Regulation (EU) 2026/1386 of the European Parliament and of the Council of 17 June 2026 on the screening of foreign investments in the Union and repealing Regulation (EU) 2019/452
Subject matter and scope
1. The objective of this Regulation is to ensure that foreign investments into the Union do not have a negative effect on security or public order.
2. This Regulation establishes a Union framework for the screening by Member States of foreign investments in their territories on the grounds of security or public order.
3. This Regulation establishes a cooperation mechanism to enable Member States and the Commission to exchange relevant information on foreign investments, assess their potential effect on security or public order, and identify potential concerns to which due consideration shall be given by the host Member State (the ‘cooperation mechanism’).
4. This Regulation is without prejudice to the sole responsibility of each Member State for its national security, as referred to in Article 4(2) TEU, or to the right of each Member State to protect its essential security interests in accordance with Article 346 TFEU.
5. This Regulation does not apply to:
(a)
foreign investments made pursuant to the application of a resolution tool or of write-down and conversion powers as defined in Article 2(1), points (19) and (66), respectively, of Directive 2014/59/EU of the European Parliament and of the Council ( 34 ) , of additional tools within the meaning of Article 37(9) of that Directive, of a resolution tool or of write-down and conversion powers as defined in Article 3(1), points (9) and (44), respectively, of Regulation (EU) No 806/2014 of the European Parliament and of the Council ( 35 ) , of a resolution tool as defined in Article 2, point (4), of Regulation (EU) 2021/23 of the European Parliament and of the Council ( 36 ) and in Article 2, point (14), of Directive (EU) 2025/1 of the European Parliament and of the Council ( 37 ) , of write-down or conversion powers as defined in Article 2, point (56), of that Directive, or of additional tools within the meaning of Article 26(7) of that Directive;
(b)
internal restructuring, unless a new legal entity, established in a third country that is not already represented in the upstream ownership chain of the Union target, is introduced in that chain.
Definitions
For the purposes of this Regulation, the following definitions apply:
(1)
‘foreign investment’ means an investment of any kind, carried out either by a foreign investor itself or through a foreign investor’s subsidiary in the Union, aiming to establish or to maintain lasting and direct links between the foreign investor and a Union target, to which the foreign investor makes capital available in order to carry out an economic activity in a Member State, enabling effective participation in the management or control of that Union target;
(2)
‘greenfield investment’ means a foreign investment carried out through the establishment of new facilities or of an undertaking for the performance of an economic activity in the Union;
(3)
‘internal restructuring’ means a reorganisation of a corporate group to which a Union target belongs, which does not result in a change of the beneficial owner of the Union target;
(4)
‘request for authorisation’ means a submission under a screening mechanism of a request to authorise a foreign investment subject to a prior authorisation requirement;
(5)
‘foreign investor’ means:
(a)
a natural person who does not hold the nationality of a Member State; or
(b)
an undertaking or entity established or otherwise organised under the laws of a third country;
(6)
‘beneficial owner’ means:
(a)
one or more natural persons:
(i)
who, directly or indirectly, own or control a foreign investor or Union target;
(ii)
who ultimately benefit from the foreign investment; or
(iii)
on whose behalf the foreign investment is made or on whose behalf the control over that foreign investment is exercised; or
(b)
where no natural persons are identified, a legal person, entity or trust which:
(i)
directly or indirectly owns or controls a foreign investor or Union target; or
(ii)
ultimately benefits from the foreign investment;
(7)
‘foreign investor’s subsidiary in the Union’ means an undertaking which is established under the laws of a Member State and directly or indirectly controlled by a foreign investor;
(8)
‘opaque ownership structure’ means an arrangement in which the ownership or control of an entity is unclear, concealed or difficult to ascertain due to, inter alia, the use of complex legal structures, multiple layers of ownership, nominee shareholders, or other mechanisms that obscure the identity of the beneficial owner;
(9)
‘Union target’ means an undertaking established or intended to be established under the laws of a Member State;
(10)
‘filing’ means an initial submission to the screening authority of all information or documentation required under the screening mechanism, including, where applicable, a complete request for authorisation;
(11)
‘host Member State’ means the Member State in which a foreign investment is planned to be or is completed;
(12)
‘screening’ means a procedure through which a host Member State can investigate, assess, authorise, authorise subject to mitigating measures, prohibit or unwind foreign investments on the grounds of security or public order;
(13)
‘screening mechanism’ means a legal instrument of general application and accompanying administrative requirements, implementing rules or guidelines, that set out the terms, conditions and procedures for screening;
(14)
‘screening decision’ means a measure adopted by a screening authority pursuant to a screening mechanism which results in the authorisation, authorisation subject to mitigating measures, prohibition or unwinding of a foreign investment;
(15)
‘screening authority’ or ‘screening authorities’ means the authority or authorities designated by a Member State to carry out screening;
(16)
‘completion’ means the point in time at which the last condition precedent has been met in relation to an investment decision by the parties to a foreign investment transaction;
(17)
‘notifying Member State’ means a Member State that has notified a foreign investment through the cooperation mechanism pursuant to Article 5;
(18)
‘multi-country transaction’ means a foreign investment subject to screening mechanisms in two or more Member States;
(19)
‘multi-country notification’ means a notification sent through the cooperation mechanism by each of the Member States concerned with regard to a multi-country transaction;
(20)
‘mitigating measure’ means any condition imposed by a Member State in order to resolve the likely negative effect on security or public order arising from a foreign investment;
(21)
‘contact point’ means the person or entity designated by a Member State to send and receive all communication through the cooperation mechanism, including notifications and exchanges of information related to foreign investments covered by this Regulation;
(22)
‘stockpiling’ means storing a quantity of a particular raw material for future use, including in anticipation of possible shortages.
Establishment of screening mechanisms
1. Each Member State shall establish a screening mechanism in accordance with this Regulation. Member States may, for that purpose, adopt national provisions that are complementary to, or more specific than, the provisions of this Regulation, provided that such national provisions do not undermine and are consistent with the objective of this Regulation.
2. Each Member State shall notify to the Commission the measures adopted pursuant to paragraph 1 by 17 January 2028.
Member States shall thereafter notify the Commission of any amendment to the screening mechanism within 30 days of the adoption of that amendment.
Minimum requirements
1. Rules and procedures related to screening shall be transparent and shall not discriminate between third countries or between the Member States.
2. For foreign investments that fall within the scope of their screening mechanism and that are subject to a filing requirement, Member States shall ensure that adequate procedures and resources are provided for the screening authority to:
(a)
carry out an initial review of a foreign investment within 45 calendar days of the filing to decide whether an in-depth investigation is necessary to determine if a foreign investment is likely to negatively affect security or public order; and
(b)
based on the results of the initial review, carry out, where necessary, an in-depth investigation to determine whether that foreign investment is likely to negatively affect security or public order;
3. Member States shall ensure that their screening authorities monitor and ensure compliance with their screening mechanism and screening decisions, in particular by identifying, preventing and addressing their circumvention, and are provided with sufficient resources to carry out those tasks.
4. Member States shall ensure that their screening authorities are empowered to screen and adopt a screening decision on foreign investments falling within the scope of the respective Member State’s screening mechanism and not subject to a prior authorisation requirement on their own initiative for at least 15 months and up to a maximum of five years, after the completion of that foreign investment where the screening authority has grounds to consider that such foreign investment may affect security or public order.
5. Member States shall ensure that their screening authorities are empowered, for at least 24 months after the completion of a foreign investment, to screen and adopt a screening decision on that foreign investment provided that it is subject to a prior authorisation requirement and was not filed or was filed after its completion.
6. Confidential information made available to a host Member State for the purposes of screening shall be protected. Member States shall ensure that their screening authorities provide entities making information available with the opportunity to indicate the information they consider to be confidential.
7. Member States shall ensure that the parties subject to the screening decision have the right to seek an effective judicial remedy against that screening decision.
8. Each Member State shall ensure that an annual report is made public, and includes information on relevant legislative developments in that Member State and aggregated and anonymised data on the foreign investments screened, including the outcome of screening decisions, nationalities, or countries of establishment, as applicable, of parties to the foreign investments notified to the screening authority, and the economic sectors in which those transactions took place, with the exception of data for which full anonymisation is not possible.
9. Member States shall ensure that a foreign investment subject to a prior authorisation requirement as referred to in paragraph 15 is filed by the applicant requesting an authorisation with the screening authority and is screened before the foreign investment is completed.
10. Member States shall ensure that their screening authorities, where applicable and without undue delay, inform the person who made the filing of the completeness of that filing.
11. Member States shall ensure that their screening authorities are empowered to impose effective, proportionate and dissuasive penalties on foreign investors that fail to comply with the requirements of the screening mechanism, including failure to file the foreign investment where required or failure to comply with mitigating measures.
12. Member States’ screening authorities and the Commission shall make publicly available the contact details through which stakeholders may submit information concerning foreign investments in a confidential manner.
13. Adequate procedures shall be provided for the notification of foreign investments through the cooperation mechanism pursuant to Article 5.
14. Before adopting a decision to authorise a foreign investment subject to mitigating measures or to prohibit or unwind a foreign investment, the screening authority shall give the parties subject to the intended screening decision the opportunity to make their views known effectively.
15. Each Member State shall ensure that its screening mechanism imposes a prior authorisation requirement for foreign investments where the Union target established in its territory:
(a)
develops, produces or commercialises items listed in Annex I to Regulation (EU) 2021/821;
(b)
develops, produces or commercialises goods or technology listed in the Annex to Directive 2009/43/EC;
(c)
produces, conducts research in or develops semiconductor or quantum technologies referred to in Annex I to this Regulation, or conducts research in or develops artificial intelligence technologies referred to in that Annex;
(d)
is active in the transport, energy or digital infrastructure sectors and is considered critical pursuant to a risk-based targeted assessment that takes into account national security and vital societal functions in light of the essential services provided by that Union target and that is performed by the Member State in which that Union target is established;
(e)
exercises, as regards any strategic raw materials listed in Section I of Annex I to Regulation (EU) 2024/1252, activities of exploration, extraction, processing, recycling or recovery as defined in Article 2 of that Regulation, or of stockpiling;
(f)
constitutes one of the following entities:
(i)
a central counterparty, namely a ‘CCP’ as defined in Article 2, point (1), of Regulation (EU) No 648/2012 of the European Parliament and of the Council ( 38 ) ;
(ii)
a central securities depository, as defined in Article 2(1), point (1), of Regulation (EU) No 909/2014 of the European Parliament and of the Council ( 39 ) ;
(iii)
an operator of regulated markets, within the meaning of Article 4(1), point (18), and Article 4(1), point (21), of Directive 2014/65/EU;
(iv)
an operator of payment systems, withing the meaning of Article 2, point (a), of Directive 98/26/EC of the European Parliament and of the Council ( 40 ) , and designated as such pursuant to Article 10(1) of that Directive, with the exclusion of payment systems operated by central banks;
(v)
any other systemically important institution within the meaning of Article 131(3) of Directive 2013/36/EU;
(vi)
a global provider of specialised financial messaging services; or
(g)
owns, develops or operates voter registration databases, voting systems and other information systems specifically designed to manage electoral operations such as the counting, auditing, and displaying of election results, and post-election reporting to certify and validate results.
