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Der Gemeinsame Bundesausschuss ist eine juristische Person des öffentlichen Rechts nach § 91 SGB V. Er wird gebildet von: Deutsche Krankenhausgesellschaft, Berlin.GKV Spitzenverband, Berlin . Kassenärztliche Bundesvereinigung, Berlin. Kassenzahnärztliche Bundesvereinigung, Köln Aufforderung zum Vorschlag geeigneter digitaler medizinischer Anwendungen: Disease-Management-Programm (DMP) Asthma bronchiale Sehr geehrte Damen und Herren, gemäß § 137f Absatz 8 Satz 1 SGB V prüft der Gemeinsame Bundesausschuss (G-BA) bei der Erstfassung einer Richtlinie zu den Anforderungen nach § 137f Absatz 2 SGB V (DMP) sowie bei jeder regelmäßigen Überprüfung seiner Richtlinien nach § 137f Absatz 2 Satz 6 SGB V die Aufnahme geeigneter digitaler medizinischer Anwendungen. Der Unterausschuss DMP hat mit der Aktualisierung der Anforderungen an das DMP Asthma bronchiale begonnen. In diesem Zusammenhang ist gemäß 6. Kapitel Verfahrensordnung (VerfO) des G-BA auch die medizinisch-inhaltliche Prüfung auf Eignung digitaler medizinscher Anwendungen zur Aufnahme in das jeweilige DMP durch den G-BA vorgesehen. Insbesondere im 6. Kapitel § 4 Absatz 2 Nummer 5 VerfO ist das Nähere zum Verfahren und zum Inhalt der Prüfung der Eignung digitaler medizinischer Anwendungen gemäß § 137f Absatz 8 Satz 1 SGB V beschrieben (https://www.g-ba.de/richtlinien/42/). Vor diesem Hintergrund werden Sie gebeten, für die Indikation Asthma bronchiale geeignete digitale medizinische Anwendungen vorzuschlagen. Sofern Sie Vorschläge machen wollen, bitten wir Sie, die im 6. Kapitel § 4 Absatz 2 unter Nummer 5 VerfO genannten Kriterien mit entsprechenden Nachweisen transparent zu belegen. Die Aufforderung soll dazu dienen, dem G- BA frühzeitig geeignete digitale medizinische Anwendungen zur Kenntnis zu geben, damit er den Prüfauftrag gemäß § 137f Absatz 8 Satz 1 SGB V umsetzen kann. Bitte beachten Sie, dass mit dieser Aufforderung zum Vorschlag geeigneter digitaler medizinischer Anwendungen nicht die gemäß § 137f Abs. 8 Satz 2 und Abs. 2 Satz 5 SGB V vorgesehenen Stellungnahmeverfahren durchgeführt werden. Es findet somit keine entsprechende schriftliche Auswertung oder mündliche Anhörung statt. Die Durchführung des An die Organisationen gemäß §§ 91 Abs. 5, Abs. 5a und 137f Abs. 2 Satz 5 und Abs. 8 Satz 2 SGB V sowie entsprechend 137f Abs. 8 Satz 2 SGB V gemäß Verteiler Gemeinsamer Bundesausschuss, Postfach 12 06 06, 10596 Berlin gemäß § 91 SGB V Unterausschuss Disease Management Programme Besuchsadresse: Gutenbergstr. 13 10587 Berlin Ansprechpartner/in: Abteilung Qualitätssicherung und sektorenübergreifende Versorgungskonzepte Telefon: 030 275838-547 Telefax: 030 275838505 E-Mail: dmp@g-ba.de Internet: www.g-ba.de Unser Zeichen: Wör Datum: 06.08.2026 https://www.g-ba.de/richtlinien/42/ 2 gesetzlichen Stellungnahmeverfahrens erfolgt zu einem späteren Zeitpunkt vor dem Abschluss der Beratungen zum DMP Asthma bronchiale. Die Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) wird gebeten, dieses Schreiben an die jeweils einschlägigen wissenschaftlichen Fachgesellschaften mit der Bitte um Vorschläge für geeignete digitale medizinische Anwendungen weiterzuleiten und der Geschäftsstelle des Gemeinsamen Bundesausschusses unverzüglich nach Weiterleitung das Datum der Weiterleitung sowie die ausgewählten Fachgesellschaften mitzuteilen. Die Auswahl hat keine Wirkung für das zu einem späteren Zeitpunkt folgende gesetzlich vorgeschriebene Stellungnahmeverfahren. Wir bitten um Ihre Vorschläge für geeignete digitale medizinische Anwendungen unter Berücksichtigung der im 6. Kapitel § 4 Absatz 2 unter Nr. 5 VerfO genannten Kriterien innerhalb einer Frist von vier Wochen bis einschließlich 3. September 2026 per E-Mail an das Postfach dmp@g-ba.de. Zudem bitten wir, soweit bekannt, um Angaben zum Namen und zur Anschrift des Herstellers der vorgeschlagenen digitalen medizinischen Anwendung. Eine Weiterleitung dieses Schreibens an die betroffenen Hersteller ist ausdrücklich gestattet, sofern dies von Ihnen als Organisation gemäß § 137f Absatz 8 Satz 2 und Absatz 2 Satz 5 SGB V als notwendig zur Bereitstellung der geforderten Unterlagen erachtet wird. Wir weisen Sie auf die Möglichkeit der Veröffentlichung der von Ihnen zur Verfügung gestellten Informationen auf den Internetseiten des G-BA hin. Bitte stellen Sie deshalb sicher, dass diese keine personenbezogenen Daten oder Betriebs- und Geschäftsgeheimnisse beinhalten. Insoweit weisen wir Sie ausdrücklich darauf hin, dass ansonsten etwaige in Ihrer Antwort enthaltene personenbezogene Daten oder Betriebs- und Geschäftsgeheimnisse in dieser verbleiben und damit ebenfalls auf den Internetseiten des G-BA veröffentlicht werden können. Sofern Sie beim Hersteller ergänzende Auskünfte einholen, weisen Sie bitte auch diesen darauf hin. Im Übrigen bleiben die Vertraulichkeitspflichten bestehen. Für Rückfragen stehen wir Ihnen gerne zur Verfügung. Mit freundlichen Grüßen gez. i. A. Dr. Markus Wörz Referent Abteilung Qualitätssicherung und sektorenübergreifende Versorgungskonzepte (QS-V) Anlage: Verteiler mailto:dmp@g-ba.de

BERLIN Friedrichstraße 134 10117 Berlin T. 030 | 308 75 96 - 0 F. 030 | 308 75 96 - 111 BONN Ubierstraße 71–73 53173 Bonn T. 0228 | 957 45 - 0 F. 0228 | 957 45 - 90 Pharma Deutschland e. V. info@pharmadeutschland.de www.pharmadeutschland.de BRÜSSEL Rue Marie de Bourgogne 58 1000 Brüssel T. +49-170-6133687 1 PHARMA DEUTSCHLAND Feedback to the European Commission Proposal for a European Biotech Act I (Health) Strengthening Europe's Biotechnology Ecosystem through a Future-Oriented Regulatory Framework 05/08/2026 Executive Summary Pharma Deutschland welcomes the European Commission's proposal for a European Biotech Act as a landmark initiative to strengthen Europe's competitiveness in biotechnology and biomanufacturing. The proposal rightly recognises biotechnology as a strategic sector for Europe's health security, economic resilience and technological sovereignty. It also acknowledges that Europe must become a more attractive location for research, clinical development and manufacturing if it wishes to remain competitive with global innovation hubs. The proposed legislation introduces several important measures that will contribute to this objective, including the acceleration of clinical trial procedures, the establishment of regulatory sandboxes, improved coordination between regulatory authorities and stronger support for strategic biotechnology projects. Pharma Deutschland strongly supports these objectives. However, achieving the full potential of the Biotech Act requires that the legislation goes beyond creating new structures. It should fundamentally reduce regulatory complexity, improve legal certainty and establish a coherent European innovation framework across the entire biotechnology value chain. In particular, Pharma Deutschland recommends that the final legislation should:  further simplify and accelerate multinational clinical trials across the European Union;  strengthen the Clinical Trials Information System (CTIS) as the central digital platform for clinical research; 2  establish a clear and proportionate regulatory framework for the use of Artificial Intelligence throughout the medicinal product lifecycle;  ensure seamless interaction between the Biotech Act, the European Health Data Space (EHDS), the AI Act and the revised pharmaceutical legislation;  provide greater legal certainty regarding supplementary protection certificates (SPCs);  strengthen regulatory sandboxes as permanent instruments for regulatory learning and innovation;  improve coordination between newly established governance structures and existing European regulatory authorities;  promote investment in European biomanufacturing, including innovative biologics and biosimilars, through a predictable and innovation-friendly regulatory framework. Europe already possesses world-class scientific excellence. The challenge is no longer generating innovation but successfully translating scientific discoveries into products that reach patients and global markets. The Biotech Act should therefore become a cornerstone of a modern European life sciences strategy that enables research, attracts investment and accelerates patient access to innovative therapies. General Remarks Pharma Deutschland welcomes the Commission's ambition to establish Europe as the world's leading biotechnology location by the end of this decade. The Biotech Act represents an important opportunity to strengthen Europe's innovation ecosystem and to improve the Union's long-term competitiveness in health biotechnology. These objectives fully reflect the increasing strategic importance of biotechnology for public health, industrial resilience and economic growth. The proposal appropriately recognises that biotechnology has become a key enabling technology across modern healthcare. Beyond innovative biological medicines, biotechnology increasingly shapes advanced therapies, vaccine development, precision medicine, diagnostics and digital drug development. Consequently, the regulatory framework governing biotechnology must evolve at the same pace as scientific progress. Pharma Deutschland particularly welcomes that the Biotech Act adopts a broad perspective on health biotechnology and combines measures addressing research, regulation, manufacturing, digitalisation and investment. This integrated approach reflects the reality that Europe's competitiveness depends on the interaction of these different policy areas rather than isolated legislative initiatives. At the same time, Europe continues to face structural disadvantages compared with other global innovation regions. Clinical development remains slower than in competing jurisdictions, regulatory 3 requirements are frequently fragmented, access to capital remains challenging for innovative companies, and manufacturing investments increasingly migrate outside Europe. The Biotech Act therefore should not merely introduce additional governance mechanisms. It should establish a genuinely innovation-oriented regulatory environment that reduces administrative complexity, increases predictability and enables faster translation of scientific discoveries into clinical applications. From Pharma Deutschland's perspective, five overarching principles should guide the final legislation. First, regulatory procedures should become significantly faster and more predictable. While maintaining Europe's high standards for quality, safety and scientific assessment, unnecessary administrative complexity should be eliminated wherever possible. Accelerating innovation requires not only shorter legal timelines but also simpler regulatory pathways and better coordination between authorities. Second, digitalisation should become a core principle of biotechnology regulation. Modern clinical research, regulatory submissions, data exchange and manufacturing increasingly rely on digital infrastructures. The Biotech Act should therefore actively promote fully digital regulatory processes and facilitate the use of innovative technologies throughout the product lifecycle. Third, the legislation should create an enabling environment for responsible innovation in Artificial Intelligence. AI has the potential to fundamentally transform drug discovery, clinical development, manufacturing and regulatory science. The regulatory framework should encourage this transformation while ensuring appropriate oversight through science-based regulation. Fourth, Europe requires a coherent legislative framework across the rapidly evolving life sciences landscape. The implementation of the Biotech Act should be closely coordinated with the revised EU pharmaceutical legislation, the AI Act, the European Health Data Space and other relevant horizontal legislation. Overlapping obligations, inconsistent requirements and regulatory duplication should be avoided. Finally, the Biotech Act should strengthen Europe's attractiveness for investment throughout the biotechnology value chain. Regulatory excellence is increasingly becoming a decisive factor in global investment decisions. Predictable legislation, efficient procedures and legal certainty are therefore essential preconditions for maintaining research, development and manufacturing activities within the European Union. Taken together, these principles provide an opportunity to position Europe not only as a global leader in scientific research but also as the preferred location for translating biotechnology innovation into products that benefit patients worldwide. 4 Accelerating Clinical Research in Europe One of the most important contributions of the Biotech Act is its proposed revision of the Clinical Trials Regulation. Faster and more efficient clinical development is essential if Europe is to regain its position as one of the world's leading regions for pharmaceutical innovation. Pharma Deutschland therefore strongly supports the Commission's objective of reducing unnecessary administrative delays while maintaining the high scientific and ethical standards that characterise the European regulatory system. The proposed shortening of assessment timelines for multinational clinical trials represents a significant improvement. In particular, Pharma Deutschland welcomes the reduction of validation periods, shorter assessment timelines for initial applications and substantial modifications, the strengthened role of the Reporting Member State, the possibility to submit parallel substantial modifications, and the improved coordination between scientific and ethical assessments. Together, these measures have the potential to significantly improve the efficiency and predictability of multinational clinical research in Europe. Further ambition on timelines While the proposed timelines constitute a major step forward, Europe should continue to pursue the objective of becoming the most attractive region globally for conducting multinational clinical trials. Pharma Deutschland believes that further reductions in assessment timelines should be considered where operationally feasible, provided that scientific quality and patient safety are fully maintained. At the same time, accelerated procedures must remain realistic for both sponsors and competent authorities. Certain deadlines proposed in the draft legislation may prove too restrictive in practice. In particular, the proposed 7-day deadline for responding to complex requests relating to substantial modifications appears challenging for scientifically complex amendments. Unrealistically short timelines may inadvertently lead to unnecessary refusals, additional requests for clarification or repeated submissions, thereby delaying rather than accelerating clinical development. Recommendation Pharma Deutschland recommends reconsidering the proposed 7-day timelines introduced through the amendments to Articles 18(6), 22(1) and 22(3) of Regulation (EU) No 536/2014, as these may not be operationally feasible for complex substantial modifications. Slightly longer but realistic procedural deadlines would better support efficient assessments while avoiding unnecessary refusals and re-submissions. Pharma Deutschland recommends reviewing the further proposed procedural timelines to ensure that they remain both ambitious and practically achievable. A balanced approach should seek to accelerate assessments while maintaining robust scientific review and reducing unnecessary administrative burden. 5 Further opportunities to simplify multinational clinical trials Beyond legislative timelines, the Biotech Act should further simplify the practical conduct of multinational clinical trials. In particular, the Commission should consider:  allowing core dossier changes and trial-specific modifications to be assessed in parallel through a coordinated procedure, thereby reducing unnecessary sequential assessments;  enabling sponsors to engage with concerned Member States during the assessment process to resolve outstanding issues before a formal refusal becomes necessary;  facilitating the establishment of EU-wide recognised lists of qualified investigational sites and principal investigators, thereby reducing repetitive administrative verification for each individual trial. These pragmatic measures would complement the proposed legislative amendments and contribute to a more efficient and predictable regulatory framework for clinical research across the Union. Towards greater harmonisation of ethics assessments Although the Clinical Trials Regulation has substantially harmonised the authorisation process, ethics assessments continue to be organised at national level and remain highly heterogeneous across Member States. Pharma Deutschland recognises that the organisation of ethics committees falls largely within Member State competence. Nevertheless, the Biotech Act provides an opportunity to promote greater convergence through non-legislative measures. The Commission should therefore support the development of common guidance, best practices and coordinated methodologies for ethics assessments in multinational clinical trials. Greater alignment of review procedures, timelines and governance would complement the objectives of the Clinical Trials Regulation and further strengthen Europe's attractiveness as a location for clinical research. Beyond legislative timelines, further improvements are necessary to fully realise the Commission's objective of making Europe a globally competitive location for clinical research. First, the Clinical Trials Information System (CTIS) should become a truly user-centred digital platform. Although CTIS represents an important step towards harmonised European clinical trial management, practical experience demonstrates that significant improvements in usability, workflow design and system performance remain necessary. A modern digital infrastructure should reduce administrative workload rather than create additional complexity. Continuous investment in user experience and functionality should therefore accompany the legislative reforms. Second, the Biotech Act should further promote fully digital clinical trial processes. Electronic informed consent (eConsent), digital documentation, electronic signatures and remote regulatory interactions should become standard practice wherever scientifically and ethically appropriate. Digitalisation has the potential not only to reduce administrative burden but also to improve patient participation and facilitate multinational research. 6 Third, the legislation should encourage greater use of risk-based and remote inspections where appropriate. Modern digital technologies enable secure access to documentation and quality systems while reducing unnecessary administrative effort for both sponsors and authorities. Finally, Europe should continue moving towards a genuinely integrated clinical research environment. While the proposed legislative amendments significantly strengthen coordination between Member States, further harmonisation of regulatory practices, scientific interpretations and administrative implementation will remain essential for achieving a truly European clinical trial ecosystem. Artificial Intelligence and Health Data as Enablers of Biotechnology Artificial Intelligence is rapidly becoming one of the key drivers of innovation throughout the pharmaceutical lifecycle. AI has the potential to accelerate target identification, optimise clinical trial design, improve manufacturing processes, strengthen pharmacovigilance and support regulatory decision-making. The European Biotech Act therefore provides an important opportunity to establish a regulatory framework that enables the responsible use of AI while maintaining Europe's high standards for safety and scientific excellence. Pharma Deutschland welcomes the Commission's intention to promote the use of Artificial Intelligence within health biotechnology. However, the final legislation should provide greater legal certainty regarding the interaction between the Biotech Act, the AI Act and existing pharmaceutical legislation. Avoiding overlapping regulatory requirements AI systems that are developed and validated as part of the medicinal product lifecycle should not be subject to unnecessary parallel regulatory assessments. Where AI-supported methodologies are evaluated within established pharmaceutical regulatory procedures, the scientific assessment performed by competent medicines authorities should remain the primary regulatory pathway. Duplicate conformity assessments under horizontal legislation should be avoided wherever equivalent scientific requirements are already fulfilled. The Biotech Act should therefore explicitly promote regulatory coherence between sector-specific pharmaceutical legislation and the AI Act, thereby reducing unnecessary administrative burden while maintaining an appropriate level of oversight. Regulatory acceptance of innovative AI methodologies The increasing use of AI creates opportunities to modernise regulatory science itself. The Commission should therefore encourage the development of European regulatory guidance on innovative AI-supported methodologies, including:  AI-assisted drug discovery;  Digital Twins; 7  AI-generated clinical endpoints;  synthetic control arms;  model-informed drug development;  AI-supported manufacturing and quality assurance. Providing early scientific guidance in these areas would increase regulatory predictability and encourage investment in innovative development approaches within Europe. In particular, Pharma Deutschland supports empowering the European Medicines Agency to further develop scientific guidance on the regulatory acceptance of AI-generated evidence where scientifically appropriate. Such guidance would facilitate innovation while ensuring that scientific standards remain fully preserved. AI-ready regulatory infrastructure Innovation in AI requires not only legal certainty but also adequate digital infrastructure. The Health Biotechnology Clusters envisaged by the Biotech Act should therefore become centres of excellence for computational biotechnology by facilitating access to high-performance computing resources, particularly for SMEs, start-ups and academic spin-offs. Access to advanced computing capacity remains a decisive factor for many AI-driven biotechnology projects and should be considered an integral component of Europe's competitiveness strategy. Recommendations Pharma Deutschland recommends that the final Regulation should:  explicitly establish the principle of sector-specific primary regulation, ensuring that AI systems scientifically evaluated within pharmaceutical legislation are not subject to duplicative conformity assessments under the AI Act;  strengthen Articles 39 and 40 by establishing dedicated AI regulatory sandboxes covering Digital Twins, AI-generated clinical endpoints and other AI-enabled development methodologies;  explicitly empower the European Medicines Agency under Article 28 to develop scientific guidance on AI-generated evidence, including synthetic control arms and AI-supported clinical development;  strengthen European high-performance computing infrastructure for biotechnology innovators, particularly SMEs and start-ups. 8 Unlocking the Potential of European Health Data Europe possesses one of the world's most valuable health data ecosystems. The successful implementation of the European Health Data Space (EHDS) creates a unique opportunity to strengthen biomedical research, accelerate innovation and improve regulatory science. Pharma Deutschland strongly welcomes the close interaction between the Biotech Act and the EHDS. Both initiatives should be implemented as complementary elements of a coherent European Life Sciences Strategy rather than as separate legislative initiatives. Facilitating secondary use of health data Secure and trustworthy secondary use of health data will become an essential driver of pharmaceutical innovation. The Biotech Act should therefore actively facilitate access to high-quality, anonymised and harmonised health datasets for research and innovation purposes, while fully respecting the European framework for data protection and patient privacy. Predictable and harmonised access procedures across Member States will be essential for enabling multinational research projects and AI development. Legal certainty for clinical research The proposed clarification of the interaction between the Clinical Trials Regulation and the General Data Protection Regulation represents a significant step towards greater legal certainty. Pharma Deutschland welcomes the proposed clarification of the legal basis for processing personal data in clinical trials as well as the harmonised interpretation of the responsibilities of sponsors and investigators under the GDPR. These amendments have the potential to substantially reduce divergent national interpretations that currently create unnecessary legal uncertainty for multinational clinical research. The final legislation should preserve this harmonised European approach and avoid introducing additional national requirements that could undermine the objective of a truly integrated European research area. Data access for strategic biotechnology projects Strategic biotechnology projects supported under the Biotech Act should benefit from efficient and predictable access to European health data infrastructures. This is particularly important for research into rare diseases, personalised medicine, advanced therapies and AI-supported drug development, where robust datasets are essential for scientific progress. The Commission should therefore ensure that the implementation of the Biotech Act and the EHDS remains closely coordinated in order to maximise the value of European health data for research, innovation and public health. 9 Recommendations Pharma Deutschland recommends that the final Regulation should:  ensure seamless interoperability between the Biotech Act and the European Health Data Space;  facilitate timely access to harmonised, anonymised health datasets for Strategic Biotechnology Projects;  maintain the proposed amendments to Article 93 CTR clarifying the legal basis for processing personal data and the responsibilities of sponsors and investigators under the GDPR;  explicitly facilitate the secondary use of clinical trial data for scientific research without creating additional consent requirements beyond those already established under EU legislation. Regulatory Sandboxes as Drivers of Innovation Pharma Deutschland strongly supports the Commission's proposal to establish regulatory sandboxes as a permanent instrument for fostering innovation in biotechnology. Regulatory sandboxes have the potential to significantly accelerate the development and regulatory acceptance of emerging technologies by enabling innovators and regulators to collaborate at an early stage of development under clearly defined conditions. They also provide valuable opportunities for regulatory learning, allowing competent authorities to adapt regulatory approaches in parallel with scientific progress. To maximise their effectiveness, the Biotech Act should establish a harmonised European framework for regulatory sandboxes that ensures consistent implementation across Member States. Participation criteria, governance structures and evaluation procedures should be transparent and predictable, allowing companies of all sizes—including SMEs, start-ups and academic innovators— to benefit from these initiatives. In addition, regulatory sandboxes should explicitly support the validation of novel scientific methodologies, including AI-supported development tools, Digital Twins, advanced manufacturing technologies and innovative clinical trial methodologies. Finally, experience gained within regulatory sandboxes should systematically contribute to future regulatory guidance and legislative development. The Biotech Act should therefore establish clear mechanisms through which lessons learned from sandbox projects can inform the continuous evolution of European pharmaceutical regulation. 10 Recommendations Pharma Deutschland recommends that the final Regulation should:  establish a harmonised European governance framework for regulatory sandboxes;  encourage cross-border participation by innovators and competent authorities;  ensure that experience gained within regulatory sandboxes systematically informs future guidance and legislative development;  explicitly include AI-supported development, Digital Twins and advanced manufacturing technologies among the priority areas eligible for participation. Strategic biotechnology projects The Biotech Act rightly recognises that biotechnology manufacturing is a strategic asset for Europe's health security, economic resilience and global competitiveness. Maintaining and expanding manufacturing capacity within the European Union is essential not only for innovation but also for ensuring secure supply chains, rapid response capabilities and long-term strategic autonomy. Pharma Deutschland strongly supports the Commission's objective of strengthening European biomanufacturing. However, regulatory simplification alone will not be sufficient to attract long-term investment. Companies make investment decisions based on the overall predictability of the regulatory environment, the speed of regulatory procedures and the availability of a coherent European innovation ecosystem. The Biotech Act should therefore establish a framework that creates confidence for long-term investments across the entire biotechnology value chain—from early research and clinical development to commercial manufacturing. The proposed framework for High-Impact Strategic Projects represents an important opportunity to accelerate Europe's biotechnology capabilities. Pharma Deutschland welcomes the intention to prioritise projects with significant societal and economic impact, particularly those contributing to innovative medicines, advanced therapies, vaccine development, biomanufacturing and preparedness for future health emergencies. To maximise the effectiveness of this instrument, the designation of Strategic Projects should provide tangible regulatory advantages. Projects receiving this designation should benefit from:  accelerated regulatory procedures;  coordinated scientific advice across relevant EU authorities;  prioritised interactions with competent authorities; 11  simplified administrative requirements where appropriate;  predictable timelines throughout development. The designation should represent more than a political label; it should deliver measurable regulatory benefits that encourage companies to locate strategic biotechnology investments within the European Union. A predictable regulatory environment for investment Global competition for biotechnology investment is intensifying. While Europe continues to produce world-leading scientific research, many innovative companies increasingly choose to conduct late-stage development, scale-up manufacturing or commercialisation outside the Union. The Biotech Act should therefore contribute to improving Europe's attractiveness by providing a stable, predictable and innovation-friendly regulatory framework. Regulatory predictability should become a strategic objective in itself. Frequent legislative changes, overlapping requirements and inconsistent implementation across policy areas create uncertainty that discourages investment. The Commission should therefore ensure that future implementing measures under the Biotech Act remain proportionate, science-based and developed in close dialogue with stakeholders. Strengthening Europe's Biosimilar Ecosystem The Biotech Act rightly recognises that Europe's biotechnology ecosystem encompasses both innovative biological medicines and biosimilars. A competitive European biosimilar sector contributes significantly to resilient supply chains, strategic autonomy, sustainable healthcare systems and timely patient access to biological therapies. Pharma Deutschland therefore welcomes the recognition of biosimilars within the scope of the Biotech Act. Measures designed to strengthen European biotechnology and biomanufacturing should explicitly benefit both innovative biologics and biosimilars, recognising their complementary contribution to Europe's life sciences ecosystem. While the European Medicines Agency provides a single scientific assessment for biosimilars across the Union, important elements affecting market uptake continue to differ considerably between Member States. Divergent approaches to interchangeability, substitution and procurement create fragmentation within the internal market and may weaken incentives for investment in European biosimilar development and manufacturing. Although these issues remain largely within Member State competence, the Biotech Act should promote greater regulatory convergence by encouraging the exchange of best practices and supporting the consistent implementation of the EMA's scientific conclusions across the Union. 12 A stronger and more harmonised European framework for biosimilars would contribute not only to patient access but also to Europe's competitiveness, resilience and long-term security of supply. Effective Governance and Regulatory Coherence The Biotech Act introduces several new governance structures designed to strengthen coordination across the European biotechnology ecosystem. Pharma Deutschland welcomes these initiatives and recognises their potential to improve strategic foresight and regulatory cooperation. In particular, the establishment of the Foresight Panel for Emerging Health Innovation and the EU Health Biotechnology Support Network can make an important contribution to identifying emerging technologies, supporting innovators and improving regulatory preparedness. However, the creation of additional governance bodies should not increase institutional complexity. Clear responsibilities The final legislation should clearly define the respective roles of all newly established bodies and ensure close coordination with existing European institutions, particularly:  the European Medicines Agency (EMA);  the European Commission;  relevant scientific expert groups;  existing coordination mechanisms established under pharmaceutical legislation. Companies should experience a coherent regulatory landscape rather than multiple overlapping interfaces. A coordinated European innovation ecosystem The Biotech Act should actively strengthen coordination across European legislation affecting biotechnology. In particular, implementation should be closely aligned with:  the revised EU pharmaceutical legislation;  the AI Act;  the European Health Data Space;  relevant data legislation;  legislation governing advanced therapies and clinical research. Avoiding inconsistent requirements across these legislative instruments will reduce regulatory burden and increase legal certainty for innovators. 13 Continuous regulatory dialogue Scientific innovation develops considerably faster than legislation. Pharma Deutschland therefore encourages the Commission to strengthen mechanisms for continuous dialogue between regulators, industry, academia and patients throughout the implementation of the Biotech Act. Beyond formal scientific advice procedures, the newly established governance structures should facilitate ongoing exchanges on emerging technologies, novel development methodologies and evolving regulatory needs. Such continuous interaction would improve regulatory learning while increasing Europe's responsiveness to scientific progress. Recommendations Pharma Deutschland recommends that the final Regulation should:  clarify the respective responsibilities of the newly established governance bodies under Articles 37 and 39 and their interaction with existing European agencies, particularly the European Medicines Agency;  avoid overlapping mandates and administrative duplication;  establish mechanisms for continuous dialogue between regulators, industry, academia and patients throughout implementation of the Biotech Act. Supplementary Protection Certificates (SPCs) Pharma Deutschland welcomes the Commission's intention to strengthen incentives for biotechnology innovation through the proposed extension of Supplementary Protection Certificates (SPCs). Appropriate intellectual property incentives remain essential for maintaining Europe's competitiveness in research-intensive biotechnology sectors. However, the proposed eligibility criteria require further clarification to ensure legal certainty and practical applicability. Clarifying the eligibility criteria The proposal requires that the medicinal product contains a new active substance that is "distinctly different" from previously authorised products. The concept of "distinctly different" is currently undefined and introduces significant legal uncertainty. European pharmaceutical legislation has traditionally relied on clearly established concepts such as novelty and new active substance status. Introducing an undefined qualitative threshold risks 14 inconsistent interpretation across Member States and could reduce the predictability of the proposed incentive. Pharma Deutschland therefore recommends replacing this terminology with objective and legally established criteria. Removing unnecessary cumulative requirements The proposal additionally requires that the medicinal product demonstrates both:  a distinctly different active substance; and  a distinctly different mechanism of action. The rationale for requiring both criteria cumulatively remains unclear. Many important biotechnology innovations are based on new molecular approaches while acting on established biological pathways. Such innovations can provide substantial therapeutic benefits without necessarily fulfilling both conditions simultaneously. The Commission should therefore reconsider whether both cumulative requirements are necessary to achieve the intended policy objectives. Practical feasibility of comparative evidence The proposal further requires demonstration that the medicinal product is at least equally safe and effective compared with all authorised medicinal products for the same indication. In practice, this requirement is unlikely to be feasible. Clinical development programmes are designed around predefined comparators and do not generate direct comparative evidence against every authorised treatment available within the Union. Maintaining this requirement could therefore unintentionally exclude genuinely innovative products from the incentive scheme. Pharma Deutschland recommends revising this provision to ensure that eligibility criteria remain scientifically robust while reflecting established principles of pharmaceutical development. Recommendations Pharma Deutschland recommends that Article 27(1) (and the corresponding provisions in Article 59 for veterinary medicinal products) be amended as follows:  Article 27(1)(a): Replace the undefined criterion "distinctly different" with legally established terminology, in order to ensure legal certainty, consistent interpretation and predictable application across the Union.  Article 27(1)(b): Reconsider the cumulative requirement that an eligible medicinal product must demonstrate both a distinctly different mechanism of action and at least equivalent safety and efficacy compared with authorised medicinal products. The current 15 formulation risks excluding important incremental and platform innovations that provide significant clinical value.  Article 27(1)(b): Revise the requirement to demonstrate safety and efficacy in comparison with any authorised medicinal product in the Union for the same disease, as such comparative evidence is generally not generated during pharmaceutical development programmes and is therefore unlikely to be feasible in practice. A more proportionate criterion aligned with established regulatory principles would provide greater legal certainty while preserving the intended innovation incentive.  Article 27(1)(c): Clarify the requirement that clinical trials must be conducted in more than two Member States. The Regulation should specify whether this refers to pivotal clinical trials only or to the overall clinical development programme, in order to avoid legal uncertainty during implementation.  Article 27(1)(d): Clarify the definition of "at least one manufacturing step" performed within the Union. More precise guidance on the qualifying manufacturing activities would improve predictability for investment decisions and reduce divergent interpretation across Member States. Concluding Remarks Pharma Deutschland strongly supports the objectives of the European Biotech Act and welcomes the Commission's ambition to strengthen Europe's biotechnology ecosystem. The proposal represents an important opportunity to improve Europe's competitiveness across research, clinical development, manufacturing and regulatory science. At the same time, the final legislation should ensure that these ambitions translate into practical improvements for innovators operating within the European regulatory framework. To maximise its impact, the Biotech Act should:  further simplify and accelerate clinical research across the European Union;  establish a coherent framework for the responsible use of Artificial Intelligence in biotechnology;  strengthen the interaction with the European Health Data Space;  create effective and harmonised regulatory sandboxes;  provide meaningful regulatory incentives for Strategic Biotechnology Projects;  improve coordination between newly established governance structures and existing European institutions;  ensure legal certainty regarding Supplementary Protection Certificates; 16  maintain coherence with the revised pharmaceutical legislation and other horizontal EU legislation. The Biotech Act has the potential to become a cornerstone of Europe's future life sciences strategy. By combining scientific excellence with a predictable, innovation-friendly regulatory framework, the European Union can strengthen its global competitiveness while ensuring that patients gain faster access to innovative therapies.

