Brussels, 30.11.2022 COM(2022) 677 final 2022/0396(COD) Proposal for a
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)
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 increas ed in recent years faster than the gross national income, which leads to soaring CO 2 - and other emissions, and the overexploitation of natural resources, biodiversity loss and pollution. Data from Eurostat1 and market data reports2 show increased use of packaging design characteristics that may inhibit recycling.
Packaging is ’unrecyclable’ when it can not 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 p ackaging 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, p reliminary 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.
3 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 20204 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 plan5 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 soc ial economy , by creating more "green" quality jobs provided the necessary investment in skills6 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.
The proposed regulation updates the EU legislative framework for packaging and packaging waste. As an integral part of the European Green Deal7 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 waste8 , 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 environment9 , Council Decision (EU, Euratom) 2020/2053 of 14 December 2020 on the system of own resources of the European Union10 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)11 .
It also complements the Commission proposals for regulations of the European Parliament and of the Council on waste shipments12
13 , and the Communication from the Commission on an EU policy framework on bio-based, biodegradable and compostable plastics14 .
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 approach15 and the Fitness check on reporting and monitoring16 .
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.
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 Deal 1 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.
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.
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.
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.
A Fitness check conducted in 201417 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 e ffectiveness of the essential requirements for packaging and packaging waste and proposals for reinforcement
18. 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 202019 . 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.
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 consultation20 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.
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
21. 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’22 , 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’
23. This study also provided further inspiration for the Commission’s Communication on an EU policy framework on bio-based, biodegradable and compostable plastics.
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 generation24 : 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.
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.
The proposal has no consequences for the protection of fundamental rights.
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.
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/EC25 and 2018/896/EC
26. 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.
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 I V lays down the obligations of economic operators and the provisions are mostly standard from Decision 768/2008/EC
27. It is however worth mentioning Article 1 4 and Articles 2 1 -2 8 . 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 31 st 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:
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:
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
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)
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,
28 ,
29 , Acting in accordance with the ordinary legislative procedure, Whereas:
(1) P roducts 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 caus e additional cost to the economic operators.
(2) In addition, packaging use s high amount s of virgin materials (40 % of plastics and 50 % of paper use in the U nion is for packaging) and represents 36 % of municipal solid waste
30. H igh 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/EC31 la ys down requirements for Member States on packaging, such as e ssential r equirements, 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/EC32 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 Deal33 , t he new Circular Economy Action Plan (CEAP)34 commits to reinforcing the essential requirements for packaging in view of makin g 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, reduc e the complexity of packaging materials and introduce requirements for recycled content in plastic packaging. It commits the Commission to assess the feasibility of U nion -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
35. Just as the European Strategy for Plastics36 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 reduc ing pollution from plastic packaging waste
37. A s 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 introduce d 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 incentive s to reduce the consumption of single-use plastics, foster recycling and boost the circular economy.
(7) The Council underlined in its C onclusions of December 202038 , 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 material s , 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 R esolution of 10 February 2021 on the New Circular Economy Action Plan39 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 [ Eco design for Sustainable Products ]40 , 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 [ Eco design for Sustainable Products ] may establish additional or more detailed requirements for the ir 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 . S ales packaging, grouped packaging and transport packaging should be defined separately avoiding d uplication 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 t ea and coffee bags a s well as coffee or tea system single-serve units , which in practice are disposed of together with the product residue lead ing 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
41. 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 , t he 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 minimi s ation , avoiding packaging where it is not needed, and increas e d 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 high er recycling rates for all packaging and high quality of the resulting secondary raw materials while reducing other forms of recove ry 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 Plan42 and the Chemicals Strategy for Sustainability43 , and to ensure the sound management of chemicals through out 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 address es 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 Plan44 , 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 Council45 and Regulation (EC) No 1272/2008 of the European Parliament and of the Council46 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 prov isions 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 Council47 , 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/EC48 and Commission Decision 2009/292/EC49 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) Th is 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 th is 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) D esigning pac kaging with the objective of its recycling , once it become s packaging waste, is one the most efficient measure s 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 harmonis ing 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, p ackaging should comply with the m only as of 1 January 2030 in order to give
sufficient time to the economic operators to adapt .
comply with the m 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 U nion . Related reporting from Member States and, where relevant, economic operators should support establish ing the recycl ability “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 recycl ed at scale as of 2035. Th at should ensure that packaging complies with the design for recycling criteria, and is also recycl ed 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 t o protect human and animal health and safety, due to the nature of the packag ed products and the related requirements , it is appropriate t hat 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 Council50 and in Article 4(25) of Regulation (EU) 2019/6 of the European Parliament and of the Council51 , which are in direct con tact 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 Council52 and of in vitro diagnostics medical devices covered by Regulation (EU) 2017/746 of the European Parliament and of the Council
53. 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 improv ing the functioning of the internal market . I t 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. I n 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-sensitivity54 of different plastic packaging applications, and ensur ing that the targets become binding by 2030. I n order to incrementally ensure packaging circularity, i ncreased 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 . Th e 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 Council55 .
(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, t here 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 in sufficient 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 plastic s 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 t he proper disposal route for compostable plastic packaging is becoming increasingly confusing for consumers, i t 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 Council56 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 a ll compostable packaging constituting a food contact m aterial 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.
T he list of the packaging performance criteria, as listed in the existing harmonised standard EN 13428:200057 , 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 , r ecyclability, 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 minimi s ation. 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 minimi s ation, 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 th at 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) T o facilitate consumer s in the sorting and dispos ing 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-compost ing . This approach should improve the separate collection of packaging waste , leading to higher quality recycling of packaging waste, and introduc e 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 th o se 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 m ay w ish to display th at information on their packaging to inform consumers thereof . To ensure that this information is communicated in a harmonised manner across the U nion , 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 provid es such information . The QR code sh ould 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 p roduct p assport should also be used for providing the relevant information under this Regulation.
(49) To support the implementation of the objectives of this Regulation, c onsumers should be protected from misleading and confusing information about packaging characteristics and its appropriate end-of-life treatment , for which harmoni s ed labels have been established under this Regulation . It should be possible to identify p ackaging included in the extended producer responsibility scheme by means of a n accreditation symbol throughout the territory of that system. Th at symbol sh ould 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 system58 , could mis lead 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 29 1 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/EC59 should be repealed as o f 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 i n 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 c onformity assessment should therefore remain solely the obligation of the manufacturer.
(53) It sho uld be ensured that supplier s 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 material s . 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 th ose 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 e conomic 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 place d 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 pa ckaging 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. R e usable packaging in a re conditioning process is normally not considered to b e 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 . I n 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 i n 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 fulfil ling 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 . T he 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) C ertain 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 us e 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 2003/36160 , or have the sales area , including all storage and dispatch areas, under a certain surface limit . T he 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
61. 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 bags62 , 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 pack ag ed 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 Council63 .
(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 information for market surveillance purposes, a single EU declaration of conformity should be drawn up in respect of all Union acts. To reduce the administrative burden on economic operators, it should be possible for that single EU declaration of conformity to be a dossier made up of relevant individual declarations of conformity.
(83) Regulation (EC) No 765/2008 of the European Parliament and of the Council64 provides a framework for the market surveillance of products and for controls on products from third countries. That Regulation should be applicable to packaging covered by this Regulation in order to ensure that packaging benefiting from the free movement of goods within the Union fulfil requirements providing a high level of protection of public interests such as human health, safety and the environment.
(84) Waste management in the Union should be improved, with a view to protecting, preserving and improving the quality of the environment, protecting human health, ensuring prudent efficient and rational utilisation of natural resources, promoting the principles of the circular economy, enhancing the use of renewable energy, increasing energy efficiency, reducing the dependence of the Union on imported resources, providing new economic opportunities and contributing to long-term competitiveness. The more efficient use of resources would also bring substantial net savings for Union businesses, public authorities and consumers, while reducing total annual greenhouse gas emissions.
(85) Despite packaging minimisation requirements and objectives as laid down in Directive 94/62/EC, packaging waste generation has been increasing in absolute terms and on a per capita basis and trends indicate a further steep decline in re-use and refill of packaging amplified by increased on-the-go consumption and e-commerce. As products, materials and consumption patterns have evolved, there has been a significant rise in the use of single use packaging, especially single use plastic. Th is is linked to the retail landscape, with larger distribution networks, manufacturing and pack ing products on high-speed packaging lines, which exert a combined downward pressure on the market for re-use and refill.
(86) In order to monitor and verify compliance of producers and producer responsibility organisations with obligations under Extended Producer Responsibility relating to the collection and treatment of waste from their products it is necessary that Member States designate one or more competent authorities.
(87) In order to ensure better, timelier and more uniform i mplementation of th e obligations by Member States and anticipate any implementation weaknesses, a system of early warning reports should be maintained to detect shortcomings and allow taking action ahead of the deadlines for meeting the targets. Extension of this system, which has under Directive 94/62 /EC covered the attainment of recycling targets, should include also packaging waste reduction target s to be attained by Member State by 2030 and 2035 .
(88) As management of packaging and packaging waste is an important element of waste management in general, Member States should dedicate a separate chapter to this issue in waste management plans prepared in the execution of obligation laid down in Directive 2008/98/EC. M easures on waste prevention and re-use should be given particular attention .
(89) This Regulation builds on the waste management rules and general principles laid down in Directive 2008/98/EC.
(90) Waste prevention is the most efficient way to improve resource efficiency and to reduce the environmental impact of waste. It is important therefore that economic operators take appropriate measures to reduce the waste generation by eliminating excessive packaging and restrict the uses of certain packaging formats , extending the life span of packaging, re-designing products so that no packaging or less packaging can be used, including bulk sales, and by shifting from single use packaging to reusable packaging.
(91) To achieve an ambitious and sustained reduction in the overall packaging waste generation , targets should be laid down for the reduction of packaging waste per capita to be achieved by 2030. Meeting a target of 5 % reduction in 2030 compared to 2018 should entail an overall absolute reduction of approximately 19 % on average across the U nion in 2030 compared to the 2030 baseline. Member States should reduce packaging waste generation by 10 % , compared to 2018, by 2035 ; this is estimated to reduce packaging waste by 29 % compared to the 2030 baseline . In order to ensure that the reduction efforts continue beyond 2030, a reduction target of 10 % from 2018, which would mean a reduction of 29 % compared to baseline, should be set for 2035 and , for 2040 , a reduction target of 15 % from 2018, which means a reduction of 37 % compared to baseline should be established.
(92) Member States may achieve th ese target s by economic instruments and other measures to provide incentives for the application of the waste hierarchy, including measures to be implemented through extended producer responsibility schemes , and by promoting the setting up and effective operation of systems for re-use and encouraging economic operators to offer the end users further possibilities to refill . Such measures should be adopted in parallel and in addition to other measures under this Regulation aiming at packaging and packaging waste reduction , such as requirements on packaging minimisation, re-use and refill targets, volume thresholds and measures to achieve the sustained reduction of consumption of lightweight plastic carrier bags . A Member State may, while observing the general rules laid down in the Treaty and complying with the provisions set out in this Regulation, adopt provisions which go beyond the minimum targets set out in this Regulation.
(93) To implement the polluter pays principle, it is appropriate to lay the obligations for the management of packaging waste on producers , which i nclude s any manufacturer, importer or distributor, who, irrespective of the selling technique used, including by means of distance contracts as defined in Article 2(7) of Directive 2011/83/EU of the European Parliament and of the Council65 , makes available packaging for the first time within a territory of a Member States on a professional basis under its own name or trademark.
(94) In order to monitor that producers meet their obligations relating to their financial, and organisational obligations to ensur ing the management of the waste from th e packaging they make available for the first time on the market of a Member State, it is necessary t hat a register is established and managed by the competent authority in each Member State and that p roducers should be obliged to register .
(95) The r egistration requirements should be harmonised across the Union to the greatest extent possible so to facilitate registration in particular where producers make packaging available in different Member States . In order to ensure uniform conditions for the implementation of the registration requirements, the power to adopt implementing acts in accordance with Article 291 of the Treaty should be delegated to the Commission to lay down a common format for registration in and reporting to the register , detailing the data to be reported.
(96) In line with the polluter-pays principle expressed in Article 191(2) of the Treaty , it is essential that the producers placing on the Union market packaging and packaged products take responsibility for their management at their end-of life. It should be recalled that e xtended p roducer r esponsibility schemes need to be established , as provided for in Directive 94/62/EC, by 31 December of 2024 , as they are the most appropriate means to achieve this and can have a positive environmental impact by reducing the generation of packaging waste and increasing its collection and recycling. T here are wide disparities in the way they are set up, in their efficiency and in the scope of responsibility of producers. The rules on extended producer responsibility laid down in Directive 2008/98/EC should therefore in general apply to extended producer responsibility schemes for producers of packaging , and be complemented by further specific provisions where this is necessary and appropriate .
(97) Producers should be able to exercise those obligations collectively, by means of producer responsibility organisations taking up the responsibility on their behalf. Producers or producer responsibility organisations should be subject to authorisation by the Member States and should document, inter alia, that they have the financial means to cover the costs entailed by the extended producer responsibility. Member States, when laying down administrative and procedural rules of authorisation of producers for individual and producer responsibility organisations for collective compliance, could differentiate processes for individual producers and producer responsibility organisation to limit the administrative burden on individual producers. It should be recalled that Member States may authorise multiple producer responsibility organisations, as competition among them may lead to greater consumer benefits. Moreover, when establishing measures ensuring that arrangements are to be concluded with distributors, public authorities or third parties carrying out waste management, Member States should allow for preliminary , or similar, agreements , and require that binding agreements are concluded only within a reasonable timeframe after the authorisation.
(98) Regulation (EU) 2022/2065 of the European Parliament and of the Council66 lays down rules on the traceability of traders, which more specifically contain obligations for providers of online platforms allowing consumers to conclude distance contracts with producers offering packaging to consumers located in the Union. In order to prevent free-riding from the extended producer responsibility obligations, it should be specified how such providers of online platforms should fulfil those obligations with regard to the registers of packaging producers established pursuant to this Regulation. In that context, providers of online platforms , falling within the scope of Section 4 of Chapter 3 of Regulation (EU) 2022/2065 , allowing consumers to conclude distance contracts with producers should obtain from those producers information about their compliance with the extended producer responsibility rules set out in this Regulation. The rules on traceability of traders selling packagin g online are subject to the enforcement rules set out in Regulation (EU) 2022/2065.
(99) Member State s should provide for the measures for the extended producer responsibility under this Regulation, in accordance with the provisions of Directive 2008/98/EC and of this Regulation .
(100) Member States should set up return and collection systems for packaging waste, so that they are channelled to the most appropriate waste management alternative, according to the waste hierarchy. The systems should be open for participation for all interested parties, in particular for economic operators and public authorities and be established taking into account the environment and consumer health, safety and hygiene. Return and collection systems should also be applicable for packaging of imported products under non-discriminatory provisions.
(101) Member States should also take measures promoting recycling which meets the quality standards for the use of the recycled materials in relevant sectors. This obligation is particularly relevant in view of minimum percentage set for recycled content in plastic packaging.
(102) It has been shown that well-functioning deposit and return systems ensure a very high collection rate, especially of beverage bottles and cans. In order to support the achievement of the separate collection target for single use plastic beverage bottles laid down in Directive (EU) 2019/904 and to further drive high collection rates of metal beverag es containers, it is appropriate that Member States establish deposit and return systems. Th o se s ystems will contribute to the increase of the supply of good quality secondary raw material suitable for closed loop recycling and reduce beverage containers litter.
(103) D eposit and return systems should be obligatory for single use plastic beverage bottles and metal beverage containers. Member States might also decide to include other packaging in these systems, in particular single use glass bottles , and should ensure that deposit and return systems for single - use packaging formats, in particular for single use glass beverage bottles, are equally available for reusable packaging, where technically and economically feasible . They should consider establishing deposit and return systems also for reusable packaging. In such situations, a Member State should be allowed, while observing the general rules laid down in the Treaty and complying with the provisions set out in this Regulation, adopt provisions which go beyond the minimum requirements set out in this Regulation.
(104) Given the nature of the products and the differences in their production and distribution systems , d eposit and return systems should however not be obligatory for packaging for wine , aromatised wine products , spirit drinks and milk and milk products listed in Part XVI of Annex I of the Regulation (EU) No 1308/2013 of the European Parliament and of t he Council
67. Member States may establish deposit and return systems covering also other packaging.
(105) All deposit and return systems should comply with the minimum general requirements laid down in this Regulation . Th o se requirements will help deliver greater consistency and higher return rates across Member States. They have been set based on stakeholder views, expert analysis and best practice s from the existing deposit and return systems. The requirements are designed to allow for innovation while offering a level of flexibility to adapt to local circumstances.
(106) Member States and all t he relevant stakeholders involved in the setting up of the deposit and return systems should strive for the maximum inter-operability of these systems and cooperate to ease the return of packaging by consumers, in particular in border areas where it is demonstrated that the lack of interoperability is causing lower return rates.
(107) Member States which achieve 90 % collection rate of the targeted packaging types without a deposit and return system two consecutive calendar years preceding the entry into force of this obligation, may request not to establish a deposit and return system.
(108) As a specific packaging waste generation prevention measure , Member States should actively encourage the re-use and refill solutions. They should support the establishment of systems for re-use and refill and monitor their functioning and compliance with the hygie ne standards . Member States are encouraged to take also other measures, such as setting up deposit and return systems covering reusable packaging formats , using economic incentives or establishing requirements for final distributors to make available a certain percentage of other products than those covered by re-use and refill targets in reusable packaging or through refill provided that such requirements will not result in fragmentation of single market and creation of trade barriers.
(109) Directive 94/62/EC was amended by Directive (EU) 2018/852 of the European Parliament and of the Council68 setting out recycling targets for Member States to be achieved by 2025 and 2030 . T hese targets and the rules for their calculation should be retained . Furthermore , measures facilitating the attainment of these targets should be set up , such as sustainability requirements for packaging , in particular provisions regarding packaging’s recyclability . For this reason, it should not be possib le to postpone the deadlines for attaining the 2030 recycling targets.
(110) Directive 94/62/EC requires the Commission to review t he 2030 recycling targets for packaging with the view to maintaining or, if appropriate, increasing them. However, i t is not yet appropriate to amend the targets set for 2030 as evidence show s that some Member States still have difficulties with meeting the existing targets. For this reason, measures encouraging manufacturers to place on the market more recyclable packaging, and thereby helping Member States to achieve the recycling targets , should be set up . In the future, more recyclable packaging, coupled with greater granularity of data on the packaging flows, should be reported to the Commission . That will enable the Commission to review the targets with the possibility of maintaining or increasing them . I n order to take account of the effect of the measures aimed at improving the packaging recyclability, th e review should not take place earlier than the envisaged general evaluation of the Regulation, i.e. 8 years after its entry into force . During that review, attention should also be paid to the possibility of introducing new targets on a more granular basis than the current targets.
(111) The calculation of the recycling targets should be based on the weight of packaging waste , which enters recycling. Member States should ensure the reliability and accuracy of the data gathered on recycled packaging waste. As a general rule, the actual measurement of the weight of packaging waste counted as recycled should be at the point where packaging waste enters the recycling operation. Nevertheless, in order to limit the administrative burden, Member States should, under strict conditions and by way of derogation from the general rule, be allowed to establish the weight of packaging waste recycled on the basis of measuring the output of any sorting operation , to be corrected with average loss rates occurring before the waste enters the recycling operations .
Losses of materials which occur before the waste enters the recycling operation, for instance due to sorting or other preliminary operations, should not be included in the waste amounts reported as recycled. Those losses can be established on the basis of electronic registries, technical specifications, detailed rules on the calculation of average loss rates for various waste streams or other equivalent measures. Member States should report on such measures in the quality check reports accompanying the data which they report to the Commission on waste recycling.
The average loss rates should preferably be established at the level of individual sorting facilities and should be linked to the different main types of waste, different sources (such as household or commercial), different collection schemes and different types of sorting processes. Average loss rates should only be used in cases where no other reliable data are available, in particular in the context of shipment and export of waste. Losses in weight of materials or substances due to physical or chemical transformation processes inherent in the recycling operation where packaging waste is actually reprocessed into products, materials or substances should not be deducted from the weight of the waste reported as recycled.
(112) Where the calculation of the recycling rate is applied to aerobic or anaerobic treatment of biodegradable packaging waste, the amount of waste that enters aerobic or anaerobic treatment can be counted as recycled provided that such treatment generates output which is to be used as a recycled product, material or substance. While the output of such treatment is most commonly compost or digestate, other output could also be taken into account provided that it contains comparable quantities of recycled content in relation to the amount of the treated biodegradable packaging waste. In other cases, in line with the definition of recycling, the reprocessing of biodegradable packaging waste into materials which are to be used as fuels or other means to generate energy, which are disposed of, or which are to be used in any operation that has the same purpose as recovery of waste other than recycling, should not be counted towards the attainment of the recycling targets.
(113) Where packaging waste materials cease to be waste as a result of a preparatory operation before being actually reprocessed, they should be counted as recycled provided that they are destined for subsequent reprocessing into products, materials or substances, whether for their original or other purposes. End-of-waste materials which are to be used as fuels or other means to generate energy, which are backfilled or disposed of, or which are to be used in any operation that has the same purpose as recovery of waste other than recycling, should not be counted towards the attainment of the recycling targets.
(114) Member States should be enabled to take into account the recycling of metals separated after incineration of waste in proportion to the share of the packaging waste incinerated provided that the recycled metals meet certain quality criteria laid down in Commission Implementing Decision (EU) 2019/100469 laying down rules for the calculation, verification and reporting of data on waste in accordance with Directive 2008/98/EC.
(115) In the case of exports of packaging waste from the Union for recycling, Regulation (EC) No 1013/2006 of the European Parliament and of the Council70 appl ies .
(116) As re-use means that no new packaging is placed on the market, reusable sales packaging that is placed on the market for the first time and wooden packaging that is repaired for re-use should be taken into account for the purposes of attaining the respective packaging recycling targets. Member States should be able to use this possibility to calculate adjusted level of recycling targets by taking into account maximum 5 percentage points of the average share, in the preceding three years, of reusable sales packaging placed on the market for the first time and reused as part of a system for re - use .
