plant biostimulants: emerging european legislative...

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.

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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


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


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


http://www.biostimulants.eu/

8 Corporate Affairs

New emerging EU Regulation structure:

current European Commission thinking


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


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



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



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 Nutrient + herbicide

Copper compounds Nutrient + fungicide

Sodium borate Nutrient + biocide

Trichoderma strains Fungicide + biostimulant


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



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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VALAGRO GROUP

WE ARE HERE



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



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/


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