Bundesinstitut für Arzneimittel und Medizinprodukte Bekanntmachung zum Homöopathischen Arzneibuch 20261 Vom 21. Juli 2026 1. Die Regeln des Arzneibuchs werden nach § 55 Absatz 2 und 6 des Arzneimittelgesetzes (AMG) von der Euro- päischen Arzneibuch-Kommission oder der Deutschen Arzneibuch-Kommission oder der Deutschen Homöopathi- schen Arzneibuch-Kommission beschlossen. 2. Die von der Deutschen Homöopathischen Arzneibuch-Kommission im Jahr 2026 beschlossenen Monographien des Homöopathischen Arzneibuchs werden hiermit nach § 55 Absatz 7 AMG im Bundesanzeiger bekannt gemacht. Die Bekanntmachung erfolgt gemäß § 55 Absatz 1 AMG, gegebenenfalls in Verbindung mit § 63 Tierarzneimittelgesetz, im Einvernehmen mit dem Bundesamt für Verbraucherschutz und Lebensmittelsicherheit und dem Paul-Ehrlich- Institut. Gemäß § 55 Absatz 7 Satz 2 AMG beschränkt sich die Bekanntmachung darauf, die Titel der Monographien in der Anlage zu veröffentlichen. Das Homöopathische Arzneibuch in der geltenden Fassung wird wie folgt geän- dert: a) Die in der Anlage in Abschnitt A genannten Monographien werden in revidierter Fassung aufgenommen. b) Die in der Anlage in Abschnitt B genannte Monographie wird gestrichen. c) Die in der Anlage in Abschnitt C genannte Monographie wird infolge der Bezugnahme auf die Vorschriften des Europäischen Arzneibuchs (Ph. Eur.), 11. Ausgabe, Amtliche deutsche Ausgabe, in einer gekürzten Fassung aufgenommen. 3. Das nach Maßgabe dieser Bekanntmachung geänderte und neu gefasste Homöopathische Arzneibuch gilt ab dem 1. Oktober 2026. Die Neufassung trägt die Bezeichnung „Homöopathisches Arzneibuch 2026 (HAB 2026)“. 4. Das Homöopathische Arzneibuch 2026 kann beim Deutschen Apotheker Verlag bezogen werden. 5. Für Arzneimittel, die sich am 1. Oktober 2026 im Verkehr befinden und die den Anforderungen des HAB 2026 nicht genügen oder nicht nach dessen Vorschriften hergestellt, geprüft oder bezeichnet worden sind, aber den am 30. September 2026 geltenden Vorschriften entsprechen, findet diese Bekanntmachung erst ab dem 1. April 2027 Anwendung. 6. Hinweis: Für Ausgangsstoffe zur Herstellung von Arzneimitteln sind alle einschlägigen Vorschriften des Europäischen Arz- neibuchs, Deutschen Arzneibuchs und Homöopathischen Arzneibuchs sowie jeweils geltende, gegebenenfalls aktuellere und weitergehende Vorschriften über die Verwendung bestimmter Stoffe zur Vermeidung des Risikos der Übertragung transmissibler spongiformer Enzephalopathien durch Arzneimittel zu beachten. Bonn, den 21. Juli 2026 Bundesinstitut für Arzneimittel und Medizinprodukte Der Präsident Prof. Dr. Bro ich 1 Notifiziert gemäß der Richtlinie (EU) 2015/1535 des Europäischen Parlaments und des Rates vom 9. September 2015 über ein Informationsverfahren auf dem Gebiet der technischen Vorschriften und der Vorschriften für die Dienste der Informationsgesellschaft (ABl. L 241 vom 17.9.2015, S. 1) Bekanntmachung Veröffentlicht am Dienstag, 4. August 2026 BAnz AT 04.08.2026 B8 Seite 1 von 2 Anlage A. Die folgenden Monographien werden in revidierter Fassung aufgenommen: Artemisia absinthium ex herba siccata, ethanol. Infusum (Absinthium, ethanol. Infusum) Artemisia vulgaris Carbo animalis Citrullus colocynthis (Colocynthis) Hamamelis virginiana, ethanol. Decoctum (Hamamelis, ethanol. Decoctum) Homalolepsis cedron (Simarouba cedron, Cedron) Magnesium chloratum Plantago major (Plantago) Strychninum nitricum Symphytum officinale (Symphytum) Teucrium marum (Marum verum) B. Die folgende Monographie wird gestrichen: Capsella bursa-pastoris, ethanol. Infusum (Capsella, ethanol. Infusum) C. Die folgende Monographie wird infolge der Bezugnahme auf die Vorschriften des Ph. Eur., 11. Ausgabe, Amtliche deutsche Ausgabe, in einer gekürzten oder geänderten Fassung aufgenommen: Iberis amara Bekanntmachung Veröffentlicht am Dienstag, 4. August 2026 BAnz AT 04.08.2026 B8 Seite 2 von 2 Bundesanzeiger Verlag GmbH 2026-08-04T08:03:58+0200 Bundesanzeiger Verlag GmbH

Der Gemeinsame Bundesausschuss ist eine juristische Person des öffentlichen Rechts nach § 91 SGB V. Er wird gebildet von: Deutsche Krankenhausgesellschaft, Berlin.GKV Spitzenverband, Berlin . Kassenärztliche Bundesvereinigung, Berlin. Kassenzahnärztliche Bundesvereinigung, Köln Aufforderung zum Vorschlag geeigneter digitaler medizinischer Anwendungen: Disease-Management-Programm (DMP) Brustkrebs Sehr geehrte Damen und Herren, gemäß § 137f Absatz 8 Satz 1 SGB V prüft der Gemeinsame Bundesausschuss (G-BA) bei der Erstfassung einer Richtlinie zu den Anforderungen nach § 137f Absatz 2 SGB V (DMP) sowie bei jeder regelmäßigen Überprüfung seiner Richtlinien nach § 137f Absatz 2 Satz 6 SGB V die Aufnahme geeigneter digitaler medizinischer Anwendungen. Der Unterausschuss DMP hat mit der Aktualisierung der Anforderungen an das DMP Brustkrebs begonnen. In diesem Zusammenhang ist gemäß 6. Kapitel Verfahrensordnung (VerfO) des G-BA auch die medizinisch-inhaltliche Prüfung auf Eignung digitaler medizinscher Anwendungen zur Aufnahme in das jeweilige DMP durch den G-BA vorgesehen. Insbesondere im 6. Kapitel § 4 Absatz 2 Nummer 5 VerfO ist das Nähere zum Verfahren und zum Inhalt der Prüfung der Eignung digitaler medizinischer Anwendungen gemäß § 137f Absatz 8 Satz 1 SGB V beschrieben (https://www.g-ba.de/richtlinien/42/). Vor diesem Hintergrund werden Sie gebeten, für die Indikation Brustkrebs geeignete digitale medizinische Anwendungen vorzuschlagen. Sofern Sie Vorschläge machen wollen, bitten wir Sie, die im 6. Kapitel § 4 Absatz 2 unter Nummer 5 VerfO genannten Kriterien mit entsprechenden Nachweisen transparent zu belegen. Die Aufforderung soll dazu dienen, dem G-BA frühzeitig geeignete digitale medizinische Anwendungen zur Kenntnis zu geben, damit er den Prüfauftrag gemäß § 137f Absatz 8 Satz 1 SGB V umsetzen kann. Bitte beachten Sie, dass mit dieser Aufforderung zum Vorschlag geeigneter digitaler medizinischer Anwendungen nicht die gemäß § 137f Abs. 8 Satz 2 und Abs. 2 Satz 5 SGB V vorgesehenen Stellungnahmeverfahren durchgeführt werden. Es findet somit keine entsprechende schriftliche Auswertung oder mündliche Anhörung statt. Die Durchführung des An die Organisationen gemäß §§ 91 Abs. 5, Abs. 5a und 137f Abs. 2 Satz 5 und Abs. 8 Satz 2 SGB V sowie entsprechend 137f Abs. 8 Satz 2 SGB V gemäß Verteiler Gemeinsamer Bundesausschuss, Postfach 12 06 06, 10596 Berlin gemäß § 91 SGB V Unterausschuss Disease Management Programme Besuchsadresse: Gutenbergstr. 13 10587 Berlin Ansprechpartner/in: Abteilung Qualitätssicherung und sektorenübergreifende Versorgungskonzepte Telefon: 030 275838-547 Telefax: 030 275838505 E-Mail: dmp@g-ba.de Internet: www.g-ba.de Unser Zeichen: Luc Datum: 04.08.2026 https://www.g-ba.de/richtlinien/42/ 2 gesetzlichen Stellungnahmeverfahrens erfolgt zu einem späteren Zeitpunkt vor dem Abschluss der Beratungen zum DMP Brustkrebs. Die Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) wird gebeten, dieses Schreiben an die jeweils einschlägigen wissenschaftlichen Fachgesellschaften mit der Bitte um Vorschläge für geeignete digitale medizinische Anwendungen weiterzuleiten und der Geschäftsstelle des Gemeinsamen Bundesausschusses unverzüglich nach Weiterleitung das Datum der Weiterleitung sowie die ausgewählten Fachgesellschaften mitzuteilen. Die Auswahl hat keine Wirkung für das zu einem späteren Zeitpunkt folgende gesetzlich vorgeschriebene Stellungnahmeverfahren. Wir bitten um Ihre Vorschläge für geeignete digitale medizinische Anwendungen unter Berücksichtigung der im 6. Kapitel § 4 Absatz 2 unter Nr. 5 VerfO genannten Kriterien innerhalb einer Frist von vier Wochen bis einschließlich 1. September 2026 per E-Mail an das Postfach dmp@g-ba.de. Zudem bitten wir, soweit bekannt, um Angaben zum Namen und zur Anschrift des Herstellers der vorgeschlagenen digitalen medizinischen Anwendung. Eine Weiterleitung dieses Schreibens an die betroffenen Hersteller ist ausdrücklich gestattet, sofern dies von Ihnen als Organisation gemäß § 137f Absatz 8 Satz 2 und Absatz 2 Satz 5 SGB V als notwendig zur Bereitstellung der geforderten Unterlagen erachtet wird. Wir weisen Sie auf die Möglichkeit der Veröffentlichung der von Ihnen zur Verfügung gestellten Informationen auf den Internetseiten des G-BA hin. Bitte stellen Sie deshalb sicher, dass diese keine personenbezogenen Daten oder Betriebs- und Geschäftsgeheimnisse beinhalten. Insoweit weisen wir Sie ausdrücklich darauf hin, dass ansonsten etwaige in Ihrer Antwort enthaltene personenbezogene Daten oder Betriebs- und Geschäftsgeheimnisse in dieser verbleiben und damit ebenfalls auf den Internetseiten des G-BA veröffentlicht werden können. Sofern Sie beim Hersteller ergänzende Auskünfte einholen, weisen Sie bitte auch diesen darauf hin. Im Übrigen bleiben die Vertraulichkeitspflichten bestehen. Für Rückfragen stehen wir Ihnen gerne zur Verfügung. Mit freundlichen Grüßen gez. i. A. Monika Luchtenberg Referentin Abteilung Qualitätssicherung und sektorenübergreifende Versorgungskonzepte (QS-V) Anlage: Verteiler mailto:dmp@g-ba.de

DG ENV, Unit B01 August 2026 Packaging and Packaging Waste Regulation (PPWR) Frequently Asked Questions EUROPEAN COMMISSION Directorate-General for Environment Directorate ENV.B — Competitive Circular Economy & Clean Industrial Policy Unit ENV.B.1 — Bioeconomy & Sustainable Materials Contact: Unit B.1 E-mail: ENV-B01-ARES@ec.europa.eu European Commission B-1049 Brussels EUROPEAN COMMISSION Packaging and Packaging Waste Regulation (PPWR) Frequently Asked Questions Directorate-General for Environment 2026 Manuscript first completed in March 2026 and updated in August 2026. 2ND edition This document has been prepared for the European Commission however it reflects the views only of the authors, and the European Commission is not liable for any consequence stemming from the reuse of this publication. It is intended to assist economic operators, national authorities and citizens in the application of the PPWR. Luxembourg: Publications Office of the European Union, 2026 © European Union, 2026 The reuse policy of European Commission documents is implemented by Commission Decision 2011/833/EU of 12 December 2011 on the reuse of Commission documents (OJ L 330, 14.12.2011, p. 39). Unless otherwise noted, the reuse of this document is authorised under a Creative Commons Attribution 4.0 International (CC BY 4.0) licence (https://creativecommons.org/licenses/by/4.0/). This means that reuse is allowed provided appropriate credit is given and any changes are indicated. For any use or reproduction of elements that are not owned by the European Union, permission may need to be sought directly from the respective rightholders. PDF ISBN 978-92-68-42316-5 doi: 10.2779/4868962 KH-01-26-068-EN-N 2 Table of Contents I. INTRODUCTION ON THE SUBJECT MATTER AND SCOPE .................................................. 5 II. DEFINITIONS ................................................................................................................................ 7 III. SUBSTANCES OF CONCERN ................................................................................................... 15 IV. RECYCLABILITY ....................................................................................................................... 21 V. RECYCLED CONTENT IN PLASTIC PACKAGING ................................................................. 25 VI. COMPOSTABILITY .................................................................................................................... 29 VII. PACKAGING MINIMISATION ................................................................................................. 30 VIII. LABELLING ................................................................................................................................. 33 IX. ENVIRONMENTAL CLAIMS .................................................................................................... 34 X. OBLIGATIONS OF MANUFACTURERS ..................................................................................... 35 XI. EMPTY SPACE ............................................................................................................................ 42 XII. BANS AND THE USE OF CERTAIN PACKAGING ................................................................ 43 XIII. REUSE AND REFILL .................................................................................................................. 46 XIV. PLASTIC CARRIER BAGS ........................................................................................................ 51 XV. ASSESSMENT OF THE CONFORMITY OF PACKAGING .................................................. 52 XVI. ENFORCEMENT OF THE NEW RULES (IMMEDIATELY AFTER THE APPLICATION DATE OF 12 AUGUST 2026) ........................................................................................ 56 XVII. WASTE PREVENTION .......................................................................................................... 57 XVIII. EXTENDED PRODUCER RESPONSIBILITY ................................................................... 59 XIX. RETURN AND COLLECTION SYSTEMS ............................................................................... 62 XX. DEPOSIT AND RETURN SYSTEMS ........................................................................................ 63 3 Abbreviations CMO: Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products DfR: Design for recycling DRS: Deposit and Return System DSA: Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market for Digital Services ECHA: European Chemicals Agency EO: Economic Operator EPR: Extended Producer Responsibility EPS: Expanded Polystyrene ESPR: Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of eco-design requirements for sustainable products FCM: Food-contact material, as regulated under Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food FIBC: Flexible Intermediate Bulk Container FIC: HoReCa: Regulation (EU) No 1169/2011 on the provision of food information to consumers. Hotel, Restaurant and Catering IBC: Intermediate bulk containers JRC: Joint Research Centre NACE: Statistical classification of economic activities / classification of economic activities in the European Union (EU) OJEU: Official Journal of the European Union PFAS: Per-and polyfluoroalkyl substances PPWD: European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste PPWR: Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste PRO: Producer Responsible Organisation REACH: Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency SoC: Substances of Concern 4 SUPD: Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment TRIS: Procedure under Directive 2015/1535 to prevent creating barriers in the internal market WFD: Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste XPS: Extruded Polystyrene 5 I. INTRODUCTION ON THE SUBJECT MATTER AND SCOPE This is the second version of this document. It includes new and updated information as compared to the first version published in March 2026. Changes made since the first version are marked as ‘NEW’ or ‘UPDATED’ as appropriate throughout the document. Regulation (EU) 2025/401 establishes a harmonised legal framework for packaging and packaging waste across the European Union. Its primary objective is to ensure the smooth functioning of the internal market while significantly reducing the environmental and health impacts associated with packaging throughout its life cycle. By replacing Directive 94/62/EC2, this regulation introduces clearer, stricter, and more uniform requirements for all economic operators and Member States, fostering a transition towards a circular economy. The scope of the Regulation is comprehensive. It applies to all packaging placed on the EU market, whether empty or filled, regardless of the material used, and whether produced within the Union or imported from third countries. It also covers all packaging waste generated within the EU. Packaging is defined broadly, as any item intended for containment, protection, handling, delivery, or presentation of products, including its components. However, items that form an integral part of a product and are disposed of together with it are excluded. Through these provisions, Regulation (EU) 2025/40 seeks to harmonise national measures on packaging, prevent market fragmentation, and promote sustainable practices. It introduces obligations such as recyclability and reuse targets, restrictions on hazardous substances, and requirements for eco-friendly design and labelling. In doing so, it not only addresses pressing environmental challenges but also creates a level playing field for businesses operating across multiple Member States. The PPWR entered into force on 11 February 2025, and its general application date is 12 August 2026, but certain provisions apply later (e.g., recyclability, recycled content targets, packaging bans and reuse targets by 2030). Some of the main provisions of the PPWR are: - Waste Prevention Targets: 5% by 2030, 10% by 2035, 15% by 2040 (compared to 2018 levels) (Article 43). - Recyclability: All packaging must be recyclable in an economically viable way by 2030 (Article 6). - Reuse Targets: For transport, e-commerce, and beverage packaging (Article 29). - Restrictions: Ban on certain single-use formats from 1 January 2030 (Article 25 and Annex V); compliance with PFAS in food contact packaging from 12 August2026 (Article 5(5)). - Empty Space threshold: Max 50% for grouped, transport, and e-commerce packaging (Article 24). - Mandatory Deposit-Return Systems: For beverage cans and plastic bottles (Article 50). - Labelling: Harmonised sorting labels for all packaging (Article 12(1)). (1) Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (OJ L, 2025/40, 22.1.2025). (2) European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365 31.12.1994, p. 10). 6 - Extended Producer Responsibility (EPR): Strengthened obligations for producers (Articles 44–47). This document clarifies some issues and answers questions that have been received by DG Environment since the adoption of the Regulation. This document complements the Commission Notice - Guidance document for Regulation 2025/40 (EU) on packaging and packaging waste (hereinafter ‘Commission guidance document’). 7 II. DEFINITIONS Definition of packaging 1) Does the wording packaging ‘…whether empty or with a product…’ modify the definitions of packaging and of manufacturer under the PPWR? Article 3(1), point (1), contains a definition of packaging, which remained largely unchanged compared to the packaging definition in the Directive 94/62/EC. However, the new definition contains the new wording ‘…whether empty or with a product…’. This new wording does not modify the definition of packaging or the definition of manufacturer but is intended to cover all different factual situations and types of packaging that come within the scope of the PPWR. For further information on the packaging definition, please consult the Commission guidance document. 2) Why does the definition of packaging for tea and coffee mention ‘machine use’ only in point (g) and not in point (f) of Article 3(1)? The wording indicates the difference between systems for filter coffee/tea bags and those for coffee extraction machines. Machine use is one of the key criteria to decide if a tea/coffee capsule falls under Article 3(1), point (1)(f), or point (1)(g). Permeability is another element that needs to be considered. This distinction is important in relation to the compostability requirements in Article 9. Permeable tea, coffee or other beverage bags, or soft after-use system single-serve units that contain tea, coffee or another beverage, which are intended to be used and disposed of together with the product (point (1)(f)), are mandatorily compostable. Non-permeable tea, coffee or other beverage system singleserve units intended for use in a machine, and which are used and disposed of together with the product (point (1)(g)) are not. However, Member States may decide to make the latter mandatorily compostable on their territories, under certain conditions, such as the existence of an appropriate collection and waste treatment infrastructure for bio-waste. Member States cannot ban or require compostability as regards metal capsules. 3) Are envelopes containing letters, invoices, statements and other correspondence which serve a communication function considered to be packaging under the PPWR? NEW! Whether an item qualifies as packaging must be assessed based on the definition of packaging set out in Article 3(1), point (1). Furthermore, Annex I to the Regulation provides an indicative list of items that are considered packaging and items that are not. Packaging is defined in Article 3(1) of the PPWR as “an item, irrespective of the materials from which it is made, that is intended to be used by an economic operator for the containment, protection, handling, delivery or presentation of products to another economic operator or to an end user, and that can be differentiated by packaging format based on its function, material and design…” Letters, invoices, statements and other correspondence which serve a communication function are not to be considered products for the purposes of the definition of packaging in the PPWR. Envelopes that contain these documents are not intended for “the containment, protection, handling, delivery or presentation of products”. 8 This is to be contrasted with empty envelopes which are intended for the containment, protection, handling, delivery or presentation of products, as well as envelopes that contain a product (such as a catalogue or magazine), both of which are to be considered packaging. Lastly, empty envelopes that are sold in a supermarket to consumers for private use are not considered to be packaging. 4) What is the difference between sales, grouped and transport packaging? NEW! Sales, grouped, and transport packaging are defined separately in the PPWR, based on their intended use. They are also subject to different requirements in the PPWR. Sales packaging (Article 3(1), point (5)) is the packaging that, together with the product, forms a unit intended for sale to an end user. Sales packaging is often in direct contact with the product and adapted to a specific product based on its special needs and characteristics. Sales packaging is also typically used for the branding of the product and for consumer information. Grouped packaging (Article 3(1), point (6)) is packaging that bundles several sales units (packaged products). It often displays the name of the specific product and can be removed without changing the characteristics of the product. Its purpose is typically adapted to the individual product, such as facilitating stockkeeping or shelf display, or enabling or encouraging consumers to buy more than one product. It varies whether it is sold with the product or not, and for this reason, grouped packaging may be disposed of either in a commercial setting or at the consumer’s premises. Transport packaging (Article 3(1), point (7)) forms the outer layer of packaged products and is used during transport of sales units. It often contains information about logistics, transport and storage. Transport packaging prevents damage to packaged products and facilitates handling, and it is therefore often more standardized, bigger in size and sturdier than sales and grouped packaging, and disposed of in a commercial or industrial setting. However, e-commerce packaging (Article 3(1), point (8)), which is a special form of transport packaging used for distance sales to ‘end users’, will often be disposed of at the consumer’s premises. Definition of ‘manufacturer’ 5) Who is the manufacturer of transport packaging? NEW! Following the definition of packaging (Article 3(1), point 1), transport packaging should be considered packaging when it is manufactured and placed on the market with the intention of being used for ‘[..] the containment, protection, handling, delivery or presentation of products [..]’. The manufacturer of transport packaging must therefore be identified at the stage where the empty packaging has reached its final form. A packaging has reached its final form when it can be used as transport packaging without any further components or ancillary elements added to it. In that respect, it is important to clearly distinguish a combination of packaging items used for transport, handling or sale of products from a genuine assembly or transformation operation of the packaging, such as on-site moulding of materials or the creation of a packaging item from components which in itself do not perform a packaging function. The use of multiple packaging items (tape, wrap, boxes, pallets etc.) together does not mean that each item is not already in its final form. Indeed, there can be packaging from multiple manufacturers in one shipment of packaged products, and each manufacturer must provide the 9 necessary technical documentation and information to demonstrate conformity with the applicable requirements for the EU declaration of conformity when they place the packaging on the market. As is also the case for sales, grouped, service and primary production packaging, if the transport packaging does not bear a name or trademark, then the decisive criterion to establish who the manufacturer is will be who places the order and decides on the design specifications for that packaging. For unbranded, generic transport packaging, this company would normally be the company who physically manufacturers the packaging. If the transport packaging is wearing a name or trademark, the company whose name or trademark is on the packaging is manufacturer. See further in the Commission guidance for the PPWR, point 2. Below are two examples of who the manufacturer of transport packaging is: • A cardboard box has reached its final form even if it is flat and requires folding. If the box has a name or trademark on it, the company carrying the name or owning the trademark will be the ‘manufacturer’. For unbranded, standardised cardboard boxes, the company that physically manufactures the boxes will be ‘manufacturer’. If a company adds a sticker on the box for shipment purposes, it is not considered to be branding, and this company should not be considered ‘manufacturer’. • Stretch wrap for stabilisation of packaged products on pallets should be considered packaging when it is sold on a roll, even if it is subsequently cut to wrap pallet loads. The ‘manufacturer’ is the company that physically manufactures the wrap and places it on the market as packaging, if it is unbranded, rather than the company that purchases the wrap and subsequently uses it to secure goods. 6) Who is the ‘manufacturer’ of branded packaging? NEW! According to the PPWR (Article 3(1), point (12)), if a packaging does not bear a name or trademark, the manufacturer will be the natural or legal person who manufactures packaging or packaged products. Where a natural or legal person has packaging or a packaged product designed or manufactured under its own name or trademark, that person is to be considered the manufacturer. This is regardless of whether another trademark is displayed on the packaging or packaged product. If a packaging bears a name or trademark, the manufacturer is the economic operator under whose name or trademark the packaging is placed on the market, even where another operator may physically carry out the manufacturing or filling. However, if this economic operator is a micro- enterprise, and if the supplier is located in the same Member State, the supplier of the packaging or packaged product will be manufacturer. The Commission guidance for the PPWR, point 2 explains that: ‘If the packaging or packaged product carries a certain name or trademark, it can be assumed that the owner of that name or trademark is the ‘manufacturer’ [..], as it will have the decisive power in the contractual relation with its suppliers and will therefore be able to determine also the packaging characteristics’. The company which commissions another company to manufacture packaging or packaged products under its name or trademark is in a position to determine the characteristics of the packaging, including the branding of packaging which could influence the packaging’s conformity assessment. This is also the case when an economic operator simply chooses a standardised packaging option and does not ask for changes to the design and the production process. 10 7) Who is the ‘manufacturer’ if a packaged product bears a name of one company and a trademark of another company? NEW! A name or trademark on a packaging holds equal weight in terms of the status of manufacturer under the PPWR (Article 3(1), point (12)). Therefore, if one company manufactures, markets and distributes products under its own name, for example as the responsible food business operator, but under the trademark of another company, the status of manufacturer applies to the company which determines the packaging design and specifications. For example, if the licensor, who is the trademark owner, specifies that the product placed on the market under their trademark must be in a specified packaging design to ensure that the packaging used for their products are identical in Member States, or globally, the trademark owner will be considered the manufacturer. However, licensors whose trademark may appear on packaging, but who do not determine the characteristics of the packaging, should not be considered to be the manufacturer. A case-by-case assessment, based on the contractual agreement between the two companies whose name and trademark are on the packaging, would therefore be necessary to establish who has the decisive power. Definition of ‘producer’ 8) Is a farmer producer for the purpose of EPR obligations? Whether a farmer is a ‘producer’ will depend on the specific situation. There is no general exemption for specific sectors such as farmers in terms of extended producer responsibility obligations since all economic operators making packaging available on the territory of a Member State for the first time will have to comply with these obligations. The following examples show some typical examples of when a farmer would normally be considered a producer and when it would not. • If a farmer packs a few apples in a container (sales packaging) and sells it under its own name or trademark to a retailer or consumer in the same Member State, the farmer is a producer. • If the farmer sells the packed apples under its own name or trademark in another Member State, the farmer is only the producer if the recipient is the end user of the apples. This means that the farmer is not the producer if it sells the apples to a retailer in another Member State. • If the farmer is a micro-enterprise, which is often the case, and the supplier of the apple container is established in the same Member State, such supplier becomes the producer in the Member State where the farmer and supplier are located. • If the container is produced under the name or trademark of an agricultural cooperative of which the farmer is part, then this cooperative, and not the individual farmer, is the producer. • If the farmer delivers apples in bulk in large containers (transport packaging) to a agricultural cooperation, who then packs the apples into containers (sales packaging) under the name or trademark of the cooperative, the agricultural cooperative is the producer. 11 The producer definition addresses packaging used in primary production. ‘Primary production’ is to be understood as ‘the production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter’ (3). Packaging material, for example foil or straps used for hay bales, is only considered to be made available on the market, and thereby packaging, when the bales are placed on the market and not when it is used in a production process, in this case on the same farm. 9) Who is the ‘producer’ of transport packaging? NEW! The producer of transport packaging must be identified when it is empty (see further explanation above [‘Who is the manufacturer of transport packaging?’]). The following provide some typical examples of who the producer of transport packaging is: • Company A is the manufacturer of unbranded, standardised cardboard boxes and sells them to Company B located in the same Member State. In this case, Company A would typically be the producer. This is also the case when the cardboard boxes are sold flat and require folding. • If company A sells the cardboard boxes to Company C in another Member State, and Company C fills the boxes to transport packaged products, then Company C would typically be the producer in that Member State. • If Company A fills the cardboard boxes and sells them to an end user in another Member State, then Company A would typically be the producer in that other Member State. • If Company A manufactures cardboard boxes under the name or trademark of Company B, then Company B will typically become the manufacturer and producer of the boxes in that Member State. However, if Company B is a micro-enterprise, then Company A is manufacturer and the producer in the Member State. 12 Further clarification of the definition of a producer of packaging can be found in section 3 of the Commission guidance document. 10) Who is the ‘producer’ in cases where sales packaging is also used for transport purposes? NEW! Sales packaging is defined in the PPWR as “packaging conceived so as to constitute a sales unit consisting of products and packaging to the end user at the point of sale”, whereas transport packaging is defined as “packaging conceived so as to facilitate the handling and transport of one or more sales units or a grouping of sales units, in order to prevent damage to the product from handling and transport”. By definition, transport packaging therefore serves to transport one or more sales units and does not replace the underlying sales packaging. If sales packaging is also used for transportation purposes, the packaging remains part of the packaged product supplied to the end user, and it is not placed on the market as empty transport packaging. Therefore, even if the packaging also performs a transport function, the packaging is still sales packaging for the purposes of establishing who the producer is. The producer would be the economic operator that fills the packaging and makes the packaged product available for the first time in the Member State concerned. Nevertheless, the assessment should always be carried out on a case-by-case basis, taking into account the packaging's design, intended use and the specific circumstances of the supply chain. The cardboard boxes carries the name or trademark of Company B, which is not a micro-enterprise. The cardboard boxes carry the name or trademark of Company B located in the same Member, but Company B is a micro-enterprise. Sells to end user in the same Member State Sells to end user in another Member State Sells to Company B in the same Member State Company A is producer Company B is producer Company A manufactures unbranded cardboard boxes (transport packaging) 13 Making available on the market 11) Why does the wording ‘making available on the market’ sometimes refer to the Union market and other times to the territory of a Member State? The definitions ‘making available on the market’ (Article 3(1), point (9)) and ‘placing on the market’ (Article 3(1), point (10)) refer to the Union market. These definitions apply throughout the PPWR reflecting the harmonisation of requirements that apply directly to economic operators. However, in the provisions on waste management, such as waste reduction and recycling targets, separate collection and extended producer responsibility, the requirements are mainly addressed to Member States. To reflect the territorial scope of the above-mentioned requirements, the Regulation uses the term ‘making available on the territory of a Member State’ (Article 3(1), point (11)). The definition has the same meaning as the definition of ‘making available on the market’, the only difference being that it circumscribes the actions to the territory of a Member State instead of the Union market. 12) How can producers know if a packaged product is made available to an end user or whether it is made further available? A product is considered to have been made available on the market when it is supplied for distribution, consumption, or use in the course of a commercial activity. An end user, whether a consumer or a professional end user, is a person or entity to whom a product is made available and who does not make that product further available on the market in the form in which it was supplied. The determining factor is therefore not the legal status of the recipient, but how the product is used. A professional end user is considered as an end user where it uses the product on its own operations or production process and does not resell or otherwise place the product back on the market in the same form. A producer of a packaged product should be able to determine, based on the nature of the packaging and the chosen marketing and distribution channels, whether the intended recipient is an end user (consumer or professional), or a commercial buyer who will resell the packaged product in another Member State. It should be noted that logistics companies that receive packaged goods, such as imported products from third countries, and perform handling activities (e.g., unpacking, repacking, or dividing products into smaller quantities) are not considered end users. Placing on the market 13) Is packaging used to ship product parts between manufacturing sites, for finalisation or assembly, considered placed on the market and therefore subject to PPWR rules? NEW! Article 3(10) of the PPWR sets out that ‘placing on the market’ occurs at the ‘first making available of packaging, whether empty or with a product, on the Union market’. Article 3(9) of the PPWR defines ‘making available on the market’ as ‘any supply of packaging, whether empty or with a product, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge’. Packaging must comply with the PPWR rules when it is placed on the market. If a packaging has not yet been placed on the market, for example if it has been produced by the company who is also responsible for the product parts, and has not formed part of any commercial transaction, it will not be subject to PPWR rules. 14 However, if a company uses transport packaging which it has not manufactured itself to ship parts between two of its company sites, PPWR rules will apply, as the packaging is considered placed on the market. Further clarifications 14) Are crown corks for beverage bottles an integrated or separate component? Crown corks for glass bottles are considered separate components, as per Article 3(1), point (44), of the Regulation. Such closures, which are not permanently attached to the bottle, need to be separated completely and permanently from the main packaging unit in order to access the product and, therefore, to ensure the functionality of the packaging unit. The future delegated act on design for recycling (DfR) will further specify the rules for integrated and separate components. 15) Are the derogations provided for in Directive 2008/68/EC on the inland transport of dangerous goods 3 applicable to all packaging that is used for the transport of dangerous goods? Are the derogations also applicable to the transport of non-dangerous goods? UPDATED! The provisions on recyclability, recycled content and reuse targets contain specific exemptions for packaging used for transport of dangerous goods. If the packaging is used for transport of dangerous goods in accordance with Directive 2008/68/EC, even though it does not require UN approval, e.g. packaging used under limited quantities (LQ) marking, the PPWR derogations are applicable. For UN approved packaging used for the transport of non-dangerous goods, the PPWR rules apply. 3 Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods 15 III. SUBSTANCES OF CONCERN 1) In the definition of Substances of Concern (SoC), which refers to the ESPR, should the conditions in Article 2(27) points (a), (b), (c), (d) of the ESPR be considered as cumulative? How should the wording ‘negatively affects the reuse and recycling of materials in the product in which it is present’ be understood? It is sufficient that only one of the conditions under points (a) to (d) of Article 2(27) ESPR is fulfilled for a substance to be considered as a SoC4. As regards the meaning of the wording ‘negatively affects the reuse and recycling…’ the Commission and the European Chemicals Agency (ECHA) are currently conducting a study on identifying the SoC that could affect human health and impact packaging reusability and recyclability. 2) What is the difference between substances and substances of concern (SoC)? Does the Ecodesign for Sustainable Products Regulation (ESPR) and the PPWR address substances of concern (SoC) in the same manner? The definition of substances of concern (SoC) refers to the ESPR (Article 3(1), fourth paragraph of the Regulation), which means that substances of concern are defined in the same manner in the PPWR and the ESPR. The ESPR establishes the criteria for identification of substances of concern. They are mainly based on their hazardous properties and classification in accordance with the CLP Regulation5 but also include a reference to negative effects on the reuse and recycling of materials in the product in which they are present6. The conditions are not cumulative, which means that if one of the conditions is fulfilled, the substance is considered as SoC. 4 The ESPR FAQ can be found here: Circabc. 5 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31/12/2008, p. 1–1355). 6 According to Article 2, point (27) of ESPR, ‘a substance of concern’ means a substance that: a) meets the criteria laid down in Article 57 of Regulation (EC) No 1907/2006 and is identified in accordance with Article 59(1) of that Regulation; b) is classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 in one of the following hazard classes or hazard categories: a. carcinogenicity categories 1 and 2; b. germ cell mutagenicity categories 1 and 2; c. reproductive toxicity categories 1 and 2; d. endocrine disruption for human health categories 1 and 2; e. endocrine disruption for the environment categories 1 and 2; f. persistent, mobile and toxic or very persistent, very mobile properties; g. persistent, bioaccumulative and toxic or very persistent, very bioaccumulative properties; h. respiratory sensitisation category 1; i. skin sensitisation category 1; j. hazardous to the aquatic environment — categories chronic 1 to 4; k. hazardous to the ozone layer; l. specific target organ toxicity — repeated exposure categories 1 and 2; m. specific target organ toxicity — single exposure categories 1 and 2. c) is regulated under Regulation (EU) 2019/1021; or d) negatively affects the reuse and recycling of materials in the product in which it is present. 16 3) How will the PPWR deal with the addition of substances of concern (SoC) and the use of recyclates? The objective of the Regulation is the minimisation of the presence of SoC in packaging. This will be done via the identification of substances of concern, as a first step, and their limitation, if they are relevant for recycling, via the DfR criteria, to be adopted under Article 6(4) PPWR, or via the update of REACH restrictions for substances that affect human health or the environment. The identification of the relevant substances is on-going via a study lead by the Commission and the European Chemicals Agency (ECHA). 4) How many substances could fall under the definition of substances of concern (SoC)? There is no definite number or list of substances of concern (SoC) in packaging. The study, which the Commission and ECHA are undertaking to comply with its implementation obligation established in Article 5(2), will look into this issue and will provide a list of SoC on the basis of the information currently available about packaging manufacturing and waste treatment. There are several sources of information that can be consulted for each criterion listed in Article 2(27) of Regulation (EU) 2024/1781 (ESPR) to identify Substances of Concern (e.g. the ‘Candidate list of Substances of very high concern for Authorisation’ managed by ECHA7; Annex VI of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures8 could be also used as a source for identifying SoCs. 5) How is the supplier of packaging obligated to comply with the data requirements of substances of concern (SoC)? Obligations of packaging suppliers are detailed in Article 16 PPWR. Accordingly, suppliers must provide the manufacturer with all the information and documentation necessary for the manufacturer to demonstrate the conformity of packaging and the packaging materials with this Regulation, either in paper or in electronic format. Manufacturers need this information from suppliers of packaging materials or converters in order to identify PFAS or other SoC present in packaging and draft the declaration of conformity demonstrating compliance with Article 5 PPWR. 6) At which value are the concentration limits for SoC set? The Regulation includes an obligation to minimise the SoC content in material and emissions. The main driving principle is that human health and environment are protected, i.e. unacceptable adverse effects should be avoided. The Regulation does not set a general concentration limit for SoC. Nevertheless, specific concentration limits are established for certain substances (e.g. PFAS and certain heavy metals). More information and knowledge on SoC are expected to come from the on-going Commission and ECHA-led study. But substances meeting the substances of concern (SoC) criteria can already be identified by the manufacturer based on the existing definition of SoC. The SoC criteria refer 7 https://echa.europa.eu/candidate-list-table. 8 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, pp. 1–1355). 17 mainly to hazardous properties but also include, on a case-by-case basis, considerations related to recycling and re-use. The possibility to establish new concentration limits for SoC in packaging may result from the evaluation to be carried out by the Commission by 2033, which will consider if the Regulation has sufficiently contributed to minimising the presence and concentration of SoC in packaging. Moreover, the Commission may adopt delegated acts in accordance with Article 6(4) to limit the presence of SoC that negatively affect recycling. 7) What is the implementation date for Article 5(1) PPWR? The Regulation and therefore the obligation to minimise substances of concern content will apply from 12 August 2026. Already PPWD contained the obligation to minimise substances of concern with regards to their presence in emissions, ash or leachate when packaging or its packaging waste residues are incinerated or landfilled and has set specific concentration limits for four heavy metals (lead, cadmium, mercury and hexavalent chromium). 8) How can manufacturers prove compliance with Article 5(1) regarding the obligation to minimise SoC in packaging? NEW! The general principle set out in Article 5(1) should be assessed in line with Annex C (Minimisation of Dangerous Substances or Preparations and Demonstration of Conformity) of the existing harmonised standard EN 13428_2004 Packaging - Requirements specific to manufacturing and composition - Prevention by source reduction. This Annex describes the steps that have to be taken by the economic operator responsible for placing a specific packaging on the market in order to determine and demonstrate minimisation. 9) Is the harmonised standard EN 13428:2004 still applicable to ensure conformity with the requirements as regards SoC? UPDATED! The requirements concerning SoCs have been strengthened in the PPWR. Under the PPWR, packaging must be manufactured so that the ‘presence and concentration of substances of concern’, both in the material itself and in emissions or waste outcomes, is minimised. It also explicitly ties these requirements to effects on reuse, recycling and chemical safety, rather than merely end-of- life disposal. EN 13428:2004 focuses primarily on minimising dangerous substances in emissions and disposal, not on the holistic lifecycle impacts, as required by Article 5 of the PPWR. Furthermore, the standard does not reflect the expanded hazard scope of the PPWR, covering SVHCs under REACH, CLP hazard classes and recyclability impacts. Therefore, Annex C of the existing harmonised standard EN 13428:2004 9 related to the ’minimisation of dangerous substances or preparations and demonstration of conformity’ can no longer create a presumption of conformity with the new rules concerning SoCs. However, until the updated harmonised standard becomes available, the existing standard EN 13428:2004 can be used. 9 Harmonised standards published in Commission communication in the framework of the implementation of the European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ C 44 of 19 February 2005), EN 13428:2004 ‘Packaging – Requirements specific to manufacturing and composition – Prevention by source reduction’. 18 10) How can manufacturers prove compliance with Article 5(4) on the limit value for heavy metals in packaging? NEW! This is not a new obligation. Manufacturers already had to comply with this obligation under Article 11 of the repealed Directive on packaging and packaging waste10. To demonstrate compliance, it is recommended to use the CEN report CR 13695-1/2000 Packaging - Requirements for measuring and verifying the four heavy metals and other dangerous substances present in packaging and their release into the environment - Part 1: Requirements for measuring and verifying the four heavy metals present in packaging. 11) Does the obligation to minimise the presence of substances of concern (SoC) in packaging apply to all economic operators? The obligation applies to all packaging placed on the market, according to the definition in the Regulation (Article 3(1), point (10)). The manufacturer placing packaging on the market or a supplier, in case a manufacturer is a microenterprise, must make sure that the provisions are complied with. 12) When does the obligation on minimisation of substances of concern (SoC) start to apply for packaging that is not food-contact sensitive? The general obligation to minimise SoC in Article 5(1) and the limits on four heavy metals in Article 5(4) apply to all packaging from 12 August 2026. The limits set in Article 5(5) for PFAS will apply to food-contact materials only. 13) Member States may submit data on a substance they believe to be of concern before 31 December 2025. If Member States inform the Commission about new substances of concern, will this information be accessible before the Commission delivers its report in 2026? According to Article 5(2) of the PPWR, Member States should inform the Commission about relevant information on SoC before 31 December 2025. This information will be considered in the development of the study. The monitoring of SoC is a permanent task for the Commission. 14) Does the derogation for glass packaging introduced by Commission Decision 2001/171/EC 11 in relation to heavy metal concentration levels in packaging and packaging waste continue to apply? Commission Decision 2001/171/EC continues to apply and has not been repealed by the PPWR. This means that the packaging may exceed the concentration limit of 100 ppm by weight for the sum of lead, cadmium, mercury and hexavalent chromium, when this exceedance is due to the addition of recycled glass. No lead, cadmium, mercury or hexavalent chromium is allowed to be intentionally introduced during the manufacturing process. The Commission may adopt delegated 10 European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste 11 Commission Decision of 19 February 2001 establishing the conditions for a derogation for glass packaging in relation to the heavy metal concentration levels established in Directive 94/62/EC on packaging and packaging waste (OJ L 62, 2.3.2001, pp. 20–21). 19 acts to amend the limit established in Article 5(4), but only to lower the permitted sum of concentration levels. The Commission is not empowered to extend the application date of the heavy-metal restrictions laid down in the PPWR. 15) Will Regulation (EC) 1935/2004 on food contact materials, Regulation (EU) 10/201112on plastic articles intended to come into contact with food, Regulation (EU) 2019/1021 on persistent organic pollutants and the REACH regulation be amended by reference to the PPWR's ban on PFAS? The PPWR does not establish a PFAS ban but rather sets maximum concentration levels. Also, it is not provided that the PFAS limits in the PPWR would be taken over into other, ‘vertical’, EU legislations. Based on Article 5(5), the Commission will carry out an evaluation to assess the need to amend or repeal the PFAS restriction in the PPWR in case of identified overlaps with restrictions or prohibitions on the use of PFAS under the FCM Regulation, the REACH Regulation or the POPs Regulation. 16) Do the PFAS restrictions in Article 5(5) apply both to intentionally added and unintentionally present PFAS? The PFAS restriction adopted by the PPWR does not differentiate between intentionally added and unintentionally present PFAS. Therefore, the provisions in Article 5(5) apply to both. To be noted, preliminary PFAS laboratory analyses results on a number of selected packaging13showed that in practice only packaging where PFAS have been intentionally added would give results above the PFAS limit values. 