COVE R STORY TAKING MEASURE
BASF
A technician at the BASF cosmetics lab in Ludwigshafen, Germany, weighs sunscreen ingredients.
EUROPE’S BEAUTY RACE Cosmetics makers worry they won’t meet the 2013 deadline for new European Union SAFETY-TESTING REGULATIONS MARC S. REISCH, C&EN NORTHEAST NEWS BUREAU
COSMETICS COMPANIES and their in-
gredient suppliers are exploring new ways to test the safety of hair conditioners, toenail polish, and everything in between. Just like makers of pesticides, food additives, medications, and a host of other everyday products, companies in the beauty industry are looking for the best ways to assure the public their products can do no harm. Many ingredient makers have turned to in vitro testing methods that substitute petri dishes with cell cultures for live animals. Researchers are working on sophisticated cellular and genomic assays capable of multiple screenings on a single slide. Toxicologists are developing sophisticated computer simulation programs in hopes that they can develop predictive tests without resorting to the use of in vivo methods. Still others in the regulatory community say they are combing existing
databases and are extrapolating results from tests already conducted instead of repeating tests unnecessarily. It seems that the lab rat’s days are numbered—at least for ingredients and personal care formulations destined for the 27 nations of the European Union. The ban on most animal testing in the Seventh Amendment to the EU Cosmetics Directive went into effect in March. The directive governs safety and labeling standards for personal care products sold in the EU. Its influence is far-reaching because it will affect substances imported into the EU and because EU regulations are often adopted in other countries.
Because ending animal testing requires the crossing of a number of hurdles, it was a topic of much discussion at the InCosmetics trade show, held late last month in Munich, Germany. Satisfying the EU’s Registration, Evaluation, Authorization & Restriction of Chemical substances (REACH) program still requires some animal testing, many attendees noted. Given that necessity, ingredient makers wonder how they can comply with the animal-testing-free imperative of the Cosmetics Directive. Moreover, government certification authorities have not validated all the tests needed to replace animal testing, others said.
In vitro testing opportunities in Europe are “popping up like dandelions in spring.”
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COVE R STORY
EFFORTS TO foster internationally ac-
cepted alternatives to animal testing for all types of consumer product safety investigations got a boost late last month when the U.S., Canada, Japan, and the EU signed a Memorandum of Cooperation to coordinate and speed scientific recommendations on alternative toxicity assessments. The far-reaching memorandum will “serve an important role in translating research advances into more effective public health tools,” notes William S. Stokes, director of the U.S. National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM). “Animal welfare will also be improved by the national and international acceptance of alternative test methods that reduce, refine, and replace the use of animals,” he says. Signing the memorandum were representatives for NICEATM; the European Centre for the Validation of Alternative Methods (ECVAM), an agency that advises the European Commission and validates safety-testing protocols; the Environmental Health Science & Research Bureau of Health Canada; and the Japanese Center for the Validation of Alternative Methods. ECVAM says it has been working hard to validate alternatives to animal testing to
INNOVATION
Novel Ingredients Spread Across InCosmetics About 4,500 visitors came to the InCosmetics show in Munich, Germany, last month. Among them were formulators of lip gloss, skin creams, and other personal care products hoping to gain an edge with novel ingredients. For diversion or for business, they had their choice among the more than 500 exhibitors who came from 35 countries to the New Munich Trade Fair Centre. But the economic slowdown has taken its toll on the show. Traffic was off by about 13% compared with the 2008 show in Amsterdam. Likewise, the personal care product industry is expected to slip below its average annual growth rate of 5% for the five years ending in 2008, when sales were $280 billion, notes Anna Ibbotson, chemical and materials industry manager at consulting firm Kline & Co. Still, in good economic times and in bad, personal care product makers yearn for innovation, Ibbotson notes. Among the innovations on display in Munich was Mibelle Biochemistry’s PhytoCellTec Malus Domestica, derived from the plant stem cells of a now-rare apple variety known for its long storage stability. According to Cornelia Schürch, head of product development at Switzerlandbased Mibelle, the firm uses tissue culture techniques to grow the apple stem cells and enhance their gene-controlling epigenetic factors. These factors balance gene function in plants and hu-
