Preservative market update: a high profile health issue puts preservatives in a good light, but regulators, consumers and many marketers continue to search for alternatives to traditional systems.
WHEN IS BAD NEWS really good news? For the embattled preservative industry, recent news reports about poorly-preserved skin care products that ultimately became contaminated and infected hospital patients have put preservatives in a more positive light.
"The biggest issue confronting the preservative market is the potential for misinformation to impact a formulator's choice in product preservation and imperil consumers," said Mark Miller, McIntyre. "Marketing claims are fine--if they're backed by safety testing and demonstrated efficacy of preservative systems via challenge studies in test formulas. Formulator's should demand that cosmetic preservative suppliers provide challenge test data from a reputable testing lab before using a novel preservative system."
It all started in Barcelona hospital back in January. Five intensive care patients became infected with a deadly bacteria called Burkholderia cepacia (B. cepacia). Officials traced the illness to a moisturizing body milk used in the patients' care.
The outbreak occurred at the Universitari del Mar Hospital in Barcelona, where it was common practice to apply moisturizer after washing intensive care patients. The lotion was available from treatment carts used in the ward. When a number of patients in nonadjacent beds came down with the same infections, investigators became suspicious of the treatment cart.
"Those infections were due to inadequately preserved cosmetics," observed David Steinberg, Steinberg & Associates, Inc. "You just need one major incident like what happened in Spain and the cosmetic companies start rethinking about 'preservative-free' formulations. Even many of the NGOs may start realizing that preservatives are really necessary."
Mr. Steinberg also noted that there has been reluctance on the part of formulators to move away from parabens because they realize parabens work. At the same time, there are no new preservative systems are on the horizon.
"The costs are just far too expensive," he observed. "Even if you discover a new system and get it approved, you'll be attacked by the NGOs. As a result, very few companies are doing research on new preservatives for cosmetics."
David Hinden of Arch Chemical warned that as companies migrate away from traditional preservatives such as formaldehyde donors, parabens and isothiazolones, the number of replacements being offered is confusing and must be carefully screened to ensure that they are safe and effective.
"Since many simply do not function very well it is important to work with suppliers that have the technical resources skilled in art and science of preservation," he observed.
In fact, Dean Bostic of Acme-Hardesty called consumer lack of information on the safety and efficacy of paraben and paraben blends the biggest issue facing the preservative industry.
"This is followed very closely by the impending changes that will occur with REACH and its far reaching implications for global cosmetic formulations," he added.
To overcome these issues, Acme-Hardesty is constantly educating its customer base with the reality of paraben safety and efficacy. But Mr. Bostic warned that the REACH initiative has only made this education process more difficult.
Will Consumers See the Light?
Nearly every preservative executive contacted by HAPPI agreed that consumers' misconceptions about preservatives continue to have a negative impact on the industry.
"The biggest issue confronting the preservative market are still the misleading reports by some groups spreading false information and rumors about the risks and safety of preservatives making the consumer feeling more and more unsure what to believe and what to buy," said Frederic Pilz of Clariant. "Many well-established and well-investigated preservatives like the parabens are under attack and some cosmetic formulators are trying to substitute these safe substances with trendy 'green' or even 'preservative-free' alternatives, where safety and efficacy of these substances are often not known to the extent of well-known systems."
To improve paraben profile, Clariant, via EIFCI, participated in a hearing on parabens in October 2007 at the SCCP in Europe to defend the parabens in cosmetic products. Colipa and the Cosmetic Preservative Council (CPC) also participated.
Lonza is investigating alternative approaches to preservation, whether it's novel synergistic blends that utilize existing chemistries, botanicals or technological methods.
"There is an increased demand for controversy-free preservative systems," explained Rosita Nunez of Lonza. "Our customers seek alternatives to traditional preservative chemistries. The most often cited requests are paraben-free, non-formaldehyde releasing, non-IPBC and non-isothiazolinone."
Linda Sedlewicz of schulke inc., said that consumer concerns about cosmetic raw materials have had an increasing effect on global regulation and global regulation has had similar effect on consumer concerns.
"Bad news travels fast. The more bad press (accurate or not) the consumer sees about our industry, the more manufacturers are influenced to change their formulations," said Ms. Sedlewicz. "The same bad press heightens the sensitivity of regulators, prompting them to tighten regulations. The consumer sees this as more evidence that they should avoid certain raw materials completely."
