This Practice Note gives a high-level overview of the designation of gatekeepers and the obligations with which they must comply under Regulation (EU) 2022/1925 on contestable and fair markets in the digital sector and amending Directive (EU) 2019/1937 and Directive (EU) 2020/1828 (EU Digital Markets Act or EU DMA), which entered into force on 1 November 2022 and which has applied since 2 May 2023. The EU DMA applies to online platforms that have been designated as having ‘gatekeeper status’. These are platforms that offer core platform services that provide a ‘gateway’ between business users and consumers for important digital services. The concern, addressed by the EU DMA, is that the position of such providers gives them the power to make their own private rules, with the potential to create bottlenecks within the digital economy. The EU DMA contains a series of obligations on ‘gatekeepers’: a set of dos and don’ts with which gatekeepers must comply. As a business user of such core platform services, it will be important to understand which

This Practice Note summarises Regulation (EU) 2022/2065 of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC, the EU Digital Services Act (EU DSA), published in the Official Journal of the EU (OJEU) on 27 October 2022 and applicable from 17 February 2024 (except for certain provisions applying to very large online platforms (VLOPs) and very large online search engines (VLOSEs) and other specific provisions which apply earlier). The EU DSA was intended, alongside the Digital Markets Act (EU DMA), to form a package of European legislation for the regulation of digital markets. The main aim of the EU DSA is to ‘keep users safe from illegal goods, content or services, and to protect their fundamental rights online’. This Practice Note provides details on the background, scope and enforcement of the EU DSA. It also sets out the key obligations and exemptions under the four-tiered system of the EU DSA. For information on the EU DMA, see Practice Notes: The

The Checklist considers which service providers Regulation (EU) 2022/2065, the EU Digital Services Act (EU DSA) applies to, outlines what they will need to do to comply with the key obligations of the Act, and notes some of the key concepts. The EU DSA entered into force on 16 November 2022. The deadline for the publication of the number of active monthly users was 17 February 2023. On 25 April 2023, the Commission has designated 17 Very Large Online Platforms (VLOPs) and two Very Large Online Search Engines (VLOSEs). The designated companies are required to comply, within four months of their designation, with obligations under the EU DSA (see: LNB News 25/04/2023 74). On 19 December 2023, the Commission designated three additional VLOPs (see: LNB News 20/12/2023 32). All other intermediary provider services had until 17 February 2024 to comply with their obligations when the majority of the EU DSA provisions came into effect. The list of VLOPs and VLOSEs is available here. For further information on the EU DSA, see Practice Notes: The EU Digital Services

This Practice Note provides a quick guide to Regulation (EU) 2022/2065, the EU Digital Services Act (EU DSA). It provides key information regarding the scope, the service categories, the four-tiered obligations model, the availability of exemptions and the enforcement regime. The EU DSA was published in the Official Journal of the EU on 27 October 2022, entered into force on 16 November 2022 and, for most providers, applied from 17 February 2024. It requires providers to address illegal content, goods and services online, and to protect users’ fundamental rights. It does not however impose general monitoring or active fact-finding obligations. The regime is asymmetric: all intermediary services are subject to baseline obligations, with additional duties for hosting services, online platforms and online search engines, and the most onerous requirements reserved for very large online platforms (VLOPs) and very large online search engines (VLOSEs). The EU DSA also preserves and clarifies the intermediary liability defences previously associated with Directive 2000/31/EC, the EU E-Commerce Directive. If you would like to check if and how the EU DSA

Directive (EU) 2022/2041 on adequate minimum wages in the EU, the EU Directive on Adequate Minimum Wages, is a key regulatory effort by the EU to ensure that all workers within its Member States receive fair and adequate minimum wages. What’s happening When Publication in the Official Journal of the EU 25 October 2022 Entry into force 14 November 2022 Transposition deadline 15 November 2024 To track the implementation of the Directive in the Member States, see the (Eur-lex website). Background, legal bases, and objectives of the Directive The main objective of EU Directive on Adequate Minimum Wages is to ensure that wages are adequate enough to allow all workers to enjoy a decent standard of living, while also addressing the growing issue of in-work poverty and reducing wage disparities across Member States. The Directive emphasises that wages should be regularly updated to account for economic conditions, inflation, and the cost of living. The issue concerning minimum

Background Financial conglomerates are large groups with significant activities in more than one financial sector (banking, investment and/or insurance). They tend to be complex in structure, operate across borders and the wider group can contain unregulated entities (from a financial legislation perspective) and entities not involved in financial services. The bancassurance model has traditionally been an important operating model for financial conglomerates in the EU. Bancassurers are groups which combine both banking and insurance business. Bancassurers are able to offer a full range of financial products in a one-stop shopping model—from traditional banking, through mutual funds to insurance products. For insurance companies, the bancassurance model offers new distribution channels with a stable customer base, while banks are able to diversify products and enhance their profitability by selling more products utilising the same infrastructure already in place and hence reducing operating fixed/overhead costs (economies of scale). One-stop-shopping in a bancassurance group provides customers with a variety of financial products, ranging from mortgages to life and non-life insurance. The Financial Conglomerates Directive (Directive 2002/87/EC) (FICOD)

