Plant biostimulants - Claims - Part 1: General principles

This EN specifies the general guidelines for trials used to justify the claims and the quality criteria which have to be used to carry out the trial.
The revised Regulation on fertilising products includes a new product function category plant biostimulants (PFC 6). For these products, it is obligatory to provide information about the effects claimed for each target plant and any relevant instructions related to the efficacy. Appropriate quality criteria and methodology to carry out the trial are necessary to check the conformity of CE marked plant biostimulants with the requirements of the FPR.  General principles need to be standardised in the framework of the SReq.
The proposed EN will allow the industry to fulfil the requirements stipulated in the FPR while helping governments and competent authorities' controls to monitor effectively compliance of the products. Consumers and environmental stakeholders will profit from the well-established uniform and reliable control of plant biostimulants applied to soil and crops.

Pflanzen-Biostimulanzien - Auslobungen - Teil 1: Allgemeine Grundsätze

Dieses Dokument legt die allgemeinen Grundsätze für die Begründung von Auslobungen zu Pflanzen-Biostimulanzien fest. Es gilt für alle Arten der Anwendung von Pflanzen-Biostimulanzien.
Allgemeine Grundsätze umfassen und definieren alle allgemeinen Parameter, Anforderungen und Qualitäts¬kriterien und sind zur Bewertung der Wirksamkeit von Versuchen vorgesehen, mit denen die Auslobung(en) nach Anwendung eines Pflanzen-Biostimulans validiert werden soll(en).
Dieses Dokument richtet sich in erster Linie an Hersteller, Labore, Forschungstätige, technische Zentren, Unternehmen, die die Produkte in Verkehr bringen werden, notifizierende Behörden, notifizierte Stellen und Marktüberwachungsbehörden.

Biostimulants des végétaux - Allégations - Partie 1 : Principes généraux

Le présent document spécifie les principes généraux permettant de justifier les allégations du produit pour les biostimulants des végétaux. Il s’applique à tous les types d’applications des biostimulants des végétaux.
Les principes généraux comprennent et définissent l’ensemble des paramètres généraux, des exigences et des critères de qualité, et sont destinés à être appliqués afin d’évaluer l’efficacité des essais mis en œuvre pour valider les allégations résultant de l’utilisation d’un biostimulant des végétaux.
Le présent document est principalement destiné aux fabricants, aux laboratoires, aux chercheurs, aux centres techniques, aux sociétés qui vont mettre les produits sur le marché, aux autorités notifiantes, aux organismes notifiés et aux autorités de surveillance du marché.

Rastlinski biostimulanti - Navedbe - 1. del: Splošna načela

General Information

Status
Not Published
Public Enquiry End Date
02-Jun-2023
Technical Committee
Current Stage
4020 - Public enquire (PE) (Adopted Project)
Start Date
21-Mar-2023
Due Date
08-Aug-2023
Completion Date
02-Jun-2023

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SLOVENSKI STANDARD
oSIST prEN 17700-1:2023
01-maj-2023
Rastlinski biostimulanti - Navedbe - 1. del: Splošna načela
Plant biostimulants - Claims - Part 1: General principles
Pflanzen-Biostimulanzien - Auslobungen - Teil 1: Allgemeine Grundsätze
Biostimulants des végétaux - Allégations - Partie 1 : Principes généraux
Ta slovenski standard je istoveten z: prEN 17700-1
ICS:
65.080 Gnojila Fertilizers
oSIST prEN 17700-1:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN 17700-1:2023

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oSIST prEN 17700-1:2023


DRAFT
EUROPEAN STANDARD
prEN 17700-1
NORME EUROPÉENNE

EUROPÄISCHE NORM

March 2023
ICS 65.080 Will supersede CEN/TS 17700-1:2022
English Version

Plant biostimulants - Claims - Part 1: General principles
Biostimulants des végétaux - Allégations - Partie 1 : Pflanzen-Biostimulanzien - Auslobungen - Teil 1:
Principes généraux Allgemeine Grundsätze
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 455.

