The export of dual-use goods to countries outside the European Union is controlled by strict rules, such as the requirement of a licence. This is described in the EU dual-use Regulation (EC) no. 428/2009.

Dual-use goods can pose a threat to public health, animal health or the environment. For reasons of international security, there are strict rules governing the export and transit of dual-use goods. These rules are based on the EU dual-use Regulation (EC) no. 428/2009. On 30 December 2019, the European Union published an updated goods list of dual-use Regulation (EC) 2019/2199 amending Regulation 428/2009. The export of dual-use goods to countries outside the European Union requires a licence. A licence can be applied for from the Central Licensing Office (CDIU) which forms part of the Dutch Tax and Customs Service.

Apply for an export licence

The CDIU and the Ministry of Foreign Affairs assess licence applications for dual-use goods to check that there are sufficient guarantees for civilian use of the goods for export. They check the combination of goods, the end-user and any brokers, and the end-use specified in the application. If you would like to know if you are eligible for an export licence, you can submit a sondage (preliminary application) to the CDIU. You can even do this before you have signed a contract.

User Guide on Strategic Goods and Services

The Ministry of Foreign Affairs has issued a ‘User Guide on Strategic Goods and Services’ which describes the laws and regulations that apply to export control. This user guide includes an overview of dual-use microorganisms and toxins. The guide also describes how to apply for an export licence from the CDIU.

EU dual-use Regulation

The Regulation lists those items that are considered to be for dual use and that are therefore controlled goods. According to the Regulation (Article 2), these are items, including software and technology, which can be used for both civil and military purposes. ‘Export’ of items refers to: ‘transmission of software or technology by electronic media, including by fax, telephone, electronic mail or any other electronic means’. Controls on the transfer of technology do not apply to information in the public domain, nor to basic scientific research.

The list of dual-use goods has 10 categories, among which in category 1: materials, chemicals, microorganisms and toxins. This category names the following microorganisms and toxins:

1C351 (page 73) Human and animal pathogens and 'toxins', as follows:

  • a) Viruses, whether natural, enhanced or modified, either in the form of ‘isolated live cultures’ or as material including living material which has been deliberately inoculated or contaminated with such cultures,
  • b) Rickettsiae, whether natural, enhanced or modified, either in the form of ‘isolated live cultures’ or as material including living material which has been deliberately inoculated or contaminated with such cultures
  • c) Bacteria, whether natural, enhanced or modified, either in the form of ‘isolated live cultures’ or as material including living material which has been deliberately inoculated or contaminated with such cultures,
  • d) Toxins and sub-units of toxins
  • e) Fungi, whether natural, enhanced or modified, either in the form of ‘isolated live cultures’ or as material including living material which has been deliberately inoculated or contaminated with such cultures.

1C353 - Genetic elements and genetically modified organisms, as follows:

  • Any ‘genetically-modified organism’ which contains, or ‘genetic element’ that codes for, any of the fol­lowing:
    • 1. Any gene or genes specific to any virus specified in 1C351.a. or 1C354.a.;
    • 2. Any gene or genes specific to 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.

1C354 - Plant pathogens, as follows:

  • a) Viruses, whether natural, enhanced or modified, either in the form of ‘isolated live cultures’ or as material including living material which has been deliberately inoculated or contaminated with such cultures,
  • b) Bacteria, whether natural, enhanced or modified, either in the form of ‘isolated live cultures’ or as material which has been deliberately inoculated or contaminated with such cultures,
  • c) Fungi, whether natural, enhanced or modified, either in the form of ‘isolated live cultures’ or as material which has been deliberately inoculated or contaminated with such cultures.

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 syn­thesized 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’sability 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.