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Opinion of the Scientific Committee on Consumer Safety on O SCCS/1613/19 Final Opinion Version S Scientific Committee on Consumer Safety SCCS OPINION ON the safety of aluminium in cosmetic products Submission II The SCCS adopted this document at its plenary meeting on 03-04 March 2020 SCCS/1613/19 Final Opinion Opinion on the safety of aluminium in cosmetic products – submission II ___________________________________________________________________________________________ ACKNOWLEDGMENTS Members of the Working Group are acknowledged for their valuable contribution to this Opinion. The members of the Working Group are: For the preliminary and the final versions SCCS members Dr U. Bernauer Dr L. Bodin (Rapporteur) Prof. Q. Chaudhry (SCCS Chair) Prof. P.J. Coenraads (SCCS Vice-Chair and Chairperson of the WG) Prof. M. Dusinska Dr J. Ezendam Dr E. Gaffet Prof. C. L. Galli Dr B. Granum Prof. E. Panteri Prof. V. Rogiers (SCCS Vice-Chair) Dr Ch. Rousselle Dr M. Stepnik Prof. T. Vanhaecke Dr S. Wijnhoven SCCS external experts Dr A. Koutsodimou Dr A. Simonnard Prof. W. Uter All Declarations of Working Group members are available on the following webpage: http://ec.europa.eu/health/scientific_committees/experts/declarations/sccs_en.htm This Opinion has been subject to a commenting period of a minimum eight weeks after its initial publication (from 16 December 2019 until 17 February 2020). Comments received during this time period are considered by the SCCS. For this Opinion, some changes occurred, in particular in sections 1, 3.2, 3.3.4.5, 3.3.8.1, 3.5, as well as in related discussion parts and conclusion (question 1). The list of references has also been updated. _________________________________________________________________________ 2 SCCS/1613/19 Final Opinion Opinion on the safety of aluminium in cosmetic products – submission II ___________________________________________________________________________________________ 1. ABSTRACT In 2014, the SCCS was asked to review the safety of aluminium in cosmetic products. Aluminium containing ingredients were reported by cosmetic industry to be used in a lot of different categories of cosmetic products. Among them antiperspirants and deodorants, lipsticks and toothpastes were considered by the SCCS to be the main contributing sources of exposure via cosmetic products. The SCCS Opinion (SCCS/1525/14) concluded that due to the lack of adequate data on dermal penetration to estimate the internal dose of aluminium following cosmetic uses, risk assessment could not be performed, and asked for internal exposure to aluminium after skin application to be determined using a human exposure study under use conditions. The current SCCS Opinion is based on the new data and exposure assessment provided by the Applicant as part of Submission II. The SCCS concludes the following: 1. In light of the new data provided, does the SCCS consider that Aluminium compounds are safe in • Antiperspirants, • Other cosmetic products such as lipsticks and toothpastes? In the light of the new data provided, the SCCS considers that the use of aluminium compounds is safe at the following equivalent aluminium concentrations up to: · 6.25% in non-spray deodorants or non-spray antiperspirants · 10.60% in spray deodorants or spray antiperspirants · 2.65% in toothpaste and · 0.77 % in lipstick 2. Does the SCCS have any further scientific concerns regarding the use of Aluminium compounds in cosmetic products taking into account exposure from other sources? The SCCS considers that the systemic exposure to aluminium via daily applications of cosmetic products does not add significantly to the systemic body burden of aluminium from other sources. Exposure to aluminium may also occur from sources other than cosmetic products, and a major source of aluminium in the population is the diet. This assessment has not taken into account the daily dietary intake of aluminium. 3. In the event that the estimated exposure to Aluminium from specific types of cosmetic products is found to be of concern, SCCS is asked to recommend safe concentration limits for the presence of Aluminium in those cosmetic products or other risk reducing measures. / Keywords: SCCS, scientific opinion, aluminium, Regulation 1223/2009 Opinion to be cited as: SCCS (Scientific Committee on Consumer Safety), Opinion on the safety of aluminium in cosmetic products, preliminary version of 30-31 October 2019, final version of 03-04 March 2020, SCCS/1613/19 _________________________________________________________________________ 3 SCCS/1613/19 Final Opinion Opinion on the safety of aluminium in cosmetic products – submission II ___________________________________________________________________________________________ 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. These Committees are: the Scientific Committee on Consumer Safety (SCCS) and the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) and they are made up of scientists appointed in their personal capacity. 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 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, Laurent Bodin, Qasim Chaudhry, Pieter Jan Coenraads, Maria Dusinska, 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, 2019 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 _________________________________________________________________________ 4 SCCS/1613/19 Final Opinion Opinion on the safety of aluminium in cosmetic products – submission II ___________________________________________________________________________________________ TABLE OF CONTENTS ACKNOWLEDGMENTS ........................................................................................... 2 1. ABSTRACT .................................................................................................. 3 2. MANDATE FROM THE EUROPEAN COMMISSION ................................................ 6 3. OPINION ..................................................................................................... 7 3.1 Chemical and Physical Specifications ....................................................... 7 3.2 Function and uses ................................................................................ 8 3.3 Toxicological evaluation ........................................................................ 8 3.3.1 Acute toxicity ......................................................................... 9 3.3.2 Irritation and corrosivity .......................................................... 9 3.3.3 Skin sensitisation and dermatitis ............................................. 10 3.3.4 Dermal / percutaneous absorption........................................... 10 3.3.5 Repeated-dose toxicity .......................................................... 20 3.3.6 Mutagenicity / Genotoxicity .................................................... 21 3.3.7 Carcinogenicity ..................................................................... 22 3.3.8 Reproductive toxicity ............................................................. 23 3.3.9 Toxicokinetics ...................................................................... 26 3.3.10 Photo-induced toxicity ........................................................... 27 3.3.11 Human data ......................................................................... 27 3.3.12 Special investigations ............................................................ 28 3.3.13 Consumer Exposure assessment ............................................. 29 3.5 SAFETY EVALUATION (including calculation of the MoS) .......................... 32 3.6 DISCUSSION ..................................................................................... 34 4. CONCLUSION ............................................................................................ 37 5. MINORITY OPINION .................................................................................... 37 6. REFERENCES ............................................................................................. 38 7. GLOSSARY OF TERMS
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