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市場調查報告書

全球生物農藥法規

Agrow Global Biopesticide Regulations 2018

出版商 AGROW 商品編碼 340861
出版日期 內容資訊 英文 270 Pages
商品交期: 最快1-2個工作天內
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全球生物農藥法規 Agrow Global Biopesticide Regulations 2018
出版日期: 2018年04月01日 內容資訊: 英文 270 Pages
簡介

本報告以全球生物農藥的法律規範為研究主題,提供各國的法規、登記、核准系統,課題及未來預測等相關的系統性資訊。

第1章 簡介

第2章 生物農藥法規:各產品類型

  • 摘要
  • 簡介
  • 微生物
  • 生物化學
  • 半化學
  • 廣管瓶
  • 其他

第3章 生物農藥法規:國際企業/方案

  • 摘要
  • 簡介
  • OECD
  • UN FAO/WHO
  • UNEP/CBD
  • IPPC
  • IOBC/WPRS
  • EPPO
  • 生物控制產業團體
  • 有機組織

第4章 生物農藥法規:國內企業/方案

  • 美國
  • 加拿大
  • EU
  • 法國
  • 荷蘭
  • 英國
  • 匈牙利
  • 澳洲
  • 中國
  • 印度
  • 日本
  • 巴西
  • 智利
  • 南非
  • 肯亞
  • 摩洛哥

第5章 結論:課題,機會,未來預測

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目錄
Product Code: 87547

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.

Table of Contents

Contents

Contents 1

Executive Summary 11

Chapter 1: Introduction 15

1.1Summary 15

1.2Definitions and scope 15

1.3The biopesticide market - global overview 18

1.4Current and emerging approaches to regulation 24

1.5Resources and references 25

Chapter 2: Biopesticide regulation - by product type 26

2.1Summary 26

2.2Introduction 26

2.3Microbials 27

    • 2.3.1 Market overview 27
    • 2.3.2 Current and emerging regulatory practice 28
      • 2.3.2.1 US 29
      • 2.3.2.2 EU 31
      • 2.3.2.3 OECD 34
    • 2.3.3 Key regulatory challenges 34

2.4Biochemicals 37

    • 2.4.1 Market overview 37
    • 2.4.2 Current and emerging regulatory practice 38
      • 2.4.2.1 US 38
      • 2.4.2.2 EU 39
      • 2.4.2.3 OECD 41
    • 2.4.3 Key regulatory challenges 41

2.5Semiochemicals 41

    • 2.5.1 Market overview 41
    • 2.5.2 Current and emerging regulatory practice 42
      • 2.5.2.1 US 42
      • 2.5.2.2 EU 43
      • 2.5.2.3 OECD 44
    • 2.5.3 Key regulatory challenges 45

2.6Macrobials 46

    • 2.6.1 Market overview 46
    • 2.6.2 Current and emerging regulatory practice 46
    • 2.6.3 Key regulatory challenges 48

2.7Others 48

    • 2.7.1 Plant-Incorporated Protectants (PIPs) 48
    • 2.7.2 Plant biostimulants 49
    • 2.7.3 Emerging genetic technologies 51

2.8References and resources 54

Chapter 3: Biopesticide regulation - International players/schemes 56

3.1Summary 56

3.2Introduction 56

3.3OECD 56

3.4UN FAO/WHO 58

3.5UNEP/CBD - Nagoya Protocol and ABS 59

3.6The International Plant Protection Convention (IPPC) 60

3.7International Organisation for Biological Control (IOBC)/Western Palearctic Region Society (WPRS) 61

3.8EPPO 61

3.9Biocontrol industry associations 62

3.10Organic organisations 63

    • 3.10.1 Codex Alimentarius (FAO, UN, WHO) 63
    • 3.10.2 International Organisation for Standardisation (ISO) 64
    • 3.10.3 The International Federation of Organic Agriculture Movements (IFOAM) 65
    • 3.10.4 EU Law on Organic Agriculture 66
    • 3.10.5 Global Organic Market Access (GoMa) Project 67

