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Risk Assessment of Fluorinated Substances in Cosmetic Products

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Risk Assessment of Fluorinated Substances in Cosmetic Products Risk assessment of fluorinated substances in cosmetic products Survey of chemical substances in consum- er products No. 169 October 2018 Publisher: The Danish Environmental Protection Agency Editors: Anna Brinch (COWI A/S) Allan Astrup Jensen (NIPSECT) Frans Christensen (COWI A/S) ISBN: 978-87-93710-94-8 The Danish Environmental Protection Agency publishes reports and papers about research and development projects within the environmental sector, financed by the Agency. The contents of this publication do not necessarily represent the official views of the Danish Environmental Protection Agency. By publishing this report, the Danish Environmental Protection Agency expresses that the content represents an important contribution to the related discourse on Danish environmental policy. Sources must be acknowledged. 2 The Danish Environmental Protection Agency / Risk assessment of fluorinated substances in cosmetic products Contents Preface 5 Summary and conclusion 6 1. Introduction 14 1.1 Background and purpose of the project 14 1.1.1 Purpose and delimitations 14 1.2 Regulation of cosmetic products 15 1.3 Description of the substances concerned 15 1.3.1 Limit values for the substances concerned 17 2. Survey of PFAS in cosmetic products 19 2.1 Method 19 2.2 Survey 19 2.2.1 Databases 19 2.2.2 Literature data 23 2.3 Summary of the survey 27 2.4 Criteria for selection of products for chemical analysis 27 3. Chemical analysis 29 3.1 Introduction 29 3.2 Method 29 3.2.1 Analytical method 30 3.3 Results 30 3.3.1 Selection of substances for hazard and risk assessment 36 4. Hazard assessment 37 4.1 Introduction 37 4.2 Method 37 4.2.1 Perfluorooctanoic acid (PFOA) 38 4.2.2 Perfluorobutanoic acid (PFBA) 48 4.2.3 Perfluoropentanoic acid (PFPeA) 53 4.2.4 Perfluorohexanoic acid (PFHxA) 56 4.2.5 Perfluoroheptanoic acid (PFHpA) 62 4.2.6 Summary and conclusion of the hazard assessment 67 5. Exposure assessment 73 5.1 Introduction 73 5.2 Method 73 5.2.1 Exposure scenarios 74 5.2.2 Data used in the exposure scenarios 74 5.2.3 Calculation of the systemic exposure dosage 75 6. Risk assessment 78 6.1 Introduction 78 6.2 Method 78 The Danish Environmental Protection Agency / Risk assessment of fluorinated substances in cosmetic products 3 6.3 Calculation of MoS 79 7. Conclusion and discussion 81 Abbreviations 84 References 86 Appendix 1 Overview of results from the survey 95 Appendix 2 Results from chemical analysis 111 4 The Danish Environmental Protection Agency / Risk assessment of fluorinated substances in cosmetic products Preface This project is part of the Danish Environmental Protection Agency's chemical initiative, with the aim of assessing consumers' exposure to problematic chemistry. The purpose of the pro- ject is to build knowledge of PFAS in cosmetic products and to clarify whether using cosmetic products containing PFAS poses a risk to consumers. The project was carried out from September to December 2017 by COWI and NIPSECT. The chemical analyses were performed by Eurofins. The project has been followed by a steering committee composed of the following members: Toke Winther, Environmental Protection Agency Bettina Ørsnes Larsen, Environmental Protection Agency Anna Brinch, COWI Frans Christensen, COWI Allan Astrup Jensen, NIPSECT. The Danish Environmental Protection Agency / Risk assessment of fluorinated substances in cosmetic products 5 Summary and conclusion The purpose of this project is to build knowledge of fluorinated substances in cosmetic prod- ucts and to clarify whether the use of cosmetic products containing certain fluorinated sub- stances presents a health risk to consumers. The project focuses on perfluoroalkyl and polyfluoroalkyl substances (PFAS), which are also denoted fluoroalkyl substances. PFAS and other fluorinated compounds are used in a variety of cosmetic products such as foundation, moisturizer, eyeshadow, powder, lipstick and shaving cream. PFAS occurs both as desired ingredients in cosmetic products and as unintentional degradation products and impurities from the production of the PFAS precursors used in certain cosmetic products. The project consists of three phases: 1. Survey of PFAS in cosmetic products 2. Chemical analyses of PFAS and total organic fluorine content in selected cosmetic prod- ucts 3. Health hazard and risk assessment It should be noted that perfluoroalkyl substances are considered to be problematic as they are very persistent (vP) in the environment, some may accumulate in humans or the environment (bioaccumulative (B) or very bioaccumulative (vB)) and because some of the substances are known to be toxic (T). For PBT/vPvB substances it is not possible to establish a safe level of exposure and emis- sions are to be minimised. Survey of PFAS in cosmetic products The purpose of the survey is to provide an overview of PFAS used in cosmetic products on the Danish market. This overview provides the basis for the selection of cosmetic products for chemical analysis in the second phase of the project. In the