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In addition to classic genetic engineering for the targeted modification of the base sequence of the DNA, epigenetic methods for the targeted modification of the genetic material without base changes are increasingly being used. Such epigenetic techniques can be used, for example, to influence stress tolerance to heat or aridity in plants. The regulatory handling of organisms generated by means of epigenetic techniques on the grounds of genetic engineering law has not yet been clarified. This paper critically reviews the legal classification of epigenetically modified organisms as GMOs as expressed in the study on New Genomic Techniques published in April 2021 by the European Commission. The paper shows that there are reasons to assume that epigenetically modified organisms are not covered by the European GMO legislation. In addition, the paper provides an introductory overview of the significance of epigenetics and the methods used to intentionally influence epigenetic traits and illustrates the possibility for a consistent, risk-based regulation of epigenetic modifications.

The Judgment of 25 July 2018 of the Court of Justice of the European Union (CJEU)1 was optimistically awaited by breeders and supporters of agricultural biotechnology, but shortly after the press release advancing the Judgment, hope turned into frustration. Opinions on how to frame the New Breeding Techniques (NBT) in the context of Directive 2001/18/EC were issued before the Judgment, while proposals to assist the EU legislator to amend the regime driven by the Directive have been also provided afterwards by scientists and institutional bodies around the EU. However, they do not seem to have paid so much attention to the Judgment itself. This paper focuses on the Judgment. It finds out that while the impacts of the Judgment on the NBT might have been slightly overvalued, its potential negative effects on techniques of random mutagenesis and varieties breed through them have been generally underestimated if not absolutely overlooked. The analysis also shows that the Judgment does not preempt the possibility to exempt certain applications of some NBT from the scope of Directive 2001/18/EC,2 and, in fact, ODM, SDN1, and SDN2 might be, under certain conditions, easily exempted from its scope without the need of a deep legislative revolution nor even the amendment of Directive 2001/18/EC. As regards techniques of random mutagenesis and mutant varieties bred by means of those techniques, until action is taken by Member States (if finally taken), no real limitations upon them are to be feared. However, if Member States start to consider the path opened by the CJEU, then their regulation at an EU level should be readily explored in order to avoid further negative effects on plant breeding as well as on the free movement inside the EU of those varieties and the products thereof.

The Judgment of 25 July 2018 of the Court of Justice of the European Union (CJEU)1 was optimistically awaited by breeders and supporters of agricultural biotechnology, but shortly after the press release advancing the Judgment, hope turned into frustration. Opinions on how to frame the New Breeding Techniques (NBT) in the context of Directive 2001/18/EC were issued before the Judgment, while proposals to assist the EU legislator to amend the regime driven by the Directive have been also provided afterwards by scientists and institutional bodies around the EU. However, they do not seem to have paid so much attention to the Judgment itself. This paper focuses on the Judgment. It finds out that while the impacts of the Judgment on the NBT might have been slightly overvalued, its potential negative effects on techniques of random mutagenesis and varieties breed through them have been generally underestimated if not absolutely overlooked. The analysis also shows that the Judgment does not preempt the possibility to exempt certain applications of some NBT from the scope of Directive 2001/18/EC,2 and, in fact, ODM, SDN1, and SDN2 might be, under certain conditions, easily exempted from its scope without the need of a deep legislative revolution nor even the amendment of Directive 2001/18/EC. As regards techniques of random mutagenesis and mutant varieties bred by means of those techniques, until action is taken by Member States (if finally taken), no real limitations upon them are to be feared. However, if Member States start to consider the path opened by the CJEU, then their regulation at an EU level should be readily explored in order to avoid further negative effects on plant breeding as well as on the free movement inside the EU of those varieties and the products thereof. [ABSTRACT FROM AUTHOR]