3.11References and resources 68

Chapter 4: Biopesticide Regulation - National Players/Schemes 69

4.1United States 69

    • 4.1.1 Summary 69
    • 4.1.2 Introduction 69
    • 4.1.3 Legislation and administration 71
      • 4.1.3.1 Microbials, biochemicals and PIPs 72
      • 4.1.3.2 Macrobials 74
    • 4.1.4 Registration process, key data requirements and guidance documents 75
      • 4.1.4.1 Microbials, biochemical and PIPs 75
      • 4.1.4.2 Macrobials 85
    • 4.1.5 Regulatory issues and challenges 86
    • 4.1.6 Registered products 88
    • 4.1.7 Related support initiatives 88
      • 4.1.7.1 National initiatives 88
      • 4.1.7.2 Industry associations 89
      • 4.1.7.3 Organic agriculture 90
      • 4.1.7.4 International co-operation 90
    • 4.1.8 References and resources 91

4.2Canada 92

    • 4.2.1 Summary 92
    • 4.2.2 Introduction 92
    • 4.2.3 Legislation and administration 94
    • 4.2.4 Registration process, key data requirements and guidance documents 95
      • 4.2.4.1 Microbials, semiochemicals and non-conventional chemcials 95
      • 4.2.4.2 Macrobials 101
    • 4.2.5 Regulatory issues and challenges 103
      • 4.2.5.1 Microbials, semiochemicals and non-conventional pest control products 103
      • 4.2.5.2 Macrobials 104
    • 4.2.6 Registered products 104
    • 4.2.7 Related support initiatives 105
    • 4.2.8 References and resources 107

4.3European Union 108

    • 4.3.1 Summary 108
    • 4.3.2 Introduction 108
    • 4.3.3 Legislation and administration 110
      • 4.3.4.1 Registration process 113
      • 4.3.4.2 Data requirements 115
      • 4.3.4.3 Guidance documents 119
      • 4.3.4.4 Fees and timelines 121
    • 4.3.5 Regulatory issues and challenges 121
    • 4.3.6 Registered products 125
    • 4.3.7 Related support initiatives 126
      • 4.3.7.1 Research and development programmes 126
      • 4.3.7.2 Industry associations 128
    • 4.3.8 References and resources 128

4.4France 129

    • 4.4.1 Summary 129
    • 4.4.2 Introduction 129
    • 4.4.3 Legislation and administration 132
    • 4.4.4 Registration process, key data requirements and guidance documents 135
      • 4.4.4.1 Microbials, chemical mediators and natural substances 135
      • 4.4.4.2 PNPPs 136
      • 4.4.4.3 Macrobials 137
    • 4.4.5 Regulatory issues and challenges 137
    • 4.4.6 Registered products 138
    • 4.4.7 Related support initiatives 139
      • 4.4.7.1 Agroecology Plan 139
      • 4.4.7.2 Public private sector partnerships: The Biocontrol Consortium 140
      • 4.4.7.3 Industry associations 140
    • 4.4.8 References and resources 141

4.5The Netherlands 141

    • 4.5.1 Summary 141
    • 4.5.2 Introduction 142
    • 4.5.3 Legislation and administration 143
      • 4.5.3.1 Microbials, semiochemicals and natural products 144
      • 4.5.3.2 Macrobials 144
    • 4.5.4 Registration process, key data requirements and guidance documents 144
      • 4.5.4.1 Microbials, semiochemicals and natural products 144
      • 4.5.4.2 Macrobials 147
    • 4.5.5 Regulatory issues and challenges 147
      • 4.5.5.1 Microbials, semiochemicals and natural products 147
      • 4.5.5.2 Macrobials 148
    • 4.5.6 Registered products 148
    • 4.5.7 Related support initiatives 149
      • 4.5.7.1 Multi-stakeholder partnerships 149
      • 4.5.7.2 Industry associations 150
      • 4.5.7.3 International co-operation 150
    • 4.5.8 References and resources 150

4.6United Kingdom 151

    • 4.6.1 Summary 151
    • 4.6.2 Introduction 152
    • 4.6.3 Legislation and administration 153
      • 4.6.3.1 Microbials, semiochemicals and plant extracts 153
      • 4.6.3.2 Macrobials 154
    • 4.6.4 Registration process, key data requirements and guidance documents 154
      • 4.6.4.1 Microbials, semiochemicals and plant extracts 154
      • 4.6.4.2 Macrobials 157
    • 4.6.5 Regulatory issues and challenges 157
      • 4.6.5.1 Microbials, semiochemicals and plant extracts 157
    • 4.6.6 Registered products 160
    • 4.6.7 Related support initiatives 161
      • 4.6.7.1 Public private sector partnerships 161
      • 4.6.7.2 Industry associations 163
      • 4.6.7.3 Organic agriculture 163
    • 4.6.8 References and resources 163

