According to ECHA's tri-annual report about the use of alternatives to animal testing, 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 analysed 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 analysed 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 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 analysing 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.
In vitro = Studies using cells, tissues or organs
Read-across = filling a data gap by using information on similar substances, either by using a category or an analogue approach
ECHA's second report on the use of alternatives to testing on animals
Summary of ECHA's second REACH 117(3) report
ECHA's first report on the use of alternatives to testing on animals
Summary of ECHA's first REACH 117 (3) report
Animal testing under REACH
OECD and EU test guidelines