(117) Producers and producer responsibility organi s ations should be actively involved in providing information to end users , in particular consumers, on prevention and management of packaging waste. This information should include availability of re-use arrangements f or packaging, meaning of labels displayed on packaging and other instructions on the discarding of packaging waste. The producers should also inform that end users have an important role in ensuring an environmentally optimal management of packaging waste. The disclosure of information to all end users as well as reporting on packaging should make use of modern information technologies. The information should be provided either by classical means, such as posters both indoors and outdoors and social media campaigns, or by more innovative means, such as electronic access to websites provided by QR codes affixed to the packaging .
(118) For each calendar year, Member States should provide the Commission with information on attainment of recycling targets . To evaluate the effectiveness of the measures aiming to reduce the consumption of lightweight plastic carrier bags, data on consumption of very lightweight plastic carrier bags and thick plastic carrier bags should also be reported to allow for the assessment whether the consumption of these bags has increased in response to the reduction measures targeting lightweight plastic carrier bags. Providing of data on the annual consumption of very thick carrier bags should be voluntary for the Member States. In order to allow assessing whether the mandatory deposit and return systems to be set up by the Member States are effective, or whether exemptions by Member States from the obligation to set up those systems are justified, it is important to obtain information on the collection rate of such packaging through Member States reporting.
(119) In order to establish the methodology for assessment of the at scale recyclability, Member States sh ould also report data on recycling rates of packaging waste per packaging material and type , amounts of separately collected packaging waste for each packaging material, amounts of packaging waste placed on the market per material and packaging type, and installed capacities of sorting and recycling . Reporting should be done annually.
(120) Member States should report data to the Commission electronically and provide it with a quality check report. In addition, data on recycling targets should be accompanied by a report describing measures undertaken in order to establish an effective system of quality control and traceability of packaging waste.
(121) In order to ensure uniform conditions for the implementation of the reporting obligations, the power to adopt implementing acts in accordance with Article 291 of the Treaty should be delegated to the Commission to establish rules for calculation and verification of data on attainment of the recycling targets, separate collection rates of packaging covered by the deposit and return system, and data necessary for establishing the methodology for recyclability at scale assessment. This implementing act should also include rules for determination of the amount of packaging waste generated as well as lay down the format for reporting of data. It should also establish the methodology for the calculation of the annual consumption of lightweight plastic carrier bags per person and the format for reporting of this data, as this is necessary to support the monitoring and the full implementation of the substantive requirements related to plastic carrier bags, in particular to ensure disaggregated and mandatory reporting on different categories of plastic carrier bags. This implementing act should replace Commission Decisions (EU) 2018/89671 and 2005/270/EC72 .
(122) I n order to contribute to enabling Member States and the Commission to monitor the implementation of the objectives set out in this Regulation, the Member States should establish packaging databases and ensure that they are well-functioning.
(123) Effective enforcement of sustainability requirements is essential to ensure fair competition to ensure that this Regulation’s expected benefits and contribution to achieving the Union’s climate, energy and circularity objectives are achieved. Therefore, Regulation (EU) 2019/1020 of the European Parliament and of the Council73 setting out a horizontal framework for market surveillance and control of products entering the Union market should apply to packaging for which sustainability requirements are set pursuant to this Regulation.
(124) Packaging should be placed on the market only if it does not present a known risk to the environment and human health . In order to better align with the specific nature of sustainability requirements and to ensure that the focus of market surveillance efforts is on non-compliance with such requirements, packaging presenting a risk should, for the purposes of this Regulation, be defined as packaging that, by not complying with a sustainability requirement or because a responsible economic operator does not comply with a sustainability requirement, may adversely affect the environment or other public interests protected by the relevant requirements.
(125) A procedure should exist under which interested parties are informed of measures intended to be taken with regard to packaging presenting a risk. It should also allow market surveillance authorities in the Member States, in cooperation with the relevant economic operators, to act at an early stage with regard to such packaging. In order to ensure uniform conditions for the implementation of this Regulation, the power to adopt implementing acts in accordance with Article 291 of the Treaty should be delegated to the Commission to determine whether national measures in respect of non-compliant products are justified or not.
(126) The market surveillance authorities should have the right to require economic operators to take corrective action on the basis of findings that either packaging is not compliant with sustainability and labelling requirements , or that the economic operator has infringed other rules on the placing or making available on the market of packaging. In order to ensure uniform conditions for the implementation of the requirement on economic operators to take corrective action, the power to adopt implementing acts in accordance with Article 291 of the Treaty should be delegated to the Commission to decide whether a national measure is justified or not.
(127) In case of human health concerns , the market surveillance shall not evaluate a risk to human or animal health originating from the packaging material, if transferred to the packaged content of the packaging material, but alert the authorities , competent for controlling the risks and appointed pursuant to Regulation (EU) 2017/625 of the European Parliament and of the Council74 , Regulation (EU) 2017/745, Regulation (EU) 2017/746, Directive 2001/8 3/EC or Regulation (EU) 2019/6.
(128) Public procurement amounts to 14 % of the Union’s GDP. To contribute to the objective of reaching climate neutrality, improving energy and resource efficiency and transitioning to a circular economy that protects public health and biodiversity, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission , which may exercise it as necessary, to require, where appropriate, contracting authorities and entities as defined in Directive 2014/24/EU of the European Parliament and of the Council75 and Directive 2014/25/EU of the European Parliament and of the Council76 , to align their procurement with specific green public procurement criteria or targets. Compared to a voluntary approach, mandatory criteria or targets should ensure that the leverage of public spending to boost demand for better performing packaging is maximised. The criteria should be transparent, objective and non-discriminatory.
(129) The implementing powers that are conferred on the Commission by this Regulation and that do not relate to the determination whether measures taken by Member States in respect of non-compliant packaging are justified or not should be exercised in accordance with Regulation (EU) No 182/2011.
(130) W hen it comes to packaging entering the Union market, priority should be given to cooperation in the market between market surveillance authorities and economic operators. Therefore, whereas they may concern any packaging entering the Union market, interventions by authorities designated pursuant to Article 25(1) of Regulation (EU) 2019/1020 should focus primarily on packaging subject to prohibition measures taken by market surveillance authorities. In case they take such prohibition measures, and they are not restricted to the national territory, market surveillance authorities should communicate to authorities designated for the controls on packaging entering the Union market the details necessary for the identification of such non-compliant packaging at the borders, including information on the packaged products and the economic operators to enable a risk-based approach for products entering the Union market. In such cases, customs will aim at identifying and stopping this packaging at the borders.
(131) In order to optimise and unburden the control process at the external borders of the Union , it is necessary to allow for an automated data transfer between the Information and Communication System on Market Surveillance (ICSMS) and customs systems. Two different data transfers should be distinguished in view of their respective purposes. Firstly, prohibitions measures decided by market surveillance authorities further to the identification of non-compliant packaging should be communicated from ICSMS to customs for use by authorities designated for controls at external borders to identify packaging that may correspond to such a prohibition measure. The Electronic System Customs Risk Management environment and Control System (CRMS) set out in Article 36 of Commission Regulation (EU) 2447/201577 , without prejudice to any future evolution of the customs risk management environment, should be used for those first data transfers. Secondly, where customs authorities identify non-compliant packaging, case management will be necessary to, among others, transfer the notification of the suspension, the conclusion of market surveillance authorities and the outcome of the actions taken by customs. The EU Single Window Environment for customs support s those second
data transfers between ICSMS and national customs systems.
Single Window Environment for customs support s those second data transfers between ICSMS and national customs systems.
(132) In order to ensure uniform conditions for the implementation of the interconnection for communication between the market surveillance authorities and the customs authorities, the power to adopt implementing acts the power to adopt implementing acts in accordance with Article 291 of the Treaty should be delegated to the Commission to specify the procedural rules and the details of the implementation arrangements, including the functionalities, data elements and data processing, as well as the rules on the processing of personal data, confidentiality and controllership for that interconnection.
(133) When adopting delegated acts pursuant to Article 290 of the T reaty, the Commission should carry out appropriate consultations during its preparatory work, including at expert level, and those consultations be conducted in accordance with the principles laid down in the Inter - institutional Agreement of 13 April 2016 on Better Law-Making
78. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. When developing these delegated acts, the Commission should take into account scientific or other available technical information, including relevant international standards.
(134) In order to ensure that product requirements in Directive (EU) 2019/ 904 can be monitored and enforced and that they are subject to subject to appropriate market surveillance , Regulation (EU) 2019/1020 should be amended to include Directive (EU) 2019/904 into its scope . The requirements the requirements related to the plastic recycled content for plastic beverage bottles as of 1 January 2030 should be deleted from Directive (EU) 2019/904, as this matter is exclusively regulated by this Regulation. The corresponding reporting obligations should also be deleted.
(135) To enhance public trust in packaging placed on the market, in particular as regards compliance with sustainability requirements, the economic operators placing non-compliant packaging on the market or who do not comply with their obligations should be subject to penalties. It is therefore necessary that Member States lay down effective, proportionate and dissuasive penalties in national law for failure to comply with this Regulation.
(136) The Commission should carry out an evaluation of this Regulation. Pursuant to paragraph 22 of the Inter - institutional Agreement on Better Law-Making, that evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and U nion value added and should provide the basis for impact assessments of possible further measures. The Commission should submit to the European Parliament, to the Council, the European Economic and Social Committee, and to the Committee of the Regions a report on the implementation of this Regulation and its impact on the environmental sustainability of p ackaging and the functioning of the internal market.
(137) It is necessary to provide for sufficient time for economic operators to comply with their obligations under this Regulation, and for Member States to set up the administrative infrastructure necessary for its application. The application of this Regulation should therefore also be deferred to a date where those preparations can reasonably be finalised. Particular attention should be paid to facilitate compliance by SMEs with their obligations and requirements under this Regulation , including through guidance to be provided by the Commission to facilitate compliance by economic operators, with a focus on SMEs.
(138) In order to meet those commitments and establish an ambitious yet harmonised framework on packaging, it is necessary to adopt a Regulation establishing requirements on packaging over its entire life-cycle. Directive 94/62/EC should therefore be repealed.
(139) In order to allow Member States to take the necessary administrative measures regarding the organisation of the authorisation procedures by the competent authorities, while keeping continuity for economic operators, the application of this Directive should be deferred.
(140) Directive 94/62/EC should be repealed with effect from the date of application of this Regulation . However, in order to ensure a smooth transition and continuity until new rules are adopted by the Commission under this Regulation, and to provide for continuity in the application of the system of own resources of the Union with regard to the own resource bases on non-recycled plastic packaging waste, certain obligations under that Directive related to labelling, recycling targets and the transmission of data to the Commission should remain in force for a certain period of time.
(141) Since the objectives of this Regulation, namely to improve the environmental sustainability of packaging and to ensure the free movement of packaging in the internal market, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, only be achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective ,
1This Regulation establishes requirements for the entire life cycle of packaging as regards environmental sustainability and labelling , to allow its placing on the marke t , as well as for the extended producer responsibility, collection, treatment and recycling of packaging waste.
2This Regulation contributes to the efficient functioning of the internal market by harmonising national measures on packaging and packaging waste in order to avoid obstacles to trade , distortion and restriction of competition within the Union , while preventing or reducing the adverse impacts of packaging and packaging waste on the environment and human health , on the basis of a high level of environmental protection .
3This Regulation contributes to the transition to a circular economy , by laying down measures in line with the hierarchy of waste in accordance with Article 4 of Directive 2008/98/EC.
1This Regulation applies to all packaging , regardless of the material used, and to all packaging waste, whether such waste is used in or originates from industry, other manufacturing, retail or distribution, offices, services or households.
2This Regulation applies without prejudice to Union regulatory requirements for packaging such as those regarding safety, quality, the protection of health and the hygiene of the packed products, or to transport requirements, as well as without prejudice to the provisions of the Directive 2008/98/EC as regards the management of hazardous waste.
For the purposes of this Regulation, the following definitions apply:
(1) ‘p ackaging’ means items of any materials that are intended to be used for the containment, protection, handling, delivery or presentation of products and that can be differentiated into packaging formats based on their function, material and design , including:
(a) items that are necessary to contain, support or preserve the product throughout its lifetime without being an integral part of the product which is intended to be used, consumed or disposed of together with the product;
(b) components of, and ancillary elements to, an item referred to in point (a) that are integrated in to the item;
(c) ancillary elements to an item referred to in point (a) that are hung directly on, or attached to, the product and that perform s a packaging function without being an integral part of the product which is intended to be used, consumed or disposed of together with the product;
(d) items designed and intended to be filled at the point of sale, provided that they perform a packaging function;
(e) disposable items sold, filled or designed and intended to be filled at the point of sale, provided that they perform a packaging function;
(f) t ea or coffee bags necessary to contain a tea or coffee product and intended to be used and disposed of together with the product;
(g) coffee or tea system single-serve unit necessary to contain a coffee or tea product and intended to be used and disposed of together with the product;
(2) ‘sales packaging’ means packaging conceived so as to constitute a sales unit consisting of products and packaging to the final user or consumer at the point of sale ;
(3) ‘grouped packaging’ means packaging conceived so as to constitute a grouping of a certain number of sales units at the point of sale whether the latter is sold as such to the end user or it serves only as a means to replenish the shelves at the point of sale or create a stock-keeping or distribution unit , and which can be removed from the product without affecting its characteristics;
(4) ‘transport packaging’ means packaging conceived so as to facilitate handling and transport of a number of sales units or grouped packages, including e-commerce packaging but excluding road, rail, ship and air containers, in order to prevent physica l handling and transport damage ;
(5) ‘e-commerce packaging’ means transport packaging used to deliver products in the context of sale online or through other means of distance s ales to the end user ;
(6) ‘making available on the market’ means any supply of a packaging for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
(7) ‘placing on the market’ means the first making available of a packaging on the Union market;
(8) ‘economic operator’ mean s manufacturers, suppliers of packaging, importers, distributors, final distributors , and fulfilment service providers ;
(9) ‘manufacturer’ means any natural or legal person who manufactures packaging under its own name or trademark , or ha s packaging designed or manufactured, and uses that packaging for the containment, protection, handling, delivery or presentation of products under its own name or trademark, without it having been placed on the market previously ;
(10) ‘producer’ means any manufacturer , importer or distributor, who , irrespective of the selling technique used, including by means of distance contracts as defined in Article 2(7) of Directive 2011/83/EU, makes available packaging for the first time within a territory of a Member States on a professional basis under its own name or trademark ;
(11) ‘ s upplier ’ means any natural or legal person who supplies packaging or packaging material to a manufacturer who uses this packaging for the containment, protection, handling, delivery or presentation of products under its own name or trademark ;
(12) ‘importer’ means any natural or legal person established within the Union who places packaging , or a packaged product, from a third country on the Union market;
(13) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a packaging , or a packaged product, available on the market;
(14) ‘authorised representative’ means any natural or legal person established in the Union who has received a written mandate from the manufacturer to act on its behalf in relation to specified tasks with regard to the m anufacturer’s obligations under this Regulation;
(15) ‘ appointed representative for the e xtended producer responsibility ’ means a legal or natural person established in a Member State where the producer makes packaging available on the market for the first time, other than the Member State where the producer is established, and who is appointed by the producer in accordance with third subparagraph of Article 8a(5) of Directive 2008/98/EC for fulfilling the obligations of that producer under Chapter VII of this Regulation;
(16) ‘final distributor’ means the distributor who delivers packaged products or products that can be purchased through refill to the end user ;
(17) ‘consumer’ means natural person s who are acting for purposes which are outside their trade, business or profession;
(18) ‘end user’ means any natural or legal person residing or established in the Union, to whom a product has been made available either as a consumer or as a professional end user in the course of its industrial or professional activities and who no longer make s this product further available on the market in the form supplied to it ;
(19) ‘ composite packaging’ means a unit of packaging made of two or more different materials, excluding materials used for labels , closures and sealing, which cannot be separated manually and therefore form a single integral unit ;
(20) ‘packaging waste’ means any packaging or packaging material falling within the definition of waste laid down in Article 3 of Directive 2008/98/EC, with the exception of production residues;
(21) ‘packaging waste prevention’ means measures that are taken before any packaging or packaging material has become packaging waste and that reduce the quantity of packaging waste, so that less or no packaging is required to contain, protect, handle, deliver or present products
(22) ‘re-use’ means any operation by which reusable packaging is used again for the same purpose for which it was conceived;
(23) ‘single - use packaging’ means packaging which is not reusable packaging;
(24) ‘rotation’ means the cycle that reusable packaging accomplishes from the moment it is placed on the market together with the products it is intended to contain, protect, handle, deliver or present, to the moment it is ready for being reuse d in a system for re-use with a view to it being suppl ied again to the end users together with the products ;
(25) ‘trip’ means transfer of packaging, from filling or loading to emptying or unloading , as part of a rotation or on its own ;
(26) ‘ systems for re-use’ means organi s ational, technical /or financial arrangements, which enable the re - use either in a closed loop or open loop system . Deposit and return system s , when they ensur e that packaging is collected for re-use , are considered as part of a ‘system for re - use’ ;
(27) ‘ r econditioning’ means an operation necessary to restore a reusable packaging to a functional state for the purpose of its re-use ;
(28) ‘refill’ means an operation by which an end user fill s its own container , which fulfil s the packaging function , with a product or several products offered by the final distributor in the co ntext of a commercial transaction ;
(29) ‘ refill station’ means a place , where a final distributor offers to end users products that can be purch ased through refill;
(30) ‘ HORECA sector ’ means Accommodation and Food Service Activities according to NACE Rev. 2 – Statistical classification of economic activities79 ;
(31) ‘d esign for recycling ’ means design of packaging, including individual components of packaging , in order to ensure its recyclability with state-of-the-art collection, sorting and recycling processes ;
(32) ‘recycled at scale’ means collected, sorted and recycled through installed state-of-the-art infrastructure and processes, covering at least 75 % of the Union population, including packagin g waste exported from the Union that meets the requirements of Article 47 (5) ;
(33) ‘packaging category’ means a combination of material and specific packaging design, which determines the recyclability with the state of the art collection sorting and recycling processes and is relevant for the definition of the design for recycling criteria ;
(34) ‘ integrated component’ means a packaging component that may be distinct from the main body of the packaging unit, and may be of a different material, but is integral to the packaging unit and its functioning and does not need to be separated from the main packaging unit in order to consume the product and is typically discarded at the same time as the packaging unit, although not necessarily in the same disposal route;
(35) ‘separate component’ means a packaging component that is distinct from the main body of the pack aging unit , which may be of a different material, that needs to be disassembled completely and permanently from the main packaging unit in order to access the product, and tha t is typically discarded prior to and sep arately from the packaging unit;
(36) ‘unit of packaging’ means a unit as a whole, including any integrated or separate components, which together serve a packaging function such as the containment, protection, handling, delivery, storage, transport and presentation of products, and including independent units of grouped or transport packaging where they are discarded prior to the point of sale;
(37) ‘innovative packaging’ means a form of packaging that is manufactured using new materials, design or production processes, resulting in a significant improvement in the functions of packaging , such as containment, protection, handling, delivery or presentation of products , and in demonstrable environmental benefits , w ith the exception of packaging that is the result of m odification of existing packaging for the sole purpose of improved presentation of products and marketing;
(38) ‘ s econdary raw materials ’ means materials that have been obtained through recycling processes and can substitute primary raw materials ;
(39) ‘ p ost-consumer plastic waste’ means plastic waste that is generated from plastic products that have been placed on the market ;
(40) ‘ c ontact sensitive packaging’ means packaging that is intended to be used in any packaging applications in the scope of Regulation s : (EC) No 1831/2003, (EC) No 1935/2004 , (EC) No 767/2009 , (EC) No 2009/1223, (EU) 2017/745, (EU) 2017/746, (EU) 2019/4 , (EU) 2019/ 6 , Directive 2001/83/EC , or Directive 2008/68/EC ;
(41) ‘compostable packaging’ means packaging capable of undergoing physical, chemical, thermal or biological decomposition such that most of the finished compost ultimately decomposes into carbon dioxide, mineral salts, biomass and water, according to Article 47 (4), and does not hinder the separate collection and the composting process or activity into which it is introduced in industrially controlled co nditions ;
(42) ‘ s ingle use plastic beverage bottles’ means beverage bottles listed in Part F of the Annex to Directive (EU) 2019/904 ;
(43) ‘plastic’ means a polymer within the meaning of Article 3(5) of Regulation (EC) No 1907/2006, to which additives or other substances may have been added, and which is capable of functioning as a main structural component of packaging, with the exception of natural polymers that have not been chemically modified;
(44) ‘plastic carrier bags’ means carrier bags, with or without handle, made of plastic, which are supplied to consumers at the point of sale of products;
(45) ‘ lightweight plastic carrier bags’ means plastic carrier bags with a wall thickness below 50 microns;
(46) ‘very lightweight plastic carrier bags’ means plastic carrier bags with a w all thickness below 15 microns;
(47) ‘thick plastic carrier bags’ means plastic carrier bags with a wall thickness between 50 and 99 microns;
(48) ‘very thick plastic carrier bags’ means plastic carrier bags with a wall thickness above 99 microns;
(49) ‘waste receptacles’ means containers , bins and bags used to store and collect waste ;
(50) ‘deposit’ means a fixed sum of money, not being part of the price of a packaged or filled product that is collected from the end user when purchasing such packaged or filled product, covered by a deposit and return system in a given Member State and redeemable when the end user returns the deposit bearing packaging to a collection poi nt established for that purpose;
(51) ‘deposit and return system’ means a system , in which a deposit is charged to the end user when purchasing a packaged or filled product c overed by this system, and redeemed to the end user when the deposit bearing packaging is returned to a collection point established for that purpose;
(52) ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a product, process or service;
(53) ‘harmonised standard’ means a standard as defined in Article 2(1), point (c) of Regulation (EU) No 1025/2012;
(54) ‘conformity assessment’ means the process demonstrating whether the sustainability, safety, labelling and information requirements of this Regulation, relating to a packaging, have been fulfilled;
(55) ‘producer responsibility organisation’ means a legal entity that financially or financially and operationally organises the fulfilment of extended producer responsibility obligations on behalf of several producers;
(56) ‘life - cycle’ means the consecutive and interlinked stages that packaging goes through , from raw material acquisition or generation from natural resources to final disposal.
