DOCSLIB.ORG

Draft Screening Assessment Parabens Group Chemical

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Draft Screening Assessment Parabens Group Chemical Draft Screening Assessment Parabens Group Chemical Abstracts Service Registry Numbers 94-13-3 94-18-8 94-26-8 99-76-3 120-47-8 4191-73-5 4247-02-3 Environment and Climate Change Canada Health Canada March 2020 Synopsis Pursuant to section 68 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of seven substances referred to collectively as the Parabens Group. Substances in this group were identified as priorities for risk assessment as part of the Identification of Risk Assessment Priorities (IRAP) approach’s 2015 review on the basis of human health concerns. The Chemical Abstracts Service Registry Numbers (CAS RN1), their Domestic Substances List (DSL) names and their common names are listed in the table below. Substances in the Parabens Group CAS RN DSL name Common name 94-13-3 Benzoic acid, 4-hydroxy-, propyl ester Propylparaben Benzoic acid, 4-hydroxy-, phenylmethyl 94-18-8 Benzylparaben ester 94-26-8 Benzoic acid, 4-hydroxy-, butyl ester Butylparaben 99-76-3 Benzoic acid, 4-hydroxy-, methyl ester Methylparaben 120-47-8 Benzoic acid, 4-hydroxy-, ethyl ester Ethylparaben Benzoic acid, 4-hydroxy-, 1-methylethyl 4191-73-5 iso-Propylparaben ester Benzoic acid, 4-hydroxy-, 2-methylpropyl 4247-02-3 iso-Butylparaben ester According to information submitted in response to a survey under section 71 of CEPA, methylparaben was reported to be manufactured and imported in Canada in 2011 in volumes of 981 kg and 563 000 kg, respectively. In a separate survey, ethylparaben, propylparaben, butylparaben, iso-propylparaben, and iso-butylparaben were not reported to be manufactured in Canada above the reporting threshold of 100 kg, but were reported to be imported into Canada in 2016 at volumes of 4 000 kg, 8 500 kg, 100 to 1 000 kg, 280 kg, and 230 kg, respectively. Benzylparaben was not reported to be imported or manufactured above threshold values in 2016. 1 The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior written permission of the American Chemical Society. i Parabens are widely used as preservatives and fragrance ingredients in cosmetic products, such as moisturizers, make-up, toothpaste, hair/shaving products, and are used as antimicrobial preservatives, fragrance ingredients and flavour enhancers in natural health products (NHPs). Parabens are also used in pest control products, consumer products, and in prescription and non-prescription drugs. Methylparaben and propylparaben are permitted for use as preservatives in certain foods and beverages sold in Canada. Parabens are also naturally present in foods, such as berries, fruit, wine and vanilla. The ecological risks of the substances in the Parabens Group were characterized using the ecological risk classification of organic substances (ERC), which is a risk-based approach that uses multiple metrics for both hazard and exposure, with weighted consideration of multiple lines of evidence for determining risk classification. Hazard profiles are based principally on metrics regarding mode of toxic action, chemical reactivity, food-web-derived internal toxicity thresholds, bioavailability, and chemical and biological activity. Metrics considered in the exposure profiles include potential emission rate, overall persistence and long-range-transport potential. A risk matrix is used to assign a low, moderate or high level of potential concern for substances based on their hazard and exposure profiles. According to the outcome of the ERC analysis, substances in the Parabens Group are considered unlikely to be causing ecological harm. Considering all available lines of evidence presented in this draft screening assessment, there is low risk of harm to the environment from methylparaben, ethylparaben, propylparaben, butylparaben, benzylparaben, iso-propylparaben, and iso-butylparaben. It is proposed to conclude that methylparaben, ethylparaben, propylparaben, butylparaben, benzylparaben, iso-propylparaben, and iso-butylparaben do not meet the criteria under paragraphs 64(a) or (b) of CEPA as they are not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends. Animals