The Cosmetic Ingredient Review (CIR) Process

The Cosmetic Ingredient Review (CIR) was established in 1976 by the Cosmetic, Toiletry & Fragrance Association (CTFA) with support of the U.S. Food & Drug Administration and the Consumer Federation of America. Although funded by the cosmetics trade association, the CIR and its review process are independent from CTFA and the cosmetics industry. The Cosmetic Ingredient Review thoroughly reviews and assesses the safety of ingredients used in cosmetics in an open, unbiased, and expert manner, and publishes the results in the open, peer-reviewed scientific literature.

The CIR Expert Panel review process is independent:

• Modeled after FDA's OTC drug review panel to ensure independence
• Same conflict of interest standards as FDA advisors
• Members are well-known and highly respected physicians & scientists
• FDA and CFA liaisons participate in deliberations as non-voting members
• FDA quoted as regarding the CIR Expert Panel determinations an important element in ensuring the safety of the cosmetic supply in the U.S.

The CIR review process is open and transparent:

• All CIR ingredient review meetings are open to the public
• FDA and CTFA liaisons participate in deliberations as non-voting members
• Anyone can submit data for CIR review
• CIR conclusions/reports are published in the peer-reviewed International Journal of Toxicology
• Full details of the CIR Expert Panel and their review process can be found both online http://www.cir-safety.org and in an AAD publication (J Amer Acad Dermatol 52(1): 125-131, 2005)

Results of CIR reviews to date:

• CIR has reviewed approx. 1200 of the most commonly used ingredients
• These ingredients are used in >100,000 marketed cosmetic products.
• 90% of reviewed ingredients may be used safely, either as currently use or with some qualification (e.g. on maximum conc. of use)
• 'Insufficient data' (~10% of reviewed ingredients) rating does not always mean that the data don't exist; companies often have their own data, that has not necessarily been shared with the public (e.g., for competitive reasons).

Use of CIR results for cosmetic safety substantiation:

• CIR evaluates both acute and long-term chronic effects like cancer and reproductive toxicity
• CIR assessments form basis for many companies' safety assessments, but additional assessments by the companies may augment CIR reviews
• Final responsibility for safety substantiation resides with the companies, as stipulated by FDA regulations