17) Do the restrictions apply only to materials used in packaging manufacturing or also to the materials and the associated inks, varnishes, glues and adhesives? The limits apply to the packaging unit as a whole, including the associated inks, varnishes, glues and adhesives placed on the market by the manufacturer. The latter is the person responsible for drawing the technical documentation needed to prove compliance (for further information, see Commission guidance document). 18) Will a list of the PFAS concerned by the ban (with CAS numbers for identification) be published? A list of PFAS subject to this restriction will not be published. The limits apply to all PFAS falling under the definition provided in the PPWR and possibly contained or contaminating the packaging. 19) How will the PFAS limits be enforced, considering there are no harmonised methodologies for PFAS in food-contact packaging at EU level? 12 Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 012 15.1.2011) 13 Skedung L.1 and Bjarnemark F.1 : A Harmonized Workflow for PFAS Compliance Testing under EU Packaging and Packaging Waste Regulation and Emerging Universal Restrictions: A Food Contact Packaging Case Study. 1RISE Research Institutes of Sweden 20 As explained in the Commission guidance document, the Commission is striving to ensure a harmonised approach of the national market surveillance authorities for the enforcement of the PFAS limits. There are intense works ongoing involving industrial stakeholders, civil society associations and the competent authorities in the Member States aiming to deliver a harmonised testing protocol for PFAS in food-contact packaging. This work stream includes engaging with the EURL on Food Contact Materials, which coordinates the network of national reference laboratories for food contact materials. 20) As the starting point for enforcement of the PFAS limits seems to be the total fluorine analysis, what laboratories offer such testing methodology? There are already plenty of commercial and university laboratories offering Total Fluorine / Total Organic Fluorine analysis. It can be expected that many other commercial and accredited laboratories will in view of the PPWR PFAS limits invest into testing capacities, and that those already doing it increase theirs. 21) Do the “refillable steel cylinders used for various kinds of gas” (Annex I of PPWR) have to comply with Article 5(4) of PPWR that sets a limit value of 100 mg/kg for heavy metals? NEW! Transport of gases in refillable cylinders must comply with Directive 2008/68/EC14, which directly implements the International Agreement on the Carriage of Dangerous Goods by Road (ADR)15 as binding EU law. ADR requires leakproof (gas tight) pressure receptacles and specifies, via standards, the use of copper-zinc-lead alloys that contain lead in concentrations much higher than those specified in Article 5(4) of the PPWR. Under these circumstances, the restriction in Article 5(4) PPWR is not intended to apply where ADR-mandated safety components leave no technical feasible alternative. This is in accordance with Article 2(2) of PPWR that states that, in case of conflict between PPWR and Directive 2008/68/EC, the latter should prevail. 14 Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods 15 Agreement concerning the International Carriage of Dangerous Goods by Road (ADR 2025) | UNECE 21 IV. RECYCLABILITY 1) In the context of recyclability performance grade assessment: • how is a packaging unit defined, • what is the difference between integrated and separate components, and • what is the main body of the packaging unit? A ‘unit of packaging’ is defined in Article 3(1), point (45), of the Regulation as a unit, including any integrated or separate components, which as a whole serves a packaging function, such as the containment, protection, handling, delivery, storage, transport or presentation of products. A unit of packaging is independent from units of grouped or transport packaging where the latter are discarded prior to the point of sale. The term ‘unit of packaging’ should be considered equal to ‘packaging unit’, which is a term also used in the PPWR. Integrated and separate components are also defined in the Regulation, in Article 3(1), points (43) and (44), respectively. An illustrative example of a packaging unit is a plastic ketchup bottle made available to consumers at the point of sale. Such a ketchup bottle consists of the following packaging components: plastic bottle, removable lid (i.e. peelable foil), which is typically fully removed by consumers to access the product, label, and the closure system. If a removable lid needs to be fully completely and permanently separated by consumers to access the ketchup, then it should be considered as a separate component. As regards the closure system, it typically does not need to be completely and permanently separated by consumers and is thus disposed of together with the ketchup bottle. Assuming that the closure system on a ketchup bottle is not meant to be separated by consumers, it should be considered as an integrated component. As for the label, it is typically attached to the plastic bottle and disposed of together with a ketchup bottle. Hence, it is considered an integrated component; in this context, the plastic bottle itself is the main body of the packaging unit. Against this background, it could be considered that the main body of the packaging unit is the packaging part of the packaging unit with the highest share, by weight, except closure on flexible packaging. According to Article 6(9), ‘where a unit of packaging includes integrated components, the assessment of compliance with the design for recycling criteria and with the recycled-at-scale requirements shall include all integrated components. A separate assessment shall be carried out for integrated components that can become separated from each other as a result of mechanical stress during transportation or sorting’. 2) If there is no recyclable alternative for a specific packaging or its components on the market, could such packaging or its component get an exemption under Article 6? The exemptions from the recyclability obligations are listed in Article 6(11). The Commission is not empowered to grant any further exemptions. However, in case of innovative packaging, as brought to the attention of the competent authorities in the Member States, the Commission must assess the requests from the competent authorities and update or adopt new delegated acts under Article 6(4). Innovative packaging is defined as ‘packaging that is manufactured using new materials, resulting in a significant improvement in the functions of the packaging, such as the containment, protection, handling, or delivery of products, and in overall demonstrable environmental benefits, with the exception of packaging that is the result of modification to existing packaging for the main purpose of improving the presentation of products and marketing’ (Article 3(1), point (46)). The Commission will monitor the impact of the derogations contained in Article 6(11) and derogations as regards innovative packaging contained in Article 6(10), and may propose amendments to the Regulation, if necessary. 22 Therefore, if a packaging or its components does not fall under the established exemptions in Article 6(11), and does not qualify as innovative packaging, the manufacturers must improve packaging design to be compliant with the DfR guidelines from 2030 or two years after the entry into force of the delegated acts adopted under Article 6(4), specifying DfR requirements. Nonrecyclable integrated components may lower the recyclability grade of a unit of packaging or may even make the entire packaging unit non-compliant. 3) What is the process for granting the derogation and what are the expected timelines for its completion? What specific criteria does the Commission use to assess innovativeness? The process is outlined in Article 6(10). Member States enjoy a margin of discretion implement the process in their national legislation while respecting the rules outlined in that provision. The criteria are outlined in Article 3(1), point (46), and the Commission is currently not envisaging the adoption of further guidance in this regard. Manufacturers using this exemption from the recyclability requirements must evidence compliance with these criteria in the technical documentation. 4) Can Member States apply their own eco-modulation criteria? Under Article 6(4)(d), the Commission will outline a framework concerning the modulation of financial contributions based on the packaging recyclability performance grades to be paid by producers to comply with their EPR obligations set out in Article 45(1). This harmonised framework is necessary to ensure the proper functioning of EU internal market, by preventing regulatory fragmentation and ensuring legal uncertainty for economic operators, in particular those placing packaging on the market in several Member States, while at the same time incentivising more sustainable packaging design. Divergent national eco-modulation schemes based on recyclability performance could otherwise create obstacles to trade and distort competition within the internal market. The harmonised framework will not set the actual amounts of such fees but will instead harmonise the criteria for the modulation of EPR fees based on the recyclability performance grade obtained through the recyclability assessment. Until the entry into force of the harmonised eco-modulation rules, Member States will remain able to eco-modulate fees based on the recyclability of packaging in accordance with their national provisions adopted under the PPWD. In doing so, Member States must consider the potential impact of such measures on the internal market. Where national ecomodulation measures constitute technical regulations or rules affecting products, they must be notified to the Commission in accordance with Directive (EU) 2015/153516 through the TRIS notification system. Following the entry into force of the delegated act on design for recycling, which will establish a harmonised framework for eco-modulation of EPR fees based on packaging recyclability performance grade, Member States will be required to apply this harmonised framework. This obligation aims to ensure the consistent application of eco-modulation rules across the Union and to safeguard the free movement of goods. However, Member States will continue to be able to eco-modulate financial contributions of producers on the basis of other criteria, such as recycled content, the presence of substances of concern, or the reusability of packaging. If Member States decide to introduce eco-modulation based on the presence of recycled content in plastic packaging, they will be required to take into 16 Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 on measures for a high common level of cybersecurity across the Union, amending Regulation (EU) No 910/2014 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148, (OJ L 333 27.12.2022) 23 account sustainability criteria of recycling technologies and the environmental cost, which are to be developed by the Commission under Article 7(9) by the end of 2026. 5) If Member States do not reach the recycling targets, is there any mechanism foreseen to take this into account in the recyclability ‘at scale’ assessment? The ‘at scale’ assessment will be based on a recycling target of 55%17 to be achieved at EU level per packaging categories listed in Table 2 of Annex II. The Commission is empowered to amend the list of these categories to adapt them to the technical and scientific developments regarding packaging and packaging waste management. The ‘at scale’ assessment is not based on the recycling rates achieved at national level and therefore there is no need for a specific mechanism in the recyclability at scale assessment, which would take into account the fact that a specific Member State did not reach specific recycling targets. However, it is important that all Member States strive to optimise their collection, sorting and recycling systems to improve the overall recycling rate at the Union level and the availability of secondary feedstock. The Regulation provides for several support measures, such as the obligation to set up deposit and return systems, mandatory harmonised waste sorting labels, the obligation on Member States to establish mandatory collection targets, and the prohibition to landfill or incinerate recyclable packaging. The implementation of these requirements will help increase the overall recycling rate in the EU and thus allow economic operators to fulfil the recycling ‘at scale’ requirement. 6) What is the scope of the exemption under Article 6(11)(e) for baby food? The exemption for baby food as referred to in Regulation (EU) No 609/201318 should be understood in line with the definition given in its Article 2(2f). Therefore, the exemption should not be understood as covering all fruit juices and purees and other products that are marketed for consumption by babies. 7) Will the recyclability ‘at scale’ assessment be based on all packaging waste generated regardless of its origin, sector or type? The recyclability ‘at scale’ assessment and the related 55% recycling target for all packaging materials and 30% for wood indeed refers to all packaging waste generated and recycled in the EU, regardless of its origin (household, commercial and industrial waste), sector or type. Calculation of the recycling rate should be based on the existing rules for the calculation of recycling rates laid down in Commission Decision 2005/270, as amended, which will be replaced by a new decision under Article 56(7) PPWR. 8) Does Article 6 apply to reusable sales and transport packaging placed on the EU market prior to the entry into force of the requirements under Article 6(1) PPWR? Recital (14) explains that ‘packaging should be placed on the market only if it complies with the sustainability requirements and labelling requirements laid down in or pursuant to this Regulation’ (emphasis added). Packaging already placed on the Union market before the date of application of relevant requirements, including packaging in the stocks, does not need to meet the sustainability 17 For all materials except for wooden packaging, where it is 30%. 18 Regulation No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, pp. 35–56) 24 and labelling requirements laid down in or pursuant to this Regulation and does not need to be withdrawn. Article 6(2) requires that all packaging placed on the market 24 months from the date of entry into force of the delegated acts adopted pursuant to Article 6(4) is recyclable according to the DfR principles laid down therein. This obligation refers to every type of packaging, regardless of whether it is reusable or single-use, or sales, grouped or transport packaging. Therefore, since the delegated acts under Article 6(4) are to be adopted by 1 January 2028, reusable or transport packaging which manufacturers will have placed on the market before 1 January 2030, can stay on the market even if it is not compliant with the recyclability requirements. Placing on the market refers to every single packaging unit and not to the packaging design. 9) Are the exemptions from the recyclability requirements for packaging made from cork, lightweight wood, textile, ceramics rubber, porcelain and wax valid until 2035? Article 6(1) requires that all packaging be recyclable. Article 6(11) establishes exemptions from this requirement for certain packaging materials and sectors. The Commission will review these exemptions by 1 January 2035 to consider if it is appropriate to maintain them. Based on this assessment, it may propose to amend or remove them. The exceptions for packaging made from cork, lightweight wood, textile, ceramics rubber, porcelain and wax apply only to sales packaging and mean that such packaging will not have to undergo the recyclability assessment for the purpose of determining if it can be placed on the market. However, the obligation to adjust the EPR fees based on the recyclability performance will apply also to such sales packaging. The recyclability assessment for such packaging will thus be carried out only for the purpose of determining the EPR fee modulation. 25 V. RECYCLED CONTENT IN PLASTIC PACKAGING 1) How should compliance with the recycled content requirements be demonstrated? Compliance with the recycled content targets in the PPWR must be demonstrated in the technical documentation for the packaging, as specified in Annex VII. Compliance with the recycled content requirements can be exemplified as follows. An economic operator places a plastic tray made of polyethylene (PET) with a peelable lid made of polypropylene (PP) on the market. In this case, we could assume that the PET tray and PP lid are manufactured in different manufacturing plants within the EU and supplied to the economic operator who assembles the packaging components into a tray with a lid, fills it with product, and eventually places it on the market. The two manufacturing plants which manufacture, respectively, the tray and the lid must each disclose information about the compliance with the minimum recycled content requirements for their components, as provided for in Article 7(2). Based on the information from these manufacturing plants, the economic operator who eventually places the tray with the lid on the market (i.e. the manufacturer), must draw up the technical documentation that demonstrates compliance with the legal requirements for recycled content. The same principle applies to intermediate plastic packaging components, empty plastic packaging or filled plastic packaging imported into the EU. The economic operator must also ensure that the requirements for the recycled content meet the sustainability and equivalence criteria, which will be set out in the implementing acts pursuant to Article 7(9) and (10), respectively. 2) What is to be understood by ‘average per manufacturing plant and year’ in the context of recycled content in plastic packaging? A manufacturing plant must be understood as the industrial facility in which packaging is manufactured. An average per year refers to the amount of recyclates (recycled content) in each plastic packaging type and format over the period of a calendar year, produced for each manufacturer in a specific manufacturing plant. The manufacturing plant will have to provide documentation demonstrating that the average supply per year to the specific manufacturer fulfils the targets for recycled content. Manufacturers usually produce several packaging formats in one manufacturing plant and will therefore have to calculate the recycled content targets for each packaging type and format. The implementing act to be adopted under Article 7(8) will outline the rules on how to calculate and verify the recycled content in plastic packaging. 3) Are adhesives, paints and inks covered by the recycled content requirements for plastic packaging? Adhesives, paints and inks are not deemed plastic under the PPWR and therefore do not need to fulfil the recycled content requirements. This is regardless of whether they represent less than 5% of the packaging unit. 4) Are environmental claims on recycled content in plastic packaging allowed? Environmental claims on recycled content in plastic packaging are allowed where the recycled content exceeds the applicable minimum requirements set out in Article 7(1) and (2) of the PPWR. Article 14 specifies that the economic operator is allowed to make environmental claims for a packaging unit, the part of the packaging unit that contains the recycled content, or all packaging placed on the market over a calendar year by the economic operator. This is exemplified in the table below. 26 Example PPWR recycled content requirements Environmental claim for: Allowed environmental claim PET plastic bottle with a closure system made of PP PET bottle: 30% PP closure: 10% Packaging unit (bottle and a closure system) The recycled content exceeds 30% for the PET bottle or 10% for the PP closure system. Regardless of the choice to make environmental claims or not, compliance with the legal requirements must be demonstrated in the technical documentation. 5) How do economic operators know which recycled content requirements to fulfil? UPDATED! The recycled content requirements apply to any plastic part of sales, grouped, and transport packaging. Firstly, the economic operator must determine whether the packaging is contact-sensitive. Secondly, the economic operator must determine what polymer the packaging is made from. Based on this information, the economic operator can then determine what recycled content requirements to fulfil. This logic is illustrated in the following table. Packaging format 1st step: Is the packaging contact sensitive? 2nd step: What is the polymer made from? 2030 applicable target Example A Pallet wrapping film to transport goods Non-contact sensitive Other than PET Art. 7(1)(d), 35% Example B Beverage carton Contact-sensitive Other than PET Art. 7(1)(b), 10% Example C Single-use plastic beverage bottle: Contact-sensitive PET Art. 7(1)(c, 30% 6) Do the requirements for recycled content apply to packaging placed on the market before 2030? The recycled content requirements apply only to packaging placed on the market from 1 January 2030 or three years after entry into force of the implementing act in Article 7(8), whichever is the latest. However, no exhaustion of stocks is envisaged for packaging supplied to manufacturers and not yet placed on the market by the latter before the due date. 7) Will also a plastic cap and a label on a glass bottle need to comply with the recycled content requirements? UPDATED! Article 7(5)(b) exempts plastic parts that represent less than 5% of the total weight of a packaging unit from the recycled content requirements. This exemption applies exclusively to plastic parts and does not extend to non-plastic materials. 27 By way of example, in the case of a glass bottle with a metallic cap and a plastic label, the metallic cap is not a plastic part and therefore falls outside the scope of the recycled content requirements. A plastic label, however, is exempted if its weight accounts for less than 5% of the total weight of the packaging unit, i.e. the bottle with cap and label. 8) Recycled plastic in plastic caps is mandatory for milk but not for infant formula packaging. Must an economic operator that uses the same caps for these products meet the targets for recycled plastic content to comply with the requirements for milk packaging? As of 2030, manufacturers must ensure that the plastic part of the packaging placed on the market is compliant with the recycled content targets of Article 7(1). Milk is not exempted from the recycled content requirements. Therefore, a manufacturer must ensure that plastic caps that are used for the milk packaging fulfil the recycled content requirements. On the other hand, plastic caps for instant baby formula are not required to include recycled content due to the exemption set out in Article 7(4), point (g). 9) Is there a difference between ‘contact-sensitive plastic packaging’ and ‘immediate packaging’ as used in the exemptions of Article 7? The term ‘immediate packaging’ refers to the ‘(…) packaging immediately in contact with the medicinal product’19, whereas according to Article 3(1), point (49), of the PPWR contact-sensitive packaging means packaging that is intended to be used for food and medicinal products. In the context of medical devices and other medicinal products ‘immediate packaging’ will generally qualify as ‘contact-sensitive plastic packaging’ according to Article 3(1), point (49), of the PPWR, and while the concepts are not identical, they should be understood in the same way for the purpose of implementation of Article 7 of the PPWR. 10) What is the interplay between the reporting obligations related to recycled content under the PPWR and under the SUPD? Article 6(5), points (a) and (b) of SUPD (i.e. recycled content targets for beverage bottles listed in Part F of Annex to SUPD), and Article 13(1)(e) SUPD on related Member States’ reporting remain in force until 1 January 2030 or 3 years after the entry into force of the implementing act on the calculation of recycled content referred to in Article 7(8). There are some differences in scope between the PPWR and the SUPD, which should be taken into account: • In the SUPD, the target is at Member State level, whereas the PPWR sets the. requirements per packaging type/format, calculated as an average per manufacturing plant and year. • There is no minimum threshold in the SUPD for composite materials, whereas the PPWR contains an exemption for the plastic part if it represents less than 5% of packaging unit weight. • There is no exemption regarding compostable plastic packaging in the SUPD. 11) Recycled content requirements for imported plastic packaging Regulation (EU) 2022/1616 and its provisions (especially Article 6) apply to all recycled plastics for food contact materials placed on the EU market, including imported packaging. 19 Article 1(23) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311 28.11.2001, p. 67) 28 Therefore, importers of plastic materials with recycled content that intend to use this material as food-contact material, including food-contact packaging, should ensure that these materials comply with the requirements outlined below. If not compliant, these materials may not be placed on the market for food contact applications, including food-contact packaging. However, they may be used for other purposes. Article 6 of that Regulation mandates the following: • Separate collection of plastic waste; • A certificate obtained with third-party certification of the pre-processing activities in accordance with Article 6, including all activities from sorting to recycling of plastic waste; • Proof that the recyclates have been produced in accordance with Regulation (EU) 10/2011. 29 VI. COMPOSTABILITY 1) Article 9(1) mandates a compostability requirement for certain packaging types. Will these packaging types be allowed in the bio-waste stream even before 12 February 2028? Indeed, the Regulation changed the definition of packaging to include tea and coffee bags which are not left empty after use. Such new packaging items will be classified as packaging when the Regulation becomes applicable, that is on 12 August 2026. As Article 9 on compostability applies from 12 February 2028, Member States are not required to accept such packaging in the bio-waste steam before that date, but they are encouraged to accept them. 2) How should manufacturers deal with the fact that not all industrial composting facilities operate in accordance with EN 13432:2000? Will waste management operators in all Member States have to accept compostable packaging if it is certified according to the harmonised standard EN 13432:2000? While the Regulation does not state explicitly that composting facilities must operate in accordance with the harmonised standard, the Commission expects that this will indeed be the case. For example, Article 9(2) conditions the Member States’ flexibility to add additional packaging items to the national lists of mandatorily compostable packaging to the existence of ‘appropriate waste collection schemes and waste management infrastructure to ensure that compostable packaging enters the bio-waste management stream’. The Commission will ensure that associations representing industrial composting will be fully involved in the development of the updated industrial compostability standards. 3) If a product is nowadays compostable, and on the market, can economic operators continue to market it after the Regulation has entered into force and become applicable? The answer is ‘yes’, if there is a clear legal requirement in the territory of a Member State where the economic operator is marketing their products that a particular packaging format must be compostable. As explained in point 8 of the Commission guidance document, Member States have the possibility until 12 August 2026 to decide that packaging formats additional to items listed in Article 9(1) and 9(2)(a) must be compostable on their territories. 30 VII. PACKAGING MINIMISATION 1) Do both Article 10(1) and (2) on packaging minimisation apply by 1 January 2030? Yes. Both Article 10(1) and (2) apply by 1 January 2030. Until the end of 2029, the essential requirements from the PPWD continue to apply and thus also the existing standard EN 2004:13428. This results from Article 70(1)(b) of the Regulation. 2) How should the term ‘increase the perceived volume of the product’ in Article 10(2) be understood? The use of certain packaging characteristics, such as double walls or false bottoms, is not allowed when the perceived volume of the product is increased. An illustrative example below is provided to help better understanding. Example Packaging minimisation Choices that might increase the perceived volume of the product Plastic or glass 50 ml jar for facial cream Plastic or glass jars are reduced to the minimum volume necessary to protect the product inside Use of double walls or false bottoms to make it appear that the content of the cream as more than 50 ml Use of cardboard boxes around the jar which make it appear that the content of the cream larger than 50 ml Moreover, the Impact Assessment that supported the legislative proposal of the PPWR outlines a few examples on ‘increase the perceived volume of the product’20. Overall, the economic operator must prove that double walls, false bottoms, frontal flaps and additional layers are used only in circumstances where the packaging functionality cannot be ensured otherwise and/or in cases where these components add legitimate functionality to the packaging. This will have to be demonstrated via tests and proven in the technical documentation, by providing a sufficient justification. 3) How will the requirements of packaging minimisation be enforced for other than the most common packaging types and formats? By 12 February 2027, the Commission will request the European standardisation organisations to prepare or update, as appropriate, harmonised standards laying down the methodology for the calculation and measurement of compliance with the minimisation requirements. These standard(s) will be an update of the existing standard EN 13428:2004 to account for the changed performance criteria set out in Annex IV of the Regulation and will outline the methodology for demonstrating compliance with the minimisation requirements for all packaging. Once adopted, economic operators will be able to use the updated standard and thus benefit from the presumption of conformity with the minimisation requirement. 20 Assessment of options for reinforcing the Packaging and Packaging Waste Directive’s essential requirements and other measures to reduce the generation of packaging waste - Publications Office of the EU, page 26: an identical packaging format in terms of size, weight and volume is used to pack different amounts of the same type of screws. In the first case, the packaging fits 100 screws, whereas in the second case the same packaging contains 20 screws of the same size. Therefore, the second case (i.e. pack of 20 screws) is considered over-packaged, both in terms of the volume and weight of the pack. 31 In addition, for the most common packaging types and formats, the Commission will request the European standardisation bodies to prepare standard(s) specifying the maximum adequate weight and volume limits and, where appropriate, wall thickness and maximum empty space. 4) What are the ‘most common packaging types and formats’ mentioned in Article 10(3)? The Commission will identify the ‘most common packaging types and formats’ in its forthcoming standardisation request pursuant to Article 10(3) PPWR. These types and formats will be identified in collaboration with the industry and other stakeholders and be based on the available market data in terms of units placed on the market, on a level of granularity which accounts for the packaging functionality, packaging material and shape, as well as the packaged product. The potential for minimisation will also be considered in the framing of the standardisation request. 5) Which packaging is exempted from the minimisation requirements? The following packaging is excluded from the minimisation requirements (Article 10(2)): Packaged products or beverages that benefit from a geographical indication protected under Union law, such as under Regulation (EU) No 1308/2013 for wine, Regulation (EU) 2019/787 for spirit drinks or Regulation (EU) 2023/2411 for craft and industrial products or is covered by a quality scheme as referred to in Regulation (EU) 2024/1143. If packaging design is protected by a Community design pursuant to Council Regulation (EC) No 6/2002 (64) or by design rights falling within the scope of Directive 98/71/EC of the European Parliament and of the Council (65), including international agreements having effect in one of the Member States. For the exemption to apply, the packaging design must be protected before 11 February 2025, and the application of the minimisation requirements affect the packaging design in a way that it would alter its novelty and its individual character If packaging shape is a trademark falling within the scope of Regulation (EU) 2017/1001 (66) or Directive (EU) 2015/2436 (67), including trademarks registered under international agreements having effect in one of the Member States. For the exemption to apply, the trademark must be protected before 11 February 2025, and the application of the minimisation requirements affect the packaging in a way that the trademark can no longer distinguish the marked product from those of other undertakings. If the economic operator wants to use these exemptions, it will need to provide evidence related to them in the technical documentation. It will not be sufficient to provide a licencing number. It will also be necessary to demonstrate the existence and assessment of other conditions. 6) How will the packaging ’shape’ affect the packaging minimisation assessment? Firstly, the economic operator will have to consider if its packaging is covered by the exemption in Article 10(2)(a) related to shapes which are protected trademarks and if the conditions set out in that provision for exemption from the minimisation requirements are fulfilled. The verification of said conditions needs to be demonstrated by the economic operator. If the packaging is not covered by the exemption, economic operators will apply the updated harmonised standard on the methodology for packaging minimisation assessment to be requested by the Commission pursuant to Article 10(3). This updated harmonised standard will take the packaging shape into account in its methodology. For example, if a specific shape is necessary to provide packaging for the packaging functionality, such as safe-handling design, child resistance, anti-tamper, anti-theft, anti-counterfeit, hazard warnings, or specific product characteristics. 32 7) What is the relationship between the minimisation requirement in the PPWR and the ones in the ESPR? The general principle is that acts under the ESPR only take the lead on regulating products when their environmental sustainability dimensions either cannot or have not been fully and appropriately addressed by other instruments. This principle applies also to packaging. As explained in Recital 25 of the ESPR, if needed, the ESPR may complement the PPWR by setting product-based requirements that focus on the packaging of specific products. The ESPR will not, however, set general eco-design or sustainability requirements for packaging as a product group because these requirements are laid down in PPWR. 33 VIII. LABELLING 1) Will labelling requirements for reusable packaging under Article 12(2) apply at the level of each individual packaging? Reusable packaging must be designed to ensure a minimum number of rotations, which will be established in the delegated act to be adopted under Article 11(2). The obligation to calculate and report on the number of rotations for reusable transport packaging will depend on the type of reuse system. Namely, open-loop reuse systems without a system operator are exempted from this obligation and from the obligation to bear a reusable packaging label and a QR code. According to Article 12(2), reusable transport packaging circulating within closed-loop systems will have to bear a reusable packaging label and a QR code or another standardised open digital data carrier that will allow for tracking of the individual packaging and the calculation of its rotations. The detailed rules, including the label informing consumers that a packaging is reusable, will be clarified in the implementing act to be adopted under Article 12(6). This act will also specify situations when it is considered that an individual QR code and tracking of rotations is not feasible and the calculation of rotations can thus be made based on an average estimation. 2) Under what circumstances are labels, marks, symbols, or inscriptions considered misleading? Marks, symbols, labels, or inscriptions should not mislead consumers regarding sustainability requirements of packaging such as its recyclability, recycled content, reusability, compostability, bio-based content, hazardous substances content or waste management options (Article 12(8)). To further understand the notion of misleading claim please refer to Directive (EU) 2024/82521‘Empowering Consumers for the Green Transition’. Claims are considered misleading if they cause the consumers to make decisions that they would not otherwise make. 3) Should a packaging bear a national DRS label when it is imported from one Member State to another? Labelling of packaging covered by the mandatory deposit and return systems has not been harmonised in the PPWR. Therefore, products will have to comply with the DRS label of the Member State where they are made available on the market. Member States may require that such packaging be marked with a ‘harmonised colour label’ as specified in Article 12(1), fourth subparagraph. If products are imported in the context of private imports, i.e. directly by the end user and with no intention to commercialise them, this is not considered ‘making available on the market’. Member States cannot prohibit the affixing of DRS labels in place in other Member States. 4) Which are the substances of concern that need to be identified by the labelling requirements in Article 12(7), second subparagraph? The European Chemicals Agency (ECHA) is currently conducting a study to identify the substances of concern (SoC) in packaging that could affect human health and those that can impact packaging reusability and recyclability. Based on this input, the Commission will develop an implementing act establishing the methodology for labelling of SoC by means of digital labelling. 21 Directive (EU) 2024/825 of the European Parliament and of the Council of 28 February 2024 amending Directives 2005/29/EC and 2011/83/EU as regards empowering consumers for the green transition through better protection against unfair practices and through better information (OJ L, 2024/825, 6.3.2024) 34 IX. ENVIRONMENTAL CLAIMS 1) Will businesses be allowed to make environmental claims about features that are equivalent to those established by the Regulation? Article 14 applies only to ‘properties for which legal requirements are set out in this Regulation’. Environmental claims and sustainability labels related to, e.g., recyclability, compostability, recycled content, reusability, weight and volume minimisation, fall under the PPWR and manufacturers will need to make sure that such claims comply with Article 14, i.e. relate to properties that go beyond minimum requirements set by the PPWR and specifies if the claim refers to the whole packaging unit or a specific part of it. As regards environmental claims related to sustainability requirements outside the scope of this Regulation, for example recycled content in aluminium packaging, they must comply with the existing EU rules on environmental claims, in particular the Empowerment of Consumers Directive (EU) 2024/825, which amends the Unfair Commercial Practices Directive (2005/29/EC) and the Consumer Rights Directive (2011/83/EU). For further information on the relationship between the Unfair Commercial Practices Directive and other legislation, please, consult the Commission Guidance document on its interpretation22, in particular parts 1.2.1. on relationship with other EU legislation and part 4.1.1.1 on the Interplay with other EU legislation on environmental claims, which explains that lex specialis (e.g. PPWR) prevails over lex generalis (UCPD) in case of conflict. 2) In case the manufacturer wants to make a claim about the share of recycled content on the packaging unit, which threshold should be considered as the minimum requirement established by law? Will it be possible to make claims about 10, 20 or 50% of recycled content in each unit? In case a manufacturer makes a claim about the share of recycled content in packaging placed on the market, the applicable minimum targets (calculated as an average per manufacturing plant and per year), will apply and the manufacturers will be allowed to make the claim only if the recycled content exceeds those targets. For recycled content, the calculation and verification methodology will be established by 31 December 2026 in an implementing act, and environmental claims will need to comply with these rules. The voluntary label for recycled content will be developed by the Commission. 3) Does Article 14 apply only for environmental claims which refer to requirements stated in the PPWR (e.g. recyclability) or also for any other kind of environmental claims on sustainable packaging? Article 14 applies only to ‘properties for which legal requirements are set out in this Regulation’. Therefore, as regards environmental claims which are not regulated under the PPWR, e.g. related to recycled aluminium content, they must comply with the existing EU rules on environmental claims, in particular the Empowerment of Consumers Directive (EU) 2024/825. 22 Commission Notice – Guidance on the interpretation and application of Directive 2005/29/EC of the European Parliament and of the Council concerning unfair business-to-consumer commercial practices in the internal market (OJ C 526, 29.12.2021, pp. 1–129). 35 X. OBLIGATIONS OF MANUFACTURERS 1) Article 15(1) states that manufacturers must place on the market only packaging which complies with the requirements set out in Articles 5 to 12. Does this obligation apply exclusively to packaging manufacturers? The obligation to place on the market only compliant packaging does not apply only to economic operators defined as the manufacturer, but also to importers and distributors. Pursuant to Article 15(1), ‘manufacturers shall only place on the market packaging which is in conformity with the requirements laid down in or pursuant to Articles 5 to 12.’ The conformity assessment procedure (Article 38) can be carried out by the manufacturer or by someone else on their behalf (e.g. a laboratory or a certification scheme), in accordance with Article 15(2). The EU declaration of conformity (Article 39) must be drafted by the manufacturer, based on the information and documentation provided by suppliers pursuant to Article 16(1), or by an authorised representative, appointed by the manufacturer by a written mandate pursuant to Article 17. This means that the manufacturer is the sole economic operator bearing legal responsibility for packaging compliance with the sustainability and labelling requirements, regardless of the fact who might have actually drafted the EU declaration of conformity or parts of it. 2) When is the effective date of application of Articles 15 and 18 of the PPWR on obligations of importers and manufacturers? PPWR will become applicable on 12 August 2026, and this includes provisions on the obligations of manufacturers and importers. However, these provisions must be read in conjunction with the substantive obligations, as defined in various provisions of the Regulation, notably in Articles 5 – 12. Some substantive provisions have different application dates, which are often linked to the adoption of a specific implementing measure by the Commission. For example, as regards recyclability, manufacturers must comply with the recyclability requirements and perform the conformity assessment procedure in accordance with Article 38 and Annex VII of the PPWR only two years from the adoption of the delegated act on design for recycling requirements. On the assumption that this delegated act will be adopted by the Commission in January 2028 and will fully harmonise design for recycling requirements and the related assessment methodology, the binding recyclability performance criteria will only apply from 1 January 2030 or two years from the date of entry into force of the delegated act. Other effective dates of application of sustainability and other key requirements under PPWR: - Recycled content in plastic packaging: 1 January 2030 or three years from the date of entry into force of the implementing act referred to in Article 7(8) PPWR. - Minimisation (Article 10(1) – (2)): 1 January 2030. - Void space requirement for transport, grouped and e-commerce packaging: from 1 January 2030 or three years after the entry into force of the implementing act under Art. 24(2); as regards void space in sales packaging, see Art. 10. - Reusable packaging (Art. 11): from the date of entry into force of the Regulation (11 February 2025), but minimum number of rotations will have to be complied with depending on the date that will be specified in the implementing act referred to in Article 11(2) to be adopted by 12 February 2027. - Reuse targets: from 1 January 2030 or 18 months from the date of entry into force of the implementing act on the calculation of reuse targets, referred to in Article 30(3), to be adopted by 30 June 2027. 36 3) Should suppliers be required to mark ‘plain’ packaging, such as plastic carrier bags, with a serial number? Suppliers of packaging or packaging material are not manufacturers according to the definition of manufacturer in Article 3(1), point (13), except when the ‘manufacturer’ is a microenterprise and the supplier is located in the same Member State. The Regulation does not require that suppliers of packaging are identifiable on the packaging or via a data carrier. They must only ensure that the manufacturer has all the information and documentation necessary to demonstrate packaging conformity. The Regulation does not require either that suppliers identify packaging with a type, batch or a serial number; this is an obligation that falls on manufacturers. However, in practice, it may well be that it will be the suppliers of packaging who will ensure that packaging is identifiable, as this is often done at the production stage. 4) What are the obligations of importers or distributors who supply packaging materials? UPDATED! In general, suppliers of packaging are not responsible for drawing up a declaration of conformity. However, pursuant to Article 16 of the Regulation, they are required to provide the manufacturer of the packaging ‘with all the information and documentation necessary for the manufacturer to demonstrate the conformity of the packaging with this Regulation’, including all the relevant technical documentation. The company which places packaging or packaged products on the EU market (manufacturer/importer) has the legal responsibility for ensuring overall compliance with relevant PPWR requirements, including those stemming from Articles 5-12. It will therefore need to ensure that compliant packaging is used by obtaining the required documentation from its suppliers. Suppliers must provide this information and documentation, as established in Article 16(1), and can therefore not refuse to provide the relevant documentation to the manufacturer. 5) What should happen to packaging held in stock or already produced prior to 12 August 2026, but not yet placed on the market by that date? Will operators be obliged to destroy, remanufacture or re-label it? NEW! Packaging that has not been placed on the market by 12 August 2026, but that has already been produced and sits in stock, does not have to be destroyed, remanufactured or re-labelled. To meet the requirements under Article 15(5) and 15(6), which establishes that packaging must bear a unique identification as well as the manufacturer’s name and address, it is possible to provide the required information by means of an accompanying document. This is also the case for reusable packaging already placed on the market. However, for packaging that is manufactured after the 12 August 2026, an accompanying document must only be used when it is not possible to affix the unique identification and the name and address directly on the packaging. Packaging that has been placed on the market before 12 August 2026 can remain on the market, even if it is non-compliant with PPWR. 6) If the supplier of already produced packaging no longer exists, or if a supplier is unwilling to provide the necessary information, how can the manufacturer of the packaging show compliance? NEW! Where the necessary information for packaging that is manufactured before 12 August 2026 is missing or insufficient, the manufacturer under the PPWR must make best efforts to provide the necessary information, for example by requesting it from the former supplier or, in the case of a business takeover/merger/acquisition, from the new resulting company, or by making own assessments. 37 7) Under what circumstances can the obligations under Article 15(5) & (6) be fulfilled via accompanying documents? NEW! These obligations apply to all packaging placed on the market after 12 August 2026, regardless of the type of packaging or the material used. Where the size or nature of the packaging does not allow for the affixing of a unique identifier and the name and address of the manufacturer, as established under articles 15(5) and (6) of the PPWR, the information can be provided in a document accompanying the packaging. Whether or not it is possible to affix the information on the packaging should be assessed on a case-by-case basis, taking into account the physical dimensions, shape and functional characteristics of the packaging. In addition, packaging that has not been placed on the market by 12 August 2026, but that has already been produced or sits in stock, may also use an accompanying document to meet these requirements before being placed on the market. 8) In practice, do the requirements of Article 15(5) mean that every individual unit of packaging needs to be traceable? NEW! Article 15(5) requires packaging to bear information enabling its unique identification, such as a serial number, batch number or another equivalent element. The purpose of this provision is to facilitate traceability of the packaging placed on the market for compliance verification and market surveillance purposes – i.e. to enable the packaging to be identified (for example a packaging type, model or production batch), so that it can be linked to the relevant technical documentation and declaration of conformity. The Regulation does not require every single component of a packaging unit to be individually marked for traceability purposes. For example, for a yoghurt cup consisting of a plastic cup, lid and sleeve or label, it should be sufficient if the required information is displayed on only one component of the sales packaging. In addition, where the size or nature of the packaging does not allow for the identifier to be on the packaging itself, Article 15(5) allows it to be provided in a document accompanying a packaged product. In general, identification may be provided through batch numbers or other equivalent means and may refer to types or production batches of packaging rather than to each individual item. Commonly used and standardised packaging items such as adhesive tapes, generic plastic bags, or desiccant bags that are bought from suppliers are normally traceable at the level of the production batch, and not at the level of each individual unit. 9) Can manufacturers delegate responsibilities to third parties? NEW! As Article 15(1) sets out, manufacturers are responsible for ensuring the compliance of the packaging they place on the market with the PPWR rules. Before placing packaging on the market, the manufacturer must therefore undertake certain steps, including those outlined in Article 15(2): carry out a conformity assessment procedure, draw up an EU declaration of conformity and compile the other technical documentation required (see Articles 38 & 39 and Annexes VII & VIII). In relation to the conformity assessment procedure: as per Article 15(2), manufacturers may carry this out themselves or opt to have it carried out on their behalf (e.g. by a laboratory or a certification 38 scheme). In relation to the EU declaration of conformity: as per Article 17, this may be drafted by the manufacturer (based on the information and documentation provided by suppliers pursuant to Article 16(1)) or drafted by an authorised representative, appointed by the manufacturer by a written mandate (in which case overall responsibility for the compliance of the EU declaration of conformity will still remain with the manufacturer). In relation to the technical documentation: as Article 17 sets out, the obligation to draw this up cannot be delegated. Manufacturers must therefore assume this responsibility themselves. Article 16 of the PPWR requires suppliers to provide manufacturers with the relevant information and documentation necessary to prove compliance. The Regulation therefore establishes a system whereby the packaging supplier provides the technical information necessary to demonstrate compliance, while the manufacturer remains the economic operator legally responsible for placing compliant packaging on the market. As Article 17(2) also makes clear however, an authorised representative appointed by a manufacturer may be made responsible for certain other tasks, including keeping the declaration of conformity and technical documentation at the disposal of the national authorities for the required amount of time, cooperating with the national authorities and making relevant documents available to them, on the manufacturer’s behalf. Regardless of who the manufacturer may appoint to carry out some of the above-mentioned tasks, the manufacturer will remain the sole economic operator bearing legal responsibility for packaging compliance under the PPWR, and this legal responsibility cannot be transferred by means of contractual arrangements. 