Plants obtained by new genomic techniques: information requirements and verification of category 1 status

301 submissions in the snapshot (253 from organisations), portal total 301. Feedback list on the portal.

253 of 253 organisation submissions analysed; the model reads them as: opposes 9 supports 44 wants changes 161 39 held back for review (low confidence).

• SAFE Food Advocacy Europe Consumer organisation, BEL; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Include complete event-specific molecular characterisation in the information requirements under Article 25(a).

    That the information requirements under Article 25(a) include a complete event-specific molecular characterisation: the sequence of the modified and flanking regions with genomic coordinates on a named reference genome, the target site and any associated PAM sequence, off-target analysis, and the parental line and originating cultivar.

  • Identify a minimum core of genomic elements to be published with the decision and entered in the Article 9 database.

    That the delegated act identify a minimum core of genomic elements to be published with the decision and entered in the Article 9 database, sufficient for a third party to develop an identification method.

  • Specify the constituent elements of the verifiable justification under Article 11(3)(b) and clarify that confidentiality cannot extend to that minimum core.

    That it specify the constituent elements of the verifiable justification under Article 11(3)(b) and clarify that confidentiality cannot extend to that minimum core.

• Verbraucherzentrale Südtirol Consumer organisation, ITA model reads as: wants changes source
  • Adapt the equivalence criteria for NGT 1 plants to reflect scientific and technological progress by amending Annex I.

    It is therefore necessary to adapt the criteria for equivalence of NGT 1 plants to conventional plants to scientific and technological progress by amending the wording of Annex I.

    machine translation by the Commission, original in DE
  • Introduce a mandatory plausibility check based on existing databases and stochastic calculations to assess whether NGT plants are truly equivalent to conventionally bred plants.

    In order to assess whether NGT plants can indeed be considered equivalent to conventionally bred or naturally produced plants according to the criteria of Annex I, we call for a mandatory plausibility check that a NGT plant can be obtained by conventional breeding or natural processes, based on existing databases (genotypes and phenotypes of conventionally bred plants) and stochastic calculations of the probability of equivalence.

    machine translation by the Commission, original in DE
  • Ensure all relevant information on NGT 1 plants is accessible in a publicly available database for maximum transparency and consumer information.

    In the interests of consumer information and maximum transparency, all relevant information on the NGT 1 plants must be accessible in the database, and a NGT plant or product is placed on the market by BEVOR.

    machine translation by the Commission, original in DE
• SAFE Food Advocacy Europe Consumer organisation, BEL; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Require that the justification under Article 14(1)(l) be reasoned for each individual NGT plant and backed by experimental evidence rather than general presumptions.

    A. That the justification under Article 14(1)(l) be reasoned in respect of the individual NGT plant and supported by experimental evidence, no general presumption of non-detectability being founded on the type of modification or technique.

  • Publish the justification and its assessment alongside the authorisation when arrangements are adapted.

    B. That, where arrangements are adapted, the justification and its assessment be published with the consent or authorisation, and the adapted arrangement stated therein, so that laboratories and operators know what performance the method offers and the adaptation can be revisited as capability advances.

  • Specify precise conditions of access to samples and reference material for official laboratories under Article 14(1)(m).

    C. That the conditions of access to the samples and reference material under Article 14(1)(m) be specified - period, form, quantity, duration and terms - so that official laboratories can use them.

• Testbiotech - Institute for Independent Impact Assessment of Biotechnology Environmental organisation, DEU; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Amend the Annex I criteria to encompass types of compact genetic changes and respective combinations which cannot be expected from random processes.

    it is proposed to amend the Annex I criteria to encompass types of compact genetic changes and respective combinations which cannot be expected from random processes.

• SOLANA GmbH Company, DEU model reads as: wants changes source
  • Do not require whole genome sequencing for verification.

    Our main concern is whole genome sequencing, and we would ask the Commission not to require it.

    machine translation by the Commission, original in DE
  • Clarify that vegetative generations of a verified plant are covered and need no further submission.

    Please make clear that vegetative generations of a verified plant, from pre-basic through to certified seed, are covered as well and need no further submission.

    machine translation by the Commission, original in DE
  • Allow several routes for showing that a sequence belongs to the breeders' gene pool.

    Several routes should be open for showing that a sequence belongs to the breeders’ gene pool, as in EFSA’s 2022 opinion.

    machine translation by the Commission, original in DE
• No patents on seeds! NGO, DEU; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Clarify the delineation between patents on NGT plants and the non-patentability of naturally occurring biological resources within the delegated acts.

    No Patents on Seeds! demands that within the delegated acts, the delineation between patents on NGT plants and the non-patentability of naturally occurring biological resources (as used in conventional breeding) is clarified.

  • Require applicants to declare that no biological material such as naturally occurring gene variants is claimed and that patents do not interfere with conventional breeding.

    Therefore, the European Commission, within the delegated acts (Article 25), should request the applicants to declare that that no biological material such as naturally occurring gene variants is claimed and that their patents do not interfere with conventional breeding activities and the marketing of respective conventionally bred plant varieties.

  • Amend Directive 98/44/EC to reduce the scope of patents or definitely exclude patents on biological material used for conventional breeding.

    In addition, the Commission should be advised to amend Directive 98/44/EC in a way to reduce the scope of patents and or to definitely exclude patents on biological material used for conventional breeding of plants and animals.

• Confagricoltura Business association, ITA model reads as: wants changes source
  • Establish harmonized requirements to prevent divergent interpretations by national authorities and ensure legal certainty.

    - siano stabiliti requisiti armonizzati.

  • Define proportionate requirements and methodologies to facilitate research and innovation without creating excessive administrative burdens.

    - siano definite prescrizioni proporzionate relative ai requisiti, alle metodologie, alle informazioni e ai dati richiesti agli operatori, puntando ad agevolare la ricerca e l'innovazione ed evitando di generare un eccessivo onere amministrativo.

  • Simplify bureaucratic procedures and contain administrative costs to benefit breeders and farmers.

    - sì, punti alla semplificazione degli iter burocratici e al contenimento dei relativi costi amministrativi, a beneficio dei selezionatori e degli agricoltori.

• copa Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • The verification procedure for NGT-1 must be simple, predictable, harmonised across the EU, and avoid duplicative national requirements.

    NGT-1 verification should therefore be simple, science-based, predictable, low-cost and fully harmonised across the EU.

