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Amended Safety Assessment of Parabens As Used in Cosmetics

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Amended Safety Assessment of Parabens As Used in Cosmetics Amended Safety Assessment of Parabens as Used in Cosmetics Status: Draft Final Amended Report for Panel Review Release Date: March 15, 2019 Panel Meeting Date: April 8-9, 2019 The 2019 Cosmetic Ingredient Review Expert Panel members are: Chair, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Executive Director is Bart Heldreth, Ph.D. This report was prepared by Jinqiu Zhu, Ph.D., Toxicologist. © Cosmetic Ingredient Review 1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 [email protected] Distributed for Comment Only -- Do Not Cite or Quote Commitment & Credibility since 1976 MEMORANDUM To: CIR Expert Panel and Liaisons From: Jinqiu Zhu, PhD, DABT, ERT Toxicologist Date: March 15, 2019 Subject: Draft Final Amended Safety Assessment of Parabens as Used in Cosmetics Attached is the Draft Final Amended Report of 20 parabens and 4-Hydroxybenzoic Acid, as used in cosmetics (parabe042019FAR). At the September 2018 meeting, the Panel issued a tentative amended report for public comment with the conclusion that the following 20 ingredients are safe in cosmetics in the present practices of use and concentration described in the safety assessment. Butylparaben Potassium Ethylparaben* Sodium Isobutylparaben Calcium Paraben* Potassium Methylparaben* Sodium Isopropylparaben* Ethylparaben Potassium Paraben* Sodium Methylparaben Isobutylparaben Potassium Propylparaben* Sodium Paraben* Isopropylparaben Propylparaben Sodium Propylparaben Methylparaben Sodium Butylparaben 4-Hydroxybenzoic Acid* Potassium Butylparaben* Sodium Ethylparaben * Not reported to be in current use. Were the ingredient in this group not in current use to be used in the future, the expectation is that it would be used in product categories and at concentrations comparable to others in this group. The Panel also determined that the available data are insufficient to determine the safety of Benzylparaben. The data needed to determine safety of this ingredient comprise a no-observed-adverse-effect-level (NOAEL) derived from developmental and reproductive toxicity (DART) studies. This ingredient is not reported to be in use. The Panel discussed concerns about the bioaccumulation potential of parabens. The Panel noted that recent studies with sensitive analytical methods have demonstrated the presence of parabens in various human tissues. However, the data are equivocal regarding cumulative storage in such tissues; and importantly, the available evidence suggests no significant association of parabens exposure with diseases or other adverse health conditions. The Panel also noted that refined aggregate exposure models suggest that cosmetic product use is a major source of parabens exposure. However, the vast quantity of biomonitoring data indicates that systemic exposure to these ingredients is very low. __________________________________________________________________________________________ 1620 L Street, NW Suite 1200, Washington, DC 20036 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) [email protected] (Website) www.cir-safety.org Distributed for Comment Only -- Do Not Cite or Quote The Panel discussed the safety of parabens as used in vaginally-applied cosmetic products. The Panel classified the currently available studies as illustrations of potential, general hazards, which fail to demonstrate risks relevant to cosmetic safety in the context of concentration of use. The Panel’s deliberations on the draft assessment report comprised extensive revisions to better identify, and explain the rationale for, the values utilized in conducting the risk assessment therein. The Panel further requested that the margin of safety (MOS) should be re-calculated, weighing the different use concentrations and exposures of Butylparaben in various cosmetic products category. The report was revised accordingly. Since the September meeting, additional data on biomonitoring, endocrine activity, dermal sensitization and epidemiological studies have been incorporated into the report. The input of new studies as well as discussions regarding bioaccumulation, dermal absorption rate, and Physiologically Based Pharmacokinetic (PBPK) Model for the estimating the internal exposure of parabens, are highlighted within the text of this report. Also included in this package for review are the CIR report history (parabe042019hist), flow chart (parabe042019flow), literature search strategy (parabe042019strat), ingredient data profile (parabe042019prof), and previous meeting transcripts (parabe042019min). Comments provided by the Council prior to the September meeting and