exposed to methylparaben in a repeat dose study showed clinical signs of ill- health, stomach erosion, spleen and thyroid atrophy, and mortality at the highest dose. Adverse effects were not reported in reproductive and prenatal developmental toxicity studies or in a study of male reproductive development. Predominant sources of exposure of the general population of Canada to methylparaben include cosmetics, NHPs, and prescription and non-prescription drugs. Margins of exposure based on biomonitoring data from the general population aged 3 to 79 years were considered adequate. Margins of exposure between the critical effect level and estimates of exposure to certain NHPs are considered potentially inadequate to account for uncertainties in the health effects and exposure databases. Repeated exposure to ethylparaben at high doses resulted in depression, decreased motor activity and mortality in animal studies. Gestational exposure to ethylparaben ii resulted in enlargement of brain ventricles and hydronephrosis in fetuses. Prenatal development of the male reproductive system and male pubertal development were not affected by ethylparaben exposure. The general population of Canada is predominantly exposed to ethylparaben via cosmetics, NHPs, and non-prescription drugs. Margins of exposure based on biomonitoring data from the general population were considered adequate to address uncertainties in the health effects and exposure databases. Propylparaben did not demonstrate significant adverse effects in repeat dose dietary toxicity studies. Adverse effects were not reported in a reproduction and developmental toxicity screen, or in studies of male and female pubertal and reproductive development. Predominant sources of exposure of the general population of Canada to propylparaben include cosmetics, NHPs, and prescription and non-prescription drugs. Margins of exposure based on biomonitoring data from the general population were considered adequate to address uncertainties in the health effects and exposure databases. Margins of exposure between the critical effect level and estimates of oral exposure to certain NHPs (at the highest dose and frequency recommended in the directions of use) are considered inadequate to address uncertainties in the health effects and exposure databases. The critical effect for butylparaben was prenatal development of the reproductive system. Gestational exposure to butylparaben was associated with delayed onset of puberty, altered morphology of reproductive organs and reduced sperm count and motility in offspring. The general population of Canada is predominantly exposed to butylparaben via cosmetics, NHPs, and non-prescription drugs. Margins of exposure based on biomonitoring data from the general population aged 3 to 79 years were considered adequate. Margins of exposure between critical effects and estimated of exposure to certain cosmetics, non-prescription drugs and NHPs are considered potentially inadequate to account for uncertainties in the health effects and exposure databases. The health effects database for benzylparaben is limited. A read-across approach was employed to select a critical effect of prenatal reproductive development based on butylparaben. No sources of exposure of the Canadian population to benzylparaben were identified. However, a biomonitoring study reported that benzylparaben was identified in the urine of pregnant Canadian women. Margins of exposure based on biomonitoring data from Canada, the United States and Europe are considered adequate to address uncertainties in the health effects and exposure databases. Repeated exposure to iso-propylparaben resulted in changes in serum histochemistry, as well as renal and hepatic effects. The predominant source of exposure to iso- propylparaben is via the use of cosmetics, NHPs, and non-prescription drugs. Margins of exposure between the critical effect level and estimates of exposure to iso- propylparaben are considered adequate to address uncertainties in the health effects and exposure databases. iii The critical effect identified for iso-butylparaben was reduced sperm motility and reduced epididymal sperm count in young males after