Product contamination is no longer the biggest bugaboo for preservative manufacturers, as every company in the category offers an array of effective products that can stop even the most persistent pests such as bacteria, yeasts and molds. Rather, suppliers must contend with negative press reports, inaccurate information from the internet and aggressive campaigns by environmental groups, many of which would try to limit or eliminate key preservatives from a formulator’s tool kit. Those are the kinds of issues that can cause headaches for suppliers around the world—particularly paraben suppliers—and it demonstrates the need for the industry to get the word out about the important health benefits that result from effective preservative systems.

“Preservatives and preservative manufacturers are under attack,” asserted industry expert David Steinberg, president, Steinberg and Associates.

In their rush to condemn select preservation systems, industry detractors often fail to note the important role that preservatives play in maintaining product integrity and, ultimately, human health.

Without proper preservation, the consumer could contaminate a product each time she applies it.

These attacks come at a time when current Congressional bills are considering an overhaul of FDA’s regulatory authority over cosmetics. In March, the Health Subcommittee of the House Committee on Energy and Commerce held a hearing examining the current state of cosmetics. Although industry groups such as the Personal Care Product Council are advocating for additional safeguards as science and technology evolves, the ever-widening rift in Washington between Democrats and Republicans means more gridlock in the nation’s Capitol.

“I don’t see the extremist bill (H.R. 2359, the Safe Cosmetics Act of 2011) going anywhere, nor the industry bill going anywhere and so, ultimately, nothing will happen,” observed Steinberg. “But if nothing happens, there will be more state legislation.”

Rather, Steinberg favors H.R. 4395, a bill sponsored by Rep. Leonard Lance (R-NJ). His bill is supported by the Personal Care Product Council. At the same time, Steinberg warned that as demand for all things natural continues to grow, the cases of product contamination continues to grow with it.

“This is the craziest it’s ever been,” he insisted. “I have never seen the country so divided and the extremists having so much impact on the press.”

If pressure from regulators isn’t enough, erroneous information from the internet has industry and its representatives scrambling on a regular basis.

According to Linda Sedlewicz, country manager, schülke inc., the ease of access to information (or misinformation) on the internet has caused the industry to become very reactionary.

“Marketing has recently been more about what isn’t in our products than what makes them the best,” she noted.

Other industry experts agree with Sedlewicz, pointing out that a range of preservatives have come under fire in recent years led, of course, by parabens.

“Parabens are the most commonly used preservatives in the personal care industry but they are also the most controversial,” noted Manny Balsamides, president, Protameen Chemicals.“AlthoughEurope and the Cosmetic Ingredient Review continue to support the use of parabens, the existing controversy surrounding their use is based on consumer fears andcompanies’ willingness to conform to their demands.”

Replacing parabens continues to require significant R&D investment in formulating and preservative efficacy testing, noted Marc Connell, director of new innovations, Jeen International. He told Happi that Jeen International is leading the way with formulation-friendly new products including the Jeecide CAP Series and two “greener” preservative alternatives, Jeeplex NAS and NAS-CG.

Parabens aren’t the only preservatives coming under fire from regulators and NGOs. As a result, industry experts say that formulators are also searching for cost-effective alternatives for formaldehyde donors, isothiazolinones, glycols and other conventional preservatives. To help them find an alternative, Lincoln Manufacturing has more than 23 alternative preservative systems, such as its Linatural MBS series, which gives the customer a natural, cost-effective, non-oil, broad spectrum alternative preservative system, according to Pat Lutz, president, Lincoln Manufacturing.

With so many raw materials receiving negative press, Sedlewicz maintained that schülke is uniquely positioned to react quickly to customer needs.

“Our expertise has always been in blending the available preservative materials to obtain optimal activity. This affords us a flexibility that few other suppliers have,” she said. “Within our euxyl line of preservative blends and our sensiva line of preservative boosters, our customers can find a system that will fit almost any product requirements.”

Don’t forget, household cleaners require preservatives too.

Expertise is easy to find in the preservative category. Late last year, Lonza Personal Care merged with Arch Personal Care to create the world’s leading microbial control business, offering a broad portfolio of registered and approved preservation and protection systems in addition to active ingredients, according to Laura Szymczak, global marketing manager, personal care preservation, Lonza Personal Care. Lonza’s portfolio of preservation and protection systems includes solutions that are broad spectrum, globally approved, have comprehensive toxicology clearance, are cost effective and meet the needs of many regions, including emerging markets, according to Szymczak.

“Lonza Personal Care offers solutions that are market standards as well as alternatives such as Ecocert-certified options, and have numerous preservation brands with enough variety to allow customers choices,” she noted.

