Genetically Modified Organisms Panel Research Articles

Scientific opinion on the ANSES analysis of Annex I of the EC proposal COM (2023) 411 (EFSA-Q-2024-00178).

EFSA was asked by the European Parliament to provide a scientific opinion on the analysis by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES) of Annex I of the European Commission proposal for a regulation 'on plants obtained by certain new genomic techniques (NGTs) and their food and feed, and amending regulation (EU) 2017/625'. The Panel on genetically modified organisms (GMO) assessed the opinion published by ANSES, which focuses on (i) the need to clarify the definitions and scope, (ii) the scientific basis for the equivalence criteria and (iii) the need to take potential risks from category 1 NGT plants into account. The EFSA GMO Panel considered the ANSES analysis and comments on various terms used in the criteria in Annex I of the European Commission proposal and discussed definitions based on previous EFSA GMO Panel opinions. The EFSA GMO Panel concluded that the available scientific literature shows that plants containing the types and numbers of genetic modifications used as criteria to identify category 1 NGT plants in the European Commission proposal do exist as the result of spontaneous mutations or random mutagenesis. Therefore, it is scientifically justified to consider category 1 NGT plants as equivalent to conventionally bred plants with respect to the similarity of genetic modifications and the similarity of potential risks. The EFSA GMO Panel did not identify any additional hazards and risks associated with the use of NGTs compared to conventional breeding techniques in its previous Opinions.

Food/Feed and Environmental Risk Assessment of Herbicide-tolerant and Insect-resistant Genetically Modified Maize NK603 x MON810 for Import, Processing, Food and Feed Uses under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2004/01)

Food/Feed and Environmental Risk Assessment of Herbicide-tolerant and Insect-resistant Genetically Modified Maize NK603 x MON810 for Import, Processing, Food and Feed Uses under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2004/01)

Evaluation of existing guidelines for their adequacy for the molecular characterisation and environmental risk assessment of genetically modified plants obtained through synthetic biology.

Synthetic Biology (SynBio) is an interdisciplinary field at the interface of engineering and biology aiming to develop new biological systems and impart new functions to living cells. EFSA has been asked by the European Commission to evaluate SynBio developments in agri‐food with the aim of identifying the adequacy of existing guidelines for risk assessment and determine if updated guidance is needed. The scope of this opinion covers the molecular characterisation and environmental risk assessment of such genetically modified plants obtained through SynBio, meant to be for cultivation or food and feed purposes. The previous work on SynBio by the non‐food scientific Committees (2014, 2015) was used and complemented with the output of a horizon scanning exercise, which was commissioned by the EFSA to identify the most realistic and forthcoming SynBio cases of relevance to this remit. The horizon scan did not identify other sectors/advances in addition to the six SynBio categories previously identified by the non‐food scientific committees of the European Commission. The exercise did show that plant SynBio products reaching the market in the near future (next decade) are likely to apply SynBio approaches to their development using existing genetic modification and genome editing technologies. In addition, three hypothetical SynBio case studies were selected by the working group of the Panel on Genetically Modified Organisms (GMO), to further support the scoping exercise of this Scientific Opinion. Using the selected cases, the GMO Panel concludes that the requirements of the EU regulatory framework and existing EFSA guidelines are adequate for the risk assessment of SynBio products to be developed in the next 10 years, although specific requirements may not apply to all products. The GMO Panel acknowledges that as SynBio developments evolve, a need may exist to adjust the guidelines to ensure they are adequate and sufficient.

Outcome of a public consultation on the draft adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post‐market environmental monitoring of genetically modified insects containing engineered gene drives

The European Food Safety Authority (EFSA) carried out an online public consultation to receive input from interested parties/persons on the draftscientific opinion on the adequacy and sufficiencyevaluation of existing guidelines for the molecular characterisation (MC), environmental risk assessment (ERA) and post-market environmental monitoring (PMEM) of genetically modified insects containing engineered gene drives. This draft scientific opinion was endorsed by the EFSA Panel on Genetically Modified Organisms (GMOs) for public consultation on 29 January 2020, and prepared by EFSA'sGene Drive expert Working Group and scientific officers. The public consultation was open from 17 February 2020 until 24 April 2020. EFSA received comments from 36 different interested parties/persons. Overall, comments raised reveal different, often contrasting, opinions and perspectives toward the deliberate release into the environment of gene drive modified insects for insect disease vector/pest control, and on the adequacy and sufficiency of current risk assessment frameworks for the MC, ERA and PMEM of such insects.The public consultation comments were analysed and taken into consideration by the GMO Panel, the Gene Drive expert Working Group and EFSA's scientific officers during the revision and finalisation of the scientific opinion.EFSA,the Gene Drive expert Working Group and the GMO Panel wish to sincerely thank all contributors to the public consultation for their invaluableinput. This technical report contains the comments received and clarifies how they have been considered for the revision and finalisation of the scientific opinion. The final scientific opinion was adopted by the GMO Panel on 14 October 2020, and published in the EFSA Journal.

