EUROPEAN COMMISSION Brussels, 30.11.2022 COM(2022) 677 final 2022/0396(COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (Text with EEA relevance) {SEC(2022) 425 final} - {SWD(2022) 384 final} - {SWD(2022) 385 final}



EXPLANATORY MEMORANDUM 1.CONTEXT OF THE PROPOSAL •Reasons for and objectives of the proposal Packaging is necessary to protect and to transport goods. The manufacturing of packaging is also a major economic activity in the EU. However, regulatory approaches differ from one Member State to another, which creates obstacles that prevent the internal market for packaging from fully functioning. Recently observed differences relate, for example, to labelling requirements for packaging, approaches to defining recyclable or reusable packaging, approaches to modulating extended producer responsibility (EPR) fees and marketing restrictions for certain packaging formats. Such discrepancies create legal uncertainty for businesses, leading to lower investment in innovative and environment-friendly packaging and new circular business models. Packaging is also a key environmental concern. It is one of the main users of virgin materials (40 % of plastics and 50 % of paper used in the EU is destined for packaging) and accounts for 36 % of municipal solid waste. The increased use of packaging coupled with low re-use and recycling rates hamper the development of a low-carbon circular economy. Packaging increased in recent years faster than the gross national income, which leads to soaring CO2- and other emissions, and the overexploitation of natural resources, biodiversity loss and pollution. Data from Eurostat and market data reports show increased use of packaging design characteristics that may inhibit recycling. Packaging is ’unrecyclable’ when it cannot be separately collected or it poses challenges for state of the art sorting and recycling processes in place in the EU. From 2012 till 2020, the share of unrecyclable packaging has grown significantly. Furthermore, technically recyclable packaging is often not recycled because the processes needed for its collection, sorting and recycling are not available in practice or not cost-efficient, or the output is not of sufficient quality to meet the demand in end markets of secondary raw materials. Moreover, preliminary results of the Commission’s second Early Warning Report show that many Member States are struggling to meet the recycling targets established in Article 6 of Directive 94/62/EC. The industrial strategy for Europe underlines the importance of the internal market for the EU’s competitiveness and prosperity. Barriers that prevent operators and the broader public from benefiting fully from the internal market include restrictive and complex national rules, limited administrative capacities, imperfect transposition of EU rules and their inadequate enforcement. The Council conclusions of December 2020 welcomed the intention of the Commission to ensure that all packaging is reusable or recyclable in an economically feasible way by 2030 and to reduce packaging, over-packaging and therefore packaging waste. The Parliament’s resolution of 10 February 2021 on the new circular economy action plan reiterated this objective and called on the Commission to present a legislative proposal that includes waste reduction measures and targets, ambitious requirements to reduce excessive packaging - and measures to improve recyclability and minimise the complexity of packaging, increase recycled content, phase out hazardous and harmful substances, and promote re-use without compromising food safety and hygiene standards. Finally, the Conference on the Future of Europe demonstrated that people and civil society organisations across the EU are calling for strong action on waste prevention, packaging waste management and packaging circularity through the increased use of recycled materials. A circular economy of packaging will help decouple economic development from the use of natural resources, contribute to achieving climate neutrality by 2050 and halting biodiversity loss, and reduce the EU economy’s strategic dependency on many materials. In addition, it can have a positive impact on employment, including and specifically in social economy, by creating more "green" quality jobs provided the necessary investment in skills is put in place and considers the specificities in the Member States, regions, and types of work. While the amendment to Directive 94/62/EC in 2018 did not address all of the weaknesses in its implementation, it included three review clauses that are being implemented by this initiative. This initiative updates the EU legislative framework for packaging and packaging waste by giving Member States and businesses adequate support to achieve waste reduction targets. This support takes the form of a harmonised regulatory framework that supports investment, reduces waste and promotes high-quality recycling, which will apply equally in all EU Member States. •Consistency with existing policy provisions in the policy area The proposed regulation updates the EU legislative framework for packaging and packaging waste. As an integral part of the European Green Deal and the new EU circular economy action plan, it will contribute to the EU's growth strategy for a modern, resource-efficient, clean and competitive economy with no net emissions of greenhouse gases by 2050 and with economic growth decoupled from resource use. The proposal is fully in line with EU environmental and waste legislation, in particular, Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste, 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, Council Decision (EU, Euratom) 2020/2053 of 14 December 2020 on the system of own resources of the European Union and 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). It also complements the Commission proposals for regulations of the European Parliament and of the Council on waste shipments, on a framework for setting eco-design requirements for sustainable products, and the Communication from the Commission on an EU policy framework on bio-based, biodegradable and compostable plastics. •Consistency with other EU policies The initiative ensures non-discrimination between products produced in the EU and imported products and is consistent with the EU’s international obligations in the area of trade policy. The proposal also aims to harmonise monitoring and reporting obligations, including producer reporting obligations under EPR schemes, in order to limit the administrative burden on Member States and economic operators in line with the EU’s better-regulation approach and the Fitness check on reporting and monitoring. In addition, in line with the EU’s commitment to the UN 2030 Agenda for Sustainable Development, including its 17 Sustainable Development Goals (SDGs), this initiative will improve the EU’s implementation of SDG 12.5 by significantly reducing waste generation by 2030 through prevention, reduction, recycling and re-use.

As regards the specific case of plastic packaging waste, the initiative also complements the non-recycled plastic based own resource according to Decision (EU, Euratom) 2020/2053 on the system of own resources of the European Union. This own resource incentivises Member States to put in place measures to reduce the quantity of non-recycled plastic packaging waste in their territory. 2.LEGAL BASIS, SUBSIDIARITY AND PROPORTIONALITY •Legal basis The legal basis for this proposal is Article 114 of the Treaty on the Functioning of the European Union (TFEU). In line with the new approach to products announced in the European Green Deal1 and the circular economy action plan, the proposal covers the entire life cycle of packaging. It follows the approach of ‘traditional’ internal market legislation by creating harmonised conditions for the placing on the market of packaging. However, by taking account of the entire life cycle of packaging, this internal market approach is extended through to the end-of-life phase, thus creating a truly internal market for packaging, without obstacles to free movement and with equal production, marketing and waste treatment conditions throughout the EU. Article 114 TFEU is the legal basis of the current Directive 94/62/EC on packaging and packaging waste. This Article allows the EU to harmonise rules and administrative measures across Member States. This legal basis will allow a number of key internal market issues that hamper the harmonised application of packaging rules to be addressed, including: (i) sustainability requirements, (ii) harmonised criteria for the eco-modulation of fees under the extended producer responsibility schemes, (iii) harmonised labelling requirements; and (iv) end-of-life requirements to complete this life-cycle approach. While leaving the detailed administrative requirements to the Member States, the proposal regulates those aspects where harmonisation will prevent market distortions and obstacles to free movement. One such aspect is extended producer responsibility, where harmonised rules – including on reporting – will remove the barriers for economic operators selling packaging in several Member States or across the EU caused by differing rules between Member States. Likewise, establishing a common framework for packaging collection, deposit and return schemes, and for re-use systems, is necessary both to achieve environmental targets and to create equal conditions for businesses active on the respective markets. This common framework will have a major impact on the recyclability of packaging and on the availability of secondary raw materials. •Subsidiarity (for non-exclusive competence) Environmental concerns and problems related to packaging (i.e. barriers to the internal market and the circular economy, growing amounts of packaging waste and other negative) cannot be sufficiently addressed by Member States alone. With high levels of trade between Member States, the EU packaging market is, in many respects, one large market rather than 27 individual markets. While national initiatives address some of these challenges, they also create further fragmentation of the internal market. Setting common requirements at EU level will have clear added value as it will ensure the proper functioning of the internal market and therefore a level playing field for economic operators (e.g. producers, suppliers, retailers). With requirements and targets set at EU level, the transition to sustainable packaging will be consistent across Member States, creating an efficient market. •Proportionality The proposed measures are intended to provide