Medicated feed compliance · Regulation (EU) 2019/4
Your medicated feed practices, positioned against Regulation (EU) 2019/4 and turned 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.
Medicated feed compliance · Regulation (EU) 2019/4
10 themes, 5-level scale.
Nordhavn Industries
53 / 100
They measure their maturity with Datamensio
An example
This could be your situation.
Take one company as an example: three sites, three spreadsheets, no shared answer.
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.
Three weeks, a single base.
One Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018, applicable since 28 January 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.
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.
This mechanism, a level, a higher level, and the action linking the two, is what turns a finding into a trajectory.
Is cross-contamination between batches from active substances controlled and demonstrated?
- N1
No carry-over measurement has been performed. Manufacturing order and cleaning rely on team habit.
- N2
Carry-over trials have been run on one line, but the results are not used to build production sequences and are not kept up to date.
- N3
Carry-over values are known by line. Manufacturing sequences and rinsing procedures are derived from them and applied generally.
- N4
Sequences are managed within the production system, rinsing is traced batch by batch, and an analytical control plan periodically verifies compliance with limits.
- N5
Carry-over data is reviewed at every equipment or formula change, with documented tracking of revisions and corrective actions triggered.
Action to move from L2 to L3
Rework the carry-over results line by line, derive a manufacturing scheduling matrix and the associated rinsing procedures, integrate it into the production plan and verify its application during next quarter’s internal audit.
« 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. »
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. »
Maja SucekChief Operating Officer, Interreg Danube
Rarely on its own
Frameworks combine. Put several together to cover your business, or have the AI write yours.
Take your first measurement
What this framework covers
Regulation (EU) 2019/4 replaced Directive 90/167/EEC and harmonised, across the Union, the rules applicable to medicated feed and intermediate products. It requires specific approval of establishments manufacturing, storing, transporting and placing products on the market, exclusive incorporation of authorised veterinary medicinal products, demonstration of homogeneous and stable incorporation, compliance with cross-contamination limits for active substances, a mandatory veterinary prescription with a limited period of validity, standardised labelling, and full batch traceability.
In practice, the difficulty is not knowing the text but proving what the plant actually does. Is homogeneity validated on the product ranges genuinely produced, or on an old trial run with a single premix? Are manufacturing sequences and rinsing procedures built from measured carry-over values, or do they rest on inherited practice? Are veterinary prescriptions checked on receipt, quantity by quantity, before production starts? Many establishments hold the documents without holding the evidence of application.
Two confusions come up repeatedly. The first is treating medicated feed as a mere special case of feed hygiene under Regulation (EC) No 183/2005: the obligations on approval, prescription and cross-contamination are additional and cannot be inferred from an existing HACCP plan. The second concerns the relationship with Regulation (EU) 2019/6 on veterinary medicinal products, particularly the restrictions on prophylactic use and antimicrobial prevention, which narrow the grounds for prescription and directly affect the volumes manufactured.
An official control ends with a binary finding: compliant, or non-conformity to correct. The maturity assessment answers a different question. It positions each practice on a five-level scale, from informal action to measured and reviewed practice, and states the precise action that moves it up a level. The result is not an opinion, it is a trajectory: a score by theme, a target, and the gap between the two converted into a costed action plan, prioritised by AI into a roadmap.
The framework is ready to use and you keep full control of it. You adjust the themes, questions and level wording to your activity, whether contract manufacturer, integrated plant within a group, or on farm mixer. AI refines the levels using the CMMI method, or builds a variant from your own procedures, HACCP plans and inspection reports.
Reference standard: Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018, applicable since 28 January 2022
The themes assessed
Approval and scope of activity
Scope of approval by activity and animal category, updates in case of changes, approval of hauliers and distributors, separation of medicated and non medicated activities.
Incorporated veterinary medicinal products
Verification of marketing authorisation, compliance with conditions of use, prohibition of unauthorised products for incorporation, receipt, secure storage and management of expired products.
Homogeneity and mixing validation
Validation protocol, choice of tracer substances, coefficient of variation achieved, representativeness of product ranges and tonnages tested, revalidation frequency, calibration of dosing equipment.
Cross-contamination and production sequencing
Measurement of carry-over between batches, scheduling of manufacturing runs, rinsing and purging procedures, compliance with regulatory limits for active substances, management of shared circuits.
Veterinary prescription and delivery
Checking the prescription on receipt, quantities and period of validity, compliance with treatment durations, delivery conditions to the farmer, archiving and management of remaining stock.
Labelling, packaging and information
Mandatory particulars, indication of active substance and content, withdrawal period, storage conditions, precautions for use, consistency between label, prescription and delivery note.
Traceability and records
Batch identification, genealogy of materials and medicinal products, manufacturing and delivery registers, retention period, ability to reconstruct a history in the event of a recall.
HACCP and process control
Integration of hazards specific to medicated feed into the HACCP plan, control points, analytical testing plan, management of non-conformities and blocked products.
Staff competence and training
Authorisations for sensitive posts, training on risks linked to active substances, qualification of dosing operators, awareness of responsible antimicrobial use.
Monitoring, review and improvement
Indicators tracked, internal audits, use of analytical results and official control observations, management review, comparison across sites and periods.
A short version of the framework is available for the online self-assessment.
Frequently asked questions
Does this assessment grant approval or a certificate of compliance?
No. Approval is granted by the competent authority in your member state, and compliance is established during official control. The assessment measures the maturity of your practices and prepares for these milestones by identifying gaps before inspection.
How is this different from a regulatory compliance audit?
An audit ends with a gap or a compliance finding on each requirement. The assessment positions the practice on a five-level scale and states the action that moves it up a level. The two are complementary: the assessment builds the trajectory, the audit validates the outcome.
How long does the assessment take?
The short self-assessment can be completed in one working session. The full version is run collaboratively across quality, production and the veterinarian, and spans one to two weeks, with most of the time spent gathering evidence of application.
Does the framework suit an on farm mixer as well as a multi-line plant?
Yes, by adjusting the scope. You edit the questions, remove out of scope themes and adjust level wording. AI can also build a variant from your procedures and HACCP plans.
How does this assessment relate to Regulation (EC) No 183/2005 and Regulation (EU) 2019/6?
The feed hygiene baseline and the veterinary medicinal products framework cover neighbouring requirements. A cross-cutting roadmap consolidates several assessments and avoids duplicating the same action twice.
Can several sites within the same group be compared?
Yes. Audits can be run industrially across all business units, with benchmarking between sites and against previous campaigns. Reporting takes place in a collaborative space branded to you.
Does every identified gap lead to a concrete action?
The gap between the score and the target generates the action plan, which AI groups into a prioritised roadmap. The service catalogue offers a solution for each item, with cost, timeframe and expected impact on the score.
Where is the data hosted?
In France, with OVH, backed up at Scaleway. No transfer outside the European Union. The AI models used can be selected, including European solutions.