Alternative approaches can reduce the use of test animals under REACH November 2004

Assessment of additional testing needs under REACH Effects of (Q)SARS, risk based testing and voluntary industry initiatives Alternative testing approaches under REACH 2 Summary In September 2003 a report was published on the impact of the REACH system on the need for further testing taking into account already existing obligations and voluntary initiatives and applying certain assumptions regarding the use of estimation techniques such as grouping of chemicals, read-across, (Quantitative) Structure-Activity Relationships ((Q)SAR) and the outcome of screening tests and risk assessments (Pedersen et al. 2003). The report was based on the interim version of the REACH Consultation Document of May 2003 and did not address the number of test animals needed for the testing. The present document is an addendum to the previous report and specifically aims at identifying the potential savings of vertebrate test animals that can be obtained through application of these alte rnative approaches. It is based on the revised Commission proposal of 29 October 2003. Moreover an update of the cost estimates presented in Pedersen et al. (2003) is included. The calculation of the test animals needed as a consequence of REACH has been carried out by using the same approach as employed by Pedersen et al. (2003). In this approach, the total amount of data required under REACH was established based on the information requirements as included in Annexes V – VIII of the legislative proposal. Then the amount of currently available data, as well as the data already promised under various programmes, was determined. The impact on the testing needs of so-called intelligent testing strategies applying methodologies such as (Q)SAR, grouping, read-across and possibilities for waiving according to Annex IX of REACH was assessed assuming three scenarios: 1) a standard scenario representing an average situation regarding acceptance of these methods, 2) a scenario based on minimum acceptance, and 3) a scenario with maximum acceptance. The currently available and expected data as well as the effect of the use of these methodologies were then 'subtracted' from the total quantity of data required under REACH, resulting in the estimated test requirements. The number of vertebrate test animals needed for the individual endpoints was established by consulting test laboratories and this was multiplied by the estimated number of studies required under REACH, resulting in estimates of the total amount of test animals which will potentially be needed for the implementation of the REACH legislation. The results …