Plant Biostimulants: Emerging European legislative Scenario

Transcription

1 Plant Biostimulants: Emerging European legislative Scenario Sacramento, 28 July

2 The world of Valagro Today Valagro is a company with over 377 employees, 12 branches and a distribution network covering 80 countries worldwide, and 2013 turnover of around 90 million. A multicultural organization where PEOPLE are the most important resource, gifted with the most potential, and driven by energy and passion. 1

3 Why a new regulation for Biostimulants? as science progresses, the regulatory framework needs to be modernised? 3

4 What issues are there with the current system in EU? EUROPE TODAY- Fertilisers : two parallel systems 1. EC Fertiliser (Reg. 2003/2003) Inorganic NPK, Secondary, Micro-elements, Type designation substance-based (=rigid). No registration necessary, EU-wide No Biostimulant category 2. National legislations / specials (Italy D.Lgs. 75/2010; Spain RD 506/2013, 1470/2007, ) (languages!) the rest : organics, organo-minerals, amendments, ph correctives, some specials, biostimulants, strengtheners substance-based Different requirements from country to country Not same requirements for formulations, labelling, agronomic, analytical methods 4

5 EUROPE TODAY work in progress! 28 Member States regulating national Fertiliser types: National fertilisers subject to Mutual Recognition between Member States is slow and/or additional data is required The definition of a biostimulant (or equivalent, if exists) varies from one country to another Consequences for the sector: Higher costs than necessary Delays in placing products on the market, or abandoned investments 5

6 Authorities and Industry working together in order to create a truly European market for Plant Biostimulants (EBIC) Clear Biostimulant definition and category Clear distinction between Plant Protection, Biostimulants, Fertilisers Within Fertiliser Regulations framework Claim-based approach (Multi-use) Specific formulation, Dosage, Application method and Conditions of use Main effect (accepted, credible, documented biostimulant claim) Safe to use EU-wide + Proportionate registration procedure Predictable and reasonable time to market Innovation and data protection Value for farmer 6

7 AT A GLANCE EBIC: 11 members in June members today, and growing Milestones: Secured the place of biostimulants in the revised fertiliser regulation Negotiated a regulatory definition with EU authorities and other stakeholders Co-designed (with authorities) an innovative regulatory framework for ensuring safety and quality and fostering continuing innovation and competition Recognised as the global reference for the Biostimulant industry 7

8 New emerging EU Regulation structure: current European Commission thinking 8

9 CURRENT EU WORKING DEFINITION OF PLANT BIOSTIMULANTS Plant biostimulant means a material which contains substance(s) and/or microorganisms whose function when applied to plants or the rhizosphere is to stimulate natural processes to benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, and/or crop quality, independently of its nutrient content. 9

10 What is claim-based, rather than substance-based? biostimulants defined by what they do, not what they are 1. Substance-based approach: 1. Starting point: Legislation defines the chemistry 2. Categories have pre-defined characteristics, minima, 3. Pro: Assures safety, efficacy at beginning 4. Con: rigid, slow, expensive, lack protection, multi-use difficult 2. Claim-based approach: 1. Starting point: Legislation defines the effect of the applied product 2. Subsequent chemistry characterisation, safety generate 3. Pro: flexible, innovative, multi-use 10

11 CROP PROTECTION «influencing the life processes of plants, such as substances influencing their growth other than as nutrients or stimulating natural processes to benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress and/or crop quality» BIOSTIMULANT Plant biostimulant means a material which contains substance(s) and/or microorganisms whose function when applied to plants or the rhizosphere is to stimulate natural processes to benefit nutrient uptake, nutrient efficiency, tolerance to abiotic stress, and/or crop quality, independently of its nutrient content FERTILISER Fertilisers, Soil improvers, Liming materials, Growing media, and BIOTIC STRESS PROTECTION ABIOTIC STRESS CLAIM APPROACH FROM PRODUCT TO SOLUTION 11 OPEN UP TO EUROPE TO ALL FERTILISER TYPES NUTRITION

12 Multi use: adopted for new Regulation approach, for all categories Functional use (claim): Substances can be used and regulated for more than one purpose (multi-identity, multi-use, dual-use ) Substance Functional uses Iron sulphate Copper compounds Sodium borate Trichoderma strains Nutrient + herbicide Nutrient + fungicide Nutrient + biocide Fungicide + biostimulant 12

13 BASIC RULES TO ENTER THE MARKET 1. Prior authorisation (Registration) with Completeness check (not evaluation) to go to market required 2. Product + Claim + Company specific registration (protect innovation) a) group registrations of same products also possible (efficient) 3. EU-wide registration, with long registration period (ca. 15 years) 4. Dossier: a) Claim justification (efficacy) b) Safety dossier (Tier approach) c) Formulation characterisation, Analytical methods 13

14 VALAGRO GROUP DRAFT PROPOSAL from DG ENTERPRISE WE ARE HERE 1 READING of EUROPEAN PARLIAMENT AND COUNCIL COUNCIL AGREE WITH EUROPEAN PARLIAMENT 2 READING of EUROPEAN PARLIAMENT andcouncil IMPLEMENTATION PERIOD EUROPEAN PARLIAMENT NOT AGREE WITH COUNCIL CONCILIATION 28 EP member and 28 Member States have 6 8 weeks to find an agreement No Agreement 14 REJECTION NEW REG WILL NOT BE ADOPTED

15 Some Industry concerns for EU EU Introduction of legislation Definition Innovation protection Authority Harmonisation Dossier completeness check As soon as possible (expected end 2016) Ensure clear distinction between Plant Biostimulants and Plant Protection in emerging legislation Data owned by a company should be protected Preferred: European Chemical Agency (ECHA) Essential that national laws to be repealed. Include post-marketing surveillance by individual MS Reasonable time to market 15

16 THANK YOU FOR YOUR ATTENTION Follow us on: Valagro: EBIC: European Commission: 16