FILE
NG–2026–07
STATUS
DOCTRINE IN DRAFT
CLASS.
TECHNICAL · PUBLIC
SCOPE
MICROORGANISMS
EXECUTION
POST-MVP
0
residual foreign DNA in the final genotype: it is the design condition, not a desirable goal
2
levels in the optimisation: the objective on the outside, the cell's growth on the inside
5
types of endogenous edit: knockout, knockdown, overexpression, swapping of curated parts and point editing
55–60 %
of realistic reuse of the existing ecosystem, with two genuinely new engines
+
+
+
+
What makes it unique
It models the fact that the cell does not cooperate. The optimisation is bilevel: the outer level pursues the production objective and the inner one maximises the organism's own growth. A design the population reverts in three passages is a failed design, and only that formulation detects it before touching the laboratory.
And it treats editability as part of the design, not as a footnote: if the locus has no usable recognition sequence, the guide is not unique or the off-target effects are unacceptable, the edit is not reachable however elegant the metabolic route.
01
The state of the art
Suggesting a knockout is easy. Turning it into a plan is not.
Metabolic models already emit suggestions to knock out or overexpress the organism's own genes. What does not exist downstream is anything able to express them as a recipe, score them, optimise them and turn them into a protocol. It is an orphaned output.
02
The three inventions
What the existing core does not have and has to be built.
The rest is reused: infrastructure, compiler, flux balance analysis, reports and interface. Building a parallel core would mean rebuilding the platform's most expensive asset.
03
The regulatory axis
Honest scope, and narrower than the name suggests.
Nothing in this section is legal advice. The module issues a classification dossier with its explicit axes, the jurisdiction declared and the uncertainty flagged. Validation is a matter for specialist legal audit.
The caveat that has to be said plainly
The European regulation on new genomic techniques, adopted in April 2026, applies to plants. It does not cover microorganisms or animals: edited microorganisms — this module's own domain — remain under the previous framework in the Union. Selling this as "no longer transgenic in Europe" would be false, and so it is not sold that way.
Axis A
Nature of the edit
Template-free indels and short-template-directed editing with no residual foreign DNA are in by construction. Inserting a gene or cassette is rejected at compile time: it is something else and is called by its name.
Axis B
Fate of the editor
Status depends not only on the edit but on whether the machinery that made it persists. Delivery as a ribonucleoprotein, a cured transient plasmid or segregation of the cassette: that is design, not paperwork.
Axis C
Product exposure
An organism that reaches the consumer alive is not the same as processed biomass from which only the metabolite emerges. The dossier declares it, because it changes the conversation entirely.
Where the value is immediate is in products that reach the consumer alive — starter cultures, probiotics, biocontrol, clean-label ferments — and in traits that are simply not portable: deep subsystems with exotic cofactors or membrane bioenergetics, where the foreign-gene route is unfeasible today.
04
The boundary
What belongs to NoGMO and what belongs to another module.
Yes
Design non-transgenic improvement over elements the organism already has.
Score and optimise those edits against the organism's real physiology.
Issue a guide plan and a classification dossier with the jurisdiction and date declared.
No
It does not design heterologous cassettes: that belongs to the foreign-gene design module.
It does not detect transgenics in food: that is the verification strand used by the kit generator, and its semantics are the opposite.
It issues no legal verdict: it issues a dossier. Legal validation belongs to a specialist lawyer.
05
Technical sheet
Name
Non-transgenic improvement: editing the organism's own genome without introducing foreign genetic material.
Operations
Knockout, expression knockdown, overexpression, swapping of curated parts and point editing of the locus.
Architecture
Hybrid by explicit decision: the engine lives inside the existing cross-cutting core and the product is a module of its own, with its licence, its interface and its reports.
Chains to
It takes from the primer design module the oligonucleotide design precedent that the guide designer extends, and from the in silico validator the check on the protocol's verification amplicons.
Status
Doctrine in draft with the architecture decided. The module exists today as a navigation entry in all four languages, with no route and no engine. Execution planned after the MVP under way.
Limit · regulatory
The European regulation on new genomic techniques applies to plants. Edited microorganisms remain under the previous framework, and the module claims otherwise in none of the documents it issues.
Limit · chassis
The curated organisms in the current catalogue are biased towards use as recipients of foreign genes. This module's best candidates — native producers, archaea, non-model organisms — are largely outside it. Curating them is real work, not an import.
Limit · scope
It does not replace heterologous design. If the trait is portable and the objective allows it, the foreign-gene route remains superior; the value of having both is being able to decide, on quantified grounds, which one applies.
Bilevel combinatorial optimisation in the family of classical knockout prediction methods. Flux balance analysis over genome-scale metabolic models for the stoichiometric component. Classification of the edit under the international site-directed nuclease categories. Regulation (EU) on new genomic techniques, adopted on 21 April 2026, with application expected in mid-2028 and scope limited to plants.
How far you get without bringing anything in from outside.
BIOTECNO.org · Vitoria-Gasteiz
EU + Codex