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EU: ECHA reports progress in the use of alternatives to animal testing

According to ECHA’s tri-annual report about the use of alter­natives to animal testing, released on June 2, 2014, registrants have widely used alternative methods to generate information required by REACH to ensure the safe use of chemicals. Most registrants conform with the data sharing obligations and indus­try has increasingly used in vitro methods, built categories and predicted substance properties by read-across.


ECHA’s second report to the European Commission on the use of alternative methods under REACH shows an increase in the use of these methods. The report’s analysis is based on over 38,000 registration dossiers submitted for the 2010 and 2013 registration deadlines.


According to the report, most registrants do conform with the data sharing obligation under REACH to fulfil the information requirements and to avoid unnecessary animal testing. Regis­trants also built categories and predicted substance properties using read-across approaches in up to 75% of analyzed dossiers for at least one endpoint. Read-across or category approach has been particularly used for higher-tier endpoints where alterna­tive, non-animal test methods are not yet available.


In addition, registrants started to take up in vitro methods for skin and eye irritation, using cells, tissues or organs. The total number of in vitro studies submitted for skin and eye irritation has tripled since 2011: almost 20% of analyzed dossiers con­tained them for these endpoints.


So far, ECHA’s database contains information on 7,939 new experimental studies for those endpoints which may involve vertebrate animal testing. Out of these, 4,887 are tests on verte­brate animals and 3,052 are in vitro tests.


During the analysis, ECHA found that 293 tests were con­ducted on vertebrate animals without a prior submission and approval of a proposal for testing, as required by REACH. Reg­istrants have the obligation to include higher tier studies even if they were conducted for e.g. other regulations and therefore ECHA’s decision requesting the study may not have been re­quired. ECHA is further analyzing the cases to establish the pos­sible reasons. ECHA will inform Member State Authorities on the final results of this further analysis so they can take the next steps they consider to be appropriate.


Testing on vertebrate animals is only allowed as a last resort under REACH and ECHA’s objective is to promote non-ani­mal testing methods and other alternatives. Every three years, ECHA reports to the Commission on how the alternative meth­ods have been used to generate information on intrinsic prop­erties of chemical substances and for the risk assessment. The next report is due in 2017.


ECHA will use the results of the report to promote the use of alternative methods in support of registrants aiming for the 2018 registration deadline.



Adapted from ECHA press release


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