(57) ‘ packaging presenting a risk’ means a packaging that, by not complying with a requirement set out in or pursuant to this Regulation other than those listed in Article 56 (1 ) , may adversely affect the environment or other public interests protected by that requirement;
(58) ‘ packaging presenting a serious risk’ means a packaging presenting a risk for which, based on an assessment, the degree of the relevant non-compliance or the associated harm is considered to require rapid intervention by the market surveillance authorities, including cases where the effects of the non-compliance are not immediate ;
(59) ‘online platform’ means online platform as defined in Article 3 point (i) of Regulation (EU) 2022/2065;
(60) ‘waste’ means waste as defined in Article 3 point (1) of Directive 2008/98/EC , with the exception of reusable packaging conveyed to reconditioning; The definitions of ‘substance of concern’ and ‘data carrier’ laid down in Article [2 points (28) and (30)] of Regulation [Ecodesign for sustainable products] shall apply;
The definitions of ‘waste management’, ‘collection’, ‘separate collection’, ‘extended producer responsibility scheme’, ‘preparing for re-use’, and ‘recycling’ laid down in Article 3 points (9), (10), (11), (21), (16) and (17) of Directive 2008/98/EC apply; The definitions of ‘market surveillance’, ‘market surveillance authority’, ‘fulfilment service provider’, ‘corrective action’, ‘recall’, ‘withdrawal’ and ‘risk’ laid down in Article 3 points (3), (4), (11), (16), (22), (23) and (18) of Regulation (EU) 2019/1020 apply.
An indicative list of items falling within the definition of packaging in point (1) is set out in Annex I.
1Packaging shall only be placed on the market if it complies with this Regulation.
2Member States shall not prohibit, restrict or impede the placing on the market of packaging that complies with the sustainability requirements set out in Articles 5 to 10 of this Regulation.
3Member States shall not prohibit, restrict or impede the placing on the market of packaging that complies with the labelling and information requirements set out in Article 11 of this Regulation.
4In case Member States choose to maintain or introduce nationa l sustainability requirements or information requirements additional to those laid down in this Regulation, those requirements shall not conflict with those laid down in this Regulation and the Member States shall not prohibit, restrict or impede the placing on the market of packaging that complies with the requiremen ts under this Regulation for reasons of non-compliance with those national requirements .
5In addition to the labelling requirements laid down in Article 11, Member States may provide for further labelling requirements, for the purpose of identifying the extended producer responsibility scheme or a deposit and return system other than those referred to in Article 44 (1).
6At trade fairs, exhibitions or similar events, Member States shall not prevent the showing of packaging, which does not comply with this Regulation, provided that a visible sign clearly indicates that such packaging does not comply with this Regulation and that it is not for sale until it ha s been brought into conformity .
1Packaging shall be so manufactured that the presence and concentration of substances of concern as constituents of the packaging material or of any of the packaging components is minimised, including with regard to their presence in emissions and any outcomes of waste management, such as secondary raw materials, ashes or other material for final disposal.
2Without prejudice to the restrictions on chemicals set out in Annex XVII of Regulation (EC) No 1907/2006 or, where applicable , to the restrictions and specific measures on food contact packaging in R egulation (EC) No 1935/2004, the sum of concentration levels of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components shall not exceed 100 mg/kg.
3Compliance with the requirements set out in paragraph 2 shall be demonstrated in the technical documentation drawn up in accordance with Annex V II.
4Recyclability requirements established in delegated acts adopted pursuant to Article 6( 5 ) shall not restrict the presence of substances in packaging or packaging components for reasons relating primarily to chemical safety. They shall address, as appropriate, substances of c oncern that negatively affect the re-use and recycling of materials in the packaging in which they are present , and shall , as appropriate, identify the specific substances concerned and their associated criteria and limitations.
5In order to take account of the scientific and technical progress, t he Commission may adopt delegated acts in accordance with Article 58 , to amend this Regulation in order to :
(a) lower the sum of concentration levels of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components referred to in paragraph 2 ;
(b) determine the conditions under which the concentration level referred to in paragraph 2 shall not apply to recycled materials and to product loops , which are in a closed and controlled chain, as well as to determin e the types of packaging which shall be exempted from the requirement s laid down in that paragraph. Such delegated acts shall be time-limited, provide for appropriate marking and information requirements, and contain requirements for regular reporting in order to ensure that the ex emption is regularly reviewed .
1All packaging shall be recyclable.
2Packaging shall be considered recyclable where it complies with the following :
(a) it is designed for recycling ;
(b) it is effectively and efficiently separately collected in accordance with Article 43 (1) and (2) ;
(c) it is sorted into defined waste streams without affecting the recyclability of other waste streams ;
(d) it can be recycled so that the resulting secondary raw materials are of sufficient quality to substitute the primary raw materials ;
(e) it can be recycled at scale. Point (a) shall apply from 1 January 2030 and point (e) shall apply from 1 January 2035.
3Recyclable packaging shall, from 1 January 2030, comply with the design for recycling criteria as laid down in the delegated acts adopted pursuant to paragraph 4 and, from 1 January 2035, also with the recyclability at scale requirements laid down in the delegated acts adopted pursuant to paragraph 6 . Where such packaging complies with those delegated acts, it shall be considered to comply with paragraph 2, points (a) and (e).
4The Commission is empowered to adopt delegated acts in accordance with Article 58 to supplement this Regulation in order to establish design for recycling criteria and recycling performance grades based on the criteria and parameters listed in Table 2 of Annex II for packaging categories listed in Table 1 of that Annex, as well as rules concerning the modulation of financial contributions to be paid by producers to comply with their extended producer responsibility obligations set out in Article 40 (1) , based on the packaging recycling performance grade , and for plastic packaging, the percentage of recycled content . Design-for-recycling criteria shall consider state of the art collection, sorting and recycling processes and shall cover all packaging components .
The Commission is empowered to adopt delegated acts in accordance with Article 58 to amend Table 1 of Annex in order to adapt it to scientific and technical development in material and product design, collection, sorting and recycling infrastructure.
5From 1 January 2030, packaging shall not be considered recyclable if it corresponds to performance grade E under the design for recycling criteria established in the del egated act adopted pursuant to paragraph 4 for the packaging category, to which the packaging belongs.
These criteria shall be based at least on the parameters as listed in Table 2 of Annex II.
6The Commission shall, for each packaging type listed in Table 1 of Annex II, establish the methodology to assess if packaging is recyclable at scale. That methodology shall be based at least on the following elements:
(a) a mounts of packaging placed on the market in the Union as a whole and in each Member State;
(b) a mounts of separately collected packaging waste, per packaging material listed in Table 1 of Annex II , in the Union as whole and in each Member State;
(c) recycling rates of packaging waste per packaging type listed in Table 1 of Annex II , in the U nion as a whole and in each Member State or, w hen such data on recycling rates for packaging waste per packaging type cannot be made available, assumptions made based on average loss rates as referred to in Article 47 (3);
(d) installed infrastructure c apacities for sorting and recycling in the Union as a whole for each packaging type listed in Table 1 of Annex II .
7The criteria and requirements referred to in paragraph 3 shall establish:
(a) the manner in which to express the result of the recyclability assessment in recyclability performance grades from A to E , as described in Table 3 of Annex II , based on the percentage of the packaging unit, in weight, which is recyclable according to paragraph 1;
(b) detailed design for recycling criteria for each packaging material and category listed in Table 1 of Annex II;
(c) a description, for each packaging category listed in Table 1 of Annex II, of the conditions for compliance with the respective performance grades;
(d) the modulation of the financial contributions to be paid by producers to comply with their extended producer responsibility obligations as referred to in Article 40 , based on the packaging performance grade;
(e) the manner in which to assess the recyclability at scale for each packaging category listed in Table 1 of Annex II in order to establish, as of 2035, updated recyclability performance grades.
8Compliance with the requirements set out in paragraphs 2 and 3 shall be demonstrated in the technical documentation concerning the packaging as set out in Annex VII .
Where a unit of packaging includes integrated components, the assessment of compliance with the design for recycling criteria and with the at scale recyclability requirements shall include all integrated components.
Where a unit of packaging includes separate components, the assessment of compliance with the design for recycling requirements and with the at scale recyclability requirements shall be done separately for each separate component. All components of a unit of packaging shall be compatible with the state of the art collection, sorting and recycling processes and shall not hinder the recyclability of the main body of the unit of packaging.
9From 1 January 2030, and b y way of derogation from paragraph s 2 and 3 , innovative packaging may be placed on the market for a maximum period of 5 years after the end of the calendar year when it has been placed on the market .
Where use is made of this derogation, innovative packaging shall be accompanied by technical documentation, referred to in Annex VII, demonstrating its innovative nature and showing compliance with the definition in Article 3(34) of this Regulation. After the period referred to in the first sub-paragraph, such packaging shall be accompanied by the technical documentation referred to in paragraph 8.
10Until 31 December 2034 , this Article shall not apply to the following:
(a) immediate packaging as defined in Article 1 , point (23), of Directive 2001/83/EC and in Article 4 , point 2 5, of Regulation (EU) 2019/6;
(b) contact sensitive plastic packaging of medical devices covered by Regulation (EU) 2017/745 ;
(c) contact sensitive plastic packaging of in vitro diagnostics medical devices covered by Regulation (EU) 2017/746.
11The financial contributions to be paid by producers to comply with their extended producer responsibility obligations as referred to in Article 40 shall be modulated on the basis of the recyclability performance grade , as determined in accordance with the delegated act s referred to in paragraph s 4 and 6 of this Article a nd , as regards plastic packaging, also in accordance with the Article 7(6) .
1From 1 January 2030 , the plastic part in packaging shall contain the following minimum percentage of recycled content recovered from post-consumer plastic waste, per unit of packaging:
(a) 30 % for contact sensitive packaging made from polyethylene terephthalate (PET) as the major component ;
(b) 10 % for contact sensitive packaging made fro m plastic materials other than PET , except single use plastic beverage bottles ;
(c) 30 % for single use plastic beverage bottles;
(d) 3 5 % for packaging other than those referred to in points (a) , (b) and ( c ).
2From 1 January 2040, the plastic part in packaging shall contain the following minimum percentage of recycled content recovered from post-consumer plastic waste, per unit of packaging:
(a) 50 % for contact sensitive plastic packaging , except single use plastic beverage bottles ;
(b) 65 % for single use plastic beverage bottles;
(c) 65 % for plastic packaging other than those referred to in points (a) and (b) ;
3P aragraph s 1 and 2 shall not apply to the following:
(a) 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;
(b) contact sensitive plastic packaging of medical devices covered by Regulation (EU) 2017/745;
(c) contact sensitive plastic packaging of in vitro diagnostics medical devices covered by Regulation (EU) 2017/746;
(d) outer packaging 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 such packaging is necessary to comply with specific requirements to preserve the quality of the medicinal product.
4Paragraphs 1 and 2 shall not apply to compostable plastic packaging .
5Compliance with the requirements set out in paragraphs 1 and 3 shall be demonstrated in the technical information concerning the packaging referred to in Annex VII .
6By 1 January 20 30 , t he financial contributions paid by producers to comply with their extended producer responsibility obligations as laid down in Article 40 shall be modulated based on the percentage of recycled content used in the packaging .
7By 31 December 2026, t he Commission is empowered to adopt implementing acts establish ing the methodology for the calculation and verification of the percentage of recycled content recovered from post-consumer plastic waste, per unit of plastic packaging, and the format for the technical documentation referred to in Annex VII . Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59 (3 ).
8As of 1 January 2029, the calculation and verification of the percentage of recycled content contained in packaging under paragraph 1 shall comply with the rules laid down in the implementing act referred to in paragraph 7.
9By 1 January 2028, the Commission shall assess the need for derogations from the minimum percentage laid down in paragraph 1 , points b and d , for specific plastic packaging , or for the revision of the derogation established under paragraph 3 for specific plastic packaging .
Based on this assessment, the Commission is empowered to adopt delegated acts in accordance with Article 58 to amend this Regulation in order to :
(a) provide for derogations from the scope, timing or level of minimum percentage laid down in paragraph 1 , points b and d, for specific plastic packaging, and, as appropriate,
(b) revise the derogations established in paragraph 3 ,
where suitable recycling technologies to recycle plastic packaging are not available because they are not authorised under the relevant Union rules or are not sufficiently installed in practice.
10Where justified by the lack of availability or excessive prices of specific recycled plastics that may have adverse effects on human or animal health, security of food supply or the environment, making compliance with the minimum percentages of recycled content set out in paragraphs 1 and 2 excessively difficult, the Commission shall be empowered to adopt a delegated act in accordance with Article 58 to amend paragraphs 1 and 2 by adjust ing the mini m um percentages accordingly. In evaluating the justification of such adjustment , the Commission shall assess requests from natural or legal persons to be accompanied by relevant information and data on the market situation for this post-consumer plastic waste and best available evidence regarding the related risks to human or animal health, to the security of food supply or to the environment.
11By [ OP: Please insert the date = 8 years after the date of entry into force of this Regulation ], the Commission shall review the situation regarding the use of recycled packaging materials in packaging other than plastics and, on this basis, assess the appropriateness of establishing measures, or setting tar gets, for increasing the use of recycled content in such other packaging, and where necessary present a legislative proposal.
1By [ OP: please insert the date = 24 months from the entry into force of this Regulation ] , packaging referred to in Article 3(1 ), points (f) and (g) , sticky labels attached to fruit and vegetables and very lightweight plastic carrier bags shall be compostable in industrially controlled conditions in bio-waste treatment facilities .
2Where appropriate waste collection schemes and waste treatment infrastructure are available to ensure that packaging referred to in paragraph 1 enters the organic waste management stream, Member States are empowered to require that l ightweight plastic carrier bags shall be made available on the ir market for the first time only if it can be demonstrat ed that those lightweight plastic carrier bags have been entirely manufactured from biodegradable plastic polymers , which are compostable in industrially controlled conditions .
3By [ OP: Please insert the date = 24 months from the date of entry into force of this Regulation ] , packaging other than that referred to in paragraphs 1 and 2, including packaging made of biodegradable plastic polymers, shall allow material recycling without affecting the recyclability of other waste streams .
4Compliance with the requirements set out in paragraphs 1 to 3 shall be demonstrated in the technical information concerning the packaging referred to in Annex VII .
5The Commission shall be empowered to adopt delegated acts in accordance with Article 58 to amend paragraphs 1 and 2 of this Article by adding other types of packaging to the types of packaging covered by those paragraphs when it is justified and appropriate due to technological and regulatory developments impacting the disposal of compostable packaging and under the conditions set out in Annex III .
1P ackaging shall be designed so that its weight and volume is reduced to the minimum necessary for ensuring its functionality taking account of the material that the packaging is made of .
2Packaging not necessary to comply with any of the performance criteria set out in Annex IV and packaging with characteristics that are only aimed to increase the perceived volume of the product , including double walls , false bottoms, and unnecessary layers, shall not be placed on the market , unless the packaging design is subject to geographical indications of origin protected under Union legislation .
3Empty space shall be reduced to the minimum necessary for ensuring the packaging functionality as follows :
(a) for sales packaging , in relation to the total volume of the packaged product and its characteristics;
(b) for grouped and transport packaging , including e-commerce packaging , in relation to the total volume of the grouped or transported products and their sales packaging; For the purpose of assessing the compliance with this paragraph, space filled by paper cuttings, air cushions, bubble wraps, sponge fillers, foam fillers, wood wool, polystyrene, styrofoam chips or other filling materials shall be considered as empty space.
4Compliance with the requirements set out in paragraphs 1 and 2 shall be demonstrated in the technical documentation referred to in Annex VII , which shall contain the following elements :
(a) an explanation of the technical specifications, standards and conditions used to assess the packaging against the performance criteria and methodology set out in Annex IV;
(b) the identification of the design requirements which prevent further reduction of the packaging weight or volume, for eac h of these performance criteria;
(c) a ny test results, st udies or other relevant sources used to assess the minimum necessary volume or weight of the packaging . For reusable packaging, the assessment of compliance with the requirements set out in paragraph 1 shall take into account the function of reusable packaging as referred to in Article 10.
1P ackaging shall be considered reusable where if fulfils the following conditions :
(a) it has been conceived, designed and placed on the market with the objective to be re - used or refilled;
(b) it has been conceived and designed to accomplish as many trips or rotations as possible in normally predictable conditions of use ;
(c) it can be emptied or unloaded without damage to the packaging , which prevents its re-use ;
(d) it is capable of being emptied, unloaded, refilled or reloaded while ensuring compliance with the applicable safety and hygiene requirements;
(e) it is capable of being reconditioned in accordance with Part B of Annex VI , w hilst maintaining its ability to perform its intended function ;
(f) it can be emptied, unloaded, refilled or reloaded while maintaining the quality and safety of the packaged product and allowing for the attach ment of labelling , and the provision of information on the properties of that product and on the packaging itself , including any relevant instructions and information for ensuring safety, adequate use, traceability and shelf-life of the product ;
(g) it can be emptied, unloaded, refilled or reloaded without risk to the health and safety of those responsible for doing so ;
(h) it fulfils the requirements specific to recyclable packaging when it becomes waste set out in Article 6 .
2Compliance with the requirements set out in paragraph 1 shall be demonstrated in the technical information concerning the packaging referred to in Annex VI I .
1From [ OP : Please insert the date = 42 months after the entry into force of this Regulation ] , packaging shall be marked with a label containing information on its material composition. This obligation does not apply to transport packaging . However, it applies to e-commerce packaging .
Packaging subject to deposit and return systems referred to in Article 44(1) shall, in addition to the labelling referred to in the first subparagraph, be marked with a harmonised label established in the relevant implementing act adopted pursuant to paragraph 5.
2From [ OP : Please insert the date = 48 months after the date of entry into force of this Regulation ], packaging shall bear a label on packaging reusability and a QR code or other type of digital data carrier that provid es further information on packaging reusability including the availability of a system for re-use and of collection points , and that facilitat es the tracking of the packaging and the calculation of trips and rotations . In addition, reusable sales packaging shall be clearly identified and distinguished from single use packaging at the point of sale.
3Where a unit of packaging covered by Article 7 is marked with a label containing information on the share of recycled content, that label shall comply with the specifications laid down in the relevant implementing act adopted pursuant to Article 11(5 ) and shall be based on the methodology pursuant to Article 7(7). Where a unit of plastic packaging is marked with a label containing information on the share of biobased plastic content, that label shall comply with the specifications laid down in the relevant implementing act adopted pursuant to Article 11(5) .
4Labels referred to in paragraphs 1 to 3 and the QR code or other type of digital data carrier referred to in paragraph 2 shall be placed, printed or engraved visibly, clearly legibly and indelibly on the packaging. Where this is not possible or not warranted on account of the nature and size of the packaging, they shall be affixed to the grouped packaging .
Where Union legislation requires information on the packaged product to be provided via a data carrier, a single data carrier shall be used for providing the information required for both the packaged product and the packaging.
5By [ OP: Please insert the date = 18 months after the date of entry into force of this Regulation ], the Commission shall adopt implementing acts to establish a harmonised label and specifications for the labelling requirements and formats for the labelling of packaging referred to in paragraphs 1 to 3 and the labelling of waste receptacles referred to in Article 12. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59 (3) .
6By [ OP: Please insert the date = 24 months after the date of entry into force of this Regulation ] , the Commission shall adopt implementing acts to establish the methodology for identifying the material composition of packaging referr ed to in paragraph 1 by means of digital marking technologies. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59 (3).
7Without prejudice to requirements concerning other harmonised EU labels, economic operator s shall not provide or display labels, marks, symbols or inscriptions that are likely to mislead or confuse consumers or other end users with respect to the sustainability requirements for packaging , other packaging characteristics or packaging waste management options , for which harmonised labelling ha s been laid down in this Regulation .
8Packaging included in an extended producer responsibility scheme or covered by a deposit and return system other than that referred to in Article 44 (1) may be identified by means of a corresponding symbol throughout the territory in which that scheme or system applies . That symbol shall be clear and unambiguous and shall not mislead consumers or users as to the recyclability or reusability of the packaging.
Article 1 2 Labelling of waste receptacles for the collection of packaging waste
By 1 January 2028, labels that enable the separate collection of each material specific fraction of packaging waste that is intended to be discarded in separate receptacles shall be affixed, printed or engraved visibly, legibly and indelibly on all waste receptacles for collection of packaging waste.
Chapter I V Obligations of economic operators other than the obligations in Chapters V and VII
1When placing packaging on the market, manufacturers shall ensure that the packaging complies with the following :
(a) it has been designed and manufactured in accordance with the applicable requirements set out in Articles 5 to 10;
(b) it is labelled in accordance with the applicable requirements set out in Article 11 .
2Before placing packaging on the market, manufacturers shall carry out the relevant conformity assessment procedure referred to in Article 3 3 , or have it carried out on their behalf, and draw up the technical documentation referred to in Annex VII .
Where compliance of packaging with the applicable requirements has been demonstrated by the relevant conformity assessment procedure referred to in Article 33, manufacturers shall draw up an EU declaration of conformity in accordance with Article 34.
3M anufacturers shall keep the technical documentation referred to in Annex VI I and the EU declaration of conformity for 10 years after the packaging has been placed on the market.
4M anufacturers shall ensure that procedures are in place for series production of packaging to remain in conformity with this Regulation. Changes in packaging design or in characteristics, as well as changes in harmonised standards, common technical specifications or other technical specifications by reference to which conformity is declared or by application of which its conformity is verified, shall be adequately taken into account by manufacturers. In case the manufacturers finds that the packaging ’s conformity may be affected, they shall carry out a re-assessment in accordance with the conformity assessment procedure specified in Article 3 3 and Annex VII , or have it carried out on their behalf.
5M anufacturers shall ensure that the packaging bears a type, batch or serial number or other element allo wing its identification or, where the size or nature of the packaging does not allow so, that the required information is provided in a document accompanying the packaged product.
