Compliance with the regulatory framework applicable to materials intended to come into contact with food · Regulation (EC) No 1935/2004
Your control over food contact materials, measured article by article 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.
Compliance with the regulatory framework applicable to materials intended to come into contact with food · Regulation (EC) No 1935/2004
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 (EC) No 1935/2004 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, one level, the level above, and the action that links the two, is what turns a finding into a trajectory.
Are your food contact material declarations of conformity checked against your actual conditions of use?
- N1
No organised collection. Declarations are requested on an ad hoc basis, during an audit or following a complaint.
- N2
Declarations are collected and filed, but they are not compared against the site’s conditions of use, temperatures, contact times and nature of foodstuffs.
- N3
Every declaration is checked on receipt against documented conditions of use. Gaps identified are referred back to the supplier.
- N4
The check is built into the listing and change management process. Files are completed with the necessary analytical evidence and tracked by version.
- N5
Files are reviewed periodically in line with regulatory monitoring and product changes, with documented tracking of revisions and multi-site consolidation.
Action to move from L2 to L3
Draw up a conditions of use sheet for each pack reference, foodstuff, temperature and contact time, then make it mandatory to check declarations against conditions of use during the monthly quality review of new listings.
« 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 1935/2004 is the framework regulation for materials and articles intended to come into contact with food. Its article 3 sets the central requirement: under normal or foreseeable conditions of use, a material must not transfer constituents to food in quantities liable to endanger health, bring about an unacceptable change in food composition, or degrade its organoleptic characteristics. It is supplemented by regulation (EC) No 2023/2006 on good manufacturing practice, and by specific measures including regulation (EU) No 10/2011 for plastics. It requires upstream and downstream traceability, and a written declaration of conformity for materials covered by a specific measure.
In practice, the difficulty lies not in the text but in the chain of parties involved. Compliance is built across several links, from the resin producer to the packer, and each depends on information passed on by the one before. Do your supplier declarations of conformity cover your actual conditions of use, temperatures, contact times, simulants, or do they refer to generic usage? Have global and specific migration tests been redone after the last change in formulation or supplier? Who at your organisation confirms that a new pack is fit for food contact before it goes into service?
Two contextual points come up repeatedly. First, substances that fall under no harmonised EU specific measure: paper and board, printing inks, adhesives, coatings, silicones. They remain subject to article 3 and to national provisions, which shifts the burden of proof onto the operator. Second, the frequent confusion between the glass and fork logo, which signals food use, and the declaration of conformity, which is the document relied upon during an official inspection. The pictogram is not a substitute for the file.
A compliance audit concludes with a gap or the absence of a gap against a given requirement. The maturity assessment answers a different question: what level of control do your practices sit at, and what precise action moves you to the next level. A site holding every declaration of conformity without having checked them against its actual conditions of use is not at the same level as a site that verifies them at every product listing. The score per theme makes that gap visible, and comparison across business units places each site against the others.
The framework is ready to use in Datamensio. You can adapt it to your scope: the AI adjusts themes, questions and levels to your material families, or builds a variant from your own procedures and technical files.
Reference standard: Regulation (EC) No 1935/2004
The themes assessed
Governance and responsibilities
Appointment of a person responsible for food contact materials, integration with the HACCP approach, resources allocated, coordination between quality, procurement and pack development.
Inventory of materials and uses
Mapping of materials and articles used, families concerned, documented actual conditions of use, temperatures, contact times, nature of foodstuffs, surface to volume ratio.
Declarations of conformity
Obtaining, content and updating of declarations, fit with declared conditions of use, version control, chaining across the whole supply chain.
Analytical evidence and migration
Global and specific migration testing plan, choice of simulants and test conditions, laboratories used, handling of test reports, checks by calculation or modelling.
Non-harmonised substances
Handling of paper, board, inks, adhesives, coatings and silicones, national or voluntary frameworks used, documented justification under article 3.
Good manufacturing practice
Application of regulation (EC) No 2023/2006, quality assurance system, quality control, documentation of processing and packing operations.
Upstream and downstream traceability
Identification of material batches, chaining with batches of packed foodstuffs, time needed to reconstruct records, ability to isolate a scope in the event of a withdrawal.
Supplier control
Contractual requirements, supplier assessment and audit for materials, management of formulation or production site changes, approval before entry into service.
Non-conformity and alert management
Handling of out of limit results, blocking and withdrawal decisions, notification to authorities, lessons learned and corrective actions.
Monitoring and continuous improvement
Tracking of changes to specific measures and lists of authorised substances, periodic file reviews, comparison of scores over time.
A short version of the framework is available for the online self-assessment.
Frequently asked questions
Is regulation 1935/2004 certifiable?
No. It is a directly applicable EU regulation, enforced by national authorities. The assessment measures the maturity of your practices and prepares you for official inspection or customer audit, it does not issue any certificate.
What is the difference between this assessment and a compliance audit?
The audit checks that requirements are met and concludes with a gap or a pass. The assessment places your practices on a maturity scale and points to the action that moves you up a level. The assessment prepares the audit, the audit confirms it.
How long does the assessment take?
The short version is run in a single working session. The full version, run collaboratively with quality, procurement and pack development, typically spans one to two weeks, most of the time being spent gathering technical files.
Can the framework be adapted to our material families?
Yes. You can change the questions, levels and themes, or add a theme dedicated to glass, metal, paper or ceramics. The AI can also generate a variant based on your procedures and specifications.
How should materials with no EU specific measure be handled?
The framework includes a dedicated theme. It assesses the substitute framework used, the applicable national provisions and the strength of the justification produced under article 3. This is often the theme where the maturity gap is widest.
Does the assessment cover good manufacturing practice?
Yes, under regulation (EC) No 2023/2006, which supplements the framework: quality assurance system, quality control and documentation. The questions address management practices, not the process parameters of your suppliers.
Can several sites be compared with each other?
Yes. Audits run on the same framework can be compared by theme, across business units and against previous campaigns. The AI groups recurring gaps into a consolidated roadmap, with cost, timeframe and expected impact on the score.
Where is the data hosted?
In France, at OVH, with backup at Scaleway. No transfer outside the European Union. The AI models used can be selected, including from European providers.