Core prohibition Regulation (EU) 2024/3015 on prohibiting products made with forced labour on the Union market and amending Directive (EU) 2019/1937 (the EU Forced Labour Regulation or EU FLR) prohibits economic operators from placing products on the EU market, making products available on the EU market, and exporting products where such are products are made with forced labour. The prohibition imposed by the EU FLR applies in all 27 EU Member States. It is also intended to become applicable in the following, once the necessary procedures are complied with: • Iceland, Liechtenstein and Norway (as signatories of the Agreement on the European Economic Area), and • Northern Ireland (in accordance with the Windsor Framework) Timeline This table includes the key legislative steps leading to the adoption of the EU FLR. What’s happening When Publication of the Commission’s proposal (Proposed Regulation on prohibiting products

The General Data Protection Regulation, Regulation (EU) 2016/679 (EU GDPR) became applicable in the EEA on 25 May 2018. Life sciences companies often collect and/or use significant amounts of personal data, including health-related data, regarding individuals (or ‘data subjects’) such as, for example, patients and clinical trial subjects. Therefore, the importance of the EU GDPR for life sciences companies cannot be underestimated. This Practice Note gives an overview of aspects provided in the EU GDPR regime which affect life sciences companies and their businesses directly. This Practice Note does not provide a comprehensive discussion of the EU GDPR regime and should be read in conjunction with the following Practice Notes: Data protection principles, Processing personal data—standard of consent and Processing personal data—obtaining, recording and managing consent. For more information about the interplay between clinical trials and data protection, see Practice Note: Conducting clinical research—data protection implications. Note that this Practice Note considers provisions under the EU GDPR applicable in EEA

ARCHIVED: This Practice Note has been archived and is not maintained. STOP PRESS: The General Product Safety Directive (GPSD) has been repealed by Regulation (EU) 2023/988, also known as the General Product Safety Regulation (GPSR). For more information on the GPSR, see Practice Note: The EU General Product Safety Regulation. This Practice Note contains guidance regarding Directive 2001/95/EC also known as the General Product Safety Directive (GPSD). The GPSD requires producers to place on the market only products that are safe. It also requires Member States to conduct market surveillance activities in order to ensure that producers and distributors comply with their obligations. This Practice Note provides an overview of the objectives, scope and recent developments of the GPSD. It also describes the producer and distributor obligations under the Directive and analyses the assessment of product safety as well as the Rapid Alert System also known as the Safety Gate. This Practice Note is focused on EU law and does not include details on the transposition of the GPSD under

This Practice Note contains guidance regarding Regulation (EU) 2023/988 on general product safety also known as the EU General Product Safety Regulation (EU GPSR). The EU GPSR requires economic operators to place on the market only products that are safe. The EU GPSR, with effect from 13 December 2024, has repealed Directive 2001/95/EC, the EU General Product Safety Directive (EU GPSD). This Practice Note provides an overview of the objectives and scope of the EU GPSR. It describes the key obligations and analyses the assessment of product safety under the Regulation. It also covers the enforcement of the EU GPSR. This Practice Note does not cover product liability legislation. For more information on EU product liability, see Practice Note: The Revised EU Product Liability Directive. Background and objectives The EU GPSR aims to improve the functioning of the internal market, while ensuring the health and safety of consumers. It lays down essential rules on the safety of consumer products placed or made available on the market. The Regulation

The EU General Product Safety Regulation, Regulation (EU) 2023/988 starts to apply on 13 December 2024. This regulation replaces Directive 2001/95/EC (General Product Safety Directive) and Council Directive 87/357/EEC (Misleading Products Directive) and aims to ensure the safety of all non-food consumer products sold in the EU, both online and offline. The new rules address challenges posed by online sales and third-country imports, improve enforcement and recall procedures, and grant consumers the right to remedy for unsafe products. The regulation is expected to yield significant societal and consumer savings by reducing preventable damages from unsafe products.

This Practice Note examines the key provisions and what approaches businesses need to adopt to comply with the EU Geo-blocking Regulation (or Geoblocking Regulation), including: • background on geo-blocking and its effects • scope of the EU Geo-blocking Regulation • the prohibitions on unjustified geo-blocking • the prohibitions on applying different general conditions of access • the prohibitions on discrimination when taking payments • restrictions on passive sales • confirmation of certain key commercial matters the EU Geo-blocking Regulation does not impact • steps traders should take to comply with the EU Geo-blocking Regulation • enforcement • European Commission review of the EU Geo-blocking Regulation Key information EU Geo-blocking Regulation Title Regulation (EU) 2018/302 of the European Parliament and of the Council of 28 February 2018 on addressing unjustified geo-blocking and other forms of discrimination based on customers' nationality, place of residence or place of establishment within the internal market and amending Regulation (EC) No 2006/2004 and Regulation (EU) 2017/2394 and Directive 2009/22/EC (EU Geo-blocking Regulation) Amending —Regulations