Global Biostimulants Regulations - 2016: Legislation, Registration Process, Data Requirements and Guidance Documents, Regulatory Issues and Challenges, Registered Products

  • ID: 4330571
  • Report
  • Region: Global
  • 177 pages
  • Agrow
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This unique Global Biostimulant Regulations 2016 study examines how regulatory frameworks for biostimulants are evolving in significant markets around the world.

It reveals the complexity and dynamism of the global regulatory picture, and highlights how regulatory uncertainty is perhaps the single largest constraint to future growth of the biostimulant sector.

The existing regulatory landscape is fragmented and contradictory. Biostimulant products are entirely unregulated in some countries, classified as fertilisers in others, and treated as plant protection products elsewhere.

However, while estimates of market size vary widely, it is broadly agreed that the market is growing rapidly - in 2015, global sales were around US$1.4bn and are projected to reach US$2.9bn by 2021 with a CAGR of 10 to 12%.

Primary growth drivers for the biostimulant market include political and societal pressure to promote high-performance sustainable agriculture; an increasingly tough regulatory climate for conventional chemical inputs; improvement in product efficacy and reliability; new product innovations; and market expansion beyond traditional niche sectors to conventional agricultural field crops.

The entry of multinationals has significantly improved market access and expansion through faster product commercialisation, increased R&D investment, and more effective technology transfer to growers. It has also brought discipline and increased professionalism, which has helped to improve the sector’s credibility.

This report highlights the dynamic tension between the need to ensure safety and, at the same time, promote the adoption of newer, safer technologies to ensure that useful products are available, controls are justified, and procedures are transparent.
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About the author
Disclaimer
Executive Summary
1. Introduction
1.1 Summary
1.2 Introduction
1.3 Definition and scope
1.4 The biostimulants market - global overview
1.5 Current and emerging approaches to regulation
1.6 References and resources

2. International players and schemes
2.1 Summary
2.2 Introduction
2.3 European Commission and Parliament
2.4 Trade Associations
2.4.1 The European Biostimulants Industry Council (EBIC)
2.4.2 Biostimulant Coalition (US and Canada)
2.5 Organic farming organisations and standards
2.5.1 Codex Alimentarius (FAO, UN, WHO)
2.5.2 International Organisation for Standardisation (ISO)
2.5.3 The International Federation of Organic Agriculture Movements (IFOAM)
2.5.4 EU Law on Organic Agriculture
2.5.5 Global Organic Market Access (GoMa) Project
2.6 References and resources