10) Manufacturers and importers are required to keep records of the ‘conceptual design, manufacturing drawings and materials of components’ of their packaging. Is it sufficient if the suppliers retain this design information, and make it available to authorities upon request? NEW! The manufacturer bears legal responsibility for ensuring that the packaging it places on the market is compliant with the obligations in the PPWR, including those stemming from Articles 5-12. To document compliance to national authorities, Articles 15(3) and 18(7) establish that manufacturers and importers of packaging must keep the technical documentation referred to in Annex VII for 5 years for single use packaging and 10 years for reusable packaging. Annex VII sets out that the technical documentation must at least include “conceptual design, manufacturing drawings and materials of components”. While this provision will need to be complied with by manufacturers, manufacturers should ensure the confidentially of commercially sensitive information in accordance with relevant EU and national law. 11) Article 18 lays down obligations on importers. What should an importer be aware of? NEW! If a packaging is imported from a third country, the importer is responsible for ensuring that the manufacturer established outside the EU has complied with the applicable requirements of the PPWR. To demonstrate that this is the case, the importer must ensure, as of 12 August 2026, that: • The conformity assessment procedure referred to in Article 38 has been carried out by the manufacturer in the third country and that that manufacturer has drawn up the Declaration of Conformity; • The manufacturer has complied with the requirements set out in Article 15(5) and 15(6); • The packaging is accompanied by the required documents. 39 Article 18 requires importers to indicate their name, registered trade name or registered trademark, and their postal address and electronic means of communication, where available, on the packaging or, where this is not possible, on an accompanying document. This also applies to imported generic or unbranded packaging materials (e.g. paper sheets) that the importer intends to place on the market, as the absence of information on the packaging does not remove the obligation to demonstrate compliance. The importer placing such packaging on the market will need to assume responsibility for the documentation and compliance requirements. As a general principle, importers should engage in dialogue and make necessary contractual arrangements with suppliers or manufactures in third countries to ensure that the products they import are in compliance with the relevant rules under PPWR. In the case of generic and/or unbranded imported packaging, a document that accompanies the packaging upon import, such as a shipping document, may be used to meet the requirements under Article 18(2)(d), provided that all information required is included in it. 12) Does packaging transiting the EU towards non-EU destinations need to comply with PPWR rules? NEW! Transit through the EU must be handled in accordance with general EU product rules and customs legislation. As specified in the Commission Guidance, point 19, packaging or packaged products intended to be placed on the EU market need to comply with the PPWR rules. If the packaging or packaged products will not be ‘declared for the release for free circulation’ but remain in transit in the EU on the way to a non-EU destination, compliance with PPWR requirements is not required as it is not considered placed on the market. For imported products, placing on the market is generally considered to occur when the products are ‘declared for the release for free circulation’ 23. The purpose of release for free circulation is to fulfil all import formalities so that the goods can be made available on and circulate freely in the EU market. Products declared as such thus need to be compliant with the applicable Union harmonisation legislation. In practice, however, the release for free circulation and the placing on the market may not take place at the same time, e.g. in the case of distance sales, when placement on the market occurs before release for free circulation. If a company imports packaged products to the EU and subsequently exports them to a third country, the packaged products will only have to comply with the PPWR requirements if they are placed on the market in the EU. Placing on the market requires an offer or an agreement between two or more legal or natural persons for the transfer of ownership, possession or any other property right concerning the product in question. Therefore, if goods only transit the EU, without being released for free circulation or placed on the market, they are not required to comply with PPWR rules. 13) Can information already required e.g. under food legislation be considered sufficient to fulfil the requirements set out in Article 15(5) and 15(6) of the PPWR? NEW! 23 Please consult the Commission’s ‘Blue Guide on the implementation of EU product rules’, section 2.3 and 2.5), as well as the Commission Notice for the PPWR, point 19. 40 Food legislation and the PPWR are different legislative frameworks and pursue different objectives and as such should be viewed as complementary. Whether or not information provided under food legislation will be sufficient to fulfil the requirements set out in Articles 15(5) and 15(6) of the PPWR will depend on the particular provision of food legislation and the type and placement of the information to be provided thereunder. Article 15(5) of the PPWR: Article 15(5) of the PPWR requires that packaging bears a type, batch or serial number or other element to allow its identification or, where the size or nature of the packaging does not so allow, the required information may be provided in a document accompanying the packaged product. The identification of packaging is required to enable the competent authority/ies (which may not be the competent authority/ies for food products) to link packaging to the declaration of conformity (the “DoC”) drawn up by the manufacturer of the packaging for the purposes of the PPWR. Traceability information provided for the purposes of food legislation will not fulfil the requirements of Article 15(5) of the PPWR unless such information can ensure that the packaging is identifiable to the competent authority/ies, can be linked to the DoC and furthermore, is placed on the packaging itself or in an accompanying document. Article 15(6) of the PPWR: the manufacturer of the packaging must be determined based on the definition of ‘manufacturer’ in the PPWR, whereas Article 8 of Regulation (EU) No 1169/2011 on the provision of food information to consumers 24 (FIC Regulation) offers flexibility to decide who the responsible food operator is. Therefore, the responsible food operator and the manufacturer of the packaging may not always be the same natural or legal person. The fact that one operator is identified for the purposes of food law does not determine the identity of the manufacturer for the purposes of the PPWR. Where the food business operator and the manufacturer of the packaging are the same natural or legal person, it is important to ensure that the information provided fulfils the requirements of both Union laws. For example, Article 9(1)(h) of the FIC Regulation requires that the name or business name and address of the food business operator be provided, and Article 12 of the FIC Regulation sets out the requirements for the placement of such information. Article 15(6) of the PPWR requires the name, registered trade name or registered trademark of the manufacturer of the packaging as well as the postal address at which and, where available, the electronic means of communication by which they can be contacted be provided. Furthermore, Article 15(6) of the PPWR specifies how this information is to be provided i.e. in physical form or in a QR code on the packaging, or if this is not possible, in a QR code on the grouped packaging (where grouped packaging is used and bears a data carrier for the provision of information in relation to Articles 12(1), 12(2) and 12(4)) or in an accompanying document. Therefore, the provision of information on the food business operator in accordance with the FIC Regulation will not necessarily meet the requirements for the provision of information on the manufacturer of the packaging in Article 15(6) of the PPWR. Where an economic operator wishes to provide one set of information for both the food business operator and the manufacturer of packaging, they must do so in a form that satisfies the requirements of both Union laws i.e. compliance with the FIC Regulation alone is not sufficient. 24 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304 22.11.2011, p. 18) 41 14) Who is the manufacturer of custom-made transport packaging that does not bear a name or trademark? NEW! If a company orders a custom-made packaging from another company, the company making the order will be considered the manufacturer under the PPWR. This is due to the fact that, for packaging that does not bear a name or trademark, the decisive criterion is who places the order and decides on the design specifications for that packaging. If the packaging is custom-made for a specific product, the packaging characteristics are based on the product, and therefore the decisive power will rest with the company that orders the custom-made packaging. The company that supplies the packaging to the manufacturer must provide the manufacturer with the necessary technical documentation, as specified in Article 16 of the PPWR. 42 XI. EMPTY SPACE 1) Who is the obligated party to comply with the empty space requirements under Article 24? Article 24(1) establishes maximum empty space ratio for grouped, transport and e-commerce packaging which needs to be met by the economic operator who fills such packaging. This may be the manufacturer as defined in Article 3(1), point (13), as well as other economic operators who make packaged products available on the market. 2) How should the term ‘minimum necessary’ in Article 24(4) be understood? The empty space ratio for sales packaging means the difference between the total internal volume of the sales packaging and the volume of the packaged product. For assessing compliance with this paragraph, space filled by filling materials, such as paper cuttings, air cushions, bubble wraps, sponge fillers, foam fillers, wood wool, polystyrene or styrofoam chips, shall be considered as empty space. For empty space ratio in sales packaging, there is no maximum threshold established in the PPWR; instead, it is left to the relevant economic operator who fills sales packaging to minimise the empty space and to demonstrate this in the technical documentation. This provision should be read in conjunction with Article 10 on packaging minimisation. 3) Are the design patents covered by the 50% empty space ratio requirement? Contrary to Article 10 on packaging minimisation, Article 24 does not have specific exemptions for packaging covered by packaging design rights or trademarks. However, the 50% threshold applies only to grouped packaging, transport packaging and e-commerce packaging (Article 24(1)). 4) How will round products and other irregular shapes be addressed by the methodology for the calculation of the empty space? By 12 February 2028, the Commission shall adopt implementing acts to establish the methodology for the calculation of the empty space ratio for grouped packaging, transport packaging and ecommerce packaging (Article 24(2)). That methodology shall consider the special characteristics of packaging which needs to be placed in an empty space that is large enough to comply with the applicable legal requirements or to protect the product. The methodology shall take into account packaged products of irregular shape, packaging containing more than one sales packaging or product, packaging containing liquid products, packaged products the content of which can easily be damaged and packaged products that can be damaged by larger products due to their small dimensions, and the minimum space on the transport packaging to enable shipment labels to be affixed. Economic operators will need to comply with the empty space ratio threshold by 1 January 2030 or 3 years after the entry into force of this implementing act. The methodology will be based on a wide range of examples, including irregular shapes. 43 XII. BANS AND THE USE OF CERTAIN PACKAGING 1) What instruments are available to ensure legal harmonisation and predictability of the implementation of Annex V? The Regulation empowers the Commission to adopt guidelines by February 2027, in consultation with Member States and EFSA (European Food Safety Authority), to explain Annex V in more detail, including examples of packaging formats in scope, and any exemptions from the restrictions, and provide a non-exhaustive list of fruits and vegetables that are excluded from point 2 of Annex V (Article 25(6) PPWR). The Commission has started preparatory works for the guidelines and intends to ensure that these guidelines are based on science and on the latest technological developments. The intention is to ensure a common understanding and the equal implementation of the packaging formats in scope, and any exemptions from restrictions. While the Regulation does not empower the Commission to harmonise the list of exempted fruits and vegetables via an implementing or delegated act, the Commission, together with EFSA, has been working hard to ensure a solid scientific basis for the future guidelines, and expects that Member States will follow the guidelines, once published. Finally, the Regulation contains a specific review clause requiring the Commission to assess, by 2032, the packaging bans and empowering it to propose new restrictions or to amend the existing derogations and exemptions. 2) What do the terms ‘unprocessed fresh fruits and vegetables’ and ‘demonstrated need’ in point 2 of Annex V mean? The terms ‘unprocessed fresh fruits and vegetables’ and ‘demonstrated need’ will be further clarified after the formal consultation with the related stakeholders and EFSA, in the context of the development of the Commission guidelines. The term ‘unprocessed fresh fruits and vegetables’ refers to fresh fruit and vegetables that have not been altered. When such fruits and vegetables weigh less than 1,5 kg, they cannot be prepacked. The Commission will develop guidelines explaining, based on scientific studies, which unprocessed fresh fruit and vegetables are appropriate for exemptions. 3) Is it possible to extend the scope of the illustrative formats and products covered by point 4 of Annex V to additional sectors (e.g. schools), beyond the exemptions explicitly listed? Point 4 of Annex V concerns single-use plastic packaging for condiments, preserves, sauces, coffee creamer, sugar and seasoning in the HORECA sector. It expressly exempts only (a) take-away ready-prepared food intended for immediate consumption and (b) the healthcare sector. The illustrative formats will be developed in the guidelines. The PPWR does not provide a legal basis to enlarge the list of exemptions to other sectors. 4) How shall the term ‘necessary to facilitate handling’ under point 1 of Annex V to be understood? The restriction in question concerns ‘single- use plastic grouped packaging used at the point of sale (…), designed as convenience packaging to enable or encourage consumers to purchase more than one product’. What is targeted is unnecessary single-use plastic grouped packaging designed for ease of use and portability, and which also incites consumers to buy more. Both conditions should be fulfilled for the ban to apply. The most common examples of such packaging are collation films and shrink wraps, grouping two or more stock keeping units (SKUs). 44 Other examples and other guiding principles will be provided in the guidelines. As regards B2B situations, they are not covered by the ban. The Commission guidelines will further specify how the term ‘necessary to facilitate handling’ will be operationalised, through illustrative examples. 5) Are biodegradable or compostable bags banned by Annex V, point 6? All very lightweight plastic carrier bags (thus including compostable or biodegradable bags) are banned under Annex V, point 6. However, if such bags are needed for hygiene purposes or provided as sales packaging for loose food to prevent food waste, they are excluded from this harmonised ban. Very lightweight plastic carrier bags, which are needed for hygiene purposes or provided as sales packaging for loose food to prevent food waste’, although not banned by Annex V, point 6, are in principle included in the 40% reduction target set out in Article 34(1) PPWR for all lightweight plastic carrier bags. However, Member States may decide to exempt that specific type of bag from the reduction target (Article 34(4) PPWR). To reach the 40% target, Member States may decide to ban very lightweight plastic carrier bags, including compostable or biodegradable bags, which are needed for hygiene purposes or provided as sales packaging for loose food to prevent food waste However, marketing restrictions (bans) by Members States must be proportionate and nondiscriminatory (Article 34(2) PPWR). 6) Can hotel miniature cosmetics be available on demand? Can derogations for products packaged for hygienic reasons, such as toothbrush and cotton pads, be expected? Annex V, point 5, refers to ‘single-use accommodation sector packaging intended for an individual booking’. The Regulation does not define the terms ‘cosmetics, hygiene and toiletry product’, nor does it exempt miniature packaging available on demand or purchased at the hotel premises, but only those intended for an individual booking. To ensure a harmonised approach, the Commission is mandated to explain Annex V in more detail, including examples of the packaging formats in scope, and any exemptions from the restrictions, by publishing guidelines by 12 February 2027 (Article 25(6) PPWR). The timely adoption of the Commission guidelines will ensure that the scope of the provision is sufficiently clear almost three years ahead of the application date. The Commission intends to consult the relevant stakeholders, including the hospitality sector, before publishing them. Furthermore, it should be recalled that only packaging is banned and not products as such, which could therefore still be made available without packaging. 7) Will single-use plastic food and beverage packaging be banned from entertainment and sporting events and festivals? Sport and entertainment venues and festivals are included in the ‘HORECA’ definition (Article 3(1), point (35)), which refers to ‘Accommodation and Food Service Activities according to NACE Rev. 2 – Statistical classification of economic activities. NACE Rev. 2 includes guidance which explains that the decisive element is that meals, including beverages, fit for immediate consumption are offered at the facility, and not the kind of facility providing them. However, establishments in the HORECA sector that do not have access to drinking water are expressly exempted from the ban, pursuant to Annex V, point 3. 8) Is hotel room service covered by the ban in Annex V, point 3? How about if a hotel delivers food outside the restaurant’s premises? 45 The packaging ban in Annex V, point 3, applies to the HORECA sector, which should be understood in line with the definition in Article 3(1), point (35), which in turn refers to NACE Rev. 2. Hotels are included in the HORECA sector, which means that room service falls under the ban. However, if a hotel delivers food and beverages in packaging outside their premises, then such packaging is not banned under Article 25 and Annex V, point 3. However, in that case, the obligations relating to refill and re-use in the take-away sector, as specified under Articles 32 and 33, apply. 9) Is the list of examples outlined in the ‘illustrative example’ column of Annex V exhaustive? The list is not exhaustive, as its wording (‘illustrative example’) demonstrates. The formats that fall within the scope of the bans will be further explained in the Commission guidelines to be developed by 12 February 2027, as mentioned in the answers to the previous questions. 46 XIII. REUSE AND REFILL Reusable packaging (Article 11) 1) How will the rotations or trips of reusable packaging be calculated? Reusable packaging must be designed to ensure a minimum number of rotations, which will be established in the delegated act to be adopted under Article 11(2). The obligation to calculate and report on the number of rotations for reusable transport packaging will depend on the type of reuse system. In particular, open-loop reuse systems without a system operator are exempted from this obligation (Annex VI, Part A, section 1 (i)). Closed-loop reuse systems with system operators must report on the number of rotations or trips for each individual reusable packaging, or for an average estimation if the calculation for each individual reusable packaging is not feasible. The detailed rules on the calculation of the achievement of the re-use targets contained Article 30 will be clarified in the implementing act to be adopted under Article 12(6). This act will also specify the situations where it is considered that an individual QR code and tracking of rotations is not feasible and the calculation of rotations can be made based on an average estimation. Manufacturers need to demonstrate that the design of reusable packaging and the related system for reuse allow packaging to comply with the minimum number of rotations requirement. This will need to be done at the time of placing packaging or a packaged product on the market in the technical documentation and applies both to reusable packaging circulating in open loop and closed loop reuse systems. According to Article 27 and Annex VI, reuse systems must be designed to ensure that reusable packaging rotating within them completes at least the minimum intended number of rotations as set out in the delegated act. This will be verified by the Member States’ market surveillance authorities (Article 62(1), point (h)). Reuse systems 2) What is an ‘open loop’ reuse system and what are some concrete examples of such systems? Open loop reuse systems are characterised by interoperability where reusable packaging can circulate across different companies, locations, product categories, or sectors rather than being returned to the single system operator. Open loop reuse systems do not necessarily mean that reusable packaging becomes the property of the consumer once paid for; this will depend on the business model. Such reuse systems are normally characterised by using standardised packaging, shared infrastructure (e.g. for collection, washing and redistribution), and are often coordinated by a system operator, who manages the logistics and ensures quality, even if the existence of a system operator is not a legal requirement under the PPWR. Under the PPWR, open-loop systems without a system operator are exempted from the reuse labelling requirements and from the reporting on the number of rotations achieved. Examples of open loop systems without a system operator are the following: The 0.33-liter longneck reusable bottle system (in Germany): this system is mostly used by brewers, but also by mineral water companies and other carbonated soft drink producers. Although there is a standard for the bottle issued by the German Brewers Association and a licensing system for participants, there is no system operator. 47 The Euro Pallet: this system has a standard for the pallets, and licensees for production are issued, but there is no system operator or system management, even though an association (i.e., EPAL) is responsible for licensing and some other services. 3) How can economic operators using reusable packaging ensure that a proper reuse system is in place? According to Article 27 PPWR, economic operators using reusable packaging must participate in one or more re-use systems and ensure that these systems comply with the requirements laid down in the PPWR, Part A of Annex VI. Economic operators also have the possibility to set up their own re-use system, which must comply with Annex VI. The PPWR establishes the minimum requirements for the reuse systems in its Annex VI, and the sector needs to find ways to cooperate and find the most appropriate solutions, depending on their respective products and the local circumstances, to optimise the functioning of the reuse system. 4) Does a reuse system need to be open for all end users? Re-use systems can vary in size and geographical coverage and range from smaller local systems to larger systems that may span over one or several Member States’ territory. Reuse systems do not have to cover the entire MS. They must however provide equal access and fair conditions to the end users in the area in which they operate. 5) Are reuse systems obliged to carry out extended producer responsibility on behalf of the producers participating in the reuse system? NEW! Extended producer responsibility (EPR) obligations apply to all producers who place packaging on the Union market, whether it is single-use or reusable. While the EPR obligation remains with the producer of the reusable packaging, the reuse system must have in place procedures to ensure that EPR obligations are implemented for the reusable packaging that is part of the system, as specified in Annex VI, Part A, point 1(i) of the PPWR. The provision in Annex VI should be viewed in the context of how re-use systems are organised. In open loop systems, which do not have a system operator, the reusable packaging circulates among an unspecified number of participants as explained in the Commission notice, point 2. Therefore, there may be more than one producer with corresponding EPR-obligations participating in the reuse system. In open loop systems where the re-use system operator is often the manufacturer, there is only one producer responsible for complying with EPR obligations. It will be at the discretion of the producer to determine how to fulfil its EPR obligations, insofar as the Member State has not laid down specified rules. Reuse targets for transport packaging 6) Would the exemption for cardboard boxes from the reuse targets for transport packaging cover interlayers and corrugated cardboard? Article 29(4)(d) exempts cardboard boxes from the scope of the reuse targets. This should be understood as including corrugated cardboard boxes. However, the list of exemptions contained in Article 29(4) must be understood strictly and is limitative, in terms of material, format and use. Therefore, the exemption of cardboard refers only to cardboard boxes and does not include interlayers. Nevertheless, since they are also not a format that is explicitly listed in Article 29(1) and therefore, interlayers are also not concerned by the reuse targets in the first place. 7) What packaging formats are covered by the exemption for flexible formats for transport packaging? 48 Article 29(4)(c) excludes from the targets transport packaging flexible packaging formats that are used for transportation and that are in direct contact with food and feed, as defined in Article 2 and in Article 3, point (4), of Regulation (EC) No 178/2002 or with food ingredients as defined in Article 2(2), point (f), of Regulation (EU) No 1169/201. Therefore, all flexible formats, such as big bags or flexible intermediate bulk containers, as listed in Article 29(1), which are not used for direct contact with food and feed, and also not used for the transportation of dangerous goods (exemption envisaged under Article 29(4)(d)), and not custom- designed for the transportation of large-scale machinery (exemption envisaged under Article 29(4)((b)) should comply with the reuse targets set forth in Article 29(1) to (3). These will be further specified in the context of the Implementing Act under Article 30 on the rules on the calculation of the achievement of the re-use targets. 8) Do ‘pallet wrappings and straps’ count as one format or two separate formats? Pallet wrappings and straps are different packaging formats, but they may be part of the same transport unit for the purpose of calculating compliance with reuse targets under Article 29. This will be further clarified in the implementing act under Article 30 on the rules on the calculation of the achievement of the re-use targets. 9) If a format is not indicated in Article 29(1), can it still be in the scope of the reuse targets for transport packaging? Are all flexible packaging formats, such as sealed bags, in that scope or only those formats listed in paragraph 1? Article 29(1) lays down an exhaustive list of packaging formats covered by reuse targets, including their flexible formats. If a sealed bag is an intermediate bulk container, it is within the scope of the reuse targets, unless it is in direct contact with food and feed, as specified in Article 29(4)(c), in which case it is exempted. 10) What is the definition of a transport unit? The term is not defined nor used in the Regulation, but it might be defined in the future for the purpose of the rules on the calculation of the achievement of the re-use targets in the implementing act to be adopted under Article 30(3). Reuse targets for beverages 11) Do the reuse targets for beverages apply to non-alcoholic and alcoholic beverages individually considered or are they joint targets? The reuse target for beverages provided for in Article 29(6) applies to both alcoholic and non- alcoholic beverages. Final distributors, such as retailers, bars and restaurants, can decide what type of beverages (alcoholic, non-alcoholic or both) they offer for sale to consumers in reusable packaging in order to fulfil the reuse target. Final distributors shall, however, ensure that beverages of their own brand contribute on a fair and proportionate basis towards the achievement of the reuse target. 12) What beverages fall under the scope of the reuse targets for beverages? The beverages within the scope of the reuse targets for beverages in Article 29(6) will be clarified in Commission guidelines to be adopted by 12 February 2027. The guidelines will be developed in consultation with the Member States and other relevant stakeholders. Article 29(7) specifies that certain beverages are exempted from the reuse targets. This includes: 49 • Beverages which are highly perishable within the meaning of Article 24 of Regulation (EU) No 1169/201125. • Milk and milk products listed in Part XVI of Annex I to Regulation (EU) No 1308/201326 and their dairy analogies falling within codes 2202 99 11 and 2202 99 15 of the Combined Nomenclature (CN) in Annex I to Council Regulation (EEC) No 2658/8727. Categories of grapevine products listed in points 1, 3 to 9, 11, 12, 15, 16 and 17 of Part II of Annex VII to Regulation (EU) No 1308/2013.Aromatised wine products as defined in Regulation 13) Can Member States set national reuse targets for beverages? By 2030, Member States shall fulfil the waste prevention targets specified in Article 43(1). Member States may need to complement the harmonised EU measures with national measures, as specified in Article 51(2)(c). Member States may increase the harmonised reuse targets set forth in Article 29(6) or set reuse targets for other beverages. This may include beverages that are expressively exempted under Article 29(7). To implement national reuse targets, a Member State needs to prove that this is necessary to meet the waste prevention targets, so as to avoid compromising the objective of market harmonisation. The targets will need to be notified to the Commission via the TRIS procedure, since such measures are technical regulations. Member States can keep existing national reuse obligations in force until 1 January 2030, but from this date onwards the reuse targets in the PPWR will prevail. For further information on under what conditions that Member States can set national reuse targets, please consult the Commission guidance document. 14) Are operators of restaurants or bars covered by the 10% reuse obligation set on beverages? All final distributors, including the ones in the HORECA sector, are obliged to fulfil the reuse targets for beverages provided for in Article 29. However, to minimise burdens on smaller businesses, final distributors with a sales area of less than 100 m2 are exempted from this obligation by Article 29(6). Final distributors which make less than 1000 kg of packaging available on the territory of the Member State per year and fall under the definition of a micro-enterprise, are also exempted from the reuse target for beverages by Article 29(13)(a). 15) Is single use beverage packaging exempted from the reuse targets for beverages if it is part of a deposit and return system? The obligation to fulfil the reuse targets for beverages in Article 29(6) applies to final distributors such as retailers and restaurants. 25 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304 22.11.2011, p. 18) 26 Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, pp. 671–854) 27 Regulation (EU) 2018/196 of the European Parliament and of the Council of 7 February 2018 on additional customs duties on imports of certain products originating in the United States of America ((OJ L 044 16.2.2018, p. 1) 50 The PPWR does not contain a general exemption for single-use beverage packaging in a deposit and return system, but it provides a large number of exemptions and flexibilities. These includes: o All final distributors with a sales area under 100 m2 are fully exempted (Article 29(10)) o Member States can exempt final distributors on small islands with less than 2000 habitants (Article 29(11)) o Member States can exempt final distributors if their sales area is located in a municipality with population density of less than 54 persons/km2. However, the targets will apply to final distributors with a sales area in population centres with more than 5000 inhabitants (Article 29(11)). o Member States can allow final distributors to form pools for the purpose of meeting their reuse obligations jointly. This means that up to 5 final distributors, for example in densely and remote areas, can share the reuse obligation (Article 29(12)). o All final distributors, who are micro-enterprises and do not make more than 1000 kg. of packaging available in a Member State a year, are fully exempted (Article 29(13)) o Member States can provide further exemptions for final distributors under certain conditions according to Article 29(14) and specified in point 25 of the Commission guidance document. If all exemptions and flexibilities are fully applied in a Member State, the number of final distributors that are required to fulfil the reuse targets for beverages, will be limited. These final distributors would enjoy a high degree of flexibility in meeting the targets ensuring that national circumstances can be taken into consideration. 16) The reuse targets for beverages apply from 2030, which allows time to make the necessary adjustments to apply to the 10 % target. The Commission will review the reuse targets in 2034 in the light of the experiences gained. Under what circumstances will the Commission use its empowerment to exempt certain packaging formats or economic operators from the reuse targets? The Regulation empowers the Commission to adopt delegated acts supplementing the harmonised reuse targets for transport packaging, grouped packaging and beverages provided for in Article 29. Such delegated acts can be adopted under strict legal conditions, and only if it is necessary to take account of the latest scientific and economic developments. The empowerment to adopt delegated acts can only be used to exempt economic operators who face particular economic constraints, or specific packaging formats where achievement of the reuse targets is hindered due to either hygiene and food safety issues or environmental issues following the proper impact assessment as specified under the better regulation guidelines (Better regulation: guidelines and toolbox). 51 XIV. PLASTIC CARRIER BAGS 1) Are compostable waste bags considered lightweight plastic carrier bags? No. Only sales bags (i.e. carrier bags) are covered by the definition of ‘packaging’ in Article 3(1), point (1), and the definition of ‘plastic carrier bags’ in Article 3(1), point (55). Waste bags or doggy bags are products, not packaging, and therefore not covered by PPWR. 2) Can a Member State ban all very lightweight plastic carrier bags? Very lightweight plastic carrier bags that are needed for hygiene purposes or provided as sales packaging for loose food to prevent food wastages are not banned under Article 25 PPWR. Member States may nevertheless decide to ban such bags to meet the sustainable reduction target for lightweight plastic carrier bags under Article 34(1). However, Article 34(2) requires Member States to consider the environmental impact of bags when they are manufactured, recycled or disposed of, and their intended use. Any bans (market restrictions) should also be proportionate and non- discriminatory. Member States must report to the Commission on the consumption of all very lightweight plastic carrier bags, even those which are excluded from the EU-wide or the national bans. 3) What are the requirements for compostable plastic carrier bags under the PPWR? Compostable bags are exempted from the general packaging ban under Article 25, Annex V, point 6, if they are very lightweight plastic carrier bags and needed for hygiene reasons or for loose food to prevent food wastage. The use of other very lightweight or lightweight plastic carrier bags is not banned under Article 25 and Annex V but could be subject to national bans, and other marketing restrictions, adopted under Article 34(2). Member States may also decide that very lightweight plastic carrier bags or lightweight plastic carrier bags that have not been banned at EU or national level should be compostable, under the conditions set out Article 9(2)(a). 52 XV. ASSESSMENT OF THE CONFORMITY OF PACKAGING 1) From which date will companies have to carry out the conformity assessment procedure mandated by the PPWR? In general, the Regulation applies from 12 August 2026 (Article 71). However, certain key provisions will apply only from the date specified therein. In several cases, the entry into force of the obligation is linked to the expiry of a certain time after the adoption of the necessary implementing or delegated acts. This will give stakeholders and Member States sufficient time to adapt. When a relevant provision does not specify a specific date for its entry into application, the general application date applies, and companies will thus have to carry out the conformity assessment procedure by 12 August 2026. 2) Annex VII refers to packaging ‘type’. Does this wording mean the same as ‘types’ in Annex II, table 1? The word ‘type’ referred to in Annex VII concerning the conformity assessment procedure is not the same as the packaging types referred to in Annex II. Annex VII refers to each packaging format or each packaging batch/series and not to packaging materials, which are used for recyclability assessment. 3) What is meant by ‘the unique identification of the packaging’ referred to in Annex VIII? Is the normal product traceability enough? The Regulation does not define ‘unique identification of the packaging”. This wording, referred to in Annex VIII, means that the packaging itself needs to be identified in terms of the type, batch, or serial number. 4) Is it sufficient that a single declaration of conformity is drawn up for packaging or a packaged product? Or is it required that a dossier of all required declarations of conformity is drawn up as a single document? When a packaged product is subject to more than one Union act requiring an EU declaration of conformity, such as the declaration of compliance under Article 15 of Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food or Article 16 of Regulation (EC) No 1935/2004 on food contact materials, a single EU declaration of conformity may be drawn up for all Union acts. That declaration must state the Union acts concerned and their publication references. It may consist of a dossier of relevant individual EU declarations of conformity. Therefore, manufacturers have a margin of discretion in assessing the necessity of drawing up a single declaration of conformity. However, in case a single declaration of conformity is drawn up, it must clearly distinguish the packaging from the packaged products. The manufacturer may decide whether the single declaration of conformity is presented as a dossier with different declarations of conformity or as a single document. If they are presented as a single document, the conformity assessment for the packaged product and the packaging should still be done and presented separately. 5) Is the assessment of conformity to be drawn up for each part of the packaging, such as a bottle, closure and label, or for the entire packaging unit? UPDATED! The assessment of conformity must be performed, and the declaration of conformity drawn up, for the entire packaging unit. In other words, for a packaging unit made up of bottle, closure and label, a single assessment of conformity and related declaration of conformity is sufficient for the unit as a whole, though the declaration should include relevant information on all the separate components used to make up that unit. 53 6) Is a conformity assessment procedure required for the exemptions set out in Article 6 on recyclability and in Article 7 on recycled content? Compliance with the exemptions set out in Article 6 on recyclability and in Article 7 on recycled content should indeed be assessed and be included as part of the technical documentation referred to in Annex VII. 7) The wording ‘type, batch or serial number or other element’ in Article 15(5) suggests that manufacturers can choose to only indicate one of these. Which one? The wording should be understood as a type, batch or serial number or other element allowing the identification of the packaging in question. Manufacturers can choose freely among these. 8) Is a manufacturer obliged to contact the competent authorities in each Member State where its packaging could end up? UPDATED! No, the manufacturer must not notify the competent authorities that it places packaging on their territory. The authorities will contact the manufacturer in case of a check. Only if the manufacturer or distributor becomes aware that a packaging it has placed on the market of a Member State is non-compliant must it inform the relevant authorities about this (see Article 15(8) and Article 19(5)). In cases where a manufacturer delivers products from one Member State to the warehouse of a distributor in another Member State, and the latter serves different national markets from the warehouse, it is the obligation of the distributor to inform the competent authority in each of those Member States about the suspicion of non-compliance. 9) How should a presumption of conformity be construed in relation to the harmonised EU standards? The PPWD sets out a number of requirements for placing packaging on the market (essential requirements). These can be considered as predecessors of the sustainability requirements in the PPWR. Under the PPWD, compliance with these essential requirements was presumed if packaging was compliant with the harmonised standards published in the Official Journal of the European Union28. Under the PPWR, the existing harmonised standards can be used only as guidance (see Recital 58), which means that there can no longer be a presumption of conformity based on these standards. The only exception to this is laid down in Article 70(1), point (b), in relation to the essential requirements on packaging minimisation of the PPWD, which applies until end of 2029. This means that the related harmonised standard can be used for the presumption of conformity until that date. The Commission will consider taking formal measures to repeal the list of the old, harmonised, standards before the PPWR becomes applicable, to avoid any confusion29. 28 EN 13427:2004 ‘Packaging – Requirements for the use of European Standards in the field of packaging and packaging waste’ EN 13429:2004 ‘Packaging – Reuse’; EN 13430:2004 ‘Packaging – Requirements for packaging recoverable by material recycling’; EN 13431:2004 ‘Packaging – Requirements for packaging recoverable in the form of energy recovery, including specification of minimum inferior calorific value’; EN 13428:2004 ‘Packaging – Requirements specific to manufacturing and composition – Prevention by source reduction’; EN 13432:2000 ‘Packaging – Requirements for packaging recoverable by composting and biodegradation’. 29 In case of safety legislation with harmonised standards, the harmonised standards cited in the Official Journal of the European Union under repealed legislation remain valid for the purpose of the presumption of conformity if these references are not withdrawn from the OJEU. This interpretation comes from ECJ ruling T-474/15, Global Garden Products vs. Commission. 54 Presumption of conformity with new or revised harmonised standards in support of PPWR will again be possible from the date when a Commission decision listing the relevant harmonised standards will be published in the Official Journal of the European Union. This publication of references will allow the presumption of conformity to apply from that date onwards. 10) If a packaging is made from the same materials, but has different sizes, should a declaration of conformity be drawn up for all sizes of or is just one declaration for all sizes enough? According to Annex VII, the manufacturer must draw up a written declaration of conformity for each packaging type. The declaration of conformity must identify the packaging for which it has been drawn up. The documentation shall make it possible to assess the packaging’s conformity with the sustainability requirements, laid down in Article 5 – 12. The technical documentation must specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture, use and operation of the packaging. For example, the assessment of the minimisation requirement will depend on the packaged product whereas the assessment of recycled content might depend on the weight of the packaging. It follows that the declaration of conformity should be drafted at the level where packaging has the same characteristics in view of the applicable requirements and the packaged products. Therefore, if the products differ, a manufacturer should not draft a single declaration of conformity for all packaging placed on the market. Concretely, if bottles are of different sizes and contain the same product, and the difference in size does not affect compliance with any of the requirements in Article 5 – 12, then the manufacturer may draft a single declaration of conformity for the bottles. Manufacturers must ensure that the series production of packaging remains in conformity with the Regulation. They must consider if changes in packaging design or in its characteristics, as well as changes in harmonised standards or other rules by reference to which conformity is declared or verified, require reassessment. 11) Does transport packaging also require a conformity assessment and a declaration of conformity? There is no exemption for transport packaging. Indeed, completely different packaging types, such as pallets, pallet collars, wrappings and straps, must undergo separate assessments and must have separate declarations of conformity. 12) Who will monitor if the recyclability assessment carried out by the manufacturer is correct? The manufacturer is obliged to carry out the recyclability performance grade assessment. The result of this assessment must be included in the technical documentation before the packaging is placed on the market. Market surveillance authorities will carry out checks based on their national plans and should apply penalties set at national level in accordance with Article 68. 13) Will economic operators face fines in case they place on the market packaging that is PPWR-compliant but does not comply with national requirements? To reply to this question, it is necessary to distinguish between: 1) additional national requirements adopted pursuant to Article 4(3) and 2) additional national requirements explicitly allowed in specific articles of the PPWR. In the case under point 1), fines are not allowed as they have a deterrent effect on the economic operators and may create market barriers. In the case under point 2), fines are allowed, given that the Regulation explicitly empowers Member States to go beyond the Regulation. However, such 55 national fines still must comply with the general rules of the Treaty, in particular proportionality, which is for Member States to demonstrate. This evidence is to be provided at the time of the TRIS notification. 14) In what language must the declaration of conformity be drafted? NEW! The declaration of conformity must be drafted in the languages of the Member State(s) to which the packaged products are supplied, so that the respective market surveillance authority can verify it upon request. Under Article 39(2) PPWR, the EU Declaration of Conformity “shall be drawn up in, or translated into, one or more languages required by the Member State in which the packaging is placed on the market or made available on the market.” 56 XVI. ENFORCEMENT OF THE NEW RULES (IMMEDIATELY AFTER THE APPLICATION DATE OF 12 AUGUST 2026) 1) Will products be banned from the EU market if their packaging is not compliant with the rules that apply as of 12 August 2026? NEW! No, the enforcement of the obligations applicable as from 12 August 2026 should not disrupt trade flows, supply chains or consumer access to goods. In line with Article 62 of the PPWR, if a Member State becomes aware of any of the instances of non-compliance set out in that Article, it must first require the relevant economic operator to put an end to that non-compliance. In other words, the economic operator should first receive a warning that non-compliance has been identified, and an opportunity to take corrective action, before any other action is taken on the side of the Member State. Only where the non-compliance is not rectified by the economic operator, but instead persists, will Member States be within their rights to take further action (such as prohibiting, recalling or withdrawing non-compliant packaging). Market surveillance authorities should - rather than following a sanction-oriented approach - support the responsible economic operators in complying with the new rules, for instance with awareness-raising, requests for information or requests for corrective action with a reasonable timeline for adaptation. 57 XVII. WASTE PREVENTION 1) How are the packaging waste reduction targets going to be implemented? The implementation of packaging waste reduction targets is the responsibility of each Member State. It is Member States’s responsibility to reach the target and put in place the waste reduction measures necessary to reach the targets set out in Article 43. While the Regulation harmonises several packaging waste prevention measures, such as laying down reuse targets, refill and reuse obligation for take-away sector, packaging bans, and minimisation of packaging requirements, including empty space thresholds, it is up to the Member States to implement some of these harmonised measures, as well as to lay down possible additional national waste prevention measures necessary to reach the targets set out in Article 43(1). National measures which are applied in addition to the EU harmonised measures may include, but are not limited to, economic incentives, EPR schemes, and public awareness campaigns, as this is outlined in Article 43(5). The measures may also include additional obligations on economic operators, such as higher or additional reuse targets, subject to the conditions under Article 29(15) and -(16) as explained also in the Commission guidance document. Pursuant to Article 43(5), national implementing measures must be proportionate and non-discriminatory and be designed to avoid barriers to trade or distortions of competition. They must not lead to a shift to lighter packaging material, which does not comply with other sustainability requirements, such as recyclability, being used to fulfil the goal of the packaging waste reduction. 