Publication: New endocrine disruptor assessment data requirements for REACH proposed

Publication: New endocrine disruptor assessment data requirements for REACH proposed

Tracey Goodband, Smithers Senior Manager, Ecotoxicology, Harrogate, recently co-authored the article, “Resource and animal use implications of the proposed REACH information requirements for endocrine disruptor assessment,” published in Regulatory Toxicology and Pharmacology. Read the abstract and link to the full article below:

Abstract

Revised information requirements for endocrine disruptor (ED) assessment of chemicals under the European Union's Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) Regulation have been proposed.

Implementation will substantially increase demands for new data to inform ED assessment. This article evaluates the potential animal use and financial resource associated with two proposed ED policy options, and highlights areas where further clarification is warranted. This evaluation demonstrates that studies potentially conducted to meet the proposed requirements could use tens of millions of animals, and that the approach is unlikely to be feasible in practice.

Given the challenges with implementing either policy option and the need to minimize the reliance on animal testing, further consideration and clarification is needed on several aspects prior to implementation of the requirements. This includes how testing will be prioritized in a proportionate approach; how to harness new approach methodologies to waive higher-tier animal testing; and need for provision of clear guidance particularly in applying weight-of-evidence approaches. There is now a clear opportunity for the European Commission to lead the way in developing a robust and transparent ED assessment process for industrial chemicals which fully implements replacement, refinement, and reduction of the use of animals (the 3Rs).

Authors: Natalie Burden, Rebecca J. Brown, Rhiannon Smith, Susy Brescia, Tracey Goodband, Gustavo Guerrero-Limón, Lauren Kent, Sue Marty, Audrey Pearson, Morné van der Mescht, Leslie J. Saunders, Fiona Sewell, Neil Wang, James R. Wheeler

Read the full article. 

Our Smithers Harrogate and Wareham facilities have performed endocrine disruptor studies as standalone designs and as combinations of the established test guidelines to meet specific requirements. Contact us to learn more about our testing capabilities. 
 

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