Bracing for the Ban

Jennifer Dionisio and Jody A. Roberts

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.

 

Jennifer Dionisio is program coordinator for biotechnology and Jody A. Roberts is program manager of the environmental history and policy program in CHF’s Center for Contemporary History and Policy.