Maturity Regulation (EU) No 10/2011 · Plastic materials intended to come into contact with food
Your grasp of Regulation 10/2011 measured by theme 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.
Maturity Regulation (EU) No 10/2011 · Plastic materials intended to come into contact with food
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 (EU) No 10/2011 of 14 January 2011 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.
It is this mechanism (a level, a level above, and the action linking the two) that turns a finding into a trajectory.
Do your suppliers’ declarations of conformity cover the actual conditions of use of each material?
- 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 their content is not checked against the temperatures, contact times and types of food actually used.
- N3
Each reference has a declaration checked against documented conditions of use, with a written record of the check and who carried it out.
- N4
Verification is systematic at supplier approval and at each notified change, linked to technical data sheets and test reports, with tracking of validity deadlines.
- N5
The system is reviewed periodically, gaps identified feed into supplier contractual requirements, and reviews are documented from one campaign to the next.
Action to move from L2 to L3
Draw up, for each packaging reference, a record of actual conditions of use (maximum temperature, contact time, type of food), check it against the conditions declared by the supplier, and log the conclusion of the check at the monthly 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 (EU) No 10/2011 is the specific measure adopted under Regulation (EC) No 1935/2004 for plastic materials and articles in contact with food. It relies on a positive list of authorised substances, Annex I, and sets an overall migration limit as well as specific migration limits substance by substance. It governs migration testing according to the simulants and conditions of use in Annex III, requires a declaration of conformity in line with Annex IV, and demands supporting documentation kept available to the authorities.
In practice, the difficulty is not knowing the text, it is maintaining the documentary chain over time. Do your suppliers’ declarations of conformity cover your actual conditions of use, temperature, contact time and type of food, or a generic assumption? Do you know, for each packaging reference, which substances subject to specific migration limits are present and who checked the calculation? What happens when a supplier changes resin, colourant or production site without notifying you?
Two confusions come up often. The first is treating the declaration of conformity as an administrative document to be filed away, when it must be backed by test or modelling data, with verifiable usage assumptions. The second concerns scope: Regulation 10/2011 does not cover printing inks, adhesives or coatings as such, and multilayer materials combining plastic with other substances fall under particular rules. Intentionally added substances are not the only ones at stake, non-intentionally added substances also require a risk assessment.
A compliance audit ends with a binary finding: the declaration is present or absent, migration meets the limit or exceeds it. The maturity assessment answers a different question. What level of control does each practice sit at, from supplier approval to change management, and what specific action moves it up to the next level. This is what allows you to arbitrate between several sites or business units whose practices differ, and to sequence a transformation programme rather than stacking up corrective actions.
In Datamensio, the framework is ready to use and adaptable. The AI adjusts the themes, rephrases the questions in the vocabulary of your workshops and refines the levels according to the CMMI method. It can also build a variant from your own documents, packaging specifications, supplier approval procedure or verification plan, then group the gaps into a prioritised roadmap.
Reference standard: Commission Regulation (EU) No 10/2011 of 14 January 2011
The themes assessed
Governance of the food contact file
Allocation of responsibilities between quality, procurement, packaging and laboratory, internal policy, monitoring of changes to the regulation and to Annex I, resources allocated.
Scope and inventory of materials
Inventory of plastic materials and articles used, distinction between monolayers, plastic multilayers and composite materials, identification of cases falling under other texts.
Authorised substances and positive list
Verification of Annex I listing, monomers and additives, associated restrictions and specifications, treatment of non-intentionally added substances, use of polymer production aids.
Migration limits and testing
Overall and specific migration testing plan, choice of simulants and conditions under Annex III, use of modelling, laboratory qualification, retention of reports.
Declaration of conformity and supporting documentation
Compliance of content with Annex IV, statement of conditions of use, fit with actual usage, completeness and accessibility of supporting documentation.
Control of the supply chain
Contractual requirements imposed on suppliers, audits and evaluation of manufacturers, transmission of usage information along the chain, management of subcontractors.
Good manufacturing practice and prevention of contamination
Application of Regulation (EC) No 2023/2006, control of storage and handling conditions, prevention of transfers between materials, management of recycled materials where applicable.
Management of changes and non-conformities
Procedure for notifying supplier changes, reassessment before industrialisation, handling of limit exceedances, withdrawal or hold decisions, notification of authorities.
Competence and awareness
Training of quality, procurement and production teams in food contact requirements, level of understanding of conditions of use, support from external expertise.
Verification, review and improvement
Internal checks of the file, monitoring indicators, periodic reviews of declarations, incorporation of feedback from inspections and client audits, comparison over time.
A short version of the framework is available for the online self-assessment.
Frequently asked questions
Does this assessment issue a certificate of compliance with Regulation 10/2011?
No. The declaration of conformity is the responsibility of the operator placing the material on the market, and official verification is the responsibility of the competent authorities. The assessment measures the maturity of your practices and prepares for these milestones by identifying the gaps to address.
How does this differ from a regulatory compliance audit?
An audit ends with a binary finding, requirement met or gap. The assessment places each practice on a five-level maturity scale and indicates the action that moves it up from one level to the next. The two are complementary: the assessment prepares, the audit validates.
How long does the assessment take?
The short version can be completed in one working session. The full version, run collaboratively with quality, procurement, packaging and the laboratory, takes one to two weeks, most of the time being spent gathering declarations and test reports.
Can the framework be adapted to our business?
Yes. You can change the questions, levels and themes, or start from your own documents. The AI rephrases in the vocabulary of your workshops and refines the levels according to the CMMI method. A film manufacturer, a converter and a party placing products on the market do not share the same scope of responsibility.
Do you need migration expertise to answer?
The questions concern organisation and documentary control, not the migration calculation itself. Some require input from the laboratory or the regulatory manager: the collaborative mode allows these questions to be assigned to the right person.
How does this assessment fit with hygiene and HACCP?
Food contact is a chemical hazard to be included in the HACCP analysis and in good hygiene practice. A solid 10/2011 assessment feeds these systems, and the cross-cutting roadmap consolidates several audits without duplicating actions.
Can several plants be compared with each other?
Yes. The same framework applies to each site or business unit, with a score per theme and a benchmark between entities as well as against previous campaigns. The reporting is shared in a collaborative space branded to your organisation.
Where is the data hosted?
In France, with OVH, with backup at Scaleway. No transfer outside the European Union. The AI models used can be selected, including from European solutions.