News & Analysis as of

European Commission Regulatory Requirements New Regulations

A&O Shearman

Delegated regulation on identifying reference data for OTC derivatives published in OJ

A&O Shearman on

Commission Delegated Regulation (EU) 2025/1003 has been published in the Official Journal of the European Union (OJ), supplementing the EU Markets in Financial Instruments Regulation (MiFIR) as regards over-the-counter...more

Mayer Brown

Country Classification, Updated FAQ and Guidance, Draft Delegated Regulation: EUDR Compliance Made Easier?

Mayer Brown on

On 22 May 2025, the European Commission (“Commission”) made public risk classification of countries under the EU Deforestation Regulation (“EUDR”)1 which assigned a low level of risk to 140 countries and high level of risk to...more

A&O Shearman

Consolidated Q&A on PRIIPs KID updated

A&O Shearman on

The Joint Committee of the European Supervisory Authorities (ESAs) has updated its consolidated Q&A on the EU packaged retail and insurance-based investment products (PRIIPs) key information document...more

A&O Shearman

EC adopts RTS on Market Abuse under MiCAR

A&O Shearman on

The European Commission (EC) has adopted a Delegated Regulation supplementing Regulation (EU) 2023/1114 on markets in cryptoassets (MiCAR), with regard to regulatory technical standards (RTS) specifying the arrangements,...more

Baker Botts L.L.P.

European Union Moves to Bolster its AI Infrastructure

Baker Botts L.L.P. on

Recently, the European Commission announced plans to advance Europe's position in the global AI race. Primarily, the Commission seeks to develop a 20 billion euro fund to build a network of AI gigafactories in Europe. This...more

Hogan Lovells

EU wholesale markets – EU Council adopts proposed EU Benchmarks Regulation amendments

Hogan Lovells on

The EU has adopted a regulation amending the EU Benchmarks Regulation. The amendments relate primarily to: reducing the population of benchmarks within scope of the Benchmarks Regulation; introducing a new spot FX-related...more

A&O Shearman

European Commission calls on Member States to fully transpose EU DORA Directive

A&O Shearman on

The European Commission (EC) has announced that it has opened infringement procedures by sending a letter of formal notice to 13 Member States (Belgium, Bulgaria, Denmark, Greece, Spain, France, Latvia, Lithuania, Malta,...more

WilmerHale

The EU Anti-Coercion Regulation: A New Tool Against Economic Pressure

WilmerHale on

As global economic pressures mount, the EU has armed itself with a powerful new tool to counter economic coercion. The EU Anti-Coercion Regulation (Regulation (EU) 2023/2675) has been fully in force for about a year...more

Goodwin

Regulatory Updates on Samsung’s Denosumab Biosimilars

Goodwin on

On February 13, 2025, the FDA approved Samsung Bioepis Co., Ltd.’s denosumab biosimilars, OSPOMYV™ (denosumab-dssb; 60 mg pre-filled syringe) and XBRYK™ (denosumab-dssb; 120 mg vial), referencing Amgen’s PROLIA® and XGEVA®,...more

Akin Gump Strauss Hauer & Feld LLP

EU Forced Labour Regulation Is Now Adopted: What Does It Mean?

On 12 December 2024, the Regulation (EU) 2024/3015 on prohibiting products made with forced labour on the Union market and amending Directive (EU) 2019/1937 (the Regulation) was published in the European Union (EU) Official...more

Skadden, Arps, Slate, Meagher & Flom LLP

Preparing for the EU Corporate Sustainability Due Diligence Directive

What is the EU Corporate Sustainability Due Diligence Directive? The Corporate Sustainability Due Diligence Directive (CS3D) is a pivotal European Union directive that mandates human rights and environmental due diligence...more

Mayer Brown

New EU Cyber Rules (NIS2) Take Effect; Implementing Rules Adopted

Mayer Brown on

On 17 October 2024, the European Commission adopted the first Implementing Regulation under the Network and Information Security 2 Directive (EU) 2022/2555 (NIS2), focusing on digital infrastructures and services. The...more

BCLP

Commission's First Decision Under the Foreign Subsidies Regulation Authorising a Concentration Subject to Conditions

BCLP on

On 24 September 2024, the European Commission adopted its first decision under the Foreign Subsidies Regulation (“FSR”)....more

Jenner & Block

Client Alert: Corporate Sustainability Due Diligence Directive: Five Key Questions Answered

Jenner & Block on

On April 24, 2024, the European Parliament approved the Corporate Sustainability Due Diligence Directive (CS3D). The directive, which must be formally endorsed by the Council of the European Union (EU) before officially...more

White & Case LLP

European Commission proposes measures to up the ante on EU FDI screening

White & Case LLP on

Foreign direct investment ("FDI") screening was one of the major topics of 2023 as a myriad of new regimes joined the FDI club and its more seasoned members continue to strengthen scope and enforcement, with the impacts felt...more

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