6M anufacturers shall indicate on the packaging or o n a QR code or another data carrier their name, registered trade name or registered trade mark as well as the postal address, and where available, the electronic means of communication, where they can be contacted. Where that is not possible, the required information shall be provided as part of the information through the QR code referred to in Article 11( 2 ) or the data carrier referred to in Article 11(4) or in a document accompanying the packaged product. The postal address shall indicate a single point at which the manufacturer can be contacted. Such information shall be clear, understandable and legible.
7Manufacturers shall ensure that information provided in accordance with paragraphs 5 and 6 is clear, understandable and legible, and does not replace, obscure or can be confused with information required by other Union legislation on the labelling of the packaged product .
8M anufacturers who consider or have reason to believe that packaging which they have placed on the market is not in conformity with one or more of the applicable requirements set out in Articles 5 to 11 shall immediately take the corrective measures necessary to bring that packaging into conformity, to withdraw it or recall it, as appropriate. M anufacturers shall immediately inform the market surveillance authority of the Member State in which they made the packaging available of the suspected non-compliance and of any corrective measures taken .
9M anufacturers shall, further to a reasoned request from a nati onal authority , provide all the information and documentation necessary to demonstrate the conformity of the packaging, including the technical documentation in a language , or languages, which can be easily understood by that authority. That information and documentation shall be provided in either paper or electronic form. The relevant documents shall be made available within 10 days of receipt of the request from the national authority. M anufacturers shall cooperate with the national authority on any action taken to remedy any case of non-compliance with the requirements set out in Articles 5 to 10 .
Article 1 4 Information o bligations of suppliers of packaging or packaging materials
1A ny supplier of packaging or packaging materials shall provide the manufacturer with all the information and documentation necessary for the manufacturer to demonstrate the conformity of the packaging and the packaging materials with this Regulation , including the technical documentation referred to in Annex VII and required under Articles 5 to 10 , in a language or languages, which can be easily understood by the manufacturer . That information and documentation shall be provided in either paper or electronic form.
2Where appropriate, the documentation and information provided for in legislation applicable to contact sensitive packaging shall be part of the information and documentation to be provided to the manufacturer pursuant to paragraph 1.
Article 1 5
1A manufacturer may, by a written mandate, appoint an authorised representative.
The obligations laid down in Article 13(1) and the obligation to draw up technical documentation referred to in Annex VII and required under Articles 5 to 10 shall not form part of the authorised representative's mandate.
2An authorised representative shall perform the tasks specified in the mandate received from the manufacturer . The mandate shall allow the authorised representative to do at least the following:
(a) keep the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for 10 years after the packaging has been placed on the market;
(b) cooperate with the national authorities, at their request, on any measures taken with regard to non-compliances of the packaging covered by the authorised representative's mandate ;
(c) further to a reasoned request from a national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of packaging in a language or languages, which can be easily understood by that authority;
(d) further to a request from a competent national authority, make available relevant documents within 10 days of the receipt of such a request ;
(e) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation . Article 1 6 Obligations of importers
1Importers shall only place on the market packaging which is compliant with the requirements of Articles 5 to 11 .
2Before placing packaging on the market, importers shall ensure the following :
(a) the appropriate conformity assessment procedure , referred to in Article 3 3 has been carried out and the technical documentation , referred to in Annex VII and required under Articles 5 to 10, has been drawn up by the manufacturer ;
(b) the packaging is labelled in accordance with Article 11 ,
(c) the packaging is accompanied by the required documents ;
(d) the manufacturer has complied with the requirements set out in Article 1 3 (5) and (6) .
Where an importer considers or has reason to believe that packaging is not in conformity with the applicable requirements set out in Articles 5 to 11, the importer shall not place the packaging on the market until it has been brought into conformity.
3Importers shall indicate on the packaging their name and their registered trade name or registered trade mark as well as the postal address, and , where available, the electronic means of communication, where they can be contacted. Where that is not possible, the required information shall be provided via the data carrier or in a document accompanying the packaged product. The contact details shall be clear, understandable and legible.
4Importers shall ensure that information provided in accordance with paragraph 3 is clear, understandable and legible, and does not replace, obscure or can be confused with information required by other Union legislation on the labelling of the package d product.
5Importers shall ensure that, while the packaging is under their responsibility, storage or transport conditions do not jeopardise its compliance with the applicable requirements set out in Articles 5 to 11 .
6Importers who consider or have reason to believe that packaging, which they have placed on the market, is not in conformity with the applicable requirements set out in Articles 5 to 11 , shall immediately take the corrective measures necessary to bring that packaging into conformity, to withdraw it or recall it, as appropriate.
7Importers shall immediately inform the market surveillance authorities of the Member States in which they made the packaging available of the suspected non-compliance and of any corrective measures taken.
8Importers shall, for 10 years after the packaging has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation referred to in Annex VII and required under Articles 5 to 10 can be made available to those authorities, upon request.
9Importers shall, further to a reasoned request from a national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of packaging, including technical documentation, with the applicable requirements set out in Articles 5 to 11 , in a language or languages, which can be easily understood by that authority. That information and documentation shall be provided either in paper or electronic form. The relevant documents shall be made available within 10 days of receipt of the request from the national authority .
10Importers shall cooperate with the competent national authority on any action taken to remedy any case of non-compliance with the requirements set out in Articles 5 to 11 .
Article 1 7
1When making packaging available on the market, distributors shall act with due care in relation to the r equirements of this Regulation.
2Before making packaging available on the market, distributors shall verify the following :
(a) the producer, that is subject to the obligations on e xtended producer responsibility for the packaging is registered in the register of producers referred to in Article 40 ;
(b) the packaging is labelled in accordance with Article 11 ;
(c) the manufacturer and the importer have complied with the requirements set out in Article 1 3 (5) and (6) and Article 1 6 (3) respectively.
3Where a distributor, before making packaging available on the market , considers or has reason to believe that the packaging is not in conformity with the requirements set out in Articles 5 to 11 or that the manufacturer is not complying with those applicable requirements, the distributo r shall not make the packaging available on the market until it has been brought into conformit y or until the manufacturer complies.
Distributors shall ensure that, while the packaging is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in Articles 5 to 11.
4Distributors who consider or have reason to believe that packaging, which they have made available on the market with the packaged product , is not in conformity with the applicable requirements set out in Articles 5 to 11 shall make sure that the corrective measures necessary to bring that packaging into conformity, to withdraw it or recall it, as appropriate, are taken .
Distributors shall immediately inform the market surveillance authorities of the Member States in which they made the packaging available of the suspected non-compliance and of any corrective measures taken.
5Distributors shall, further to a reasoned request from a national authority, provide that authority with all the information and documentation to which they have access and that is relevant for demonstrating the conformity of a packaging with the applicable requirements set out in Articles 5 to 11 in a language or languages, which can be easily understood by that authority. That information and documentation shall be provided in paper or electronic form.
Distributors shall cooperate with the national authority on any action taken to remedy any case of non-compliance with the requirements set out in Articles 5 to 11. Article 1 8 Obligations of fulfilment service providers
Fulfilment service providers shall ensure that for packaging that they handle, the conditions during warehousing, handling and packing, addressing or dispatching, do not jeopardise the packaging’s compliance with the requirements set out in Articles 5 to 11.
An importer or a distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer under Article 14, where they place packaging on the market under their own name or trademark or modify packaging already placed on the market in a way that may affect compliance with the relevant requirements of this Regulation.
Article 2 0 Identification of economic operators
1Economic operators shall, upon request, provide information to the market surveillance authorities on the following:
(a) the identity of any economic operator that has supplied them with packaging;
(b) the identity of any economic operator to which they have supplied packaging.
2Economic operators shall be able to provide the information referred to in paragraph 1 for 10 years after they have been supplied with the packaging and for 10 years after they have supplied the packaging.
1Economic operators who supply products to a final distributor or an end user in grouped packaging , transport packaging or e-commerce packaging, shall ensure that the empty space ratio is maximum 40 %.
2For the purpose of this calculation:
(a) empty space shall mean the difference between the total volume of grouped packaging , transport packaging or e-commerce packaging and the volume of sales packaging contained therein;
(b) empty space ratio shall mean the ratio of the empty space as defined in point (a) of this paragraph and the total volume of the grouped packaging , transport packaging or e-commerce packaging. Space filled by filling materials such as paper cuttings, air cushions, bubble wraps, sponge fillers, foam fillers, wood wool, polystyrene or Styrofoam chips, shall be considered as empty space.
3Economic operators using sales packaging as e-commerce packaging shall be exempted from the obligation laid down in paragraph 1. They shall nevertheless ensure that such sales packaging complies with the requirements in Article 9.
1Economic operators shall not place on the market packa ging in the formats and for the purposes listed in Annex V.
2By way of derogation from paragraph 1, e conomic operators shall not place on the market packaging in the formats and for the purposes listed in point 3 of Annex V as of 1 January 2030.
3Member States may exempt e conomic operators from point 3 of Annex V if they comply with the definition of micro-company in accordance with rules set out in the Commission Recommendation 2003/361, as applicable on [ OP: Please insert the date = the date of entry into force of this Regulation ] , and where it is not technically feasible not to use packaging or to obtain access to infrastructure that is necessary for the functioning of a reuse system.
4T he Commission shall be empowered to adopt delegated acts in accordance with Article 58 to amend Annex V in order to adapt it to technical and scientific progress with the objective to reducing packaging waste . When adopting those delegated acts, the Commission shall consider the potential of the restriction s on the use of specific packaging formats to reduc e the packaging waste generated while ensuring an overall positive environmental impact , and shall take into account the availability of alternative packaging solutions that meet requirements set out in legislation applicable to contact sensitive packaging , as well as their capability to prevent microbiological contamination of the packaged product.
Article 2 3 Obligations in relation to reusable packaging
1Economic operators who place r eusable packaging on the market shall ensure that a system for re-use of such packaging is in place, which meets the requirements laid down in Article 24 and Annex VI.
2The description of the system’s compliance with th o se requirements shall be drawn up as part of the technical documentation on reusable packaging to be provided pursuant to Article 10(2). For that purpose, the manufacturer shall request the relevant written confirmations from system participants set out in Annex VI.
Article 2 4 Obligation related to s ystems for re-use
1Economic operators making use of reusable packaging shall participat e in one or more systems for re-use and shall ensure that the system s for re-use, which th e reusable packaging is part of, compl y with the requirements laid down in Part A of Annex VI .
2Economic operators making use of r eusable packaging shall recondition such packaging in compliance with Part B of Annex VI , prior to offering it again for use by end user s .
1Where economic operators offer the possibility to purchase products through refill, they shall inform end users o f the following :
(a) the types of containers that may be used to purchase the products on offer through refill ;
(b) the hygiene standards for refill,
(c) the responsibility of the end user in relation to the health and safety regarding the use of the containers referred to in point (a) . This information shall be regularly updated and either clearly displayed on the premises or otherwise provided to end users.
2Economic operators enabling refill shall ensure that refill stations comply with the requirements laid down in Part C of Annex VI and with any requirements set in other Union legisla tion for the sale of products through refill .
3Economic operators enabling refill shall ensure that packaging offered to the end users at the refill stations is not provided free of charge or is provided as a part of a deposit and return system .
4Economic operators may refuse to refill a container provided by the end user , if the end user does not abide with the requirements communicated by the economic operator in accordance with paragraph 1.
1From 1 January 2030, economic operator s making large household appliances listed in point 2 of Annex II to Directive 2012/19/EU available on the market for the first time within the territory of a Member State shall ensure that 90 % of tho se products are made available in reusable transport packaging within a system for re-use.
2T he final distributor making available on the market within the territory of a Member State in sales packaging cold or hot beverages filled into a container at the point of sale for take-away shall ensure that:
(a) from 1 January 2030 , 2 0 % of th o se beverages are made available in reusable packaging within a system for re-use or by enabling refill;
(b) from 1 January 2040 , 80 % of th o se beverages are made available in reusable packaging within a system for re-use or by enabling refill .
3A final distributor that is conducting its business activity in the HORECA sector and that is making available on the market within the territory of a Member State in sales packaging take-away ready-prepared food , intended for immediate consumption without the need of any further preparation , and typically consumed from the receptacle , shall ensure that:
(a) from 1 January 2030 , 1 0 % of th o se products are made available in reusable packaging within a system for re-use or by enabling refill;
(b) from 1 January 2040 , 40 % of tho se products are made available in reusable packaging within a system for re-use or by enabling refill .
4The manufacturer and the final distributor making available on the market within the territory of a Member State in sales packaging alcoholic beverages in the form of beer, carbonated alcoholic beverages, fermented beverages other than wine, aromatised wine products and fruit wine, products based on spirit drink s , wine or other fermented beverages mixed with beverages , soda, cider or juice, shall ensure that:
(a) from 1 January 2030 , 1 0 % of tho se products are made available in reusable packaging within a system for re-use or by enabling refill ;
(b) from 1 January 2040 , 2 5 % of tho se products are made available in reusable packaging within a system for re-use or by enabling refill .
5The manufacturer and the final distributor making available on the market within the territory of a Member State in sales packaging alcoholi c beverages in the form of wine , with the exception of sparkling wine, shall ensure that:
(a) from 1 January 2030 , 5 % of tho se products are made available in reusable packaging within a system for re-use or by enabling refill;
(b) from 1 January 2040 , 1 5 % of tho se products are made available in reusable packaging within a system for re-use or by enabling refill .
6The manufacturer and the final distributor making available on the market within the territory of a Member State in sales packaging non-alcoholic beverages in the form of water, water with added sugar, water with other sweetening matter , flavoured water , soft drinks, soda lemonade, iced tea and similar beverages which are immediately ready to drink, pure juice, juice or must of fruits or vegetables and smoothies without milk and non-alcoholic beverages containing milk fat, shall ensure that:
(a) from 1 January 2030 , 1 0 % of tho se products are made available in reusable packaging within a system for re-use or by enabling refill ;
(b) from 1 January 2040 , 2 5 % of tho se products are made available in reusable packaging within a system for re-use or by enabling refill .
7Economic operators using transport packaging in the form of pallets, plastic crates, foldable plastic boxes, pails and drums for the conveyance or packaging of products in conditions other than provided for under paragraphs 12 and 13 shall ensure that :
(a) from 1 January 2030 , 3 0 % of such packaging used is reusable packaging within a system for re-use;
(b) from 1 January 2040 , 90 % of such packa ging used is reusable packaging within a system for re-use .
8Economic operators using transport packaging for the transport and delivery of non-food items made available on the market for the first time via e-commerce shall ensure that:
(a) from 1 January 2030 , 1 0 % of such packaging used is reusable packaging within a system for re-use;
(b) from 1 January 2040 , 5 0 % of such packaging used is reusable packaging within a system for re-use;
9Economic operators using transport packaging in the form of pallet wrappings and straps for stabilization and protection of products put on pallets during transport shall ensure that:
(a) from 1 January 2030 , 1 0 % of such packaging used is reusable packaging within a system for re-use;
(b) from 1 January 2040 , 30 % of such packaging used for transport is reusable packaging within a system for re-use;
10Economic operators using grouped packaging in the form of boxes , excluding cardboard, used outside of sales packaging to group a certain number of products to create a stock-keeping unit shall ensure that:
(a) from 1 January 2030 , 10 % of such packaging used is reusable packaging within a system for re-use;
(b) from 1 January 2040 , 2 5 % of such packaging they used is reusable packaging within a system for re-use .
11Targets laid down in paragraphs 1 to 10 shall be calculated for the period of a calendar year.
12Transport packaging used by an economic operator shall be reusable where it is used for transport ing products :
(a) between different sites , on which the operator performs its activity ; or
(b) between any of the sites on which th e operator performs its activity and the sites of any other linked enterprise or partner enterprise, as defined in Article 3 of the Annex to Com mission Recommendation 2003/361 , as applicable on [ OP: Please insert the date = the date of entry into force of this Regulation ] . This obligation applies to pallets, boxes, excluding cardboard, trays, plastic crates, intermediate bulk containers, drums and canisters, of all sizes and materials, including flexible formats.
13Economic operators delivering products to another economic operator within the same Member State shall use only reusable transport packaging for the purpose of the transportation of such product s.
This obligation applies to pallets, boxes, excluding cardboard, plastic crates intermediate bulk containers, and drums, of all sizes and materials, including flexible formats.
14Economic operators shall be exempted from the obligation to meet the targets in paragraphs 2 to 10 if , during a calendar year , they :
(a) placed not more than 1000 kg of packaging on the market; or
(b) complied with the definition of micro-company in accordance with rules set out in the Commission Recommendation 2003/361 , as applicable on [ OP: Please insert the date = th e date of entry into force of this Regulation ] .
15Economic operators shall be exempted from the obligation to meet the targets in paragraphs 2 to 6 if, during a calendar year, they ha ve a sales area of not more than 100 m 2 , including also all storage and dispatch area s .
16The Commission shall be empowered to adopt delegated acts in accordance with Article 58 to supplement this Regulation in order t o establish :
(a) targets for other products than those covered by paragraphs 1 to 6 of this Article and other packaging formats than those in paragraphs 7 to 10 , based on the positive experiences with measures taken by Member States under Article 45 (2),
(b) exemptions for economic operators additional to those listed in points (a) to (c) of paragraph 14 of this Article,
(c) exemptions for specific packaging formats covered by the targets laid down in paragraphs 2 to 6 of this Article in case of hygiene, food safety or environmental issues preventing the achievement of those targets.
17By [ OP: Please insert the date = 8 years after the date of entry into force of this Regulation ], the Commission shall review the situation regarding reuse of packaging and, on this basis, assess the appropriateness of establishing measures, reviewing the targets laid down in this Article , and setting new targets for the reuse and refill of packaging , and where necessary present a legislative proposal.
Article 2 7 Rules on the calculation of the attainment of the re - use and refill targets
1For the purpose of demonstrating the attainment of the targets laid down in Article 26 (1) , the economic operator making large household appliances listed in point 2 of Annex II to Directive 2012/19/EU available on the market for the first time within the territory of a Member State shall calculate the following :
(a) the number of units of sales of th o se appliances in reusable packaging within a system for re-use made available on the market for the first time within the territory of a Member State in a calendar year ;
(b) the number of units of sales of th o se appliances in packaging other than reusable packaging as referred to in point (a) made available on the market for the first time within the territory of a Member State in a calendar year.
2For the purpose of demonstrating the attainment of the targets laid down in Article 2 6 (2) to ( 6 ) , the final distributor , or manufacturer, as appropriate, making available on the market such product s within the territory of a Member State shall calculate, for each target separately , the following :
(a) the number of units of sales of beverages and food in reusable packaging within a system for re-use made available on the market within the territory of a Member State in a calendar year ;
(b) the number of units of sales of beverages and food made available on the market within the territory of a Member State in a calendar year through refill ;
(c) the number of units of sales of beverages and food made available on the market within the territory of a Member State by other means than those referred to in points (a) and (b) in a calendar year.
3For the purpose of demonstrating the attainment of the targets laid down in Article 2 6 ( 7 ) to ( 10 ) , the economic operator using such packaging shall calculate, for each target separately , the following :
(a) the number of equivalent units of each of the packaging formats listed in Article 2 6 ( 7 ) to (10 ) constituting reusable packaging within a system for re-use they us ed in a calendar year;
(b) the number of equivalent units of each of the packaging formats listed in Article 2 6 ( 7 ) to (10 ) , other than those indicated in point (a) , that they used in a calendar year.
4By 31 December 2028 , the Commission shall adopt implementing act s establishing detailed calculation rules and methodology regarding the targets set out in Article 2 6 .
The implementing act shall be adopted in accordance with the examination procedure referred to in Article 59(3). Article 2 8 Reporting to the competent authorities on re - use and refill targets
1The economic operators referred to in Article 2 6 ( 1 ) to ( 10 ) shall report to the competent authority , referred to in Article 35 of this Regulation, data concerning the attainment of the targets laid down in Article 2 6 for each calendar year.
2The report referred to in paragraph 1 shall be submitted within six months after the end of the reporting year for which the data are collected.
3The first reporting period shall concern the calendar year starting o n 1 January 2030.
4The competent authorities shall establish electronic systems through which data shall be reported to them and specify the formats to be used.
5C ompetent authorities may request any additional information necessary to ensure the reliability of the data reported.
6Member States shall make public the results of the reports referred to in paragraph 1 .
1Member States shall take measures to achieve a sustained reduction in the consumption of lightweight plastic carrier bags on their territory.
A sustained reduction is achieved if the annual consumption does not exceed 40 lightweight plastic carrier bags per person, or the equivalent target in weight, by 31 December 2025, and subsequently by 31 December in each year thereafter.
2Measures to be taken by Member States to meet the target set out in paragraph 1 may vary depending on the environmental impact of lightweight plastic carrier bags when they are manufactured, recycled or disposed of, and their composting properties, durability or specific intended use. Such measures may , by way of derogation from Article 4, include marketing restrictions, provided that they are proportionate and non-discriminatory.
3Member States may take measures , such as economic instruments and national reduction targets, as regards any kind of plastic carrier bags, regardless of their wall thickness , in accordance with the obligation s arising from the Treaty .
4Member States may 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 obligations set out in paragraph 1.
For the purposes of compliance and verification of compliance of packaging with the requirements set out in Articles 5 to 11 and 24 of this Regulation, tests, measurements and calculations shall be made using reliable, accurate and reproducible methods, which take into account the generally recognised state-of-the art methods, and whose results are deemed to be of low uncertainty.
1Tests, measurements or calculation methods referred to in Article 30 which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union , shall be presumed to be in conformity with the requirements covered by those standards or parts thereof set out in that Article.
2Packaging which is in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union , shall be presumed to be in conformity with the requirements , or parts thereof, covered by those standards set out in Articles 5 to 11 and 2 4 .
1Packa ging which is in conformity with common technical specifications referred to in paragraph 2 , or parts thereof , shall be presumed to be in conformity with the requirements set out in Articles 5 to 11 and 2 4 to the extent that those requirements are covered by those common technical specification s or parts thereof .
2The Commission may, by means of implementing acts, establish common technical specifications for the requirements set out in Articles 5 to 11 and Article 2 4 where the following conditions are fulfilled:
(a) there is no harmonised standard covering the relevant requirements the reference of which is published in the Official Journal of the European Union or the standard does not satisfy the requirements it aims to cover;
(b) the Commission has requested, pursuant to Article 10(1) of Regulation 1025/2012, one or more European standardisation organisations to draft or to revise a harmonised standard for the requirements set out in Articles 5 to 11 and Article 2 4 and either of the following conditions are fulfilled:
(i) the request has not been accepted by any of the European standardisation organisations to which the request was addressed;
(ii) the request has been accepted by at least one of the European standardisation organisations to which the request was addressed, but the standards requested:
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3).
