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A Legal Framework for Plant Biostimulants and Agronomic Fertiliser Additives

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A Legal Framework for Plant Biostimulants and Agronomic Fertiliser Additives Ref. Ares(2014)1712793 - 26/05/2014 A Legal Framework for Plant Biostimulants and Agronomic Fertiliser Additives in the EU Report for the European Commission Enterprise & Industry Directorate - General Contract n° 255/PP/ENT/IMA/13/1112420 January 2014 A Legal Framework for Plant Biostimulants and Agronomic Fertiliser Additives in the EU Report for the European Commission Enterprise & Industry Directorate - General Daniel Traon, Arcadia International Laurence Amat, Arcadia International Ferdinand Zotz, BiPRO Prof. Patrick du Jardin, Plant Biology Unit of Gembloux Agro-Biotech Correspondence to Daniel Traon; Email: [email protected] Disclaimer: The content of this report and the opinions expressed in this report are those of the authors and do not necessarily reflect the views of the European Commission. Contents Executive summary .................................................................................. vii 1 Introduction ........................................................................................ 1 1.1 Policy background ......................................................................... 2 1.2 Study objectives............................................................................ 3 1.3 Methodology ................................................................................. 3 1.4 Structure of this report .................................................................. 5 2 Context .............................................................................................. 7 2.1 Preliminary definitions and scope of the future regulation ................... 7 2.2 Industry description, business dynamics and future opportunities ........ 8 2.3 How are plant biostimulants and agronomic fertiliser additives currently placed to the market at EU/MS level? At international level? ....................... 15 2.4 What can be learned from comparable EU regulatory frameworks? ..... 28 2.4.1 General information ....................................................................................................... 29 2.4.4 The regulatory process and timing ................................................................................. 39 2.4.5 Data protection ............................................................................................................... 42 2.4.6 Confidentiality ................................................................................................................ 43 2.4.7 Data requirements .......................................................................................................... 43 2.4.8 Cost of registration ......................................................................................................... 54 3 Approach to a legal framework for plant biostimulants and agronomic fertiliser additives ..................................................................................... 59 3.1 Setting the scene: definitions of plant biostimulants and agronomic fertiliser additives, and their regulatory environment. ................................ 59 3.1.1 Definitions of plant biostimulants and of agronomic fertiliser additives in the future regulation ..................................................................................................................................... 59 3.1.2 Business and regulatory environments .......................................................................... 61 3.1.3 Who are the applicants? ................................................................................................. 63 3.2 General principles ......................................................................... 63 3.3 Data requirements ........................................................................ 65 3.3.1 Identification and characterisation ................................................................................. 65 3.3.2 Function, mode of action ................................................................................................ 69 3.3.3 Physico-chemical properties ........................................................................................... 70 A legal framework for plant biostimulants and agronomic fertiliser additives in the EU………………………………………………………………………………………………………………… i 3.3.4 Contaminants .................................................................................................................. 75 3.3.5 Manufacturing, quality control, and analytical methods ............................................... 77 3.3.6 Efficacy/utility ................................................................................................................. 79 3.3.7 Toxicology, ecotoxicology and environmental fate ........................................................ 83 3.4 Registration process and responsibilities .......................................... 94 3.5 Costs of implementation .............................................................. 105 Annex I: Cost of OECD test studies ........................................................... 108 Annex II: Comparison between EFSA and ECHA ......................................... 109 Annex III: Estimated application cost of an active substance based on a plant extract in the context of the Plant Protection Product Regulation (EC) No 1107/2009............................................................................................. 112 Annex IV: EBIC proposal: Guidance document for determining the number of trials needed .......................................................................................... 114 A legal framework for plant biostimulants and agronomic fertiliser additives in the EU………………………………………………………………………………………………………………… ii List of Tables Table 1 EBIC member companies business areas .......................................... 10 Table 2 Large agrochemical companies move into the biological industry ......... 11 Table 3 Comparison between the EU plant biostimulants and the agronomic fertiliser additives business sectors ............................................................. 15 Table 4 Registration process and data requirements for placing of PB on the market at EU and TC levels ........................................................................ 27 Table 5 Distribution of responsibilities ......................................................... 30 Table 6 Support to EU authorities in charge of risk assessment and risk management............................................................................................ 31 Table 7 Regulatory provisions related to dual use and borderline products ....... 33 Table 8 Type of authorisation issued by legislative sector .............................. 34 Table 9 Scope definition of the various sectorial legislations under analysis ...... 36 Table 10 Type of applicants per sectorial legislation ...................................... 38 Table 11 Data requirements addressing stability and homogeneity of substances/products during registration processes........................................ 46 Table 12 Safety assessment based on tiered approaches ............................... 48 Table 13 Post-authorisation obligations ....................................................... 53 Table 14 Registration fees ......................................................................... 55 Table 15 Registration costs for applicants .................................................... 56 Table 16 Costs for risk assessors for processing application dossiers in various regulatory fields ....................................................................................... 57 Table 17 Justification of the amendments to the definitions ............................ 60 Table 18 Physico-chemical data requirements for synthetised chemical products .............................................................................................................. 70 Table 19 Physico-chemical data requirements for non synthetised chemical products .................................................................................................. 74 Table 20 Advantages and disadvantages of the two options for the data requirements related to PB&AFA efficacy ..................................................... 82 Table 21 Summary of the toxicology, ecotoxicology and environmental fate data requirements ........................................................................................... 92 Table 22 Advantages and disadvantages of the two options for the completeness check process .......................................................................................... 97 Table 23 Summary of cost for registrant .................................................... 107 A legal framework for plant biostimulants and agronomic fertiliser additives in the EU………………………………………………………………………………………………………………… iii List of Figures Figure 1 Overall project workflow ................................................................ 5 Figure 2 EU & TC regulatory processes for placing of PB (and AFA) on the market .............................................................................................................. 26 Figure 3 Approach to data bridging ............................................................. 64 Figure 4 Approach to data bridging ............................................................. 69 Figure 5 The human and environmental safety tier approach .......................... 85 Figure 6 The registration process: from registration decision to
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