Generic formulations: availability and applicability for exposure assessment

Abstract Background Generic formulations (GFs), representations of the composition of consumer and industrial products based upon function rather than specific substances, can be useful tools for exposure and risk assessors. They provide a way to share the information needed for screening assessments of product safety without disclosing specific product formulations. GFs provide a structure for organizing the product/process type and associated qualitative and quantitative chemical ingredient information. Objective This perspective seeks to explain and highlight how GFs can be useful in exposure and risk evaluation, provides examples of GF information sources, and offers suggestions for further development of GFs. The primary emphasis here is on available information for industrial products, as this space is historically data-poor with respect to publicly available GF information. Methods Publicly accessible GF references were located and mapped to the Organization for Economic Co-operation and Development (OECD) harmonized use categories. Authors’ personal knowledge of sources of GFs played a key role because a great deal of GF-related information is embedded within spreadsheets or documents posted on the European Chemical Agency (ECHA) website or websites of commercial enterprises, and these sources may not be readily identified using typical internet or literature search strategies. Results Industrial GF information was found for 13 of 20 OECD use categories, but only for 20 of 91 OECD product-subcategory combinations. Limitations in findability and disparity in availability across sources support the value of developing common, consistent practices and platforms across stakeholder communities for sharing GFs and other exposure-relevant information. Significance This paper highlights available data, makes the case for systematic development and public availability of GF data, and explains the benefits of having this information available for various user sectors.