satisfy both REACH and Cosmetics Directive requirements. Among alternatives it has validated are tests from Episkin and SkinEthic, both owned by French cosmetics maker L’Oreal. In 2007, ECVAM approved Episkin, a human epidermis obtained from hospital surgeries and reconstructed on collagen, as an animal replacement for assessing the skin irritancy potential of chemicals. In late 2008, ECVAM approved SkinEthic’s reconstructed epidermis model, the RHE Assay, to replace the Draize eye test conducted on rabbits. At the same time, ECVAM approved a skin irritation test called Modified EpiDerm SIT from U.S.-based MatTek. Others are working on in vitro testing WWW.CEN-ONLINE.ORG
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mans alike, Schürch says. A liposomeencapsulated extract of the stem cells’ epigenetic factors protects the skin’s own stem cells and reduces skin wrinkling, she claims. Another innovation is the appearance of fullerenes, also known as buckyballs, in the personal care realm. Properly purified and prepared, buckyballs are WAC KER
“It is in everyone’s best interest to eliminate animal testing. No one wants to harm rabbits,” says Janet Winter Blaschke, managing director of REACH Chemical Consulting, an advisory firm. “But at this time, some animal testing is still needed to ensure product safety.” Barbara Vogt, a principal at the toxicology consulting firm Tox Focus, is worried that scientists won’t have validated in vitro tests available for critical tests, such as repeated-dose and reproductive toxicity, when a total ban on animal testing takes effect under the Cosmetics Directive in 2013. She adds that although she recognizes that regulations can help force advances in science, “it takes time for science to develop protocols for nonanimal tests.” Toxicologists have been successful in reducing their dependence on in vivo animal models over the past quarter century, according to the Johns Hopkins University Center for Alternatives to Animal Testing. The group notes that some companies reduced in vivo methods by 90% for some types of tests and that the U.S. cosmetics industry reduced in vivo eye irritation tests by 87%.
IN BLOOM An essential oil with antiseptic
properties comes from the tea tree.
powerful antioxidants for skin creams and lotions, says Shuichi Yamana, chief executive officer of Vitamin C60 BioResearch, a firm owned by Japan’s Mitsubishi Corp. In the firm’s product, called Radical Sponge, fullerenes are entrapped in a water-soluble polymer, keeping them on the surface of the skin
protocols to tap into a growing market for animal alternatives. Scientists at Rensselaer Polytechnic Institute, in Troy, N.Y., and the University of California, Berkeley, developed two biochips that together reveal the potential toxicity of chemical and drug candidates on various organs in the human body and whether, when metabolized, those compounds could become toxic. The DataChip, composed of up to 1,080 human cell cultures, screens for potential chemical toxicity on human cells. The MetaChip mimics the metabolic reactions of the human liver and can thus screen for harmful metabolites. David Rozzell, chief executive officer of Solidus Biosciences, a Troy-based start-
where they can capture free radicals generated when the skin is exposed to bright sun, Yamana explains. Wacker extended its range of cyclodextrin encapsulants to incorporate tea tree oil, an antibacterial ingredient and insect repellant that can irritate skin. Cyclodextrins are biofermented starch capsules that slowly meter out their encapsulated ingredients, such as tea tree oil, on the skin, notes Nicole Amann, cyclodextrin sales and marketing manager. Wacker has other cyclodextrin complexes in its line, such as those containing retinol and vitamin E, both of which have skin-enhancing properties. Dow Corning, known as a supplier of silicone ingredients, teamed up with Elevance Renewable Science to offer soyderived petrolatum substitutes for skin and hair care products. Elevance uses olefin metathesis to convert vegetable oil into waxes and lubricants. HY-3051 soy wax blend imparts a smooth feel to skin care products. As a hair-conditioning agent, HY-3051 can add shine and control frizz, notes Andrew L. Shafer, Elevance’s executive vice president. Shafer anticipates that the cost of petrolatum will rise as oil refiners tweak their product mix. The Elevance soy-derived materials are cost-effective substitutes, he says. Unlike more cautious industries such as coatings or pharmaceuticals, the cosmetics industry embraces innovation by its suppliers, Kline’s Ibbotson notes. She is confident it will continue to reward makers that develop novel ingredients.
