2025/40

22.1.2025

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)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee (1),

Acting in accordance with the ordinary legislative procedure (2),

Whereas:

(1) Products need appropriate packaging in order to be protected and easy to transport from where they are produced to where they are used or consumed. Prevention of barriers on the internal market for packaging is key for the functioning of the internal market for products. Fragmented rules and vague requirements cause uncertainty and additional cost to economic operators.

(2) The Commission’s (Eurostat’s) packaging waste statistics for the period 2010-2021 indicate that packaging uses large quantities of primary raw material (virgin materials). 40 % of plastics and 50 % of paper used in the Union is used for packaging, and packaging represents 36 % of municipal solid waste. High and constantly increasing quantities of packaging generated, as well as low levels of re-use and collection and poor recycling, present significant barriers to achieving a low-carbon circular economy. This Regulation should therefore establish rules covering the entire life-cycle of packaging, contributing to the efficient functioning of the internal market by harmonising national measures, while preventing and reducing the adverse impacts of packaging and packaging waste on the environment and human health. By laying down measures in line with the waste hierarchy set out in Directive 2008/98/EC of the European Parliament and of the Council (3) (‘waste hierarchy’), this Regulation should contribute to the transition to a circular economy.

(3) European Parliament and Council Directive 94/62/EC (4) lays down requirements for packaging, which relate to the composition of packaging and its reusable and recoverable nature (‘essential requirements for packaging’), and sets recovery and recycling targets for Member States.

(4) In 2014, in its Fitness check relating to Directive 94/62/EC, the Commission recommended adaptations to the essential requirements for packaging, which were seen as a key tool to achieve better environmental performance of packaging, to make those requirements more concrete and more easily enforceable and to strengthen them.

(5) In line with the European Green Deal, set out in the communication of the Commission of 11 December 2019, the new Circular Economy Action Plan for a cleaner and more competitive Europe (CEAP), set out in the communication of the Commission of 11 March 2020, commits to reinforcing the essential requirements for packaging with a view to making all packaging reusable or recyclable by 2030, and to considering other measures to reduce (over)packaging and packaging waste, drive design for re-use and recyclability of packaging, reduce the complexity of packaging materials and introduce requirements for recycled content in plastic packaging. The CEAP also highlights the need to reduce food waste. The Commission commits to assess the feasibility of Union-wide labelling that facilitates the correct separation of packaging waste at source.

(6) Plastic is the most carbon-intensive packaging material and, in terms of fossil fuel use, recycling of plastic waste is approximately five-times better than incineration with energy recovery. As stated in the European Strategy for Plastics in a Circular Economy, set out in the communication of the Commission of 16 January 2018, the CEAP commits to increase uptake of recycled plastics and contribute to the more sustainable use of plastics. The Union budget and the system of own resources contribute to reducing pollution from plastic packaging waste. From 1 January 2021, Council Decision (EU, Euratom) 2020/2053 (5) introduced a national contribution that is proportional to the quantity of plastic packaging waste that is not recycled in each Member State. That own resource forms part of the incentives to reduce the consumption of single-use plastics, foster recycling and boost the circular economy.

(7) The Council, in its conclusions on ‘Making the Recovery Circular and Green’ adopted on 11 December 2020, underlined that the revision of Directive 94/62/EC should update and establish more concrete, effective and easy-to-implement provisions in order to foster sustainable packaging in the internal market and to minimise the complexity of packaging, in order to foster economically feasible solutions, to improve the reusability and recyclability of packaging, as well as to minimise substances of concern in packaging materials, especially in food packaging materials. The Council also stressed that the revision of Directive 94/62/EC should also provide for labelling of packaging in an easily understandable way to inform consumers about the recyclability of packaging and where packaging waste should be discarded to facilitate recycling.

(8) The European Parliament’s resolution of 10 February 2021 on the New Circular Economy Action Plan (6) reiterated the objective of making all packaging reusable or recyclable in an economically viable way by 2030 and called on the Commission to present a legislative proposal revising Directive 94/62/EC which would include waste reduction measures and targets and ambitious essential requirements to reduce excessive packaging, including in e-commerce, improve recyclability and minimise the complexity of packaging, increase recycled content, phase out hazardous and harmful substances, and promote re-use.

(9) This Regulation complements Regulation (EU) 2024/1781 of the European Parliament and of the Council (7), under which packaging is not addressed as a specific product category. However, it should be recalled that it is possible for delegated acts adopted on the basis of Regulation (EU) 2024/1781 to establish additional or more detailed requirements for packaging for specific products, in particular in relation to packaging minimisation where the design or re-design of products can lead to packaging that is environmentally less impactful.

(10) This Regulation should apply to all packaging placed on the market in the Union and to all packaging waste, regardless of the type of packaging or the material used. For reasons of legal clarity, the definition of packaging under Directive 94/62/EC should be restructured without changing the substance. Sales packaging, grouped packaging and transport packaging should be defined separately. Duplication of terminology should be avoided. In this Regulation therefore sales packaging corresponds to primary packaging, grouped packaging to secondary packaging and transport packaging to tertiary packaging.

(11) Cups, food containers, sandwich bags or other items which can perform a packaging function should not be considered to be packaging where they are designed and intended to be sold empty by the final distributor. Such items should only be considered to be packaging where they are designed and intended to be filled at the point of sale, in which case they should be considered to be ‘service packaging’, or sold by the final distributor containing food and beverages, provided that they perform a packaging function.

(12) The definition of primary production packaging should not entail an expansion of products being considered to be packaging under this Regulation. The introduction of that definition and its use in the definition of ‘producer’ should ensure that the natural or legal person making that kind of packaging available for the first time is considered to be the producer under this Regulation and not the primary sector businesses, such as farmers, using that kind of packaging.

(13) An item which is an integral part of a product and is necessary to contain, support or preserve that product throughout its lifetime and where all elements of that item are intended to be used, consumed or disposed of together should not be considered to be packaging given that its functionality is intrinsically linked to it being part of the product. However, in light of the disposal behaviour of consumers regarding tea and coffee bags as well as coffee or tea system single-serve units, which, in practice, are disposed of together with the product residue, leading to the contamination of compostable and recycling streams, those specific items should be treated as packaging. That approach is in line with the objective to increase the separate collection of bio-waste, as required by Article 22 of Directive 2008/98/EC, and ensures coherence regarding end-of-life financial and operational obligations. Paints, inks, varnishes, lacquers and adhesives that have been applied directly on a product should not be considered to be packaging. However, labels hung directly on or affixed to a product, including sticky labels affixed to fruits and vegetables, should be considered to be packaging, since, while the glue on the label is adhesive, the label itself is not. Furthermore, if a given material represents only an insignificant part of a packaging unit, and in any event no more than 5 % of the total mass of the packaging unit, such a packaging unit should not be considered to be composite packaging. The definition of composite packaging in this Regulation should not exempt single-use packaging partially made of plastics, regardless of the threshold level, from the requirements of Directive (EU) 2019/904 of the European Parliament and of the Council (8).

(14) Packaging should be placed on the market only if it complies with the sustainability requirements and labelling requirements laid down in or pursuant to this Regulation. Packaging should be considered to have been placed on the market when the packaging is made available for the first time on the Union market, which means supplied by the manufacturer or importer for distribution, consumption or use in the course of a commercial activity, whether in return for payment or free of charge. Thus, packaging already placed on the Union market before the date of application of relevant requirements and in the stocks of distributors, including retailers and wholesalers, should not need to meet the sustainability and labelling requirements laid down in or pursuant to this Regulation.

(15) In line with the waste hierarchy and with life-cycle thinking to deliver the best overall environmental outcome, the measures provided for in this Regulation should aim to reduce the quantity of packaging placed on the market in terms of its volume and weight, to prevent packaging waste from being generated, in particular through packaging minimisation, avoiding packaging where it is not needed and increasing re-use of packaging. In addition, the measures provided for in this Regulation should aim to increase the use of recycled content in packaging, in particular in plastic packaging, where the uptake of recycled content is very low, by strengthening high-quality recycling systems, thereby increasing recycling rates for all packaging and improving the quality of the resulting secondary raw materials while reducing other forms of recovery and final disposal.

(16) In line with the waste hierarchy, which places waste disposal through landfills as the least preferred option, the measures provided for in this Regulation should aim to reduce the quantity of landfill of packaging waste.

(17) Packaging should be designed, manufactured and commercialised in such a way as to allow for its re-use as many times as possible or for high-quality recycling, and to minimise its impact on the environment during its entire life-cycle and the life-cycle of the products for which it was designed. In order to achieve that objective, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) should be delegated to the Commission in respect of establishing a minimum number of rotations for reusable packaging for the packaging formats which are most frequently used in re-use.

(18) In line with the objectives of the CEAP and the Commission’s communication of 14 October 2020‘Chemicals Strategy for Sustainability Towards a Toxic-Free Environment’ (‘Chemicals Strategy for Sustainability’), and to ensure the sound management of chemicals throughout their life-cycle and the transition to a toxic-free and circular economy, and considering the relevance of packaging in everyday life, it is necessary that this Regulation address the impact of packaging on human health, the environment and on broader sustainability performance throughout its whole life-cycle, including circularity, resulting from the presence of substances of concern throughout the whole life-cycle of packaging, from manufacture to use and end-of-life, including waste management.

(19) Taking into consideration scientific and technological progress, packaging should be designed and manufactured in such a way as to limit the presence of certain heavy metals and other substances of concern in its composition. As stated in the Chemicals Strategy for Sustainability, substances of concern are to be minimised and substituted as far as possible, phasing out the most harmful ones for non-essential societal use, in particular in consumer products. Accordingly, substances of concern as constituents of packaging material or of packaging components should be minimised with the objective to ensure that packaging, as well as materials recycled from packaging, do not have any adverse effect on human health or the environment throughout their life-cycle.

(20) Per- and polyfluoroalkyl substances (PFAS) are a group of thousands of synthetic chemicals that are used widely in the Union as well as in the rest of the world in a broad range of applications. Regarding PFAS tonnage, food-contact material and packaging is one of the most relevant sectors. All PFAS within the scope of this Regulation are either very persistent themselves or degrade into very persistent PFAS in the environment. When looking specifically at those human health endpoints that are considered to be of most concern following long-term exposure of humans, i.e. carcinogenicity, mutagenicity, reproductive toxicity, including effects on or via lactation, and specific target organ toxicity, a large number of PFAS have a classification for at least one of those endpoints. Based on the physical properties of PFAS, particularly their persistence, together with the identified effects on health of some PFAS, PFAS represent an environmental and human health hazard.

(21) PFAS in food-contact materials will inevitably lead to the exposure of humans to PFAS. Due to the non-threshold nature of the PFAS hazards, exposure to PFAS from food-contact materials is an unacceptable risk for human health. PFAS should therefore be restricted in food-contact packaging. In order to avoid overlaps with restrictions on the use of PFAS laid down in other Union legal acts, the Commission should carry out an evaluation to assess the need to amend or repeal the restriction of PFAS in food-contact packaging laid down in this Regulation.

(22) Bisphenol A (BPA) is a chemical compound used in the manufacture of materials that come into contact with food, such as reusable plastic kitchenware or linings for cans, mainly as a protective layer. Exposure to BPA, which can occur through its migration into food and drink and subsequent ingestion by consumers, can pose a risk to consumers even at low levels, according to an assessment published in 2023 by the European Food Safety Authority (EFSA).

(23) In the light of the ongoing procedure on BPA, in accordance with the powers conferred on the Commission under Regulation (EC) No 1935/2004 of the European Parliament and of the Council (9) on food-contact materials, a restriction on the use of BPA is expected to be adopted before the end of 2024. Once adopted, the restriction on the use of BPA will apply to all food packaging and to other food-contact materials, with a general transition period of 18 months.

(24) In line with the EU Action Plan: ‘Towards Zero Pollution for Air, Water and Soil’, set out in the communication of the Commission of 12 May 2021, Union policies should be based on the principle that preventive action should be taken at source. In the Chemicals Strategy for Sustainability, the Commission underlines that Regulations (EC) No 1907/2006 (10) and (EC) No 1272/2008 (11) of the European Parliament and of the Council should be reinforced as the cornerstones for regulating chemicals in the Union and that they should be complemented by coherent approaches to assess and manage chemicals in existing sectorial law. Substances in packaging and in packaging components are therefore restricted at source and primarily addressed under Regulation (EC) No 1907/2006 in accordance with the rules and procedures laid down under Title VIII of that Regulation, in order to protect human health and the environment along all stages of the life-cycle of the substance, including the waste stage. Hence, it should be recalled that Regulation (EC) No 1907/2006 applies to the adoption or amendment of restrictions on substances manufactured for use or used in the production of packaging or packaging components as well as on the placing on the market of substances present in packaging or packaging components. As regards packaging that falls within the scope of Regulation (EC) No 1935/2004, it should be recalled that that Regulation aims to ensure a high level of protection of the consumers of packaged food. Furthermore, it is possible that substances in packaging, in packaging components or in packaging waste are also subject to restrictions laid down in other Union legal acts, such as restrictions and prohibitions established for persistent organic pollutants under Regulation (EU) 2019/1021 of the European Parliament and of the Council (12).

(25) In addition to the restrictions applicable to food-contact materials and articles set out in Annex XVII to Regulation (EC) No 1907/2006, and in Regulation (EC) No 1935/2004, it is appropriate, for reasons of consistency, to maintain existing restrictions for lead, cadmium, mercury and hexavalent chromium present in packaging or packaging components.

(26) Conditions for derogations in respect of the concentrations of lead, cadmium, mercury and hexavalent chromium present in packaging or packaging components are established in Commission Decisions 2001/171/EC (13) and 2009/292/EC (14), adopted under Directive 94/62/EC, and should be maintained under this Regulation. However, in order to take account of scientific and technical progress, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of lowering the concentrations for any of those metals laid down in this Regulation or determining the conditions under which the sum of the concentrations of those metals is not to apply to recycled materials or to product loops which are in a closed and controlled chain or to certain packaging types or formats of packaging. On the basis of the Chemicals Strategy for Sustainability, the same concentrations for hazardous substances should, as a principle, apply for virgin and recycled material. However, there may be exceptional circumstances where a derogation from that principle might be necessary. Those exceptional circumstances justifying different concentrations for recycled material compared to primary raw material should be based on a case-by-case analysis. When amending the existing exemptions in respect of the concentrations of lead, cadmium, mercury and hexavalent chromium, the Commission should take that principle into consideration.

(27) Without prejudice to the restriction of PFAS, this Regulation should not provide for the possibility of imposing restrictions on the use of substances based on reasons of chemical safety or for reasons related to food safety, unless there is an unacceptable risk to human health or the environment, including, but not limited to, the restrictions on lead, cadmium, mercury and hexavalent chromium that were already established on the basis of Directive 94/62/EC and that should be maintained under this Regulation, given that such restrictions are addressed under other Union legal acts. It should nevertheless also allow for the restriction, primarily for reasons other than chemical or food safety, on substances present in packaging and packaging components or used in their manufacturing processes, which negatively affect the sustainability of packaging, in particular as regards its circularity, especially re-use or recycling processes.

(28) Packaging that is designed with the objective of its recycling, once it becomes packaging waste, is one of the most efficient ways to improve packaging circularity and raise packaging recycling rates and the use of recycled content in packaging. Industry, through voluntary industry schemes, and some Member States have established packaging design for recycling criteria for a number of packaging formats for the purpose of the modulation of extended producer responsibility fees. In order to prevent barriers on the internal market and to provide industry with a level playing field, and with the objective to promote the sustainability of packaging, it is important to set mandatory requirements regarding the recyclability of packaging by harmonising the criteria and the methodology for assessing packaging recyclability based on a design for recycling methodology at Union level. In order to meet the objective set out in the CEAP that, by 2030, all packaging should be recyclable in an economically viable manner, recyclable packaging should be designed for material recycling and, when it becomes waste, be capable of being collected separately, sorted into specific waste streams without affecting the recyclability of other waste streams and recycled at scale. Packaging recyclability should be expressed in recyclability performance grades established on the basis of design for recycling criteria from 2030 and on the basis of both design for recycling and recycled-at-scale criteria from 2035 for packaging categories as listed in Annex II and expressed in grades A, B or C. Packaging of those grades should be considered to be recyclable and, consequently, be allowed to be placed on the market. Packaging below grade C should be considered to be technically non-recyclable and the placing on the market of such packaging should be restricted. However, packaging should comply with those criteria only from 1 January 2030 in order to give sufficient time to the economic operators to adapt. From 1 January 2038, packaging should be at least grade B in order to be placed on the market.

(29) The definition of material recycling in this Regulation should complement the definitions of recycling and material recovery set out in Directive 2008/98/EC. Material recycling keeps resources in circulation within the material economy and should therefore not include the biological treatment of waste. The definition of material recycling should not affect the calculation of the recycling targets set for Member States under this Regulation. Those targets and their calculation are based on the definition of recycling set out in Directive 2008/98/EC.

(30) High-quality recycling implies that the recycled materials, based on their preserved technical characteristics, are of equivalent or higher quality compared to the original material and can be used as a substitute for primary raw materials for packaging or similar applications. The recycled material can be recycled multiple times. To enable the production of high-quality recycled raw materials, the collection of properly sorted packaging waste is crucial. The difference between material recycling and high-quality recycling is that in material recycling the packaging material is recycled into materials, while in high-quality recycling the packaging material is recycled into materials of such quality that those materials can be used as the same quality grade for packaging or for other applications where the quality of the recycled material is retained.

(31) The fact that a design for recycling assessment has been carried out does not, in itself, ensure that packaging is recycled in practice. In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to establish a uniform methodology and a chain of custody mechanism that ensures that the packaging waste is effectively recycled at scale, based on established state-of-the-art separate collection processes and on established sorting and recycling processes that have been proven in an operational environment. Consequently, from 2035, a new assessment should be carried out based on the quantity, i.e. the weight, of the material effectively recycled from each of the packaging categories according to the methodology and thresholds set in this Regulation. The thresholds for recycled at scale should be set taking into account the target for the annual quantity of recycled material provided for in this Regulation. By 2030, Member States are expected to have already reported to the Commission the first data on quantities of packaging waste recycled by packaging category for the purposes of monitoring. The producers, in the case of individual fulfilment of extended producer responsibility obligations, the producer responsibility organisations entrusted with the fulfilment of those obligations or the packaging waste management operators, in the case where public authorities are responsible for the organisation of the management of packaging waste, should make sure that the packaging waste is collected separately, sorted and that the material is recycled in installed infrastructure, using established processes that have been proven in an operational environment, and should provide the manufacturer with all the technical documentation demonstrating that packaging is recycled at scale.

(32) In order to establish harmonised rules on packaging design to ensure its recyclability, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of establishing design for recycling criteria and recyclability performance grades, establishing how to perform recyclability performance assessment and express its result, establishing a description of the conditions for compliance of each packaging category with its respective recyclability performance grades, establishing a framework concerning the modulation of financial contributions to be paid by producers to comply with their extended producer responsibility obligations, as well as amending the related Annexes to this Regulation.

(33) In order to stimulate innovation in packaging, packaging which presents innovative features resulting in significant improvement in the core function of packaging and that has demonstrable environmental benefits should be given an additional time to comply with the recyclability requirements. The innovative features should be justified, especially as regards the use of new materials, and the planned establishment of a recycling path should be explained in the technical documentation accompanying the packaging. That information should be used, inter alia, where necessary, to amend the implementing acts on design for recycling criteria. The economic operator should also notify the Commission and the competent authority before placing innovative packaging on the market.

(34) In order to protect human and animal health and safety, due to the nature of the packaged products and the related requirements, the recyclability requirements should not be mandatory for immediate packaging in accordance with Directive 2001/83/EC of the European Parliament and of the Council (15) and with Regulation (EU) 2019/6 of the European Parliament and of the Council (16), which is in direct contact with the medicinal product, as well as outer packaging as defined in those legislative acts in cases where such packaging is necessary to comply with specific requirements to preserve the quality of the medicinal product. In addition, the recyclability requirements should not be mandatory for contact-sensitive plastic packaging for medical devices covered by Regulation (EU) 2017/745 of the European Parliament and of the Council (17), contact-sensitive plastic packaging for

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diagnostics medical devices covered by Regulation (EU) 2017/746 of the European Parliament and of the Council (18), contact-sensitive plastic packaging for foods intended for infants and young children and food for special medical purposes covered by Regulation (EU) No 609/2013 of the European Parliament and of the Council (19) or for packaging used for the transport of dangerous goods in accordance with Directive 2008/68/EC of the European Parliament and of the Council (20). Sales packaging made from lightweight wood, cork, textile, rubber, ceramic or porcelain should also be exempted, since those materials are placed on the market in very small quantities, i.e. each category amounts to less than 1 % of the weight of the packaging placed on the Union market. The obligation to pay financial contributions in accordance with the extended producer responsibility should not be covered by that exemption.

(35) Some Member States are taking action to encourage packaging recyclability through modulation of extended producer responsibility fees. Such initiatives taken at the national level can create regulatory uncertainty for economic operators, in particular those that supply packaging in several Member States. At the same time, the modulation of extended producer responsibility fees is an effective economic instrument to incentivise more sustainable packaging design leading to more easily recyclable packaging while improving the functioning of the internal market. It is therefore necessary to harmonise criteria for the modulation of extended producer responsibility fees based on the recyclability performance grade obtained through the recyclability assessment, while not setting the actual amounts of such fees. As the criteria should be related to the criteria on packaging recyclability, it is appropriate to empower the Commission to adopt such harmonised criteria at the same time as establishing the detailed design for recycling criteria per packaging category.

(36) To ensure packaging circularity, packaging should be designed and manufactured in such a way as to allow for the increased substitution of primary raw materials with recycled materials. The increased use of recycled materials supports the development of the circular economy with well-functioning markets for recycled materials, reduces costs, dependencies and negative environmental impacts related to the use of primary raw materials, and allows for a more resource-efficient use of materials. In relation to the different packaging materials, the lowest input of recycled materials is in plastic packaging. In order to address these concerns in the most appropriate manner, it is necessary to increase the uptake of recycled plastics by establishing mandatory targets for recycled content in plastic packaging at different levels depending on the contact-sensitivity (21) of different plastic packaging applications and by ensuring that those targets become binding by 2030. In order to ensure packaging circularity on an incremental basis, increased targets should apply from 2040.

(37) Paper material resulting from the wood pulping process should not be considered as falling within the definition of plastic under this Regulation.

(38) In order to ensure a high level of protection of human and animal health in accordance with Union law, and to avoid any risk to the security of supply or to the safety of medicinal products and medical devices, certain types of plastic packaging should be excluded from the obligation of having a minimum recycled content. Those types of plastic packaging are immediate packaging as defined in Directive 2001/83/EC and in Regulation (EU) 2019/6, contact-sensitive plastic packaging for medical devices covered by Regulation (EU) 2017/745, contact-sensitive packaging for

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diagnostic medical devices covered by Regulation (EU) 2017/746, contact-sensitive plastic packaging for food intended only for infants and young children and contact-sensitive plastic packaging for food for special medical purposes covered by Regulation (EU) No 609/2013. That exclusion should also apply to outer packaging for human and veterinary medicinal products as defined in Regulation (EU) 2019/6 and Directive 2001/83/EC in cases where the packaging has to comply with specific requirements to preserve the quality of the medicinal product.

(39) In order to achieve the targets for the integration of recycled content under this Regulation, the Commission should publish, no later than 3 years after the entry into force of this Regulation, a review of the state of technological development and environmental performance of biobased plastic packaging, and, where appropriate, present a legislative proposal with sustainability requirements and targets.

(40) In order to prevent barriers on the internal market and to ensure the efficient implementation of this Regulation, economic operators should ensure that any plastic part in packaging contains a certain minimum percentage of recycled content recovered from post-consumer plastic waste, per packaging type and format as referred to in this Regulation, calculated as an average per manufacturing plant and year.

(41) Using the manufacturing plant as a basis for calculation provides the packaging manufacturer with some flexibility in reaching the minimum percentage of recycled content. The manufacturing plant should be understood as referring only to one industrial facility where packaging is manufactured.

(42) There should be an incentive for economic operators to increase the recycled content in the plastic part of packaging. One way to achieve this is to ensure the modulation of extended producer responsibility fees based on the percentage of recycled content in packaging. The fee modulation in such cases should be based on common rules for the calculation and verification of the recycled content contained in such packaging. In that context, Member States should be allowed to maintain existing systems granting prior and fair access to recycled material in order to meet the minimum recycled content targets provided that they comply with this Regulation. Furthermore, priority access should be granted at market prices for the recycled materials and the quantity of recyclates to which priority access is given should correspond to the quantity of packaging made available on the territory of the Member State concerned by the economic operator within a specified timeframe.

(43) Implementing powers should be conferred on the Commission in order to ensure uniform conditions for the implementation of the rules on calculating and verifying the percentage of recycled content obtained from the recovery of post-consumer plastic waste, calculated per packaging type and format as an average per manufacturing plant and year while taking into consideration the environmental impact of the recycling process, and to establish the format for technical documentation.

(44) In order to provide an internal market for high-quality recycling of plastics and the use of secondary raw materials, any plastic part in packaging placed on the market should contain a certain minimum percentage of recycled content recovered from post-consumer plastic waste, per packaging type and format as referred to in this Regulation, calculated as an average per manufacturing plant and year. The packaging type should be understood as referring to the predominant polymer the packaging is made of, while packaging format should be understood as referring to the size and shape of a specific packaging unit.

(45) A high level of protection of environment and human health, in particular with regard to the level of emissions into the air, water and soil, is necessary for several reasons. First, climate change is a global phenomenon that has no boundaries and its effects do not have a direct connection to the source of the emissions of greenhouse gases: countries with low emissions of greenhouse gases can experience effects of climate change that are disproportionate to their individual contributions to the global emissions of greenhouse gases. Second, water systems are interconnected, for example via oceanic currents, and past experience shows that pollution, including plastic waste pollution, happening in one part of the planet can spread widely to other oceans and continents. Third, emissions into the soil can have not only local, but also transboundary effects, especially when those emissions pass into the watercourses. The promotion of the use of recycled content in plastic packaging is based on the premise that the recycled content itself was produced in an environmentally sustainable way, so that the carbon footprint is reduced and the circular economy is encouraged. To that end, certain safeguards need to be put in place in order to ensure that the way in which recycled content is obtained does not cancel out the environmental benefits of using such recycled content in subsequent plastic packaging. It is therefore necessary to address the related environmental concerns in a non-discriminatory manner with regard to both domestically produced and imported plastic packaging. To that end, imports into the Union should be subject to equivalent conditions with regard to emissions and separate collection and sustainability criteria for recycling technologies.

(46) The separate collection of plastic waste is essential, as it has a direct, positive impact on the collection rate, on the quality of the collected material and on the quality of the recyclates. It enables high-quality recycling and boosts the uptake of quality secondary raw materials. Moving closer to a ‘recycling society’ helps to avoid waste generation and encourages the use of waste as a resource, while avoiding locking in resources at the lower levels of the waste hierarchy with detrimental effects on the environment and disregarding environmentally sound management of waste. Separate collection also avoids mixing hazardous and non-hazardous waste, ensuring the safety of the waste and of its shipment, and avoids pollution, as provided by international rules such as the Basel Convention on the control of transboundary movements of hazardous wastes and their disposal (22) of 22 March 1989, the United Nations Convention on the Law of the Sea of 10 December 1982 (23), the Convention on the Prevention of Marine Pollution by Dumping of Wastes and Other Matter, done in London on 29 December 1972, and its 1996 Protocol, and Annex V to the International Convention for the Prevention of Pollution from Ships of 2 November 1973 (MARPOL), as modified by the Protocol of 1978 relating thereto.

(47) Furthermore, discussions at international level within the different meetings of the Intergovernmental Negotiating Committee to develop an international legally binding instrument on plastic pollution, including in the marine environment under the auspices of the United Nations Environmental Programme (‘INC on Plastic Pollution’), have demonstrated at international level the need to step up action concerning the separate collection of plastics to limit their environmental impacts and to boost the circular economy in order to prevent the generation of waste and reduce the exploitation of natural resources. They also demonstrated the will of the contracting parties to adopt measures in that direction. The Convention on long-range transboundary air pollution (24), done in Geneva on 14 November 1979, requires the parties to that Convention to protect the environment against air pollution and to endeavour to limit and, as far as possible, gradually reduce and prevent air pollution, including long-range transboundary air pollution. Under the Convention on the protection and use of transboundary watercourses and international lakes (25), done in Helsinki on 17 March 1992, the parties are required to take measures to prevent, control and reduce any transboundary impact of water pollution. In line with the 1992 Rio Declaration of the United Nations Conference on Environment and Development, the polluter should, in principle, bear the cost of pollution. Hence, industrial activities such as recycling of plastic, should go hand in hand with pollution prevention and reduction measures.

