justifying plant biostimulants claims for european regulation · 2020-02-18 · presentation...
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Justifying Plant Biostimulants Claims for
European Regulation
Manuele RicciChair of EBIC Agriculture
Committeeand
Agronomy Manager at Lallemand Plant Care
20 February 2020
AAPFCO Methods Forum
New Orleans, Louisiana
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European Biostimulants Industry Council
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Founded in June 2011
www.biostimulants.eu
@biostimulantsEU
…and still growingFounded in 2011
56 Member companies (2019)
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“Our mission in EBIC is
to ensure biostimulant technologies are valued as integral to sustainable agriculture,
while securing an enabling regulatory framework for all of them.”
Imp
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EBIC mid-term strategy 2019-2023Engagement & Implementation Pillars
Presentation overview
• Regulating plant biostimulants in Europe
– National regulations
– EU Fertilising Products Regulation (FPR) 2019/1009
– How harmonized European standards support the EU regulation
• EBIC guidelines for justifying claims for regulatory purposes
– Needs to fit into the framework for standards
– Should be differentiated from the broader use of claims justification for product development and commercialization
• Towards harmonized European standards on claims justification
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Biostimulants occupy a unique and newly recognised place in the spectrum of crop inputs
Until now, there have been 28 (27) different sets of requirements
for marketing biostimulants in the EU
→ From July 2022, producers can choose one single harmonized set of rules and requirements providing access
to all EU countries→ National regulations will continue to co-exist with the new EU
regulation (unless countries withdraw them)
Fertilizing Products
Regulation(FPR)
Benefits of biostimulants in the FPR
For Industry For farmers and other users
For environment & safety
CE-mark for all fertilising products and access to Single Market
Levelplaying field for farmers across the EU in terms of inputs
Defined safety thresholds
Reduced market distortion
Reduced market distortion for farmers
and evaluation based on common rules
Less administrative burden
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Fertilizing Products Regulation (FPR)
➢ Regulation (EU) 2019/1009 FPR published in July 2019, fully operational in July 2022
➢ Placing plant biostimulants on the market: ➢ Product Function Categories (PFCs) – Basic quality and safety
requirements➢ Component Material Categories (CMCs) – Basic safety
requirements (some criteria, some positive lists)➢ Conformity Assessment Process
➢ Methodologies for demonstrating conformity are elaboratedin harmonized standards➢ The Europe Standardization Committee (CEN) is
independent from the EU institutions➢ CEN TC 455 on Plant Biostimulants
PFC1Fertilizers
PFC 2Limingmaterials
PFC 3Soilimprovers
PFC 4Growing media
PFC 5Agronomic additives / inhibitors
PFC 6 Bio-stimulants
PFC 7Combinations
“Fertilising products” comprise7 Product Function Categories (PFCs)
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The FPR uses a functional definition of plant biostimulants
EU fertilising product the function of which is to stimulate plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere:
(a) nutrient use efficiency,
(b) tolerance to abiotic stress,
(c) quality traits, or
(d) availability of confined nutrients in the soil or rhizosphere.
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Conformity assessment process (not a registration like pesticides)
Type examination by Conformity Assessment Body (CAB)*
• Description of the formulation of the product (i.e. list of ingredients)
• Where appropriate information about raw materials
• List of harmonized standards applied
• Test reports
• Product samples
• Other supporting documentation
•For each relevantcriterion, the CAB confirms an acceptable value is reported and thatmethods are reliable• If all the criteria are satisfied, the CAB authorises the use of the CE-Mark
Internal production control by producer
• Monitoring and control to ensure that products are in conformity with the approved type
• Self-certification of products by affixing the CE-mark and providing certificates of conformity
*Also called a Notified Body
No national authorization is needed for a product that is CE-marked. Companies can submit their dossiers to any CAB, even if it is not in the main market they want to target.
