Perhaps the first salvo fired at the preservative industry came from, of all places, the beer industry. Back in the 1970s, Miller Brewing Company came out with the wildly successful Miller Lite and beer-bellied men in gin mills across America rejoiced, and why not? After all, here was a beer that tasted great and was less filling, too.
But the folks at Miller also included the line “no additives and no preservatives.”
If you’re gulping pilsners at a prodigious rate, why would you possibly care if that mug o’ suds contained preservatives? Alcohol is a toxin! Nearly 40 years later, and the preservative-free angle still doesn’t make sense—whether you’re talking about beer or BB cream. Especially with concerns about product contamination on the rise.
“I think the bad guys are winning. Unless there is decisive action from FDA, we are losing the battle,” warned industry expert David Steinberg, president, Steinberg Associates. “Bloggers are winning the hearts and minds of the consumer.”
Tal Green of Sharon Laboratories, agreed.
“The greatest impact is not from regulatory changes, but from pressure groups that use public relations instead of robust science to denounce ingredients, especially preservatives,” he told Happi.
Bloggers and NGOs are winning in state houses, too. Last year, the Minnesota legislature voted to ban formaldehyde and formaldehyde donors (such as DMDM hydantoin and quaternium-15) from children’s toiletries. The ban is set to go into effect for manufacturers in August and retailers will have until August 2015 to sell products.
Luckily for industry, a levelheaded politician is fighting back. According to Steinberg, a Minnesota Assembly member, who just happens to be a chemist, is drafting legislation to repeal the ban.
Hans Hummel of Lonza Hygiene & Preservation said the regulatory landscape has become increasingly restrictive for some common preservation chemistries and fragmented too, as various regions, countries, and US states enact their own laws.
Legislative bodies often take action based on the perceived hazards of a preservative rather than evaluating the risks and benefits.
“This has resulted in a complex landscape for suppliers and formulators to navigate,” he noted. “Lonza is reaching out to legislators and other key stakeholders as well as collaborating with customers to address these possible restrictions.”
But while industry looks for allies in legislative aisles, the damage may already be done, worries Steinberg, who insists Minnesotans haven’t been able to purchase effectively preserved wipes or cleansers since the ban went into effect. What’s worse, Steinberg worries that consumer product companies won’t be able to toughen up GMP standards to make sure contamination won’t take place during manufacturing process.
“If manufacturers can’t raise the drawbridge, they may lower the river in order to pass the test,” he warned.
With contamination and health risks on the horizon, it’s no surprise that suppliers take seriously the war on preservatives. According to Linda Sedlewicz of schülke, the regulatory and public pressure to eliminate whole categories of preservatives has put an enormous amount of pressure on formulators over the past several years.
“This pressure comes with little, if any, thought as to alternatives that may be used or the health risks of unpreserved or under-preserved products,” warned Sedlewicz. “Marketers’ eagerness to use ‘free-from’ claims as an easy way of differentiating their products raises consumer concerns about chemistries that have been used safely and effectively for decades. This forces formulators to substitute newer, less tested preservation methods.”
An International Issue
Issues surrounding preservatives are by no means a US-only problem. According to Laura Szymczak-Frye of Lonza Personal Care, there is much discussion among multiple personal care organizations about limiting or banning many well-known and well-documented ingredients that have been used safely for years. What is happening is that the safety data available is being looked at with an increasingly precautionary approach and the opinions of certain personal care organization boards are changing. A consistent trend can be observed toward the removal of selected chemistries from the market. Such restrictions may be based on a legislatively driven review by regulatory bodies or be voluntary on the part of formulators based on a concern for public perception of the safety of individual preservatives.
“This is of particular concern in the EU, which operates a positive list of allowed preservatives under Annex V of the Cosmetic Regulation,” she told Happi. “It is increasingly apparent that few new actives are added to this Annex and those present are under increasing pressure. Thus, the palette of available preservatives is being severely restricted.”
