Cosmetic Ingredient Review (CIR)

The Expert Panel for Cosmetic Ingredient Safety is an independent, nonprofit scientific body, established in 1976 to assess the safety of cosmetic ingredients used in the U.S. through the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) program. The Expert Panel consists of world-renowned scientists and physicians who have been publicly nominated by consumer, scientific and medical groups; government agencies; and industry. The Personal Care Products Council (PCPC) initiated the CIR program and associated Expert Panel at the suggestion of and with support from FDA and Consumer Federation of America (CFA).

For more than 45 years, the Expert Panel, with support from CIR, has examined and evaluated worldwide published and unpublished scientific safety data for a majority of ingredients used in cosmetics and personal care products. Representatives from FDA, CFA and PCPC serve as non-voting liaisons to the Expert Panel and are actively involved in the comment and discussion processes. Expert Panel members must meet similar conflict of interest requirements regarding financial interests as special non-government advisory experts to FDA. Meeting four times per year in Washington, D.C., the Expert Panel conducts safety data evaluations in an open and unbiased manner.

The Expert Panel develops safety assessment monographs, publishes its work in the peer-reviewed International Journal of ToxicologyToxicology is the study of the adverse effects of chemical and physical agents on living organisms., and issues an annual comprehensive collection of all CIR reports, including abstracts, discussions and conclusions. The Expert Panel has received several awards, including the American Academy of Dermatology Gold Triangle Award and the National Association of Insurance Agents Consumer Product Safety Award. Executive Director Bart Heldreth, PhD, manages all of the staff’s activities to effectively and efficiently implement the program’s procedures.

The Expert Panel website provides additional information about the members. The CIR website provides additional information about the staff and provides all final reports of the Expert Panel, free of charge.

How CIR Works

This Expert Panel conducts its reviews in a science-based, open, unbiased and transparent manner, and publishes the results of its work in peer-reviewed scientific literature. FDA, CFA and PCPC each provide non-voting liaisons to the panel and are actively involved in the comment and discussion process, which includes multiple opportunities for public comment and open, public discussion of the monograph by the Expert Panel.

Step 1: Ingredient Selection

Ingredients used in cosmetics and personal care products are selected from a priority list for review. This list is comprised first of ingredients requested by government, industry and the public. When there are not enough requests to fill the Expert Panel’s annual docket, ingredients with the highest frequency of use (i.e., ingredients used in the greatest number of products) are selected to fill in the spots.

Step 2: Data Collection

CIR’s staff of scientific writers and other technical experts is responsible for the conduct of extensive literature searches online, retrieval of full citations and compilation of data. These experts gather and prepare data for review, but do not perform the safety assessment, which is the exclusive purview of the Expert Panel. All interested parties (IP) may participate by providing information in addition to that summarized by the staff. Cosmetics and personal care products companies, in particular, support the program in a very tangible way by providing published and unpublished data from safety testing they have done. These studies become public as part of the process, are summarized in the review, and are readily available to view.

Step 3: Safety Assessment

The Expert Panel reviews all data, identifies any gaps and solicits data to fill those gaps. If the initial review of the open scientific literature and the data provided are not sufficient to complete a safety assessment, the Expert Panel will call on industry or other IPs to provide additional information. Upon completion of the assessment process, a tentative safety assessment that includes the Expert Panel’s rationale for its decision is issued for additional public comment.

Step 4: Final Decision

The Expert Panel considers the input received at this stage and issues a final safety assessment. The safety assessment is completed when the Expert Panel makes one of four potential conclusions:
– The ingredient(s) are safe as used;
– The ingredient(s) are safe with qualifications;
– The ingredient(s) are unsafe; or
– There are insufficient data or information to make a safety determination.

Three categories are established by CIR for ingredients classified as having “insufficient data” by the Expert Panel:
– For two years after the Expert Panel Final Report is issued, the ingredient will remain classified as “Insufficient Data;”
– After two years, the ingredient is reclassified as “Use Not Supported;” or
– “No Reported Use,” if there are no uses in the FDA database.

Safety assessment monographs, as well as unpublished safety test data reviewed by the Expert Panel, are publicly available from CIR.

Step 5: Publish Findings

As an additional step to ensure broad distribution of its findings, CIR submits its safety assessments for peer-review and publication in the International Journal of Toxicology.

Following this process, a new assignment – the next item on the high-priority list – is given to a CIR staff person, and the process begins anew.

Information about CIR, meetings of the Expert Panel and ingredient safety assessment conclusions are also available via CIR’s website. Questions may be sent to cirinfo@cir-safety.org.

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