This article gives an overview of legal and procedural uncertainties regarding genome edited organisms and possible ways forward for European GMO policy. After a recent judgment by the European Court of Justice (ECJ judgment of 25 July 2018, C-528/16), organisms obtained by techniques of genome editing are GMOs and subject to the same obligations as transgenic organisms. Uncertainties emerge if genome edited organisms cannot be distinguished from organisms bred by conventional techniques, such as crossing or random mutagenesis. In this case, identical organisms can be subject to either GMO law or exempt from regulation because of the use of a technique that cannot be identified. Regulatory agencies might not be able to enforce GMO law for such cases in the long term. As other jurisdictions do not regulate such organisms as GMOs, accidental imports might occur and undermine European GMO regulation. In the near future, the EU Commission as well as European and national regulatory agencies will decide on how to apply the updated interpretation of the law. In order to mitigate current legal and procedural uncertainties, a first step forward lies in updating all guidance documents to specifically address genome editing specifically address genome editing, including a solution for providing a unique identifier. In part, the authorization procedure for GMO release can be tailored to different types of organisms by making use of existing flexibilities in GMO law. However, only an amendment to the regulations that govern the process of authorization for GMO release can substantially lower the burden for innovators. In a second step, any way forward has to aim at amending, supplementing or replacing the European GMO Directive (2001/18/EC). The policy options presented in this article presuppose political readiness for reform. This may not be realistic in the current political situation. However, if the problems of current GMO law are just ignored, European competitiveness and research in green biotechnology will suffer.

Abstract The GMO Panel has previously assessed genetically modified (GM) carnation FLO‐40689‐6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO‐40689‐6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for carnation FLO‐40689‐6 and to indicate whether the conclusions of the GMO Panel on the previously assessed GM carnation FLO‐40689‐6 remain valid. The new sequencing data indicated the correction of one nucleotide compared to the sequencing data originally provided. The new sequence was corrected by removal of one nucleotide from the polylinker region in locus 1. The removal of this base pair reported in the new nucleic acid sequencing data for carnation FLO‐40689‐6 has been already present in the original plant material used for the risk assessment. Thus, with the exception of bioinformatics analyses, the studies performed for the risk assessment of GM carnation FLO‐40689‐6 remain valid. The new sequencing data and the bioinformatic analyses performed on the new sequence, did not give rise to safety issues. Therefore, EFSA concludes that the original risk assessment of carnation FLO‐40689‐6 remains valid.

Abstract The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (GMO Panel) has evaluated the overall safety of genetically modified (GM) carnation FLO‐40685‐2 cut flowers to be imported into the EU for ornamental use. The genetic modification results in the flowers having purple petals. The stability of the newly introduced trait (purple flower colour) was observed over multiple vegetative generations. The purple colour of the petals comes from the altered expression levels of anthocyanins, common pigments found in edible fruits and vegetables. Considering the intended use of the GM carnation and the possible routes of exposure, the GMO Panel did not find indications that the genetic modification will increase the risk of allergy among those coming into contact with carnations. Overall there are no reasons for safety concerns of carnation FLO‐40685‐2 for humans. The GMO Panel also considered whether viable seed or pollen from GM carnation cut flowers could be dispersed into the environment and whether GM carnation can be propagated by rooting. Owing to the limited environmental exposure and the biology of the plant, the GMO Panel did not identify any environmental safety concerns and agrees with the scope of the post‐market environmental monitoring (PMEM) plan. The GMO Panel concludes that the import, distribution and retailing of the GM carnation will not cause adverse effects on human health or the environment.

In addition to classic genetic engineering for the targeted modification of the base sequence of the DNA, epigenetic methods for the targeted modification of the genetic material without base changes are increasingly being used. Such epigenetic techniques can be used, for example, to influence stress tolerance to heat or aridity in plants. The regulatory handling of organisms generated by means of epigenetic techniques on the grounds of genetic engineering law has not yet been clarified. This paper critically reviews the legal classification of epigenetically modified organisms as GMOs as expressed in the study on New Genomic Techniques published in April 2021 by the European Commission. The paper shows that there are reasons to assume that epigenetically modified organisms are not covered by the European GMO legislation. In addition, the paper provides an introductory overview of the significance of epigenetics and the methods used to intentionally influence epigenetic traits and illustrates the possibility for a consistent, risk-based regulation of epigenetic modifications., Competing Interests: The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2023 Faltus.)

