Key information EU NEC Directive Title Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (NEC Directive) Entry into force 31 December 2016 Transposition deadlines 1 July 2018 (except for Article 10(2) on national emission inventories which had to be transposed by 15 February 2017) National transposition See Eur-Lex list of national transposition measures, as provided by Member States Amendments Commission Delegated Directive (EU) 2024/299 of 27 October 2023 amending Directive (EU) 2016/2284 of the European Parliament and of the Council on the methodology for the reporting of projected emissions of certain atmospheric pollutants. In force: 6 February 2024 Subject Air emissions; Air pollution Background International context The 1979 Convention on Long-range Transboundary Air Pollution (the LRTAP Convention) was the first international legally binding instrument to deal with problems of air pollution on a broad regional basis. It was created in

MLex: An Austrian vote to approve the EU’s controversial Nature Restoration Law today has triggered a legal dispute at the top of the country’s government, raising questions over whether the law can legally be adopted. Austria’s center-right chancellor says climate action minister Leonore Gewessler, a Green politician, wasn’t entitled to greenlight the law, and his spokesperson said EU judges would be asked to annul the move. Gewessler also faces a criminal complaint for abuse of office.

Background European Green Deal and the EU Biodiversity Strategy for 2030 The European Green Deal was launched in December 2019 as ‘a roadmap for making the EU’s economy sustainable by turning climate and environmental challenges into opportunities across all policy areas and making the transition just and inclusive for all’. As part of the European Green Deal, the Commission adopted the EU Biodiversity Strategy for 2030 on 20 May 2020. The key legislative proposal to emerge from the Biodiversity Strategy was that for the first EU-level ‘Nature Restoration Act’. The EU legal framework on biodiversity, up to 2024, was comprised primarily of the Habitats Directive (Directive 92/43/EEC), Birds Directive (Directive 2009/147/EC). and Water Framework Directive (Directive 2000/60/EC). Together these Directives impose obligations on Member States to take appropriate measures to maintain and restore natural habitats, wild animal and plant species, and water ecosystems and to protect them from deterioration. The new Nature Restoration Act was proposed with the aim of setting out concrete requirements and targets as to where and how such ‘appropriate measures’

Key information Nitrates Directive Title Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (Nitrates Directive) Entry into force 19 December 1991 Transposition deadline 19 December 1993 National transposition measures See Eur-Lex information on national transposition measures, as provided by Member States Amendments —Regulation (EC) 1882/2003 of the European Parliament and of the Council of 29 September 2003—Regulation (EC) 1137/2008 of the European Parliament and of the Council of 22 October 2008—Commission Directive (EU) 2026/288 of 9 February 2026. Transposition deadline of 2 March 2028Note that the amending Regulations were replaced by Regulation (EU) 182/2011 following the entry into force of the Lisbon Treaty. Therefore, the 2011 Regulation is in force with respect to the amendments to the Annexes. Subject Water pollution, agriculture, nitrates Purpose of the EU Nitrates Directive Nitrogen is a crucial nutrient that helps plants and crops grow, but high concentrations are harmful to people and nature. Nitrates and organic nitrogen compounds

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