The Cosmetic Ingredient Review (CIR) Expert Panel, is an independent, non-profit scientific body established in 1976 and initiated by the Personal Care Products Council (the Council) at the suggestion and with the support of the Food and Drug Administration (FDA) and the Consumer Federation of America (CFA) to thoroughly review and assess the safety of ingredients used in cosmetics in the U.S.
The CIR Expert Panel consists of world-renowned scientists and physicians who have been publicly nominated by either consumers, scientific and medical groups, government agencies, or industry. Members of the Panel must meet the same conflict of interest requirements regarding financial interests as special non-government advisory experts to FDA.
This Expert Panel conducts their 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 the Council provide non-voting liaisons to the panel and are actively involved in the comment and discussion process. The CIR process includes multiple opportunities for public comment and open, public discussion of the monograph by the Expert Panel.
Step 1: Cosmetic ingredients are selected from priority list for review.
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 the data. These experts gather the data and prepare it for review, but do not perform the safety assessment, which is the purview of the CIR Expert Panel. All interested parties may participate by providing information in addition to that summarized by the staff. Industry, in particular, supports the CIR program in a very tangible way by providing unpublished and published data from safety testing they have done.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 for review by any interested party.
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 interested parties to provide additional information. At 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;
- There are insufficient data or information to make a safety determination
Three categories are established by CIR for ingredients that are 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 or Information”;
- After two years, the ingredient is reclassified as “Use Not Supported”; or
- “No Reported Use”, If there are no uses in the FDA database;
CIR safety assessment monographs as well as unpublished safety test data reviewed by the CIR 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 publication in peer-reviewed special issues of the International Journal of Toxicology.
Following this process, a new assignment is then given to the CIR staff person—the next item on the high-priority list—and the process begins anew.
Distribution of conclusions in Cosmetic Ingredient Review safety assessments through June 2013
- Cosmetic Ingredient Review Procedures (October 2010)
- Safety of Ingredients Used in Cosmetics; J Am Acad Dermatol, Jan 2005, pp: 125-131