Applicability of the EFSA Opinion on site-directed nucleases type 3 for the safety assessment of plants developed using site-directed nucleases type 1 and 2 and oligonucleotide-directed mutagenesis.

The European Commission requested the EFSA Panel on Genetically Modified Organisms (GMO) to assess whether section 4 (hazard identification) and the conclusions of EFSA's Scientific opinion on the risk assessment of plants developed using zinc finger nuclease type 3 technique (ZFN‐3) and other site‐directed nucleases (SDN) with similar function are valid for plants developed via SDN‐1, SDN‐2 and oligonucleotide‐directed mutagenesis (ODM). In delivering this Opinion, the GMO Panel compared the hazards associated with plants produced via SDN‐1, SDN‐2 and ODM with those associated with plants obtained via both SDN‐3 and conventional breeding. Unlike for SDN‐3 methods, the application of SDN‐1, SDN‐2 and ODM approaches aims to modify genomic sequences in a way which can result in plants not containing any transgene, intragene or cisgene. Consequently, the GMO Panel concludes that those considerations which are specifically related to the presence of a transgene, intragene or cisgene included in section 4 and the conclusions of the Opinion on SDN‐3 are not relevant to plants obtained via SDN‐1, SDN‐2 or ODM as defined in this Opinion. Overall, the GMO Panel did not identify new hazards specifically linked to the genomic modification produced via SDN‐1, SDN‐2 or ODM as compared with both SDN‐3 and conventional breeding. Furthermore, the GMO Panel considers that the existing Guidance for risk assessment of food and feed from genetically modified plants and the Guidance on the environmental risk assessment of genetically modified plants are sufficient but are only partially applicable to plants generated via SDN‐1, SDN‐2 or ODM. Indeed, those guidance documents’ requirements that are linked to the presence of exogenous DNA are not relevant for the risk assessment of plants developed via SDN‐1, SDN‐2 or ODM approaches if the genome of the final product does not contain exogenous DNA.

Scientific Opinion on application EFSA-GMO-NL-2016-132 for authorisation of genetically modified of insect-resistant and herbicide-tolerant soybean DAS-81419-2×DAS-44406-6 for food and feed uses, import and processing submitted in accordance with Regulation (EC) No 1829/2003 by DowAgrosciencesLCC.

Soybean DAS–8419–2 × DAS–44406–6 was developed to provide protection against certain lepidopteran pests and tolerance to 2,4–dichlorophenoxyacetic acid and other related phenoxy herbicides, and glyphosate‐ and glufosinate ammonium‐containing herbicides. The Genetically Modified Organisms (GMO) Panel previously assessed the two single soybean events and did not identify safety concerns. No new data on the single soybean events, leading to modification of the original conclusions on their safety have been identified. The molecular characterisation, comparative analysis (agronomic, phenotypic and compositional characteristics) and the outcome of the toxicological, allergenicity and nutritional assessment indicate that the combination of the single soybean events and of the newly expressed proteins in the two‐event stack soybean does not give rise to food and feed safety and nutritional concerns. In the case of accidental release of viable DAS–8419–2 × DAS–44406–6 seeds into the environment, soybean DAS–8419–2 × DAS–44406–6 would not raise environmental safety concerns. The post‐market environmental monitoring plan and reporting intervals are in line with the intended uses of soybean DAS–8419–2 × DAS–44406–6. In conclusion, the GMO Panel considers that soybean DAS–8419–2 × DAS–44406–6, as described in this application, is as safe as its conventional counterpart and the non‐genetically modified soybean reference varieties tested with respect to potential effects on human and animal health and the environment.