(48) The environmental objective of encouraging the use of materials recovered from post-consumer plastic waste requires plastic recycling to be done in a way that minimises the resulting pollution. If this does not occur, the industrial pollutants emitted in the course of recycling would reduce or eliminate the environmental added value of encouraging the use of recycled plastic. Sustainability criteria should be developed with regard to recycling technologies for post-consumer plastic waste. They should ensure a high level of protection of environment and human health, in particular with regard to the level of emissions into the air, water and soil, and to resource efficiency. For that purpose, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of establishing sustainability criteria for plastic recycling technologies. Accordingly, recycling should be performed in an environmentally sound manner, leading to the high quality of recycling processes and products and ensuring high standards for the recycling sector. By ensuring the appropriate level of sustainability of the recycling technology and, consequently, the recyclate, the encouragement of the use of recycled content in plastic packaging becomes an environmentally responsible measure. Discussions during the meetings of the INC on Plastic Pollution also stressed the importance of ensuring that recycling technologies operate in an environmentally sound manner.

(49) The methodology for assessing, verifying and certifying, including through third-party audit, the equivalence of the rules applied where recycled content recovered from post-consumer plastic waste is recycled or collected in a third country should ensure a high level of protection of environment and human health, in particular with regard to the level of emissions into the air, water and soil, taking into account the need to ensure that recycling is performed in an environmentally sound manner, the possibility to ensure high-quality recycling, the level of the quality standards for the recycling sector, and the level of resource efficiency. Such considerations are key to achieving circularity of resources, thereby putting less pressure on exhaustible natural resources. In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission to establish that methodology.

(50) Food-contact materials containing recycled plastic have to meet the requirements set out in Commission Regulation (EU) 2022/1616 (26), which includes requirements on recycling technologies. Regarding plastic packaging, except where that packaging is made from polyethylene terephthalate (PET), it is appropriate to re-assess the availability of suitable recycling technologies for such plastic packaging sufficiently ahead of the date of application of the related recycled content requirements. That assessment should also cover the state of authorisation under relevant Union rules and the installation in practice of such technology. Based on that assessment, there might be a need to provide for derogations from the recycled content requirements for specific contact-sensitive plastic packaging or to amend the list of exceptions laid down in this Regulation. To that end, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission.

(51) In order to take into account the risks related to a possible insufficient supply of a specific plastic waste for recycling that might lead to excessive prices or adverse effects on health, safety and the environment, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of adjusting the minimum percentages of recycled content recovered from post-consumer plastic waste. In evaluating the justification of such a delegated act, the Commission should assess well-reasoned requests from natural and legal persons.

(52) For materials other than plastic, such as glass or aluminium, the trend to replace primary raw material with recycled materials is evident and expected to continue because of the development in the legal and economic environment and the consumers` expectations. Nonetheless, the Commission should monitor closely the use of recycled content in packaging materials other than plastics and should assess the appropriateness of proposing to establish further measures, including the setting of targets, aiming to increase the use of recycled content in packaging other than plastic packaging.

(53) The bio-waste waste stream is often contaminated with conventional plastics and the material recycling streams are often contaminated with compostable plastics. This cross-contamination leads to waste of resources and lower quality secondary raw materials and should be prevented at source. In light of that concern, Member States should specify the appropriate waste management on their territory for compostable packaging. As the proper disposal route for compostable plastic packaging is becoming increasingly confusing for consumers, it is justified and necessary to lay down clear and common rules on the use of compostable plastic packaging, mandating it only when its use brings a clear benefit for the environment or for human health. This is particularly the case when the use of compostable packaging helps collect or dispose of bio-waste, for example for products where the separation between the content and packaging is particularly complex, such as tea bags.

(54) For limited packaging applications made of biodegradable plastic polymers, there is a demonstrable environmental benefit in using compostable packaging which enters composting plants, including anaerobic digestion facilities under controlled conditions. Furthermore, where a Member State applies Article 22(1), second subparagraph, of Directive 2008/98/EC and appropriate waste collection schemes and waste treatment infrastructures are available in that Member State, there should be flexibility for that Member State to decide whether to allow the making available on its territory for the first time of compostable packaging for coffee, tea or other beverage system single-serve units that are composed of packaging material other than metal, and very lightweight plastic carrier bags, lightweight plastic carrier bags and the making available on their territory for the first time of other packaging that was subject to a requirement to be compostable before the date of application of this Regulation. In order to avoid consumer confusion about the correct disposal route, and considering the environmental benefit of circularity of carbon, all other packaging should go into material recycling and the design of such packaging should ensure that it does not affect the recyclability of other waste streams.

(55) In addition, biodegradable waste should not lead to the presence of contaminants in the compost produced. The requirements of harmonised standard EN 13432:2000 ‘Packaging – Requirements for packaging recoverable by composting and biodegradation – Test scheme and evaluation criteria for final acceptance of packaging’ should be revised with regard to composting times, permissible levels of contamination and restrictions on the release of microplastic to allow those materials to be processed in bio-waste treatment facilities in an appropriate manner. In addition, a similar standard for home composting should be established in the Union.

(56) As described in the ‘EU policy framework on biobased, biodegradable and compostable plastics’, set out in the communication of the Commission of 30 November 2022, compliance with standards for industrial composting does not imply decomposition in home composting. In industrial composting, the required conditions are high temperatures and high humidity levels. In home composting, which is carried out by private individuals, including in communities, the actual conditions depend very much on local climate circumstances and consumer practices. Hence, biodegradation in home composting risks being slower than in industrial composting or not to be completed. In particular, home composting for plastic packaging should only be considered for specific applications and in the context of specific local conditions under the supervision of the relevant authorities.

(57) Where justified and appropriate due to technological and regulatory developments impacting the disposal of compostable plastics, and under the specific conditions ensuring that the use of such materials is beneficial for the environmental and human health, the Commission should present, where appropriate, a legislative proposal to amend the list of packaging that is allowed to be compostable.

(58) In order to facilitate conformity assessment as regards requirements under this Regulation on compostable packaging, it is necessary to provide for a presumption of conformity for compostable packaging that is in line with harmonised standards adopted under Regulation (EU) No 1025/2012 of the European Parliament and of the Council (27). In determining whether the presumption applies, detailed technical specifications of those requirements should be taken into account, in line with the latest scientific and technological developments. The parameters, including composting times and admissible levels of contamination, should reflect the actual conditions in bio-waste treatment facilities, including anaerobic digestion processes. The current standard for industrial composting cannot be relied upon as a basis for a presumption of conformity, as that standard needs to be revised and replaced by an updated version. However, until such time as there is a new, or updated, harmonised standard available, the current standard can be used as guidance. Regarding home-compostable packaging, the Commission should request the development of EN-standardisation as appropriate.

(59) All packaging that is intended to come into contact with food or already in contact with food, including compostable packaging, has to meet the requirements set out in Regulation (EC) No 1935/2004. Where appropriate, it should be possible to use the documentation and information required under Union legal acts on food-contact materials as part of the information and documentation required under this Regulation.

(60) Packaging should be designed so as to minimise its volume and weight and to enable recyclability while maintaining its ability to perform the packaging functions. The manufacturer should assess the packaging against the performance criteria listed in this Regulation. In view of the objectives of this Regulation to reduce packaging and packaging waste generation, and to improve circularity of packaging across the internal market, it is appropriate to further supplement and clarify the current criteria and to make them more stringent. The list of the packaging performance criteria, as listed in harmonised standard EN 13428:2004 ‘Packaging – Requirements specific to manufacturing and composition – Prevention by source reduction’, should therefore be modified. However, until such time as a new or updated harmonised standard becomes available, the existing standard, EN 13428:2004, can be used. While marketing and consumer acceptance remain relevant for packaging design, they should not be part of performance criteria justifying on their own additional packaging weight and volume. However, this should not compromise product specifications for craft and industrial products and food and agricultural products that are registered and protected under the EU geographical indication protection scheme, as part of the Union’s objective to protect cultural heritage and traditional know-how, including under Regulation (EU) No 1308/2013 of the European Parliament and of the Council (28) for wine, Regulation (EU) 2019/787 of the European Parliament and of the Council (29) for spirit drinks or Regulation (EU) 2023/2411 of the European Parliament and of the Council (30) for craft and industrial products or covered by quality schemes referred to in Regulation (EU) 2024/1143 of the European Parliament and of the Council (31). It should also not compromise packaging designs that are protected under Union or national law on design or trademarks or international agreements having effect in one of the Member States. The exception of such packaging is justified only to the extent that the new rules on packaging minimisation affect the shape of the packaging in such a way that the trademark can no longer distinguish the trademarked good from goods of another undertaking, and the design can no longer keep its new and individual characteristics. In order to avoid the risk of abuse, the exception should apply only to trademark and design rights protected before 11 February 2025. On the other hand, recyclability, the use of recycled content and re-use of packaging could justify additional packaging weight or volume and should be added to the performance criteria. Packaging with double walls, false bottoms and other characteristics aimed only at increasing the perceived product volume should not be placed on the market, as such packaging does not meet the requirement for packaging minimisation. The same rule should apply to superfluous packaging not necessary for ensuring packaging functionality.

(61) In order to comply with the packaging minimisation requirements, particular attention should be paid to limiting the empty space in grouped and transport packaging, including e-commerce packaging.

(62) In order to facilitate conformity assessment as regards requirements under this Regulation on packaging minimisation, it is necessary to provide for a presumption of conformity for packaging which is in conformity with harmonised standards adopted in accordance with Regulation (EU) No 1025/2012 for the purpose of expressing detailed technical specifications of those requirements and specifying measurable design criteria, including, where appropriate, maximum weight or empty space limits for specific packaging formats, as well as by-default, standardised packaging designs that comply with the packaging minimisation requirements.

(63) To promote the circularity and sustainable use of packaging, reusable packaging and re-use systems should be incentivised. For that purpose, it is necessary to clarify the notion of reusable packaging and ensure that it is linked not only to the packaging design, but also to the setting up of re-use systems that comply with minimum requirements as set out in this Regulation. The packaging design should enable the highest possible number of rotations and maintain the safety, quality and hygiene requirements when being emptied, unloaded, refilled or reloaded. In order to facilitate conformity assessment as regards requirements under this Regulation on reusable packaging, it is necessary to provide for a presumption of conformity for packaging which is in conformity with harmonised standards adopted in accordance with Regulation (EU) No 1025/2012 for the purpose of expressing detailed technical specifications under that Regulation and for establishing reusable packaging criteria and formats, including minimum number of trips or rotations, standardised designs, as well as requirements for re-use systems, including hygiene requirements.

(64) It is necessary to inform consumers and enable them to dispose of packaging waste in an appropriate manner. To that end, it is appropriate to establish a harmonised labelling system based on the material composition of packaging for sorting of waste and paired with corresponding labels on waste receptacles. The need for such a harmonised labelling system to be recognised by all citizens, irrespective of their circumstances, such as age and language knowledge, should be a guiding factor in the design of the labels. Such a system can be achieved through the use of pictograms, with minimal use of language. Such designs would also serve to minimise translation costs, which would otherwise be incurred.

(65) Sorting is an essential step to ensure greater circularity of packaging. The improvement of sorting capacities, in particular through technological innovations, should be encouraged in order to enable more effective sorting, and thus better quality feedstock for recycling.

(66) To facilitate consumers in the sorting and disposal of packaging waste, a system of harmonised symbols should be introduced and required to be placed both on packaging and on waste receptacles, thus enabling consumers to match the symbols for the purposes of disposal. The symbols should enable appropriate waste management as they should provide consumers with information about the composting properties of such packaging. Such information should, in particular, avoid consumer confusion regarding compostable packaging, which is not, as such, suitable for home composting, but only compostable in industrially controlled conditions. Such information should therefore prevent compostable packaging from being thrown away in nature. That approach will improve the separate collection of packaging waste, leading to higher quality recycling of packaging waste, and is intended to introduce a level of harmonisation of the packaging waste collection systems on the internal market. It is also necessary to harmonise symbols associated with the mandatory deposit and return systems established after the entry into force of this Regulation. It should be possible for Member States to require the use of such harmonised labels on packaging subject to deposit and return systems established under national law before the entry into force of this Regulation. Considering that transport packaging is not collected through municipal waste collection systems, the use of those symbols should not be mandatory for transport packaging, with the exception of the e-commerce packaging.

(67) The labelling of recycled content in packaging should not be mandatory, as that information is not critical to ensure the proper end-of-life treatment of packaging. However, manufacturers will be required to meet recycled content targets under this Regulation and they might wish to display that information on their packaging to inform consumers of recycled content in the packaging. To ensure that such information is communicated in a harmonised manner across the Union, a label to indicate the recycled content should be harmonised.

(68) Labelling of biobased plastic content in packaging should also not be mandatory as there are a number of conditions that biobased plastics have to meet to ensure sustainability and more scientific evidence is necessary to ensure that, over their whole life-cycle, the use of biobased plastic is in line with the principles of circular economy, set out in the communication of the Commission of 30 November 2022 on a Union policy framework on biobased, biodegradable and compostable plastic. However, manufacturers might wish to display that information on their packaging to inform consumers of the biobased plastic content in the packaging. To ensure that such information is communicated in a harmonised manner across the Union, a label to indicate the biobased plastic content should be harmonised.

(69) As regards reusable packaging, in order to inform end users about reusability, the availability of re-use systems and the location of collection channels, such packaging should bear a QR code or other standardised, open, digital data carrier that provides such information. The QR code or data carrier should contain information which facilitates tracking and the calculation of trips and rotations, or an average estimation if such calculations are not feasible. That label should be voluntary for open loop systems which do not have a system operator. In addition, reusable sales packaging should be clearly identified at the point of sale.

(70) There should be no multiplication of labels on packaging. In order to avoid this, where other Union legal acts require information on the packaged product to be available digitally through a data carrier, the information required under this Regulation for the packaging and for the packaged product under the other Union legal act should be accessible via the same data carrier. That data carrier should comply with the requirements under this Regulation or other applicable Union law. In particular, where the packaged product is covered by Regulation (EU) 2024/1781 or other Union law requiring a digital product passport, that digital product passport should also be used for providing the relevant information under this Regulation. Where packaging contains substances of concern, it should be marked using a standardised, open, digital-marking technology as established in implementing acts adopted by the Commission. That information should ensure that waste operators have access to relevant information on the chemical composition of the packaging to determine the most appropriate waste management option in line with the waste hierarchy, thus promoting packaging circularity.

(71) To help achieve the objectives of this Regulation, consumers should be protected from misleading and confusing information about the characteristics and appropriate end-of-life treatment of packaging for which harmonised labels have been established under this Regulation. It should be possible to identify packaging included in the extended producer responsibility scheme by a corresponding symbol throughout the territory in which that scheme applies in order to signify that the producer fulfils its extended producer responsibility obligations. Such identification should be achieved only by means of a QR code or other standardised, open, digital-marking technology. That symbol should be clear and unambiguous to consumers as to the recyclability of packaging.

(72) Packaging covered by mandatory deposit and return systems should bear a label informing the consumers that the packaging is covered by that system and that the packaging should therefore be collected through specific collection channels that are authorised for that purpose by national authorities. That label should be a harmonised EU label established by the Commission. It should be possible for Member States to require such harmonised labels to be used on packaging that is subject to deposit and return systems that have been established under national law before the entry into force of this Regulation.

(73) Directive 2005/29/EC of the European Parliament and of the Council (32) works as a ‘safety net’ that ensures a high level of consumer protection in all sectors, complementing more detailed requirements in sector-specific or product-specific Union law, except in the case of conflict between that Directive and other Union rules related to specific aspects of unfair commercial practices, in which case the latter should prevail in relation to those specific aspects. Directive (EU) 2024/825 of the European Parliament and of the Council (33) provides that displaying a voluntary sustainability label which does not meet certain requirements constitutes an unfair commercial practice.

(74) In order to ensure uniform conditions for the implementation of the labelling requirements, implementing powers should be conferred on the Commission to further improve waste sorting, to establish the methodology for identifying the material composition of packaging and for identifying substances of concern by means of standardised, open, digital technologies and to establish a harmonised label and specifications and format for the labelling requirements for packaging and waste receptacles established under this Regulation. When developing those specifications, the Commission should keep linguistic elements to a minimum and take into account scientific or other available technical information, including relevant international standards. The existence of any variations between Member States in the amount of the deposit charged should be taken into account in the design of the harmonised labelling of packaging that is subject to a deposit and return system. In view of the new system, Commission Decision 97/129/EC (34) should be repealed from 12 August 2028 and its content incorporated into the implementing act.

(75) Economic operators should ensure that packaging complies with the requirements under this Regulation. They should take appropriate measures to ensure such compliance in relation to their respective roles in the supply chain in order to ensure the free movement of packaging in the internal market and to improve its sustainability.

(76) The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment provided for under this Regulation. Conformity assessment under this Regulation should therefore remain solely the obligation of the manufacturer.

(77) It should be ensured that suppliers of packaging or packaging materials provide the manufacturer with all the information and documentation necessary for the manufacturer to demonstrate the conformity of the packaging and the packaging materials. That information and documentation should be provided in either paper or electronic form.

(78) In order to safeguard the functioning of the internal market, it is necessary to ensure that packaging from third countries that enters the Union market complies with this Regulation, whether 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. Importers should therefore ensure that the packaging they place on the market complies with those requirements and that documentation drawn up by manufacturers is available for inspection by the competent national authorities.

(79) When placing packaging on the market, every importer should indicate on the packaging their name, registered trade name or registered trademark as well as their postal address and, where available, electronic means of communication through which it can be contacted. Exceptions should be provided for in cases where the packaging does not allow for such indications.

(80) As the distributor makes packaging available on the market after it has been placed there by the manufacturer or importer, they should act with due care in relation to the applicable requirements of this Regulation. The distributor should also ensure that their handling of the packaging does not adversely affect its compliance with those requirements.

(81) As distributors and importers are close to the marketplace and have an important role in ensuring packaging compliance, they should be involved in market surveillance tasks carried out by the competent national authorities, and should be prepared to participate actively, providing those authorities with all necessary information relating to the packaging concerned.

(82) Any importer or distributor that either places on the market packaging under their own name or trademark or modifies packaging already placed on the market in a way that could affect compliance with this Regulation should be considered to be the manufacturer and should assume responsibility for the manufacturer’s obligations.

(83) Ensuring packaging’s traceability throughout the whole supply chain facilitates the market surveillance authorities’ task of tracing economic operators who placed on the market or made available on the market non-compliant packaging. The economic operators should therefore be required to keep the information on their transactions for a certain period of time.

(84) The problem of excessive packaging waste generation cannot be fully addressed by laying down obligations on packaging design. For certain packaging types, obligations to reduce the empty space ratio should be imposed on economic operators who fill or otherwise use such packaging. In the case of grouped, transport and e-commerce packaging used for supply of products to final distributors or end users, the empty space ratio should not exceed 50 %. That obligation should not apply to reusable packaging. In line with the waste hierarchy and to promote packaging innovation with the aim of reducing packaging waste, it should be possible for economic operators using sales packaging as e-commerce packaging to be exempted from that obligation. In order to ensure uniform conditions for the calculation of the empty space ratio, implementing powers should be conferred on the Commission to establish the methodology for its calculation.

(85) In order to ensure a high level of environmental protection in the internal market as well as a high level of food safety and food hygiene and to facilitate the achievement of the packaging waste prevention targets, unnecessary or avoidable packaging should not be placed on the market. The list of such packaging formats is provided in this Regulation. The Commission should publish guidelines to explain that list in more detail, including by providing examples of the packaging and guidance on the exemptions to the restrictions.

(86) In order to further the aim of circularity and sustainable use of packaging, it is necessary to limit the risk that packaging marketed as reusable is not re-used in practice, and to ensure that consumers return reusable packaging. The most appropriate manner to achieve this is to oblige economic operators who use reusable packaging to ensure that a re-use system is put in place, thus allowing such packaging to circulate, rotate and be used repeatedly. To maximise the benefits of such systems, minimum requirements should be laid down for open loop and closed loop systems. Confirmation of compliance of reusable packaging with a re-use system should also be a part of the technical documentation of such packaging. Re-use systems can vary in size and geographical coverage and range from smaller local systems to larger systems that may span over one or several Member States’ territory.

(87) Reusable packaging has to be safe for its users. Therefore, economic operators offering their products in reusable packaging should ensure that, before a reusable packaging is used again, it is subject to a reconditioning process, for which requirements should be laid down.

(88) Reusable packaging becomes waste, within the meaning of the Article 3, point (1), of Directive 2008/98/EC, when its holder discards it, intends to discard it or is required to discard it. Reusable packaging in a reconditioning process is normally not considered to be waste.

(89) To incentivise waste prevention, a new concept of ‘refill’ should be introduced. Refill should be understood as a specific waste prevention measure that counts towards, and is necessary for, meeting the prevention targets set out in this Regulation.

(90) Where economic operators offer the possibility to purchase products through refill, they should ensure that their refill stations meet certain requirements in order to ensure the health and safety of consumers. In that context, where the consumers use their own containers, the economic operators should provide information about the conditions for the safe refill and use of those containers. In order to encourage refill, economic operators should not provide packaging free of charge or packaging that is not part of a deposit and return system at the refill stations. Economic operators should be exempt from liability for food safety problems that could arise from the use of containers provided by consumers.

(91) In order to reduce the increasing proportion of packaging that is single-use and the growing quantities of packaging waste that are generated, it is necessary to establish quantitative re-use targets on packaging in sectors which have been assessed as having the greatest potential for packaging waste reduction, namely food and beverages for take-away, large-white goods and transport packaging. This was appraised based on factors such as existing re-use systems, necessity of using packaging and the possibility of fulfilling the functional requirements in terms of containment, tidiness, health, hygiene and safety. Differences of the products and their production and distribution systems were also taken into account. The implementation of such targets should take into account the environmental benefits achieved throughout the whole life-cycle of a product. The setting of the targets is expected to support innovation and increase the proportion of re-use packaging and refill solutions. Single-use plastic packaging for food and beverages filled and consumed within the premises in the HORECA sector should not be allowed. Consumers should always have the option to purchase food and beverages for take-away in reusable or their own containers under conditions that are no less favourable than those applicable to food and beverages offered in single-use packaging. Economic operators selling food or beverages for take-away should offer consumers the option to purchase the food or beverages in their own containers and the option to purchase food and beverages in reusable packaging.

(92) Under certain conditions, Member States should be able to exempt economic operators from re-use obligations for a renewable period of 5 years. Those conditions should be based on high recycling and applicable waste prevention rates in the exempting Member State, including a first intermediary waste prevention rate of 3 % by 2028, as well as the adoption of a corporate waste prevention and recycling plan by the economic operators.

(93) The placing on the market of packaging that is subject to the restrictions on use of certain packaging formats under this Regulation for means of transport operating cross-border where catering services are available on-board, such as aircrafts, planes, trains, cruise ships, ferries, yachts and boats, should be understood as travelling with that packaging to or within the Union. Travelling within the Union should be understood as a situation where the transport vehicle departs from and arrives at a destination located in the Union.

(94) To increase their effectiveness and ensure the equal treatment of economic operators, the re-use targets should be placed on the economic operators. In the case of re-use targets for beverages, the re-use targets should be placed on final distributors that make beverages in sales packaging available to consumers. Certain beverages that are considered perishable because they are sensitive to microbiological spoilage caused by bacteria or yeasts, need specific aseptic technology to protect them from spoilage while keeping a long shelf life. Therefore, milk and other perishable beverages should be exempt from the obligation to meet the packaging re-use targets. The targets should be calculated as a percentage of sales, volume or weight sold in reusable packaging within a re-use system or, in the case of transport packaging, as a percentage of number of times used. The targets should be material neutral. In order to ensure uniform conditions for the implementation of the re-use targets, implementing powers should be conferred on the Commission as regards the methodology for their calculation.

(95) In some cases, the use of single-use transport packaging formats is not necessary, as there is a wide range of well-functioning reusable alternatives. In order to ensure that such alternatives are used in an effective manner, it is appropriate to require economic operators, when transporting products between different sites of the same economic operator or between the economic operator and linked or partner enterprises, to use only reusable transport packaging with respect to packaging formats such as pallets, foldable plastic boxes, plastic crates, intermediate bulk containers, both rigid and flexible, or drums. The same obligation should, for the same reasons, apply to economic operators transporting products within one Member State. For certain types of transport or sales packaging, reusable alternatives are not an option. This is the case for cardboard boxes, where the number of rotations is very low, and for packaging used for certain contact-sensitive products, which require special washing between uses. Therefore, such packaging should be exempted from the obligation to meet the re-use targets for transport packaging and sales packaging used for transporting products.

(96) Achieving re-use and refill targets can be challenging for smaller economic operators. Therefore, certain economic operators should be exempt from the obligation to meet the packaging re-use targets if they place less than a certain volume of packaging on the market and fulfil the definition of micro-enterprise set out in Commission Recommendation 2003/361/EC (35) as applicable on 11 February 2025, or if a final distributor has a sales area under a certain surface limit. For those purposes, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending the sales area threshold, establishing and specifying the detailed conditions and reporting requirements to be applied to final distributors’ pooling arrangements, amending the size threshold for the exemption of economic operators, and establishing further exemptions for certain other economic operators or specific packaging formats covered by the re-use or refill targets in case of particular economic constraints, severe hygiene, food safety or environmental issues preventing the achievement of those targets.

(97) To enable the verification of compliance with the re-use targets, it is necessary that the respective economic operators report to the competent authorities. Economic operators should report the relevant data for each calendar year, starting from the calendar year 2030. Member States should make this data publicly available.

(98) As economic operators can have several different packaging formats, the attainment of the re-use targets should be calculated on the basis of the total quantity of food or beverages made available on the market, by reference to the total number of sales units, or to the weight of the food or volume of beverages, as applicable.

(99) In view of the continued high consumption levels of plastic carrier bags, inefficient use of resources and their potential to be discarded as litter, it is appropriate to maintain provisions aimed at reaching a sustained reduction in the consumption of plastic carrier bags, as had already been established by Directive 94/62/EC as amended by the Directive (EU) 2015/720 of the European Parliament and of the Council (36). In view of the current divergent approaches and limited reporting requirements on the plastic carrier bags, it is difficult to assess whether the consumption reduction measures taken by the Member States have achieved the objective of a ‘sustained’ reduction in the consumption of such bags, and also if they have not increased the consumption of other types of plastic carrier bags. It is therefore necessary to harmonise a definition of sustained reduction in the consumption of plastic carrier bags and set a common target as well as introduce new reporting requirements.

(100) In view of the results of the 2021 evaluation study on plastic carrier bags entitled ‘Scoping study to assess the feasibility of further EU measures on waste prevention and implementation of the Plastic Bags Directive, Part II, Implementation of the Plastic Bags Directive’, further measures need to be taken to reduce the consumption of lightweight plastic carrier bags and assess possible substitution effects with very lightweight plastic carrier bags and thicker plastic carrier bags above 50 microns.

(101) As very lightweight plastic carrier bags, below 15 microns, have a high potential to become waste and contribute to marine pollution, measures should be taken to restrict their placing on the market except for strictly necessary uses. Those plastic bags should not be placed on the market as packaging for bulk foodstuffs, except for hygienic reasons or for packaging wet bulk foodstuffs such as raw meat, fish or dairy products.

(102) To achieve a sustained reduction in the consumption of lightweight plastic carrier bags on their territory, Member States should be able to adopt measures which include banning these types of plastic carrier bags, implementing national reduction targets, maintaining or introducing economic instruments as well as other marketing restrictions, provided that these measures are proportionate and non-discriminatory. Such measures may vary depending on the environmental impact of lightweight plastic carrier bags when they are recovered or disposed of, their composting properties, durability or specific intended use. Provided that the objectives set out in this Regulation for plastic carrier bags are achieved, it should be possible for Member States to implement the provisions concerning those bags by means of agreements between the competent authorities and the economic sectors concerned.

(103) A reduction in the use of plastic carrier bags should not lead to their substitution with bags from other packaging materials. The Commission should monitor the use of other packaging materials and propose a target and, if appropriate, measures for the reduction of the consumption of such packaging materials.