on the tentative amended report have been addressed (parabe042019pcpc1 and parabe042019pcpc2, respectively). The Panel should carefully review the Abstract, Discussion, and Conclusion of this report. If these are satisfactory, the Panel should issue a final amended report. __________________________________________________________________________________________ 1620 L Street, NW Suite 1200, Washington, DC 20036 (Main) 202-331-0651 (Fax) 202-331-0088 (Email) [email protected] (Website) www.cir-safety.org Distributed for Comment Only -- Do Not Cite or Quote RE-REVIEW FLOW CHART INGREDIENT/FAMILY___Parabens______________________________________________________ MEETING _______ April 2019_________________________________________________________ Public Comment CIR Expert Panel Re-Review Rpt Status ; or New Data Sodium Methylparaben announce 15 years OR request since last was included on the review 2017 Priority List due to frequency of use Re-review to Panel PRIORITY LIST June 2017 led to RR of IJT 27 (Suppl Are new data cause to reopen? June 2017: RR was re-opened because 4):1- 82; 2008 of new data, and additional ingredients were added. Pending rpt was then (3 previous reports exist) tabled for SME review of DART data. Mar 2018: DART presentation; no YES decision made NO DRAFT AMENDED REPORT DAR June 2017; Mar 2018 Are new ingredients appropriate for inclusion/re-open? 13 add-ons Table Tabled IDA TAR June 2017 mtg Yes No IDA Notice IDA RE-REVIEW Admin Book DRAFT TENTATIVE SUMMARY Draft TAR AMENDED REPORT Sept 2018 Table Table Tentative Amended Report Jan 23, 2019 Issue TAR Draft FAR DRAFT FINAL 60 day Public comment period AMENDED REPORT Apr 2019 Table Table Different Conclusion Final Amended Issue PUBLISH Report FAR Distributed for Comment Only -- Do Not Cite or Quote CIR History of: Parabens 1984 – Report published for Methylparaben, Ethylparaben, Propylparaben, and Butylparaben with the conclusion that these ingredients are safe as cosmetic ingredients in the present practices of use. 1986 – Report on Benzylparaben was published with an insufficient data conclusion. The data needs were: 1. UV absorption spectrum. If absorption occurs between 280 and 360 nm, a photosensitization study is required (in animals only, not in clinical assays). 2. Data detailing the possible presence of impurities. 3. Subchronic feeding study-90-day in rats. 4. Mutagenicity studies and/or in vitro assays for genotoxicity. 5. Eye irritation study at concentration of use. 6. Metabolism and associated pharmacokinetic studies are not requested at this time. If significant toxicity is shown in the above tests, the Expert Panel may request this additional type of testing. 1995 – Report on Isobutylparaben and Isopropylparaben was published with a conclusion of safe as cosmetic ingredients in the present practices of use. 2008 – Amended report published. The ingredients in the three previous reports are included. The Conclusion was that these ingredients are safe as cosmetic ingredients in the present practices of use. “The CIR Expert Panel considered exposures to cosmetic products containing a single parabens preservative (use level of 0.4%) separately from products containing multiple parabens (use level of 0.8%) and infant exposures separately from adult exposures in determining margins of safety (MOS). The MOS for infants ranged from ~6000 for single paraben products to ~3000 for multiple paraben products. The MOS for adults ranged from 1690 for single paraben products to 840 for multiple paraben products. The Expert Panel considers that these MOS determinations are conservative and likely represent an overestimate of the possibility of an adverse effect (e.g., use concentrations may be lower, penetration may be less) and support the safety of cosmetic products in which parabens preservatives are used.” March 2012 – “The Panel reaffirmed the safety of parabens as preservatives in the present practices of use and concentration in cosmetics. At the request of the Personal Care Products Council, the Panel re-examined its 2008 published safety assessment of parabens. The Council cited new opinions from the European Commission’s Scientific Committee on Consumer Safety (SCCS) regarding (1) safe levels of parabens in cosmetics and (2) parabens in products intended for children under 3 years of age. The SCCS updated opinion on parabens confirmed that methyl- and ethylparaben are safe up to 0.4% for one and a total of 0.8% for any mixture, but lowered the level in cosmetics considered safe for propyl- and butylparaben to 0.19% for any one or any mixture. This lowering appeared to be based on a re-evaluation of existing dermal penetration/metabolism data, not on new data. The Panel reiterated its very conservative
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