Food Enzymes Compliance · Regulation (EC) No 1332/2008
Your food enzymes practices, mapped against Regulation (EC) No 1332/2008 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.
Food Enzymes Compliance · Regulation (EC) No 1332/2008
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 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes 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 level above, and the action that links the two, is what turns a finding into a trajectory.
Is the regulatory status of every enzyme preparation used documented and kept up to date?
- N1
No inventory of enzyme preparations. Regulatory status is not documented and relies on the supplier’s technical data sheet.
- N2
A list exists for the main enzymes. Supporting evidence is partial and its update depends on external requests.
- N3
The inventory covers all preparations used. Each enzyme is linked to its function, its origin and the supplier’s regulatory evidence, reviewed at a set interval.
- N4
The inventory is integrated into the document system and checked at every listing or source change. Gaps trigger a tracked action and a hold until they are closed.
- N5
The system is steered by indicators, fed by monitoring of authorisation dossiers, and substitution decisions are anticipated with suppliers and documented.
Action to move from L2 to L3
Complete the inventory with secondary enzymes and processing aids, request status evidence and specifications from every supplier, then add a review of this inventory to the quarterly quality review with a named owner.
« 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 1332/2008 governs the enzymes used in food production, whether present as an ingredient or used as processing aids. It sets out a simple principle: only enzymes listed on the Community list, together with their conditions of use, may be placed on the market and used. It also defines the labelling rules that apply to enzymes sold as such, the specifications expected (origin, enzymatic activity, purity criteria) and the evaluation procedure carried out by EFSA under Regulation (EC) No 1331/2008.
In practice, the difficulty lies not in the text itself but in the information chain that makes it workable. Is the origin and regulatory status of each enzyme preparation documented all the way back to the supplier, or does it rest on an outdated technical data sheet? Can teams reliably tell, within recipes, what counts as a processing aid from what must appear on the label? Are carriers, diluents and culture media traced to the same standard as the active substance? These questions tend to surface during a customer audit, rarely before.
One point of context matters here. The Community list of food enzymes has not yet been established: the evaluation programme run by EFSA is ongoing, submitted dossiers continue to be assessed, and national measures remain applicable in the meantime. This transitional situation feeds a common confusion: enzymes are not additives. They fall under Regulation 1332/2008, not Regulation (EC) No 1333/2008, with direct consequences for labelling and for the authorisation regime.
A compliance audit ends with a binary finding: the preparation is authorised or it is not, the label is correct or it is not. The maturity assessment answers a different question. What level of control does the organisation have over supplier qualification, over monitoring authorisation dossiers, over labelling decisions, over managing allergens carried by carriers. And above all: what specific action moves each theme up to the next level, with its cost and timeframe.
The framework is ready to use in Datamensio and adapts to your organisation. AI adjusts the themes, rephrases the questions to match your product categories, and refines the levels according to the CMMI method. It can also build a version derived from your own documents: supplier specifications, ingredient qualification procedures, group framework.
Reference standard: Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes
The themes assessed
Inventory of enzyme preparations
Exhaustive listing of enzymes used, declared enzymatic activity, producing organism, technological function, sites and lines concerned.
Regulatory status and authorisations
Verification of status under Regulation 1332/2008, tracking of submitted dossiers and EFSA opinions, consideration of national measures applicable during the transitional period.
Specifications and quality of preparations
Origin, strain and production process, purity criteria, absence of viable producing micro organisms, contaminants, supplier certificates of analysis.
Supplier qualification and monitoring
Specifications, documentary requirements imposed on the manufacturer, supplier audits, management of source or formulation changes.
Processing aid or ingredient
Rules for qualifying the function, decision criteria, traceability of the rationale, review whenever a recipe or process changes.
Labelling and information
Statements applicable to enzymes sold as such, consequences for the finished product’s ingredient list, information provided to business customers, consistency of technical data sheets.
Allergens and carriers
Identification of diluents, carriers and culture media, management of allergens carried through, assessment of transfer into the finished product.
Traceability and batch control
Upstream and downstream traceability of enzyme preparations, actual dosage applied in production, records, ability to reconstruct history in the event of a withdrawal.
Regulatory monitoring and change management
Sources monitored, review frequency, decision process when status changes, updates to product files and labels.
Competence and integration into the quality system
Training for R&D, procurement and production teams, place of the topic within the HACCP plan and quality reviews, dedicated internal audits.
A short version of the framework is available for the online self-assessment.
Frequently asked questions
Is Regulation (EC) No 1332/2008 certifiable?
No. It is a directly applicable EU regulation, enforced by the competent authorities under Regulation (EU) 2017/625. The assessment measures your maturity level and prepares you for official controls or customer audits, it does not issue any certificate of compliance.
What is the difference between this assessment and a compliance audit?
An audit rules on whether a requirement is met and ends with a finding of a gap. The assessment places each theme on a five level maturity scale and identifies the action that moves it up a level. The two complement each other: the assessment prepares for the audit, the audit validates.
Are food enzymes additives?
No, and the confusion is common. Additives fall under Regulation (EC) No 1333/2008, enzymes under Regulation (EC) No 1332/2008. The authorisation regimes and labelling rules differ, particularly depending on whether the enzyme is used as an ingredient or as a processing aid.
Has the Community list of enzymes been published?
EFSA’s dossier evaluation programme is ongoing and the list has not yet been established. National provisions remain applicable during this transitional period. The framework specifically assesses your ability to track these developments and act on the enzymes in your portfolio.
How long does the assessment take?
The short version takes about thirty minutes for someone familiar with the file. The full version, run collaboratively with procurement, R&D and production, usually spans one to two weeks, most of the time going into gathering supplier evidence.
Can the framework be adapted to our product categories?
Yes. Themes, questions and levels can all be modified, and AI can generate a version based on your procedures or supplier specifications. You remain the owner of the resulting framework.
Can several sites be compared with each other?
Yes. The assessment scales across all plants or business units, with a score per theme and a benchmark between entities as well as against previous rounds. A cross site roadmap consolidates action plans and groups common gaps.
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 providers.