Table 1.

Table of genome editing directed policy options for different actors. Sorted by timing.

Action	Actors	Start of effecta	Effect
Make use of flexibility within current legal framework: – Transparency: revise guidance documents explicitly addressing GEOs – Predictability: if not scientifically warranted, do not ask for additional information or further assessments – Lower barriers for GEO authorization, especially for field trials and non-food&feed release	Regulatory agencies in member states and on European level	1 year	(Slightly) lowering legal uncertainty
Amend Commission Implementing Regulation (EU) No 503/2013: – Scale process of approval to allow differential treatment for different types of gmos, i.e., explicitly addressing geos – Relax ERA duration and number of locations, adapt to hypothesis of risk – 90 days feed studies only where hypothesis of risk – Relax monitoring modalities to hypothesis of risk	EU commission	2-5 years	Lowering cost for innovators
Update Annexes II, III, VI, VII of GMO Directive 2001/18/EC: – Scale process of approval to allow differential treatment for different types of GMOs, i.e., explicitly addressing GEOs	EU commission	2-5 years	Lowering cost for innovators
Probe ECJ judgment by putting new cases to trial: – Clarify what is a long safety record for mutagenesis – Clarify if every smallest base edit really leads to GMO in the sense of Dir. 2001/18/EC Art. 2(2) – Clarify how judgment is enforced regarding non-detectability	Various stakeholders	3-10+ years	Lowering legal uncertainty
Amend, supplement or replace GMO law (primarily Dir. 2001/18/EC): – Amend Dir. 2001/18/EC Art. 2(2) or Art. 3 i.c.w. Annex IB to exclude geos – Amend Dir. 2001/18/EC Rec. 17: What is long safety record? – Supplement by specific act for geos – Replace by outcome-based regulation (e.g., novel trait) – Replace by sectorial law	EU parliament & commission	5-10+ years	Solves all issues, including enforcement issue
Develop new technologies (speculative): – Alternatives to altering germline DNA for breeding e.g., epigenetic modifications, mRNA interference or proteome modifications are not currently regulated – Alternative employments of techniques of conventional (by chemicals or radiation, in vivo) mutagenesis	Basic research	Decades	Circumventing regulation

¹Commission Directive EU No 2018/350 of 8 March 2018 amending Directive 2001/18/EC of the European Parliament and of the Council as Regards the Environmental Risk Assessment of Genetically Modified Organisms. 67, 30-45. Available online at: http://data.europa.eu/eli/dir/2018/350/oj (accessed September 12, 2018).

^a All timespans given in Table are only rough estimates. The values for “start of effect” are estimated based on the following evidence: The duration of release or amendment of regulations by the parliament and/or by the commission can be estimated based on the history of e.g, Regulation (EC) No 1829/2003 and Commission Regulation (EC) No 641/2004. Regulation (EC) No 1829/2003 was adopted by the commission on 25.7.2001 and the date of its official publication was 22.9.2003, i.e., 2 years (without timespan for implementation). In the case of Commission Regulation (EC) No 641/2004, which is based on Regulation (EC) No 1829/2003 the date of effect is 7.4.2004, which is presumably even less than one year after drafting. Other regulations have been released within similar timeframes. The duration of the committee procedure of article 27 i.c.w. Art. 30(2) of the GMO Directive 2001/18/EC can be estimated on prior instances of its application. On 8.3.2018 changes to various Annexes of the GMO Directive were implemented (Commission Directive EU No 2018/350) involving a committee procedure, whereby the first draft was published on 10.11.2016, giving the procedure a total timespan from drafting to publication of c. 1.5 years. The estimate was heightened to 2–5 years since changes to the annexes of Directive 2001/18/EC are only effective in combination with amendments in the corresponding regulations. The estimates of 2–5 years given above are slightly more generous, to account for the politically delicate nature of the amendments and a longer timespan required by authorities to apply new legislation in the regulatory process. Amendments to the Directive have been brought into force on four dates (07.11.2003; 21.03.2008; 02.04.2015; 29.03.2018) between publication of Directive 2001/18/EC and Nov 2018 (see history of amendment available on http://data.europa.eu/eli/dir/2001/18/oj), which allows to deduce a span of 3-8 years. The duration of a major redrafting and replacement of the entire Directive was estimated as 5-10+ years based on the timeframe it took for Directive 2001/18/EC of 12 March 2001 to be drafted and replace its antecessor Directive 90/220/EEC of 23 April 1990. The process of redrafting did of course not start immediately after publication of 90/220/EEC but only a few years later. The first proposal by the commission was published on 26 Nov 1997, hence the estimate of a minimum of 5 years. After implementation into the directive of the above legislative procedures on European level, transposition by member states might take about 1.5 years (e.g., this is the timeframe for Commission Directive EU 2018/350). The duration of legal actions that involve a clarification of GMO law is very unpredictable and the vague span of 3-10+ years reflect this fact. Finally, research and development of new breeding techniques is ongoing (e.g., CRISPR mediated epigenetic modification) but technologies developed in basic research usually take decades to be transferred to market readiness.