Bracing for the Ban
Cosmetics testing has created an issue for consumers: the potential cruelty to lab animals of tests meant to ensure product safety.
For years regulators have concerned themselves with the chemical products we use on our bodies daily: soaps, shampoos, lotions, makeup. The concern, however, has always been for the well-being of the humans who use these items. The push for safety testing has now created another issue: the extensive testing on animals that takes place to assure product safety. Although many alternatives to animal testing exist, they are not widely used. Beginning next year, cosmetics and personal-care product manufacturers, as well as chemical producers, will have to start employing those alternatives if they wish to keep selling their products in the European Union (EU) market.
In 2003 the European Commission (the EU’s executive branch) passed the seventh amendment to its Cosmetics Directive with the intention of weaning the cosmetics industry from its use of animal testing. Among a series of deadlines set within this directive, the most sweping of the regulations takes effect just one year from now. The legislation marked 2009 as the final year in which industries that produce cosmetics and other personal-care items containing ingredients that have been tested on animals can be produced, marketed, or sold within the EU. As companies based in the United States export over $2 billion in products such as makeup, deodorant, and shampoo to Europe, the pressure is on American companies to develop innovative, animal-free safety tests to meet these new standards.
In the context of the Directive the term cosmetics includes any material applied to external human body parts with the intent of “cleaning them, perfuming them, changing their appearance, and/or correcting body odors.” Passed in 1976, the Cosmetics Directive’s intent was to ensure product safety for European consumers through regulation of the industry. In 1992 the European Commission began to debate a possible new initiative of the Cosmetics Directive that would ban the marketing of products tested on animals. Although this sixth amendment passed, with enforcement scheduled for 1998, the deadline for compliance was repeatedly pushed back because it was believed that there were not enough alternative testing methods available. In 2003, following 11 years of discussion, debate, and continued research, the European Commission reopened debate on cosmetics and other personal-care items that contained chemicals tested on animals. This time the ban was applied not only to marketing but also to animal testing. The new amendment was approved by the European parliament in 2004, and a series of compliance deadlines quickly followed. For cosmetics manufacturers and manufacturers of the chemicals used in the cosmetics, this meant that by September of that year all animal testing was prohibited when alternative tests were available.
On 1 September 2009 the European Commission will implement the next phase of the directive. Sales of cosmetics containing any ingredients tested on animals after that date will be banned in the EU regardless of whether alternative tests exist. In order to remain compliant (and therefore competitive) in the EU market, industry in the United States has worked both to adopt available alternative testing methods and to develop new ones where alternatives are not yet available.
In their rush to beat the 2009 deadline competing EU-based cosmetics businesses are sharing techniques to ensure their collective survival and keep up with the efforts of major international companies such as L’Óreal. While the media have focused attention on cosmetics manufacturers, compliance with the Cosmetics Directive will require many international chemical suppliers to change their methods as well; the directive asserts that all chemical components, not just finished products, will be subject to the animal testing ban. While many cosmetics manufacturers have had the luxury of preparing for the effects of the directive for many years, their suppliers may find themselves in the position of having to rapidly change their testing procedures, or risk losing the business of many major customers.
Although the industry is not legally required to conduct animal testing, it has long relied on animal-based tests to determine and demonstrate product safety, including procedures that expose the eyes of albino rabbits to the substance under review. Particularly in Europe, the very tests that are intended to console consumers have made the public anxious about the potential cruelty of such procedures.
While the seventh amendment is designed to eliminate all animal testing, there are some notable exceptions to the deadlines. Many of these exceptions are the result of another EU measure aimed at chemical regulation, the REACH (Registration, Evaluation, and Assessment of CHemicals) Act, a recently adopted set of EU rules and standards for the broader chemical industry (see “Breaking New Regulatory Ground,” CH, Winter 2007/08, pp. 38–39). While the Cosmetics Directive seeks to eliminate animal testing for chemical safety, REACH is adding increased pressure on chemical manufacturers to do more testing on more chemicals in response to new concerns regarding, for example, possible hormone-disrupting effects of synthetic chemicals like phthalates, which are often found in cosmetics. Similar concerns regarding a host of synthetic chemicals have led regulators to provide more time to seek nonanimal methods for conducting these tests. Thus, the extended deadline provides manufacturers enough time to fully comply with REACH regulations while also developing non-animal-based testing methods that can be used for compliance with both directives. The final deadline, 2013, will require full compliance even in the cases currently exempted.
In the meantime companies are racing to implement the available alternative tests and develop new ones. Promising replacements include testing chemicals on artificial human skin and reconstructed eye tissue, as well as predicting their effects via sophisticated microchips and computer simulations. These emerging technologies provide industry representatives and government regulators with hope that they can entirely eradicate animal testing for consumer products on schedule. But an equal number from both camps have raised doubts about whether widespread implementation of alternative tests will happen in time.
With the Cosmetics Directive and REACH, two EU initiatives that directly impact U.S. production and trade, it is increasingly clear that European and American regulatory agencies will need to work together to harmonize standards and keep companies competitive in the global market. Steps have already been made in this direction: in November 2007 officials from both governments met to discuss methods for collaboration.
Scientists and cosmetic industry representatives have already made strides in their race to meet the EU’s deadline. But more must be done. In the United States many businesses still appear to be unprepared, and scientists, industry representatives, and regulators must come together to gather information on how exactly the Cosmetics Directive will operate and what will be required for compliance. If U.S. companies are to remain competitive in the global marketplace, especially in the EU, understanding the shifting global regulatory terrain will be essential.
For information on the intricacies of the new EU cosmetics regulations visit www.spotlightoningredients.com.