Phthalates "Safe As Used" Recommendation To Be Reevaluated By CIR
This article was originally published in The Rose Sheet
Executive Summary
The Cosmetic Ingredient Review Expert Panel will reevaluate its 1984 "safe as used" conclusion on dibutyl, dimethyl and diethyl phthalates beginning at its Nov. 29-30 meeting. The board voted unanimously to re-review phthalates during a June 4-5 meeting in Washington, D.C.
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The Cosmetic Ingredient Review Expert Panel will reevaluate its 1984 "safe as used" conclusion on dibutyl, dimethyl and diethyl phthalates beginning at its Nov. 29-30 meeting. The board voted unanimously to re-review phthalates during a June 4-5 meeting in Washington, D.C. CIR will use the time leading up to the November meeting to collect information on both completed and pending studies on phthalates. The new data will help CIR determine whether to support or amend its previous ruling, the panel agreed. The Centers for Disease Control & Prevention, National Institutes of Health, National Toxicology Program, National Institute for Occupational Safety & Health and Environmental Protection Agency are conducting studies on the ingredients. The agencies expect to complete between 8-10 studies on phthalates "over the next few years," according to CDC. A new CDC study will examine human exposure to phthalates from consumer products based on evaluation of urinary metabolites. Findings from that review will be released "some time this year," CDC noted. Another study by CDC and EPA will assess the levels of phthalates in rodents, the agency said. CIR is providing industry with a 90-day de facto comment period to respond to its decision to reconsider the ingredients, the group said. The decision to re-review phthalates followed the release of two CDC studies in the past six months that raise questions about the ingredient's safety. One of the studies, published in the October issue of Environmental Health Perspectives, found higher levels of phthalate exposure in human urine than previously expected (1 ). The findings were supported by another CDC study released in March (2 (Also see "Diethyl, Dibutyl Phthalates Exposure Pathways Studied By CDC" - HBW Insight, 26 Mar, 2001.)). Phthalates, which have been shown to cause cancer, birth defects and adverse hormone reactions in laboratory animals, are found in cosmetics including nail polishes, nail polish removers and perfumes. The Cosmetic, Toiletry and Fragrance Association has maintained the ingredients are safe in cosmetics based on CIR's 1984 conclusion. Phthalates were one of five ingredients considered for re-review during the CIR meeting; the panel also evaluated previous final safety rulings on avocado oil, isopropyl lanolate, wheat and caprylic/capric triglyceride. The ingredients are among approximately 60 that will be addressed this year after being deemed safe in the 1980s. The process allows the panel to review new data to reaffirm, amend or create a new addendum to the original ruling, CIR said. Avocado oil was concluded "safe as used" in 1980. Since the decision, two articles on the hepatotoxicity of avocado fruit and two case studies on allergies related to avocado oil have been released, leading the panel to re-evaluate the ingredient. The panel primarily is concerned with a protein contaminant found in avocado oil that can cause allergic reactions in people who react negatively to latex, according to CIR Director and Scientific Coordinator Alan Anderson, PhD. Latex allergies have surfaced more recently as a public health concern. Industry will be given a 90-day comment period to respond to the panel's concerns. A draft report with new data on avocado oil will be considered during the November CIR meeting. The remaining three ingredients considered for re-review - caprylic/capric triglyceride, isopropyl lanolate and wheat - received "safe as used" reaffirmations on the basis that there is no new information to challenge their safety in cosmetics, according to the panel. CIR is considering publishing an annual "letter" in the Journal of Toxicology listing ingredients with reaffirmed safety rulings along with an abstract of any safety issues considered. The letter would be used to update industry on the group's decisions. The panel will formally decide whether to proceed with such a notice at its next meeting, scheduled for Sept. 10-11. In addition to evaluating ingredients for re-review, the panel agreed that four ingredients - ascorbic acid, rice, silicate salts and urea - are "safe as used" in reports made final during the June meeting (see chart, p. 4). Butyl, isobutyl and lauryl methacrylate were deemed "safe as used" for professional use on artificial nails, but a lack of safety information for other methacrylate esters led the panel to table the entire ingredient family. |