Global Biopesticide Regulations 2018

  • ID: 4534822
  • Report
  • Region: Global
  • 270 pages
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The report profiles 20 countries and examines 26 crops. The crop protection market of Africa is valued at US$2.6 billion. 77% of this market is made up of insecticides and herbicides. China supplies most of the crop protection products at 31% and India supplies 13%. The level of urbanisation of Africa is expected to increase to 50% by 2040 and this will lead to fundamental changes to the food system. Fresh and perishable goods including meat and vegetables will become more important. Crop protection will become vital as horticultural farmers work to increase yields and minimise damage to crops by insects, disease, and weed infestation.
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FEATURED COMPANIES

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Executive Summary

Chapter 1: Introduction
1.1 Summary
1.2 Definitions and scope
1.3 The biopesticide market - global overview
1.4 Current and emerging approaches to regulation
1.5 Resources and references

Chapter 2: Biopesticide regulation - by product type
2.1 Summary
2.2 Introduction
2.3 Microbials
2.3.1 Market overview
2.3.2 Current and emerging regulatory practice
2.3.2.1 US
2.3.2.2 EU
2.3.2.3 OECD
2.3.3 Key regulatory challenges
2.4 Biochemicals
2.4.1 Market overview
2.4.2 Current and emerging regulatory practice
2.4.2.1 US
2.4.2.2 EU
2.4.2.3 OECD
2.4.3 Key regulatory challenges
2.5 Semiochemicals
2.5.1 Market overview
2.5.2 Current and emerging regulatory practice
2.5.2.1 US
2.5.2.2 EU
2.5.2.3 OECD
2.5.3 Key regulatory challenges
2.6 Macrobials
2.6.1 Market overview
2.6.2 Current and emerging regulatory practice
2.6.3 Key regulatory challenges
2.7 Others
2.7.1 Plant-Incorporated Protectants (PIPs)
2.7.2 Plant biostimulants
2.7.3 Emerging genetic technologies
2.8 References and resources

Chapter 3: Biopesticide regulation - International players/schemes
3.1 Summary
3.2 Introduction
3.3 OECD
3.4 UN FAO/WHO
3.5 UNEP/CBD - Nagoya Protocol and ABS
3.6 The International Plant Protection Convention (IPPC)
3.7 International Organisation for Biological Control (IOBC)/Western Palearctic Region Society (WPRS)
3.8 EPPO
3.9 Biocontrol industry associations
3.10 Organic organisations
3.10.1 Codex Alimentarius (FAO, UN, WHO)
3.10.2 International Organisation for Standardisation (ISO)
3.10.3 The International Federation of Organic Agriculture Movements (IFOAM)
3.10.4 EU Law on Organic Agriculture
3.10.5 Global Organic Market Access (GoMa) Project
3.11 References and resources