(104) In order to ensure the effective and harmonised application of sustainability requirements laid down in or pursuant to this Regulation, compliance with those requirements should be measured using reliable, accurate and reproducible methods that take into account generally recognised state-of-the-art methods.

(105) In order to ensure that there are no barriers to trade on the internal market, requirements on packaging sustainability, including on substances of concern in packaging, compostable packaging, packaging minimisation, reusable packaging and re-use systems, should be harmonised at Union level. In order to facilitate conformity assessment as regards such requirements, including methods for tests, measurements or calculations, it is necessary to provide for a presumption of conformity for packaging and packaged products which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 for the purpose of expressing detailed technical specifications of those requirements.

(106) In the absence of harmonised standards, recourse to common specifications should be used as a fall-back solution to facilitate the manufacturer’s obligation to comply with sustainability requirements, for instance where there are undue delays in establishing a harmonised standard. In addition, recourse to common specifications should be possible where the Commission has restricted or withdrawn the references to relevant harmonised standards in accordance with Article 11(5) of Regulation (EU) No 1025/2012. Compliance with common specifications adopted by the Commission by means implementing acts should also give rise to a presumption of conformity.

(107) In order to ensure uniform conditions for the implementation of the recourse to common specifications, implementing powers should be conferred on the Commission to lay down, amend or repeal common specifications for the requirements on sustainability, labelling and re-use systems, and to adopt test, measurement or calculation methods. The Commission should take into account the views of relevant bodies and expert groups and should consult all relevant stakeholders when preparing the draft implementing acts.

(108) To ensure coherence with other Union law, the conformity assessment procedure should be the internal production control module included in this Regulation based on the modules included in Decision No 768/2008/EC of the European Parliament and of the Council (37).

(109) CE marking on packaging should not indicate compliance of the packaging with the requirements of this Regulation, but only indicate compliance of the packaged product with the applicable Union product law, if relevant. Indeed, Union product law typically requires affixing the CE marking concerning the product either on the product itself or on its packaging. Requiring CE marking on the packaging to show compliance with the requirements of this Regulation could lead to confusion and misunderstanding in relation to the question whether the marking refers to the packaging itself or to the packaged product and ultimately to uncertainties about the effective safety and compliance of the packaged products concerned.

(110) Compliance of the packaging of a product with the requirements of this Regulation should be demonstrated by the EU declaration of conformity.

(111) Manufacturers should draw up an EU declaration of conformity to provide information on the conformity of packaging with this Regulation. It is possible that manufacturers are also required to draw up an EU declaration of conformity under other Union law. To ensure access to information for market surveillance purposes, a single EU declaration of conformity should be drawn up in respect of all relevant Union legal acts. To reduce the administrative burden on economic operators, it should be possible for that single EU declaration of conformity to comprise a dossier of relevant individual declarations of conformity.

(112) Regulation (EU) 2019/1020of the European Parliament and of the Council (38) provides a framework for the market surveillance of products and for controls on products from third countries. That Regulation should be applicable to packaging covered by this Regulation in order to ensure that packaging benefiting from the free movement of goods within the Union fulfil requirements providing a high level of protection of public interests such as human health, safety and the environment.

(113) Waste management in the Union should be improved with a view to protecting, preserving and improving the quality of the environment, protecting human health, ensuring prudent, efficient and rational utilisation of natural resources, promoting the principles of the circular economy, enhancing the use of renewable energy, increasing energy efficiency, reducing the dependence of the Union on imported resources, providing new economic opportunities and contributing to long-term competitiveness. The more efficient use of resources would also bring substantial net savings for Union businesses, public authorities and consumers, while reducing total annual emissions of greenhouse gases.

(114) Despite the packaging minimisation requirements and the objectives laid down in Directive 94/62/EC, packaging waste generation has been increasing in absolute terms and on a per capita basis, and trends indicate a further steep decline in re-use and refill of packaging amplified by increased on-the-go consumption and e-commerce. As products, materials and consumption patterns have evolved, there has been a significant rise in the use of single-use packaging, especially single-use plastic. This is linked to the retail landscape, with larger distribution networks, manufacturing and packing products on high-speed packaging lines, which exert a combined downward pressure on the market for re-use and refill.

(115) In order to monitor and verify compliance of producers and producer responsibility organisations with obligations under extended producer responsibility relating to the collection and treatment of waste from their products, it is necessary that Member States designate one or more competent authorities.

(116) In order to ensure a better, more timely and more uniform implementation of the waste prevention and recycling targets by Member States and anticipate any implementation weaknesses, a system of early warning reports should be maintained to detect shortcomings and allow taking action ahead of the deadlines for meeting the targets. An extension of this system, which, under Directive 94/62/EC, covered the attainment of recycling targets, should also include packaging waste reduction targets to be attained by Member States by 2030, 2035 and 2040.

(117) As management of packaging and packaging waste is an important element of waste management in general, Member States should dedicate a separate chapter to that issue in their waste management plans prepared in the execution of obligation laid down in Directive 2008/98/EC. The measures on waste prevention and re-use should be included in the waste prevention programmes required pursuant to Directive 2008/98/EC. Those chapters should be included in the waste management plans and the waste prevention programmes as part of their next regular evaluation as required pursuant to Directive 2008/98/EC, or earlier.

(118) This Regulation builds on the waste management rules and general principles laid down in Directive 2008/98/EC.

(119) Waste prevention is the most efficient way to improve resource efficiency and to reduce the environmental impact of waste. It is important therefore that economic operators take appropriate measures to reduce the generation of waste by eliminating excessive packaging and the use of certain packaging formats, by extending the life span of packaging, by re-designing products or sales strategies so that no or less packaging can be used, including bulk sales, and by shifting from single-use packaging to reusable packaging.

(120) To achieve an ambitious and sustained reduction in the overall generation of packaging waste, the waste prevention targets should be set for the reduction of packaging waste per capita to be achieved by 2030. Meeting a target of 5 % reduction of packaging waste by 2030 compared to 2018 should entail an overall absolute reduction of approximately 19 % on average across the Union in 2030 compared to the 2030 baseline scenario. In order to ensure that the reduction efforts continue beyond 2030, a reduction target of 10 % compared to 2018 should be set for 2035; this is estimated to reduce packaging waste by 29 % compared to the 2035 baseline scenario. An additional reduction target of 15 % compared to 2018 should also be set for 2040; this is estimated to reduce packaging waste by 37 % compared to the 2040 baseline scenario. In order to support Member States in achieving the packaging waste prevention targets, implementing powers should be conferred on the Commission to establish a correction factor to account for the increase or decrease in tourism in relation to the base year 2018. As the generation of commercial and industrial packaging waste is not related to household consumption, the waste prevention targets per capita cannot apply as such to commercial and industrial packaging waste. Member States which have established a different system for the management of household packaging waste, on one hand, and of industrial and commercial packaging waste, on the other, should be able to retain their specificity.

(121) It should be possible for Member States to achieve the waste prevention targets by economic instruments and other measures to provide incentives for the application of the waste hierarchy, including measures to be implemented through extended producer responsibility schemes, by promoting the setting up and effective operation of re-use systems and by encouraging economic operators to offer end users further possibilities to refill. Such measures should be adopted in parallel and in addition to other measures under this Regulation that aim to reduce packaging and packaging waste, such as requirements on packaging minimisation, re-use targets and refill obligations, volume thresholds and measures to achieve the sustained reduction in the consumption of lightweight plastic carrier bags. It should be possible for Member States, 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 waste prevention targets set out in this Regulation. When implementing such measures, Member States should be aware of the risk of a shift from heavier to lighter packaging materials and should prioritise measures that minimise that risk.

(122) To implement the polluter pays principle, which is expressed in Article 191(2) TFEU, it is appropriate to lay the obligations for the management of packaging waste on producers. To that end, this Regulation builds on the extended producer responsibility requirements laid down in Directive 2008/98/EC in order to ensure that the extended producer responsibility scheme covers the full waste management costs of packaging and to facilitate adequate controls by the competent authorities. This Regulation seeks to clearly define one producer per packaging unit, whether it is for empty packaging or for packaging containing products. As a general rule, the producer should be the economic operator who, as a manufacturer, importer or distributor established in a Member State, makes available packaged products from within the territory of that Member State and on that same territory. This includes any offer for distribution, consumption or use which could result in actual supply. Thus, where a company buys a packaged product from another Member State other than that where the company is located, or from a third country, and supplies that packaged product in the Member State where it is located, that company should be considered to be the producer, as it is the first company making the packaged product available on the territory of that Member State. With regard to online platforms, the initial offering of a product should be considered as being made available in the sense of the producer definition. However, to minimise any unnecessary administrative burden for small businesses that fill transport packaging, primary production packaging or service packaging, whether as a single-use packaging or as reusable packaging, at the point of sale, the producer should be the manufacturer, distributor or importer of such packaging that makes the packaging available for the first time from within the territory of the Member State, since that economic operator is best placed to comply with the extended producer responsibility obligations.

(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

1.   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.

2.   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.

3.   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

1.   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.

2.   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

1.   For the purposes of this Regulation, the following definitions apply:

(1) ‘packaging’ means an item, irrespective of the materials from which it is made, that is intended to be used by an economic operator for the containment, protection, handling, delivery or presentation of products to another economic operator or to an end user, and that can be differentiated by packaging format based on its function, material and design, including:

(a) an item that is necessary to contain, support or preserve a product throughout its lifetime, without being an integral part of the product, and which is intended to be used, consumed or disposed of together with the product;

(b) a component of, and ancillary element to, an item referred to in point (a) that is integrated into the item;

(c) an ancillary element to an item referred to in point (a) that is hung directly on, or attached to, the product and that performs a packaging function, without being an integral part of the product, and which is intended to be used, consumed or disposed of together with the product;

(d) an item that is designed and intended to be filled at the point of sale in order to dispense the product, which is also referred to as ‘service packaging’;

(e) a disposable item that is sold and filled or designed and intended to be filled at the point of sale and which performs a packaging function;

(f) a permeable tea, coffee or other beverage bag, or soft after-use system single-serve unit that contains tea, coffee or another beverage, and which is intended to be used and disposed of together with the product;

(g) a non-permeable tea, coffee or other beverage system single-serve unit intended for use in a machine and which is used and disposed of together with the product;

(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;

(13) ‘manufacturer’ means any natural or legal person that manufactures packaging or a packaged product; however:

(a) subject to point (b), where a natural or legal person has packaging or a packaged product designed or manufactured under its own name or trademark, regardless of whether any other trademark is visible on the packaging or on the packaged product, ‘manufacturer’ means that natural or legal person;

(b) where the natural or legal person that has the packaging or packaged product designed or manufactured under its own name or trademark falls within the definition of micro-enterprise set out in Recommendation 2003/361/EC as applicable on 11 February 2025, and the natural or legal person that supplies the packaging to the natural or legal person that has the packaging designed or manufactured under its own name or trademark is located in the same Member State, ‘manufacturer’ means the natural or legal person that supplies the packaging;

(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);

(15) ‘producer’ means any manufacturer, importer or distributor to whom, irrespective of the selling technique used, including by means of distance contracts, one of the following applies:

(a) the manufacturer, importer or distributor is established in a Member State and makes available for the first time from within the territory of that Member State and on that same territory transport packaging, service packaging, or primary production packaging, whether as single-use packaging or as reusable packaging; or

(b) the manufacturer, importer or distributor is established in a Member State and makes available for the first time from within the territory of that Member State and on that same territory products packaged in packaging other than those referred to in point (a); or

(c) the manufacturer, importer or distributor is established in a Member State or in a third country and makes available for the first time on the territory of another Member State, directly to end users, transport packaging, service packaging or primary production packaging, whether as single-use packaging or as reusable packaging; or

(d) the manufacturer, importer or distributor is established in a Member State or in a third country and makes available for the first time on the territory of another Member State, directly to end users, products packaged in packaging other than those referred to in point (c); or

(e) the manufacturer, importer or distributor is established in a Member State and unpacks packaged products without being an end user, unless another person is the producer as defined in point (a), (b), (c) or (d);

(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.

2.   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

1.   Packaging shall only be placed on the market if it complies with this Regulation.

2.   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.

3.   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.

4.   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

1.   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.

2.   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.

3.   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.

4.   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.

5.   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 (CF

3

-) or methylene (-CF

2

-) carbon atom (without any H/Cl/Br/I attached to it), except substances that only contain the following structural elements: CF

3

-X or X-CF

2

-X′, where X = -OR or -NRR′ and X′ = methyl (-CH

3

), methylene (-CH

2

-), an aromatic group, a carbonyl group (-C(O)-), -OR′′, -SR′′ or –NR′′R′′′; and where R/R′/R′′/R′′′ is a hydrogen (-H), methyl (-CH

3

), methylene (-CH

2

-), 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.

6.   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.

7.   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.

8.   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.

9.   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

1.   All packaging placed on the market shall be recyclable.

2.   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.

3.   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.

4.   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:

(a) design for recycling criteria and recyclability performance grades based on Table 3 of Annex II and the parameters listed in Table 4 of Annex II for packaging categories listed in Table 1 of Annex II; design for recycling criteria and recyclability performance grades shall be developed on the basis of the predominant material and shall:

(i) take into account the ability of packaging waste to be separated into different material streams for recycling, sorted and recycled, so that the resulting secondary raw materials are of sufficient quality compared to the original material and can be used to substitute primary raw materials for packaging or other applications where the quality of the recycled material is retained, where feasible;

(ii) consider established collection and sorting processes proven in an operational environment and cover all packaging components;

(iii) take into account available recycling technologies, 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;

(iv) where appropriate, identify substances of concern that negatively affect the re-use and recycling of materials in the packaging in which they are present;

(v) where appropriate, impose restrictions on the presence of substances of concern, or of groups of such substances, in packaging or packaging components for reasons not relating primarily to chemical safety; such restrictions may also serve to reduce unacceptable risks to human health or the environment, without prejudice to the restrictions on chemicals set out in Annex XVII to Regulation (EC) No 1907/2006 or, where applicable, the restrictions and specific measures on food-contact materials and articles in Regulation (EC) No 1935/2004;

(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.

5.   By 1 January 2030, the Commission shall adopt implementing acts establishing:

(a) the methodology for the recycled-at-scale assessment per packaging category listed in Table 2 of Annex II, supplementing Table 3 of Annex II with thresholds for the recycled-at-scale assessment and, if necessary, updating the overall recyclability performance grades described in Table 3 of Annex II; that methodology shall be based on at least the following elements:

(i) quantities of packaging per packaging category listed in Table 2 of Annex II placed on the market in the Union as a whole and in each Member State;

(ii) quantities of recycled packaging waste, as calculated at the calculation point in accordance with the implementing act adopted under Article 56(7), point (a), per packaging category listed in Table 2 of Annex II, in the Union as a whole and in each Member State;

(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.

6.   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.

7.   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.

8.   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.

9.   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.

10.   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.

11.   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.

12.   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

1.   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.

2.   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.

3.   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.

4.   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;

(g) contact-sensitive plastic packaging for food that is intended only for infants and young children, food for special medical purposes and packaging for drinks and food typically used for young children as referred to in Article 1, points (a), (b) and (c), of Regulation (EU) No 609/2013;

(h) packaging of supplies, components and immediate packaging components for the manufacturing of medicinal products covered by Directive 2001/83/EC and veterinary medicinal products covered by Regulation (EU) 2019/6, where such packaging is needed to be in line with the quality standards of the medicinal product.

5.   Paragraphs 1 and 2 shall not apply to:

(a) plastic packaging that is intended to come into contact with food where the quantity of recycled content poses a threat to human health and results in non-compliance of packaged products with Regulation (EC) No 1935/2004;

(b) any plastic part representing less than 5 % of the total weight of the whole packaging unit.

6.   Compliance with the requirements set out in paragraphs 1 and 2 of this Article shall be demonstrated by manufacturers or importers in the technical information concerning the packaging referred to in Annex VII.

7.   The financial contributions paid by producers in order to comply with their extended producer responsibility obligations as laid down in Article 45 may be modulated based on the percentage of recycled content used in the packaging. Any such modulation shall take into account sustainability criteria of the recycling technologies and the environmental costs for the purposes of recycled content.

8.   By 31 December 2026, the Commission shall adopt implementing acts establishing the methodology for the calculation and verification of the percentage of recycled content recovered from post-consumer plastic waste recycled and collected within the Union in accordance with the conditions set out in paragraph 3 of this Article, as well as the format for the technical documentation referred to in Annex VII. For that purpose, the Commission shall take into account 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. The verification methodology may include the obligation to carry independent third-party audits on manufacturers of recycled content in the Union and of plastic packaging placed on the market as a sales unit separate from other products, to ensure that the conditions set out in paragraph 3 of this Article and in the delegated act adopted pursuant to paragraph 9 of this Article are met.

When adopting the implementing acts, the Commission shall 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.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2).

9.   By 31 December 2026, on the basis of the assessment referred to in paragraph 8, second subparagraph, the Commission shall adopt delegated acts in accordance with Article 64 to supplement this Regulation with sustainability criteria for plastic recycling technologies.

For the purposes of this Article, recycled content shall be recovered from post-consumer plastic waste that has been recycled either in:

(a) installations located within the Union using recycling technologies which meet such sustainability criteria established pursuant to this paragraph; or

(b) installations located in a third country using recycling technologies in accordance with standards equivalent to the sustainability criteria developed under the delegated acts.

10.   By 31 December 2026, the Commission shall adopt implementing acts establishing the methodology for assessing, verifying and certifying, including through third-party audit, the equivalence of the rules applied in cases where the recycled content recovered from post-consumer plastic waste is recycled or collected in a third country. The assessment shall consider the standards of protection of environment and human health, including standards to ensure that recycling is performed in an environmentally sound manner, and standards on high-quality recycling, such as on resource efficiency and quality standards for the recycling sectors. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2).

11.   By 1 January 2029 or 24 months from the date of entry into force of the implementing act referred to in paragraph 8, whichever is the latest, the calculation and verification of the percentage of recycled content contained in packaging under paragraph 1 shall comply with the rules laid down in the implementing act adopted pursuant to paragraph 8.

12.   By 1 January 2028, the Commission shall assess the need for derogations from the minimum percentages of recycled content laid down in paragraph 1, points (b) and (d), for specific plastic packaging, or the revision of the list of exceptions in paragraph 4 for specific plastic packaging.

Based on the assessment referred to in the first subparagraph of this paragraph, where suitable recycling technologies to recycle plastic packaging are not authorised under the relevant Union rules or are not sufficiently available in practice, taking into account any safety related requirements, especially concerning contact-sensitive plastic packaging, including food packaging, the Commission is empowered to adopt delegated acts in accordance with Article 64 to amend this Regulation in order to:

(a) provide for derogations from the scope, timing or level of minimum percentage laid down in paragraph 1, points (b) and (d), of this Article, for specific plastic packaging; and

(b) as appropriate, amend the list of the exceptions in paragraph 4 of this Article.

13.   Where the lack of availability or excessive prices of specific recycled plastics makes compliance with the minimum percentages of recycled content set out in paragraphs 1 and 2 of this Article excessively difficult, the Commission shall be empowered to adopt a delegated act in accordance with Article 64 to amend those paragraphs by adjusting the minimum percentages accordingly. In evaluating whether such adjustment is appropriate, the Commission shall assess requests from natural or legal persons to be accompanied by relevant information and data on the market situation for the post-consumer plastic waste and best available evidence regarding the related risks to human or animal health, to the security of food supply or to the environment. The Commission shall adopt such a delegated act only in exceptional cases where there would be severe adverse effects for human or animal health, the security of food supply or the environment.

14.   By 12 February 2032, taking into account the evolution of the state of the art of the technology and the practical experience gained by economic operators and Member States, the Commission shall present a report reviewing the implementation of the 2030 minimum percentages of recycled content set out in paragraph 1 and evaluating to what extent those percentages lead to solutions fostering sustainable packaging that are effective and easy to implement, the feasibility of the achievement of the 2040 minimum percentages on the basis of the experience in achieving the 2030 minimum percentages and the evolving circumstances, the relevance of maintaining the exceptions and derogations set out in this Article, and the necessity or pertinence of setting new minimum percentages of recycled content. That report shall, where appropriate, be accompanied by a legislative proposal amending this Article, in particular the 2040 minimum percentages of recycled content.

15.   By 12 February 2032, the Commission shall review the situation regarding the use of recycled packaging materials in packaging other than plastics and, on that basis, assess the appropriateness of establishing measures, or setting targets, for increasing the use of recycled content in such other packaging, and, where appropriate, present a legislative proposal.

Article 8

Biobased feedstock in plastic packaging

1.   By 12 February 2028, the Commission shall review the state of technological development and environmental performance of biobased plastic packaging, taking into consideration the sustainability criteria laid down in Article 29 of Directive (EU) 2018/2001 of the European Parliament and of the Council (63).

2.   Based on the review referred to in paragraph 1, the Commission shall, where appropriate, present a legislative proposal in order to:

(a) lay down sustainability requirements for biobased feedstock in plastic packaging;

(b) lay down targets to increase the use of biobased feedstock in plastic packaging;

(c) introduce the possibility to achieve the targets set out in Article 7(1) and (2) of this Regulation by using biobased plastic feedstock instead of recycled content recovered from post-consumer plastic waste in the event that suitable recycling technologies for food-contact packaging complying with the requirements laid down in Regulation (EU) 2022/1616 are not available;

(d) amend, where appropriate, the definition of biobased plastic set out in Article 3(1), point (53).

Article 9

Compostable packaging

1.   By way of derogation from Article 6(1), by 12 February 2028, where packaging referred to in Article 3(1), point (1)(f), and sticky labels affixed to fruit and vegetables are placed on the market, that packaging and sticky labels shall be compatible with the standard for composting in industrially controlled conditions in bio-waste treatment facilities and shall be compatible, where required by the Member States, with the home-composting standards referred to in paragraph 6 of this Article.

2.   By way of derogation from Article 6(1), where Member States allow waste with similar biodegradability and compostability properties as bio-waste pursuant to Article 22(1) of Directive 2008/98/EC to be collected together with bio-waste, and appropriate waste collection schemes and waste treatment infrastructure are available to ensure that compostable packaging enters the bio-waste management stream, Member States may require that the following packaging shall be made available on their territory for the first time only if the packaging is compostable:

(a) packaging referred to in Article 3(1), point (1)(g), composed of material other than metal, very lightweight plastic carrier bags and lightweight plastic carrier bags;

(b) packaging other than that referred to in point (a) of this paragraph for which the Member State already required that they be compostable before the date of application of this Regulation.

3.   By 12 February 2028, packaging other than that referred to in paragraphs 1 and 2, including packaging made of biodegradable plastic polymers and other biodegradable materials, shall be designed for material recycling in accordance with Article 6 without affecting the recyclability of other waste streams.

4.   Compliance with the requirements set out in paragraphs 1, 2 and 3, of this Article shall be demonstrated in the technical information concerning the packaging referred to in Annex VII.

5.   The Commission may analyse whether other packaging should be included in paragraph 1 or paragraph 2, point (a), of this Article if justified and appropriate due to technological and regulatory developments that affect the elimination of compostable packaging and in the conditions established in Annex III, and, where appropriate, present a legislative proposal.

6.   By 12 February 2026, the Commission shall request the European standardisation organisations to prepare or update harmonised standards laying down the detailed technical specifications of the requirements on compostable packaging. When doing so, the Commission shall request that, in line with the latest scientific and technological developments, parameters such as retention times, temperatures and stirring, which reflect the actual conditions in home composts and in bio-waste treatment facilities, including anaerobic digestion processes, are taken into account. The Commission shall request that those standards include verification that the compostable packaging undergoing the biological decomposition subject to the specified parameters results ultimately in conversion into carbon dioxide or, in absence of oxygen, methane, and mineral salts, biomass and water.

By 12 February 2026, the Commission shall also request the European standardisation organisations to prepare harmonised standards laying down the detailed technical specifications of the requirements on home compostability of packaging referred to in paragraph 1.

Article 10

Packaging minimisation

1.   By 1 January 2030, the manufacturer or importer shall ensure that the packaging placed on the market is designed so that its weight and volume is reduced to the minimum necessary to ensure its functionality, taking account of the shape and material from which the packaging is made.

2.   The manufacturer or importer shall ensure that packaging which does not comply with the performance criteria set out in Annex IV of this Regulation and packaging with characteristics that aim only to increase the perceived volume of the product, including double walls, false bottoms and unnecessary layers, is not placed on the market, unless:

(a) the packaging design is protected by a Community design pursuant to Council Regulation (EC) No 6/2002 (64) or by design rights falling within the scope of Directive 98/71/EC of the European Parliament and of the Council (65), including international agreements having effect in one of the Member States, or its shape is a trademark falling within the scope of Regulation (EU) 2017/1001 of the European Parliament and of the Council (66) or Directive (EU) 2015/2436 of the European Parliament and of the Council (67), including trademarks registered under international agreements having effect in one of the Member States, the design rights and trademarks are protected before 11 February 2025, and the application of the requirements under this Article would affect the packaging design in a way that it would alter its novelty or its individual character, or would affect the trademark in a way that the trademark is no longer capable of distinguishing the marked product from those of other undertakings; or

(b) the packaged product or beverage benefits from a geographical indication protected under Union law, such as under Regulation (EU) No 1308/2013 for wine, Regulation (EU) 2019/787 for spirit drinks or Regulation (EU) 2023/2411 for craft and industrial products, or is covered by a quality scheme as referred to in Regulation (EU) 2024/1143.

3.   By 12 February 2027, the Commission shall request the European standardisation organisations to prepare or update, as appropriate, harmonised standards laying down the methodology for the calculation and measurement of compliance with the requirements concerning packaging minimisation under this Regulation. For most common packaging types and formats, such standards should specify maximum adequate weight and volume limits, and, where appropriate, wall thickness and maximum empty space.

4.   Compliance with the requirements set out in paragraphs 1 and 2 of this Article shall be demonstrated in the technical documentation referred to in Annex VII, which shall contain the following elements:

(a) an explanation of the technical specifications, standards and conditions used to assess the packaging against the performance criteria and methodology set out in Annex IV;

(b) for each of those performance criteria, the identification of the design requirements which prevent further reduction of the packaging weight or volume;

(c) any test results, studies or other relevant sources, such as modelling and simulations, used to assess the minimum necessary volume or weight of the packaging.

For reusable packaging, the assessment of compliance with the requirements set out in paragraph 1 of this Article shall take into account the characteristics of reusable packaging, and in the first place the requirements set out in Article 11.

Article 11

Reusable packaging

1.   Packaging placed on the market from 11 February 2025 shall be considered to be reusable where it fulfils all of the following requirements:

(a) it has been conceived, designed and placed on the market with the objective to be re-used multiple times;

(b) it has been conceived and designed to accomplish as many rotations as possible under normally predictable conditions of use;

(c) it fulfils applicable requirements regarding consumer health, safety and hygiene;

(d) it can be emptied or unloaded without being damaged in a way that would prevent its further function and re-use;

(e) it is capable of being emptied, unloaded, refilled or reloaded while maintaining the quality and safety of the packaged product and ensuring compliance with the applicable safety and hygiene requirements, including those on food safety;

(f) it is capable of being reconditioned in accordance with Part B of Annex VI, while maintaining its ability to perform its intended function;

(g) it allows for affixing of labels and the provision of information on the properties of that product and on the packaging itself, including any relevant instructions and information for ensuring safety, adequate use, traceability and shelf-life of the product;

(h) it can be emptied, unloaded, refilled or reloaded without risk to the health and safety of those responsible for doing so; and

(i) it fulfils the requirements specific to recyclable packaging set out in Article 6, so that it can be recycled when it becomes waste.

2.   By 12 February 2027, the Commission shall adopt a delegated act in accordance with Article 64 to supplement this Regulation by establishing a minimum number for the rotations for reusable packaging, for the purpose of paragraph 1, point (b), of this Article for the packaging formats which are most frequently used in re-use, taking into account hygiene and other requirements such as logistics.

3.   Compliance with the requirements set out in paragraph 1 of this Article shall be demonstrated in the technical information concerning the packaging referred to in Annex VII.

CHAPTER III

LABELLING, MARKING AND INFORMATION REQUIREMENTS

Article 12

Labelling of packaging

1.   From 12 August 2028 or 24 months from the date of entry into force of the implementing acts adopted pursuant to paragraphs 6 or 7 of this Article, whichever is the latest, packaging placed on the market shall be marked with a harmonised label containing information on its material composition in order to facilitate consumer sorting. The label shall be based on pictograms and be easily understandable, including for persons with disabilities. For the packaging referred to in Article 9(1) and, where applicable, packaging referred to in Article 9(2), the label shall indicate that the material is compostable, that it is not suitable for home composting and that compostable packaging is not to be discarded in nature. With the exception of e-commerce packaging, this obligation does not apply to transport packaging or to packaging that is subject to a deposit and return system.

