Abstract
Welcome to this special edition celebrating the 40th year of the Cosmetic Ingredient Review (CIR). The CIR was established in 1976 and was the result of a collaborative effort between government, industry, and consumer groups. The CIR was created solely for the purpose of assessing the safety of cosmetic ingredients, and it does so in an independent, open, unbiased, and expert manner. The CIR identifies, gathers, and analyzes scientific data for the development of safety assessment monographs, which are used by its Expert Panel to determine safety.
All determinations of safety are made by the CIR Expert Panel—an independent, nonprofit scientific body of world-renowned scientists and physicians who have been publicly nominated by consumer, scientific and medical groups, government agencies, and industry. The Food and Drug Administration, the Consumer Federation of America, and the Personal Care Products Council provide nonvoting liaisons to the Expert Panel who are actively involved in the comment and discussion process. Final decisions rendered by the Expert Panel are published in the peer-reviewed journal International Journal of Toxicology.
This anniversary edition includes an overview of CIR that provides a broader discussion of the infrastructure, the Expert Panel’s decision-making process, and approaches to modern challenges, such as the review of botanical ingredients and safety evaluations using nonanimal data. Included in this edition are the full safety assessments of crosslinked alkyl acrylates and of diethanolamine and its salts as used in cosmetics.
Also included are 18 rereview summaries. Rereviews are performed 15 years after a safety assessment was published, and the process is intended to uncover any new data that have become available for an ingredient (or ingredient group) since safety was last evaluated. In some cases, newly available data are largely redundant compared with the data available in the original safety assessment. In other cases, new data present new safety issues. If after considering the newly available information, the Expert Panel decides to not reopen a safety assessment, thereby reaffirming the original conclusion, this finding, along with any background material, is summarized and announced publicly. To assure that the scientific community is aware of any new information and the decision not to reopen the assessment, this Annual Review of Cosmetic Ingredient Safety Assessments is prepared.
A list of reference sources is provided as part of a rereview summary; this listing indicates the update to the available published literature and includes any unpublished data made available since the previous safety assessment. The rereview also captures information on the industry’s current practices of ingredient use. Although these rereview summaries provide the opinion of the Expert Panel regarding the new data that have become available, it does not constitute a full safety review.
The Expert Panel has assessed the safety of over 4,500 cosmetic ingredients since its inception in 1976. These safety assessments have been published in the Journal of Environmental Pathology and Toxicology (1980), the Journal of the American College of Toxicology (1982 to 1996), and the International Journal of Toxicology (1997 to current).
The ingredients the Expert Panel reconsidered during the 2011 to 2015 period and did not reopen are: Alpha hydroxyl acids (AHA) 2-Amino-6-chloro-4-nitrophenol Bisabolol 4-Chlororesorcinol Glutaral HC Orange No. 1 HC Red No. 1 HC Yellow No. 4 Isostearamidopropyl morpholine lactate Iodopropynyl butylcarbamate Methyldibromo glutaronitrile m-Phenylenediamine and m-phenylenediamine sulfate Dibutyl, diethyl, and dimethyl phthalate Polyvinyl alcohol Polyvinyl acetate PVP (also known as polyvinylpyrrolidone) Quaternium-15 Retinyl palmitate and retinol
Footnotes
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The articles in this supplement were sponsored by the Cosmetic Ingredient Review.