  • The 20-modification threshold should account for ploidy and exclude natural genetic variation.

    The 20-modification threshold should take account of ploidy, in line with Recital 17.

  • Group or batch submissions should be permitted for research and breeding to avoid duplicative submissions.

    The EU should therefore allow group or batch submissions under objective and clearly defined conditions, for example where plants belong to the same species and involve comparable categories of intended genetic changes.

• Cogeca Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • The verification procedure for NGT-1 must be simple, predictable, harmonised across the EU, and avoid duplicative national assessments.

    NGT-1 verification should therefore be simple, science-based, predictable, low-cost and fully harmonised across the EU.

  • The 20-modification threshold should account for ploidy and focus strictly on intentionally introduced changes.

    The 20-modification threshold should take account of ploidy, in line with Recital 17.

  • The rules should allow group or batch submissions for research and breeding under clearly defined conditions.

    The EU should therefore allow group or batch submissions under objective and clearly defined conditions, for example where plants belong to the same species and involve comparable categories of intended genetic changes.

• Micro company, GBR NGO, GBR model reads as: wants changes source
  • The Annex I criteria must be supplemented to adequately evaluate equivalence with conventional plants.

    These criteria must therefore be supplemented, either by amending Annex I or by mandating EFSA to set data requirements.

• CropLife Europe Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Implementation should not introduce additional requirements or restrictions beyond what is explicitly laid down in Regulation (EU) 2026/1388.

    To ensure a level playing field across the EU, implementation- including at Member State/national level- should not introduce additional requirements or restrictions beyond what is explicitly set out in Regulation (EU) 2026/1388.

  • The verification process must benchmark against conventional breeding and avoid becoming a de facto risk assessment.

    The verification procedure should therefore confirm compliance with Category 1 criteria, have conventional breeding approaches as a benchmark, and must not become a de facto risk assessment.

  • Annex I thresholds must only account for intended genetic changes, and the 20-modification limit should be adjusted for polyploid crops.

    To ensure equal treatment of polyploid crops, the limit of 20 modifications should be multiplied by the number of monoploid genome copies present in the crop.

• CropLife Europe Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Assessment for Category 2 NGT plants should be risk-proportionate, hypothesis-driven, and avoid rigid GMO-style upfront data requirements.

    Assessment should be risk-proportionate and hypothesis-driven.

  • Directives on animal protection and OECD data acceptance should be explicitly referenced to avoid untargeted animal feeding studies.

    Both Directive 2010/63/EU and the OECD Mutual Acceptance of Data system should therefore be explicitly referenced in the implementing regulation to prevent unnecessary animal testing.

  • Detection requirements must be flexible and waived if not technically feasible.

    Detection requirements must be flexible, with the possibility not to be required if they are not feasible, as most of Category 2 NGTs will likely not yield a unique, quantifiable signature meeting Minimum Performance Requirements.

• Micro company, DEU NGO, DEU model reads as: wants changes source
  • Exclude whole genome sequencing as a mandatory requirement for proving NGT-1 status.

    Whole genome sequencing should not be required for the demonstration of NGT-1 status.

    machine translation by the Commission, original in DE
  • Define the concept of insecticidal substances more precisely and allow plants using such genes as markers to obtain NGT-1 status.

    The concept of insecticidal substance should be defined more precisely.

    machine translation by the Commission, original in DE
  • Base category 2 risk assessments on a case-by-case evaluation reflecting equivalence to conventional plants rather than standard GMO dossiers.

    The risk assessment for category 2 NGT plants should be based on a case-by-case assessment and reflect the fact that the NGT 2 plants are equivalent to conventionally bred plants.

    machine translation by the Commission, original in DE
• EUROPLANT Innovation GmbH & Co. KG Company, DEU model reads as: wants changes source
  • Focus verification solely on target regions in the genome and ignore spontaneous or somaclonal mutations.

    For verification purposes, only the target regions in the genome should be considered, and spontaneous mutations and somaclonal variation should be disregarded, as this also occurs in conventional varietal development and maintenance.

    machine translation by the Commission, original in DE
  • Ensure that clonal production from pre-basic material to certified seed potatoes is covered by a single one-off verification.

    It must be ensured that the clonal production from pre-basic material to certified seed potatoes is covered by the one-off verification and does not require new applications.

    machine translation by the Commission, original in DE
  • Do not exclude plants from Category 1 for reinforcing natural defensive mechanisms such as insecticidal substances.

    Reinforcing these defensive mechanisms (including insecticidal substances such as glycoalkaloids in the leaves of Solanaceae) must not lead to exclusion.

    machine translation by the Commission, original in DE
• National Directorate of Bioeconomy, Secretary of Agriculture, Livestock and Fisheries of Argentina Public authority, ARG model reads as: wants changes source
  • Limit category 1 verification strictly to the criteria in Annex I without expanding it into a full authorization or risk assessment.

    Verification should be limited to verifying compliance with the criteria set out in Annex I and should not become, in practice, an authorisation or a risk assessment.

    machine translation by the Commission, original in ES
  • Accept data already submitted in other jurisdictions and recognize previous determinations of equivalence to avoid duplicate studies.

    It is recommended to accept information already submitted in other jurisdictions and to consider previous analyses carried out by authorities that have determined that the product is equivalent to one obtained through conventional breeding.

    machine translation by the Commission, original in ES
  • Clarify how the limit of 20 modifications per monoploid genome is applied in polyploid crops.

    With regard to the number of accepted changes, it should be clarified how the limit of 20 modifications per monoploid genome is applied in polyploid species and crops such as papa and wheat.

    machine translation by the Commission, original in ES
• National Directorate of Bioeconomy, Secretary of Agriculture, Livestock and Fisheries of Argentina Public authority, ARG model reads as: wants changes source
  • Base category 2 risk assessments on a proportionate, tiered problem-formulation approach adapted to the final plant rather than uniform study sets.

    The assessment should focus on the characteristics of the final plant and start with a problem formulation allowing to identify hazards, possible pathways to harm and concrete risk scenarios.

    machine translation by the Commission, original in ES
  • Do not exclude traits such as insect resistance or herbicide tolerance from Category 1 based solely on the trait itself.

    With regard to the sustainability criteria used, there is no scientific reason to exclude certain characteristics from Category 1 on the basis of the trait itself.

    machine translation by the Commission, original in ES
  • Specify official control methods and information requirements for practical detection in commodity consignments.

