Novel food compliance · Regulation (EU) 2015/2283
Your Novel Food framework assessed requirement by requirement, translated 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.
Novel food compliance · Regulation (EU) 2015/2283
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 (EU) 2015/2283 of 25 November 2015 on novel foods, applicable since 1 January 2018 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 them, is what turns a finding into a trajectory.
Is novel food status determined and documented before any development of a new ingredient?
- N1
No status analysis is carried out upstream. The question is raised only when a customer, distributor or authority asks it.
- N2
The regulatory team handles it case by case, often late in development. Conclusions are not kept in any shared record.
- N3
A documented status review is carried out for each new ingredient, at a defined milestone in the development process. Evidence of use before 15 May 1997 is referenced.
- N4
The review is systematic, logged in an ingredient register, validated by a designated owner, and rerun whenever a process or supplier changes.
- N5
The register is periodically checked against the Union list and EFSA opinions, past decisions are reassessed in light of new positions, and revisions are documented.
Action to move from level 2 to level 3
Make a status review mandatory at the feasibility milestone of the product development process, using a standard template that requires the target category under Regulation 2015/2283, evidence of pre-1997 consumption and the name of the decision maker, then present it at the monthly project committee.
« 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) 2015/2283 governs novel foods, meaning food and ingredients whose human consumption in the Union was negligible before 15 May 1997. It covers ten categories, including food from new production processes, engineered nanomaterials, insects and their parts, cell cultures, and substances extracted from animals or plants using a novel process. No product may be placed on the market without prior Commission authorisation, entered on the Union list under implementing Regulation (EU) 2017/2470. A lighter notification procedure exists for traditional foods from third countries.
In practice, the difficulty starts before the dossier. Status qualification is an exercise in interpretation, and that is where projects go off track. Who in your organisation decides whether a plant extract counts as a novel food or a documented historical use? What evidence of pre-1997 consumption do you rely on, and is it kept in a usable form? What happens when a supplier changes an extraction process during the product’s life, without R&D or quality being informed?
Two recent points of context deserve attention. First, the five year data protection granted to an authorisation applicant, which makes dossier precedence a competitive issue rather than a mere regulatory cost. Second, the boundary with other regimes: an ingredient can fall under novel food status as well as the additives regulation, food supplements or health claims. A common confusion worth clearing up: listing a substance on the Union list authorises an applicant, specifications, conditions of use and specific labelling, not the substance in general.
A compliance audit checks a state: the product is authorised or it is not, the dossier is complete or it shows gaps. The maturity assessment answers a different question. What level of control does your qualification, monitoring and authorisation tracking process actually have, and what specific action moves you to the next level. This is the lens that lets you decide whether to strengthen regulatory watch, structure status review earlier in projects, or industrialise supplier monitoring.
In Datamensio, the framework is ready to use and remains yours. The AI adjusts themes, questions and levels to your scope, plant ingredients, alternative proteins or new processes, or builds a variant from your existing procedures and dossiers.
Reference standard: Regulation (EU) 2015/2283 of 25 November 2015 on novel foods, applicable since 1 January 2018
The themes assessed
Governance and regulatory responsibilities
Ingredient qualification policy, identified roles and decision makers, coordination between regulatory, R&D, quality and procurement, allocated resources.
Novel food status qualification
Determination process, mapping to the regulation’s ten categories, evidence of significant consumption before 15 May 1997, traceability of decisions and external opinions.
Monitoring the Union list
Tracking of implementing Regulation (EU) 2017/2470, authorisations and withdrawals, specifications, conditions of use and usage restrictions by food category.
Building the application dossier
Description of the production process, composition and specifications, stability data, history of use, toxicological data, nutritional assessment, allergenicity, proposed use and exposure levels.
Traditional foods from third countries
Use of the notification procedure, evidence of safe use history for at least twenty five years, handling of duly reasoned objections from member states and EFSA.
Data protection and ownership
Application for protection of newly established scientific data, confidentiality management, tracking of the five year protection period, agreements with partners and suppliers.
Labelling and consumer information
Food name, mentions and additional requirements set by the authorisation, conditions of use and warnings, consistency with Regulation (EU) No 1169/2011.
Supply chain control
Supplier qualification, compliance with authorised specifications, detection of process changes, contractual clauses, incoming analytical checks.
Traceability and non-conformity management
Identification of affected batches, withdrawal and recall procedure, notification to competent authorities, coordination with Regulation (EC) No 178/2002 obligations.
Post-authorisation monitoring and improvement
Monitoring requirements set by the authorisation, collection of consumption data, reassessment when new information emerges, feedback loop and procedure updates.
A short version of the framework is available for the online self-assessment.
Frequently asked questions
Is Regulation (EU) 2015/2283 certifiable?
No. It is a directly applicable EU regulation, enforced by member states’ competent authorities. What can be obtained is a product by product market authorisation, following scientific evaluation. The assessment measures the maturity of your framework and prepares you for inspection, it does not grant any authorisation.
What is the difference between this assessment and a regulatory compliance audit?
The audit concludes with a gap or a pass on a given state. The assessment places your practices on a maturity scale and points to the action that moves you up one level. The two are complementary: the assessment prepares for the audit and supports internal decision making.
How long does the assessment take?
The short version can be completed in one working session. The full version, run collaboratively with regulatory, R&D, quality and procurement, takes one to two weeks, most of the time being spent gathering evidence from teams.
Can the framework be adapted to our portfolio?
Yes. Questions, levels and themes can be edited, and you can add your own. The AI generates a variant targeted at your categories, plant extracts, insects, fermentation proteins or new processes, based on your procedures.
How do we handle an already marketed ingredient with uncertain status?
The assessment distinguishes control of the incoming flow, new projects, from control of the existing stock, the legacy portfolio. The action plan then sequences the rebuild of the ingredient register, requesting evidence from suppliers and, where needed, consulting the competent authority.
Does this assessment also cover additives, flavourings and supplements?
No, these regimes have their own frameworks. A single ingredient can fall under several frameworks. The cross-cutting roadmap consolidates several assessments and avoids duplicating common actions, particularly on regulatory watch and supplier qualification.
Can multiple sites or subsidiaries be compared?
Yes. Assessments can be rolled out across multiple business units, with a score per theme and a benchmark between entities as well as against previous campaigns. A consolidated roadmap groups recurring actions.
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 European solutions.