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Opinion of the Scientific Committee on Consumer Safety on O SCCS/1575/16 Final version of 6 October 2016 Version S Scientific Committee on Consumer Safety SCCS OPINION ON Phenoxyethanol The SCCS adopted this opinion at its 2nd plenary meeting on 6 October 2016 SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ About the Scientific Committees Two 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, Environmental and Emerging Risks (SCHEER) The Scientific Committees review and evaluate relevant scientific data and assess potential risks. Each Committee has top independent scientists from all over the world who are committed to work in the public interest. 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, on request of Commission services, provides Opinions on questions concerning health and safety risks (notably chemical, biological, mechanical and other physical risks) of non-food consumer products (e.g. cosmetic products and their ingredients, toys, textiles, clothing, personal care and household products such as detergents, etc.) and services (e.g.: tattooing, artificial sun tanning, etc.). Scientific Committee members Ulrike Bernauer, Laurent Bodin, Leonardo Celleno, Qasim Chaudhry, Pieter Jan Coenraads, Maria Dusinska, Jeanne Duus-Johansen, Janine Ezendam, Eric Gaffet, Corrado Lodovico Galli, Berit Granum, Eirini Panteri, Vera Rogiers, Christophe Rousselle, Maciej Stepnik, Tamara Vanhaecke, Susan Wijnhoven Contact European Commission Health and Food Safety Directorate C: Public Health, Country Knowledge and Crisis Management Unit C2 – Country Knowledge and Scientific Committees L-2920 Luxembourg [email protected] © European Union, 2016 ISSN ISBN Doi: ND- The opinions of the Scientific Committees present the views of the independent scientists who are members of the committees. They do not necessarily reflect the views of the European Commission. The opinions are published by the European Commission in their original language only. http://ec.europa.eu/health/scientific_committees/consumer_safety/index_en.htm 2 SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ ACKNOWLEDGMENTS SCCS members listed below are acknowledged for their valuable contribution to the finalisation of this Opinion. Dr U. Bernauer Dr L. Bodin Dr L. Celleno Prof. Q. Chaudhry Prof. P.J. Coenraads (Chairperson) Prof. M. Dusinska Prof. J. Duus-Johansen Dr J. Ezendam Dr E. Gaffet Prof. C. L. Galli Dr B. Granum Prof. E. Panteri Prof. V. Rogiers Dr Ch. Rousselle Dr M. Stepnik Prof. T. Vanhaecke Dr S. Wijnhoven The additional contribution for the drafting of the preliminary Opinion of former members of the SCCS (2013-2016) and external experts listed below is gratefully acknowledged. Former SCCS Members Prof. G. H. Degen Dr. W. Lilienblum (Rapporteur) Dr. E. Nielsen Prof. T. Platzek Dr. J. van Benthem Former SCCS External experts Prof. A. Bernard Prof. A. M. Giménez-Arnau Dr. E. Mirkova This Opinion has been subject to a commenting period of a minimum four weeks after its initial publication. Comments received during this time were considered by the SCCS and discussed in the subsequent plenary meetings. For this Opinion, comments received resulted in the following changes: PBPK and toxicokinetic sections, including the respective parts in the discussion, as well as a corrective action on the last page of the opinion (Annex I) where the wrong part of the figure has been replaced. Keywords: SCCS, scientific opinion, Phenoxyethanol, Regulation 1223/2009, CAS No. 122- 99-6, EC No. 204-589-7 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on Phenoxyethanol, 16 March 2016, final version of 6 October 2016, SCCS/1575/16 3 SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ Table of Contents ACKNOWLEDGMENTS ........................................................................................... 3 1. BACKGROUND ............................................................................................. 5 2. TERMS OF REFERENCE .................................................................................. 5 3. OPINION ..................................................................................................... 6 3.1 Chemical and Physical Specifications ....................................................... 6 3.1.1 Chemical identity .................................................................... 6 3.1.2 Physical form ......................................................................... 6 3.1.3 Molecular weight .................................................................... 6 3.1.4 Purity, composition and substance codes .................................... 6 3.1.5 Impurities / accompanying contaminants ................................... 7 3.1.6 Solubility ............................................................................... 7 3.1.7 Partition coefficient (Log Pow) .................................................... 7 3.1.8 Additional physical and chemical specifications ............................ 7 3.1.9 Homogeneity and Stability ....................................................... 7 3.2 Function and uses ................................................................................ 7 3.3 Toxicological Evaluation ........................................................................ 8 3.3.1 Acute toxicity ......................................................................... 8 3.3.2 Irritation and corrosivity ........................................................ 10 3.3.3 Skin sensitisation .................................................................. 11 3.3.4 Dermal / percutaneous absorption........................................... 12 3.3.5 Repeated dose toxicity .......................................................... 17 3.3.6 Mutagenicity / Genotoxicity .................................................... 29 3.3.7 Carcinogenicity ..................................................................... 36 3.3.8 Reproductive toxicity ............................................................. 41 3.3.9 Toxicokinetics ...................................................................... 47 3.3.10 Photo-induced toxicity ........................................................... 64 3.3.11 Human data ......................................................................... 65 3.3.12 Special investigations ............................................................ 68 3.3.13 Safety evaluation (including calculation of the MoS) ................... 72 3.3.14 Discussion ........................................................................... 73 4 CONCLUSION ............................................................................................ 83 5 MINORITY OPINION .................................................................................... 83 6 REFERENCES SUBMISSION I ....................................................................... 84 7 REFERENCES SUBMISSION II (2015 and 2016) .............................................. 93 8 ADDITIONAL REFERENCES .......................................................................... 94 9 Annex 1 .................................................................................................... 96 4 SCCS/1575/16 Final version of the Opinion on Phenoxyethanol ___________________________________________________________________________________________ 1. BACKGROUND Phenoxyethanol CAS n. 122-99-6 as preservative is regulated in Annex V/29 of the Cosmetics Regulation (EC) n. 1223/2009. According to the Cosmetics Regulation (EC) n.1223/2009 Phenoxyethanol is authorized as a preservative in cosmetic formulations at a maximum concentration of 1.0%. In September 2012, the Commission received a risk assessment submitted by the French Agency ANSM (Agence nationale de sécurité des médicaments et des produits de santé) which rose concerns about the use of Phenoxyethanol as preservatives in cosmetic products. The ANSM report (Evaluation du risque lié à l'utilisation du phénoxyéthanol dans les produits cosmétiques) concludes that the maximum authorised concentration (currently of 1%) of Phenoxyethanol for use as a preservative should be lowered to 0.4% in cosmetic products for children less than three years. In addition, Phenoxyethanol should not be used in cosmetic products intended for their nappy area. The Commission received information from other member States which raised similar concern on the use of Phenoxyethanol, in particular on children. In December 2013, in response to a call for data on Phenoxyethanol by the Commission, Cosmetics Europe submitted a safety dossier in order to defend the current use of Phenoxyethanol as preservative in cosmetic formulations at a maximum concentration of 1.0%. In December
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