Features
Formulators are increasingly concerned about microbial contamination in cosmetics.
CHEMICAL REGULATION
With fewer preservatives in use, chemists worry about protecting consumer products from contamination MARC S. REISCH, C&EN NEW YORK CITY
t has been a slow war of attrition. For the past decade, environmental groups have called out a growing number of cosmetic preservatives as suspected endocrine disruptors, cancer-causing agents, and skin irritants. Regulators have examined the claims and in some cases enacted restrictions on widely used preservatives.
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Now the list of useful preservatives is down to a handful, say cosmetic formulators and suppliers. And because of the high cost of developing new preservatives and strictures against animal testing, few qualified alternatives are in the offing. Without a preservative, often used at less than 1%, skin creams, makeup, and shampoos can become contaminated with mold, fungi, and bacteria. Some contaminants can spoil the appearance and smell of cosmetics. Others can lead to skin, scalp,
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and eye infections, or even worse. Bad actors include Staphylococcus aureus, a gram-positive bacteria that can cause skin infections, and Escherichia coli, a gram-negative bacteria that can cause stomach cramps and diarrhea when people share cosmetics. “Consumers assume that preservatives are bad without understanding how necessary they are,” says Janet Blaschke, chief executive officer of the consulting firm International Cosmetics & Regulatory Specialists.
Preservatives are meant “to keep cosmetics safe throughout their useful life from production until the last bit is used at the bottom of the jar,” Blaschke says. She fears that, over time, bacteria will build up resistance to the diminishing number of options now available. She doesn’t see alternatives such as single-use or aseptic packaging as realistic—both because of the additional cost and because of the increased packaging waste. When it comes to preservatives, the most important regulator is the European Union. The EU has a list of allowable preservatives, known as Annex V, that not only governs preservative use in the 28-nation alliance but also influences regulations in many other countries. Although the list contains more than 50 approved ingredients, often only two or three options are appropriate for a particular formulation, formulators and preservative suppliers say. Among the preservatives European authorities have restricted are methylisothiazolinone and the mixture of methylisothiazolinone and methylchloroisothiazoli-
CREDIT: SHUTTERSTOCK
Restrictions ramp up on cosmetic preservatives
“Consumers assume that preservatives are bad without understanding how necessary they are.”
none for use in cosmetics, such as lotions, that remain on the skin. The restrictions, effective earlier this year for the combination and in 2017 for the single ingredient, were widely expected. Most everyone, including their maker, Dow Chemical, agreed the ingredients can irritate skin. An unfavorable review by the Scientific —Janet Blaschke, CEO, International Cosmetics & Regulatory Specialists Committee on Consumer Safety (SCCS), an EU panel of experts, judged one widely enough. Following criticism from outside detrimental consequence of a possible ban used preservative, poly(hexamethylene) groups, some consumer product formulater,” he explains. biguanide hydrochloride (PHMB), not safe lators have banned what they consider Questioning old standby preservatives for use at a maximum concentration of chemicals of concern. For example, Johnis not necessarily a bad thing, Mitaroton0.3% because of mutagenic and cancer con- son & Johnson removed formaldehyde-reda observes. “What was considered safe cerns. SCCS is now considering whether leasing preservatives, which might evoke 20 years ago, tested using methods and PHMB is safe for use at concentrations of an allergic response, from all its products. protocols available at that time, needs to up to 0.1%, says PHMB maker Lonza. That It also removed parabens from baby be reviewed in light of the knowledge and opinion is expected in December. products. technologies available now,” he says. Insiders also say EU authorities may Andrea Mitarotonda, chief scientific ofNeal’s Yard Remedies draws on the insoon ban chloroacetamide. French authorficer of Neal’s Yard Remedies, a U.K.