Plant biostimulants - Claims - Part 1: General principles

This document specifies the general principles for justifying the product claims for 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 market, notifying authorities, notified bodies, and market surveillance authorities.

Biostimulanzien für die pflanzliche Anwendung - Angaben - Teil 1: Allgemeine Grundsätze

Dieses Dokument legt die allgemeinen Grundsätze für die Begründung von Produktangaben zu Biostimulanzien für die pflanzliche Anwendung fest.
Allgemeine Grundsätze umfassen und definieren alle allgemeinen Parameter, Anforderungen und Qualitätskriterien und sind zur Bewertung der Wirksamkeit von Versuchen vorgesehen, mit denen die Angaben nach Anwendung eines Biostimulans für die pflanzliche Anwendung validiert werden sollen.
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.
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 oeuvre 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 biostimulansi - Navedbe - 1. del: Splošna načela

General Information

Status
Not Published
Current Stage
5060 - Closure of Vote - Formal Approval
Due Date
02-Dec-2021
Completion Date
02-Dec-2021

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SLOVENSKI STANDARD
kSIST-TS FprCEN/TS 17700-1:2021
01-november-2021
[Not translated]
Plant biostimulants - Claims - Part 1: General principles
Biostimulanzien für die pflanzliche Anwendung - Angaben - Teil 1: Allgemeine
Grundsätze
Biostimulants des végétaux - Allégations - Partie 1 : Principes généraux
Ta slovenski standard je istoveten z: FprCEN/TS 17700-1
ICS:
65.080 Gnojila Fertilizers
kSIST-TS FprCEN/TS 17700-1:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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kSIST-TS FprCEN/TS 17700-1:2021
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kSIST-TS FprCEN/TS 17700-1:2021
FINAL DRAFT
TECHNICAL SPECIFICATION
FprCEN/TS 17700-1
SPÉCIFICATION TECHNIQUE
TECHNISCHE SPEZIFIKATION
September 2021
ICS 65.080
English Version
Plant biostimulants - Claims - Part 1: General principles

Biostimulants des végétaux - Allégations - Partie 1 : Biostimulanzien für die pflanzliche Anwendung -

Principes généraux Angaben - Teil 1: Allgemeine Grundsätze

This draft Technical Specification is submitted to CEN members for Vote. It has been drawn up by the Technical Committee

CEN/TC 455.

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, Turkey 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 Technical Specification. It is distributed for review and comments. It is subject to change

without notice and shall not be referred to as a Technical Specification.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TS 17700-1:2021 E

worldwide for CEN national Members.
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kSIST-TS FprCEN/TS 17700-1:2021
FprCEN/TS 17700-1:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

Introduction .................................................................................................................................................................... 4

1 Scope .................................................................................................................................................................... 5

2 Normative references .................................................................................................................................... 5

3 Terms and definitions ................................................................................................................................... 5

4 Type of information that can be used to demonstrate efficacy of a claim .................................. 6

4.1 Field and/or protected crop experimental data .................................................................................. 6

4.2 Under controlled conditions (e.g.: laboratory data, greenhouse, growth chamber…) .......... 6

4.3 Literature review ............................................................................................................................................ 6

5 General guideline for trials/assays of plant biostimulants ............................................................. 7

5.1 General ................................................................................................................................................................ 7

5.2 Crop groupings for the performance of plant biostimulant trials ................................................. 7

5.3 Minimum number of trials to be provided ......................................................................................... 10

5.4 Trial design and statistical analysis ...................................................................................................... 11

6 Terminology of crops on the label ......................................................................................................... 13

7 Quality Criteria.............................................................................................................................................. 13

7.1 General ............................................................................................................................................................. 13

7.2 Criteria for type of organization in charge of trial ........................................................................... 14

7.3 Modes of operation ...................................................................................................................................... 14

8 Information to be collected in individual trials ................................................................................ 15

8.1 Experimental conditions ........................................................................................................................... 15

8.2 Application of the product ........................................................................................................................ 16

8.3 Recording measurements ......................................................................................................................... 16

8.4 Presentation of the Results....................................................................................................................... 16

Annex A (informative) P-value choice and impact on the results quality ............................................ 17

Bibliography ................................................................................................................................................................. 18

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kSIST-TS FprCEN/TS 17700-1:2021
FprCEN/TS 17700-1:2021 (E)
European foreword

This document (FprCEN/TS 17700-1:2021) 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 Vote on TS.

The CEN/TS 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 nutrient in the soil or rhizosphere.

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kSIST-TS FprCEN/TS 17700-1:2021
FprCEN/TS 17700-1:2021 (E)
Introduction

This document has been developed to provide guidance for a consistent approach to justify the claims

associated with the use of plant biostimulants in agriculture.

The definition of plant biostimulants to be used in the regulation on fertilizing materials 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 should never be considered to guarantee effectiveness

under all conditions, as many factors may 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. This document is applicable to all application types of plant biostimulants in agriculture.

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kSIST-TS FprCEN/TS 17700-1:2021
FprCEN/TS 17700-1:2021 (E)
1 Scope

This document specifies the general principles for justifying the product claims for 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 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.

