Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (Text with EEA relevance)
(123) On the other hand, when the packaging or the packaged product is made available by means of distance contracts directly to the end user, the producer could also be established in another Member State or in a third country. In such cases, if the producer is established in another Member State, it should appoint an authorised representative for the extended producer responsibility in the Member State where the end user is located. In cases where the producer is established in a third country, it should also be possible for Member States to provide that the appointment of an authorised representative for the extended producer responsibility be mandatory in order to avoid the risk of eluding the extended producer responsibility obligations. In order to ensure respect for the polluter pays principle, and in the context of compliance with extended producer responsibility, it is necessary to ensure certainty as to which kind of producer is responsible for packaging waste, in particular in the case of ‘logistics companies’. Logistics companies are companies that receive imported goods from third countries and that conduct handling activities regarding the imported goods (e.g. unpacking and repacking into smaller formats or quantities to comply with clients’ requests) before sending the goods to clients, whether in the same or another Member State, with all, part of or without the original transport packaging. In such cases, a producer should be identified for the original transport packaging that comes from a third country, remains with the logistics company and becomes waste in the Union. Typically, the logistics company will not have ownership of the goods, but should be considered as the producer for packaging that comes from a third country and that it handles during its activity.
(124) In addition to the costs imposed on producers pursuant to this Regulation and pursuant to Directive 2008/98/EC, Member States retain the possibility to cover the necessary costs resulting from cleaning activities, including transport and subsequent treatment of packaging waste present in litter, as a part of the full waste management cost of packaging which should be covered by the extended producer responsibility. Those costs should not exceed the costs that are necessary to provide those services in a cost-efficient way and should be established in a transparent and non-discriminatory way between the actors concerned.
(125) In order to monitor that producers meet their financial and organisational obligations to ensuring the management of the waste from the packaging they make available on the territory of a Member State for the first time, or unpack packaged products without being end users, it is necessary that a register of producers be established and managed by the competent authority in each Member State and that producers be obliged to register.
(126) The producer registration requirements should be harmonised across the Union to the greatest extent possible to facilitate registration, in particular given that producers make packaging available in different Member States. In order to ensure uniform conditions for the implementation of the registration requirements, implementing powers should be conferred on the Commission to establish the format for registration in, and reporting to, the register and specifying the granularity of data to be provided and the packaging types and material categories to be covered by the information submitted.
(127) In line with the polluter pays principle, it is essential that the producers, including e-commerce actors, that place packaging and packaged products on the Union market, or unpack packaged products without being end users, take responsibility for the management of that packaging and those packaged products at their end-of-life. Extended producer responsibility schemes are to be established, as provided for in Directive 94/62/EC, by 31 December 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 the collection and recycling of packaging waste. There are wide disparities in the way extended producer responsibility schemes 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 under this Regulation, and be complemented by further specific provisions where this is necessary and appropriate. For example, in order to facilitate the separate collection of packaging waste, the producers should finance the labelling of waste receptacles. Such an obligation would be in line with the polluter pays principle and the general minimum requirements for extended producer responsibility schemes established under Directive 2008/98/EC.
(128) As regards the extended producer responsibility obligations, this Regulation is a lex specialis in relation to Directive 2008/98/EC. That means that the provisions related to the extended producer responsibility in this Regulation should prevail over any conflicting provisions in that Directive. This principle concerns, for example, requirements on producer registration, modulation of extended producer responsibility fees and reporting.
(129) In addition to the harmonised requirement on recyclability for the modulation of the producers’ financial contributions to be laid down in delegated acts adopted in accordance with this Regulation, Member States should be allowed to use other criteria, such as recycled content, reusability, presence of hazardous substances or other criteria in accordance with Directive 2008/98/EC.
(130) Producers should be able to fulfil obligations related to the extended producer responsibility 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, amongst other things, that they have the financial means to cover the costs entailed by the extended producer responsibility. When laying down administrative and procedural rules of authorisation of producers for individual and producer responsibility organisations for collective compliance, it should be possible for Member States to differentiate processes for individual producers and producer responsibility organisations to limit the administrative burden on individual producers. Member States can authorise multiple producer responsibility organisations, as competition among them may lead to greater consumer benefits. The competent authority should be able to charge cost-based and proportionate fees to producers or producer responsibility organisations entrusted with the fulfilment of the extended producer responsibility obligations for the authorisation procedure concerning the fulfilment of those obligations.
(131) In cases where the extended producer responsibility fee charged by a producer responsibility organisation is categorised as public revenue, as in the case of a state-run producer responsibility organisation, and in order to follow the budgetary rules that require the public revenue to be based on accurate data, it should be possible for the Member State to require more frequent submission of the information for reporting to the competent authority responsible for the register by the producer than once a year. Since state-run producer responsibility organisations do not have a represented producer’s mandate, the requirements provided in this Regulation concerning such mandates should not apply.
(132) This Regulation should specify how the traceability of traders’ obligations laid down in Regulation (EU) 2022/2065 of the European Parliament and of the Council (39), including Article 30(2) and (3) thereof, are to be applied to providers of online platforms allowing consumers to conclude distance contracts with producers offering packaging to consumers located in the Union in relation to the registers of producers established pursuant to this Regulation. For the purposes of this Regulation, any producer, whether established in a Member State or a third country, that offers packaging by means of distance contracts directly to consumers located in a Member State should be considered to fall within the definition of trader under Regulation (EU) 2022/2065. In order to prevent free-riding from the extended producer responsibility obligations, it should be specified how the providers of online platforms should fulfil those obligations with regard to the registers of packaging producers established pursuant to this Regulation. In that context, where providers of online platforms that fall within the scope of Section 4 of Chapter III of Regulation (EU) 2022/2065 enable consumers to conclude distance contracts with producers, they should, in accordance with Regulation (EU) 2022/2065 and prior to allowing producers to use their services, obtain information from those producers about their compliance with the extended producer responsibility obligations set out in this Regulation. The rules on traceability of traders selling packaging online are subject to the enforcement rules set out in Regulation (EU) 2022/2065.
(133) Similar undesirable situations of free-riding could occur in relation to fulfilment service providers. This Regulation aims to prevent such free-riding by means of an approach similar to that of Regulation (EU) 2022/2065 as regards providers of online platforms.
(134) The register of producers established pursuant to this Regulation is to be considered a public register for the purposes of Regulation (EU) 2022/2065. Therefore, providers of online platforms allowing consumers to conclude distance contracts with producers should make their best efforts to assess whether the information provided by the producers concerned is reliable and complete, in particular by using or verifying freely available official online databases and online interfaces or by requesting the traders concerned to provide trustworthy supporting documents, in accordance with Regulation (EU) 2022/2065. As far as publicly available data in the register of producers is concerned, ‘making best efforts’ within the meaning of Article 30(2), first subparagraph, of Regulation (EU) 2022/2065 usually requires the verification of the information provided by the producer with the publicly available data in the register of producers. In particular, this applies if a Member States has established an online interface for automated data reconciliation in accordance with this Regulation.