Dan Beio of RITA noted that with demand for "preservative-free" on the rise, many customers are asking for RITA to get very creative with the chemistry revolving around its ingredients. RITA is searching for ways to build preservation activity into more of its products. This can be done by choosing a particular class of chemical, such as lactylates, which have known antimicrobial activity, and combining them with natural essential extracts. At the same time, marketers are rethinking product development when it comes to preservation.
"We see them using less traditional emulsion systems, which puts heavier burdens on their preservatives, and moving more toward thickening emulsifiers, like our Viscolam AT100EF," said Mr. Beio. "You get the same emulsifying power of traditional nonionic emulsifiers with virtually no emulsifiers, which reduces the requirement of preservatives."
In a similar manner, Sinerga has improved its preservative-free claim by using self-preserving intermediates, explained Daniela Storni.
International Specialty Products is tracking any developments on the different preservative actives with respect to consumer insistence or changes in regulations, according to Sangeetha Subramanian of ISP. "We are working with industry trade organizations to provide the scientific information and data on these actives as needed."
ISP is also generating analytical data on formaldehyde donors so as to present and communicate the safety of formaldehyde donors to its customers and consumers.
Many suppliers bemoaned the lack of a comprehensive preservative regulation that is accepted worldwide. Executives at Ciba noted, for example, in the U.S., there is no positive list while in EU and Japan there is, making it difficult for new preservatives to be globally approved.
A Lot of Activity in the EU
Still, Mr. Steinberg said that, overall, regulators have backed off on their scrutiny of preservatives in cosmetics. What's more there may be some relief on the way in Europe. That's because the EU has proposed an 8th Amendment to the Cosmetic Directive that specifically explains what is required of a safety assessment.
"Microbiology is a part of the 8th Amendment," noted Mr. Steinberg, "So that is a positive thing for the preservative industry."
Despite this positive move, issues remain in Europe. Lambros Kromidas of Coty observed that methyldibromoglutaronitrile is no longer permitted in cosmetics or on the market as of March 23, 2008, per the EU's 41st ATP. Products already on the market must not be sold to the final consumer/users after June 23, 2008.
In that same ATP, the use of benzoic acid and salts thereof was changed.
"Benzoic acid may be used in rinse-off products at 2.5% or less, in oral care products at 1.7% or less, and on leave-on products at 0.5% or less," said Dr. Kromidas. "For salts of benzoic acid, like sodium benzoate and methyl benzoate, they can only be used at 0.5% or less."
Dr. Kromidas noted too that the 42nd ATP, published April 17, 2007, amended the use of iodopropynyl butylcarbamate (IPBC). As a result, it cannot be used in oral and lip products, or in children's products (age three or below) except in bath and rinse-off products.
In fact, if used in any cosmetic product except bath and rinse-off, the product must contain the warning statement, "not to be used for children under three years of age." IPBC should also not be used in creams and lotions aimed to be applied on a large part of the body. Otherwise, it may be used in rinse-off products at 0.02% or below, in leave-on products at 0.01% or below, and in antiperspirants/deodorants at 0.0075% or below.
Dr. Kromidas also warned that the uproar caused by S. Oishi that linked parabens to reproductive toxicity remains fresh in some people's minds.
That's why on Feb. 12, 2008, Colipa wrote to DG SANCO proposing to conduct pharmacokinetic studies to evaluate the absorption, distribution and elimination of oral doses of methyl, propyl and butyl parabens in rats. Two additional studies will examine the fate of parabens under dermal application and subcutaneous dosing. All of these studies are seeking to answer questions raised by the SCCP and hopefully secure a favorable opinion from the commission about the safety of parabens.
"The bad publicity with parabens does not end there," said Dr. Kromidas.
"In January, an Environmental Health Perspective paper by R. Danovaro and others claimed that butyl paraben damages coral. This paper was picked up by the National Geographic website, the Nature Conservancy and others."
Although parabens make the biggest headlines, Louis L. Punto of Jeen Chemical, pointed out that other preservatives are under attack as well.
"The drive to eliminate phenoxyethanol in Europe is of concern because phenoxyethanol works so well and is so frequently used," explained Mr. Punto. "With the drive to eliminate parabens and now phenoxyethanol and more companies having an aversion to using formaldehyde donors, the formulation chemist will face greater challenges preserving personal care products which increasing contain active ingredients prone to microbial contamination."
