Novel database for exposure to fragrance ingredients in cosmetics and personal care products

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Highlights

  • A database of cosmetics and personal care product use data for the analysis of fragrance ingredient exposure was developed.

  • The data and modelling methods presented show potential as a means of calculating aggregate exposure to fragrance ingredients.

  • The market study of 36,446 subjects across EU and US was a valuable source of information on usage habits.

  • This model constitutes the most comprehensive survey of habits and practices data for personal care and cosmetics.

  • Statistical analyses show the robustness of the data and the ability to estimate aggregate consumer product exposure.

Abstract

Exposure of fragrance ingredients in cosmetics and personal care products to the population can be determined by way of a detailed and robust survey. The frequency and combinations of products used at specific times during the day will allow the estimation of aggregate exposure for an individual consumer, and to the sample population. In the present study, habits and practices of personal care and cosmetic products have been obtained from market research data for 36,446 subjects across European countries and the United States in order to determine the exposure to fragrance ingredients. Each subject logged their product uses, time of day and body application sites in an online diary for seven consecutive days. The survey data did not contain information on the amount of product used per occasion or body measurements, such as weight and skin surface area. Nevertheless, this was found from the literature where the likely amount of product used per occasion or body measurement could be probabilistically chosen from distributions of data based on subject demographics. The daily aggregate applied consumer product exposure was estimated based on each subject’s frequency of product use, and Monte Carlo simulations of their likely product amount per use and body measurements. Statistical analyses of the habits and practices and consumer product exposure are presented, which show the robustness of the data and the ability to estimate aggregate consumer product exposure. Consequently, the data and modelling methods presented show potential as a means of performing ingredient safety assessments for personal care and cosmetics 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 equationDE=F×A×R

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.

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Acknowledgments

This research was supported entirely by the Research Institute for Fragrance Materials, Inc.

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    1

    Present address: SH Robison Consulting, LLC, P.O. Box 688, Milford, OH 45150, United States.

    2

    Current address.

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