2) What happens if a Member State does not reach the waste prevention targets? Each Member State must reduce the packaging waste generated per capita, as compared to the packaging waste generated per capita in 2018 and as reported to the Commission in accordance with Decision 2005/270/EC, by at least 5% by 2030, 10% by 2035 and 15% by 2040. The Commission will monitor the implementation of these targets based on the data on packaging waste generated reported by Member States. A Member State’s failure to meet the targets is susceptible to lead to appropriate enforcement action by the Commission. 3) Does the waste reduction target cover all packaging waste generated in a Member State or only household packaging waste? The PPWR applies to all packaging and to all packaging waste, whether it originates from industry, other manufacturing, retail or distribution, offices, services or households. The provisions related to the calculation of the packaging waste generated (see Article 53(2)) cover all packaging waste generated on the territory of a Member State. Therefore, the statistical data on packaging waste generated, as reported by Member States to the Commission, cover all packaging waste generated on the territory of a Member State. It is up to Member States to decide how they implement Article 43 and what measures they take to meet the waste reduction targets established in that provision. Member States can exclude certain types of waste from the national waste prevention targets and focus merely on the household packaging waste, if they consider that this will be sufficient to meet the targets. Member States may maintain the established separate systems for the management of household packaging waste, on the one hand, and for industrial and commercial packaging waste, on the other hand (Article 43(3)). 4) Will Member States be obliged to notify the national rules they wish to introduce to achieve the waste reduction targets via the TRIS? 58 Directive (EU) 2015/1535 30 imposes an obligation on the Member States to notify to the Commission all draft technical regulations concerning products (and Information Society Services) before they are adopted in national law. The term ‘technical regulation’ should be understood broadly. It means technical specifications, other requirements or rules on Information Society services which are laid down by the Member States, the observance of which is compulsory, de jure or de facto, for the marketing or use of a product, for the provision of a service or the establishment of a service operator. It covers also regulations or administrative provisions prohibiting the manufacture, importation, marketing or use of a product or prohibiting the provision or use of a service, or establishment as a service provider. Therefore, all new draft implementing measures, which are technical regulations, must be notified in the Technical Regulations Information System (TRIS)31. Member States do not need to renotify under the TRIS notification procedure their existing national measures which are compliant with the Regulation. Notifications by Member States are made at the draft stage, that is, at a stage of preparation at which substantial amendments can still be made (Article 1(1)g) of Directive (EU) 2015/1535). National technical regulations which were not notified can be declared inapplicable to individuals by the national courts32. 5) Obligation for the Member States to ensure that their national measures that were adopted to achieve the packaging waste reduction targets do not ‘lead to a shift to lighter packaging material being used to fulfil the goal of packaging waste reduction’ and that such measures also ‘reduce the quantity of plastic packaging waste generated’. This obligation is placed on the Member States, and they must inform on how they achieve this result in their waste prevention programmes adopted under Article 42(2) PPWR and in the TRIS notification procedure. The Commission has a general monitoring competence and may also decide to help Member States by giving additional guidance. However, the Commission does not have a specific empowerment to provide guidance on the implementation of this provision. 30 Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17/09/2015, p. 1–15). 31 TRIS – European Commission 32 ’CIA-Security’ (Case C-194/94). 59 XVIII. EXTENDED PRODUCER RESPONSIBILITY 1) Are micro-enterprises exempted from Extended producer responsibility (EPR) obligations? There is no general exemption for micro-enterprises from EPR obligations in the PPWR or Directive 2008/98/EC (Waste Framework Directive (WFD)). All producers are responsible for waste management of the packaging that they make available on the territory of a Member State for the first time. This includes registering in and reporting to that Member State’s register of producers according to Article 44. To minimise administrative burdens on small producers, the PPWR sets fewer reporting obligations on producers who make less than 10 tonnes a year of packaging available on the market of a Member State. Furthermore, Member States and producer responsibility organisations (PRO) must ensure equal treatment of producers regardless of their origin or size and must not place disproportionate burdens on small producers. Member States continue to have the right to invoke lower administrative fees for smaller producers as established in the WFD after the application of PPWR. WFD establishes that were justified by the need to ensure proper waste management and the economic viability of the extended producer responsibility scheme, Member States may, provide that: • in the case of extended producer responsibility schemes established to attain waste management targets and objectives established under legislative acts of the Union, the producers of products bear at least 80% of the necessary costs; • in the case of extended producer responsibility schemes established on or after 4 July 2018 to attain waste management targets and objectives solely established in Member State legislation, the producers of products bear at least 80% of the necessary costs; • in the case of extended producer responsibility schemes established before 4 July 2018 to attain waste management targets and objectives solely established in Member State legislation, the producers of products bear at least 50% of the necessary costs; • and provided that the remaining costs are borne by original waste producers or distributors. This derogation may not be used to lower the proportion of costs borne by producers of products under extended producer responsibility schemes established before 4 July 2018. The PPWR establishes that the producer is either the manufacturer, importer or distributor of packaging – depending on the context and whether the packaging is transport, sales, grouped, primary or service packaging. If a manufacturer is a micro-enterprise and that manufacturer is also the producer of the packaging, it will be exempted from its EPR-requirements when the supplier of the packaging materials is established in the same Member State. 2) To what extent does the PPWR harmonise national EPR schemes? The PPWR harmonises certain administrative EPR obligations to lower the administrative burden for economic operators selling packaging or packaged products in multiple Member States. These requirements are related to registration, reporting deadlines and frequency, and the granularity of the data that needs to be reported. The PPWR also harmonises who the producer is in a Member State. It is the packaging type and selling technique that determine whether a company is responsible for EPR obligations. Further information on how the definition of the producer applies, can be found under point II of this document. 60 Finally, the PPWR also harmonises the criteria for eco-modulation of EPR-fees. The ecomodulation will be based on the recyclability performance grades set in Article 6. Member States are allowed to use additional criteria, such as reusability and recycled content, when they apply the framework for eco-modulation in their national EPR schemes. In other areas, Member States continue to have a wide flexibility to organize EPR systems and waste management according to the national conditions and legal settings. 3) Which is the first calendar year that producers must report to the register of producers? All Member States shall establish a register of producers that producers must register in and report to. By February 2026, the Commission shall adopt an implementing act laying down the format for EPR registering in and reporting to the EPR register (Article 44(14) PPWR). Member States will have 18 months to establish the register after the adoption of the act (Article 44(1) PPWR). Producers shall report by June for each full preceding calendar year, and producers will therefore have to report to the national EPR registers according to the new harmonised rules for the first time by 1 June 2030. 4) What is the scope of the activities that online platforms can fulfil on behalf of their sellers? Based on a written mandate by producers, online platforms can offer to pay the EPR fees in each Member State where the packaging or packaged products are made available on the market directly to consumers (Article 45(4) PPWR). However, only the producer, or its PRO or authorised representative, is responsible for the EPR registration and reporting. An online platform cannot fulfil these obligations on their behalf unless the producer has chosen to appoint the platform as an authorised representative. 5) Does an online platform need to check every producer before allowing them to use the platform? To prevent free riding as regards EPR obligations, and in line with the obligations in the Digital Services Act (DSA)33, the PPWR provides that online platforms that allow consumers to conclude distance contracts with producers shall obtain information from producers that they are registered in the EPR register in the Member State where the consumer resides and a self-certification confirming that their EPR-obligations for packaging are fulfilled. The online platform shall obtain this information prior to allowing the producers to use the platform’s services. The online platform shall make best efforts to assess whether the information provided is reliable and complete, by using or verifying freely available online databases and online interfaces (Article 45(6) PPWR). This may include requesting the producers to provide supporting documents (Article 45(8) PPWR). Making best efforts usually requires the verification of the information provided by the producer with the data in the register of producers. 6) Can Member States ask for information beyond what is specified in the PPWR to monitor extended producer responsibility obligations? NEW! The PPWR harmonises the information to be provided when producers register and report amounts of packaging made available, collected and recycled in a Member State to a Member State’s register of producers. 33 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (OJ L 277, 27.10.2022, pp. 1– 102) 61 According to Article 44(5) of the PPWR, a Member State can require additional information or documents for registration purposes, beyond those specified in the Regulation, where such information is necessary and proportionate for the purposes of monitoring compliance with extended producer responsibility obligations laid down in Chapter VIII of the PPWR. Member States shall lay down rules to ensure that EPR obligations are complied with as specified in Article 40(2). Such rules must include: (a) the registration of producers in accordance with Article 44; (b) the organisation and monitoring of reporting requirements under Article 44(7) and (8); (c) the oversight of the implementation of the extended producer responsibility obligations in accordance with Article 45; (d) the authorisation on fulfilment of extended producer responsibility in accordance with Article 47; (e) the making available of information in accordance with Article 56. For the purposes of enforcement of the obligations for management of packaging and packaging waste set out in Chapter VIII of the PPWR, and insofar as this is not harmonised in the PPWR, Member States can require information beyond what is established in the PPWR, as long as it is necessary and proportionate. 62 XIX. RETURN AND COLLECTION SYSTEMS 1) How will priority access for recycled materials work in practice? Collection systems and recycling facilities may provide priority access to recycled materials for use in applications where the distinct quality of the recycled material is preserved or recovered in such a way that it can be recycled further and used in the same way and for a similar application with minimal loss of quantity, quality or function (Article 48(2) PPWR). The objective of this provision is to help economic operators comply with their recycled content requirements for plastic packaging under the PPWR. Therefore, Member States may establish such systems with regards to plastic packaging. If such systems are established, priority access to the plastic recycled materials should be granted at market prices. The quantity of recyclates to which priority access is given should correspond to the quantity of packaging made available on the territory of the Member State by the economic operator within a specified timeframe. It is Member States who decide to establish such priority access systems must ensure that these conditions are complied with and monitored and shall notify such systems via TRIS. 2) What does it mean that packaging is separately collected? Separate collection is defined in the WFD as ‘the collection where a waste stream is kept separately by type and nature so as to facilitate a specific treatment’. Member States must ensure that systems and infrastructure are set up to provide for the separate collection of packaging waste in accordance with the waste hierarchy, and to facilitate its preparation for re-use and high-quality recycling. More generally, Member States must ensure that the collection of the packaging materials is sufficient to achieve the recycling targets laid down in Article 52 and they must establish mandatory collection objectives for this purpose. The requirements for separate collection vary. For example, separate collection of single-use beverage packaging of plastic and aluminium in Article 50 refers to collection in a deposit and return system. Calculation and reporting requirements for separate collection for the purpose of complying with the separate collection requirement under Article 50(1), and for the purpose of establishing the ‘at scale’ methodology, will be specified in an implementing act to be adopted by 12 February 2027 under Article 56(7). 3) How is composite packaging accounted for in the calculation of recycling targets? According to Article 53(3), Member States must calculate recycling targets for composite packaging based on all materials contained in the packaging unit. Pursuant to Article 53(4), Member States may derogate from this requirement where a given material constitutes an insignificant part of the packaging unit, and in no case more than 5% of the total mass of the packaging unit. The 5 % threshold applies to the total mass of the packaging unit. 4) Are the terms ‘ferrous metal’, ‘ferrous metal (including tinplate)’ and ‘steel’ all synonymous for ‘ferrous metal including tinplate’? The terms ‘ferrous metal (including tinplate)’ is used in the PPWR only in the context of Member States’ reporting on reusable packaging. It is also referred in Table 1 of Annex II regarding materials and formats for which DfR criteria will be established. In the interest of coherence, the terms ‘steel’ in Table 3 of Annex XII and the term ‘ferrous metals’ used in Article 52(1)(b) and (d), and in Table 1 of Annex XII, also include tinplate. 63 XX. DEPOSIT AND RETURN SYSTEMS 1) Does the exemption from setting up a deposit and return systems (DRS) apply to the two beverage packaging types separately? The 90 % separate collection targets for single-use plastic beverage bottles and metal beverage containers are two separate collection targets that apply by 1 January 2029. An exemption from the requirement to be part of a DRS would therefore need to be obtained separately for each format. Article 50(5) establishes that Member States which collect more than 80% of all single-use plastic beverage bottles or metal beverage containers within the scope of the PPWR by 2026 may be exempt from the obligation to set up a DRS. Member States would also have to show with concrete measures how they will reach 90% separate collection targets by 2029 without setting up a DRS when notifying the Commission about their request for an exemption. 2) Can a Member State set additional national requirements for DRS? Pursuant to Article 50(9) PPWR, Member States may adopt provisions for DRS which go beyond the minimum requirements set forth in Article 50 and in Annex X, while observing the Treaty on the functioning of the EU and acting in accordance with the PPWR. For example, Member States are encouraged to establish or maintain DRS for single-use glass beverage bottles and beverage cartons and may include beverages which are not required to be part of a DRS under Article 50(4), such as wine, spirits or milk-based products, as well as for other products. They should, however, be mindful of the negative impact on the internal market of such rules and should take account of the recommendations in the Communication from the Commission — Beverage packaging, deposit systems and free movement of goods (2009/C 107/01). Member States should encourage DRS for reusable packaging, in particular for reusable glass beverage bottles. Member States must ensure that the return of packaging is convenient for end users and may establish additional minimum requirements to ensure that the objectives of the Regulation are met and to increase the purity of the collected packaging waste and reduce litter (Article 50(9) PPWR). 3) What is to be understood by ‘high transboundary business’ in Annex X? Annex X requires that Member States with regions with high transboundary business ensure that the DRS allow for collection of packaging from other Member States’ DRS at designated collection points and that they must endeavour to enable the possibility of return of a deposit that was charged to the end user when purchasing the packaging. Member States will need to assess if this requirement applies when ensuring compliance with the minimum requirements in Annex X. The minimum requirements apply to DRS established after 11 February 2025, whereas for the existing DRS, Member States must only apply the requirements from 1 January 2035 if the 90% separate collection targets are not reached by 1 January 2029 (Article 50(11) PPWR). Given that an increasing number of Member States is establishing DRS, the need for transboundary collaboration between the DRS’ is likely to increase to ensure separate collection of beverage packaging. The Commission must assess best practice of such measures by 2038 in collaboration with Member States to strengthen interoperability of DRS from different Member States (Article 50(11) PPWR). 4) Do all DRS have to be non-profit? A DRS for single-use beverage bottles of plastic and metal containers established after 11 February 2025 must be non-profit, as specified in the minimum criteria set out in Annex X, point f. 64 DRS established before 11 February 2025 are required to be non-profit by 1 January 2035 only if the Member State does not reach the 90% separate collection targets when they are first reviewed or at the latest by 1 January 2029 (Article 50(11) PPWR). 5) Is packaging of milk, wine and spirits also exempted from the 90% separate collection targets? According to Article 50(4), single-use plastic beverage bottles and metal containers with milk and milk-products, wine or products similar to wine and spirits are exempted from the requirement to be part of a DRS. However, such products must be included in the calculation of the separate collection targets under Article 50(1). Moreover, Member States have flexibility on whether or not to include the packaging for these products in their DRS. 6) Can single use Deposit and Return Systems register and report on behalf of producers to comply with extended producer responsibility obligations? NEW! Deposit and return systems for single-use packaging established pursuant to Article 50 of the PPWR, which have organisational, technical and financial arrangements comparable to those of producer responsibility organisations, can register and report on behalf of the producers participating in those systems to the register of producers established under Article 44(1) of the PPWR. Getting in touch with the EU In person All over the European Union there are hundreds of Europe Direct centres. You can find the address of the centre nearest you online (europeanhttps://european-union.europa.eu/contact-eu/meet- us_enunion.europa.eu/contact-eu/meet-us_en). 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DG ENV, Unit B01 August 2026 Packaging and Packaging Waste Regulation (PPWR) Frequently Asked Questions EUROPEAN COMMISSION Directorate-General for Environment Directorate ENV.B — Competitive Circular Economy & Clean Industrial Policy Unit ENV.B.1 — Bioeconomy & Sustainable Materials Contact: Unit B.1 E-mail: ENV-B01-ARES@ec.europa.eu European Commission B-1049 Brussels EUROPEAN COMMISSION Packaging and Packaging Waste Regulation (PPWR) Frequently Asked Questions Directorate-General for Environment 2026 Manuscript first completed in March 2026 and updated in August 2026. 2ND edition This document has been prepared for the European Commission however it reflects the views only of the authors, and the European Commission is not liable for any consequence stemming from the reuse of this publication. It is intended to assist economic operators, national authorities and citizens in the application of the PPWR. Luxembourg: Publications Office of the European Union, 2026 © European Union, 2026 The reuse policy of European Commission documents is implemented by Commission Decision 2011/833/EU of 12 December 2011 on the reuse of Commission documents (OJ L 330, 14.12.2011, p. 39). Unless otherwise noted, the reuse of this document is authorised under a Creative Commons Attribution 4.0 International (CC BY 4.0) licence (https://creativecommons.org/licenses/by/4.0/). This means that reuse is allowed provided appropriate credit is given and any changes are indicated. For any use or reproduction of elements that are not owned by the European Union, permission may need to be sought directly from the respective rightholders. PDF ISBN 978-92-68-42316-5 doi: 10.2779/4868962 KH-01-26-068-EN-N 2 Table of Contents I. INTRODUCTION ON THE SUBJECT MATTER AND SCOPE .................................................. 5 II. DEFINITIONS ................................................................................................................................ 7 III. SUBSTANCES OF CONCERN ................................................................................................... 15 IV. RECYCLABILITY ....................................................................................................................... 21 V. RECYCLED CONTENT IN PLASTIC PACKAGING ................................................................. 25 VI. COMPOSTABILITY .................................................................................................................... 29 VII. PACKAGING MINIMISATION ................................................................................................. 30 VIII. LABELLING ................................................................................................................................. 33 IX. ENVIRONMENTAL CLAIMS .................................................................................................... 34 X. OBLIGATIONS OF MANUFACTURERS ..................................................................................... 35 XI. EMPTY SPACE ............................................................................................................................ 42 XII. BANS AND THE USE OF CERTAIN PACKAGING ................................................................ 43 XIII. REUSE AND REFILL .................................................................................................................. 46 XIV. PLASTIC CARRIER BAGS ........................................................................................................ 51 XV. ASSESSMENT OF THE CONFORMITY OF PACKAGING .................................................. 52 XVI. ENFORCEMENT OF THE NEW RULES (IMMEDIATELY AFTER THE APPLICATION DATE OF 12 AUGUST 2026) ........................................................................................ 56 XVII. WASTE PREVENTION .......................................................................................................... 57 XVIII. EXTENDED PRODUCER RESPONSIBILITY ................................................................... 59 XIX. RETURN AND COLLECTION SYSTEMS ............................................................................... 62 XX. DEPOSIT AND RETURN SYSTEMS ........................................................................................ 63 3 Abbreviations CMO: Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products DfR: Design for recycling DRS: Deposit and Return System DSA: Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market for Digital Services ECHA: European Chemicals Agency EO: Economic Operator EPR: Extended Producer Responsibility EPS: Expanded Polystyrene ESPR: Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of eco-design requirements for sustainable products FCM: Food-contact material, as regulated under Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food FIBC: Flexible Intermediate Bulk Container FIC: HoReCa: Regulation (EU) No 1169/2011 on the provision of food information to consumers. Hotel, Restaurant and Catering IBC: Intermediate bulk containers JRC: Joint Research Centre NACE: Statistical classification of economic activities / classification of economic activities in the European Union (EU) OJEU: Official Journal of the European Union PFAS: Per-and polyfluoroalkyl substances PPWD: European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste PPWR: Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste PRO: Producer Responsible Organisation REACH: Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency SoC: Substances of Concern 4 SUPD: Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment TRIS: Procedure under Directive 2015/1535 to prevent creating barriers in the internal market WFD: Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste XPS: Extruded Polystyrene 5 I. INTRODUCTION ON THE SUBJECT MATTER AND SCOPE This is the second version of this document. It includes new and updated information as compared to the first version published in March 2026. Changes made since the first version are marked as ‘NEW’ or ‘UPDATED’ as appropriate throughout the document. Regulation (EU) 2025/401 establishes a harmonised legal framework for packaging and packaging waste across the European Union. Its primary objective is to ensure the smooth functioning of the internal market while significantly reducing the environmental and health impacts associated with packaging throughout its life cycle. By replacing Directive 94/62/EC2, this regulation introduces clearer, stricter, and more uniform requirements for all economic operators and Member States, fostering a transition towards a circular economy. The scope of the Regulation is comprehensive. It applies to all packaging placed on the EU market, whether empty or filled, regardless of the material used, and whether produced within the Union or imported from third countries. It also covers all packaging waste generated within the EU. Packaging is defined broadly, as any item intended for containment, protection, handling, delivery, or presentation of products, including its components. However, items that form an integral part of a product and are disposed of together with it are excluded. Through these provisions, Regulation (EU) 2025/40 seeks to harmonise national measures on packaging, prevent market fragmentation, and promote sustainable practices. It introduces obligations such as recyclability and reuse targets, restrictions on hazardous substances, and requirements for eco-friendly design and labelling. In doing so, it not only addresses pressing environmental challenges but also creates a level playing field for businesses operating across multiple Member States. The PPWR entered into force on 11 February 2025, and its general application date is 12 August 2026, but certain provisions apply later (e.g., recyclability, recycled content targets, packaging bans and reuse targets by 2030). Some of the main provisions of the PPWR are: - Waste Prevention Targets: 5% by 2030, 10% by 2035, 15% by 2040 (compared to 2018 levels) (Article 43). - Recyclability: All packaging must be recyclable in an economically viable way by 2030 (Article 6). - Reuse Targets: For transport, e-commerce, and beverage packaging (Article 29). - Restrictions: Ban on certain single-use formats from 1 January 2030 (Article 25 and Annex V); compliance with PFAS in food contact packaging from 12 August2026 (Article 5(5)). - Empty Space threshold: Max 50% for grouped, transport, and e-commerce packaging (Article 24). - Mandatory Deposit-Return Systems: For beverage cans and plastic bottles (Article 50). - Labelling: Harmonised sorting labels for all packaging (Article 12(1)). (1) Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (OJ L, 2025/40, 22.1.2025). (2) European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365 31.12.1994, p. 10). 6 - Extended Producer Responsibility (EPR): Strengthened obligations for producers (Articles 44–47). This document clarifies some issues and answers questions that have been received by DG Environment since the adoption of the Regulation. This document complements the Commission Notice - Guidance document for Regulation 2025/40 (EU) on packaging and packaging waste (hereinafter ‘Commission guidance document’). 7 II. DEFINITIONS Definition of packaging 1) Does the wording packaging ‘…whether empty or with a product…’ modify the definitions of packaging and of manufacturer under the PPWR? Article 3(1), point (1), contains a definition of packaging, which remained largely unchanged compared to the packaging definition in the Directive 94/62/EC. However, the new definition contains the new wording ‘…whether empty or with a product…’. This new wording does not modify the definition of packaging or the definition of manufacturer but is intended to cover all different factual situations and types of packaging that come within the scope of the PPWR. For further information on the packaging definition, please consult the Commission guidance document. 2) Why does the definition of packaging for tea and coffee mention ‘machine use’ only in point (g) and not in point (f) of Article 3(1)? The wording indicates the difference between systems for filter coffee/tea bags and those for coffee extraction machines. Machine use is one of the key criteria to decide if a tea/coffee capsule falls under Article 3(1), point (1)(f), or point (1)(g). Permeability is another element that needs to be considered. This distinction is important in relation to the compostability requirements in Article 9. Permeable tea, coffee or other beverage bags, or soft after-use system single-serve units that contain tea, coffee or another beverage, which are intended to be used and disposed of together with the product (point (1)(f)), are mandatorily compostable. Non-permeable tea, coffee or other beverage system singleserve units intended for use in a machine, and which are used and disposed of together with the product (point (1)(g)) are not. However, Member States may decide to make the latter mandatorily compostable on their territories, under certain conditions, such as the existence of an appropriate collection and waste treatment infrastructure for bio-waste. Member States cannot ban or require compostability as regards metal capsules. 3) Are envelopes containing letters, invoices, statements and other correspondence which serve a communication function considered to be packaging under the PPWR? NEW! Whether an item qualifies as packaging must be assessed based on the definition of packaging set out in Article 3(1), point (1). Furthermore, Annex I to the Regulation provides an indicative list of items that are considered packaging and items that are not. Packaging is defined in Article 3(1) of the PPWR as “an item, irrespective of the materials from which it is made, that is intended to be used by an economic operator for the containment, protection, handling, delivery or presentation of products to another economic operator or to an end user, and that can be differentiated by packaging format based on its function, material and design…” Letters, invoices, statements and other correspondence which serve a communication function are not to be considered products for the purposes of the definition of packaging in the PPWR. Envelopes that contain these documents are not intended for “the containment, protection, handling, delivery or presentation of products”. 8 This is to be contrasted with empty envelopes which are intended for the containment, protection, handling, delivery or presentation of products, as well as envelopes that contain a product (such as a catalogue or magazine), both of which are to be considered packaging. Lastly, empty envelopes that are sold in a supermarket to consumers for private use are not considered to be packaging. 4) What is the difference between sales, grouped and transport packaging? NEW! Sales, grouped, and transport packaging are defined separately in the PPWR, based on their intended use. They are also subject to different requirements in the PPWR. Sales packaging (Article 3(1), point (5)) is the packaging that, together with the product, forms a unit intended for sale to an end user. Sales packaging is often in direct contact with the product and adapted to a specific product based on its special needs and characteristics. Sales packaging is also typically used for the branding of the product and for consumer information. Grouped packaging (Article 3(1), point (6)) is packaging that bundles several sales units (packaged products). It often displays the name of the specific product and can be removed without changing the characteristics of the product. Its purpose is typically adapted to the individual product, such as facilitating stockkeeping or shelf display, or enabling or encouraging consumers to buy more than one product. It varies whether it is sold with the product or not, and for this reason, grouped packaging may be disposed of either in a commercial setting or at the consumer’s premises. Transport packaging (Article 3(1), point (7)) forms the outer layer of packaged products and is used during transport of sales units. It often contains information about logistics, transport and storage. Transport packaging prevents damage to packaged products and facilitates handling, and it is therefore often more standardized, bigger in size and sturdier than sales and grouped packaging, and disposed of in a commercial or industrial setting. However, e-commerce packaging (Article 3(1), point (8)), which is a special form of transport packaging used for distance sales to ‘end users’, will often be disposed of at the consumer’s premises. Definition of ‘manufacturer’ 5) Who is the manufacturer of transport packaging? NEW! Following the definition of packaging (Article 3(1), point 1), transport packaging should be considered packaging when it is manufactured and placed on the market with the intention of being used for ‘[..] the containment, protection, handling, delivery or presentation of products [..]’. The manufacturer of transport packaging must therefore be identified at the stage where the empty packaging has reached its final form. A packaging has reached its final form when it can be used as transport packaging without any further components or ancillary elements added to it. In that respect, it is important to clearly distinguish a combination of packaging items used for transport, handling or sale of products from a genuine assembly or transformation operation of the packaging, such as on-site moulding of materials or the creation of a packaging item from components which in itself do not perform a packaging function. The use of multiple packaging items (tape, wrap, boxes, pallets etc.) together does not mean that each item is not already in its final form. Indeed, there can be packaging from multiple manufacturers in one shipment of packaged products, and each manufacturer must provide the 9 necessary technical documentation and information to demonstrate conformity with the applicable requirements for the EU declaration of conformity when they place the packaging on the market. As is also the case for sales, grouped, service and primary production packaging, if the transport packaging does not bear a name or trademark, then the decisive criterion to establish who the manufacturer is will be who places the order and decides on the design specifications for that packaging. For unbranded, generic transport packaging, this company would normally be the company who physically manufacturers the packaging. If the transport packaging is wearing a name or trademark, the company whose name or trademark is on the packaging is manufacturer. See further in the Commission guidance for the PPWR, point 2. Below are two examples of who the manufacturer of transport packaging is: • A cardboard box has reached its final form even if it is flat and requires folding. If the box has a name or trademark on it, the company carrying the name or owning the trademark will be the ‘manufacturer’. For unbranded, standardised cardboard boxes, the company that physically manufactures the boxes will be ‘manufacturer’. If a company adds a sticker on the box for shipment purposes, it is not considered to be branding, and this company should not be considered ‘manufacturer’. • Stretch wrap for stabilisation of packaged products on pallets should be considered packaging when it is sold on a roll, even if it is subsequently cut to wrap pallet loads. The ‘manufacturer’ is the company that physically manufactures the wrap and places it on the market as packaging, if it is unbranded, rather than the company that purchases the wrap and subsequently uses it to secure goods. 6) Who is the ‘manufacturer’ of branded packaging? NEW! According to the PPWR (Article 3(1), point (12)), if a packaging does not bear a name or trademark, the manufacturer will be the natural or legal person who manufactures packaging or packaged products. Where a natural or legal person has packaging or a packaged product designed or manufactured under its own name or trademark, that person is to be considered the manufacturer. This is regardless of whether another trademark is displayed on the packaging or packaged product. If a packaging bears a name or trademark, the manufacturer is the economic operator under whose name or trademark the packaging is placed on the market, even where another operator may physically carry out the manufacturing or filling. However, if this economic operator is a micro- enterprise, and if the supplier is located in the same Member State, the supplier of the packaging or packaged product will be manufacturer. The Commission guidance for the PPWR, point 2 explains that: ‘If the packaging or packaged product carries a certain name or trademark, it can be assumed that the owner of that name or trademark is the ‘manufacturer’ [..], as it will have the decisive power in the contractual relation with its suppliers and will therefore be able to determine also the packaging characteristics’. The company which commissions another company to manufacture packaging or packaged products under its name or trademark is in a position to determine the characteristics of the packaging, including the branding of packaging which could influence the packaging’s conformity assessment. This is also the case when an economic operator simply chooses a standardised packaging option and does not ask for changes to the design and the production process. 10 7) Who is the ‘manufacturer’ if a packaged product bears a name of one company and a trademark of another company? NEW! A name or trademark on a packaging holds equal weight in terms of the status of manufacturer under the PPWR (Article 3(1), point (12)). Therefore, if one company manufactures, markets and distributes products under its own name, for example as the responsible food business operator, but under the trademark of another company, the status of manufacturer applies to the company which determines the packaging design and specifications. For example, if the licensor, who is the trademark owner, specifies that the product placed on the market under their trademark must be in a specified packaging design to ensure that the packaging used for their products are identical in Member States, or globally, the trademark owner will be considered the manufacturer. However, licensors whose trademark may appear on packaging, but who do not determine the characteristics of the packaging, should not be considered to be the manufacturer. A case-by-case assessment, based on the contractual agreement between the two companies whose name and trademark are on the packaging, would therefore be necessary to establish who has the decisive power. Definition of ‘producer’ 8) Is a farmer producer for the purpose of EPR obligations? Whether a farmer is a ‘producer’ will depend on the specific situation. There is no general exemption for specific sectors such as farmers in terms of extended producer responsibility obligations since all economic operators making packaging available on the territory of a Member State for the first time will have to comply with these obligations. The following examples show some typical examples of when a farmer would normally be considered a producer and when it would not. • If a farmer packs a few apples in a container (sales packaging) and sells it under its own name or trademark to a retailer or consumer in the same Member State, the farmer is a producer. • If the farmer sells the packed apples under its own name or trademark in another Member State, the farmer is only the producer if the recipient is the end user of the apples. This means that the farmer is not the producer if it sells the apples to a retailer in another Member State. • If the farmer is a micro-enterprise, which is often the case, and the supplier of the apple container is established in the same Member State, such supplier becomes the producer in the Member State where the farmer and supplier are located. • If the container is produced under the name or trademark of an agricultural cooperative of which the farmer is part, then this cooperative, and not the individual farmer, is the producer. • If the farmer delivers apples in bulk in large containers (transport packaging) to a agricultural cooperation, who then packs the apples into containers (sales packaging) under the name or trademark of the cooperative, the agricultural cooperative is the producer. 11 The producer definition addresses packaging used in primary production. ‘Primary production’ is to be understood as ‘the production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter’ (3). Packaging material, for example foil or straps used for hay bales, is only considered to be made available on the market, and thereby packaging, when the bales are placed on the market and not when it is used in a production process, in this case on the same farm. 9) Who is the ‘producer’ of transport packaging? NEW! The producer of transport packaging must be identified when it is empty (see further explanation above [‘Who is the manufacturer of transport packaging?’]). The following provide some typical examples of who the producer of transport packaging is: • Company A is the manufacturer of unbranded, standardised cardboard boxes and sells them to Company B located in the same Member State. In this case, Company A would typically be the producer. This is also the case when the cardboard boxes are sold flat and require folding. • If company A sells the cardboard boxes to Company C in another Member State, and Company C fills the boxes to transport packaged products, then Company C would typically be the producer in that Member State. • If Company A fills the cardboard boxes and sells them to an end user in another Member State, then Company A would typically be the producer in that other Member State. • If Company A manufactures cardboard boxes under the name or trademark of Company B, then Company B will typically become the manufacturer and producer of the boxes in that Member State. However, if Company B is a micro-enterprise, then Company A is manufacturer and the producer in the Member State. 12 Further clarification of the definition of a producer of packaging can be found in section 3 of the Commission guidance document. 10) Who is the ‘producer’ in cases where sales packaging is also used for transport purposes? NEW! Sales packaging is defined in the PPWR as “packaging conceived so as to constitute a sales unit consisting of products and packaging to the end user at the point of sale”, whereas transport packaging is defined as “packaging conceived so as to facilitate the handling and transport of one or more sales units or a grouping of sales units, in order to prevent damage to the product from handling and transport”. By definition, transport packaging therefore serves to transport one or more sales units and does not replace the underlying sales packaging. If sales packaging is also used for transportation purposes, the packaging remains part of the packaged product supplied to the end user, and it is not placed on the market as empty transport packaging. Therefore, even if the packaging also performs a transport function, the packaging is still sales packaging for the purposes of establishing who the producer is. The producer would be the economic operator that fills the packaging and makes the packaged product available for the first time in the Member State concerned. Nevertheless, the assessment should always be carried out on a case-by-case basis, taking into account the packaging's design, intended use and the specific circumstances of the supply chain. The cardboard boxes carries the name or trademark of Company B, which is not a micro-enterprise. The cardboard boxes carry the name or trademark of Company B located in the same Member, but Company B is a micro-enterprise. Sells to end user in the same Member State Sells to end user in another Member State Sells to Company B in the same Member State Company A is producer Company B is producer Company A manufactures unbranded cardboard boxes (transport packaging) 13 Making available on the market 11) Why does the wording ‘making available on the market’ sometimes refer to the Union market and other times to the territory of a Member State? The definitions ‘making available on the market’ (Article 3(1), point (9)) and ‘placing on the market’ (Article 3(1), point (10)) refer to the Union market. These definitions apply throughout the PPWR reflecting the harmonisation of requirements that apply directly to economic operators. However, in the provisions on waste management, such as waste reduction and recycling targets, separate collection and extended producer responsibility, the requirements are mainly addressed to Member States. To reflect the territorial scope of the above-mentioned requirements, the Regulation uses the term ‘making available on the territory of a Member State’ (Article 3(1), point (11)). The definition has the same meaning as the definition of ‘making available on the market’, the only difference being that it circumscribes the actions to the territory of a Member State instead of the Union market. 12) How can producers know if a packaged product is made available to an end user or whether it is made further available? A product is considered to have been made available on the market when it is supplied for distribution, consumption, or use in the course of a commercial activity. An end user, whether a consumer or a professional end user, is a person or entity to whom a product is made available and who does not make that product further available on the market in the form in which it was supplied. The determining factor is therefore not the legal status of the recipient, but how the product is used. A professional end user is considered as an end user where it uses the product on its own operations or production process and does not resell or otherwise place the product back on the market in the same form. A producer of a packaged product should be able to determine, based on the nature of the packaging and the chosen marketing and distribution channels, whether the intended recipient is an end user (consumer or professional), or a commercial buyer who will resell the packaged product in another Member State. It should be noted that logistics companies that receive packaged goods, such as imported products from third countries, and perform handling activities (e.g., unpacking, repacking, or dividing products into smaller quantities) are not considered end users. Placing on the market 13) Is packaging used to ship product parts between manufacturing sites, for finalisation or assembly, considered placed on the market and therefore subject to PPWR rules? NEW! Article 3(10) of the PPWR sets out that ‘placing on the market’ occurs at the ‘first making available of packaging, whether empty or with a product, on the Union market’. Article 3(9) of the PPWR defines ‘making available on the market’ as ‘any supply of packaging, whether empty or with a product, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge’. Packaging must comply with the PPWR rules when it is placed on the market. If a packaging has not yet been placed on the market, for example if it has been produced by the company who is also responsible for the product parts, and has not formed part of any commercial transaction, it will not be subject to PPWR rules. 14 However, if a company uses transport packaging which it has not manufactured itself to ship parts between two of its company sites, PPWR rules will apply, as the packaging is considered placed on the market. Further clarifications 14) Are crown corks for beverage bottles an integrated or separate component? Crown corks for glass bottles are considered separate components, as per Article 3(1), point (44), of the Regulation. Such closures, which are not permanently attached to the bottle, need to be separated completely and permanently from the main packaging unit in order to access the product and, therefore, to ensure the functionality of the packaging unit. The future delegated act on design for recycling (DfR) will further specify the rules for integrated and separate components. 15) Are the derogations provided for in Directive 2008/68/EC on the inland transport of dangerous goods 3 applicable to all packaging that is used for the transport of dangerous goods? Are the derogations also applicable to the transport of non-dangerous goods? UPDATED! The provisions on recyclability, recycled content and reuse targets contain specific exemptions for packaging used for transport of dangerous goods. If the packaging is used for transport of dangerous goods in accordance with Directive 2008/68/EC, even though it does not require UN approval, e.g. packaging used under limited quantities (LQ) marking, the PPWR derogations are applicable. For UN approved packaging used for the transport of non-dangerous goods, the PPWR rules apply. 3 Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods 15 III. SUBSTANCES OF CONCERN 1) In the definition of Substances of Concern (SoC), which refers to the ESPR, should the conditions in Article 2(27) points (a), (b), (c), (d) of the ESPR be considered as cumulative? How should the wording ‘negatively affects the reuse and recycling of materials in the product in which it is present’ be understood? It is sufficient that only one of the conditions under points (a) to (d) of Article 2(27) ESPR is fulfilled for a substance to be considered as a SoC4. As regards the meaning of the wording ‘negatively affects the reuse and recycling…’ the Commission and the European Chemicals Agency (ECHA) are currently conducting a study on identifying the SoC that could affect human health and impact packaging reusability and recyclability. 2) What is the difference between substances and substances of concern (SoC)? Does the Ecodesign for Sustainable Products Regulation (ESPR) and the PPWR address substances of concern (SoC) in the same manner? The definition of substances of concern (SoC) refers to the ESPR (Article 3(1), fourth paragraph of the Regulation), which means that substances of concern are defined in the same manner in the PPWR and the ESPR. The ESPR establishes the criteria for identification of substances of concern. They are mainly based on their hazardous properties and classification in accordance with the CLP Regulation5 but also include a reference to negative effects on the reuse and recycling of materials in the product in which they are present6. The conditions are not cumulative, which means that if one of the conditions is fulfilled, the substance is considered as SoC. 4 The ESPR FAQ can be found here: Circabc. 