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Chemical-safety costs uncertain

Researchers and regulators disagree on how REACH legislation will affect costs and loss of animal lives.

Europe's chemical regulator has questioned a study suggesting that industry will have to spend €9.5 billion (US$13.6 billion)—six times more than expected—on toxicity testing over the next decade, to comply with European Union (EU) legislation on chemical safety. The tests would require an estimated 54 million animals—a situation dismissed as a "worst-case scenario" by the European Chemical Industry Council (Cefic), a Brussels-based organization representing the European chemical industry.

The EU's REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) legislation, which came into force in 2007, is the world's most extensive attempt at improving the safe use of chemicals. It requires the registration and submission of toxicity data for all chemicals sold in the EU in quantities of more than one tonne per year by 2018.

But a study by Thomas Hartung, former head of the European Centre for the Validation of Alternative Methods (ECVAM) in Ispra, Italy, and Costanza Rovida, a consultant chemist in Varese, Italy, says that Europe lacks enough laboratories to carry out all the tests that the legislation demands. This will render the legislation unfeasible, concludes the study, which will be presented at the World Congress on Alternatives and Animal Use in the Life Sciences in Rome that begins on 30 August.

REACH's aim "will not be achieved" using traditional toxicity testing methods, says Hartung, now at Johns Hopkins University in Baltimore, Maryland. "The problem is that REACH will exceed the test capacities in Europe," he says. "This will cause delays in testing, and [regulators] will not get all the data needed to take the decisions that are necessary."

Hartung calls for a moratorium on the requirement to test chemicals' effects on reproductive systems in two generations of animals. These two-generation studies account for the lion's share of the increase in costs and test animals, the study says. The Organisation for Economic Co-operation and Development (OECD) is drawing up guidance for an extended one-generation reproductive toxicity test. The aim of this scheme is that tests beyond the first generation would be conducted only if a specific cause for concern arose in the first-generation offspring.

The OECD will hold a meeting in October to discuss outstanding technical issues, including what would be considered as a trigger for additional tests. Draft guidelines are expected to be submitted for approval in March 2010. If they get the green light, the guidelines would be published around September 2010, and could then be instituted before testing begins in December 2010.

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FRAME Training School in Experimental Design and Statistical Analysis
May 31-June 2, 2017
Saskatoon, Canada

Advances in Cell and Tissue Culture 2017
May 22-24, 2017
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CAAT Academy
In Vitro Skin and Eye Models Hands-on Training
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ecopa SSCT Workshop 2017
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Thomas Hartung will deliver a keynote address

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Updates on Hepatotoxicity AOP Landscape and on the ADME Field - Season 2
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9th Euro-Global Summit on Toxicology and Applied Pharmacology
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6th Annual Meeting of the American Society for Cellular and Computational Toxicology (ASCCT)
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