Key information Offshore Oil and Gas Directive Title Directive 2013/30/EU of the European Parliament and of the Council of 12 June 2013 on safety of offshore oil and gas operations and amending Directive 2004/35/EC (Offshore Oil and Gas Directive) Entry into force 18 July 2013 (see Article 43 of Directive 2013/30/EU) Transposition deadline 19 July 2015 (see Article 41 of Directive 2013/30/EU) National transposition measures See Eur-Lex information on national transposition measures, as provided by Member States Amendments —Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action. Article 55 of Regulation (EU) 2018/1999 amended Article 25 of Directive 2013/30/EU, and the information referred to in its Annex IX, point 3, with effect from 1 January 2021 Subject Oil and gas operations; accidents prevention, energy projects Background and objectives Most oil and gas production in Europe takes place offshore. As of 2023, EU countries reported 313 installations in European waters.

Type of act, non-binding in nature, that the EU institutions can adopt to exercise the competences conferred upon them by the Treaties which is part of sub-set of acts usually known as EU soft law.

Orphan medicinal products (OMPs) are medicines used to prevent, diagnose or treat rare medical conditions and diseases. Given that the number of patients affected is very low, in the absence of incentives, pharmaceutical companies may be uncertain whether they could recover, through sales, the costs of research and development (R&D) of medical products to diagnose, prevent and treat these rare diseases. 'Rare' is defined in the relevant EU legislation as affecting less than five in 10,000 people in the EU. However, most rare diseases affect less than one in 100,000 people. Despite the low prevalence of individual rare diseases, they are of significant public health importance. There are estimated to be over 6,000 rare diseases, so while individually rare, collectively they represent a significant number of patients, amounting to approximately one in every 12 people in the EU (all rare diseases combined). Without incentives, it is often not commercially viable for pharmaceutical companies to develop and market OMPs, and only around 5% of rare diseases have an authorised treatment option. Based on

Key information EU ODS Regulation Title Regulation (EU) 2024/590 of the European Parliament and of the Council of 7 February 2024 on substances that deplete the ozone layer (EU ODS Regulation) Entry into force 11 March 2024, subject to the following exceptions:—Articles 16(1), (2) and (4)–(15), Article 17(5) and Annex VII, point 2 shall apply from 3 March 2025 for release for free circulation as referred to in Article 201 of Regulation (EU) 952/2013 and for all other import procedures and for export.Regulation (EC) 1005/2009 has been repealed with effect from 11 March 2024, subject to the following exceptions:—Article 18 as applicable on 10 March 2024 continued to apply up to 2 March 2025—Article 27 as applicable on 10 March 2024 continued to apply with regard to the reporting period from 1 January 2023 to 31 December 2023 Status Directly applicable (no transposition deadline) Subject Protection of the ozone layer; Climate action What are ozone-depleting substances? Ozone-depleting substances (ODS) are man-made chemicals

The PRIIPs Regulation and level 2 measures The purpose of this Practice Note is to provide an overview of PRIIPs Regulation (Regulation (EU) 1286/2014) on Packaged Retail and Insurance-based Investment Products (PRIIPs) and related Level 2 measures. At the core of the PRIIPs Regulation is a requirement for product manufacturers to produce a standardised, pre-investment Key Information Document (KID) for PRIIPs to help retail investors to compare different PRIIPs and make an informed decision on whether a PRIIP is right for them. The concept is not new, being largely derived from the undertakings for collective investment in transferable securities (UCITS) Key Investor Information Document (KIID). Regulation (EU) 1286/2014 was published in the Official Journal of the European Union (OJ) on 9 December 2014 and applied from 1 January 2018, although there is an exemption for UCITS until 31 December 2022. This exemption also applies to those non-UCITS retail funds which prepare a UCITS KIID (Article 32(2) of Regulation (EU) 1286/2014). This extended exemption (which originally

The European Commission has announced that Regulation (EU) 2025/40 (the Packaging and Packaging Waste Regulation (PPWR)) begins applying on 12 August 2026, introducing rules to: (1) tackle environmental challenges caused by packaging; (2) reduce Europe's dependence on imported fossil fuels and (3) support the EU's transition to a circular economy and climate neutrality by 2050. The key immediate measure restricts per- and polyfluoroalkyl substances (PFAS) in food-contact packaging, prohibiting products exceeding strict limits from the EU market. PFAS—referred to as 'forever chemicals' due to their persistence in the environment and human body—have been widely used in takeaway containers, fast-food wrappers, microwave popcorn bags and pizza boxes to repel water or grease. The restriction aims to protect human health and reduce the release of these harmful substances into the environment. The PPWR also harmonises definitions for extended producer responsibility and introduces marking requirements so packaging manufacturers or importers can be identified. Further obligations apply in phases: (1) a harmonised labelling system from 2028 and (2) the majority of measures from 2030, including packaging waste reduction limits, reuse targets, restrictions on small single-use plastic formats in hotels and restaurants, mandatory recycled plastic content in new packaging and a requirement that all packaging be recyclable.

