A Matter of Self-Preservation

By Tom Branna, Editorial Director | May 3, 2011

If marketers think that they can rework formulations and remove tried-and-true preservation systems, they face the prospect of contamination and, ultimately, backlash from consumers and health authorities.

And then there was one? Now, nobody is suggesting that public opinion and international regulations will ultimately narrow preferred preservative lists to a single ingredient, but there’s no doubt that non-government organizations and regulators have swayed the preservation conversation in recent years — much to the detriment of product stability, insist some industry observers.

Nearly every supplier contacted by Happi agrees that the industry has been impacted by articles and data that exaggerate the dangers of preservatives. Rosita Nunez, manager, commercial development, preservatives, Lonza, noted that some of them are not scientifically sound and many are misleading.

“Every few months, we receive inquiries from different customers asking about the validity of these same articles and data,” she explained. “We spend a good deal of time providing scientifically based information to our customers in response.”

According to Dan Beio, VP-R&D, RITA Corp., the biggest challenge that the industry faces regarding preservatives is education.

“The typical consumer just doesn’t have a good understanding of the need for preservation,” he observed. “They are being told by the press and some marketing companies that preservatives are toxic, harmful to humans, harmful to the environment and that they are possibly not needed. And, if you take the data out of context, you can see how they would come to these conclusions.”

Need an example? Just last month, in an April 11 issue of The New York Times, actress Mary Louise Parker attributed her good looks to clean living, a vegan diet and “trying to stay away from products containing parabens.”

Wrong Conclusions

It’s one thing for Hollywood-types to get their chemistry wrong. But when formulators come to a wrong conclusion, it can have an impact on public safety. Industry veteran David Steinberg, president of Steinberg & Associates, Inc., noted that he’s been getting more frequent phone calls from formulators who are complaining about contaminated batches. According to Steinberg, the higher frequency of contamination is frequently the result of chemists moving away from parabens and formaldehyde-releasing preservatives.

“(Formulators) give marketing whatever it wants and the end resultcan be contaminated batches,” asserted Steinberg. “So the question becomes, does marketing want to take care of these issues or pay more for strictly complying with GMPs?”

In fact, Steinberg asserts that some major companies are quietlymoving back to parabens because they know that these preservatives work and that there is no evidence that they are not safe.

“Parabens are back, we are supplying more material than ever, even to customers who were planning on removing the material from their products,” said Manny Balsamides Jr. of Protameen Chemical. “Most customers found that natural preservatives were not nearly as functional as parabens.”

He added that in their rush to remove parabens from their products, formulators were quick to try natural preservatives with no historical data to prove their stability.

While controversies with the media and NGOs cause problems for the industry, there are other issues that create headaches for suppliers.

Andrea Wingenfeld, ISP’s global business manager, preservatives, said that many personal care producers use similar preservatives in their plants, which heightens the risk that so-called “house bugs” may develop — bugs that need to be controlled by a high level of hygiene or increased preservative levels.

“A well balanced preservative system containing different active ingredients in the right ratios will help to protect the product against spoilage, and at the same time, help to maintain low preservative dosage ranges, an important route to ‘responsible care for the end-user,’” she noted.

EU OKs Parabens

Even European regulators have confirmed the safety of parabens. In December, the Scientific Committee on Consumer Safety (SCCS) published a paper titled “Opinion on Parabens.” The SCCS considers the use of butylparaben and propylparaben as preservatives in finished cosmetic products to be safe for the consumer, provided that the sum of their individual concentrations does not exceed 0.19%. This is a significantreduction from their old opinion of 0.4% for each. Other parabens, including methyl- and ethylparaben, are considered safe at concentrations of 0.4% or up to 0.8% combined. They also concluded that the isos (isopropylparabenand isobutylparaben) needed more data before that could recommend their continued use.

“I have mixed feelings about the ruling,” said Steinberg, who noted that his third edition of Cosmetics for Preservatives is due out later this year. “The bad news is that the ruling will require reformulation. The good news is that formulators were using too much anyway and the methyl and ethyl are the most water soluble and effective.”

What’s more, many of the SCCS rulings don’t mean all that much because they are not binding until the European Commission publishes these as Adaptations to Technical Progress (ATPs) and amends the Cosmetic Directive or Regulations. Many SCCS recommendations, according to Steinberg, languish in limbo as the Commission never acts onthem.

“About seventy-five percent of SCCS opinions are never acted upon,” he asserted.

Maybe so, but industry suppliers are still watching these developments carefully.

“Parabens are among the safest and most effective antifungal preservatives for use in cosmetics,” explained Linda Sedlewicz, country manager, schülke. “They are also relatively inexpensive, making them difficult to replace. The biggest threat to the use of parabens in personal care products today is the ban on branched-chain parabens proposed by the SCCS and the proposed Danish ban on all parabens for use in children’s products designed for use by kids under the age of 3.”

According to Sedlewicz, the ban will likely cause a further marketing backlash against all parabens.