Assessment of the outcomes of the project “Risk Assessment of Genetically Engineered Organisms in the EU and Switzerland” (RAGES)

The Risk “Assessment of genetically engineered organisms in the EU and Switzerland” (RAGES) project (2016-2019) evaluated the risk assessment of genetically modified plants (GMPs) as performed by the European Food Safety Authority (EFSA) and its Swiss counterpart. RAGES claims shortcomings in several areas of the European risk assessment of GMPs, in particular: (1) the risk posed by herbicide tolerant GMPs on animal and human health; (2) the risk assessment approach of GMPs producing insecticidal proteins; (3) the risk assessment of nutritionally altered GMPs; (4) the assessment of GMPs combining different traits; (5) the environmental risk assessment of GMPs that can persist and spontaneously propagate in the environment; and (6) genetically modified organisms (GMOs) produced using new genetic engineering technologies. Following a request of the European Commission, EFSA reviewed the main scientific arguments raised by RAGES, and assessed whether thereports published by RAGES contain elements that could lead the GMO Panel to reconsider the outcome of its previous scientific opinions on GMPs. EFSA confirms that its risk assessment approach and data requirements are adequate and sufficient for the risk assessment of current GMPs, and that they are consistent with the applicable EU legislation and internationally agreed standards. Moreover, EFSAhas gained more than 20 years of experience in the risk assessment of GMPs, and conducts a continued scientific review of all relevant evidenceby following the scientific and technical developments in the GMO area.Overall, EFSA concludes that the final RAGES reports do not contain elements that would lead the GMO Panel to reconsider the outcome of its previous scientific opinions on GMPs. Therefore, EFSA considers that the previous GMO Panel risk assessment conclusions remain valid.

Statement complementing the EFSA Scientific Opinion on application (EFSA‐GMO‐NL‐2009‐75) for placing on the market of genetically modified oilseed rape Ms8 × Rf3 × GT73 and subcombinations, which have not been authorised previously (i.e. Ms8 × GT73 and Rf3 × GT73) independently of their origin, for food and feed uses, import and processing, with the exception of isolated seed protein for

The EFSA Panel on Genetically Modified Organisms (GMO) previously assessed oilseed rape Ms8 × Rf3 × GT73 and its subcombinations Ms8 × GT73 and Rf3 × GT73 according to the scope as defined in the application EFSA‐GMO‐NL‐2009‐75, and was not in the position to complete the safety assessment of products rich in protein, such as rapeseed protein isolates or products of this nature in animal feeding. Following a mandate from the European Commission, the GMO Panel assessed a 28‐day toxicity study in mice with the glyphosate oxidoreductase (GOXv247) protein, provided to complement information related to application EFSA‐GMO‐NL‐2009‐75 for the placing on the market of oilseed rape Ms8 × Rf3 × GT73 and its subcombinations Ms8 × GT73 and Rf3 × GT73, for food and feed uses, import and processing, with the exception of isolated seed protein for food. The 28‐day toxicity study on Escherichia coli‐ produced GOXv247 protein did not show adverse effects in mice, at the gavage doses up to 1000 mg/kg body weight (bw) per day. Taking into account its previous assessment on EFSA‐GMO‐NL‐2009‐75 and the outcome of the 28‐day toxicity study in mice with the GOXv247 protein provided in this mandate, the GMO Panel, based on a weight of evidence approach, concludes that food and feed containing, consisting and produced from genetically modified oilseed rape Ms8 × Rf3 × GT73 and its sub combinations Ms8 × GT73 and Rf3 × GT73, are as safe as its conventional counterpart, according to the scope as defined in the application EFSA‐GMO‐NL‐2009‐75.

Food/Feed and Environmental Risk Assessment of Genetically Modified Glufosinate-tolerant Oilseed Rape MS8, RF3 and MS8 x RF3 for Import, Processing and Feed Uses under Directive 2001/18/EC (Notification C/BE/96/01)

Food/Feed and Environmental Risk Assessment of Genetically Modified Glufosinate-tolerant Oilseed Rape MS8, RF3 and MS8 x RF3 for Import, Processing and Feed Uses under Directive 2001/18/EC (Notification C/BE/96/01)

Food/Feed and Environmental Risk Assessment of Insect-resistant and Herbicide-tolerant Genetically Modified Maize GA21 from Syngenta Seeds for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2005/19)

Food/Feed and Environmental Risk Assessment of Insect-resistant and Herbicide-tolerant Genetically Modified Maize GA21 from Syngenta Seeds for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2005/19)