16. Member States may decide to apply the screening mechanism to foreign investments falling within the scope of this Regulation other than those referred to in paragraph 15. Where Member States decide to apply the screening mechanism to such foreign investments, this Regulation shall apply to the screening of those foreign investments.
17. Paragraph 15 does not apply to greenfield investments.
Notification of foreign investments
1. Member States shall notify the other Member States and the Commission through the cooperation mechanism of any foreign investment in a Union target established in their territory to which Article 4(15) and any of the following criteria apply:
(a)
the foreign investor or the foreign investor’s subsidiary in the Union is directly or indirectly controlled by the government, including state bodies, regional or local authorities or armed forces, of a third country, including in the form of ownership structure, significant funding, special rights or state-appointed board directors or managers;
(b)
the foreign investor, a natural person or an entity controlling the foreign investor, the beneficial owner of the foreign investor, any of the subsidiaries of the foreign investor, or any other party owned or controlled by, or acting on behalf or at the direction of, such a foreign investor is subject to Union restrictive measures pursuant to Article 29 TEU and Article 215 TFEU;
(c)
the foreign investor, a natural person or an entity controlling the foreign investor, the beneficial owner of the foreign investor, or any of the foreign investor’s subsidiaries was involved in a foreign investment which was previously screened by a Member State and was not authorised or was authorised subject to mitigating measures, which were significantly or repeatedly not complied with; to determine that, the notifying Member State shall rely on information available to it, including the information contained in the secure database referred to in Article 18 and information provided by the foreign investor on that matter.
2. Member States shall notify the other Member States and the Commission of any foreign investment in a Union target in their territory where they initiate an in-depth investigation in the framework of their screening procedures, where either of the following conditions are met:
(a)
the Union target is active in a project or programme of Union interest, as listed in Annex II;
(b)
the Union target has one or more subsidiaries in at least one other Member State, or is part of a group that has one or more subsidiaries in at least one other Member State.
3. Member States shall notify the other Member States and the Commission of any foreign investment in their territory where, in exceptional cases, they intend to impose a mitigating measure or to prohibit or unwind the transaction without an in-depth investigation. The conditions set out in paragraph 2, points (a) and (b), shall also apply to this paragraph.
4. Foreign investments notified pursuant to paragraph 1 shall not be notified pursuant to paragraph 2 or paragraph 3.
5. A host Member State shall notify the other Member States and the Commission of any foreign investment that falls within the scope of its screening mechanism but is not covered by paragraph 1, 2 or 3 of this Article, if it considers that the foreign investment could negatively affect security or public order in at least one other Member State, especially where the Union target has significant operations in other Member States, or belongs to a corporate group that consists of two or more entities in different Member States which are covered by Article 4(15), points (a) to (g). Any such notification shall be duly justified.
Content and procedures for notification of foreign investments
Member States shall ensure that a notification pursuant to Article 5 contains the information set out in Article 15(1) and is sent to the other Member States and the Commission:
(a)
within 15 calendar days of the filing for foreign investments meeting the criteria set out in Article 5(1);
(b)
within 45 calendar days of the filing for foreign investments meeting the conditions set out in Article 5(2);
(c)
without undue delay where Article 5(3) applies;
(d)
without undue delay after making the decision to notify a foreign investment in accordance with Article 5(5).
Specific rules applicable to multi-country transactions
Without prejudice to Article 6, the following procedures shall apply to multi-country transactions:
(a)
the person making the filing shall endeavour to do so in all Member States concerned on the same day, and each filing shall make reference to the other filings;
(b)
where a Member State receives a filing that meets the requirements set out in point (a) of this Article, it shall discuss with the other Member States concerned, inter alia, whether the conditions set out in Article 5 are met; at the request of a Member State, the Commission may participate in such discussions;
(c)
if the filing concerns a foreign investment that meets the conditions set out in Article 5(1), (2) or (5), the Member States concerned shall endeavour to send their notifications through the cooperation mechanism on the same day;
(d)
the Member States concerned shall coordinate closely throughout the process and, in particular, endeavour to align the timing of their respective screening procedures, including as regards the adoption of their respective screening decisions, and, where appropriate, shall discuss whether their respective screening decisions are compatible with each other and adequately address the identified risks to security or public order.
Comments and opinions on notified foreign investments
1. Any Member State may provide duly justified comments to the notifying Member State if it:
(a)
considers that the notified foreign investment is likely to negatively affect its security or public order; or
(b)
has information relevant for the screening of that foreign investment.
2. The Commission shall, where appropriate, issue a duly justified opinion addressed to the notifying Member State if it:
(a)
considers that the notified foreign investment is likely to negatively affect the security or public order of more than one Member State;
(b)
considers that the notified foreign investment is likely to negatively affect a project or programme of Union interest, as listed in Annex II, on grounds of security or public order; or
(c)
has additional information relevant for the screening of that foreign investment.
The Commission may issue an opinion regardless of whether any Member State has provided comments.
3. Where the notifying Member State duly considers that the notified foreign investment is likely to affect its security or public order, it may request the Commission to issue an opinion or other Member States to provide comments.
4. Where appropriate, the opinion of the Commission may propose mitigating measures.
5. The Commission shall, where appropriate, issue a duly justified opinion addressed to all Member States if it considers that two or more foreign investments, whether completed or not, taken together and having regard to their characteristics could negatively affect security or public order. After issuing its opinion, the Commission shall, where appropriate, discuss with Member States how to address the identified risks.
Intention to provide comments or issue an opinion
Before a Member State provides comments or the Commission issues an opinion pursuant to Article 8, the following procedure shall apply:
(a)
that Member State shall inform the notifying Member State of its intention to provide comments no later than 15 calendar days from the receipt of a notification pursuant to Article 5;
(b)
the Commission shall inform the notifying Member State of its intention to issue an opinion no later than 20 calendar days from the receipt of a notification pursuant to Article 5.
Additional information
1. When informing the notifying Member State of their intention to provide comments or issue an opinion, Member States and the Commission may request information from the notifying Member State in addition to the information referred to in Article 15(1).
2. Member States and the Commission may request additional information, where such information is necessary for responding to a request for an opinion or for a comment provided by the notifying Member State pursuant to Article 8(3).
3. Any request for additional information shall be:
(a)
duly justified;
(b)
limited to the information necessary for the Member States to provide comments pursuant to Article 8(1) or in response to a request pursuant to Article 8(3), or for the Commission to issue an opinion pursuant to Article 8(2) or Article 8(5) or in response to a request pursuant to Article 8(3);
(c)
proportionate to the purpose of the request; and
(d)
not unduly burdensome for the notifying Member State.
4. Where a Member State requests additional information from the notifying Member State, it shall send such requests to the Commission simultaneously.
5. The notifying Member State shall provide the additional information, requested by the Commission or other Member States pursuant to paragraph 1 or paragraph 2 without undue delay. Where the notifying Member State provides additional information to a Member State, that additional information shall be sent to the Commission simultaneously.
6. Where the notifying Member State receives two or more requests for additional information about the same notified foreign investment, it shall endeavour to provide all the requested additional information simultaneously.
7. Where two or more notifying Member States receive requests for additional information about a multi-country notification, they shall endeavour to provide all of the requested information simultaneously.
Provision of comments and issuing of opinions
1. The Member State providing comments shall simultaneously send those comments to the Commission and inform all other Member States that comments have been provided.
2. The Commission shall:
(a)
send the opinions referred to in Article 8(2), points (a) and (c), to all Member States that provided comments and notify the other Member States that an opinion has been issued;
(b)
send the opinions referred to in Article 8(2), point (b), and in Article 8(5) to all Member States.
3. The following deadlines shall apply to the provision of comments by Member States and opinions by the Commission:
(a)
where a Member State makes known its intention to provide comments on a notified foreign investment without requesting additional information from the notifying Member State, the respective comments shall be provided to the notifying Member State within a reasonable timeframe, and in any event no later than 20 calendar days from the receipt of the notification of the foreign investment;
(b)
where the Commission makes known its intention to issue an opinion on a notified foreign investment without requesting additional information from the notifying Member State, that opinion shall be issued to the notifying Member State within a reasonable timeframe, and in any event no later than 30 calendar days from the receipt of the notification of the foreign investment;
(c)
where a Member State makes known its intention to provide comments on a notified foreign investment and requests additional information from the notifying Member State, those comments shall be provided to the notifying Member State within a reasonable timeframe, and in any event no later than 15 calendar days from the receipt of the additional information;
(d)
where the Commission makes known its intention to issue an opinion on a notified foreign investment and requests additional information from the notifying Member State, that opinion shall be issued to the notifying Member State within a reasonable timeframe, and in any event no later than 25 calendar days from the receipt of the additional information.
4. The notifying Member State shall communicate to the other Member States and the Commission any substantial new information or circumstances relevant for the assessment of a foreign investment already notified pursuant to Article 5. If that information or those circumstances are communicated before the respective deadline set out in paragraph 3 of this Article, the notifying Member State may, on a reasoned request by another Member State or the Commission, extend the relevant deadlines by up to 20 calendar days. The deadlines may be extended only once. The notifying Member State shall inform the other Member States, the Commission and the foreign investor that made the filing that the deadline has been extended.
5. The notifying Member State shall adopt its screening decision only after the relevant deadline set out in paragraph 3, points (a) to (d), has expired.
6. Where, due to exceptional circumstances, the notifying Member State considers that its security or public order requires the adopting of a screening decision before the expiry of the relevant deadlines set out in paragraph 3, it shall notify the other Member States and the Commission of its intention and duly justify the need for immediate action. The other Member States and the Commission shall provide comments or issue an opinion expeditiously. That procedure shall not be invoked to serve purely commercial interests of the applicant requesting the authorisation.
7. When providing comments or issuing an opinion pursuant to this Article, the Member States or the Commission, as applicable, shall consider whether such comments or opinion should be protected as classified information and what level of classification should apply thereto, in accordance with Union law and the applicable national law on classified information.
Consideration of comments and opinions
1. Where a notifying Member State receives a comment from another Member State pursuant to Article 8(1) or an opinion from the Commission pursuant to Article 8(2) or Article 8(5), it shall give due consideration to that comment or opinion.
2. Following the receipt of comments or an opinion, and at the request of a Member State having provided comments or of the Commission, where the latter issued an opinion, the notifying Member State shall organise a meeting to discuss how best to address the risks identified.
The meeting referred to in the first subparagraph shall be organised with:
(a)
the Member States that provided comments and the Commission; or
(b)
the Commission, where no comments were provided.
Where the comments or the opinion concern a multi-country transaction, the notifying Member State shall invite to the meeting referred to in the first subparagraph the other Member States who notified the foreign investment.
3. The screening decision shall be adopted by the Member State undertaking the screening.
4. Following the receipt of comments pursuant to Article 8(1) or an opinion pursuant to Article 8(2) or Article 8(5), the notifying Member State shall notify to the Member States concerned and to the Commission, no later than seven calendar days from the date of entry into force of the screening decision, the operative part of its screening decision as well as a summary of the main reasons thereof in view of the provided comments or issued opinion, including:
(a)
the extent to which it gave the Member States’ comments or the Commission opinion due consideration; and
(b)
where applicable, the reason for its disagreement with the Member States’ comments or the Commission opinion.
