Novel database for exposure to fragrance ingredients in cosmetics and personal care products
Introduction
Comprehensive habits and practices data on the consumption of cosmetic and personal care products between different subject demographics is necessary for safety assessments. Specifically, data on product use, co-use and non-use provides an accurate portrayal of the exposure that subjects in the population are exposed to over a time period. Currently for substances in cosmetics and personal care products, European regulations require that an evaluation of exposure to the substance be carried out (Commission, 2009) and additionally requires overall exposure and vulnerable subpopulations be evaluated for substances that are carcinogenic, mutagenic or toxic for reproduction.
Current methods used to estimate aggregate exposure to fragrance ingredients in cosmetics is based on deterministic summation of individual consumer product exposures, without considering co-use or population variability, according to the SCCS Notes of Guidance (SCCS, 2012). Typically, high end (upper percentile) exposures of each product are summed to provide the aggregate exposure. This approach overestimates exposure to cosmetics and will lead to overly conservative safety assessments.
At present there is a lack of co-use data available in the literature that will allow an accurate estimation of aggregate exposure to members of the population. Population-based studies involving cosmetic diaries sourced from market survey companies have been conducted previously (Hall et al., 2007, Hall et al., 2011, McNamara et al., 2007). The approach outlined in this study is an extension of this approach, but covers more product categories, a larger number of consumers and more regions (including Europe and the United States). On-line survey data that examines co-use has been used in the past to analyse air care exposure, but these were questions based on use per month (Moran et al., 2012). Other surveys on exposure of products to children has been conducted which can be used to determine product consumption per unit body weight, however, product co-use was not recorded (Gomez-Berrada et al., 2013).
In order to estimate aggregate exposure to individual ingredients/fragrances present in multiple product categories at varying concentrations, a dataset is required that details how different product categories are used in different combinations by a population of consumers. In addition, there needs to be an understanding of concentration levels of the individual ingredients/fragrances in these products. The product use data exists in market surveys performed by market research companies such as Kantar Worldpanel, who routinely survey consumer habits and practices. There is still however a need for a detailed analysis of the co-use of cosmetic and personal care products used during the day, over several days, by different demographics in the population, and amounts of product used per application. This will allow the calculation of aggregate exposure to cosmetic and personal care products in a representative population. The use levels of the individual ingredients/fragrances in products were obtained by surveying member companies and data in the peer-reviewed literature (Cowan-Ellsberry and Robison, 2009).
It is the aim of the present study to develop an aggregate exposure model that is based on survey data to accurately estimate aggregate exposure to fragrance ingredients in cosmetic products. To do this, we combine data from a cosmetics market research survey and product amount usages data from the literature, both of which are cross referenced with the survey subjects’ demographics. Then, we probabilistically estimate bodyweights and surfaces areas based on subject demographics to estimate applied consumer product exposure per unit bodyweight and per unit surface area.
Section snippets
Methods
The calculation of applied consumer product exposure to cosmetics requires the following quantifiable components: (1) frequency of product use per day, F, (2) amount of product used per occasion, A, and (3) product retention, R. The daily exposure, DE, (g/day) of a single product can be described mathematically by the following equation
To calculate the exposure to a fragrance ingredient in a product, there are two concentration values that must be known; the percentage concentration of
Frequency of product use
In this section, density plots are produced for all subjects in EU and US for certain products that may have an interesting co-use and/or specific demographic groupings for the same product (Fig. 2). The ‘modes’ of the density plots can be seen as peaks and indicate the most popular usage habits. For many of the products and demographic groups, distinct modes can be seen. For example, it is most common to observe modes at the following significant frequencies: 1 (or maybe 2) uses per week, 7
Discussion
It was the goal of the present study to establish a database of cosmetics and personal care product use data for the analysis of fragrance ingredient exposure from multiple products (aggregate exposure). Estimating exposure from various products allows a better understanding of the products that contribute to overall exposure in the representative population. The market study of 36,446 subjects across EU and US was a valuable source of information on usage habits. To the authors’ knowledge,
Conflict of interest
The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this article.
Transparency Document
Acknowledgments
This research was supported entirely by the Research Institute for Fragrance Materials, Inc.
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Present address: SH Robison Consulting, LLC, P.O. Box 688, Milford, OH 45150, United States.
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