“The Personal Care Product Council (PCPC) has been strenuously opposing these bans,” she noted. “Their opinion is that the parabens used in the production of personal care products are safe as used. This is also the opinion of most of the industry and supported by a significant amount of data and a history of safe use.”

In fact, the industry is addressing this issue by providing resources that consumers can access that provide information about the benefits of using preservatives to keep personal care products safe, noted Nunez. The PCPC, working with the industry, has created informational videos that are available on cosmeticsinfo.org, as well as on youtube.com.

But sometimes, concerted efforts by suppliers and industry associations isn’t enough.

“Even if considered safe by the SCCS of the European Commission, we still see a general trend to formulate without parabens,” said Jose Mosquera, global strategic marketing manager, Dow Microbial Control. “Therefore, we, at Dow Microbial Control offer a complete portfolio of products to preserve and protect cosmetics formulations, including effective alternatives to parabens.”

Mosquera said he anticipates new formulations to be preserved with alternatives to parabens while existing products would not be reformulated immediately. At the same time, cosmetics manufacturers are addressing this issue by reducing the occurrence of microbial contamination by working in more “clean-room” type environments.

Moreover, he warned that the common marketing tactic that proclaims products to be “free of” certain ingredients is taking its toll on product safety.

“As a consequence, other less known and less tested ingredients are entering cosmetics formulations,” according to Mosquera, who noted that regulators have lists of approved preservatives in many regions such as the EU. “However, the reality is that many approved preservatives are not used because of their negative public perceptions,” he observed.

Tal Green, personal care business unit manager, Sharon Laboratories Ltd., noted that the industry has been facing requests for non-preservative formulas or greener options in the past couple of years. Some customers are aiming for trends like short-chain parabens, others are trying to move toward options like organic acids combinations or non-preservative systems.

“The bad reputation that parabens have gained in the last few years was proved to have no scientific foundation,” noted Green. “Although we provide a wide array of other options regarding preservative systems, we know that most of the manufacturers of cosmetics continue to use parabens and the numbers speak for themselves. Many companies continue to work with parabens or short-chain parabens, although in some cases they keep looking for other solutions for new lines. The popular alternatives are the organic acid

preservative systems.”

In fact, Green asserts that the actions taken by the NGOs and marketers have not affected the availability and consumption of traditional preservatives.

“Although there is a niche following the green trend, we can say—based on the segmentation of our sales and the demands we are facing from our customers—that this is a rather small market that doesn’t affect the main mass market.”

Sharon Labs is providing other solutions to meet the green trend. For example, there has been an increase in the consumption of organic acids and these blends have become popular.

“All the preservative ingredients allowed by the legislation are available and still in use,” Green asserted.

Yet, the wide-ranging debate on preservatives continues to take its toll. According to Wingenfeld, on-going debate about preservative safety and pending plans by regulatory agencies to phase out some technologies may ultimately impact the type and number of preservatives available.

“For example, methyldibromoglutaronitrile is one preservative technology on the way out,” she told Happi.“Others may follow, further reducing preservation choices.”

The Problem with NaturalRegardless of how regulators vote, there’s no doubt that the limited number of preservatives that are available to formulators has severely impacted product safety as well as product performance. According to Beio, many of the“acceptable” preservatives being utilized are not as effective on a per-gram basis as many that are finding their way on to the do not use list.

“Let’s face it, preservatives are toxins, that’s their job,” he told Happi. “At the right level with the right combination, they take care of microorganisms within a manufactured product and package. The key words here are ‘right level’ and ‘right combination.’ Taking this into account allows us to use the absolute minimum to get the job done.”

He insists that some of the newer, more politically correct choices are not as effective and require very high levels in formulations. But, since they’re not as effective, they may not be able to kill all of the microorganisms as quickly as they once did. Moreover, Beio maintains that some of these levels have become so high, that they are now functioning as aesthetics ingredients in formulations, which requires the over use of other ingredients to compensate, like surfactants and emulsifiers, which can have their own negative effects of de-fatting and drying out the skin.

“We are all trying to avoid any product contamination and the less effective preservatives we use, the greater the potential,” he said.

Pat Lutz, president of Lincoln Manufacturing Inc., noted that it is a challenge to find all-natural or naturally-derived preservatives that are broad spectrum and cost effective like conventional preservatives. Lincoln says its new Linatural MBS (microbial blocking systems) are naturally-derived, inexpensive, preservative-free systems that block microorganisms from growing, thus keeping the formulation stable.

“These systems give the customer the option for a cost effective alternative to preservatives that block a broad spectrum of microorganisms from contaminating the formulation while the customer can claim preservative-free and no oils,” Lutz explained.

He said that another big issue confronting the preservative market is having reliable domestic manufacturing and a direct contact manufacturing person to discuss preservative choices. Lutz pointed out that with more mergers and manufacturing taking place outside the U.S., customers cannot get the services they need and the product turn around that they require.

“Lincoln Fine Ingredients has added to its commitment to address these issues by adding a Lincoln Manufacturing division last year and this year is expanding its capacity in Lincoln, RI to include three new reactors,” explained Lutz.