Comments and opinions on non-notified foreign investments
1. Any Member State may provide duly justified comments to a host Member State on a foreign investment which has not been notified through the cooperation mechanism, where the Member State providing those comments:
(a)
considers that that foreign investment is likely to negatively affect its security or public order; or
(b)
has information relevant for the screening of that foreign investment.
The Member State providing comments shall simultaneously send its comments to the Commission and inform all other Member States that comments have been provided.
2. The Commission may issue a duly justified opinion to a host Member State on a foreign investment which has not been notified through the cooperation mechanism where the Commission:
(a)
considers that the foreign investment is likely to negatively affect security or public order in more than one Member State; or
(b)
considers that the foreign investment is likely to negatively affect projects or programmes of Union interest, as listed in Annex II, on grounds of security or public order; or
(c)
has information relevant for the screening of that foreign investment.
3. The Commission shall:
(a)
send opinions meeting the conditions set out in paragraph 2, points (a) and (c), to all Member States that provided comments and notify the other Member States that an opinion was issued;
(b)
send opinions meeting the conditions set out in paragraph 2, point (b), to all Member States.
4. Member States, before providing comments, and the Commission before issuing an opinion, shall check whether the host Member State has already started or completed screening the foreign investment and whether it intends to notify the foreign investment through the cooperation mechanism pursuant to Article 5.
5. Before providing comments or issuing an opinion in relation to a foreign investment pursuant to paragraph 1, point (a), and paragraph 2, point (a) or (b), the Member States or the Commission shall send a request for information to the host Member State.
6. Any request for information pursuant to paragraph 5 shall be:
(a)
duly justified;
(b)
limited to the information necessary for a Member State to provide comments or for the Commission to issue an opinion;
(c)
proportionate to the purpose of the request; and
(d)
not unduly burdensome for the host Member State.
Where the request for information is submitted by a Member State, that Member State shall send the request to the Commission simultaneously.
7. The host Member State shall provide the information requested by the other Member States or the Commission pursuant to paragraph 5 without undue delay. Where the host Member State provides information to another Member State, the host Member State shall simultaneously send that information to the Commission.
8. Comments provided pursuant to paragraph 1, point (a), and opinions issued pursuant to paragraph 2, point (a) or (b), shall be sent to the host Member State within a reasonable timeframe, and in any event no later than 20 calendar days from the receipt of the information pursuant to paragraph 7.
Where a Member State has provided comments pursuant to paragraph 1, point (a), the Commission’s deadline, as set out in the first subparagraph of this paragraph, for issuing its opinion shall be extended by an additional 10 calendar days.
9. The host Member State shall give due consideration to the comments of the other Member States and to the opinion of the Commission. If the host Member State, on the basis of the comments of the other Member States and the opinion of the Commission, does not intend to screen the foreign investment, it shall inform the Member States that have provided comments and the Commission thereof.
10. If, following the information referred to in paragraph 9, a Member State that provided comments so requests, the host Member State shall organise a meeting with the Member States that provided comments and with the Commission or, if the Commission so requests, a meeting with the Commission alone where only the Commission issued an opinion.
11. Where, following a meeting as referred to in paragraph 10, the host Member State decides not to screen the foreign investment, it shall inform Member States that provided comments and the Commission thereof and provide them with a written explanation on:
(a)
the reasons for not screening the foreign investment, including where applicable the reasons for its disagreement with the comments provided or opinion issued; and
(b)
where applicable, any alternative measures it intends to take in order to address the risks identified in the comments or the opinion.
12. Without prejudice to Article 5(1), (2) and (3), where the host Member State decides to screen the foreign investment, it shall notify the foreign investment in accordance with Article 5(5).
13. Member States may provide comments pursuant to paragraph 1 and the Commission may issue an opinion pursuant to paragraph 2 no later than 15 months from the completion of a foreign investment.
General requirements
1. Member States and the Commission shall provide the necessary resources and legal and administrative means to efficiently and effectively meet the objective of this Regulation, including as regards their participation in the cooperation mechanism.
2. Each Member State and the Commission shall designate a contact point for the purposes of the cooperation mechanism.
3. Member States shall ensure that the deadlines and procedures set out in their screening mechanisms allow them to provide answers to requests for additional information by other Member States or the Commission.
4. Member States shall ensure that their screening mechanisms give sufficient time and means to assess and give due consideration to other Member States’ comments and Commission opinions before a screening decision is adopted. This includes having at their disposal, in any relevant instrument, including their screening mechanisms, the necessary legal means and powers to consider concerns expressed or likely effects identified by another Member State or the Commission.
5. Screening authorities shall be empowered to investigate, assess, decide on and monitor foreign investments that fall within the scope of their screening mechanisms and are brought to their attention pursuant to Article 13(1) or Article 13(2).
6. Member States shall ensure that they have the necessary legal means and powers to effectively address within their territory the consequences of non-compliance with the mitigating measures provided for in their screening decisions. Where mitigating measures in a screening decision require compliance by undertakings established in other Member States, the Member State that adopted that screening decision and other relevant Member States shall endeavour to cooperate with each other in the monitoring and enforcement of the screening decision, in accordance with their national laws.
7. Where, following the adoption of a screening decision on a foreign investment that was subject to the cooperation mechanism, a host Member State imposes penalties in accordance with Article 4(11), it shall, where appropriate, notify the Commission and the Member States that provided comments on that foreign investment within a reasonable timeframe.
Information requirements
1. Member States shall ensure that information provided in the notification referred to in Article 5 or pursuant to Article 13(7) includes:
(a)
the name, if possible written in both the Latin alphabet and in the original characters where applicable, and the address, website address and activities of the foreign investor, and, where applicable, the name, if possible written in both the Latin alphabet and in the original characters where applicable, and the address and website address of the beneficial owner of the foreign investor;
(b)
the ownership structure of the foreign investor and, where applicable, of the corporate group of which the foreign investor forms part;
(c)
a comprehensive description of the foreign investment, its approximate value, its funding and source, on the basis of the best information available to the Member State, and the date by which the foreign investment is planned to be or is completed;
(d)
the name and address of the Union target, its activities and alternative providers, the beneficial owner of the Union target, the ownership structure of the Union target before and after the foreign investment, and, where applicable, of the corporate group of which the Union target forms part, before and after the foreign investment;
(e)
where applicable, information about the other legal entities of the same corporate group as the Union target that are located in other Member States and about relevant business operations that the Union target conducts in other Member States;
(f)
where applicable, details about the participation of the Union target in projects or programmes of Union interest, as listed in Annex II;
(g)
whether the Union target, within the preceding five years, has been awarded at least one Union grant of EUR 750 000 or more;
(h)
where applicable, which of the conditions set out in Article 5 are fulfilled.
2. By 17 January 2028, the Commission shall establish, by means of an implementing act, the form to be used to provide the information referred to in paragraph 1 of this Article, and update that form thereafter as necessary. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 29(2).
3. The host Member State may request the foreign investor or any other natural or legal person either within the chain of control of the foreign investor or within the chain of control of the Union target to provide the information referred to in paragraph 1 of this Article and Article 10(1) and (2). The requested information shall be provided to the host Member State within 15 calendar days of the request. The host Member State may extend that deadline as it deems appropriate in light of the complexity or quantity of the requested information.
4. A Member State shall notify the other Member States concerned and the Commission if, in exceptional circumstances, it is unable, despite its best efforts, to provide the information referred to in paragraph 1 and indicate the nature of those circumstances.
5. If no or incomplete information is provided, the comments provided by Member States, or the opinion issued by the Commission may be based on the information available to them.
6. Where the information referred to in paragraphs 1 and 3 originates from a natural or legal person, the Member State receiving the information shall, where it has reasonable grounds to doubt the completeness and accuracy of that information, take reasonable steps to ensure that the information is complete and accurate before providing it to other Member States and the Commission.
Information-gathering assistance
1. The host Member State and the Commission may request another Member State to gather information from a natural person residing or a legal person established in its territory, provided that the natural or legal person concerned is likely to possess the information in question. The Member State receiving the request for information shall endeavour, without delay, to gather that information and provide it to both the host Member State and the Commission.
2. The host Member State may request the Commission to gather information from a natural person residing or a legal person established in another Member State’s territory, provided that the natural or legal person concerned is likely to possess the information in question. Provided that the Member State in whose territory the natural person resides or the legal person is established has been informed by the Commission and does not, within a reasonable timeframe, object or offer to provide that information itself, the Commission shall endeavour, without delay, to gather that information and provide it to both the host Member State and the other Member State.
3. The information requested pursuant to paragraph 1 or 2 of this Article shall be relevant and strictly necessary for assessing a foreign investment pursuant to Article 19 and the request for assistance in gathering information pursuant to paragraph 1 or 2 of this Article shall be duly justified.
4. Where the Commission requests information from a natural or legal person pursuant to paragraph 2, the request by the Commission shall:
(a)
state its legal basis and purpose;
(b)
state which national authority was informed by the Commission;
(c)
specify the requested information; and
(d)
set an appropriate time-limit for providing that information.
5. Where, as a result of the application of this Article, a natural or legal person receives confidential information from a Member State or the Commission, that person shall not use that information for any other purpose than to reply to the request for information and shall not disclose it.
6. Article 15(4) and (6) shall apply mutatis mutandis .
Confidentiality of information exchanges in the cooperation mechanism
1. Information received as a result of the application of this Regulation shall be used only for the purpose for which it was provided, unless the originator of the information explicitly agrees to another use.
2. Member States and the Commission shall ensure the confidentiality of the information they provide or receive in application of this Regulation, in accordance with Union and national law. When dealing with requests for access to documents provided or received in application of this Regulation, Member States and the Commission shall refrain from disclosing any information that would undermine the purpose of the investigations conducted pursuant to this Regulation.
3. Member States and the Commission shall ensure that classified information provided or exchanged under this Regulation is not downgraded or declassified without the prior written consent of the originator.
Secure and encrypted system, online EU portal and secure database
1. By 17 July 2027, the Commission shall establish and subsequently maintain a secure and encrypted system to facilitate the exchange of information between the contact points. All substantive communications between Member States, as well as between Member States and the Commission under this Regulation, shall be transmitted through that secure and encrypted system, unless the nature of the information requires other means, such as physical documents.
2. As part of the secure and encrypted system, and at the request of at least nine Member States, the Commission shall establish an online EU portal for the electronic filing of foreign investments with screening authorities and for communications between natural or legal persons making a filing and those authorities (the ‘online EU portal’). The online EU portal shall be operational no later than 12 months from that request.
3. The online EU portal shall be used in Member States that requested its establishment pursuant to paragraph 2. It shall also be used in Member States which, after the establishment of the online EU portal, so request. The online EU portal shall no longer be used in a given Member State where it so requests. The Commission shall publish and keep updated a list of Member States using the online EU portal.
4. Filings of foreign investments in the Member States where the online EU portal is used shall only be made through an online form available on the online EU portal. That form shall include the information required under Article 15(1).
