Industry United?

With regulators and NGOs firmly aligned on one side of the issue, several preservative suppliers told Happi that they have joined forces under the Cosmetic Preservative Council.

“The industry must organize,” noted Craig Carter of Lonza. “Lonza is an active participant in Cosmetic Preservative Council. The goal is to organize interested parties around these issues to garner support to defend these chemistries and provide a platform to educate consumers.”

Melissa Frischling of Lipo Chemicals agreed.

“The industry needs to be united against erroneous attacks which are often made on inconclusive information,” she said. “As a self-regulated industry, it is important that we are forthcoming with large scale test results to support the safety of our ingredients.”

According to Sangeetha Subramanian of International Specialty Products, the personal care industry needs to continue educating the end-consumer about the safety and efficacy of preservatives that have been used in consumer products for decades.

“Preservatives are an essential ingredient of the formulation,” she said. “They have been used successfully in the cosmetic industry for many years.”

Linda Sedlewicz of Schulke & Mayr said it is incumbent on industry, both raw material suppliers and finished good manufacturers, to let the public know that they go to great lengths to assure products are safe for consumer use.

“The industry as a whole, as well as individual manufacturers, should promote the safety and efficacy of our products,” said Ms. Sedlewicz. “If products were no longer marketed based on what they do not contain, we may find that there is less political pressure to remove materials that have been used safely for years.”

Dan Beio of RITA insisted that the industry must constantly try to maintain a consistent message.

“We are a reactionary society, we enjoy a good, negative press story,” he said. “However, we are also a very conscientious industry, which, for the most part, has done its homework and has the data to back up its product choices, claims and safety.  We need to be more aggressive with our industry-funded associations to more publicly share our data and knowledge.  We need to be more offensive in our messaging, rather than defensive as we’ve been in the past.”

Suppliers Respond

A number of years ago, Lonza launched a line of patent-pending synergistic preservative blends that are well known and have been used in food products for many years. As attacks have increased on conventional preservatives, Lonza’s customers have shown increased interest in alternative preservation solutions, several of which are on Ecocer’s positive list.

“Ecocert is increasingly emerging as a standard for determining which ingredients are considered natural,” explained Mr. Carter.

Louis L. Punto of Jeen International agreed that parabens have been used safely for many years but he also pointed out that cosmetic marketers must react when their customers question the use of these ingredients.  To meet the growing needs of paraben alternatives, Jeen International has developed a new line of preservatives that are paraben-free. The Jeecide CAP series of five different systems addresses the need of marketers to be paraben-free but also addresses the needs of cosmetic chemists for easy to use liquid systems that are globally approved, formaldehyde-free and have broad spectrum activity against bacteria, yeast and mold and are used at low concentrations without impacting formula stability.

“These five different systems were tailor-made for use in any type of cosmetic, pharmaceutical or I&I product,” said Mr. Punto.

A Range of Alternatives

ISP’s customers, too, demand alternative preservative systems to fit the overall claims they look to make with their products or to fit the markets in which they will be selling their products.

“For example, if a company plans to launch a formula in several countries, they are more apt to use a global preservative such as our LiquaPar range or the Optiphen range for paraben-free preservation,” explained Penny Antonopoulos of ISP. “Partnering with our customers enables ISP to develop new preservative solutions to address the changing market environment.”

ISP’s Optiphen ND is a broad-spectrum liquid preservative system that does not contain any halo-organic components, formaldehyde or formaldehyde releasers and is paraben-free. Germaben M is billed as an easy-to-use, broad spectrum, liquid preservative system of Germall II and methylparaben solubilized in propylene glycol. Also new is LiquaGard, a patent-pending liquid preservative blend of the highest grade of pure iodopropynyl butylcarbamate in a solvent, butylene glycol, according to ISP.

Optiphen MIT is a globally approved preservative based on 9.9% methylisothiazolinone in water, which can be used in products that are typically considered difficult to preserve with conventional preservatives. 

“Many biocidal ingredients are destroyed by conditions such as high temperature or alkaline environments and are ultimately deactivated,” explained Ms. Antonopoulos. “Optiphen MIT is well suited to protect even those products.”

At the same time, ISP has launched Optiphen MIT Plus, a patent-pending, globally-approved preservative blend based on 5.0% methylisothiazolinone in combination with a booster component, phenethyl alcohol. This combination widens the activity profile and provides broad spectrum protection, according to Ms. Antonopoulos.

Schulke & Mayr’s Euxyl K 700, K 701 and K 702 are all based on organic acid chemistry, are broad-spectrum and approved for global formulation.  

“The natural trend remains very strong, as is a desire for organic ingredients,” noted Ms. Sedlewicz. “The use of organic acids as preservatives in foods makes these materials appear much less threatening to consumers when they are seen on cosmetic labels, even though these materials are usually synthetically derived.”

With more marketers eager to try paraben alternatives, Vertellus Special-ties has reintroduced cetylpyridinium chloride (CPC) under a new brand name, ZeStat.

“CPC is not a new chemical but is being considered once again as formulators look for alternatives,” explained Jeannene Ackerman of Vertellus. “It is best known as an antibacterial for oral care.  However, it is also a very effective product for general product preservation.  ZeStat cetylpyridinium chloride has a long history of being safe and effective as an antibacterial compound.”

Mason Chemical has created many multifunctional alternative systems such as Enhansys ECO, which is designed to be eco-friendly and economical to address the regulatory issues and perceptions, according to Pat Lutz of Mason. In another development, Mason’s has launched Maquat SOY-QSX, which is a multifunctional hair care product with very unique properties and it  can help formulators create preservative-free formulations.

