- List
- EU dual-use list – Annex I to Regulation (EU) 2021/821, updated annually
- Originating regime
- Nhóm Úc (AG)
a. Any 'genetically-modified organism' which contains, or 'genetic element' that codes for, any of the following:
1. Any gene, genes, translated product or translated products, specific to any virus specified in 1C351.a. or 1C354.a.;
2. Any gene or genes specific to any bacterium specified in 1C351.c. or 1C354.b. or fungus specified in 1C351.e. or 1C354.c., and which is any of the following:
a. In itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health; or
b. Could 'endow or enhance pathogenicity'; or
3. Any "toxins" specified in 1C351.d. or "sub-units of toxins" therefor;
b. Not used.
Technical Notes:
1. 'Genetically-modified organisms' include organisms in which the nucleic acid sequences have been created or altered by deliberate molecular manipulation.
2. 'Genetic elements' include inter alia chromosomes, genomes, plasmids, transposons, vectors and inactivated organisms containing recoverable nucleic acid fragments, whether genetically modified or unmodified, or chemically synthesised in whole or in part. For the purposes of the genetic elements control, nucleic acids from an inactivated organism, virus, or sample are considered recoverable if the inactivation and preparation of the material is intended or known to facilitate isolation, purification, amplification, detection, or identification of nucleic acids.
3. 'Endow or enhance pathogenicity' is defined as when the insertion or integration of the nucleic acid sequence or sequences is/are likely to enable or increase a recipient organism’s ability to be used to deliberately cause disease or death. This might include alterations to, inter alia: virulence, transmissibility, stability, route of infection, host range, reproducibility, ability to evade or suppress host immunity, resistance to medical countermeasures, or detectability.
Note 1:
1C353 does not control nucleic acid sequences of shiga toxin producing Escherichia coli of serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other shiga toxin producing serogroups, other than those genetic elements coding for shiga toxin, or for its subunits.
Note 2:
1C353 does not control "vaccines".
1. Any gene, genes, translated product or translated products, specific to any virus specified in 1C351.a. or 1C354.a.;
2. Any gene or genes specific to any bacterium specified in 1C351.c. or 1C354.b. or fungus specified in 1C351.e. or 1C354.c., and which is any of the following:
a. In itself or through its transcribed or translated products represents a significant hazard to human, animal or plant health; or
b. Could 'endow or enhance pathogenicity'; or
3. Any "toxins" specified in 1C351.d. or "sub-units of toxins" therefor;
b. Not used.
Technical Notes:
1. 'Genetically-modified organisms' include organisms in which the nucleic acid sequences have been created or altered by deliberate molecular manipulation.
2. 'Genetic elements' include inter alia chromosomes, genomes, plasmids, transposons, vectors and inactivated organisms containing recoverable nucleic acid fragments, whether genetically modified or unmodified, or chemically synthesised in whole or in part. For the purposes of the genetic elements control, nucleic acids from an inactivated organism, virus, or sample are considered recoverable if the inactivation and preparation of the material is intended or known to facilitate isolation, purification, amplification, detection, or identification of nucleic acids.
3. 'Endow or enhance pathogenicity' is defined as when the insertion or integration of the nucleic acid sequence or sequences is/are likely to enable or increase a recipient organism’s ability to be used to deliberately cause disease or death. This might include alterations to, inter alia: virulence, transmissibility, stability, route of infection, host range, reproducibility, ability to evade or suppress host immunity, resistance to medical countermeasures, or detectability.
Note 1:
1C353 does not control nucleic acid sequences of shiga toxin producing Escherichia coli of serogroups O26, O45, O103, O104, O111, O121, O145, O157, and other shiga toxin producing serogroups, other than those genetic elements coding for shiga toxin, or for its subunits.
Note 2:
1C353 does not control "vaccines".