survey, various data sources have been identified - databases addressing cosmetic products and their ingredients, as well as a literature search on PFAS in cosmetic products - and reviewed. One of the main sources for the survey is an app from the Danish Consumer Council Tænk Kemi called 'Kemiluppen', which contains information about ingredients in a wide range of cosmetic products, reported by Danish consumers. In addition, two Danish trade associations have been contacted; however, this did not result in any additional information relevant to this project. The results from the survey show that a variety of fluoroalkyl substances and other fluorinated compounds are present in cosmetic products. As already mentioned, this project only focuses on a part of these, namely fluoroalkyl substances. According to the databases reviewed, Poly- tetrafluoroethylene (PTFE) was found in most different product types, followed by C9-15 fluoro- alcohol phosphate. Generally, fluoroalkyl substances are used in a wide range of products, with emphasis on foundations, BB/CC1 cream, creams/lotions and powders. The concentration of PFAS in cosmetic products has been studied in two previous projects. Here the results showed that there was a large variation in the concentration of PFAS depend- ing on the product type being analysed and the product brand. With the exception of sun- screens, the highest measured concentrations were found in foundations; the highest meas- ured value was 2,160 ng/g for perfluorooctanoic acid (PFOA). 1 BB can stand for both Beauty Balm and Blemish Balm. CC stands for Color Corrector. 6 The Danish Environmental Protection Agency / Risk assessment of fluorinated substances in cosmetic products The results from the survey also indicate that cosmetic products containing fluoroalkyl sub- stances and other fluorinated compounds on the Danish market typically have women and, in a few cases, men as target groups. The survey has not identified cosmetic products containing PFAS-related substances distinctly targeting children. Based on the results of the survey, 22 products, as well as two control products, were selected for chemical analysis. Only products with a declared content of PFAS in the product itself or with declared ingredients where there was knowledge of possible PFAS degradation prod- ucts/impurities were selected. The constituents of the products were identified based on infor- mation from the product's International Nomenclature of Cosmetic Ingredients (INCI) list. Products with the following ingredients (INCI names) were prioritized: C9-15 fluoroalcohol phosphate Perfluorononylethyl carboxydecyl PEG-10 dimethicone Perfluorononyl dimethicone Perfluorooctyl triethoxysilane PTFE Polyperfluoroethoxymethoxy difluoroethyl PEG phosphate Ammonium C6-16 perfluoroalkyl ethyl phosphate Actual products were then selected on the basis of a number of criteria, including the number of scans of the product in the 'Kemiluppen' app, product type, position of the ingredient name on the product ingredient list (where earlier listing indicate higher concentration), product tar- get group and product price. In addition, the products' immediate availability in stores was taken into account. Chemical analysis of PFAS and total organic fluorine content in selected cosmetic products Of the 22 selected products, only 18 products were analysed, as three of the products no longer indicated declared content of the selected PFAS or other fluorinated compounds and the last product was not possible to purchase. The selected products were analysed for a number of single PFAS where analytical standards were available, as well as for total organic fluorine (TOrF) content. One or more PFAS substances was identified in 17 products2 (for hair spray and eyeliner, the substances were found only in one of the duplicate determinations). The highest concentration of a single substance was 3,340 ng/g PFHxA (perfluorohexanoic acid) found in a foundation, while the highest concentration of total PFAS (10,700 ng/g) was found in a concealer. In addition, for two of the products (both foundations) perfluorooctanoic acid (PFOA) was found in concentrations above the forthcoming EU limit value of 25 ng/g. In six of the products, the proposed REACH EU sum limit value for C9 -C14 perfluoroalkyl acids or perfluorocarboxylic acids (PFCAs) was also exceeded. Using the TOrF method, fluorine was found in all analysed products, except for a single prod- uct (hair spray). There was a relatively large difference between the content of the individual 2 The number of products is reduced from 18 to 17, as review of the INCI list of products re- vealed that one product (No. 13) has a declared content of synthetic fluoroplogopite instead of C9-15 fluorophosphate (the presence of which was the reason for this product’s selection for analysis. Therefore, in practice, the number of analysed products, based on information on ingredients from the INCI list assumed to contain PFAS, was reduced to 17 in total. The Danish Environmental Protection Agency / Risk assessment of fluorinated substances in cosmetic products 7 PFASs and the concentration of organic fluorine in the products.
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