Not only that, but more customers prefer to have preservation technologies which are globally accepted or broadly available, noted Hummel, who added that the combination of constantly evolving regulations and customer preferences has made the job of developing global formulations very challenging.
Yet, not every new regulation has the same impact on preservative suppliers, their customers or the end-consumer, according to Green, who told Happi that the bans of quaternium 15 in the EU, and benzyl, pentyl and phenylparaben did not affect the beauty industry whatsoever since these ingredients have almost never been used in cosmetics. Also, the restriction of CMIT/MIT to rinse-off products has had little effect.
“The banning of the isoparabens makes little difference for those who use the blends that contain isobutylparaben, because there are straightforward replacements like Sharon’s phenochem NIB, Sharomix 824 and many others,” said Green.
He went on to explain that the future for MIT is in question, as it seems likely, but not yet certain, that a much lower maximum concentration will be permitted in the EU.
Inolex develops mainly multifunctional materials that are viewed positively by regulatory agencies, according to Dan Winn, since they have much milder toxicological and environmental effects as compared to biocides.
“So, from this perspective, the regulatory situation is positive,” he explained. “On the other hand, for those cosmetic companies that prefer to use biocides the situation is becoming more difficult.”
schülke, too, has a long history of blending different chemistries to develop optimized preservative system.
“Our non-traditional, multifunctional systems are tested to the same high standards as our traditional preservative blends,” explained Sedlewicz. “Our sensiva PA 40, launched last year, is effective enough to allow high SPF sunscreens to pass challenge testing without the use of a traditional preservative.”
This blend of natural Zemea propanediol, with a nature-identical fragrance compound and a gentle synthetic moisturizer can be used alone or in combination with a chelating agent at levels very similar to more traditional preservative blends, according to Sedlewicz.
With the traditional preservative palette growing more limited, Winn warned that it the end of an era of using traditional biocides as cosmetic preservatives.
“There is now a once-in-a-generation shift away from biocides to using the “hurdle technology,” glycols, acids and other multi-functional materials with secondary benefits as preservatives,” he explained.
Salicylates and Chemicals Pvt. Ltd. (SCPL) has launched four paraben-free, formaldehyde-free and isothiazolinone-free preservatives with multifunctional benefits, according to Krishna Sarvaiya. Saliguard EHG (ethylhexylglycerin) is multifunctional ingredient with applications as skin conditioning agent, a deodorant agent and a preservative/preservative booster. Saliguard EHGP (ethylhexylglycerin/phenoxyethanol) provides broad spectrum protection against bacteria, yeast and mold. Saliguard EZ (ethylhexylglycerin/1, 3 propane diol) acts as an emollient and a solubilizer for various extracts. Finally, Saliguard EU (ethylhexylglycerin/undecylenic acid) acts as a versatile skin care ingredient.
Green noted that the negative press surrounding traditional preservative systems has created a substantial market for natural and/or alternative preservatives. He warned, however, that natural preservatives must often be used at high concentrations to be effective preservatives, which can cause color, odor, or texture issues to the end products. Even at high concentrations, most natural preservatives are not as effective as traditional synthetic preservatives, Green maintained.
“Whether natural preservatives are safer than traditional preservatives is still under discussion; naturals have not been as extensively tested for safety as synthetic preservatives,” he observed. “The new trends become critical when some companies use a very mild, unsuitable preservative system, unwittingly taking risks. Unsuitably preserved products can cause skin irritation, infections, blindness, and even death.”
Preservative-Free and Die?
It may not carry the same cache as New Hampshire’s State Motto, Live Free or Die, but more than a few marketers take pleasure in touting their formulas as being “preservative-free.”
The negative press over traditional preservatives has caused some manufacturers to seek natural, green, or “preservatives free” alternatives, noted Green of Sharon Laboratories. This movement against traditional preservatives has created a substantial market for natural and/or alternative preservatives—even when there are drawbacks.
“Natural preservatives must often be used at high concentrations to be effective preservatives, which can cause color, odor, or texture issues to the end products,” explained Green. “Even at high concentrations, most natural preservatives are not as effective as traditional synthetic preservatives.”
