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EU Fertilising Products Compliance · Regulation (EU) 2019/1009

Your fertiliser framework measured against Regulation 2019/1009, and costed into an action plan.

10 themes, a 5-level scale. And the action that moves each level to the next.

The framework’s 10 themes, already written from L1 to L5. One company, one business unit, or 300 at once.

EU Fertilising Products Compliance · Regulation (EU) 2019/1009

Product classification and function categoriesN1 → N5
Component materials and eligibilityN1 → N5
Contaminants and safety criteriaN1 → N5
Supplier qualification for materialsN1 → N5

10 themes, 5-level scale.

Nordhavn Industries

53 / 100

Product classification and function categories6484
Component materials and eligibility5379
Contaminants and safety criteria6182
Supplier qualification for materials3773
IAIndustrialised: your interview notes are enough, the AI fills in the audit.

They measure their maturity with Datamensio

  • Agri Sud-Ouest Innovation
  • ODA
  • Chambre de commerce et d'industrie
  • Eurobiomed
  • Enterprise Europe Network
  • HGK, Chambre de commerce croate

An example

This could be your situation.

Take one company as an example: three sites, three spreadsheets, no shared answer.

01

Nobody can consolidate.

Nordhavn Industries, 2,400 people in Hamburg, Lyon and Porto. A client asks where the group stands. Each site answers in its own spreadsheet, with its own scales.

02

Three weeks, a single base.

One Regulation (EU) 2019/1009 of 5 June 2019, applicable since 16 July 2022 assessment launched across all three sites at once, from the managers’ interview notes. The framework was already written, its 10 themes and levels L1 to L5 too.

03

Two costs avoided before being committed.

A score of 53 out of 100, with the gap concentrated on three themes. The AI companion spotted that two actions duplicated those of another audit. The committee report took one sentence to request.

What it saved them

  • 3sites measured on the same base, instead of three questionnaires to reconcile
  • 2duplicate actions caught before the spend
  • 1committee report, with no manual rework

These figures are an example. They could be yours.

The standard imposes processes. Datamensio says where you stand.

01

The framework is already written

Themes, questions and levels L1 to L5, all written. You do not start from an empty spreadsheet.

02

The score lands the same day

Online, by self-assessment link or in interview. Theme by theme, comparable over time.

03

The gap becomes a costed plan

Every step up carries its action. The AI prioritises on expected effect, not on the order of the standard.

04

Progress can be demonstrated

Campaign after campaign, against your target and against your own past. That is what your board asks for.

The maturity scale

One level, the next, and the action that links the two.

It is this mechanism, one level, the level above, and the action connecting the two, that turns a finding into a trajectory.

Is the link between each product line and the component material categories documented and kept up to date?

  1. N1

    No formal link. Composition is known to technical teams but CMC eligibility is not documented product line by product line.

  2. N2

    A mapping table exists for the main product lines. It was built during the move to CE marking and has not been reviewed since.

  3. N3

    Each product line has a documented CMC link, included in the technical file and reviewed whenever the formula or material changes.

  4. N4

    The link is backed by supplier specifications and incoming controls. Origin changes trigger a traced review before release.

  5. N5

    The framework is reviewed periodically against delegated acts and new CMCs, with a history of classification decisions and associated arbitrations.

Action to move from L2 to L3

Attach the classification table to the technical file of each product line, appoint a single regulatory approver, and make the CMC link review a mandatory step in the change procedure for formulas or raw materials.

« With Datamensio, we meet our objectives far more efficiently. The ERDF inspection services and our supervising ministry particularly appreciated an approach that gives them reliable data. »
Chambre de commerce et d'industrie

Director, CCI 94CCI Île-de-France

« We believe this is the most suitable solution to scale our transformation project and measure impact according to our needs. »
Interreg Danube Region

Maja SucekChief Operating Officer, Interreg Danube

Take your first measurement

What this framework covers

Regulation (EU) 2019/1009 replaced Regulation (EC) No 2003/2003 and extended the scope well beyond mineral fertilisers. It now covers soil improvers, plant biostimulants, inhibitors, growing media, and blends. An EU fertilising product must fall under a product function category (PFC), be composed exclusively of materials falling under component material categories (CMCs), meet contaminant limits and safety criteria, carry the labelling prescribed in Annex III, and undergo a conformity assessment procedure leading to an EU declaration of conformity and CE marking.

The difficulty is not reading the text, it is sustaining the framework over time. Is the classification of each product line documented, with the PFC and CMC link traced back to the raw material? Do contaminant testing plans, cadmium, hexavalent chromium, mercury, nickel, lead, inorganic arsenic, biuret, cover every material origin or only long-standing suppliers? What happens when a supplier changes process or a formula shifts by a few points: does the EU declaration of conformity and technical documentation follow, or do they stay frozen at the original version?

