A global bath and body brand initiates a voluntary recall with the Food and Drug Administration (FDA) for personal care products with microbial contamination due to bacteria found in the formulations. These beauty products are distributed to hotel and spas all over the nation. Meanwhile, on a smaller scale but equally noteworthy, a US-based independent marketer recalls a color cosmetic item sold in up to five different states because of potential bacillus and staphylococcus contamination.

The common thread to these two cases is a faulty Preservative system. The right preservative is critical to a product’s efficacy and safety.

As formulators are increasingly selecting specialty ingredients to improve the performance of their formulations, the share for such personal care ingredients has increased from 40% to 45% over the past several years, finds Kline’s recently published Personal Care Ingredients: Global Market Analysis. This report consists of concise regional reports per ingredient group and a comprehensive database containing data on over 130 personal care ingredients in all key regional markets.

The growing popularity of multifunctional products results in growth in the consumption of performance-oriented multifunctional ingredients, driving the promising specialty sector. For example, consumption of preservative boosters—such as caprylyl glycol, glyceryl caprylate and ethylhexylglycerin—is growing at the expense of traditional preservatives as they also deliver emolliency to formulations, said Kline in its findings. Similarly, PEG derivatives that act as a rheology modifier and also have emulsifying properties have increased over the past few years and are expected to grow further in the future.

Synthetic ingredients dominate the personal care ingredient playbook, but natural ingredients are increasing their share as consumers demand rises for these ingredients. However, natural ingredients are more prone to microbial attacks and also face compatibility issues with other ingredients in various formulations that could adversely affect their growth, according to Kline.

Globally, sales of specialty ingredients are expected to increase at a compound annual growth rate of 2.8% during 2015-2020 and will cross the $10 billion mark by 2020. All the ingredient groups are expected to grow.

Replacement of traditional preservatives due to regulations will increase demand for other alternative ingredients, such as organic acids and boosters, added Kline.       

Inside View
Formula preservation is ultimately one of the most important features a formulation must have, noted Peter Frantz, personal care business unit manager, Vigon International, Inc., East Stroudsburg, PA.

“The consumer will never notice if a formula is correctly preserved but will always remember and notice when a product has any kind of preservation issues,” he told Happi.  “We make sure that we offer each customer we service a preservative or preservative booster that we know will help assure them that they will have a well-preserved formulation.”

Franz’s company’s latest offering is from Symrise—SymSave H. With an INCI of Hydroxyacetophenone, SymSave H is a nature-identical compound found in Lampaya hieronymi (a herb native to Latin America) and Rubus chamaemorus (cloudberry found in Alpine region). According to Franz, SymSave H provides multifunctional benefits on top of its preservative-boosting effect. It is listed on FEMA/GRAS and on CleanGredients.    

“Historically, preservative boosters have shown weakness in certain formulation types and have created emulsion stability issues when used at effective dosage levels,” he told Happi. “SymSave H helps the formulator overcome these historical challenges and provides preservative-boosting efficacy in a variety of cosmetic formulations. It also provides antioxidant and soothing properties for the formulation.”
     
Food and cosmetics companies have the same concern: to assure the integrity of their products to consumers, noted Julie Vaughn Biege, vice president, business development and marketing, Emerald Performance Materials, Cuyahoga Falls, OH.

“Proper preservation and strict adherence to GMPs are important components of product safety,” she said. “This is where benzoates can play an important part of the preservation package: the products themselves have an excellent regulatory profile.”

According to Vaughn Biege, the personal care formulator has several options when selecting products in the benzoate family—benzoic acid, sodium benzoate and benzyl Alcohol —based on solubility needs ( Water and/or organics) and pH of the formulation. Often, these products are used in combination with other benzoates and/or with other types of preservatives, such as phenoxyethanol.

Emerald has new applications data to support use of its food-grade preservatives in cleansing systems as a “drop in” preservation solution, said Vaughn Biege. Unlike many other paraben-free alternatives, these materials are economical for all surfactant systems, offer improved color stability, and are considered globally acceptable, in addition to helping formulators to avoid other ingredients that may concern consumers.

Traditionally, benzoate-type preservatives are erroneously believed to be limited to lower pH formulations. New data shows efficacy in skin neutral and above wash-off systems, passing USP 51 challenge testing at pH ranges from 4.5-6.5 using both sodium benzoate and combinations with benzyl alcohol.

