The export or supply of some types of materials, equipment and technology used in the Biotech Industry may require approval to comply with the Customs (Prohibited Exports) Regulations 1958, the Weapons of Mass Destruction (Prevention of Proliferation) Act 1995, or Sanctions Regulations.
These biological materials can take the form of:
Technology including technical data or technical assistance relating to the development, production and in some cases the use of controlled materials and equipment used in the Biotech Industry is also controlled when exported in tangible form.
Technical data may take the form of blueprints, plans, diagrams, models, formulae, tables, engineering designs and specifications, manuals and instructions.
Technical assistance is skill, knowledge, consulting services and may involve the transfer of technical data.
Development is related to all stages prior to serial production, such as: design, design research, design analysis, design concepts, assembly and testing of prototypes, pilot production schemes, design data, process of transforming design data into a product, configuration design, integration design, layouts.
Production means all production phases, such as: construction, production engineering, manufacture, integration, assembly (mounting), inspection, testing and quality assurance.
Use means operation, installation (including on-site installation), maintenance (checking), repair, overhaul and refurbishing.
Goods that leave Australia with an intention to be landed outside Australia are considered to be an export. This includes goods and technologies sent by air and sea, through a freight forwarder, Australia Post, or carried in personal (checked-in or hand) luggage. Goods and technology sent overseas for sale, demonstration, repairs or return to the manufacturer are considered to be an export. Goods and technologies that have been temporarily imported under a Customs carnet are also subject to export controls when leaving Australia.
The Australian Government controls the export of certain goods and technologies from Australia. Permission is required to export restricted goods and technologies. Defence Export Controls (DEC) is one of many agencies that provide permission to export restricted goods. We regulate the export of goods controlled under Regulation 13E of the Customs (Prohibited Export) Regulations 1958 and administer the Weapons of Mass Destruction (Prevention of Proliferation) Act 1995 (the WMD Act).
The Defence and Strategic Goods List (DSGL) is the complete list of goods and technologies that are controlled for export under Regulation 13E. Part 1 of the DSGL , the Munitions List, includes items that are designed or adapted for use by armed forces, or goods that are inherently lethal. This includes non-military firearms and ammunition, commercial explosives and initiators. Items in Part 1 commence with the prefix ML.
Part 2 of the DSGL , the Dual-use List contains dual-use goods and technologies. These are items are developed to meet commercial needs but may be used either as military components, or in the development or production of military systems, or weapons of mass destruction (WMD).
Further information on the DSGL is available on the Defence and Strategic Goods List page.
The WMD Act enables the Government to control the export or supply of goods or services that may assist a WMD program. The WMD Act does not, however, contain a list of goods and services that may be controlled.
Further information on the WMD Act is available from Weapons of Mass Destruction (Prevention of Proliferation) Act 1995 page.
Australia has strengthened export controls by bringing legislation into line with international standards. During a two-year transition period, Defence worked with stakeholders to address concerns with the Defence Trade Controls Act 2012, and as a result, amendments to the Act were adopted through the Defence Trade Controls Amendment Act 2015.
The Defence Trade Controls Amendment Act 2015, which received Royal Assent on 2 April 2015, expands the existing defence exports control regime to cover:
The offence provisions of the Act, for supplying and publishing DSGL technology and for brokering DSGL goods and technology, came into force on 2 April 2016. They will not be applied retrospectively.
Sanctions imposed by the United Nations Security Council, as well as by the Australian Government, place restrictions on the supply, sale or transfer of a range of goods on the DSGL , as well as a number of additional military and WMD dual-use goods, to certain countries. Sanctions also impose restrictions on commercial dealings with designated companies in certain countries, including some involved in the extractive industries sector.
Australian laws giving effect to United Nations Security Council or autonomous sanctions are administered by the Department of Foreign Affairs and Trade (DFAT). Information concerning these laws may be found on DFAT 's website.
Further information on sanctions is also available on the Sanctions page.
You should submit an Application to Export Controlled Goods and Technology form to us if you intend to export and believe your goods and technology are controlled. If you are unsure about the control status of the goods or technology to be exported, you may also submit an Application to Export Controlled Goods and Technology form, to ask us to establish their control status.
Further information on theses proccess is available on the Apply for a licence or permission to export controlled goods or technology page and Understand the status of goods and technology page.
Export control legislation contains offences for the unlawful export or supply of controlled goods and services. DEC is committed to ensuring that exporters are aware of the legislative requirements that apply as non-compliance can lead to significant penalties.
Further information on the penalties associated with unlawful export of controlled goods, services and technology is available on the Penalties page.
If you are unsure if your goods, technologiy or services are controlled for export, you should seek advice from DEC. More information on the export controls administered by us is available throughout this website.