Two confusions recur often. The first: the EU regime is optional. A manufacturer can continue selling under a national regime, but then loses the benefit of free movement, and mixing national and EU logics within the same range complicates governance. The second concerns materials from animal by-products or recovered waste: the end point in the manufacturing chain under Regulation (EC) No 1069/2009 and the end-of-waste criteria determine CMC eligibility, which requires coordination between quality, procurement and regulatory teams.

A compliance audit ends with a binary finding: the product meets the requirements, or it does not. The maturity assessment asks a different question. What level of control does each practice sit at, from product classification to handling nonconformities raised by distributors, and what specific action moves it up a level. The result is not an opinion, it is a costed trajectory that can be arbitrated in committee.

The framework is ready to use in Datamensio and adapts to your range. AI adjusts themes, questions and levels to your positioning, mineral fertilisers, biostimulants, growing media, or builds a variant from your technical files and existing procedures. Multi-site assessments can then be compared across business units and over time.

Reference standard: Regulation (EU) 2019/1009 of 5 June 2019, applicable since 16 July 2022

The themes assessed

  • Product classification and function categories

    Linking each product line to a PFC, documented justification, blend management, consistency between marketing claims and declared category.

  • Component materials and eligibility

    Linking to CMCs, traceability back to the raw material, end-of-waste criteria, end point for animal by-products, materials from digestates and composts.

  • Contaminants and safety criteria

    Testing plans for cadmium, hexavalent chromium, mercury, nickel, lead, inorganic arsenic, biuret, perchlorate depending on the PFC, applicable microbiological criteria, choice of laboratories and methods.

  • Supplier qualification for materials

    Material specifications, contractual requirements, incoming controls, management of process or origin changes at the supplier.

  • Labelling and product information

    Statements required under Annex III, declared nutrient content and tolerances, usage instructions and dosage, target market languages, consistency with marketing materials.

  • Conformity assessment and technical file

    Assessment module used, notified body involvement where required, content and updating of the technical file, EU declaration of conformity, application of CE marking.

  • Production and batch control

    In-process manufacturing controls, homogeneity and sampling, batch identification, management of deviations between declared and measured values.

  • Change and nonconformity management

    Review procedure when a formula or material changes, handling of nonconformities, corrective measures, withdrawal and recall, informing authorities and supply chain operators.

  • Roles of economic operators

    Allocation of obligations between manufacturer, importer and distributor, mandates, import checks, document retention for the required period.

  • Regulatory monitoring and improvement

    Monitoring delegated acts and new CMCs, tracking official controls and market feedback, periodic review of the framework, comparing sites over time.

A short version of the framework is available for the online self-assessment.

Frequently asked questions

Is Regulation 2019/1009 mandatory for all fertilisers?

No. The EU regime is optional and opens up free movement across the internal market. A manufacturer can remain under a national marketing regime, but cannot then apply CE marking under this regulation. The assessment covers both situations and clarifies the gap to close in order to switch.

Does this assessment deliver compliance or a certificate?

No. Datamensio measures the maturity of your practices and prepares the conformity assessment. Certification falls under the procedure set out in the regulation, with notified body involvement where the applicable module requires it.

How does this differ from a standard compliance audit?

An audit concludes with a gap or a compliance finding against a given requirement. The assessment places each practice on a maturity scale and indicates the action that moves it to the next level. The two complement each other: the assessment builds the roadmap, the audit validates the outcome.

How long does the assessment take?

The short version can be completed in a single working session. The full version, run collaboratively with regulatory, production and procurement teams, typically takes one to two weeks, most of the time going into gathering technical files and testing plans.

Can the framework be adapted to our range?

Yes. You can edit the questions, levels and themes, or start from your own procedures. AI builds a variant suited to your positioning, mineral fertilisers, biostimulants or growing media, and refines the levels following the CMMI method.

How can we compare several production sites?

Each site is assessed against the same framework, and scores are then compared by theme across business units and against previous cycles. A cross-site roadmap consolidates the assessments and groups common actions rather than duplicating them site by site.

Is the action plan costed?

Yes. Every gap between the score and the target generates an action, and the service catalogue matches a solution to each action, with cost, timeline and expected impact on the score. The result can be arbitrated in committee.

Where is the data hosted?

In France, with OVH, backed up with Scaleway. No transfer outside the European Union. The AI models used can be selected, including European solutions.

Take your first measurement