up company with an exclusive license to the DataChip and MetaChip, says one of the best near-term markets for the firm’s technology is the cosmetics industry. Solidus has been working with L’Oreal for about a year and has had success in testing ingredients and formulations with the personal care company. He hopes to eventually get ECVAM to validate the testing protocol. CeeTox, a Michigan-based in vitro safety-testing firm, which until now has specialized in serving the pharmaceutical market, sees great potential in testing cosmetic and other ingredients for customers trying to satisfy REACH and Cosmetics Directive regulations. The firm was one of
a number of safety-testing outfits at InCosmetics trawling for business opportunities. Although CeeTox’s pharmaceutical-testing market is dropping off as a result of mergers such as Pfizer’s pending acquisition of Wyeth, in vitro testing opportunities in Europe are “popping up like dandelions in spring,” says Syed A. Mustafa, director of sales and marketing at the firm.
Guillaume Laugier, project manager for ImmunoSearch, a three-year-old REACH consultancy and toxicology-testing firm based in France, set up a booth at InCosmetics to engage potential cosmetics clients. ImmunoSearch sees opportunity in the animal-testing ban and already conducts a variety of in vitro tests for clients, including those using Episkin. The firm
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MSDS Authoring Services and Software Tools also has developed a peptide-binding test for skin sensitization that it hopes ECVAM will validate within a few months. The push toward in vitro and other testing models for cosmetics makers “is traumatic for the cosmetics industry and good for us,” says Jacques Bouffechoux, a toxicologist and founder of JB Consulting. Under the Cosmetics Directive, smaller companies will be especially hardpressed to validate their formulations because they often lack a testing infrastructure, he says. Jean Pachot, president and scientific director of testing firm Oroxcell, says the rush toward in vitro testing CLOSE SCRUTINY for cosmetics and the lack of qualiproducts trigger normal ISP uses confocal fied animal-testing alternatives has REACH approvals,” and that imaging to created “a foggy situation.” The includes, in some instances, visualize the French firm, which until now had activity of peptides animal-testing requirements, an emphasis in the pharmaceutiRettig explains. The chemical in the epidermis, a layer of the skin. cal market, thinks the in vitro-only industry is trying to work out testing requirements might stifle a compromise with European innovation in the cosmetics market. regulators. But Rettig adds “In vitro positives could be false positives that if the effort is unsuccessful, the dispute and otherwise prevent safe molecules from may have to go to court. coming into the market,” he warns. Even firms that don’t conduct animal tests on cosmetic ingredients are troubled INDEED, many personal care ingredient by the state of affairs. “Historically, we’ve makers are uncertain about what to do been a pharmaceutical company where, about the total ban on animal testing for for many years, it was normal to do animal cosmetic ingredients and formulations to testing,” says Christian Artaria, marketing come into force in 2013. To prepare, Bayer director for Italian plant extracts maker Incompleted all the safety testing it expects dena. “But since the 1990s, we’ve stopped it will need to do on existing and developanimal testing on ingredients destined only mental compounds for the next five years, for the cosmetics market.” says Steffen Hofacker, head of cosmetics. Artaria has worried for some time that Hofacker says he is counting on Eurosome of the in vitro tests are not valid subpean regulators to resolve contradictions stitutes and thus “create a risk for us.” Afin the directive later this year and to allow ter in vitro testing, and with the approval of limited animal testing into the foreseeable an ethics committee, Indena will conduct future. Although the industry is working in vivo human testing, which the Cosmethard to develop alternatives to animal testics Directive does not ban. For the time ing, Hofacker argues that EU ingredient being, he says, Indena isn’t