Only for use inside EBIC member companies
Harmonized European Standards indicate what constitutes compelling evidence
Plant Biostimulants “shall have effects that are claimed on the label”
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The conformity assessment dossier should include evidence of the product’s effects
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The concept of a product in EU regulation
Product
Includes all the ingredients
in their relative
concentrations and obtained
through a specificprocess
Preparation + claim(s) + application rate + timing + target crops + other relevant parameters
Preparation
Ingredient
Could be combined with a diversity of other ingredients and involved in different functions in different products
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EBIC has been developing guidelinesfor justifying claims for regulatory
purposes for 2+ years
Common experimental framework on HOW to demonstrate a biostimulant effect
“Agronomic case studies” help demonstrate boundaries between product categories in stakeholder communications
Trial protocols will help to demonstrate the biostimulanteffects
Justified effects will notbe observed under all conditions because of influencing factors
5 EBIC guidelines
to demonstrate
CLAIMS
Underlying principles(see next slides)
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Underlying Principles to Justify a Biostimulant
Claim: Data
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1. Existing data can justify a claim
2. New data should comply with acceptable Experimental Quality Criteria
3. Agronomic relevance i.e.: yield improvement, must demonstrate a biologically relevant agronomic trend
1. Existing Data
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Existing experimental data OK
Apply “Klimischscore” to indicate reliability
Supporting information
Non-EU experimental data under similar geo-
climatic conditions
Published literature (Klimisch score also
applies)
Reference: Klimisch et al. (1997)
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Klimisch Scoring System
Score Description
1 Reliable without restriction
2 Reliable with restriction
3 Not reliable
4 Not assignable
Only 1 and 2 can be used.
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Klimisch Scoring System
Score Description
1 Reliable without restriction
2 Reliable with restriction
3 Not reliable
4 Not assignable
Only 1 and 2 can be used.
Assignment Criteria in UICLID
Guideline study (preferably performed according to GLP)
Comparable to guideline study
Test procedure in accordance with national standard methods
Test procedure in accordance with generally accepted scientific standards and described in detail
2. New Data
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“Acceptable experimental
quality criteria”
Type of information that
can support claims
Common experimental framework
Qualifications of Study Personnel
Study Plan
Who did What, When,
and Why
3. Agronomic relevance
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EBIC’s Agriculture Committee is currently discussing the respective roles of agronomic trends versus and statistical significance when justifying claims. This topic will be discussed in-depth at an internal workshop on 1 April
• Having solid data on product effects doesn’t matter if it makes no contribution to real farmer value
• However, value is sometimes only measurable under certain conditions (i.e. the effects of increased root growth on water uptake may only be visible where water is restricted)
Underlying Principles to Justify a Biostimulant
Claim: Number of Trials
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Crops Number of trials per 1 CLAIM
1 crop 3 trials
1 group 6 trials (3 in 2 crops or 3 in 2 crops)
All crops 12 trials (3 in 4 different groups)
CROP GROUPS
1. Cereals (wheat, barley, oat, rice, minor grains) and corn
2. Pulses and oilseeds
3. Tree fruit, nuts, and olive
4. Grape (wine and table)
5. Other soft fruit and vegetables (all leafy, fruiting and root vegetables, and leguminosae)
6. All others [loam (turf), ornamentals, and mushrooms, etc.]
→Controlled conditions should be combined with open-field conditions to isolate the biostimulanteffect
→A common, yet flexible, experimental framework is required so that we know the results are credible
How can we make sure our results are relevant in the field and make scientific sense?
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Label claims should be supported by appropriate data of acceptable experimental quality…
Label Claim Supporting Data
“Increases root growth”
Increased root growth demonstrated (in controlled conditions and/or in the field)
“Improves yield” Yield data indicating an increased yield trend, preferably in open-field conditions
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…measured by appropriate parameters
Example: stress tolerance
✓The study of specific parameters in controlled conditions (laboratory, greenhouse, growth chamber) can demonstrate that a specific stress exists and that a biostimulant is improving tolerance to that stress
(Stress tolerance can be harder to demonstrate in the field because it is impossible to isolate the stress variable, let alone to predict it to conduct the experiment at the right time)
• A heat tolerance claim should be supported by parameters that demonstrate:
– The accumulation of stress protective proteins and/or osmolytes
– Changes in phenotype (such as plant growth, fruit set, and/or pollen viability).