maternal dosing (gestational and postnatal). The predominant source of exposure to iso-butylparaben is via use of cosmetics, NHPs and non-prescription drugs. Margins of exposure between the critical effect level and estimates of exposure to cosmetics, non-prescription drugs and NHPs containing iso-butylparaben are considered potentially inadequate to address uncertainties in the health effects and exposure databases. On the basis of the information presented in this draft screening assessment, it is proposed to conclude that methylparaben, propylparaben, butylparaben and iso- butylparaben meet the criteria under paragraph 64(c) of CEPA as they are entering or may enter the
Load more

Recommended publications
  • Water Quality Testing Summary
    WATER QUALITY TESTING SUMMARY A DETAILED REVIEW OF THE TEST RESULTS FOR THE DRINKING WATER PRODUCED BY THE CARY/APEX WATER TREATMENT FACILITY 2020 JOHN CONLEY (Senior Laboratory Analyst) has been employed by the Town of Cary at the Cary/Apex Water Treatment Facility Laboratory since September 2001. CARY/APEX WATER TREATMENT FACILITY 2020 WATER QUALITY TESTING SUMMARY We are pleased to present to you the Cary/ If you have any questions or concerns regarding this Apex Water Treatment Facility Test Result report, please contact Rachel Monschein, Water System Summary for 2020. This report is a snapshot of last Laboratory Supervisor, at (919) 362-5507. year’s water quality. The values contained in this report In order to ensure that tap water is safe to drink, EPA are based on single measurements or yearly averages depending on the contaminant. The Environmental prescribes regulations that limit the amount of certain Protection Agency and/or the State requires us to contaminants in water provided by public water systems. monitor for certain substances less than once per year Drinking water, including bottled water, may reasonably because the concentrations of these substances are not be expected to contain at least small amounts of some expected to vary significantly from year to year. Some of contaminants. The presence of contaminants does not the data, though representative of the water quality, is necessarily indicate the water poses a health risk. To obtain more than one year old. In these cases, the most recent more information about contaminants and potential data is included, along with the year in which the sample health effects, call the EPA’s Safe Drinking Water Hotline was taken.
    [Show full text]
  • Parabens Preservatives for Focused Protection
    PARABENS Preservatives For Focused Protection Parabens are the most commonly used preservatives in personal care products. Parabens display a low irritation potential, have low toxicity levels, and are active against a wide spectrum of fungi and bacteria at low concentrations. They are stable and effective over a wide pH range, can withstand temperatures up to 100°C, and are biodegradable. Also, they are highly compatible with other compounds. When combining two or more Parabens, their antimicrobial performance is enhanced due to a synergistic effect. While this is not a complete listing of Paraben features, it is clear why they are such an effective preservative and so commonly used. MINIMUM INHIBITION CONCENTRATIONS (MIC) FOR PARABENS Microorganism Methyl Ethyl Propyl Butyl Aspergillus niger 600 300 300 200 Candida albicans 900 500 200 100 Pseudomonas aeruginosa 1600 1500 >900 - Bacillus cereus 1600 800 300 100 Burkholderia cepacia 600 350 200 200 Escherichia coli 1400 700 350 140 INCI CAS Staphylococcus epidermidis 2000 900 350 150 Methylparaben 99-76-3 Staphylococcus aureus 2000 1000 300 110 Ethylparaben 120-47-8 Propylparaben 94-13-3 All the Parabens have low aqueous solubility, but will dissolve in most systems Butylparaben 94-26-6 at temperatures above 60°C. When considering the solubility of Parabens, we recommend dissolving short-chained Parabens (such as Methylparaben) Appearance in the aqueous phase and longer-chained Parabens in the oil phase. If all the White, dry powder Parabens must be introduced to the water phase, pre-heating of the water is recommended. In the event that heating is undesirable, we recommend using Solubility Paraben sodium salts.