Context and adoption High and constantly growing levels of packaging generation along with low levels of re-use and collection and poor recycling present significant barriers to achieving a low-carbon circular economy in the EU. Packaging uses high amounts of virgin materials and represents 36% of the EU’s municipal solid waste. According to the Commission, 40% of plastics and 50% of paper used in the EU is used in packaging. On 11 March 2020, the Commission adopted a new Circular Economy Action Plan. The Action Plan, which forms part of both the European Green Deal and the EU’s Industrial Strategy, introduced measures to make sustainable products the norm in the EU and ensure less waste. On 30 November 2022, pursuant to commitments in the Action Plan, the Commission adopted a proposal for a new regulation on packaging and packaging waste, to amend Regulation (EU) 2019/1020 (the Market Surveillance Regulation) and Directive (EU) 2019/904 (the Single Use Plastics Directive), and to repeal Directive 94/62/EC (the EU Packaging and Packaging Waste Directive). The resulting Regulation (EU)

Context and adoption High and constantly growing levels of packaging generation along with low levels of re-use and collection and poor recycling present significant barriers to achieving a low-carbon circular economy in the EU. Packaging uses high amounts of virgin materials and represents 36% of the EU’s municipal solid waste. According to the Commission, 40% of plastics and 50% of paper used in the EU is used in packaging. On 11 March 2020, the Commission adopted a new Circular Economy Action Plan. The Action Plan, which forms part of both the European Green Deal and the EU’s Industrial Strategy, introduced measures to make sustainable products the norm in the EU and ensure less waste. On 30 November 2022, pursuant to commitments in the Action Plan, the Commission adopted a proposal for a new regulation on packaging and packaging waste, to amend Regulation (EU) 2019/1020 (the Market Surveillance and Compliance of Products Regulation) and Directive (EU) 2019/904 (the EU Single Use Plastics Directive), and repeal Directive 94/62/EC (the EU Packaging and Packaging Waste Directive). The

ARCHIVED: This Practice Note has been archived and is not maintained. Objectives The EU Packaging and Packaging Waste Directive 94/62/EC (EU PPWD) aimed to harmonise national measures to prevent or reduce the impacts of packaging on the environment and to remove obstacles to trade and restrictions on competition. The focus of the EU PPWD is to prevent the production of packaging waste and to ensure that whatever packaging is necessary is adequately recycled and recovered to reduce the amount of waste. The EU PPWD is based on the concept of polluter pays and producer responsibility where those businesses responsible for production and manufacture of packaging are made to take responsibility for recycling and recovery to reduce waste levels. The EU PPWD is a New Approach directive, which means it sets down essential requirements (in Article 9) for Member States to adhere to, but leaves out the details for how to achieve these requirements. Article 10 of the EU PPWD empowers the Commission to promote the preparation of harmonised standards

Also produced in partnership with contributions from Marylis Clerc of Bird & Bird and Sapna Palla of White & Case LLP What are paediatric medicines and why do we need them? Paediatric medicines are medicinal products for use in children from birth until (but not including) the age of 18. In the past decades, little to no research and development into paediatric medicines took place. Many medicines were indeed not studied nor authorised for paediatric use, thereby forcing physicians to adapt dosage and form of medicinal products for the adult population based on their personal experience. It should not cause surprise that such large-scale off-label use entailed an increased risk of ineffective treatment and adverse reactions in children. A report from the European Medicines Agency (EMA) describes that while little data is available, harm did occur and was often underreported. There are several reasons for the lack of research and development of paediatric medicines, such as the fact that

Key information EU Paints Directive Title Directive 2004/42/EC of the European Parliament and of the Council of 21 April 2004 on the limitation of emissions of volatile organic compounds due to the use of organic solvents in certain paints and varnishes and vehicle refinishing products and amending Directive 1999/13/EC (the EU Paints Directive) Entry into force 30 April 2004 Transposition deadline 30 October 2005 National transposition See Eur-Lex information on national transposition measures as provided by Member States Key amendments —Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008, making amendments to reflect Regulation (EC) 1272/2008 on classification, labelling and packaging of substances and mixtures—transposition deadline: 1 April 2010; application date: 1 June 2010—Directive 2010/79/EU of 19 November 2010 on the adaptation to technical progress of Annex III to Directive 2004/42/EC of the European Parliament and of the Council on the limitation of emissions of volatile organic compounds—transposition deadline: 10 June 2012—Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June

Law360: The European Parliament approved a regulation to strengthen the EU’s protections from global steel overcapacity, cutting the tariff-free import quota by 47% while doubling the duty on imports beyond the quota to 50%, according to a news release on 19 May 2026.