the regulatory certainty necessary to encourage large-scale investment into sustainable packaging solutions. They address the entire packaging value chain, while ensuring a high level of environmental and human health protection. The objective of this initiative is to modernise and strengthen the existing legislative framework to allow for economies of scale through common approaches, while giving industry and Member States the necessary flexibility, where this is necessary for innovation or because of local circumstances. For some of the proposed policy options, a step-by-step approach in strengthening the requirements is considered to best uphold the principle of proportionality. The proposal therefore includes a gradual increase in ambition and requirements, such as the sustainability requirement on recycable packaging and the reconsideration of the need for exemptions from concentration limits for substances of concern in certain packaging materials. Overall, the proposed measures do not go beyond what is necessary to ensure regulatory compliance while guaranteeing the protection of human health and the environment. •Choice of the instrument Despite its concrete measures, the current legislation has failed to achieve its environmental and internal market objectives. Differing national approaches to transposition and unilateral packaging policy measures by certain Member States have led to uneven national regulatory frameworks. This trend is set to continue, given the challenges to packaging sustainability outlined in the impact assessment report, in particular the increasing amounts of packaging waste, barriers to packaging circularity and low use of recycled content in plastic packaging. Diverse national rules reduce the effectiveness of the policy and put the effective establishment of a circular economy in jeopardy. The regulatory failures of the current Directive (e.g. poorly designed essential requirements for packaging and difficulties encountered by Member States in enforcing them) has made it clear that harmonisation is necessary, and that the harmonised rules should take the form of a regulation, rather than a revision of the current Directive. To further promote the move to a low-carbon and circular economy and remove barriers to the internal market, a new comprehensive set of regulatory solutions is needed, including specific requirements for businesses. The move to a regulation setting out harmonised rules is strongly supported by all business stakeholders. A regulation will ensure that all 27 Member States fulfil their obligations at the same time and in the same way. The same requirements for all market players will provide the necessary legal certainty, reduce distortion of competition, and send clear signals to non-EU market actors intending to place products on the EU market. It will also give the Commission a mandate to develop implementing measures to flesh out the regulation further, where necessary, so that common rules can be set swiftly. 3.RESULTS OF EX-POST EVALUATIONS, STAKEHOLDER CONSULTATIONS AND IMPACT ASSESSMENTS •Ex-post evaluations/Fitness checks of existing legislation

A Fitness check conducted in 2014 identified weaknesses in the essential requirements for packaging and recommended making them ‘more concrete and easily enforceable’, noting that strengthening essential requirements would be ‘a key tool to achieve better environmental performance of packaging’. However, the amendment of Directive 94/62/EC in 2018 did not address those weaknesses directly, but rather introduced three revision clauses: (1) to examine the feasibility of reinforcing the essential requirements with a view to, inter alia, improving design for re-use and promoting high quality recycling as well as strengthening their enforcement; (2) to examine the feasibility of setting quantitative targets on re-use of packaging and any further measures to promote re-use of packaging; and (3), to evaluate the effectiveness of the measures aiming to reduce the consumption of lightweight plastic carrier bags and to examine other possible ways to achieve this objective. The revision clauses also provided the Commission with a mandate to present a legislative proposal on these issues, if appropriate. In April 2020, the Commission published an evaluation study on the effectiveness of the essential requirements for packaging and packaging waste and proposals for reinforcement. The main findings of the evaluation helped to define the problem and to develop the initial set of measures for the impact assessment. This study helped inform the Commission’s Inception Impact Assessment published on 11 June 2020. This proposal includes measures that address the issues identified in the Fitness check and in the 2020 evaluation study, as well as other measures identified in the impact assessment and its extensive stakeholder consultation. •Stakeholder consultations The impact assessment accompanying Directive 94/62/EC on packaging and packaging waste involved a thorough consultation of stakeholders to ensure that views from a broad range of organisations were presented and considered. Over 800 organisations with more than 1,800 contact points contributed to the consultation. Targeted and broader methods used to consult stakeholders included: gathering feedback on the inception impact assessment, a public questionnaire, a Member State questionnaire, online workshops and webinars, and one-to-one interviews. The consultation on the inception impact assessment generated 110 responses and an open public consultation generated 425 responses. A targeted consultation was also carried out to strengthen the evidence base, which involved collecting more specialised feedback from specific stakeholder groups during stakeholder workshops, among other events. Six stakeholder webinars were held in June 2021 to present and gather feedback on the interim results of the study. More than 950 individuals (from 250 organisations) participated in these webinars and almost 100 organisations provided detailed feedback and position papers. An additional workshop was held on 30 May 2022 with 517 attendees, during which 50 stakeholders intervened. In parallel, both the consultant supporting the Commission’s impact assessment and the relevant Commission departments carried out further targeted consultations with Member State experts, stakeholders, NGOs and consumer associations. Most stakeholders considered that technological, economic and social developments justified the creation of a new regulatory framework for packaging. Most also agreed on the need for further harmonisation of existing rules and called for a European framework covering the whole life cycle of packaging and the entire value chain. Many stakeholders considered that this framework should include stricter common rules on the sustainability of packaging to ensure the functioning of the EU internal market and underlined the need for a common approach to defining packaging recyclability, in particular the ‘design for recycling’ criteria approach. More specifically, industry representatives stressed the need for: (i) a stable and harmonised legal framework that ensures security of investment; (ii) a level playing field that encourages the production of sustainable packaging; and (iii) the efficient functioning of recycling markets to improve the availability and the quality of secondary raw materials. Civil society representatives called for the effective implementation of the waste hierarchy in the packaging value chain with measures incentivising packaging waste prevention and re-use. Detailed conclusions of the stakeholder consultations can be found in Annex 2 of the Impact Assessment. •Collection and use of expertise In addition to the stakeholder consultation, several further key sources of information were used for the impact assessment. To further analyse the various options, external consultants were engaged by the Commission under two support contracts. These studies developed ‘impact modelling methodology’ and ‘baseline methodology’. The former is used to model the impacts of the proposed measures, i.e. to model the change in mass flows, financial costs, environmental and social (employment) impacts. The latter (the baseline methodology) provides an overview of packaging waste consumption, waste generation and management for the 27 EU Member States. It includes both historic trends based on existing data and future projections until 2050. The baseline is essentially a ‘no policy change’ scenario, i.e. a modelling of future trends where all relevant EU-level and national policies and measures remain in force, complemented by any future legislative proposal(s) by the Commission. Another supporting study was carried out by the Commission’s Joint Research Centre (JRC) to analyse the impacts of measures that combine symbols on waste receptacles with matching labels on packaging (the latter was developed under the two studies mentioned above). The consultant and its experts worked closely with the relevant Commission departments during the various stages of the study. Additional data and comments were gathered through targeted interviews with stakeholders and in-depth consultations with the Member States. Possible measures on plastic carrier bags were first developed in the ‘Study on the Implementation of the Plastic Bags Directive combined with the Scoping Study to assess the feasibility of further EU measures on waste prevention and implementation of the Plastic Bags Directive’, and an impact assessment of the proposed measures was conducted in the second support study. Finally, measures on compostable packaging were developed as part of the 2020 Study on the ‘Relevance of biodegradable and compostable consumer plastic products and packaging in a circular economy’. This study also provided further inspiration for the Commission’s Communication on an EU policy framework on bio-based, biodegradable and compostable plastics. •Impact assessment The proposal is based on an impact assessment. After addressing the comments of the Regulatory Scrutiny Board in its negative opinion of 13 May 2022 and making the necessary modifications and additions, the impact assessment received a positive opinion with reservations on 30 September 2022. The impact assessment detected three main problems: (1)Growing packaging waste generation: Directive 94/62/EC has not been able to reverse this trend, despite specific provisions on minimising packaging. The growth trend has been accentuated by new consumption habits (e.g. on-the-go consumption, increased online sales and home deliveries).