4.7Hungary 164

    • 4.7.1 Summary 164
    • 4.7.2 Introduction 165
    • 4.7.3 Legislation and administration 166
    • 4.7.4 Registration process, key data requirements and guidance documents 167
      • 4.7.4.1 Microbials, plants and plant extracts, pheromones 167
      • 4.7.4.2 Plant protection tools 167
      • 4.7.4.3 Macrobials 168
    • 4.7.5 Regulatory issues and challenges 168
    • 4.7.6 Registered products 169
    • 4.7.7 Related support initiatives 170
      • 4.7.7.1 Organic agriculture 170
    • 4.7.8 References and resources 170

4.8Australia 171

    • 4.8.1 Summary 171
    • 4.8.2 Introduction 171
    • 4.8.3 Legislation and administration 172
      • 4.8.3.1 Agricultural biological products 173
      • 4.8.3.2 Macrobials 174
    • 4.8.4 Registration process, key data requirements and guidance documents 174
      • 4.8.4.1 Agricultural biological products 174
      • 4.8.4.2 Macrobials 174
    • 4.8.5 Regulatory issues and challenges 175
    • 4.8.6 Registered products 177
    • 4.8.7 References and resources 177

4.9China 178

    • 4.9.1 Summary 178
    • 4.9.2 Introduction 178
    • 4.9.3 Legislation and administration 180
    • 4.9.4 Registration process, key data requirements and guidance documents 184
    • 4.9.5 Regulatory issues and challenges 189
    • 4.9.6 Registered products 189
    • 4.9.7 Related support initiatives 190
    • 4.9.8 References and resources 191

4.10India 191

    • 4.10.1 Summary 191
    • 4.10.2 Introduction 192
    • 4.10.3 Legislation and administration 193
      • 4.10.3.1 Microbials, semiochemicals and botanicals 193
      • 4.10.3.2 Macrobials 194
    • 4.10.4 Registration process, key data requirements and guidance documents 194
      • 4.10.4.1 Microbials, semiochemicals and plant extracts 194
      • 4.10.4.2 Macrobials 196
    • 4.10.5 Regulatory issues and challenges 197
      • 4.10.5.1 Microbials, semiochemicals and plant extracts 197
      • 4.10.5.2 Macrobials 197
    • 4.10.6 Registered products 198
    • 4.10.7 Related support initiatives 199
      • 4.10.7.1 Central and State Government programmes 199
      • 4.10.7.2 Organic Farming - National Program for Organic Production (NPOP) 200
      • 4.10.7.3 Industry associations 200
    • 4.10.8 References and resources 201

4.11Japan 201

    • 4.11.1 Summary 201
    • 4.11.2 Introduction 202
    • 4.11.3 Legislation and administration 203
    • 4.11.4 Registration process, key data requirements and guidance documents 204
    • 4.11.5 Regulatory issues and challenges 207
    • 4.11.6 Registered products 207
    • 4.11.7 Related support initiatives 208
      • 4.11.7.1 Industry associations 208
    • 4.11.8 References and resources 208

4.12Brazil 208

    • 4.12.1 Summary 208
    • 4.12.2 Introduction 209
    • 4.12.3 Legislation and administration 210
    • 4.12.5 Regulatory issues and challenges 215
    • 4.12.6 Registered products 216
    • 4.12.7 Related support initiatives 217
      • 4.12.7.1 National initiatives 217
      • 4.12.7.2 Industry associations 217
      • 4.12.7.3 Organic agriculture 218
    • 4.12.8 References and resources 218

4.13Chile 219

    • 4.13.1 Summary 219
    • 4.13.2 Introduction 219
    • 4.13.3 Legislation and administration 220
    • 4.13.4 Registration process, key data requirements and guidance documents 221
    • 4.13.5 Regulatory issues and challenges 223
    • 4.13.6 Registered products 224
    • 4.13.7 Related support initiatives 225
      • 4.13.7.1 National initiatives 225
    • 4.13.8 References and resources 225