Emerald produces several grades and different physical forms of food- and pharmaceutical-grade benzoic acid and sodium benzoate. Emerald’s Kalama benzyl alcohol, produced by an oxidation process, is chlorine-free and extremely low in odor, having minimal influence on the aroma of the final product, noted Vaughn Biege.

“Consumers also continue to increasingly look for labels for organic ingredients and for non-irritating ingredients for sensitive skin; sodium benzoate is approved for use In cosmetics by Ecocert, an international organic certification organization, and is considered non-irritating to the skin by a WHO assessment,” she said.

The team at Sharon Laboratories has been developing products under a new approach of “natural like,” or “a bridge between natural and synthetic,” according to business unit manager Naama Eylon. She explained, “We are trying to close the gap between the consumer’s desire for ‘green’ and the formulator’s need for a preservative that offers efficacy, stability, consistency, safety and is also globally accepted as well as cost-effective.”

This year, Sharon Laboratories introduced SharoSense. Launched in April, this line offers broad spectrum, highly effective products, based on a patented blend of thymol and linalool.

“The concept is to rely on naturally occurring ingredients for a green and natural approach which consumers prefer, while creating a synthetic blend, to achieve the qualities the manufacturer needs,” said Eylon. “True natural preservatives are available, suitable for organic products and for specific applications requiring such a solution. The Sharon Biomix line, based on a blend of organic citrus extracts, is the answer for this market. It delivers strong broad-spectrum protection and can meet ‘preservative-free’ claims, ‘100% natural,’ Ecocert and more. Biomix preservatives are non pH dependent and highly soluble.”

The demand for alternative preservatives with mild safety profile will keep growing, observed Fana Makonnen, global technical marketing manager, Inolex, Philadelphia, PA.

“Consumers want safe and natural products that are certified because they have been screened to a standard that identifies them to be natural and safe,” she added.
According to Makonnen, ingredients like Spectrastat G2-N are ideal to meet these demands. It was launched this past April at In-Cosmetics Paris, France, expanding the patented Spectrastat CHA range to include an option for use in organic personal care products under NSF/ANSI 305-2012.

The CHA range is a multi-mechanism alternative preservative system that uses a blend of a unique patented Chelating agent caprylhydroxamic acid (CHA) with an assortment of alcohols and glycols as a part of hurdle technology, providing safe preservation for all formulation types. Spectrastat G2-N is an NSF certified option within the CHA Spectrastat range.

Makonnen told Happi that Spectrastat G2-N and the Spectrastat CHA range are alternative preservative systems that don’t contain biocides or typical preservatives. Instead, they use a combination of multifunctional agents such as the chelating agent caprylhydroxamic acid that have “excellent” efficacy as biostatic and fungistatic agents. Spectrastat G2-N is ideal for organic or natural formulations where a paraben-free or preservative-free claim is needed. Similar to others in the Spectrastat CHA range, Spectrastat G2-N also performs superbly at neutral pH, a state where many other fungistatic materials are ineffective, she said. 

Every formulation is unique, so it’s ideal to use the preservative that is optimized for your formulation. According to David Koehl, global business manager, Home & Personal Care for Troy Corporation, Florham Park, NJ, formulators of personal care and cosmetics products don’t understand the performance advantages of broad-spectrum preservatives.

“While these products provide protection against both bacteria and fungi, suppliers typically offer only one blend ratio. The result is poor cost performance, because personal care manufacturers are forced to pay for either extra Bactericide or extra fungicide,” he explained.

To address this market need, Troy Corporation introduced the TroyCare FE and PE series of customized broad-spectrum preservative blends developed specifically for personal care and cosmetics applications. Troy is also introducing the EPP series to the line of Customized Preservative Solutions. With the expanding portfolio of TroyCare Customized Preservative Solutions, formulators can select a customized broad-spectrum preservative in a choice of chemistries and active ratios with optimized levels of bactericide, fungicide and boosting agents, yielding the lowest total preservative cost. The TroyCare FE series preservative blends are based on IPBC and phenoxyethanol; the PE series blends are based on ethylhexylglycerin (EHG) in phenoxyethanol; the new EPP series currently being introduced is based on EHG and phenylpropanol. The broad selection of customized blends in different ratios is globally approved for all rinse-off and leave-on formulations.