Reza Kamarei, VP-science and technology, Sabinsa, agreed that the biggest issue confronting the preservative market is the potential for misinformation that impacts formulator’s choice in product preservation and misleading consumers. But, at the same time, Kamarei noted that consumers are rapidly adopting a natural lifestyle with a paradigm shift toward health and wellbeing that endorses green living and sustainability. Similar to food and dietary supplements, interest in personal care products is gradually shifting in natural preservatives, natural pesticides, natural colors, natural flavors and natural fragrances.

“Sabinsa strives to define sustainable development of its ingredients including preservatives and showcase its potent futuristic prototypes for the personal care industry which would leave a long-lasting impact,” she explained.

At Inolex, the emphasis is on the use of multifunctional, non-biocide materials that create a self-preserving formulation—across more product forms.

“It is not just skin care products seeking to make preservative-free or paraben-free claims, but almost every product category,” explained Dan Winn, business director, Inolex. “We see baby products, hair products, bath products, and even wipe manufacturers seeking to implement the biostatic approach.”
Such an approach requires a lot of formulation insight that, in turn, puts pressure on the Inolex team to offer both the formulation expertise and a wide ingredient portfolio to the personal care companies.

“Our whole sales and marketing team must be experts,” said Winn. “At Inolex, we can’t just talk preservativesin the old way, which was to recommend a particular biocide. Instead we must provide a whole strategy for how to implement the ‘hurdle technology.’”

Regulatory Hotspots
In the US, the addition of CDEA to Prop 65 is the hot topic for this year. As this was not unexpected, Rhodia has prepared a range of liquid CMEA and CMIPA delivery options. These efficient CDEA alternatives are said to significantly reduce Green House Gas emissions by delivering CMEA or CMIPA in a cold-process, easy-to-use, liquid form, according to Rhodia.

Keeping up with changing regulatory compliance requirements worldwide in countries such as Canada and China as well as the upcoming 2013 changes in Europe remain at the top of the list for Jeen’s business, according to Connell. To stay on top of these regulatory issues, Jeen is active with the Personal Care Products Council and constantly monitors key trade publications and peer review journals.

“We also have found that working with several regulatory agents throughout the world has been instrumental in advising us on the ever-changing regulatory landscape,” he added.

Shampoo and other bath products are prime candidates for contamination.

The questionable status of parabens in the EU continues to put pressure on formulators to remove these preservatives from their personal care product formulations. According to Sedlewicz, this sort of regulatory pressure has been felt by the preservative industry for many years and schülke has made it a priority to be proactive in addressing the issue. In 1996, schülke launched its first organic acid-based preservative blend (euxyl K 702) to be used in systems where more traditional preservative systems were not acceptable. Since then, schülke has expanded this range to include a wide variety of organic acid blend systems to address the changing needs of the market. For example, in 2004, the company launched euxyl PE 9010 as a direct replacement for traditional phenoxyethanol/paraben blends.

“Additionally, we offer the sensiva range of preservative boosters that can improve the microbiological stability of cosmetic systems without the use of more traditional actives,” Sedlewicz explained.
The most recent addition to this line is sensiva PA 20. This blend of nature-identical phenethyl alcohol and the preservative booster ethylhexylglycerin can be used to produce microbiologically stable products without the use of traditional preservative materials, according to the company.

And although European and Canadian scientific authorities have confirmed that triclosan as used in personal care products poses no risk to human or environmental safety, there are still products where an alternative is preferred. For these systems, schülke has launched sensidin DO, which is said to effectively control odor-causing bacteria at low use levels. It is colorless and practically odorless, with broad pH and temperature stability.

If regulatory pressure in the EU and US weren’t enough, China is now a concern for at least one preservative supplier.

“Most major personal care producers want to do business in China, and they need their ingredients to be China compliant,” observed Winn. “However, the SFDA has not clarified how it will handle new ingredient technologies. Right now suppliers are under the impression that any new ingredient since 2004 may find resistance from Chinese authorities.”

He explained that Inolex’s most advanced hurdle technology concept is the CHA technology (capryhydroxamic acid), which is a chelating agent that enables fungistatic formulation.
“This technology is post-2004,” observed Winn. “So it is crucial for Inolex and its customers to resolve the Chinese regulatory situation.”

Not every challenge comes from regulators. According to Lutz, one of the biggest issues confronting the preservative market is finding preservatives that are domestically manufactured. Nowadays, with company mergers and most manufacturing done outside the US, customers are looking for domestic manufacturing to get consistent quality products with fewer hassles and faster turnaround—be it in manufacturing time and/or having stock in the US.

To address this issue, Lincoln Fine Ingredients has it own manufacturing division, Lincoln Manufacturing, to improve the quality of preservatives and reduce turnaround time. This gives the customer direct contact with the manufacturer, according to company officials.