(2)Barriers to packaging recycling and re-use: these include factors such as the increased use of packaging design features that prevent recycling, increased cross-contamination of compostable recycling streams, substances in packaging that may be hazardous and unclear labelling of packaging for sorting. As a result, the priority of re-use and recycling over recovery and landfill is not yet fully implemented. (3)Low recycling quality in plastic packaging and use of secondary raw materials: this limits the EU's ability to reduce the use of virgin materials in new packaging. Market failures and shortcomings in the current regulatory framework hamper the profitability of recycling activities and weigh on the investment in technology and supply logistics needed to ensure that packaging is collected, sorted and recycled at a high quality level. Given the above, the overarching objectives of this legislative proposal are to reduce the negative environmental impacts of packaging and packaging waste, while improving the functioning of the internal market. The specific objectives are: (i) to reduce the generation of packaging waste; (ii) to promote a circular economy for packaging in a cost-effective manner; and (iii) to promote the use of recycled content in packaging. The impact assessment compiled all possible measures for analysis, based on three studies conducted by an external consultant, stakeholder workshops, an online public consultation and targeted interviews. The diverse, complex and often interrelated measures were grouped under three policy options, which are compared to a business-as-usual scenario. Options 1 to 3 increase in strength in terms of their environmental effectiveness, but also their implementation burden and intrusiveness, as follows: ·Option 1 sets out measures to increase standardisation and establishes clearer essential requirements that tend to be pre-requisites for measures in other groups. ·Option 2 sets mandatory targets for waste reduction, re-use for certain sectors and minimum recycled content in plastic packaging, requirements to ensure full recyclability by 2030 and harmonised product rules. ·Option 3 sets higher mandatory targets than Option 2 and additional product requirements. The main policy choices for decision makers in the 27 EU Member States in the three intervention areas are national waste reduction targets, re-use targets for economic operators in certain sectors, measures to increase recyclability, and targets for recycled content in plastic packaging. Of the enabling measures, mandatory deposit return systems and labelling rules to facilitate consumers´ sorting are the outstanding policy choices. The measures contained in each option are presented in the following Table. In order to demonstrate the interlinkages between them, alternatives measures have the same number, e.g. M2b and M2c. Measures concerning the main policy choices are in bold. Option 1: Better standardisation & clearer Essential Requirements Option 2: Mandatory targets and stricter requirements Option 3: Far-reaching targets and requirements M5: Minimization of empty space in packaging in selected sectors, including e-commerce M1: Update of Essential Requirements to minimize over-packaging M10a: Revision of CEN standard for defining reusable packaging M19: providing clarity on the definition of reuse activity versus a “preparing for reuse” activity M8b: Mandatory reuse targets for selected packaging groups for 2030/2040 in selected sectors +M19+M10a+M10b: Definitions and mandatory requirements for reusable packaging formats set in EU legislation and standards for some formats+M10c: Definition and mandatory standards for reuse systems M7: Phase out avoidable / unnecessary packaging M2b: Mandatory target of 19% reduction of packaging waste per capita in 2030 compared to the baseline +M1+M5 M8c: Mandatory high level targets to increase the reuse of packaging by 2030/2040 in selected sectors +M10a+ M10b+M10c+M19 M2c: Mandatory target of 23% reduction of packaging waste per capita in 2030 compared to the baseline +M1+M5+M7+M3: Banning by 2030 of heaviest packaging for selected items based on existing lighter alternatives M21a: All packaging shall be reusable or recyclable by 2030- clarification of Essential Requirements and recyclability definition +M21b: All reusable packaging must be recyclable as of 2030 M22a: Qualitative definition of recyclable packaging M28: Clarification of biodegradability and compostability and updates of respective Essential Requirements & standard EN 13432 M29a: Allowing compostable and conventional plastics for selected packaging types M22b: Definition of recyclable packaging based on design for recycling (DfR) criteria complemented by the recyclability assessment procedure and a negative list of non-recyclable packaging characteristics +M21a+M21b+M22a+M23: Harmonisation of EPR Fee Modulation Criteria M29d: Mandatory compostability for certain out of the selected plastics packaging types and for the remaining ones compostable or conventional plastics possible +M28 M22c: Quantitative definition of recyclable packaging +M21a+M21b+M22a+M23 M29b: Mandatory compostability for all selected plastics packaging types +M28 M37: Definition of Recycled Content and measurement method M35em: Broad targets for recycled content in plastic packaging based on contact-sensitivity for 2030 and 2040 +M37 M35eh: Higher ambition, broad targets for recycled content in plastic packaging based on contact-sensitivity for 2030 and 2040 +M37 Mx: Update of current material-based labelling: Removal of alphanumeric codes for waste sorters M31: Update of definitions concerning hazardous substance M32a: Expanding the information on hazardous substances Ma&b: Mandatory DRS and minimum requirements for all DRS M27c-y: Harmonised labelling of products and waste receptacles to facilitate consumers´ sorting (advanced Nordic pictograms system)+Mx+Mk: Restrictions on use of confusing labels M12-u: Harmonised, mandatory labelling for reusable packaging M38-j: Labelling criteria for Recycled Content M32b: Notification of substances of concern in packaging +M33a: Restrictions of substances under REACH +M31 M40b: Mandatory minimum GPP criteria for packaging of priority products and services M42b: Harmonization of EPR reporting system MPCB: Extended reporting obligation on PCB Mc: Prioritized use of recycled packaging from DRS +Ma&b M26cc: Waste collection schemes alternative to DRS+Mx+M12-u+M38-j+M27c-y+Mk M32c: Notification of all substances in packaging +M33b: Restrictions of substances under the reviewed PPWD +M31 M40c: Mandatory minimum GPP criteria for packaging of all products and services M34b: Mandatory reporting requirement for recycled content for all packaging +M42b + MPCB Based on the assessment of the impacts of the measures, the Commission favours Option 2. •Regulatory fitness and simplification The proposed measures have different levels of administrative burden, which would mainly result from monitoring and reporting on compliance, both for public authorities and for businesses. At the same time, this proposal makes full use of digitalisation to reduce administrative burden. For example, it is envisaged that the Commission would adopt an implementing act to establish the conditions for identifying the material composition of packaging by means of digital marking technologies. It is also recommended that reusable packaging would have QR codes or equivalent means to facilitate their recovery and harmonised specific labels that properly inform consumers about packaging reusability, the availability of re-use systems. Moreover, the harmonised packaging labelling for consumers` sorting should improve the waste separation and means a significant simplification for the operators. •Fundamental rights The proposal has no consequences for the protection of fundamental rights. 4.BUDGETARY IMPLICATIONS The financial statement included shows the detailed budgetary implications and the human and administrative resources required by this Proposal. The European Commission, and more specifically the Directorate-General for Environment (DG ENV), will be responsible for negotiating the regulation through the regular co-decision procedure, as well as for its general implementation and adoption of all the implementing and delegated acts envisaged in it. Other departments and agencies that will provide input include Eurostat, the Joint Research Centre (JRC) and the European Chemicals Agency (ECHA).

The current financial simulations are based on three full-time equivalent Administrator (AD) posts only to carry out: (i) the negotiation and general implementation of the Regulation; and (ii) the preparatory work for the drafting of the secondary legislation. The technical tasks are envisaged to be performed by two full-time equivalent seconded national experts (given the expected timeline) and two contractual agents. The costs for Commission staff amount to a total of EUR 6 537 000 based on the latest salary scales, which are publicly available. 5.OTHER ELEMENTS •Implementation plans and monitoring, evaluation and reporting arrangements The proposal includes several provisions to improve monitoring and the understanding of packaging flows. These will add to the existing calculation and reporting requirements for Member States under Commission Decisions 2005/270/EC and 2018/896/EC. These decisions will need to be replaced to include additional reporting requirements necessary to support the monitoring and the full implementation of the substantive requirements related to: (1) plastic carrier bags (i.e. disaggregated and mandatory reporting and different categories of plastic carrier bags); (2) the collection rate of packaging covered by the obligation to set up deposit and return systems; and (3) data related to specific packaging categories, which is necessary to develop the methodology for assessing the recyclability of packaging. To support the monitoring of extended producer responsibility (EPR) at Member State-level, and harmonise EPR requirements to make them more effective across the EU, this initiative also proposes a registration requirement for economic operators (producers) and their producer responsibility organisations when they make packaging available on a Member State market for the first time. This is accompanied by harmonised requirements to report data on such packaging to the national authorities. This will reduce the administrative burden on producers that currently have to adapt to increasingly divergent national requirements on EPR reporting, and allow Member States to meet their reporting obligations and provide the necessary level of data granularity to support future policy adjustments, particularly on packaging recyclability. The proposal limits the reporting of data on re-use and refill targets to that submitted by the obliged economic operators to the competent authorities; no additional reporting to the Commission is envisaged. The calculation rules will be adopted by the Commission in implementing acts. • Detailed explanation of the specific provisions of the proposal Chapter I sets out the general provisions. Article 1 lays down the subject matter of this Regulation. It explains that it introduces requirements over the entire life-cycle of packaging as regards its environmental sustainability and labelling to allow placing packaging on the market, as well as requirements for the extended producer responsibility, collection, treatment, recycling of packaging waste. It explains that this Regulation contributes to the efficient functioning of the internal market while pursuing environmental objectives as regards preventing or reducing the negative impacts of packaging and packaging waste on the environment and human health. In this way, it contributes to the transition to a circular economy in line with the hierarchy of waste. Article 2 lays down that this Regulation applies to all packaging, regardless of the material used, and to all packaging waste. Article 3 lays down the definitions needed for the purposes of this Regulation. A number of these definitions are taken over from the New Legislative Framework (Regulation (EC) No 765/2008 and Decision 768/2008/EC), from the repealed Packaging and Packaging Waste Directive or from existing Union legislation (such as the Waste Framework Directive and the Market Surveillance Regulation). A set of new definitions is brought in, notably to implement the main measures of this initiative with the focus on recyclable packaging, use of recycled content in plastic packaging, reusable packaging and packaging waste prevention. Article 4 lays down the principle of free movement on the single market for packaging which complies with the sustainability requirements and labelling requirements as laid down in this Regulation. Chapter II contains sustainability requirements for packaging. Article 5 lays down requirements for substances in packaging, in particular a restriction on the concentration level of lead, cadmium, mercury and hexavalent chromium. The Commission is empowered to adopt delegated acts lowering the level of this restriction as well as laying down exemptions from it. Article 6 requires packaging to be recyclable and sets out what requirements will need to be met in a two-stepped approach. As of 1/1/2030, packaging will have to comply with the design for recycling criteria and, as of 1/1/2035 the requirements will be further adjusted to ensure that recyclable packaging is also sufficiently and effectively collected, sorted and recycled (‘recycled at scale’) . The criteria for the design of recycling and the methodology to assess if packaging is recycled at scale will be established in delegated acts to be adopted by the Commission. The differed application of these provisions is necessary in order to adopt the necessary legislation detailing the recyclability requirements and to grant sufficient time to the industry to adapt to the new rules. This provision furthermore establishes the rule that financial contributions to be paid by producers to comply with their extended producer responsibility obligations shall be modulated based on the recyclability performance grades under the design for recycling criteria, which will be updated to include recyclability at scale thresholds to be applied as of 2035. Finally, specific rules are set for innovative packaging for which the recyclability requirements shall only be required to be documented 5 years from its first placing on the market. Additionally, immediate packaging meeting the definition of immediate packaging in Article 4(25) of Regulation (EU) 2019/6, as well as contact sensitive plastic packaging of medical devices covered by Regulation (EU) 2017/745 and of in vitro diagnostics medical devices covered by Regulation (EU) 2017/746 are exempted from the recyclability requirements set up under this Article until 2034 to take account of the human and animal health and safety considerations. Article 7 requires that, as of 1 January 2030, plastic packaging shall contain certain minimum amount of recycled content recovered from post-consumer plastic waste, per unit of plastic packaging; specific packaging has been exempted, as appropriate. These amounts shall increase by 1 January 2040 and the derogations should be revised. The Commission will adopt an implementing act to establish the methodology for the calculation and verification of the percentage of recycled content recovered from post-consumer plastic waste and the format for the related technical documentation. This provision also empowers the Commission to adopt delegated acts to amend the minimum percentage of recycled content recovered from post-consumer plastic waste. Article 8, combined with the definition in Article 3, defines conditions for packaging to be considered compostable and prescribes that filter coffee pods, sticky labels attached to fruit and vegetables and very lightweight plastic carrier bags shall be compostable by 24 months after the entry into force of this Regulation. Other packaging shall, with the exception of lightweight plastic carrier bags, for which a flexibility was granted to the Member States, be eligible for material recycling. It also empowers the Commission to adopt delegated acts to amend the list of packaging that need to be compostable. Article 9 requires that the weight and volume of packaging shall be minimised with due account taken of the packaging’s safety and functionality. The compliance with this obligation shall be proven by technical documentation. Article 10 lays down the requirements for reusable packaging. One of the requirements is e.g. that the packaging is conceived, designed and placed on the market with the objective to be re-used or refilled a maximum number of times. Reusable packaging must be also part of a system for re-use compliant with the minimum conditions as set out in Annex VI of this Regulation. Chapter III lays down labelling, marking and information requirements.