Food/Feed and Environmental Risk Assessment of Insect-Resistant and Herbicide-Tolerant Genetically Modified Maize Bt11 x GA21 in the European Union under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2007/49)

Food/Feed and Environmental Risk Assessment of Insect-Resistant and Herbicide-Tolerant Genetically Modified Maize Bt11 x GA21 in the European Union under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2007/49)

Food/Feed and Environmental Risk Assessment of Insect-resistant Genetically Modified Maize MIR604 for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2005/11)

Food/Feed and Environmental Risk Assessment of Insect-resistant Genetically Modified Maize MIR604 for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2005/11)

Food/Feed and Environmental Risk Assessment of Insect-Resistant and Herbicide-Tolerant Genetically Modified Maize Bt11 from Syngenta Seeds for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 (EFSA/GMO/RX/Bt11)

Food/Feed and Environmental Risk Assessment of Insect-Resistant and Herbicide-Tolerant Genetically Modified Maize Bt11 from Syngenta Seeds for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 (EFSA/GMO/RX/Bt11)

Food/Feed and Environmental Risk Assessment of Application (Reference EFSA/GMO/UK/2008/56) for Authorization of Insect Resistant and Herbicide Tolerant Genetically Modified Maize Bt11 x MIR604 x GA21 for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 from Syngenta Seeds

Food/Feed and Environmental Risk Assessment of Application (Reference EFSA/GMO/UK/2008/56) for Authorization of Insect Resistant and Herbicide Tolerant Genetically Modified Maize Bt11 x MIR604 x GA21 for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 from Syngenta Seeds

Food/feed and Environmental Risk Assessment of Insect-resistant and Herbicide-tolerant Genetically Modified Maize MIR604 x GA21 in the European Union under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2007/48)

Food/feed and Environmental Risk Assessment of Insect-resistant and Herbicide-tolerant Genetically Modified Maize MIR604 x GA21 in the European Union under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2007/48)

Food/Feed and Environmental Risk Assessment of Insect-resistant and Herbicide-tolerant Genetically Modified Maize Bt11 x MIR604 in the European Union under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2007/50)

Food/Feed and Environmental Risk Assessment of Insect-resistant and Herbicide-tolerant Genetically Modified Maize Bt11 x MIR604 in the European Union under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2007/50)

Food/Feed and Environmental Risk Assessment of Insect Resistant Genetically Modified Maize 1507 for Cultivation, Import, Processing, Food and Feed Uses under Directive 2001/18/EC and Regulation (EC) No 1829/2003 (C/ES/01/01, C/NL/00/10, EFSA/GMO/NL/2004/02)

Food/Feed and Environmental Risk Assessment of Insect Resistant Genetically Modified Maize 1507 for Cultivation, Import, Processing, Food and Feed Uses under Directive 2001/18/EC and Regulation (EC) No 1829/2003 (C/ES/01/01, C/NL/00/10, EFSA/GMO/NL/2004/02)

Food, Feed and Environmental Risk Assessment of Glufosinatetolerant Genetically Modified Oilseed Rape T45 for Food and Feed Uses, Import and Processing Under Regulation (EC) No 1829/2003 (Application EFSA/GMO/UK/2005/25)

Food, Feed and Environmental Risk Assessment of Glufosinatetolerant Genetically Modified Oilseed Rape T45 for Food and Feed Uses, Import and Processing Under Regulation (EC) No 1829/2003 (Application EFSA/GMO/UK/2005/25)

Food and Environmental Risk Assessment of Herbicide-tolerant Genetically Modified Maize NK603 for Food Uses, Import and Processing under Directive 2001/18/EC (Notification C/ES/00/01)

Food and Environmental Risk Assessment of Herbicide-tolerant Genetically Modified Maize NK603 for Food Uses, Import and Processing under Directive 2001/18/EC (Notification C/ES/00/01)

Food/feed and Environmental Risk Assessment of Insect-resistant and Herbicide-tolerant Genetically Modified Maize 59122 x NK603 for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2005/20)

Food/feed and Environmental Risk Assessment of Insect-resistant and Herbicide-tolerant Genetically Modified Maize 59122 x NK603 for Food and Feed Uses, Import and Processing under Regulation (EC) No 1829/2003 (EFSA/GMO/UK/2005/20)