Abstract Genetically modified (GM) carnation IFD‐26407‐2 was developed to express anthocyanins in the petals conferring a mauve colour to the flowers. The GM carnation is intended to be imported in the European Union as cut flower for ornamental use only. Based on the molecular characterisation data, the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) confirms the stability of the newly introduced trait and the absence of disruption of known endogenous genes. Since anthocyanins are common pigments in many food plants, it is not expected that accidental intake of petals of carnation IFD‐26407‐2 would contribute substantially to the overall intake of anthocyanins from foods. Considering the ornamental use of cut flowers, and the limited exposure scenarios expected, the EFSA GMO Panel identified no reasons for any food safety concerns relating to carnation IFD‐26407‐2. The EFSA GMO Panel is also of the opinion that accidental release of GM carnations into the environment would not give rise to environmental safety concerns. The EFSA GMO Panel agrees with the methodology, including reporting intervals, proposed for post‐market environmental monitoring. In response to the European Commission, the EFSA GMO Panel concludes that, in the light of the ornamental use of carnation IFD‐26407‐2 cut flowers, there is no scientific reason to consider that the placing on the market of the GM carnation will cause any adverse effects on human health or the environment.

Abstract Genetically modified (GM) carnation IFD‐25958‐3 was developed to express anthocyanins in the petals conferring a mauve colour to the flowers. The GM carnation is intended to be imported in the European Union as cut flower for ornamental use only. Based on the molecular characterisation data, the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) confirms the stability of the newly introduced trait and the absence of disruption of known endogenous genes. Since anthocyanins are common pigments in many food plants, it is not expected that accidental intake of petals of carnation IFD‐25958‐3 would contribute substantially to the overall intake of anthocyanins from foods. Considering the ornamental use of cut flowers, and the limited exposure scenarios expected, the EFSA GMO Panel identified no reasons for any food safety concerns relating to carnation IFD‐25958‐3. The EFSA GMO Panel is also of the opinion that accidental release of GM carnations into the environment would not give rise to environmental safety concerns. The EFSA GMO Panel agrees with the methodology, including reporting intervals, proposed for post‐market environmental monitoring. In response to the European Commission, the EFSA GMO Panel concludes that, in the light of the ornamental use of carnation IFD‐25958‐3 cut flowers, there is no scientific reason to consider that the placing on the market of the GM carnation will cause any adverse effects on human health or the environment.

Abstract The European Commission asked the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) to address the objections of Cyprus to the placing on the market of the genetically modified (GM) carnation SHD‐27531‐4. The GM carnation cut flowers, with a modified petal colour, are intended to be imported and distributed in the European Union for ornamental use only. The EFSA GMO Panel responded to the objections of Cyprus, taking into account the limited intended use of carnation SHD‐27531‐4 and the information available. First, the EFSA GMO Panel concludes that the propagation of carnation SHD‐27531‐4 by individuals cannot be excluded. However, should this occur, carnation SHD‐27531‐4 would not show any potential for increased survival, fitness or weediness compared with its parental line. Second, the EFSA GMO Panel is of the opinion that the potential spread of pollen of the GM carnation SHD‐27531‐4 by Lepidoptera to wild Dianthus species cannot be eliminated but is highly unlikely to occur and, if it did occur, it is very unlikely that viable hybrids would be produced, survive and result in adverse environmental effects. Third, considering the very low potentials for hybridisation and/or seed production of (GM) carnations, the EFSA GMO Panel concludes that plant‐to‐plant gene transfer of the introduced genes is very unlikely and, if it did occur, it is unlikely to result in viable seed production leading to adverse environmental effects.

