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Free NGT Quick Scan

If your organization develops plants using New Genomic Techniques (NGTs), the EU NGT Regulation (ST-17037-2025-INIT) determines whether your plant is treated as conventionally bred (Category 1 NGT), falls under full GMO legislation (Category 2 NGT), or sits entirely outside the scope. The regulatory consequences differ dramatically: from a simple declaration procedure to a full market authorisation dossier. 3BIO therefore offers a free, 10-minute Quick Scan to help you classify your plant. You receive an instant snapshot of the likely category, and one of our biotech regulatory experts will contact you within 48 hours to schedule a free 20-minute review call.

Duration
≈ 10 minutes
Instant
Category classification
Within 48h
Free 20-min expert call
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How this works. The NGT Regulation classifies plants through a sequential decision tree based on the techniques used and the modifications introduced. Answer Yes or No to each step (some steps may not apply depending on earlier answers; mark these as Not applicable). You receive an immediate classification, and a biotech regulatory expert will contact you within 48 hours to schedule a free 20-minute review call. Click the green next to any question for guidance on the legal basis.
Section 1 of 4

Scope of the NGT Regulation

The NGT Regulation applies only to plants. Animals, micro-organisms, fungi and other organisms remain governed by the existing GMO framework (Directive 2001/18 and Regulation 1829/2003), regardless of the technique used.
Please select one option.
Legal basis: Art. 3(9)–(11). Targeted mutagenesis introduces substitutions, insertions or deletions at defined genomic locations without inserting foreign DNA. Cisgenesis inserts genetic material from sexually compatible species (the conventional breeding gene pool). Any plant retaining DNA from outside that gene pool, or produced by transgenesis, falls outside the NGT Regulation; the existing GMO legislation applies.
Please select one option.
Section 2 of 4

Technique and mutagenesis criteria

Legal basis: Art. 3(10), Annex I §1. If targeted mutagenesis is used (alone or in combination with cisgenesis), the Annex I mutagenesis criteria apply (Steps 3–4). If cisgenesis is used alone (no mutagenesis), Steps 3–4 do not apply.
Please select one option.
Skip this step (select "Not applicable") if you answered No to Step 2 (cisgenesis only).
Legal basis: Annex I §1(a)(b). The Annex I size limit caps substitutions and insertions at 20 nucleotides each. Larger modifications push the plant into Category 2 NGT, where full GMO legislation applies.
Please select one option.
Skip this step (select "Not applicable") if you answered No to Step 2 (cisgenesis only).
Legal basis: Annex I §1. The Annex I per-gene frequency limit restricts targeted modifications to 3 per protein-coding sequence. Modifications in introns and regulatory regions do not count toward this limit.
Please select one option.
Skip this step (select "Not applicable") if you answered No to Step 2 (cisgenesis only); in that case cisgenesis is already implied.
Legal basis: Annex I §§1–3. When both techniques are used in combination, the cisgenesis criteria of Steps 6–7 also apply. If only mutagenesis is used, those steps can be skipped.
Please select one option.
Section 3 of 4

Cisgenesis criteria

Skip this step (select "Not applicable") if Step 5 was No (mutagenesis only).
Legal basis: Annex I §2(a). Cisgenic material must originate within the conventional breeding gene pool and remain as continuous sequences. Material from outside that gene pool, or assembled discontinuously, triggers Category 2 NGT classification.
Please select one option.
Skip this step (select "Not applicable") if Step 5 was No (mutagenesis only).
Legal basis: Annex I §2(b)(i)(ii). Intragenic modifications that disrupt endogenous genes or generate chimeric proteins are excluded from Category 1, following EFSA opinions (2012, 2022).
Please select one option.
Section 4 of 4

Genome-wide limit and excluded traits

Legal basis: Annex I §3. The Annex I genome-wide ceiling caps the total number of modifications at 20 per monoploid genome, regardless of the technique used. This step always applies.
Please select one option.
Legal basis: Annex II §1. Herbicide tolerance is explicitly excluded from Category 1, regardless of whether all Annex I criteria are otherwise met. Plants with this trait default to Category 2 NGT.
Please select one option.
Legal basis: Annex II §2. Production of a known insecticidal substance is an excluded trait under Annex II §2. Plants with this trait default to Category 2 NGT.
Please select one option.
Your details

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Likely classification
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Result

Decision path

This is a preliminary indication based on your answers, not a formal regulatory classification. A formal declaration from the competent authority is required before deliberate release or market placement (Articles 6–7 of the NGT Regulation).

✓ Your free 20-minute call is reserved

A biotech regulatory expert will contact you within 48 hours at the email you provided to schedule a time. They will review your classification in advance so the call is focused on your specific plant and intended use.

Questions? Contact us