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1 Corporate Affairs
Corporate Affairs
Plant Biostimulants: Emerging European
legislative Scenario
Sacramento, 28 July 2014
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 Corporate Affairs
Why a new regulation for Biostimulants ?
… as science progresses, the regulatory framework
needs to be modernised ?
VALAGRO GROUP Plant Biostimulants: Emerging European legislative Scenario
4 Corporate Affairs
VALAGRO GROUP
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
Plant Biostimulants: Emerging European legislative Scenario
5 Corporate Affairs
VALAGRO GROUP
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
Plant Biostimulants: Emerging European legislative Scenario
6 Corporate Affairs
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
VALAGRO GROUP Plant Biostimulants: Emerging European legislative Scenario
7 Corporate Affairs
11 members in June 2011 46 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
VALAGRO GROUP
AT A GLANCE EBIC: www.biostimulants.eu
Plant Biostimulants: Emerging European legislative Scenario
8 Corporate Affairs
New emerging EU Regulation structure:
current European Commission thinking
VALAGRO GROUP Plant Biostimulants: Emerging European legislative Scenario
9 Corporate Affairs
VALAGRO GROUP
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.
CURRENT EU WORKING DEFINITION OF
PLANT BIOSTIMULANTS
Plant Biostimulants: Emerging European legislative Scenario
10 Corporate Affairs
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
VALAGRO GROUP Plant Biostimulants: Emerging European legislative Scenario
11 Corporate Affairs
CROP PROTECTION FERTILISER
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”
Fertilisers, Soil
improvers, Liming
materials, Growing
media, and…
PROTECTION NUTRITION
BIOSTIMULANT
“« 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
»
BIOTIC STRESS ABIOTIC STRESS
CLAIM APPROACH
FROM PRODUCT TO SOLUTION
OPEN UP TO
EUROPE TO ALL
FERTILISER TYPES
VALAGRO GROUP Plant Biostimulants: Emerging European legislative Scenario
12 Corporate Affairs
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 )
VALAGRO GROUP Plant Biostimulants: Emerging European legislative Scenario
Substance Functional uses
Iron sulphate Nutrient + herbicide
Copper compounds Nutrient + fungicide
Sodium borate Nutrient + biocide
Trichoderma strains Fungicide + biostimulant
13 Corporate Affairs
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
VALAGRO GROUP Plant Biostimulants: Emerging European legislative Scenario
14 Corporate Affairs
DRAFT PROPOSAL
from
DG ENTERPRISE
REJECTION
NEW REG WILL NOT BE
ADOPTED
1° READING
of
EUROPEAN PARLIAMENT AND
COUNCIL
2° READING of
EUROPEAN PARLIAMENT
andCOUNCIL
CONCILIATION
28 EP member and 28 Member States
have
6 – 8 weeks to find an agreement
IMPLEMENTATION PERIOD
COUNCIL AGREE WITH EUROPEAN
PARLIAMENT
EUROPEAN PARLIAMENT NOT AGREE WITH COUNCIL
No Agreement
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01
6
VALAGRO GROUP
WE ARE HERE
Plant Biostimulants: Emerging European legislative Scenario
15 Corporate Affairs
VALAGRO GROUP
EU
Introduction of
legislation
As soon as possible (expected end 2016)
Definition Ensure clear distinction between Plant Biostimulants
and Plant Protection in emerging legislation
Innovation protection Data owned by a company should be protected
Authority Preferred: European Chemical Agency (ECHA)
Harmonisation Essential that national laws to be repealed. Include
post-marketing surveillance by individual MS
Dossier
completeness check
Reasonable time to market
Some Industry concerns for EU
Plant Biostimulants: Emerging European legislative Scenario
16 Corporate Affairs
VALAGRO GROUP
THANK YOU
FOR YOUR ATTENTION
Follow us on:
Valagro: www.valagro.com
EBIC: www.biostimulants.eu
European Commission: http://ec.europa.eu/enterprise/
Plant Biostimulants: Emerging European legislative Scenario