    The methods and information required for official controls and their practical application, particularly in consignments of commodities, should therefore be specified.

    machine translation by the Commission, original in ES
• Secretary of Agriculture Livestock and Fisheries Public authority, ARG model reads as: wants changes source
  • Limit Category 1 verification to Annex I compliance without turning it into an authorization or risk assessment process.

    Verification should be limited to confirming compliance with the criteria set out in Annex I and should not become an authorization or risk assessment procedure.

  • Accept information submitted in other jurisdictions and avoid duplicated studies.

    Information submitted in other jurisdictions should be accepted, and previous determinations concluding that a product is equivalent to one obtained through conventional breeding should be considered.

  • Introduce a prior consultation procedure for products still at the design or development stage.

    It would be useful to introduce a prior consultation procedure for products that are still at the design or development stage, providing early regulatory guidance to be subsequently confirmed with experimental information on the obtained product.

• Secretary of Agriculture, Livestock and Fisheries Public authority, ARG model reads as: wants changes source
  • Risk assessments for Category 2 plants should be proportionate, product-specific, and not trigger uniform mandatory studies.

    For Category 2 plants subject to risk assessment in the European Union, the assessment should be proportionate and tailored to each product. Classification in this category should not automatically trigger a complete and uniform set of studies.

  • Traits like insect resistance or herbicide tolerance should not be excluded from Category 1 solely based on the trait itself.

    There appear to be no scientific grounds for excluding certain characteristics from Category 1 solely because of the trait itself.

  • Assessments conducted by exporting countries should be considered to avoid duplicated evaluations and trade disruption.

    Assessments conducted by exporting countries should therefore be considered, and duplicated evaluations should be avoided when the available information supports a decision.

• Verband Lebensmittel ohne Gentechnik e.V. (VLOG) ( German Association Food without Genetic Engineering) Business association, DEU model reads as: wants changes source
  • Complete genome sequence data of the plant before and after the intervention must be provided for NGT 1 verification.

    For reliable verification of NGT 1 status, complete genome sequence data of the plant must be provided before and after the intervention.

    machine translation by the Commission, original in DE
  • Sequence data of genetic modifications and varietal markers must be made publicly available upon placing on the market.

    When placed on the market, at least the sequence data of the genetic modifications and appropriate varietal markers shall be publicly available.

    machine translation by the Commission, original in DE
• Verband Lebensmittel ohne Gentechnik e.V. (VLOG) (German Association Food without Genetic Engineering) Business association, DEU model reads as: wants changes source
  • Specific detection of NGT 2 plants must combine NGT modification evidence with variety-specific markers rather than considering the modification alone.

    For the specific detection of NGT 2 plants, the individual genetic modification shall not be considered alone.

    machine translation by the Commission, original in DE
  • Multi-stage analytical methods combining identification and quantification should be included in the means of proof.

    This should also include multi-stage analytical methods, where different methods are used for identification and quantification.

    machine translation by the Commission, original in DE
• Micro company, PRT NGO, PRT model reads as: wants changes source
  • Whole-genome sequencing should not be a routine verification requirement.

    Whole-genome sequencing should not be a routine requirement and should only be requested where scientifically justified.

    machine translation by the Commission, original in PT
  • Natural variation and tissue culture effects should not be counted as NGT modifications unless attributable to the intervention.

    Natural variation, pre-existing heterogeneity, variation arising during conventional breeding, segregation, tissue culture or Endogenous DNA repair should not be counted as NGT modifications unless they can be attributed to the intended NGT intervention.

    machine translation by the Commission, original in PT
  • Herbicide tolerance used strictly as a technical breeding tool should not exclude plants from Category 1 status.

    Herbicide tolerance used only as a selectable marker or technical breeding tool, and not as an intended commercial trait, should not exclude Category 1 status.

    machine translation by the Commission, original in PT
• Euroseeds Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Category 1 verification status should be durable and treat resulting plants and offspring as conventional.

    Once a plant has received Category 1 verification, this status should remain durable and plants and edits and their offspring treated as conventional.

  • Only intended genetic changes from the NGT application should count toward Annex I numerical thresholds.

    Only intended genetic changes resulting from the NGT application should count toward the Annex I thresholds.

  • For polyploid crops, the limit of 20 modifications per monoploid genome should scale with genome copy number.

    For polyploid crops, the limit of 20 modifications per monoploid genome should be multiplied by the number of genome copies.

• Euroseeds Business association, BEL; register: Trade and business associations model reads as: wants changes source
  • Secondary legislation should tailor requirements to product characteristics rather than imposing uniform demands on all Category 2 plants.

    Secondary legislation should therefore reflect product-specific characteristics rather than apply uniform requirements to all Category 2 applications.

  • Animal feeding studies should be limited strictly to specific scientific questions unresolvable by alternative evidence.

    90-day animal feeding studies should only be considered where a specific scientific question cannot be addressed through existing evidence or alternative approaches, consistent with the objectives of Directive 2010/63/EU.

  • Detection requirements must account for technical feasibility where modifications lack distinct analytical signatures.

    The implementing acts should consider these technical realities and avoid creating requirements that are not feasible in practice.

• Micro company, PRT NGO, PRT model reads as: wants changes source
  • Category 2 rules should be tailored to gene editing and cisgenesis rather than classical GMO transgenic frameworks.

    The implementing rules should therefore be tailored to targeted genome editing and cisgenesis rather than importing requirements developed for plants containing exogenous genes.

  • The verification system should accept robust scientific evidence not generated under GLP or ISO standards.

    The system should accept robust scientific evidence even when it has not been generated under GLP or ISO conditions, provided its reliability and relevance can be demonstrated.

  • Inability to provide analytical detection methods matching conventional GMO criteria should not prevent market access.

    In such cases, inability to provide a method meeting conventional GMO detection performance criteria should not preclude market access, and documentation-based approaches should be considered.

• Micro company, SWE Business association, SWE model reads as: wants changes source
  • Delegated acts should limit administrative requirements to what is necessary and proportionate, avoiding complementary national restrictions.

    A balanced implementation should create clear and predictable conditions for breeders and other stakeholders, while limiting administrative requirements to what is necessary and proportionate.

    machine translation by the Commission, original in SV
  • Verification for category 1 plants should be limited to compliance criteria and not evolve into a general risk assessment.