3. Biostimulants Regulation - National Players/Schemes
3.1 United States
3.1.1 Summary
3.1.2 Introduction
3.1.3 Legislation and administration
3.1.4 Registration process, key data requirements and guidance documents
3.1.5 Regulatory issues and challenges
3.1.6 Registered products
3.1.7 Related support activities
3.1.7.1 Industry associations
3.1.7.2 Natural Resources Conservation Service (NRCS) Agency
3.1.7.3 Organic agriculture
3.1.8 References and resources
3.2 Canada
3.2.1 Summary
3.2.2 Introduction
3.2.3 Legislation and administration
3.2.4 Registration process, key data requirements and guidance documents
3.2.5 Regulatory issues and challenges
3.2.6 Registered products
3.2.7 Related support initiatives
3.2.7.1 Industry Associations
3.2.8 References and resources
3.3 Spain
3.3.1 Summary
3.3.2 Introduction
3.3.3 Legislation and administration
3.3.3.1 Otros Medios de Defensa Fitosanitoria (OMDF).
3.3.3.2 Fertiliser regulation
3.3.4 Registration process, key data requirements and guidance documents
3.3.4.1 Medios de Defensa Fitosanitaria (MDF)
3.3.4.2 Fertilisers
3.3.5 Regulatory issues and challenges
3.3.6 Registered products
3.3.6.1 OMDF/MDF
3.3.6.2 Fertilisers
3.3.7 Related support initiatives
3.3.7.1 Spanish Association of Agronutrients Manufacturers (AEFA)
3.3.8 References and resources
3.4 Italy
3.4.1 Summary
3.4.2 Introduction
3.4.3 Legislation and administration
3.4.3.1 Plant biostimulants
3.4.3.2 Plant strengtheners
3.4.4 Registration process, key data requirements and guidance documents
3.4.4.1 Plant biostimulant products registered under fertiliser legislation
3.4.4.2 Plant strengthener products registered under organic farming legislation
3.4.5 Regulatory issues and challenges
3.4.6 Registered products
3.4.6.1 Products registered under fertiliser legislation
3.4.6.2 Products registered under organic farming legislation
3.4.7 Related support initiatives
3.4.8 References and resources
3.5 France
3.5.1 Summary
3.5.2 Introduction
3.5.3 Legislation and administration
3.5.3.1 Biostimulants classified as agronomic additives
3.5.3.2 Biostimulants classified as natural preparations of low concern (PNPP)
3.5.4 Registration process, key data requirements and guidance documents
3.5.4.1 Biostimulants classified as agronomic additives
3.5.4.2 Biostimulants classified as PNPPs
3.5.5 Regulatory issues and challenges
3.5.6 Registered products
3.5.7 Related support initiatives
3.5.7.1 Agroecology Plan
3.5.8 References and resources
3.6 Germany
3.6.1 Summary
3.6.2 Introduction
3.6.3 Legislation and administration
3.6.3.1 Plant strengtheners
3.6.3.2 Plant aid agents and soil improvers
3.6.4 Registration process, key data requirements and guidance documents
3.6.4.1 Plant strengtheners
3.6.4.2 Plant aid agents and soil improvers
3.6.5 Regulatory issues and challenges
3.6.6 Registered products
3.6.6.1 Plant strengtheners
3.6.6.2 Plant aid agents and soil improvers
3.6.7 Related support initiatives
3.6.8 References and resources
3.7 Hungary
3.7.1 Summary
3.7.2 Introduction
3.7.3 Legislation and administration
3.7.4 Registration process, key data requirements and guidance documents
3.7.5 Regulatory issues and challenges
3.7.6 Registered products
3.7.7 Related support initiatives
3.7.7.1 Organic agriculture
3.7.7.2 Key university and other research projects
3.7.8 References and resources
3.8 United Kingdom
3.8.1 Summary
3.8.2 Introduction
3.8.3 Legislation and administration
3.8.4 Registration process, key data requirements and guidance documents
3.8.5 Regulatory issues and challenges
3.8.6 Registered products
3.8.7 References and resources
3.9 China
3.9.1 Summary
3.9.2 Introduction
3.9.3 Legislation and administration
3.9.4 Registration process, key data requirements and guidance documents
3.9.5 Regulatory issues and challenges
3.9.6 Registered products
3.9.7 Related support initiatives
3.9.7.1 Industry co-operation
3.9.8 References and resources
3.10 India
3.10.1 Summary
3.10.2 Introduction
3.10.3 Legislation and administration
3.10.4 Registration process, key data requirements and guidance documents
3.10.5 Regulatory issues and challenges
3.10.6 Registered products
3.10.7 Related support initiatives
3.10.7.1 National Project on Development and Use of Biofertilisers (NPDB)
3.10.7.2 Organic Farming - National Program for Organic Production (NPOP)
3.10.7.3 Industry Associations
3.10.8 References and resources
3.11 Japan
3.11.1 Summary
3.11.2 Introduction
3.11.3 Legislation and administration
3.11.3.1 Pesticide legislation
3.11.3.2 Fertiliser legislation
3.11.3.3 Organic farming legislation
3.11.4 Registration process, key data requirements and guidance documents
3.11.4.1 Pesticide registration (including plant growth regulators)
3.11.4.2 Fertiliser and soil improver registration
3.11.5 Regulatory issues and challenges
3.11.6 Registered products
3.11.7 Related support initiatives
3.11.7.1 Forum for Nuclear Cooperation in Europe (FNCA): Biofertiliser Project)
3.11.7.2 Production of biofertilisers
3.11.8 References and resources
3.12 Brazil
3.12.1 Summary
3.12.2 Introduction
3.12.3 Legislation and administration
3.12.3.1 Biofertilisers and inoculants
3.12.3.2 Plant growth regulators based on synthetic plant hormones
3.12.3.3 Organic legislation
3.12.4 Registration process, key data requirements and guidance documents
3.12.4.1 Biofertilisers and inoculants
3.12.4.2 Plant growth regulators
3.12.5 Regulatory issues and challenges
3.12.6 Related support initiatives
3.12.6.1 Associacao Brasileira das Industrias de Tecnologia em Nutricao Vegetal (ABISOLO) ([external URL]
3.12.6.2 Organic agriculture
3.12.7 References and resources
3.13 South Africa
3.13.1 Summary
3.13.2 Introduction
3.13.3 Legislation and administration
3.13.4 Registration process, key data requirements and guidance documents
3.13.4.1 General requirements
3.13.4.2 Additional requirements for microorganisms
3.13.4.3 Additional requirements for fulvic, humic, amino and other organic acids
3.13.4.4 Additional requirements for seaweed and products of plant and animal origin (other than those specified in section 3.13.4.3)
3.13.4.5 Label requirements
3.13.4.6 Fees
3.13.5 Regulatory issues and challenges
3.13.6 Registered products
3.13.7 References and resources
3.14 Egypt
3.14.1 Summary
3.14.2 Introduction
3.14.3 Legislation and administration
3.14.4 Registration process, key data requirements and guidance documents
3.14.5 Regulatory issues and challenges
3.14.6 Registered products
3.14.7 References and resources
3.15 Morocco
3.15.1 Summary
3.15.2 Introduction
3.15.3 Legislation and administration
3.15.4 Registration process, key data requirements and guidance documents
3.15.5 Regulatory issues and challenges
3.15.6 Registered products
3.15.7 Related support initiatives
3.15.7.1 EU-Morocco Action Plan on the Control of Plant Protection Products, Fertilisers and Growing media (Project No ENP!/2011/022-778).
3.15.7.2 Organic farming
3.15.8 References and resources
3.16 Israel
3.16.1 Summary
3.16.2 Introduction
3.16.3 Legislation and administration
3.16.4 Registration process, key data requirements and guidance documents
3.16.5 Regulatory issues and challenges
3.16.6 Registered products
3.16.7 References and resources
4. Conclusions: Challenges, opportunities and future prospects
4.1 The future looks bright
4.2 Regulatory challenges, opportunities and future prospects

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