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.”

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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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