Article 11 requires that packaging is marked with a label containing information on its material composition in order to facilitate consumer sorting. The same labels shall be placed on waste receptacles for the consumer to easily identify the appropriate disposal route (Article 12). Harmonized label shall be designed also to inform, at the choice of the manufacturer, about the recycled content in plastic packaging. Reusable packaging shall bear a QR code or other type of data carrier giving access to the relevant information facilitating its re-use. The Commission shall be empowered to, by implementing acts, establish harmonised labelling requirements and formats for packaging and waste receptacles as well as for identifying the material composition of packaging means of digital marking technologies. Chapter IV lays down the obligations of economic operators and the provisions are mostly standard from Decision 768/2008/EC. It is however worth mentioning Article 14 and Articles 21-28. Article 14 requires suppliers of packaging or packaging material to provide the manufacturer with all the information and documentation necessary for manufacturer to demonstrate the conformity of the packaging. Article 21 stipulates that economic operators that supply products to final distributors or end users in grouped, transport or e-commerce packaging must ensure that the ratio of empty space in the packaging in relation to the packaged product(s) is maximum 40 %. Article 22 stipulates that economic operators should not place on the market packaging in the formats and for the purposes listed in Annex V to the Regulation. The Commission is empowered to amend this list by adopting a delegated act. Articles 23 and 24 require that the economic operator who places reusable packaging on the market shall ensure a system for re-use for that packaging is in place. The economic operators that make use of reusable packaging shall also set up or participate in a system for re-use of such packaging. The requirements for the system for re-use and for the reconditioning of reusable packaging are laid down in Annex VI to the Regulation. Article 25 requires economic operators who offer products for purchase through refill to provide certain information to end-users and to ensure the compliance of refill stations with the requirements laid down in Part C of Annex VI. Article 26 lays down a number of targets on re-use and refill for different sectors and packaging formats. It also establishes exemptions from the obligation to meet the re-use and refill targets. The Commission may adopt delegated acts laying down more specific re-use targets and further exemptions. Articles 27 and 28 lays down the rules on the calculation of the attainment of the different re-use and refill targets laid down in Article 26 and reporting to the competent authority on those targets. By 31 December 2028 the Commission shall adopt an implementing act establishing detailed calculation rules and the methodology regarding the targets laid down in Article 26. Chapter V (Article 29) lays down that the annual consumption of lightweight plastic carrier bags cannot exceed 40 such bags per person by the 31st December 2025. Member States can exclude very lightweight plastic carrier bags, which are required for hygiene purposes or provided as sales packaging for loose food to prevent food wastage, from the obligation to meet the target. Chapter VI on the conformity of packaging is mostly standard provisions from Decision 768/2008/EC on how to assess the conformity of packaging. It concerns: – the use of reliable, accurate and reproducible methods for tests, measurements and calculations (Article 30); – harmonised standards providing a presumption of conformity (Article 31); – the possibility for the Commission to adopt common technical specifications where harmonised standards are not available (Article 32); – the conformity assessment procedure (Article 33); and – the EU declaration of conformity (Article 34). Chapter VII concerns the management of packaging and of packaging waste. Article 35 requires that Member States designate a competent authority for the implementation and enforcement of the obligations arising from Articles 26 to 29 and Chapter VII. Article 36 concerns the early warning report, to be drafted by the Commission in cooperation with the European Environment Agency, concerning the progress towards the attainment of the targets laid down in Articles 38 and 46. Article 37 requires Member States to introduce a chapter on the management of packaging and packaging waste into their waste management plans as required in Article 28 of Directive 2008/98/EC.

Article 38 requires each Member State to progressively reduce the packaging waste generated per capita as compared to the packaging waste generated per capita in 2018, by 5 % by 2030, 10 % by 2035 and 15 % by 2040. The Member States shall implement measures, such as economic instruments and other measures, to provide incentives for the application of the waste hierarchy, in order to prevent the generation of packaging waste and to minimise the environmental impact of packaging. Article 39 requires Member States to establish a register which shall serve to monitor the compliance of producers of packaging with the requirements of Chapter VII. Producers, producer responsibility organisations in case such an organisation was appointed by a producer, or the appointed representative for the extended producer responsibility shall be registered in the register of the Member State in which the producer makes packaging available for the first time. Producers who are not registered, shall not make available packaging on the market of a Member State. Article 40 lays down that producers that make available packaging on the market for the first time within the territory of a Member State will have extended producer responsibility for their packaging in line with Article 8 and Article 8a of Directive 2008/98/EC. Article 41 concerns producer responsibility organisations. If multiple producer responsibility organisations exist, it must be ensured that they perform their obligations over the whole territory of a Member State. Article 42 requires that producers or an appointed producer responsibility organisation apply for an authorisation from the competent authority. Article 43 requires that Member States ensure that systems are set up to enable the return and/or collection of all packaging and packaging waste from the consumer, other final user, or from the waste stream. Article 44 requires a deposit and return system (DRS) for single-use plastic beverage bottles with the capacity of up to three litres and single-use metal and aluminium beverage containers with a capacity of up to three litres. It also lays down exemptions to this rule. By 1 January 2029, Member States must ensure that all DRS follow the minimum requirements set out in Annex X. Member States are also allowed to include glass in the DRS and should ensure that DRS for single-use packaging formats, in particular for single-use glass beverage bottles, where technically and economically feasible, are equally available for reusable packaging. Article 45 requires Members States to take measures to encourage the increase of systems to enable re-use. Such measures can be e.g. the use of deposit-return systems for packaging which is not covered by the deposit return systems mandated by Article 44. Article 46 lays down recycling targets of packaging waste that Member States must meet by 31 December 2025 and by 31 December 2030, which are the same as in Directive 94/62/EC. If Member States postpone the deadlines for achieving the 2025 targets they must submit an implementation plan in line with Annex XI. The Commission can request that a Member State revise their implementation plan. Article 47 and 48 lays down the rules on calculation of the attainment of the recycling targets laid down in Article 46(1). Article 49 requires that producers or producer responsibility organisations make available information on the prevention and management of packaging waste for the packaging they supply within the territory of a Member State. Article 50 concerns reporting for each calendar year from the Member States to the Commission on: - the attainment of the recycling targets, - consumption of very lightweight, lightweight and thick plastic carrier bags, - the collection rate of packaging covered by the obligation to set up deposit and return systems, and - the packaging placed on the market and recycling rates for packaging formats/types as indicated in Table 3, Part 3, of Annex II. Article 51 sets out rules for databases on packaging and on the information they must contain. Chapter VIII concerns safeguard procedures and is based on standard provisions. Chapter IX (Article 57) concerns green public procurement and, more specifically, the possibility for the Commission to adopt delegated acts to establish requirements applicable to public contracts (e.g. technical specifications, selection criteria, award criteria, etc.), based on the sustainability requirements laid down in this Regulation. Chapter X is a standard chapter with articles on delegated acts (Article 58) and on implementing acts (Article 59).

