Nonanimal Test Methods Must Be Considered for REACH

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By Pat Rizzuto

Sept. 23 — Chemical manufacturers must show the European Chemicals Agency they have considered alternative toxicity testing methods before proposing to obtain required toxicity data through animal tests, said an EU ombudsman in a decision announced Sept. 23.

ECHA has agreed to two proposals suggested by the ombudsman, which is therefore closing a complaint nongovernmental organizations filed against the chemicals agency in November 2013, the chemicals agency said (Case No. 1606/2013/AN).

The NGOs, which the ombudsman said requested anonymity, alleged the chemicals agency has failed to fully implement the EU's registration, evaluation, authorization and restriction of chemicals, or REACH, regulation ((EC) 1907/2006), because the agency does not reject animal testing proposals when data could be generated by an alternative method that would replace, reduce or refine the use of animals.

Ombudsman's Proposals Accepted 

“The ombudsman's inquiry concluded that ECHA's interpretation of its role was too strict and did not take into account the fact that the avoidance of animal testing was, together with the protection of human health and the environment, one of the guiding principles of the regulation,” the ombudsman wrote in a Sept. 11 decision.

The ombudsman therefore proposed to ECHA that it should:

• require all chemical registrants to show they have considered alternative test methods that could generate toxicity and other data required under REACH and found those methods could not reasonably do so; and

• provide registrants with information about the existence of alternative tests methods that may be able to generate required data and require registrants to explain to ECHA's satisfaction why those methods would not work.


ECHA agreed to the first proposal and said it already did the second.

The ombudsman said that reply meant the agency accepted its proposals.

Report From ECHA Due in Six Months 

It directed the agency to report to the ombudsman in six months about progress it has made in carrying out those tasks.

“It’s a pity that a complaint from an NGO was necessary to get ECHA to accept its responsibility to require all registrants to demonstrate they have tried to avoid testing on animals and provide registrants with all information at its disposal which could help them to avoid testing on animals,” Gilly Stoddart, associate director of PETA's International Science Consortium, told Bloomberg BNA by e-mail. PETA, or People for the Ethical Treatment of Animals, established the consortium to help its scientists support the development, validation and global use of alternative tests.

“It’s too late for the animals who have already been killed in chemical tests that could have been avoided but we hope that the ombudsman’s decision will result in potentially thousands of animals being saved in the coming years,” Stoddart said.

U.S. Workshop 

In a separate but related development, U.S. regulators that require the submission of acute toxicity data will meet with federal, chemical industry, academic and NGO scientists Sept. 24-25 at a workshop called Alternative Approaches for Identifying Acute Systemic Toxicity: Moving from Research to Regulatory Testing.

To contact the reporter on this story: Pat Rizzuto in Washington at

To contact the editor responsible for this story: Larry Pearl at

The ombudsman's proposal, decision and related information are available at

Information about the U.S. workshop is available at

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