(135) Financial contributions imposed on producers pursuant to this Regulation in addition to the costs referred to in Article 8a(4), point (a), of Directive 2008/98/EC should be without prejudice to any voluntary agreement between online marketplaces and producers, where online marketplaces, on behalf of producers by written mandate, consent to accept all or part of those costs.
(136) Member States should provide for measures implementing the extended producer responsibility, rules on separate collection of packaging waste and rules on the labelling of waste receptacles where this Regulation does not provide for full harmonisation of those measures and rules. Furthermore, it should be possible for Member States to provide for additional requirements for the implementation of the extended producer responsibility, in accordance with Directive 2008/98/EC and this Regulation, provided that such measures do not create barriers on the internal market. This Regulation does not regulate which operator is responsible for the collection of packaging waste and other national contractual arrangements for packaging waste collection.
(137) Member States should set up return and collection systems for packaging waste, so that packaging waste is channelled to the most appropriate waste management alternative, in line with the waste hierarchy. The systems should be open for the participation of all interested parties, in particular for economic operators and public authorities. The systems should be established taking into account the environment and consumer health, safety and hygiene. Return and collection systems should also be accessible and applicable for the packaging of imported products under non-discriminatory provisions.
(138) Some Member States could have already established separate waste collection and recycling systems which are the basis for relevant national authorisations and contractual arrangements, when transposing Article 7 of Directive 94/62/EC in national law. It should be possible for those Member States to continue to use those systems, provided that they correctly implement the obligations under this Regulation.
(139) Member States should also take measures promoting recycling which meets the quality standards for the use of the recycled materials in relevant sectors. That obligation is particularly relevant in view of the minimum percentage set for recycled content in plastic packaging.
(140) The collection of packaging is a crucial step to ensure its circularity and to ensure a strong market for secondary raw materials. The establishment of a mandatory collection rate is an incentive to develop efficient and targeted collection systems at national level and is intended to increase the quantity of waste sorted and potentially recycled.
(141) It has been shown that well-functioning deposit and return systems ensure a very high collection rate and high-quality recycling, 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, to drive up collection rates further and to achieve higher-quality recycling of metal beverages containers, it is appropriate that Member States establish deposit and return systems. Those systems will contribute to increasing the supply of good quality secondary raw material suitable for closed loop recycling and reduce beverage container litter.
(142) Deposit and return systems should be obligatory for single-use plastic beverage bottles and metal beverage containers. Member States can also decide to include other packaging for other products or made of other materials in those systems, in particular single-use glass bottles. Member States 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. Member States should be allowed, while observing the general rules laid down in the TFEU and acting in accordance with this Regulation, to adopt provisions which go beyond the minimum requirements set out in this Regulation, such as charging a deposit at the point of sale in the case of consumption in hospitality premises or the obligation for all final distributors to accept the deposit-bearing packaging regardless of the packaging material and format that they distribute or their sale surface area.
(143) This Regulation should take into account the diversity of deposit and return systems that exist in the Union and ensure that technological developments in those systems are not hindered as long as they meet the requirements and criteria for increasing collection rates and ensuring better-quality recycling.
(144) Given the nature of the products and the differences in their production and distribution systems, deposit and return systems should however not be obligatory for packaging for wine, aromatised wine products and similar products to wine, spirit drinks and milk and milk products listed in Part XVI of Annex I to Regulation (EU) No 1308/2013. However, Member States may establish deposit and return systems covering such beverage packaging and also other beverage and non-beverage packaging.
(145) By 1 January 2029, all deposit and return systems for single-use plastic beverage bottles and single-use metal beverage containers should comply with the general minimum requirements laid down in this Regulation, with the exception of deposit and return systems established before the entry into force of this Regulation which achieve the 90 % separate collection target by 1 January 2029. Those 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 practices 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.
(146) Member States with regions with high transboundary business should ensure that the deposit and return systems allow for collection of packaging from deposit and return systems of the Member States concerned at designated collection points and should endeavour to enable the possibility of returning the deposit.
(147) It should be possible for Member States which achieve an 80 % collection rate of the targeted packaging types without a deposit and return system in 2026 to request not to establish a deposit and return system.
(148) It should be possible for Member States to choose to implement the deposit and return system at subnational level, taking into account relevant national administrative divisions and the specific situation of overseas territories, as long as they demonstrate the environmental and economic performance of such a scheme and that it is fully consistent with the 90 % collection rate for single-use plastic beverage bottles and metal beverage containers set out in this Regulation.
(149) As a specific packaging waste generation prevention measure, Member States should actively encourage re-use and refill solutions. They should support the establishment of re-use and refill systems and monitor their functioning and compliance with hygiene standards. Member States are encouraged to also take 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 a certain percentage of other products available than those covered by re-use targets and refill obligations in reusable packaging or through refill provided that such requirements will not result in fragmentation of single market and creation of trade barriers.
(150) Requirements for collection, sorting, redistribution to fillers and cleaning are of a completely different nature for single-use deposit and return systems and for deposit-based re-use systems. Therefore, the minimum requirements for deposit and return systems should not apply to deposit-based re-use systems. Instead, specific requirements should apply to re-use systems.
(151) Directive 94/62/EC was amended by Directive (EU) 2018/852 of the European Parliament and of the Council (40) setting out recycling targets for Member States to be achieved by 2025 and 2030. Those targets and the rules for their calculation should be retained. While recognising the different starting point of each Member State in relation to recycling targets and while measures facilitating the attainment of those targets are proposed in this Regulation, it should still be possible to postpone the deadlines for attaining the 2030 recycling targets, under certain conditions. However, the Commission should be empowered to reject a revised implementation plan submitted by a Member State.
(152) Directive 94/62/EC requires the Commission to review the 2030 recycling targets for packaging with the view to maintaining or, if appropriate, increasing them. However, it is not yet appropriate to amend the targets set for 2030, as evidence shows that some Member States still have difficulties to meet the existing targets. For that 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 granular data on packaging and packaging waste recycling flows should be reported to the Commission. The reporting of that data will enable the Commission to review the targets with the possibility of maintaining or increasing them. In order to take account of the effect of the measures aimed at improving the packaging recyclability, the review should not take place earlier than the envisaged general evaluation of this Regulation, that is 7 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.
(153) 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 to be 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 by taking into account 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 quantities of waste 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 include information on such measures in the quality check reports accompanying the data which they submit 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 main different 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.
(154) Where the calculation of the recycling rate is applied to aerobic or anaerobic treatment of biodegradable packaging waste, the quantity 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 quantity 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.
(155) 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.
(156) When establishing the methodology for the calculation and verification of the percentage of recycled content, the Commission should assess the available recycling technologies, taking into account their economic and environmental performance, including the quality of the output, the availability of the waste, the energy needed and the emissions of greenhouse gases and other relevant environmental impacts. The Commission should also take into account the potential of such technologies to be used for misleading environmental claims.