3When references of a harmonised standard are published in the Official Journal of the European Union , the Commission shall assess whether implementing acts referred to in paragraph 2, or parts thereof which cover the same requirements set out in Articles 5 to 11 and Article 2 4 need to be repealed or amended.
Article 3 3 Conformity assessment procedure Conformity assessment of packaging with the requirements set out in Articles 5 to 11 shall be carried out in accordance with the procedure set out in Annex VII. Article 3 4 EU declaration of conformity
1The EU declaration of conformity shall state that the fulfilment of the requirements set out in Articles 5 to 11 has been demonstrated.
2The EU declaration of conformity shall have the model structure set out in Annex VII I , shall contain the elements specified in the module set out in Annex VI I and shall be continuously updated . It shall be translated into the language or languages required by the Member State in which the packaging is placed on the market or made available on the market .
3Where pack a ging or the packaged product are subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall state the Union acts concerned and their publication references. It may be a dossier made up of relevant individual EU declarations of conformity.
4By drawing up the EU declaration of conformity, the manufacturer assume s responsibility for the compliance of the packaging with the requirements laid down in this Regulation.
SECTION 1 – General provisions
1Member States shall designate one or more competent authorities responsible for implementation and enforcement of the obligations set out in this Chapter and in Article 26 (1) to ( 10 ), Article 2 7 , Article 2 8 and Article 29 .
2Member States shall lay down the details of the organisation and operation of the competent authority or competent authorities, including administrative and procedural rules governing:
(a) the registration of producers in accordance with Article 39 ;
(b) the organisation and monitoring of reporting requirements under Article 39 (7);
(c) the oversight of the implementation of the extended producer responsibility obligations in accordance with Article 40 ;
(d) the making available of information in accordance with Article 50 .
3By [ OP: Please insert the date = 3 months after the date of entry into force of this Regulation ] , Member States shall notify the Commission of the names and addresses of the competent authorities designated pursuant to paragraph 1. Member States shall inform the Commission without undue delay of any changes to the names or addresses of those competent authorities.
1The Commission shall, in cooperation with the European Environment Agency, draw up reports on the progress towards the attainment of the targets laid down in Articles 38 and 46 at the latest three years before each of the deadlines laid down in those Articles.
2The reports referred to in paragraph 1 shall include the following:
(a) an estimation of the attainment of the targets by each Member State;
(b) a list of Member States at risk of not attaining the targets within the respective deadlines, accompanied by appropriate recommendations for the Member States concerned;
(c) examples of best practices that are used throughout the Union which could provide guidance for progressing towards attaining the targets.
Member States shall include in the waste management plans required pursuant to Article 28 of Directive 2008/98/EC a dedicated chapter on the management of packaging and packaging waste, including measures taken pursuant to Articles 38 and 45 of this Regulation. SECTION 2 – Waste prevention
1Each Member State shall reduce the packaging waste generated per capita, as compared to the packaging waste generated per capita in 2018 as reported to the Commission in accordance with Decision 2005/270/EC , by
(a) 5 % by 2030;
(b) 10 % by 2035;
(c) 15 % by 2040.
2Member States shall implement measures aiming to prevent the generation of p ackaging waste and to minimise the environmental impact of packaging .
3For the purpose of paragraph 2, Member States may use economic instruments and other measures to provide incentives for the application of the waste hierarchy, such as measures referred to in Annexes IV and IVa to Directive 2008/98/EC, or other appropriate instruments and measures, including incentives through extended producer responsibility schemes and requirements on producers or producer responsibility organisations to adopt waste prevention plans. Such measures shall be proportionate and non-discriminatory and be designed so as to avoid barriers to trade or distortions of competition in conformity with the Treaty.
4By [ OP: Please insert the dat e = 8 years after the date of entry into force of this Regulation ], the Commission shall review the targets laid down in paragraph 1. To that end, the Commission shall submit a report to the European Parliament and to the Council, accompanied, if the Commission finds it appropriate, by a legislative proposal.
5A Member State may, while observing the general rules laid down in the Treaty and complying with the provisions set out in this Regulation, adopt provisions which go beyond the minimum requir ements set out in this Article.
1Member States shall establish a register which shall serve to monitor compliance of producers of packaging with the requirements set out in this Chapter.
The register shall provide links to other national registers of producers’ websites to facilitate, in all Member States, registration of producers or appointed representatives for the extended producer responsibility.
2Producers shall be obliged to register in the register referred to in paragraph 1. They shall , to that end , submit an application for registration in each Member State where they make packaging available on the market for the first time. Where a producer has appointed a producer responsibility organisation as referred to in Article 41 (1) , the obligations set out in this Article shall be met by that organisation, unless otherwise specified by the Member State in which the register is established .
3The obligations set out in this Article may, on the producer’s behalf, be met by an appointed representative for the extended producer responsibility.
4Producers shall not make available packaging on the market , if they or, where applicable, their appointed representatives for the extended producer responsibility, are not registered in such Member State.
5The application for registration shall include the information to be provided in accordance with Part A of Annex I X. Member States may request additional information or documents if it is necessary for an efficient use of the register.
6Where an appointed representative for the extended producer responsibility represents more than one producer, it shall in addition to the information to be provided pursuant to paragraph 5, provide the name and the contact details of each one of the represented producers separately.
7The producer or, where applicable, the producer’s appointed representative for the extended producer responsibility or the producer responsibility organisation shall report to the competent authority responsible for the register , by 1 March for each full preceding calendar year, the information set out in Part B of Annex I X.
8The competent authority responsible for the register:
(a) shall receive applications for the registration of producers referred to in paragraph 2 via an electronic data-processing system, the details of which shall be made available on the competent authorities’ website;
(b) shall grant registrations and provide a registration number within a maximum period of twelve weeks from the moment that all the information laid down in paragraphs 5 and 6 is provided;
(c) may lay down modalities with respect to the requirements and process of registration without adding substantive requirements to the ones laid down in paragraphs 5 and 6;
(d) may charge cost-based and proportionate fees to producers for the processing of applications referred to in paragraph 2;
(e) shall receive and monitor the reporting referred to in paragraph 7.
9The producer, or, where applicable, the producer’s appointed representative for the extended producer responsibility or the producer responsibility organisation shall without undue delay notify the competent authority of any changes to the information contained in the registration and of any permanent cessation of the making available on the market within the territory of the Member State of the packaging referred to in the registration. A producer shall be excluded from the register if the producer has ceased to exist.
10Where the information in the register of producers is not publicly accessible, Member States shall ensure that providers of online platforms allowing consumers to conclude distance contracts with producers are granted access, free of charge, to the information in the register.
11The Commission shall adopt implementing acts establishing the format for registration in, and reporting to , the register and specifying the granularity of data to be reported and the packaging types and material categories to be covered by the reporting .
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3).
1Producers of packaging shall have extended producer responsibility under the schemes established in accordance with Articles 8 and 8a of Directive 2008/98/EC and with this Section for the packaging that they make available on the market for the first time within the territory of a Member State .
2A producer shall appoint, by written mandate, an appointed representative for the extended producer responsibility in each Member State other than the Member State where it is established where it makes packaging available for the first time.
3P roviders of online platforms , falling within the scope of Section 4 of Chapter 3 of Regulation (EU) 2022/2065 , allowing consumers to conclude distance contracts with producers shall obtain the following information from producers offering packaging to consumers located in the Union:
(a) information on the regist ration of the producers referred to in Article 39 in the Member State where the consumer is located and the registration number(s) of the producer in that register;
(b) a self-certification by the producer committing to only offer packaging with regard to which the extended producer responsibility requirements referred to in paragraphs 1 and 2 of this article are complied with in the Member State where the consumer is located.
1Producers may entrust a producer responsibility organisation authorised in accordance with Article 42 to carry out the extended producer responsibility obligations on their behalf. Member States may adopt measures to make the entrustment of a producer responsi bility organisation mandatory.
2Where, in the territory of a Member State, multiple producer responsibility organisations are authorised to fulfil extended producer responsibility obligations on behalf of producers, the Member State shall ensure that the producer responsibility organisations, when taken together, cover the whole territory of the Member State as regards the activities in accordance with Article s 42 (3) , 43 and 44 . Member States shall entrust the competent authority , or appoint an independent third party, to oversee that producer responsibility organisations fulfil their obligation s in a coordinated manner.
3Producer responsibility organisations shall ensure the confidentiality of the data in its possession as regards proprietary information or information directly attributable to individual producers or their appointed representatives.
4In addition to the information referred to in Article 8a(3), point (e), of Directive 2008/98/EC, producer responsibility organisations shall publish on their websites, at least every year and subject to commercial and industrial confidentiality, information on the amount of packaging made available on the market for the first time in the territory of a Member State and on the levels of recovered and recycled materials in relation to the amount of packaging for which they have been performing producer responsibility obligations.
1A producer , in the case of individual fulfilment of extended producer responsibility obligations, or the appointed producer responsibility organisations in the case of collective fulfilment of extended producer responsi bility obligations, shall apply for an authorisation from the competent authority.
2The Member State shall in its measures laying down administrative and procedural rules referred to in Article 35 , establish the requirements and details of the authorisation procedure, which can be different for either individual or collective fulfilment of the extended producer responsibility, and the modalities for verifying compliance, including the information to be provided by producers or producers responsibility organisations to that end. The authorisation procedure shall include requirements on the verification of the arrangements put in place to ensure compliance with the requirements laid down in paragraph 3 , and timeframes for this verification, which shall not exceed twelve weeks from the submission of a complete application dossier. This verification shall be done by an independent expert who shall issue a verification report on its result. The independent expert shall be independent of the competent authority and of the producer responsibility organisations or the producers authorised for individual fulfilment .
3The measures to be established by Member States in accordance with paragraph 2 shall include measures ensuring that:
(a) the requirements laid down in of Article 8a(3), points (a) to (d), of Directive 2008/98/EC are complied with ;
(b) the measures put in place by the producer or producer responsibility organisation are sufficient to allow for the return or collection in accordance with Article 43 (1) and (2) and Article 44 , free of charge, with a frequency proportionate to the area and volume covered, of packaging waste with regard to the amount and types of packaging made available on the market for the first time within the territory of a Member State by that producer or producers on whose behalf the producer responsibility organisation acts;
(c) the necessary arrangements , including preliminary arrangements, to that end are in place with distributors, public authorities or third parties carrying out waste management on their behalf;
(d) the necessary sorting and rec ycling capacity is available to ensure that packaging waste collected is subsequently subject to preliminary treatment and recycling;
(e) the requirement laid down in paragraph 6 is complied with ;
4The producer or the producer responsibility organisations shall notify the competent authority without undue delay of any changes to the information contained in the application for an authorisation, of any changes that concern the terms of the authorisation or of the permanent cessation of operations.
5The competent authority may decide to revoke the relevant authorisation in particular if the producer or producer responsibility organisation no longer fulfils the requirements with regard to the organisation of the treatment of packaging waste or fails in relation to reporting to the competent authority or in relation to the notification of any changes that concern the terms of the authorisation, or has ceased operations.
6A producer, in the case of individual fulfilment of extended producer responsibility obligations, and producer responsibility organisations appointed in the case of collective fulfilment of extended producer responsibility, shall provide a n adequate guarantee intended to cover the costs related to waste management operations due by the producer, or the producer responsibility organisation, in case of non compliance with the extended producer responsibility obligations, including in case of permanent cessation of its operations or insolvency. That guarantee may take the form of a recycling insurance or a blocked bank account or participation by the prodcuer in the producer responsibility organisation. Member S tate s may specify additional requirements on this guarantee.
1Member States shall ensure that systems are set up to provide for the return and separate collection of all packaging waste from the end users in order to ensure that it is treated in accordance with Articles 4 and 13 of Directive 2008/98/EC , and to facilitate its preparation for re-use and high quality recycling .
2Member States may allow derogations from paragraph 1 provided that collecting packaging or fractions of packaging waste together or together with other waste does not affect the potential of such packaging or fractions of packaging waste to undergo preparing for re-use, recycling or other recovery operations in accordance with Article s 4 and 13 of Directive 2008/98/EC and generate s output from those operations which is of comparable quality to that achieved through separate collection .
3Th e systems referred to in paragraph 1 shall :
(a) be open to the participation of the economic operators of the sectors concerned, the competent public authorities and third parties carrying out waste management on their behalf ;
(b) cover the whole territory of the Member State and all packaging waste from all types of packaging and activities , and take into account population size, expected volume and composition of packaging waste, a s well as accessibility and vicinity to end users . They shall include the separate collection in public spaces, business premises and residential areas ;
(c) be open to imported products under non-discriminatory conditions with regard to the detailed arrangements and any tariffs imposed for access to the systems and any other conditions, and be designed so as to avoid barriers to trade or distortions of competition in conformity with the Treaty .
4Member States shall take measures to promote recycling of packaging waste which meet s the quality standards for the use of recycled materials in the relevant sectors.
5By way of derogation from the separate waste collection obligation in paragraph 3 , certain types of packaging waste may be collected together where such collection does not affect their potential to undergo recycling operations and results in output from those operations which is of comparable quality to that achieved through separate collection.
1By 1 January 202 9 , Member States shall take the necessary measures to ensure that deposit and return systems are set up for:
(a) single use plastic beverage bottles with the capacity of up to three litres; and
(b) single use metal beverage containers with a capacity of up to three litres.
2The obligation laid down in paragraph 1 does not apply to packaging for:
(a) wine , aromatised wine products , and spirit drinks;
(b) milk and milk products listed in Part XVI of Annex I to Regulation (EU) No 1308/2013.
3Without prejudice to paragraph 1 of this Article, a Member State will be exempted from the obligation under paragraph 1 under the following conditions :
(a) the rate of separate collection as required under Article 43 (3) and (4) of the respective packaging format as reported to the Commission under Article 50 (1 ) point (c) is above 90 % by weight of such packaging placed on the market on the territory of that Member State in the calendar years 2026 and 2027. Where such reporting has not yet been submitted to the Commission, the Member State shall provide a reasoned justification, based on validated national data , and description of the implemented measures , that the conditions for the exemption set out in this paragraph are fulfilled ;
(b) at the latest 24 months before the deadline laid down in paragraph 1 of this Article, the Member State notifies the Commission of its request for exemption and submits an implementation plan showing a strategy with concrete actions , including timeline that ensure the achievement of the 90 % separate collection rate by weight of the packaging referred to in paragraph 1 .
4Within three months of receipt of the implementation plan submitted pursuant to paragraph 3 , point (b) , the Commission may request a Member State to revise that plan , if it considers that it does not comply with the requirements set out in point (c) of that paragraph . The Member State concerned shall submit a revised plan within 3 months of receipt of the Commission’s request .
5If the separate collection rate of the packaging referred to in paragraph 1 in a Member State concerned decreases and remains below 90 % by weight of a given packaging format placed on the market for three consecutive calendar years, the Commission shall notify the Member State concerned that the exemption no longer applies. The deposit and return system shall be established by 1 January in the second calendar year following the year in which the Commission notified the Member State concerned that the exemption no longer applies .
6Member States shall endeavour to establish and maintain deposit and return systems in particular for s ingle use glass beverage bottles, beverage cartons and for reusable packaging. Member States shall endeavour to ensure that deposit and return systems for single-use packaging formats, in particular for single use glass beverage bottles, are equally available for reusable packaging where technically and economically feasible.
7A Member State may, while observing the general rules laid down in the Treaty and complying with the provisions set out in this Regulation, adopt provisions which go beyond the minimum requirements set out in this Article.
8Member States shall ensure that return points and opportunities for reusable packaging with a similar purpose and format to those established under paragraph 1 are not less convenient for end users than opportunities to return single-use packaging to a deposit and return system.
9By 1 January 2028, Member States shall ensure that all deposit and return systems , including those established under paragraph 5, meet the minimum criteria listed in Annex X.
1Member States shall take measures to encourage the set-up of systems for re-use of packaging and systems for refill in an environmentally sound manner. Those systems shall comply with the requirements laid down in Article s 2 4 and 2 5 and Annex V I of this Regulation and shall not compromise food hygiene or the safety of consumers.
2The measures referred to in paragraph 1 may include:
(a) the use of deposit and return systems compliant with minimum requirements in Annex X for reusable packaging and for other packaging formats that those referred to in Article 44 (1) ,
(b) the use of economic incentives , including requirements to final distributors , to charge the use of single-use packaging or to inform consumers about the cost of such packaging at the point of sale ,
(c) requirements on final distributors to make available in reusable packaging within a system for re-use or through refill a certain percentage of other products than those covered by targets laid down in Article 26 on the condition that this does not lead to distortions on the internal market or trade barriers for products from other Member States .
1Member States shall take the necessary measures to attain the following recycling targets covering the whole of their territory :
(a) by 31 December 2025, a minimum of 65 % by weight of all packaging waste generated ;
(b) by 31 December 2025, the following minimum percentages by weight of the following specific materials contained in packaging waste generated :
(i) 50 % of plastic;
(ii) 25 % of wood;
(iii) 70 % of ferrous metals;
(iv) 50 % of aluminium;
(v) 70 % of glass;
(vi) 75 % of paper and cardboard;
(c) by 31 December 2030, a minimum of 70 % by weight of all packaging waste generated ;
(d) by 31 December 2030, the following minimum percentages by weight of the following specific materials contained in packaging waste generated :
(i) 55 % of plastic;
(ii) 30 % of wood;
(iii) 80 % of ferrous metals;
(iv) 60 % of aluminium;
(v) 75 % of glass;
(vi) 85 % of paper and cardboard.
2Without prejudice to paragraph 1, point (a), a Member State may postpone the deadlines set out in paragraph 1, points (b)( i ) to (vi), by up to 5 years, under the following conditions:
(a) the derogation from the targets in the period of postponement is limited to a maximum of 15 percentage points from a single target or divided between two targets,
(b) as a result of the derogation from the targets in the period of postponement, the recycling rate for a single target is not reduced below 30 %,
(c) as a result of the derogation from the targets in the period of postponement, the recycling rate for a single target referred to in paragraph 1, points (b)(v) or (vi) of paragraph 1 is not reduced below 60 %, and
(d) at the latest 24 months before the respective deadline laid down in paragraph 1, point (b), of this Article, the Member State notifies the Commission of its intention to postpone the deadline and submits to the Commission an implementation plan in accordance with Annex XI to this Regulation, which may be combined with an implementation plan submitted pursuant to Article 11(3), point (b), of Directive 2008/98/EC .
3Within three months of receipt of the implementation plan submitted pursuant to paragraph 2, point (d), the Commission may request a Member State to revise that plan if the Commission considers that the plan does not comply with the requirements set out in Annex XI. The Member State concerned shall submit a revised plan within 3 months of receipt of the Commission’s request.
4B y [ OP: Please insert the date = 8 years after the date of entry into force of this Regulation ], the Commission shall review the targets laid down in paragraph 1, points (c) and (d), of with a view to increasing them or setting further targets. To that end, the Commission shall submit a report to the European Parliament and to the Council, accompanied, if the Commission finds it appropriate, by a legislative proposal.
5Member States shall, where appropriate, encourage the use of materials obtained from recycled packaging waste for the manufacturing of packaging and other products by:
(a) improving market conditions for such materials;
(b) reviewing existing rules preventing the use of such materials.
6A Member State may, while observing the general rules laid down in the Treaty and complying with the provisions set out in this Regulation , adopt provisions which go beyond the minimum requirements set out in this Article.
1The calculati on whether the targets laid down in Article 46 (1) have been attained shall be carried out in accordance with the rules laid down in this Article.
2Member States shall calculate the weight of packaging waste generated in a given calendar year. The calculation of packaging waste generated in a Member State must be exhaustive.
3Member States shall calculate the weight of packaging waste recycled in a given calendar year. The weight of packaging waste recycled shall be calculated as the weight of packaging that has become waste which, having undergone all necessary checking, sorting and other preliminary operations to remove waste materials that are not targeted by the subsequent reprocessing and to ensure high-quality recycling, enters the recycling operation whereby waste materials are actually reprocessed into products, materials or substances.
4C omposite packaging and other packaging composed of more than one material shall be calculated and reported per material contained in the packaging. Member States may derogate from this requirement where a given material constitutes an insignificant part of the packaging unit, and in no case more than 5 % of the total mass of the packaging unit .
5P ackaging waste exported out of the Union shall be c alculated as recycled by the Member State in which it was collected only if, in accordance with Regulation (EC) No 1013/2006, the exporter can prove that the shipment of waste complies with the requirements of this Regulation and that the recycling of packaging waste outside the Union took place under conditions that are broadly equivalent to those prescribed by the relevant Union legislation.
6For the purposes of paragraph 3 , the weight of packaging waste recycled shall be measured when the waste enters the recycling operation.
By way of derogation from the first sub-paragraph of this Article, the weight of the packaging waste recycled may be measured at the output of any sorting operation provided that:
(a) such output waste is subsequently recycled;
(b) the weight of materials or substances that are removed by further operations preceding the recycling operation and are not subsequently recycled is not included in the weight of waste reported as recycled.
7Member States shall establish an effective system of quality control and traceability of the packaging waste to ensure that the conditions laid down in paragraphs 2 and to 7 are met. That system may consist of electronic registries s et up pursuant to Article 35(4) of Directive 2008/98/EC or technical specifications for the quality requirements of sorted waste. It may also consist of average loss rates for sorted waste for various waste types and waste management practices respectively, provided that reliable data cannot be otherwise obtained . Average loss rates shall be calculated on the basis of the calculation rules established in the delegated act adopted pursuant to Article 11a(10) of Directive 2008/98/EC.
8The amount of biodegradable packaging waste that enters aerobic or anaerobic treatment may be counted as recycled where that treatment generates compost, digestate, or other output with a similar quantity of recycled content in relation to input, which is to be used as a recycled product, material or substance. Where the output is used on land, Member States may count it as recycled only if this use results in benefits to agriculture or ecological improvement.