Chapter XI sets out amendments to Regulation (EU) 2019/1020 and Directive (EU) 2019/904. Chapter XII is a standard chapter on final provisions, with articles on penalties (Article 62), on carrying out an evaluation of the Regulation 8 years after adoption (Article 63), and on repeal and transitional provisions (Article 64). 2022/0396 (COD) Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof, Having regard to the proposal from the European Commission, After transmission of the draft legislative act to the national parliaments, Having regard to the opinion of the European Economic and Social Committee, Having regard to the opinion of the Committee of the Regions, Acting in accordance with the ordinary legislative procedure, Whereas: (1)Products need packaging to be protected and easy to transport from where they are produced to where they are used or consumed. Prevention of barriers to the internal market for packaging is key for the functioning of the internal market for products. Fragmented rules and vague requirements cause additional cost to the economic operators. (2)In addition, packaging uses high amounts of virgin materials (40 % of plastics and 50 % of paper use in the Union is for packaging) and represents 36 % of municipal solid waste. High and constantly growing levels of packaging generated as well as low levels of re-use and poor recycling, present significant barriers to achieving a low-carbon circular economy. For these reasons, this Regulation should establish rules over the entire life-cycle of packaging contributing to the efficient functioning of the internal market by harmonising national measures, while preventing and reducing the adverse impacts of packaging and packaging waste on the environment and human health. By laying measures in line with the hierarchy of waste, it should contribute to the transition to a circular economy. (3)European Parliament and Council Directive 94/62/EC lays down requirements for Member States on packaging, such as essential requirements, which relate to the composition of packaging and its reusable and recoverable nature, and recovery and recycling targets. (4)In 2014, a Fitness Check relating to Directive 94/62/EC recommended adaptations of the essential requirements to make them “more concrete and easily enforceable” and to strengthen them, which were seen as a key tool to achieve better environmental performance of packaging.

(5)In line with the Green Deal, the new Circular Economy Action Plan (CEAP) commits to reinforcing the essential requirements for packaging in view of making all packaging reusable or recyclable by 2030, and to consider other measures to reduce (over)packaging and packaging waste, drive design for re-use and recyclability of packaging, reduce the complexity of packaging materials and introduce requirements for recycled content in plastic packaging. It commits the Commission to assess the feasibility of Union-wide labelling that facilitates the correct separation of packaging waste at source. (6)Plastic packaging is the most carbon-intensive material and, in terms of fossil fuel use, recycling of plastic waste is approximately five-times better than incineration with energy recovery. Just as the European Strategy for Plastics states, CEAP commits to increase uptake of recycled plastics and contribute to the more sustainable use of plastics. The Union budget and the system of own resources contribute to reducing pollution from plastic packaging waste. As of 1 January 2021, the Council Decision (EU, Euratom) 2020/2053 of 14 December 2020 on the system of own resources of the European Union introduced a national contribution that is proportional to the quantity of plastic packaging waste that is not recycled in each Member State. This own resource is part of incentives to reduce the consumption of single-use plastics, foster recycling and boost the circular economy. (7)The Council underlined in its Conclusions of December 2020, that the revision of Directive 94/62/EC should update and establish more concrete, effective and easy to implement provisions to facilitate sustainable packaging in the internal market and minimise the complexity of packaging in order to foster economically feasible solutions, to improve the reusability and recyclability as well as minimise substances of concern in packaging materials, especially concerning food packaging materials, and to provide for labelling packaging in an easily understandable way to inform consumers about its recyclability and where its waste should be discarded to facilitate sorting and recycling. (8)The European Parliament’s Resolution of 10 February 2021 on the New Circular Economy Action Plan reiterated the objective of making all packaging reusable or recyclable in an economically viable way by 2030 and called on the Commission to present a legislative proposal including waste reduction measures and targets and ambitious essential requirements in the Packaging and Packaging Waste Directive to reduce excessive packaging, including in e-commerce, improve recyclability and minimise the complexity of packaging, increase recycled content, phase out hazardous and harmful substances, and promote re-use. (9)This Regulation complements Regulation [Ecodesign for Sustainable Products], under which packaging is not addressed as a specific product category. However, it should be recalled that with respect to specific products, delegated acts adopted on the basis of Regulation [Ecodesign for Sustainable Products] may establish additional or more detailed requirements for their packaging, in particular in relation to packaging minimisation when design or re-design of products can lead to environmentally less impactful packaging. (10)This Regulation should apply to all packaging placed on the market in the Union and to all packaging waste, regardless of the type of packaging or the material used. For reasons of legal clarity the definition of packaging under the previous Directive 94/62/EC should be restructured without changing the substance. Sales packaging, grouped packaging and transport packaging should be defined separately avoiding duplication of terminology. Consequently, sales packaging corresponds to primary packaging, grouped packaging to secondary packaging and transport packaging to tertiary packaging. (11)An item, which is an integral part of a product and is necessary to contain, support or preserve that product throughout its lifetime and where all elements are intended to be used, consumed or disposed of together, should not be considered as being packaging given that its functionality is intrinsically linked to it being part of the product. However, in light of the disposal behaviour of consumers regarding tea and coffee bags as well as coffee or tea system single-serve units, which in practice are disposed of together with the product residue leading to the contamination of compostable and recycling streams, those specific items should be treated as packaging. This is in line with the objective to increase the separate collection of bio-waste, as required by Article 22 of Directive 2008/98/EC of the European Parliament and of the Council. Furthermore, to ensure coherence regarding end-of-life financial and operational obligations, also all coffee or tea system single-serve units necessary to contain coffee or tea should be treated as packaging. (12)In line with the waste hierarchy set out in Article 4(2) of Directive 2008/98/EC, and in line with life-cycle thinking to deliver the best overall environmental outcome, the measures provided for under this Regulation aim at reducing the amount of packaging placed on the market in terms of its volume and weight, and preventing the generation of packaging waste, especially through packaging minimisation, avoiding packaging where it is not needed, and increased re-use of packaging. In addition, the measures aim at increasing the use of recycled content in packaging, especially in plastic packaging where the uptake of recycled content is very low, as well as higher recycling rates for all packaging and high quality of the resulting secondary raw materials while reducing other forms of recovery and final disposal. (13)Packaging should be designed, manufactured and commercialised in such a way as to allow for its re-use or high-quality recycling, and to minimise its impact on the environment during its entire life-cycle and the life cycle of products, for which it was designed. (14)In line with the objectives of the Circular Economy Action Plan and the Chemicals Strategy for Sustainability, and to ensure the sound management of chemicals throughout their life cycle and the transition to a toxic-free and circular economy, and considering the relevance of packaging in everyday life, it is necessary that this Regulation addresses impacts on human health and on the environment and on broader sustainability performance, including circularity, resulting from impacts of substances of concern on the whole life cycle of packaging, from manufacture to use and end-of life, including, waste management. (15)Taking into consideration the scientific and technological progress, packaging should be designed and manufactured in a way as to limit the presence of certain heavy metals and other substances of concern in its composition. As stated in the Chemicals Strategy for Sustainability, substances of concern are to be minimised and substituted as far as possible, phasing out the most harmful ones for non-essential societal use, in particular in consumer products. Accordingly, substances of concern as constituents of packaging material or of any of the packaging components should be minimised with the objective to ensure that packaging, as well as materials recycled from packaging, do not have an adverse effect on human health or the environment, throughout their life-cycle. (16)In line with the Zero Pollution Action Plan, Union policies should be based on the principle that preventive action should be taken at source. The Commission underlines in the Chemicals Strategy for Sustainability that Regulation (EC) No 1907/2006 of the European Parliament and of the Council and Regulation (EC) No 1272/2008 of the European Parliament and of the Council should be reinforced as the cornerstones for regulating chemicals in the Union and that they should be complemented by coherent approaches to assess and manage chemicals in existing sectorial legislation. Substances in packaging and packaging components are therefore restricted at source and primarily addressed under Regulation (EC) No 1907/2006 in accordance with the rules and procedures laid out under its Title VIII, in order to protect human health and the environment, along all stages of the life cycle of the substance, including the waste stage. Hence, it should be recalled that the provisions of that Regulation apply for adopting or amending restrictions on substances manufactured for use or used in the production of packaging or packaging components as well as on the placing on the market of substances present in packaging or packaging components. Concerning packaging falling within the scope of Regulation (EC) No 1935/2004 of the European Parliament and of the Council, it should be recalled that that Regulation applies to ensure a high level of protection of the consumers of packaged food. (17)In addition to the restrictions set out in Annex XVII to Regulation (EC) No 1907/2006 and, as applicable to food contact packaging, to provisions under Regulation (EC) No 1935/2004, it is appropriate, for reasons of consistency, to maintain existing restrictions for lead, cadmium, mercury and hexavalent chromium present in packaging or packaging components. (18)Exemptions to the concentration levels of lead, cadmium, mercury and hexavalent chromium present in packaging or packaging components are established in Commission Decision 2001/171/EC and Commission Decision 2009/292/EC adopted under Directive 94/62/EC and should be maintained also under this Regulation. However, in order to amend or repeal them as well as to determine, if appropriate, further exemptions from the concentration levels of lead, cadmium, mercury and hexavalent chromium present in packaging or packaging components, or to amend the concentration limit value for these metals in this Regulation in order to adapt it to technical and scientific progress, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission. (19)This Regulation should not enable the restriction of substances based on reasons of chemical safety, or for reasons related to food safety, with the exception of the restrictions on lead, cadmium, mercury and hexavalent chromium that were already established on the basis of Directive 94/62/EC and should continue to be addressed under this Regulation, given that such restrictions are addressed under other Union legislation. It should, however allow for the restriction, primarily for reasons other than chemical or food safety, of substances present in packaging and packaging components or used in their manufacturing processes, which negatively affect the sustainability of packaging, in particular as regards its circularity, especially re-use or recycling. (20)Designing packaging with the objective of its recycling, once it becomes packaging waste, is one the most efficient measures to improve the packaging circularity and raise packaging recycling rates and the use of recycled content in packaging. Packaging design for recycling