    [Show full text]
  • 01 Excipients Prelims 1..9
    Ethylparaben 1 Nonproprietary Names BP: Ethyl Hydroxybenzoate SEM 1: Excipient: ethylparaben; magnification: 600Â. JP: Ethyl Parahydroxybenzoate PhEur: Ethyl Parahydroxybenzoate E USP-NF: Ethylparaben 2 Synonyms Aethylum hydrobenzoicum; CoSept E; E214; ethylis parahydroxy- benzoas; ethyl p-hydroxybenzoate; Ethyl parasept; 4-hydroxyben- zoic acid ethyl ester; Nipagin A; Solbrol A; Tegosept E; Uniphen P- 23. 3 Chemical Name and CAS Registry Number Ethyl-4-hydroxybenzoate [120-47-8] 4 Empirical Formula and Molecular Weight C9H10O3 166.18 5 Structural Formula SEM 2: Excipient: ethylparaben; magnification: 3000Â. 6 Functional Category Antimicrobial preservative. 7 Applications in Pharmaceutical Formulation or Technology Ethylparaben is widely used as an antimicrobial preservative in cosmetics,(1) food products, and pharmaceutical formulations. It may be used either alone or in combination with other paraben esters or with other antimicrobial agents. In cosmetics it is one of the most frequently used preservatives. The parabens are effective over a wide pH range and have a broad spectrum of antimicrobial activity, although they are most effective against yeasts and molds; see Section 10. Owing to the poor solubility of the parabens, paraben salts, particularly the sodium salt, are frequently used. However, this may cause the pH of poorly buffered formulations to become more alkaline. See Methylparaben for further information. 8 Description Ethylparaben occurs as a white, odorless or almost odorless, active against yeasts and molds than against bacteria. They crystalline powder. are also more active against Gram-positive than against Gram-negative bacteria. 9 Pharmacopeial Specifications The activity of the parabens increases with increasing chain See Table I. See also Section 18. length of the alkyl moiety, but solubility decreases.
    [Show full text]
  • 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.
    [Show full text]
  • Sccs/1404/11
    SCCS/1404/11 EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL Public Health and Risk Assessment Risk assessment Scientific Committee on Consumer Safety 9th plenary Meeting Held on 14 December 2010 in Brussels MINUTES 1. WELCOME AND APOLOGIES The chairman of the SCCS welcomed all the participants. Apologies were received from Dr. Q. Chaudry, Dr. S.C. Rastogi, Prof. K. Savolainen and Dr. R. Waring. 2. DECLARATIONS OF INTEREST No member declared any interest that could prevent him/her from participating in the discussion of the items on the agenda. 3. APPROVAL OF THE DRAFT AGENDA SCCS/1388/10 The agenda was approved without changes. 4. ADOPTION OF THE DRAFT MINUTES OF THE 8TH PLENARY MEETING SCCS/1379/10 The minutes of the 8th plenary meeting of 21 September 2010 were approved. 5. INFORMATION FROM CHAIRMAN/MEMBERS Information from the Chairman No issues were raised. Commission follow-up to earlier opinions In the absence of a representative of SANCO Unit B2 - Cosmetics and Medical Devices – the secretariat said that no legal implementations for cosmetic ingredients were made since the last plenary of 21 September 2010. 6. NEW REQUESTS 6.1. SCCS New requests were received for Zinc oxide (nano-size), ethyl lauroyl arginate (P95) and for Benzisothiazolinone (P96). SCCS/1404/11 Minutes 9th plenary meeting of the SCCS of 14 December 2010 ___________________________________________________________________________________________ 6.2. Mandates for other / all Committees / 7. REPORTS FROM THE WORKING GROUPS 7.1. Cosmetic Ingredients The Chairperson of the WG reported on the ongoing work. Draft opinions on parabens (P82), dihydroxyacetone (DHA) and on trisodium nitrilotriacetate (NTA) were prepared and tabled for formal adoption.
