ICMAD vice president and technical/regulatory/legislative chair Carl Geffken provided ICMAD members and guests a whirlwind tour of the global regulatory landscape during the ICMAD “Hot Topics” Breakfast held on July 21, 2009.
Geffken noted that Canada is currently working on its Chemical Management Plan, a 20-year program that will review substances in 12 batches. Approximately 200 substances are of concern to the beauty industry, and the reviews will also look at the environmental impact of these chemicals—a refocus from safety issues. In November 2008, Canada issued guidelines for advertising and labeling claims that made that “cosmeceutical” and "nutraceutical” claims no longer acceptable. Health Canada has also renewed threats to crackdown on failure to notify products being placed on the market in the country.
California has also been busy lately, said Geffken. On June 19, 2009, the chief of the California Safe Cosmetic Program notified stakeholders that an electronic reporting system is now live and products containing chemicals considered by the state to be cancer causing or reproductively toxic must be reported. Companies with worldwide sales of more than $1 million are required to register.
In the European Union, there is much activity—with REACH currently requesting the formation of SIEFs to begin to compile safety data. Due dates for this information are based on the quantities of the chemicals used within the EU. Additionally, the latest amendment to the EU Cosmetic Directive has been reworked as legislation, not a directive, and is known as the “Recast.” It consolidates the current 55 amendments, and requires individual member states to adopt the law uniformly. There will be major changes in product labeling, particularly with respect to nano-sized ingredients, cosmetic notifications, poison control declarations (one for all countries), and PIP and safety assessments.
In China, BSE certificates are no longer required, the U.S. Food and Drug Administration (FDA) is opening offices in several cities, including Beijing, and VOC regulations took effect in Hong Kong. However, the Chinese Health Authority is still undergoing restructure.
In the U.S., the FDA is putting on muscle, both in terms of dollars and personnel. The U.S. House of Representatives approved a $373 million increase to $1.99 billion for the FDA in fiscal 2010, with the Center for Food Safety and Applied Nutrition, the home of the cosmetics office, scheduled to receive $783 million. Clearly, said Geffken, new FDA commissioner Margaret Hamburg and deputy commissioner Josh Sharfstein, have taken active leadership roles to let the public know of their activities and, said Geffken, “we will see renewed activity.” There is a new regulatory attitude, with longer warning letters and more structured inspections already being noticed. Legislatively, the new FDA Globalization Act of 2009 was reintroduced in January, 2009, which seems to focus more heavily on food safety. The cosmetics provisions appear more uncertain.