(157) Claims on packaging characteristics for which legal requirements are set out in this Regulation, such as recyclability, the level of recycled content and reusability, should only be made in relation to packaging properties exceeding the applicable minimum requirements set out in this Regulation and in accordance with the methodologies and rules established under this Regulation. Such claims should also specify whether they relate to the packaging unit, part of the packaging unit or to all packaging placed on the market by the economic operator.
(158) Member States should have the right 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) 2019/1004 (41).
(159) 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 Council (42) and Regulation (EU) 2024/1157 of the European Parliament and of the Council (43) apply.
(160) As re-use means that no new packaging is placed on the market, reusable sales packaging that is placed on the market 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 that 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 within a re-use system.
(161) Producers and producer responsibility organisations should be actively involved in providing information to end users, in particular consumers, on prevention and management of packaging waste. That information should include availability of re-use arrangements for packaging, meaning of labels displayed on packaging and other instructions on the discarding of packaging waste. Producers and producer responsibility organisations should also inform consumers that packaging marked as compostable means that the packaging is compostable in industrially controlled conditions in bio-waste treatment facilities and is not suitable for home composting. Packaging should not be discarded as litter. 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.
(162) Separate out-of-home collection is an important element to increase collection rates of packaging and improve its circularity. Member States and economic actors should be able to take specific measures for separate out-of-home collection, adapted to the location and habits of consumers.
(163) 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, lightweight plastic carrier bags, thick plastic carrier bags and of very 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. In order to allow for the assessment of 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, through Member States reporting, on the separate collection rate of packaging covered by the obligation to establish deposit and return system.
(164) In order to establish the methodology on the recycled-at-scale assessment, Member States should also report, on an annual basis, data on the quantity of recycled packaging waste per packaging category and the quantity of packaging made available for the first time on the territory of the Member State, or unpacked by a producer who is not an end user, per packaging category. The Commission should aggregate those data and publish them to monitor the annual evolution of the recycled-at-scale packaging waste.
(165) 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 which describes the measures undertaken to establish an effective system of quality control and traceability of packaging waste.
(166) In order to ensure uniform conditions for the implementation of the reporting obligations, implementing powers should be conferred on 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 the recycled-at-scale assessment. That implementing act should also include methodology for determining the quantity of packaging waste generated as well as lay down the format for the submission of data. It should also establish the methodology for the calculation of the annual consumption of lightweight plastic carrier bags per capita and the format for the submission of those data, as those data are necessary to support the monitoring and full implementation of the substantive requirements related to plastic carrier bags, in particular to ensure disaggregated and mandatory data on different categories of plastic carrier bags. That implementing act should replace Commission Decision 2005/270/EC (44) and Commission Implementing Decision (EU) 2018/896 (45).
(167) In 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 those databases function well.
(168) Effective enforcement of sustainability requirements is essential to ensure fair competition and to ensure that this Regulation’s expected benefits and contribution to achieving the Union’s climate, energy and circularity objectives are achieved. Therefore, competent authorities should endeavour to carry out checks on the accuracy of at least part of the EU declarations of conformity each year. Regulation (EU) 2019/1020 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. The market surveillance mechanisms laid down in Regulation (EU) 2019/1020 sets out the requirements for market surveillance relating to the marketing of products and provides for safeguard mechanisms to check compliance with this Regulation in respect of placing packaging on the market.
(169) 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 focus market surveillance efforts, 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, could adversely affect the environment or other public interests protected by the relevant requirements.
(170) 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, implementing powers should be conferred on the Commission to determine whether national measures in respect of non-compliant products are justified. The Commission should adopt immediately applicable implementing acts where, in duly justified cases relating to the protection of the environment or human health, imperative grounds of urgency so require.
(171) The market surveillance authorities should have the right to require economic operators to take corrective action on the basis of findings either that 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, implementing powers should be conferred on the Commission to decide whether a national measure is justified.
(172) In case of human health concerns, the market surveillance authority should 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 should alert the authorities competent to carry out controls on that risk and appointed pursuant to Regulation (EU) 2017/625 of the European Parliament and of the Council (46), Regulations (EU) 2017/745, (EU) 2017/746, (EU) 2019/6 or Directive 2001/83/EC.
(173) Public procurement amounts to 14 % of the Union’s GDP. In order to contribute to the objectives of reaching climate neutrality, improving energy and resource efficiency and transitioning to a circular economy that protects public health and biodiversity, implementing powers should be conferred on the Commission to require, where appropriate, contracting authorities and entities as defined in Directives 2014/24/EU (47) and 2014/25/EU (48) of the European Parliament and of the Council, to align their public procurement with specific minimum mandatory green public procurement requirements, to be set out in the implementing acts adopted pursuant to this Regulation. Compared to a voluntary approach, mandatory requirements should maximise the leverage of public spending to boost demand for better performing packaging. The requirements should be transparent, objective and non-discriminatory. It should be possible for Member States to refer to technical specifications, selection criteria or contract performance conditions in their public procurement requirements and it should not be necessary for those requirements to be cumulative. Contracting authorities and entities should be able, while observing the general rules laid down in the TFEU and acting in accordance with this Regulation, to adopt provisions which go beyond the minimum green public procurement requirements laid down in this Regulation.
(174) In order to safeguard the functioning of the internal market and create a level playing field, it is necessary to ensure that packaging from third countries entering the Union market complies with this Regulation, whether it is imported as standalone packaging or in association with 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. 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. Where they take such prohibition measures, and the prohibition measures 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.
(175) 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. First, prohibition measures decided by market surveillance authorities further to the identification of non-compliant packaging should be communicated from the ICSMS to customs for use by authorities designated for the purpose of carrying out controls at external borders to identify packaging to which such prohibition measure should apply. The electronic Customs Risk Management System set out in Article 36 of Commission Implementing Regulation (EU) 2015/2447 (49), 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 supports those second data transfers between the ICSMS and national customs systems.
(176) In order to ensure uniform conditions for the implementation of the interconnection for communication between the market surveillance authorities and the customs authorities, implementing powers should be conferred on 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.
(177) When adopting delegated acts pursuant to Article 290 TFEU, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making (50). 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.
(178) The implementing powers that are conferred on the Commission by this Regulation should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council (51).
(179) In order to ensure that product requirements in Directive (EU) 2019/904 can be monitored and enforced, and that they are subject to appropriate market surveillance, Regulation (EU) 2019/1020 should be amended to include Directive (EU) 2019/904 into its scope. Provisions concerning requirements related to the recycled plastic content for plastic beverage bottles as of 1 January 2030 and corresponding reporting obligations should be deleted from Directive (EU) 2019/904, as this matter is exclusively regulated by this Regulation.
