Special ArticleSafety of ingredients used in cosmetics
Section snippets
The CIR program
The CIR mission statement calls for the thorough review and assessment of the safety of ingredients used in cosmetics in an open, unbiased, and expert manner—with results published in the peer-reviewed scientific literature. CIR operates within a set of procedures written by former FDA General Counsel, Peter Barton Hutt, and patterned after the FDA process for scientific review of over-the-counter drugs.
A 5-member CIR Steering Committee is chaired by the CTFA President, currently E. Edward
Selecting ingredients for review
Cosmetic ingredients are catalogued in the International Cosmetic Ingredient Dictionary and Handbook.6 From this list of more than 10,000 individual chemicals that were once used or are currently used (or are merely a supplier's hope for future use), CIR selects ingredients for its review.
Some ingredients are excluded from review by the CIR procedures.7 Fragrance ingredients are reviewed by the Research Institute for Fragrance Materials (RIFM) and the International Fragrance Association; with
Responses to current needs
Acting on a request from the CTFA in 1994, the CIR Expert Panel included alpha hydroxy acids in its high-priority group of ingredients and began its safety assessment. Both the FDA and CFA supported this decision. Extensive unpublished data were provided by the industry, FDA's own research laboratories also provided their study results, and the views of researchers active in the field were solicited.
The CIR Expert Panel concluded in 1997 that alpha hydroxy acids are safe for use in cosmetic
The CIR process
CIR's staff of scientific writers is responsible for the conduct of extensive literature searches online, retrieval of full citations, and compilation of the data. These individuals gather the data and prepare it for review, but do not perform an evaluation—evaluation 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
CIR Expert Panel findings
From 1976 to September 2004, the CIR Expert Panel completed safety assessments of 1194 ingredients. These ingredients are estimated to be used in more than 100,000 cosmetic products. The distribution of conclusions into the categories of safe as used, safe with qualifications, unsafe, and insufficient data are given in Table II.
For 683 ingredients (approximately 58%), the conclusion was safe as used. In this context, “as used” refers to the practices of use and concentrations described in each
Hair dyes
Prominent among the ingredients reviewed by the CIR Expert Panel have been hair dyes. Three phenylenediamine hair dyes and HC blue No. 1 have been found to be carcinogenic in animal tests and have been deemed unsafe for use in cosmetics. An additional 63 hair dye ingredients have been reviewed by the CIR Expert Panel. All hair dye conclusions are available at URL:http://www.cir-safety.org/findings.shtml.
The CIR Expert Panel recognizes that many hair dyes contain ingredients that may be cause
Re-review
It is inevitable that new information will become available concerning ingredients for which safety assessments were completed in the early days of the program. To ensure that no new data are overlooked, the CIR Expert Panel has instituted a re-review program.
Staff members conduct a new online search and summarize the findings for consideration by the CIR Expert Panel. If a safety assessment is reopened, a new scientific literature review will be prepared combining the old and new data and made
High-priority list
New safety assessments will be initiated from the following high-priority list:
- 1.
Pentasodium pentetate
- 2.
Sodium hyaluronate and hyaluronic acid
- 3.
3-Methylamino-4-nitrophenoxyethanol
- 4.
Dimethyl ether
- 5.
Hydrochlorofluorocarbon 22 and 142B; hydrofluorocarbon 134A, 152A, and 227ea
- 6.
DM hydantoin
- 7.
Hydrogenated polyisobutene and polyisobutane
- 8.
PEG-7, -9, -10, -12, -14, -16, -18, -20, -40, -45, -55, -60, -90, -100, -135, -180, -200, -220, -240, -350, -400, -500, and -800
- 9.
PPG-2 methyl ether and PPG-2 methyl ether acetate
- 10.
Safety assessments currently under development
The safety assessment of the following cosmetic ingredients or ingredient groups are currently underway.
- 1.
Alcohol denat. including SD alcohol 3-A, 30, 39, 39-B, 39-C, 40, 40-B, and 40-C
- 2a.
Ammonium glycyrrhizate, dipotassium glycyrrhizate, disodium glycyrrhizate, disodium succinoyl glycyrrhetinate, glyceryl glycyrrhetinate, glycyrrhetinic acid, glycyrrhetinyl stearate, glycyrrhizic acid, methyl glycyrrhizate, potassium glycyrrhetinate, potassium glycyrrhizinate, and stearyl glycyrrhetinate
- 2b.
Discussion
With almost 1200 individual cosmetic ingredients reviewed (collectively used in more than 100,000 cosmetic products), more than 90% of the ingredients considered by the CIR Expert Panel may be used safely in cosmetics, either with some qualification or in the current practices of use.
There remain insufficient resources available at the FDA for the Agency to implement its own review of safety data on the vast array of cosmetic ingredients. Where a clear hazard is identified, FDA can and does
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Support for the Cosmetic Ingredient Review (CIR) program, including members of the CIR Expert Panel (Drs Bergfeld, Belsito, and Marks) and director of the CIR (Dr Andersen), is received from the Cosmetics, Toiletry, and Fragrance Association.
Disclosure: Dr Marks coordinates a meeting, “contact dermatitis, state-of-the-art issues” through the Pennsylvania State University continuing education department that receives funding from the Rohm and Haas company, a manufacturer of chemicals used in cosmetics.