    For category 1 plants, the verification should be limited to establishing compliance with the criteria and the methods used should be scientifically based. The procedure should not evolve into a general risk assessment, as the Regulation requires these plants to be treated in the light of their equivalence to conventionally bred plants.

    machine translation by the Commission, original in SV
  • Only intentional changes from NGT use should be counted against Annex I thresholds, with ploidy levels taken into account.

    Only intentional changes resulting from NGT use should be taken into account when applying the thresholds in Annex I. For polyploid crops, the number of permitted changes should be determined taking into account the number of genomes, and the concept of natural genetic variation should be interpreted broadly as existing databases only represent a limited part of biodiversity and evolve over time.

    machine translation by the Commission, original in SV
• ASEBIO Business association, ESP; register: Trade and business associations model reads as: wants changes source
  • The limit of 20 modifications per monoploid genome must be applied proportionally to ploidy without counting non-NGT genetic differences.

    The limit of 20 modifications per monoploid genome should be applied proportionally to ploidy, without penalising polyploid species or classifying biologically equivalent modifications differently. Spontaneous mutations, somaclonal variation and other genetic differences not attributable to the NGT intervention should not be counted.

  • Grouped verification should be allowed for lines sharing an editing project or common evidence base to prevent repetitive dossiers.

    AseBio calls for grouped verification where several plants or lines share the same editing project, relevant modifications, an intended trait or a common evidence base, thereby avoiding repetitive dossiers.

  • When a verified category 1 NGT plant is modified further, verification should only consider the newly introduced modifications.

    A verified category 1 NGT plant should be usable as starting material in subsequent breeding programmes and, where new modifications are introduced through NGTs, the new verification should consider only those modifications, avoiding cumulative application of the limit.

• ASEBIO Business association, ESP; register: Trade and business associations model reads as: wants changes source
  • Risk assessment for category 2 NGT plants must be adapted, case-by-case, and only require additional studies for specific, plausible risk hypotheses.

    Risk assessment should be adapted, proportionate and product-based. It should be conducted on a case-by-case basis, taking into account the characteristics of the plant and trait, the function of the modified sequences, experience with comparable plants, the intended use and the receiving environment. Additional data or studies should only be required where they address plausible and specific risk hypotheses.

  • Technical inability to satisfy standard analytical validation requirements should not prevent authorization if alternative control methods exist.

    Technical inability to meet standard validation requirements should not prevent authorisation where technically feasible methods, complementary measures, adapted arrangements or derogations enable effective official controls.

  • Post-market environmental monitoring should be restricted to cases where specific risks or uncertainties justify it.

    Post-market environmental monitoring should only be required where the assessment identifies specific risks or uncertainties that justify it.

• EU-SAGE Academic or research institution, BEL; register: Academic institutions model reads as: wants changes source
  • Data requirements should remain technology-neutral and fit for purpose rather than mandating fixed approaches like whole-genome sequencing.

    Data requirements should be fit for purpose and technology-neutral, allowing appropriate analytical methods rather than prescribing a single approach such as whole-genome sequencing.

  • The verification system should allow multiple related NGT plants to be submitted in a single dossier.

    EU-SAGE therefore supports the possibility of covering multiple related NGT plants in a single verification dossier, proportionate information requirements at early research stages, clear procedures and timelines, and a verification system that remains accessible to universities, public research organisations, SMEs and smaller breeders.

  • Clear implementation guidance must be provided on gene interruption, the conventional gene pool, and regulatory treatment of progeny and specific traits.

    EU-SAGE also highlights several areas where clear implementation guidance is needed, including the interpretation of gene interruption, the conventional breeding gene pool, the regulatory status of progeny, and the treatment of herbicide tolerance used solely as a technical selection marker and of traits involving insect defence.

• EU-SAGE Academic or research institution, BEL model reads as: wants changes source
  • Technical limitations in detection and origin identification should not prevent Category 2 applications from proceeding.

    EU-SAGE considers that technical limitations of detection should not prevent Category 2 applications.

  • Risk assessment should be problem-driven and avoid developing into general variety-performance testing.

    Agronomic, phenotypic and compositional information should be required where it addresses a relevant safety question, but the assessment should not develop into general variety-performance testing.

  • Coexistence measures must not become routine obstacles to cultivation and should only be applied to address clearly identified needs.

    EU-SAGE also considers that coexistence measures should not become a routine barrier to the cultivation of authorised Category 2 NGT plants. Where such measures are considered necessary, they should address a clearly identified need and remain targeted and proportionate to the crop, agricultural context and likelihood of unintended presence.

• ANOVE (Asociación nacional de obtentores vegetales) Business association, ESP model reads as: wants changes source
  • Only intended modifications generated by NGTs should be considered, with the 20-modification limit multiplied across polyploid genome copies.

    The limit of 20 modifications per monoploid genome should be applied proportionally to the ploidy level of the species, multiplied by the number of copies of the genome. For verification it should be sufficient to demonstrate that the total number of planned modifications remains within the relevant limit set out in Annex I.

    machine translation by the Commission, original in ES
  • When an NGT 1 variety is used in further breeding, new verification should assess only newly added modifications.

    Accordingly, if a NGT 1 variety is taken as a starting point and new modifications are introduced by NGT techniques, the verification of the new variety should consider only the new modifications generated by NGTs, and not the NGT 1 modifications already present in the starting variety.

    machine translation by the Commission, original in ES
  • Descendant lines that no longer carry the classifying NGT modification should be eligible for status review and relief from NGT 1 requirements.

    In addition, for the regulatory status of lines descending from an NGT 1 plant that no longer contain the genetic modification that gave rise to that classification, consideration should be given to the possibility for the developer to request a review of their regulatory status and that, once the absence of the NGT modification (s) is documented and confirmed, these lines are no longer subject to the requirements applicable to NGT 1 plants.

    machine translation by the Commission, original in ES
• ANOVE (Asociación nacional de obtentores vegetales) Business association, ESP model reads as: wants changes source
  • Adapt Category 2 information requirements to plant characteristics on a case-by-case basis rather than requiring pre-defined data packages.

    The information requirements of the assessment process should be adapted to the characteristics of the NGT plant and determined on a case-by-case basis rather than requiring pre-defined data packages, as is the case for GMOs.

    machine translation by the Commission, original in ES
  • Do not prevent market access due to the absence of analytical detection methods validated against GMO criteria.