(180) This Regulation establishes general rules that apply to all packaging. However, certain single-use plastic products covered by Directive (EU) 2019/904, such as plastic carrier bags, beverage cups, food and beverage containers, including bottles, are considered to be packaging. Directive (EU) 2019/904 is a lex specialis in relation to this Regulation. In the event of a conflict between Directive (EU) 2019/904 and this Regulation, Directive (EU) 2019/904 should prevail within the scope of its application. Directive (EU) 2019/904 requires Member States to take measures to reduce the consumption of certain single-use plastic products, including marketing restrictions. Such marketing restrictions should apply and prevail over any conflicting provisions in this Regulation. This Regulation provides a restriction on the placing on the market of plastic products listed in Annex V point 3 thereto, while Directive (EU) 2019/904 allows the Member States to take the necessary measures to achieve reduction in the consumption of those single-use plastic products. Since national implementing measures under Directive (EU) 2019/904 can be less restrictive than a ban on the placing on the market, this Regulation should prevail over Directive (EU) 2019/904 as regards such products falling within the definition of packaging, in order to boost the reduction of single-use plastic packaging and reduce the quantity of single-use plastic packaging in the environment. As a consequence, it should not be possible for Member States to adopt an exemption from the ban in Directive (EU) 2019/904 on placing packaging made of expanded polystyrene on the market. To reflect this, Directive (EU) 2019/904 should be amended accordingly.
(181) As this Regulation does not regulate the recycled content in any plastic part of packaging before 1 January 2030, provisions regarding requirements for recycled content for plastic beverage bottles in Directive (EU) 2019/904 should remain in force until that date.
(182) To enhance public trust in packaging placed on the market, in particular as regards compliance with sustainability requirements, the economic operators who place 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.
(183) Article 19(1) of the Treaty on European Union (TEU) requires Member States to provide remedies that are sufficient to ensure effective judicial protection in the fields covered by Union law, including the courts of the Member States. In that respect, Member States should ensure that persons concerned, such as natural or legal persons having complained about or having reported an alleged non-compliance of packaging, whether as standalone packaging or in association with a packaged product, with this Regulation, have access to justice in line with the obligations that Member States have agreed to as parties to the Convention on Access to Information, Public Participation in Decision-making and Access to Justice in Environmental Matters (52), done in Aarhus on 25 June 1998 (the ‘Aarhus Convention’).
(184) The Commission should carry out an evaluation of this Regulation. Pursuant to paragraph 22 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making, that evaluation should be based on the five criteria of efficiency, effectiveness, relevance, coherence and Union 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 packaging and the functioning of the internal market.
(185) It is necessary to provide for sufficient time for economic operators to adapt their operations in order to fulfil their obligations and comply with the requirements of this Regulation. Similarly, it is necessary to provide for sufficient time for Member States to adopt administrative measures regarding the organisation of the authorisation procedures by the competent authorities, while maintaining continuity for economic operators, and to set up the administrative infrastructure necessary for application of this Regulation. The application of this Regulation should therefore be deferred to a date by which those preparations can reasonably be finalised. Particular attention should be paid to facilitate compliance by micro, small and medium-sized enterprises (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.
(186) 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.
(187) 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 based 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.
(188) 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, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU. 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 those objectives,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
GENERAL PROVISIONS
Article 1
Subject matter
This Regulation establishes requirements for the entire life-cycle of packaging as regards environmental sustainability and labelling, to allow its placing on the market. It also establishes requirements for extended producer responsibility, packaging waste prevention, such as the reduction of unnecessary packaging and the re-use or refill of packaging, as well as the collection and treatment, including recycling, of packaging waste.
This 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 and the 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.
This Regulation contributes to the transition to a circular economy and to achieving climate neutrality at the latest by 2050, as provided for under Regulation (EU) 2021/1119 of the European Parliament and of the Council (53), by laying down measures in line with the waste hierarchy set out in Article 4 of Directive 2008/98/EC (‘waste hierarchy’).
Article 2
Scope
This Regulation applies to all packaging, regardless of the material used, and to all packaging waste, whether such packaging is used in or such packaging waste originates from industry, other manufacturing, retail or distribution, offices, services or households.
This Regulation applies without prejudice to the provisions of Directive 2008/98/EC as regards the management of hazardous waste as well as to Union regulatory requirements for packaging such as those for safety, quality, the protection of health and the hygiene of packed products, and to transport requirements. However, where this Regulation conflicts with Directive 2008/68/EC, Directive 2008/68/EC shall prevail.
Article 3
Definitions
For the purposes of this Regulation, the following definitions apply:
(2) ‘waste’ means waste as defined in Article 3, point (1), of Directive 2008/98/EC; reusable packaging sent to reconditioning is not considered to be waste;
(3) ‘take-away packaging’ means service packaging filled at attended points of sale with beverages or ready-prepared food that are packaged for transportation and immediate consumption at another location without the need for any further preparation and are typically consumed from the packaging;
(4) ‘primary production packaging’ means an item designed and intended to be used as packaging for unprocessed products from primary production as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council (54);
(5) ‘sales packaging’ means packaging conceived so as to constitute a sales unit consisting of products and packaging to the end user at the point of sale;
(6) ‘grouped packaging’ means packaging conceived so as to constitute a grouping of a certain number of sales units at the point of sale, irrespective of whether that grouping of sales units is sold as such to the end user or whether it serves as a means to facilitate the restocking of shelves at the point of sale or to create a stock-keeping or distribution unit, and which can be removed from the product without affecting its characteristics;
(7) ‘transport packaging’ means packaging conceived so as to facilitate the handling and transport of one or more sales units or a grouping of sales units, in order to prevent damage to the product from handling and transport, but which excludes road, rail, ship and air containers;
(8) ‘e-commerce packaging’ means transport packaging used to deliver products in the context of sale online or through other means of distance sales to the end user;
(9) ‘making available on the market’ means any supply of packaging, whether empty or with a product, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
(10) ‘placing on the market’ means the first making available of packaging, whether empty or with a product, on the Union market;
(11) ‘making available on the territory of the Member State’ means any supply of packaging, whether empty or with a product, for distribution, consumption or use on the territory of the Member State in the course of a commercial activity, whether in return for payment or free of charge;
(12) ‘economic operator’ means the manufacturer, the supplier, the importer, the distributor, the authorised representative, the final distributor and the fulfilment service provider;
(14) ‘distance contract’ means distance contract as defined in Article 2(7) of Directive 2011/83/EU of the European Parliament and of the Council (55);
(16) ‘supplier’ means any natural or legal person that supplies packaging or packaging material to a manufacturer;
