Slovenia—GMOs and Synthetic Biology Regulations and Biodiversity: A Slovenian Legal Perspective

Abstract

Modern biotechnology and synthetic biology are globally recognized as the most rapidly evolving fields in life sciences. In Slovenia, most of the activities in these fields are linked to contained use of GMOs, and to a minor extent to experimental release into the environment. In compliance with the legislative requirements, 81 systems for contained use of GMOs (laboratories, production sites or other premises) are currently recorded in the Slovenian GMOs Register. This corresponds to 3.4 contained systems per 100,000 inhabitants, which is comparable to other highly developed EU countries. The majority (78.8%) of contained systems is located in universities and research institutes; the remaining 19.7% are located in companies (18.2%) and high schools (1.5%), respectively. The vast majority of activities with GMOs (82%) pose no or negligible risk to humans or the environment. The remaining 18% are conducted in Containment Level II facilities as their risk to the environment and biodiversity was concluded to be low. Slovenian research institutes and universities are actively involved in the progress of modern biotechnology and synthetic biology. Genome editing techniques such as oligonucleotide-directed mutagenesis (ODM), zinc finger nucleases (ZFNs), transcription activator-like effector nucleases (TALENs) and CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats associated (Cas) nucleases) are used. All genetic modifications are strictly adhered to national legislation which fully implements the European Union (EU) directives and guidelines.