If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard was established by CEN in three official versions (English, French, German). A version in any other
language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC
Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.

Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are
aware and to provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without
notice and shall not be referred to as a European Standard.


EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2023 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 17700-1:2023 E
worldwide for CEN national Members.

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Contents Page
European foreword . 4
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Type information that can be used to demonstrate efficacy of a claim. 8
4.1 General. 8
4.2 Field and/or protected crop experimental data. 8
4.3 Under controlled conditions (e.g. laboratory data, greenhouse, growth chamber) . 8
4.4 Literature review . 8
5 General guideline for trials/assays of plant biostimulants . 8
5.1 General. 8
5.2 Crop groupings for the performance of plant biostimulant trials . 8
5.3 Minimum number of trials to be provided . 11
5.4 Trial design and statistical analysis . 13
5.4.1 Control . 13
5.4.2 Minimum plot size . 14
5.4.3 Application rates . 15
5.4.4 Minimum number of replicates . 15
5.4.5 Minimum number of trials to define a trials series . 15
5.4.6 Controlled condition parameters . 15
5.4.7 Statistical analysis . 15
6 Terminology of crops on the label . 16
7 Quality Criteria . 17
7.1 General. 17
7.2 General criteria for trial conduction. 17
7.2.1 Identity of the organization in charge of trials . 17
7.2.2 Identity of the trial sites . 17
7.2.3 Staff . 17
7.2.4 Equipment . 18
7.2.5 Facilities . 18
7.3 Modes of operation. 18
7.3.1 General. 18
7.3.2 Verification of quality criteria . 18
7.3.3 Verification at the planning stage . 18
7.3.4 Verification during conduction of the trials . 18
8 Information to be collected in individual trials . 19
8.1 Experimental conditions . 19
8.1.1 Objective(s) of the trial and basic information on the trial site . 19
8.1.2 Trial conditions . 19
8.2 Application of the product . 19
8.3 Recording measurements . 20
8.4 Presentation of the results . 20
2

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Annex A (informative) P-value choice and impact on the results quality . 21
Annex B (informative) Plant biostimulant claim completeness check form . 22
Bibliography . 27

3

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European foreword
This document (prEN 17700-1:2023) has been prepared by Technical Committee CEN/TC 455 “Plant
biostimulants”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
This document will supersede CEN/TS 17700-1:2022.
prEN 17700-1:2023 includes the following significant technical changes with respect to
CEN/TS 17700-1:2022:
— Addition of some definitions;
— Addition of a model of check form in Annex B.
This document has been prepared under a Standardization Request given to CEN by the European
Commission and the European Free Trade Association.
The EN 17700 series, Plant biostimulants — Claims, consists of the following parts:
— Part 1:General principles;
— Part 2: Nutrient use efficiency resulting from the use of a plant biostimulant;
— Part 3: Tolerance to abiotic stress resulting from the use of a plant biostimulant;
— Part 4: Determination of quality traits, resulting from the use of a plant biostimulant;
— Part 5: Determination of availability of confined nutrients in the soil or rhizosphere.
4

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Introduction
This document has been developed to provide guidance for a consistent approach to justify the claims
associated with the use of plant biostimulants.
The definition of plant biostimulants to be used in Regulation (EU) 2019/1009 is claims-based. For this
reason, demonstrating that a product is indeed a bona fide plant biostimulant depends on a
demonstration of its effect.
The placing of a plant biostimulant on the market does not guarantee effectiveness under all conditions,
as many factors can influence the performance of a plant biostimulant in the field.
Plant biostimulants used in agriculture can be applied in multiple ways: on soil, on plant, as seed
treatment, etc.
WARNING — Persons using this document should be familiar with normal laboratory practice. This
document does not purport to address all of the safety problems, if any, associated with its use. It is the
responsibility of the user to establish appropriate safety and health practices and to ensure compliance
with any national regulatory conditions.
IMPORTANT — It is absolutely essential that tests conducted in accordance with this document be
carried out by suitably trained staff.