criteria have been established for a number of packaging formats under voluntary industry schemes or by some Member States for the purpose of the modulation of extended producer responsibility fees. In order to prevent barriers to the internal market and provide industry with a level playing field, and with the objective to promote the sustainability of packaging, it is important to set mandatory requirements regarding the recyclability of packaging, by harmonising the criteria and the methodology for assessing packaging recyclability based on a design for recycling methodology at the Union level. In order to meet the objective set out in the CEAP that, by 2030, all packaging should be recyclable or reusable, in an economically viable manner, packaging recyclability performance grades should be established based on design for recycling criteria for packaging categories as listed in Annex II. However, packaging should comply with them only as of 1 January 2030 in order to give sufficient time to the economic operators to adapt. (21)As design for recycling assessment in itself does not ensure that packaging is recycled in practice, it is necessary to establish a uniform methodology and criteria for assessing the recyclability of packaging in practice based on the state-of-the-art separate collection, sorting and recycling processes and infrastructure actually available in the Union. Related reporting from Member States and, where relevant, economic operators should support establishing the recyclability “at scale” thresholds and update, on this basis, the recyclability performance grades with respect to the specific packaging materials and categories. (22)In order to establish harmonised rules on packaging design to ensure its recyclability, the power to adopt delegated acts should be delegated to the Commission to set out detailed criteria for packaging design for recycling per packaging materials and categories, as well as for the assessment of the packaging recyclability at scale including for categories of packaging not listed in this Regulation. In order to give economic operators and Member States sufficient time to collect and report the necessary data to establish the “at scale” recycling methodology, the manufacturers should ensure that packaging is recycled at scale as of 2035. That should ensure that packaging complies with the design for recycling criteria, and is also recycled in practice on the basis of the state of the art processes for separate collection, sorting and recycling. (23)In order to stimulate innovation in packaging, it is appropriate to allow that packaging, which presents innovative features resulting in significant improvement in the core function of packaging and has demonstrable environmental benefits, is given limited additional time of five years to comply with the recyclability requirements. The innovative features should be explained in the technical documentation accompanying the packaging. (24)In order to protect human and animal health and safety, due to the nature of the packaged products and the related requirements, it is appropriate that the recyclability requirements should not apply to immediate packaging as defined in Article 1 of Directive 2001/83/EC of the European Parliament and of the Council and in Article 4(25) of Regulation (EU) 2019/6 of the European Parliament and of the Council , which are in direct contact with the medicinal product, as well as contact sensitive plastic packaging of medical devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council and of in vitro diagnostics medical devices covered by Regulation (EU) 2017/746 of the European Parliament and of the Council . These exemptions should apply until 1 January 2035.

(25)Some Member States are taking action to encourage recyclability of packaging through modulation of extended producer responsibility fees; such initiatives taken at the national level may create regulatory uncertainty for the economic operators, in particular where they supply packaging in several Member States. At the same time, modulation of extended producer responsibility fees is an effective economic instrument to incentivise more sustainable packaging design leading to better recyclable packaging while improving the functioning of the internal market. It is therefore necessary to harmonise criteria for the modulation of extended producer responsibility fees based on the recyclability performance grade obtained through recyclability assessment, while not setting the actual amounts of such fees. As the criteria should be related to the criteria on packaging recyclability, it is appropriate to empower the Commission to adopt such harmonised criteria at the same time as establishing the detailed design for recycling criteria per packaging categories. (26)To ensure packaging circularity, packaging should be designed and manufactured in such a way as to allow for the increased substitution of virgin materials with recycled materials. The increased use of recycled materials supports the development of the circular economy with well-functioning markets for recycled materials, reduces costs, dependencies and negative environmental impacts related to the use of primary raw materials, and allows for a more resource-efficient use of materials. In relation to the different packaging materials, the lowest input of recycled materials is in plastic packaging. In order to address these concerns in the most appropriate manner, it is necessary to increase the uptake of recycled plastics, by establishing mandatory targets for recycled content in plastic packaging at different levels depending on the contact-sensitivity of different plastic packaging applications, and ensuring that the targets become binding by 2030. In order to incrementally ensure packaging circularity, increased targets should apply as of 2040. (27)It should be clarified, that paper material resulting from the wood pulping process is not considered to be included in the definition of plastic under point 43 of Article 3. (28)In order to ensure a high level of human and animal health protection in accordance with requirements in Union legislation and to avoid any risk to the security of supply and to the safety of medicines and medical devices safety, it is appropriate to provide for the exclusion from the obligation of a minimum recycled content in plastic packaging for immediate packaging as defined in Article 1, point 23, of Directive 2001/83/EC and in Article 4, point 25, of Regulation (EU) 2019/6, as well as for contact sensitive plastic packaging of medical devices covered by Regulation (EU) 2017/745 and for contact sensitive packaging of in vitro diagnostics medical devices covered by Regulation (EU) 2017/746. This exclusion should also apply to outer packaging of human and veterinary medicinal products as defined in Article 1, point 24, of Directive 2001/83/EC and in Article 4, point 26, of Regulation (EU) 2019/6 in cases where it has to comply with specific requirements to preserve the quality of the medicinal product. (29)In order to prevent barriers to the internal market and ensure the efficient implementation of the obligations, economic operators should ensure that the plastic part of each unit of packaging contains a certain minimum percentage of recycled content recovered from post-consumer plastic waste. (30)There should be an incentive for economic operators to increase the recycled content in the plastic part of packaging. The most appropriate means to achieve this is to ensure the modulation of extended producer responsibility fees based on the percentage of recycled content in packaging. The fee modulation should be based on common rules for the calculation and verification of the recycled content contained in such packaging. (31)In order to ensure uniform conditions for the implementation of the rules on calculating and verifying, per unit of post-consumer plastic waste in packaging, the share of recycled content recovered from post-consumer plastic waste present and establishing the format for technical documentation, the Commission should be empowered to adopt implementing provisions, in accordance with Article 5 of Regulation (EU) No 182/2011 of the European Parliament and of the Council . (32)Regarding plastic packaging, except where made from polyethylene terephthalate (PET), it will be warranted, sufficiently ahead of the date of application of the related recycled content requirements, to re-assess the availability of suitable recycling technologies for such plastic packaging, also with respect to the state of authorisation under relevant Union rules, and the installation in practice of such technology. Based on this assessment, there might be need to provide for derogations from the recycled content requirements for specific contact sensitive plastic packaging concerned, or to revise the derogations. To that end, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission. (33)In order to take into account the risks related to a possible insufficient supply of a specific plastic waste for recycling that might lead to excessive prices or adverse effects on health, safety and the environment, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission in respect of temporarily amending the targets for mandatory recycled content in plastic packaging. In evaluating the justification of such a delegated act, the Commission should assess well-reasoned requests from natural and legal persons. (34)For materials other than plastic, such as glass or aluminium, the trend to replace primary raw material with recycled materials is evident and expected to continue because of the development in the legal and economic environment and the consumers` expectations. Nonetheless, the Commission should monitor closely the use of recycled content in packaging materials other than plastics and should assess the appropriateness of proposing to establish further measures, including setting targets, aiming to increase the use of recycled content in packaging other than plastic packaging. (35)The bio-waste waste stream is often contaminated with conventional plastics and the material recycling streams are often contaminated with compostable plastics. This cross-contamination leads to waste of resources, lower quality secondary raw materials and should be prevented at source. As the proper disposal route for compostable plastic packaging is becoming increasingly confusing for consumers, it is justified and necessary to lay down clear and common rules on the use of compostable plastic packaging, mandating it only when its use brings a clear benefit for the environment or for human health. This is particularly the case when the use of compostable packaging helps collect or dispose of bio-waste. (36)For limited packaging applications made of biodegradable plastic polymers, there is a demonstrable environmental benefit of using compostable packaging, which enters composting plants, including anaerobic digestion facilities under controlled conditions. Furthermore, where appropriate waste collection schemes and waste treatment infrastructures are available in a Member State, there should be a limited flexibility in deciding whether to mandate the use of compostable plastics for lightweight plastic carrier bags on its territory. In order to avoid consumer confusion about the correct disposal and considering the environmental benefit of circularity of the carbon, all other plastic packaging should go into material recycling and the design of such packaging should ensure that it does not affect the recyclability of other waste streams. (37)Where justified and appropriate due to technological and regulatory developments impacting the disposal of compostable plastics and under the specific conditions ensuring that the use of such materials is beneficial for the environmental and human health, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend or extend the list of compostable packaging. (38)In order to facilitate conformity assessment with requirements on compostable packaging, it is necessary to provide for presumption of conformity for compostable packaging which is in conformity with harmonised standards adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council for the purpose of expressing detailed technical specifications of those requirements and take into account, in line with the latest scientific and technological developments, the parameters, including composting times and admissible levels of contamination, which reflect the actual conditions in bio-waste treatment facilities, including anaerobic digestion processes. (39)It should be recalled that all compostable packaging constituting a food contact material is to meet the requirements set out in the Regulation (EC) No 1935/2004. (40)Packaging should be designed so as to minimise its volume and weight while maintaining its ability to perform the packaging functions. The manufacturer of packaging should assess the packaging against the performance criteria, as listed in Annex IV of this Regulation. In view of the objective of this Regulation to reduce packaging and packaging waste generation and to improve circularity of packaging across the internal market, it is appropriate to further specify the existing criteria and to make them more stringent. The list of the packaging performance criteria, as listed in the existing harmonised standard EN 13428:2000 , should therefore be modified. While