5. By 12 months from the request referred to in paragraph 2 of this Article, the Commission shall set out, by means of implementing acts, the arrangements for the functioning of the online EU portal and update those arrangements thereafter as necessary. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 29(2).
6. By 17 July 2027, the Commission shall set up a secure database available to all Member States with information on the foreign investments notified through the cooperation mechanism and the outcome of the assessments of those foreign investments under screening mechanisms.
7. After completion of the national procedure, Member States shall upload to the secure database the following information:
(a)
name, address or registered office and, where applicable, national registration number of the foreign investor and, where applicable, of the foreign investor’s subsidiary in the Union;
(b)
name, registered office and national registration number of the Union target;
(c)
name, registered office and national registration number of companies affiliated with the Union target;
(d)
outcome of the national procedure under the following categories:
(i)
not subject to national screening mechanism (non-eligible);
(ii)
authorisation;
(iii)
authorisation subject to mitigating measures;
(iv)
prohibition;
(v)
withdrawal of a filing;
(vi)
other;
(e)
the Member States that have provided comments and whether the Commission issued an opinion.
Points (a) to (c) of the first subparagraph of this paragraph shall only apply where the information referred to in those points has not been previously provided pursuant to Article 15(1) or where it has changed since the notification.
8. Member States may upload to the secure database relevant information on cases where mitigating measures were significantly or repeatedly not complied with.
9. By 17 October 2027, the Commission shall provide, by means of implementing acts, technical guidance to Member States concerning the implementation of paragraphs 7, 8 and 11 of this Article, and update that technical guidance thereafter as necessary. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 29(2).
10. By 17 July 2027, the Commission shall upload to the secure database the information it has at its disposal since 12 October 2020 based on the notifications sent by Member States that screened foreign investments pursuant to Regulation (EU) 2019/452.
11. By 17 January 2028, Member States shall upload to the secure database the information at their disposal about the outcome of their screening mechanisms under Regulation (EU) 2019/452. The Member States and the Commission may also provide additional information or explanations, including, where applicable, relevant business intelligence they have procured and verified from commercial vendors.
12. By 17 July 2027, the Commission shall set out, by means of implementing acts, the arrangements for the functioning of the secure and encrypted system referred to in paragraph 1 of this Article and the secure database referred to in paragraph 6 of this Article, and update those arrangements thereafter as necessary. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 29(2).
Determination of likely negative effect on security or public order
1. When assessing whether a foreign investment is likely to negatively affect security or public order, for the purposes of adopting a screening decision, or providing comments or issuing an opinion, the Member States and the Commission shall in particular consider its potential effects on:
(a)
a project or programme of Union interest, as listed in Annex II;
(b)
the availability, including outside the Union as a result of the foreign investment, of critical technologies, in particular those referred to in Annex III, and the protection and availability of intellectual property or other intangible assets;
(c)
the security, integrity, resilience and functioning of a critical entity or critical infrastructure within the meaning of Article 2 of Directive (EU) 2022/2557, including the land and property necessary for the operation of such infrastructure, as well as those of entities falling within the scope of Directive (EU) 2022/2555 of the European Parliament and of the Council ( 41 ) , taking into account the relevant Union-level coordinated security risk assessments carried out in accordance with Article 22 of Directive (EU) 2022/2555;
(d)
the continuity of supply of critical inputs, including services;
(e)
the protection of sensitive information, including personal data as defined in Article 4, point (1), of Regulation (EU) 2016/679, in particular with regard to the ability of the foreign investor to access, control, and otherwise process such information;
(f)
the freedom and pluralism of the media, including online and social media platforms that can be used for large-scale disinformation or criminal activities;
(g)
the protection of electoral processes;
(h)
the protection of public health, including the provision and availability of the critical medicines listed in Annex IV;
(i)
the protection of food security, including farming when the Union target possesses or operates more than 10 000 ha of farmland;
(j)
the security of military facilities and other sensitive public facilities in the immediate geographical proximity of the Union target.
2. When assessing whether a foreign investment is likely to negatively affect security or public order, for the purposes of adopting a screening decision, providing comments or issuing an opinion, the Member States and the Commission shall also take into account information related to the foreign investor, including:
(a)
whether the foreign investor, a natural person or entity controlling the foreign investor, the beneficial owner of the foreign investor, any of the subsidiaries of the foreign investor, or any other party owned or controlled by, or acting on behalf or at the direction of the foreign investor:
(i)
is likely to pursue a third country’s policy objectives, including by using the investment to coerce a Member State or the Union to prevent or obtain the cessation, modification or adoption of a particular act;
(ii)
is likely to facilitate the development of a third country’s military capabilities;
(iii)
is likely to use the foreign investment to support internal repression in a third country or the commission of serious violations of human rights or international humanitarian law, in particular when the Union target develops or produces items included in Annex I to Regulation (EU) 2021/821 or items included in Annex I to Directive 2009/43/EC;
(iv)
has made a foreign investment that was previously screened by a Member State and not authorised or only authorised subject to mitigating measures which were significantly or repeatedly not complied with; to determine that, Member States and the Commission shall rely on information available to them, including the information contained in the secure database set up pursuant to Article 18(6) and information provided by the foreign investor on that matter;
(v)
has already been involved in activities negatively affecting the security or public order in a Member State; or
(vi)
has engaged in illegal or criminal activities, including the circumvention of Union restrictive measures adopted pursuant to Article 29 TEU and Article 215 TFEU;
(b)
where applicable, the reasons for subjecting the foreign investor, a natural person or entity controlling the foreign investor, the beneficial owner of the foreign investor, any of the subsidiaries of the foreign investor, or any other party owned or controlled by or acting on behalf or at the direction of the foreign investor to restrictive measures adopted pursuant to Article 29 TEU and Article 215 TFEU;
(c)
whether the foreign investor is established in a third country identified as having significant strategic deficiencies in its national regime on anti-money laundering and on countering the financing of terrorism in accordance with Article 29 of Regulation (EU) 2024/1624 of the European Parliament and of the Council ( 42 ) ;
(d)
whether the foreign investor is subject to the law of a third country that imposes obligations on natural or legal persons to share information for intelligence purposes without due process or oversight mechanisms;
(e)
whether the foreign investor has an opaque ownership structure.
3. The Commission shall make available a risk evaluation form that may be used by Member States to assess the elements referred to in paragraphs 1 and 2.
4. The Commission may carry out risk assessments relating to specific sectors, critical technologies, foreign investors or Union undertakings. Those risk assessments shall be made available in the secure database set up pursuant to Article 18(6) and may be taken into account by Member States when determining whether a foreign investment is likely to negatively affect security or public order.
Screening decisions on foreign investments likely to negatively affect security or public order
1. Where, taking into account the criteria laid down in Article 19 as well as any additional information or elements it considers relevant to the foreign investment and, where applicable, in the light of comments provided by other Member States, or an opinion issued by the Commission, the host Member State concludes that the foreign investment is likely to negatively affect security or public order, it shall adopt a screening decision:
(a)
authorising the foreign investment subject to mitigating measures; or
(b)
prohibiting or ordering the unwinding of the foreign investment.
The screening decision referred to in the first subparagraph shall rely on a risk-based analysis and take into consideration all circumstances of the foreign investment.
2. The host Member State shall consider whether other measures pursuant to Union or national law are available and appropriate to address the foreign investment’s likely negative effect on security or public order.
3. The host Member State shall only adopt a screening decision prohibiting or ordering the unwinding of the foreign investment where the likely negative effect on security or public order cannot be adequately addressed through other means.
4. The mitigating measures referred to in paragraph 1, first subparagraph, point (a), shall be sufficient to resolve the foreign investment’s likely negative effect on security or public order. Those measures may include:
(a)
changes to the proposed governance structure of the Union target;
(b)
modifications to the voting rights conferred on the foreign investor;
(c)
conditions on access to sensitive technologies or information;
(d)
commitments to ensure a specific supply and/or supply to a specific client;
(e)
measures to ensure the continuation of business activities;
(f)
requirements to source critical components from secure and reliable suppliers;
(g)
implementation of cybersecurity protocols to protect against potential threats;
(h)
an obligation to store and process specific data within the Union.
Group of experts on the screening of foreign investments into the Union
1. The group of experts on the screening of foreign investments into the Union (the ‘group of experts’), which provides advice and expertise to the Commission, shall continue to engage in discussions regarding foreign investment screening. The group of experts shall share best practices and lessons learnt, and exchange views on emerging trends and issues of common concern related to foreign investments. The Commission shall seek the advice of the group of experts on systemic matters concerning the implementation of this Regulation. The group of experts shall also assess and compare different databases and sources of market and business information.
2. The discussions in the group of experts shall be kept confidential.
International cooperation
Member States and the Commission may cooperate with the responsible authorities of third countries and engage bilaterally and multilaterally on issues relating to the screening of investments on grounds of security or public order.
Public transparency requirements
1. The Commission shall make publicly available a list of Member States’ screening mechanisms no later than three months from the deadline referred to in Article 3(2), first subparagraph. That list shall contain the contact details referred to in Article 4(12), and, where available, relevant links to information on the screening mechanisms, including the guidance referred to in paragraph 2 of this Article. The Commission shall keep that list up to date.
2. To the extent that this is not laid down in national law, Member States shall publish and regularly update detailed guidance on the scope of their screening mechanism, the thresholds and triggers for filing obligations, and the applicable timelines and procedural rules.
Annual reporting at Union level
1. By 31 March of each year beginning in 2029, Member States shall report to the Commission, on a confidential basis, on their activities under their screening mechanism and the cooperation mechanism for the preceding calendar year. That report shall contain information on:
(a)
the number of foreign investments screened;
(b)
the number of foreign investments authorised or authorised subject to mitigating measures;
(c)
the number of foreign investments prohibited, withdrawn or unwound;
(d)
the number of foreign investments notified through the cooperation mechanism;
(e)
the number of comments provided by the respective Member State;
(f)
the origin of the foreign investors and their beneficial owners and the sector of activity of the targets of the foreign investments screened, authorised, subject to mitigating measures, prohibited or unwound, respectively;
(g)
an aggregate presentation of the risks and vulnerabilities identified in the foreign investments that led to a screening decision;
(h)
the number of comments provided pursuant to Article 13(1) and the number of screening procedures initiated following the receipt of comments by other Member States pursuant to Article 13(1) or opinions by the Commission pursuant to Article 13(2).
2. By 1 January 2029, the Commission shall set out, by means of implementing acts, the form to be used for reporting the information referred to in paragraph 1 of this Article, and update the form thereafter as necessary. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 29(2).
3. Based on the information received in accordance with paragraph 1, the Commission’s implementation practice, and its assessment of trends and developments, the Commission shall provide an annual report on implementation of this Regulation in the preceding year to the European Parliament and to the Council by 31 October of each year beginning in 2029. That report shall be made public with a level of detail that ensures the anonymity of specific transactions.
4. The Commission’s annual report shall include an overview of the information referred to in paragraph 1, the figures on and an assessment of the trends relating to foreign investments into the Union, relevant legislative developments across Member States and international cooperation efforts.