But luckily for the industry, both the Personal Care Products Council and the CPC have been working to try to counteract the attacks on preservatives, according to Ms. Sedlewicz.
"The CPC has addressed these issues through its consumer website and directly with regulators in Europe. The CPC has also spoken directly to regulators in Europe," she said. "The persistence of these organizations and others has succeeded in postponing any decision being made on the banning of long-chain parabens in Europe. It is a small step, but significant."
Mr. Punto agreed that the efforts of the CPC have provided a lift for the industry.
"The members of CPC are from many companies in the preservative industry that have joined together to defend all cosmetic preservatives from regulatory restrictions or prohibitions," he noted. "It is an uphill battle that unfortunately the industry will be addressing for many years."
What About Formaldehyde?
Two years ago, Mr. Steinberg formed the CPC. Most recently, the group has defended the use of isopropyl parabens in Europe and, in the U.S., is trying to get the INCI name of formaldehyde changed to methylene glycol, a move that should relieve some of the pressure caused by California's Safe Cosmetic Act, according to Mr. Steinberg. The Act cites California's Prop. 65, which only refers to formaldehyde gas and does not regulate the use of methylene glycol.
However, the cosmetic industry does not use formaldehyde gas and as a result, The CPC has petitioned the Personal Care Product Council to get the name changed.
John Bailey of The Council agreed with the CPC position.
"It's a valid point. Formaldehyde gas is different than the formaldehyde used in cosmetic products," he told HAPPI.
Dr. Bailey noted that The Council is the custodian of the INCI process. Yet, it is a process that must include opportunities for comment from regulatory authorities.
Some Words on Naturals
Real or imagined, public concern about some preservative systems has marketers calling for natural preservation systems. According to Ellen Werner and Dr. Karla Wilzer of Ciba, there are natural preservatives, but their efficacy is formulation dependent. They noted, for example, that Ciba's Tinosan SDC silver-based preservative is natural, but has some limitations when used in highly cationic systems.
Ms. Sedlewicz noted that batch-to-batch consistency is very difficult to accomplish in a truly natural product--and consistency is exactly what is required in a preservative.
"Synthetic organic acids are used to preserve foods, making them consumer-friendly alternatives," said Ms. Sedlewicz. "The Euxyl K 700-series (K 700, 701, and 702) is based on organic acid chemistry, formulated to provide broad-spectrum, safe and effective preservation."
Mr. Hinden agreed that consistency questions continue to dog naturals.
"The fundamental issue is what the definition of 'natural' is and whether or not they are any safer than synthetic technologies. Naturals that are based on botanicals may be subject to a natural variation in the biomass and resultant composition that may cause inconsistencies in efficacy, safety and odor," he explained.
Dr. Pilz of Clariant had an interesting take on the natural issue when he called parabens the most effective and mostly used "natural" preservative.
"Parabens are ubiquitously found in many different plants and organisms and are also readily biodegradable; a fact which is normally not appreciated," he insisted. "Other natural, non-classical preservatives often have the disadvantage that they show relatively low activity and a narrow anti-microbial spectrum.
Natural preservatives also often have color and odor issues. As a result, there is no real "natural" preservative on the market that is broadly being used or accepted, according to Dr. Pilz.
But there are some suppliers who have embraced the natural preservative issue.
"Here at Bio-Botanica we can provide our customers with an all-natural preservative," explained Ellen Delisle of Bio-Botanica. "As an alternative to synthetic preservatives, plant materials are a significant source of active constituents with a high level of antimicrobial activity."
Ms. Delisle insisted that plant components have a strong scientific validation supporting their active role as antimicrobials, and she pointed out that many different plants are already recognized by CAS and EINECS for their antimicrobial benefits.
"The benefit is having a preservative-free claim on your label that the consumer perceives as being less toxic and more beneficial," she added.
To meet market demand, BioBotanica offers three patented natural preservatives: Suprapein, Biopein and Neopein. All three are propriety blends of botanical fractions having anti-microbial activity against a broad spectrum of organisms, including possible pathogenic organisms such as S. aureus, E. coli, Salmonella typhimurim and Candida albacans.
RITA has generated data to show that natural ingredients can have preservation activity.
"There are essential oils, some extracts, various glycols and some chemistries that have antimicrobial activity," explained Mr. Beio. "The biggest benefits are their natural names and the comfort level with consumers. The more natural sounding, the better, and in the customers' eyes, that translates into safer products from an irritation and sensitization standpoint."
