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European Union › Risk Assessment › Regulatory Requirements

The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of... more +
The European Union is an economic and political partnership comprised of 27 nations within the Eurozone. The EU was established in 1948 to promote stability and cooperation among member states in the aftermath of WWII. The EU maintains a common currency as well as several intranational institutions, including the European Parliament and the European Commission. less -
Hogan Lovells

Who gets to see inside? The EU’s Operational Rules on Data Access under Article 40 of the DSA

Hogan Lovells on

The European Commission has adopted a Delegated Act under Article 40 of the DSA, creating a new framework for vetted researchers to access non-public data from Very Large Online Platforms and Very Large Search Engines. This...more

A&O Shearman

EBA publishes spring 2025 risk assessment report

A&O Shearman on

The European Banking Authority (EBA) has published its spring 2025 risk assessment report alongside a press release, outlining key developments and emerging risks within the European Union/European Economic Area (EU/EEA). The...more

Bergeson & Campbell, P.C.

Council of the EU and EP Agree on “One Substance, One Assessment” Legislative Package

Bergeson & Campbell, P.C. on

The Council of the European Union (EU) announced on June 12, 2025, that it reached a provisional agreement with the European Parliament (EP) on the “one substance, one assessment” (OSOA) legislative package, “which aims to...more

BakerHostetler

DSIR Deeper Dive: Artificial Intelligence - Banner Years (and Counting) for AI Guidance and Regulation

BakerHostetler on

The period of 2024-2025 was significant for AI law, regulation, and guidance, beginning in early February 2024, and the news told the tale...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

Bergeson & Campbell, P.C.

Registration Open until May 16, 2025, for Joint Regulatory Risk Assessors Summit on Advancing Safety and Sustainability Assessment...

Bergeson & Campbell, P.C. on

On June 19 to June 20, 2025, the European Union (EU) Horizon Europe projects ACCORDs, iCare, MACRAMÉ, and nanoPASS are hosting a joint summit to address the needs of industry and regulators in assessing the safety and...more

Bergeson & Campbell, P.C.

ECHA Will Propose EU-Wide Restrictions on Certain Hexavalent Chromium Substances

Bergeson & Campbell, P.C. on

The European Commission (EC) requested that the European Chemicals Agency (ECHA) assess the risks posed by certain hexavalent chromium substances. ECHA announced on April 29, 2025, that it has concluded that a European Union...more

Pillsbury Winthrop Shaw Pittman LLP

The EU’s Cyber Resilience Act: New Cybersecurity Requirements for Connected Products and Software

Pillsbury Winthrop Shaw Pittman LLP on

The CRA will affect a broad range of digital products placed on the EU market (including by those based outside the EU), including connected hardware/devices, software and remote data processing solutions. The EU has adopted...more

Bergeson & Campbell, P.C.

EUON Publishes Nanopinion on Enhancing the Regulatory Application of NAMs to Assess Nanomaterial Risks in the Food and Feed Sector

Bergeson & Campbell, P.C. on

On April 8, 2025, the European Union (EU) Observatory for Nanomaterials (EUON) published a Nanopinion entitled “A Qualification System to Accelerate Development and Regulatory Implementation of New Approach Methodologies...more

A&O Shearman

European Commission adopts RTS on the elements to assess when subcontracting certain ICT services under DORA

A&O Shearman on

The European Commission has adopted a Delegated Regulation supplementing Regulation 2022/2554 on digital operational resilience for the financial sector (DORA) with regard to regulatory technical standards specifying the...more

A&O Shearman

Zooming in on AI #18: Cybersecurity requirements for AI systems

A&O Shearman on

The Artificial Intelligence Act (AI Act) is the world's first comprehensive legal framework for AI regulation, which entered into force on August 1, 2024. The AI Act aims to ensure that AI systems are trustworthy, safe and...more

Ropes & Gray LLP

A Fleet of Omnibuses and Other Takeaways from Monday’s Responsible Business Alliance Conference on the CSDDD in Brussels