Genetically modified (GM) carnation IFD-25958-3 was developed to express anthocyanins in the petals conferring a mauve colour to the flowers. The GM carnation is intended to be imported in the European Union as cut flower for ornamental use only. Based on the molecular characterisation data, the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) confirms the stability of the newly introduced trait and the absence of disruption of known endogenous genes. Since anthocyanins are common pigments in many food plants, it is not expected that accidental intake of petals of carnation IFD-25958-3 would contribute substantially to the overall intake of anthocyanins from foods. Considering the ornamental use of cut flowers, and the limited exposure scenarios expected, the EFSA GMO Panel identified no reasons for any food safety concerns relating to carnation IFD-25958-3. The EFSA GMO Panel is also of the opinion that accidental release of GM carnations into the environment would not give rise to environmental safety concerns. The EFSA GMO Panel agrees with the methodology, including reporting intervals, proposed for post-market environmental monitoring. In response to the European Commission, the EFSA GMO Panel concludes that, in the light of the ornamental use of carnation IFD-25958-3 cut flowers, there is no scientific reason to consider that the placing on the market of the GM carnation will cause any adverse effects on human health or the environment. [ABSTRACT FROM AUTHOR]

Genetically modified (GM) carnation IFD-26407-2 was developed to express anthocyanins in the petals conferring a mauve colour to the flowers. The GM carnation is intended to be imported in the European Union as cut flower for ornamental use only. Based on the molecular characterisation data, the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) confirms the stability of the newly introduced trait and the absence of disruption of known endogenous genes. Since anthocyanins are common pigments in many food plants, it is not expected that accidental intake of petals of carnation IFD-26407-2 would contribute substantially to the overall intake of anthocyanins from foods. Considering the ornamental use of cut flowers, and the limited exposure scenarios expected, the EFSA GMO Panel identified no reasons for any food safety concerns relating to carnation IFD-26407-2. The EFSA GMO Panel is also of the opinion that accidental release of GM carnations into the environment would not give rise to environmental safety concerns. The EFSA GMO Panel agrees with the methodology, including reporting intervals, proposed for post-market environmental monitoring. In response to the European Commission, the EFSA GMO Panel concludes that, in the light of the ornamental use of carnation IFD-26407-2 cut flowers, there is no scientific reason to consider that the placing on the market of the GM carnation will cause any adverse effects on human health or the environment. [ABSTRACT FROM AUTHOR]

The European Commission asked the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) to address the objections of Cyprus to the placing on the market of the genetically modified (GM) carnation SHD-27531-4. The GM carnation cut flowers, with a modified petal colour, are intended to be imported and distributed in the European Union for ornamental use only. The EFSA GMO Panel responded to the objections of Cyprus, taking into account the limited intended use of carnation SHD-27531-4 and the information available. First, the EFSA GMO Panel concludes that the propagation of carnation SHD-27531-4 by individuals cannot be excluded. However, should this occur, carnation SHD-27531-4 would not show any potential for increased survival, fitness or weediness compared with its parental line. Second, the EFSA GMO Panel is of the opinion that the potential spread of pollen of the GM carnation SHD-27531-4 by Lepidoptera to wild Dianthus species cannot be eliminated but is highly unlikely to occur and, if it did occur, it is very unlikely that viable hybrids would be produced, survive and result in adverse environmental effects. Third, considering the very low potentials for hybridisation and/or seed production of (GM) carnations, the EFSA GMO Panel concludes that plant-to-plant gene transfer of the introduced genes is very unlikely and, if it did occur, it is unlikely to result in viable seed production leading to adverse environmental effects. [ABSTRACT FROM AUTHOR]