Whether natural preservatives are safer than traditional preservatives is still under discussion, he added, noting that naturals have not been as extensively tested for safety as synthetic preservatives.
“The new trends become critical when some companies use a very mild, unsuitable preservative system, unwittingly taking risks,” observed Green. “Unsuitably preserved products can cause skin irritation, infections, blindness, and even death. We take a more responsible approach; all our blends are based on intensive research because we understand the big responsibility we are facing.”
Suppliers, then, struggle with keeping products safe for consumers, answering marketers’ demands for “preservative-free” label copy and fending off scientifically unsound legislation. Keeping all these balls in the air is quite a juggling act, indeed, but forward-thinking suppliers are offering a range of solutions for formulators of personal care and household products.
Last month at In-Cosmetics, Lonza Personal Care launched Rômacil V, a multifunctional cosmetic ingredient that imparts a delicate fragrance to mildly enhance the attributes of a personal care product. In addition, it offers broad-spectrum antimicrobial capabilities to add an additional level of protection in order to maintain the product’s integrity.
“Rômacil V was developed to respond to formulators’ desires for products that offer multiple benefits, that simplify the formulation process, and that offer consumers key desired effects,” explained Szymczak-Frye.
According to Hummel, Lonza’s current focus is to evaluate its existing portfolio of preservation technologies and develop new and innovative combinations that can potentially increase effectiveness while mitigating customers’ concerns.
Protameen introduced Pro-Aqua Isosteareth 200 linoleate, which Manny Balsamides described as a unique, water-soluble ester.
Inolex continues to launch solutions based on its multifunctional chelating agent, CHA. The most recent additions include two systems for cold-process applications: Spectrastat OL and Spectrastat OEL.
“We did extensive research on their ability to preserve wet wipes and found them to be extraordinarily effective,” explained Winn, who added that market response has been superb.
Blends Meet Global Demands
Following the growing worldwide demand for milder and greener cosmetic formulations, Sharon Labs developed a wide selection of unique broad spectrum preservative solutions which provide answers for the marketing demands and at the same time give full protection to end products.
“Some of our new synergistic blends are based on well-known preservative ingredients which meet global trends,” explained Green. “Others contain ingredients that have preservative activity, yet are not listed on Annex VI, which is a list of preservatives permitted in cosmetics sold in the EU.”
In 2012, the company launched the Sharon Biomix line and added two new products last year. Just last month, the company introduced Sharon Biomix Free C and Sharon Biomix Free H. These liquid blends are based on unique natural organic citrus extracts and do not contain ingredients which are listed on Annex VI, according to Green. They are paraben- and formaldehyde-free, broad spectrum, soluble in water, odorless, may tolerate elevated temperatures, and work in a wide pH range. The recommended use level of these products is less than 1%, ideal for leave-on and rinse-off products, according to the company. Coast Southwest distributes Sharon’s preservatives.
At schülke, euxyl K 900 is the latest addition to its family of boosted preservation systems. Like its sister products, euxyl PE 9010 and sensiva PA 20, euxyl K 900 uses the preservative booster, ethylhexylglycerin, to provide a broader spectrum of preservative activity. According to Sedlewicz, schülke’s patented stabilization process for ethylhexylglycerin provides consistently high quality, without the risk of color and odor changes.
“Our extensive safety dossier provides confidence that our quality of ethylhexylglycerin can be used even in products for sensitive populations,” she added.
With the high costs associated with developing preservative systems, industry experts expect any new product activity to be dominated by multifunctional blends.
“It’s too expensive to create new preservatives just for cosmetics,” noted Steinberg, who pointed out that Kathon was originally developed for the agricultural industry. “The cosmetic markets are too small to warrant the R&D costs. Plus, there is the added cost of product approval and then, the NGOs come after you! As soon as a company comes out with a new chemical structure, you can be sure that somebody will come along to tear it apart.”
With opponents like that, it’s enough to drive a formulator to drink—perhaps something a bit more potent than light beer!