More New Products
In addition, Lincoln Manufacturing has added more than 10 preservatives in the past 12 months. Lincoln’s natural preservative line, Linatural MBS (Microbial Blocking Systems), which was introduced last year, has been expanded to include cost-effective, water-white, low-odor systems.

Lincoln is taking a lead position this year by adding Linatural MBS-Pro. They are natural, preservative boosters designed for more professional and salon type personal care products. The Pro line offers multifunctional activity such as emolliency, moisturization and/or a humectant effect for facial cream and lotions while naturally boosting overall product preservation.

Also new is Lincoserve HpH, a new line of globally approved, alternative, high pH preservatives. They are designed to work in formulations that are above pH7. Finally, Lincoln has added a certified organic natural and whole foods listed preservatives.

Jeen International recently launched Jeeplex NAS and Jeeplex NAS-CG greener preservative alternatives. Both are free of parabens—a key issue for most formulators—as well as formaldehyde releasers and represent the latest in “greener” Jeen technologies.

These products contain a proprietary blend of naturally occurring organic acids, which have broad antimicrobial activity across a wide pH range. Jeeplex NAS has also recently been granted EPA registration for a variety of hard-surface applications.

The Jeeplex line delivers “greenovation” with these safe and effective preservative-alternative products, according to Connell.

Inolex continues to investigate new ways of delivering CHA technology into multifunctional systems that implement the “hurdle” approach to preservation.

Its most recent offering is Zeastat, a mixture of CHA and Zemea, the natural glycol from DuPont Tate & Lyle. Next month, Inolex will expand its Spectrastat L Series. These offer strong glycol and CHA performance in completely liquid form designed for cold process toiletries and wipe manufacturers, according to Winn.

For household cleaning product formulators, Purac offers Sanilac, a registered L-lactic acid biocide for use in disinfection and sanitizing cleaners, and home care products. In the US, it is registered under FIFRA and in Europe, it is notified at the Biocidal Product Directive 98/8/EC for product types 2, 3, 4 and 6.

“Sanilac is widely used in household detergents due to its excellent fit in today’s search for environmentally friendly yet effective cleaning and disinfection,” explained Ewa Dratwa of Purac. (For more on household product preservation, see p. 77.)

Natural Alternatives
Sabinsa offers a range of proprietary blends of natural antimicrobial actives that will help meet the all-too-common challenge of finding an effective natural preservative for use in cosmetics and personal care products.

A classic example is SabiLize-New, a natural preservative with proven efficacy that is better than parabens, according to Kamarei. This proprietary blend of natural ingredients includes essential oil fractions and extracts with antimicrobial and antioxidant activities with proven preservative efficacy for stabilizing cosmetic and personal care formulations.

The proliferation of green products and “preservative-free” claims make product preservation more complicated than ever.

“In recent years, there has been increased dialogue related to natural antimicrobials as topical actives and preservatives in the personal care industry,” explained Kamarei, who also noted that synthetic compounds long-accepted as effective in controlling microbial growth have come under scientific and regulatory scrutiny.

“These efforts are mainly driven by safety and environmental concerns, and the increased incidence of antibiotic resistant microbial strains,” she added. “Natural alternatives derived from botanicals are therefore being explored by researchers across the world for their preservative benefits.”

At In-Cosmetics last month, Sharon Laboratories introduced Sharon Biomix Blends. Developed in cooperation with the Biosecur Company, this range of broad-spectrum products is based on organic citrus extracts. The liquid blends are paraben- and formaldehyde-free, soluble in water, may tolerate elevated temperatures, work in a wide pH range, have a recommended use level of less than 1%, and are said to be ideal for leave-on and rinse-off products.

“The biggest issue in the industry is the growing demand for non-preservative formulas or very mild green options,” explained Tal Green, personal care business unit manager, Sharon Laboratories Ltd. “In a few countries around the world, mainly in Europe, this trend gained some popularity.”

Not every new idea in preservation revolves around new products. For example, Lonza Personal Care just launched FormulaProtect, a new interactive, online application that allows formulators to save time and easily identify preservatives that best suit their specific needs. By simply selecting specific formulation criteria such as pH, required spectrum, formulation type, regulatory and organizational approvals, among other criteria, the formulator is presented with a selection of recommended preservative options along with detailed information on each of them. The tool provides guidance for the preservatives that meet formulators’ marketing requirements and that provide the efficacy required throughout the lifetime of the cosmetic product, according to Szymczak.

But while suppliers have developed a range of solutions to cure formulators’ preservation problems, they still have to work on public relation efforts to stem negative overtures from NGOs and regulators.