May 3, 2016
EU Chemicals Law First in World to Adopt Animal-Free Testing Strategy for Skin Allergy Based on ‘Tox21’ Paradigm
HSI celebrates beginning of new era for human-relevant, non-animal toxicity testing; calls on regulators in other countries and industry sectors to follow suit
Humane Society International anticipates a substantial reduction in animal testing for skin allergy under the European “REACH” chemicals law following a recent move by EU nations to embrace the world’s first non-animal replacement strategy for a complex area of toxicity based on a robust understanding of human biology. Skin allergy testing has traditionally relied on invasive and dubious tests on guinea pigs and mice, and this remains the case in chemical, pesticide and cosmetic regulations in much of the world, even though animal tests have been shown to be less predictive of human responses than modern non-animal approaches.
“We are extremely pleased that EU nations have recognised the value of pathway-based non-animal test methods and integrated them into REACH as the default for provision of skin allergy data,” said Troy Seidle, HSI’s director of research and toxicology. “But to ensure that the obsolete animal tests really do become a thing of the past, it will be necessary now for the European Commission and European Chemicals Agency to provide clear guidance to industry on how to use the new methods, and for authorities in other nations and industry sectors to revise their respective data requirements to align with the scientific state of the art.”
The Tox21 approach to chemical safety testing began as a recommendation of the U.S. National Research Council in 2007 to map the biological “adverse outcome pathways” disrupted by chemical toxins in human beings, rather than observing the effects they have on other animal species. Today, an extensive international effort to map AOPs is under way through the 34-member-country Organization for Economic Cooperation and Development.
Humane Society International is a key player in the global shift under way in toxicology toward an animal-free Tox21 approach -- from pressing national governments to provide increased funding for non-animal Tox21 research and method validation, through serving as an invited expert to OECD bodies working on AOP and test guideline development, to persuading national authorities to adopt the new methods. HSI was a leading advocate for the recent revisions to REACH in the EU, and is leading a similar scientific dialogue with industry and regulators in the United States, Canada, Brazil, India, South Korea, Japan and elsewhere towards the elimination of redundant animal test requirements and optimizing processes for acceptance and use of available, valid animal testing alternatives.
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