Processing of personal data
1. Any processing of personal data pursuant to this Regulation shall be carried out in accordance with Regulation (EU) 2016/679 and with Regulation (EU) 2018/1725 and to the extent that it is necessary for the screening of foreign investments by Member States and for ensuring the effectiveness of the cooperation mechanism.
2. The national screening authorities of the Member States and the Commission shall be considered joint controllers in accordance with Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 for the processing of operational personal data under this Regulation.
3. Personal data related to foreign investments processed pursuant to this Regulation shall be retained only for the time necessary to achieve the purposes for which those data were collected.
Evaluation
1. The Commission shall evaluate the functioning and effectiveness of this Regulation by 17 January 2031 and every five years thereafter and present a report to the European Parliament and to the Council. Member States shall be involved in this evaluation process and, if necessary, provide the Commission with additional information for the preparation of that report. That report shall include an analysis of the evolution of foreign investments into the Union as well as an assessment of the contribution of this Regulation to the economic security of the Union. It shall include an assessment of whether Article 4(15) should be amended, including as regards foreign investments into Union targets that manufacture or hold a marketing authorisation for critical medicines. The report shall also assess the compliance costs faced by businesses.
2. Where the report from the Commission recommends amendments to this Regulation, it may be accompanied by a legislative proposal.
Delegated acts
1. The Commission is empowered to adopt delegated acts in accordance with Article 28 for the purposes of amending, where necessary, the list of projects or programmes of Union interest, as set out in Annex II, in order to take account of the adoption or amendment of Union legal acts establishing projects or programmes that provide for the development, maintenance or acquisition of critical infrastructure, technologies, inputs or capabilities which are of particular importance for security or public order.
2. The Commission is empowered to adopt delegated acts in accordance with Article 28 for the purposes of amending, where necessary, the list of technology areas set out in Annex III, to take account of changes in the circumstances relevant to security or public order. In particular, these considerations shall include the following:
(a)
the resilience of supply chains of particular importance for the security or public order;
(b)
the resilience of infrastructures of particular importance for the security or public order;
(c)
the results of relevant risk assessments undertaken by the Commission and Member States;
(d)
the advancement of technologies of particular importance for security or public order;
(e)
the risk of leakage or misuse of technologies of particular importance for security or public order;
(f)
the emergence of vulnerabilities in relation to access to or other forms of processing of sensitive information, including personal data to the extent they are likely to negatively affect the security or public order;
(g)
the emergence of a geopolitical situation of particular importance for security or public order; and
(h)
whether the technology area has a dual-use potential.
3. The Commission is empowered to adopt delegated acts in accordance with Article 28 amending this Regulation in order to delete Annex IV and at the same time to replace the reference to that Annex in Article 19(1), point (h), with a reference to the Union List of Critical Medicinal Products and the legal acts establishing it, when that list is established by the Commission pursuant to the Regulation laying down Union procedures for the authorisation and supervision of medicinal products for human use and establishing rules governing the European Medicines Agency, amending Regulations (EC) No 1394/2007 and (EU) No 536/2014 and repealing Regulations (EC) No 141/2000, (EC) No 726/2004 and (EC) No 1901/2006.
Exercise of the delegation
1. The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2. The power to adopt delegated acts referred to in Article 27 shall be conferred on the Commission for a period of five years from 16 July 2026. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or Council opposes such extension not later than three months before the end of each period.
3. The delegation of power referred to in Article 27 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5. As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6. A delegated act adopted pursuant to Article 27 shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.
Committee procedure
1. The Commission shall be assisted by a committee. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
Repeal of Regulation (EU) 2019/452 and transitional measures
1. Regulation (EU) 2019/452 is repealed with effect from 17 January 2028. Without prejudice to paragraphs 2 and 3 of this Article, references to the repealed Regulation shall be construed as references to this Regulation.
2. Regulation (EU) 2019/452 shall continue to apply for foreign direct investments undergoing screening, as defined in Article 2, point (5), of Regulation (EU) 2019/452, on 17 January 2028 and to foreign direct investments, as defined in Article 2, point (1), of that Regulation, completed by 17 January 2028.
3. This Regulation shall not apply to the foreign direct investments referred to in paragraph 2 of this Article nor to foreign investments as defined in Article 2, point (1), of this Regulation, which are undergoing screening on 17 January 2028 or are completed by 17 January 2028.
4. When producing the first report pursuant to Article 24(1), Member States and the Commission shall also include information on foreign investments not already covered by a previous report pursuant to Article 5 of Regulation (EU) 2019/452.
Entry into force and application
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
It shall apply from 17 January 2028.
However, Article 3(2), Article 15(2), Article 18(1) to (6), Article 18(9) to (12), and Articles 27, 28 and 29 shall apply from 16 July 2026.
Supplementary provisions
TECHNOLOGY AREAS RELEVANT FOR THE COMMON MINIMUM SCOPE PURSUANT TO ARTICLE 4(15)
ANNEX ISupplementary provisions
ANNEX I
TECHNOLOGY AREAS RELEVANT FOR THE COMMON MINIMUM SCOPE PURSUANT TO ARTICLE 4(15)
1.
Semiconductor technologies, meaning any technology or know-how related to:
(a)
the design of integrated circuits and other semiconductors, including microprocessors, cryogenic components, graphic processors, microcontrollers, logic chips, memory chips, radio frequency chips, photonic chips, analog chips, quantum chips, optical semiconductors, power semiconductors, discretes, micro-electro-mechanical systems (MEMS), sensors and microsystems, as well as related semiconductor intellectual property core;
(b)
electronic design automation (EDA) software used for the design of integrated circuits and other semiconductors, or for the design of advanced packaging;
(c)
front-end fabrication of integrated circuits and other semiconductors;
(d)
the assembly, testing and packaging of integrated circuits and other semiconductors, including advanced printed circuit boards and advanced packaging technologies;
(e)
semiconductor manufacturing equipment, both for the front-end and back-end fabrication of integrated circuits and other semiconductors, including etching, deposition, epitaxy, lithography, advanced packaging, testing or metrology tools;
(f)
core components or software of semiconductor manufacturing equipment;
(g)
materials used in the fabrication of integrated circuits and other semiconductors, in particular specialty chemicals, rare gases, substrates or wafers.
2.
Quantum technologies, meaning any technology or know-how related to:
(a)
quantum computing;
(b)
quantum communications;
(c)
quantum sensing.
3.
Artificial intelligence (AI) technologies, meaning any technology or know-how specifically related to a machine-based system that is designed to operate with varying levels of autonomy and that may exhibit adaptiveness after deployment, and that, for explicit or implicit objectives, infers, from the input it receives, how to generate outputs such as predictions, content, recommendations, or decisions that can influence physical or virtual environments (‘AI system’), used for:
(a)
general-purpose AI models as defined in Article 3, point (63), of Regulation (EU) 2024/1689 of the European Parliament and of the Council ( 1 ) or AI systems based on such models suitable for the development of space or defence application; or
(b)
general-purpose AI models with systemic risk within the meaning of Article 51 of Regulation (EU) 2024/1689 or AI systems based on such models.
( 1 ) Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act) ( OJ L, 2024/1689, 12.7.2024, ELI: http://data.europa.eu/eli/reg/2024/1689/oj ).
PROJECTS OR PROGRAMMES OF UNION INTEREST
ANNEX IISupplementary provisions
ANNEX II
PROJECTS OR PROGRAMMES OF UNION INTEREST
1. Preparatory Action on Preparing the new EU GOVSATCOM programme
Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 on the financial rules applicable to the general budget of the Union, and in particular Article 58(2), point (b), thereof ( OJ L, 2024/2509, 26.9.2024, ELI: http://data.europa.eu/eli/reg/2024/2509/oj ).
2. Space Programme
Regulation (EU) 2021/696 of the European Parliament and of the Council of 28 April 2021 establishing the Union Space Programme and the European Union Agency for the Space Programme and repealing Regulations (EU) No 912/2010, (EU) No 1285/2013 and (EU) No 377/2014 and Decision No 541/2014/EU ( OJ L 170, 12.5.2021, p. 69 , ELI: http://data.europa.eu/eli/reg/2021/696/oj ).
3. Union secure connectivity programme
Regulation (EU) 2023/588 of the European Parliament and of the Council of 15 March 2023 establishing the Union Secure Connectivity Programme for the period 2023-2027 ( OJ L 79, 17.3.2023, p. 1 , ELI: http://data.europa.eu/eli/reg/2023/588/oj ).
4. Horizon 2020, including research and development programmes pursuant to Article 185 TFEU, and joint undertakings or any other structure set up pursuant to Article 187 TFEU
Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 – the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC ( OJ L 347, 20.12.2013, p. 104 , ELI: http://data.europa.eu/eli/reg/2013/1291/oj ).
5. Horizon Europe, including research and development programmes pursuant to Article 185 TFEU, and joint undertakings or any other structure set up pursuant to Article 187 TFEU
Regulation (EU) 2021/695 of the European Parliament and of the Council of 28 April 2021 establishing Horizon Europe – the Framework Programme for Research and Innovation, laying down its rules for participation and dissemination, and repealing Regulations (EU) No 1290/2013 and (EU) No 1291/2013 ( OJ L 170, 12.5.2021, p. 1 , ELI: http://data.europa.eu/eli/reg/2021/695/oj ).
6. Euratom Research and Training Programme 2021-2025
Council Regulation (Euratom) 2025/1304 of 23 June 2025 establishing the Research and Training Programme of the European Atomic Energy Community for the period 2026-2027 complementing Horizon Europe – the Framework Programme for Research and Innovation and repealing Regulation (Euratom) 2021/765 ( OJ L, 2025/1304, 3.7.2025, ELI: http://data.europa.eu/eli/reg/2025/1304/oj ).
7. Trans-European Networks for Transport (TEN-T)
Regulation (EU) 2024/1679 of the European Parliament and of the Council of 13 June 2024 on Union guidelines for the development of the trans-European transport network, amending Regulations (EU) 2021/1153 and (EU) No 913/2010 and repealing Regulation (EU) No 1315/2013 ( OJ L, 2024/1679, 28.6.2024, ELI: http://data.europa.eu/eli/reg/2024/1679/oj ).
8. Trans-European Networks for Energy (TEN-E)
Regulation (EU) 2022/869 of the European Parliament and of the Council of 30 May 2022 on guidelines for trans-European energy infrastructure, amending Regulations (EC) No 715/2009, (EU) 2019/942 and (EU) 2019/943 and Directives 2009/73/EC and (EU) 2019/944, and repealing Regulation (EU) No 347/2013 ( OJ L 152, 3.6.2022, p. 45 , ELI: http://data.europa.eu/eli/reg/2022/869/oj ).
9. Trans-European Networks for Telecommunications ( 1 )
Regulation (EU) No 283/2014 of the European Parliament and of the Council of 11 March 2014 on guidelines for trans-European networks in the area of telecommunications infrastructure and repealing Decision No 1336/97/EC ( OJ L 86, 21.3.2014, p. 14 , ELI: http://data.europa.eu/eli/reg/2014/283/oj ).
10. Connecting Europe Facility
Regulation (EU) 2021/1153 of the European Parliament and of the Council of 7 July 2021 establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/2013 and (EU) No 283/2014 ( OJ L 249, 14.7.2021, p. 38 , ELI: http://data.europa.eu/eli/reg/2021/1153/oj ).