(17) ‘importer’ means any natural or legal person established within the Union that places packaging from a third country on the market;
(18) ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or importer, that makes packaging available on the market;
(19) ‘authorised representative’ means any natural or legal person established in the Union that has received a written mandate from the manufacturer to act on that manufacturer’s behalf in relation to specified tasks with regard to the manufacturer’s obligations under this Regulation;
(20) ‘authorised representative for the extended producer responsibility’ means any natural or legal person established in the Member State where the producer makes packaging or packaged products available on the territory of the Member State for the first time, or where it unpacks packaged products without being an end user, other than the Member State or the third country where the producer is established, and that is appointed by the producer in accordance Article 8a(5), third subparagraph, of Directive 2008/98/EC to fulfil the obligations of that producer under Chapter VIII of this Regulation;
(21) ‘final distributor’ means the natural or legal person in the supply chain that delivers packaged products, including through re-use, or products that can be purchased through refill to the end user;
(22) ‘consumer’ means any natural person who is acting for purposes which are outside their trade, business or profession;
(23) ‘end user’ means any natural or legal person that resides or is 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 that does not make that product further available on the market in the form supplied to it;
(24) ‘composite packaging’ means a unit of packaging made of two or more different materials which are part of the weight of the main packaging material and cannot be separated manually and therefore form a single integral unit, unless one of the materials constitutes an insignificant part of the packaging unit and in any event no more than 5 % of the total mass of the packaging unit and excluding labels, varnishes, paints, inks, adhesives and lacquers; this is without prejudice to Directive (EU) 2019/904;
(25) ‘packaging waste’ means any packaging or packaging material that is waste, with the exception of production residues;
(26) ‘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, including measures as regards the re-use of the packaging and measures to extend the life of the packaging before it becomes waste;
(27) ‘re-use’ means any operation by which reusable packaging is used again multiple times for the same purpose for which it was conceived;
(28) ‘single-use packaging’ means packaging which is not reusable packaging;
(29) ‘rotation’ means the cycle that reusable packaging accomplishes from the moment it is placed on the market together with the product it is intended to contain, protect, handle, deliver or present to the moment it is ready to be re-used within a re-use system with a view to it being supplied again to end users together with another product;
(30) ‘trip’ means the transfer of packaging, from filling or loading to emptying or unloading, as part of a rotation or on its own;
(31) ‘re-use system’ means the organisational, technical or financial arrangements, together with incentives, that allow re-use either in a closed loop or open loop system, such as a deposit and return system that ensures that packaging is collected for re-use;
(32) ‘reconditioning’ means any operation listed in Part B of Annex VI necessary to restore reusable packaging to a functional state for the purpose of its re-use;
(33) ‘refill’ means an operation by which a container that fulfils the packaging function, and that is either owned by the end user or purchased by the end user at the point of sale of the final distributor is filled by the end user or by the final distributor with one or several products purchased by the end user from the final distributor;
(34) ‘refill station’ means a place where a final distributor offers to end users products that can be purchased through refill;
(35) ‘HORECA sector’ means Accommodation and Food Service Activities according to NACE Rev. 2 – Statistical classification of economic activities;
(36) ‘sales area’ means the area dedicated to the display of goods offered for sale, to the payment for such goods, and to the circulation and presence of customers, but does not include the areas which are not open to the public, such as storage areas, or other areas where products are not displayed, such as car parks; in the context of e-commerce packaging, the storage and dispatch area is to be considered as sales area;
(37) ‘design for recycling’ means the design of packaging, including individual components of packaging, that ensures the recyclability of the packaging with established collection, sorting and recycling processes proven in an operational environment;
(38) ‘recyclability’ means the compatibility of packaging with the management and processing of waste by design, based on separate collection, sorting in separate streams, recycling at scale and the use of recycled materials to replace primary raw materials;
(39) ‘packaging waste recycled at scale’ means packaging waste which is collected separately, sorted and recycled in installed infrastructure, using established processes proven in an operational environment which ensure, at Union level, an annual quantity of recycled material under each packaging category listed in Table 2 of Annex II equal to or greater than 30 % for wood and 55 % for all other materials; it includes packaging waste that is exported from the Union for the purpose of waste management and which can be considered to meet the requirements of Article 53(11);
(40) ‘material recycling’ means any recovery operation by which waste materials are reprocessed into materials or substances, whether for the original or other purposes, with the exception of biological treatment of waste, reprocessing of organic material, energy recovery and reprocessing into materials that are to be used as fuels or for backfilling operations;
(41) ‘high-quality recycling’ means any recycling process which produces recycled materials that are of equivalent quality to the original materials, based on preserved technical characteristics, and that are used as a substitute to primary raw materials for packaging or other applications where the quality of the recycled material is retained;
(42) ‘packaging category’ means a combination of material and specific packaging design which determines recyclability by reference to established state-of-the-art collection, sorting and recycling processes proven in an operational environment and which is relevant for the definition of the design for recycling criteria;
(43) ‘integrated component’ means a packaging component, whether or not of the same material as, or distinct from, the main body of the packaging unit, that is integral to the packaging unit and its functioning, that does not need to be separated from the main body of the packaging unit in order to ensure the functionality of the packaging unit and that is typically discarded at the same time as the main body of the packaging unit, although not necessarily via the same disposal route;
(44) ‘separate component’ means a packaging component, whether or not from the same material as the main body of the packaging unit, that is distinct from the main body of the packaging unit, that needs to be disassembled completely and permanently from the main body of the packaging unit and that is typically discarded prior to and separately from the main body of the packaging unit, including packaging components that can be separated from each other simply through mechanical stress during transportation or sorting;
(45) ‘unit of packaging’ means a unit, including any integrated or separate components, which as a whole serves a packaging function, such as the containment, protection, handling, delivery, storage, transport or presentation of products, and includes independent units of grouped or transport packaging where they are discarded prior to the point of sale;
(46) ‘innovative packaging’ means a form of packaging that is manufactured using new materials, resulting in a significant improvement in the functions of the packaging, such as the containment, protection, handling, or delivery of products, and in overall demonstrable environmental benefits, with the exception of packaging that is the result of modification to existing packaging for the main purpose of improving the presentation of products and marketing;
(47) ‘secondary raw materials’ means materials that have undergone all necessary checking and sorting and been obtained through recycling processes and can substitute primary raw materials;
(48) ‘post-consumer plastic waste’ means waste that is plastic and that has been generated from plastic products that have been placed on the market or supplied for distribution, consumption or use in a third country in the course of a commercial activity, whether in return for payment or free of charge;
