b'Source: EU-SAGEThis regulation leads to provide extensively documentedAfrican and European countries, with the exception of Spain files, including studies of highly unlikely prospective hypothesesand Portugal).and includes drastic and expensive post-market monitoring toSo, this clearly distinguishes probiotech countries (which detect an uncertain and unknown anomaly that might be relatedgrow and import GMO crops) and those that are more reserved to the cultivation of a transgenic plant (no hypothesis driven).(which import GMO crops but refuse to grow them). This is fur-Only the major international conglomerates in the sector (nowther reflected by the rules that are applied for genome editing the American Corteva, the Chinese ChemChina and the Germaninnovations.Bayer), have sufficient financial base to assume such regulatory requirements, which are added to the normal application processGENOME-EDITING PRODUCTS NON SUBMITTED for marketing authorisation for a new plant variety. TO GMO REGULATIONS IN MANY COUNTRIESIf it might seem appropriate to have such regulations atIt is therefore not unexpected that the first regulations applied a time when there were many unknowns about the behaviourto genome-editing products were taken in South America, of genetically modified plants in the field, is it still the samewhere countries are often described as the "land of choice" for today? There are several arguments in favour of its relief. Forbiotech plants.example, the three American National Academies of Arts andArgentina, Chile, Colombia, Brazil and Paraguay decided Sciences, Engineering and Medicine published a more than 600- to proceed on a case-by-case basis but by exempting from reg-page report in 2016, following the analysis of more than 1000ulation any new organism genetically modified by NBT that scientific publications on cultivated plants produced by geneticwould not incorporate "new combinations of genetic material". engineering over a 20-year period and concludes that these bio- Genome-editing products that do not incorporate external DNA tech plants grown in accordance with good agricultural practicesare not considered GMOs. Presently Uruguay does not have any do not present more toxicity and ecotoxicity or environmentalspecific regulations for genome-editing products but has signed risks than conventional plants.a manifesto with 12 other countries in 2018 to the World Trade It was in this context that the question of regulations thatOrganization stating that "arbitrary and unjustified distinctions" should be applied to the NBTs has arisen from 2015 onwards. between cultures derived from genome-editing or conventional grow-up should be outlawed. A DIVIDED WORLD In North America, a new regulation, called the SECURE Since 1996, the year in which the first transgenic crops (bio- (Sustainable, Ecological, Consistent, Uniform, Responsible and tech) were planted, the world is divided into two parts: on theEfficient) Rule applied to new genome-editing biotechnology, one hand the countries that adopted them (North and Southwas published on 18 May 2020 in the American Federal Registry America, Asia and the Pacific-Oceania region) and on the otherafter a wide consultation was held to gather the opinion of all. A hand, those that rejected them (Middle East and a majority ofplant genetically edited for minor changes in the genome such EUROPEAN-SEED.COMIEUROPEAN SEED I 31'