Compliance with pharmacologically active substances · Regulation (EU) No 37/2010
Control of pharmacologically active substances, measured by theme and turned into a costed action plan.
9 themes, a 5-level scale. And the action that moves each level to the next.
The framework’s 9 themes, already written from L1 to L5. One company, one business unit, or 300 at once.
Compliance with pharmacologically active substances · Regulation (EU) No 37/2010
9 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 Commission Regulation (EU) No 37/2010 of 22 December 2009 assessment launched across all three sites at once, from the managers’ interview notes. The framework was already written, its 9 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 an observation into a trajectory.
Are withdrawal periods for treated animals recorded and verified before slaughter or collection?
- N1
No structured recording of treatments. Compliance with the withdrawal period relies on the memory of the farmer or the batch manager.
- N2
Treatments are logged on paper or in a local file, but verification before animals depart or collection takes place is not systematic.
- N3
Treatments are recorded in a common format and the withdrawal period is verified before every departure. Gaps are occasional and corrected.
- N4
Verification is a hard stop: an animal or batch still under withdrawal cannot be released. Checks are logged and periodically audited at suppliers.
- N5
Treatment data is integrated into the information system and cross-checked against analytical results. Rules are revised each time the substance table changes, with documented follow-up.
Action to move from L2 to L3
Set up a single format for recording treatments (substance, species, date, withdrawal period, animal identification), make it mandatory for all suppliers, and build a documented checkpoint into the collection order sign-off, reviewed at the monthly quality meeting.
« 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) No 37/2010 is the act that replaced the annexes to Regulation (EEC) No 2377/90. It presents, in a single table, authorised pharmacologically active substances with their maximum residue limit (MRL), the animal species concerned, the foodstuffs covered (muscle, fat, liver, kidney, milk, eggs, honey) and, where applicable, specific provisions. A second table lists prohibited substances, for which no MRL can be established. It links to Regulation (EC) No 470/2009, which sets out the assessment procedure, and governs the placing on the market of veterinary medicines intended for food-producing animals.
In practice, the difficulty is not reading the table, it is ensuring the whole chain complies with it. Are withdrawal periods actually applied and recorded on farm, including for off-label uses under the cascade? Does the self-monitoring plan cover the substances relevant to each species and matrix, or does it replicate a legacy plan that has not kept pace with supply changes? What actually happens, in practice, between a non-compliant lab result and the effective blocking of the batch? The answers rarely fit into a single document.
The context has evolved with Regulation (EU) 2019/6 on veterinary medicines and Regulation (EU) 2019/4 on medicated feed, which came into application in 2022 and strengthened treatment recording obligations and controls on antimicrobial resistance. Regulation (EU) 2019/1871 also introduced reference points for action applicable to prohibited substances. One confusion recurs often: pesticide MRLs fall under Regulation (EC) No 396/2005, veterinary medicine MRLs under Regulation 37/2010. The two control plans are distinct and sampling under one does not substitute for the other.
A compliance audit ends with a yes or no: the MRL is met, the document exists or it is missing. The maturity assessment asks a different question. What level of control applies to residue surveillance, farm record management, handling of non-conformities, and what precise action moves you to the next level. This progressive reading is what makes it possible to compare sites, track a trajectory over time, and justify analytical investment.
The framework is available in the catalogue and ready to use immediately. It adapts to your scope: species, sectors, operator status. AI adjusts the themes, questions and levels according to the CMMI method, or builds a variant from your surveillance plans, supplier specifications and internal procedures.
Reference standard: Commission Regulation (EU) No 37/2010 of 22 December 2009
The themes assessed
Knowledge and monitoring of the regulatory framework
Tracking updates to the table of authorised substances, accounting for prohibited substances, alignment with Regulations (EC) No 470/2009, (EU) 2019/6 and (EU) 2019/4, internal dissemination of changes.
Control of upstream treatments
Veterinary prescription, use of the cascade, compliance with and recording of withdrawal periods, upkeep of the farm register, identification of treated animals.
Supplier requirements and contracting
Residue clauses in specifications, guarantees required from farmers and importers, non-treatment attestations, batch acceptance conditions.
Surveillance and self-monitoring plan
Selection of substances and matrices, sampling frequency and representativeness, sampling procedures, alignment with the national residue control plan.
Analysis and laboratories
Accreditation and scope of methods, limits of quantification relative to MRLs and reference points for action, turnaround times, handling of counter-analyses.
Handling non-compliant results
Trigger criteria, batch blocking and holding, investigation into origin, notification to competent authorities, withdrawal and recall where applicable.
Traceability and documentation
Link between batch, animal and treatment, record retention, ability to reconstruct the history for official controls, data consistency between upstream and processing stages.
Skills and awareness
Training of farmers and operators, qualification of samplers, knowledge of prohibited substances, role of the referring veterinarian.
Steering, indicators and improvement
Compliance indicators by sector and site, periodic review of the surveillance plan, use of gap findings, comparison over time between business units.
A short version of the framework is available for the online self-assessment.
Frequently asked questions
Can Regulation (EU) No 37/2010 be certified?
No. It is a directly applicable regulation, whose compliance is checked by competent authorities during official controls and national surveillance plans. The Datamensio assessment measures the maturity of your practices and prepares for these controls, it does not issue any certificate.
What is the difference between this assessment and a residue compliance audit?
An audit checks whether a requirement is met and concludes with a gap or a pass. The assessment places each practice on a five-level maturity scale and identifies the action that moves it to the next level. The two complement each other: the assessment prepares for the audit, the audit validates it.
Should this framework be distinguished from the one on pesticide MRLs?
Yes. Veterinary medicine residues fall under Regulation (EU) No 37/2010, pesticide residues under Regulation (EC) No 396/2005. The substances, matrices and control plans differ. A cross-cutting roadmap allows both assessments to be consolidated without duplicating actions.
How long does the assessment take?
The short version takes 20 to 30 minutes for a quality manager to complete. The full version, run collaboratively with the veterinarian, laboratory and procurement, typically spans one to two weeks, with most of the time spent gathering input from contributors.
Can the framework be adapted to our sector?
Yes. Themes, questions and level wording can all be modified. AI adjusts the framework to your species, operator status and scope, or builds a variant from your surveillance plans and specifications.
How can multiple sites or sectors be compared?
Each assessment produces a score per theme. The benchmark compares business units against each other and each entity against its own history. AI groups the gaps into a prioritised roadmap, and the services catalogue links each action to a cost, a timeframe and an impact on the score.
Is veterinary expertise required to answer?
The questions cover organisation and management practices, not pharmacology. A quality manager can answer them. Some questions fall to the veterinarian or the laboratory: collaborative mode allows them to be assigned to the right person.
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 from European solutions.