marketing and consumer acceptance remain relevant for packaging design, they should not be part of performance criteria justifying on their own additional packaging weight and volume. However, this should not compromise product specifications for craft and industrial products and food and agricultural products that are registered and protected under the EU geographical indication protection scheme, as part of the Union’s objective to protect cultural heritage and traditional know-how. On the other hand, recyclability, the use of recycled content, and re-use may justify additional packaging weight or volume, and should be added to the performance criteria. Packaging with double walls, false bottoms and other characteristics only aimed to increase the perceived product volume should not be placed on the market, as it does not meet the requirement for packaging minimisation. The same rule should apply to superfluous packaging not necessary for ensuring packaging functionality. (41)In order to comply with the packaging minimisation requirements, particular attention should be paid to limiting the empty space, grouped and transport packaging, including e-commerce packaging. (42)In order to facilitate conformity assessment with requirements on packaging minimisation, it is necessary to provide presumption of conformity for packaging which is in conformity with harmonised standards adopted in accordance with Regulation (EU) No 1025/2012 for the purpose of expressing detailed technical specifications of those requirements and specify measurable design criteria, including where appropriate, maximum weight or empty space limits for specific packaging formats as well as by-default, standardised packaging designs that comply with the packaging minimisation requirement. (43)To promote the circularity and sustainable use of packaging, reusable packaging and systems for re-use should be incentivised. For that purpose, it is necessary to clarify the notion of reusable packaging and to ensure that it is linked not only to the packaging design, which should enable a maximum number of trips or rotations and maintaining the safety, quality and hygiene requirements when being emptied, unloaded, refilled or reloaded, but also to the setting up of systems for re-use respecting minimum requirements as set out in this Regulation. In order to facilitate conformity assessment with requirements on reusable packaging, it is necessary to provide for presumption of conformity for packaging which is in conformity with harmonised standards adopted in accordance with Regulation (EU) No 1025/2012 for the purpose of expressing detailed technical specifications of those requirements and define reusable packaging criteria and formats, including minimum number of trips or rotations, standardised designs, as well as requirements for systems for re-use, including hygiene requirements. (44)It is necessary to inform consumers and to enable them to appropriately dispose of packaging waste, including compostable lightweight and very lightweight plastic carrier bags. The most appropriate manner to do this is to establish a harmonised labelling system based on the material composition of packaging for sorting of waste, and to pair it with corresponding labels on waste receptacles.

(45)To facilitate consumers in the sorting and disposing of packaging waste, a system of harmonised symbols should be introduced and required to be placed both on packaging and on waste receptacles, thus allowing consumers to match the symbols for the purposes of disposal. The symbols should enable appropriate waste management as it should provide consumers with information about the composting properties of such packaging, in particular to avoid consumer confusion that compostable packaging is not as such suitable for home-composting. This approach should improve the separate collection of packaging waste, leading to higher quality recycling of packaging waste, and introduce a level of harmonisation of the packaging waste collection systems on the internal market. It is also necessary to harmonise symbols associated with the mandatory deposit and return systems. Considering that it is not collected through municipal waste collection systems, the use of those symbols should not be mandatory for transport packaging with the exception of the e-commerce packaging. (46)Labelling of recycled content in packaging should not be mandatory as this information is not critical to ensure the proper end-of-life treatment of packaging. However, manufacturers will be required to meet recycled content targets under this Regulation and they may wish to display that information on their packaging to inform consumers thereof. To ensure that this information is communicated in a harmonised manner across the Union, a label to indicate the recycled content should be harmonised. (47)In order to inform end-users about reusability, availability of systems for re-use and location of collection points as regards reusable packaging, such packaging should bear a QR code or other data carrier that provides such information. The QR code should also facilitate tracking and the calculation of trips and rotations. In addition, reusable sales packaging should be clearly identified at the point of sale. (48)There should be no multiplication of labels on packaging. In order to avoid this, where other Union legislation requires information on the packaged product to be available digitally through a data carrier, the information required for the packaging under this Regulation and the information required for the packaged product should be accessible via the same data carrier. That data carrier should comply with the requirements under this Regulation or other applicable Union legislation. In particular, where the packaged product is covered by the Regulation [Ecodesign for Sustainable Products] or other Union legislation requiring a digital product passport, that digital product passport should also be used for providing the relevant information under this Regulation. (49)To support the implementation of the objectives of this Regulation, consumers should be protected from misleading and confusing information about packaging characteristics and its appropriate end-of-life treatment, for which harmonised labels have been established under this Regulation. It should be possible to identify packaging included in the extended producer responsibility scheme by means of an accreditation symbol throughout the territory of that system. That symbol should be clear and unambiguous to consumers or users as to the recyclability of packaging. To this end, it could be considered that the Green Dot symbol, which is used in some Member States to signify that a producer has made a financial contribution to a national packaging recovery system , could mislead consumers to believe that packaging bearing such a symbol is always recyclable. (50)In order to ensure uniform conditions for the implementation of the labelling requirements, the power to adopt implementing acts in accordance with Article 291 of the Treaty should be delegated to the Commission to further improve waste sorting, to establish the conditions for identifying the material composition of packaging by means of digital marking technologies, and to lay down detailed harmonized specifications for the labelling requirements for packaging and waste receptacles established under this Regulation. When developing these specifications, the Commission should take into account scientific or other available technical information, including relevant international standards. In view of the new system, Commission Decision 97/129/EC should be repealed as of 42 months after the date of entry into force of this Regulation and its content incorporated into this implementing act. (51)Economic operators should ensure that packaging complies with the requirements under this Regulation. They should take appropriate measures to ensure such compliance in relation to their respective roles in the supply chain in order to ensure the free movement of packaging in the internal market and to improve its sustainability. (52)The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure provided for under this Regulation. Such conformity assessment should therefore remain solely the obligation of the manufacturer. (53)It should be ensured that suppliers of packaging or packaging materials provide the manufacturer with all the information and documentation necessary for the manufacturer to demonstrate the conformity of the packaging and the packaging materials. That information and documentation should be provided in either paper or electronic form. (54)In order to safeguard the functioning of the internal market, it is necessary to ensure that packaging from third countries entering the Union market comply with this Regulation, whether imported as self-standing packaging or in a packaged product. In particular, it is necessary to ensure that appropriate conformity assessment procedures have been carried out by manufacturers with regard to that packaging. Importers should therefore ensure that the packaging they place on the market comply with those requirements and that documentation drawn up by manufacturers are available for inspection by the competent national authorities. (55)When placing packaging on the market, every importer should indicate on the packaging their name, registered trade name or registered trade mark as well as their postal address and, where available, electronic means of communication through which it can be contacted. Exceptions should be provided for in cases where the packaging does not allow for such indications. (56)As the distributor makes packaging available on the market after it has been placed there by the manufacturer or importer, they should act with due care in relation to the applicable requirements of this Regulation. The distributor should also ensure that their handling of the packaging does not adversely affect its compliance with those requirements. (57)As distributors and importers are close to the marketplace and have an important role in ensuring packaging compliance, they should be involved in market surveillance tasks carried out by the competent national authorities, and should be prepared to participate actively, providing those authorities with all necessary information relating to the product concerned. (58)Any importer or distributor that either places on the market packaging under their own name or trademark, or modifies such a product in such a way that compliance with this Regulation might be affected, should be considered to be the manufacturer and should assume the manufacturer’s obligations. (59)Ensuring packaging’s traceability throughout the whole supply chain facilitates the market surveillance authorities' task of tracing economic operators who placed on the market or made available on the market non-compliant packaging. The economic operators should therefore be required to keep the information on their transactions for a certain period of time. (60)The problem of excessive packaging waste generation cannot be fully addressed by setting obligations on packaging design. For certain packaging types, obligations to reduce the empty space should be set on economic operators in terms of reducing the empty space when using such packaging. In case of grouped, transport and e-commerce packaging used for supply of products to final distributors or end user, the empty space ration should not exceed 40 %. In line with the waste hierarchy, it should be possible for economic operators using sales packaging as e-commerce packaging to be exempted from this obligation. (61)In order to ensure a high level of environmental protection in the internal market as well as a high level of food safety and hygiene, and facilitate the achievement of the packaging waste prevention targets, unnecessary or avoidable packaging should not be allowed to be placed on the market. The list of such packaging formats is provided in Annex V of this Regulation. In order to adapt the list to the technical and scientific progress the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend the list. (62)In order to further the aim of circularity and sustainable use of packaging, it is necessary to limit the risk that packaging marketed as reusable is not re-used in practice and to ensure that consumers return reusable packaging. The most appropriate manner to achieve this is to oblige economic operators, who use reusable packaging, to ensure that a system for re-use is put in place, thus allowing such packaging to circulate, rotate and be repeatedly used. To ensure maximum benefits of such systems, minimum requirements should be laid down for open loop and closed loop systems. Confirmation of compliance of reusable packaging with an existing system for re-use should also be a part of the technical documentation of such packaging. (63)Reusable packaging has to be safe for its users. Therefore, economic operators offering their products in reusable packaging have to ensure that, before a reusable packaging is used again, it is subject to a reconditioning process, for which requirements should be laid down. (64)Reusable packaging becomes waste, in the sense of the Article 3(1) of Directive 2008/98/EC, when its holder discards it, intends to discard it or is obligated to discard it. Reusable packaging in a reconditioning process is normally not considered to be waste.

