Subsequent amendments to Executive Order no. 981 of 15 October 2009 Annex 1:
The materials, delivery systems and biological substances that are subject to control are listed in Annex 1 to Executive Order no. 475 of 25 May 2016 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 (virus, rickettsia, bacteria, fungi and toxins) that meet one or more of the following criteria are exempted from the Biosecurity Act.
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. 475 of 25 May 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.
Clostridium perfringens toxin
Staphylococcus aureus toxins
Verotoxin and shiga-like ribosome-inactivating proteins
Viscum album Lectin 1 (viscumin)
Genetic elements included in Annex 1 to Executive Order no. 475 of 25 May 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.
Specific strains and forms of biological substances are excluded from the Executive Order, cf. Annex 1 as described in the following list:
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.
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.
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 § 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:
Technology which without further modifications can be used to produce or make use of biological weapons – a licence must be obtained from CBB prior to project launch
Serious potential for misuse in relation to weapons development – mandatory supervision from CBB prior to project launch
Less critical and more general dual-use potential – awareness and biosecurity at the company or institution.
Examples of technologies that require special awareness:
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.