He warned, however, that these naturals are not as potent as traditional preservatives and use levels can often reach "a couple of percent" of a formula.
"At these levels, you not only have to worry about safety issues, you must look at them as possible formulation functional ingredients that could effect aesthetics, stability, odor and color, in addition to adding cost," said Mr. Beio.
What's New from Suppliers?
With the cost of introducing a new preservative prohibitive, suppliers are taking different tacks when it comes to new product development. Mr. Bostic of Acme-Hardesty, for example, noted that Acme/Sharon has not introduced any new preservatives into the market.
"In fact, the market has not approved any new molecules and the only introductions occurring are merely blends of already approved materials," he noted. "From this perspective, Acme and Sharon are very active in the custom blending category to meet demands."
Dr. Pilz said Clariant remains confident about the safety of parabens, safety that has been proven by the toxicological data and the history of their safe and broad use.
"Nevertheless, the cosmetic formulator should have a real choice what kind of preservative he wants to use and to offer to the consumer," explained Dr. Pilz. "Therefore, we have developed two new special and extremely effective preservative blends based on Piroctone olamine, which can be seen as substitutes for all kind of blends containing the long-chain parabens."
The new blends Nipaguard POB (phenoxyethanol (and) piroctone olamine (and) benzoic acid) and Nipaguard POM (phenoxyethanol (and) piroctone olamine (and) methylparaben) are said to combine the good efficacies of the single components to create highly synergistic and extremely powerful broadspectrum blends. These clear liquid blends are easily incorporated in every kind of formulation even at temperatures as high as 80[degrees]C. They are most powerful between a pH value of 4-10 and so they give the utmost freedom of handling to the formulator. Although the allowed maximum use concentration is as high as 1.25%, typical use concentrations of 0.5-0.8% are enough to preserve a formulation and achieve the best marks in a challenge test.
Dr. Pilz said even hard to preserve formulations like sunscreens or wet wipes can be easily preserved with these effective, though mild, new blends.
"As we expect that piroctone olamine will be listed as a preservative in the Japanese positive list this year, formulators will be able to launch their products globally in the near future," concluded Dr. Pilz.
One of the recent additions to the list of globally approved preservatives is methylisothiazolinone (MIT). Euxyl K 220, from schulke, combines MIT with ethylhexylglycerin to boost its efficacy and broaden the spectrum of antimicrobial activity. The globally approved combination can be used up to pH 10 in both leave-on and rinse-off products.
When developing products, RITA looks at the entire chemistry and starting materials to get as much functionality out its ingredients as possible.
"With preservatives, we are using as many naturals as possible mixed with some traditional ingredients to yield some interesting combinations," said Mr. Beio.
For example, Ritative SR4L Magnolia is a unique combination of the natural components of Magnolia acuminata bark extract with the antimicrobial chemistry of glyceryl caprylate. This blend is augmented with phenoxyethanol.
"This gives a nice blend of natural and traditional ingredients which will give broad spectrum coverage," he explained
McIntyre recently introduced two new preservative systems and one antimicrobial ester at In-Cosmetics. These patent-pending products are based on a high-monoester content glyceryl caprylate with demonstrated efficacy in shampoo, conditioner and skin lotion formulation challenge studies.
"Of course, the results of these challenge studies are available to formulators' complete with formulation guidelines on use, formulation pH, and heat, to ensure finished product integrity," added Mr. Miller.
ISP has introduced two aromatics that have antimicrobial properties--Conarom P and Conarom H-3. Both work over a broad pH range (4-8) and can be used in both leave-on and rinse-off applications. They can be labeled as perfume or aroma or with their INCI names in end-use packaging.
"We have broadened our offering of acid-based preservative systems," added Ms. Subramanian. "Optiphen BSP consists of a combination of nature-identical benzoic and sorbic acid in phenoxyethanol. Optiphen BSB-N combines benzoic and sorbic acid with benzyl alcohol. Both mild preservatives are effective against bacteria, yeast and mold at acid pH values. Optiphen BSBN ingredients are compliant with Ecocert."
Three of Lonza's existing preservatives have been added to Ecocert's list of permitted preservatives for certified organic products: Geogard 111A, Geogard 111S and Geogard 221.
"We are continuing to work with Ecocert to gain approval of other preservatives in our portfolio," added Ms. Nunez.
Looking for a preservative system for your new formula? A list starts on p. 118.