Microbiological Criteria Maturity · Regulation (EC) No 2073/2005
Your microbiological criteria, measured against Regulation 2073/2005 and turned into a costed 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.
Microbiological Criteria Maturity · Regulation (EC) No 2073/2005
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 Commission Regulation (EC) No 2073/2005 of 15 November 2005 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 that links the two) is what turns an observation into a trajectory.
Are sampling frequencies justified and reviewed based on results obtained?
- N1
No written justification. Frequencies were carried over from an old plan or a customer request, with no documented link to the products manufactured.
- N2
A sampling plan exists and covers the main production lines, but how it was built is not explained and it has not been reviewed for several rounds.
- N3
Frequencies are justified by product category, linked to hazards identified in the HACCP study, and reviewed during a documented periodic review.
- N4
Frequencies change based on results: reinforced after an unsatisfactory result, reasonably eased after a compliant series, with every change traced and approved.
- N5
The plan is steered by trend analysis and multisite history, benchmarked against sector data, with revisions tracked and presented at management review.
Action to move from L2 to L3
For each product category, formalise a justification note linking the applicable criterion, the sampling stage and the chosen frequency to the hazards identified in the HACCP study, then place its review on the agenda of the annual quality review.
« 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 (EC) No 2073/2005 spells out obligations that Regulation 852/2004 leaves general. It distinguishes two families. Food safety criteria apply to products placed on the market throughout their shelf life: Listeria monocytogenes in ready-to-eat foods, Salmonella, staphylococcal enterotoxins, Cronobacter in powdered infant formula, histamine in fishery products. Process hygiene criteria concern control of manufacturing: Enterobacteriaceae, Escherichia coli, aerobic colony counts. The annexes set out the sampling plan (n, c, m, M), the reference method and the stage of application.
In practice, the difficulty is not knowing the thresholds, it is demonstrating that the whole system holds together. On what basis was the sampling frequency set, and when was it last reviewed? Do shelf-life studies on Listeria monocytogenes exist for every ready-to-eat food that supports its growth, or does the company simply rely on the 100 CFU/g threshold without having justified it? Is the production environment monitoring plan, zones and contact surfaces, steered by results or repeated identically year after year? What actually happens, in practice, between an unsatisfactory result and the decision to withdraw a product?
Two confusions come up repeatedly. The first concerns the nature of process hygiene criteria: an exceedance does not make the product unsafe, it triggers corrective actions on the process, whereas exceeding a food safety criterion leads to withdrawal or recall under Article 19 of Regulation 178/2002. The second concerns trend analysis: the regulation requires organisations to make use of the series of results, not merely to compare each value against a threshold. Many organisations file away test reports without ever drawing a trend reading from them.
A compliance audit asks a binary question: are the applicable criteria met, yes or no. A maturity assessment asks another: at what level of control does the system sit, sampling plan, choice of laboratory, interpretation of results, management of non-conformities, and what precise action moves it up a level. The first records a snapshot. The second builds a trajectory, site by site, and allows plants with uneven practices to be compared.
In Datamensio, the framework is ready to use and adaptable. You can adjust the themes and questions to your product categories, meat, dairy, fishery products, ready-to-eat plant-based foods, and the AI refines the wording of maturity levels using the CMMI method. It can also build a tailored version from your own documents: control plan, customer specifications, procedures for managing unsatisfactory results.
Reference standard: Commission Regulation (EC) No 2073/2005 of 15 November 2005
The themes assessed
Identifying applicable criteria
Mapping of food categories produced, linking to food safety criteria and process hygiene criteria, stage of application, out-of-scope products explicitly justified.
Sampling plan and frequencies
Number of units sampled, n, c, m and M values used, justification of frequencies, account taken of production volume, planned adaptation under Article 5 and traceability of revisions.
Sample collection and transport
Sampling procedures, training of samplers, representativeness, temperature conditions, delivery times, sample identification and recording.
Analytical methods and laboratories
Use of reference methods from the annexes, validated alternative methods, laboratory accreditation, measurement uncertainty, turnaround times for results.
Shelf life and ageing studies
Shelf-life studies for Listeria monocytogenes in ready-to-eat foods, growth tests, predictive microbiology, justification of the chosen threshold, review when recipes or packaging change.
Production environment monitoring
Surface and zone sampling plan, mapping of sampling points, targeting of at-risk zones, use of results, actions on cleaning and disinfection.
Interpreting results and trend analysis
Decision rules, distinction between an unsatisfactory result on a safety criterion and on a hygiene criterion, tracking series over time, internal alert thresholds, reporting to production teams.
Managing unsatisfactory results
Defined response procedure, blocking and disposition of batches, withdrawal and recall, notification to the competent authority, root cause analysis, verification of the effectiveness of corrective actions.
Documentation and evidence
Retention of test reports, maintenance of the control plan, records presentable during an official inspection, alignment with good practice guides and the HACCP study.
Competence and system review
Training of quality and production teams, periodic review of the control plan, integration of regulatory changes and lessons learned, management oversight.
A short version of the framework is available for the online self-assessment.
Frequently asked questions
Can Regulation 2073/2005 be certified?
No. It is a directly applicable EU regulation, compliance with which is checked by authorities during official inspections and by auditors under private schemes. The assessment measures the maturity of the system and prepares for these checks, it does not issue any certificate.
What is the difference between this assessment and a compliance audit?
An audit checks compliance with requirements at a given moment 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 up a level. The two are complementary: the assessment prepares, the audit validates.
How long does the assessment take?
The short version can be completed in one session by a site quality manager. The full version, run collaboratively with the laboratory, production and the quality department, usually takes one to two weeks, most of the time being spent gathering documentary evidence.
Can the framework be adapted to our product categories?
Yes. Themes, questions and the wording of maturity levels can be changed, and you can add your own customer requirements. The AI adjusts levels using the CMMI method or builds a tailored version from your control plan and procedures.
How does this framework relate to HACCP and Regulation 852/2004?
Regulation 2073/2005 provides the numerical criteria used to verify the effectiveness of the control measures set out in the HACCP study. An assessment of microbiological criteria directly informs the validation and verification of the HACCP plan. A cross-cutting roadmap allows the two to be consolidated without duplicating actions.
Can several production sites be compared?
Yes. The same framework is deployed across all sites, with a score by theme, a benchmark between business units, and a comparison against previous assessments. Consolidated gaps feed into a group-wide roadmap.
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 from European providers.