5

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1 Scope
This document specifies the general principles for justifying the product claims for plant biostimulants.
It is applicable to all application types of plant biostimulants.
General principles consist of and define all general parameters, requirements and quality criteria, and
are intended to be applied in order to assess the efficacy of trials used for claim(s) validation as a result
of the use of a plant biostimulant.
This document is aimed primarily at manufacturers, laboratories, researchers, technical centres,
companies that will put the products on the market, notifying authorities, notified bodies, and market
surveillance authorities.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
1
EN 17700-5:— , Plant biostimulants — Claims — Part 5: Determination of availability of confined nutrients
in the soil or rhizosphere
2
EN 17724:— , Plant biostimulants — Terminology
3 Terms and definitions
2
For the purposes of this document, the terms and definitions given in EN 17724:— and the following
apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https://www.iso.org/obp/
— IEC Electropedia: available at https://www.electropedia.org/
3.1
plant biostimulant
product stimulating 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:
— nutrient use efficiency,
— tolerance to abiotic stress,
— quality traits,
— availability of confined nutrient in soil or rhizosphere
3.2
claim
effect(s) of the product that can be asserted on the product label of a plant biostimulant after the
conformity assessment procedure

1
Under preparation
2
Under preparation
6

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3.3
general principle
rule defining the crops and quality criteria applicable to all plant biostimulants for carrying out the tests
necessary to justify the claim
3.4
crop
cultivated plant including all components of the plant (above ground parts and below ground parts),
mushrooms, microalgae and macroalgae
3.5
plant nutrient
chemical element used by the plant for growth and development, classified as a Primary Macronutrient,
Secondary Macronutrient or Micronutrient per the quantity required by the plant
Note 1 to entry: Primary Macronutrients – Nitrogen (N), Phosphorus (P), Potassium (K),
Secondary Macronutrients – Calcium (Ca), Magnesium (Mg), Sodium (Na), Sulphur (S),
Micronutrients – Boron (B), Cobalt (Co), Copper (Cu), Iron (Fe), Manganese (Mn), Molybdenum
(Mo), Zinc (Zn).
3.6
protected crop
crop cultivation in greenhouses or plastic tunnels with or without specific control of climate conditions
according to the farming practice
EXAMPLE cucumber or tomato cultivation
3.7
controlled conditions trial
trial carried out in a specific place like glasshouse, climatic chamber, etc., where part of the environmental
parameters can be controlled or can be measured (like soil, temperature, light, humidity, etc.,)
3.8
trial series
grouping of a number of independent field trials (e.g strip, randomized complete block designs), including
protected crops carried out with plants, which have the same objectives, experimental design, protocol,
parameters to prove the consistency of a result
Note 1 to entry: It can be conducted in different locations and /or over a number of consecutive years, as long as
it satisfies quality criteria described in this document (same protocol, same crop, control, timing)”.
3.9
strip trial
trial carried out using two strips, next to each other, in the same field, to compare control with plant
biostimulant treatment without repetition
3.10
replicates
repetition of each treatment in the same trial and under the same agronomic management practices
(application of fertilizers, plant protection products) as all other treatments
7