9The amount of packaging waste materials that have ceased to be waste as a result of a preparatory operation before being reprocessed may be counted as recycled provided that such materials are destined for subsequent reprocessing into products, materials or substances to be used for the original or other purposes. However, end-of-waste materials to be used as fuels or other means to generate energy, or to be incinerated, backfilled or landfilled, shall not be counted as recycled.
10Member States may take into account the recycling of metals separated after incineration of waste in proportion to the share of the packaging waste incinerated provided that the recycled metals meet certain quality criteria laid down in Commission Implementing Decision (EU) 2019/1004 .
11Packaging waste sent to another Member State for the purposes of recycling in that other Member State may only be counted as recycled by the Member State in which that packaging waste was collected.
12Packaging waste exported from the Union shall be counted as recycled by the Member State in which it was collected only if the requirements set out in paragraph 3 are met and if, in accordance with Regulation (EC) No 1013/2006, the exporter can prove that the shipment of waste complies with the requirements of that Regulation, including that the treatment of packaging waste outside the Union took place under conditions that are broadly equivalent to the requirements of the relevant Union environmental law.
1A Member State may decide to attain an adjusted level of the targets referred to Article 46 (1) for a given year by taking into account the average share, in the preceding three years, of reusable sales packaging placed on the market for the first time and re-used as part of a system for re-use of packaging.
The adjusted level shall be calculated by subtracting:
(a) from the targets laid down in Article 46 (1 ), points (a) and (c), the share of the reusable sales packaging referred to in the first subparagraph in all sales packaging placed on the market, and
(b) from the targets laid down in Article 46 ( 1), points (b) and (d), the share of the reusable sales packaging referred to in the first subparagraph, composed of the respective packaging material, in all sales packaging composed of that material placed on the market. No more than five percentage points of the average share of reusable sales packaging shall be taken into account for the calculation of the respective adjusted target level.
2A Member State may take into account the amounts of wooden packaging that is repaired for re-use in the calculation of the targets laid down in Article 46 (1), point (a), Article 46 (1), point (b)(ii), Article 46 (1), point (c), and Article 46 (1), point (d)(ii).
1In addition to the information referred to in Article 8a(2) of Directive 2008/98/EC and in Article 11 of this Regulation, producers or, where appointed in accordance with Article 41 (1), producer responsibility organisations shall make available to end-users, in particular consumers, the following information regarding the prevention and management of packaging waste with respect to the packaging that the producers supply within the territory of a Member State:
(a) the role of end-users in contributing to waste prevention, including any best practices;
(b) re-use arrangements available for packaging;
(c) the role of end-users in contributing to the separate collection of packaging waste materials, including handling of packaging containing hazardous products or waste;
(d) the meaning of the labels and symbols affixed, marked or printed on packaging in accordance with Article 11 or present in the documents accompanying the packaged product;
(e) the impact on the environment and on human health or safety of persons of inappropriate discarding of packaging waste, such as littering or discarding in mixed municipal waste, and the adverse environmental impact of single-use packaging, in particular plastic carrier bags;
(f) the composting properties and appropriate waste management options for compostable packaging.
2The information referred to in paragraph 1 shall be up to date and provided by means of:
(a) a website or other means of electronic communication;
(b) public information ;
(c) education programmes and campaigns ;
(d) signposting in a language, or languages, which can be easily understood by users and consumers.
3Where information is provided publicly, the confidentiality of commercially sensitive information in conformity with the relevant Union and national law shall be preserved.
1Member States shall report to the Commission for each calendar year the following data:
(a) data on the implementation of Article 46 (1), points (a) to (d), and on reusable packaging,
(b) the annual consumption of very l ightweight plastic carrier bags, lightweight plastic carrier bags and thick plastic carrier bags per person, separately for each category ;
(c) the separate c ollection rate of packaging covered by the obligation to establish dep o sit and return systems set out in Article 44 (1), Member States may provide data on the annual consumption of very thick plastic carrier bags per person .
2Member States shall report for each packaging material and type as listed in Table 1 of Annex I X for each calendar year data on :
(a) th e amounts of packaging placed on the market for each packaging type and material as listed in Table 1 of Annex I X ;
(b) a mounts of separately collected packaging waste for each packaging material as listed in Table 1 in the Annex I X ;
(c) the recycling rates;
(d) installed c apacities for s orting and recycling for each packaging type and material as listed in Table 1 of Annex II .
3The first reporting period shall concern :
(a) with respect to oblig ation s laid down in paragraph 1, points a and b, and paragraph 2, the first full calendar year after the entry into force of the implementing act that establishes the format for reporting to the Commission, in accordance with paragraph 7 ;
(b) with respect to oblig ation laid down in paragraph 1 , point c , the calendar year starting from 1 January 2028.
4Member States shall make the data referred to in paragraphs 1 and 2 available electronically within 19 months after the end of the reporting year for which the data are collected. They shall report the data electronically within 1 9 months of the end of the reporting year for which the data are collected in the format established by the Commission in accordance with paragraph 7 .
5The data made available by Member States in accordance with this Article shall be accompanied by a quality check report. That quality check report shall be presented in the format established by the Commission in accordance with paragraph 7.
6The data made available by Member States in accordance with this Article shall be accompanied by a report on the measures taken pursuant to Article 47 ( 5 ) and (8), including detailed information about the average loss rates where applicable.
7The Commission shall, by [OP: Please insert the date = 24 months after the date of entry into force of this Regulation ] , adopt implementing acts establishing :
(a) rules for the calculation, verification and reporting of data in accordance with paragraphs 1 , points (a) and (c) , and 2, including the methodology for determining packaging waste generated, and the format for the reporting;
(b) the methodology for the calculation of the annual consumption of l ightweight plastic carrier bags per person referred to in paragraph 1, point (b), and the format for their reporting; Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 59(3).
8Member States shall require that all economic operators making packaging available in the Member States provide competent authorities with accurate and reliable data allowing Member States to fulfil their reporting obligations under this Article, taking into account, where relevant, particular problems facing small and medium-sized enterprises with regard to the provision of detailed data.
1Member States shall take the necessary measures to ensure that databases on packaging and packaging waste are established, where not already in place, on a harmonised basis .
2The databases referred to in paragraph 1 shall include the following:
(a) information on the magnitude, characteristics and evolution of the packaging and packaging waste flows at the level of individual Member States;
(b) information on the toxicity or danger of packaging materials and components used for their manufacture;
(c) the data listed in Annex XII . Chapter VII I Safeguard procedures
1Without prejudice to Article 19 of the Regulation (EU) 2019/1020, where the market surveillance authorities of one Member State have sufficient reason to believe that packaging covered by this Regulation presents a risk to the environment or human health, they shall carry out an evaluation in relation to the packaging concerned covering all requirements laid down in this Regulation that are relvant to the risk. The relevant economic operators shall cooperate as necessary with the market surveillance authorities.
Where, in the course of that evaluation, the market surveillance authorities find that the packaging does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operator to take appropriate and proportionate corrective measures, within a reasonable period prescribed by the market surveillance authorities which is commensurate with the nature and, where relevant the degree of the non-compliance, to bring the packaging in compliance with those requirements.
2By derogation from paragraph 1, in case of risk to human health concerns relating to contact sensitive packaging subject to specific legislation aimed at protecting human health, the surveillance authorities shall not evaluate a risk to human or animal health originating from the packaging material, if transferred to the packaged content of the packaging material, but alert the authorities competent for controlling those risk s . These authorities shall be the competent authorities referred to in Regulation (EU) 2017/625, Regulation (EU) 2017/745, Regulation (EU) 2017/746, Directive 2001/83/EC or Regulation (EU) 2019/6.
3Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.
4The economic operator shall ensure that all appropriate corrective measures is taken in respect of all the concerned packaging that the economic operator has made available on the market throughout the Union.
5Where the relevant economic operator does not take adequate corrective measures within the period referred to in paragraph1, second subparagraph, or the non-compliance persists, the market surveillance authorities shall take all appropriate provisional measures to prohibit the making available of the packaging on their national market, to withdraw the packaging from that market or to recall it.
The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.
6The information to the Commission and the other Member States referred to in paragraph 4 shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 and shall include all available details, in particular the data necessary for the identification of the non-compliant packaging, the origin of the packaging, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator and, where applicable, the infor mation referred to in Article 54 (1) . The market surveillance authorities shall also indicate whether the non-compliance is due to either of the following:
(a) failure of the packaging to meet the sustainability requirements set out in Articles 5 to 10 of this Regulation;
(b) shortcomings in the harmonised standards or common specifications referred to in Articles 31 and 32 of this Regulation.
7Member States other than the Member State initiating the procedure shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the packaging concerned, and, in the event of disagreement with the adopted national measure, of their objections.
8Where, within three months of receipt of the information referred to in paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.
Provisional measures may provide for a period longer or shorter than three months in order to take account of the specificities of the requirements concerned.
9Member States shall ensure that the packaging is withdrawn from their market or that other appropriate restrictive measures are taken without delay in respect of the packaging or the manufacturer concerned.
1Where, on completion of the procedure set out in Article 52 (3) and (4), objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall decide by means of an implementing act whether the national measure is justified or not.
That implementing act shall be adopted in accordance with the examination procedure referred to in Article 59(3).
2The Commission shall address its decision to all Member States and shall without delay communicate it to them and the relevant economic operator or operators.
If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant packaging is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned shall withdraw that measure.
3Where the national measure is considered justified and the non-compliance of the packaging is attributed to shortcomings in the harmonised standards referred to in Article 3 1 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
4Where the national measure is considered justified and the non-compliance of the packaging is attributed to shortcomings in the common technical specifications referred to in Article 32 , the Commission shall, without delay, amend or repeal the common technical specifications concerned.
1Where, having carried out an evaluation under Ar ticle 52 , a Member State finds that although packaging is in compliance with the applicable requirements set out in Articles 5 to 11, it presents a risk to the environment or human health, it shall without delay require the relevant economic operator to take all appropriate measures, within a reasonable period prescribed by the market surveillance authorities and commensurate with the nature and, where relevant, the degree of risk , to ensure that the packaging concerned, when placed on the market, no longer presents that risk, to withdraw the packaging from the market or to recall it.
2By derogation from paragraph 1, in case of risk to human health concerns relating to contact sensitive packaging subject to specific legislation aimed at protecting human health, the surveillance authorities shall not evaluate a risk to human or animal health originating from the packaging material, if transferred to the packaged content of the packaging material, but alert the authorities competent for controlling those risk s . These authorities shall be the competent authorities referred to in Regulation (EU) 2017/625, Regulation (EU) 2017/745, Regulation (EU) 2017/746, Directive 2001/83/EC or Regulation (EU) 2019/6.
3The economic operator shall ensure that corrective measures are taken in respect of all the concerned packaging that the economic operator has made available on the market throughout the Union.
4The Member State shall immediately inform the Commission and the other Member States of its findings and subsequent actions pursuant to paragraph 1 . That information shall include all available details, in particular the data necessary for the identification of the packaging concerned, the origin and the supply chain of the packaging, the nature of the risk involved and the nature and duration of the national measures taken.
5The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall decide whether the national measure is justified or not and, where necessary, propose appropriate measures.
That implementing act shall be adopted in accordance with the examination procedure referred to in Article 59(3). On duly justified imperative grounds of urgency relating to the protection of the environment or human health, the Commission shall adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 58(4).
The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.
1Market surveillance authorities shall communicate without delay to the authorities designated pursuant to Article 25(1) of Regulation (EU) 2019/1020 the measures referred to in Article 52 (4) of this Regulation where the non-compliance is not restricted to their national territory. This communication shall include all relevant information, in particular the details necessary for the identification of the non-compliant packaging to which the measures apply and, in case of packaged product, the product itself .
2The communication of information referred to in paragraph 1 shall take place through entering the information in the relevant customs risk management environment.
3The Commission shall develop an interconnection to automate the communication referred to in paragraph 1 from the information and communication system referred to in Article 52 (5) to the environment referred to in paragraph 3. That interconnection shall start operating no later than two years from the date of the adoption of the implementing act referred to in paragraph 5.
4The Commission is empowered to adopt implementing acts specifying the procedural rules and the details of the implementation arrangements for paragraph 4, including the functionalities, data elements and data processing, as well as the rules on the processing of personal data, confidentiality and controllership for the interconnection referred to in paragraph 4. Those implementing acts shall be adopted in accordance with the examination procedure pursuant to Article 59 (3).
1Where a Member State makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:
(a) the EU declaration of conformity has not been drawn up
(b) the EU declaration of conformity has not been drawn up correctly;
(c) the QR code or data carrier referred to in Article 11 do not provide access to the required information in accordance with that Article;
(d) the technical documentation referred to in Annex VII is not available, is not complete or contains errors;
(e) the information referred to in Article 1 3 (6) or Article 1 6 (3) is absent, false or incomplete;
(f) any other administrative requirement set out in Article 1 3 or Article 1 6 is not fulfilled;
(g) the requirements on restrictions on uses of certain packaging formats and on excessive packaging set out in Articles 2 1 and 2 2 are not complied with;
(h) in relation to reusable packaging, the requirements on the establishment, operation and participation in a system for re-use referred to in Article 2 4 are not fulfilled;
(i) in relation to refill, the information requirements set out in Article 2 5 (1) and (2) are not fulfilled;
(j) the requirements on the refill stations set out in Article 2 5 (3) are not fulfilled;
(k) the re-use and refill targets in Article 26 are not achieved.
2Where the non-compliance referred to in paragraph 1, points (a) to (f), persists, the Member State concerned shall take all appropriate measures to prohibit the packaging being made available on the market or ensure that it is recalled or withdrawn from the market.
3Where the non-compliance referred to in paragraph 1, points (g) to (k), persists, Member States shall apply the rules on penalties applicable to infringements of this Regulation which are laid down by the Member States in accordance with Article 62 .
Chapter I X Green public procurement
1Contracting authorities, as defined in Article 2(1) of Directive 2014/24/EU or Article 3(1) of Directive 2014/25/EU, or contracting entities, as defined in Article 4(1) of Directive 2014/25/EU , shall, when awarding any public contracts for packaging or packaged products or for services using packaging or packaged products in situations covered by those Directives, apply the green public procurement criteria to be developed in delegated acts adopted pursuant to paragraph 3 .
2The obligation set out in paragraph 1 shall apply to any procedure for procurement by contracting authorities or contracting entities for the awarding of public contracts for packaging or packaged products or for services using packaging or packaged products , which is initiated 12 months or later after the entry into force of the respective delegated act to be adopted pursuant to paragraph 3.
3The Commission shall , by [ OP: please insert the date = 60 months after the date of entry into force of this Regulation ], adopt delegated acts in accordance with Article 5 8 supplementing this Regulation by establishing minimum mandatory green public procurement criteria based on the requirements set out in Article 5 to 10 and on the following elements :
(a) the value and volume of public contracts awarded for packaging or packaged products or for the services or works using packaging or packaged products;
(b) the need to ensure sufficient demand for more environmentally sustainable packaging or packaged products;
(c) the economic feasibility for contracting authorities or contracting entities to buy more environmentally sustainable packaging or packaged products, without entailing disproportionate costs. Those green public procurement criteria shall be developed in accordance with the principles contained in Directive 2014/24/EU and in Directive 2014/25/EU and with the principle that the packaging to be chosen on the basis of those criteria facilitates the achievement of the objectives of this Regulation.
Delegated powers and committee procedure
1The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.
2The power to adopt delegated acts referred to in Article 5(5), Article 6(4 ), Article 6(6), Article 7( 9 ), Article 7( 10), Article 7( 11 ), Article 8(5) , Article 22( 4 ), Article 26( 1 6 ) and Article 57 (3) shall be conferred on the Commission for a period of ten years from date of entry into force of this Regulation. The Commission shall draw up a report in respect of the delegation of power no later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension no later than 3 months before the end of each period.
3The delegation of power referred to in Article 5(5), Article 6 (4), Article 6(6) , Article 7( 9 ), Article 7( 10), Article 7( 11 ), Article 8(5) , Article 22( 4 ), Article 26( 1 6 ) and Article 57 (3) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.
4Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.
5As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.
6A delegated act adopted pursuant to Article 5(5), Article 6( 4 ), Article 6(6), Article 7( 9 ), Article 7( 10), Article 7( 11 ), Article 8(5) , Article 22( 4 ), Article 26( 1 6 ) and Article 57 (3) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. Th at period shall be extended by two months at the initiative of the European Parliament or of the Council.
1The Commission shall be assisted by the committee referred to in Article 39 of Directive 2008/98/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.
2Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
3Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act in respect of the implementing powers referred to in Article 72, and Article 5(4), third subparagraph, of Regulation (EU) No 182/2011 shall apply.
4Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 of that Regulation, shall apply.
Regulation (EU) 2019/1020 is amended as follows:
(a) Annex I is amended as follows:
(i) point 9 is deleted ;
(ii) the following point s are added: ’X [ OP Please insert the next consecutive number ] Directive (EU) 2019/904 of the European Parelimant and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment (OJ L 155, 12.6.2019, p.1);
‘X [ OP Please insert the next consecutive number ] Regulation (EU)…/… on packaging and packaging waste, amending Regulation (EU) 2019/1020 and repealing Direcitve 94/62/EC [ for the Publications Office to fill in the OJ publication details ].
(b) i n Annex II, point 8 is deleted .
Directive (EU) 2019/904 is amended as follows:
(a) in Article 6(5) , point (b) , is deleted ;
(b) in Article 13(1), point (e), is deleted ;
(c) Article 13(3) is be replaced by ‘ 3. The Commission shall review the data and information reported in accordance with this Article and publish a report on the results of its review. The report shall assess the organisation of the collection of the data and information, the sources of data and information and the methodology used in Member States as well as the completeness, reliability, timeliness and consistency of that data and information. The assessment may include specific recommendations for improvement. The report shall be drawn up after the first reporting of the data and information by the Member States a nd every four years thereafter.’ Chapter XI I Final provisions
1By [ OP: Please insert the date = 24 months after the date of entry into force of this Regulation ], Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Failure to comply with the requirements of Articles 2 1 to 2 6 shall be sanctioned by an administrative fine imposed on the relevant economic operator.
2Where the legal system of the Member State does not provide for administrative fines, the first paragraph may be applied in such a manner that the fining procedure is initiated by the relevant authority and imposed by competent national courts, while ensuring that those legal remedies are effective and have equivalent effect to the administrative fines referred to in that paragraph . In any event, the fines imposed shall also be effective, proportionate and dissuasive.
3Member States shall , by [ OP: please insert the date = 1 year after the date of entry into force of this Regulation ] , notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.
By [ OP: Please insert the date = 8 years after the date of application of this Regulation ], the Commission shall carry out an evaluation of this Regulation and of its contribution to the functioning of the internal market and the improvement of the environmental sustainability of packaging. The Commission shall present a report on the main findings of that evaluation to the European Parliament, the Council, the European Economic and Social Committee, and the Committee of the Regions. Member States shall provide the Commission with the information necessary for the preparation of that report.
Directive 94/62/EC is repealed with effect from [ OP: Please insert the date = 12 months after the date of entry into force of this Regulation ]. However, the following transitional provisions shall apply:
(a) Article 8(2) of Directive 94/62/EC shall continue to apply until [OP: Please insert the date = 42 months after the date of entry into force of this Regulation ];
(b) Article 5(2) and (3), Article 6(1), points (d) and (e), and Article 6a of Directive 94/62 /EC shall continue to apply until [ OP: Please insert the date = the last day of the calendar year following 3 6 months after the data entry into force of this Regulation ];
(c) Article s 12(3a), (3b), (3c) and (4) of Directive 94/62/EC shall continue to apply until [ OP: Please insert the date = the last day of the calendar year following 36 months after the date entry into force of this Regulation ] , except as regards the transmission of data to the Commission which shall continue to apply until [OP: Please insert the date = the last day of the calendar year following 54 months after the date entry into force of this Regulation ] . References to the repealed Directive shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex XIII.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union . It shall apply from [ OP: Please insert the date = 12 months after the date of entry into force of this Regulation ]. This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, For the European Parliament For the Council The President
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
1.3. The proposal/initiative relates to:
80 the extension of an existing action a merger or redirection of one or more actions towards another/a new action
The general objective of the legislative proposal is to reduce negative environmental impacts of packaging and packaging waste and improve the functioning of the internal market, thus boosting efficiency gains in the sector. The aim is to create a resilient value chain, starting from the design of the packaging till its re-use or -integration in high quality products, thus creating innovative, “green” jobs in a low carbon packaging industry.
1Reduce the generation of packaging waste;
2Promote a circular economy for packaging in a cost-efficient way;
3Promote the uptake of recycled content in packaging.
The modelling of the preferred option suggests for 2030 a reduction of waste generation, reduction in GHG, and environmental externalities avoided. Reduced waste management costs and reduced sales and consumption of packaging result in overall economic savings. The complex impacts on employment are estimated to result in a slight net increase of about 29.000 “green” jobs.
The preferred option results in a decrease in fossil fuel needs and increases the overall packaging recycling rate by 6.5 % in 2030, whereas landfill is decreased by 9 %. This push for circularity results in significantly reduced needs of virgin raw materials such as wood, glass and aluminium.
Overall, moving towards a more circular economy within packaging would deliver benefits such as empowering consumers, reducing negative impacts on the environment and human health, reducing the EU`s import dependency for raw materials and fossil fuel, stimulating innovation and boosting economic growth, and finally reducing unnecessary household expenditures.
The indicators of progress and achievement of the objectives will be: Increased quality of recyclates (secondary raw materials); Improved recycling efficiencies and higher material recovery for packaging materials (e.g. plastic, metal, glass, paper/cardboard, textile, wood, ceramics); All packaging will be fully recyclable by 2030;
Extended Responsibility Schemes fees are properly modulated; Mandatory targets for recycled content for plastic packaging; Re-use and refill targets for certain sectors.
