CONAM March 2007F2

EU 6 th Framework Programme Project # LSSB-CT-2004-504776 THE IMPACT OF REACH The report of the CONAM / ecopa Chemical Policy Working Group March 2007 “Copyright 2007 by ecopa (the European Consensus Platform for 3R -alternatives), resp. covered under the regulations of the EU 6 th Framework Programme-Reprint and reference consent to be obtained by the editors”. Edition ecopa : Report 1, Brussels 2007. Participants/Contributors : Tonia Devolder , BE Vera Rogiers, BE Bernward Garthoff, DE Horst Spielmann,DE Karsten Müller, DE Simon Webb, UK Marleen Pauwels, BE Executive Summary About ecopa and CONAM ecopa is the European Consensus Platform on 3R-Alternatives. It is an international not-for- profit organisation, officially established in April 2004 according to Belgian law. ecopa is the only quadripartite umbrella organisation at the European level concerned with the development and implementation of 3R-alternative methods to animal experimentation. The parties involved are Academia, Industry, Animal Welfare and Governmental Institutes. ecopa is a success thanks to the creation of so-called National Consensus Platforms (NCPs) in the different European Member States. Actually, 13 full member NCPs (Austria, Belgium, Czech Republic, Denmark, Finland, Germany, Hungary, Italy, The Netherlands, Spain, Sweden, Switzerland and the United Kingdom) and 3 associate members (NCPs under formation) exist (Ireland, Norway, and Poland). Recently, Norway and France officially finalised their consensus platform preparations. As ecopa believes in international networking, exchange of information and good science as a solid basis for alternatives development, the CONAM (Consensus Networking on Alternative Methods within Europe)-project was initiated under FP6 (Project nr. LSSB-CT- 2004-504776), coordinated by ecopa 's chair Prof. Vera Rogiers. Major objectives consist of building new NCPs, creation of a newsletter ( ecopa messenger), website expansion, organisation of scientific workshops and meetings and stimulation of international cooperation. These goals are accomplished by the activities organised within 4 workgroups, including a workgroup on political/scientific developments within REACH. The latter is at the origin of the in-depth analysis with respect to the impact of the REACH chemical legislation in the EU. Within the CONAM-Project (EU 6 th FP, Project # 2004-504776), ecopa , its partners 1 and the stakeholder parties involved in the discussion around alternative testing to laboratory animal experiments, addressed the potential impact of the REACH chemical legislation in the EU on the future use of animals and the implementation of alternative methods and strategies. The impact was demonstrated, discussed and analyzed in several workshops and evaluated in a software tool “the ecopa REACH Animal Testing Calculator”. For the future regulatory implementation on REACH and actual day-to-day practice of the legislation, the following key points and recommendations were identified by the WG: • The REACH-legislation has changed and evolved over time since the publication of the original EU Chemical Policy White Paper. There is now a much more explicit role within REACH related to the use and promotion of alternative methods. • Based on the outcome of discussions amongst stakeholders at the different ecopa workshops and use of the downloadable ecopa REACH Animal Testing Calculator, the likely minimum number for laboratory animal use under REACH will be at least 6 million (but most likely significantly more, i.e. + 50 - 100%); 1 :The view of of Animal Welfare, represented by the ecopa board member Roman Kolar of Deutscher Tierschutzbund, is given at the end of this report, i.e. on page 60. ecopa / CONAM report "The Impact of REACH", Mar 2007 1 • The major part (approx. 70%) of these animals will be employed during the testing phase <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 regulatory bodies) and the testing timetable of REACH. This is particularly striking, even if one assumes the most optimistic outcome of the FP6 projects addressing alternative testing. The implications of this have to be acknowledged by the Commission and national regulators and should be clearly communicated to the different stakeholders and the European public. • The results of the REACH Implementations Projects (RIPs) and the post-implementation behaviour of all stakeholders will be critical for the “animal testing need” of REACH. • In order to comply with the envisaged resource lack in the EU in regard to regulatory toxicology experts and study capacities, the Member States and the Commission will have an obligation to start not only immediate recruitment, but also initiate an obligatory training programme due to the complexity of REACH. • New alternative approaches should be considered by the REACH regulation as soon as they are validated and accepted by regulators. Each formal and informal method validation applies only to a limited set of test substances, the so-called “applicability domain”. The neglect of this consideration in the process of identifying “suitable” methods would be detrimental for the reputation of alternative methodologies. • While working together under the provisions of the REACH regulation, a certain level of mutual consent between industry and ECHA (European Ch emical Agency) and the competent authorities within the Member States has to be reached as soon as possible. Trust-building has to be facilitated. • The availability of testing resources and capacities (experts, labs, CROs), total number of substances and different chemical classes to be assessed, the outcome of socio- economic analyses etc. are outside the scope of this project. Nevertheless, they are likely to be significant determinants of the implementation of REACH and should not be ignored.. • Therefore, a clear definition, after carefully identifying, of those alternative methods acceptable to the regulatory communities and strategies (meant by “suitable" respectively "adequate” methods) is key in avoiding unnecessary testing on animals. ecopa / CONAM report "The Impact of REACH", Mar 2007 2 Table of contents 1. Introduction..........................................................................................................................4 1.1 Development of REACH ................................................................................................4 1.2 ecopa ’s Role..................................................................................................................4 1.3 Creation of CONAM (6 th EU Framework Programme Project).......................................5 1.4 Intention of this Report...................................................................................................6 2. CONAM / ecopa -supported activities ................................................................................7 2.1 Animal Use under REACH and the ecopa REACH Animal Testing Calculator..............7 2.2 CONAM / ecopa w orkshops.........................................................................................15 2.3 Conclusions, Propositions............................................................................................23 3. Impact on and influence of relevant institutions............................................................24 3.1 Competent Authorities of Member States ....................................................................24 3.2 EU Scientific Committees.............................................................................................24 3.3. "European Toxicologists" .............................................................................................25 3.4 Contract Research Organisations................................................................................25 3.5 The Future European Chemical Agency......................................................................25 3.6 ReProTect Consortium.................................................................................................26 3.7 epaa .............................................................................................................................26 3.8 Stakeholders ................................................................................................................26 3.9 Industry ........................................................................................................................26 3.10 ECVAM (European Centre for the Validation of Alternative Methods).........................27 3.11 ESAC (ECVAM Scientific Advisory Committee)...........................................................27 4. Summarizing Recommendations.....................................................................................28 5. Glossary .............................................................................................................................31 6. References .........................................................................................................................34 7. Appendices ........................................................................................................................36 A. Templates for Assessment, Test Numbers of Studies B. Listing of Issues addressed

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