This document provides guidance for the environmental risk assessment (ERA) of living genetically modified (GM) animals, namely fish, insects and mammals and birds, to be placed on the European Union (EU) market in accordance with Regulation (EC) No 1829/2003 or Directive 2001/18/EC. It provides guidance for assessing potential effects of GM animals on animal and human health and the environment and the rationales for data requirements for a comprehensive ERA. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. This document describes the six sequential steps for the ERA of GM animals, as indicated in Directive 2001/18/EC: (1) problem formulation including hazard and exposure identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk evaluation. The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority follows Annex II of Directive 2001/18/EC, considering specific areas of risk to be addressed by applicants and risk assessors during the ERA of GM fish, GM insects and GM mammals and birds. Each specific area of risk is considered in a structured and systematic way following the aforementioned six steps. In addition, this Guidance Document describes several generic cross-cutting considerations (e.g. choice of comparators, use of non-GM surrogates, experimental design and statistics, long-term effects, uncertainty analysis) that need to be accounted for throughout the whole ERA.

Pancreas disease caused by salmonid alphavirus in farmed Atlantic salmon (Salmo salar) leads to high mortality rates post infection and histopathological lesions in several organs. As protection against pancreas disease, Novartis developed a prophylactic DNA plasmid-based vaccine to be administered to salmon as naked plasmid in a single intramuscular injection. In order to assess the legal status of the fish vaccinated with this new vaccine with regard to the legislation on genetically modified organisms, the European Commission suggested that the company carry out a scientific study on the integration/non-integration of the plasmid DNA into the fish genome. Subsequently, the European Commission requested EFSA to give scientific advice on the study design and the conclusions drawn by the company. PCR based analysis of genomic DNA from muscle samples, taken from at or around the injection site 436 days post vaccination, led the company to conclude that integration of plasmid DNA into the fish genome is extremely unlikely. After an assessment of the study, EFSA considers that the study presented by Novartis Animal Health on the integration/non-integration of DNA plasmid-based vaccine into the salmon genomic DNA provides insufficient information on the potential integration of plasmid DNA fragments into the fish genome due to a limited coverage of the plasmid DNA by the detection method provided, the limited number of samples analysed and an insufficient limit of detection and method validation. Therefore, EFSA is of the opinion that the results from the integration/non-integration study submitted by Novartis Animal Health are not sufficient to support the conclusion of non-integration of plasmid DNA into the fish genome drawn by the company.

Austria notified the European Commission of its new scientific elements justifying the prolongation for three additional years of the implementation of a national safeguard measure prohibiting the placing on the market of genetically modified maize MON 863 in Austria. Subsequently, the European Commission asked the European Food Safety Authority (EFSA) to assess the new scientific information supporting the prolongation of the prohibition. Having considered the information provided by Austria and all relevant scientific publications, the EFSA Panel on Genetically Modified Organisms (GMO Panel) concluded that the new scientific elements submitted by the Austrian Authorities do not lead EFSA to reconsider the conclusions in its opinions on maize MON 863. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) evaluated the documentation provided by Austria to support the prolongation of the safeguard clause measure prohibiting the placing on the market of the genetically modified oilseed rape events Ms8, Rf3 and Ms8 x Rf3 for import, processing and feed uses in Austria. The EFSA GMO Panel assessed whether the submitted documentation comprised new scientific information that would change or invalidate the conclusions of its previous risk assessments on oilseed rape Ms8, Rf3 and Ms8 x Rf3. The EFSA GMO Panel also considered the relevance of the concerns raised by Austria in the light of the most recent data published in the scientific literature. The authorised uses of oilseed rape Ms8, Rf3 and Ms8 x Rf3 exclude cultivation, but data on gene flow, persistence and invasiveness derived from cultivation were considered as a worst case, representing conditions where exposure and potential impact are expected to be the highest, to assess possible environmental impacts resulting from seed import spills. In the documentation provided by Austria and in the scientific literature, the EFSA GMO Panel could not identify new scientific evidence that indicates that the import and processing of oilseed rape Ms8, Rf3 and Ms8 x Rf3 for feed uses in the EU pose a significant and imminent risk to the environment. In conclusion, the EFSA GMO Panel considers that, based on the documentation supplied by Austria and a review of recent scientific literature, there is no specific scientific evidence in terms of risk to the environment that would support the notification of a safeguard clause measure under Article 23 of Directive 2001/18/EC nor its prolongation, and that would invalidate its previous risk assessments of oilseed rape Ms8, Rf3 and Ms8 x Rf3.