(65)To incentivise waste prevention, a new concept of ‘refill’ should be introduced. Refill should be considered as a specific waste prevention measure that counts towards and is necessary for meeting of the re-use and refill targets. However, containers owned by the consumer, performing a packaging function in the context of refill, such as reusable cups, mugs, bottles or boxes are not packaging in the sense of this Regulation. (66)Where economic operators offer the possibility to purchase products through refill, they should ensure that their refill stations meet certain requirements in order to ensure the health and safety of consumers. In this context, where the consumers use their own containers, the economic operators should therefore inform about the conditions for safe refill and use of those containers. In order to encourage refill, economic operators should not provide packaging free of charge or not being a part of deposit and return system at the refill stations. (67)In order to reduce the increasing proportion of packaging that is single use and the growing amounts of packaging waste generated, it is necessary to establish quantitative re-use and refill targets on packaging in sectors, which have been assessed as having the greatest potential for packaging waste reduction, namely food and beverages for take-away, large-white goods and transport packaging. This was appraised based on factors such as existing systems for re-use, necessity of using packaging and the possibility of fulfilling the functional requirements in terms of containment, tidiness, health, hygiene and safety. Differences of the products and their production and distribution systems, were also taken into account. The setting of the targets is expected to support the innovation and increase the proportion of re-use and refill solutions. The use of single use packaging for food and beverages filled and consumed within the premises in the HORECA sector should not be allowed. (68)To increase their effectiveness and ensure the equal treatment of economic operators, the re-use and refill targets should be placed on the economic operators. In cases of targets for beverages, they should be additionally placed also on the manufacturers, as these actors are able to control the packaging formats used for the products they offer. The targets should be calculated as a percentage of sales in reusable packaging within a system for re-use or through refill or, in case of transport packaging, as a percentage of uses. The targets should be material neutral. In order to ensure uniform conditions for the implementation of targets for re-use and refill, the power to adopt an implementing act in accordance with Article 291 of the Treaty on the methodology for their calculation, should be delegated to the Commission. (69)Certain uses of single use transport packaging formats are not necessary, as there is a wide range of well-functioning reusable alternatives. In order to ensure that such alternatives are effectively used, it is appropriate to require economic operators, when transporting products between different sites of the same economic operator or between the economic operator and the linked or partner enterprises, to use only reusable transport packaging with respect to packaging formats such as pallets, foldable plastic boxes, plastic crates, intermediate bulk containers, both rigid and flexible, or drums. The same obligation should, for the same reasons, apply to economic operators transporting products within one Member State. (70)Achieving re-use and refill targets can be challenging for smaller economic operators. Therefore, certain economic operators should be exempted from the obligation to meet the packaging re-use targets if they place less than a certain volume of packaging on the market, or fulfil the definition of micro-company under Commission Recommendation 2003/361 , or have the sales area, including all storage and dispatch areas, under a certain surface limit. The power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to establish re-use and refill targets for other products, to lay down further exemptions for other economic operators or to exempt specific packaging formats covered by the reuse or refill targets in case of severe hygiene, food safety or environmental issues preventing the achievement of these targets. (71)To enable the verification of compliance with the re-use and refill targets, it is necessary that the respective economic operators report to the competent authorities. Economic operators should report the relevant data for each calendar year, starting from 1 January 2030. Member States should make this data publicly available. (72)In view of the continued high consumption levels of plastic carrier bags, inefficient use of resources and their littering potential, it is appropriate to maintain provisions aimed at reaching a sustained consumption reduction of plastic carrier bags, as had already been established by Directive 94/62/EC as amended by the Directive (EU) 2015/720 of the European Parliament and of the Council . In view of the current divergent approaches and limited reporting requirements on the plastic carrier bags, it is difficult to assess whether the consumption reduction measures taken by the Member States have achieved the objective of a ‘sustained’ reduction in the consumption of such bags and also, if they have not increased the consumption of other types of plastic carrier bags. It is therefore necessary to harmonise a definition of sustained reduction consumption and set a common target as well as introduce new reporting requirements. (73)In view of the results of the evaluation study on plastic carrier bags , further measures need to be taken to reduce the consumption of lightweight plastic carrier bags and assess possible substitution effects with very lightweight plastic carrier bags and thicker plastic carrier bags above 50 microns. (74)The measures by Member States to achieve a sustained reduction in the consumption of lightweight plastic carrier bags on their territory may include the use of national reduction targets, maintaining or introducing economic instruments as well as marketing restrictions, provided that these restrictions are proportionate and non-discriminatory. Such measures may vary depending on the environmental impact of lightweight plastic carrier bags when they are recovered or disposed of their composting properties, durability or specific intended use. (75)In order to ensure the effective and harmonised application of sustainability requirements set under this Regulation, compliance with those requirements should be measured using reliable, accurate and reproducible methods that take into account the generally recognised state-of-the-art methods. (76)In order to ensure that there are no barriers to trade on the internal market, requirements on packaging sustainability, including on substances of concern in packaging, compostable packaging, packaging minimisation, reusable packaging and systems for re-use should be harmonised at Union level. In order to facilitate conformity assessment with such requirements, including methods for tests, measurement or calculation, it is necessary to provide for presumption of conformity for packaging and packaged products which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 for the purpose of expressing detailed technical specifications of those requirements, especially that the life-cycle of packaging and packaged products, reflect the average range of consumer behaviour and be robust in order to deter intentional and unintentional circumvention. (77)In the absence of harmonised standards, recourse to common technical specifications should be used as a fall back solution to facilitate the manufacturer’s obligation to comply with sustainability requirements, for instance where there are undue delays in establishing a harmonised standard. In addition, recourse to this solution should be possible where the Commission has restricted or withdrawn the references to relevant harmonised standards in line with Article 11(5) of Regulation (EU) No 1025/2012. Compliance with common technical specifications adopted by the Commission through implementing acts should also give rise to the presumption of conformity. (78)In order to ensure uniform conditions for the implementation of the recourse to common technical specifications, the power to adopt implementing acts in accordance with Article 291 of the Treaty should be delegated to the Commission to lay down, amend or repeal common technical specifications for the requirements on sustainability, labelling and systems for re-use, and to adopt test, measurement or calculation methods. (79)To ensure coherence with other Union law, the conformity assessment procedure should be the internal production control module included in this Regulation based on the modules included in Decision No 768/2008/EC of the European Parliament and of the Council . (80)CE marking on packaging should not indicate compliance of the packaging with the requirements of this Regulation but only indicate compliance of the packaged product with the applicable Union product legislation, if relevant. Indeed, Union product legislation typically requires affixing the CE marking concerning the product either on the product itself or on its packaging. Requiring CE marking on the packaging to show compliance with the requirements of this Regulation can lead to confusion and misunderstanding in relation to the question whether the marking refers to the packaging itself or to the packaged product and ultimately to uncertainties about the effective safety and compliance of the concerned packaged products. (81)Compliance of packaging itself with the requirements of this Regulation should instead be shown with the EU declaration of conformity. (82)Manufacturers should draw up an EU declaration of conformity to provide information on the conformity of packaging with this Regulation. Manufacturers may also be required by other Union legislation to draw up an EU declaration of conformity. To ensure effective access to informatio