The packaging placed on the market containing substances of concern shall be marked by means of standardised, open, digital-marking technologies in accordance with the methodology referred to in paragraph 7, second subparagraph.

In addition to the harmonised label referred to in this paragraph, economic operators may place a QR code or other type of standardised, open, digital data carrier on the packaging that contains information on the destination of each separate component of the packaging in order to facilitate consumer sorting.

Packaging that is subject to deposit and return systems as referred to in Article 50(1) shall be marked with a clear and unambiguous label. In addition to the national label, packaging may be marked with a harmonised colour label established in the relevant implementing act adopted pursuant to paragraph 6 of this Article. Member States may require that packaging that is subject to deposit and return systems be marked with that harmonised colour label, provided that that does not lead to distortions on the internal market or trade barriers for products from other Member States.

2.   Reusable packaging placed on the market from 12 February 2029 or 30 months from the date of entry into force of the implementing act adopted pursuant to paragraph 6, whichever is the latest, shall bear a label informing users that the packaging is reusable. Further information on reusability, including the availability of a local, national or Union-wide re-use system and information on collection points, shall be made available through a QR code or other type of standardised, open, digital data carrier that facilitates the tracking of the packaging and the calculation of trips and rotations, or, if that calculation is not feasible, an average estimation. In addition, reusable sales packaging shall be clearly identified and distinguished from single-use packaging at the point of sale.

3.   By way of derogation from paragraph 2 of this Article, the requirement to bear a label and a QR code or other type of standardised, open, digital data carrier shall not apply to open loop systems which do not have a system operator in accordance with Annex VI.

4.   Where packaging to which Article 7 applies is placed on the market from 12 August 2028 or 24 months from the date of entry into force of the implementing act adopted pursuant to paragraph 6 of this Article, whichever is the latest, and is marked with a label containing information on the share of recycled content, that label and, where applicable, the QR code or other type of standardised, open, digital data carrier shall comply with the specifications laid down in the relevant implementing act adopted pursuant to paragraph 6 of this Article and shall be based on the methodology established pursuant to Article 7(8). Where packaging is marked with a label containing information on the share of biobased plastic content, that label shall comply with the specifications laid down in the relevant implementing act adopted pursuant to paragraph 6 of this Article.

5.   Labels referred to in paragraphs 1, 2 and 4 and the QR code or other type of standardised, open, digital data carrier referred to in paragraph 2 shall be affixed, printed or engraved visibly, legibly and firmly on the packaging, so that they cannot be easily erased. The information contained therein shall also be available to end users before the purchase of the product through online sales. Where such affixing, printing or engraving is not possible or not warranted on account of the nature and size of the packaging, the label, QR code or other standardised, open, digital data carrier shall be affixed to the grouped packaging. Where even that is not possible or not warranted on account of the nature and size of the packaging or where it is relevant to provide for non-discriminatory access to information for vulnerable groups, particularly visually impaired persons, the information shall be provided via a single electronically readable code or other type of data carrier.

The information contained in the labels referred to in paragraphs 1, 2 and 4 and the QR code or other type of standardised, open, digital data carrier shall be made available in one or more languages which can be easily understood by end users, as determined by the Member State in which the packaging is to be made available on the market.

Where information is provided by electronic means in accordance with paragraphs 1, 2 and 4, the following requirements shall apply:

(a) adequate and relevant personal data shall be collected only for the limited purpose of giving the user access to relevant compliance information referred to in paragraphs 1, 2 and 4 of this Article in respect of Article 5(1) of Regulation (EU) 2016/679 of the European Parliament and of the Council (68);

(b) the information shall not be displayed with other information intended for sales or marketing purposes.

Where Union law requires information on the packaged product to be provided via a data carrier, a single data carrier shall be used for providing the information required for the packaged product and for the packaging, and both shall be easily distinguishable.

6.   By 12 August 2026, the Commission shall adopt implementing acts to establish a harmonised label and specifications for the labelling requirements and formats, including where provided through digital means, for the labelling of packaging referred to in paragraphs 1, 2 and 4 of this Article. When developing those implementing acts, the Commission shall take into account the specificities of composite packaging. When developing the harmonised label for packaging subject to deposit and return systems referred to in Article 50(2), the Commission shall take into consideration any variation which exists in the deposit charged by Member States. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2).

7.   By 12 August 2026, the Commission shall adopt implementing acts to establish the methodology for identifying the material composition of packaging referred to in paragraph 1 by means of standardised, open, digital-marking technologies, including for composite packaging and integrated or separate components of packaging.

By 1 January 2030, the Commission shall also adopt implementing acts to establish the methodology for identifying substances of concern by means of standardised, open, digital-marking technologies. That methodology shall ensure that the marking includes at least the name and concentration of the substance of concern present in each material in a packaging unit.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2).

8.   Without prejudice to requirements concerning other harmonised EU labels, economic operators shall not provide or display labels, marks, symbols or inscriptions that are likely to mislead or confuse consumers or other end users with respect to the sustainability requirements for packaging, other packaging characteristics or packaging waste management options for which harmonised labelling has been laid down in this Regulation. The Commission shall, where appropriate, adopt guidelines in order to clarify aspects that are likely to mislead or confuse consumers or other end users.

9.   By 12 February 2027, packaging included in an extended producer responsibility scheme may be identified throughout the territory of the Member States in which that scheme or system applies. Such identification shall be achieved only by means of a corresponding symbol in a QR code or other standardised, open, digital-marking technology in order to indicate that the producer fulfils its extended producer responsibility obligations. That symbol shall be clear and unambiguous and shall not mislead consumers or other end users as to the recyclability or reusability of the packaging.

10.   Packaging covered by a deposit and return system other than that referred to in Article 50(1) may, under national law, be identified by means of a corresponding symbol throughout the territory in which that scheme or system applies. That symbol shall be clear and unambiguous and shall not mislead consumers or other end users about the packaging recyclability and reusability in the Member States where it is to be returned. Member States shall not prohibit the affixing of labels related to deposit and return systems in place in other Member States.

11.   This Article shall not apply to immediate and outer packaging as defined in Regulations (EU) 2017/745, (EU) 2017/746 and (EU) 2019/6 and Directive 2001/83/EC, if there is no space on the packaging due to other labelling requirements as defined in those Union legislative acts or if the labelling of the packaging could jeopardise the safe use of medicinal products for human use or of veterinary medicinal products.

12.   Packaging as referred to in paragraphs 1, 2 and 4 that is manufactured in the Union or imported before the deadlines referred in those paragraphs and that does not comply with the criteria laid down in those paragraphs may be made available on the market until 3 years from the date of entry into force of the labelling requirements laid down in those paragraphs.

Article 13

Labelling of waste receptacles for the collection of packaging waste

1.   By 12 August 2028 or 30 months from the adoption of the implementing acts referred to in paragraph 2, whichever is the latest, Member States shall ensure that harmonised labels that enable the separate collection of each material specific fraction of packaging waste that is intended to be discarded in separate receptacles are affixed, printed or engraved visibly, legibly and indelibly on all waste receptacles for collection of packaging waste. A receptacle for packaging waste may bear more than one label. This obligation does not apply to receptacles subject to deposit and return systems.

2.   By 12 August 2026, the Commission shall adopt implementing acts to establish harmonised labels and specifications for the labelling requirements and formats for the labelling of the receptacles referred to in paragraph 1 of this Article. When developing those implementing acts, the Commission shall take into account the specificities of the collection systems established in the Member States as well as the specificities of composite packaging. The labelling for receptacles shall correspond to the labelling for packaging as referred to in Article 12(6) with the exception of labelling for packaging subject to deposit and return systems. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2).

Article 14

Environmental claims

Environmental claims as defined in Article 2, point (o), of Directive 2005/29/EC concerning packaging properties for which legal requirements are set out in this Regulation may be made in relation to packaging placed on the market if they fulfil the following requirements:

(a) the claims are made only in relation to packaging properties exceeding the applicable minimum requirements set out in this Regulation, in accordance with the criteria, methodologies and calculation rules set out therein; and

(b) the claims specify whether they relate to the packaging unit, part of the packaging unit or all packaging placed on the market by the economic operator.

Compliance with the requirements set out in this Article shall be demonstrated in the technical documentation concerning the packaging as set out in Annex VII to this Regulation.

CHAPTER IV

GENERAL OBLIGATIONS

Article 15

Obligations of manufacturers

1.   Manufacturers shall only place on the market packaging which is in conformity with the requirements laid down in or pursuant to Articles 5 to 12.

2.   Before placing packaging on the market, manufacturers shall carry out the conformity assessment procedure referred to in Article 38 or have it carried out on their behalf, and shall draw up the technical documentation referred to in Annex VII.

Where compliance of packaging with the applicable requirements has been demonstrated by the conformity assessment procedure referred to in Article 38, manufacturers shall draw up an EU declaration of conformity in accordance with Article 39.

3.   Manufacturers shall keep the technical documentation referred to in Annex VII and the EU declaration of conformity as follows:

(a) in the case of single-use packaging: for 5 years from the date the packaging was placed on the market;

(b) in the case of reusable packaging: for 10 years from the date the packaging was placed on the market.

4.   Manufacturers shall ensure that procedures are in place for series production of packaging to remain in conformity with this Regulation. Manufacturers shall adequately take into account changes in packaging design or in characteristics, as well as changes in harmonised standards, common technical specifications or other technical specifications by reference to which conformity is declared or by application of which its conformity is verified. Where the manufacturers find that the packaging’s conformity could be affected, they shall carry out a re-assessment in accordance with the conformity assessment procedure referred to in Article 38, or have it carried out on their behalf.

5.   Manufacturers shall ensure that the packaging bears a type, batch or serial number or other element allowing its identification or, where the size or nature of the packaging does not so allow, that the required information is provided in a document accompanying the packaged product.

6.   Manufacturers shall indicate on the packaging or on a QR code or another data carrier their name, registered trade name or registered trademark as well as the postal address at which and, where available, the electronic means of communication by which they can be contacted. Where that is not possible, the required information shall be provided as part of the information through the QR code or other type of standardised, open, digital data carrier as referred to in Article 12(1), (2), (4) or (5) or in a document accompanying the packaged product. The postal address shall indicate a single point at which the manufacturer can be contacted.

7.   Manufacturers shall ensure that information provided in accordance with paragraphs 5 and 6 is clear, understandable and legible, and that it does not replace, or obscure nor can be confused with information required by other Union legal acts on the labelling of the packaged product.

8.   Manufacturers who consider or have reason to believe that packaging which they have placed on the market from the date of entry into force of this Regulation is not in conformity with one or more of the applicable requirements laid down in or pursuant to Articles 5 to 12 shall immediately take the corrective measures necessary to bring that packaging into conformity, to withdraw it or to recall it, as appropriate. Manufacturers shall immediately inform the market surveillance authority of the Member State in which they made the packaging available of the suspected non-compliance and of the corrective measures taken.

9.   By way of derogation from paragraph 8 of this Article, the obligation to bring into conformity, withdraw or recall packaging which is believed not to be in conformity with the requirements laid down in or pursuant to Articles 5 to 12 shall not apply to reusable packaging placed on the market before 11 February 2025.

10.   Manufacturers shall, upon a reasoned request from a national authority, provide all the information and documentation necessary to demonstrate the conformity of the packaging with the requirements laid down in or pursuant to Articles 5 to 12, including the technical documentation, in one or more languages which can be easily understood by that authority. That information and documentation shall be provided in electronic form and, on request, in paper form. The relevant documents shall be made available within 10 days of receipt of the request from the national authority. Manufacturers shall cooperate with the national authority on any action taken to remedy any case of non-compliance with the requirements laid down in or pursuant to Articles 5 to 12.

11.   Paragraphs 2 and 3 shall not apply to custom-made transport packaging for configurable medical devices and medical systems that are to be used in industrial and healthcare environments.

12.   Where the natural or legal person that has the packaging designed or manufactured under its own name or trademark falls within the definition of micro-enterprise set out in Recommendation 2003/361/EC as applicable on 11 February 2025, and the natural or legal person that supplies the packaging to the natural or legal person that has the packaging designed or manufactured under its own name or trademark is located in the Union, the natural or legal person that supplies the packaging shall be considered to be the manufacturer for the purposes of this Article.

Article 16

Information obligations of suppliers of packaging or packaging materials

1.   Suppliers shall provide the manufacturer with all the information and documentation necessary for the manufacturer to demonstrate the conformity of the packaging and the packaging materials with this Regulation, including the technical documentation referred to in Annex VII and required under or pursuant to Articles 5 to 11, in one or more languages which can be easily understood by the manufacturer. That information and documentation shall be provided in either paper or electronic form.

2.   Where appropriate, the documentation and information required under Union legal acts applicable to contact-sensitive packaging shall be part of the information and documentation to be provided to the manufacturer pursuant to paragraph 1.

Article 17

Authorised representatives

1.   A manufacturer may, by a written mandate, appoint an authorised representative.

2.   An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

(a) keep the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities as follows:

(i) as regards single-use packaging: for 5 years from the date the packaging was placed on the market; and

(ii) as regards reusable packaging: for 10 years from the date the packaging was placed on the market;

(b) cooperate with the competent national authorities, at their request, on any measures taken with regard to cases of non-compliance of the packaging covered by the authorised representative’s mandate;

(c) upon a reasoned request from a competent national authority, provide that authority with all the information and technical documentation necessary to demonstrate the conformity of packaging in one or more languages which can be easily understood by that authority;

(d) upon a request from a competent national authority, make available relevant documents within 10 days of the receipt of such a request;

(e) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.

The obligations laid down in Article 15(1) and the obligation to draw up the technical documentation referred to in Annex VII and required under or pursuant to Articles 5 to 11 shall not form part of the authorised representative’s mandate.

Article 18

Obligations of importers

1.   Importers shall only place on the market packaging which is in conformity with the requirements laid down in or pursuant to Articles 5 to 12.

2.   Before placing packaging on the market, importers shall ensure that:

(a) the conformity assessment procedure referred to in Article 38 has been carried out by the manufacturer and that the manufacturer has drawn up the technical documentation referred to in Annex VII and required under or pursuant to Articles 5 to 11;

(b) the packaging is labelled in accordance with Article 12;

(c) the packaging is accompanied by the required documents; and

(d) the manufacturer has complied with the requirements set out in Article 15(5) and (6).

Where an importer considers or has reason to believe that packaging is not in conformity with the applicable requirements laid down in or pursuant to Articles 5 to 12, the importer shall not place the packaging on the market until it has been brought into conformity.

3.   Importers shall indicate on the packaging their name and their registered trade name or registered trademark as well as the postal address at which and, where available, the electronic means of communication by which they can be contacted. Where it is not possible to indicate that information on the packaging, it shall be provided via standardised, open, digital data carrier as referred to in Article 12 or in a document accompanying the packaged product.

4.   Importers shall ensure that information provided in accordance with paragraph 3 is clear, understandable and legible, and does not replace or obscure, nor can be confused with information required by other Union legal acts on the labelling of the packaged product.

5.   Importers shall ensure that while the packaging is under their responsibility, whether empty or with a product, storage or transport conditions do not jeopardise its compliance with the applicable requirements laid down in or pursuant to Articles 5 to 12.

6.   Importers who consider or have reason to believe that packaging which they have placed on the market is not in conformity with the applicable requirements laid down in or pursuant to Articles 5 to 12 shall immediately take the corrective measures necessary to bring that packaging into conformity, to withdraw it or to recall it, as appropriate. Importers shall immediately inform the market surveillance authorities of the Member States in which they made the packaging available of the suspected non-compliance and of the corrective measures taken.

7.   Importers shall keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation referred to in Annex VII and required under or pursuant to Articles 5 to 11 can be made available to those authorities, upon request, as follows:

(a) as regards single-use packaging: for 5 years from the date the packaging was placed on the market; and

(b) as regards reusable packaging: for 10 years from the date the packaging was placed on the market.

8.   Importers shall, upon a reasoned request from a national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of packaging, including technical documentation, with the applicable requirements laid down in or pursuant to Articles 5 to 12, in one or more languages which can be easily understood by that authority. That information and documentation shall be provided in electronic form and, on request, in paper form. The relevant documents shall be made available within 10 days of receipt of the request from the national authority.

9.   Importers shall cooperate with the competent national authority on any action taken to remedy any case of non-compliance with the requirements laid down in or pursuant to Articles 5 to 12.

Article 19

Obligations of distributors

1.   When making packaging available on the market, distributors shall act with due care in relation to the requirements of this Regulation.

2.   Before making packaging available on the market, distributors shall verify that:

(a) the producer that is subject to the obligations on extended producer responsibility for the packaging is registered in the register of producers referred to in Article 44;

(b) the packaging is labelled in accordance with Article 12; and

(c) the manufacturer and the importer have complied with the requirements set out in Article 15(5) and (6) and Article 18(3), respectively.

3.   Where a distributor, before making packaging available on the market, considers or has reason to believe that the packaging is not in conformity with the requirements laid down in or pursuant to Articles 5 to 12 or that the manufacturer or importer is not complying with the requirements set out in Article 15(5) and (6) and Article 18(3), respectively, the distributor shall not make the packaging available on the market until it has been brought into conformity or until the manufacturer or importer complies.

Distributors shall ensure that, while the packaging, whether empty or with a product, is under their responsibility, the storage or transport conditions do not jeopardise its conformity with the requirements laid down in or pursuant to Articles 5 to 12.

4.   Information disclosed by the producer shall not be used by the distributor for any purpose other than to verify compliance with applicable requirements laid down in or pursuant to Articles 5 to 12. In particular, the misuse of such information by distributors for commercial purposes shall be prohibited.

5.   Distributors who consider or have reason to believe that packaging which they have made available on the market with the packaged product is not in conformity with the applicable requirements laid down in or pursuant to Articles 5 to 12 shall make sure that the necessary corrective measures are taken to bring that packaging into conformity, to withdraw it or to recall it, as appropriate.

Distributors shall immediately inform the market surveillance authorities of the Member States in which they made the packaging available of the suspected non-conformity and of the corrective measures taken.

6.   Distributors shall, upon a reasoned request from a national authority, provide that authority with all the information and documentation to which they have access and that is relevant for demonstrating the conformity of the packaging with the applicable requirements laid down in or pursuant to Articles 5 to 12 in one or more languages which can be easily understood by that authority. That information and documentation shall be provided in electronic form and, on request, in paper form.

Distributors shall cooperate with the national authority on any action taken to remedy any case of non-compliance with the requirements laid down in or pursuant to Articles 5 to 12.

Article 20

Obligations of fulfilment service providers

Fulfilment service providers shall ensure that for packaging, whether empty or with a product, that they handle, the conditions during warehousing, handling and packing, addressing or dispatching do not jeopardise the packaging’s compliance with the requirements laid down in or pursuant to Articles 5 to 12.

Article 21

Case in which obligations of manufacturers apply to importers and distributors

Where an importer or a distributor places packaging on the market under its own name or trademark or modifies packaging already placed on the market in a way that could affect compliance with the relevant requirements of this Regulation, that importer or distributor shall be considered to be a manufacturer for the purposes of this Regulation and shall be subject to the obligations of the manufacturer under Article 15.

Where an importer or a distributor as referred to in the first subparagraph falls within the definition of micro-enterprise set out in Recommendation 2003/361/EC as applicable on 11 February 2025, and the natural or legal person that supplies the packaging to the importer or distributor is located in the Union, the natural or legal person that supplies the packaging shall be considered to be the manufacturer for the purposes of Article 15.

Article 22

Identification of economic operators

1.   Economic operators shall, upon request, provide information to the market surveillance authorities on the following:

(a) the identity of any economic operator that has supplied them with packaging or packaged products;

(b) the identity of any economic operator to which they have supplied packaging or packaged products.

2.   Economic operators shall be able to provide the information referred to in paragraph 1, point (a), as follows:

(a) as regards single use packaging: for 5 years from the date they supplied or were supplied with the packaging;

(b) as regards reusable packaging: for 10 years from the date they have supplied or been supplied with the reusable packaging.

Article 23

Information obligations of packaging waste management operators

Packaging waste management operators shall, on an annual basis, provide the competent authorities with the information on packaging waste listed in Table 3 of Annex XII to this Regulation, with the exception of information on packaging made available on the territory of the Member State for the first time, through the electronic registry or registries, in accordance with Article 35(1) of Directive 2008/98/EC.

The packaging waste management operators shall, on an annual basis, provide the producers, in the case of individual fulfilment of extended producer responsibility obligations, or the producer responsibility organisation entrusted with carrying out those obligations, in the case of collective fulfilment of extended producer responsibility obligations, with all the information necessary to comply with the information obligations laid down in Article 44(10).

Member States may, in accordance with national law, provide that, where public authorities are responsible for the organisation of the management of packaging waste, packaging waste management operators shall, on an annual basis, provide such public authorities with all the information necessary to comply with the information obligations laid down in Article 44(10), or with other means to supplement the electronic registry or registries, in accordance with Article 35(1) of Directive 2008/98/EC.

CHAPTER V

OBLIGATIONS OF ECONOMIC OPERATORS TO REDUCE PACKAGING AND PACKAGING WASTE

Article 24

Obligation related to excessive packaging

1.   By 1 January 2030 or 3 years from the entry into force of the implementing acts adopted pursuant to paragraph 2, whichever is the latest, economic operators who fill grouped packaging, transport packaging or e-commerce packaging shall ensure that the maximum empty space ratio, expressed as a percentage, is 50 %.

2.   By 12 February 2028, the Commission shall adopt implementing acts to establish the methodology for the calculation of the empty space ratio referred to in paragraph 1. That methodology shall take into account the special characteristics of packaging which needs to be placed in an empty space that is large enough to comply with applicable legal requirements or to protect the product, such as, in particular, packaged products of irregular shape, packaging containing more than one sales packaging or product, packaging containing liquid products, packaged products the content of which can easily be damaged and packaged products that can be damaged by larger products due to their small dimensions, and the minimum space on the transport packaging to enable shipment labels to be affixed.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2).

3.   For the purpose of the calculation of the ratio referred to in paragraph 1:

(a) empty space shall mean the difference between the total volume of grouped packaging, transport packaging or e-commerce packaging and the volume of sales packaging contained therein;

(b) empty space ratio shall mean the ratio of the empty space as defined in point (a) and the total volume of the grouped packaging, transport packaging or e-commerce packaging.

Space filled by filling materials, such as paper cuttings, air cushions, bubble wraps, sponge fillers, foam fillers, wood wool, polystyrene or Styrofoam chips, shall be considered as empty space.

4.   By 12 February 2028, the economic operators who fill sales packaging shall ensure that empty space is reduced to the minimum necessary for ensuring the packaging functionality, including product protection. The empty space ratio for sales packaging shall mean the difference between the total internal volume of the sales packaging and the volume of the packaged product.

For the purpose of assessing compliance with this paragraph, space filled by filling materials, such as paper cuttings, air cushions, bubble wraps, sponge fillers, foam fillers, wood wool, polystyrene or Styrofoam chips, shall be considered as empty space.

For sales packaging for products that are subject to settlement during transportation or where headspace is required to protect the food product, or other products that present these characteristics:

(a) compliance with this paragraph shall be assessed as the pack-fill level at the time of filling;

(b) air between or within packed foodstuff or protective gases shall not be considered as empty space.

5.   Economic operators using sales packaging as e-commerce packaging or using reusable packaging within a system of re-use shall be exempt from the obligation laid down in paragraph 1 of this Article. They shall nevertheless ensure that such sales packaging complies with the requirements set out in Article 10.

6.   By 12 February 2032, the Commission shall review the empty space ratio referred to in paragraph 1 as well as the exemptions in paragraph 5, and assess the possibility of establishing empty space ratios for sales packaging, particularly for toys, cosmetics, do-it-yourself kits and electronic products.

Article 25

Restrictions on use of certain packaging formats

1.   From 1 January 2030, economic operators shall not place on the market packaging in the formats and for the uses listed in Annex V.

2.   By way of derogation from Article 4(2), Member States may maintain restrictions adopted before 1 January 2025 on the placing on the market of packaging in the formats and for the uses listed in Annex V but made from materials not listed in Annex V.

3.   Paragraph 1 of this Article shall be without prejudice to Article 9(2), point (b).

4.   By way of derogation from paragraph 1 of this Article, Member States may allow micro-enterprises as defined in Recommendation 2003/361/EC as applicable on 11 February 2025 to place on the market packaging in the formats and for the uses listed in point 3 of Annex V to this Regulation where it has been demonstrated that it is not technically feasible not to use such packaging or to obtain access to infrastructure that is necessary for the functioning of a re-use system.

5.   By 12 February 2032, the Commission shall assess the positive environmental impact of the restrictions and derogations and exemptions from these restrictions, and shall take into account the availability of alternative packaging solutions that meet safety and hygiene requirements applicable to contact-sensitive packaging. On the basis of that assessment, the Commission shall, with the objective of reducing packaging waste, review this Article and Annex V to adapt them to technical and scientific progress. On the basis of that review, the Commission shall assess the appropriateness of establishing new restrictions on the use of specific packaging formats and the relevance of maintaining the derogations and exemptions set out in this Article, and, where appropriate, shall present a legislative proposal.

6.   By 12 February 2027, the Commission shall publish guidelines, in consultation with Member States and the European Food Safety Authority, which explain Annex V in more detail, including examples of the packaging formats in scope, and any exemptions from the restrictions, and provide a non-exhaustive list of fruits and vegetables that are excluded from point 2 of Annex V.

Article 26

Obligations in relation to reusable packaging

1.   Economic operators who make reusable packaging available on the territory of a Member State for the first time shall ensure that a system is in place in that Member State for the re-use of that packaging which includes an incentive to ensure the collection of that packaging and which meets the requirements laid down in Annex VI. Those economic operators shall be considered to comply with this paragraph where they make use of existing re-use systems that are already in place in the Member States.

2.   The description of the system’s compliance with requirements pursuant to paragraph 1 of this Article shall be drawn up as part of the technical documentation on reusable packaging to be provided pursuant to Article 11(3). For that purpose, the manufacturer shall request the relevant written confirmations from system participants set out in Annex VI.

Article 27

Obligation related to re-use systems

1.   Economic operators that make use of reusable packaging shall participate in one or more re-use systems and shall ensure that the re-use systems within which the reusable packaging can be re-used comply with the requirements laid down in Part A of Annex VI.

2.   Economic operators that make use of reusable packaging shall ensure that such packaging is reconditioned in accordance with Part B of Annex VI prior to offering it again for use by end users.

3.   Economic operators that make use of reusable packaging may appoint a third party to be responsible for one or more mutualised re-use systems.

Where economic operators have appointed a third party as referred to in the first subparagraph, the obligations set out in this Article shall be met by that third party on their behalf.

4.   Economic operators that make use of reusable packaging in closed loop systems in accordance with the requirements in Annex VI shall be required to return the packaging to one or more of the collection points identified by the system participants and approved by the system operator.

Article 28

Obligations related to refill

1.   Economic operators who offer the possibility to purchase products through refill shall inform end users of the following (‘rules for refill’):

(a) the types of containers that can be used to purchase the products on offer through refill;

(b) the hygiene standards for refill;

(c) the responsibility of the end user in relation to health and safety regarding the use of the containers referred to in point (a).

The rules for refill shall be regularly updated and shall be either clearly displayed on the premises or otherwise provided to end users.

2.   Economic operators who offer the possibility to purchase products through refill shall ensure that refill stations comply with the requirements laid down in Part C of Annex VI and with any requirements laid down in other Union legal acts for the sale of products through refill.

3.   Economic operators who offer the possibility to purchase products through refill shall ensure that if packaging or containers are offered to the end users at refill stations, that packaging and those containers are not provided free of charge if they do not meet the requirements laid down in Annex VI or are provided as a part of a deposit and return system.

4.   Economic operators may refuse to refill a container provided by the end user if the end user does not comply with the rules for refill communicated by the economic operator pursuant to paragraph 1, in particular if the economic operators consider the container to be unhygienic or unsuitable for the sale of food or drink. Economic operators shall bear no liability for hygiene or food safety issues that arise from the use of containers provided by the end user.

5.   From 1 January 2030, final distributors with a sales area of more than 400 m

2

shall endeavour to dedicate 10 % of that sales area to refill stations for both food and non-food products.

