New EU Regulation 2021/821 on dual-use organisms

Already in the AGCT Genetic Engineering report In the January 30, 2025, "UPDATE - New Biological Agents Ordinance (BioStoffV) entered into force," we referred to the amended lists of dual-use organisms in the new EU regulation. But what exactly has changed? Information on dual-use organisms can still be found in the lists of • No. 1C351 (human and animal pathogens and "toxins"), • No. 1C353 ("genetic elements and "genetically modified organisms"), and • No. 1C354 (plant pathogens). "Animal pathogens" no longer have a separate number (previously 1C352). Both the lists of human and animal pathogenic viruses (e.g. SARS-associated coronavirus) and the lists of human and animal pathogenic bacteria (e.g. new serotypes of Shiga toxin-producing E. coli) contained in No. 1C351 have been expanded. The list of toxins and their toxin subunits (1C351d) has not changed, but has been supplemented with an explanation of Staphylococcus aureus enterotoxins. No. 1C351e (human and animal pathogenic fungi) remains unchanged. No. 1C354 on plant pathogens (viruses, bacteria, fungi) has been revised and includes additions in the area of ​​plant pathogenic fungi (e.g. Thecaphora solani ). No. 1C353 on "genetic elements" and "genetically modified organisms," however, has been revised to a greater extent. The terms "genes" or "any group of genes" are now used. These are intended to be specific to the viruses, bacteria, or fungi covered by the corresponding subheadings. The following properties are also included for the genes of the bacteria and fungi covered: "They pose a significant threat to the health of humans, animals, or plants, either by themselves or through transcription or translation products, or they may confer or enhance pathogenicity." The technical notes have also been expanded and made more specific. Genetically modified organisms now include organisms in which the nucleic acid sequences have been created or altered by targeted molecular manipulation . Genetic elements now also include inactivated organisms containing recoverable nucleic acid fragments, whether genetically modified or unmodified, or wholly or partially chemically synthesized . The new EU regulation can be found here.