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4 Type information that can be used to demonstrate efficacy of a claim
4.1 General
For the demonstration of the effectiveness of the plant biostimulant product on the requested claim, field
trials are to be preferred according to the quality criteria established in this document.
However, if the performance of trials under controlled conditions has been indicated as possible in the
claims standards or if the implementation of field tests is difficult or uncertain (measurement of the roots,
cold stress.) then the trials under controlled conditions should be accepted.
4.2 Field and/or protected crop experimental data
Field trials are essential to justify plant biostimulant claims. For some claims, however, the appropriate
field conditions cannot always be easily reached (for example, salt stress, cold stress, root
measurements…) in the field. In those contexts, trials under controlled conditions can be allowed.
4.3 Under controlled conditions (e.g. laboratory data, greenhouse, growth chamber)
Plant biostimulant claims can be proven by data generated under controlled conditions (e.g. greenhouses,
growth room, growth chamber, laboratory data), depending on the claim defined in the dedicated
standard.
4.4 Literature review
3 4 5
Scientific literature can be used as given in EN 17700-2:— , EN 17700-3:— , EN 17700-4:— and
1
to describe analytical methods and methods used to measure the effect of a product. Only
EN 17700-5:—
peer review literature (e.g. referenced by the Scopus/Web of science databases) shall be accepted.
5 General guideline for trials/assays of plant biostimulants
5.1 General
All trials/assays shall be performed according to the Quality Criteria defined in this document.
5.2 Crop groupings for the performance of plant biostimulant trials
For the trials carried out with plants, the crop groupings for conduction of plant biostimulant trials are
defined in Table 1, except for the availability of confined nutrients in a soil claim. If the crop is not listed
in Table 1, refer to the definition below to determine the appropriate crop group.
— Broadacre crops (combinable and processing products): annual and non-annual crops usually
characterized by being grown in large extensions, harvested via combiners or industrial harvesters,
with the aim of obtaining vegetative organs, Roots, Tubers and/or seeds/grains,
— Woody perennials: non-annual crops with the ability to cover their stems with suberized cork,
— Vegetables, ornamental and AMP (Aromatic and Medicinal Plant) crops: annual and non-annual
crops usually correlated with seasonality and not included in the broadacre and woody perennial
crops.

3
Under preparation
4
Under preparation
5
Under preparation
8

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Table 1 — Crop groupings
Broadacre:
a
Woody Perennials Vegetables, ornamental and AMP crops
Combinable and Processing

Products
BARLEY ALMOND ANGELICA
BEAN APPLE ANISE
BEET APRICOT ASPARAGUS
BORAGE AVOCADO AUBERGINE
BUCKWHEAT BAY BALM
CHICKPEA BILBERRY BANANA
CLOVER BLACK CURRANT BASIL
COTTON BLACKBERRY BROCCOLI and CALABRESE
DURUM WHEAT BLUEBERRY BRUSSELS SPROUT
EVENING PRIMROSE CAPERS BULB ONION
GRASSLAND CHERIMOYA CABBAGE
HEMP CHERRY CARDOON
LENTIL CHESTNUT CARROT
LINSEED CITRUS FRUITS CAULIFLOWER
LUCERNE COCOA TREE CELERIAC
LUPIN COFFEE TREE CELERY
MAIZE CRANBERRY CELERY LEAVES (Caraway and Salad Burnet)
MUSTARD (for seed) CURRY LEAVES CHERVIL
OAT DATE CHICORY (Witloof)
PEA ELDERBERRY CHILLI
POPPY FIG CHINESE CABBAGE
POTATO GRAPE CHIVES
QUINOA GUAVA CHOI SUM
RAPE HAZELNUT COLLARD
RICE HOPS CORIANDER
RYE JUNIPER COURGETTE and SUMMER SQUASH
SAFFLOWER KAFFIR LIME CRESS
SAINFOIN KIWI CUCUMBER
SESAME LIQUORICE DILL
SORGHUM LOGANBERRY EDIBLE FLOWERS
SOYBEAN MANGO EDIBLE LEAF MUSTARD
SPELT MEDLAR ENDIVE
SUGAR BEET MULBERRY FENNEL
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Broadacre:
a
Woody Perennials Vegetables, ornamental and AMP crops
Combinable and Processing