    The absence of an analytical method validated against the criteria established for GMOs should not prevent market access.

    machine translation by the Commission, original in ES
  • Require post-market monitoring only when the assessment identifies risks differing from conventionally bred plants.

    Post-market monitoring of cat 2 NGT plants should be required only where the assessment identifies risks different from the risks of similar plants obtained by conventional breeding.

    machine translation by the Commission, original in ES
• British Agriculture Bureau Other, BEL; register: Trade and business associations model reads as: wants changes source
  • Ensure the Category 1 verification process is a simple, focused compliance check rather than a risk assessment.

    The purpose of Category 1 verification is to establish whether the legislated criteria have been met. It should therefore be a focused verification process, not a de facto risk assessment.

  • Exclude natural variation from the modification threshold and account for ploidy in the 20-modification limit.

    Naturally occurring variation and changes resulting from normal biological processes should not unnecessarily add to the regulatory burden or count towards the modification threshold.

  • Ensure Category 1 verification determinations provide lasting certainty across Member States without duplicate assessments.

    Once a plant has been verified as Category 1, that determination should provide lasting certainty for breeders, the supply chain and farmers.

• Union française des semenciers (UFS) Business association, FRA; register: Trade unions and professional associations model reads as: wants changes source
  • Strictly regulate the reasoned objection procedure to prevent unjustified blocking between Member States.

    The ‘reasoned objection’ procedure which may be activated by a Member State against a decision on the issue of NGT1 status will have to be precisely defined and strictly regulated in order to avoid any unjustified blocking.

    machine translation by the Commission, original in FR
  • Display the patent publication number in a public database while keeping development data confidential.

    It would be appropriate to display the publication number of the patent rather than a status display in order to maintain the best possible match with its status.

    machine translation by the Commission, original in FR
  • Reset modification meters for future breeding stages once a plant obtains Category 1 status.

    LUFS therefore recommends that once the plant has NGT1 status, the meters should be reset for future selection stages.

    machine translation by the Commission, original in FR
• Union française des semenciers (UFS) Business association, FRA; register: Trade unions and professional associations model reads as: wants changes source
  • Exclude plants without foreign DNA from a GMO-type risk assessment and reduce assessments based solely on mutation counts.

    NGT2 candidate plants will include plants that do not have foreign DNA, which should exclude them from a GMO-type risk assessment.

    machine translation by the Commission, original in FR
  • Avoid requiring repetitive risk assessments for varieties sharing traits that have already been evaluated.

    The fact that it is not necessary, for reasons already assessed elsewhere, to go through a risk assessment stage again.

    machine translation by the Commission, original in FR
  • Establish a public patent database that displays patent publication numbers to ensure transparency.

    This transparency must make it possible to set up a comprehensive database of patents with reliable and relevant data (No of publication of the patent to avoid regular updating), which will be valuable information for each stakeholder in the sector.

    machine translation by the Commission, original in FR
• Seeds Canada Business association, CAN model reads as: wants changes source
  • Focus verification on the final plant outcome rather than the technical breeding steps.

    Verification should focus on the final plant, not the technique or the number of technical steps used.

  • Apply and scale the 20-modification threshold per monoploid genome for polyploid crops.

    To ensure equal treatment of polyploid crops such as wheat, potato and rapeseed, the 20-modification limit should be applied per monoploid genome and scaled according to ploidy.

  • Create a mechanism to treat herbicide tolerant and insect resistant traits as Category 1 for import purposes.

    A mechanism is needed to effectively treat HT and IR traits as Category 1 where they genetic equivalence criteria and are intended only for import into the EU.

• Seeds Canada Business association, CAN model reads as: wants changes source
  • Provide a process to treat herbicide tolerant and insect resistant traits intended only for import like Category 1 NGTs.

    HT and IR traits that meet the genetic equivalence criteria for Category 1 and are not intended for cultivation in the EU but could be imported, should have a process to treat like Category 1 NGTs.

  • Exempt products that do not meet the definition of a living modified organism from OECD unique identifier requirements.

    OECD unique identifier should not be required for products that dont meet the definition of an LMO.

  • Do not trigger new assessments or detection methods when stacking already-assessed plants through conventional breeding.

    Stacking of already-assessed Category 2 plants or combining an NGT plant with an already-assessed GMO through conventional breeding should not trigger a new assessment or detection method.

• Bayer CropScience Company, DEU; register: Companies & groups model reads as: wants changes source
  • Benchmark Category 2 NGT plant assessments against conventional breeding and focus on plausible pathways to harm.

    Hence, the implementing act should use conventional breeding as the primary benchmark for Category 2 NGT plants assessment, ensuring it remains science-based and proportionate to the nature of these products.

  • Request additional studies only to address clearly defined uncertainties relevant to regulatory decisions.

    Familiarity with the crop, characteristic and breeding history should guide the assessment, while additional studies should be requested only to resolve clearly defined uncertainty relevant to a regulatory decision.

  • Provide a derogation where imposing detection methods for numerous distinct loci is impractical.

    To ensure that regulatory requirements remain proportionate and workable, the implementing act must provide a derogation in situations where it is impractical to impose detection method requirements on both developers who design the methods and the competent authority who need to validate them.

• Bayer CropScience Company, DEU; register: Companies & groups model reads as: wants changes source
  • Secondary legislation should allow fit-for-purpose evidence and flexible verification methods for Category 1 NGT plants.

    we recommend that verification allows fit-for-purpose evidence, preserving the objectives of Regulation (EU) 2026/1388 while enabling new genomic techniques (NGTs) to be used effectively as breeding tools.

  • Verification should focus on shared characteristics of an editing application through batch verification rather than line-by-line checks.

    Consistent with breeding practice, batch verification offers a proportionate and efficient means of covering multiple plants sharing a defined editing approach, intended modifications, target loci or phenotype.

  • Plants already verified as Category 1 should not require subsequent verification for their progenies unless new edits are introduced.

    Therefore, edits of NGT plants having already acquired Category 1 status should not necessitate subsequent verification and any additional verification should be restricted only to newly introduced edits.

• Micro company, ESP Business association, ESP model reads as: wants changes source
  • Additional studies should only be required when there is a specific, scientifically justified safety issue.