developing new makers are at a disadvantage to those in chemical entities for cosmetic use, but if the U.S. and Asia, where companies aren’t it does, he is concerned that such an effort bound by the same regulations. And like would be “problematic.” Pachot, Hofacker is worried the animalMakers of cosmetic ingredients protesting ban may slow the development of ducing less than 1 metric ton per year can, unique personal care ingredients. under REACH regulations, avoid animal Claus Rettig, president of Evonik Industesting entirely, notes Claude Dal Farra, tries’ consumer specialties business, says vice president of R&D at International uncertainty stemming from the conflicts Specialty Products. Most of ISP’s biofuncinherent between REACH and the Cosmettional ingredients fall below this threshold, ics Directive is not good for business. “Our he notes, but the company does employ a advantage as a company is that we develop number of in vitro tests to ensure the safety our products for multiple uses,” he says. of its products. “But because of the volumes we make, our But for those that produce high-volume WWW.CEN-ONLINE.ORG
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COVE R STORY
ingredients, the answers are not so easy. “People have been working for years to develop alternative test methods,” says Andy Boon, global director for toxicology and product safety at pigment maker Sun Chemical. “So far the pace has been quite slow, and only a small number of alternative tests have been validated. “WE’RE ALL AWARE of the need to reduce
is that they should avoid ‘animal-testingfree’ labels because the regulations are not entirely clear.” The day may be approaching when the lab rat is a thing of the past. For cosmetics, the deadline in Europe is in 2013. Some are puzzled about how they will satisfy the ban without compromising customer safety. Others doubt whether the ban is
the use of animals as much as possible,” he adds. “It is often said animals are not good models for humans. But how can you look at the distribution, metabolism, and organ interplay of a substance if you do not want to experiment on a human being?” Boon asks. As of now, “you are still stuck with animal models.” Boon says he envisions a day when scientists will be able to run a computer simulation that accurately models chemical effects on genes. The notion now lies between science fiction and science fact, he says. But with an increase in genetics know-how, it might be possible to generate computer toxicity simulations in 20 or 30 years’ time, he says. Dow Chemical has a fairly black-andwhite interpretation of the Cosmetics Directive ban on animal testing and its relationship to REACH. “The ban is applicable only if testing is done in animals,” says Chris Newsome, product steward. Thus, ingredients meant only for use in a cosmetic product are not subject to REACH requirements for safety training, according to Dow. If ingredients are also intended for other uses, then REACH requirements do apply, Newsome notes. With its focus on the environment, REACH could trigger some animal testing of high-volume products intended solely for cosmetic use, “but this would not contradict the testing or marketing bans in the Cosmetics Directive since environmental safety is not in the scope of the directive,” Newsome says. For now, a legalistic approach may be the best one for formulators and ingredient makers. Harald Dittmar, a lawyer and managing director of the Federation of German Industrial & Commercial Enterprises (known by its German initials BDIH), whose members include cosmetics makers, says REACH regulations trump the Cosmetics Directive if an ingredient is not exclusively used for cosmetic purposes. For personal care formulators “that only becomes a problem for those who want to label their products ‘animal-testing-free,’ ” Dittmar says. “Our advice to formulators
achievable and say, at best, it can be only a partial ban because of REACH restrictions. For Vogt of Tox Focus, the ban on animal testing in cosmetics is not just a marketing conundrum: If the EU doesn’t harmonize REACH and Cosmetics Directive regulations, cosmetics makers may have a smaller palette of ingredients to choose from in the future. ■
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