On July 1, 2024, the Italian Ministry of Foreign Affairs adopted a Decree establishing the National Control List for dual-use goods and technology not listed in Annex I to Regulation (EU) 2021/821 (the “EU Dual-Use Regulation”).  This new list supplements and goes beyond controls under the EU Dual-Use Regulation.

With respect to the newly listed items, the Italian Government has introduced unilateral authorization requirements not only for their export from the Italian territory to non-EU countries but also for the provision of brokering services and technical assistance related to such items.

The new authorization requirements will apply on the 15th day following the publication in the Italian Official Journal of the notice.  At that time, the Ministry of Foreign Affairs will make the adoption of the Decree public.

Products covered by the National Control List include goods and technology falling under Category 2 (Materials processing), Category 3 (Electronics) and Category 4 (Computers), such as:

  1. Equipment for additive manufacturing of metal / aluminum components, with sources such as laser and electron beam, in inert gas or vacuum environments and software for the development, production and use of additive manufacturing equipment.
  2. Cryogenic Complementary Metal Oxide Semiconductor (CryoCMOS) integrated circuits, high-speed circuits, parametric amplifiers, and cryogenic cooling systems.
  3. Dry etching equipment, extreme UV masks, semiconductor Scanning Electron Microscopes (SEM), and cryogenic wafer probing equipment.
  4. Silicon/germanium epitaxial materials, fluorides, hydrides, chlorides, and silicon/germanium oxides.
  5. Semiconductor development and manufacturing technology and integrated circuit process design kits.
  6. Quantum computers, divided by number of ‘controlled’, ‘connected’ and ‘working’ ‘physical qubits’ (34-2000+ qubits) with C-NOT error specifications.
  7. Software and technology for the development and production of quantum devices and components.

The full list of dual-use items included in the National Control List, together with their technical specifications, is available here.

Legislative Background

The Decree has been adopted by the Italian Government pursuant to Article 9 of the EU Dual-Use Regulation, which allows Member States to may impose an authorization requirement on the export of dual-use items not listed in Annex I for reasons of public security, including the prevention of acts of terrorism, or for human rights considerations.

Indeed, in the preamble of the Decree, the Ministry of Foreign Affairs considers that the adoption of these measures is based on the need to combat international terrorism, prevent possible violations of human rights, avoid the transfer of critical technologies to countries at risk and notes that, pending possible decisions within multilateral control mechanism, other EU Member States (France, the Netherlands and Spain) have already implemented unilateral export control measures pursuant to Article 9 of the EU Dual-Use Regulation. 

Whilst the establishment of the National Control List is a brand-new measure for Italy, the Decree is additional to one adopted in 2023 whereby, pursuant to Article 9 of Legislative Decree No. 221/2017, the Italian Government imposed a prior authorization requirement on exports to Armenia, Iran, Kazakhstan and Kyrgyzstan of engines, and parts thereof, to be used in the aviation sector.  Together, these measures demonstrated the Italian Government’s increased attention on new dual-use goods and technology which may be used for the development and production of nuclear, chemical or biological weapons, or for other end-uses that raise international security concerns.  

Business Impact

Italian exporters should closely review the goods/technologies described in Annex A to the Decree to determine whether their goods/technologies are affected. If an exporter is uncertain whether their goods/technologies are affected by the Decree, they should apply with the Ministry of Foreign Affairs for a “Zero License” pursuant to Article 8(5) of Legislative Decree No. 221/2017 confirming that their products are not subject to authorization requirements under the dual-use legislation.

Going forward, Italian exporters should continue to expect the implementation of further unilateral export controls measures due to the difficulty in reaching consensus to implement new controls among the membership of multilateral export control regimes.  Indeed, we see unilateral export controls from Western countries becoming more common given Russia’s membership in Wassenaar and its efforts to block controls proposed by these countries, which has also been the case in the UK and Canada where unilateral authorization requirements have been recently introduced in respect of advance technologies similar to those included in the Italian National Control List (please see our previous blogs on the UK here and Canada here).

Author

Roberto Cursano focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. He is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. Roberto advises primarily on pharmaceutical and healthcare matters. These include product licensing and marketing, clinical trials, pricing and reimbursement, promotions, interactions with healthcare professionals, distribution of products, and public procurement issues. Additionally, he assists in anti-bribery matters and related investigations, and helps set up internal compliance models preventing corruption-related crimes, money laundering and corporate crimes (so-called Law 231 Models). He also advises on administrative/public law, including export control law and public procurement law.

Author

Riccardo focuses his practice on pharmaceutical and healthcare law issues, advising on regulatory matters concerning the manufacturing, marketing, distribution and import of medicinal products and medical devices. Additionally, he assists multinational companies on a wide range of trade matters relating to the import, export, transfer, brokering and transit of controlled goods, including the obtainment of authorizations from the Italian Government for activities subject to sanctions regulations and EU export control regulations. Riccardo's practice extends to assistance in setting-up compliance programs aimed at preventing corruption-related and corporate crimes and in developing internal policies and procedures and codes of conduct.