    La generación de estudios adicionales debería solicitarse únicamente cuando exista una cuestión de seguridad específica y científicamente justificada que requiera información complementaria.

  • Alternative documentation-based mechanisms should be permitted when validated analytical detection methods are unavailable.

    Cuando no sea posible disponer de un método analítico específico o validado para identificar un producto o modificación concreta, deberían contemplarse mecanismos alternativos basados en la documentación, la identificación del material y el intercambio de información a lo largo de la cadena de suministro.

  • The regulation must be harmonised across Member States to avoid divergent national implementations.

    Por otro lado, resulta fundamental garantizar una aplicación plenamente armonizada del Reglamento en todos los Estados miembros.

• Donald Danforth Plant Science Center Academic or research institution, USA model reads as: wants changes source
  • Guidance should clarify that the conditions in Annex I point 2(b) are alternative rather than cumulative.

    Annex I point 2(b) requires the modifications to "fulfil one or both" of its two conditions. They are therefore alternatives, and guidance should ensure verification bodies do not treat them as cumulative.

  • Plants should be judged based on the resulting modifications described in Annex I rather than the specific technique used.

    A plant carrying the modifications Annex I describes should be verified against Annex I, whatever route produced it.

  • Thresholds should apply to intended modifications rather than detected unintended natural changes, scaling with ploidy.

    A ceiling based on detected changes would make the same plant pass or fail depending on how it was examined. It should instead apply to the intended modifications, which are documented and fixed, and scale with ploidy.

• Donald Danforth Plant Science Center Academic or research institution, USA model reads as: wants changes source
  • Verification guidance must treat the conditions in Annex I point 2(b) as alternatives rather than cumulative requirements.

    Annex I point 2(b) requires the modifications to "fulfil one or both" of its two conditions. They are therefore alternatives, and guidance should ensure verification bodies do not treat them as cumulative.

  • Plants exhibiting Annex I modifications should be verified regardless of which technique produced them.

    A plant carrying the modifications Annex I describes should be verified against Annex I, whatever route produced it.

  • Limits should apply to intended modifications instead of detected unintended background changes.

    A ceiling based on detected changes would make the same plant pass or fail depending on how it was examined. It should instead apply to the intended modifications, which are documented and fixed, and scale with ploidy.

• Micro company, DEU Environmental organisation, DEU model reads as: wants changes source
  • Verification must require whole-genome sequencing of both the NGT plant and the actual parental line used.

    𝗧𝗵𝗲 𝗿𝗲𝗰𝗲𝗻𝘁 𝗮𝗻𝗮𝗹𝘆𝘀𝗶𝘀 𝗯𝘆 𝗠𝘂𝗻𝗱𝗼𝗿𝗳 & 𝗦𝗶𝗺𝗼𝗻 (𝗕𝗳𝗡, 𝟮𝟬𝟮𝟲) 𝘀𝗵𝗼𝘄𝘀 𝘁𝗵𝗮𝘁 𝘁𝗵𝗶𝘀 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝘀 𝘄𝗵𝗼𝗹𝗲-𝗴𝗲𝗻𝗼𝗺𝗲 𝘀𝗲𝗾𝘂𝗲𝗻𝗰𝗶𝗻𝗴 𝗼𝗳 𝗯𝗼𝘁𝗵 𝘁𝗵𝗲 𝗡𝗚𝗧 𝗽𝗹𝗮𝗻𝘁 𝗮𝗻𝗱 𝘁𝗵𝗲 𝗮𝗰𝘁𝘂𝗮𝗹 𝗽𝗮𝗿𝗲𝗻𝘁𝗮𝗹 𝗹𝗶𝗻𝗲 𝘂𝘀𝗲𝗱, 𝗮𝘀 𝘄𝗲𝗹𝗹 𝗮𝘀 𝗵𝗮𝗿𝗺𝗼𝗻𝗶𝘀𝗲𝗱 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀 𝗳𝗼𝗿 𝘀𝗲𝗾𝘂𝗲𝗻𝗰𝗶𝗻𝗴 𝗾𝘂𝗮𝗹𝗶𝘁𝘆, 𝗴𝗲𝗻𝗼𝗺𝗲 𝗮𝘀𝘀𝗲𝗺𝗯𝗹𝘆, 𝗮𝗻𝗻𝗼𝘁𝗮𝘁𝗶𝗼𝗻, 𝘃𝗮𝗿𝗶𝗮𝗻𝘁 𝗰𝗮𝗹𝗹𝗶𝗻𝗴, 𝗽𝗼𝗹𝘆𝗽𝗹𝗼𝗶𝗱𝘆, 𝗮𝘁𝘁𝗿𝗶𝗯𝘂𝘁𝗶𝗼𝗻 𝗮𝗻𝗱 𝗰𝗼𝘂𝗻𝘁𝗶𝗻𝗴.

  • All nucleic acid sequences used during the development process must be disclosed to exclude residual foreign sequences.

    All nucleic acid sequences used during the development process must be disclosed so that transgenic or transformation-associated residual sequences can be excluded.

  • Applied methods and molecular data relevant to verification decisions must be documented and made public.

    The methods applied and the molecular information relevant to the decision must be documented and made publicly accessible in a way that allows the official decision to be independently scrutinised and independent identification and detection methods to be developed.

• Interseed Potatoes GmbH Company, DEU model reads as: wants changes source
  • Verification should proceed without requiring a full genome analysis.

    Therefore, the verification of a modification should be carried out without the need for an overall genome analysis.

    machine translation by the Commission, original in DE
  • Verified NGT1 plants, their descendants, and conventional crosses should not require further verification.

    Successfully verified NGT1 plants and their descendants and also conventional crosses with verified NGT1 plants should not require further verification.

    machine translation by the Commission, original in DE
  • Strengthening existing defense mechanisms should not disqualify a plant from the NGT1 category.

    In order not to compromise the objective of reducing plant protection products, the reinforcement of existing defensive mechanisms or deterrent substances should not lead to exclusion from the NGT1 category.

    machine translation by the Commission, original in DE
• Poznańska Hodowla Roślin Sp. z o.o. Company, POL model reads as: wants changes source
  • Sequence information should focus on the target editing site rather than mandatory full genome sequencing.

    Relevant DNA sequence information should refer to editing site-oriented testing and not automatically to full genome sequencing.

    machine translation by the Commission, original in PL
  • Formal confirmation of NGT1 status should not require repetition across breeding stages or variety registration.