New Solutions?

To help its customers capitalize on the self-preservation trend, RITA has introduced Ritative AN, which is a blend of emulsifiers and humectants that have broad-spectrum microbiological activity. It can be used alone or in combination with other preservative to achieve the desired kill times. RITA is also promoting its line of lactylate ingredients that also have microbiological activity. 

“More companies are going to aseptic manufacturing and totally sealed packaging, which relieves the demand for preservatives as it minimizes potential for contamination,” added Mr. Beio. “Companies that are concerned with this situation are looking at all three of these options.”

In addition to eliminating parabens from their formulas, marketers are also removing phenoxyethanol from formulations, according to Daniela Storni of Sinerga. To meet these demands, Sinerga has launched Fenilight and Feniol. Sinerga describes Feniol as a well-balanced combination of widely-accepted and safe cosmetic ingredients which has a synergistic antimicrobial action, preventing microbial growth with a broad spectrum protection against Gram-negative bacteria, Gram-positive bacteria, yeasts and molds. It exhibits full bactericidal activity against Gram-positive and Gram-negative bacteria with a concentration of 0.4% and a fungicidal effect at levels of 0.7%.

To capitalize on the natural trend, Ciba launched Tinosan SDC last year. This preservative is a natural, silver-based preservative. Unlike earlier silver preservatives, in most systems, it will not darken—though highly cationic systems may be incompatible. It is said to be very effective against pseudo- monas, so it can be used as a stand-alone preservative and is effective at levels from 0.1-0.3%.

TRI-K Industries recently launched B52, a patented moisturizing active from RODA Research. It is based on benzyl PCA, which has documented bacteriostatic properties.

“B52 is a gentle, non-irritating moisturizer and emollient that can condition and protect the skin,” said Ben Blinder of TRI-K. “As a side benefit, it exhibits strong activity against bacteria, yeasts and mold.”

According to Mr. Blinder, it is an ideal component for any preservative-free cream, lotion, milk, shampoo or bath product and it is globally-approved. Although it is not classified as a preservative, TRI-K’s technical service department can offer many formulating suggestions.

“The natural and organic segment continues to grow,” observed Carole Smargon and Yvonne Quirk, Ciba. “Consumers want natural products as they view them as safer, but they also want these products to be efficacious.   If a product is organic or natural, then marketers should look to natural preservatives to preserve their products.”

Bio-Botanica introduced Suprapein, which it bills as a cost-effective, totally natural preservative with a broad-spectrum activity effective against many organisms.

“Bio-Botanica has taken an all-natural approach and developed totally natural preservatives,” explained Mark C. Sysler of Bio-Botanica. “This has been well received by the cosmetic and personal care industries and our products enable formulators to create all-natural products.”

The most significant trend impacting the cosmetic and personal care industries for preservatives is that towards all natural products and the elimination of artificial preservatives, noted Mr. Sysler. 

“‘Organic’ product companies should have natural preservative systems or risk presenting a less than desirable product,” he added.

Arch Chemicals offers preservative systems that are based on natural enzymes (Biovert), a patented synergistic blend of chlorphenesin and caprylyl glycol and phenoxyethanol (Mikrokill COS) and patented synergistic blend of chlorxylenol and caprylyl glycol and phenoxyethanol (Mikrokill PCC), and  lastly polyaminiopropyl biguanide (Cosmocil CQ). Since these technologies do not contain parabens, formaldehyde or isothiazolones they are not subject to the growing regulatory restrictions or negative press associated with these compounds, according to Steve Hinden of Arch.

“However no preservative system is completely immune from attack. The general public would rather not have preservatives in food and cosmetics,” he observed. “While there is a general aversion to the concept of preservation there is no practical alternative to ensuring product freshness on the shelf life and in-use.”

Marketing vs. R&D

Clearly, there are a lot of new preservative systems available to marketers. At the same time, cosmetic formulators continue to roll out a range of natural products that they insist are preserved with natural preservatives.

“With nearly one out of every three consumers seeking personal care products which claim to be natural, a profound change is occurring in the choice of preservative systems,” explained Mr. Hinden. “That accounts for the growing demand for ‘alternative systems’ that are consistent with these types of products.”

Despite the growing popularity of natural products and natural preservatives, some industry experts remain unconvinced about their efficacy.

“Many botanicals touted as preservatives are either unstable in formulation or weakly effective, and therefore much more work needs to be done in this area,” observed Mr. Blinder.

“We have screened dozens, and I mean dozens, of so-called natural preservatives and we are not impressed,” Mr. Kromidas told Happi. “None are as robust as the parabens, if they work at all.  From all the ones we screened, none of them can stand alone. They may make a great marketing story, but one better formulate smart.”

Unfortunately, at the rate things are going, even the most wily formulator could find him or herself working with a much smaller palette of preservative systems. Although some blame overzealous regulators and misinformed NGOs, some experts say the industry itself is partly to blame.

“To paraphrase Pogo, ‘we have met the enemy and he is us,’” observed Mr. Steinberg. “Marketing runs the cosmetic industry and that’s not going to change. And if marketing doesn’t want an ingredient, it must be taken out of the formulation! But what do you replace it with?”

In the coming years, the entire industry may be scrambling to find an answer to that question.

Looking for a preservative system for your new formula? A list of them starts on p. 84 in Happi