4.14South Africa 226

    • 4.14.1 Summary 226
    • 4.14.2 Introduction 227
    • 4.14.3 Legislation and administration 229
    • 4.14.4 Registration process, key data requirements and guidance documents 229
    • 4.14.5 Regulatory issues and challenges 235
    • 4.14.6 Registered products 236
    • 4.14.7 Related support initiatives 237
      • 4.14.7.1 Industry associations 237
    • 4.14.8 References and resources 237

4.15Kenya 238

    • 4.15.1 Summary 238
    • 4.15.2 Introduction 239
    • 4.15.3 Legislation and administration 240
    • 4.15.4 Registration process, key data requirements and guidance documents 242
      • 4.15.4.1 Import and export of microbials and macrobials 242
      • 4.15.4.2 Application to register a biopesticide 243
      • 4.15.4.3 Fees and timelines 246
    • 4.15.5 Regulatory issues and challenges 246
    • 4.15.6 Registered products 247
    • 4.15.7 Related support initiatives 248
      • 4.15.7.1 Public-private sector partnerships 248
      • 4.15.7.2 Industry associations 249
      • 4.15.7.3 Organic organisations 250
    • 4.15.8 References and resources 250

4.16Morocco 251

    • 4.16.1 Summary 251
    • 4.16.2 Introduction 251
    • 4.16.3 Legislation and administration 252
    • 4.16.4 Registration process, key data requirements and guidance documents 253
      • 4.16.4.1 Microbials 254
      • 4.16.4.2 Plant extracts 254
      • 4.16.4.3 Pheromones 254
    • 4.16.5 Regulatory issues and challenges 254
    • 4.16.6 Registered products 254
    • 4.16.7 Related support initiatives 255
      • 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). 255
      • 4.16.7.2 Organic farming 255
    • 4.16.8 References and resources 256

Chapter 5: Conclusions: Challenges, opportunities and future prospects 257

Appendices 263

List of Tables

Table 1: Classification of biopesticides by active ingredient 16

Table 2: Definitions and scope of biopesticide categories recognised under different

regulatory jurisdictions 17

Table 3: Significant partnerships and acquisitions in the biopesticides sector 22

Table 4: OECD seminars and workshops related to biopesticides 58

Table 5: Definition and characteristics of key biopesticide categories in the US 70

Table 6: Regulatory authorities and key legislation governing biopesticides 72

Table 7: U.S. Oversight of Plant-Incorporated Protectants 73

Table 8: Key guidance documents supporting research and registration of biopesticides 78

Table 9: Biopesticides registered in USA (active substances) 88

Table 10: Definitions and characteristics of key biopesticide categories in Canada 93

Table 11: Regulatory authorities and key legislation governing biopesticides in Canada 94

Table 12: Key guidance documents supporting research and registration of biopesticides 97

Table 13: Biopesticides registered in Canada for commercial use 105

Table 14: Definitions and characteristics of key biopesticide categories in EU 109

Table 15: Key EU legislation governing biopesticides 110

Table 16: Revised low risk criteria for active substances other than microorganisms 117

Table 17: Revised low risk criteria for active substances which are microorganisms 118

Table 18: 'Basic' substances and products - criteria and derogations 118

Table 19: Key guidance documents supporting research and registration of biopesticides 120

Table 20: Problems with procedures for low risk active substances and products 122

Table 21: Biopesticide active substances approved in the EU 126

Table 22: Official definitions and key characteristics of key biopesticide categories in France 131

Table 23: Official definitions of preparation naturelle peu preocuppante (PNPP) 132

Table 24: Key regulatory bodies and legislation governing biopesticides in France 133

Table 25: Criteria for inclusion on official list of biocontrol products 134

Table 26: Comparison of administrative fees for different types of application 136

Table 27: Biopesticides registered in France for commercial use 139

Table 28: Key regulatory bodies and legislation governing biopesticides in the Netherlands 143

Table 29: Biopesticides registered in the Netherlands for commercial use 148

Table 30: Definitions and characteristics of key biopesticide categories in the United Kingdom 152

Table 31: Key UK regulatory bodies and legislation governing biopesticides 153

Table 32: Key guidance documents supporting research and registration of biopesticides 155

Table 33: Biopesticides approved in the UK for commercial use (1 Nov 2017) 161

Table 34: Key regulatory bodies and legislation governing biopesticides in Hungary 167

Table 35: Biopesticides registered in Hungary for commercial use 169

Table 36: Definitions and characteristics of key biopesticide categories in Australia 172