Chapter 4: Biopesticide Regulation - National Players/Schemes
4.1 United States
4.1.1 Summary
4.1.2 Introduction
4.1.3 Legislation and administration
4.1.3.1 Microbials, biochemicals and PIPs
4.1.3.2 Macrobials
4.1.4 Registration process, key data requirements and guidance documents
4.1.4.1 Microbials, biochemical and PIPs
4.1.4.2 Macrobials
4.1.5 Regulatory issues and challenges
4.1.6 Registered products
4.1.7 Related support initiatives
4.1.7.1 National initiatives
4.1.7.2 Industry associations
4.1.7.3 Organic agriculture
4.1.7.4 International co-operation
4.1.8 References and resources
4.2 Canada
4.2.1 Summary
4.2.2 Introduction
4.2.3 Legislation and administration
4.2.4 Registration process, key data requirements and guidance documents
4.2.4.1 Microbials, semiochemicals and non-conventional chemcials
4.2.4.2 Macrobials
4.2.5 Regulatory issues and challenges
4.2.5.1 Microbials, semiochemicals and non-conventional pest control products
4.2.5.2 Macrobials
4.2.6 Registered products
4.2.7 Related support initiatives
4.2.8 References and resources
4.3 European Union
4.3.1 Summary
4.3.2 Introduction
4.3.3 Legislation and administration
4.3.4.1 Registration process
4.3.4.2 Data requirements
4.3.4.3 Guidance documents
4.3.4.4 Fees and timelines
4.3.5 Regulatory issues and challenges
4.3.6 Registered products
4.3.7 Related support initiatives
4.3.7.1 Research and development programmes
4.3.7.2 Industry associations
4.3.8 References and resources
4.4 France
4.4.1 Summary
4.4.2 Introduction
4.4.3 Legislation and administration
4.4.4 Registration process, key data requirements and guidance documents
4.4.4.1 Microbials, chemical mediators and natural substances
4.4.4.2 PNPPs
4.4.4.3 Macrobials
4.4.5 Regulatory issues and challenges
4.4.6 Registered products
4.4.7 Related support initiatives
4.4.7.1 Agroecology Plan
4.4.7.2 Public private sector partnerships: The Biocontrol Consortium
4.4.7.3 Industry associations
4.4.8 References and resources
4.5 The Netherlands
4.5.1 Summary
4.5.2 Introduction
4.5.3 Legislation and administration
4.5.3.1 Microbials, semiochemicals and natural products
4.5.3.2 Macrobials
4.5.4 Registration process, key data requirements and guidance documents
4.5.4.1 Microbials, semiochemicals and natural products
4.5.4.2 Macrobials
4.5.5 Regulatory issues and challenges
4.5.5.1 Microbials, semiochemicals and natural products
4.5.5.2 Macrobials
4.5.6 Registered products
4.5.7 Related support initiatives
4.5.7.1 Multi-stakeholder partnerships
4.5.7.2 Industry associations
4.5.7.3 International co-operation
4.5.8 References and resources
4.6 United Kingdom
4.6.1 Summary
4.6.2 Introduction
4.6.3 Legislation and administration
4.6.3.1 Microbials, semiochemicals and plant extracts
4.6.3.2 Macrobials
4.6.4 Registration process, key data requirements and guidance documents
4.6.4.1 Microbials, semiochemicals and plant extracts
4.6.4.2 Macrobials
4.6.5 Regulatory issues and challenges
4.6.5.1 Microbials, semiochemicals and plant extracts
4.6.6 Registered products
4.6.7 Related support initiatives
4.6.7.1 Public private sector partnerships
4.6.7.2 Industry associations
4.6.7.3 Organic agriculture
4.6.8 References and resources
4.7 Hungary
4.7.1 Summary
4.7.2 Introduction
4.7.3 Legislation and administration
4.7.4 Registration process, key data requirements and guidance documents
4.7.4.1 Microbials, plants and plant extracts, pheromones
4.7.4.2 Plant protection tools
4.7.4.3 Macrobials
4.7.5 Regulatory issues and challenges
4.7.6 Registered products
4.7.7 Related support initiatives
4.7.7.1 Organic agriculture
4.7.8 References and resources
4.8 Australia
4.8.1 Summary