(49) ‘contact-sensitive packaging’ means packaging that is intended to be used for products falling within the scope of Regulations (EC) No 1831/2003 of the European Parliament and of the Council (56), (EC) No 1935/2004, (EC) No 767/2009 of the European Parliament and of the Council (57), (EC) No 1223/2009 of the European Parliament and of the Council (58), (EU) 2017/745, (EU) 2017/746, (EU) 2019/4 of the European Parliament and of the Council (59) or (EU) 2019/6, or of Directives 2001/83/EC, 2002/46/EC of the European Parliament and of the Council (60) or 2008/68/EC, or for products as defined in Articles 1 and 2 of Commission Decision (EU) 2023/1809 (61);
(50) ‘compostable packaging’ means packaging that biodegrades in industrially controlled conditions or that is capable of undergoing biological decomposition in such conditions, including through anaerobic digestion, but not necessarily in a home-composting environment, combined, if necessary, with physical treatment, resulting ultimately in the conversion of the packaging into carbon dioxide or, in the absence of oxygen, methane, and mineral salts, biomass and water, and that does not hinder or jeopardise the separate collection and the composting and anaerobic digestion process;
(51) ‘home compostable packaging’ means packaging that can biodegrade in non-controlled conditions that are not industrial-scale composting facilities and the composting process of which is performed by private individuals with the aim of producing compost for their own use;
(52) ‘plastic’ means a material consisting of a polymer within the meaning of Article 3, point (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;
(53) ‘biobased plastics’ means plastics made from biological resources, such as biomass feedstock, organic waste or by-products, and irrespective of whether the plastics are biodegradable or non-biodegradable;
(54) ‘single-use plastic beverage bottles’ means beverage bottles listed in Part F of the Annex to Directive (EU) 2019/904;
(55) ‘plastic carrier bags’ means carrier bags, with or without a handle, made of plastic, which are supplied to consumers at the point of sale of products;
(56) ‘lightweight plastic carrier bags’ means plastic carrier bags with a wall thickness below 50 microns;
(57) ‘very lightweight plastic carrier bags’ means plastic carrier bags with a wall thickness below 15 microns;
(58) ‘thick plastic carrier bags’ means plastic carrier bags with a wall thickness between 50 and 99 microns;
(59) ‘very thick plastic carrier bags’ means plastic carrier bags with a wall thickness above 99 microns;
(60) ‘waste receptacles’ means receptacles used to store and collect waste, for example containers, bins and bags;
(61) ‘deposit’ means a defined 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 or any other person returns the deposit bearing packaging to a collection point established for that purpose;
(62) ‘deposit and return system’ means a system in which a deposit is charged to the end user when purchasing a packaged or filled product covered by that system, and redeemed when the deposit bearing packaging is returned through one of the collection channels that are authorised for that purpose by the national authorities;
(63) ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by a product, process or service;
(64) ‘harmonised standard’ means a standard as defined in Article 2(1), point (c), of Regulation (EU) No 1025/2012;
(65) ‘conformity assessment’ means the process demonstrating whether the sustainability, safety, labelling and information requirements of this Regulation relating to packaging have been fulfilled;
(66) ‘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;
(67) ‘life-cycle’ means the consecutive and interlinked stages of the life of packaging, consisting of raw material acquisition or generation from natural resources, pre-processing, manufacturing, storage, distribution, use, repair, re-use and end-of-life;
(68) ‘packaging presenting a risk’ means packaging that, by not complying with a requirement set out in or pursuant to this Regulation other than those requirements listed in Article 62(1), could adversely affect the environment, health or other public interests protected by that requirement;
(69) ‘packaging presenting a serious risk’ means 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;
(70) ‘online platform’ means online platform as defined in Article 3, point (i), of Regulation (EU) 2022/2065;
(71) ‘public contracts’ means public contracts as defined in Article 2, point (5), of Directive 2014/24/EU or as referred to in Directive 2014/25/EU, as applicable.
The definitions of ‘waste management’, ‘collection’, ‘separate collection’, ‘treatment’, ‘preparing for re-use’, ‘recycling’ and ‘extended producer responsibility scheme’ in Article 3, points (9), (10), (11), (14), (16), (17) and (21), respectively, of Directive 2008/98/EC apply.
The definitions of ‘market surveillance’, ‘market surveillance authority’, ‘fulfilment service provider’, ‘corrective action’, ‘risk’, ‘recall’ and ‘withdrawal’ in Article 3, points (3), (4), (11), (16), (18), (22) and (23), respectively, of Regulation (EU) 2019/1020 apply.
The definitions of ‘substance of concern’ and ‘data carrier’ in Article 2, points (27) and (29), respectively, of Regulation (EU) 2024/1781 apply.
An indicative list of items falling within the definition of packaging in paragraph 1, first subparagraph, point (1) of this Article, is set out in Annex I.
Article 4
Free movement
Packaging shall only be placed on the market if it complies with this Regulation.
Member States shall not prohibit, restrict or impede the placing on the market of packaging that complies with the sustainability, labelling and information requirements laid down in or pursuant to Articles 5 to 12.
If Member States choose to maintain or introduce national 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 this Regulation for reasons of non-compliance with those national requirements.
At 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 has been brought into conformity.
CHAPTER II
SUSTAINABILITY REQUIREMENTS
Article 5
Requirements for substances in packaging
Packaging placed on the market 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, and to the adverse impact on the environment due to microplastics.
The Commission shall monitor the presence of substances of concern in packaging and packaging components and shall take, where appropriate, the relevant follow-up measures.
By 31 December 2026, the Commission, assisted by the European Chemicals Agency, shall prepare a report on the presence of substances of concern in packaging and packaging components, to determine the extent to which they negatively affect the re-use and recycling of materials or impact chemical safety. That report may list the substances of concern present in packaging and packaging components and indicate the extent to which they could present an unacceptable risk to human health and the environment.
The Commission shall submit the report to the European Parliament, to the Council and to the committee referred to in Article 65 of this Regulation setting out its findings and shall consider appropriate follow-up measures, including:
(a) for substances of concern in packaging materials which primarily affect human health or the environment, the use of the procedures referred to in Article 68(1) and (2) of Regulation (EC) No 1907/2006 to adopt new restrictions;
(b) for substances of concern that negatively affect the re-use and recycling of materials in the packaging in which they are present, the establishment of restrictions as a part of design for recycling criteria in accordance with Article 6(4) of this Regulation.
If a Member State considers that a substance negatively affects the re-use and recycling of materials in the packaging in which it is present, it shall, by 31 December 2025, supply such information to the Commission and the European Chemicals Agency and, where available, refer to the relevant risk assessments or other relevant data.
Member States may request the Commission to consider restricting, pursuant to Article 6(4), point (a), the use of substances of concern that potentially negatively affect the re-use and recycling of materials in packaging in which they are present, for reasons other than those related primarily to the chemical safety of those substances. Member States shall accompany such requests with a report documenting the identity and uses of the substances and a description of how the use of the substances in packaging hinders recycling, for reasons other than those related primarily to chemical safety. The Commission shall evaluate the request and present the results of that evaluation to the committee referred to in Article 65.
Without prejudice to the restrictions on chemicals set out in Annex XVII to Regulation (EC) No 1907/2006 or, where applicable, to the restrictions and specific measures on food-contact materials and articles in Regulation (EC) No 1935/2004, the sum of the concentrations of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components shall not exceed 100 mg/kg.
