(CTFA) to review and assess the safety of cosmetic ingredients in the marketplace.
The CIR Program is funded by industry, but its review process is independent and open to public and scientific scrutiny (Bergfeld and Andersen, 2000). Approximately 2,800 cosmetic ingredients were on the market in 1976 when the CIR Program was established. In response, the CIR Program developed a system to prioritize these ingredients before performing the safety review. First it excluded or deferred ingredients being reviewed by other groups, such as fragrances and ingredients being evaluated by FDA, including color additives and over-the-counter (OTC) drug ingredients. The CIR Program then grouped the remaining ingredients into chemically related families and prioritized based on the following factors: frequency of use, ingredient concentration in cosmetic products, area of human exposure, number of products containing the ingredient used by sensitive population subgroups (such as infants and the elderly), biological activity, frequency of consumer complaints, and skin penetration. Using a ranking methodology, ingredients were given a weighted score based on these factors and were then reviewed in priority order. Frequency of use and biological activity were given the most weight in the ranking. This priority listing and ranking methodology is updated periodically.
The safety review starts with a comprehensive literature search by CIR staff. The staff summarizes the available published data and publishes the summaries for public comment. During a 90-day period, interested parties may submit comments or additional data.
Following this comment period, a CIR Expert Panel begins its review of the collected data and determines whether more data are needed. The panel consists of seven scientists and physicians who serve as voting members and three nonvoting liaison members, representing CTFA, FDA, and the Consumer Federation of America. CIR emphasizes that voting members are careful to avoid any perceived or real conflicts of interest. Liaison members serve to keep consumer groups, FDA, and industry informed of the panel’s deliberations.
If additional data are required, an informal request is directed toward the cosmetic industry. If data are not forthcoming or are still inadequate for the safety assessment, a formal request is made. Once all the necessary data are received, the panel reviews them and produces a tentative report that is released for public comment. At the end of the comment period, comments are considered and the final report is written.
In determining safety for the final report, the panel looks at all the available data, considers structurally similar substances, and relies on panel members’ experience and expertise. The data needed for the safety assessment are dependent on the particular ingredient under review. However, the panel usually considers chemical and physical properties, impurities,