4.8.2 Introduction
4.8.3 Legislation and administration
4.8.3.1 Agricultural biological products
4.8.3.2 Macrobials
4.8.4 Registration process, key data requirements and guidance documents
4.8.4.1 Agricultural biological products
4.8.4.2 Macrobials
4.8.5 Regulatory issues and challenges
4.8.6 Registered products
4.8.7 References and resources
4.9 China
4.9.1 Summary
4.9.2 Introduction
4.9.3 Legislation and administration
4.9.4 Registration process, key data requirements and guidance documents
4.9.5 Regulatory issues and challenges
4.9.6 Registered products
4.9.7 Related support initiatives
4.9.8 References and resources
4.10 India
4.10.1 Summary
4.10.2 Introduction
4.10.3 Legislation and administration
4.10.3.1 Microbials, semiochemicals and botanicals
4.10.3.2 Macrobials
4.10.4 Registration process, key data requirements and guidance documents
4.10.4.1 Microbials, semiochemicals and plant extracts
4.10.4.2 Macrobials
4.10.5 Regulatory issues and challenges
4.10.5.1 Microbials, semiochemicals and plant extracts
4.10.5.2 Macrobials
4.10.6 Registered products
4.10.7 Related support initiatives
4.10.7.1 Central and State Government programmes
4.10.7.2 Organic Farming - National Program for Organic Production (NPOP)
4.10.7.3 Industry associations
4.10.8 References and resources
4.11 Japan
4.11.1 Summary
4.11.2 Introduction
4.11.3 Legislation and administration
4.11.4 Registration process, key data requirements and guidance documents
4.11.5 Regulatory issues and challenges
4.11.6 Registered products
4.11.7 Related support initiatives
4.11.7.1 Industry associations
4.11.8 References and resources
4.12 Brazil
4.12.1 Summary
4.12.2 Introduction
4.12.3 Legislation and administration
4.12.5 Regulatory issues and challenges
4.12.6 Registered products
4.12.7 Related support initiatives
4.12.7.1 National initiatives
4.12.7.2 Industry associations
4.12.7.3 Organic agriculture
4.12.8 References and resources
4.13 Chile
4.13.1 Summary
4.13.2 Introduction
4.13.3 Legislation and administration
4.13.4 Registration process, key data requirements and guidance documents
4.13.5 Regulatory issues and challenges
4.13.6 Registered products
4.13.7 Related support initiatives
4.13.7.1 National initiatives
4.13.8 References and resources
4.14 South Africa
4.14.1 Summary
4.14.2 Introduction
4.14.3 Legislation and administration
4.14.4 Registration process, key data requirements and guidance documents
4.14.5 Regulatory issues and challenges
4.14.6 Registered products
4.14.7 Related support initiatives
4.14.7.1 Industry associations
4.14.8 References and resources
4.15 Kenya
4.15.1 Summary
4.15.2 Introduction
4.15.3 Legislation and administration
4.15.4 Registration process, key data requirements and guidance documents
4.15.4.1 Import and export of microbials and macrobials
4.15.4.2 Application to register a biopesticide
4.15.4.3 Fees and timelines
4.15.5 Regulatory issues and challenges
4.15.6 Registered products
4.15.7 Related support initiatives
4.15.7.1 Public-private sector partnerships
4.15.7.2 Industry associations
4.15.7.3 Organic organisations
4.15.8 References and resources
4.16 Morocco
4.16.1 Summary
4.16.2 Introduction
4.16.3 Legislation and administration
4.16.4 Registration process, key data requirements and guidance documents
4.16.4.1 Microbials
4.16.4.2 Plant extracts
4.16.4.3 Pheromones
4.16.5 Regulatory issues and challenges
4.16.6 Registered products
4.16.7 Related support initiatives
4.16.7.1 EU-Morocco Action Plan on the control of plant protection products, fertilisers and growing media (Project No ENP1/2011/022-778).
4.16.7.2 Organic farming
4.16.8 References and resources