CEN/TS 17700-5:— , Plant biostimulants - Claims - Part 5: Determination of availability of confined

nutrients in the soil or rhizosphere
CEN/TS 17724:— , Plant biostimulants - Terminology
3 Terms and definitions

For the purposes of this document, the terms and definitions given in CEN/TS 17724:— and the following

apply.
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 could be asserted on the product label of a plant Biostimulant after the

conformity assessment procedure
Under preparation. Current stage is: FprCEN/TS 17700-5:2021.
Under preparation. Current stage is: FprCEN/TS 17724:2021.
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FprCEN/TS 17700-1:2021 (E)
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, usually classified as a Primary

Macronutrient, Secondary Macronutrient or Micronutrient in the quantity required by the plant

Note 1 to entry: Carbon, hydrogen, and oxygen are also essential elements for plant growth.

Note 2 to entry: Primary Macronutrients – Nitrogen (N), Phosphorus (P), Potassium (K),

Secondary Macronutrients – Sulphur (S), Calcium (Ca), Magnesium (Mg), Sodium (Na),

Micronutrients – Iron (Fe), Molybdenum (Mo), Boron (B), Copper (Cu), Manganese (Mn), Zinc (Zn), Cobalt (Co).

3.6
protected crop

crop cultivation in greenhouses or plastic tunnels with or without specific control of climate conditions

according to the farming practice (for example: cucumbers/ tomatoes cultivation)
4 Type of information that can be used to demonstrate efficacy of a claim
4.1 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 or cold stress) in the field.

4.2 Under controlled conditions (e.g.: laboratory data, greenhouse, growth chamber…)

Plant Biostimulant claims can be proven (depending on the claim defined in the dedicated Technical

Specification) by data generated under controlled conditions (e.g. greenhouses, growth room, growth

chamber, laboratory data).
4.3 Literature review

Scientific literature can be used as given in Technical Specifications CEN/TS 17700-2:— , CEN/TS 17700-

4 5

3:— , CEN/TS 17700-4:— and CEN/TS 17700-5:— to describe methods used to measure the effect of

the product and analytical methodologies.

Only peer review literature (e.g. referenced by the Scopus/Web of science databases) shall be accepted.

Under preparation. Current stage is: FprCEN/TS 17700-2:2021.
Under preparation. Current stage is: FprCEN/TS 17700-3:2021.
Under preparation. Current stage is: FprCEN/TS 17700-4:2021.
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FprCEN/TS 17700-1:2021 (E)
5 General guideline for trials/assays of plant biostimulants
5.1 General

All experiments/trials shall be performed according to the Quality Criteria defined in this document.

5.2 Crop groupings for the performance of plant biostimulant trials

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. Moreover, if the crop does not fit one of these definitions

below, the “specific cultures” rules described in Table 2 will be followed.

• 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.
Table 1 — Crop groupings
Broadacre:
Vegetables, ornamental and AMP
crops
Woody Perennials
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
CELERY LEAVES (Caraway and Salad
MAIZE CRANBERRY
Burnet)
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FprCEN/TS 17700-1:2021 (E)
Broadacre:
Vegetables, ornamental and AMP
Woody Perennials crops
Combinable and Processing
Products
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 HAZENUT 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
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
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kSIST-TS FprCEN/TS 17700-1:2021
FprCEN/TS 17700-1:2021 (E)
Broadacre:
Vegetables, ornamental and AMP
Woody Perennials crops
Combinable and Processing
Products
OTHERS PMA
PARSLEY
PARSNIP
PEANUT
PEPPER
PINEAPPLE
PUMPKIN and WINTER SQUASH
PURSALNE
RADISH
RED BEET
RHUBARB
ROCKET
ROSEMARY
SAFFRON
SAGE
SALAD ONION
SALSIFY
SAVORY
SEA KALE
SHALLOT
SPINACH
STRAWBERRY
SWEDE
SWEET CICELY
SWISS CHARD (Spinach Beet)
TARRAGON
THYME
TOMATO
TURNIP
VANILLA
WATERCRESS
WATERMELON
Aromatic and Medicinal Plant
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kSIST-TS FprCEN/TS 17700-1:2021
FprCEN/TS 17700-1:2021 (E)
5.3 Minimum number of trials to be provided

To justify a claim, a minimum number of trials shall be performed with the same protocol and methods

per claim according to the criteria described in the Table 2.

When the trials are carried without crops, three pH categories (pH < 6,2 /6,2 < pH < 7,5 /pH > 7,5) and

four type of textures categories (Silty, Sandy, Clay, Loam) have to be considered, as described in the

Table 2.
NOTE For more information, refer to CEN/TS 17700-5:—.
Table 2 — Minimum number of trials based on the claim to be justified
Claim that can credibly be made on this basis Minimum number of trials
Trial carried out with plants
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 can be 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
Effect can be claimed for two entire crop groups
4 trials per group (with min of 2 different crops per group)
later
Claim is successfully demonstrated on crops chosen during
the same year or different year.
9 trials in total from 3 different groups
Effect can be claimed without being required to
3 trials per group (with min of 2 different crops per group)
limit it to any specific crop grouping
Claim is successfully demonstrated on crops chosen during
the same year or different years.
Trial carried out without plants
2 trials in total from 2 different pH categories in one specific
type of soil

Effect claimed for specific type of soil categories The type of soil shall be chosen according the rules mentioned

and all pHs in CEN/TS 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

Effect claimed for specific pH categories for all The type of soil shall be chosen according to the rules

type of soil textures categories mentioned in CEN/TS 17700-5:—, 6.2.1
Claim is successfully demonstrated on the soil chosen during
the same year or different years
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kSIST-TS FprCEN/TS 17700-1:2021
FprCEN/TS 17700-1:2021 (E)
Claim that can credibly be made on this basis Minimum number of trials
...

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