11. Digital Europe Programme
Regulation (EU) 2021/694 of the European Parliament and of the Council of 29 April 2021 establishing the Digital Europe Programme and repealing Decision (EU) 2015/2240 ( OJ L 166, 11.5.2021, p. 1 , ELI: http://data.europa.eu/eli/reg/2021/694/oj ).
12. European Defence Industrial Development Programme
Regulation (EU) 2021/697 of the European Parliament and of the Council of 29 April 2021 establishing the European Defence Fund and repealing Regulation (EU) 2018/1092 ( OJ L 170, 12.5.2021, p. 149 , ELI: http://data.europa.eu/eli/reg/2021/697/oj ).
13. Preparatory Action on Defence Research
Regulation (EU, Euratom) 2024/2509 of the European Parliament and of the Council of 23 September 2024 on the financial rules applicable to the general budget of the Union, and in particular Article 58(2), point (b), thereof.
14. European Defence Fund
Regulation (EU) 2021/697 of the European Parliament and of the Council of 29 April 2021 establishing the European Defence Fund and repealing Regulation (EU) 2018/1092 ( OJ L 170, 12.5.2021, p. 149 , ELI: http://data.europa.eu/eli/reg/2021/697/oj ).
15. Act in Support of Ammunition Production (ASAP)
Regulation (EU) 2023/1525 of the European Parliament and of the Council of 20 July 2023 on supporting ammunition production (ASAP) ( OJ L 185, 24.7.2023, p. 7 , ELI: http://data.europa.eu/eli/reg/2023/1525/oj ).
16. European Defence Industry Reinforcement through common Procurement Act (EDIRPA)
Regulation (EU) 2023/2418 of the European Parliament and of the Council of 18 October 2023 on establishing an instrument for the reinforcement of the European defence industry through common procurement (EDIRPA) ( OJ L, 2023/2418, 26.10.2023, ELI: http://data.europa.eu/eli/reg/2023/2418/oj ).
17. Permanent structured cooperation (PESCO)
Council Decision (CFSP) 2018/340 of 6 March 2018 establishing the list of projects to be developed under PESCO ( OJ L 65, 8.3.2018, p. 24 , ELI: http://data.europa.eu/eli/dec/2018/340/oj ).
Council Decision (CFSP) 2023/995 of 22 May 2023 amending and updating Decision (CFSP) 2018/340 establishing the list of projects to be developed under PESCO ( OJ L 135, 23.5.2023, p. 123 , ELI: http://data.europa.eu/eli/dec/2023/995/oj ).
18. European Defence Industry Programme (EDIP)
Regulation (EU) 2025/2643 of the European Parliament and of the Council of 16 December 2025 establishing the European Defence Industry Programme and a framework of measures to ensure the timely availability and supply of defence products (‘EDIP Regulation’) ( OJ L, 2025/2643, 29.12.2025, ELI: http://data.europa.eu/eli/reg/2025/2643/oj ).
19. European Joint Undertaking for ITER
Council Decision 2007/198/Euratom of 27 March 2007 establishing the European Joint Undertaking for ITER and the Development of Fusion Energy and conferring advantages upon it ( OJ L 90, 30.3.2007, p. 58 , ELI: http://data.europa.eu/eli/dec/2007/198/oj ).
20. EU4Health Programme
Regulation (EU) 2021/522 of the European Parliament and of the Council of 24 March 2021 establishing a Programme for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, and repealing Regulation (EU) No 282/2014 ( OJ L 107, 26.3.2021, p. 1 , ELI: http://data.europa.eu/eli/reg/2021/522/oj ).
21. Important Projects of Common European Interest (IPCEI)
Projects that the Commission has considered, in a decision adopted pursuant to Article 108 TFEU, to constitute an important project of common European interest within the meaning of Article 107(3), point (b), TFEU.
22. Projects of common interest and projects of mutual interest
Commission Delegated Regulation (EU) 2024/1041 of 28 November 2023 amending Regulation (EU) 2022/869 of the European Parliament and of the Council as regards the Union list of projects of common interest and projects of mutual interest ( OJ L, 2024/1041, 8.4.2024, ELI: http://data.europa.eu/eli/reg_del/2024/1041/oj ).
( 1 ) Regulation (EU) No 283/2014 is maintained in this Annex in view of Article 27(2) of Regulation (EU) 2021/1153 establishing the Connecting Europe Facility and repealing Regulations (EU) No 1316/2013 and (EU) No 283/2014.
TECHNOLOGY AREAS RELEVANT TO RISK ASSESSMENTS PURSUANT TO ARTICLE 19
ANNEX IIISupplementary provisions
ANNEX III
TECHNOLOGY AREAS RELEVANT TO RISK ASSESSMENTS PURSUANT TO ARTICLE 19
a.
Biotechnologies:
—
techniques of genetic modification
—
new genomic techniques
—
gene-drive
—
synthetic biology
b.
Advanced connectivity, navigation and digital technologies:
—
secure digital communications and connectivity, such as RAN & Open RAN (Radio Access Network) and 6G
—
cyber security technologies including cyber-surveillance, encryption, security and intrusion prevention and detection systems, digital forensics
—
Internet of Things and Virtual Reality
—
distributed ledger and digital identity technologies
—
advanced guidance, navigation and control technologies, including avionics and marine positioning
c.
Submarine fibre-optic cables
d.
Advanced sensing technologies:
—
electro-optical, radar, chemical, biological, radiation and distributed sensing
—
magnetometers, magnetic gradiometers
—
underwater electric field sensors
—
gravity meters and gradiometers
e.
Space and propulsion technologies:
—
dedicated space-focused technologies, ranging from component to system level
—
space surveillance and Earth observation technologies
—
space positioning, navigation and timing (PNT)
—
secure communications including Low Earth Orbit (LEO) connectivity
—
propulsion technologies, including hypersonics and components for military use
f.
Aerospace technologies
g.
Energy technologies:
—
nuclear fusion technologies, reactors and power generation, radiological conversion/enrichment/recycling technologies
—
hydrogen and new fuels
—
net-zero technologies, including photovoltaics
—
smart grids and energy storage, batteries
h.
Robotics and autonomous systems:
—
drones and vehicles (air, land, surface and underwater)
—
robots and robot-controlled precision systems
—
exoskeletons
—
AI-enabled systems
i.
Advanced materials, manufacturing and recycling technologies:
—
technologies for nanomaterials, smart materials, advanced ceramic materials, stealth materials, safe and sustainable by design materials
—
additive manufacturing, including in the field
—
digitally controlled micro-precision manufacturing and small-scale laser machining/welding
LIST OF CRITICAL MEDICINES
ANNEX IVSupplementary provisions
ANNEX IV
LIST OF CRITICAL MEDICINES
ATC level 5
ATC description ( 1 )
Route of administration
A - Alimentary tract and metabolism
A02B - Drugs for peptic ulcer and gastro-oesophageal reflux disease (GORD)
A02BC05
ESOMEPRAZOLE
intravenous use
A03B - Belladonna and derivatives, plain
A03BA01
ATROPINE
intramuscular, intravenous, subcutaneous use
A03F - Propulsives
A03FA01
METOCLOPRAMIDE
intramuscular, intravenous, subcutaneous use
A07A - Intestinal antiinfectives
A07AA12
FIDAXOMICIN
oral use
A07B - Intestinal adsorbents
A07BA01
MEDICINAL CHARCOAL
oral use
A10A - Insulins and analogues
A10AB01
INSULIN HUMAN (fast-acting)
intramuscular, intravenous, subcutaneous use
A10AB05
INSULIN ASPART
intravenous, subcutaneous use
A10AC01
INSULIN HUMAN (intermediate-acting)
intramuscular, intravenous, subcutaneous use
A10AD01
INSULIN HUMAN (intermediate - or long-acting combined with fast-acting)
intramuscular, intravenous, subcutaneous use
A10AE06
INSULIN DEGLUDEC
subcutaneous use
A12C - Other mineral supplements
A12CC02
MAGNESIUM SULFATE
intravenous, intramuscular use
A16A - Other alimentary tract and metabolism products
A16AB02
IMIGLUCERASE
intravenous use
B - Blood and blood forming organs
B01A - Antithrombotic agents
B01AA03
WARFARIN
oral use
B01AB01
HEPARIN
haemodialysis, intraarterial, intravenous, subcutaneous use
B01AB02
ANTITHROMBIN III
intravenous use
B01AC04
CLOPIDOGREL
oral use
B01AC16
EPTIFIBATIDE
intravenous use
B01AD02
ALTEPLASE
intravenous use
B01AD11
TENECTEPLASE
intravenous use
B01AE07
DABIGATRAN
oral use
B02A - Antifibrinolytics
B02AA02
TRANEXAMIC ACID
oral, intravenous use
B02B - Vitamin K and other hemostatics
B02BA01
PHYTOMENADIONE
intramuscular, intravenous, oral use
B02BB01
HUMAN FIBRINOGEN
intravenous use
B02BD01
HUMAN PROTHROMBIN COMPLEX
intravenous use
B02BD02
HUMAN COAGULATION FACTOR VIII
intravenous use
B02BD03
FACTOR VIII INHIBITOR BYPASSING ACTIVITY
intravenous use
B02BD04
HUMAN COAGULATION FACTOR IX
intravenous use
B02BD05
HUMAN COAGULATION FACTOR VII
intravenous use
B02BD07
HUMAN COAGULATION FACTOR XIII
intravenous use
B02BD08
EPTACOG ALFA
intravenous use
B03B - Vitamin B12 and folic acid
B03BA03
HYDROXOCOBALAMIN
intravenous, intramuscular, subcutaneous, oral use
B05A - Blood and related products
B05AA01
ALBUMIN
intravenous use
B05AA02
