P1-1044 WC-6 Tokyo 2007 The impact of REACH upon animal use in the European Union; Report of the ecopa CONAM Chemical Policy Working Group Tonia Devolder1, Bernward Garthoff2, Karsten Müller3, Marleen Pauwels4, Vera Rogiers4, Horst Spielmann5, Simon Webb6 1 - European Consensus Platform for 3R Alternatives (ecopa), Belgium; 2 - Bayer AG, Germany; 3 - BASF, Germany; 4 - Vrije Universiteit Brussel (VUB), Belgium; 5 - Zentralstelle zur Erfassung und Bewertung von Ersatz- und Ergänzungsmethoden zum Tierversuch (ZEBET), Germany; 6 - Procter & Gamble, Belgium. EU 6th Framework Programme Project # LSSB-CT-2004-504776 Abstract: Under the aegis of the CONAM project, ecopa, its partners and stakeholders co-operated to evaluate the potential impact of the REACH on the future use of animals and the implementation of 3R alternative methods and strategies in the EU. The impact was demonstrated, discussed and analyzed in several workshops and evaluated via a software tool, the ecopa Animal Testing Calculator. Based on the outcome of discussions at the different ecopa workshops and use of the ecopa Calculator, the minimum number for laboratory animal use under REACH will be at least 6 million (but likely significantly more, i.e. +50 - 100% under the current strategy). The major part (70%) of these animals will be employed <2014. Animal use to address reproductive and developmental endpoints will account for >80% of overall animal use. This is significant as these are the endpoints likely to be most resistant to the successful development of replacements. There is a clear mismatch between the likely development of alternatives (let alone acceptance by regulators) and the testing timetable of REACH despite the fact that there is now an explicit role within REACH related to the use and promotion of 3R alternative methods. Scenarios: Input assumptions employed when using the calculator are key to the output. Two default scenarios are included; (i) “Available Data” where all data gaps are filled and (ii) “Reduced Data Need” with an assumption that reduced testing is possible based on opportunities for read-across, grouping, QSAR etc. Data availability and testing need for each endpoint within the default scenarios are taken from Pedersen et al. (2003; http://ecb.jrc.it/documents/REACH/PUBLICATIONS/REACH_testing_needs_final.pdf). Registration, evaluation and testing time frames for the different tonnage group chemicals: Higher tonnage substances are registered earlier on in REACH. Percentages of animal use allocated to the different REACH Annexes under (a) the Reduced Data Need Scenario or under (b) the Available Data Scenario (Annex VII ≥1 tonne/a; Annex VIII ≥ 10 tonnes/a; Annex IX ≥ 100 tonnes/a; Annex X: ≥ 1000 tonnes/a): Higher tonnage substances necessitate more testing and animal use. Q2 = second quarter Animal use per year in the Reduced Data Need Scenario. Baseline level of 142,000 animals for toxicological safety testing of industrial, household & cosmetics chemicals according to the 4th Report on Animal Numbers [COM(2005) 7]: The major part (70%) of animal use will be required prior to 2014. There is a mismatch between the likely development and regulatory acceptance of 3R alternatives and the testing timetable of REACH. The implications of this should be acknowledged by the Commission and national regulators and clearly communicated to the different stakeholders and the European public. Access to the ecopa CONAM Chemical Policy WG report: http://www.ecopa.eu/download.php?file=CONAM_Impact_of_REACH_2007.pdf Acces to the ecopa REACH Animal Testing Calculator: http://www.ecopa.eu/download.php?file=Animaluse_REACH_calculator.xls ecopa information: http://www.ecopa.eu Contact: ecopa@vub.ac.be Distribution of overall animal use by study and endpoint under (a) the Reduced Data Need Scenario or (b) the Available Data Scenario: Animal use to address reproductive and developmental endpoints will account for >80% of overall use. These are also the endpoints likely to be most resistant to the successful development of full replacement tests.