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• W2940645019 abstract "Opinion23 April 2019free access Implementing an EU opt-in mechanism for GM crop cultivation Dennis Eriksson [email protected] orcid.org/0000-0002-5205-3396 Swedish University of Agricultural Sciences, Alnarp, Sweden Search for more papers by this author Eugénia de Andrade INIAV, I.P., Oeiras, Portugal Search for more papers by this author Borut Bohanec University of Ljubljana, Ljubljana, Slovenia Search for more papers by this author Sevasti Chatzopoulou Roskilde University, Roskilde, Denmark Search for more papers by this author Roberto Defez IBBR-CNR, Napoli, Italy Search for more papers by this author Nélida Leiva Eriksson Lund University, Lund, Sweden Search for more papers by this author Piet van der Meer Ghent University; Vrije Universiteit Brussel (VUB), Brussels, Belgium Search for more papers by this author Bernd van der Meulen European Institute for Food Law, Amsterdam, The Netherlands Search for more papers by this author Anneli Ritala VTT Technical Research Centre of Finland Ltd, Espoo, Finland Search for more papers by this author László Sági Centre for Agricultural Research HAS, Martonvásár, Hungary Search for more papers by this author Joachim Schiemann Julius Kühn-Institut, Quedlinburg, Germany Search for more papers by this author Tomasz Twardowski Institute of Bioorganic Chemistry, PAS, Poznan, Poland Search for more papers by this author Tomáš Vaněk Institute of Experimental Botany AS CR, Prague, Czech Republic Search for more papers by this author Dennis Eriksson [email protected] orcid.org/0000-0002-5205-3396 Swedish University of Agricultural Sciences, Alnarp, Sweden Search for more papers by this author Eugénia de Andrade INIAV, I.P., Oeiras, Portugal Search for more papers by this author Borut Bohanec University of Ljubljana, Ljubljana, Slovenia Search for more papers by this author Sevasti Chatzopoulou Roskilde University, Roskilde, Denmark Search for more papers by this author Roberto Defez IBBR-CNR, Napoli, Italy Search for more papers by this author Nélida Leiva Eriksson Lund University, Lund, Sweden Search for more papers by this author Piet van der Meer Ghent University; Vrije Universiteit Brussel (VUB), Brussels, Belgium Search for more papers by this author Bernd van der Meulen European Institute for Food Law, Amsterdam, The Netherlands Search for more papers by this author Anneli Ritala VTT Technical Research Centre of Finland Ltd, Espoo, Finland Search for more papers by this author László Sági Centre for Agricultural Research HAS, Martonvásár, Hungary Search for more papers by this author Joachim Schiemann Julius Kühn-Institut, Quedlinburg, Germany Search for more papers by this author Tomasz Twardowski Institute of Bioorganic Chemistry, PAS, Poznan, Poland Search for more papers by this author Tomáš Vaněk Institute of Experimental Botany AS CR, Prague, Czech Republic Search for more papers by this author Author Information Dennis Eriksson1, Eugénia Andrade2, Borut Bohanec3, Sevasti Chatzopoulou4, Roberto Defez5, Nélida Leiva Eriksson6, Piet Meer7, Bernd Meulen8, Anneli Ritala9, László Sági10, Joachim Schiemann11, Tomasz Twardowski12 and Tomáš Vaněk13 1Swedish University of Agricultural Sciences, Alnarp, Sweden 2INIAV, I.P., Oeiras, Portugal 3University of Ljubljana, Ljubljana, Slovenia 4Roskilde University, Roskilde, Denmark 5IBBR-CNR, Napoli, Italy 6Lund University, Lund, Sweden 7Ghent University; Vrije Universiteit Brussel (VUB), Brussels, Belgium 8European Institute for Food Law, Amsterdam, The Netherlands 9VTT Technical Research Centre of Finland Ltd, Espoo, Finland 10Centre for Agricultural Research HAS, Martonvásár, Hungary 11Julius Kühn-Institut, Quedlinburg, Germany 12Institute of Bioorganic Chemistry, PAS, Poznan, Poland 13Institute of Experimental Botany AS CR, Prague, Czech Republic EMBO Rep (2019)20:e48036https://doi.org/10.15252/embr.201948036 PDFDownload PDF of article text and main figures. ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinked InMendeleyWechatReddit Figures & Info The cultivation of genetically modified (GM) crops in the EU remains a highly polemic issue. The only GM crop event that is currently authorised is the insect-resistant maize “MON810”. The GM potato variety “Amflora” with improved tuber starch composition was approved for cultivation in 2010, but later withdrawn. One of the main reasons that not more GM crops are authorised for cultivation is a regulatory gridlock with a recurring inability to reach a qualified majority in the designated committee for either approval or rejection 1. Several EU member states experience domestic pressure against adoption of GM crops 2-4. The European Commission (EC) therefore developed legislation—the Directive EU 2015/412, adopted by the European Parliament (EP) in 2015—to give member states the possibility to restrict or prohibit cultivation of authorised GM crops in their territory (opt-out mechanism). The request to exclude a particular GM event from cultivation may be communicated to the EC after risk assessment, or after authorisation provided that the restriction is in conformity with the EU law, reasoned, proportional, non-discriminatory and based on compelling grounds (Article 26b(3) of Directive 2015/412). To date, 17 member states and two autonomous regions have used this possibility. In parallel, the EC also proposed an analogous mechanism for the import of GM food and feed, which was rejected by the EP. This illustrates a paradox: 62 different GM products that have passed the risk assessment by the European Food Safety Authority (EFSA) and are authorised (https://webgate.ec.europa.eu/dyna/gm_register/index_en.cfm) are entering the EU as food and feed but cannot be cultivated in the EU. As some EU member states favour approving the cultivation of certain GM crops given a positive risk assessment by EFSA, we have proposed a mechanism that would allow them to take individual decisions on authorising (“opt in”) GM crops 5. The response from various stakeholders has been mostly positive, but questions have been raised about implementation. We here describe two scenarios for implementing a national opt-in mechanism for the cultivation of GM crops under the current EU legislation. In the first scenario (Fig 1A), the initial steps of the authorisation procedure remain exactly as today. After EFSA has delivered the risk assessment, the EC drafts a first decision for voting in the Regulatory Committee. In case a qualified majority is not reached in either direction, the proposed opt-in mechanism would allow individual member states to take a national decision to authorise the cultivation of the GM event in question. In case a qualified majority votes against the EU-wide authorisation of a GM event, the opt-in mechanism would not be available. The current opt-out mechanism remains available just as today, if there is a qualified majority voting for EU-wide authorisation of a GM event. Figure 1. Two scenarios for modifying the existing authorisation procedure to implement an opt-in mechanism for the cultivation of GM crops(A) If the Regulatory Committee fails to deliver a decision based on a qualified majority, the opt-in mechanism enters into force. (B) The opt-in mechanism enters into force immediately after a positive risk assessment by EFSA. Download figure Download PowerPoint In the second scenario (Fig 1B), a positive assessment by EFSA means that the event would be immediately available for opt-in by each member state. This would eliminate the need for the collective authorisation procedure, and an opt-out mechanism as member states can simply refrain from opting in. We estimate that the first scenario may be the more realistic in terms of political viability, and in line with the overall EU principles. It would maintain a certain degree of harmonisation while providing member states with more discretionary power whenever committees fail to deliver a decision. It would also underline the importance of a collective risk assessment procedure as managed by EFSA. Moreover, the first scenario would re-establish the balance in subsidiarity that was distorted in 2015 with the opt-out mechanism. As member states have the right to opt out from GM crop cultivation, they should also have a right to opt in. For countries that are currently cultivating EU-authorised GM crops, it may also be politically more sensitive to take national opt-in decisions that may go against the policies of neighbouring countries, than to rely on EU-wide authorisation. The second scenario is attractive in its simplicity. It