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On Monday, the Responsible Business Alliance hosted a stellar event in Brussels, Driving Effective Due Diligence: Omnibus Unpacked. This waitlisted, standing room-only event – co-hosted with the European People’s Party,...more

Latham & Watkins LLP

Kingdom of Saudi Arabia Issues New Data Transfer Risk Assessment Guidelines

Latham & Watkins LLP on

The guidelines specify the requirements for data controllers to conduct risk assessments related to the transfer or disclosure of personal data outside the Kingdom. ...more

J.S. Held

2025 J.S. Held Global Risk Report: Artificial Intelligence, Data & Digital Regulations

J.S. Held on

Artificial Intelligence (AI) has been touted as the answer to a multitude of business challenges. However, AI – along with machine learning and large language models (LLMs) – is still fraught with technical and regulatory...more

A&O Shearman

EBA consultation on amending data collection for 2026 benchmarking under CRD IV

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The European Banking Authority (EBA) has published a consultation paper containing draft implementing technical standards (ITS) on amending Commission Implementing Regulation (EU) 2016/2070 with regard to the benchmarking of...more

A&O Shearman

Regulatory monitoring: EU version Newsletter - February 2025

A&O Shearman on

1. Bank regulation - 1.1 PRUDENTIAL REGULATION - a) General - (i) International - BCBS: Work programme and strategic priorities for 2025/26 Status: Final - The BCBS has published its work programme and strategic...more

A&O Shearman

European Commission adopts Delegated Regulation on RTS on threat-led penetration testing under DORA

A&O Shearman on

The European Commission (EC) has adopted a Commission Delegated Regulation supplementing the Digital Operational Resilience Act (DORA) with regard to RTS specifying the criteria used for identifying financial entities...more

K&L Gates LLP

New EDPB Statement on Age Assurance: What You Need to Know

K&L Gates LLP on

On 11 February 2024, the European Data Protection Board (EDPB) adopted a new statement on age assurance. This statement, while not legally binding, will guide the enforcement of age-gating methods across the EU. Age assurance...more

A&O Shearman

European Commission rejects draft technical standards on sub-contracting ICT services under Digital Operational Resilience Act

A&O Shearman on

The European Commission has published a letter (dated 21 January 2025) addressed to the Joint Committee of the European Supervisory Authorities (ESAs) rejecting certain draft regulatory technical standards (RTS) the ESAs...more

A&O Shearman

European Supervisory Authorities approve terms of reference for new EU systemic cyber incidence co-ordination framework forum...

A&O Shearman on

The European Supervisory Authorities have published the terms of reference for the EU systemic cyber incident co-ordination framework Forum established under the EU Digital Operational Resilience Act. The Forum will be...more

Conyers

Regulatory & Risk Advisory Outlook 2025: Cayman Islands

Conyers on

2024 was once again an active year for the Cayman Islands regulatory industry. In this edition of our Regulatory & Risk Advisory Outlook, our team has summarised the key changes and news during 2024 and taken a look at the...more

DLA Piper

Navigating AI Liability Risks

DLA Piper on

Our webinar explored liability that can be incurred from the creation use or deployment of AI systems and raised some important questions around the current and future regulatory landscape applicable to AI and liability. We...more

A&O Shearman

Zooming in on AI – #4: What is the interplay between “Deployers” and “Providers” in the EU AI Act?

A&O Shearman on

One of the key aspects of the EU AI Act (“AI Act”)[1] is linked to the qualification of providers and deployers and the nuances which help distinguish between the two categories of stakeholders. What would this mean in...more

Skadden, Arps, Slate, Meagher & Flom LLP

AI Safety: The Role of the Board in Assessing and Managing AI Risk

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As AI systems become more complex, companies are increasingly exposed to reputational, financial and legal risk from developing and deploying AI systems that do not function as intended or that yield problematic outcomes. The...more

Littler

EU AI Act Will Formally Become Law and Provisions Will Start to Apply on a Staged Basis

Littler on

As previously discussed, in March the European Parliament approved the EU Artificial Intelligence Act (the “Act”), creating the world’s first comprehensive set of rules for artificial intelligence. On July 12, 2024, the Act...more

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