– Photosynthesis and antioxidant system evaluation (desirable but not conclusive)*.
* according to current scientific bibliography
Example: Framework for a Heat Stress claim
Specificity of method versus claim
Possible method
General Phenotype (biomass/yield)
General Photosynthesis (SPAD Fv/Fm, …)
General Antioxidant enzymes
General Osmolytes (soluble sugars and proline accumulation)
Specific Cell membrane integrity (MDA accumulation)
Very Specific Gene expression/Western blotting (stress protectant proteins (LEAs, HSPs)
general
specific
30Fv/Fm chlorophyll fluorescence: Fv = F max-Fmin; Fm = F maxSPAd = chlorophyll content
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• Plant biostimulants – Claims – part 1: General principles
• Claims – Part X: Nutrient use efficiency resulting from the use of plant
biostimulants
• Claims – Part X: Tolerance to abiotic stress resulting from the use of
plant biostimulants
• Claims – Part X: Determination of quality traits, resulting from the use
of plant biostimulants
• Claims – Part X: Determination of availability of confined nutrients in
the soil and or rhizosphere
Only for use inside EBIC member companies
Harmonized standards that are expected to be developed for plant biostimulants by WG 2*
* Subject to confirmation when the COM Request for Standards is published
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The EBIC guidelines are our contribution to
the elaboration of Harmonized European
Standards for justifying claims
EBIC’s Role in Standardization
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→ EBIC coordinates industrial input into standardization by offering a forum for companies to discuss related issues
→ EBIC identifies appropriate existing standards and best practices that can be adapted to fulfill the regulator’s request
→ EBIC identifies additional issues that would benefit from standardisation to foster harmonization beyond Europe
Many of the national experts involved in CEN TC 455 and its 5 Working Groups work for EBIC member companies.
Together with other stakeholders, they develop appropriate technical standards for plant biostimulants based on best practices which can then be used to justify product claims.
CEN/TC 455 “Plant Biostimulants and Agricultural Micro-Organisms”
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❑ Analytical methods will be standardized to ensure comparability of results regarding contaminants, minimum content, etc.
❑ Methodologies for making and justifying claims provided will be standardized to ensure verifiability of claims and to help users interpret claims.
❑ List of labelling requirements in the regulation will be complemented by guidelines from the European Commission and standards.
CEN/TC 455 “Plant Biostimulants and Agricultural Micro-Organisms”
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• WG 1 – Sampling
• WG 2 – Claims
• WG 3 – Pathogenic and Non-Pathogenic
Microorganisms
• WG 4 – Other Safety Parameters
• WG 5 – Labelling and Terms
• Justifying claims with the use of a combination of controlled and open-field conditions can successfully demonstrate to regulators that plant biostimulants make a difference and provide added value to the farmer and the crop
• Standards can define a common experimental framework to show that the claim is credible
• The Harmonized European Standards currently under development to support the implementation of the EU Fertilising Products Regulation include several on justifying claims for plant biostimulants
Conclusion
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• Publication
– This presentation was based on a peer-reviewed article drafted by EBIC experts and published in Frontiers Plant Science5
(Ricci M, Tilbury L, Daridon B, Sukalac K. (2019) General Principles to Justify Plant Biostimulant Claims. Frontiers in Plant Science Vol 10: 494)
• Acknowledgements
– EBIC would like to thank all the co-authors of our paper:
Lorraine Tilbury, Bruno Daridon & Kristen Sukalac
– EBIC would also like to thank the members of the EBIC Agriculture Committee and all its current and past members.
Publication & Acknowledgements
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