5 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31/12/2008, p. 1–1355). 6 According to Article 2, point (27) of ESPR, ‘a substance of concern’ means a substance that: a) meets the criteria laid down in Article 57 of Regulation (EC) No 1907/2006 and is identified in accordance with Article 59(1) of that Regulation; b) is classified in Part 3 of Annex VI to Regulation (EC) No 1272/2008 in one of the following hazard classes or hazard categories: a. carcinogenicity categories 1 and 2; b. germ cell mutagenicity categories 1 and 2; c. reproductive toxicity categories 1 and 2; d. endocrine disruption for human health categories 1 and 2; e. endocrine disruption for the environment categories 1 and 2; f. persistent, mobile and toxic or very persistent, very mobile properties; g. persistent, bioaccumulative and toxic or very persistent, very bioaccumulative properties; h. respiratory sensitisation category 1; i. skin sensitisation category 1; j. hazardous to the aquatic environment — categories chronic 1 to 4; k. hazardous to the ozone layer; l. specific target organ toxicity — repeated exposure categories 1 and 2; m. specific target organ toxicity — single exposure categories 1 and 2. c) is regulated under Regulation (EU) 2019/1021; or d) negatively affects the reuse and recycling of materials in the product in which it is present. 16 3) How will the PPWR deal with the addition of substances of concern (SoC) and the use of recyclates? The objective of the Regulation is the minimisation of the presence of SoC in packaging. This will be done via the identification of substances of concern, as a first step, and their limitation, if they are relevant for recycling, via the DfR criteria, to be adopted under Article 6(4) PPWR, or via the update of REACH restrictions for substances that affect human health or the environment. The identification of the relevant substances is on-going via a study lead by the Commission and the European Chemicals Agency (ECHA). 4) How many substances could fall under the definition of substances of concern (SoC)? There is no definite number or list of substances of concern (SoC) in packaging. The study, which the Commission and ECHA are undertaking to comply with its implementation obligation established in Article 5(2), will look into this issue and will provide a list of SoC on the basis of the information currently available about packaging manufacturing and waste treatment. There are several sources of information that can be consulted for each criterion listed in Article 2(27) of Regulation (EU) 2024/1781 (ESPR) to identify Substances of Concern (e.g. the ‘Candidate list of Substances of very high concern for Authorisation’ managed by ECHA7; Annex VI of Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures8 could be also used as a source for identifying SoCs. 5) How is the supplier of packaging obligated to comply with the data requirements of substances of concern (SoC)? Obligations of packaging suppliers are detailed in Article 16 PPWR. Accordingly, suppliers must provide the manufacturer with all the information and documentation necessary for the manufacturer to demonstrate the conformity of packaging and the packaging materials with this Regulation, either in paper or in electronic format. Manufacturers need this information from suppliers of packaging materials or converters in order to identify PFAS or other SoC present in packaging and draft the declaration of conformity demonstrating compliance with Article 5 PPWR. 6) At which value are the concentration limits for SoC set? The Regulation includes an obligation to minimise the SoC content in material and emissions. The main driving principle is that human health and environment are protected, i.e. unacceptable adverse effects should be avoided. The Regulation does not set a general concentration limit for SoC. Nevertheless, specific concentration limits are established for certain substances (e.g. PFAS and certain heavy metals). More information and knowledge on SoC are expected to come from the on-going Commission and ECHA-led study. But substances meeting the substances of concern (SoC) criteria can already be identified by the manufacturer based on the existing definition of SoC. The SoC criteria refer 7 https://echa.europa.eu/candidate-list-table. 8 Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, pp. 1–1355). 17 mainly to hazardous properties but also include, on a case-by-case basis, considerations related to recycling and re-use. The possibility to establish new concentration limits for SoC in packaging may result from the evaluation to be carried out by the Commission by 2033, which will consider if the Regulation has sufficiently contributed to minimising the presence and concentration of SoC in packaging. Moreover, the Commission may adopt delegated acts in accordance with Article 6(4) to limit the presence of SoC that negatively affect recycling. 7) What is the implementation date for Article 5(1) PPWR? The Regulation and therefore the obligation to minimise substances of concern content will apply from 12 August 2026. Already PPWD contained the obligation to minimise substances of concern with regards to their presence in emissions, ash or leachate when packaging or its packaging waste residues are incinerated or landfilled and has set specific concentration limits for four heavy metals (lead, cadmium, mercury and hexavalent chromium). 8) How can manufacturers prove compliance with Article 5(1) regarding the obligation to minimise SoC in packaging? NEW! The general principle set out in Article 5(1) should be assessed in line with Annex C (Minimisation of Dangerous Substances or Preparations and Demonstration of Conformity) of the existing harmonised standard EN 13428_2004 Packaging - Requirements specific to manufacturing and composition - Prevention by source reduction. This Annex describes the steps that have to be taken by the economic operator responsible for placing a specific packaging on the market in order to determine and demonstrate minimisation. 9) Is the harmonised standard EN 13428:2004 still applicable to ensure conformity with the requirements as regards SoC? UPDATED! The requirements concerning SoCs have been strengthened in the PPWR. Under the PPWR, packaging must be manufactured so that the ‘presence and concentration of substances of concern’, both in the material itself and in emissions or waste outcomes, is minimised. It also explicitly ties these requirements to effects on reuse, recycling and chemical safety, rather than merely end-of- life disposal. EN 13428:2004 focuses primarily on minimising dangerous substances in emissions and disposal, not on the holistic lifecycle impacts, as required by Article 5 of the PPWR. Furthermore, the standard does not reflect the expanded hazard scope of the PPWR, covering SVHCs under REACH, CLP hazard classes and recyclability impacts. Therefore, Annex C of the existing harmonised standard EN 13428:2004 9 related to the ’minimisation of dangerous substances or preparations and demonstration of conformity’ can no longer create a presumption of conformity with the new rules concerning SoCs. However, until the updated harmonised standard becomes available, the existing standard EN 13428:2004 can be used. 9 Harmonised standards published in Commission communication in the framework of the implementation of the European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ C 44 of 19 February 2005), EN 13428:2004 ‘Packaging – Requirements specific to manufacturing and composition – Prevention by source reduction’. 18 10) How can manufacturers prove compliance with Article 5(4) on the limit value for heavy metals in packaging? NEW! This is not a new obligation. Manufacturers already had to comply with this obligation under Article 11 of the repealed Directive on packaging and packaging waste10. To demonstrate compliance, it is recommended to use the CEN report CR 13695-1/2000 Packaging - Requirements for measuring and verifying the four heavy metals and other dangerous substances present in packaging and their release into the environment - Part 1: Requirements for measuring and verifying the four heavy metals present in packaging. 11) Does the obligation to minimise the presence of substances of concern (SoC) in packaging apply to all economic operators? The obligation applies to all packaging placed on the market, according to the definition in the Regulation (Article 3(1), point (10)). The manufacturer placing packaging on the market or a supplier, in case a manufacturer is a microenterprise, must make sure that the provisions are complied with. 12) When does the obligation on minimisation of substances of concern (SoC) start to apply for packaging that is not food-contact sensitive? The general obligation to minimise SoC in Article 5(1) and the limits on four heavy metals in Article 5(4) apply to all packaging from 12 August 2026. The limits set in Article 5(5) for PFAS will apply to food-contact materials only. 13) Member States may submit data on a substance they believe to be of concern before 31 December 2025. If Member States inform the Commission about new substances of concern, will this information be accessible before the Commission delivers its report in 2026? According to Article 5(2) of the PPWR, Member States should inform the Commission about relevant information on SoC before 31 December 2025. This information will be considered in the development of the study. The monitoring of SoC is a permanent task for the Commission. 14) Does the derogation for glass packaging introduced by Commission Decision 2001/171/EC 11 in relation to heavy metal concentration levels in packaging and packaging waste continue to apply? Commission Decision 2001/171/EC continues to apply and has not been repealed by the PPWR. This means that the packaging may exceed the concentration limit of 100 ppm by weight for the sum of lead, cadmium, mercury and hexavalent chromium, when this exceedance is due to the addition of recycled glass. No lead, cadmium, mercury or hexavalent chromium is allowed to be intentionally introduced during the manufacturing process. The Commission may adopt delegated 10 European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste 11 Commission Decision of 19 February 2001 establishing the conditions for a derogation for glass packaging in relation to the heavy metal concentration levels established in Directive 94/62/EC on packaging and packaging waste (OJ L 62, 2.3.2001, pp. 20–21). 19 acts to amend the limit established in Article 5(4), but only to lower the permitted sum of concentration levels. The Commission is not empowered to extend the application date of the heavy-metal restrictions laid down in the PPWR. 15) Will Regulation (EC) 1935/2004 on food contact materials, Regulation (EU) 10/201112on plastic articles intended to come into contact with food, Regulation (EU) 2019/1021 on persistent organic pollutants and the REACH regulation be amended by reference to the PPWR's ban on PFAS? The PPWR does not establish a PFAS ban but rather sets maximum concentration levels. Also, it is not provided that the PFAS limits in the PPWR would be taken over into other, ‘vertical’, EU legislations. Based on Article 5(5), the Commission will carry out an evaluation to assess the need to amend or repeal the PFAS restriction in the PPWR in case of identified overlaps with restrictions or prohibitions on the use of PFAS under the FCM Regulation, the REACH Regulation or the POPs Regulation. 16) Do the PFAS restrictions in Article 5(5) apply both to intentionally added and unintentionally present PFAS? The PFAS restriction adopted by the PPWR does not differentiate between intentionally added and unintentionally present PFAS. Therefore, the provisions in Article 5(5) apply to both. To be noted, preliminary PFAS laboratory analyses results on a number of selected packaging13showed that in practice only packaging where PFAS have been intentionally added would give results above the PFAS limit values. 17) Do the restrictions apply only to materials used in packaging manufacturing or also to the materials and the associated inks, varnishes, glues and adhesives? The limits apply to the packaging unit as a whole, including the associated inks, varnishes, glues and adhesives placed on the market by the manufacturer. The latter is the person responsible for drawing the technical documentation needed to prove compliance (for further information, see Commission guidance document). 18) Will a list of the PFAS concerned by the ban (with CAS numbers for identification) be published? A list of PFAS subject to this restriction will not be published. The limits apply to all PFAS falling under the definition provided in the PPWR and possibly contained or contaminating the packaging. 19) How will the PFAS limits be enforced, considering there are no harmonised methodologies for PFAS in food-contact packaging at EU level? 12 Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 012 15.1.2011) 13 Skedung L.1 and Bjarnemark F.1 : A Harmonized Workflow for PFAS Compliance Testing under EU Packaging and Packaging Waste Regulation and Emerging Universal Restrictions: A Food Contact Packaging Case Study. 1RISE Research Institutes of Sweden 20 As explained in the Commission guidance document, the Commission is striving to ensure a harmonised approach of the national market surveillance authorities for the enforcement of the PFAS limits. There are intense works ongoing involving industrial stakeholders, civil society associations and the competent authorities in the Member States aiming to deliver a harmonised testing protocol for PFAS in food-contact packaging. This work stream includes engaging with the EURL on Food Contact Materials, which coordinates the network of national reference laboratories for food contact materials. 20) As the starting point for enforcement of the PFAS limits seems to be the total fluorine analysis, what laboratories offer such testing methodology? There are already plenty of commercial and university laboratories offering Total Fluorine / Total Organic Fluorine analysis. It can be expected that many other commercial and accredited laboratories will in view of the PPWR PFAS limits invest into testing capacities, and that those already doing it increase theirs. 21) Do the “refillable steel cylinders used for various kinds of gas” (Annex I of PPWR) have to comply with Article 5(4) of PPWR that sets a limit value of 100 mg/kg for heavy metals? NEW! Transport of gases in refillable cylinders must comply with Directive 2008/68/EC14, which directly implements the International Agreement on the Carriage of Dangerous Goods by Road (ADR)15 as binding EU law. ADR requires leakproof (gas tight) pressure receptacles and specifies, via standards, the use of copper-zinc-lead alloys that contain lead in concentrations much higher than those specified in Article 5(4) of the PPWR. Under these circumstances, the restriction in Article 5(4) PPWR is not intended to apply where ADR-mandated safety components leave no technical feasible alternative. This is in accordance with Article 2(2) of PPWR that states that, in case of conflict between PPWR and Directive 2008/68/EC, the latter should prevail. 14 Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods 15 Agreement concerning the International Carriage of Dangerous Goods by Road (ADR 2025) | UNECE 21 IV. RECYCLABILITY 1) In the context of recyclability performance grade assessment: • how is a packaging unit defined, • what is the difference between integrated and separate components, and • what is the main body of the packaging unit? A ‘unit of packaging’ is defined in Article 3(1), point (45), of the Regulation as a unit, including any integrated or separate components, which as a whole serves a packaging function, such as the containment, protection, handling, delivery, storage, transport or presentation of products. A unit of packaging is independent from units of grouped or transport packaging where the latter are discarded prior to the point of sale. The term ‘unit of packaging’ should be considered equal to ‘packaging unit’, which is a term also used in the PPWR. Integrated and separate components are also defined in the Regulation, in Article 3(1), points (43) and (44), respectively. An illustrative example of a packaging unit is a plastic ketchup bottle made available to consumers at the point of sale. Such a ketchup bottle consists of the following packaging components: plastic bottle, removable lid (i.e. peelable foil), which is typically fully removed by consumers to access the product, label, and the closure system. If a removable lid needs to be fully completely and permanently separated by consumers to access the ketchup, then it should be considered as a separate component. As regards the closure system, it typically does not need to be completely and permanently separated by consumers and is thus disposed of together with the ketchup bottle. Assuming that the closure system on a ketchup bottle is not meant to be separated by consumers, it should be considered as an integrated component. As for the label, it is typically attached to the plastic bottle and disposed of together with a ketchup bottle. Hence, it is considered an integrated component; in this context, the plastic bottle itself is the main body of the packaging unit. Against this background, it could be considered that the main body of the packaging unit is the packaging part of the packaging unit with the highest share, by weight, except closure on flexible packaging. According to Article 6(9), ‘where a unit of packaging includes integrated components, the assessment of compliance with the design for recycling criteria and with the recycled-at-scale requirements shall include all integrated components. A separate assessment shall be carried out for integrated components that can become separated from each other as a result of mechanical stress during transportation or sorting’. 2) If there is no recyclable alternative for a specific packaging or its components on the market, could such packaging or its component get an exemption under Article 6? The exemptions from the recyclability obligations are listed in Article 6(11). The Commission is not empowered to grant any further exemptions. However, in case of innovative packaging, as brought to the attention of the competent authorities in the Member States, the Commission must assess the requests from the competent authorities and update or adopt new delegated acts under Article 6(4). Innovative packaging is defined as ‘packaging that is manufactured using new materials, resulting in a significant improvement in the functions of the packaging, such as the containment, protection, handling, or delivery of products, and in overall demonstrable environmental benefits, with the exception of packaging that is the result of modification to existing packaging for the main purpose of improving the presentation of products and marketing’ (Article 3(1), point (46)). The Commission will monitor the impact of the derogations contained in Article 6(11) and derogations as regards innovative packaging contained in Article 6(10), and may propose amendments to the Regulation, if necessary. 22 Therefore, if a packaging or its components does not fall under the established exemptions in Article 6(11), and does not qualify as innovative packaging, the manufacturers must improve packaging design to be compliant with the DfR guidelines from 2030 or two years after the entry into force of the delegated acts adopted under Article 6(4), specifying DfR requirements. Nonrecyclable integrated components may lower the recyclability grade of a unit of packaging or may even make the entire packaging unit non-compliant. 3) What is the process for granting the derogation and what are the expected timelines for its completion? What specific criteria does the Commission use to assess innovativeness? The process is outlined in Article 6(10). Member States enjoy a margin of discretion implement the process in their national legislation while respecting the rules outlined in that provision. The criteria are outlined in Article 3(1), point (46), and the Commission is currently not envisaging the adoption of further guidance in this regard. Manufacturers using this exemption from the recyclability requirements must evidence compliance with these criteria in the technical documentation. 4) Can Member States apply their own eco-modulation criteria? Under Article 6(4)(d), the Commission will outline a framework concerning the modulation of financial contributions based on the packaging recyclability performance grades to be paid by producers to comply with their EPR obligations set out in Article 45(1). This harmonised framework is necessary to ensure the proper functioning of EU internal market, by preventing regulatory fragmentation and ensuring legal uncertainty for economic operators, in particular those placing packaging on the market in several Member States, while at the same time incentivising more sustainable packaging design. Divergent national eco-modulation schemes based on recyclability performance could otherwise create obstacles to trade and distort competition within the internal market. The harmonised framework will not set the actual amounts of such fees but will instead harmonise the criteria for the modulation of EPR fees based on the recyclability performance grade obtained through the recyclability assessment. Until the entry into force of the harmonised eco-modulation rules, Member States will remain able to eco-modulate fees based on the recyclability of packaging in accordance with their national provisions adopted under the PPWD. In doing so, Member States must consider the potential impact of such measures on the internal market. Where national ecomodulation measures constitute technical regulations or rules affecting products, they must be notified to the Commission in accordance with Directive (EU) 2015/153516 through the TRIS notification system. Following the entry into force of the delegated act on design for recycling, which will establish a harmonised framework for eco-modulation of EPR fees based on packaging recyclability performance grade, Member States will be required to apply this harmonised framework. This obligation aims to ensure the consistent application of eco-modulation rules across the Union and to safeguard the free movement of goods. However, Member States will continue to be able to eco-modulate financial contributions of producers on the basis of other criteria, such as recycled content, the presence of substances of concern, or the reusability of packaging. If Member States decide to introduce eco-modulation based on the presence of recycled content in plastic packaging, they will be required to take into 16 Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 on measures for a high common level of cybersecurity across the Union, amending Regulation (EU) No 910/2014 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148, (OJ L 333 27.12.2022) 23 account sustainability criteria of recycling technologies and the environmental cost, which are to be developed by the Commission under Article 7(9) by the end of 2026. 5) If Member States do not reach the recycling targets, is there any mechanism foreseen to take this into account in the recyclability ‘at scale’ assessment? The ‘at scale’ assessment will be based on a recycling target of 55%17 to be achieved at EU level per packaging categories listed in Table 2 of Annex II. The Commission is empowered to amend the list of these categories to adapt them to the technical and scientific developments regarding packaging and packaging waste management. The ‘at scale’ assessment is not based on the recycling rates achieved at national level and therefore there is no need for a specific mechanism in the recyclability at scale assessment, which would take into account the fact that a specific Member State did not reach specific recycling targets. However, it is important that all Member States strive to optimise their collection, sorting and recycling systems to improve the overall recycling rate at the Union level and the availability of secondary feedstock. The Regulation provides for several support measures, such as the obligation to set up deposit and return systems, mandatory harmonised waste sorting labels, the obligation on Member States to establish mandatory collection targets, and the prohibition to landfill or incinerate recyclable packaging. The implementation of these requirements will help increase the overall recycling rate in the EU and thus allow economic operators to fulfil the recycling ‘at scale’ requirement. 6) What is the scope of the exemption under Article 6(11)(e) for baby food? The exemption for baby food as referred to in Regulation (EU) No 609/201318 should be understood in line with the definition given in its Article 2(2f). Therefore, the exemption should not be understood as covering all fruit juices and purees and other products that are marketed for consumption by babies. 7) Will the recyclability ‘at scale’ assessment be based on all packaging waste generated regardless of its origin, sector or type? The recyclability ‘at scale’ assessment and the related 55% recycling target for all packaging materials and 30% for wood indeed refers to all packaging waste generated and recycled in the EU, regardless of its origin (household, commercial and industrial waste), sector or type. Calculation of the recycling rate should be based on the existing rules for the calculation of recycling rates laid down in Commission Decision 2005/270, as amended, which will be replaced by a new decision under Article 56(7) PPWR. 8) Does Article 6 apply to reusable sales and transport packaging placed on the EU market prior to the entry into force of the requirements under Article 6(1) PPWR? Recital (14) explains that ‘packaging should be placed on the market only if it complies with the sustainability requirements and labelling requirements laid down in or pursuant to this Regulation’ (emphasis added). Packaging already placed on the Union market before the date of application of relevant requirements, including packaging in the stocks, does not need to meet the sustainability 17 For all materials except for wooden packaging, where it is 30%. 18 Regulation No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, pp. 35–56) 24 and labelling requirements laid down in or pursuant to this Regulation and does not need to be withdrawn. Article 6(2) requires that all packaging placed on the market 24 months from the date of entry into force of the delegated acts adopted pursuant to Article 6(4) is recyclable according to the DfR principles laid down therein. This obligation refers to every type of packaging, regardless of whether it is reusable or single-use, or sales, grouped or transport packaging. Therefore, since the delegated acts under Article 6(4) are to be adopted by 1 January 2028, reusable or transport packaging which manufacturers will have placed on the market before 1 January 2030, can stay on the market even if it is not compliant with the recyclability requirements. Placing on the market refers to every single packaging unit and not to the packaging design. 9) Are the exemptions from the recyclability requirements for packaging made from cork, lightweight wood, textile, ceramics rubber, porcelain and wax valid until 2035? Article 6(1) requires that all packaging be recyclable. Article 6(11) establishes exemptions from this requirement for certain packaging materials and sectors. The Commission will review these exemptions by 1 January 2035 to consider if it is appropriate to maintain them. Based on this assessment, it may propose to amend or remove them. The exceptions for packaging made from cork, lightweight wood, textile, ceramics rubber, porcelain and wax apply only to sales packaging and mean that such packaging will not have to undergo the recyclability assessment for the purpose of determining if it can be placed on the market. However, the obligation to adjust the EPR fees based on the recyclability performance will apply also to such sales packaging. The recyclability assessment for such packaging will thus be carried out only for the purpose of determining the EPR fee modulation. 25 V. RECYCLED CONTENT IN PLASTIC PACKAGING 1) How should compliance with the recycled content requirements be demonstrated? Compliance with the recycled content targets in the PPWR must be demonstrated in the technical documentation for the packaging, as specified in Annex VII. Compliance with the recycled content requirements can be exemplified as follows. An economic operator places a plastic tray made of polyethylene (PET) with a peelable lid made of polypropylene (PP) on the market. In this case, we could assume that the PET tray and PP lid are manufactured in different manufacturing plants within the EU and supplied to the economic operator who assembles the packaging components into a tray with a lid, fills it with product, and eventually places it on the market. The two manufacturing plants which manufacture, respectively, the tray and the lid must each disclose information about the compliance with the minimum recycled content requirements for their components, as provided for in Article 7(2). Based on the information from these manufacturing plants, the economic operator who eventually places the tray with the lid on the market (i.e. the manufacturer), must draw up the technical documentation that demonstrates compliance with the legal requirements for recycled content. The same principle applies to intermediate plastic packaging components, empty plastic packaging or filled plastic packaging imported into the EU. The economic operator must also ensure that the requirements for the recycled content meet the sustainability and equivalence criteria, which will be set out in the implementing acts pursuant to Article 7(9) and (10), respectively. 2) What is to be understood by ‘average per manufacturing plant and year’ in the context of recycled content in plastic packaging? A manufacturing plant must be understood as the industrial facility in which packaging is manufactured. An average per year refers to the amount of recyclates (recycled content) in each plastic packaging type and format over the period of a calendar year, produced for each manufacturer in a specific manufacturing plant. The manufacturing plant will have to provide documentation demonstrating that the average supply per year to the specific manufacturer fulfils the targets for recycled content. Manufacturers usually produce several packaging formats in one manufacturing plant and will therefore have to calculate the recycled content targets for each packaging type and format. The implementing act to be adopted under Article 7(8) will outline the rules on how to calculate and verify the recycled content in plastic packaging. 3) Are adhesives, paints and inks covered by the recycled content requirements for plastic packaging? Adhesives, paints and inks are not deemed plastic under the PPWR and therefore do not need to fulfil the recycled content requirements. This is regardless of whether they represent less than 5% of the packaging unit. 4) Are environmental claims on recycled content in plastic packaging allowed? Environmental claims on recycled content in plastic packaging are allowed where the recycled content exceeds the applicable minimum requirements set out in Article 7(1) and (2) of the PPWR. Article 14 specifies that the economic operator is allowed to make environmental claims for a packaging unit, the part of the packaging unit that contains the recycled content, or all packaging placed on the market over a calendar year by the economic operator. This is exemplified in the table below. 26 Example PPWR recycled content requirements Environmental claim for: Allowed environmental claim PET plastic bottle with a closure system made of PP PET bottle: 30% PP closure: 10% Packaging unit (bottle and a closure system) The recycled content exceeds 30% for the PET bottle or 10% for the PP closure system. Regardless of the choice to make environmental claims or not, compliance with the legal requirements must be demonstrated in the technical documentation. 5) How do economic operators know which recycled content requirements to fulfil? UPDATED! The recycled content requirements apply to any plastic part of sales, grouped, and transport packaging. Firstly, the economic operator must determine whether the packaging is contact-sensitive. Secondly, the economic operator must determine what polymer the packaging is made from. Based on this information, the economic operator can then determine what recycled content requirements to fulfil. This logic is illustrated in the following table. Packaging format 1st step: Is the packaging contact sensitive? 2nd step: What is the polymer made from? 2030 applicable target Example A Pallet wrapping film to transport goods Non-contact sensitive Other than PET Art. 7(1)(d), 35% Example B Beverage carton Contact-sensitive Other than PET Art. 7(1)(b), 10% Example C Single-use plastic beverage bottle: Contact-sensitive PET Art. 7(1)(c, 30% 6) Do the requirements for recycled content apply to packaging placed on the market before 2030? The recycled content requirements apply only to packaging placed on the market from 1 January 2030 or three years after entry into force of the implementing act in Article 7(8), whichever is the latest. However, no exhaustion of stocks is envisaged for packaging supplied to manufacturers and not yet placed on the market by the latter before the due date. 7) Will also a plastic cap and a label on a glass bottle need to comply with the recycled content requirements? UPDATED! Article 7(5)(b) exempts plastic parts that represent less than 5% of the total weight of a packaging unit from the recycled content requirements. This exemption applies exclusively to plastic parts and does not extend to non-plastic materials. 27 By way of example, in the case of a glass bottle with a metallic cap and a plastic label, the metallic cap is not a plastic part and therefore falls outside the scope of the recycled content requirements. A plastic label, however, is exempted if its weight accounts for less than 5% of the total weight of the packaging unit, i.e. the bottle with cap and label. 8) Recycled plastic in plastic caps is mandatory for milk but not for infant formula packaging. Must an economic operator that uses the same caps for these products meet the targets for recycled plastic content to comply with the requirements for milk packaging? As of 2030, manufacturers must ensure that the plastic part of the packaging placed on the market is compliant with the recycled content targets of Article 7(1). Milk is not exempted from the recycled content requirements. Therefore, a manufacturer must ensure that plastic caps that are used for the milk packaging fulfil the recycled content requirements. On the other hand, plastic caps for instant baby formula are not required to include recycled content due to the exemption set out in Article 7(4), point (g). 9) Is there a difference between ‘contact-sensitive plastic packaging’ and ‘immediate packaging’ as used in the exemptions of Article 7? The term ‘immediate packaging’ refers to the ‘(…) packaging immediately in contact with the medicinal product’19, whereas according to Article 3(1), point (49), of the PPWR contact-sensitive packaging means packaging that is intended to be used for food and medicinal products. In the context of medical devices and other medicinal products ‘immediate packaging’ will generally qualify as ‘contact-sensitive plastic packaging’ according to Article 3(1), point (49), of the PPWR, and while the concepts are not identical, they should be understood in the same way for the purpose of implementation of Article 7 of the PPWR. 10) What is the interplay between the reporting obligations related to recycled content under the PPWR and under the SUPD? Article 6(5), points (a) and (b) of SUPD (i.e. recycled content targets for beverage bottles listed in Part F of Annex to SUPD), and Article 13(1)(e) SUPD on related Member States’ reporting remain in force until 1 January 2030 or 3 years after the entry into force of the implementing act on the calculation of recycled content referred to in Article 7(8). There are some differences in scope between the PPWR and the SUPD, which should be taken into account: • In the SUPD, the target is at Member State level, whereas the PPWR sets the. requirements per packaging type/format, calculated as an average per manufacturing plant and year. • There is no minimum threshold in the SUPD for composite materials, whereas the PPWR contains an exemption for the plastic part if it represents less than 5% of packaging unit weight. • There is no exemption regarding compostable plastic packaging in the SUPD. 11) Recycled content requirements for imported plastic packaging Regulation (EU) 2022/1616 and its provisions (especially Article 6) apply to all recycled plastics for food contact materials placed on the EU market, including imported packaging. 19 Article 1(23) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311 28.11.2001, p. 67) 28 Therefore, importers of plastic materials with recycled content that intend to use this material as food-contact material, including food-contact packaging, should ensure that these materials comply with the requirements outlined below. If not compliant, these materials may not be placed on the market for food contact applications, including food-contact packaging. However, they may be used for other purposes. Article 6 of that Regulation mandates the following: • Separate collection of plastic waste; • A certificate obtained with third-party certification of the pre-processing activities in accordance with Article 6, including all activities from sorting to recycling of plastic waste; • Proof that the recyclates have been produced in accordance with Regulation (EU) 10/2011. 29 VI. COMPOSTABILITY 1) Article 9(1) mandates a compostability requirement for certain packaging types. Will these packaging types be allowed in the bio-waste stream even before 12 February 2028? Indeed, the Regulation changed the definition of packaging to include tea and coffee bags which are not left empty after use. Such new packaging items will be classified as packaging when the Regulation becomes applicable, that is on 12 August 2026. As Article 9 on compostability applies from 12 February 2028, Member States are not required to accept such packaging in the bio-waste steam before that date, but they are encouraged to accept them. 2) How should manufacturers deal with the fact that not all industrial composting facilities operate in accordance with EN 13432:2000? Will waste management operators in all Member States have to accept compostable packaging if it is certified according to the harmonised standard EN 13432:2000? While the Regulation does not state explicitly that composting facilities must operate in accordance with the harmonised standard, the Commission expects that this will indeed be the case. For example, Article 9(2) conditions the Member States’ flexibility to add additional packaging items to the national lists of mandatorily compostable packaging to the existence of ‘appropriate waste collection schemes and waste management infrastructure to ensure that compostable packaging enters the bio-waste management stream’. The Commission will ensure that associations representing industrial composting will be fully involved in the development of the updated industrial compostability standards. 3) If a product is nowadays compostable, and on the market, can economic operators continue to market it after the Regulation has entered into force and become applicable? The answer is ‘yes’, if there is a clear legal requirement in the territory of a Member State where the economic operator is marketing their products that a particular packaging format must be compostable. As explained in point 8 of the Commission guidance document, Member States have the possibility until 12 August 2026 to decide that packaging formats additional to items listed in Article 9(1) and 9(2)(a) must be compostable on their territories. 30 VII. PACKAGING MINIMISATION 1) Do both Article 10(1) and (2) on packaging minimisation apply by 1 January 2030? Yes. Both Article 10(1) and (2) apply by 1 January 2030. Until the end of 2029, the essential requirements from the PPWD continue to apply and thus also the existing standard EN 2004:13428. This results from Article 70(1)(b) of the Regulation. 2) How should the term ‘increase the perceived volume of the product’ in Article 10(2) be understood? The use of certain packaging characteristics, such as double walls or false bottoms, is not allowed when the perceived volume of the product is increased. An illustrative example below is provided to help better understanding. Example Packaging minimisation Choices that might increase the perceived volume of the product Plastic or glass 50 ml jar for facial cream Plastic or glass jars are reduced to the minimum volume necessary to protect the product inside Use of double walls or false bottoms to make it appear that the content of the cream as more than 50 ml Use of cardboard boxes around the jar which make it appear that the content of the cream larger than 50 ml Moreover, the Impact Assessment that supported the legislative proposal of the PPWR outlines a few examples on ‘increase the perceived volume of the product’20. Overall, the economic operator must prove that double walls, false bottoms, frontal flaps and additional layers are used only in circumstances where the packaging functionality cannot be ensured otherwise and/or in cases where these components add legitimate functionality to the packaging. This will have to be demonstrated via tests and proven in the technical documentation, by providing a sufficient justification. 3) How will the requirements of packaging minimisation be enforced for other than the most common packaging types and formats? By 12 February 2027, the Commission will request the European standardisation organisations to prepare or update, as appropriate, harmonised standards laying down the methodology for the calculation and measurement of compliance with the minimisation requirements. These standard(s) will be an update of the existing standard EN 13428:2004 to account for the changed performance criteria set out in Annex IV of the Regulation and will outline the methodology for demonstrating compliance with the minimisation requirements for all packaging. Once adopted, economic operators will be able to use the updated standard and thus benefit from the presumption of conformity with the minimisation requirement. 20 Assessment of options for reinforcing the Packaging and Packaging Waste Directive’s essential requirements and other measures to reduce the generation of packaging waste - Publications Office of the EU, page 26: an identical packaging format in terms of size, weight and volume is used to pack different amounts of the same type of screws. In the first case, the packaging fits 100 screws, whereas in the second case the same packaging contains 20 screws of the same size. Therefore, the second case (i.e. pack of 20 screws) is considered over-packaged, both in terms of the volume and weight of the pack. 31 In addition, for the most common packaging types and formats, the Commission will request the European standardisation bodies to prepare standard(s) specifying the maximum adequate weight and volume limits and, where appropriate, wall thickness and maximum empty space. 4) What are the ‘most common packaging types and formats’ mentioned in Article 10(3)? The Commission will identify the ‘most common packaging types and formats’ in its forthcoming standardisation request pursuant to Article 10(3) PPWR. These types and formats will be identified in collaboration with the industry and other stakeholders and be based on the available market data in terms of units placed on the market, on a level of granularity which accounts for the packaging functionality, packaging material and shape, as well as the packaged product. The potential for minimisation will also be considered in the framing of the standardisation request. 5) Which packaging is exempted from the minimisation requirements? The following packaging is excluded from the minimisation requirements (Article 10(2)): Packaged products or beverages that benefit from a geographical indication protected under Union law, such as under Regulation (EU) No 1308/2013 for wine, Regulation (EU) 2019/787 for spirit drinks or Regulation (EU) 2023/2411 for craft and industrial products or is covered by a quality scheme as referred to in Regulation (EU) 2024/1143. If packaging design is protected by a Community design pursuant to Council Regulation (EC) No 6/2002 (64) or by design rights falling within the scope of Directive 98/71/EC of the European Parliament and of the Council (65), including international agreements having effect in one of the Member States. For the exemption to apply, the packaging design must be protected before 11 February 2025, and the application of the minimisation requirements affect the packaging design in a way that it would alter its novelty and its individual character If packaging shape is a trademark falling within the scope of Regulation (EU) 2017/1001 (66) or Directive (EU) 2015/2436 (67), including trademarks registered under international agreements having effect in one of the Member States. For the exemption to apply, the trademark must be protected before 11 February 2025, and the application of the minimisation requirements affect the packaging in a way that the trademark can no longer distinguish the marked product from those of other undertakings. If the economic operator wants to use these exemptions, it will need to provide evidence related to them in the technical documentation. It will not be sufficient to provide a licencing number. It will also be necessary to demonstrate the existence and assessment of other conditions. 6) How will the packaging ’shape’ affect the packaging minimisation assessment? Firstly, the economic operator will have to consider if its packaging is covered by the exemption in Article 10(2)(a) related to shapes which are protected trademarks and if the conditions set out in that provision for exemption from the minimisation requirements are fulfilled. The verification of said conditions needs to be demonstrated by the economic operator. If the packaging is not covered by the exemption, economic operators will apply the updated harmonised standard on the methodology for packaging minimisation assessment to be requested by the Commission pursuant to Article 10(3). This updated harmonised standard will take the packaging shape into account in its methodology. For example, if a specific shape is necessary to provide packaging for the packaging functionality, such as safe-handling design, child resistance, anti-tamper, anti-theft, anti-counterfeit, hazard warnings, or specific product characteristics. 32 7) What is the relationship between the minimisation requirement in the PPWR and the ones in the ESPR? The general principle is that acts under the ESPR only take the lead on regulating products when their environmental sustainability dimensions either cannot or have not been fully and appropriately addressed by other instruments. This principle applies also to packaging. As explained in Recital 25 of the ESPR, if needed, the ESPR may complement the PPWR by setting product-based requirements that focus on the packaging of specific products. The ESPR will not, however, set general eco-design or sustainability requirements for packaging as a product group because these requirements are laid down in PPWR. 33 VIII. LABELLING 1) Will labelling requirements for reusable packaging under Article 12(2) apply at the level of each individual packaging? Reusable packaging must be designed to ensure a minimum number of rotations, which will be established in the delegated act to be adopted under Article 11(2). The obligation to calculate and report on the number of rotations for reusable transport packaging will depend on the type of reuse system. Namely, open-loop reuse systems without a system operator are exempted from this obligation and from the obligation to bear a reusable packaging label and a QR code. According to Article 12(2), reusable transport packaging circulating within closed-loop systems will have to bear a reusable packaging label and a QR code or another standardised open digital data carrier that will allow for tracking of the individual packaging and the calculation of its rotations. The detailed rules, including the label informing consumers that a packaging is reusable, will be clarified in the implementing act to be adopted under Article 12(6). This act will also specify situations when it is considered that an individual QR code and tracking of rotations is not feasible and the calculation of rotations can thus be made based on an average estimation. 2) Under what circumstances are labels, marks, symbols, or inscriptions considered misleading? Marks, symbols, labels, or inscriptions should not mislead consumers regarding sustainability requirements of packaging such as its recyclability, recycled content, reusability, compostability, bio-based content, hazardous substances content or waste management options (Article 12(8)). To further understand the notion of misleading claim please refer to Directive (EU) 2024/82521‘Empowering Consumers for the Green Transition’. Claims are considered misleading if they cause the consumers to make decisions that they would not otherwise make. 3) Should a packaging bear a national DRS label when it is imported from one Member State to another? Labelling of packaging covered by the mandatory deposit and return systems has not been harmonised in the PPWR. Therefore, products will have to comply with the DRS label of the Member State where they are made available on the market. Member States may require that such packaging be marked with a ‘harmonised colour label’ as specified in Article 12(1), fourth subparagraph. If products are imported in the context of private imports, i.e. directly by the end user and with no intention to commercialise them, this is not considered ‘making available on the market’. Member States cannot prohibit the affixing of DRS labels in place in other Member States. 4) Which are the substances of concern that need to be identified by the labelling requirements in Article 12(7), second subparagraph? The European Chemicals Agency (ECHA) is currently conducting a study to identify the substances of concern (SoC) in packaging that could affect human health and those that can impact packaging reusability and recyclability. Based on this input, the Commission will develop an implementing act establishing the methodology for labelling of SoC by means of digital labelling. 21 Directive (EU) 2024/825 of the European Parliament and of the Council of 28 February 2024 amending Directives 2005/29/EC and 2011/83/EU as regards empowering consumers for the green transition through better protection against unfair practices and through better information (OJ L, 2024/825, 6.3.2024) 34 IX. ENVIRONMENTAL CLAIMS 1) Will businesses be allowed to make environmental claims about features that are equivalent to those established by the Regulation? Article 14 applies only to ‘properties for which legal requirements are set out in this Regulation’. Environmental claims and sustainability labels related to, e.g., recyclability, compostability, recycled content, reusability, weight and volume minimisation, fall under the PPWR and manufacturers will need to make sure that such claims comply with Article 14, i.e. relate to properties that go beyond minimum requirements set by the PPWR and specifies if the claim refers to the whole packaging unit or a specific part of it. As regards environmental claims related to sustainability requirements outside the scope of this Regulation, for example recycled content in aluminium packaging, they must comply with the existing EU rules on environmental claims, in particular the Empowerment of Consumers Directive (EU) 2024/825, which amends the Unfair Commercial Practices Directive (2005/29/EC) and the Consumer Rights Directive (2011/83/EU). For further information on the relationship between the Unfair Commercial Practices Directive and other legislation, please, consult the Commission Guidance document on its interpretation22, in particular parts 1.2.1. on relationship with other EU legislation and part 4.1.1.1 on the Interplay with other EU legislation on environmental claims, which explains that lex specialis (e.g. PPWR) prevails over lex generalis (UCPD) in case of conflict. 2) In case the manufacturer wants to make a claim about the share of recycled content on the packaging unit, which threshold should be considered as the minimum requirement established by law? Will it be possible to make claims about 10, 20 or 50% of recycled content in each unit? In case a manufacturer makes a claim about the share of recycled content in packaging placed on the market, the applicable minimum targets (calculated as an average per manufacturing plant and per year), will apply and the manufacturers will be allowed to make the claim only if the recycled content exceeds those targets. For recycled content, the calculation and verification methodology will be established by 31 December 2026 in an implementing act, and environmental claims will need to comply with these rules. The voluntary label for recycled content will be developed by the Commission. 