    [Show full text]
  • Exposure to and Toxicity of Methyl-, Ethyl- and Propylparaben a Literature Review with a Focus on Endocrine-Disrupting Properties
    National Institute forPublic Health and the Environment Ministryof Health, Welfare and Sport Exposure to and toxicity of methyl-, ethyl- and propylparaben A literature review with a focus on endocrine-disrupting properties RIVM Report 2017-0028 W. Brand et al. Exposure to and toxicity of methyl-, ethyl- and propylparaben A literature review with a focus on endocrine-disrupting properties RIVM Report 2017-0028 RIVM Report 2017-0028 Colophon © RIVM 2018 Parts of this publication may be reproduced, provided acknowledgement is given to: National Institute for Public Health and the Environment, along with the title and year of publication. DOI 10.21945/RIVM-2017-0028 W. Brand (author), RIVM P.E. Boon (author), RIVM E.V.S. Hessel (author), RIVM J.A.J. Meesters (author), RIVM M. Weda (author), RIVM A.G. Schuur (author), RIVM Contact: dr.ir. Walter Brand Centre for Safety of Substances and Products [email protected] This investigation has been performed by order and for the account of The Netherlands Food and Consumer Product Safety Authority (NVWA), within the framework of research question 9.1.67 ‘Exposure of consumers to substances with possible effects on the endocrine system’. This is a publication of: National Institute for Public Health and the Environment P.O. Box 1 | 3720 BA Bilthoven The Netherlands www.rivm.nl/en Page 2 of 109 RIVM Report 2017-0028 Synopsis Exposure to and toxicity of methyl-, ethyl- and propylparaben A literature review with a focus on endocrine-disrupting properties Parabens inhibit the growth of fungi and bacteria and, as such, are substances that can be used as preservatives in a variety of consumer products, such as personal care products, food and medicines.
    [Show full text]
  • Easy Removal of Methylparaben and Propylparaben from Aqueous
    Easy Removal of Methylparaben and Propylparaben from Aqueous Solution Using Nonionic Micellar System Safia Habbal, Boumediene Haddou, Jean-Paul Canselier, Christophe Gourdon To cite this version: Safia Habbal, Boumediene Haddou, Jean-Paul Canselier, Christophe Gourdon. Easy Removal of Methylparaben and Propylparaben from Aqueous Solution Using Nonionic Micellar System. Tenside Surfactants Detergents, Carl Hanser Verlag 2019, 56 (2), pp.112-118. 10.3139/113.110611. hal- 02330481 HAL Id: hal-02330481 https://hal.archives-ouvertes.fr/hal-02330481 Submitted on 24 Oct 2019 HAL is a multi-disciplinary open access L’archive ouverte pluridisciplinaire HAL, est archive for the deposit and dissemination of sci- destinée au dépôt et à la diffusion de documents entific research documents, whether they are pub- scientifiques de niveau recherche, publiés ou non, lished or not. The documents may come from émanant des établissements d’enseignement et de teaching and research institutions in France or recherche français ou étrangers, des laboratoires abroad, or from public or private research centers. publics ou privés. Open Archive Toulouse Archive Ouverte OATAO is an open access repository that collects the work of Toulouse researchers and makes it freely available over the web where possible This is an author’s version published in: http://oatao.univ-toulouse.fr/24275 Official URL: https://doi.org/10.3139/113.110611 To cite this version: Habbal, Safia and Haddou, Boumediene and Canselier, Jean- Paul and Gourdon, Christophe Easy Removal of Methylparaben and Propylparaben from Aqueous Solution Using Nonionic Micellar System. (2019) Tenside Surfactants Detergents, 56 (2). 112-118. ISSN 0932-3414 Any correspondence concerning this service should be sent to the repository administrator: [email protected] y S.