Table 37: Key regulatory bodies and legislation governing biopesticides in Australia 173

Table 38: Biopesticides registered in Australia for commercial use 177

Table 39: Definitions and characteristics of key biopesticide categories in China 179

Table 40: Key regulatory bodies and legislation governing biopesticides 180

Table 41: Comparison of registration requirements for chemicals and biopesticides 187

Table 42: Specific data requirements for microbial pesticides 187

Table 43: Specific data requirements for botanicals in China 188

Table 44: Specific data requirements for biochemical pesticides 188

Table 45: Biopesticides approved in China for commercial use 190

Table 46: Key regulatory bodies and legislation governing biopesticides in India 193

Table 47: Key guidance documents supporting research and registration of biopesticides in India 195

Table 48: Biopesticide active substances approved in India for commercial use 198

Table 49: Definitions and characteristics of key biopesticide categories in Japan 202

Table 50: Key regulatory bodies and legislation governing biopesticides 203

Table 51: Key guidance documents supporting research and registration of biopesticides in Japan 205

Table 52: Biopesticide active substances approved in Japan for commercial use 208

Table 53: Definitions and characteristics of key biopesticide categories in Brazil 210

Table 54: Key regulatory bodies and legislation governing biopesticides in Brazil 211

Table 55: Key guidance documents supporting research and registration of biopesticides in Brazil 212

Table 56: Biological pesticides registered in Brazil for commercial use 216

Table 57: Definitions and characteristics of key biopesticide categories in Chile 220

Table 58: Regulatory authorities and key legislation governing biopesticides in Chile 220

Table 59: Biopesticides registered in Chile for commercial use 224

Table 60: Definitions and characteristics of key biopesticide categories in South Africa 228

Table 61: Key regulatory bodies and legislation governing biopesticides in South Africa 229

Table 62: Key guidance documents supporting research and registration of biopesticides in South Africa 230

Table 63: Core data requirements for biopesticide registration 231

Table 64: Additional data requirements for registration of microbials 232

Table 65: Additional data requirements for registration of biochemical and semiochemicals 232

Table 66: Additional data requirements for registration of macro-organisms -

entomopathogenic nematodes 233

Table 67: Additional data requirements for registration of macro-organisms -

insects and other macrobials 233

Table 68: Biopesticides approved in South Africa for commercialisation 237

Table 69: Definitions and characteristics of key biopesticide categories in Kenya 240

Table 70: Regulatory authorities and key legislation governing biopesticides in Kenya 240

Table 71: Key guidance documents supporting research and registration of biopesticides 243

Table 72: Biopesticides approved in Kenya (October 2017) 247

Table 73: Key regulatory bodies and legislation governing biopesticides in Morocco 252

Table 74: Key guidance documents supporting registration of biopesticides in Morocco 253

Table 75: Biopesticides approved in Morocco for commercial use 255

Table 76: Numbers of biopesticide active substances registered by country/region 259

Table 77: Specific measures to promote and support successful biopesticide applications 260

Appendix 1: List of key (international) guidance documents and other useful references relating to the regulation of microbial pesticides 263

Appendix 2: List of key guidance documents and other useful references relating to the regulation of botanicals/biochemical pesticides 266

Appendix 3: List of key (international) guidance documents and other useful references relating to the regulation of semiochemicals 267

Appendix 4: List of key (international) guidance documents and other useful references relating to the regulation of invertebrate biological control agents 268

List of Figures

Figure 1: Evolution of biocontrol market (US$ bn) 19

Figure 2: Global biocontrol market by product type (US$ bn) 19

Figure 3: Global biocontrol market by product type (CAGR %) 20

Figure 4: Global biocontrol market by region (US$ bn) 20

Figure 5: Global biocontrol by region (CAGR %). 21

Figure 6: Global microbial biopesticide market showing breakdown by product subtype (US$bn) 27

Figure 7: Global biochemicals market 38

Figure 8: US Biopesticide Data requirements 79

Figure 9: Change in the numbers of biopesticide active substances and products registered in the UK between 2004 and 2017 (excluding macrobials). 160

Figure 10: Pesticide registration approval process - Ministry of Agriculture, China 185

Figure 11: Composition of Japanese biopesticides market, 2014 203

Figure 12: Registration process in Japan 204

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