Article 29

Re-use targets

1.   From 1 January 2030, economic operators that use transport packaging, or sales packaging used for transporting products, including for products distributed via e-commerce, within the territory of the Union, in the form of pallets, foldable-plastic boxes, boxes, trays, plastic crates, intermediate bulk containers, pails, drums and canisters of any size or material, including flexible formats or pallet wrappings or straps for stabilisation and protection of products put on pallets during transport, shall ensure that at least 40 % of such packaging in total is reusable packaging within a re-use system.

From 1 January 2040, those economic operators shall endeavour to use at least 70 % of the packaging referred to in the first subparagraph in a reusable format within a re-use system.

2.   From 1 January 2030, by way of derogation from paragraph 1 of this Article, economic operators that use transport packaging or sales packaging used for transporting products, in the forms as listed in paragraph 1 of this Article, within the territory of the Union, between different sites on which the operator performs its activity, or between any of the sites on which the operator performs its activity and the sites of any other linked enterprise or partner enterprise, as defined in Article 3 of the Annex to Recommendation 2003/361/EC as applicable on 11 February 2025, shall ensure that such packaging is reusable within a re-use system.

3.   From 1 January 2030, by way of derogation from paragraph 1, economic operators that use transport packaging or sales packaging used for transporting products, including for products distributed via e-commerce, in the forms as listed in paragraph 1, to deliver products to another economic operator within the same Member State shall ensure that such packaging is reusable within a re-use system.

4.   The obligations set out in paragraphs 1, 2 and 3 do not apply to transport packaging or sales packaging:

(a) used for the transportation of dangerous goods in accordance with Directive 2008/68/EC;

(b) used for the transportation of large-scale machinery, equipment and commodities for which packaging is custom-designed to fit the individual requirements of the economic operator that made the order;

(c) in flexible format that is used for transportation and that is in direct contact with food and feed as defined in Article 2 and in Article 3, point (4), of Regulation (EC) No 178/2002 or with food ingredients as defined in Article 2(2), point (f), of Regulation (EU) No 1169/2011 of the European Parliament and of the Council (69);

(d) in the form of cardboard boxes.

5.   From 1 January 2030, economic operators that use grouped packaging in the form of boxes, excluding cardboard, outside of sales packaging to group a certain number of products to create a stock-keeping or distribution unit shall ensure that at least 10 % of such packaging is reusable packaging within a re-use system.

From 1 January 2040, economic operators shall endeavour to use at least 25 % of the packaging referred to in the first subparagraph in a reusable format within a re-use system.

6.   From 1 January 2030, final distributors that make alcoholic and non-alcoholic beverages in sales packaging available on the territory of a Member State to consumers shall ensure that at least 10 % of those products are made available in reusable packaging within a re-use system.

From 1 January 2040, economic operators shall endeavour to make at least 40 % of the products referred to in the first subparagraph available in reusable packaging within a re-use system.

Final distributors shall ensure that packaged products manufactured under their own brand contribute on a fair and proportionate basis towards to the achievement of the targets set out in this paragraph.

7.   The targets laid down in paragraph 6 shall not apply to:

(a) beverages which are highly perishable within the meaning of Article 24 of Regulation (EU) No 1169/2011 and milk and milk products listed in Part XVI of Annex I to Regulation (EU) No 1308/2013 and their dairy analogies falling within codes 2202 99 11 and 2202 99 15 of the Combined Nomenclature (CN) in Annex I to Council Regulation (EEC) No 2658/87 (70);

(b) categories of grapevine products listed in points 1, 3 to 9, 11, 12, 15, 16 and 17 of Part II of Annex VII to Regulation (EU) No 1308/2013;

(c) aromatised wine products as defined in Regulation (EU) No 251/2014 of the European Parliament and of the Council (71);

(d) products that are similar to wine products and aromatised wine products and that are obtained from fruit other than grapes and vegetables, and other fermented beverages falling within CN code 2206 00;

(e) alcohol-based spirituous beverages corresponding to CN heading 2208.

8.   By 12 February 2027, the Commission, in consultation with Member States, shall publish guidelines on the types of products falling within the scope of paragraphs 6 and 7.

9.   Final distributors as referred to in paragraph 6 shall take back, free of charge, all reusable packaging of the same type, form and size as the packaging made available on the market by them, within that specific re-use system at the point of sale, ensuring the recovery and return of such packaging through the entire distribution chain. Final distributors shall ensure that end users are able to return the packaging at the location where the actual handover of such packaging takes place or in close proximity thereto. The final distributor shall fully redeem associated deposits or notify the return of the packaging according to the governance rules of the specific re-use system in order that any associated deposits be redeemed, as the case may be.

10.   If, in a given calendar year, a final distributor has a sales area of not more than 100 m

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, that final distributor shall be exempt from the obligation to meet the targets set out in paragraph 6 in that calendar year. On the basis of the special conditions of final distribution and some manufacturing sectors, even at national level, the Commission is empowered to adopt delegated acts in accordance with Article 64 to amend the sales area threshold.

11.   Member States may exempt final distributors from the obligation to meet the targets set out in paragraph 6 if their sales area is located on an island with a population of less than 2 000 inhabitants.

Member States may also exempt final distributors from the obligation to meet the targets set out in paragraph 6 if their sales area is located in a municipality with a population density less than 54 persons/km

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, however, the targets set out in paragraph 6 shall apply to final distributors with a sales area in population centres with more than 5 000 inhabitants.

If a final distributor that has been exempted pursuant to the first or second subparagraph sells products referred to in paragraph 6 in re-usable packaging, it shall arrange a take-back for such packaging in accordance with paragraph 9. If the final distributor that has been exempted pursuant to the first or second subparagraph has more than one sales area and only one or only some of those areas are located on such an island or in such a municipality, the relevant beverages made available on the territory of a Member State in such sales areas shall not be calculated for the purpose of meeting the targets set out in paragraph 6.

12.   Member States may allow final distributors to form pools for the purpose of meeting their obligations laid down in paragraph 6, provided that each pool:

(a) does not exceed more than 40 % of the market share of the relevant beverage category;

(b) consists of no more than five final distributors; and

(c) only covers beverage categories made available on the territory of a Member State by all pool members.

The condition under point (b) does not apply if the final distributors operate under the same brand name.

Where a Member State allows final distributors to form pools pursuant to the first subparagraph, each pool shall provide the competent authority of the Member State with at least the following information:

(a) the final distributors included in the pool; and

(b) the final distributor appointed as pool manager and contact point.

Member States may require further information to be provided as necessary for the enforcement of the obligations under paragraph 6 in conjunction with this paragraph.

Final distributors shall ensure that their pooling arrangements comply with Articles 101 and 102 TFEU. Without prejudice to the general applicability of Union competition rules to such pools, all members of a pool shall in particular ensure that neither data-sharing nor information exchange, including in relation to prospective sales data, occur in the context of their pooling arrangements, except in respect of the information referred to in Article 30(2) of this Regulation.

By 1 January 2028, the Commission shall adopt delegated acts in accordance with Article 64 to supplement this Regulation by establishing and specifying the detailed conditions and reporting requirements to be applied to the pooling arrangements referred to in this paragraph, taking into account the type and quantity of packaging each final distributor places on the market each calendar year and the location of the final distributors.

13.   Economic operators shall be exempt from the obligation to meet the targets set out in this Article for a calendar year, if during that calendar year they:

(a) made not more than 1 000 kg of packaging available on the territory of a Member State; and

(b) fall within the definition of micro-enterprise as set out in Recommendation 2003/361/EC as applicable on 11 February 2025.

On the basis of the special conditions of final distribution and of some manufacturing sectors, including at national level, the Commission is empowered to adopt delegated acts in accordance with Article 64 to amend the threshold set out in point (a) of this paragraph.

14.   Member States may exempt economic operators for a period of 5 years from the obligations under this Article under the following conditions:

(a) the exempting Member State reaches 5 percentage points above the targets for recycling of packaging waste per material to be achieved by 2025 and is expected to reach 5 percentage points above the 2030 target according to the report published by the Commission 3 years before that date;

(b) the exempting Member State is on track to achieve the relevant waste prevention targets set out in Article 43 and can demonstrate to have reduced the packaging waste generated per capita by at least 3 % by 2028 compared to the packaging waste generated per capita in 2018; and

(c) the economic operators have adopted a corporate waste prevention and recycling plan that contributes to achieving the waste prevention and recycling objectives set out in Articles 43 and 52, respectively.

That period of 5 years may be renewed by the Member State provided that all the conditions are fulfilled.

15.   Subject to the conditions set out in Article 51, Member States may set targets for economic operators that exceed the minimum targets set out in paragraphs 1, 2, 3, 5 and 6 of this Article to the extent that such higher targets are necessary for the Member State to achieve one or more of the targets set out in Article 43.

16.   Subject to the conditions set out in Article 51, Member States may set targets for economic operators with regard to beverages made available in sales packaging which does not fall under paragraph 6 of this Article, if those additional targets are necessary for the Member State to achieve one or more of the targets set out in Article 43.

17.   Targets laid down in or pursuant to this Article shall be calculated for the period of a calendar year.

18.   In order to take account of the latest scientific and economic data and developments, the Commission is empowered to adopt delegated acts in accordance with Article 64 to supplement this Regulation by establishing:

(a) exemptions for economic operators that are additional to those provided for in this Article, due to particular economic constraints encountered in a specific sector related to the compliance with the targets set out in paragraphs 1, 2, 3, 5 and 6 of this Article;

(b) exemptions for specific packaging formats covered by the targets set out in paragraphs 1, 2, 3, 5 and 6 of this Article, where hygiene and food safety issues prevent the achievement of those targets;

(c) exemptions for specific packaging formats covered by the targets set out in paragraphs 1, 2, 3, 5 and 6 of this Article, where environmental issues prevent the achievement of those targets.

19.   By 1 January 2034, taking into account the evolution of the state of the art of technology and the practical experience gained by economic operators and Member States, the Commission shall present a report reviewing the implementation of the 2030 targets set out in this Article. In that report, it shall evaluate, including from the perspective of the life-cycle assessment of single-use and re-use packaging, the following:

(a) the extent to which the 2030 targets have led to solutions fostering sustainable packaging that are effective and easy to implement;

(b) the feasibility of the achievement of the 2040 targets on the basis of the experience in achieving the 2030 targets and the evolving circumstances;

(c) the relevance of maintaining the exemptions and derogations set out in this Article; and

(d) the necessity or pertinence of setting new targets for the re-use and refill of other packaging categories.

The Commission’s report shall include an employment impact assessment. The report shall, where appropriate, be accompanied by a legislative proposal amending this Article, in particular the 2040 targets. By December 2032, Member States shall provide data to the Commission on the employment impact assessment related to the implementation of the re-use targets in their national territories. Before submitting the data to the Commission, Member States shall inform and consult national social partners representing workers and employers in the sectors covered by packaging re-use targets.

Article 30

Rules on the calculation of the achievement of the re-use targets

1.   For the purpose of demonstrating the achievement of the targets set out in Article 29(1) and (5), the economic operator using the packaging shall calculate, for each target separately, the following:

(a) the number of equivalent units of any of the packaging formats listed in Article 29(1) or (5), as applicable, constituting reusable packaging within a re-use system that it used in a calendar year;

(b) the number of equivalent units of any of the packaging formats listed in Article 29(1) or (5), as applicable, other than those indicated in point (a) of this paragraph, that it used in a calendar year.

2.   For the purpose of demonstrating the achievement of the targets set out in Article 29(6) and Article 33, the final distributor making available such products to consumers on the territory of a Member State shall calculate, for each target separately, the following:

(a) the total number of sales units or total volume of beverages in reusable packaging within a re-use system made available on the territory of a Member State in a calendar year;

(b) the total number of sales units or total volume of beverages made available on the territory of a Member State in packaging other than that referred to in point (a) in a calendar year.

3.   By 30 June 2027, the Commission shall adopt implementing acts establishing the methodology for the calculation of the re-use targets set out in Article 29.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2).

4.   The obligation to demonstrate the achievement of the re-use targets set out in Article 29 shall apply from 1 January 2030 or 18 months from the date of entry into force of the implementing act referred to in paragraph 3 of this Article, whichever is later.

Article 31

Reporting to the competent authorities on re-use targets

1.   Economic operators as referred to in Article 29(1) to (8) shall submit a report containing data concerning the achievement of the re-use targets set out in Article 29 for each calendar year to the competent authority referred to in Article 40.

2.   The report referred to in paragraph 1 shall be submitted within 6 months from the end of the reporting year for which the data are collected.

3.   The first reporting year shall concern the calendar year 2030.

4.   The competent authorities shall establish electronic systems through which data shall be reported to them and specify the formats to be used.

5.   Competent authorities may request economic operators to provide any additional information necessary to ensure the reliability of the data reported.

6.   Member States shall make the report referred to in paragraph 1 public.

7.   By 12 February 2027, the Commission shall establish a European observatory on re-use. The observatory shall be responsible for monitoring the implementation of the measures laid down in this Regulation, collecting data on re-use practices and contributing to the development of best practices in the field of re-use.

Article 32

Refill obligation for the takeaway sector

1.   By 12 February 2027:

(a) final distributors that conduct their business activity in the HORECA sector and that make available on the territory of a Member State hot or cold beverages in take-away packaging shall provide a system for consumers to bring their own container to be filled;

(b) final distributors that conduct their business activity in the HORECA sector and that make available on the territory of a Member State ready-prepared food in take-away packaging shall provide a system for consumers to bring their own container to be filled.

2.   Where consumers bring their own container to be filled, final distributors as referred to in paragraph 1 shall offer them the products at no higher cost and under no less favourable conditions than when selling the sales unit consisting of the same product and single-use packaging.

Final distributors shall inform consumers at the point of sale, through clearly visible and legible information boards or signs, about the possibility of obtaining the products in a refillable container provided by the consumer.

Article 33

Re-use offer obligation for the take-away sector

1.   By 12 February 2028, final distributors that conduct their business activity in the HORECA sector and that make available on the territory of a Member State hot or cold beverages or ready-prepared food in take-away packaging shall give consumers the option of obtaining the products in re-useable packaging within a system for re-use.

2.   Final distributors shall inform consumers at the point of sale, through clearly visible and legible information boards or signs, about the possibility of obtaining the products in reusable packaging.

3.   Final distributors shall offer the products filled in reusable packaging at no higher cost and under no less favourable conditions than a sales unit consisting of the same product and single-use packaging.

4.   Final distributors shall be exempt from the application of this Article if they fall within the definition of a micro-enterprise set out in Recommendation 2003/361/EC as applicable on 11 February 2025.

5.   From 2030, final distributors shall endeavour to offer 10 % of products for sale in a reusable packaging format.

6.   Under the conditions set out in Article 51, Member States may set targets for economic operators that go beyond the minimum target set out in paragraph 5 of this Article to the extent that higher targets are necessary for the Member State to achieve one or more of the targets set out in Article 43.

CHAPTER VI

PLASTIC CARRIER BAGS

Article 34

Plastic carrier bags

1.   Member States shall take measures to achieve a sustained reduction in the consumption of lightweight plastic carrier bags on their territory.

A sustained reduction is considered to be achieved if the annual consumption does not exceed 40 lightweight plastic carrier bags per capita, or the equivalent target in weight, by 31 December 2025 and subsequently by 31 December each year thereafter.

2.   Measures to be taken by Member States to meet the target set out in paragraph 1 shall take into consideration the environmental impact of lightweight plastic carrier bags when they are manufactured, recycled or disposed of, and their composting properties, durability or specific intended use. Such measures may, by way of derogation from Article 4, include marketing restrictions, provided that they are proportionate and non-discriminatory.

3.   In addition to the measures under paragraphs 1 and 2 of this Article, Member States may take measures, such as economic instruments and national reduction targets, as regards any kind of plastic carrier bags, regardless of their wall thickness, in accordance with the obligations arising from the TFEU.

4.   Member States may exclude from the obligations set out in paragraph 1 very lightweight plastic carrier bags which are required for hygiene purposes or provided as sales packaging for loose food to prevent food wastage.

5.   By 12 February 2032, the Commission shall prepare a report on packaging materials, other than those referred to in paragraphs 1 and 2, which are likely to have a more detrimental impact on the environment than lightweight plastic carrier bags and, where appropriate, present a legislative proposal setting out reduction targets and measures to achieve those targets.

CHAPTER VII

CONFORMITY OF PACKAGING

Article 35

Test, measurement and calculation methods

For the purposes of compliance and verification of compliance of packaging with the requirements laid down in or pursuant to Articles 5 to 12, 24 and 26, tests, measurements and calculations shall be made using reliable, accurate and reproducible methods which take into account the generally recognised state-of-the art methods and whose results are considered to be of low uncertainty.

Article 36

Presumption of conformity

1.   Test, measurement or calculation methods referred to in Article 35 which are in conformity with harmonised standards or parts thereof, the references of which have been published in the

Official Journal of the European Union

, shall be presumed to be in conformity with the requirements covered by those standards or parts thereof set out in that Article.

2.   Where test, measurement or calculation methods as referred to in paragraph 1 of this Article are performed by conformity assessment bodies under accreditation in accordance with Regulation (EC) No 765/2008 of the European Parliament and of the Council (72), they shall be presumed to be in conformity with the requirements under paragraph 1 of this Article.

3.   Packaging which is in conformity with harmonised standards or parts thereof, the references of which have been published in the

Official Journal of the European Union

, shall be presumed to be in conformity with the requirements laid down in or pursuant to Articles 5 to 12, 24 and 26 covered by those standards or parts thereof.

Article 37

Common specifications

1.   Packaging which is in conformity with common specifications referred to in paragraph 2 of this Article, or parts thereof, shall be presumed to be in conformity with the requirements laid down in or pursuant to Articles 5 to 12, 24 and 26 to the extent that those requirements are covered by those common specifications or parts thereof.

2.   The Commission may, by means of implementing acts, establish common specifications for the requirements laid down in or pursuant to Articles 5 to 12, 24 and 26 where the following conditions are fulfilled:

(a) either:

(i) no reference to harmonised standards covering the relevant requirements laid down in or pursuant to Articles 5 to 12, 24 and 26 of this Regulation has been published in the

Official Journal of the European Union

in accordance with Regulation (EU) No 1025/2012 and no such reference is expected to be published within a reasonable period; or

(ii) the existing standard does not satisfy the requirements the request aims to cover; and

(b) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft or to revise a harmonised standard for the requirements laid down in or pursuant to Articles 5 to 12, 24 and 26 of this Regulation and either:

(i) the request has not been accepted by any of the European standardisation organisations to which the request was addressed; or

(ii) the request has been accepted by at least one of the European standardisation organisations to which the request was addressed, but the requested harmonised standards:

— are not adopted within the deadline set in the request,

— do not comply with the request, or

— are not fully in line with the requirements they aim to cover.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2).

3.   Before preparing a draft implementing act as referred to in paragraph 2 of this Article, the Commission shall inform the committee referred to in Article 22 of Regulation (EU) No 1025/2012 that it considers that the conditions set out in paragraph 2 of this Article have been fulfilled.

4.   Where a European standardisation organisation adopts a harmonised standard and proposes the harmonised standard to the Commission for the publication of its reference in the

Official Journal of the European Union

, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. When such a reference to a harmonised standard is published in the

Official Journal of the European Union

, the Commission shall repeal the implementing acts referred to in paragraph 2 of this Article, or parts thereof, which cover the same requirements laid down in or pursuant to Articles 5 to 12, 24 and 26.

5.   Where a Member State or the European Parliament considers that a common specification does not entirely satisfy the requirements laid down in or pursuant to Articles 5 to 12, 24 and 26, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.

Article 38

Conformity assessment procedure

Conformity assessment of packaging as regards the requirements laid down in or pursuant to Articles 5 to 12 shall be carried out in accordance with the procedure set out in Annex VII.

Article 39

EU declaration of conformity

1.   The EU declaration of conformity shall state that the fulfilment of the requirements laid down in or pursuant to Articles 5 to 12 has been demonstrated.

2.   The EU declaration of conformity shall have the model structure set out in Annex VIII, contain the elements specified in the module set out in Annex VII and be continuously updated. It shall be drawn up in, or translated into, one or more languages required by the Member State in which the packaging is placed on the market or made available on the market.

3.   Where packaging or the packaged product are subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall, where appropriate, be drawn up in respect of all such Union acts. That declaration shall state the Union acts concerned and their publication references. The declaration may consist of a dossier made up of relevant individual EU declarations of conformity.

4.   By drawing up the EU declaration of conformity, the manufacturer assumes responsibility for the compliance of the packaging with the requirements laid down in this Regulation.

5.   Competent authorities shall endeavour to control the accuracy of at least part of the declarations of conformity per year, assessed on a risk-based approach and shall take the necessary measures to address non-compliance, such as the withdrawal of non-compliant products from the market.

CHAPTER VIII

MANAGEMENT OF PACKAGING AND OF PACKAGING WASTE

Section 1

General provisions

Article 40

Competent authority

1.   Member States shall designate one or more competent authorities to be responsible for implementation and enforcement of the obligations set out in this Chapter and in Article 6(10), Article 29(1) to (7) and (9) and Articles 30 to34.

2.   Member States shall lay down the details of the organisation and operation of the competent authority or competent authorities, including administrative and procedural rules governing:

(a) the registration of producers in accordance with Article 44;

(b) the organisation and monitoring of reporting requirements under Article 44(7) and (8);

(c) the oversight of the implementation of the extended producer responsibility obligations in accordance with Article 45;

(d) the authorisation on fulfilment of extended producer responsibility in accordance with Article 47;

(e) the making available of information in accordance with Article 56.

3.   By 12 July 2025, Member States shall notify the Commission of the names and addresses of the competent authorities designated pursuant to paragraph 1. Member States shall inform the Commission without undue delay of any changes to the names or addresses of those competent authorities.

Article 41

Early warning report

1.   The Commission shall, in cooperation with the European Environment Agency, draw up reports on the progress made towards the achievement of the targets laid down in Articles 43 and 52 at the latest 3 years before each of the deadlines laid down in those Articles.

2.   The reports referred to in paragraph 1 shall include the following:

(a) an estimation of the achievement of the targets by each Member State;

(b) a list of Member States at risk of not achieving the targets by the respective deadlines, accompanied by appropriate recommendations for the Member States concerned;

(c) examples of best practices throughout the Union which could provide guidance for progressing towards achievement of the targets.

Article 42

Waste management plans and waste prevention programmes

1.   Member States shall include in the waste management plans required pursuant to Article 28 of Directive 2008/98/EC a dedicated chapter on the management of packaging and packaging waste, including measures taken pursuant to Articles 48, 50 and 52 of this Regulation.

2.   Member States shall include in the waste prevention programmes required pursuant to Article 29 of Directive 2008/98/EC a dedicated chapter on the prevention of packaging, packaging waste and packaging discarded as litter, including measures taken pursuant to Articles 43 and 51 of this Regulation.

Section 2

Waste prevention

Article 43

Prevention of packaging waste

1.   Each Member State shall reduce the packaging waste generated per capita, as compared to the packaging waste generated per capita in 2018 as reported to the Commission in accordance with Decision 2005/270/EC, by at least:

(a) 5 % by 2030;

(b) 10 % by 2035;

(c) 15 % by 2040.

2.   In order to support Member States achieve the packaging waste prevention targets set out in paragraph 1 of this Article, by 12 February 2027, the Commission shall establish a correction factor to account for the increase or decrease in tourism in relation to the base year 2018 by means of implementing acts adopted pursuant to Article 56(7), point (c). That correction factor shall be based on the rate of packaging waste generation per tourist and the variation in the number of tourists relative to the base year 2018 and take the packaging waste reduction potential in tourism into account.

3.   Without prejudice to paragraphs 1 and 4, Member States that have already established separate systems for the management of household packaging waste, on the one hand, and for industrial and commercial packaging waste, on the other, may retain those systems.

4.   In achieving the targets set out in paragraph 1, each Member State shall endeavour to reduce the quantity of plastic packaging waste generated.

5.   In addition to the measures provided for by this Regulation, Member States shall, in line with the overall objectives of the Union’s waste policy and in order to reach the targets set out in this Article, implement measures that aim to prevent the generation of packaging waste and to minimise the environmental impact of packaging. Such measures may include the use of economic instruments and other measures to provide incentives for the application of the waste hierarchy, such as the measures referred to in Annexes IV and IVa to Directive 2008/98/EC, or other appropriate instruments and measures, including incentives provided through extended producer responsibility schemes, and obligations on producers or producer responsibility organisations to adopt waste prevention plans. The measures shall be proportionate and non-discriminatory and be designed so as to avoid barriers to trade or distortions of competition. Such measures shall not lead to a shift to lighter packaging material being used to fulfil the goal of packaging waste reduction.

6.   For the purpose of paragraph 5 of this Article and without prejudice to Article 16(2) of Directive (EU) 2020/2184 of the European Parliament and of the Council (73), Member States shall incentivise restaurants, canteens, bars, cafés and catering services to serve their customers tap water, where available, free of charge or for a low service fee, in a reusable or refillable format.

7.   For the purpose of paragraph 5, Member States may introduce packaging waste prevention measures that exceed the minimum targets set out in paragraph 1, while acting in accordance with this Regulation.

8.   By way of derogation from paragraph 1, Member States may, by 31 December 2025, request the Commission to use a base year other than 2018 for the calculations of the targets set out in paragraph 1. If a Member State makes such request, the Commission may, without prejudice to paragraphs 5 and 7, allow the Member State to use such other base year for the purpose of calculating the targets set out in paragraph 1 on condition that the Member State provide substantiated evidence:

(a) of a significant increase in packaging waste during the year that it requests to use as a base year for the purpose of calculating the targets set out in paragraph 1;

(b) that the significant increase in packaging waste demonstrated under point (a) is due to changes in the reporting procedures only;

(c) that the significant increase in packaging waste demonstrated under point (a) is not due to an increased consumption; and

(d) of better comparability of data between the Member States.

9.   By 12 February 2032, the Commission shall review the targets laid down in paragraph 1 and assess the need to include specific targets for certain packaging materials. To that end, the Commission shall submit a report to the European Parliament and to the Council, accompanied, if the Commission finds it appropriate, by a legislative proposal.

Section 3

Register of producers and extended producer responsibility

Article 44

Register of producers

1.   Each Member State shall, within 18 months of the date of entry into force of first implementing act adopted pursuant to paragraph 14, establish a national register which shall serve to monitor compliance of producers with the requirements set out in this Chapter.

Each national register shall provide links to other national registers of producers’ websites to facilitate, in all Member States, registration of producers or authorised representatives for the extended producer responsibility.

2.   Producers shall be obliged to register in the register referred to in paragraph 1 of this Article in each Member State where they make packaging or packaged products available on the territory of the Member State for the first time or where they unpack packaged products without being end users, by submitting an application for registration to the competent authority responsible for the register of each such Member State. Where a producer has entrusted a producer responsibility organisation with carrying out the extended producer responsibility obligations on its behalf pursuant to Article 46(1), the obligations set out in this Article shall be met by that organisation, unless otherwise specified by the Member State in which the register is established.

3.   Member States may provide that the obligations set out in this Article may, on the basis of a written mandate, be met on behalf of producers by an authorised representative for the extended producer responsibility.

4.   Producers shall not make available packaging or packaged products on the territory of a Member State for the first time, or unpack packaged products without being end users, if they or, where applicable, in accordance with Article 45, their authorised representatives for the extended producer responsibility are not registered in that Member State.

5.   The application for registration shall include the information to be provided in accordance with Part A of Annex IX. A Member State may request producers to provide additional information or documents if such information or documents are necessary to monitor and ensure compliance with this Regulation and with the rules adopted by that Member State pursuant to Article 40(2).

6.   Where an authorised representative for the extended producer responsibility represents more than one producer, it shall, in addition to the information to be provided pursuant to paragraph 5, provide the name and the contact details of each one of the producers which it represents, separately.

7.   The producer or, where applicable, the producer’s authorised representative for the extended producer responsibility or the producer responsibility organisation, as stipulated by national law in accordance with paragraphs 2 and 3 of this Article, shall submit the information set out in Part B, point 1, of Annex IX to the competent authority responsible for the register, by 1 June for each full preceding calendar year.

Member States may require the information provided pursuant to this paragraph to be audited and certified by independent auditors under the supervision of the competent authorities referred to in Article 40(1), on the basis of national standards, if any.