    [Show full text]
  • Effects of Butylparaben Exposure on Pancreatic Development in Zebrafish (Danio Erio)R Embryos
    University of Massachusetts Amherst ScholarWorks@UMass Amherst Masters Theses Dissertations and Theses November 2016 Effects of Butylparaben Exposure on Pancreatic Development in Zebrafish (Danio erio)r Embryos Sarah E. Brown University of Massachusetts Amherst Follow this and additional works at: https://scholarworks.umass.edu/masters_theses_2 Recommended Citation Brown, Sarah E., "Effects of Butylparaben Exposure on Pancreatic Development in Zebrafish (Danio rerio) Embryos" (2016). Masters Theses. 411. https://doi.org/10.7275/9028692 https://scholarworks.umass.edu/masters_theses_2/411 This Open Access Thesis is brought to you for free and open access by the Dissertations and Theses at ScholarWorks@UMass Amherst. It has been accepted for inclusion in Masters Theses by an authorized administrator of ScholarWorks@UMass Amherst. For more information, please contact [email protected]. Effects of Butylparaben Exposure on Pancreatic Development in Zebrafish (Danio rerio) Embryos A Thesis Presented by SARAH E. BROWN Submitted to the Graduate School of the University of Massachusetts Amherst in partial fulfillment of the requirements for the degree of MASTER OF SCIENCE September 2016 Environmental Health Sciences i © Copyright by Sarah E. Brown 2016 All Rights Reserved ii Effects of Butylparaben Exposure on Pancreatic Development in Zebrafish (Danio rerio) Embryos A Thesis Presented by SARAH E. BROWN Approved as to style and content by: _________________________________________________ Alicia R. Timme-Laragy, Chair _________________________________________________ Laura N. Vandenberg, Member _________________________________________________ Alexander V. Suvorov, Member ___________________________________________ Edward J. Stanek III, Department Chair, Department of Environmental Health Sciences iii ACKNOWLEDGMENTS I would like to thank my thesis advisor, Dr. Alicia Timme-Laragy, for this incredible opportunity. Working with Dr.
    [Show full text]
  • Review of Butylparaben: Exposure, Toxicity and Risk Assessment with the Focus on Endocrine-Disrupting Properties and Cumulative Risk Assessment
    National Institute forPublic Health and the Environment Ministryof Health, Welfare and Sport Review on butylparaben: exposure, toxicity and risk assessment With a focus on endocrine disrupting properties and cumulative risk assessment RIVM Report 2018-0161 E.V.S Hessel et al. Review on butylparaben: exposure, toxicity and risk assessment With a focus on endocrine disrupting properties and cumulative risk assessment RIVM Report 2018-0161 RIVM Report 2018-0161 Colophon © RIVM 2019 Parts of this publication may be reproduced, provided acknowledgement is given to: National Institute for Public Health and the Environment, along with the title and year of publication. DOI 10.21945/RIVM-2018-0161 E.V.S Hessel (author), RIVM P.E. Boon (author), RIVM S.P. den Braver-Sewradj (author), RIVM J.A.J. Meesters (author), RIVM M. Weda (author), RIVM W. Brand (author), RIVM Contact: Walter Brand Centre for Safety of Substances and Products [email protected] This investigation has been performed by order and for the account of The Netherlands Food and Consumer Product Safety Authority (NVWA), within the framework of research question 9.1.67 “Exposure of consumers to substances with possible effects on the endocrine system”. This is a publication of: National Institute for Public Health and the Environment P.O. Box1 | 3720 BA Bilthoven The Netherlands www.rivm.nl/en Page 2 of 120 RIVM Report 2018-0161 Synopsis Review of butylparaben: exposure, toxicity and risk assessment With the focus on endocrine-disrupting properties and cumulative risk assessment Butylparaben is used as a preservative because it inhibits the growth of fungi and bacteria in, for example, personal care products.
    [Show full text]
  • Sccs/1514/13
    SCCS/1514/13 Scientific Committee on Consumer Safety SCCS OPINION ON Parabens Updated request for a scientific opinion on propyl- and butylparaben COLIPA n° P82 The SCCS adopted this opinion by written procedure on 3 May 2013 1 SCCS/1514/13 Opinion on parabens, updated request on propyl- and butylparaben About the Scientific Committees Three independent non-food Scientific Committees provide the Commission with the scientific advice it needs when preparing policy and proposals relating to consumer safety, public health and the environment. The Committees also draw the Commission's attention to the new or emerging problems which may pose an actual or potential threat. They are: the Scientific Committee on Consumer Safety (SCCS), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) and are made up of external experts. In addition, the Commission relies upon the work of the European Food Safety Authority (EFSA), the European Medicines Agency (EMA), the European Centre for Disease prevention and Control (ECDC) and the European Chemicals Agency (ECHA). SCCS The Committee shall provide opinions on questions concerning all types of health and safety risks (notably chemical, biological, mechanical and other physical risks) of non-food consumer products (for example: cosmetic products and their ingredients, toys, textiles, clothing, personal care and household products such as detergents, etc.) and services (for example: tattooing, artificial sun tanning, etc.). Scientific Committee members Ulrike Bernauer, Qasim Chaudhry, Gisela Degen, Elsa Nielsen, Thomas Platzek, Suresh Chandra Rastogi, Christophe Rousselle, Jan van Benthem, Pieter Coenraads, Maria Dusinska, David Gawkrodger, Werner Lilienblum, Andreas Luch, Manfred Metzler, Nancy Monteiro-Rivière.