New from Jeen is Jeecide Chloro-Lo and Jeequat MCA-1. According to Albert Babik, general manager, Jeen International Corporation, Fairfield, NJ, Jeecide Chloro-Lo is chlorphenesin, a preservative with antibacterial and antifungal properties that can be used alone or in conjunction with other preservatives and potentiators in leave-on or rinse-off products. Jeequat MCA-1 is a proprietary blend of Glycerin , citric acid, lactic acid, l-ascorbic acid and didecyldimonium chloride, a mild yet effective disinfecting agent for leave-on, rinse-off and wipes.  

Babik told Happi that Jeecide Chloro-Lo is an active agent against bacteria, fungi and yeast. It is equally effective at stabilizing and guarding the integrity of finished cosmetics as it is as an Antimicrobial agent. Meanwhile, Jeequat MCA-1 is an active disinfecting agent that is free of parabens, isothiazolinones, phenoxyethanol and formaldehyde releasers; it is a mild yet effective alternative for any finished product between a final pH of 4.0 to 8.0, according to Jeen.

Sometimes, what’s old is new again when it comes to high-performing preservatives. schülke has relaunched its euxyl K 903 personal care preservative blend, now stabilized with natural tocopherol. Linda Sedlewicz, country manager, schülke inc., Fairfield, NJ, told Happi, “In response to our customers’ requests for preservatives that are compliant with various ‘natural’ certification bodies, we have reformulated euxyl K 903 to contain natural tocopherol. This allows euxyl K 903 to be used in products requiring NaTrue (including Ecocert) and Cosmos certification. Also this year, we have launched euxyl K 940 for use in personal care products. This boosted preservative blend is effective at lower use levels than many other traditional preservative blends.”

Lincoln Manufacturing (LMFG), Lincoln, RI, has a new line of value-added multifunctional antimicrobials, the Lintelligence IQ line. According to Pat Lutz, president, LMFG, the system provides protection against a broad spectrum of microorganisms while adding “extra value” to a formulation like a vitamin, humectant or slip agent.


“Lintelligence IQ are safer designed systems that are alternatives to conventional preservatives and get the customers away from parabens, formaldehyde, isothiazolinones and phenoxyethanol which are all under some kind of regulatory pressure and/or consumer perception—wrong or right,” he told Happi. “Lincoln MFG’s new Lintelligence IQ line provides value-added ingredients combined with the antimicrobials to give a boost in efficacy.”

Melissa A. Gillis, market development specialist, Coast Southwest, Inc., Placentia, CA, cited an example of suppliers connecting with clients in the industry for specific preservative needs. She explained, “Our customer was using a mild preservative in a surfactant system that needed to be warmed so it could be mixed to make it homogenous for production. Typically, the surfactant product turned a shade of pink because of fragrance interactions with the preservative. The customer replaced his preservative with Biomix Free II, which needed no mixing or heating. He saved manufacturing time with a ready-to-use preservative that didn’t need color correction and had a more robust preservative used at a lower addition level, which gave a better sense of safety for his customer and the consumer.”

A unique preservative is available now from Brenntag Specialties, Inc., South Plainfield, NJ, is the exclusive distributor of Pure Bioscience Inc.’s Silvérion 2400. This preservative is a colorless, odorless and stable solution that provides ionic silver in a water-soluble form. It can be added to personal care products at low concentrations to fight against a broad range of bacteria, viruses, yeast and mold.

“It’s a great product for any formulator looking for an effective alternative to formaldehyde or parabens,” said Ashley Hussey, product manager, Life Sciences, Brenntag, South Plainfield, NJ.

Protameen Chemicals’ researchers, who have been searching for the most efficacious, cost-efficient and safest possible preservation systems for personal care and cosmetic products, find that parabens fit the bill. Carla Garnett, quality manager, Protameen Chemicals, Inc., Totowa, NJ, told Happi, “While in recent years, many companies steered away from using parabens and many labels boasted ‘paraben-free,’ we are now seeing an increase in customers requesting parabens for their formulations. While there are no real advancements or new developments with parabens, the tried and true preservatives are still widely used in the industry to deliver effective preservation at low-use-levels. Products with parabens as the preservation system are as safe as the formula itself and will remain as fresh as the day it was made in the laboratory as long as conditions permit.”

