Updated 03.07.2017

What is subject to control?

The materials, delivery systems and biological substances that are subject to control are listed  in Annex 1 to Executive Order no. 803 of 22 June 2017 and Annex 1 to Executive Order no. 981 of 15 October 2009 with subsequent amendments.

The controlled biological substances, delivery systems, and related materials are in general the same as listed in the EU regulation for export control of products and technology with dual-use potential (Commission Delegated Regulation (EU) No 1382/2014 with subsequent amendments).

In pursuance of the Biosecurity Acts (no. 53 of 11 January 2017 and no. 474 of 17 June 2008), certain elements regarding biological agents, delivery systems and related materials require additional explanation. This can be, for example, general exceptions from control, as well as lower threshold values.

The exceptions and explanations for the various groups and substances are listed in the menu below:

 


Biological substances (general delimitation)

Biological substances (virus, rickettsia, bacteria, fungi and toxins) that meet one or more of the following criteria are exempted from the Biosecurity Act.

  • Biological substances in their natural environment as long as they have not been deliberately inoculated, subcultured, isolated or otherwise extracted. For example, naturally occurring toxins in the form of fungal contaminated crops (aflatoxins), or bean bearing castor oil plants, Ricinus communis (containing natural ricin), are thus not subject to control.  
  • Non-viable viruses, rickettsia, bacteria and fungi, as well as non-functional types of toxins. 
  • Specific strains, or forms of controlled biological substances can be exempted from the Biosecurity Act if they are impaired in such a way that they do not pose a disease risk or risk of poisoning. Assessments of specific strains/forms will be conducted by the Centre for Biosecurity and Preparedness, which also maintains an updated list of the specific strains that are exempted from the Act (See the list of exemptions below). Companies or individuals that wish a specific strain etc. added to the list of exemptions, can apply for this by submitting relevant scientific explanation and documentation to CBB. Any alteration or manipulation of a strain on the list of exemptions that can restore or enhance its virulence will repeal the strain from the list of exemptions.

When permission for a specific biological substance has been obtained, additional findings of the same biological substance are included in the permission and only the change in stock has to be recorded in the inventory list.

A licence can also be issued for diagnostic investigations which involve the biological substances included in Executive Order no. 803 of 22 June 2016 or Executive Order no. 981 of 15 October 2009 with subsequent amendments . These biological substances are to be disposed of within 14 days of the completion date of the investigation, unless licences for the specific biological substances have been applied for.


Biological substances (specific remarks)

Virus

Rickettsiae

Bacteria

  • "Enterohaemorrhagic Escherichia coli" (EHEC) refers exclusively to verotoxigenic E. coli (regardless of serotype), which is isolated from human patients with bloody diarrhea and/or hemolytic uremic syndrome (HUS)
  • Generally, Clostridium perfringens strains of type B and D are included in Annex 1 to Executive Order with subsequent amendments,  and, therefore, a licence is necessary for possession, unless it is demonstrated that these strains do not produce functional epsilon toxin. However, Clostridium perfringens strains of type A, C and E are not included in Annex 1 to Executive Order with subsequent amendments  and do not require a licence

Fungi

Toxins

  • Possession, use and storage of toxins may be exempted from the specific requirements in Annex 1 to Executive Order no. 981 of 15 October 2009 with subsequent amendments, if the accumulated amount does not exceed the amounts specified below. Production of controlled toxins always requires specific requirements regardless of quantity

Table 1: Threshold amounts for toxins

Toxins

Threshold amounts

Abrin  

5 mg

Aflatoxins 

1000 mg

Botulinum toxins

  0,05 mg

Cholera toxin 

1000 mg 

Clostridium perfringens toxin

5 mg

Conotoxin

100 mg

Diacetoxyscirpenol toxin 

1000 mg

HT-2 toxin 

1000 mg

Microcystin (Cyanginosin) 