Products
SUGARCANE NECTARINE FLOWERS and FILLERS
SUNFLOWER OLIVE GARLIC
SWEET POTATO PAPAYA GHERKIN
SWEETCORN PASSION FRUIT GLOBE ARTICHOKE
TOBACCO PEACH HORSERADISH
TRITICALE PEAR JERUSALEM ARTICHOKE
TURF PERSIMMON KALE and CAVOLO NERO
VETCH PISTACHIO KOHLRABI
WHEAT PLUM LAMB'S LETTUCE

POMEGRANATE LAND CRESS

QUINCE LEEK

RASPBERRY LETTUCE

RED CURRANT LOVAGE

ROSEHIP MAJORAM

TEA TREE MELON

WALNUT MINT

MUSHROOM

OREGANO

OTHERS AMP

PARSLEY

PARSNIP

PEANUT

PEPPER

PINEAPPLE

PUMPKIN and WINTER SQUASH

PURSLANE
 RADISH

RED BEET

RHUBARB

ROCKET

ROSEMARY

SAFFRON

SAGE

SALAD ONION
10

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Broadacre:
a
Woody Perennials Vegetables, ornamental and AMP crops
Combinable and Processing

Products

SALSIFY

SAVORY

SEA KALE

SHALLOT

SPINACH

STRAWBERRY

SWEDE

SWEET CICELY

SWISS CHARD (Spinach Beet)

TARRAGON

THYME
 TOMATO
 TURNIP
 VANILLA
 WATERCRESS
 WATERMELON
a
Aromatic and Medicinal Plant
5.3 Minimum number of trials to be provided
To justify a specific claim as defined in its related claim standard, a minimum number of trials shall be
performed with the same protocol (trial design) and methods per claim according to the criteria
described in the Table 2.

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Table 2 — Minimum number of trials carried out with plant based on the claim to be justified
Claim that may credibly be made on this basis Minimum number of trials
3 trials on the crop
Effect claimed for a specific crop
Claim is successfully demonstrated on the crop chosen
during the same year or different years.
6 trials with minimum of 2 different crops
Claim is successfully demonstrated on two crops chosen
Effect claimed for the entire crop group during the same year or different years.
When the claim is demonstrated for two crops within a
group, this is regarded as valid for the entire crop group
8 trials in total from 2 different groups
=
4 trials per group (with min of 2 different crops per
Effect claimed for two entire crop groups later
group)
Claim is successfully demonstrated on crops chosen
during the same year or different year.
9 trials in total from 3 different groups
=
Effect claimed without being required to limit it
3 trials per group (with min of 2 different crops per
to any specific crop grouping
group)
Claim is successfully demonstrated on crops chosen
during the same year or different years.
Table 3 — Minimum number of trials series carried out with plant based on the claim to be
justified
Claim that may credibly be made on this basis Minimum number of trial series
One trial series on the crop
Effect claimed for a specific crop
Claim is successfully demonstrated on the crop chosen
during the same year or different years.
One trial series by crop with a minimum of 2 different
crops
Claim is successfully demonstrated on two crops chosen
Effect claimed for the entire crop group
during the same year or different years.
When the claim is demonstrated for two crops within a
group, this is regarded as valid for the entire crop group.
One trial series by crop with a minimum of 2 different
crops per group
=
Effect claimed for two entire crop groups later
4 trials series minimum in total
Claim is successfully demonstrated on crops chosen
during the same year or different year.
One trial series by crop with a minimum of 2 different
crops per group
=
Effect claimed without being required to limit it
to any specific crop grouping
6 trials series minimum in total
Claim is successfully demonstrated on crops chosen
during the same year or different years.
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When trials are carried out without crops, three pH categories (pH < 6,2 /6,2 ≤ pH ≤ 7,5/pH > 7,5) and
four type of textures categories (Silt, Sand, Clay, Loam) have to be considered, as described in Table 4.
1
NOTE For more information, refer to EN 17700-5:— .
Table 4 — Minimum number of trials carried out without plant based on the claim to be justified
Claim that may credibly be made on this basis Minimum number of trials
2 trials in total from 2 different pH categories in one
specific soil type
The soil type shall be chosen according to the rules
Effect claimed for specific soil type categories and
1
all pHs mentioned in EN 17700-5:— , 6.2.1.
Claim is successfully demonstrated on the soil chosen
during the same year or different years.
3 trials in total from 3 different soil texture categories
in one specific pH category
The soil type shall be chosen according to the rules
Effect claimed for specific pH categories for all types
1
of soil textures categories mentioned in EN 17700-5:— , 6.2.1.
Claim is successfully demonstrated on the soil chosen
during the same year or different years.
6 trials in total from 2 different pH categories and 3
different soil texture categories
The soil type shall be chosen according to the rules
Effect claimed for all soil types and all pH categories
1
mentioned in EN 17700-5:— , 6.2.1.
Claim is successfully demonstrated on the soil chosen
during the same year or different years.
5.4 Trial design and statistical analysis
5.4.1 Control
The control or untreated control is a treatment that is conducted under the same agronomic management
practices (application of fertilizers, plant protection products) as all other treatments, except application
of the product tested. It is mandatory to use the same water application rate in all treatments. The control
shall be included in the experimental design.
It shall be checked that the efficacy of the plant biostimulant is not due to the plant biostimulant's nutrient
content.
A nutrient analysis of the product shall be done according to the available harmonized standards or other
available analytical methods prior to trial conduction.
And if the total nutrient amount applied by the plant biostimulant (quantity of the nutrient content
notified x rate of application of the plant biostimulant) is higher than the reference values in Table 5, an
adequate quantity of nutrients (equivalent forms) shall be applied in the control for each application to
balance the difference.
For the case of strip trials, the two treatments (control and plant biostimulant product) shall be directly
next to each other in the same field with an appropriate buffer area.

