Abstract
SummaryGrouping of substances and utilizing read-across of data within those groups represents an important data gap filling technique for chemical safety assessments. Categories/analogue groups are typically developed based on structural similarity and, increasingly often, also on mechanistic (biological) similarity. While read-across can play a key role in complying with legislation such as the European REACH regulation, the lack of consensus regarding the extent and type of evidence necessary to support it often hampers its successful application and acceptance by regulatory authorities. Despite a potentially broad user community, expertise is still concentrated across a handful of organizations and individuals. In order to facilitate the effective use of read-across, this document presents the state of the art, summarizes insights learned from reviewing ECHA published decisions regarding the relative successes/pitfalls surrounding read-across under REACH, and compiles the relevant activities and guidance documents. Special emphasis is given to the available existing tools and approaches, an analysis of ECHA's published final decisions associated with all levels of compliance checks and testing proposals, the consideration and expression of uncertainty, the use of biological support data, and the impact of the ECHA Read-Across Assessment Framework (RAAF) published in 2015.
Highlights
Over the last decade, the world has witnessed the introduction of new regulations on chemicals in several geographic regions and countries that require companies to meet safety data requirements for their already marketed chemicals, often resulting in the generation of new toxicological data and the execution of a risk assessment to address any hazards identified
With an understanding of the state of the art of read-across and some important experience gained through the REACH Regulation, we find ourselves in a position where there is some understanding of the available tools and where we appear to be failing/succeeding
This paper has attempted to lay out the current state of the art of read-across and, based on the analysis of its effectiveness under the EU REACH Regulation, highlights the areas that should become a priority for further work to ensure that read-across continues to be an effective way to characterize the hazards of substances without triggering the need for extensive testing programs
Summary
The world has witnessed the introduction of new regulations on chemicals in several geographic regions and countries (for example EU, China, Taiwan, Korea, Turkey) that require companies to meet safety data requirements for their already marketed chemicals, often resulting in the generation of new toxicological data and the execution of a risk assessment to address any hazards identified. Within these regulations, the data needs are driven by some form of proxy for potential exposure (e.g., manufacturing or import volume) and as a consequence of the hazard and risk assessments undertaken, chemicals may be subject to restrictions on how they are used or, alternatively, phased out. Two stakeholder fora, one in Brussels on February 26, 2016 (jointly with CEFIC and other stakeholders) and a similar one in Washington on March 1, 2016 (hosted by FDA), presented and discussed the derived insights
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