Following a request of the European Commission, the European Food Safety Authority’s Panel on Genetically Modified Organisms (EFSA GMO Panel) evaluated the documentation submitted by Greece in support of its request for the prohibition of the placing on the market of the genetically modified maize MON 810 according to Article 23 of Directive 2001/18/EC. The EFSA GMO Panel notes that the majority of the publications referred to by Greece were already addressed by the EFSA GMO Panel in previous scientific outputs on maize MON 810 or other related insect-resistant genetically modified maize transformation events. In the remaining evidence provided by Greece, the EFSA GMO Panel could not identify any new data subject to scientific scrutiny or scientific information that would invalidate its previous risk assessments of maize MON 810. With regard to issues related to management and monitoring of maize MON 810, the EFSA GMO Panel refers to its recent recommendations for management and monitoring measures of maize MON 810. In conclusion, the EFSA GMO Panel considers that, based on the documentation submitted by Greece, there is no specific scientific evidence, in terms of risk to human and animal health or the environment, that would support the notification of a safeguard clause under Article 23 of Directive 2001/18/EC and that would invalidate the GMO Panel’s previous risk assessments of maize MON 810.

Following a request from the European Commission, the Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel) evaluated the documentation provided by Austria to support the prolongation of the safeguard clause measure prohibiting the placing on the market of the genetically modified oilseed rape event GT73 for import, processing and feed uses in Austria. The EFSA GMO Panel assessed whether the submitted documentation comprised new scientific information that would change or invalidate the conclusions of its previous risk assessments on oilseed rape GT73. The EFSA GMO Panel also considered the relevance of the concerns raised by Austria in the light of the most recent data published in the scientific literature. The authorised uses of oilseed rape GT73 exclude cultivation, but data on gene flow, persistence and invasiveness derived from cultivation were considered as a worst case, representing conditions where exposure and potential impact are expected to be the highest, to assess possible environmental impacts resulting from seed import spills. In the documentation provided by Austria and in the scientific literature, the EFSA GMO Panel could not identify new scientific evidence that indicates that the import and processing of oilseed rape GT73 for feed uses in the EU pose a significant and imminent risk to the environment. In conclusion, the EFSA GMO Panel considers that, based on the documentation supplied by Austria and a review of recent scientific literature, there is no specific scientific evidence in terms of risk to the environment that would support the notification of a safeguard clause measure under Article 23 of Directive 2001/18/EC nor its prolongation, and that would invalidate its previous risk assessments of oilseed rape GT73.

Luxembourg notified to the European Commission its scientific arguments justifying the implementation of a national safeguard measure prohibiting the placing on the market of GM potato EH92-527-1 for cultivation purposes in Luxembourg, after which the European Commission asked the European Food Safety Authority (EFSA) to assess the scientific information supporting the prohibition. Having considered the information package provided by Luxembourg and all relevant scientific publications, the EFSA Panel on Genetically Modified Organisms (GMO Panel) concluded that: (i) no new data specific to the safety of the nptII gene have been provided; (ii) although bacterial DNA release and development of competence are expected to occur more efficiently in biofilms, the link between resistance in biofilms and cultivation/processing of GM potato EH92-527-1 was not established by Luxembourg, and the main barriers, limiting the transformation frequency of bacterial cells with transgenic plant DNA, remain; (iii) the risk posed by the formation of mosaic structures of aminoglycoside phosphotransferase genes could not be assessed without data documenting the existence of such structures among the existing gene variants, and such data were not provided; (iv) the knowledge gaps and uncertainties highlighted in the Luxembourgeois document and the therapeutic relevance of kanamycin and neomycin have already been considered in the previous EFSA opinion on antibiotic resistance marker genes, and no new information on the safety of nptII gene as present in the GM potato EH92-527-1 has been identified in the scientific literature that would cause the GMO Panel to change its previous conclusions. Therefore, the EFSA GMO Panel concludes that no grounds exist to date that would lead to reconsideration of its opinion on GM potato EH92-527-1.