From 12 August 2026, food-contact packaging shall not be placed on the market if it contains per- and polyfluorinated alkyl substances (PFAS) in a concentration equal to or above the following limit values to the extent that the placing on the market of packaging containing such a concentration of PFAS is not prohibited pursuant to another Union legal act:
(a) 25 ppb for any PFAS as measured with targeted PFAS analysis (polymeric PFAS excluded from quantification);
(b) 250 ppb for the sum of PFAS measured as the sum of targeted PFAS analysis, where applicable with prior degradation of precursors (polymeric PFAS excluded from quantification); and
(c) 50 ppm for PFASs (including polymeric PFAS); if total fluorine exceeds 50 mg/kg the manufacturer, importer or downstream user as defined respectively in Article 3, points (9), (11) and (13) of Regulation (EC) No 1907/2006 shall, upon request, provide to the manufacturer or the importer as defined respectively in Article 3(1), points (13) and (17), of this Regulation proof of the quantity of fluorine measured as content of either PFAS or non-PFAS in order for them to draw up the technical documentation as referred to in Annex VII to this Regulation.
‘PFAS’ means any substance that contains at least one fully fluorinated methyl (CF3-) or methylene (-CF2-) carbon atom (without any H/Cl/Br/I attached to it), except substances that only contain the following structural elements: CF3-X or X-CF2-X′, where X = -OR or -NRR′ and X′ = methyl (-CH3), methylene (-CH2-), an aromatic group, a carbonyl group (-C(O)-), -OR′′, -SR′′ or –NR′′R′′′; and where R/R′/R′′/R′′′ is a hydrogen (-H), methyl (-CH3), methylene (-CH2-), an aromatic group or a carbonyl group (-C(O)-).
By 12 August 2030, the Commission shall carry out an evaluation to assess the need to amend or repeal this paragraph in order to avoid overlaps with restrictions or prohibitions on the use of PFAS laid down in accordance with Regulations (EC) No 1935/2004, (EC) No 1907/2006, or (EU) 2019/1021.
Compliance with the requirements set out in paragraphs 4 and 5 of this Article shall be demonstrated in the technical documentation drawn up in accordance with Annex VII.
In order to take account of scientific and technical progress, the Commission may adopt delegated acts in accordance with Article 64 to amend this Regulation in order to lower the sum of the concentrations of lead, cadmium, mercury and hexavalent chromium resulting from substances present in packaging or packaging components referred to in paragraph 4 of this Article.
In order to take account of scientific and technical progress, the Commission may adopt delegated acts in accordance with Article 64 to supplement this Regulation in order to determine the conditions under which the sum of the concentrations referred to in paragraph 4 of this Article shall not apply to recycled materials or to product loops which are in a closed and controlled chain, as well as to determine the packaging types or formats of packaging, based on the packaging categories listed in Table 1 of Annex II to this Regulation, which shall be exempted from the requirements laid down in that paragraph. Such delegated acts shall be justified on the basis of a case by case analysis, time-limited, provide for appropriate marking and information requirements, and contain requirements for regular reporting in order to ensure that the exemption is regularly reviewed. Delegated acts adopted in accordance with this paragraph shall only be adopted to amend derogations established in Decisions 2001/171/EC and 2009/292/EC.
By 12 August 2033, the Commission shall carry out an evaluation to assess whether this Article and the design for recycling criteria set out in accordance with Article 6(4) have contributed sufficiently to minimising the presence and concentration of substances of concern as constituents of packaging materials.
Article 6
Recyclable packaging
All packaging placed on the market shall be recyclable.
Packaging shall be considered to be recyclable if it fulfils the following conditions:
(a) it is designed for material recycling, which enables the use of resulting secondary raw materials that are of sufficient quality when compared to the original material that they can be used to substitute primary raw materials, in accordance with paragraph 4; and
(b) when it becomes waste, it can be collected separately in accordance with Article 48(1) and (5), sorted into specific waste streams without affecting the recyclability of other waste streams and recycled at scale, on the basis of the methodology set out in accordance with paragraph 5 of this Article.
Packaging that is in compliance with the delegated acts adopted pursuant to paragraph 4 shall be deemed to comply with the condition set out in point (a) of the first subparagraph of this paragraph.
Packaging that is in compliance with the delegated acts adopted pursuant to paragraph 4 and the implementing acts adopted pursuant to paragraph 5 shall be deemed to comply with the conditions set out in the first subparagraph of this paragraph.
Point (a) of the first subparagraph of this paragraph shall apply from 1 January 2030 or 24 months from the date of entry into force of the delegated acts adopted pursuant to the first subparagraph of paragraph 4, whichever is the latest.
Point (b) of the first subparagraph of this paragraph shall apply from 1 January 2035 or, as regards the recycled-at-scale requirement, from 1 January 2035 or five years from the date of entry into force of the implementing acts adopted pursuant to paragraph 5, whichever is the latest.
The manufacturer shall assess packaging recyclability on the basis of the delegated acts adopted pursuant to in paragraph 4 of this Article and the implementing acts adopted pursuant to paragraph 5 of this Article. Packaging recyclability shall be expressed in the recyclability performance grades A, B or C as described in Table 3 of Annex II.
Without prejudice to paragraph 10, from 1 January 2030 or 24 months from the entry into force of the delegated acts adopted pursuant to paragraph 4 of this Article, whichever is the latest, packaging shall not be placed on the market unless it is recyclable within grades A, B or C as described in Table 3 of Annex II.
Without prejudice to paragraph 10 of this Article, from 1 January 2038 packaging shall not be placed on the market unless it is recyclable within grades A or B as described in Table 3 of Annex II.
By 1 January 2028, the Commission shall, after taking into consideration standards developed by the European standardisation organisations, adopt delegated acts in accordance with Article 64 to supplement this Regulation by establishing:
(b) how to perform recyclability performance assessment and express its result in recyclability performance grades per packaging unit, in terms of weighting, including material-specific criteria and sorting efficiency, to determine whether packaging is to be considered recyclable under paragraph 2;
(c) a description, for each packaging category listed in Table 1 of Annex II, of the conditions for compliance with their respective recyclability performance grades;
(d) a framework concerning the modulation of financial contributions to be paid by producers to comply with their extended producer responsibility obligations set out in Article 45(1), based on the packaging recyclability performance grades.
When adopting the delegated acts referred to in the first subparagraph of this paragraph, the Commission shall take into account the results of the assessment, if any, carried out pursuant to Article 5(2).
The Commission is empowered to adopt delegated acts in accordance with Article 64 to amend Table 1 of Annex II in order to adapt it to the scientific and technical developments in material and product design, and in collection, sorting and recycling infrastructure. In those delegated acts, the Commission may lay down design for recycling criteria for additional packaging categories or create sub-categories within the categories listed in Table 1 of Annex II.
Economic operators shall comply with new or updated design for recycling criteria within 3 years of the date of entry into force of the relevant delegated act.
By 1 January 2030, the Commission shall adopt implementing acts establishing:
(b) the chain of custody mechanism ensuring that packaging is recycled at scale.
