CTFA Regulatory Science Summit Covers All Bases

More than 150 industry experts and government scientists came together for the first ever Cosmetic, Toiletry and Fragrance Association (CTFA) Regulatory Science Summit. The event was held Sept. 6–7, 2007, in Washington, D.C., USA.

The event was kick-started with a presentation on the safety substantiation of products and ingredients in the "real" world, by Dan Bagley, PhD, from Colgate-Palmolive Co. Following Bagley was Linda Katz, PhD, director of the office of cosmetics and colors for the US Food and Drug Administration (FDA), with a speech on the administration's policy regarding industry responsibilities and safety requirements enforced by the agency under the Food, Drug and Cosmetic Act. Katz also offered a summary of the status of animal alternatives in the United States and Europe.

But the discussion on animal alternatives did not end with Katz. Rather, it continued with presentations by John Harbell, PhD, senior principal scientist at Mary Kay Inc.; William Stokes, PhD, of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM); and Gerald Renner, PhD, of Colipa. Renner provided a summary of the status of alternative methods in Europe relative to the ban on animal testing in 2009. The ICCVAM recently prepared draft performance standards for the murine local lymph node assay (LLNA), which is a method for assessing the potential of a test substance to induce allergic contact dermatitis. The agency is now requesting public comment and information submissions on the assay.

The first day of the summit was concluded with presentations by Susan Felter, a toxicologist for Procter & Gamble Co.; Robert Bronaugh, PhD, of the FDA;  and Alan Rulis, PhD, senior managing scientist for Exponent. Rulis spoke on the uses of a Threshold of Toxicological Concern (TTC) approach to safety substantiation. According to the International Life Sciences Institute, the TTC is a "principle that assumes the existence of a human exposure threshold for most chemicals below which there is a very low, negligible probability of any risk to human health. " The notion maintains that the levels of exposure below those producing side effects can be used to set acceptable daily intakes for chemicals with known toxicological profiles. The TTC also proposes that a threshold can be identified and applied to most chemicals or to groups of chemicals. Rulis covered the application of the TTC approach to regulatory approval.

The second day of the conference ran the gamut with talks on international initiatives on standardization in cosmetics. Examples included: ISO, the International Cooperation Cosmetic Regulations, the Cosmetic Ingredient Review, and the FDA's scientific projects. The ICCR met for the first time on Sept. 26-28, 2007, in Brussels to harmonize international regulation of cosmetics products. The FDA; the Ministry of Health, Labour and Welfare of Japan; the European Commission Directorate General Enterprise; and Health Canada were present for the meeting and focused on good manufacturing practices, alternatives to animal testing, INCI nomenclature and ingredients labeling, nanotechnology, market surveillance systems and co-operation and the safety evaluation of ingredients. The members of the ICCR committed to using the ISO standard 22716, which is a guideline for the production, control, storage and shipment of cosmetic products.

Keynote speaker, Norris Alderson, PhD, associate commissioner of science at the FDA, rounded out the second day with a presentation on the role of science at the FDA. For more information, visit www.ctfa.org.

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