8.   Where a producer has made available for the first time on the territory of the Member State a quantity of packaging, including packaging of packaged products, of less than 10 tonnes during one calendar year, or where a producer as defined in Article 3(1), point (15)(e), unpacks a quantity of packaging of less than 10 tonnes during one calendar year, the producer or, where applicable, the producer’s authorised representative for the extended producer responsibility or the producer responsibility organisation, as stipulated by national law in accordance with paragraphs 2 and 3 of this Article, shall submit the information set out in Part B, point 2, of Annex IX to the competent authority responsible for the register, by 1 June for each full preceding calendar year.

By way of derogation from the first subparagraph, a Member State may, for a specific calendar year, set a lower maximum threshold than that referred to in the first subparagraph if the Member State would otherwise have insufficient accurate data in order to:

(a) comply with the reporting obligations under Article 56(1) and (2) in that calendar year; and

(b) ensure that the database under Article 57 is complete and provide the data under Article 56(2), point (a).

9.   If it is necessary for budgetary reasons, a Member State may require the producer to submit the information set out in Part B, points 1 and 2, of Annex IX to the competent authority responsible for the register on a quarterly basis.

10.   Producers, in the case of individual fulfilment of extended producer responsibility obligations, the producer responsibility organisation entrusted with carrying out those obligations, in the case of collective fulfilment of extended producer responsibility obligations, or the re-use system operators, in the case where re-use systems are fulfilling the extended producer responsibility obligations, shall submit the information set out in Part B, point 3, of Annex IX to the competent authority for each preceding calendar year on an annual basis.

Where under national law public authorities are responsible for the organisation of the management of packaging waste, Member States may provide that those authorities shall submit the information set out in Part B, point 3, of Annex IX.

11.   The competent authority responsible for the register:

(a) shall receive applications for registration as referred to in paragraph 2 via an electronic data-processing system, the details of which shall be made available on the competent authority’s website;

(b) shall grant registrations and provide a registration number within a maximum period of twelve weeks from the moment that all the information required under paragraphs 5 and 6 is provided;

(c) may lay down modalities with respect to the requirements and process of registration without adding substantive requirements to those laid down in paragraphs 5 and 6;

(d) may charge producers cost-based and proportionate fees for the processing of applications for registration as referred to in paragraph 2;

(e) shall receive and monitor the information submitted pursuant to paragraphs 7 and 8.

12.   The producer, or, where applicable, the producer’s authorised representative for the extended producer responsibility or the producer responsibility organisation shall, without undue delay, notify the competent authority of any changes to the information contained in the registration and of any permanent cessation of the making available for the first time on the territory of the Member State of the packaging or packaged product referred to in the registration. A producer shall be removed from the register 3 years from the end of the calendar year in which the producer’s registration ends if the producer has ceased to exist as a producer.

13.   Member States shall ensure that the list of registered producers is easily accessible, publicly available and free of charge, without prejudice to the preservation of the confidentiality of commercially sensitive information in conformity with the relevant Union and national law. The list of registered producers shall be machine readable, sortable and searchable, and shall respect open standards for third-party use.

14.   The Commission shall, by 12 February 2026, adopt implementing acts establishing 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.

The format for the submission of information pursuant to this Article shall be interoperable, shall be based on open standards and machine-readable data, and shall be transferable through an interoperable data exchange network without vendor lock-in.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2).

Article 45

Extended producer responsibility

1.   Producers shall have extended producer responsibility under the schemes established in accordance with Articles 8 and 8a of Directive 2008/98/EC and with this Section for the packaging, including packaging of packaged products, that they make available for the first time on the territory of a Member State or that they unpack without being end users.

2.   In addition to the costs referred to in Article 8a(4), point (a), of Directive 2008/98/EC, the financial contributions paid by the producer shall cover the following costs:

(a) costs of labelling waste receptacles for the collection of packaging waste as referred to in Article 13 of this Regulation; and

(b) costs of carrying out compositional surveys of collected mixed municipal waste under Commission Implementing Regulation (EU) 2023/595 (74) and under the implementing acts to be adopted pursuant to Article 56(7), point (a), of this Regulation where those implementing acts provide for an obligation to carry out such surveys.

The costs to be covered shall be established in a transparent, proportional, non-discriminatory and efficient way.

3.   A producer referred to in Article 3(1), point (15)(c) and (d), shall appoint, by written mandate, an authorised representative for the extended producer responsibility in each Member State where the producer makes packaging or packaged products available for the first time, other than the Member State where the producer is established. Member States may provide that producers established in third countries shall appoint, by written mandate, an authorised representative for the extended producer responsibility when making packaging or packaged products available on their territory for the first time.

4.   For the purposes of compliance with Article 30(1), points (d) and (e), of Regulation (EU) 2022/2065, providers of online platforms that fall within the scope of Section 4 of Chapter III of that Regulation and that allow consumers to conclude distance contracts with producers shall obtain the following information from producers that offer packaging or packaged products to consumers located in the Union prior to allowing those producers to use their services:

(a) information on the registration of the producers referred to in Article 44 of this Regulation in the Member State where the consumer is located and the registration number(s) of the producer in that register;

(b) a self-certification by the producer confirming that it only offers packaging with regard to which the extended producer responsibility requirements referred to in paragraphs 1, 2 and3 of this Article are complied with in the Member State where the consumer is located.

Where a producer sells its products via an online marketplace, the obligations set out in paragraph 2 of this Article may, on the basis of written mandate, be met by the provider of the online platform, on behalf of the producer.

5.   Member States may provide that, where automated data reconciliation with the national register is provided for in that Member State, it shall be applicable for verification of the information referred to in paragraph 4, points (a) and (b).

6.   Upon receiving the information referred to in paragraph 4 and prior to allowing producers to use its services, the provider of the online platform shall make best efforts to assess whether the information received is complete and reliable.

7.   Producers offering packaging or packaged products to consumers located in the Union shall provide fulfilment service providers with the information referred to in paragraph 4, points (a) and (b), of this Article at the moment of the conclusion of the contract between the fulfilment service provider and the producer for any of the services referred to in Article 3, point (11), of Regulation (EU) 2019/1020.

8.   Upon receiving the information referred to in paragraph 7of this Article and at the moment of the conclusion of the contract between the fulfilment service provider and the producer for any of the services referred to in Article 3, point (11), of Regulation (EU) 2019/1020, the fulfilment service provider shall, through the use of any freely accessible official online database or online interface made available by a Member State or the Union or by means of the publicly available registration list under Article 44(13) of this Regulation or requests to the producer to provide supporting documents from reliable sources, make best efforts to assess whether the information referred to in paragraph 7 of this Article is reliable and complete. For the purposes of this Regulation, producers shall be responsible for the accuracy of the information provided.

Where the fulfilment service provider obtains sufficient indications or has reason to believe that any item of information referred to in paragraph 7 obtained from the producer concerned is inaccurate, incomplete or not up-to-date, that fulfilment service provider shall request that the producer remedies that situation without delay or within the period set by Union or national law, as applicable.

Where the producer fails to correct or complete that information, the fulfilment service provider shall swiftly suspend the provision of its service to that producer in relation to the offering of packaging or packaged products to consumers located in the Union until the request has been fully complied with. The fulfilment service provider shall provide the producer with the reasons for the suspension.

9.   Without prejudice to Article 4 of Regulation (EU) 2019/1150 of the European Parliament and of the Council (75), in the event that a fulfilment service provider suspends the provision of its services pursuant to paragraph 8 of this Article, the producer concerned shall have the right to challenge the decision of the fulfilment service provider before a court in a Member State in which the fulfilment service provider is established.

Article 46

Producer responsibility organisation

1.   Producers may entrust a producer responsibility organisation authorised in accordance with Article 47 with carrying out the extended producer responsibility obligations on their behalf. Member States may adopt measures to make entrusting the extended producer responsibility obligations to a producer responsibility organisation mandatory.

2.   Where, on the territory of a Member State, one or multiple producer responsibility organisations are authorised to fulfil extended producer responsibility obligations on behalf of producers, the Member State shall ensure that the producer responsibility organisation or organisations and producers that have not entrusted the carrying out of the extended producer responsibility obligations to a producer responsibility organisation, when taken together, cover the whole territory of the Member State as regards the activities in accordance with Article 47(3) and Articles 48 and 50. Member States shall appoint an independent third party to oversee the carrying out of the extended producer responsibility obligations by the producer responsibility organisations in a coordinated manner or shall entrust such oversight to the competent authority.

3.   Producer responsibility organisations shall ensure the confidentiality of the data in their possession as regards proprietary information or information directly attributable to individual producers or their authorised representatives.

4.   In addition to the information referred to in Article 8a(3), point (e), of Directive 2008/98/EC, producer responsibility organisations shall publish on their websites, at least once a year, information on the quantity of packaging, including packaging of packaged products, made available for the first time on the territory of a Member State, or unpacked by a producer without being an end user, and on the levels of recovered and recycled materials in relation to the quantity of packaging for which they have been performing producer responsibility obligations.

Member States may provide that public authorities that are responsible for the organisation of the management of packaging waste shall publish on their websites, at least once a year, information on the levels of recovered and recycled materials in relation to the quantity of packaging waste generated on their territory.

5.   Producer responsibility organisations shall ensure equal treatment of producers regardless of their origin or size, without placing a disproportionate burden on producers of small quantities of packaging, including packaging of packaged products, including small and medium-sized enterprises.

Article 47

Authorisation on fulfilment of extended producer responsibility

1.   The producer, in the case of individual fulfilment of extended producer responsibility obligations, or the producer responsibility organisation entrusted with carrying out those obligations, in the case of collective fulfilment of extended producer responsibility obligations, shall apply for an authorisation on fulfilment of extended producer responsibility from the competent authority.

2.   When adopting measures laying down the administrative and procedural rules referred to in Article 40(2), Member States shall establish the requirements and details of the authorisation procedure. Those requirements and details may differ for individual and collective fulfilment of the extended producer responsibility obligations. Member States shall also establish the modalities for verifying compliance, including the information to be provided by producers or producer responsibility organisations to that end. The authorisation procedure shall include requirements on the verification of the arrangements put in place to ensure compliance with the requirements laid down in paragraph 3 of this Article, and timeframes for that verification, which shall not exceed 18 weeks from the submission of a complete application dossier. That verification shall be carried out by a competent authority or an independent expert who shall issue a verification report on its result. The independent expert shall be independent of the competent authority and of the producer responsibility organisations or the producers authorised for individual fulfilment.

3.   The measures to be established by Member States in accordance with paragraph 2 shall include measures ensuring that:

(a) the requirements laid down in Article 8a(3), points (a) to (d), of Directive 2008/98/EC are complied with;

(b) the measures put in place or paid for by the producer or producer responsibility organisation are sufficient to allow for the return and waste management of all packaging waste in accordance with Article 48(1) and (5) and Article 50, free of charge for consumers, with a frequency proportionate to the area and volume of packaging waste covered with regard to the quantity and types of packaging, including packaging of packaged products, made available for the first time on the territory of a Member State by that producer or producers on whose behalf the producer responsibility organisation acts, or packaging unpacked by such producer or producers without being end users;

(c) the necessary arrangements, including preliminary arrangements, to that end are in place with distributors, public authorities or third parties carrying out waste management on their behalf;

(d) the necessary sorting and recycling capacity is available to ensure that packaging waste collected is subsequently subject to preliminary treatment and high-quality recycling;

(e) the requirement laid down in paragraph 6 of this Article is complied with.

4.   The producer or the producer responsibility organisation shall notify the competent authority without undue delay of any changes to the information contained in the application for an authorisation, of any changes that concern the terms of the authorisation, or of the permanent cessation of operations. On the basis of some or all of such notified changes, the competent authority may decide to amend the authorisation.

5.   The competent authority may decide to revoke the authorisation, in particular if the producer or producer responsibility organisation no longer fulfils the requirements on the organisation of the treatment of packaging waste or fails to fulfil other extended producer responsibility obligations under the schemes established in accordance with Articles 8 and 8a of Directive 2008/98/EC or under this Section, such as obligations to report to the competent authority, or obligations to notify any changes to the terms of the authorisation or if the producer has permanently ceased operations.

6.   The producer, in the case of individual fulfilment of extended producer responsibility obligations, or the producer responsibility organisation entrusted with carrying out those obligations, in the case of collective fulfilment of extended producer responsibility obligations, shall provide an adequate guarantee intended to cover the costs related to waste management operations owed by the producer or the producer responsibility organisation, in the event of non-compliance with the extended producer responsibility obligations, including in the permanent cessation of its operations, or insolvency. Member States may specify additional requirements for the guarantee. The guarantee may take the form of a public fund that is financed by producers’ fees and for which a Member State is jointly and severally liable.

Section 4

Return, collection, deposit and return systems

Article 48

Return and collection systems

1.   Member States shall ensure that systems and infrastructures are set up to provide for the return and separate collection of all packaging waste from the end users, in order to ensure that it is treated in accordance with Articles 4, 10 and 13 of Directive 2008/98/EC, and to facilitate its preparation for re-use and high-quality recycling.

Packaging that complies with design for recycling criteria as established in delegated acts adopted pursuant to Article 6(4) of this Regulation shall be collected for recycling. Incineration and landfill of such packaging shall be prohibited, with the exception of waste resulting from subsequent treatment operations of separately collected packaging waste for which recycling is not feasible or does not deliver the best environmental outcome.

2.   In order to facilitate high-quality recycling, Member States shall ensure that systems and infrastructures for comprehensive collection and sorting are in place to facilitate recycling and to ensure that plastic feedstock is available for recycling. Such systems and infrastructures may provide priority access to recycled materials for use in applications where the distinct quality of the recycled material is preserved or recovered in such a way that it can be recycled further and used in the same way and for a similar application with minimal loss of quantity, quality or function.

3.   Member States may derogate from the return and separate waste collection obligation in paragraph 1 of this Article for certain formats of waste, provided that collecting fractions of packaging waste together, or collecting packaging waste or fractions of such packaging waste together with other waste does not affect the capacity of such packaging or fractions of packaging waste to undergo preparing for re-use, recycling or other recovery operations in accordance with Articles 4 and 13 of Directive 2008/98/EC and generates output from those operations which is of comparable quality to that achieved through separate collection.

4.   Member States may ensure that packaging waste that is not collected separately is sorted prior to disposal or energy recovery operations to remove packaging designed for recycling.

5.   The systems and infrastructures referred to in paragraph 1 shall:

(a) be open to the participation of the economic operators of the sectors concerned, the competent public authorities and third parties carrying out waste management on their behalf;

(b) cover the whole territory of the Member State and all packaging waste from all types of packaging and activities, and take into account population size, expected volume and composition of packaging waste, as well as accessibility and proximity to end users; they shall include the separate collection in public spaces, business premises and residential areas, and shall be of sufficient capacity;

(c) be open to imported products under non-discriminatory conditions, in particular with regard to the detailed arrangements and any tariffs imposed for access, and be designed so as to avoid barriers to trade or distortions of competition.

6.   Member States may provide for public waste management systems to participate in the organisation of the systems referred to in paragraph 1.

7.   Member States shall take measures to promote recycling of packaging waste which meets the quality standards for the use of recycled materials in relevant sectors.

Article 49

Mandatory collection

By 1 January 2029, Member States shall set mandatory collection objectives and take the necessary measures to ensure that the collection of the materials listed in Article 52 is consistent with the recycling targets set out in that Article and with the mandatory recycled content targets set out in Article 7.

Article 50

Deposit and return systems

1.   By 1 January 2029, Member States shall take the necessary measures to ensure the separate collection of at least 90 % per year by weight of the following packaging formats made available on the market for the first time in that Member State in a given calendar year:

(a) single-use plastic beverage bottles with a capacity of up to three litres; and

(b) single-use metal beverage containers with a capacity of up to three litres.

Member States may use the quantity of packaging waste generated from packaging placed on the market to calculate, in accordance with the implementing acts adopted pursuant to Article 56(7), point (a), the targets set out in the first subparagraph, points (a) and (b), of this paragraph.

2.   In order to achieve the targets set out in paragraph 1, Member States shall take the necessary measures to ensure that deposit and return systems are set up for the relevant packaging formats referred to in paragraph 1 and that a deposit is charged at the point of sale.

3.   By way of derogation from paragraph 2, Member States may exempt economic operators in the HORECA sector from charging a deposit where the following conditions are fulfilled:

(a) the deposit bearing packaging is opened on the premises;

(b) the product is consumed on the premises; and

(c) the empty deposit bearing packaging is returned at the premises.

4.   Paragraph 2 shall not apply to packaging for:

(a) categories of grapevine products listed in points 1, 3, 8, 9, 11, 12, 15, 16 and 17, Part II of Annex VII to Regulation (EU) No 1308/2013 or for aromatised wine products as defined in Regulation (EU) No 251/2014;

(b) products that are similar to wine products and aromatised wine products and that are obtained from fruit other than grapes and from vegetables, and other fermented beverages falling within CN code 2206 00;

(c) alcohol-based spirituous beverages corresponding to CN heading 2208; and

(d) milk and milk products listed in Part XVI of Annex I to Regulation (EU) No 1308/2013.

By way of derogation from paragraph 2, Member States may exempt single-use plastic beverage bottles and single use metal beverage containers with capacities lower than 0,1 litres from participation in the deposit and return systems, where such participation is not technically feasible.

5.   Member States may be exempt from the obligation under paragraph 2 under the following conditions:

(a) the rate of separate collection as required under Article 48 of the relevant packaging format as submitted to the Commission under Article 56(1), point (c), is 80 % or more by weight of such packaging made available on the territory of that Member State for the first time in the calendar year 2026; and

(b) by 1 January 2028, the Member State notifies the Commission of its request for exemption and submits an implementation plan showing a strategy with concrete measures, including their timeline, that ensure achievement of the 90 % separate collection rate by weight of the packaging referred to in paragraph 1.

For the purposes of point (a), where the information on the rate of separate collection of the relevant packaging format has not yet been submitted to the Commission, the Member State shall provide a reasoned explanation as to how the conditions for the exemption set out in this paragraph are otherwise fulfilled. The reasoned explanation shall be based on validated national data and include a description of the measures implemented.

6.   Within 3 months of receipt of the implementation plan submitted pursuant to paragraph 5, point (b), the Commission may request the Member State to revise the plan if it considers that the plan does not comply with the requirements set out in paragraph 5, point (b). The Member State shall submit a revised implementation plan within 3 months of receipt of the Commission’s request.

7.   If the separate collection rate of the packaging referred to in paragraph 1 in a Member State decreases and remains below 90 % by weight of a given packaging format placed on the market for three consecutive calendar years, the Commission shall notify that Member State that the exemption no longer applies. A deposit and return system shall be established by 1 January of the second calendar year following the year in which the Commission notified the Member State concerned that the exemption no longer applies.

8.   Member States shall endeavour to establish and maintain deposit and return systems in particular for single-use glass beverage bottles and beverage cartons. Member States shall endeavour to ensure that deposit and return systems for single-use packaging formats, in particular for single-use glass beverage bottles, are equally available for reusable packaging where technically and economically feasible.

9.   A Member State may, while observing the general rules laid down in the TFEU and acting in accordance with this Regulation, adopt provisions which go beyond the minimum requirements set out in this Article, such as the possibility to include packaging listed in paragraph 4, and packaging for other products or made of other materials.

10.   Member States shall ensure that return points and opportunities for reusable packaging with a similar purpose and format to those established under paragraph 1 are as convenient for end users as return points and opportunities are to return single-use packaging to a deposit and return system.

11.   By 1 January 2029, Member States shall ensure that at least the deposit and return systems established under paragraph 2 of this Article following the entry into force of this Regulation meet the minimum requirements listed in Annex X.

The minimum requirements listed in Annex X shall not apply to deposit and return systems established before the entry into force of this Regulation which achieve the 90 % target set out in paragraph 1 of this Article by 1 January 2029. Member States shall endeavour to ensure that existing single-use deposit and return systems comply with the minimum requirements in Annex X when they are first reviewed. If the 90 % target is not achieved by 1 January 2029, existing single-use deposit and return systems shall comply with the minimum requirements in Annex X at the latest by 1 January 2035.

By 1 January 2038, the Commission, in collaboration with the Member States, shall assess the implementation of this Article and identify how to maximise the interoperability of deposit and return systems.

12.   The minimum requirements listed in Annex X to this Regulation shall not apply in outermost regions as recognised in Article 349, third paragraph, TFEU, taking into account their local specificities.

Section 5

Re-use and refill

Article 51

Re-use and refill

1.   Member States shall take measures to encourage the establishment of re-use systems for packaging with sufficient incentives for return and of refill systems in an environmentally sound manner. Those systems shall comply with the requirements laid down in Articles 27 and 28 and Annex VI and shall not compromise food hygiene or the safety of consumers.

2.   The measures referred to in paragraph 1 may include:

(a) the use of deposit and return systems compliant with minimum requirements in Annex X for reusable packaging and for packaging formats other than those referred to in Article 50(1);

(b) the use of economic incentives, including obligations on final distributors to charge for the use of single-use packaging and to inform consumers about the cost of such packaging at the point of sale;

(c) obligations on manufacturers or final distributors to make available in reusable packaging within a re-use system or through refill a certain percentage of products other than those covered by the re-use targets laid down in Article 29, on condition that that does not lead to distortions on the internal market or trade barriers for products from other Member States.

3.   Member States shall ensure that extended producer responsibility schemes and deposit and return systems allocate a minimum share of their budget to financing reduction and prevention actions.

Section 6

Recycling targets and promotion of recycling

Article 52

Recycling targets and promotion of recycling

1.   Member States shall take the necessary measures to achieve the following recycling targets covering the whole of their territory:

(a) by 31 December 2025, a minimum of 65 % by weight of all packaging waste generated;

(b) by 31 December 2025, the following minimum percentages by weight of the following specific materials contained in packaging waste generated:

(i) 50 % of plastic;

(ii) 25 % of wood;

(iii) 70 % of ferrous metals;

(iv) 50 % of aluminium;

(v) 70 % of glass;

(vi) 75 % of paper and cardboard;

(c) by 31 December 2030, a minimum of 70 % by weight of all packaging waste generated;

(d) by 31 December 2030, the following minimum percentages by weight of the following specific materials contained in packaging waste generated:

(i) 55 % of plastic;

(ii) 30 % of wood;

(iii) 80 % of ferrous metals;

(iv) 60 % of aluminium;

(v) 75 % of glass;

(vi) 85 % of paper and cardboard.

2.   Without prejudice to paragraph 1, points (a) and (c), a Member State may postpone the deadlines set out in paragraph 1, points (b) and (d), by up to 5 years under the following conditions:

(a) the derogation from the targets in the period of postponement is limited to a maximum of 15 percentage points from a single target or divided between two targets;

(b) as a result of the derogation from the targets in the period of postponement, the recycling rate for a single target is not reduced below 30 %;

(c) as a result of the derogation from the targets in the period of postponement, the recycling rate for a single target set out in paragraph 1, points (b)(v) and (vi), is not reduced below 60 %, and the recycling rate for a single target set out in paragraph 1, points (d)(v) and (vi), is not reduced below 70 %; and

(d) at the latest 24 months before the respective deadline laid down in paragraph 1, points (b) and (d), of this Article, the Member State notifies the Commission of its intention to postpone the deadline and submits to the Commission an implementation plan in accordance with Annex XI to this Regulation, which may be combined with an implementation plan submitted pursuant to Article 11(3), point (b), of Directive 2008/98/EC.

3.   Where a Member State requests to postpone the deadline laid down in paragraph 1, point (d), of this Article the Commission may, within 3 months of receipt of the implementation plan submitted pursuant to paragraph 2, point (d), of this Article request the Member State to revise the plan if the Commission considers that the plan does not comply with the requirements set out in Annex XI. The Member State shall submit a revised implementation plan within 3 months of receipt of the Commission’s request. If the Commission considers that the revised implementation plan does not comply with the requirements set out in Annex XI and that it is unlikely that the Member State will be able to meet the targets within the period of postponement pursuant to paragraph 2 of this Article, the Commission shall reject the implementation plan and the Member State shall be obliged to comply with the targets within the deadlines set in paragraph 1, point (d), of this Article.

4.   By 12 February 2032, the Commission shall review the targets laid down in paragraph 1, points (c) and (d), with a view to increasing them or setting further targets. To that end, the Commission shall submit a report to the European Parliament and to the Council, accompanied, if the Commission finds it appropriate, by a legislative proposal.

5.   Member States shall, where appropriate, encourage the use of materials obtained from recycled packaging waste for the manufacturing of packaging and other products by:

(a) improving market conditions for such materials;

(b) reviewing existing rules that prevent the use of such materials.

6.   A Member State may, while observing the general rules laid down in the TFEU and acting in accordance with this Regulation, adopt provisions which go beyond the minimum targets set out in this Article.

Article 53

Rules on the calculation of the achievement of the recycling targets

1.   The calculation to determine whether the targets laid down in Article 52(1) have been achieved shall be carried out in accordance with the rules laid down in this Article.

2.   Member States shall calculate the weight of packaging waste generated in a given calendar year. The calculation of packaging waste generated in a Member State shall be exhaustive.

The methodology to calculate the packaging waste generated shall be based on the following approaches:

(a) the packaging made available on the territory of a Member State, or unpacked by a producer without being an end user, in that specific year; or

(b) the quantity of packaging waste generated in the same year in that Member State.

Calculations performed pursuant to this paragraph shall be adjusted to ensure the comparability, reliability and exhaustiveness of the results in accordance with the requirements and verifications to be established by the implementing act adopted pursuant to Article 56(7), point (a).

3.   Member States shall calculate the weight of packaging waste recycled in a given calendar year. The weight of packaging waste recycled shall be calculated as the weight of packaging that has become waste which, having undergone all necessary checking, sorting and other preliminary operations to remove waste materials that are not targeted by the subsequent reprocessing and to ensure high-quality recycling, enters the recycling operation whereby waste materials are actually reprocessed into products, materials or substances.

4.   Composite packaging and other packaging composed of more than one material shall be calculated and reported per material contained in the packaging. Member States may derogate from this requirement where a given material constitutes an insignificant part of the packaging unit, and in no case more than 5 % of the total mass of the packaging unit.

5.   For the purposes of paragraph 3, the weight of packaging waste recycled shall be measured when the waste enters the recycling operation.

By way of derogation from the first subparagraph of this paragraph, the weight of the packaging waste recycled may be measured at the output of any sorting operation provided that:

(a) such output waste is subsequently recycled;

(b) the weight of materials or substances that are removed by further operations preceding the recycling operation and are not subsequently recycled is not included in the weight of waste reported as recycled.

6.   Member States shall establish an effective system of quality control and traceability of the packaging waste to ensure that the conditions laid down in paragraphs 2 to 5 of this Article are met. That system may consist of electronic registries set up pursuant to Article 35(4) of Directive 2008/98/EC or technical specifications for the quality requirements of sorted waste. It may also consist of average loss rates for sorted waste for various waste types and waste management practices, respectively, provided that reliable data cannot be otherwise obtained. Average loss rates shall be calculated on the basis of the calculation rules established in the delegated act adopted pursuant to Article 11a(10) of Directive 2008/98/EC.

7.   The quantity of biodegradable packaging waste that enters aerobic or anaerobic treatment may be counted as recycled where that treatment generates compost, digestate, or other output with a similar quantity of recycled content in relation to input, which is to be used as a recycled product, material or substance. Where the output is used on land, Member States may count it as recycled provided that this use results in benefits to agriculture or ecological improvement.

8.   The quantity of packaging waste materials that have ceased to be waste as a result of a preparatory operation before being reprocessed may be counted as recycled provided that such materials are destined for subsequent reprocessing into products, materials or substances to be used for the original or other purposes. However, end-of-waste materials to be used as fuels or other means to generate energy, or to be incinerated, backfilled or landfilled, shall not be counted as recycled.

9.   Member States may take into account the recycling of metals separated after incineration of waste in proportion to the share of the packaging waste incinerated provided that the recycled metals meet the quality criteria laid down in Decision (EU) 2019/1004.

10.   Where packaging waste is sent to another Member State for the purposes of recycling in that other Member State, only the Member State in which that packaging waste was collected may count it as recycled.

11.   Packaging waste exported from the Union shall be counted as recycled by the Member State in which it was collected only if the requirements set out in paragraph 3 are met and if, in accordance with Regulation (EC) No 1013/2006 or Regulation (EU) 2024/1157, as applicable, the exporter provides documentary evidence that the shipment of waste complies with the requirements of that Regulation, including that the treatment of packaging waste in a third country took place under conditions that are equivalent to the requirements of the relevant Union environmental law.