500 mg

Modeccin 

50 mg

Ricin 

50 mg

Saxitoxin 

100 mg

Shigatoxin        

5 mg

Staphylococcus aureus toxins 

500 mg

T-2 toxin

 1000 mg

Tetrodotoxin 

100 mg

Verotoxin and shiga-like ribosome-inactivating proteins  

 0,5 mg

Viscum album Lectin 1 (viscumin) 

50 mg

Volkensin 

50 mg

 


Genetic elements

Genetic elements included in Annex 1 to Executive Order no. 803 of 22 June 2016 and Annex 1 to Executive Order no. 981 of 15 October 2009 with subsequent amendments, are nucleic acid sequences which are longer than 200 nucleotides. See detailed description in Annex 1 to Executive Order no. 981 of 15 October 2009 with subsequent amendments. Thus, production, storage and use of any nucleic acid sequence that contains less than 200 nucleotides is not subject to control. 

List of exemptions

Specific strains and forms of biological substances are excluded from the Executive Order, cf. Annex 1 as described in the following list:

  • Bacillus anthracis strains that do not contain pXO2 or closely related plasmids (e.g., B. anthracis Sterne)


Delivery systems

Delivery systems subject to control only include spray or mist systems which are specifically designed or modified for installation on aircraft as specified in section 2 in Annex 1 to Executive Order no. 981 of 15 October 2009 with subsequent amendments.


  • Related material

Equipment

Control of biological detection systems, as described in Annex 1 to Executive Order no. 981 of 15 October 2009 with subsequent amendments, Chapter 3, section h, only apply if these are specifically designed or modified to detect or identify biological substances listed in Annex 1, Chapter 1.

Link to: Controlled equipment and laboratories

Comprising

 


Technology

Development of technology which can either be used directly as a biological weapon, or can be used to manufacture biological weapons without any further modifications, requires a licence from CBB. To obtain a licence, the purpose of the activity must be legitimate, which in this context means that the development is part of a trial test of countermeasures, or has another beneficial purpose. Application for this is individual, and is to be prepared for in agreement with CBB.

Other technology, including technology that has a legitimate purpose, but which can be misused as part of biological weapons development (dual-use), does not require prior authorisation (cf ยง 1, paragraph 2). Companies that are developing such technology must obtain guidance from CBB to reduce the misuse potential. Control does not apply to technology that is already in the public domain.

Controlled technology is divided into three categories:

A.      

Technology which without further modifications can be used to produce or make use of biological weapons โ€“ a licence must be obtained from CBB prior to project launch

B.

Serious potential for misuse in relation to weapons development โ€“ mandatory supervision from CBB prior to project launch

C.

Less critical and more general dual-use potential โ€“ awareness and biosecurity at the company or institution.

 

Examples of technologies that require special awareness:

  • Modifications of pathogens so that they become undetectable, or so existing vaccines or treatments are ineffective
  • Change of host range for pathogens
  • Increase of disease causing characteristics of microorganisms
  • Increase of the infectivity of pathogens
  • Development of new biological agents with serious, or increased, potentials for causing harm
  • Development of dispersal methods for biological substances, particularly aerosolisation, but also via food or drinking water

 


Recommendations for companies

Clarify whether the company conducts activities with dual-use potential. CBB has developed a check form that companies can use to determine whether their research involves projects with dual-use of concern. See Questionnaire about dual-use research of concern for companies, project managers etc. If necessary, CBB can help companies in this process. If the company becomes aware of technology with misuse potential, employees should be informed about it and receive a step by step instruction on how to prevent the misuse.

Also, consider what knowledge the company discloses to partners and customers and be aware of any unusual circumstances or activities in connection with the provision of technical assistance to external partners.
CBB also recommends that companies working with technology which can be misused for weapons development, implement a code of conduct for good scientific practice at their company, for example, the code of conduct for biosciences that CBB has adopted. See Code of ethics (internal link).

Read more about the application process and who should apply under the menu Application process.

Contact us

Centre for Biosecurity and Biopreparedness 
Statens Serum Institut

5 Artillerivej
DK-2300 Copenhagen S

Telefon: +45 32688127
Email: cbb@ssi.dk