PLASMA PROTEIN FRACTION
intravenous use
B05B - IV solutions
B05BB01
POTASSIUM CHLORIDE
intravenous use
B05BC01
MANNITOL
intravenous use
B05X - IV solution additives
B05XA01
POTASSIUM CHLORIDE
intravenous use
B05XA05
MAGNESIUM SULFATE
intravenous use
B06A - Other hematological agents
B06AB01
HUMAN HEMIN
intravenous use
B06AC01
COMPLEMENT C1 ESTERASE INHIBITOR
intravenous, subcutaneous use
C - Cardiovascular system
C01A - Cardiac glycosides
C01AA05
DIGOXIN
oral, intravenous use
C01B - Antiarrhythmics, class I and III
C01BB01
LIDOCAINE
parenteral use
C01BB02
MEXILETINE
oral use
C01BC04
FLECAINIDE
oral use
C01BD01
AMIODARONE
intravenous use
C01C - Cardiac stimulants excl cardiac glycosides
C01CA02
ISOPRENALINE
intravenous use
C01CA03
NOREPINEPHRINE
intravenous use
C01CA04
DOPAMINE
intravenous use
C01CA07
DOBUTAMINE
intravenous use
C01CA24
EPINEPHRINE
endotracheopulmonary, intracardiac, intraosseous, intramuscular, intravenous, subcutaneous use
C01CA26
EPHEDRINE
intravenous, intramuscular, subcutaneous use
C01CE02
MILRINONE
intravenous use
C01D - Vasodilators used in cardiac diseases
C01DA02
GLYCERYL TRINITRATE
intravenous, sublingual use
C01E - Other cardiac preparations
C01EB10
ADENOSINE
intravenous use
C02A - Antiadrenergic agents, centrally acting
C02AB01
METHYLDOPA (levorotatory)
oral use
C02AB02
METHYLDOPA (racemic)
oral use
C02AC01
CLONIDINE
intramuscular, intravenous, subcutaneous, oral use
C02D - Arteriolar smooth muscle, agents acting on
C02DD01
SODIUM NITROPRUSSIDE
intravenous use
C03C - High-ceiling diuretics
C03CA01
FUROSEMIDE
intravenous, intramuscular use
C07A - Beta blocking agents
C07AA05
PROPRANOLOL
oral use
C07AG01
LABETALOL
intravenous use
C08C - Selective calcium channel blockers with mainly vascular effects
C08CA06
NIMODIPINE
intravenous, intracisternal use
C08D - Selective calcium channel blockers with direct cardiac effects
C08DA01
VERAPAMIL
intravenous use
G - Genito urinary system and sex hormones
G02A - Uterotonics
G02AB01
METHYLERGOMETRINE
intramuscular, intrauterine, intravenous, subcutaneous use
G03X - Other sex hormones and modulators of the genital system
G03XB01
MIFEPRISTONE
oral use
H - Systemic hormonal preparations, excl sex hormones and insulins
H01B - Posterior pituitary lobe hormones
H01BA01
ARGIPRESSIN
intramuscular, intravenous, subcutaneous use
H01BA02
DESMOPRESSIN
intramuscular, intravenous, subcutaneous use
H01BB02
OXYTOCIN
intramuscular, intravenous use
H01BB03
CARBETOCIN
intramuscular, intravenous use
H02A - Corticosteroids for systemic use, plain
H02AA02
FLUDROCORTISONE
oral use
H02AB04
METHYLPREDNISOLONE
intraarticular, intrabursal, intradermal, intralesional, intramuscular, intravenous, periarticular, rectal use
H02AB06
PREDNISOLONE
oral use
H02AB09
HYDROCORTISONE
intraarticular, intramuscular, intravenous, oral use
H03B - Antithyroid preparations
H03BA02
PROPYLTHIOURACIL
oral use
H03BB01
CARBIMAZOLE
oral use
H03BB02
THIAMAZOLE
oral use
H04A - Glycogenolytic hormones
H04AA01
GLUCAGON
intramuscular, intravenous, nasal, subcutaneous use
J - Antiinfectives for systemic use
J01A - Tetracyclines
J01AA02
DOXYCYCLINE
oral use
J01C - Beta-lactam antibacterials, penicillins
J01CA01
AMPICILLIN
intramuscular, intravenous use
J01CA04
AMOXICILLIN
oral, intravenous, intramuscular use
J01CE01
BENZYLPENICILLIN
intraarticular, intramuscular, intrapleural, intrathecal, intravenous use
J01CE02
PHENOXYMETHYLPENICILLIN
oral use
J01CE08
BENZATHINE BENZYLPENICILLIN
intramuscular use
J01CF02
CLOXACILLIN
intravenous, intramuscular use
J01CF05
FLUCLOXACILLIN
inhalation, intraarticular, intramuscular, intrapleural, intravenous, oral use
J01CR02
AMOXICILLIN, CLAVULANIC ACID
oral, intravenous use
J01CR05
PIPERACILLIN, TAZOBACTAM
intravenous use
J01D - Other beta-lactam antibacterials
J01DC02
CEFUROXIME
oral use
J01DD01
CEFOTAXIME
intramuscular, intravenous use
J01DD02
CEFTAZIDIME
intramuscular, intravenous use
J01DD04
CEFTRIAXONE
intramuscular, intravenous, subcutaneous use
J01DD08
CEFIXIME
oral use
J01DD52
CEFTAZIDIME, AVIBACTAM
intravenous use
J01DF01
AZTREONAM
intramuscular, intravenous use
J01DH56
CILASTATIN SODIUM, IMIPENEM, RELEBACTAM
intravenous use
J01DI54
TAZOBACTAM, CEFTOLOZANE
intravenous use
J01E - Sulfonamides and trimethoprim
J01EA01
TRIMETHOPRIM
oral use
J01EE01
CO-TRIMOXAZOLE
oral, intravenous use
J01F - Macrolides, lincosamides and streptogramins
J01FA01
ERYTHROMYCIN
intravenous use
J01FA09
CLARITHROMYCIN
intravenous use
J01FA10
AZITHROMYCIN
intravenous, oral use
J01FF01
CLINDAMYCIN
intramuscular, intravenous use
J01G - Aminoglycoside antibacterials
J01GB01
TOBRAMYCIN
inhalation, intramuscular, intravenous use
J01GB03
GENTAMICIN
intramuscular, intravenous, subconjunctival use
J01GB06
AMIKACIN
intramuscular, intravenous use
J01M - Quinolone antibacterials
J01MA02
CIPROFLOXACIN
intravenous use
J01MA12
LEVOFLOXACIN
intravenous use
J01X - Other antibacterials
J01XA01
VANCOMYCIN
intraperitoneal, intravenous, oral use
J01XA02
TEICOPLANIN
intramuscular, intravenous use
J01XB01
COLISTIN
inhalation, intrathecal, intravenous use
J01XD01
METRONIDAZOLE
intravenous use
J01XX01
FOSFOMYCIN
intravenous use
J02A - Antimycotics for systemic use
J02AA01
AMPHOTERICIN B
intravenous use
J02AC01
FLUCONAZOLE
intravenous use
J02AC04
POSACONAZOLE
intravenous use
J02AC05
ISAVUCONAZOLE
intravenous, oral use
J04A - Drugs for treatment of tuberculosis
J04AB02
RIFAMPICIN
oral use
J04AB04
RIFABUTIN
oral use
J04AC01
ISONIAZID
oral use
J04AK01
PYRAZINAMIDE
oral use
J04AK02
ETHAMBUTOL
oral use
J04AK05
BEDAQUILINE
oral use
J04AM02
ISONIAZID, RIFAMPICIN
oral use
J04B - Drugs for treatment of lepra
J04BA02
DAPSONE
oral use
J05A - Direct acting antivirals
J05AB01
ACICLOVIR
intravenous use
J05AB06
GANCICLOVIR
intravenous use
J05AB14
VALGANCICLOVIR
oral use
J05AD01
FOSCARNET
intravenous use
J05AF01
ZIDOVUDINE
intravenous, oral use
J05AF05
LAMIVUDINE
oral use
J05AF06
ABACAVIR
oral use
J05AF09
EMTRICITABINE
oral use
J05AG01
NEVIRAPINE
oral use
J05AR02
ABACAVIR, LAMIVUDINE
oral use
J06B - Immunoglobulins
J06BA01
HUMAN NORMAL IMMUNOGLOBULIN
intravenous, subcutaneous use
J06BA02
HUMAN NORMAL IMMUNOGLOBULIN
intravenous use
J06BB01
HUMAN ANTI-D IMMUNOGLOBULIN
intramuscular, intravenous use
J06BB02
HUMAN TETANUS IMMUNOGLOBULIN
intramuscular, subcutaneous use
J06BB04
HUMAN HEPATITIS B IMMUNOGLOBULIN
intramuscular, intravenous, subcutaneous use
J06BB05
HUMAN RABIES IMMUNOGLOBULIN
intramuscular use
J07A - Bacterial vaccines
J07AE01
CHOLERA VACCINE (inactivated)
oral use
J07AH07
MENINGOCOCCAL GROUP C VACCINE
intramuscular use
J07AH09
MENINGOCOCCAL GROUP B VACCINE
intramuscular use
J07AJ51
DIPHTHERIA, TETANUS, PERTUSSIS VACCINE (inactivated, whole cell)
intramuscular, subcutaneous use
J07AJ52
DIPHTHERIA, TETANUS, PERTUSSIS VACCINE (purified antigen)
intramuscular, subcutaneous use
J07AM51
DIPHTHERIA, TETANUS VACCINE
intramuscular, subcutaneous use
J07AP03
TYPHOID VACCINE (polysaccharide)
intramuscular, subcutaneous use
J07B - Viral vaccines
J07BA02
ENCEPHALITIS (Japanese, whole virus, inactivated)
intramuscular use
J07BB01
INFLUENZA VACCINE (various forms, strains)
intramuscular use
J07BB02
INFLUENZA VACCINE (various forms, strains)
intramuscular, subcutaneous use
J07BC01
HEPATITIS B VACCINE
intramuscular, subcutaneous use
J07BC02
HEPATITIS A VACCINE
intramuscular, subcutaneous use
J07BC20
HEPATITIS A AND B VACCINE
intramuscular, subcutaneous use
J07BD52
MEASLES, MUMPS, RUBELLA VACCINE
intramuscular, subcutaneous use
J07BD54
MEASLES, MUMPS, RUBELLA, VARICELLA VACCINE
intramuscular, subcutaneous use
J07BF03
POLIOMYELITIS VACCINE (trivalent)
intramuscular, subcutaneous use
J07BG01
RABIES VACCINE
intradermal, intramuscular, subcutaneous use
J07BH02
ROTAVIRUS PENTAVALENT VACCINE
oral use
J07BK01
VARICELLA VACCINE (live)
intramuscular, subcutaneous use
J07BL01
YELLOW FEVER VACCINE
intramuscular, subcutaneous use
J07BM01
PAPILLOMAVIRUS VACCINE
intramuscular use
J07BM02
PAPILLOMAVIRUS VACCINE
intramuscular use
J07BM03
HUMAN PAPILLOMAVIRUS VACCINE (9-valent)
intramuscular use
J07C - Bacterial and viral vaccines, combined
J07CA01
DIPHTHERIA, TETANUS, POLIOMYELITIS VACCINE
intramuscular, subcutaneous use
J07CA02
DIPHTHERIA, TETANUS, PERTUSSIS, POLIOMYELITIS VACCINE
intramuscular, subcutaneous use
J07CA06
DIPHTHERIA, TETANUS, PERTUSSIS VACCINE
intramuscular, subcutaneous use
J07CA12
DIPHTHERIA, TETANUS, PERTUSSIS, POLIOMYELITIS, HEPATITIS B VACCINE
intramuscular use
L - Antineoplastic and immunomodulating agents
L01A - Antineoplastic agents
L01AA01
CYCLOPHOSPHAMIDE
intramuscular, intravenous, oral use
L01AA02
CHLORAMBUCIL
oral use
L01AA03
MELPHALAN
intraarterial, intravenous, oral use
L01AA06
IFOSFAMIDE
intraarterial, intravenous use
L01AB01
BUSULFAN
intravenous, oral, subcutaneous use