Safety Alert
There is a heightened public awareness regarding safety concerns with certain chemicals in consumer products—bisphenol A, phthalates, other endocrine disruptors, skin sensitizers and cancer suspect agents, observed Vaughn Biege.

“Consumers are now inundated with information, and in some cases, misinformation, on news and talk shows and on the internet by bloggers,” she told Happi. “These news sources have been educating the public about the risks. For example, endocrine disruptors in consumer products can lead to a range of health issues ranging from obesity in children, to testosterone deficiencies in men, to breast cancer in women. Consumer pressure coupled with changing regulation and labeling requirements of certain preservatives have had a great impact on preservation systems in personal care products.”

In April, the EU announced the newest restriction on preservatives: a limitation on the use of methyl isothiazolinone in rinse off products and a ban on its use in leave-on products.

“While companies have been gradually formulating away from parabens and formaldehyde donors for some time, legislation and consumer sentiment are accelerating these efforts,” said Vaughn Biege.

Also in April, the Scientific Committee on Consumer Safety (SCCS) released an opinion on the safety of phenoxyethanol used as a preservative in cosmetic products, according to the May 2016 newsletter of the Independent Cosmetic Manufacturers & Distributors. It stated, “There was some concern within the industry that the ingredient, currently used at a maximum concentration of 1.0%, would be further restricted, as the regulators in France had suggested. Although the consultation period remains open, the result is that the current concentration level likely will be maintained.”

Regulators aren’t only interested in what’s in the bottle; they want to know how ingredients were put into the bottle! The US Food and Drug Administration in February issued new guidelines for cosmetic site inspection. According to David Steinberg, president, Steinberg & Associates, who recently presented at a NYSCC networking event in New York City, FDA is concerned that cosmetic products with label claims such as: “green,” “natural,” “no parabens” and “no preservatives” may not be safe without appropriate safety testing.

Therefore, companies that make such label statements should be given priority over traditionally manufactured cosmetics during inspection and sampling, according to FDA, which considers non-traditional preservatives to include botanical extracts, organic acids, alcohols and glycerols.

FDA instructs manufacturers to collect samples of recently produced and retained products, especially those that are water-based, when the manufacturer is unable to produce challenge test documentation or the adequacy of preservation is otherwise in doubt or non-traditional preservative systems are used.

“The FDA is not concerned with traditional preservatives such as parabens, quaternium-15 and DMDM hydantoin,” he said.

A Bright Outlook
Continued expansion of natural or nature-identical preservative ingredients is critical for the future of preservatives, said Franz of Vigon. “Increasing demand from the end consumer for preservatives that are natural and that provide multifunctional benefits are forthcoming in this sector,” he said. 

“We see a continued drive to reformulate the preservation package to assure both proper preservation and safety. There is not significant traction in the industry to move to preservative-free products in a big way in personal care applications; the cost of recalls and potential damage to the brand is significant, and data on new product launches from Mintel GNPD supports this,” added Vaughn Biege of Emerald. “According to our analysis, new product launches of beauty and personal care products without antimicrobials represent about 19% of all new product launches—holding steady in share over the last five years—and even fewer of these products bear an associated ‘free from additives and antimicrobials’ claim on its label.’”

The demand for alternative preservatives with mild safety profile will keep growing, noted Fana Makonnen of Inolex.

“Consumers want safe and natural products that are certified because they have been screened to a standard that identifies them to be natural and safe,” she explained.

As preservative chemistries are increasingly under attack from non-scientific NGOs and consumer groups, it is important for the scientific community to work together to support “tried and true” preservatives, said Sedlewicz of schülke inc. She added, “The risk to the consumer of unpreserved or under-preserved products should be our focus. Not every preservative can work in every formulation or against every organism. The fewer preservatives we have to work with, the more difficult it will be for formulators to produce adequately preserved products that are safe in the hands of the consumer.”

All in all, the industry is dealing with a gap, and it will be a while until there is closure, noted Eylon of Sharon Laboratories. “It’s a gap between the wishes of the consumers (even if not the majority) for ‘free of… everything’ and the needs of the formulator to deliver a safe product, but one that the marketing group can sell.”