The company has increased warehousing and distributing throughout the U.S. and the world, he added.

What’s New from Suppliers?

According to Sedlewicz of schülke, the ever-shrinking number of well-accepted actives is the biggest limiting factor for the preservative market. She said that schülke’s expertise is in the development of innovative blends of available materials with antimicrobial properties.

“As the list of traditional preservatives at our disposal has become severely limited, we have focused our attention on more multifunctional materials,” said Sedlewicz. “Our most recent introduction, sensiva PA 20, is the result of our research into nature-identical materials.”

According to Sedlewicz, sensiva PA 20 combines phenethyl alcohol, traditionally used as a fragrance ingredient, with ethylhexylglycerin for its preservative boosting effect. “The result is a biodegradable blend that can maintain the microbiological stability of a wide range of products,” she said.

At In-Cosmetics in March, Dow Microbial Control introduced a new version of Kathon CG called Kathon CG III, aproprietary formulation which does not use nitrate salts, for additional compatibility with surfactants and ease of formulation, according to Mosquera, who said that there is also strong demand for Dow Microbial Control’s Neolone MIT-based preservatives. Finally, this month, the company will officially open a new customer application center in Australia.

Sharon Labs recently purchased new production high-tech gear. The investment of more than €1 million includes a building addition and up-to-date devices dedicated to increase the company’s production capacity. A new warehouse at Sharon Laboratories is now under construction by means of the latest technology in stock management. The state-of-the-art 3,800 square-meter facility is designed to sustain safety and environment as priorities, providing an operational and control system to improve procedures and increase stock holding capacity, according to the company. At press time, the first construction phase was scheduled to be complete by the end of April. The cost is estimated to be around €4 million. The investment in stock management and logistics is intended to strengthen the partnership with the customers. The goal is to expand the foundation for greater market supply.

According to Green, Sharon Labs’R&D is always innovating based on the needs of the clients, many times designing tailor-made blends for specific formulas. For example, Sharomix 705 Plus and Sharomix 706 Plus are paraben-, formaldehyde- and halogen-free.

“When using organic acids in a preservative system, oxidation may occur, which is why Sharon Labs created Sharomix 705 Plus and Sharomix 706 Plus,” explained Green. “These new versions of the already acknowledged blends Sharomix 705 and 706 will enjoy the benefits of vitamin E as an antioxidant.”

According to Sedlewicz, schülke is very focused on sustainability, both in its products and its processes.

“We are ISO 14001 certified for our environmental management system and were one of the first companies in the area of our headquarters in Germany to have its environmental management system confirmed and validated in accordance with the European Eco-Management and Audit Scheme (EMAS),” she explained. “Many of our euxyl line of preservative blends and all of our sensiva line of preservative boosters are biodegradable and all are produced with a focus on sustainable processing and quality manufacturing.”

Now, with the introduction of sensiva PA 20, schülke has a product that contains nature-identical phenethyl alcohol, boosted by ethylhexylglycerin, which can be used to maintain the microbiological stability of a wide variety of product types, according to Sedlewicz.

Lincoln Manufacturing has increased its capacity in Lincoln, RI, as well as adding new warehousing, sales staff and distributors throughout the U.S. and the world.

At the same time, in the past 12 months, Lincoln has added 12 new preservatives, including eight in 2011 alone. These include two all-natural preservatives, Linatural NLP-T, based on turmeric and clove bud oil, and Linatural NLP-B, based on basil and clove bud oils.

Lincoln has also expanded its global line of Lincoserve globally-approved alternative preservatives to include more blends from their domestic manufacturing, such as Lincoserve CG-2, 4 and 5 blends based on caprylyl glycol and phenoxyethanol. Finally, Lincocide IPBC-WS is a new, very unique, patent pending, water soluble fungicidal based on iodopropynyl butylcarbamate (IPBC) that also has other value added properties for formulations, according to Lutz.

Lonza’s Geogard line of preservatives is now Soil Association and NaTrue approved. According to Nunez, both were already Ecocert compliant, so now Lonza offers a preservative system that can be used in certified organic products in a number of regions.

ISP recently added Optiphen MIT Ultra, a patent-pending liquid blend of methylisothiazolinone with a booster that can be found naturally in flowers and fruits. This system addresses a range of regulatory, customer and formulator demands. The blend is applicable over a broad pH range, according to Sangeetha Subramanian, global marketing director, hair care and oral care, ISP.“We find that Optiphen MIT Ultra can be used to effectively preserve difficult-to-protect formulations,” she added.

Still, no matter how many products are available to formulators, the long-term health of the industry still comes down to education, according to Beio.

“We have preservatives that have been safely used for many years; we’ve developed very sophisticated testing and screening methods and we have great safety testing methodologies and historical data to draw upon to help us make smart decisions,” he explained. “This needs to be communicated to our customers, so they can feel as good about the preservatives we’re using as they do about the overall performance of the products.

“Preservatives, if properly used, are a good thing and add value to a product,” he continued. “Let’s stop being defensive and start becoming more offensive with our acquired knowledge.”