Article 54

Rules on the calculation of the achievement of the recycling targets by including re-use

1.   A Member State may decide to achieve an adjusted level of the targets set out in Article 52(1) for a given year by taking into account the average share, in the preceding 3 years, of reusable sales packaging placed on the market for the first time and re-used within a re-use system.

The adjusted level shall be calculated by subtracting:

(a) from the targets laid down in Article 52(1), points (a) and (c), the share of the reusable sales packaging referred to in the first subparagraph of this paragraph in all sales packaging placed on the market; and

(b) from the targets laid down in Article 52(1), points (b) and (d), the share of the reusable sales packaging referred to in the first subparagraph of this paragraph, composed of the respective packaging material, in all sales packaging composed of that material placed on the market.

No more than five percentage points of the average share of reusable sales packaging shall be taken into account for the calculation of the adjusted target level.

2.   A Member State may take into account the quantity of wooden packaging that is repaired for re-use in the calculation of the targets laid down in Article 52(1), point (a), Article 52(1), point (b)(ii), Article 52(1), point (c), and Article 52(1), point (d)(ii).

Section 7

Information and reporting

Article 55

Information on prevention and management of packaging waste

1.   In addition to the information referred to in Article 8a(2) of Directive 2008/98/EC and in Article 12 of this Regulation, producers or, where entrusted with carrying out extended producer responsibility obligations in accordance with Article 46(1) of this Regulation, producer responsibility organisations, or public authorities appointed by Member States when applying Article 8a(2) of Directive 2008/98/EC, shall make available to end users, in particular consumers, the following information regarding the prevention and management of packaging waste with respect to the packaging that the producers supply on the territory of a Member State:

(a) the role of end users in contributing to waste prevention, including any best practices;

(b) re-use arrangements available for packaging;

(c) the role of end users in contributing to the separate collection of packaging waste materials, including handling of packaging containing hazardous products or waste;

(d) the meaning of the labels and symbols affixed, printed or engraved on packaging in accordance with Article 12 of this Regulation or present in the documents accompanying the packaged product;

(e) the impact of inappropriate discarding of packaging waste, for example as litter or in mixed municipal waste, on the environment and on human health or the safety of persons and the adverse environmental impact of single-use packaging, in particular plastic carrier bags;

(f) the composting properties and appropriate waste management options for compostable packaging in accordance with Article 9(2) of this Regulation; consumers shall be informed that compostable packaging is not suitable for home composting and that compostable packaging is not to be discarded in nature.

Obligations under the first subparagraph, point (d) of this paragraph shall apply from 12 August 2028 or from the date of application of the relevant provision of Article 12, whichever is the latest.

2.   The information referred to in paragraph 1 shall be up to date and provided by means of:

(a) a website or other means of electronic communication;

(b) public information;

(c) education programmes and campaigns;

(d) signposting in one or more languages which can be easily understood by end users and consumers.

3.   Where information is provided publicly, the confidentiality of commercially sensitive information in accordance with the relevant Union and national law shall be preserved.

Article 56

Reporting to the Commission

1.   Member States shall submit the following data to the Commission for each calendar year:

(a) data on the implementation of Article 52(1), points (a) to (d), and data pursuant to Table 2 of Annex XII on reusable packaging;

(b) the annual consumption of very lightweight plastic carrier bags, lightweight plastic carrier bags, thick plastic carrier bags and very thick plastic carrier bags per capita, separately for each category as listed in Table 4 of Annex XII;

(c) the separate collection rate of packaging as listed in Table 5 of Annex XII covered by the obligation to establish deposit and return systems set out in Article 50(2).

Member States may also provide data on the annual consumption of carrier bags of other materials.

2.   Member States shall submit the following data to the Commission for each calendar year:

(a) the quantity of packaging made available for the first time on the territory of that Member State, or unpacked by a producer without being an end user, for each packaging category as listed in Table 3 of Annex XII;

(b) the quantity of collected packaging waste for each packaging material as referred to in Article 52;

(c) the quantity of recycled packaging waste and recycling rates for each packaging category as listed in Table 3 of Annex XII.

3.   The first reporting year shall concern:

(a) with respect to the obligations laid down in paragraph 1, points (a) and (b), and paragraph 2, the second full calendar year after the entry into force of the implementing act that establishes the format for reporting to the Commission, in accordance with paragraph 7;

(b) with respect to the obligation laid down in paragraph 1, point (c), the calendar year 2028.

4.   Member States shall submit the data referred to in paragraphs 1 and 2 electronically within 19 months of the end of the reporting year for which the data are collected in the format established by the Commission in accordance with paragraph 7.

5.   The data submitted by Member States in accordance with this Article shall be accompanied by a quality check report. That quality check report shall be presented in the format established by the Commission in accordance with paragraph 7.

6.   The data submitted by Member States in accordance with this Article shall be accompanied by a report on the application of Article 53(7) and (11), and shall include detailed information about the average loss rates where applicable.

7.   The Commission shall, by 12 February 2027, adopt implementing acts establishing:

(a) rules for the calculation, verification and submission of data in accordance with paragraph 1, points (a) and (c), and paragraph 2, including the methodology for determining the quantity of packaging waste generated, and the format for the submission of those data;

(b) the methodology for the calculation of the annual consumption of lightweight plastic carrier bags per capita referred to in paragraph 1, point (b), and the format for the submission of those data;

(c) the correction factor referred to in Article 43(2) to account for the increase or decrease in tourism in relation to the base year.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2).

8.   Member States shall require that system operators of re-use systems and all economic operators making packaging available in the Member States provide competent authorities with accurate and reliable data allowing Member States to fulfil their reporting obligations under this Article, taking into account, where relevant, particular problems faced by small and medium-sized enterprises with regard to the provision of detailed data.

Article 57

Packaging databases

1.   By 12 months from the date of adoption of the implementing acts referred to in Article 56(7), Member States shall take the necessary measures to ensure that databases on packaging and packaging waste are established, where not already in place, on a harmonised basis, for the purpose of fulfilling their reporting obligations laid down in Article 56.

2.   The databases referred to in paragraph 1 shall include the following:

(a) information on the magnitude, characteristics and evolution of the packaging and packaging waste flows at the level of individual Member States;

(b) the data listed in Annex XII.

3.   The packaging databases shall be accessible to the wider public in a machine-readable format that allows access to up-to-date data regarding reporting and cost of packaging waste management and that ensures interoperability and the re-use of data. They shall be provided in the official language or languages of the Member State concerned by means of:

(a) a website or other means of electronic communication; or

(b) public reports.

The requirements referred to in the first subparagraph shall be without prejudice to commercially sensitive information or data protection laws.

CHAPTER IX

SAFEGUARD PROCEDURES

Article 58

Procedure for dealing with packaging presenting a risk at national level

1.   Without prejudice to Article 19 of Regulation (EU) 2019/1020, where the market surveillance authorities of a Member State have sufficient reason to believe that packaging covered by this Regulation presents a risk to the environment or human health, they shall, without undue delay, carry out an evaluation in relation to the packaging concerned covering all requirements laid down in this Regulation that are relevant to that risk. The relevant economic operators shall cooperate as necessary with the market surveillance authorities.

For the purposes of the first subparagraph, the authorities responsible for the enforcement of this Regulation shall follow up on complaints or reports related to alleged non-compliance of packaging with this Regulation, and verify that the appropriate corrective action has been taken.

Where, in the course of the evaluation carried out pursuant to the first subparagraph, the market surveillance authorities find that the packaging does not comply with the requirements laid down in this Regulation, they shall, without delay, require the relevant economic operator to take appropriate and proportionate corrective measures, within a period prescribed by the market surveillance authorities which is reasonable and commensurate with the nature and, where relevant, the degree of the non-compliance, to bring the packaging into compliance with those requirements.

2.   By way of derogation from paragraph 1, where there is a risk to human health relating to contact-sensitive packaging that is subject to a specific law aimed at protecting human health and that risk is transferred to the packaged content of the packaging material, the market surveillance authorities shall not carry out an evaluation in relation to the risk to human or animal health originating from the packaging material. Instead, they shall alert the authorities competent for evaluating such risks, namely the competent authorities referred to in Regulations (EU) 2017/625, (EU) 2017/745, (EU) 2017/746 or (EU) 2019/6 or Directive 2001/83/EC.

3.   Where the market surveillance authorities consider that non-compliance is not restricted to their territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.

4.   The economic operator shall ensure that all appropriate corrective measures are taken in respect of all the non-compliant packaging that the economic operator has made available on the market throughout the Union.

5.   Where the economic operator does not take adequate corrective measures within the period referred to in paragraph 1, third subparagraph, or the non-compliance persists, the market surveillance authorities shall take all appropriate provisional measures to prohibit the making available of the packaging on their territory, to withdraw it or to recall it.

The market surveillance authorities shall inform the Commission and the other Member States of those measures without delay.

6.   The information to be sent to the Commission and the other Member States pursuant to paragraph 5 of this Article shall be communicated through the information and communication system referred to in Article 34 of Regulation (EU) 2019/1020 and shall include all available details, in particular the data necessary for the identification of the non-compliant packaging, the origin of the packaging, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the economic operator and, where applicable, the information referred to in Article 61(1) of this Regulation. The market surveillance authorities shall also indicate whether the non-compliance is due to either of the following:

(a) failure of the packaging to meet the sustainability requirements laid down in or pursuant to this Regulation;

(b) shortcomings in the harmonised standards or common specifications referred to in Articles 36 and 37 of this Regulation.

7.   Member States other than the Member State taking the measures pursuant to paragraph 5 shall, without delay, inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the packaging concerned, and, in the event that Member States object to the measures taken pursuant to paragraph 5, of their objections.

8.   Where, within 3months of receipt of the information referred to in paragraph 5 or 7 no objection has been raised either by a Member State or the Commission in respect of provisional measures taken by a Member State, those measures shall be considered justified.

Member States may provide for a longer or shorter period of application for provisional measures than 3months in order to take account of the specificities of the requirements concerned.

9.   Member States shall ensure that the packaging is withdrawn from their market or that other appropriate restrictive measures are taken without delay in respect of the packaging or the manufacturer concerned.

Article 59

Union safeguard procedure

1.   Where, on completion of the procedure set out in Article 58(5) and (6), objections are raised against a measure taken by a Member State pursuant to Article 58, or where the Commission considers a national measure to be contrary to Union law, the Commission shall, without delay, enter into consultation with the Member States and the relevant economic operator and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified.

That implementing act shall be adopted in accordance with the examination procedure referred to in Article 65(2).

2.   The Commission shall address the implementing act referred to in paragraph 1 to all Member States and shall communicate it to them and the relevant economic operator without delay.

If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant packaging is withdrawn from their market, and shall inform the Commission accordingly.

If the national measure is considered unjustified, the Member State concerned shall withdraw that measure.

3.   Where the national measure is considered justified and the non-compliance of the packaging is attributed to shortcomings in the harmonised standards referred to in Article 36 of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.

4.   Where the national measure is considered justified and the non-compliance of the packaging is attributed to shortcomings in the common technical specifications referred to in Article 37, the Commission shall, without delay, amend or repeal the common technical specifications concerned.

Article 60

Compliant packaging which presents a risk

1.   Where, having carried out an evaluation under Article 58, a Member State finds that although packaging is in compliance with the applicable requirements laid down in or pursuant to Articles 5 to 12, it nevertheless presents a risk to the environment or human health, it shall, without delay, require the relevant economic operator to:

(a) take all appropriate measures, within a reasonable period prescribed by the market surveillance authorities and commensurate with the nature and, where relevant, the degree of risk, to ensure that the packaging concerned, when placed on the market, no longer presents that risk;

(b) bring the packaging into conformity;

(c) withdraw the packaging from the market; or

(d) recall the packaging.

2.   By way of derogation from paragraph 1, where there is a risk to human health relating to contact-sensitive packaging that is subject to a specific law aimed at protecting human health and that risk is transferred to the packaged content of the packaging material, the surveillance authorities shall not carry out an evaluation in relation to the risk to human or animal health originating from the packaging material. Instead, they shall alert the authorities competent for controlling such risks, namely the competent authorities referred to in Regulations (EU) 2017/625, (EU) 2017/745, (EU) 2017/746 or (EU) 2019/6 or Directive 2001/83/EC.

3.   The economic operator shall ensure that corrective measures are taken in respect of all the non-compliant packaging that the economic operator has made available on the market throughout the Union.

4.   The Member State shall immediately inform the Commission and the other Member States of its findings and subsequent actions pursuant to paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the non-compliant packaging, the origin and the supply chain of the packaging, the nature of the risk involved and the nature and duration of the national measures taken.

5.   The Commission shall, without delay, enter into consultation with the Member State and the relevant economic operator and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified and, where necessary, propose appropriate measures.

That implementing act shall be adopted in accordance with the examination procedure referred to in Article 65(2).

On duly justified imperative grounds of urgency relating to the protection of the environment or human health, the Commission shall adopt an immediately applicable implementing act in accordance with the procedure referred to in Article 65(3).

The Commission shall address the implementing act referred to in this paragraph to all Member States and shall immediately communicate it to them and the relevant economic operator.

Article 61

Controls on packaging entering the Union market

1.   Market surveillance authorities shall, without delay, communicate to the authorities designated pursuant to Article 25(1) of Regulation (EU) 2019/1020 the measures referred to in Article 58(5) of this Regulation where the non-compliance is not restricted to their territory. That communication shall include all relevant information, in particular the details necessary for the identification of the non-compliant packaging to which the measures apply and, in the case of a packaged product, the product itself.

2.   The authorities designated pursuant to Article 25(1) of Regulation (EU) 2019/1020 shall use the information communicated pursuant to paragraph 1 of this Article for carrying out their risk analysis under Article 25(3) of Regulation (EU) 2019/1020.

3.   The communication of information referred to in paragraph 1 shall take place through entering the information in the relevant customs risk management environment.

4.   The Commission shall develop an interconnection to automate the communication referred to in paragraph 1 of this Article from the information and communication system referred to in Article 58(6) to the environment referred to in paragraph 3 of this Article. That interconnection shall start operating no later than 24 months from the date of the adoption of the implementing act referred to in paragraph 5 of this Article.

5.   The Commission is empowered to adopt implementing acts specifying the procedural rules and the details of the implementation arrangements for paragraph 4 including the functionalities, data elements and data processing, as well as the rules on the processing of personal data, confidentiality and controllership for the interconnection referred to in paragraph 4.

Those implementing acts shall be adopted in accordance with the examination procedure pursuant to Article 65(2).

Article 62

Formal non-compliance

1.   Where a Member State becomes aware of any of the following circumstances, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(a) the EU declaration of conformity has not been drawn up;

(b) the EU declaration of conformity has not been drawn up correctly;

(c) the QR code or data carrier referred to in Article 12 do not provide access to the information required in accordance with that Article;

(d) the technical documentation referred to in Annex VII is not available, is not complete or contains errors;

(e) the information referred to in Article 15(6) or Article 18(3) is absent, false or incomplete;

(f) any other administrative requirement set out in Article 15 or Article 18 is not fulfilled;

(g) the requirements on restrictions on excessive packaging or on uses of certain packaging formats set out in Articles 24 and 25 are not complied with;

(h) in relation to reusable packaging, the requirements on the establishment, operation or participation in a re-use system referred to in Article 27 are not fulfilled;

(i) in relation to refill, the information requirements set out in Article 28(1) and (2) are not fulfilled;

(j) the requirements on the refill stations set out in Article 28(3) are not fulfilled;

(k) the re-use targets set out in Article 29 are not achieved;

(l) the refill obligations in Article 32 and re-use offer obligation in Article 33 are not fulfilled;

(m) the requirements on recyclable packaging set out in Article 6 are not fulfilled;

(n) the requirements on minimum recycled content in plastic packaging set out in Article 7 are not fulfilled.

2.   Where the non-compliance referred to in paragraph 1, points (a) to (f), persists, the Member State concerned shall take all appropriate measures to prohibit the packaging from being made available on the market or to ensure that the packaging is recalled or withdrawn from the market.

3.   Where the non-compliance referred to in paragraph 1, points (g) to (n), of this Article persists, Member States shall apply the rules on penalties applicable to infringements of this Regulation which are laid down by the Member States in accordance with Article 68.

CHAPTER X

GREEN PUBLIC PROCUREMENT

Article 63

Green public procurement

1.   In order to incentivise the supply and demand for environmentally sustainable packaging, the Commission shall, by 12 February 2030, adopt implementing acts specifying minimum mandatory requirements for public contracts falling within the scope of Directive 2014/24/EU for packaging or packaged products or for services using packaging or packaged products or Directive 2014/25/EU, and awarded by contracting authorities, as defined in Article 2(1) of Directive 2014/24/EU or Article 3(1) of Directive 2014/25/EU, or contracting entities, as defined in Article 4(1) of Directive 2014/25/EU, in which the packaging or packaged products represent more than 30 % of the estimated contract value or of the value of products used by the services that are the object of the contract. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 65(2) of this Regulation.

2.   The requirements set out in the implementing acts adopted pursuant to paragraph 1 shall apply to procedures for the awarding of public contracts referred to in that paragraph initiated 12 months or later from the date of entry into force of the implementing act concerned.

3.   The minimum mandatory green public procurement requirements shall be based on the requirements laid down in or pursuant to Articles 5 to 11 and on the following elements:

(a) the value and volume of public contracts awarded for packaging or packaged products or for the services or works using packaging or packaged products;

(b) the economic feasibility for contracting authorities or contracting entities to buy more environmentally sustainable packaging or packaged products, without entailing disproportionate costs;

(c) the market situation at Union level of the relevant packaging or packaged products;

(d) the effects of the requirements on competition;

(e) packaging waste management obligations.

4.   The minimum mandatory green public procurement requirements may take the form of:

(a) technical specifications within the meaning of Article 42 of Directive 2014/24/EU and of Article 60 of Directive 2014/25/EU;

(b) selection criteria within the meaning of Article 58 of Directive 2014/24/EU and of Article 80 of Directive 2014/25/EU; or

(c) contract performance conditions within the meaning of Article 70 of Directive 2014/24/EU and of Article 87 of Directive 2014/25/EU.

Those minimum mandatory green public procurement requirements shall be developed in accordance with the principles contained in Directives 2014/24/EU and 2014/25/EU to facilitate the achievement of the objectives of this Regulation.

5.   Contracting authorities and contracting entities referred to in paragraph 1 may, in duly justified cases, derogate from the requirements set out in the implementing acts adopted pursuant to paragraph 1 on the grounds of public security or public health. Contracting authorities and contracting entities may also, in duly justified cases, derogate from those requirements, if those would lead to unresolvable technical difficulties.

CHAPTER XI

DELEGATED POWERS AND COMMITTEE PROCEDURE

Article 64

Exercise of the delegation

1.   The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.   The power to adopt delegated acts referred to in Article 5(7) and (8), Article 6(4), first and third subparagraphs, Article 6(6), Article 7(9), Article 7(12), second subparagraph, Article 7(13), Article 11(2), Article 29(10), Article 29(12), sixth subparagraph, Article 29(13), second subparagraph, and Article 29(18) shall be conferred on the Commission for a period of 10 years from 11 February 2025. The Commission shall draw up a report in respect of the delegation of power no later than 9 months before the end of the ten-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension no later than 3 months before the end of each period.

3.   The delegation of power referred to in Article 5(7) and (8), Article 6(4), first and third subparagraphs, Article 6(6), Article 7(9), Article 7(12), second subparagraph, Article 7(13), Article 11(2), Article 29(10), Article 29(12), sixth subparagraph, Article 29(13), second subparagraph, and Article 29(18) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the

Official Journal of the European Union

or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.   Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5.   As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.   A delegated act adopted pursuant to Article 5(7) or (8), Article 6(4), first or third subparagraph, Article 6(6), Article 7(9), Article 7(12), second subparagraph, Article 7(13), Article 11(2), Article 29(10), Article 29(12), sixth subparagraph, Article 29(13), second subparagraph, or Article 29(18) shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of 2 months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 2 months at the initiative of the European Parliament or of the Council.

Article 65

Committee procedure

1.   The Commission shall be assisted by the committee referred to in Article 39 of Directive 2008/98/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.   Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

3.   Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 of that Regulation, shall apply.

CHAPTER XII

AMENDMENTS

Article 66

Amendments to Regulation (EU) 2019/1020

Regulation (EU) 2019/1020 is amended as follows:

(1) in Annex I, the following points are added:

‘74.

Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment (

OJ L 155, 12.6.2019, p. 1

);

75.

Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (

OJ L, 2025/40, 22.1.2025, ELI: http://data.europa.eu/eli/reg/2025/40/oj

).’

;

(2) in Annex II, point 8 is deleted.

Article 67

Amendments to Directive (EU) 2019/904

Directive (EU) 2019/904 is amended as follows:

(1) Article 2 is amended as follows:

(a) paragraph 2 is replaced by the following:

‘2.   Where this Directive conflicts with Directive 94/62/EC or 2008/98/EC, this Directive shall prevail unless provided otherwise by Regulation (EU) 2025/40 of the European Parliament and of the Council

 (

*1

)

.

(

*1

)

  Regulation (EU) 2025/40 of the European Parliament and of the Council of 19 December 2024 on packaging and packaging waste, amending Regulation (EU) 2019/1020 and Directive (EU) 2019/904, and repealing Directive 94/62/EC (

OJ L, 2025/40, 22.1.2025, ELI: http://data.europa.eu/eli/reg/2025/40/oj

)’;"

(b) the following paragraph is added:

‘3.   Where Article 4 of this Directive conflicts with Article 25(1) and (6) of Regulation (EU) 2025/40 as regards single-use plastic packaging listed in point (3) of Annex V to that Regulation, Article 25(1) and (6) of that Regulation shall prevail.’

;

(2) in Article 6(5), points (a) and (b) are deleted from 1 January 2030 or 3 years from the date of entry into force of the implementing act referred to in Article 7(8) of Regulation (EU) 2025/40, whichever is the latest;

(3) in Article 13(1), point (e) is deleted from 1 January 2030 or 3 years from the date of entry into force of the implementing act referred to in Article 7(8) of Regulation (EU) 2025/40, whichever is the latest;

(4) in Article 13, paragraph 3 is replaced by the following:

‘3.   The Commission shall review the data and information reported in accordance with this Article and publish a report on the results of its review. The report shall assess the organisation of the collection of the data and information, the sources of data and information and the methodology used in Member States as well as the completeness, reliability, timeliness and consistency of those data and information. The assessment may include specific recommendations for improvement. The report shall be drawn up after the first reporting of the data and information by the Member States and every 4 years thereafter.’

;

(5) Part B of the Annex is amended as follows:

(a) points 7, 8 and 9 are replaced by the following:

‘(7)

Food containers made of expanded (EPS) or extruded (XPS) polystyrene, i.e. receptacles such as boxes, with or without a cover, used to contain food which:

(a) is intended for immediate consumption, either on-the-spot or take-away;

(b) is typically consumed from the receptacle; and

(c) is ready to be consumed without any further preparation, such as cooking, boiling or heating,

including food containers used for fast food or other meal ready for immediate consumption, except beverage containers, plates and packets, and wrappers containing food;

(8) Beverage containers made of expanded (EPS) or extruded (XPS) polystyrene, including their caps and lids;

(9) Cups for beverages made of expanded (EPS) or extruded (XPS) polystyrene, including their covers and lids;’

;

(b) the following points are added:

‘(10)

Shrink wrap that is used in airports or train stations for the protection of luggage during transport;

(11) Chips of polystyrene and other plastics that are used to protect packed goods during transport and handling;

(12) Multi-pack plastic rings used as grouped packaging as defined in Article 3(1), point 6, of Regulation (EU) 2025/40.’.

CHAPTER XIII

FINAL PROVISIONS

Article 68

Penalties

1.   By 12 February 2027, Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.

2.   The penalties for failure to comply with Articles 24 to 29 shall include administrative fines. Where the legal system of the Member State does not provide for administrative fines, this paragraph may be applied in such a manner that the fining procedure is initiated by the relevant authority and that the fine is imposed by competent national courts, while ensuring that those legal remedies are effective and have equivalent effect to the administrative fines referred to in this paragraph. In any event, the fines imposed shall also be effective, proportionate and dissuasive.

3.   Member States shall, by 12 February 2027, notify the Commission of the rules and measures referred to in paragraph 1 and 2 and shall notify it, without delay, of any subsequent amendment affecting them.

Article 69

Evaluation

By 12 August 2034, the Commission shall carry out an evaluation of this Regulation and of its contribution to the functioning of the internal market and the improvement of the environmental sustainability of packaging. That evaluation shall have a part dedicated, inter alia, to the impact of this Regulation on the agri-food system and on food waste. The Commission shall present a report on the main findings of that evaluation to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions. Member States shall provide the Commission with the information necessary for the preparation of that report.

Article 70

Repeal and transitional provisions

1.   Directive 94/62/EC is repealed with effect from 12 August 2026, with the exception of:

(a) Article 8(2) of Directive 94/62/EC, which shall continue to apply until 30 months from the date of entry into force of the implementing act adopted pursuant to Article 12(6) of this Regulation;

(b) Article 9(1) and (2) of Directive 94/62/EC, which shall continue to apply with regard to the essential requirements pursuant to point 1, first indent, of Annex II to that Directive until 31 December 2029;

(c) Article 5(2) and (3), Article 6(1), points (d) and (e), and Article 6a of Directive 94/62/EC, which shall continue to apply until 31 December 2028;

(d) Article 12(3a), (3b), (3c) and (4) of Directive 94/62/EC, which shall continue to apply until 31 December 2028, except as regards the transmission of data to the Commission, in respect of which it shall continue to apply until 31 December 2029.

2.   Decision 97/129/EC is repealed with effect from 12 August 2028.

3.   Decisions 2001/171/EC and 2009/292/EC shall remain in force and continue to apply until repealed by delegated acts adopted by the Commission pursuant to Article 5(8) of this Regulation.

4.   Member States may maintain national provisions restricting the placing on the market of packaging in the formats and for uses listed in points 2 and 3 of Annex V until 1 January 2030. Article 4(3) shall not apply in relation to those national measures until 1 January 2030.

5.   References to the repealed Directive 94/62/EC shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex XIII to this Regulation.

Article 71

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the

Official Journal of the European Union

.

It shall apply from 12 August 2026.

However, Article 67(5) shall apply from 12 February 2029.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 19 December 2024.

For the European Parliament

The President

R. METSOLA

For the Council

The President

BÓKA J.

(1)  

OJ C 228, 29.6.2023, p. 114

.

(2)  Position of the European Parliament of 24 April 2024 (not yet published in the Official Journal) and decision of the Council of 16 December 2024.

(3)  Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (

OJ L 312, 22.11.2008, p. 3

).

(4)  European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (

OJ L 365, 31.12.1994, p. 10

).

(5)  Council Decision (EU, Euratom) 2020/2053 of 14 December 2020 on the system of own resources of the European Union and repealing Decision 2014/335/EU, Euratom (

OJ L 424, 15.12.2020, p. 1

).

(6)  

OJ C 465, 17.11.2021, p. 11

.

(7)  Regulation (EU) 2024/1781 of the European Parliament and of the Council of 13 June 2024 establishing a framework for the setting of ecodesign requirements for sustainable products, amending Directive (EU) 2020/1828 and Regulation (EU) 2023/1542 and repealing Directive 2009/125/EC (

OJ L, 2024/1781, 28.6.2024, ELI: http://data.europa.eu/eli/reg/2024/1781/oj

).

(8)  Directive (EU) 2019/904 of the European Parliament and of the Council of 5 June 2019 on the reduction of the impact of certain plastic products on the environment (

OJ L 155, 12.6.2019, p. 1

).

(9)  Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (

OJ L 338, 13.11.2004, p. 4

).

(10)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (

OJ L 396, 30.12.2006, p. 1

).

(11)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (

OJ L 353, 31.12.2008, p. 1

).

(12)  Regulation (EU) 2019/1021 of the European Parliament and of the Council of 20 June 2019 on persistent organic pollutants (

OJ L 169, 25.6.2019, p. 45

).

(13)  Commission Decision 2001/171/EC of 19 February 2001 establishing the conditions for a derogation for glass packaging in relation to the heavy metal concentration levels established in Directive 94/62/EC on packaging and packaging waste (

OJ L 62, 2.3.2001, p. 20

).

(14)  Commission Decision 2009/292/EC of 24 March 2009 establishing the conditions for a derogation for plastic crates and plastic pallets in relation to the heavy metal concentration levels established in Directive 94/62/EC of the European Parliament and of the Council on packaging and packaging waste (

OJ L 79, 25.3.2009, p. 44

).