1.5.1. Requirement(s) to be met in the short or long term including a detailed timeline for roll-out of the implementation of the initiative
The detailed requirements would need to be specified through implementing/delegated acts in a time horizon of 3-8 years. A series of actions in terms of delegated or implementing acts and possibly impact assessment reports will stem from this proposed Regulation. These will cover verification of compliance with sustainability requirements, conformity checking system, sustainability requirements, as well as information and labelling. A detailed list of these envisaged actions is provided below:
1.5.2. Added value of Union involvement (it may result from different factors, e.g. coordination gains, legal certainty, greater effectiveness or complementarities). For the purposes of this point 'added value of Union involvement' is the value resulting from Union intervention which is additional to the value that would have been otherwise created by Member States alone.
Recent internal market notifications from the Member States show that the implementation of some not-fully-harmonised provisions of the currently applicable Packaging and Packaging Waste Directive (PPWD), such as labelling requirements, or vague requirements, such as essential requirements on packaging minimisation or recyclability, are causing additional cost to the economic operators. These are strongly calling for further harmonisation not only to be able to work more cost efficiently, but also to overcome regulatory uncertainty about the environmental requirements for packaging, so that appropriate infrastructure investments can be made.
The problems cannot be sufficiently addressed by the Member States alone. The EU packaging market is in many respects one large market, rather than 27 individual markets. The packaging market is characterised by high-levels of cross-border trade between Member States, with many producers placing packaging on the market in multiple Member States. National initiatives in many aspects contribute to further fragmentation of the internal market and lack of effectiveness. Similarly, the packaging-related environmental concerns are widespread, with key underlying causes being common across all Member States.
There is clear added value in setting common requirements at EU level, as this will ensure a harmonised and well-functioning internal market and, therefore, a level playing field for packaging producers. With requirements and targets set at EU level, the move towards packaging being reusable or recyclable in an economically viable manner will take place in a coherent way in all Member States, creating a larger and more efficient market. Harnessing its strength to support the move towards a circular economy for packaging will support the achievement of targets in a more cost-effective way.
Economies of scale will be achieved through consistent approaches to, for example, influencing packaging design in such a way that packaging can be more cost-efficiently collected, sorted and recycled everywhere in the EU. Member State action alone could not achieve such harmonisation and thus economies of scale.
A number of related initiatives are very important for packaging: The Waste Framework Directive (WFD) establishes horizontally applicable concepts related to waste generation and waste management, including waste treatment, recycling and recovery. It creates the waste hierarchy, giving priority to waste prevention over reuse and/or recycling, subsequently recycling over other recovery options and final disposal via landfilling. Further, it obliges Member States to have in place functioning Extended Producer’s Responsibility (EPR) schemes, which ensure that producers of products bear responsibility for the management of the waste stage of their products. In the Circular Economy Action Plan (CEAP), the Commission committed to assess feasibility of harmonising the separate waste collection systems in the Member States.
The Single-Use Plastic Directive (SUPD) focusses - amongst other plastic products - also on certain plastic packaging (e.g. carrier bags, beverages cups, food and beverage containers including bottles) with the main purpose to prevent littering and its environmental impact. It contains product bans, the obligation for Member States to ensure the separate collection for recycling and to reduce the volume of certain groups of single use plastics. Finally, it established minimum recycled content targets for single use plastic beverage bottles.
Another legal act with respect to plastic packaging is the 2020 Own Resource Decision (ORD), which established an own resource based on plastic packaging waste not recycled in a specific Member States, irrespective whether this Member States meets the target or not. The ORD creates an incentive for Member States to put in place measures in the pursuit of high recycling rates for plastic packaging. It gives flexibility to the Member States in deciding on their efforts to have high plastic recycling rates in line with the WFD.
However, the PPWD is the main EU-level instrument dealing with placing on the market of packaging and requirements for its end-of life. There are also provisions on packaging or relevant to it in other EU legislation. The review of the PPWD has resulted in proposing a comprehensive Regulation setting sustainability requirements for packaging (recyclability, bio-based, compostable and bio-degradable packaging, use of recycled content and hazardous substances in packaging), dealing with packaging waste prevention and re-use, labelling for separate collection, collection and recycling of packaging, deposit and return systems, EPR requirements and packaging related green public procurement requirements.
1.5.4. Compatibility with the Multiannual Financial Framework and possible synergies with other appropriate instruments The initiatives fall under the umbrella of the European Green Deal, which guides the EU's recovery strategy. The Green Deal recognises the advantages of investing in our competitive sustainability by building a fairer, greener and more digital Europe. This includes circular economy, which is the main driver of increasing material recovery and improving quality of secondary raw materials.
The support and commitment of the European Commission in the research in the field of circular economy and in particular of better design of packaging and improving material recovery is expressed by the number of projects funded under the H2020 programme (over to 100 projects) and the financial contribution to their implementation (around 500 Million Euros). The results of these projects will support and promote circularity and recyclability of packaging formats. 1.5.5. Assessment of the different available financing options, including scope for redeployment
In theory, national legislations in Member States could have been established. However, there would have been no guarantee of consistent application across the EU and would inevitably contribute to further fragmentation of the internal market. Tasks related to development of secondary legislation at the EU level cannot be externalised.
limited duration
Financial impact from YYYY to YYYY for commitment appropriations and from YYYY to YYYY for payment appropriations. unlimited duration
81 Direct management by the Commission
Specify frequency and conditions. Standard rules for this type of expenditure apply.
2.2.1. Justification of the management mode(s), the funding implementation mechanism(s), the payment modalities and the control strategy proposed N/A – cf. above.
2.2.2. Information concerning the risks identified and the internal control system(s) set up to mitigate them N/A – cf. above. 2.2.3. Estimation and justification of the cost-effectiveness of the controls (ratio of "control costs ÷ value of the related funds managed"), and assessment of the expected levels of risk of error (at payment & at closure) N/A – cf. above.
Specify existing or envisaged prevention and protection measures, e.g. from the Anti-Fraud Strategy. N/A – cf. above.
3.1. Heading(s) of the multiannual financial framework and expenditure budget line(s) affected · Existing budget lines In order of multiannual financial framework headings and budget lines.
Heading of multiannual financial framework Budget line Type of expenditure Contribution Number Diff./Non-diff.
1 03 02 05 Single Market Programme — Producing and disseminating high quality statistics on Europe Diff.
3 09 02 02 Circular Economy and quality of life Diff.
7 20 01 02 01 – Remuneration and allowances Non-diff.
7 20 02 01 01 Contract staff Non-diff.
7 20 02 01 03 – National civil servants temporarily assigned to the institution Non-diff.
7 20 02 06 01 - Mission and representation expenses Non-diff.
7 20 02 06 02 – Meetings, expert groups Non-diff.
NO NO NO NO · New budget lines requested N/A 3.2. Estimated financial impact of the proposal on appropriations 3.2.1. Summary of estimated impact on operational appropriations – The proposal/initiative does not require the use of operational appropriations – The proposal/initiative requires the use of operational appropriations, as explained below:
EUR million (to three decimal places) Heading of multiannual financial framework
DG: ESTAT 2023 2024 2025 2026 2027 and beyond TOTAL □ Operational appropriations 03 02 05 Single Market Programme — Producing and disseminating high quality statistics on Europe Commitments (1) 0.090 0.090 0.090 0.125 0.140 0.535 Payments (2) 0.090 0.090 0.090 0.125 0.140 0.535 TOTAL appropriations
appropriations for DG ESTAT Commitments =(1) 0.090 0.090 0.090 0.125 0.140 0.535 Payments =(2) 0.090 0.090 0.090 0.125 0.140 0.535 In order to support the data collection in the area of packaging and packaging waste, service contracts for methodology and validation are needed, increasing in volume in 2026 and 2027 because of the new reporting obligation. The expected result of these actions is an increase in data quality which will not only benefit packaging and packaging waste and plastic carrier bags, but also the plastic own resource Heading of multiannual financial framework
DG: ENV 2023 2024 2025 2026 2027 and beyond TOTAL □ Operational appropriations 09 02 02 Circular Economy and quality of life Commitments (1) 0,500 0,500 0,500 0,200 0,400 2,100 Payments (2) 0,500 0,500 0,500 0,200 0,400 2,100 TOTAL appropriations for DG ENV Commitments =(1)
0,500 0,500 0,500 0,200 0,400 2,100 Payments =(2) 0,500 0,500 0,500 0,200 0,400 2,100 DG ENV costs stem from procurement needs for data collection and analysis on recyclability of packaging types, establishing a methodology for recycled content in plastic packaging etc. (estimated 2.1 million EUR for the period 2023-2027).
TOTAL Commitments (4) 0,590 0,590 0,590 0,325 0,540 2,635 Payments (5) 0,590 0,590 0,590 0,325 0,540 2,635 TOTAL appropriations under HEADING 1 to 3 of the multiannual financial framework Commitments =4 0,590 0,590 0,590 0,325 0,540 2,635 Payments =5 0,590 0,590 0,590 0,325 0,540 2,635 Heading of multiannual financial framework
This section should be filled in using the 'budget data of an administrative nature' to be firstly introduced in the Annex to the Legislative Financial Statement (Annex V to the internal rules), which is uploaded to DECIDE for interservice consultation purposes. EUR million (to three decimal places) 2023 2024 2025 2026 2027 and beyond TOTAL DG: ENV □ Human resources 0,644 0,732 0,732 0,817 0,817 3,742 □ Other administrative expenditure 0,484 0,484 0,484 0,484 0,484 2,420 TOTAL DG ENV Appropriations 1,128 1,216 1,216 1,301 1,301 6,162 3 AD posts are needed (existing staff) for the negotiation and general implementation of the regulation. and the different preparatory work and drafting of secondary legislation according to the deadlines proposed in the Packaging and Packaging Waste Regulation.
4 additional contractual staff (2 SNE and 2 CAs) are needed to perform the technical work, including:
TOTAL DG: ESTAT □ Human resources 0,157 0,157 0,242 0,242 0,242 1,040 □ Other administrative expenditure TOTAL DG ESTAT Appropriations 0,157 0,157 0,242 0,242 0,242 1,040
ESTAT currently devotes half AD post for validation and methodological guidance of packaging and packaging waste and lightweight carrier plastic bags. In order to address the many challenges related to packaging and packaging waste and consumption of lightweight carrier plastic bags, quality statistics based on exhaustive and comparable measures across countries are needed. For example, measuring reusable packaging in open loop systems poses several technical challenges. For the purpose of development of better methodological guidance and technical support and follow-up with Member States, an additional half AD is needed from 2023.
For the development and set up of the methodology for the additional reporting obligation on recyclability for 2028, a CA position is needed from 2025 onwards.
TOTAL appropriations under HEADING 7 of the multiannual financial framework (Total commitments = Total payments) 1,285 1,373 1,458 1,543 1,543 7,202 EUR million (to three decimal places) 2023 2024 2025 2026 2027 and beyond TOTAL TOTAL appropriations under HEADINGS 1 to 7 of the multiannual financial framework Commitments 1,875 1,963 2,048 1,868 2,083 9,837 Payments 1,875 1,963 2,048 1,868 2,083 9,837 3.2.2. Estimated output funded with operational appropriations Commitment appropriations in EUR million (to three decimal places) Indicate objectives and outputs Year N Year N+1 Year N+2 Year N+3 Enter as many years as necessary to show the duration of the impact (see point 1.6) TOTAL OUTPUTS Type
Total cost
… - Output - Output - Output Subtotal for specific objective No 1
TOTALS 3.2.3. E stimated impact on the COM administrative appropriations 3.2.3.1. Summary of estimated impact on administrative appropriations – The proposal/initiative does not require the use of appropriations of an administrative nature – The proposal/initiative requires the use of appropriations of an administrative nature, as explained below: 3.2.3.2.
EUR million (to three decimal places) 2023 2024 2025 2026 2027 and beyond TOTAL HEADING 7 of the multiannual financial framework Human resources 0,801 0,889 0,974 1,059 1,059 4,782 Other administrative expenditure 0,480 0,480 0,480 0,480 0,480
2,400 Subtotal HEADING 7 of the multiannual financial framework 1,285 1,373 1,458 1,543 1,543 7,202 Outside HEADING 787 of the multiannual financial framework N/A N/A N/A N/A N/A N/A Human resources Other expenditure of an administrative nature Subtotal outside HEADING 7 of the multiannual financial framework N/A N/A N/A N/A N/A N/A TOTAL 1,285 1,373 1,458 1,543 1,543 7,202 The appropriations required for human resources and other expenditure of an administrative nature will be met by appropriations from the DG that are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.
The proposal/initiative does not require the use of human resources.
The proposal/initiative requires the use of human resources, as explained below:
2023 2024 2025 2026
23455
88
Other budget lines (specify)
67899
XX is the policy area or budget title concerned. The human resources required will be met by staff from the DG who are already assigned to management of the action and/or have been redeployed within the DG, together if necessary with any additional allocation which may be granted to the managing DG under the annual allocation procedure and in the light of budgetary constraints.
Description of tasks to be carried out: Officials and temporary staff DG ENV: 3 AD posts are needed (existing staff) for the negotiation and general implementation of the regulation. and the different preparatory work and drafting of secondary legislation according to the deadlines proposed in the Packaging and Packaging Waste Regulation.
DG ESTAT: Staff will measure reusable packaging in open loop systems poses several technical challenges. For the purpose of development of better methodological guidance and technical support and follow-up with Member States, an additional half AD is needed from 2023. IT support is ensured by horizontal services in the unit ESTAT.E.2, which are estimated to be 1/20 of an AST post for the packaging and packaging waste and lightweight carrier plastic bags data collections. 2023 2024 2025 2026 2027
External staff
The END positions (existing) and the CA (additional) are needed to perform the technical work, supporting the preparation of acts relating to: · Reporting obligations on recycling targets, collection of certain packaging formats and consumption of plastic carrier bags’ · Recyclability requirements for certain packaging categories; · Harmonised reporting rules for extended reporting responsibility schemes; · Harmonised calculation and verification rules for the recycled content in packaging; · Review recycled content targets in light of technical and economic developments; · Harmonisation rules for the labelling requirements and formats for consumer sorting, reusable packaging, recycled content, compostable and a QR code and other digital data carriers;
· Review exemptions to restrictions on substances of concern in packaging; · Establish minimum mandatory green public procurement criteria; The execution of these tasks require 4 additional contractual staff, 2 SNE and 3 CAs (1 CA is allocated to ESTAT)
The proposal/initiative:
requires use of the unallocated margin under the relevant heading of the MFF and/or use of the special instruments as defined in the MFF Regulation.
The proposal/initiative:
Appropriations in EUR million (to three decimal places) Year N 89 Year N+1 Year N+2 Year N+3 Enter as many years as necessary to show the duration of the impact (see point 1.6) Total Specify the co-financing body TOTAL appropriations co-financed 3.3. Estimated impact on revenue – The proposal/initiative has no financial impact on revenue.
Appropriations available for the current financial year Impact of the proposal/initiative
Enter as many years as necessary to show the duration of the impact (see point 1.6) Article …………. For assigned revenue, specify the budget expenditure line(s) affected. N/A. Other remarks (e.g. method/formula used for calculating the impact on revenue or any other information).
(6)
T he European Skills Agenda is a five-year plan to help individuals and businesses develop more and better skills in the context of green transitions https://ec.europa.eu/social/BlobServlet?docId=22832&langId=en
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2019%3A640%3AFIN
(13)
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52022PC0142
(20)
Reducing packaging waste – public consultation. https://ec.europa.eu/info/law/better-regulation/have-your-say/initiatives/12263-Reducing-packaging-waste-review-of-rules/public-consultation_en
(22)
Scoping study to assess the feasibility of further EU measures on waste prevention and implementation of the Plastic Bags Directive. Part II, Implementation of Plastic Bags Directive - Publications Office of the EU (europa.eu) .
.
(25)
Commission Decision 2005/270/EC of 22 March 2005 establishing the formats relating to the database system under Directive 94/62/EC of the European Parliament and of the Council on packaging and packaging waste, as last amended by Commission Implementing Decision (EU) 2019/665 of 17 April 2019 (consolidated version OJ L 112, 26.4.2019, p. 26–46) .
(27)
Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC ( OJ L 218, 13.8.2008, p. 82–128) .
(34)
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM:2020:98:FIN&WT.mc_id=Twitter
(2022), Environmental and economic assessment of plastic waste recycling, Mechanical, physical and chemical recycling technologies, publication pending .
(38)
https://data.consilium.europa.eu/doc/document/ST-13852-2020-INIT/en/pdf
(43)
Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Chemicals Strategy for Sustainability Towards a Toxic-Free Environment, COM/2020/667 final.
(45)
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1) . (46)
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 ( OJ L 353, 31.12.2008, p. 1 ).
(48)
Commission Decision 2001/171/EC of 19 February 2001 establishing the conditions for a derogation for glass packaging in relation to the heavy metal concentration levels established in Directive 94/62/EC on packaging and packaging waste , OJ L 62, 2.3.2001, p. 20.
(50)
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use ( OJ L 311, 28.11.2001, p. 67 ).
(53)
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
(54) Contact sensitive packaging refers to plastic packaging of products covered by Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29), Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food (OJ L 338 13.11.2004, p.
4), Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (OJ L 229, 1.9.2009, p. 1), Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (OJ L 342, 22.12.2009, p.
59), Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1), Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p.
176), Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (OJ L 4, 7.1.2019, p. 1), Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43) , Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p.
67) and Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (OJ L 260, 30.9.2008, p. 13–59).
(56)
Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council Text with EEA relevance (OJ L 316, 14.11.2012, p. 12).
(59)
Commission Decision of 28 January 1997 establishing the identification system for packaging materials pursuant to European Parliament and Council Directive 94/62/EC on packaging and packaging waste (OJ L 50, 20.2.1997, p. 28–31) .
(62)
Scoping study to assess the feasibility of further EU measures on waste prevention and implementation of the Plastic Bags Directive. Part II, Implementation of the Plastic Bags Directive, Eunomia (2021), published by the Publication Office of the European Union, 2022.
(65)
Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64).
(67)
Regulation (EU) No 1308/2013 of the European Parliament and of t he Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 ( OJ L 347, 20.12.2013, p. 671 ).
(69)
Commission Implementing Decision (EU) 2019/1004 of 7 June 2019 laying down rules for the calculation, verification and reporting of data on waste in accordance with Directive 2008/98/EC of the European Parliament and of the Council and repealing Commission Implementing Decision C(2012)2384 (OJ L 163, 20.6.2019, p. 66).
(72)
Commission Decision 2005/270/EC of 22 March 2005 establishing the formats relating to the database system pursuant to Directive 94/62/EC of the European Parliament and of the Council on packaging and packaging waste (OJ L 86, 5.4.2005, p. 6).
(74)
Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).
(79)
NACE Rev. 2 - Statistical classification of economic activities - Products Manuals and Guidelines - Eurostat (europa.eu) ; Accommodation and food service statistics - NACE Rev. 2 - Statistics Explained (europa.eu)
https://myintracomm.ec.europa.eu/budgweb/EN/man/budgmanag/Pages/budgmanag.aspx
(85)
Outputs are products and services to be supplied (e.g.: number of student exchanges financed, number of km of roads built, etc.).
(90)
As regards traditional own resources (customs duties, sugar levies), the amounts indicated must be net amounts, i.e. gross amounts after deduction of 20 % for collection costs.
Brussels, 30.11.2022 COM(2022) 677 final
to the Proposal for a Regulation of the European Parliament and the Council on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC {SEC(2022) 425 final} - {SWD(2022) 384 final} - {SWD(2022) 385 final}
Items covered by Article 3(1)(a) Packaging Sweet boxes Film overwrap around a CD case Mailing pouches for catalogues and magazines (with a magazine inside)
Cake doilies sold with a cake Rolls, tubes and cylinders around which flexible material (e.g. plastic film, aluminium, paper) is wound, except rolls, tubes and cylinders intended as parts of production machinery and not used to present a product as a sales unit Flower pots intended to be used only for the selling and transporting of plants and not intended to stay with the plant throughout its life time Glass bottles for injection solutions CD spindles (sold with CDs, not intended to be used as storage) Clothes hangers (sold with a clothing item) Matchboxes Sterile barrier systems (pouches, trays and materials necessary to preserve the sterility of the product) Beverage system capsules (e.g. coffee, cacao, milk)
Refillable steel cylinders used for various kinds of gas, excluding fire extinguishers Tea and coffee foil pouches Non-packaging Flower pots intended to stay with the plant throughout its life time Tool boxes Wax layers around cheese Sausage casing skins Clothes hangers (sold separately) Cartridges for printers CD, DVD and video cases (sold together with a CD, DVD or video inside) CD spindles (sold empty, intended to be used as storage) Soluble bags for detergents Grave side lights (containers for candles) Mechanical quern (integrated in a refillable recipient, e.g. refillable pepper mill) Items covered by Article 3(1)(d-e) Packaging, if designed and intended to be filled at the point of sale Paper or plastic carrier bags Disposable plates and cups Cling film
Sandwich bags Aluminium foil Plastic foil for cleaned clothes in laundries Non-packaging Stirrer Disposable cutlery Wrapping paper (sold separately to consumers and business operators) Paper baking cases (sold empty) Cake doilies sold without a cake Items covered by Article 3(1)(b-c) Packaging Labels hung directly on or attached to a product including sticky labels attached to fruits and vegetables Part of packaging Mascara brush which forms part of the container closure Sticky labels attached to another packaging item Staples Plastic sleeves Device for measuring dosage, which forms part of the container closure for detergents Mechanical quern (integrated in a non-refillable recipient, filled with a product, e.g. pepper mill filled with pepper) Non-packaging
Radio frequency identification (RFID) tags
Table 1: Indicative list of packaging materials, types and categories referred to in Article 6 Category No Predominant packaging material Packaging type Format (illustrative)
| 1 | Glass | Glass | Bottles, jars, flacons, cosmetics pots, tubs etc. made of glass (soda lime silica) |
| 2 | Glass | Composite packaging, of which the majority is glass | Bottles, jars, flacons, cosmetics pots, tubs |
| 3 | Paper/cardboard | Paper/cardboard packaging | Boxes, trays, grouped packaging |
| 4 | Paper/cardboard | Composite packaging of which the majority is paper/cardboard |
Including beverage cartons, plates and cups, i.e., metallised or plastic laminated paper/card, liquid paperboard, paper/cardboard with plastic liners/windows 5 Metal Steel Rigid packaging formats (aerosols, cans, paint tins, boxes, etc.) made of steel, including tinplate 6 Metal Composite packaging, of which the majority is steel Drums, tubes, cans, boxes, trays, etc.