    Once the NGT1 has been formally confirmed, further propagation and field trials should not trigger a full re-verification obligation.

    machine translation by the Commission, original in PL
  • Article 7 should serve as a complementary pathway for unverified material rather than a second mandatory procedure.

    Article 7 should be a complementary procedure and not a second mandatory procedure for the same material.

    machine translation by the Commission, original in PL
• MAS Seeds Company, FRA model reads as: wants changes source
  • Scientific and documentary verification requirements should focus only on the final plant.

    That verification must relate to the final plant and not to all the stages which led to its being obtained.

    machine translation by the Commission, original in FR
  • Patent requirements must not create an additional obstacle to utilizing NGT1 plants.

    Patent requirements shall not constitute an additional barrier to the use of NGT1.

    machine translation by the Commission, original in FR
  • The transmission of NGT1 status through conventional crosses should not impose additional verification or traceability obligations.

    The transmission of NGT1 status during conventional generations and crosses must be clearly guaranteed, without new disproportionate verification or traceability obligations.

    machine translation by the Commission, original in FR
• Simplot Plant Sciences Company, USA model reads as: wants changes source
  • The delegated act should keep NGT-1 verification distinct from GMO risk assessments.

    Accordingly, implementation measures should ensure that verification remains distinct from a GMO risk assessment and that information requirements remain limited to those necessary to demonstrate compliance with Annex I.

  • Implementation rules must account for the specific breeding constraints of vegetatively propagated crops.

    Implementation should also recognize the unique circumstances of vegetatively propagated crops such as potato and strawberry.

  • Counting methodologies for genetic modifications under Annex I must remain consistent and biologically relevant.

    With respect to counting methodologies, implementation should remain focused on biological relevance, reproducibility, and consistency.

• Micro company, AUS Business association, AUS model reads as: wants changes source
  • Implementation must ensure international compatibility and prevent unnecessary barriers in global seed supply chains.

    ASF therefore encourages implementation that supports international regulatory compatibility and avoids unnecessary barriers to seed trade.

  • Information requirements should align with standards accepted by other regulatory authorities.

    Information requirements should, wherever possible, be compatible with those accepted by other regulatory authorities, and the framework should be practically accessible to applicants outside the European Union.

  • Annex II exclusions should not prevent imported plants from obtaining Category 1 status when cultivation occurred outside the EU.

    ASF therefore supports an approach under which the Annex II exclusions do not prevent an otherwise eligible NGT plant from being treated as Category 1 solely because it is imported into the EU, particularly where the relevant trait has no bearing on cultivation practices within the European Union.

• Micro company, AUS Business association, AUS model reads as: wants changes source
  • Category 2 rules on traceability, detection, and compliance should avoid creating technical trade barriers.

    In particular, traceability, detection, documentation and compliance requirements should avoid creating unnecessary technical barriers to trade and should take account of the regulatory approaches adopted by third countries.

  • Where NGT products cannot be distinguished from conventional plants, requirements must reflect those practical limitations.

    Where products cannot be reliably distinguished from conventionally bred products, implementation requirements should reflect those practical limitations and avoid imposing obligations that cannot reasonably be met by exporters or supply-chain participants.

  • Category 2 risk assessments should be hypothesis-driven on a case-by-case basis rather than requiring GMO-like data packages.

    Any assessment and associated data requirements should therefore be determined on a case-by-case basis, based on problem formulation and testable risk hypotheses for the specific crop-trait combination, and not subject to GMO-like data requirements for approval.

• DI Business association, DNK; register: Trade and business associations model reads as: supports source
  • The verification procedure for category 1 NGT plants should be simple, transparent, efficient, and science-based.

    It should be simple, transparent, efficient and science-based.

  • Information requirements should be clear and restricted to what is necessary to establish category 1 status.

    Information requirements should be clear and limited to what is necessary to establish that status.

  • Harmonized documentation requirements, formats, and procedures must be established across the EU.

    Harmonised documentation requirements, formats and procedures are essential, whether verification is carried out at national or EU level.

• Danish Agriculture & Food Council Business association, DNK; register: Trade and business associations model reads as: supports source
  • The verification procedure must remain simple and follow the principle of equivalence to traditional plant breeding methods.

    Therefore, it is essential that the NGT-1 verification procedure is simple and follow the principle of being equivalent to traditional plant breeding methods.

  • Verification decisions by one national authority should be automatically recognized by all Member States without extra administrative steps.

    When a national authority has verified an NGT-1 all other Member States at EU level should follow suit without further administrative actions.

• Micro company, ESP Business association, ESP model reads as: wants changes source
  • Maintain Category 1 verification status for descendants and modifications without additional Member State restrictions.

    Once a plant has been verified as belonging to Category 1, this consideration should be maintained for its modifications and descendants, providing regulatory stability and avoiding divergent interpretations between Member States.

    machine translation by the Commission, original in ES
  • Count only intentional modifications from NGTs and consider genome copy number in polyploids.

    With regard to the Category 1 criteria, APROSE considers that only intentional genetic modifications resulting from the application of NGT should be taken into account.

    machine translation by the Commission, original in ES
  • Circumscribe reasoned objections with clear and binding deadlines while protecting confidential business information.

    The reasoned objection mechanism should be clearly defined and circumscribed to ensure a rigorous process without unnecessary delays.

    machine translation by the Commission, original in ES
• German Federal Agency for Nature Conservation (BfN) Public authority, DEU model reads as: wants changes source
  • Sequencing requirements should be established through technology-neutral performance criteria.

    Sequencing requirements should be defined through technology-neutral performance criteria covering inter alia read quality, genome coverage, assembly quality, variant detection, and structural-variant resolution.

  • Future guidelines must clearly define what qualifies as a genetic modification introduced by new genomic techniques.

    Future guidelines need to be very clear on what is considered genetic modifications introduced by new genomic techniques to enable consistent and reproducible counting results.

  • A clear procedure must be defined for evaluating compliance with Annex II exclusions.

    In addition, since compliance with Annex II is an essential prerequisite to be considered under NGT1, a clear procedure for evaluation must also be established here (for instance, how exactly to identify known insecticidal substances, which may also develop as a result of broad metabolic changes).

• Nordsaat Saatzucht GmbH Company, DEU model reads as: wants changes source
  • Information requested for NGT1 verification should be confined to the targeted genomic region.