    [Show full text]
  • Safety Assessment of Parabens As Used in Cosmetics
    Safety Assessment of Parabens as Used in Cosmetics Status: Draft Tentative Report for Panel Review Release Date: May 19, 2017 Panel Meeting Date: June 12-13, 2017 The 2017 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 Director is Lillian J. Gill, D.P.A. This report was prepared by Ivan J. Boyer, Senior Toxicologist and Lillian C. Becker, Scientific Analyst/Writer. © Cosmetic Ingredient Review 1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 [email protected] Commitment & Credibility since 1976 MEMORANDUM To: CIR Expert Panel and Liaisons From: Ivan J. Boyer, PhD, DABT Senior Toxicologist Lillian C. Becker, M.S. Scientific Analyst and Writer Date: May 19, 2017 Subject: Re-review of Parabens Attached is the re-review of 20 parabens as used in cosmetics. These parabens are reported to function in cosmetics primarily as preservatives. In 2016, Sodium Methylparaben (which had not been reviewed by the Panel) was included in the CIR 2017 Priority List due to the large number of uses reported in the FDA’s VCRP database. The Expert Panel agreed that it would be appropriate to group this ingredient, and some additional parabens and paraben salts, with the previously reviewed ingredients, Methylparaben, Ethylparaben, Propylparaben, Isopropylparaben, Butylparaben, Isobutylparaben, and Benzylparaben, for review.
    [Show full text]
  • Occurrence of Pharmaceuticals and Personal Care Products in the Water Environment of Poland: a Review
    water Review Occurrence of Pharmaceuticals and Personal Care Products in the Water Environment of Poland: A Review Kinga Sl´ ósarczyk * , Sabina Jakóbczyk-Karpierz, Jacek Rózkowski˙ and Andrzej J. Witkowski Institute of Earth Sciences, Faculty of Natural Sciences, University of Silesia in Katowice, 60 B˛edzi´nskaSt., 41-200 Sosnowiec, Poland; [email protected] (S.J.-K.); [email protected] (J.R.); [email protected] (A.J.W.) * Correspondence: [email protected] Abstract: The issue of pharmaceuticals and personal care products (PPCPs) in the water environment has gained increasing interest worldwide. To determine the nature and extent of this problem for Poland, this paper presents a review of research on the presence of PPCPs in Poland, looking at results for different water samples, including wastewater (before and after treatment), landfill leachate, surface water (standing water bodies and rivers), seawater, groundwater and drinking water. The review is based on over 50 scientific articles and dissertations referring to studies of PPCPs. It also briefly outlines possible sources and the fate of PPCPs in the aquatic environment. The review of Polish research has revealed that studies have previously covered at least 39 PPCP groups (270 compounds in total). These studies focused mainly on wastewater and rivers, and only a few concerned landfill leachate and seawater. They most often reported on nonsteroidal anti-inflammatory drugs and antibiotics. The highest concentrations of the analysed PPCPs were found mainly in raw wastewater (e.g., naproxen, up to 551,960 ng/L), but they were also occasionally found in surface Citation: Slósarczyk,´ K.; water (e.g., azithromycin, erythromycin, irbesartan and metoprolol) and in groundwater (e.g., N,N- Jakóbczyk-Karpierz, S.; Rózkowski,˙ J.; diethyl-meta-toluamide, known as DEET, up to 17,280 ng/L).
    [Show full text]