9 Metal Composite packaging of which the majority is Aluminium Drums, tubes, cans, boxes, trays, etc.
PET - rigid Rigid packaging other than bottles and flasks (Includes pots, tubs and trays) Transparent
27
Plastic Other flexible plastics including multilayer plastic films and multi material materials - flexible Pouches
30 Ceramics or porcelain stoneware Clay, stone Pots, containers, bottles Table 2: Recyclability performance grades Recyclability Performance Grade Assessment of recyclability per unit, in weight Grade A higher or equal to 95 % Grade B higher or equal to 90 % Grade C higher or equal to 80 % Grade D higher or equal to 70 % Grade E lower than 70 % ANNEX II I COMPOSTABLE PACKAGING Conditions to be considered when mandating the use of compostable packaging format:
(a) it could not have been designed as reusable packaging or the products could not be placed on the market without packaging;
(b) it is designed to enter the organic wast e stream at the end of its life;
(c) it is of b iodegradable nature allowing the packaging to undergo physical, chemical, thermal or biological decomposition , including anaerobic digestion, resulting ultimately in conversion into carbon dioxide or methane, in the absence of oxygen , mineral salts, biomass and water,
(d) i t s use significantly increases the collection of organic waste compared to the use of non-compostable packaging materials;
(e) it s use significantly reduces the contamination of compost with non-compostable packaging; and
(f) its use does not increase the contamination of non-compostable packaging waste streams.
1Product protection: packaging design shall ensure the product protection from the point of packaging or filling until the end use, with a view to prevent significant product damage, loss, deterioration or waste. Requirements may consist of protection against mechanical or chemical damage, vibration, compression, humidity, light, oxygen, microbiological infection, pest, deterioration of organoleptic properties etc. and include references to specific legislation setting out requirements on product quality.
2Packaging manufacturing processes: The packaging design shall be compatible with the packaging manufacturing and filling processes.
3Logistics: The packaging design shall ensure adequate and safe distribution, transport, handling and warehousing of the packaged product.
4Information requirements: The packaging design shall ensure that any necessary information regarding the packaged product itself, its use, storage and care, including safety instructions can be provided to users and consumers.
5Hygiene and safety : the packaging design shall ensure user and consumer safety as well as product safety and hygiene throughout the distribution, end use and disposal.
6Legal requirements : the packaging design shall ensure that the packaging and packaged product can comply with the applicable legislation.
7Recycled content, recyclability and re-use : The packaging design shall ensure recyclability and inclusion of recycled content as required under this Regulation. If the packaging is intended for re-use, it shall fulfil the requirements laid down in Article 10(1) of this Regulation .
Assessment methodology and determination of the minimum packaging volume and weight The assessment of the minimum packaging volume and weight necessary to ensure the packaging functionality as described in Article 3(1) of the Regulation shall be explained in the technical documentation and shall include at least:
(a) f or each performance criterion as listed in Part I, a list of design requirements which prevent further reduction of the packaging weight or volume without endangering the packaging functionality, including safety and hygiene , for the packaged product, packaging and user. The method used for the identification of these design requirements shall be described, and the reasons preventing further reduction of the packaging weight or volume shall be explained. All reduction opportunities with a given packaging material shall be investigated . It shall not be sufficient to substitute one packaging material with another ;
(b) t he description of the outcome of the assessment, including the details of the calculation of the minimum necessary weight and volume for the packaging . P ossible variations between production batches for a same packaging shall be taken into account and documented ;
(c) a ny test results, market research or studies that have been used for the assessment conducted under points (a) and (b).
Packaging format Restricted use Illustrative example
Plastic packaging used at retail level to group goods sold in cans, tins, pots, tubs, and packets designed as convenience packaging to enable or encourage end users to purchase more than one product. This excludes grouped packaging necessary to facilitate handling in distribution. Collation films, shrink wrap
Single use packaging for less than 1.5 kg fresh fruit and vegetables, unless there is a demonstrated need to avoid water loss or turgidity loss, microbiological hazards or physical shocks. Nets, bags, trays, containers
Single use packaging for foods and beverages filled and consumed within the premises in the HORECA sector, which include all eating area inside and outside a place of business, covered with tables and stools, standing areas, and eating areas offered to the end users jointly by several economic operators or third party for the purpose of food and drinks consumption Trays, disposable plates and cups, bags, foil, boxes
Single use packaging in the HORECA sector, containing individual portions or servings, used for condiments, preserves, sauces, coffee creamer, sugar and seasoning, except such packaging provided together with take-away ready-prepared food intended for immediate consumption without the need of any further preparation Sachets, tubs, trays, boxes
For cosmetics, hygiene and toiletry products of less than 50 ml for liquid products or less than 100 g for non-liquid products Shampoo bottles, hand and body lotion bottles, sachets around miniature bar soap
For the purposes of this Annex, the following definitions shall apply:
(a) ‘c losed l oop system’ shall mean a system for re-use in which reusable packaging is circulated by a system operator or a co-operating group of system participants without the change of the ownership of packaging ;
(b) ‘o pen loop system’ shall mean a system for re-use in which reusable packaging circulates amongst unspecified number of system participants , and the ownership of the packaging changes at one or more points in the re - use process ;
(c) ‘system operator’ shall mean any natural or legal person being a system participant, who manages a system for re-use ;
(d) ‘system participants’ shall mean any natural or legal person, who participates in the system for re-use and performs at least one of the following actions: collects the packaging either from end users or from other system participants, reconditions it, distributes it among system participants, transports it, fills it with products, packs it, or offers it to end users. System for re - use can comprise one or more participant s performing these actions.
The following requirements apply for all systems for re-use and shall be simultaneously satisfied:
In addition to the general requirements under point 1, the following requirements shall be simultaneously satisfied:
In addition to the general requirements under point 1, the following requirements must be simultaneously satisfied:
Part B Reconditioning
1The r econditioning process shall not create risk s to the health and safety of those responsible for doing so and strive to reduce its impact on the environment. It shall be operated in accordance with applicable legislation on contact sensitive materials.
2Reconditioning shall cover the following operations adapted to the reusable packagin g format and its intended use:
3Where necessary, cleaning and washing processes should be applied at differ ent stages of the reconditioning and repeated.
4The reconditioned product shall meet health and safety requirements applicable to it.
As regard refill stations shall fulfil the following requirements:
(a) contain a clear and precise information on :
container ;
1Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 45, and ensures and declares on his sole responsibility that the packaging concerned satisfies the requirements of Articles 5 to 10 of this Regulation that apply to them.
The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the packaging’s conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s). The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the packaging. The technical documentation shall contain, wherever applicable, at least the following elements:
(i) the harmonised standards, referred to in Article 31, applied in full or in part
(ii) the common technical specifications, referred to in Article 32, applied in full or in part
(iii) other relevant technical specifications used for measurement or calculation purposes,
(iv) in the event of partly applied harmonised standards and/or common specifications, an indication of the parts which have been applied,
(iv) in the event of harmonised standards and/or common technical specifications not being applied, a description of the solutions adopted to meet the requirements referred to in point 1.
The manufacturer shall take all measures necessary, so that the manufacturing process and its monitoring ensure compliance of the manufactured packaging with the technical documentation referred to in point 2 and with the requirements referred to in point 1.
The manufacturer shall draw up a written declaration of conformity for a packaging type and keep it together with the technical documentation at the disposal of the national authorities for 10 years after the packaging has been placed on the market. The declaration of conformity shall identify the packaging for which it has been drawn up.
A copy of the declaration of conformity shall be made available to the relevant authorities upon request.
The manufacturer's obligations set out in point 4 may be fulfilled by his authorised representative, on his behalf and under his responsibility, provided that they are specified in the mandate.
1No…. (unique identification of the packaging) :
2Name and address of the manufacturer and, where applicable, its authorised representative .
3This declaration of conformity is issued under the sole responsibility of the manufacturer.
4Object of the declaration (identification of the packaging allowing traceability): description of the packaging .
5The object of the declaration described in point 4 is in conformity with the relevant Union harmonisation legislation: … (reference to the other Union acts applied).
6References to the relevant harmonised standards or the common specifications used or references to the other technical specifications in relation to which conformity is declared.
7The notified body … (name, address, number) … performed … (description of intervention) … and issued the certificate(s): … (details, including its date, and, where appropriate, information on the duration and conditions of its validity).
Signed for and on behalf of: (place and date of issue): (name, function) (signature) * (identification number of the declaration)
1The i nformation to be submitted by the producer or its authorised representative for EPR shall include:
(a) n ame and brand names (if available) under which the producer operates in the Member State and address of the producer including postal code and place, street and number, country, telephone, if any, web address and e-mail address, indicating a single contact point;
(b) nation al identification code of the producer, including its trade register number or equivalent official registration number and the European or national tax identification number;
(c) quantities by weight of type s of packaging as set out in Table 1 of Annex II , that the producer makes available in the Member State for the first time;
(d) a declaration on how the producer meets its responsibilities under Article 40 .
2W here a producer responsibility organisation is entrusted to carry out the EPR obligations , the information to be provided shall include the name and contact details, including postal code and place, street and number, country, telephone, web address and e-mail address and the national identification code of the producer responsibility organisation, including the trade register number or an equivalent official registration number and the European or national tax identification number of the producer responsibility organisation, and the represented producer’s mandate, a statement by the producer or, where applicable, producer’s authorised representative for the EPR or the producer responsibility organisation, stating that the information provided is true.
3In the case of an authorisation in accordance with Article 41 (1) , the producer responsibility organisation shall, in addition to the information required under point 1 of Part A of this Annex , provide:
(a) the names and contact details, including postal codes and places, streets and numbers, countries, telephones, web addresses and e-mail addresses of the producers represented;
(b) the mandate of each represented producer, where applicable;
(c) where the producer responsibility organisation represents more than one producer, it shall indicate separately how each one of the represented producers meets the responsibilities set out in Article 40 . B. Information to be submitted for reporting
(a) n ational identification code of the producer ;
For the purpose of this Annex, the following definition shall apply:
‘system operator’ means any natural or legal person, who is entrusted with a responsibility to establish or operate a deposit and return system in a Member State.
Minimum general requirements for deposit and return systems Member States shall ensure that the deposit and return systems established on their territories meet the following minimum requirements:
(i) a statute establishing its internal organization;
(ii) evidence of its funding system;
(iii) a statement proving the compliance of the system with the requirements laid down in the Regulation, as well as any additional requirements established in the Member State in which it operates;
(i) sales surface area allowing end users to return deposit bearing packaging in their local conditions;
(ii) buying and selling habits and traditions;
(iii) food safety;
(iv) health and safety;
(v) public health;
In addition to the minimum requirements, Member States may set additional requirements, as appropriate, in order to ensure the fulfilment of the objectives of this Regulation, in particular to increase the purity of the collected packaging waste, reduce litter or promote other circular economy objectives.
Member States with regions with high transboundary business shall ensure that the functioning of the DRS allows for the inter-operability of DRS and that the implementation of the minimum requirements and of any additional requirements does not result in discrimination of business and consumers and market distortions.
Member States are allowed to create exemptions from charging a deposit for a deposit bearing packaging in the context of consumption in hospitality premises provided that a deposit bearing packaging is opened, the product is consumed, and the empty deposit bearing packaging is returned within the premises.
The implementation plan to be submitted pursuant to Article 46(2), point (d), shall contain the following:
(a) assessment of the past, current and projected rates of recycling, landfilling and other treatment of packaging waste and the streams of which it is composed;
(b) assessment of the implementation of waste management plans and waste prevention programmes in place pursuant to Articles 28 and 29 of Directive 2008/98/EC;
(c) reasons for which the Member State considers that it might not be able to attain the rel evant target laid down in point (b) of Article 46 (1) within the deadline set therein and an assessment of the time extension necessary to meet that target;
(d) measures necessary to attain the targets set out in points (b) of Article 46 (1) of this Regulation that are applicable to the Member State during the time extension, including appropriate economic instruments and other measures to provide incentives for the application of the waste hierarchy as set out in Article 4(1) of, and Annex IVa to, Directive 2008/98/EC;
(e) a timetable for the implementation of the measures identified in point 4, determination of the body competent for their implementation and an assessment of their individual contribution to attaining the targets applicable in the event of a time extension;
(f) information on funding for waste management in line with the polluter-pays principle;
(g) measures to improve data quality, as appropriate, with a view to better planning and monitoring performance in waste management.
1For sales , grouped and transport packaging:
(a) quantities, for each packaging categories of packaging generated within the Member State (produced + imported + stored - exported) (Table 1);
(b) quantities reused (Table 2).
2For sales, grouped and transport packaging waste:
(a) Quantities for separately collected packaging waste per material (Table 3)
(b) Q uantities recovered and disposed of, recycled and quantities recovered for each packaging type (Table 4 ).
(c) The annual consumption of very lightweight plastic carrier bags, lightweight plastic carrier bags and thick plastic carrier bags per person, separately for each category, as laid down in Article 50 (1) point (b) (Table 5)
(d) Separate collection rate of the packaging formats covered by the deposit return systems, as laid down in Article 44 (1) (Table 6)
TABLE 1 Quantity of packaging (sales, grouped and transport) generated within the national territory Tonnage produced - Tonnage exported + Tonnage imported + Tonnage stored = Total Glass Plastic Paper/cardboard (including composite) Ferrous metal Aluminium Wood Other Total TABLE 2 Quantity of packaging (sales, grouped and transport) reused within the national territory Tonnage of packaging placed on the market for the first time Reusable packaging Reusable sales packaging tonnage Percentage Tonnage Percentage Glass Plastic Paper/cardboard (including composite packaging) Ferrous metal (including tinplate and composite packaging) Aluminium Wood Other Total
Quantity of separately collected packaging waste per material (sales, grouped an transport) generated within the national territory Packaging material Waste generation (t) From separate collection (t) Glass Plastic (rigid and flexible) Paper/cardboard (including composite) Metals (Ferrous metal and aluminium) Wood Other Total TABLE 4 Quantity of packaging waste recovered and disposed of within the national territory Packaging Total tonnage recovered and disposed of Quantity recycled Quantity recovered Tonnage Percentage Tonnage Percentage Glass, including composite Plastic, PET Rigid Plastic, PP Plastic, HDPE and PP Plastic, PS Plastic, HDPE Plastic, PVC Plastic, PC Plastic, EPS Plastic, XPS Plastic, PET Flexible Plastic, PP Plastic, PE Plastic, multilayer
Paper/cardboard (non-composite) Composite Paper/cardboard Ferrous metal (including tinplate and composite packaging of which the majority is steel) Aluminium (including composite packaging of which the majority is aluminium Wood Textile Ceramic, porcelain or stoneware Other Total packaging waste Table 5 Quantity of very lightweight plastic carrier bags, lightweight plastic carrier bags, thick plastic carrier bags, and very thick plastic carrier bags per person, consumed within the national territory Plastic carrier bags consumed within the national territory Number per person Tonnes per person very lightweight plastic carrier bags plastic carrier bags with a wall thickness below 15 microns lightweight plastic carrier bags plastic carrier bags with a wall thickness below 50 microns
thick plastic carrier bags plastic carrier bags with a wall thickness between 50 and 99 microns Table 6 Separate collection rate of packaging formats covered under the deposit return systems, as laid down in Article 44(1) Tonnes of packaging placed on the market for the first time within the national territory (t) Separately collected within the national territory by the deposit and return scheme (t) Single use plastic beverage bottles with the capacity of up to 3 litres Single use metal beverage containers with a capacity of up to 3 litres
Directive 94/62/EC This Regulation Article 1(1) Article 1(1-2) Article 1(2) Article 1(3) Article 2(1) Article 2(1) Article 2(2) Article 2(2) Article 3(1), first subparagraph Article 3(1)
Article 3(1), second subparagraph, point (a) Article 3(2) Article 3(1), second subparagraph, (b) Article 3(3) Article 3(1), second subparagraph, point (c) Article 3(4) Article 3(1), third subparagraph, point (i) Article 3(1)(a) Article 3(1), third subparagraph, point (ii) Article 3(1)(d-e) Article 3(1), third subparagraph, point (iii) Article 3(1)(b-c) Article 3(1a) Article 3(43) Article 3(1b) Article 3(44) Article 3(1c) Article 3(45) Article 3(1d) Article 3(46) Article 3(1e) --- Article 3(2) Article 3(20) Article 3(2a) Article 10(1) Article 3(2b) Article 3(19) Article 3(2c) Article 3(60) and fourth subparagraph of Article 3 Article 3(11) Article 3(8) Article 3(12) --- Article 4(1), first subparagraph Article 38(2) Article 4(1), second subparagraph ---
Article 4(1), third subparagraph Article 38(3) Article 4(1a), first subparagraph Article 29(1), first subparagraph Article 4(a1), second subparagraph Article 29(2), second sentence Article 4(a1), third subparagraph Article 29(2), first sentence Article 4(1a), fourth subparagraph, point (a) Article 29(1), second subparagraph Article 4(1a), fourth subparagraph, point (b) Article 29(4) Article 4(1a), fifth subparagraph Article 50(1), point (b) Article 4(1a), sixth subparagraph Article 50(7), point (b) Article 4(1b) Article 29(3) Article 4(1c) --- Article 4(2) --- Article 5(1) Article 45(1) Article 5(1)(a) Article 45(2), point (a) Article 5(1)(b) Article 26(1-10) Article 5(1)(c) Article 45(2), point (b) Article 5(1)(d) Article 45(2) point (c) Article 5(2), first subparagraph
Article 48(1), first subparagraph Article 5(2), second subparagraph, point (a) Article 48(1), second subparagraph, point (a) Article 5(2), second subparagraph, point (b) Article 48(1), second subparagraph, point (b) Article 5(2), third subparagraph Article 48(1), third subparagraph Article 5(3) Article 48(2) Article 5(4) Article 50(7), point (a) Article 5(5) --- Article 6(1)(a) --- Article 6(1)(b) --- Article 6(1)(c) --- Article 6(1)(d) --- Article 6(1)(e)(i) --- Article 6(1)(e)(ii) --- Article 6(1)(e)(iii) --- Article 6(1)(e)(iv) --- Article 6(1)(e)(v) --- Article 6(1)(f) Article 46(1)(a) Article 6(1)(g)(i) Article 46(1)(b)(i) Article 6(1)(g)(ii) Article 46(1)(b)(ii) Article 6(1)(g)(iii) Article 46(1)(b)(iii) Article 6(1)(g)(iv) Article 46(1)(b)(iv) Article 6(1)(g)(v)
Article 46(1)(b)(v) Article 6(1)(g)(vi) Article 46(1)(b)(vi) Article 6(1)(h) Article 46(1)(c) Article 6(1)(i)(i) Article 46(1)(d)(i) Article 6(1)(i)(ii) Article 46(1)(d)(ii) Article 6(1)(i)(iii) Article 46(1)(d)(iii) Article 6(1)(i)(iv) Article 46(1)(d)(iv) Article 6(1)(i)(v) Article 46(1)(d)(v) Article 6(1)(i)(vi) Article 46(1)(d)(vi) Article 6(1a)(a) Article 46(2)(a) Article 6(1a)(b) Article 46(2)(b) Article 6(1a)(c) Article 46(2)(c) Article 6(1a)(d) Article 46(2)(d) Article 6(1b) Article 46(3) Article 6(1c) Article 46(4) Article 6(4)(a) Article 46(5)(a) Article 6(4)(b) Article 46(5)(b) Article 6(6) Article 49(2) Article 6(7) --- Article 6(10) Article 46(6) Article 6(11) --- Article 6a(1)(a) Article 47(2) Article 6a(1)(b) Article 47(3) Article 6a(2) Article 47(6)
Article 6a(2)(a) Article 47(6)(a) Article 6a(2)(b) Article 47(6)(b) Article 6a(3) Article 47(7) Article 6a(4) Article 47(8) Article 6a(5) Article 47(9) Article 6a(6) Article 47(10) Article 6a(7) Article 47(11) Article 6a(8) Article 47(12) Article 6a(9) Article 50(7), point (a)
Article 43(1) and (2) Article 7(2) Articles 39-42 Article 7(3) Article 43(3) Article 7(4) Article 43(4) Article 8(1)
Article 11(1) Article 8(3) Article 11(4)
Article 9(1) Articles 5-10 Article 9(2)(a)
--- Article 9(3) --- Article 9(4) --- Article 9(5) ---
Article 11(1) Article 5(2) Article 11(2) --- Article 11(3) Article 5(5) Article 12(1) Article 51(1)
Article 12(2) Article 51(2) Article 12(3a) Articles 50(1) point (a), 50(3) point (a) and 50(4) Article 12(3b) Article 50(5) and 50(6) Article 12(3c)
Article 50(7) Article 12(4) Article 50(8) Article 12(6) Article 50(8) Article 13, first subparagraph Article 49(1) Article 13, second subparagraph ---
Article 16(1) --- Article 16(2) ---
--- Article 19(2) ---
Article 20a(1) --- Article 20a(2) --- Article 20a(3) --- Article 21(1) Article 59(1) Article 21(2), first subparagraph Article 59(3), first subparagraph Article 21(2), second subparagraph Article 59(3), second subparagraph Article 21a(1) Article 58(1) Article 21a(2) Article 58(2)
Article 21a(3) Article 58(3) Article 21a(4) Article 58(4) Article 21a(5) Article 58(5) Article 21a(6) Article 58(6) Article 22(1) --- Article 22(2) --- Article 22(3) --- Article 22(3a), first subparagraph --- Article 22(3a), second subparagraph, point (a) --- Article 22(3a), second subparagraph, point (b) --- Article 22(3a), second subparagraph, point (c) --- Article 22(3a), second subparagraph, point (d) --- Article 22(3a), second subparagraph, point (e) --- Article 22(3a), second subparagraph, point (f) --- Article 22(4) --- Article 22(5) ---
Articles 5, 6, 9 and 10 and Annexes II and IV Annex II, point 2 Article 10 and Annex IV Annex II, point 3(a) Article 6 and Annex II
Annex II, point 3(b) --- Annex II, point 3(c) Articles 8 and 3(41) and Annex III Annex II, point 3(d) Articles 8 and 3(41) and Annex II