would provide a higher degree of depoliticisation in the risk management of GM crops, and facilitate decisions based to a higher degree on scientific evidence whenever the national political and societal context supports it. Both scenarios would apply only to the cultivation of GM crops; the effects on food and feed products will be limited as market access will remain covered by the EU-wide regulations (EC) 1829/2003 and (EC) 1830/2003 on the authorisation of GM food and feed. A reasonable expectation is that GM events other than MON810 could become available for production in some EU member states. The consequences in terms of cross-border drift may therefore be exacerbated as a member state opting in for a particular GM event may have neighbours that have not. We would envisage that the same provisions that are included in the opt-out Directive would apply: member states in which GM crops are cultivated are responsible for taking appropriate measures to avoid possible cross-border drift. Specific to the second scenario, it needs to be established whether the right to request further information from EFSA should lie with the EC as today, or also with the member states. Another detail is the development of a procedure whereby the applicant, or any other, can approach any member state in addition to the one where the original application was filed initially, in order to request an opt-in decision after positive EFSA assessment. A national opt-in mechanism for GM crops may not fit readily with the EU internal market philosophy. However, the political reality justifies unorthodox solutions. In addition, the opt-out mechanism introduced by Directive 2015/412 has been characterised as very atypical in terms of the EU internal market policy 6, 7. As the current implementation of the EU legislation arguably does not fulfil the criteria of legal certainty, non-discrimination and scientific adaptability 8, we suggest that the proposed opt-in mechanism would provide a more balanced regulatory setting, particularly as it would facilitate science-based considerations for implementation. We therefore encourage the EC to invite a wide range of stakeholders to discuss this proposal, and to bring these issues forward at a high political level. Article 2 of Directive 2015/412 states that the EC shall present a report to the EP and the Council in 2019 regarding the use member states made of the opt-out mechanism, possibly accompanied by any legislative proposals. It is therefore high time to consider drafting a legislative proposal complementing the opt-out mechanism with an opt-in as discussed here. References 1. Smart R, Blum M, Wesseler J (2015) Ger J Agric Econ 64: 244–262Web of Science®Google Scholar 2. Ricroch A, Bergé JB, Kuntz M (2010) Transgenic Res 19: 1–12CrossrefCASPubMedWeb of Science®Google Scholar 3. Kuntz M (2012) GM Crops Food 3: 1–7CrossrefPubMedGoogle Scholar 4. Lucht J (2015) Viruses 7: 4254–4281CrossrefPubMedWeb of Science®Google Scholar 5. Eriksson D, de Andrade E, Bohanec B et al (2018) Nat Biotechnol 36: 18–19CrossrefCASPubMedWeb of Science®Google Scholar 6. Randour F, Janssens C, Delreux T (2014) J Common Mark Stud 52: 1307–1323Wiley Online LibraryWeb of Science®Google Scholar 7. Haut Conseil des Biotechnologies (2016) http://www.hautconseildesbiotechnologies.fr/sites/www.hautconseildesbiotechnologies.fr/files/file_fields/2017/02/17/recommandationduceesrelativealadirective2015-412-versionanglaise.pdfGoogle Scholar 8. Zetterberg C, Björnberg KE (2017) J Agr Environ Ethics 30: 325–347CrossrefWeb of Science®Google Scholar Previous ArticleNext Article Read MoreAbout the coverClose modalView large imageVolume 20,Issue 5,May 2019Caption: Electron micrograph image of a neonatal human dermal fibroblast exhibiting peripheral heterochromatin along the nuclear periphery. By Radhika Arasala Rao, Alhad Ashok Ketkar, Shravanti Rampalli and colleagues: KMT1 family methyltransferases regulate heterochromatin–nuclear periphery tethering via histone and non‐histone protein methylation. Scientific image by Kriti Kestur Biligiri, Institute for Stem Cell Biology and Regenerative Medicine, Bangalore, India Volume 20Issue 51 May 2019In this issue FiguresReferencesRelatedDetailsLoading ..." @default.
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