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Table 5 — Maximum quantity of nutrient applied per plant biostimulant application tested
Quantity of nutrient applied Quantity of nutrient applied
Nutrients
(kg/ha) per soil application (kg/ha) per foliar application
N 10 2
P O 10 1,5
2 5
K 0 10 2
2
MgO 3 1
CaO 10 1,5
SO 10 2
3
B 0,4 0,1
Co 0,05 0,005
Cu 0,4 0,025
Fe 15 0,2
Mn 3 0,15
Mo 0,05 0,003
Zn 1,00 0,15
Other types of controls can be added if the petitioner/applicant thinks that it is useful and necessary to
demonstrate the efficiency of the product.
For the case of strip trials, the two treatments (control and plant biostimulant product) shall be directly
next to each other in the same field with an appropriate buffer area.
5.4.2 Minimum plot size
5.4.2.1 Field trials
It is important to select plots as homogenous as possible and/or use adequate experimental design.
It is important to create buffer areas among the plots in order to maintain the plots separated and
independent and limit the border effect.
— For single trials:
The minimum plot size is required as defined below according to the type of crops referred to in
Table 1:
2
— Minimum 20 m for Broadacre crops,
— Minimum 3 plants for Woody perennials crops [and minimum 25 units/plot (i.e.
fruits/shoots/leaves/flowers)],
2
— Minimum 10 m for Vegetables, Ornamentals and AMP crops.
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— For strip trials:
The minimum plot size is:
2
— 200m for Broadacre crops,
— 12 plants for woody perennial crops [and minimum 100 units/plot (i.e.
fruits/shoots/leaves/flowers)],
2
— 40 m for vegetables.
5.4.2.2 Controlled conditions and protected crops
A minimum of 3 plants per replicate is required (e.g. greenhouses, growth room, growth chamber,
laboratory data, etc.).
5.4.3 Application rates
The rate(s) tested during the trials shall be in the range of the doses recommended by the manufacturer
and indicated on the label.
5.4.4 Minimum number of replicates
A minimum of 4 replicates is requested for each treatment in the same
...

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