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Free NGT Quick Scan

If your organization develops plants using New Genomic Techniques (NGTs), the EU NGT Regulation (Council position ST-17037-2025-REV 1, adopted 21 April 2026) 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
0 of 13 answered 0%
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.
Confidentiality undertaking. 3BIO hereby undertakes to keep strictly confidential and not to disclose any information provided in response to questions 0 through 11 of this Free NGT Risk Scan to any third party, unless to technical processors acting on our behalf in accordance with our privacy policy, or unless required by law.
Disclaimer — no legal advice. The Free NGT Risk Scan does not provide any legal advice. It provides a free and preliminary indication, and not a formal regulatory classification, based on your answers provided through the questionnaire, to help you classify your plant under the EU NGT Regulation (ST-17037-2025-INIT). 3BIO does not guarantee the accuracy of this preliminary indication. A formal determination from the competent authority is required before deliberate release or market placement (see Articles 6–7 of the NGT Regulation). Any business or other decision taken by the user based on this preliminary indication, as well as any consequences arising therefrom, shall remain solely the user's own responsibility. 3BIO shall not be held liable for any reliance placed on this preliminary indication or for any decisions made on that 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.
Legal basis: Art. 3(13)(b). A plant obtained by crossing a verified NGT1 plant with another plant, using only conventional breeding, qualifies as NGT Category 1 without requiring a new verification decision — provided no new targeted mutagenesis or cisgenesis modifications have been introduced. No Annex II excluded traits may have been introduced by the crossing.
Please select one option.
Skip this step (select "Not applicable") if you answered Yes to Step 11.
Legal basis: Art. 4(a)(i). A plant that meets all Annex I criteria and carries no Annex II excluded traits must nonetheless obtain a formal declaration of NGT Category 1 status before it can be treated as a conventionally bred plant (Art. 5). Until that declaration is issued, the plant must be treated as NGT Category 2 and handled under full GMO legislation.
Please select one option.
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Likely classification
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Decision path

Disclaimer — no legal advice The Free NGT Risk Scan does not provide any legal advice. It provides a free and preliminary indication, and not a formal regulatory classification, based on your answers provided through the questionnaire, to help you classify your plant under the EU NGT Regulation (ST-17037-2025-INIT). 3BIO does not guarantee the accuracy of this preliminary indication. A formal determination from the competent authority is required before deliberate release or market placement (see Articles 6–7 of the NGT Regulation). Any business or other decision taken by the user based on this preliminary indication, as well as any consequences arising therefrom, shall remain solely the user's own responsibility. 3BIO shall not be held liable for any reliance placed on this preliminary indication or for any decisions made on that basis.

✓ 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.

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