The chain of custody mechanism referred to in point (b) shall be based on at least the following elements:
(i) technical documentation referring to the quantity of collected packaging waste that is sent to sorting and recycling facilities;
(ii) a verification process that allows manufacturers to obtain the necessary data from the downstream operators ensuring that packaging is recycled at scale.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2).
The data referred to in the first subparagraph of this paragraph shall be available and easily accessible by the public.
The Commission shall assess the granularity of data that need to be reported for the recycled-at-scale methodology. Where appropriate, the Commission shall adopt delegated acts in accordance with Article 64 to amend Table 2 of Annex II and Table 3 of Annex XII to adapt them to technical and scientific development.
By 2035, the Commission, on the basis of developments in sorting and recycling technologies, may review the minimum thresholds for packaging to be considered recycled at scale and, where appropriate, present a legislative proposal to revise the thresholds.
In order to increase the level of recyclability of packaging, 18 months from the date of entry into force of the delegated acts adopted pursuant to paragraph 4 of this Article and implementing acts adopted pursuant to paragraph 5 of this Article, the financial contributions paid by producers in order to comply with their extended producer responsibility obligations as laid down in Article 45 shall be modulated in accordance with the recyclability performance grades, as set out in detail in the delegated acts adopted pursuant to paragraph 4 of this Article and the implementing acts adopted pursuant to paragraph 5 of this Article.
Regarding financial contributions paid by producers in order to comply with their extended producer responsibility obligations as laid down in Article 45 in respect of packaging referred to in paragraph 11, point (g), of this Article, Member States shall take into account the technical feasibility and economic viability of recycling of that packaging.
Compliance with the requirements set out in paragraphs 2 and 3 of this Article 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 recycled-at-scale requirements shall include all integrated components. A separate assessment shall be carried out for integrated components that can become separated from each other as a result of mechanical stress during transportation or sorting.
Where a unit of packaging includes separate components, the assessment of compliance with the design for recycling requirements and with the recycled-at-scale requirements shall be carried out separately for each separate component.
All components of a unit of packaging shall be compatible with the established collection, sorting and recycling processes proven in an operational environment and shall not hinder the recyclability of the main body of the packaging unit.
By way of derogation from paragraphs 2 and 3, from 1 January 2030, innovative packaging that does not comply with the requirements under paragraph 2 may be made available on the market up to 5 years from the end of the calendar year in which it was placed on the market.
Where use is made of this derogation, the economic operator shall notify the competent authority before the innovative packaging is placed on the market and shall include all technical details demonstrating that the packaging is innovative packaging. That notification shall include a timeline for reaching the recycled-at-scale requirements in terms of collection and recycling of the innovative packaging. The information shall be made available to the Commission and the national authorities carrying out market surveillance.
If the competent authority considers that the packaging is not innovative packaging, the economic operator shall comply with the existing design for recycling criteria.
If the competent authority considers that the packaging is innovative packaging, it shall inform the Commission accordingly.
The Commission shall assess requests by competent authorities in relation to innovative nature of packaging and update or adopt new delegated acts under paragraph 4 of this Article, as appropriate.
The Commission shall monitor the impact of the derogation referred to in the first subparagraph on the quantity of packaging placed on the market. The Commission shall, where appropriate, present a legislative proposal with a view to amending that subparagraph.
Member States shall continuously aim to improve collection and sorting infrastructures for innovative packaging with expected environmental benefits.
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 (25), of Regulation (EU) 2019/6;
(b) contact-sensitive packaging of medical devices covered by Regulation (EU) 2017/745;
(c) contact-sensitive packaging of in vitro diagnostic 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;
(e) contact-sensitive packaging for infant formula and follow-on formula, processed cereal-based food and baby food, and food for special medical purposes as defined in Article 1, points (a), (b) and (c), of Regulation (EU) No 609/2013;
(f) packaging used for the transport of dangerous goods in accordance with Directive 2008/68/EC;
(g) sales packaging made from lightweight wood, cork, textile, rubber, ceramic, porcelain or wax; however, paragraph 8 shall apply to such packaging.
By 1 January 2035, the Commission shall review the exceptions under paragraph 11, taking into account at least the evolution of sorting and recycling technologies and practical experience gained by the economic operators and Member States. On that basis, the Commission shall assess the appropriateness of the continuation of those exceptions and, where appropriate, present a legislative proposal.
Article 7
Minimum recycled content in plastic packaging
By 1 January 2030 or 3 years from the date of entry into force of the implementing act referred to in paragraph 8 of this Article, whichever is the latest, any plastic part of packaging placed on the market shall contain the following minimum percentage of recycled content recovered from post-consumer plastic waste, per packaging type and format as referred to in Table 1 of Annex II, calculated as an average per manufacturing plant and year:
(a) 30 % for contact-sensitive packaging made from polyethylene terephthalate (PET) as the major component, except single-use plastic beverage bottles;
(b) 10 % for contact-sensitive packaging made from plastic materials other than PET, except single-use plastic beverage bottles;
(c) 30 % for single-use plastic beverage bottles;
(d) 35 % for plastic packaging other than those referred to in points (a), (b) and (c) of this paragraph.
By 1 January 2040, any plastic part of packaging placed on the market shall contain the following minimum percentage of recycled content recovered from post-consumer plastic waste, per packaging type and format as referred to in Table 1 of Annex II, calculated as an average per manufacturing plant and year:
(a) 50 % for contact-sensitive packaging made from PET as the major component, except single-use plastic beverage bottles;
(b) 25 % for contact-sensitive packaging made from plastic materials other than PET, except single-use plastic beverage bottles;
(c) 65 % for single-use plastic beverage bottles;
(d) 65 % for plastic packaging other than those referred to in points (a), (b) and (c) of this paragraph.
For the purposes of this Article, recycled content shall be recovered from post-consumer plastic waste that:
(a) has been collected within the Union pursuant to this Regulation or the national rules transposing Directives 2008/98/EC and (EU) 2019/904, as relevant, or that has been collected in a third country in accordance with standards for separate collection to promote high-quality recycling equivalent to those referred to in this Regulation and Directives 2008/98/EC and (EU) 2019/904, as relevant; and
(b) where applicable, has been recycled in an installation located within the Union to which Directive 2010/75/EU of the European Parliament and of the Council (62) applies, or that has been recycled in an installation located in a third country to which rules concerning the prevention and reduction of emissions into air, water and land associated to the recycling operations apply, and those rules are equivalent to those concerning emissions limits and environmental performance levels established in accordance with Directive 2010/75/EU that are applicable to an installation located in the Union carrying out the same activity; that condition shall apply only in the case where those limits and levels would be applicable to an installation located in the Union and carrying out the same activity as an analogous installation located in the third country.
Paragraphs 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, devices exclusively destined for research use and investigational devices covered by Regulation (EU) 2017/745;
(c) contact-sensitive plastic packaging of in vitro diagnostic 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;
(e) compostable plastic packaging;
(f) packaging used for the transport of dangerous goods in accordance with Directive 2008/68/EC;
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