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Cover Story

May 11, 2009
Volume 87, Number 19
pp. 10-15

Europe's Beauty Race

Cosmetics makers worry they won't meet the 2013 deadline for new European Union safety-testing regulations

Marc S. Reisch

COSMETICS COMPANIES and their ingredient 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.

TAKING MEASURE A technician at the BASF cosmetics lab in Ludwigshafen, Germany, weighs sunscreen ingredients. BASF
TAKING MEASURE A technician at the BASF cosmetics lab in Ludwigshafen, Germany, weighs sunscreen ingredients.

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.

"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."

In vitro testing opportunities in Europe are "popping up like dandelions in spring."

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%.

EFFORTS TO foster internationally accepted 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 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 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-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 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 hard-pressed to validate their formulations because they often lack a testing infrastructure, he says.

CLOSE SCRUTINY ISP uses confocal imaging to visualize the activity of peptides in the epidermis, a layer of the skin. Lucid
CLOSE SCRUTINY ISP uses confocal imaging to visualize the activity of peptides in the epidermis, a layer of the skin.
Well Planned Each dot on Solidus Biosciences' DataChip represents a cell
culture that screens compounds for toxicity Solidus Biosciences
Well Planned Each dot on Solidus Biosciences' DataChip represents a cell culture that screens compounds for toxicity

Jean Pachot, president and scientific director of testing firm Oroxcell, says the rush toward in vitro testing for cosmetics and the lack of qualified animal-testing alternatives has created "a foggy situation." The French firm, which until now had an emphasis in the pharmaceutical market, thinks the in vitro-only testing requirements might stifle innovation in the cosmetics market. "In vitro positives could be false positives and otherwise prevent safe molecules from coming into the market," he warns.

INDEED, many personal care ingredient makers are uncertain about what to do about the total ban on animal testing for cosmetic ingredients and formulations to come into force in 2013. To prepare, Bayer completed all the safety testing it expects it will need to do on existing and developmental compounds for the next five years, says Steffen Hofacker, head of cosmetics.

Hofacker says he is counting on European regulators to resolve contradictions in the directive later this year and to allow limited animal testing into the foreseeable future. Although the industry is working hard to develop alternatives to animal testing, Hofacker argues that EU ingredient makers are at a disadvantage to those in the U.S. and Asia, where companies aren't bound by the same regulations. And like Pachot, Hofacker is worried the animal-testing ban may slow the development of unique personal care ingredients.

Claus Rettig, president of Evonik Industries' consumer specialties business, says uncertainty stemming from the conflicts inherent between REACH and the Cosmetics Directive is not good for business. "Our advantage as a company is that we develop our products for multiple uses," he says. "But because of the volumes we make, our products trigger normal REACH approvals," and that includes, in some instances, animal-testing requirements, Rettig explains. The chemical industry is trying to work out a compromise with European regulators. But Rettig adds that if the effort is unsuccessful, the dispute may have to go to court.

Even firms that don't conduct animal tests on cosmetic ingredients are troubled by the state of affairs. "Historically, we've been a pharmaceutical company where, for many years, it was normal to do animal testing," says Christian Artaria, marketing director for Italian plant extracts maker Indena. "But since the 1990s, we've stopped animal testing on ingredients destined only for the cosmetics market."

Artaria has worried for some time that some of the in vitro tests are not valid substitutes and thus "create a risk for us." After in vitro testing, and with the approval of an ethics committee, Indena will conduct in vivo human testing, which the Cosmetics Directive does not ban. For the time being, he says, Indena isn't developing new chemical entities for cosmetic use, but if it does, he is concerned that such an effort would be "problematic."

Makers of cosmetic ingredients producing less than 1 metric ton per year can, under REACH regulations, avoid animal testing entirely, notes Claude Dal Farra, vice president of R&D at International Specialty Products. Most of ISP's biofunctional ingredients fall below this threshold, he notes, but the company does employ a number of in vitro tests to ensure the safety of its products.

But for those that produce high-volume 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 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-and-white 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 is that they should avoid 'animal-testing-free' 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 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.

Cover Story

  • Europe's Beauty Race
  • Cosmetics makers worry they won't meet the 2013 deadline for new European Union safety-testing regulations
  • Innovation
  • Novel ingredients spread across InCosmetics

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Chemical & Engineering News
ISSN 0009-2347
Copyright © 2009 American Chemical Society

Cover Story

  • Europe's Beauty Race
  • Cosmetics makers worry they won't meet the 2013 deadline for new European Union safety-testing regulations
  • Innovation
  • Novel ingredients spread across InCosmetics

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