-based gredients from the Annex V list, but Mitaroities banned it in 2012, but it still appears cosmetics retailer and formulator, notes tonda is also interested in using them in on the Annex V list of allowable preserthat any suspicion, even if undeserved, can combination with natural alternatives not vatives. The U.S. Cosmetic Ingredient prompt corporate action. Without waiting on the list. “Very few formulators will be Review, a government-sanctioned industry for the outcome of an investigation, comaware of the chemistry of essential oils or organization, determined in 1991 that the panies often reformulate entire ranges of plant extracts, which is obviously a shame ingredient is “a potential human sensitizproducts so they don’t have to face “the as they may be missing out on opportunier” and thus not safe for cosmetic ties to use substances to enhance use. the preservation profile of their European authorities have banned three preservatives products.” EU authorities have examined and reviewed four others over the past five years. other preservatives on Annex V Some industry players are leery and found them acceptable but of essential oils and plant extracts, INGREDIENT DATE ACTION sometimes at reduced allowable use which are often called “nonpreservaBANS levels. The widely used preservative tive preservatives.” Oils and extracts phenoxyethanol received a clean bill can vary in quality and consistency, Chloroacetamide June 2012 French regulatory ban of health earlier this year. In 2015, notes David Steinberg, a cosmetic phenylphenol got a passing grade formulation consultant. “How do Methylisothiazolinone February 2017 EC disallows for but at reduced use levels. SCCS said you guarantee the purity of extracts CH3 leave-on products it did not have enough data to judge compared with the purity of synthetN O S safe use of sodium o-phenylphenate ic preservatives like parabens?” he and potassium o-phenylphenate. asks. Methylisothiazolinone & April 2016 EC disallows for A 2013 SCCS review of parabens, Steinberg also wonders about the methylchloroisothiazolinone leave-on products compounds the advocacy organizaefficacy of alternative preservatives, mixture tion Environmental Working Group noting that they don’t have the long has targeted as endocrine system history of use and characterization disruptors, found they were safe that backs the traditional sort. ReRECENT EU REVIEWS to use. SCCS did recommend new, calls of contaminated cosmetics are Parabens May 2013 SCCS rules safe with O lower concentration limits for prodwarfed by those of clothing, toys, some restriction pylparaben and butylparaben, both and other consumer products on O on propyl- and of which it judged to have “a weak the EU’s Rapid Alert recall database, butylparaben HO endocrine-modifying potential.” he says. But he notes a subtle rise in Butylparaben Rob Taalman, director of research cosmetic recalls in the past few years, Phenoxyethanol October 2016 SCCS rules safe for and science at Cosmetics Europe, which he attributes to lower levels of all uses O which represents European coseffective preservatives and the use of OH metics makers, says the parabens alternatives. recommendation reflects the EU’s Some products that are primarily o-Phenylphenol December 2015 SCCS rules safe at risk-based assessment process for added as emollients or conditioners, prescribed levels cosmetic ingredients. An ingredient for instance, can also have preservaPoly(hexamethylene) July 2015 SCCS rules says “may have an intrinsic undesirable tive qualities, notes Rick Strittmatbiguanide hydrochloride not safe at 0.3% by property, but EU authorities don’t ter, global microbial control R&D weight or higher automatically ban it,” he says. Predirector at Dow. Like plant extracts, servatives are used in cosmetics to they also fall into the category of EC = European Commission. SCCS = Scientific Committee on Consumer ensure public safety, he notes. nonpreservative preservatives and Safety, which advises EC on the safety of preservatives. Yet for companies, a government “can clearly play a preservation role,” Sources: European Commission, Agence Nationale de Sécurité du stamp of approval isn’t always Médicament et des Produits de Santé he says.