3) Does Article 14 apply only for environmental claims which refer to requirements stated in the PPWR (e.g. recyclability) or also for any other kind of environmental claims on sustainable packaging? Article 14 applies only to ‘properties for which legal requirements are set out in this Regulation’. Therefore, as regards environmental claims which are not regulated under the PPWR, e.g. related to recycled aluminium content, they must comply with the existing EU rules on environmental claims, in particular the Empowerment of Consumers Directive (EU) 2024/825. 22 Commission Notice – Guidance on the interpretation and application of Directive 2005/29/EC of the European Parliament and of the Council concerning unfair business-to-consumer commercial practices in the internal market (OJ C 526, 29.12.2021, pp. 1–129). 35 X. OBLIGATIONS OF MANUFACTURERS 1) Article 15(1) states that manufacturers must place on the market only packaging which complies with the requirements set out in Articles 5 to 12. Does this obligation apply exclusively to packaging manufacturers? The obligation to place on the market only compliant packaging does not apply only to economic operators defined as the manufacturer, but also to importers and distributors. Pursuant to Article 15(1), ‘manufacturers shall only place on the market packaging which is in conformity with the requirements laid down in or pursuant to Articles 5 to 12.’ The conformity assessment procedure (Article 38) can be carried out by the manufacturer or by someone else on their behalf (e.g. a laboratory or a certification scheme), in accordance with Article 15(2). The EU declaration of conformity (Article 39) must be drafted by the manufacturer, based on the information and documentation provided by suppliers pursuant to Article 16(1), or by an authorised representative, appointed by the manufacturer by a written mandate pursuant to Article 17. This means that the manufacturer is the sole economic operator bearing legal responsibility for packaging compliance with the sustainability and labelling requirements, regardless of the fact who might have actually drafted the EU declaration of conformity or parts of it. 2) When is the effective date of application of Articles 15 and 18 of the PPWR on obligations of importers and manufacturers? PPWR will become applicable on 12 August 2026, and this includes provisions on the obligations of manufacturers and importers. However, these provisions must be read in conjunction with the substantive obligations, as defined in various provisions of the Regulation, notably in Articles 5 – 12. Some substantive provisions have different application dates, which are often linked to the adoption of a specific implementing measure by the Commission. For example, as regards recyclability, manufacturers must comply with the recyclability requirements and perform the conformity assessment procedure in accordance with Article 38 and Annex VII of the PPWR only two years from the adoption of the delegated act on design for recycling requirements. On the assumption that this delegated act will be adopted by the Commission in January 2028 and will fully harmonise design for recycling requirements and the related assessment methodology, the binding recyclability performance criteria will only apply from 1 January 2030 or two years from the date of entry into force of the delegated act. Other effective dates of application of sustainability and other key requirements under PPWR: - Recycled content in plastic packaging: 1 January 2030 or three years from the date of entry into force of the implementing act referred to in Article 7(8) PPWR. - Minimisation (Article 10(1) – (2)): 1 January 2030. - Void space requirement for transport, grouped and e-commerce packaging: from 1 January 2030 or three years after the entry into force of the implementing act under Art. 24(2); as regards void space in sales packaging, see Art. 10. - Reusable packaging (Art. 11): from the date of entry into force of the Regulation (11 February 2025), but minimum number of rotations will have to be complied with depending on the date that will be specified in the implementing act referred to in Article 11(2) to be adopted by 12 February 2027. - Reuse targets: from 1 January 2030 or 18 months from the date of entry into force of the implementing act on the calculation of reuse targets, referred to in Article 30(3), to be adopted by 30 June 2027. 36 3) Should suppliers be required to mark ‘plain’ packaging, such as plastic carrier bags, with a serial number? Suppliers of packaging or packaging material are not manufacturers according to the definition of manufacturer in Article 3(1), point (13), except when the ‘manufacturer’ is a microenterprise and the supplier is located in the same Member State. The Regulation does not require that suppliers of packaging are identifiable on the packaging or via a data carrier. They must only ensure that the manufacturer has all the information and documentation necessary to demonstrate packaging conformity. The Regulation does not require either that suppliers identify packaging with a type, batch or a serial number; this is an obligation that falls on manufacturers. However, in practice, it may well be that it will be the suppliers of packaging who will ensure that packaging is identifiable, as this is often done at the production stage. 4) What are the obligations of importers or distributors who supply packaging materials? UPDATED! In general, suppliers of packaging are not responsible for drawing up a declaration of conformity. However, pursuant to Article 16 of the Regulation, they are required to provide the manufacturer of the packaging ‘with all the information and documentation necessary for the manufacturer to demonstrate the conformity of the packaging with this Regulation’, including all the relevant technical documentation. The company which places packaging or packaged products on the EU market (manufacturer/importer) has the legal responsibility for ensuring overall compliance with relevant PPWR requirements, including those stemming from Articles 5-12. It will therefore need to ensure that compliant packaging is used by obtaining the required documentation from its suppliers. Suppliers must provide this information and documentation, as established in Article 16(1), and can therefore not refuse to provide the relevant documentation to the manufacturer. 5) What should happen to packaging held in stock or already produced prior to 12 August 2026, but not yet placed on the market by that date? Will operators be obliged to destroy, remanufacture or re-label it? NEW! Packaging that has not been placed on the market by 12 August 2026, but that has already been produced and sits in stock, does not have to be destroyed, remanufactured or re-labelled. To meet the requirements under Article 15(5) and 15(6), which establishes that packaging must bear a unique identification as well as the manufacturer’s name and address, it is possible to provide the required information by means of an accompanying document. This is also the case for reusable packaging already placed on the market. However, for packaging that is manufactured after the 12 August 2026, an accompanying document must only be used when it is not possible to affix the unique identification and the name and address directly on the packaging. Packaging that has been placed on the market before 12 August 2026 can remain on the market, even if it is non-compliant with PPWR. 6) If the supplier of already produced packaging no longer exists, or if a supplier is unwilling to provide the necessary information, how can the manufacturer of the packaging show compliance? NEW! Where the necessary information for packaging that is manufactured before 12 August 2026 is missing or insufficient, the manufacturer under the PPWR must make best efforts to provide the necessary information, for example by requesting it from the former supplier or, in the case of a business takeover/merger/acquisition, from the new resulting company, or by making own assessments. 37 7) Under what circumstances can the obligations under Article 15(5) & (6) be fulfilled via accompanying documents? NEW! These obligations apply to all packaging placed on the market after 12 August 2026, regardless of the type of packaging or the material used. Where the size or nature of the packaging does not allow for the affixing of a unique identifier and the name and address of the manufacturer, as established under articles 15(5) and (6) of the PPWR, the information can be provided in a document accompanying the packaging. Whether or not it is possible to affix the information on the packaging should be assessed on a case-by-case basis, taking into account the physical dimensions, shape and functional characteristics of the packaging. In addition, packaging that has not been placed on the market by 12 August 2026, but that has already been produced or sits in stock, may also use an accompanying document to meet these requirements before being placed on the market. 8) In practice, do the requirements of Article 15(5) mean that every individual unit of packaging needs to be traceable? NEW! Article 15(5) requires packaging to bear information enabling its unique identification, such as a serial number, batch number or another equivalent element. The purpose of this provision is to facilitate traceability of the packaging placed on the market for compliance verification and market surveillance purposes – i.e. to enable the packaging to be identified (for example a packaging type, model or production batch), so that it can be linked to the relevant technical documentation and declaration of conformity. The Regulation does not require every single component of a packaging unit to be individually marked for traceability purposes. For example, for a yoghurt cup consisting of a plastic cup, lid and sleeve or label, it should be sufficient if the required information is displayed on only one component of the sales packaging. In addition, where the size or nature of the packaging does not allow for the identifier to be on the packaging itself, Article 15(5) allows it to be provided in a document accompanying a packaged product. In general, identification may be provided through batch numbers or other equivalent means and may refer to types or production batches of packaging rather than to each individual item. Commonly used and standardised packaging items such as adhesive tapes, generic plastic bags, or desiccant bags that are bought from suppliers are normally traceable at the level of the production batch, and not at the level of each individual unit. 9) Can manufacturers delegate responsibilities to third parties? NEW! As Article 15(1) sets out, manufacturers are responsible for ensuring the compliance of the packaging they place on the market with the PPWR rules. Before placing packaging on the market, the manufacturer must therefore undertake certain steps, including those outlined in Article 15(2): carry out a conformity assessment procedure, draw up an EU declaration of conformity and compile the other technical documentation required (see Articles 38 & 39 and Annexes VII & VIII). In relation to the conformity assessment procedure: as per Article 15(2), manufacturers may carry this out themselves or opt to have it carried out on their behalf (e.g. by a laboratory or a certification 38 scheme). In relation to the EU declaration of conformity: as per Article 17, this may be drafted by the manufacturer (based on the information and documentation provided by suppliers pursuant to Article 16(1)) or drafted by an authorised representative, appointed by the manufacturer by a written mandate (in which case overall responsibility for the compliance of the EU declaration of conformity will still remain with the manufacturer). In relation to the technical documentation: as Article 17 sets out, the obligation to draw this up cannot be delegated. Manufacturers must therefore assume this responsibility themselves. Article 16 of the PPWR requires suppliers to provide manufacturers with the relevant information and documentation necessary to prove compliance. The Regulation therefore establishes a system whereby the packaging supplier provides the technical information necessary to demonstrate compliance, while the manufacturer remains the economic operator legally responsible for placing compliant packaging on the market. As Article 17(2) also makes clear however, an authorised representative appointed by a manufacturer may be made responsible for certain other tasks, including keeping the declaration of conformity and technical documentation at the disposal of the national authorities for the required amount of time, cooperating with the national authorities and making relevant documents available to them, on the manufacturer’s behalf. Regardless of who the manufacturer may appoint to carry out some of the above-mentioned tasks, the manufacturer will remain the sole economic operator bearing legal responsibility for packaging compliance under the PPWR, and this legal responsibility cannot be transferred by means of contractual arrangements. 10) Manufacturers and importers are required to keep records of the ‘conceptual design, manufacturing drawings and materials of components’ of their packaging. Is it sufficient if the suppliers retain this design information, and make it available to authorities upon request? NEW! The manufacturer bears legal responsibility for ensuring that the packaging it places on the market is compliant with the obligations in the PPWR, including those stemming from Articles 5-12. To document compliance to national authorities, Articles 15(3) and 18(7) establish that manufacturers and importers of packaging must keep the technical documentation referred to in Annex VII for 5 years for single use packaging and 10 years for reusable packaging. Annex VII sets out that the technical documentation must at least include “conceptual design, manufacturing drawings and materials of components”. While this provision will need to be complied with by manufacturers, manufacturers should ensure the confidentially of commercially sensitive information in accordance with relevant EU and national law. 11) Article 18 lays down obligations on importers. What should an importer be aware of? NEW! If a packaging is imported from a third country, the importer is responsible for ensuring that the manufacturer established outside the EU has complied with the applicable requirements of the PPWR. To demonstrate that this is the case, the importer must ensure, as of 12 August 2026, that: • The conformity assessment procedure referred to in Article 38 has been carried out by the manufacturer in the third country and that that manufacturer has drawn up the Declaration of Conformity; • The manufacturer has complied with the requirements set out in Article 15(5) and 15(6); • The packaging is accompanied by the required documents. 39 Article 18 requires importers to indicate their name, registered trade name or registered trademark, and their postal address and electronic means of communication, where available, on the packaging or, where this is not possible, on an accompanying document. This also applies to imported generic or unbranded packaging materials (e.g. paper sheets) that the importer intends to place on the market, as the absence of information on the packaging does not remove the obligation to demonstrate compliance. The importer placing such packaging on the market will need to assume responsibility for the documentation and compliance requirements. As a general principle, importers should engage in dialogue and make necessary contractual arrangements with suppliers or manufactures in third countries to ensure that the products they import are in compliance with the relevant rules under PPWR. In the case of generic and/or unbranded imported packaging, a document that accompanies the packaging upon import, such as a shipping document, may be used to meet the requirements under Article 18(2)(d), provided that all information required is included in it. 12) Does packaging transiting the EU towards non-EU destinations need to comply with PPWR rules? NEW! Transit through the EU must be handled in accordance with general EU product rules and customs legislation. As specified in the Commission Guidance, point 19, packaging or packaged products intended to be placed on the EU market need to comply with the PPWR rules. If the packaging or packaged products will not be ‘declared for the release for free circulation’ but remain in transit in the EU on the way to a non-EU destination, compliance with PPWR requirements is not required as it is not considered placed on the market. For imported products, placing on the market is generally considered to occur when the products are ‘declared for the release for free circulation’ 23. The purpose of release for free circulation is to fulfil all import formalities so that the goods can be made available on and circulate freely in the EU market. Products declared as such thus need to be compliant with the applicable Union harmonisation legislation. In practice, however, the release for free circulation and the placing on the market may not take place at the same time, e.g. in the case of distance sales, when placement on the market occurs before release for free circulation. If a company imports packaged products to the EU and subsequently exports them to a third country, the packaged products will only have to comply with the PPWR requirements if they are placed on the market in the EU. Placing on the market requires an offer or an agreement between two or more legal or natural persons for the transfer of ownership, possession or any other property right concerning the product in question. Therefore, if goods only transit the EU, without being released for free circulation or placed on the market, they are not required to comply with PPWR rules. 13) Can information already required e.g. under food legislation be considered sufficient to fulfil the requirements set out in Article 15(5) and 15(6) of the PPWR? NEW! 23 Please consult the Commission’s ‘Blue Guide on the implementation of EU product rules’, section 2.3 and 2.5), as well as the Commission Notice for the PPWR, point 19. 40 Food legislation and the PPWR are different legislative frameworks and pursue different objectives and as such should be viewed as complementary. Whether or not information provided under food legislation will be sufficient to fulfil the requirements set out in Articles 15(5) and 15(6) of the PPWR will depend on the particular provision of food legislation and the type and placement of the information to be provided thereunder. Article 15(5) of the PPWR: Article 15(5) of the PPWR requires that packaging bears a type, batch or serial number or other element to allow its identification or, where the size or nature of the packaging does not so allow, the required information may be provided in a document accompanying the packaged product. The identification of packaging is required to enable the competent authority/ies (which may not be the competent authority/ies for food products) to link packaging to the declaration of conformity (the “DoC”) drawn up by the manufacturer of the packaging for the purposes of the PPWR. Traceability information provided for the purposes of food legislation will not fulfil the requirements of Article 15(5) of the PPWR unless such information can ensure that the packaging is identifiable to the competent authority/ies, can be linked to the DoC and furthermore, is placed on the packaging itself or in an accompanying document. Article 15(6) of the PPWR: the manufacturer of the packaging must be determined based on the definition of ‘manufacturer’ in the PPWR, whereas Article 8 of Regulation (EU) No 1169/2011 on the provision of food information to consumers 24 (FIC Regulation) offers flexibility to decide who the responsible food operator is. Therefore, the responsible food operator and the manufacturer of the packaging may not always be the same natural or legal person. The fact that one operator is identified for the purposes of food law does not determine the identity of the manufacturer for the purposes of the PPWR. Where the food business operator and the manufacturer of the packaging are the same natural or legal person, it is important to ensure that the information provided fulfils the requirements of both Union laws. For example, Article 9(1)(h) of the FIC Regulation requires that the name or business name and address of the food business operator be provided, and Article 12 of the FIC Regulation sets out the requirements for the placement of such information. Article 15(6) of the PPWR requires the name, registered trade name or registered trademark of the manufacturer of the packaging as well as the postal address at which and, where available, the electronic means of communication by which they can be contacted be provided. Furthermore, Article 15(6) of the PPWR specifies how this information is to be provided i.e. in physical form or in a QR code on the packaging, or if this is not possible, in a QR code on the grouped packaging (where grouped packaging is used and bears a data carrier for the provision of information in relation to Articles 12(1), 12(2) and 12(4)) or in an accompanying document. Therefore, the provision of information on the food business operator in accordance with the FIC Regulation will not necessarily meet the requirements for the provision of information on the manufacturer of the packaging in Article 15(6) of the PPWR. Where an economic operator wishes to provide one set of information for both the food business operator and the manufacturer of packaging, they must do so in a form that satisfies the requirements of both Union laws i.e. compliance with the FIC Regulation alone is not sufficient. 24 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304 22.11.2011, p. 18) 41 14) Who is the manufacturer of custom-made transport packaging that does not bear a name or trademark? NEW! If a company orders a custom-made packaging from another company, the company making the order will be considered the manufacturer under the PPWR. This is due to the fact that, for packaging that does not bear a name or trademark, the decisive criterion is who places the order and decides on the design specifications for that packaging. If the packaging is custom-made for a specific product, the packaging characteristics are based on the product, and therefore the decisive power will rest with the company that orders the custom-made packaging. The company that supplies the packaging to the manufacturer must provide the manufacturer with the necessary technical documentation, as specified in Article 16 of the PPWR. 42 XI. EMPTY SPACE 1) Who is the obligated party to comply with the empty space requirements under Article 24? Article 24(1) establishes maximum empty space ratio for grouped, transport and e-commerce packaging which needs to be met by the economic operator who fills such packaging. This may be the manufacturer as defined in Article 3(1), point (13), as well as other economic operators who make packaged products available on the market. 2) How should the term ‘minimum necessary’ in Article 24(4) be understood? The empty space ratio for sales packaging means the difference between the total internal volume of the sales packaging and the volume of the packaged product. For assessing compliance with this paragraph, space filled by filling materials, such as paper cuttings, air cushions, bubble wraps, sponge fillers, foam fillers, wood wool, polystyrene or styrofoam chips, shall be considered as empty space. For empty space ratio in sales packaging, there is no maximum threshold established in the PPWR; instead, it is left to the relevant economic operator who fills sales packaging to minimise the empty space and to demonstrate this in the technical documentation. This provision should be read in conjunction with Article 10 on packaging minimisation. 3) Are the design patents covered by the 50% empty space ratio requirement? Contrary to Article 10 on packaging minimisation, Article 24 does not have specific exemptions for packaging covered by packaging design rights or trademarks. However, the 50% threshold applies only to grouped packaging, transport packaging and e-commerce packaging (Article 24(1)). 4) How will round products and other irregular shapes be addressed by the methodology for the calculation of the empty space? By 12 February 2028, the Commission shall adopt implementing acts to establish the methodology for the calculation of the empty space ratio for grouped packaging, transport packaging and ecommerce packaging (Article 24(2)). That methodology shall consider the special characteristics of packaging which needs to be placed in an empty space that is large enough to comply with the applicable legal requirements or to protect the product. The methodology shall take into account packaged products of irregular shape, packaging containing more than one sales packaging or product, packaging containing liquid products, packaged products the content of which can easily be damaged and packaged products that can be damaged by larger products due to their small dimensions, and the minimum space on the transport packaging to enable shipment labels to be affixed. Economic operators will need to comply with the empty space ratio threshold by 1 January 2030 or 3 years after the entry into force of this implementing act. The methodology will be based on a wide range of examples, including irregular shapes. 43 XII. BANS AND THE USE OF CERTAIN PACKAGING 1) What instruments are available to ensure legal harmonisation and predictability of the implementation of Annex V? The Regulation empowers the Commission to adopt guidelines by February 2027, in consultation with Member States and EFSA (European Food Safety Authority), to explain Annex V in more detail, including examples of packaging formats in scope, and any exemptions from the restrictions, and provide a non-exhaustive list of fruits and vegetables that are excluded from point 2 of Annex V (Article 25(6) PPWR). The Commission has started preparatory works for the guidelines and intends to ensure that these guidelines are based on science and on the latest technological developments. The intention is to ensure a common understanding and the equal implementation of the packaging formats in scope, and any exemptions from restrictions. While the Regulation does not empower the Commission to harmonise the list of exempted fruits and vegetables via an implementing or delegated act, the Commission, together with EFSA, has been working hard to ensure a solid scientific basis for the future guidelines, and expects that Member States will follow the guidelines, once published. Finally, the Regulation contains a specific review clause requiring the Commission to assess, by 2032, the packaging bans and empowering it to propose new restrictions or to amend the existing derogations and exemptions. 2) What do the terms ‘unprocessed fresh fruits and vegetables’ and ‘demonstrated need’ in point 2 of Annex V mean? The terms ‘unprocessed fresh fruits and vegetables’ and ‘demonstrated need’ will be further clarified after the formal consultation with the related stakeholders and EFSA, in the context of the development of the Commission guidelines. The term ‘unprocessed fresh fruits and vegetables’ refers to fresh fruit and vegetables that have not been altered. When such fruits and vegetables weigh less than 1,5 kg, they cannot be prepacked. The Commission will develop guidelines explaining, based on scientific studies, which unprocessed fresh fruit and vegetables are appropriate for exemptions. 3) Is it possible to extend the scope of the illustrative formats and products covered by point 4 of Annex V to additional sectors (e.g. schools), beyond the exemptions explicitly listed? Point 4 of Annex V concerns single-use plastic packaging for condiments, preserves, sauces, coffee creamer, sugar and seasoning in the HORECA sector. It expressly exempts only (a) take-away ready-prepared food intended for immediate consumption and (b) the healthcare sector. The illustrative formats will be developed in the guidelines. The PPWR does not provide a legal basis to enlarge the list of exemptions to other sectors. 4) How shall the term ‘necessary to facilitate handling’ under point 1 of Annex V to be understood? The restriction in question concerns ‘single- use plastic grouped packaging used at the point of sale (…), designed as convenience packaging to enable or encourage consumers to purchase more than one product’. What is targeted is unnecessary single-use plastic grouped packaging designed for ease of use and portability, and which also incites consumers to buy more. Both conditions should be fulfilled for the ban to apply. The most common examples of such packaging are collation films and shrink wraps, grouping two or more stock keeping units (SKUs). 44 Other examples and other guiding principles will be provided in the guidelines. As regards B2B situations, they are not covered by the ban. The Commission guidelines will further specify how the term ‘necessary to facilitate handling’ will be operationalised, through illustrative examples. 5) Are biodegradable or compostable bags banned by Annex V, point 6? All very lightweight plastic carrier bags (thus including compostable or biodegradable bags) are banned under Annex V, point 6. However, if such bags are needed for hygiene purposes or provided as sales packaging for loose food to prevent food waste, they are excluded from this harmonised ban. Very lightweight plastic carrier bags, which are needed for hygiene purposes or provided as sales packaging for loose food to prevent food waste’, although not banned by Annex V, point 6, are in principle included in the 40% reduction target set out in Article 34(1) PPWR for all lightweight plastic carrier bags. However, Member States may decide to exempt that specific type of bag from the reduction target (Article 34(4) PPWR). To reach the 40% target, Member States may decide to ban very lightweight plastic carrier bags, including compostable or biodegradable bags, which are needed for hygiene purposes or provided as sales packaging for loose food to prevent food waste However, marketing restrictions (bans) by Members States must be proportionate and nondiscriminatory (Article 34(2) PPWR). 6) Can hotel miniature cosmetics be available on demand? Can derogations for products packaged for hygienic reasons, such as toothbrush and cotton pads, be expected? Annex V, point 5, refers to ‘single-use accommodation sector packaging intended for an individual booking’. The Regulation does not define the terms ‘cosmetics, hygiene and toiletry product’, nor does it exempt miniature packaging available on demand or purchased at the hotel premises, but only those intended for an individual booking. To ensure a harmonised approach, the Commission is mandated to explain Annex V in more detail, including examples of the packaging formats in scope, and any exemptions from the restrictions, by publishing guidelines by 12 February 2027 (Article 25(6) PPWR). The timely adoption of the Commission guidelines will ensure that the scope of the provision is sufficiently clear almost three years ahead of the application date. The Commission intends to consult the relevant stakeholders, including the hospitality sector, before publishing them. Furthermore, it should be recalled that only packaging is banned and not products as such, which could therefore still be made available without packaging. 7) Will single-use plastic food and beverage packaging be banned from entertainment and sporting events and festivals? Sport and entertainment venues and festivals are included in the ‘HORECA’ definition (Article 3(1), point (35)), which refers to ‘Accommodation and Food Service Activities according to NACE Rev. 2 – Statistical classification of economic activities. NACE Rev. 2 includes guidance which explains that the decisive element is that meals, including beverages, fit for immediate consumption are offered at the facility, and not the kind of facility providing them. However, establishments in the HORECA sector that do not have access to drinking water are expressly exempted from the ban, pursuant to Annex V, point 3. 8) Is hotel room service covered by the ban in Annex V, point 3? How about if a hotel delivers food outside the restaurant’s premises? 45 The packaging ban in Annex V, point 3, applies to the HORECA sector, which should be understood in line with the definition in Article 3(1), point (35), which in turn refers to NACE Rev. 2. Hotels are included in the HORECA sector, which means that room service falls under the ban. However, if a hotel delivers food and beverages in packaging outside their premises, then such packaging is not banned under Article 25 and Annex V, point 3. However, in that case, the obligations relating to refill and re-use in the take-away sector, as specified under Articles 32 and 33, apply. 9) Is the list of examples outlined in the ‘illustrative example’ column of Annex V exhaustive? The list is not exhaustive, as its wording (‘illustrative example’) demonstrates. The formats that fall within the scope of the bans will be further explained in the Commission guidelines to be developed by 12 February 2027, as mentioned in the answers to the previous questions. 46 XIII. REUSE AND REFILL Reusable packaging (Article 11) 1) How will the rotations or trips of reusable packaging be calculated? Reusable packaging must be designed to ensure a minimum number of rotations, which will be established in the delegated act to be adopted under Article 11(2). The obligation to calculate and report on the number of rotations for reusable transport packaging will depend on the type of reuse system. In particular, open-loop reuse systems without a system operator are exempted from this obligation (Annex VI, Part A, section 1 (i)). Closed-loop reuse systems with system operators must report on the number of rotations or trips for each individual reusable packaging, or for an average estimation if the calculation for each individual reusable packaging is not feasible. The detailed rules on the calculation of the achievement of the re-use targets contained Article 30 will be clarified in the implementing act to be adopted under Article 12(6). This act will also specify the situations where it is considered that an individual QR code and tracking of rotations is not feasible and the calculation of rotations can be made based on an average estimation. Manufacturers need to demonstrate that the design of reusable packaging and the related system for reuse allow packaging to comply with the minimum number of rotations requirement. This will need to be done at the time of placing packaging or a packaged product on the market in the technical documentation and applies both to reusable packaging circulating in open loop and closed loop reuse systems. According to Article 27 and Annex VI, reuse systems must be designed to ensure that reusable packaging rotating within them completes at least the minimum intended number of rotations as set out in the delegated act. This will be verified by the Member States’ market surveillance authorities (Article 62(1), point (h)). Reuse systems 2) What is an ‘open loop’ reuse system and what are some concrete examples of such systems? Open loop reuse systems are characterised by interoperability where reusable packaging can circulate across different companies, locations, product categories, or sectors rather than being returned to the single system operator. Open loop reuse systems do not necessarily mean that reusable packaging becomes the property of the consumer once paid for; this will depend on the business model. Such reuse systems are normally characterised by using standardised packaging, shared infrastructure (e.g. for collection, washing and redistribution), and are often coordinated by a system operator, who manages the logistics and ensures quality, even if the existence of a system operator is not a legal requirement under the PPWR. Under the PPWR, open-loop systems without a system operator are exempted from the reuse labelling requirements and from the reporting on the number of rotations achieved. Examples of open loop systems without a system operator are the following: The 0.33-liter longneck reusable bottle system (in Germany): this system is mostly used by brewers, but also by mineral water companies and other carbonated soft drink producers. Although there is a standard for the bottle issued by the German Brewers Association and a licensing system for participants, there is no system operator. 47 The Euro Pallet: this system has a standard for the pallets, and licensees for production are issued, but there is no system operator or system management, even though an association (i.e., EPAL) is responsible for licensing and some other services. 3) How can economic operators using reusable packaging ensure that a proper reuse system is in place? According to Article 27 PPWR, economic operators using reusable packaging must participate in one or more re-use systems and ensure that these systems comply with the requirements laid down in the PPWR, Part A of Annex VI. Economic operators also have the possibility to set up their own re-use system, which must comply with Annex VI. The PPWR establishes the minimum requirements for the reuse systems in its Annex VI, and the sector needs to find ways to cooperate and find the most appropriate solutions, depending on their respective products and the local circumstances, to optimise the functioning of the reuse system. 4) Does a reuse system need to be open for all end users? Re-use systems can vary in size and geographical coverage and range from smaller local systems to larger systems that may span over one or several Member States’ territory. Reuse systems do not have to cover the entire MS. They must however provide equal access and fair conditions to the end users in the area in which they operate. 5) Are reuse systems obliged to carry out extended producer responsibility on behalf of the producers participating in the reuse system? NEW! Extended producer responsibility (EPR) obligations apply to all producers who place packaging on the Union market, whether it is single-use or reusable. While the EPR obligation remains with the producer of the reusable packaging, the reuse system must have in place procedures to ensure that EPR obligations are implemented for the reusable packaging that is part of the system, as specified in Annex VI, Part A, point 1(i) of the PPWR. The provision in Annex VI should be viewed in the context of how re-use systems are organised. In open loop systems, which do not have a system operator, the reusable packaging circulates among an unspecified number of participants as explained in the Commission notice, point 2. Therefore, there may be more than one producer with corresponding EPR-obligations participating in the reuse system. In open loop systems where the re-use system operator is often the manufacturer, there is only one producer responsible for complying with EPR obligations. It will be at the discretion of the producer to determine how to fulfil its EPR obligations, insofar as the Member State has not laid down specified rules. Reuse targets for transport packaging 6) Would the exemption for cardboard boxes from the reuse targets for transport packaging cover interlayers and corrugated cardboard? Article 29(4)(d) exempts cardboard boxes from the scope of the reuse targets. This should be understood as including corrugated cardboard boxes. However, the list of exemptions contained in Article 29(4) must be understood strictly and is limitative, in terms of material, format and use. Therefore, the exemption of cardboard refers only to cardboard boxes and does not include interlayers. Nevertheless, since they are also not a format that is explicitly listed in Article 29(1) and therefore, interlayers are also not concerned by the reuse targets in the first place. 7) What packaging formats are covered by the exemption for flexible formats for transport packaging? 48 Article 29(4)(c) excludes from the targets transport packaging flexible packaging formats that are used for transportation and that are in direct contact with food and feed, as defined in Article 2 and in Article 3, point (4), of Regulation (EC) No 178/2002 or with food ingredients as defined in Article 2(2), point (f), of Regulation (EU) No 1169/201. Therefore, all flexible formats, such as big bags or flexible intermediate bulk containers, as listed in Article 29(1), which are not used for direct contact with food and feed, and also not used for the transportation of dangerous goods (exemption envisaged under Article 29(4)(d)), and not custom- designed for the transportation of large-scale machinery (exemption envisaged under Article 29(4)((b)) should comply with the reuse targets set forth in Article 29(1) to (3). These will be further specified in the context of the Implementing Act under Article 30 on the rules on the calculation of the achievement of the re-use targets. 8) Do ‘pallet wrappings and straps’ count as one format or two separate formats? Pallet wrappings and straps are different packaging formats, but they may be part of the same transport unit for the purpose of calculating compliance with reuse targets under Article 29. This will be further clarified in the implementing act under Article 30 on the rules on the calculation of the achievement of the re-use targets. 9) If a format is not indicated in Article 29(1), can it still be in the scope of the reuse targets for transport packaging? Are all flexible packaging formats, such as sealed bags, in that scope or only those formats listed in paragraph 1? Article 29(1) lays down an exhaustive list of packaging formats covered by reuse targets, including their flexible formats. If a sealed bag is an intermediate bulk container, it is within the scope of the reuse targets, unless it is in direct contact with food and feed, as specified in Article 29(4)(c), in which case it is exempted. 10) What is the definition of a transport unit? The term is not defined nor used in the Regulation, but it might be defined in the future for the purpose of the rules on the calculation of the achievement of the re-use targets in the implementing act to be adopted under Article 30(3). Reuse targets for beverages 11) Do the reuse targets for beverages apply to non-alcoholic and alcoholic beverages individually considered or are they joint targets? The reuse target for beverages provided for in Article 29(6) applies to both alcoholic and non- alcoholic beverages. Final distributors, such as retailers, bars and restaurants, can decide what type of beverages (alcoholic, non-alcoholic or both) they offer for sale to consumers in reusable packaging in order to fulfil the reuse target. Final distributors shall, however, ensure that beverages of their own brand contribute on a fair and proportionate basis towards the achievement of the reuse target. 12) What beverages fall under the scope of the reuse targets for beverages? The beverages within the scope of the reuse targets for beverages in Article 29(6) will be clarified in Commission guidelines to be adopted by 12 February 2027. The guidelines will be developed in consultation with the Member States and other relevant stakeholders. Article 29(7) specifies that certain beverages are exempted from the reuse targets. This includes: 49 • Beverages which are highly perishable within the meaning of Article 24 of Regulation (EU) No 1169/201125. • Milk and milk products listed in Part XVI of Annex I to Regulation (EU) No 1308/201326 and their dairy analogies falling within codes 2202 99 11 and 2202 99 15 of the Combined Nomenclature (CN) in Annex I to Council Regulation (EEC) No 2658/8727. Categories of grapevine products listed in points 1, 3 to 9, 11, 12, 15, 16 and 17 of Part II of Annex VII to Regulation (EU) No 1308/2013.Aromatised wine products as defined in Regulation 13) Can Member States set national reuse targets for beverages? By 2030, Member States shall fulfil the waste prevention targets specified in Article 43(1). Member States may need to complement the harmonised EU measures with national measures, as specified in Article 51(2)(c). Member States may increase the harmonised reuse targets set forth in Article 29(6) or set reuse targets for other beverages. This may include beverages that are expressively exempted under Article 29(7). To implement national reuse targets, a Member State needs to prove that this is necessary to meet the waste prevention targets, so as to avoid compromising the objective of market harmonisation. The targets will need to be notified to the Commission via the TRIS procedure, since such measures are technical regulations. Member States can keep existing national reuse obligations in force until 1 January 2030, but from this date onwards the reuse targets in the PPWR will prevail. For further information on under what conditions that Member States can set national reuse targets, please consult the Commission guidance document. 14) Are operators of restaurants or bars covered by the 10% reuse obligation set on beverages? All final distributors, including the ones in the HORECA sector, are obliged to fulfil the reuse targets for beverages provided for in Article 29. However, to minimise burdens on smaller businesses, final distributors with a sales area of less than 100 m2 are exempted from this obligation by Article 29(6). Final distributors which make less than 1000 kg of packaging available on the territory of the Member State per year and fall under the definition of a micro-enterprise, are also exempted from the reuse target for beverages by Article 29(13)(a). 15) Is single use beverage packaging exempted from the reuse targets for beverages if it is part of a deposit and return system? The obligation to fulfil the reuse targets for beverages in Article 29(6) applies to final distributors such as retailers and restaurants. 25 Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304 22.11.2011, p. 18) 26 Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ L 347, 20.12.2013, pp. 671–854) 27 Regulation (EU) 2018/196 of the European Parliament and of the Council of 7 February 2018 on additional customs duties on imports of certain products originating in the United States of America ((OJ L 044 16.2.2018, p. 1) 50 The PPWR does not contain a general exemption for single-use beverage packaging in a deposit and return system, but it provides a large number of exemptions and flexibilities. These includes: o All final distributors with a sales area under 100 m2 are fully exempted (Article 29(10)) o Member States can exempt final distributors on small islands with less than 2000 habitants (Article 29(11)) o Member States can exempt final distributors if their sales area is located in a municipality with population density of less than 54 persons/km2. However, the targets will apply to final distributors with a sales area in population centres with more than 5000 inhabitants (Article 29(11)). o Member States can allow final distributors to form pools for the purpose of meeting their reuse obligations jointly. This means that up to 5 final distributors, for example in densely and remote areas, can share the reuse obligation (Article 29(12)). o All final distributors, who are micro-enterprises and do not make more than 1000 kg. of packaging available in a Member State a year, are fully exempted (Article 29(13)) o Member States can provide further exemptions for final distributors under certain conditions according to Article 29(14) and specified in point 25 of the Commission guidance document. If all exemptions and flexibilities are fully applied in a Member State, the number of final distributors that are required to fulfil the reuse targets for beverages, will be limited. These final distributors would enjoy a high degree of flexibility in meeting the targets ensuring that national circumstances can be taken into consideration. 16) The reuse targets for beverages apply from 2030, which allows time to make the necessary adjustments to apply to the 10 % target. The Commission will review the reuse targets in 2034 in the light of the experiences gained. Under what circumstances will the Commission use its empowerment to exempt certain packaging formats or economic operators from the reuse targets? The Regulation empowers the Commission to adopt delegated acts supplementing the harmonised reuse targets for transport packaging, grouped packaging and beverages provided for in Article 29. Such delegated acts can be adopted under strict legal conditions, and only if it is necessary to take account of the latest scientific and economic developments. The empowerment to adopt delegated acts can only be used to exempt economic operators who face particular economic constraints, or specific packaging formats where achievement of the reuse targets is hindered due to either hygiene and food safety issues or environmental issues following the proper impact assessment as specified under the better regulation guidelines (Better regulation: guidelines and toolbox). 51 XIV. PLASTIC CARRIER BAGS 1) Are compostable waste bags considered lightweight plastic carrier bags? No. Only sales bags (i.e. carrier bags) are covered by the definition of ‘packaging’ in Article 3(1), point (1), and the definition of ‘plastic carrier bags’ in Article 3(1), point (55). Waste bags or doggy bags are products, not packaging, and therefore not covered by PPWR. 2) Can a Member State ban all very lightweight plastic carrier bags? Very lightweight plastic carrier bags that are needed for hygiene purposes or provided as sales packaging for loose food to prevent food wastages are not banned under Article 25 PPWR. Member States may nevertheless decide to ban such bags to meet the sustainable reduction target for lightweight plastic carrier bags under Article 34(1). However, Article 34(2) requires Member States to consider the environmental impact of bags when they are manufactured, recycled or disposed of, and their intended use. Any bans (market restrictions) should also be proportionate and non- discriminatory. Member States must report to the Commission on the consumption of all very lightweight plastic carrier bags, even those which are excluded from the EU-wide or the national bans. 3) What are the requirements for compostable plastic carrier bags under the PPWR? Compostable bags are exempted from the general packaging ban under Article 25, Annex V, point 6, if they are very lightweight plastic carrier bags and needed for hygiene reasons or for loose food to prevent food wastage. The use of other very lightweight or lightweight plastic carrier bags is not banned under Article 25 and Annex V but could be subject to national bans, and other marketing restrictions, adopted under Article 34(2). Member States may also decide that very lightweight plastic carrier bags or lightweight plastic carrier bags that have not been banned at EU or national level should be compostable, under the conditions set out Article 9(2)(a). 52 XV. ASSESSMENT OF THE CONFORMITY OF PACKAGING 1) From which date will companies have to carry out the conformity assessment procedure mandated by the PPWR? In general, the Regulation applies from 12 August 2026 (Article 71). However, certain key provisions will apply only from the date specified therein. In several cases, the entry into force of the obligation is linked to the expiry of a certain time after the adoption of the necessary implementing or delegated acts. This will give stakeholders and Member States sufficient time to adapt. When a relevant provision does not specify a specific date for its entry into application, the general application date applies, and companies will thus have to carry out the conformity assessment procedure by 12 August 2026. 2) Annex VII refers to packaging ‘type’. Does this wording mean the same as ‘types’ in Annex II, table 1? The word ‘type’ referred to in Annex VII concerning the conformity assessment procedure is not the same as the packaging types referred to in Annex II. Annex VII refers to each packaging format or each packaging batch/series and not to packaging materials, which are used for recyclability assessment. 3) What is meant by ‘the unique identification of the packaging’ referred to in Annex VIII? Is the normal product traceability enough? The Regulation does not define ‘unique identification of the packaging”. This wording, referred to in Annex VIII, means that the packaging itself needs to be identified in terms of the type, batch, or serial number. 