    The requested data for verification of NGT1 status should be limited to the targeted region.

    machine translation by the Commission, original in DE
  • Only the final plant product should be assessed for NGT1 verification rather than intermediate process stages.

    Only the final product should be relevant for the verification of NGT1 status.

    machine translation by the Commission, original in DE
  • Patent rights should not prevent breeders from using biological material to breed or develop new plant varieties.

    it must be ensured that the rights conferred by a patent do not extend to the use of biological material for the purpose of breeding, discovering or developing other plant varieties2.

    machine translation by the Commission, original in DE
• El Pinar Medioambiente SLU Company, ESP model reads as: supports source
  • Implementation rules should be clear, predictable, proportionate, and supportive of innovation across the European berry sector.

    We encourage implementation measures that are clear, predictable, proportionate and supportive of innovation across the European berry sector.

• Micro company, ITA Business association, ITA model reads as: wants changes source
  • Mandating genome-wide off-target audits or complete DNA sequencing outside the target site should be avoided.

    Mandating genome-wide off-target audits or complete DNA sequencing outside the target site is scientifically unnecessary and unfairly disadvantage minor crops.

  • For polyploid crops, the 20-modification threshold should scale by multiplying the monoploid limit by the plant's total genome copies.

    For polyploid crops, the 20-modification threshold must scale proportionally by multiplying the monoploid limit by the plant's total genome copies.

  • The public database for NGT1 verification decisions and patent declarations should be centralized and managed by the CPVO.

    Furthermore, the public database for NGT1 verification decisions and patent declarations should be managed by the CPVO.

• Micro company, LTU Business association, LTU model reads as: wants changes source
  • The delegated act must provide a clear rule setting a limit of 20 modifications per copy in polyploid genomes.

    The plant genome is often polyploid and there should be a very clear provision for a limit of 20 modifications per copy, otherwise important crops such as wheat, oilseed rape or potatoes will become inapplicable NGT 1 rules.

    machine translation by the Commission, original in LT
  • The delegated act should allow batch checks for plants produced by the same editing method or achieving the same intended phenotype.

    For reasons of efficiency, the delegated act should provide for the possibility to carry out batch or batch checks in the case of plants produced by the same editing method, targeting comparable genomic regions or achieving the same intended phenotypic outcome, which would reduce unnecessary duplication and burden for administrations.

    machine translation by the Commission, original in LT
  • Disclosed patent information should be restricted to publication numbers directly related to the specific genetic modifications.

    Patents and applications disclosed should be limited to those containing one or more requirements directly related to the specific genetic modifications introduced by the use of new genomic technologies and for which the approval of the category 1 NGT plant status is requested and the information disclosed should be limited to the publication numbers of the relevant patent or application.

    machine translation by the Commission, original in LT
• IFOAM Organics Europe NGO, BEL; register: Non-governmental organisations, platforms and networks and similar model reads as: wants changes source
  • Whole genome sequencing must be required to perform a comparative analysis between the NGT1 candidate plant and its non-NGT parent.

    Whole genome sequencing is necessary to perform a comparative analysis on the NGT1 candidate plant and its non-NGT parent plant.

  • Applicants should be required to provide peer-reviewed publications describing NGT plants prior to marketing registration.

    IFOAM Organics Europe supports Testbiotech recommendations that To fulfil the provisions of Recital 34, 66 and Article 9 of Regulation (EU) 2026/1388, the applicants should be requested to provide peer-reviewed publications describing the NGT plants before the product is registered for marketing purposes.

  • Implementing legislation should explicitly ensure that patents obtained on NGTs do not cover genetic material and traits obtainable through conventional breeding.

    It is essential that patents obtained on NGTs do not cover genetic material and traits that can be obtained by conventional breeding, and this should be explicit in the implementation legislation of Regulation (EU) 2026/1388.

• Phyteis Business association, FRA; register: Trade and business associations model reads as: wants changes source
  • Avoid using Regulation 503/2013 as the baseline model and require additional studies only upon a plausible risk hypothesis.

    Regulation 503/2013 should not serve as a basic model for the assessment of cat 2 NGTs, as they do not contain genetic material external to the gene pool of conventional breeding and are therefore clearly distinguishable from transgenic plants.

    machine translation by the Commission, original in FR
  • Reference Directive 2010/63/EU and the OECD MAD system to exclude scientifically unjustified animal feeding studies.

    This Directive and the OECD Mutual Acceptance of Data (MAD) system should be referenced in the NGT legislation to avoid unnecessary sacrifice of animals.

    machine translation by the Commission, original in FR
  • Ensure post-market environmental monitoring and detection rules are flexible and do not prevent market access due to technical infeasibility.

    Technical infeasibility or the time of its implementation should not prevent market access.

    machine translation by the Commission, original in FR
• Micro company, BEL Company, BEL model reads as: wants changes source
  • Implement a tiered risk assessment driven by plausible risk hypotheses and waive default transgenic GMO requirements.

    Data requirements should start from problem formulation, driven by a plausible risk hypothesis linked to the specific modification and trait, in a tiered approach.

  • Rely on documentary traceability instead of event-specific detection or costly identity preservation.

    Compliance should rely on documentary traceability, with unique identifiers linked to a registry and supply-chain documentation, not on identity preservation, which would be complex, costly and impractical in commodity chains.

  • Differentiate import-only applications from cultivation, accept data from other jurisdictions, and provide a safe harbour for undetectable material.

    We ask for a clear distinction between cultivation and import-only applications, with much reduced data for import, acceptance of data generated in other jurisdictions and legal certainty for importers, including a good-faith safe harbour for undetectable material.

• The Asia and Pacific Seed Alliance NGO, THA model reads as: wants changes source
  • Allow entities without an EU presence to submit verification requests.

    Confirm that entities without an established presence in the EU may submit verification requests as many developers of varieties for EU import markets are based outside the EU.

  • Count only intended mutations at targeted sites toward the 20-edit threshold in Annex I.

    The regulation should be interpreted to count only intended mutations at the targeted site(s) toward the 20-edit limit set out in Annex I.

  • Keep NGT-1 verification strictly focused on Annex I criteria rather than risk assessment.

    NGT1 verification should remain focused on the Annex I criteria, rather than becoming an open-ended safety or risk assessment.

154 more analysed submissions on the consultation page.