Under fire
NOVEMBER 28, 2016 | CEN.ACS.ORG | C&EN
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But the assessment of such preservatives “also must be subject to the same riskbased approach that traditional preservatives have been subject to,” Strittmatter says. “If it is being used as a preservative, it needs to be assessed on a level playing field.” Companies are pursuing all preservative options to combat the shrinking arsenal of traditional products. Niall D’Arcy, project manager for the Ireland-based consulting firm Biocide Information, sees a business opportunity because the new products are generally more expensive than parabens and other traditional ingredients. He says the $1 billion-a-year global market for preservatives of all types is growing 4 to 5% annually. Of the more than 50 preservatives listed on Annex V, only about one-third are in regular use, says Andrea Wingenfeld, a technical marketing manager at the specialty chemical maker Ashland. Temperature sensitivity, pH sensitivity, and antimicrobial activity all play a role in the choice a formulator makes. In addition, formulators may avoid using a preservative approved in Europe or other regions if that preservative has been the subject of negative publicity, she says. For leave-on products such as sunblock or makeup, the choice of preservatives is especially limited, Wingenfeld says. Since the bans on use of isothiazolinones, formulators rely mostly on phenoxyethanol, benzyl alcohol, and organic acids, she notes. Although they do not like the attacks on what they view as beneficial ingredients, preservative suppliers acknowledge market realities. Lonza, for instance, just revamped its FormulaProtect online preservative selector tool, which allows users to avoid controversial products such as formaldehyde donors and instead choose “less controversial products,” says Phil Hindley, Lonza Consumer Care’s global marketing head for preservation. Lonza is also interested in developing new preservatives that are acceptable to regulators, formulators, and environmental groups. Hindley says he is open to working with all stakeholders to develop such alternatives (see sidebar). But only a “robust solution” with performance, safety, and cost benefits will work in the long run, he says. Other challenges to the development of new preservatives are the time, cost, and effort required to win regulatory approval. Ashland’s Wingenfeld says it took eight years from the time authorities received a dossier on the most recent addition to Annex V, citric acid/silver citrate, until it appeared in 2014. Given that timetable, “most companies will not see a business case in
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commercializing new preservatives,” she says. The ban on animal testing for cosmetics, in place in Europe since 2009, makes it difficult for developers to submit required safety data on a new preservative, Wingenfeld adds. Cosmetics Europe’s Taalman says member companies are working with regulators to qualify new skin exposure and risk-assessment models. However, at the moment, it’s not easy to
qualify a new preservative, Taalman says. “We are basically stuck,” he says, at least until new testing protocols are approved, and that is at least a few years off. Cosmetic products today are by and large safe, Blaschke, the consultant, emphasizes. By worrying about preservative options now, formulators and suppliers “are trying to keep up their good record,” she says, and keep crises from occurring down the road. ◾
Contest will offer cash for new preservatives A group of consumer product formulawho don’t have the resources to get new tors, preservative makers, retailers, and ‘green’ preservatives to market,” she says. nongovernment organizations is coming In all, 17 entities are backing the contogether under the banner of the Green test. Among them are retailers Walmart Chemistry & Commerce Council (GC3) and Target. Both firms have pressured to stage a crowdsourcing competition for suppliers to reduce or eliminate ingrenew preservative technologies. dients in household goods that they Details on the competition, to be deem harmful to human health and the managed by the open innovation expert environment. InnoCentive, are still being worked out. Consumer goods makers such as But when the competition gets under Johnson & Johnson, which pledged to way in about six months, it’s expected eliminate certain chemicals of concern to offer up to 10 prizes of $5,000 to from its products in 2012, are among the $10,000 apiece for early-stage ideas backers. Additional contest underwriters and $20,000 to $25,000 for more adinclude the advocacy group Environmenvanced preservative concepts, according tal Defense Fund and large preservative to Monica Becker, codirector of GC3, an makers such as Dow Chemical, Lonza, organization of chemical makers, product and Schülke & Mayr. manufacturers, and retailers. The preservation project has been The goal, Becker says, is to accelerate two years in the making, Becker says. An commercialization of safe and effective executive at J&J got the ball rolling when preservative systems. Contest-judging he watched a webinar on open innovation criteria, now being developed, are likely at which Becker was a speaker. to echo a “need statement” GC3 deWhen they talked, Becker and the J&J veloped with a number of formulators executive realized that many compaabout a year ago. The statement called nies in the personal care and household for preservatives that are biodegradable, products space share a need for new, free of carcinogen and endocrine disrupsafe, and effective preservatives, Becker tion concerns, and not recounts. “We thought we likely to build microbial could make it a collaboraresistance. tive effort,” she says. The contest backers After gathering an inidon’t want intellectual A list of contest supporters tial group of formulators, property rights, Becker that agreed to be named: Becker also drew in pre▸ Babyganics says. Instead, their goal servative makers. Though ▸ Beiersdorf is “to bring promising not initially involved, large ▸ Dow Chemical technology to light” and retailers heard about it ▸ Environmental Defense connect innovators to and asked to join, she companies with which Fund says. ▸ Johnson & Johnson they can partner to deBecker says she is ▸ Lonza velop, test, register, and hoping the challenge will ▸ Method manufacture inherently attract a large number of ▸ Schülke & Mayr safer preservatives. entries. “We’ve never done ▸ Seventh Generation “We want to help anything like this before. ▸ Target academic researchers I’m cautiously optimistic,” ▸ Walmart or small companies she says.
Backers
