General Aspects of Regulation 1 Regulation of biological control agents and the EU Policy Support Action REBECA 1.1 Biological control and regulation of biological control agents 1.2 Regulation of biological control agents in Europe - the REBECA Policy Support Action 1.3 History of biocontrol registration 1.4 The precautionary principle in risk assessment 1.5 Stakeholders 1.6 References 2 Regulation according to EU Directive 91/414: data requirements and procedure compared with regulation practice in other OECD countries 2.1. Introduction 2.2. Methodology and Terminology 2.3. Legal framework and regulatory procedures 2.4. Analysis of formal data requirements 2.5. Practical experience with the regulatory process 2.6. Initiatives taken to facilitate the registration of BCAs in the EU 2.7. Major changes due to the New Regulation 1107/2009 2.8. Overall conclusions 3 An international comparison of invertebrate biological control agent regulation: what can Europe learn? 3.1 Introduction 3.2 Comparative analyses of international regulation 3.3 Conclusions and recommendations 3.4 References 4 Regulation of plant protection in organic farming 4.1 What is organic farming? 4.2 Regulation of organic farming 4.3 Plant protection in organic farming 4.4 Authorization of new pesticides for organic farming 4.5 Organic plant protection in practice: regulation and other determinants 4.6 References 5 Policy Aspects of Regulation 5.1 The Regulatory State 5.2 Dysfunctional aspects of regulation 5.3 Governance 5.4 Solution oriented stakeholder engagement 5.5 Regulatory innovation 5.6 References 6 Cost-benefit, risk and trade-off analysis of regulation 6.1 The risk society and regulation of biological control 6.2 Methods for assessing the cost-benefit relation and economic efficacy of regulation 6.3 Costs of regulation 6.4 Benefits of regulation and cost-benefit ratio 6.5 Trade-off analysis 6.6 Agriculture policy and biological control 6.7 References Risks and Risk Assessment 7 Risks of microbial biocontrol agents and regulation: are they in balance? 7.1 Introduction 7.2 Regulation as it exists today 7.3 Requirements of Annex II B of Directive 91/414 7.4 Conclusion 7.5 References 8 Ecology and human pathogenicity of plant-associated bacteria 8.1 Molecular ecology of plant-associated bacteria 8.2 Plants as reservoir for opportunistic human pathogenic bacteria? 8.3 Caenorhabditis elegans: a model to assess pathogenicity factors 8.4 Influence of antagonistic bacteria on indigenous microbial communities 8.5 Conclusions 8.6 References 9 Metabolite toxicology of fungal biocontrol agents 1. Introduction 2. Mycotoxins of fungal biological control agents 3. Standard procedure for toxic metabolite assessment 4. Conclusion 5. References 10 Risks of biocontrol agents containing compounds of botanical origin or semiochemicals 10.1 Introduction 10.1 Botanicals and semiochemicals: definitions for a concept in evolution 10.2 Risk assessment 10.3 Pheromones 10.4 Botanicals and plant allelochemicals 10.5 Conclusion 10.6 References 11 Risks of invertebrate biological control agents - Harmonia axyridis as a case study 11.1 Benefits and risks of biological control 11.2 Harmonia axyridis as a model high risk biological control agent 11.3 Concluding remarks 11.4 References Proposals for Balanced Regulation Procedures 12 Facilitations in the regulation of plant protection products containing baculoviruses 12.1 Introduction 12.2 The OECD consensus document 12.3 Genetic composition of baculovirus isolates 12.4 Potential risks from plant protection products containing baculoviruses 12.5 Current regulatory situation in the EU 12.6 Proposal for facilitated regulation of baculoviruses as active ingredients in plant protection products 12.7 Data Protection 12.8 Remark on genetically modified baculoviruses 12.9 Regulatory situation 12.10 Proposal on threshold levels for microbial contaminations in baculovirus products 13 Proposals for bacterial and fungal biocontrol agents 13.1