Chapter 5: Conclusions: Challenges, opportunities and future prospects
  • Appendices
List of Tables
Table 1: Classification of biopesticides by active ingredient
Table 2: Definitions and scope of biopesticide categories recognised under different regulatory jurisdictions
Table 3: Significant partnerships and acquisitions in the biopesticides sector
Table 4: OECD seminars and workshops related to biopesticides
Table 5: Definition and characteristics of key biopesticide categories in the US
Table 6: Regulatory authorities and key legislation governing biopesticides
Table 7: U.S. Oversight of Plant-Incorporated Protectants
Table 8: Key guidance documents supporting research and registration of biopesticides
Table 9: Biopesticides registered in USA (active substances)
Table 10: Definitions and characteristics of key biopesticide categories in Canada
Table 11: Regulatory authorities and key legislation governing biopesticides in Canada
Table 12: Key guidance documents supporting research and registration of biopesticides
Table 13: Biopesticides registered in Canada for commercial use
Table 14: Definitions and characteristics of key biopesticide categories in EU
Table 15: Key EU legislation governing biopesticides
Table 16: Revised low risk criteria for active substances other than microorganisms
Table 17: Revised low risk criteria for active substances which are microorganisms
Table 18: ‘Basic’ substances and products - criteria and derogations
Table 19: Key guidance documents supporting research and registration of biopesticides
Table 20: Problems with procedures for low risk active substances and products
Table 21: Biopesticide active substances approved in the EU
Table 22: Official definitions and key characteristics of key biopesticide categories in France
Table 23: Official definitions of préparation naturelle peu préocuppante (PNPP)
Table 24: Key regulatory bodies and legislation governing biopesticides in France
Table 25: Criteria for inclusion on official list of biocontrol products
Table 26: Comparison of administrative fees for different types of application
Table 27: Biopesticides registered in France for commercial use
Table 28: Key regulatory bodies and legislation governing biopesticides in the Netherlands
Table 29: Biopesticides registered in the Netherlands for commercial use
Table 30: Definitions and characteristics of key biopesticide categories in the United Kingdom
Table 31: Key UK regulatory bodies and legislation governing biopesticides
Table 32: Key guidance documents supporting research and registration of biopesticides
Table 33: Biopesticides approved in the UK for commercial use (1 Nov 2017)
Table 34: Key regulatory bodies and legislation governing biopesticides in Hungary
Table 35: Biopesticides registered in Hungary for commercial use
Table 36: Definitions and characteristics of key biopesticide categories in Australia
Table 37: Key regulatory bodies and legislation governing biopesticides in Australia
Table 38: Biopesticides registered in Australia for commercial use
Table 39: Definitions and characteristics of key biopesticide categories in China
Table 40: Key regulatory bodies and legislation governing biopesticides
Table 41: Comparison of registration requirements for chemicals and biopesticides
Table 42: Specific data requirements for microbial pesticides
Table 43: Specific data requirements for botanicals in China
Table 44: Specific data requirements for biochemical pesticides
Table 45: Biopesticides approved in China for commercial use
Table 46: Key regulatory bodies and legislation governing biopesticides in India
Table 47: Key guidance documents supporting research and registration of biopesticides in India
Table 48: Biopesticide active substances approved in India for commercial use
Table 49: Definitions and characteristics of key biopesticide categories in Japan
Table 50: Key regulatory bodies and legislation governing biopesticides
Table 51: Key guidance documents supporting research and registration of biopesticides in Japan
Table 52: Biopesticide active substances approved in Japan for commercial use
Table 53: Definitions and characteristics of key biopesticide categories in Brazil
Table 54: Key regulatory bodies and legislation governing biopesticides in Brazil
Table 55: Key guidance documents supporting research and registration of biopesticides in Brazil
Table 56: Biological pesticides registered in Brazil for commercial use
Table 57: Definitions and characteristics of key biopesticide categories in Chile
Table 58: Regulatory authorities and key legislation governing biopesticides in Chile
Table 59: Biopesticides registered in Chile for commercial use
Table 60: Definitions and characteristics of key biopesticide categories in South Africa
Table 61: Key regulatory bodies and legislation governing biopesticides in South Africa
Table 62: Key guidance documents supporting research and registration of biopesticides in South Africa
Table 63: Core data requirements for biopesticide registration
Table 64: Additional data requirements for registration of microbials
Table 65: Additional data requirements for registration of biochemical and semiochemicals
Table 66: Additional data requirements for registration of macro-organisms - entomopathogenic nematodes
Table 67: Additional data requirements for registration of macro-organisms - insects and other macrobials Table 68: Biopesticides approved in South Africa for commercialisation
Table 69: Definitions and characteristics of key biopesticide categories in Kenya
Table 70: Regulatory authorities and key legislation governing biopesticides in Kenya
Table 71: Key guidance documents supporting research and registration of biopesticides
Table 72: Biopesticides approved in Kenya (October 2017)
Table 73: Key regulatory bodies and legislation governing biopesticides in Morocco
Table 74: Key guidance documents supporting registration of biopesticides in Morocco
Table 75: Biopesticides approved in Morocco for commercial use
Table 76: Numbers of biopesticide active substances registered by country/region
Table 77: Specific measures to promote and support successful biopesticide applications
  • Appendix 1: List of key (international) guidance documents and other useful references relating to the regulation of microbial pesticides
  • Appendix 2: List of key guidance documents and other useful references relating to the regulation of botanicals/biochemical pesticides
  • Appendix 3: List of key (international) guidance documents and other useful references relating to the regulation of semiochemicals
  • Appendix 4: List of key (international) guidance documents and other useful references relating to the regulation of invertebrate biological control agents
List of Figures
Figure 1: Evolution of biocontrol market (US$ bn)
Figure 2: Global biocontrol market by product type (US$ bn)
Figure 3: Global biocontrol market by product type (CAGR %)
Figure 4: Global biocontrol market by region (US$ bn)
Figure 5: Global biocontrol by region (CAGR %).
Figure 6: Global microbial biopesticide market showing breakdown by product subtype (US$bn)
Figure 7: Global biochemicals market
Figure 8: US Biopesticide Data requirements
Figure 9: Change in the numbers of biopesticide active substances and products registered in the UK between 2004 and 2017 (excluding macrobials).
Figure 10: Pesticide registration approval process - Ministry of Agriculture, China
Figure 11: Composition of Japanese biopesticides market, 2014
Figure 12: Registration process in Japan
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  • Bayer
  • SynGenta
  • BASF
  • Dow
  • DuPont
  • Monsanto
  • FMC
  • Hebang
  • Arysta
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