Introduction
On 17 June 2026 the European Parliament and Council formally adopted Regulation (EU) 2026/1386 on the screening of foreign investments (“FDIs”) in the EU. This new regulation repeals and replaces the current EU FDI regulation (Regulation (EU) 2019/452). It entered into force on 16 July 2026 and, while the provisions of the new regulation will only start to apply from 17 January 2028, it is pertinent to consider how this new regulation will impact FDI screening going forward and invariably lead to changes to the existing Maltese FDI framework over the next 12 months or so.
Background
The need for a new EU regulation was based on two main considerations. Firstly, while the current regulation established an EU framework for national screening of FDIs, Member States remained largely free to decide whether to have a screening mechanism at all and, if so, how that screening mechanism might operate. The new regulation now makes the requirement to have a domestic FDI regime mandatory and introduces a set of sensitive sectors requiring mandatory screening under national regimes, which include defence, dual-use items, semiconductors, AI, quantum technologies, critical raw materials, critical infrastructure, financial services and electoral infrastructure.
Secondly, the current regulation introduced a cooperation mechanism that facilitated information-sharing on FDIs between Member States and the Commission, but while comments and opinions by other Member States and the Commission were possible, their effect in practice was fairly limited. The new regulation substantially strengthens the cooperation mechanism by introducing broader information obligations and more structured review procedures between Member States and the Commission.
Measures introduced by the new FDI regulation
With the above context in mind, the new regulation introduces a substantial package of measures that create a more robust and harmonised EU FDI framework, with the aim to “strengthen the efficiency and effectiveness of the screening of foreign direct investments and to ensure a higher degree of harmonisation across the Union”.1
The main measures introduced by the new regulation are the following
• All Member States are now obliged to have an FDI screening mechanism in place that is based on the framework set out in the new regulation. Each state must establish this regime and notify the Commission of such by 17 January 2028;
• In-scope FDIs are no longer restricted to investments directly carried out by foreign (non-EU) investors, but now extend to investments made through EU entities that are directly or indirectly owned or controlled by foreign (non-EU) investors;
• While the current regulation did not set out areas requiring mandatory notification, all Member States shall now be required to preauthorize FDIs in targets that are active in the sensitive sectors set out in Annex I of the new EU regulation, which include: dual-use items; defence-related products; semiconductor, quantum, and artificial intelligence technologies; critical raw materials; critical infrastructure in transport, energy, and digital sectors; financial services; and electoral infrastructure;
• The FDI review process is now structured as a two-phase procedure. For notifiable transactions, Member States must complete an initial review within 45 calendar days to determine whether an in-depth second phase of investigation is required. The timelines for the second phase of review remain at the discretion of each Member State;
• Where investments may affect a Member State’s security or public order but are technically non-notifiable, authorities will have the power to also call-in such investments for review. This power must be remain available for a minimum of 15 months and a maximum of 5 years after completion of the investment. Notifiable investments that were not notified or were notified after their completion may be reviewed for at least 24 months after completion;
• The EU cooperation mechanism has been substantially strengthened, with broader information obligations and more structured review procedures. The European Commission’s role remains non-decision-making but becomes more influential through the enhanced cooperation framework.
Maltese Law Areas Likely Requiring Amendment
Malta formally introduced its domestic FDI regime in 2020 through the enactment of the National Foreign Direct Investment Screening Office Act (Chapter 620, Laws of Malta). The Act was largely based on the current EU FDI regulation. In this sense, some of the measures that are being introduced through the new EU regulation (notably, the requirement to have a screening mechanism in the first place) are already in force. Moreover, while not specifically required in the current regulation, the capturing of investments made through EU entities that are directly or indirectly owned or controlled by foreign (non-EU) investors was already included in the Act.
The amendments that will likely be required to be made to the Act to align with the new EU regulation will include
• Amending the review procedure to include a 45-day initial review phase and a subsequent, more in-depth phase II period;
• Substantially widening the sensitive areas requiring mandatory notification to align with those sectors set out in Annex I of the new EU regulation;
• Providing a more detailed description of the criteria upon which the Maltese FDI office will determine whether an investment is likely to have a negative effect on security or public order, as set out in Article 19 of the new EU regulation;
• Providing a more comprehensive framework that will allow the Maltese FDI office to align with the enhanced cooperation mechanism being introduced between FDI authorities across the Union.
1 Preamble (16), Regulation (EU) 2026/1386.
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