According to European Union (EU) legislation, genetically modified (GM) crops released for commercial cultivation have to be monitored. Here we summarise the discussion of a working group that convened during the 4th International Workshop on Post Market Environmental Monitoring (PMEM) of Genetically Modified Plants in Quedlinburg from 3–4 May 2010 to discuss the necessity, extent and design of PMEM plans of genetically modified herbicide tolerant (GMHT) crops. The following workshop report summarises the questions specific to the monitoring of GMHT crops and seeks to answer what should be monitored and who should perform such a monitoring. In addi­tion, the main challenges when monitoring GMHT crops are presented and it is discussed how these challenges could be addressed.

Pancreas disease caused by salmonid alphavirus in farmed Atlantic salmon ( Salmo salar) leads to high mortality rates post infection and histopathological lesions in several organs. As protection against pancreas disease, Novartis developed a prophylactic DNA plasmid-based vaccine to be administered to salmon as naked plasmid in a single intramuscular injection. In order to assess the legal status of the fish vaccinated with this new vaccine with regard to the legislation on genetically modified organisms, the European Commission suggested that the company carry out a scientific study on the integration/non-integration of the plasmid DNA into the fish genome. Subsequently, the European Commission requested EFSA to give scientific advice on the study design and the conclusions drawn by the company. PCR based analysis of genomic DNA from muscle samples, taken from at or around the injection site 436 days post vaccination, led the company to conclude that integration of plasmid DNA into the fish genome is extremely unlikely. After an assessment of the study, EFSA considers that the study presented by Novartis Animal Health on the integration/non-integration of DNA plasmid-based vaccine into the salmon genomic DNA provides insufficient information on the potential integration of plasmid DNA fragments into the fish genome due to a limited coverage of the plasmid DNA by the detection method provided, the limited number of samples analysed and an insufficient limit of detection and method validation. Therefore, EFSA is of the opinion that the results from the integration/non-integration study submitted by Novartis Animal Health are not sufficient to support the conclusion of non-integration of plasmid DNA into the fish genome drawn by the company. [ABSTRACT FROM AUTHOR]

This document provides guidance for the environmental risk assessment (ERA) of living genetically modified (GM) animals, namely fish, insects and mammals and birds, to be placed on the European Union (EU) market in accordance with Regulation (EC) No 1829/2003 or Directive 2001/18/EC. It provides guidance for assessing potential effects of GM animals on animal and human health and the environment and the rationales for data requirements for a comprehensive ERA. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. This document describes the six sequential steps for the ERA of GM animals, as indicated in Directive 2001/18/EC: (1) problem formulation including hazard and exposure identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk evaluation. The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority follows Annex II of Directive 2001/18/EC, considering specific areas of risk to be addressed by applicants and risk assessors during the ERA of GM fish, GM insects and GM mammals and birds. Each specific area of risk is considered in a structured and systematic way following the aforementioned six steps. In addition, this Guidance Document describes several generic cross-cutting considerations (e.g. choice of comparators, use of non-GM surrogates, experimental design and statistics, long-term effects, uncertainty analysis) that need to be accounted for throughout the whole ERA. [ABSTRACT FROM AUTHOR]