4) Is it sufficient that a single declaration of conformity is drawn up for packaging or a packaged product? Or is it required that a dossier of all required declarations of conformity is drawn up as a single document? When a packaged product is subject to more than one Union act requiring an EU declaration of conformity, such as the declaration of compliance under Article 15 of Regulation (EU) 10/2011 on plastic materials and articles intended to come into contact with food or Article 16 of Regulation (EC) No 1935/2004 on food contact materials, a single EU declaration of conformity may be drawn up for all Union acts. That declaration must state the Union acts concerned and their publication references. It may consist of a dossier of relevant individual EU declarations of conformity. Therefore, manufacturers have a margin of discretion in assessing the necessity of drawing up a single declaration of conformity. However, in case a single declaration of conformity is drawn up, it must clearly distinguish the packaging from the packaged products. The manufacturer may decide whether the single declaration of conformity is presented as a dossier with different declarations of conformity or as a single document. If they are presented as a single document, the conformity assessment for the packaged product and the packaging should still be done and presented separately. 5) Is the assessment of conformity to be drawn up for each part of the packaging, such as a bottle, closure and label, or for the entire packaging unit? UPDATED! The assessment of conformity must be performed, and the declaration of conformity drawn up, for the entire packaging unit. In other words, for a packaging unit made up of bottle, closure and label, a single assessment of conformity and related declaration of conformity is sufficient for the unit as a whole, though the declaration should include relevant information on all the separate components used to make up that unit. 53 6) Is a conformity assessment procedure required for the exemptions set out in Article 6 on recyclability and in Article 7 on recycled content? Compliance with the exemptions set out in Article 6 on recyclability and in Article 7 on recycled content should indeed be assessed and be included as part of the technical documentation referred to in Annex VII. 7) The wording ‘type, batch or serial number or other element’ in Article 15(5) suggests that manufacturers can choose to only indicate one of these. Which one? The wording should be understood as a type, batch or serial number or other element allowing the identification of the packaging in question. Manufacturers can choose freely among these. 8) Is a manufacturer obliged to contact the competent authorities in each Member State where its packaging could end up? UPDATED! No, the manufacturer must not notify the competent authorities that it places packaging on their territory. The authorities will contact the manufacturer in case of a check. Only if the manufacturer or distributor becomes aware that a packaging it has placed on the market of a Member State is non-compliant must it inform the relevant authorities about this (see Article 15(8) and Article 19(5)). In cases where a manufacturer delivers products from one Member State to the warehouse of a distributor in another Member State, and the latter serves different national markets from the warehouse, it is the obligation of the distributor to inform the competent authority in each of those Member States about the suspicion of non-compliance. 9) How should a presumption of conformity be construed in relation to the harmonised EU standards? The PPWD sets out a number of requirements for placing packaging on the market (essential requirements). These can be considered as predecessors of the sustainability requirements in the PPWR. Under the PPWD, compliance with these essential requirements was presumed if packaging was compliant with the harmonised standards published in the Official Journal of the European Union28. Under the PPWR, the existing harmonised standards can be used only as guidance (see Recital 58), which means that there can no longer be a presumption of conformity based on these standards. The only exception to this is laid down in Article 70(1), point (b), in relation to the essential requirements on packaging minimisation of the PPWD, which applies until end of 2029. This means that the related harmonised standard can be used for the presumption of conformity until that date. The Commission will consider taking formal measures to repeal the list of the old, harmonised, standards before the PPWR becomes applicable, to avoid any confusion29. 28 EN 13427:2004 ‘Packaging – Requirements for the use of European Standards in the field of packaging and packaging waste’ EN 13429:2004 ‘Packaging – Reuse’; EN 13430:2004 ‘Packaging – Requirements for packaging recoverable by material recycling’; EN 13431:2004 ‘Packaging – Requirements for packaging recoverable in the form of energy recovery, including specification of minimum inferior calorific value’; EN 13428:2004 ‘Packaging – Requirements specific to manufacturing and composition – Prevention by source reduction’; EN 13432:2000 ‘Packaging – Requirements for packaging recoverable by composting and biodegradation’. 29 In case of safety legislation with harmonised standards, the harmonised standards cited in the Official Journal of the European Union under repealed legislation remain valid for the purpose of the presumption of conformity if these references are not withdrawn from the OJEU. This interpretation comes from ECJ ruling T-474/15, Global Garden Products vs. Commission. 54 Presumption of conformity with new or revised harmonised standards in support of PPWR will again be possible from the date when a Commission decision listing the relevant harmonised standards will be published in the Official Journal of the European Union. This publication of references will allow the presumption of conformity to apply from that date onwards. 10) If a packaging is made from the same materials, but has different sizes, should a declaration of conformity be drawn up for all sizes of or is just one declaration for all sizes enough? According to Annex VII, the manufacturer must draw up a written declaration of conformity for each packaging type. The declaration of conformity must identify the packaging for which it has been drawn up. The documentation shall make it possible to assess the packaging’s conformity with the sustainability requirements, laid down in Article 5 – 12. The technical documentation must specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture, use and operation of the packaging. For example, the assessment of the minimisation requirement will depend on the packaged product whereas the assessment of recycled content might depend on the weight of the packaging. It follows that the declaration of conformity should be drafted at the level where packaging has the same characteristics in view of the applicable requirements and the packaged products. Therefore, if the products differ, a manufacturer should not draft a single declaration of conformity for all packaging placed on the market. Concretely, if bottles are of different sizes and contain the same product, and the difference in size does not affect compliance with any of the requirements in Article 5 – 12, then the manufacturer may draft a single declaration of conformity for the bottles. Manufacturers must ensure that the series production of packaging remains in conformity with the Regulation. They must consider if changes in packaging design or in its characteristics, as well as changes in harmonised standards or other rules by reference to which conformity is declared or verified, require reassessment. 11) Does transport packaging also require a conformity assessment and a declaration of conformity? There is no exemption for transport packaging. Indeed, completely different packaging types, such as pallets, pallet collars, wrappings and straps, must undergo separate assessments and must have separate declarations of conformity. 12) Who will monitor if the recyclability assessment carried out by the manufacturer is correct? The manufacturer is obliged to carry out the recyclability performance grade assessment. The result of this assessment must be included in the technical documentation before the packaging is placed on the market. Market surveillance authorities will carry out checks based on their national plans and should apply penalties set at national level in accordance with Article 68. 13) Will economic operators face fines in case they place on the market packaging that is PPWR-compliant but does not comply with national requirements? To reply to this question, it is necessary to distinguish between: 1) additional national requirements adopted pursuant to Article 4(3) and 2) additional national requirements explicitly allowed in specific articles of the PPWR. In the case under point 1), fines are not allowed as they have a deterrent effect on the economic operators and may create market barriers. In the case under point 2), fines are allowed, given that the Regulation explicitly empowers Member States to go beyond the Regulation. However, such 55 national fines still must comply with the general rules of the Treaty, in particular proportionality, which is for Member States to demonstrate. This evidence is to be provided at the time of the TRIS notification. 14) In what language must the declaration of conformity be drafted? NEW! The declaration of conformity must be drafted in the languages of the Member State(s) to which the packaged products are supplied, so that the respective market surveillance authority can verify it upon request. Under Article 39(2) PPWR, the EU Declaration of Conformity “shall be drawn up in, or translated into, one or more languages required by the Member State in which the packaging is placed on the market or made available on the market.” 56 XVI. ENFORCEMENT OF THE NEW RULES (IMMEDIATELY AFTER THE APPLICATION DATE OF 12 AUGUST 2026) 1) Will products be banned from the EU market if their packaging is not compliant with the rules that apply as of 12 August 2026? NEW! No, the enforcement of the obligations applicable as from 12 August 2026 should not disrupt trade flows, supply chains or consumer access to goods. In line with Article 62 of the PPWR, if a Member State becomes aware of any of the instances of non-compliance set out in that Article, it must first require the relevant economic operator to put an end to that non-compliance. In other words, the economic operator should first receive a warning that non-compliance has been identified, and an opportunity to take corrective action, before any other action is taken on the side of the Member State. Only where the non-compliance is not rectified by the economic operator, but instead persists, will Member States be within their rights to take further action (such as prohibiting, recalling or withdrawing non-compliant packaging). Market surveillance authorities should - rather than following a sanction-oriented approach - support the responsible economic operators in complying with the new rules, for instance with awareness-raising, requests for information or requests for corrective action with a reasonable timeline for adaptation. 57 XVII. WASTE PREVENTION 1) How are the packaging waste reduction targets going to be implemented? The implementation of packaging waste reduction targets is the responsibility of each Member State. It is Member States’s responsibility to reach the target and put in place the waste reduction measures necessary to reach the targets set out in Article 43. While the Regulation harmonises several packaging waste prevention measures, such as laying down reuse targets, refill and reuse obligation for take-away sector, packaging bans, and minimisation of packaging requirements, including empty space thresholds, it is up to the Member States to implement some of these harmonised measures, as well as to lay down possible additional national waste prevention measures necessary to reach the targets set out in Article 43(1). National measures which are applied in addition to the EU harmonised measures may include, but are not limited to, economic incentives, EPR schemes, and public awareness campaigns, as this is outlined in Article 43(5). The measures may also include additional obligations on economic operators, such as higher or additional reuse targets, subject to the conditions under Article 29(15) and -(16) as explained also in the Commission guidance document. Pursuant to Article 43(5), national implementing measures must be proportionate and non-discriminatory and be designed to avoid barriers to trade or distortions of competition. They must not lead to a shift to lighter packaging material, which does not comply with other sustainability requirements, such as recyclability, being used to fulfil the goal of the packaging waste reduction. 2) What happens if a Member State does not reach the waste prevention targets? Each Member State must reduce the packaging waste generated per capita, as compared to the packaging waste generated per capita in 2018 and as reported to the Commission in accordance with Decision 2005/270/EC, by at least 5% by 2030, 10% by 2035 and 15% by 2040. The Commission will monitor the implementation of these targets based on the data on packaging waste generated reported by Member States. A Member State’s failure to meet the targets is susceptible to lead to appropriate enforcement action by the Commission. 3) Does the waste reduction target cover all packaging waste generated in a Member State or only household packaging waste? The PPWR applies to all packaging and to all packaging waste, whether it originates from industry, other manufacturing, retail or distribution, offices, services or households. The provisions related to the calculation of the packaging waste generated (see Article 53(2)) cover all packaging waste generated on the territory of a Member State. Therefore, the statistical data on packaging waste generated, as reported by Member States to the Commission, cover all packaging waste generated on the territory of a Member State. It is up to Member States to decide how they implement Article 43 and what measures they take to meet the waste reduction targets established in that provision. Member States can exclude certain types of waste from the national waste prevention targets and focus merely on the household packaging waste, if they consider that this will be sufficient to meet the targets. Member States may maintain the established separate systems for the management of household packaging waste, on the one hand, and for industrial and commercial packaging waste, on the other hand (Article 43(3)). 4) Will Member States be obliged to notify the national rules they wish to introduce to achieve the waste reduction targets via the TRIS? 58 Directive (EU) 2015/1535 30 imposes an obligation on the Member States to notify to the Commission all draft technical regulations concerning products (and Information Society Services) before they are adopted in national law. The term ‘technical regulation’ should be understood broadly. It means technical specifications, other requirements or rules on Information Society services which are laid down by the Member States, the observance of which is compulsory, de jure or de facto, for the marketing or use of a product, for the provision of a service or the establishment of a service operator. It covers also regulations or administrative provisions prohibiting the manufacture, importation, marketing or use of a product or prohibiting the provision or use of a service, or establishment as a service provider. Therefore, all new draft implementing measures, which are technical regulations, must be notified in the Technical Regulations Information System (TRIS)31. Member States do not need to renotify under the TRIS notification procedure their existing national measures which are compliant with the Regulation. Notifications by Member States are made at the draft stage, that is, at a stage of preparation at which substantial amendments can still be made (Article 1(1)g) of Directive (EU) 2015/1535). National technical regulations which were not notified can be declared inapplicable to individuals by the national courts32. 5) Obligation for the Member States to ensure that their national measures that were adopted to achieve the packaging waste reduction targets do not ‘lead to a shift to lighter packaging material being used to fulfil the goal of packaging waste reduction’ and that such measures also ‘reduce the quantity of plastic packaging waste generated’. This obligation is placed on the Member States, and they must inform on how they achieve this result in their waste prevention programmes adopted under Article 42(2) PPWR and in the TRIS notification procedure. The Commission has a general monitoring competence and may also decide to help Member States by giving additional guidance. However, the Commission does not have a specific empowerment to provide guidance on the implementation of this provision. 30 Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17/09/2015, p. 1–15). 31 TRIS – European Commission 32 ’CIA-Security’ (Case C-194/94). 59 XVIII. EXTENDED PRODUCER RESPONSIBILITY 1) Are micro-enterprises exempted from Extended producer responsibility (EPR) obligations? There is no general exemption for micro-enterprises from EPR obligations in the PPWR or Directive 2008/98/EC (Waste Framework Directive (WFD)). All producers are responsible for waste management of the packaging that they make available on the territory of a Member State for the first time. This includes registering in and reporting to that Member State’s register of producers according to Article 44. To minimise administrative burdens on small producers, the PPWR sets fewer reporting obligations on producers who make less than 10 tonnes a year of packaging available on the market of a Member State. Furthermore, Member States and producer responsibility organisations (PRO) must ensure equal treatment of producers regardless of their origin or size and must not place disproportionate burdens on small producers. Member States continue to have the right to invoke lower administrative fees for smaller producers as established in the WFD after the application of PPWR. WFD establishes that were justified by the need to ensure proper waste management and the economic viability of the extended producer responsibility scheme, Member States may, provide that: • in the case of extended producer responsibility schemes established to attain waste management targets and objectives established under legislative acts of the Union, the producers of products bear at least 80% of the necessary costs; • in the case of extended producer responsibility schemes established on or after 4 July 2018 to attain waste management targets and objectives solely established in Member State legislation, the producers of products bear at least 80% of the necessary costs; • in the case of extended producer responsibility schemes established before 4 July 2018 to attain waste management targets and objectives solely established in Member State legislation, the producers of products bear at least 50% of the necessary costs; • and provided that the remaining costs are borne by original waste producers or distributors. This derogation may not be used to lower the proportion of costs borne by producers of products under extended producer responsibility schemes established before 4 July 2018. The PPWR establishes that the producer is either the manufacturer, importer or distributor of packaging – depending on the context and whether the packaging is transport, sales, grouped, primary or service packaging. If a manufacturer is a micro-enterprise and that manufacturer is also the producer of the packaging, it will be exempted from its EPR-requirements when the supplier of the packaging materials is established in the same Member State. 2) To what extent does the PPWR harmonise national EPR schemes? The PPWR harmonises certain administrative EPR obligations to lower the administrative burden for economic operators selling packaging or packaged products in multiple Member States. These requirements are related to registration, reporting deadlines and frequency, and the granularity of the data that needs to be reported. The PPWR also harmonises who the producer is in a Member State. It is the packaging type and selling technique that determine whether a company is responsible for EPR obligations. Further information on how the definition of the producer applies, can be found under point II of this document. 60 Finally, the PPWR also harmonises the criteria for eco-modulation of EPR-fees. The ecomodulation will be based on the recyclability performance grades set in Article 6. Member States are allowed to use additional criteria, such as reusability and recycled content, when they apply the framework for eco-modulation in their national EPR schemes. In other areas, Member States continue to have a wide flexibility to organize EPR systems and waste management according to the national conditions and legal settings. 3) Which is the first calendar year that producers must report to the register of producers? All Member States shall establish a register of producers that producers must register in and report to. By February 2026, the Commission shall adopt an implementing act laying down the format for EPR registering in and reporting to the EPR register (Article 44(14) PPWR). Member States will have 18 months to establish the register after the adoption of the act (Article 44(1) PPWR). Producers shall report by June for each full preceding calendar year, and producers will therefore have to report to the national EPR registers according to the new harmonised rules for the first time by 1 June 2030. 4) What is the scope of the activities that online platforms can fulfil on behalf of their sellers? Based on a written mandate by producers, online platforms can offer to pay the EPR fees in each Member State where the packaging or packaged products are made available on the market directly to consumers (Article 45(4) PPWR). However, only the producer, or its PRO or authorised representative, is responsible for the EPR registration and reporting. An online platform cannot fulfil these obligations on their behalf unless the producer has chosen to appoint the platform as an authorised representative. 5) Does an online platform need to check every producer before allowing them to use the platform? To prevent free riding as regards EPR obligations, and in line with the obligations in the Digital Services Act (DSA)33, the PPWR provides that online platforms that allow consumers to conclude distance contracts with producers shall obtain information from producers that they are registered in the EPR register in the Member State where the consumer resides and a self-certification confirming that their EPR-obligations for packaging are fulfilled. The online platform shall obtain this information prior to allowing the producers to use the platform’s services. The online platform shall make best efforts to assess whether the information provided is reliable and complete, by using or verifying freely available online databases and online interfaces (Article 45(6) PPWR). This may include requesting the producers to provide supporting documents (Article 45(8) PPWR). Making best efforts usually requires the verification of the information provided by the producer with the data in the register of producers. 6) Can Member States ask for information beyond what is specified in the PPWR to monitor extended producer responsibility obligations? NEW! The PPWR harmonises the information to be provided when producers register and report amounts of packaging made available, collected and recycled in a Member State to a Member State’s register of producers. 33 Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (OJ L 277, 27.10.2022, pp. 1– 102) 61 According to Article 44(5) of the PPWR, a Member State can require additional information or documents for registration purposes, beyond those specified in the Regulation, where such information is necessary and proportionate for the purposes of monitoring compliance with extended producer responsibility obligations laid down in Chapter VIII of the PPWR. Member States shall lay down rules to ensure that EPR obligations are complied with as specified in Article 40(2). Such rules must include: (a) the registration of producers in accordance with Article 44; (b) the organisation and monitoring of reporting requirements under Article 44(7) and (8); (c) the oversight of the implementation of the extended producer responsibility obligations in accordance with Article 45; (d) the authorisation on fulfilment of extended producer responsibility in accordance with Article 47; (e) the making available of information in accordance with Article 56. For the purposes of enforcement of the obligations for management of packaging and packaging waste set out in Chapter VIII of the PPWR, and insofar as this is not harmonised in the PPWR, Member States can require information beyond what is established in the PPWR, as long as it is necessary and proportionate. 62 XIX. RETURN AND COLLECTION SYSTEMS 1) How will priority access for recycled materials work in practice? Collection systems and recycling facilities may provide priority access to recycled materials for use in applications where the distinct quality of the recycled material is preserved or recovered in such a way that it can be recycled further and used in the same way and for a similar application with minimal loss of quantity, quality or function (Article 48(2) PPWR). The objective of this provision is to help economic operators comply with their recycled content requirements for plastic packaging under the PPWR. Therefore, Member States may establish such systems with regards to plastic packaging. If such systems are established, priority access to the plastic recycled materials should be granted at market prices. The quantity of recyclates to which priority access is given should correspond to the quantity of packaging made available on the territory of the Member State by the economic operator within a specified timeframe. It is Member States who decide to establish such priority access systems must ensure that these conditions are complied with and monitored and shall notify such systems via TRIS. 2) What does it mean that packaging is separately collected? Separate collection is defined in the WFD as ‘the collection where a waste stream is kept separately by type and nature so as to facilitate a specific treatment’. Member States must ensure that systems and infrastructure are set up to provide for the separate collection of packaging waste in accordance with the waste hierarchy, and to facilitate its preparation for re-use and high-quality recycling. More generally, Member States must ensure that the collection of the packaging materials is sufficient to achieve the recycling targets laid down in Article 52 and they must establish mandatory collection objectives for this purpose. The requirements for separate collection vary. For example, separate collection of single-use beverage packaging of plastic and aluminium in Article 50 refers to collection in a deposit and return system. Calculation and reporting requirements for separate collection for the purpose of complying with the separate collection requirement under Article 50(1), and for the purpose of establishing the ‘at scale’ methodology, will be specified in an implementing act to be adopted by 12 February 2027 under Article 56(7). 3) How is composite packaging accounted for in the calculation of recycling targets? According to Article 53(3), Member States must calculate recycling targets for composite packaging based on all materials contained in the packaging unit. Pursuant to Article 53(4), Member States may derogate from this requirement where a given material constitutes an insignificant part of the packaging unit, and in no case more than 5% of the total mass of the packaging unit. The 5 % threshold applies to the total mass of the packaging unit. 4) Are the terms ‘ferrous metal’, ‘ferrous metal (including tinplate)’ and ‘steel’ all synonymous for ‘ferrous metal including tinplate’? The terms ‘ferrous metal (including tinplate)’ is used in the PPWR only in the context of Member States’ reporting on reusable packaging. It is also referred in Table 1 of Annex II regarding materials and formats for which DfR criteria will be established. In the interest of coherence, the terms ‘steel’ in Table 3 of Annex XII and the term ‘ferrous metals’ used in Article 52(1)(b) and (d), and in Table 1 of Annex XII, also include tinplate. 63 XX. DEPOSIT AND RETURN SYSTEMS 1) Does the exemption from setting up a deposit and return systems (DRS) apply to the two beverage packaging types separately? The 90 % separate collection targets for single-use plastic beverage bottles and metal beverage containers are two separate collection targets that apply by 1 January 2029. An exemption from the requirement to be part of a DRS would therefore need to be obtained separately for each format. Article 50(5) establishes that Member States which collect more than 80% of all single-use plastic beverage bottles or metal beverage containers within the scope of the PPWR by 2026 may be exempt from the obligation to set up a DRS. Member States would also have to show with concrete measures how they will reach 90% separate collection targets by 2029 without setting up a DRS when notifying the Commission about their request for an exemption. 2) Can a Member State set additional national requirements for DRS? Pursuant to Article 50(9) PPWR, Member States may adopt provisions for DRS which go beyond the minimum requirements set forth in Article 50 and in Annex X, while observing the Treaty on the functioning of the EU and acting in accordance with the PPWR. For example, Member States are encouraged to establish or maintain DRS for single-use glass beverage bottles and beverage cartons and may include beverages which are not required to be part of a DRS under Article 50(4), such as wine, spirits or milk-based products, as well as for other products. They should, however, be mindful of the negative impact on the internal market of such rules and should take account of the recommendations in the Communication from the Commission — Beverage packaging, deposit systems and free movement of goods (2009/C 107/01). Member States should encourage DRS for reusable packaging, in particular for reusable glass beverage bottles. Member States must ensure that the return of packaging is convenient for end users and may establish additional minimum requirements to ensure that the objectives of the Regulation are met and to increase the purity of the collected packaging waste and reduce litter (Article 50(9) PPWR). 3) What is to be understood by ‘high transboundary business’ in Annex X? Annex X requires that Member States with regions with high transboundary business ensure that the DRS allow for collection of packaging from other Member States’ DRS at designated collection points and that they must endeavour to enable the possibility of return of a deposit that was charged to the end user when purchasing the packaging. Member States will need to assess if this requirement applies when ensuring compliance with the minimum requirements in Annex X. The minimum requirements apply to DRS established after 11 February 2025, whereas for the existing DRS, Member States must only apply the requirements from 1 January 2035 if the 90% separate collection targets are not reached by 1 January 2029 (Article 50(11) PPWR). Given that an increasing number of Member States is establishing DRS, the need for transboundary collaboration between the DRS’ is likely to increase to ensure separate collection of beverage packaging. The Commission must assess best practice of such measures by 2038 in collaboration with Member States to strengthen interoperability of DRS from different Member States (Article 50(11) PPWR). 4) Do all DRS have to be non-profit? A DRS for single-use beverage bottles of plastic and metal containers established after 11 February 2025 must be non-profit, as specified in the minimum criteria set out in Annex X, point f. 64 DRS established before 11 February 2025 are required to be non-profit by 1 January 2035 only if the Member State does not reach the 90% separate collection targets when they are first reviewed or at the latest by 1 January 2029 (Article 50(11) PPWR). 5) Is packaging of milk, wine and spirits also exempted from the 90% separate collection targets? According to Article 50(4), single-use plastic beverage bottles and metal containers with milk and milk-products, wine or products similar to wine and spirits are exempted from the requirement to be part of a DRS. However, such products must be included in the calculation of the separate collection targets under Article 50(1). Moreover, Member States have flexibility on whether or not to include the packaging for these products in their DRS. 6) Can single use Deposit and Return Systems register and report on behalf of producers to comply with extended producer responsibility obligations? NEW! Deposit and return systems for single-use packaging established pursuant to Article 50 of the PPWR, which have organisational, technical and financial arrangements comparable to those of producer responsibility organisations, can register and report on behalf of the producers participating in those systems to the register of producers established under Article 44(1) of the PPWR. Getting in touch with the EU In person All over the European Union there are hundreds of Europe Direct centres. You can find the address of the centre nearest you online (europeanhttps://european-union.europa.eu/contact-eu/meet- us_enunion.europa.eu/contact-eu/meet-us_en). 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Official address Domenico Scarlattilaan 6 ● 1083 HS Amsterdam ● The Netherlands An agency of the European Union Address for visits and deliveries Refer to www.ema.europa.eu/how-to-find-us Send us a question Go to www.ema.europa.eu/contact Telephone +31 (0)88 781 6000 © European Medicines Agency, 2026. Reproduction is authorised provided the source is acknowledged. 3 August 20261 EMA/PRAC/155652/2026 Pharmacovigilance Risk Assessment Committee (PRAC) PRAC recommendations on signals Adopted at the 6-9 July 2026 PRAC meeting This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 6-9 July 2026 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT]2 reference numbers). PRAC recommendations to provide supplementary information are directly actionable by the concerned marketing authorisation holders (MAHs). PRAC recommendations for regulatory action (e.g. amendment of the product information) are submitted to the Committee for Medicinal Products for Human Use (CHMP) for endorsement when the signal concerns Centrally Authorised Products (CAPs), and to the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) for information in the case of Nationally Authorised Products (NAPs). Thereafter, MAHs are expected to take action according to the PRAC recommendations. When appropriate, the PRAC may also recommend the conduct of additional analyses by the Agency or Member States. MAHs are reminded that in line with Article 16(3) of Regulation No (EU) 726/2004 and Article 23(3) of Directive 2001/83/EC, they shall ensure that their product information is kept up to date with the current scientific knowledge including the conclusions of the assessment and recommendations published on the European Medicines Agency (EMA) website (currently acting as the EU medicines webportal). For CAPs, at the time of publication, PRAC recommendations for update of product information have been agreed by the CHMP at their plenary meeting (20-23 July 2026) and corresponding variations will be assessed by the CHMP. For nationally authorised medicinal products, it is the responsibility of the National Competent Authorities (NCAs) of the Member States to oversee that PRAC recommendations on signals are adhered to. Variations for CAPs are handled according to established EMA procedures. MAHs are referred to the available guidance. Variations for NAPs (including via mutual recognition and decentralised procedures) are handled at national level in accordance with the provisions of the Member States. 1 Expected publication date. The actual publication date can be checked on the webpage dedicated to PRAC recommendations on safety signals. 2 The relevant EPITT reference number should be used in any communication related to a signal. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/signal-management/prac-recommendations-safety-signals PRAC recommendations on signals EMA/PRAC/155652/2026 Page 2/7 The timeline recommended by PRAC for submission of variations following signal assessment is applicable to both innovator and generic medicinal products, unless otherwise specified. For procedural aspects related to the handling of PRAC recommendations on signals (e.g. submission requirements, contact points, etc.) please refer to the Questions and Answers on signal management. https://www.ema.europa.eu/documents/other/questions-answers-signal-management_en.pdf PRAC recommendations on signals EMA/PRAC/155652/2026 Page 3/7 1. Recommendations for update of the product information3 1.1. Desogestrel; etonogestrel – Meningioma Authorisation procedure Non-centrally authorised EPITT No 20167 PRAC Rapporteur Karin Bolin (SE) Date of adoption 9 July 2026 Recommendation [see also section 3] Having considered the available evidence in EudraVigilance and literature, including the data submitted by the Marketing Authorisation Holder (MAH), the PRAC has agreed that the MAHs of all desogestrel and etonogestrel containing products should submit a variation within 2 months from the publication of the PRAC recommendation, to amend the product information as described below taking into account the already existing wording in some nationally authorised products the text needs to be adapted by MAHs to individual products (new text underlined): Summary of product characteristics 4.3 Contraindications Meningioma or history of meningioma (see section 4.4) 4.4 Special warnings and precautions for use Meningioma Current, prolonged use (≥1 year) of desogestrel has been associated with a small increased risk of meningioma (see sections 4.3 and 4.8). [For etonogestrel-containing products: Desogestrel is metabolised to etonogestrel.] The risk increased with longer duration of treatment. The risk may be higher in women with previous exposure to progestogens associated with an increased risk of meningioma, which should be considered before initiating treatment. Patients treated with <substance> should be monitored for signs and symptoms of meningioma. If a patient is diagnosed with meningioma, treatment with <substance> must be discontinued. Available data suggest that the risk of meningioma may decrease after treatment discontinuation. 4.8 Undesirable effects The following adverse reaction should be added under the SOC Neoplasms benign, malignant and unspecified, with a frequency ‘not known’: Meningioma Under Description of selected adverse reactions: Meningioma A case-control study found that current, prolonged use (≥1 year) of desogestrel 75 μg was associated with a small increased risk of intracranial meningioma requiring surgery (odds ratio, 1.3 [95% 3 Translations in all official EU languages of the new product information adopted by PRAC are also available to MAHs on the EMA website. https://www.ema.europa.eu/en/human-regulatory/post-authorisation/pharmacovigilance/signal-management/prac-recommendations-safety-signals PRAC recommendations on signals EMA/PRAC/155652/2026 Page 4/7 confidence interval (CI), 1.1 to 1.5]). The estimated number needed to harm was overall 67 300 women for one intracranial meningioma. The risk increased with longer duration (≥7 years) of treatment (odds ratio, 2.1 [95% CI, 1.5 to 2.9]). Excess risk was greater in women who had previously used a progestogen with a known association to meningioma (odds ratio 3.3 [95% CI 2.6 to 4.1]). The increased risk was no longer observed one year after discontinuation of desogestrel. [For etonogestrel-containing products: Since desogestrel is metabolised to etonogestrel, the results of this study are also of clinical relevance for <product name>.] Package leaflet 2. What you need to know before you take [product name] Do not take [product name] • […] • If you have meningioma or have ever been diagnosed with a meningioma (a tumour of the tissue layer surrounding the brain and spinal cord that is usually benign). See section Warnings and precautions. • […] Warnings and precautions […] Meningiomas Use of [active substance] has been linked to a small increased risk for tumours of the tissue surrounding the brain and spinal cord that are usually benign (meningiomas). The risk appears to increase with longer use and in women who have previously used progestogens associated with meningioma. Overall, about one additional case of meningioma is estimated to occur for every 67,300 women treated with [active substance]. If you are diagnosed with meningioma, your doctor will stop treatment with [Product name] (see section ‘Do not use [Product name]’). If you notice any symptoms such as changes in vision (e.g. double vision or blurred vision), hearing loss or ringing in the ears, loss of smell, headaches that get worse over time, memory loss, seizures, or weakness in your arms or legs you must tell your doctor straight away. […] 4. Possible side effects Not known (cannot be estimated from the available data) • Tumour of the tissue surrounding the brain and spinal cord that is usually benign (meningioma). PRAC recommendations on signals EMA/PRAC/155652/2026 Page 5/7 1.2. Levonorgestrel intrauterine device 13.5 mg – Increased risk of ectopic pregnancy Authorisation procedure Non-centralised EPITT No 20251 PRAC Rapporteur Dennis Lex (DE) Date of adoption 9 July 2026 Recommendation Having considered the responses to the LoQ on the study by Roland et al. submitted by the Marketing Authorisation Holder (MAH), the PRAC has agreed that the MAH of Jaydess (Bayer) should submit a variation within 2 months from the publication of the PRAC recommendation, to amend the product information as described below (new text underlined, text to be deleted strikethrough): Summary of product characteristics 4.4 Special warnings and precautions for use Ectopic pregnancy In clinical trials, the overall incidence of ectopic pregnancy with Jaydess was approximately 0.11 per 100 woman-years. Approximately half of the pregnancies that occur during Jaydess use are likely to be ectopic. Data from post-authorisation observational studies report higher incidence rates of ectopic pregnancy with Jaydess (13.5 mg), compared to other IUSs and copper IUDs (see section 4.8, description of selected adverse reactions). Women considering Jaydess should be counselled on the signs, symptoms and risks of ectopic pregnancy. For women who become pregnant while using Jaydess, the possibility of an ectopic pregnancy must be considered and evaluated. Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection carry an increased risk of ectopic pregnancy. The possibility of ectopic pregnancy should be considered in the case of lower abdominal pain, especially in connection with missed periods or if an amenorrheic woman starts bleeding. Because an ectopic pregnancy may impact compromise future fertility, the benefits and risks of using Jaydess should be carefully evaluated, in particular for nulliparous women on an individual basis. This includes consideration of other IUSs/IUDs, particularly in women who may wish to become pregnant in the future. Use in nulliparous women: Jaydess is not first choice for contraception in nulliparous women as clinical experience is limited. 4.8 Undesirable effects c. Description of selected adverse reactions […] If a woman becomes pregnant while using Jaydess, the relative likelihood of this pregnancy being ectopic is increased (see section 4.4 under Ectopic Pregnancy). In a nationwide cohort study using data from the French National Healthcare Data System, hormonal IUSs and copper IUDs were compared. At 1-year, ectopic pregnancy incidence rates were 0.18 (95% PRAC recommendations on signals EMA/PRAC/155652/2026 Page 6/7 CI 0.14–0.23), 0.10 (95% CI 0.08–0.11), 0.04 (95% CI 0.03–0.05), and 0.07 (95% CI 0.07–0.08) per 100 person-years, for the levonorgestrel 13.5 mg, 19.5 mg, 52 mg IUSs and copper IUDs, respectively. Compared with copper IUDs, hazard ratios for ectopic pregnancy were 2.57 (95% CI 1.92–3.43), 1.37 (95% CI 1.15–1.62), and 0.62 (95% CI 0.49–0.80) for the levonorgestrel 13.5 mg, 19.5 mg, and 52 mg IUSs, respectively. Package leaflet 2. What you need to know before you use Jaydess […] Extrauterine pregnancy (pregnancy outside the womb) It is uncommon to become pregnant while using Jaydess. However, if you become pregnant while using Jaydess, the risk that the pregnancy could develop outside the womb (have an extrauterine or ectopic pregnancy) is increased. Women who have already had an extrauterine pregnancy, surgery of the fallopian tubes or a pelvic infection carry a higher risk for this type of pregnancy. Real-world studies report higher risk of ectopic pregnancy with Jaydess compared with other IUSs (levonorgestrel 19.5 and 52 mg) and copper intrauterine devices (IUDs). An extrauterine pregnancy is a serious condition, which calls for immediate medical attention (see section 2, “Warnings and precautions” for signs and symptoms) and may impact compromise future fertility. 2. Recommendations for submission of supplementary information INN Signal (EPITT No) PRAC Rapporteur Action for MAH MAH Atogepant Insomnia (20291) Rugile Pilviniene (LT) Assess in the ongoing PSUR (submission by 30 September 2026 with the MAH comments to the PSUR preliminary assessment report) AbbVie Deutschland GmbH & Co. KG Atogepant; eptinezumab; erenumab; fremanezumab; galcanezumab; rimegepant Raynaud’s phenomenon (20292) Terhi Lehtinen (FI) Supplementary information requested (submission by 14 October 2026) AbbVie Deutschland GmbH & Co. KG, Eli Lilly Nederland B.V., H. Lundbeck A/S, Novartis Europharm Limited, Pfizer Europe MA EEIG, Teva GmbH PRAC recommendations on signals EMA/PRAC/155652/2026 Page 7/7 INN Signal (EPITT No) PRAC Rapporteur Action for MAH MAH Oseltamivir; intravenous zanamivir New information on safety in patients critically ill with influenza (20299) Terhi Lehtinen (FI) Supplementary information requested (submission by 26 August 2026) Roche Registration GmbH, GlaxoSmithKline Trading Services Limited Sacituzumab govitecan Interstitial lung disease (20290) Bianca Mulder (NL) Supplementary information requested (submission by 23 September 2026) Gilead Sciences Ireland UC Selpercatinib Lymphangiectasia intestinal (20289) Bianca Mulder (NL) Assess in the next PSUR (submission by 17 January 2027) Eli Lilly Nederland B.V. Sevoflurane Acute encephalopathy in patients carrying the mitochondrial DNA variant m.11232T>C (20285) Eamon O Murchu (IE) Supplementary information requested (submission by 23 September 2026) AbbVie SA, Baxter SA, Piramal Critical Care B.V. 3. Other recommendations INN Signal (EPITT No) PRAC Rapporteur Action for MAH MAH Desogestrel; etonogestrel Meningioma (20167) Karin Bolin (SE) ∙ See section 1.1 ∙ All MAHs of desogestrel containing medicinal products and etonogestrel- containing medicinal products ∙ Distribute a Direct Healthcare Professional Communication (DHPC) by 6 August 2026 ∙ Organon Venlafaxine Cardiotoxicity (20230) Karin Bolin (SE) Monitor in PSUR Viatris Limited (innovator MAH of venlafaxine) 1. Recommendations for update of the product information2F 1.1. Desogestrel; etonogestrel – Meningioma Recommendation [see also section 3] 1.2. Levonorgestrel intrauterine device 13.5 mg – Increased risk of ectopic pregnancy Recommendation 2. Recommendations for submission of supplementary information 3. Other recommendations

The European Association of Medical devices Notified Bodies Team-NB Presentation TEAM-NB Team-NB-RiskAdaptativeSurveillance-presentation-20260724 Page 1/1 Briefing Note: Risk-Adaptive Surveillance under the MDR/IVDR Purpose: This note explains Team-NB’s proposal for risk-adaptive notified body surveillance. It shows how simplification can reduce unnecessary burden while maintaining patient safety and effective oversight. The problem Medical devices need continued monitoring after they are placed on the EU market. The key question is not whether surveillance should continue, but how it can become more proportionate. A blanket reduction would create safety risks. A smarter model reduces routine oversight where there is evidence that the manufacturer and its devices are performing well. What risk-adaptive surveillance means • Higher oversight where risks, new concerns or weak compliance are present. • Lower routine oversight where stable compliance and post-market performance are demonstrated. • Immediate escalation if serious incidents, recurring non-conformities, poor responsiveness, negative vigilance trends or other safety signals arise. Policy value • Keeps patient safety central while reducing unnecessary routine checks. • Focuses notified body capacity on higher-risk manufacturers, devices and situations. • Rewards well-performing manufacturers with less routine oversight, potentially reducing notified body effort and manufacturer compliance costs. • Avoids a purely reactive system where additional checks occur only after problems have arisen. Fairness to early MDR/IVDR adopters The first MDR certificates were issued in 2019 and the first IVDR certificates in 2020. Manufacturers that moved early to MDR/IVDR compliance have had several years to build evidence of conformity, post-market performance and quality system stability. Risk-adaptive surveillance allows these early adopters to be recognised where the evidence supports it, rather than being treated the same as manufacturers that waited until the end of the transition periods. Key message Risk-adaptive surveillance focuses scrutiny where risks are higher, rewards proven compliance, and keeps patient safety at the centre. Sources: Team-NB Position Papers on Risk-Adaptive Surveillance under MDR and IVDR (30 June 2026). Available via the Team-NB website: MDR proposal and IVDR proposal. https://www.team-nb.org/mdr-proposal-for-risk-adaptive-surveillance-system/ https://www.team-nb.org/ivdr-proposal-for-risk-adaptive-surveillance-system/

The European Association of Medical devices Notified Bodies Team-NB Presentation TEAM-NB Team-NB-Transparency-presentation-20260724 Page 1/2 Briefing Note: Transparency under the MDR/IVDR Purpose: To explain why notified bodies need broader EUDAMED access to support proportionate, risk-adaptive surveillance under the MDR and IVDR, while preserving confidentiality of sensitive information. The problem The Commission proposal gives notified body access to EUDAMED information for devices for which they issue certificates. It does not, however, provide broader visibility of vigilance, clinical investigation and performance study data for comparable devices certified by other notified bodies. This creates an incomplete EU-market picture: notified bodies can assess their own certification portfolio, but cannot reliably benchmark risks, adverse events, field safety corrective actions or state-of-the-art developments across comparable technologies. In practice, this may lead to reliance on non-EU public databases, duplicate requests to manufacturers and surveillance decisions based on partial evidence. What broader EUDAMED transparency should provide • EU-wide visibility of relevant vigilance data, including serious incidents, field safety corrective actions, field safety notices and emerging safety trends for comparable devices. • Access to clinical investigation and performance study information needed to assess state of the art, comparable technologies and relevant adverse events. • A stronger evidence base for risk-based decisions on technical documentation sampling, surveillance intensity and unannounced audits. • Clear confidentiality rules so data accessed through EUDAMED are used only for regulatory purposes and protected against inappropriate onward disclosure. Policy value • Enables notified bodies to benchmark risks against the wider EU market, not only their own certification portfolio. • Reduces duplicate information requests where data are already available in EUDAMED. • Supports consistent escalation where signals justify additional scrutiny and reduced routine burden where compliance is stable. • Strengthens patient safety by making surveillance more targeted, evidence-based and proportionate. Link to Team-NB amendments This is reflected in Topic 5 of the Team-NB amendments, “Transparency of EUDAMED”. Team- NB proposes broader notified body access to EUDAMED vigilance and clinical investigation/performance study information, accompanied by confidentiality safeguards in MDR Article 109, IVDR Article 102 and Annex VII. This balances better regulatory use of data with protection of confidential information. The European Association of Medical devices Notified Bodies Team-NB Presentation TEAM-NB Team-NB-Transparency-presentation-20260724 Page 2/2 Key message The issue is not whether notified bodies can see the devices they certify; they can. The issue is whether they can see enough EU-wide evidence to make surveillance genuinely risk- adaptive. Sources: Commission proposal COM(2025) 1023 final; Team-NB amendments for MDR/IVDR, Topic 5 “Transparency of EUDAMED”, including proposed amendments to MDR Articles 92(2), 106b and 109, MDR Annex VII 1.3.1, IVDR Articles 82a, 87(2) and 102, and IVDR Annex VII 1.3.1. – See page 24 of attached document.