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9 ibid. The techniques are those listed in Annex IA, Part 1; additionally, techniques listed in Annex IA, Part 2 are deemed not to give rise to GMOs.

10 It stands for “site-Directed Nuclease-3”.

11 EFSA (European Food Safety Authority), “Scientific Opinion Addressing the Safety Assessment of Plants Developed Using Zinc Finger Nucleases 3 and Other Site-Directed Nucleases with Similar Function” (2012) 10 EFSA J 2943 <doi.org/10.2903/j.efsa.2012.2943> accessed 19 September 2019.CrossRef+accessed+19+September+2019.>Google Scholar

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25 CRISPR/Cas9 stands for “Clustered Regularly Interspaced Short Palindromic Repeats” associated to a Cas9 protein.

26 TALEN stands for “Transcription Activator-Like Effector Nucleases”.

27 ZNF stands for “Zinc-Finger Nucleases”.

28 Zhang et al, supra, note 7.

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42 Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed [2003] OJ L 268.

43 Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients [1997] OJ L 043, Art 3(4). This Regulation has been replaced by Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 [2015] OJ L 327/1.

44 See Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms [1990] OJ L 117; Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms [1990] OJ L 117; Council Directive 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work (seventh individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC) [1990] OJ L 374. A fourth directive on the matter was enacted in 1994 (Council Directive 94/55/EC of 21 November 1994 on the approximation of the laws of the Member States with regard to the transport of dangerous goods by road [1994] OJ L 319).

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51 EASAC confirmed this position in its Report “Genome Editing: Scientific Opportunities, Public Interests and Policy Options in the EU” (EASAC Policy Report 31, 2017) <www.easac.eu/fileadmin/PDF_s/reports_statements/Genome_Editing/EASAC_Report_31_on_Genome_Editing.pdf> accessed 19 September 2019.

52 For an overview of the different positions and opinions, see European Parliament, New plant-breeding techniques Applicability of GM Rules (May 2016) <www.europarl.europa.eu/RegData/etudes/BRIE/2016/582018/EPRS_BRI(2016)582018_EN.pdf> accessed 19 September 2019; T Sprink et al, “Regulatory Hurdles for Genome Editing: Process- vs. Product-based Approaches in Different Regulatory Contexts” (2016) 35 Plant Cell Rep 1493.

53 See supra, note 23.

54 Art 3(1) provides as follows: “This Directive shall not apply to organisms obtained through the techniques of genetic modification listed in Annex IB”. Annex IB provides as follows: “Techniques referred to in Article 3. Techniques/methods of genetic modification yielding organisms to be excluded from the Directive, on the condition that they do not involve the use of recombinant nucleic acid molecules or genetically modified organisms other than those produced by one or more of the techniques/methods listed below are: (1) mutagenesis (2) cell fusion (including protoplast fusion) of plant cells of organisms which can exchange genetic material through traditional breeding methods”.

55 On the ambiguous character of this question from a legal viewpoint, see Albujar, GF and van der Meulen, B, “The EU’s GMO Concept: Analysis of the GMO Definition in EU Law in the Light of New Breeding Techniques (NBTs)” (2018) 1 EFFL 14Google Scholar.

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57 ibid, at para 28.

58 ibid, at para 29.

59 ibid, at para 54.

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64 See “Expert Reaction to Court of Justice of the European Union Ruling that GMO Rules Should Cover Plant Genome Editing Techniques” (Science Media Centre, 2018) <www.sciencemediacentre.org/expert-reaction-to-court-of-justice-of-the-european-union-ruling-that-gmo-rules-should-cover-plant-genome-editing-techniques/> accessed 19 September 2019.

65 “The decision is not only an obstacle to faster successes in modern agriculture in the breeding of more robust crops with higher yields; it also impairs the production of biopharmaceuticals and bio-based chemicals. The Court takes the wrong standpoint on how to regulate genome editing methods, since researchers obtain with Crispr/CAS the same results as with conventional breeding methods – but much faster” <www.vci.de/vci-online/presse/pressemitteilungen/backward-minded-and-hostile-to-progress-vci-on-ecj-judgment-on-genome-editing.jsp> accessed 19 September 2019.

66 “We regret that implementation of this ruling could cause European life science innovation effectively to come to a halt. If fast mitigation is not done, the ruling will cause a halt to EU sustainability and competitiveness ambitions by hindering the delivery of innovative bio-based products to the market, sustainable innovative food-solutions and certain healthcare solutions to patients” <www.europabio.org/sites/default/files/EuropaBio_statement_CourtRuling_final_forWEB.pdf> accessed 19 September 2019.

67 Bioökonomierat, “Genome editing: Europe Needs New Genetic Engineering Legislation” (2018) BÖRMEMO 07 <biooekonomierat.de/fileadmin/Publikationen/berichte/BOER-Memo_Genome-Editing_ENG.pdf> accessed 19 September 2019.

68 “These new ‘GMO 2.’” genetic engineering techniques must be fully tested before they are let out in the countryside and into our food. We welcome this landmark ruling which defeats the biotech industry’s latest attempt to push unwanted genetically-modified products onto our fields and plates” <foeeurope.org/eu-top-court-confirms-safety-checks-needed-new-gmo-250718> accessed 19 September 2019.

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86 EFSA, Guidance on Communication of Uncertainty in Scientific Assessments (2018) <efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5520> accessed 19 September 2019.

86 EFSA, Guidance on Communication of Uncertainty in Scientific Assessments (2018) <efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2019.5520> accessed 19 September 2019.

87 Regulation (EU) 2019/1381 of the European Parliament and of the Council of 20 June 2019 on the transparency and sustainability of the EU risk assessment in the food chain and amending Regulations (EC) No 178/2002, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 2065/2003, (EC) No 1935/2004, (EC) No 1331/2008, (EC) No 1107/2009, (EU) 2015/2283 and Directive 2001/18/EC, OJ L 231/1.

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89 See <www.ifoam-eu.org/en/news/2018/06/18/general-food-law-unsuccessful-attempt-european-commission-bring-more-transparency> accessed 19 September 2019.

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