Skip to content
RecyFert

What does a notified body need to assess my biostimulant trials?

Last reviewed 16 October 2026. Source: EN 17700-1 to EN 17700-5:2024 (Plant biostimulants — Claims); Regulation (EU) 2019/1009, Annex I PFC 6 and Annex IV. Selected facts summarised in original wording; consult the official standards for the full conditions.

In simple words

A notified body, often called a NoBo, checks whether your evidence supports what you say your biostimulant does. A good result alone is not enough. The work must be reliable, and the conclusion must fit the claim on your label. Speak to your chosen notified body before starting trials.

What is the notified body looking for?

The main question is simple: does the evidence support the claim?

The assessor needs to understand what was tested, how the work was done and what the results mean. It also considers whether the evidence fits the product and the way customers will use it.

A promising trial is not the same as an accepted dossier. Trial evidence is only one part of the product assessment.

From evidence to an assessment question

Evidence areaWhy it mattersExample of a gap
Product identityConnects the trial material to the assessed product.A report does not identify the formulation tested.
Claim and intended useDefines what the results are meant to support.The label covers uses not investigated.
Trial comparisonHelps explain whether the product caused the response.Treated plants received different nutrition or management.
Measurements and analysisShows the effect, variation and basis of the conclusion.Only a favourable graph is available.
Trial-provider qualityGives confidence in how the work was performed.A certificate is supplied without checking its scope.
Records and limitationsMakes the work traceable and the interpretation understandable.Missing data or changes are not explained.

This is an editorial overview of common evidence questions, not an official acceptance checklist. Your notified body determines what is needed for your assessment.

Start with what your product does

Be clear about the effect you want to claim. “Makes plants stronger” is too broad to explain what you tested.

For example, you may want to show better use of nutrients or better tolerance to drought. The trial must help answer that specific question. The claim on your label should not promise more than the evidence supports.

Reliable work matters

The assessor needs confidence in the work, not just an attractive graph. The trial should use a fair comparison and suitable methods. The people doing it should have the knowledge and experience needed.

The company carrying out the trials must be able to show that it follows the quality criteria for the approach used. Under EN 17700, this means competent staff and properly managed trial work. Certification is not a blanket requirement for every biostimulant efficacy trial.

Ask your notified body whether it requires a particular certification, accreditation or recognised quality scheme for the work you plan to submit. Check this before choosing a trial provider. A certificate alone does not guarantee that the trial evidence will be accepted.

Keep the records behind the results. Explain problems or changes openly. This makes it easier to understand how you reached the conclusion.

Make the evidence easy to follow

The assessor should be able to link the tested product to the product in your dossier. Identify the version or batch used, and explain differences in composition or intended use.

Then connect the trial question, method, measurements and conclusion. A report should explain why the result supports the proposed claim, including where that conclusion stops.

Show the result and its limits

A useful report gives more than a favourable percentage. It explains the comparison, variation between observations and the analysis used.

Include results that did not show a benefit, as well as positive results, and explain important problems. A programme with mixed results needs an honest interpretation, not just a selection of the best graphs.

Connect the numbers to the assessment

If your evidence follows EN 17700, the assessor needs to see how the programme meets the chosen route, not just a total count. For a one-crop claim, the individual-trial minimum is 3 trials; the alternative is at least 1 trial series, containing at least 4 trials or 15 strip trials. Those alternatives have different analysis conditions.

For replicated field work, check that the provider explains the minimum of 4 replicates per treatment. In EN 17700-1:2024, the significance thresholds are p < 0.15 for field/protected-crop trials and field series, and p < 0.10 for individual controlled-condition trials. The underlying data and analysis must let the assessor check the conclusion.

These are selected standard facts, not a universal NoBo acceptance checklist. A three-trial report can still leave gaps if it concerns the wrong formulation, unsuitable growing conditions or a claim broader than the evidence. Include inconclusive results and explain the whole programme rather than submitting only the most favourable trials.

What should the provider be able to explain?

Ask how it plans and reviews the work, trains the people involved, checks its measurements and keeps the records. These are practical ways to understand how the work is managed, not a reproduction of a standard’s qualification checklist.

If the provider has a certificate or accreditation, check what work it actually covers. Laboratory analysis and field efficacy trials are different activities. A certificate for one does not automatically cover the other.

The notified body can clarify which quality evidence or recognised scheme is relevant for your assessment.

An example of an evidence gap

You want to claim drought tolerance, but the report contains only higher yield from a season described as dry. The assessor may still need evidence that the crop experienced relevant stress and that the comparison can explain the claimed benefit.

The issue is not that yield is useless. It is that the result needs enough context to answer the claim. Discuss the gap before deciding whether further trials or better supporting records are needed.

Talk before you start

Discuss your intended claim and proposed approach with your chosen notified body before committing to trials. Ask what evidence it will need and whether your plan is suitable for the assessment.

If you already have trial results, ask how they can be used. Do not assume they will be accepted, or that you must start again.

Early discussion can help avoid missing evidence and unnecessary work. It is not a guarantee that the final results will be accepted.

Where do the standards fit?

The EN 17700 series provides a recognised framework for evidence supporting plant biostimulant claims. Using standards is voluntary; the product must still meet the legal requirements.

This article combines original explanations with selected numerical and scope requirements from the standards. It is not a complete protocol or a substitute for the official standards and their full conditions. Agree the chosen approach with a qualified trial specialist and your notified body.

Common gaps that make assessment harder

  • The claim promises more than the trials show.
  • It is not clear whether the tested product matches the product being assessed.
  • The comparison does not clearly show the product’s effect.
  • The report gives a result, but the records behind it are missing.
  • Changes or problems during the work are not explained.
  • The evidence does not cover the intended crops or uses.

These gaps may lead to questions or further work. Discuss them with your notified body rather than assuming that a positive result will be enough.

How does RecyFert help?

RecyFert helps organise the trial evidence in your product dossier and identify information that is missing. The trial provider is responsible for its work. The manufacturer stays responsible for the product. The notified body makes the assessment decision.

Common questions

Will a positive trial result always be accepted?

No. The result must come from suitable work and support the intended claim. The notified body assesses the evidence as part of the product dossier.

Should I contact a notified body before doing trials?

Yes. An early discussion helps you understand what evidence is needed before you spend time and money.

Does trial acceptance mean I can add the CE marking?

Not on its own. The product must also meet the other relevant requirements and complete its conformity assessment.

Words used in this article (7)
Notified body
An independent organisation that an EU country has approved to check products or quality systems. Some modules need one.
Plant biostimulant (PFC 6)
A product that helps plants take up and use nutrients, whatever amount of nutrients the product itself contains.
FPR (Fertilising Products Regulation)
The EU law that sets the rules for selling fertilising products with a CE marking in all EU countries. Its full name is Regulation (EU) 2019/1009.
Technical documentation
The set of documents that show the product follows the rules. It includes the product description, the materials, the production process, test reports and the label.
Module
One of the fixed routes for conformity assessment. The regulation has Module A, Module B followed by Module C, Module D1 and Module A1.
Manufacturer
The company that makes the product, or has it made, and sells it under its own name or brand.
CE marking
A mark on the packaging. It shows that the manufacturer states that the product follows the EU rules.

Related articles

Next step