In its judgement of July 25, 2018, the Court of Justice of the European Union (CJEU) in the case C-528/16, Confédération paysanne and Others , held that organisms obtained by techniques of mutagenesis are 'genetically modified organisms' (GMOs). It follows from the Court's reasoning that genome-edited organisms, ie organisms resulting from techniques of directed mutagenesis, are GMOs as well and are fully regulated by Directive 2001/18/EC. However, Directive 2001/18/EC only stipulates rules for the deliberate release and placing on the market of GMOs. By contrast, the European Union (EU) has adopted a separate set of rules laid down in Directive 2009/41/EC, which apply to the so-called 'contained use' of 'genetically modified micro-organisms' (GMMs). Whether also genome-edited micro-organisms are GMMs and, thus, subject to Directive 2009/41/EC is of crucial importance since contained use activities with genome-edited micro-organisms are currently carried out extensively, eg in laboratories and research facilities. An in-depth legal analysis shows that the CJEU's interpretation of Directive 2001/18/EC can be extended to Directive 2009/41/EC which means that, in the end, genome-edited micro-organisms are GMMs invariably subject to Directive 2009/41/EC., (© The Author(s) 2022. Published by Oxford University Press on behalf of Duke University School of Law, Harvard Law School, Oxford University Press, and Stanford Law School. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

This article gives an overview of legal and procedural uncertainties regarding genome edited organisms and possible ways forward for European GMO policy. After a recent judgment by the European Court of Justice (ECJ judgment of 25 July 2018, C-528/16), organisms obtained by techniques of genome editing are GMOs and subject to the same obligations as transgenic organisms. Uncertainties emerge if genome edited organisms cannot be distinguished from organisms bred by conventional techniques, such as crossing or random mutagenesis. In this case, identical organisms can be subject to either GMO law or exempt from regulation because of the use of a technique that cannot be identified. Regulatory agencies might not be able to enforce GMO law for such cases in the long term. As other jurisdictions do not regulate such organisms as GMOs, accidental imports might occur and undermine European GMO regulation. In the near future, the EU Commission as well as European and national regulatory agencies will decide on how to apply the updated interpretation of the law. In order to mitigate current legal and procedural uncertainties, a first step forward lies in updating all guidance documents to specifically address genome editing specifically address genome editing, including a solution for providing a unique identifier. In part, the authorization procedure for GMO release can be tailored to different types of organisms by making use of existing flexibilities in GMO law. However, only an amendment to the regulations that govern the process of authorization for GMO release can substantially lower the burden for innovators. In a second step, any way forward has to aim at amending, supplementing or replacing the European GMO Directive (2001/18/EC). The policy options presented in this article presuppose political readiness for reform. This may not be realistic in the current political situation. However, if the problems of current GMO law are just ignored, European competitiveness and research in green biotechnology will suffer.

The GMO Panel has previously assessed genetically modified (GM) carnation FLO-40689-6 and concluded that there is no scientific reason to consider that the import, distribution and retailing in the EU of carnation FLO-40689-6 cut flowers for ornamental use will cause any adverse effects on human health or the environment. On 27 October 2017, the European Commission requested EFSA to analyse new nucleic acid sequencing data and updated bioinformatics data for carnation FLO-40689-6 and to indicate whether the conclusions of the GMO Panel on the previously assessed GM carnation FLO-40689-6 remain valid. The new sequencing data indicated the correction of one nucleotide compared to the sequencing data originally provided. The new sequence was corrected by removal of one nucleotide from the polylinker region in locus 1. The removal of this base pair reported in the new nucleic acid sequencing data for carnation FLO-40689-6 has been already present in the original plant material used for the risk assessment. Thus, with the exception of bioinformatics analyses, the studies performed for the risk assessment of GM carnation FLO-40689-6 remain valid. The new sequencing data and the bioinformatic analyses performed on the new sequence, did not give rise to safety issues. Therefore, EFSA concludes that the original risk assessment of carnation FLO-40689-6 remains valid., (© 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.)