L01AB02
TREOSULFAN
intravenous use
L01AC01
THIOTEPA
intramuscular, intrapericardial, intraperitoneal, intrapleural, intravascular, intravenous use
L01AX04
DACARBAZINE
intravenous use
L01B - Antimetabolites
L01BA01
METHOTREXATE
epidural, intraarterial, intraarticular, intrabursal, intracoronary, intradiscal, intramuscular, intrathecal, intravenous, oral, periarticular, perineural, rectal, retrobulbar, subconjunctival, subcutaneous, transdermal use
L01BB02
MERCAPTOPURINE
oral use
L01BB03
TIOGUANINE
oral use
L01BB05
FLUDARABINE
epidural, intrabursal, intracoronary, intradiscal, intramuscular, intravenous, oral, perineural, retrobulbar use
L01BC01
CYTARABINE
intramuscular, intrathecal, intravenous, subcutaneous use
L01BC02
FLUOROURACIL
intraarterial, intraarticular, intramuscular, intraperitoneal, intrapleural, intravenous use
L01BC05
GEMCITABINE
intravenous use
L01C - Plant alkaloids and other natural products
L01CA01
VINBLASTINE
epidural, intrabursal, intracoronary, intradiscal, intramuscular, intravenous, perineural, retrobulbar use
L01CA02
VINCRISTINE
epidural, intrabursal, intracoronary, intradiscal, intramuscular, intravenous, perineural, retrobulbar use
L01CB01
ETOPOSIDE
epidural, intrabursal, intracoronary, intradiscal, intramuscular, intravenous, oral, perineural, retrobulbar use
L01CD01
PACLITAXEL
intravenous use
L01CE01
TOPOTECAN
intravenous, oral use
L01D - Cytotoxic antibiotics and related substances
L01DB01
DOXORUBICIN
intravenous, intravesical use
L01DB02
DAUNORUBICIN
intravenous use
L01DB03
EPIRUBICIN
epidural, intrabursal, intracoronary, intradiscal, intramuscular, intravenous, intravesical, perineural, retrobulbar use
L01DB06
IDARUBICIN
intravenous use
L01DB07
MITOXANTRONE
intrapleural, intravenous use
L01DC01
BLEOMYCIN
intraarterial, intramuscular, intraperitoneal, intrapleural, intratumoral, intravenous, subcutaneous use
L01DC03
MITOMYCIN
intravenous, intravesical use
L01E - Protein kinase inhibitors
L01EA03
NILOTINIB
oral use
L01EC02
DABRAFENIB
oral use
L01EC03
ENCORAFENIB
oral use
L01EE01
TRAMETINIB
oral use
L01EL01
IBRUTINIB
oral use
L01F - Monoclonal antibodies and antibody drug conjugates
L01FA03
OBINUTUZUMAB
intravenous use
L01FB01
INOTUZUMAB OZOGAMICIN
intravenous use
L01FC01
DARATUMUMAB
intravenous, subcutaneous use
L01FF01
NIVOLUMAB
intravenous, subcutaneous use
L01FF02
PEMBROLIZUMAB
intravenous use
L01FF03
DURVALUMAB
intravenous use
L01FX02
GEMTUZUMAB OZOGAMICIN
intravenous use
L01FX05
BRENTUXIMAB VEDOTIN
intravenous use
L01FX17
SACITUZUMAB GOVITECAN
intravenous use
L01X - Other neoplastic agents
L01XA01
CISPLATIN
epidural, intrabursal, intracoronary, intradiscal, intramuscular, intravenous, perineural, retrobulbar use
L01XA02
CARBOPLATIN
epidural, intrabursal, intracoronary, intradiscal, intramuscular, intravenous, perineural, retrobulbar use
L01XA03
OXALIPLATIN
epidural, intrabursal, intracoronary, intradiscal, intramuscular, intravenous, perineural, retrobulbar use
L01XB01
PROCARBAZINE
oral use
L01XF01
TRETINOIN
oral use
L01XJ01
VISMODEGIB
oral use
L01XX05
HYDROXYCARBAMIDE
oral use
L01XX23
MITOTANE
oral use
L01XX24
PEGASPARGASE
intramuscular, intravenous use
L02B - Hormone antagonists and related agents
L02BA01
TAMOXIFEN
oral use
L03A - Immunostimulants
L03AB11
PEGINTERFERON ALFA-2A
subcutaneous use
L03AX03
BCG VACCINE (various forms)
intravesical use
L03AX13
GLATIRAMER
intraarticular, intravenous, periarticular, subcutaneous, transdermal use
L03AX16
PLERIXAFOR
subcutaneous use
L04A - Immunosuppressants
L04AA03
ANTILYMPHOCYTE IMMUNOGLOBULIN (horse)
intravenous use
L04AA04
ANTITHYMOCYTE IMMUNOGLOBULIN (rabbit)
intravenous use
L04AC02
BASILIXIMAB
intravenous use
L04AC03
ANAKINRA
subcutaneous use
L04AD01
CICLOSPORIN
intravenous, oral use
L04AD02
TACROLIMUS
intravenous, oral use
L04AH01
SIROLIMUS
oral use
L04AX02
THALIDOMIDE
oral use
L04AX03
METHOTREXATE
oral use
M - Musculo-skeletal system
M01C - Specific antirheumatic agents
M01CC01
PENICILLAMINE
oral use
M03A - Muscle relaxants, peripherally acting agents
M03AB01
SUXAMETHONIUM
intramuscular, intraosseous, intravenous use
M03AC04
ATRACURIUM
intravenous use
M03AC09
ROCURONIUM
intravenous use
M03AC11
CISATRACURIUM
intravenous use
M03C - Muscle relaxants, directly acting agents
M03CA01
DANTROLENE
intravenous use
N - Nervous system
N01A - Anesthetics, general
N01AH01
FENTANYL
epidural, intramuscular, intravenous use
N01AH03
SUFENTANIL
epidural, intravenous use
N01AH06
REMIFENTANIL
intramuscular, intravenous use
N01AX03
KETAMINE
intramuscular, intravenous use
N01AX10
PROPOFOL
intravenous use
N01AX14
ESKETAMINE
intramuscular, intravenous use
N02A - Opioids
N02AA01
MORPHINE
epidural, intramuscular, intravenous, subcutaneous use
N02B - Other analgesics and antipyretics
N02BE01
PARACETAMOL
intravenous use
N03A - Antiepileptics
N03AA02
PHENOBARBITAL
intramuscular, intravenous, oral use
N03AB02
PHENYTOIN
intramuscular, intravenous, oral use
N03AD01
ETHOSUXIMIDE
oral use
N03AE01
CLONAZEPAM
oral use
N03AF01
CARBAMAZEPINE
oral use
N03AG01
VALPROIC ACID
intravenous, oral use
N03AG04
VIGABATRIN
oral use
N04A - Anticholinergic agents
N04AA02
BIPERIDEN
intramuscular, intravenous use
N05A - Antipsychotics
N05AD01
HALOPERIDOL
intraarticular, intramuscular, intravascular, intravenous, oral use
N05AH03
OLANZAPINE
intramuscular use
N05AN01
LITHIUM
oral use
N05B - Anxiolytics
N05BA01
DIAZEPAM
intramuscular, intravenous, rectal use
N05BA06
LORAZEPAM
intramuscular, intravenous use
N05C - Hypnotics and sedatives
N05CD08
MIDAZOLAM
intramuscular, intravenous, subcutaneous, rectal use
N05CM18
DEXMEDETOMIDINE
intravenous, subcutaneous use
N06A - Antidepressants
N06AX27
ESKETAMINE
nasal use
N06B - Psychostimulants, agents used for ADHD and nootropics
N06BC01
CAFFEINE
intravenous, oral use
N07A - Parasympathomimetics
N07AA01
NEOSTIGMINE
intramuscular, intravenous, subcutaneous use
N07X - Other nervous system drugs
N07XX02
RILUZOLE
oral use
P - Antiparasitic products, insecticides and repellents
P01A - Agents against amoebiasis and other protozoal diseases
P01AB01
METRONIDAZOLE
intravenous use
P01C - Agents against leishmaniasis and trypanosomiasis
P01CX01
PENTAMIDINE
inhalation, intramuscular, intravenous use
P02C - Antinematodal agents
P02CA03
ALBENDAZOLE
oral use
R - Respiratory system
R03A - Adrenergics, inhalants
R03AC02
SALBUTAMOL
inhalation, nasal, oral use
R03B - Other drugs for obstructive airway diseases, inhalants
R03BB01
IPRATROPIUM
inhalation, oral use
R03C - Adrenergics for systemic use
R03CA02
EPHEDRINE
intramuscular, intravenous, subcutaneous use
R03CC02
SALBUTAMOL
intramuscular, intravenous, subcutaneous use
R05C - Expectorants, excl combinations with cough suppressants
R05CB01
ACETYLCYSTEINE
intravenous use
R05CB13
DORNASE ALFA (DESOXYRIBONUCLEASE)
inhalation use
S - Sensory organs
S01E - Antiglaucoma preparations and miotics
S01EB01
PILOCARPINE
ocular use
S01EB09
ACETYLCHOLINE
intraocular use
S01EC01
ACETAZOLAMIDE
oral use
S01F - Mydriatics and cycloplegics
S01FA04
CYCLOPENTOLATE
ocular use
S01L - Ocular vascular disorder agents
S01LA01
VERTEPORFIN
intravenous use
S02A - Antiinfectives
S02AA15
CIPROFLOXACIN
oral use
S03A - Antiinfectives
S03AA07
CIPROFLOXACIN
oral use
V - Various
V03A - All other therapeutic products
V03AB06
SODIUM THIOSULFATE
intravenous use
V03AB14
PROTAMINE
intravenous use
V03AB15
NALOXONE
intramuscular, intravenous, subcutaneous use
V03AB17
METHYLTHIONINIUM
intravenous use
V03AB23
ACETYLCYSTEINE
intravenous use
V03AB25
FLUMAZENIL
intravenous use
V03AB33
HYDROXOCOBALAMIN
intramuscular, intravenous, oral, subcutaneous use
V03AB34
FOMEPIZOLE
intravenous use
V03AB35
SUGAMMADEX
intravenous use
V03AB37
IDARUCIZUMAB
intravenous use
V03AC01
DEFEROXAMINE
intramuscular, intraperitoneal, intravenous, subcutaneous use
V03AE01
POLYSTYRENE SULFONIC ACID
oral use
V03AF01
MESNA
intravenous, oral use
V03AF02
DEXRAZOXANE
intravenous use
V03AF03
FOLINIC ACID
intramuscular, intravenous use
V03AF07
RASBURICASE
intravenous use
V04C - Other diagnostic agents
V04CF01
TUBERCULIN
intradermal use
V09G - Cardiovascular system
V09GA04
ALBUMIN (Technetium, 99mTc)
intravenous use
V09GB02
ALBUMIN (Iodine, 125I)
intradermal, intratumoral, intravenous, subcutaneous use
V10X - Other therapeutic radiopharmaceuticals
V10XX03
RADIUM (223RA) DICHLORIDE
intravenous use
( 1 ) The Anatomical Therapeutic Chemical (ATC) code: a unique code assigned to a medicine according to the organ or system it works on and how it works. The classification system is maintained by the World Health Organization (WHO).
A statement has been made with regard to this Regulation and can be found in OJ C, C/2026/3337, 26.6.2026, ELI: http://data.europa.eu/eli/C/2026/3337/oj.
Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.