(15)  Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (

OJ L 311, 28.11.2001, p. 67

).

(16)  Regulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (

OJ L 4, 7.1.2019, p. 43

).

(17)  Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (

OJ L 117, 5.5.2017, p. 1

).

(18)  Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on

in vitro

diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (

OJ L 117, 5.5.2017, p. 176

).

(19)  Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (

OJ L 181, 29.6.2013, p. 35

).

(20)  Directive 2008/68/EC of the European Parliament and of the Council of 24 September 2008 on the inland transport of dangerous goods (

OJ L 260, 30.9.2008, p. 13

).

(21)  Contact-sensitive packaging refers to plastic packaging of products covered by Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (

OJ L 268, 18.10.2003, p. 29

), Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food (

OJ L 338 13.11.2004, p. 4

), Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (

OJ L 229, 1.9.2009, p. 1

), Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (

OJ L 342, 22.12.2009, p. 59

), Regulation (EU) 2017/745, Regulation (EU) 2017/746, Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (

OJ L 4, 7.1.2019, p. 1

), Regulation (EU) 2019/6, Directive 2001/83/EC and Directive 2008/68/EC.

(22)  

OJ L 39, 16.2.1993, p. 3

.

(23)  

OJ L 179, 23.6.1998, p. 3

.

(24)  

OJ L 171, 27.6.1981, p. 13

.

(25)  

OJ L 186, 5.8.1995, p. 44

.

(26)  Commission Regulation (EU) 2022/1616 of 15 September 2022 on recycled plastic materials and articles intended to come into contact with foods, and repealing Regulation (EC) No 282/2008 (

OJ L 243, 20.9.2022, p. 3

).

(27)  Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (

OJ L 316, 14.11.2012, p. 12

).

(28)  Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (

OJ L 347, 20.12.2013, p. 671

).

(29)  Regulation (EU) 2019/787 of the European Parliament and of the Council of 17 April 2019 on the definition, description, presentation and labelling of spirit drinks, the use of the names of spirit drinks in the presentation and labelling of other foodstuffs, the protection of geographical indications for spirit drinks, the use of ethyl alcohol and distillates of agricultural origin in alcoholic beverages, and repealing Regulation (EC) No 110/2008 (

OJ L 130, 17.5.2019, p. 1

).

(30)  Regulation (EU) 2023/2411 of the European Parliament and of the Council of 18 October 2023 on the protection of geographical indications for craft and industrial products and amending Regulations (EU) 2017/1001 and (EU) 2019/1753 (

OJ L, 2023/2411, 27.10.2023, ELI: http://data.europa.eu/eli/reg/2023/2411/oj

).

(31)  Regulation (EU) 2024/1143 of the European Parliament and of the Council of 11 April 2024 on geographical indications for wine, spirit drinks and agricultural products, as well as traditional specialities guaranteed and optional quality terms for agricultural products, amending Regulations (EU) No 1308/2013, (EU) 2019/787 and (EU) 2019/1753 and repealing Regulation (EU) No 1151/2012 (

OJ L, 2024/1143, 23.4.2024, ELI: http://data.europa.eu/eli/reg/2024/1143/oj

).

(32)  Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market and amending Council Directive 84/450/EEC, Directives 97/7/EC, 98/27/EC and 2002/65/EC of the European Parliament and of the Council and Regulation (EC) No 2006/2004 of the European Parliament and of the Council (‘Unfair Commercial Practices Directive’) (

OJ L 149, 11.6.2005, p. 22

).

(33)  Directive (EU) 2024/825 of the European Parliament and of the Council of 28 February 2024 amending Directives 2005/29/EC and 2011/83/EU as regards empowering consumers for the green transition through better protection against unfair practices and through better information (

OJ L, 2024/825, 6.3.2024, ELI: http://data.europa.eu/eli/dir/2024/825/oj

).

(34)  Commission Decision 97/129/EC of 28 January 1997 establishing the identification system for packaging materials pursuant to European Parliament and Council Directive 94/62/EC on packaging and packaging waste (

OJ L 50, 20.2.1997, p. 28

).

(35)  Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (

OJ L 124, 20.5.2003, p. 36

).

(36)  Directive (EU) 2015/720 of the European Parliament and of the Council of 29 April 2015 amending Directive 94/62/EC as regards reducing the consumption of lightweight plastic carrier bags (

OJ L 115, 6.5.2015, p. 11

).

(37)  Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (

OJ L 218, 13.8.2008, p. 82

).

(38)  Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (

OJ L 169, 25.6.2019, p. 1

).

(39)  Regulation (EU) 2022/2065 of the European Parliament and of the Council of 19 October 2022 on a Single Market For Digital Services and amending Directive 2000/31/EC (Digital Services Act) (

OJ L 277, 27.10.2022, p. 1

).

(40)  Directive (EU) 2018/852 of the European Parliament and of the Council of 30 May 2018 amending Directive 94/62/EC on packaging and packaging waste (

OJ L 150, 14.6.2018, p. 141

).

(41)  Commission Implementing Decision (EU) 2019/1004 of 7 June 2019 laying down rules for the calculation, verification and reporting of data on waste in accordance with Directive 2008/98/EC of the European Parliament and of the Council and repealing Commission Implementing Decision C(2012)2384 (

OJ L 163, 20.6.2019, p. 66

).

(42)  Regulation (EC) No 1013/2006 of the European Parliament and of the Council of 14 June 2006 on shipments of waste (

OJ L 190, 12.7.2006, p. 1

).

(43)  Regulation (EU) 2024/1157 of the European Parliament and of the Council of 11 April 2024 on shipments of waste, amending Regulations (EU) No 1257/2013 and (EU) 2020/1056 and repealing Regulation (EC) No 1013/2006 (

OJ L, 2024/1157, 30.4.2024, ELI: http://data.europa.eu/eli/reg/2024/1157/oj

).

(44)  Commission Decision 2005/270/EC of 22 March 2005 establishing the formats relating to the database system pursuant to Directive 94/62/EC of the European Parliament and of the Council on packaging and packaging waste (

OJ L 86, 5.4.2005, p. 6

).

(45)  Commission Implementing Decision (EU) 2018/896 of 19 June 2018 laying down the methodology for the calculation of the annual consumption of lightweight plastic carrier bags and amending Decision 2005/270/EC (

OJ L 160, 25.6.2018, p. 6

).

(46)  Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (

OJ L 95, 7.4.2017, p. 1

).

(47)  Directive 2014/24/EU of the European Parliament and of the Council of 26 February 2014 on public procurement and repealing Directive 2004/18/EC (

OJ L 94, 28.3.2014, p. 65

).

(48)  Directive 2014/25/EU of the European Parliament and of the Council of 26 February 2014 on procurement by entities operating in the water, energy, transport and postal services sectors and repealing Directive 2004/17/EC (

OJ L 94, 28.3.2014, p. 243

).

(49)  Commission Implementing Regulation (EU) 2015/2447 of 24 November 2015 laying down detailed rules for implementing certain provisions of Regulation (EU) No 952/2013 of the European Parliament and of the Council laying down the Union Customs Code (

OJ L 343, 29.12.2015, p. 558

).

(50)  

OJ L 123, 12.5.2016, p. 1

.

(51)  Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (

OJ L 55, 28.2.2011, p. 13

).

(52)  

OJ L 124, 17.5.2005, p. 4

.

(53)  Regulation (EU) 2021/1119 of the European Parliament and of the Council of 30 June 2021 establishing the framework for achieving climate neutrality and amending Regulations (EC) No 401/2009 and (EU) 2018/1999 (‘European Climate Law’) (

OJ L 243, 9.7.2021, p. 1

).

(54)  Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (

OJ L 31, 1.2.2002, p. 1

).

(55)  Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (

OJ L 304, 22.11.2011, p. 64

).

(56)  Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (

OJ L 268, 18.10.2003, p. 29

).

(57)  Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC (

OJ L 229, 1.9.2009, p. 1

).

(58)  Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (

OJ L 342, 22.12.2009, p. 59

).

(59)  Regulation (EU) 2019/4 of the European Parliament and of the Council of 11 December 2018 on the manufacture, placing on the market and use of medicated feed, amending Regulation (EC) No 183/2005 of the European Parliament and of the Council and repealing Council Directive 90/167/EEC (

OJ L 4, 7.1.2019, p. 1

).

(60)  Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements (

OJ L 183, 12.7.2002, p. 51

).

(61)  Commission Decision (EU) 2023/1809 of 14 September 2023 establishing the EU Ecolabel criteria for absorbent hygiene products and for reusable menstrual cups (

OJ L 234, 22.9.2023, p. 142

).

(62)  Directive 2010/75/EU of the European Parliament and of the Council of 24 November 2010 on industrial emissions (integrated pollution prevention and control) (

OJ L 334, 17.12.2010, p. 17

).

(63)  Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (

OJ L 328, 21.12.2018, p. 82

).

(64)  Council Regulation (EC) No 6/2002 of 12 December 2001 on Community designs (

OJ L 3, 5.1.2002, p. 1

).

(65)  Directive 98/71/EC of the European Parliament and of the Council of 13 October 1998 on the legal protection of designs (

OJ L 289, 28.10.1998, p. 28

).

(66)  Regulation (EU) 2017/1001 of the European Parliament and of the Council of 14 June 2017 on the European Union trade mark (

OJ L 154, 16.6.2017, p. 1

).

(67)  Directive (EU) 2015/2436 of the European Parliament and of the Council of 16 December 2015 to approximate the laws of the Member States relating to trade marks (

OJ L 336, 23.12.2015, p. 1

).

(68)  Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (

OJ L 119, 4.5.2016, p. 1

).

(69)  Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (

OJ L 304, 22.11.2011, p. 18

).

(70)  Council Regulation (EEC) No 2658/87 of 23 July 1987 on the tariff and statistical nomenclature and on the Common Customs Tariff (

OJ L 256, 7.9.1987, p. 1

).

(71)  Regulation (EU) No 251/2014 of the European Parliament and of the Council of 26 February 2014 on the definition, description, presentation, labelling and the protection of geographical indications of aromatised wine products and repealing Council Regulation (EEC) No 1601/91 (

OJ L 84, 20.3.2014, p. 14

).

(72)  Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and repealing Regulation (EEC) No 339/93 (

OJ L 218, 13.8.2008, p. 30

).

(73)  Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (

OJ L 435, 23.12.2020, p. 1

).

(74)  Commission Implementing Regulation (EU) 2023/595 of 16 March 2023 establishing the form for the statement relating to the own resource based on non-recycled plastic packaging waste pursuant to Council Regulation (EU, Euratom) 2021/770 (

OJ L 79, 17.3.2023, p. 151

).

(75)  Regulation (EU) 2019/1150 of the European Parliament and of the Council of 20 June 2019 on promoting fairness and transparency for business users of online intermediation services (

OJ L 186, 11.7.2019, p. 57

).

ANNEX I

Indicative list of items in the scope of the definition of packaging in Article 3(1), point (1)

A.   Article 3(1), point (1)(a)

1.

Items that are packaging:

 

Sweet boxes

 

Film overwrap around a CD case

 

Mailing pouches for catalogues and magazines (with a magazine inside)

 

Cake doilies sold with a cake

 

Rolls, tubes and cylinders around which flexible material (e.g. plastic film, aluminium or paper) is wound, except rolls, tubes and cylinders intended as parts of production machinery and not used to present a product as a sales unit

 

Flower and plant pots, including seed trays, intended to be used only for selling and transporting

 

Glass bottles for injection solutions

 

CD spindles (sold with CDs, not intended to be used as storage)

 

Clothes hangers (sold with a clothing item)

 

Matchboxes

 

Sterile barrier systems (pouches, trays and materials necessary to preserve the sterility of the product)

 

Refillable steel cylinders used for various kinds of gas, excluding fire extinguishers

 

Tea and coffee foil pouches

 

Boxes used for toothpaste tubes

2.

Items that are not packaging:

 

Flower and plant pots, including seed trays, used in business-to-business relations throughout different stages of production or intended to be sold with the plant

 

Tool boxes

 

Wax layers around cheese

 

Sausage casing skins

 

Clothes hangers (sold separately)

 

Cartridges for printers

 

CD, DVD and video cases (sold together with a CD, DVD or video inside)

 

CD spindles (sold empty, intended to be used as storage)

 

Soluble bags for detergents

 

Graveside lights (containers for candles)

 

Mechanical quern (integrated in a refillable recipient, e.g. refillable pepper mill)

B.   Article 3(1), points (1)(b) and (c)

1.

Items that are packaging:

 

Labels hung directly on or attached to a product including sticky labels attached to fruits and vegetables

 

Mascara brush which forms part of the container closure

 

Sticky labels attached to another packaging item

 

Staples

 

Plastic sleeves

 

Device for measuring dosage, which forms part of the container closure for detergents

 

Mechanical quern (integrated in a non-refillable recipient, filled with a product, e.g. pepper mill filled with pepper)

2.

Items that are not packaging:

 

Radio frequency identification (RFID) tags

 

Tyre labels in the form of stickers in accordance with Regulation (EU) 2020/740 of the European Parliament and of the Council (1)

C.   Article 3(1), points (1)(d) and (e)

1.

Items that are packaging, if designed and intended to be filled at the point of sale:

 

Paper or plastic carrier bags

 

Disposable plates and cups

 

Cling film

 

Sandwich bags

 

Aluminium foil

 

Plastic foil for cleaned clothes in laundries

2.

Items that are not packaging:

 

Stirrer

 

Disposable cutlery

 

Wrapping paper (sold separately to consumers and business operators)

 

Paper baking cases (sold empty)

 

Cake doilies sold without a cake

 

Disposable plates and cups not intended to be filled at the point of sale

(1)  Regulation (EU) 2020/740 of the European Parliament and of the Council of 25 May 2020 on the labelling of tyres with respect to fuel efficiency and other parameters, amending Regulation (EU) 2017/1369 and repealing Regulation (EC) No 1222/2009 (

OJ L 177, 5.6.2020, p. 1

).

ANNEX II

Categories and parameters for assessment of recyclability of packaging

Table 1

Indicative list of packaging materials, types and categories referred to in Article 6

Table 2

Indicative list of packaging materials and categories referred to in Article 6

Table 3

Recyclability performance grades

Packaging recyclability shall be expressed in the performance grades A, B or C.

From 2030, recyclability performance is based on design for recycling criteria. The design for recycling criteria shall ensure the circularity of the use of the resulting secondary raw materials of sufficient quality to substitute the primary raw materials.

The assessment based on design for recycling criteria shall be carried out for each packaging category listed in Table 1, taking into account the methodology established under Article 6(4) and the related delegated acts, as well as the parameters established in Table 4. After weighing the criteria per packaging unit, it will be classified into categories A, B or C. When a packaging unit’s recyclability performance grade is below 70 %, it is considered to be non-compliant with the recyclability performance grades and therefore the packaging will be considered technically non-recyclable and its placing on the market shall be restricted.

From 2035, a new factor shall be added to the assessment of the packaging recyclability, which is the recycled-at-scale assessment. Consequently, a new assessment shall be carried out based on the quantity (weight) of the material effectively recycled from each of the packaging categories in accordance with the methodology established in the implementing acts adopted under Article 6(5). The thresholds related to the annual recycled packaging materials for compliance with the recycled-at-scale assessment shall be defined taking into account the targets set in Article 3(1), point (39).

Table 4

Non-exhaustive list of parameters for setting design for recycling criteria under Article 6

The list in this Table shall be used as a basis when defining design for recycling criteria, as set out in Article 6(4). The design for recycling criteria shall then be used in order to set the calculations leading to the performance grades listed in Table 3. In addition, the assessment of the parameters set out in that list shall consider:

— separability of any component of packaging, either manually by end users or in processing plants,

— efficiency of sorting and recycling processes, for example yield,

— evolution of sorting and recycling technologies (to address the aspect if the packaging cannot be sorted today, but it might be sortable in 2 years), and

— preservation of functionality of secondary raw materials enabling the substitution of primary raw materials.

The packaging functionality that the following parameters provide to the packaging shall be factored-in in the setting of design for recycling criteria.

(1)  Please note that this category contains plastics that are readily biodegradable (meaning a proven ability to convert >90 % of the original material into CO

2

, water and minerals by biological processes within 6 months) and regardless of the feedstock used for their production. Biobased polymers that are not readily biodegradable are covered under the other relevant plastic categories.

ANNEX III

Compostable packaging

Conditions to be considered when mandating or introducing the use of compostable packaging format:

(a) it could not have been designed as reusable packaging or the products could not be placed on the market without packaging;

(b) it is designed to enter the organic waste stream at the end of its life;

(c) it is of such biodegradable nature that it allows the packaging to undergo physical or biological decomposition, including anaerobic digestion, resulting ultimately in conversion into carbon dioxide and water, new microbial biomass, mineral salts, and, in the absence of oxygen, methane;

(d) its use significantly increases the collection of organic waste compared to the use of non-compostable packaging materials;

(e) its use significantly reduces the contamination of compost with non-compostable packaging and does not cause any problems in bio-waste processing;

(f) its use does not increase the contamination of non-compostable packaging waste streams.

ANNEX IV

Methodology for packaging minimisation assessment

Part A

Performance criteria

1.

Product protection: packaging design shall ensure protection of the product, from the point of packaging or filling until its end use, with a view to preventing significant product damage, loss, deterioration or waste. Requirements may consist of protection against mechanical or chemical damage, vibration, compression, humidity, moisture loss, oxidation, light, oxygen, microbiological infection, pest, deterioration of organoleptic properties, etc. and include references to specific Union law setting out requirements on product quality.

2.

Packaging manufacturing processes: the packaging design shall be compatible with the packaging manufacturing and filling processes. The packaging manufacturing processes may determine packaging design elements, such as the shape of a container, thickness tolerances, size, feasibility of tooling, or specifications minimising waste in manufacturing. The processes operated by manufacturer of products may also require certain design elements of packaging, such as impact and stress resistance, mechanical strength, packing line speed and efficiency, stability in conveying, heat resistance, effective closing, minimum headspace, or hygiene.

3.

Logistics: the packaging design shall ensure adequate and safe distribution, transport, handling and warehousing of the packaged product. Requirements may consist of dimensional coordination for optimum space utilisation, compatibility with palletising and de-palletising systems, handling and warehousing system, and packaging system integrity during transport and handling.

4.

Packaging functionality: the packaging design shall ensure its functionality, taking into account the purpose of the product and particularities giving rise to its sale, such as sales for gift purposes, or on the occasion of seasonal events.

5.

Information requirements: the packaging design shall ensure that any necessary information regarding the packaged product itself, its use, storage and care, including safety instructions, can be provided to end users. Requirements may include providing product information, instructions for storage, application and use, bar codes and the best before date.

6.

Hygiene and safety: the packaging design shall ensure user and consumer safety as well as product safety and hygiene throughout the distribution, end use and disposal of the packaged product. Requirements may include those on safe handling design, child resistance, anti-tamper, anti-theft, anti-counterfeit, hazard warnings, clear identification of content, safe opening device or pressure-release closure.

7.

Legal requirements: the packaging design shall ensure that the packaging and packaged product can comply with applicable law.

8.

Recycled content, recyclability and re-use: the packaging design shall ensure reusability, recyclability and inclusion of recycled content as required under this Regulation. If the packaging is intended for re-use, it shall fulfil the requirements laid down in Article 11(1). This means that the packaging weight or volume may have to be increased beyond what would otherwise be possible under the other performance factors in order to enable for example a higher number of trips or rotations, to facilitate inclusion of recycled content or to enhance recyclability (for example when moving to a mono-material or post-consumer recycled content).

Part B

Assessment methodology and determination of the minimum packaging volume and weight

The assessment of the minimum packaging volume and weight necessary to ensure the packaging functionality as described in Article 3(1), point (1), shall be explained in the technical documentation and shall include at least:

(a) the description of the outcome of the assessment, including the details of the calculation of the minimum necessary weight and volume for the packaging; possible variations between production batches for a same packaging shall be taken into account and documented;

(b) for each performance criterion as listed in Part A, a description which explains the design requirement that prevents further reduction of the packaging weight or volume without endangering the packaging functionality, including safety and hygiene, for the packaged product, packaging and user; the method used for the identification of these design requirements shall be described, and the reasons preventing further reduction of the packaging weight or volume shall be explained; all reduction opportunities with a given packaging material shall be investigated, such as the reduction of any superfluous layer which does not perform a packaging function; substitution of one packaging material with another shall not be considered sufficient;

(c) any test results, market research or studies that have been used for the assessment conducted under points (a) and (b).

ANNEX V

Restrictions on use of packaging formats

(1)  Regulation (EU) 2018/848 of the European Parliament and of the Council of 30 May 2018 on organic production and labelling of organic products and repealing Council Regulation (EC) No 834/2007 (

OJ L 150, 14.6.2018, p. 1

).

ANNEX VI

Requirements specific to re-use systems and refill stations

For the purposes of this Annex, the following definitions apply:

(a) ‘governance guidelines’ means the governance structure of a re-use system that defines the role of system participants, ownership and any envisaged transfer of ownership of packaging, as well as other relevant governance elements of the re-use system as defined in this Annex;

(b) ‘closed loop system’ means a re-use system in which reusable packaging is circulated by a system operator or a co-operating group of system participants without the change of the ownership of packaging;

(c) ‘open loop system’ means a re-use system in which reusable packaging circulates amongst an unspecified number of system participants, and the ownership of the packaging changes at one or more points in the re-use process;

(d) ‘system operator’ means any natural or legal person who is a system participant and manages a re-use system;

(e) ‘system participant’ shall mean any natural or legal person who participates in a re-use system and performs at least one of the following actions: collects the packaging either from end users or from other system participants, reconditions it, distributes it among system participants, transports it, fills it with products, packs it or offers it to end users; a re-use system can comprise one or more system participants.

Part A

Requirements for re-use systems

1.   General requirements for re-use systems

All re-use systems shall:

(a) have a clearly defined governance structure as described in the governance guidelines;

(b) have a governance structure that:

(i) ensures that the objectives of the system in the governance guidelines and, if applicable, the re-use targets and any other objectives of the system can be met;

(ii) allows for equal access and fair conditions of all economic operators wishing to become a part of the system;

(iii) allows for equal access and fair conditions for all end users;

(c) be designed to ensure that reusable packaging rotating within them completes at least the minimum intended number of rotations as set out in the delegated act adopted pursuant to Article 11(2);

(d) have rules defining their functioning, including requirements for packaging use, that are accepted by all system participants and which:

(i) specify types and design of packaging allowed to circulate in the system;

(ii) describe the products intended to be used, filled or transported through the system;

(iii) specify the terms and conditions for proper handling and packaging use;

(iv) specify detailed requirements for packaging reconditioning;

(v) specify the requirements for packaging collection;

(vi) specify the requirements for packaging storage;

(vii) specify the requirements for packaging filling or uploading;

(viii)

specify rules to ensure the effective and efficient collection of reusable packaging, including by providing for incentives for end users to return the packaging to the collection points or grouped collection system;

(ix) specify rules to ensure equal and fair access to the re-use system, including for vulnerable consumers;

(e) have a system operator that controls the proper functioning of the system and verifies whether re-use is properly enabled;

(f) have reporting rules allowing to access data on the number of fillings or re-uses (i.e. rotations per category) and rejects, collection rate (i.e. return rates), sales units or equivalent units, including the material and per category, or an average estimation if the calculation is not feasible, number of units of reusable or refillable packaging added to the system, and number of units of packaging that have been handled by the end-of-life plan;

(g) ensure that the design of the packaging is laid down in accordance with mutually agreed specifications or standards;

(h) ensure a fair distribution of costs and benefits for all system participants;

(i) ensure the implementation of the extended producer responsibility obligations for reusable packaging used in the system and that has become waste.

The open loop systems which do not have a system operator shall be exempt from points (b)(i), (e), (f) and (h).

Open loop systems established prior to the entry into force of this Regulation shall be exempt from the requirements under points (a), (b)(i) and (ii), (e), (f) and (h).

2.   Requirements for closed loop systems

In addition to the general requirements for re-use systems listed under point 1, closed loop systems shall satisfy the following requirements:

(a) the system has reverse logistics facilitating transfer of the packaging from the end users back to the system participants;

(b) the system ensure the collection, reconditioning and redistribution of packaging;

(c) system participants are obliged to take the packaging back from the collection point if it has been used, collected and stored in accordance with the system rules.

3.   Requirements for open loop systems

In addition to the general requirements for re-use systems listed under point 1, open loop systems shall satisfy the following requirements:

(a) after packaging is used, the system participant decides whether to re-use the packaging or to pass it to another system participant for re-use;

(b) the system ensures that the collection, reconditioning and redistribution of packaging are in place and are generally available;

(c) reconditioning meeting the requirements under Part B is part of the system.

Part B

Reconditioning

1.

The reconditioning process shall not create risks for the health and safety of those responsible for carrying out the reconditioning of the packaging and shall minimise the impact of that process on the environment. It shall be operated in accordance with applicable laws on contact-sensitive materials, waste and industrial emissions.

2.

Reconditioning shall cover the following operations adapted to the reusable packaging format and its intended use:

(a) assessment of the condition of the packaging;

(b) removal of damaged or non-reusable components of the packaging;

(c) conveyance of removed components of the packaging to an appropriate recovery process;

(d) cleaning and washing the packaging according to required hygiene conditions;

(e) repair of the packaging;

(f) inspection and assessment of fitness-for-purpose of the packaging.

3.

Where necessary, cleaning and washing processes shall be carried out at different stages of the reconditioning and repeated.

4.

The reconditioned product shall meet health and safety requirements applicable to it.

Part C

Requirements for refill

Refill stations shall satisfy the following requirements:

(a) the refill station displays clear and precise information on:

(i) the hygiene standards that the end user’s container must meet in order for it to be used to purchase products at the refill station;

(ii) the types and features of containers that can be used to purchase products through refill;

(iii) the contact details of the final distributor to ensure compliance with hygiene standards under applicable law;

(b) the refill station comprises a measuring device or provides alternative means of ensuring that the end user can choose a specified quantity of product for purchase;

(c) the price paid by end users does not include the weight of the container.

ANNEX VII

Conformity assessment procedure

Module A

Internal production control

1.

Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 3 and 4 and ensures and declares on his sole responsibility that the packaging concerned satisfies the requirements of Articles 5 to 12 of this Regulation that apply to it.

2.   Technical documentation

The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the packaging’s conformity with the applicable requirements, and shall include an adequate analysis and assessment of the risks of non-conformity.

The technical documentation shall specify the applicable requirements and shall cover, as far as relevant for the assessment, the design, manufacture and operation of the packaging. The technical documentation shall contain, wherever applicable, at least the following elements:

(a) a general description of the packaging and its intended use;

(b) conceptual design, manufacturing drawings and materials of components;

(c) descriptions and explanations necessary for the understanding of the drawings provided under point (b) and the schemes and operation of the packaging;

(d) a list of:

(i) the harmonised standards, referred to in Article 36, applied in full or in part;

(ii) the common specifications, referred to in Article 37, applied in full or in part;

(iii) other relevant technical specifications used for measurement or calculation purposes;

(iv) in the event of partly applied harmonised standards or common specifications, an indication of the parts which have been applied;

(v) in the event of harmonised standards or common specifications not being applied, a description of the solutions adopted to meet the requirements referred to in point 1;

(e) a qualitative description of how the assessments provided for in Articles 6, 10 and 11 have been carried out; and

(f) test reports.

3.   Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and the monitoring thereof ensure compliance of the manufactured packaging with the technical documentation referred to in point 2 and with the requirements referred to in point 1.

4.   Declaration of conformity

The manufacturer shall draw up a written declaration of conformity for each packaging type and keep it together with the technical documentation at the disposal of the national authorities for 5 years after single-use packaging has been placed on the market, and 10 years after reusable packaging has been placed on the market. The declaration of conformity shall identify the packaging for which it has been drawn up.

A copy of the declaration of conformity shall be made available to the relevant authorities upon request.

5.   Authorised representative

The manufacturer’s obligations set out in point 4 as regards keeping the technical documentation may be fulfilled by its authorised representative, on its behalf and under its responsibility, provided that those obligations are specified in the mandate.

ANNEX VIII

EU declaration of conformity No 

(

*1

)

…

1.   

No … (unique identification of the packaging):

2.   

Name and address of the manufacturer and, where applicable, the manufacturer’s authorised representative:

3.   

This declaration of conformity is issued under the sole responsibility of the manufacturer.

4.   

Object of the declaration (identification of the packaging allowing traceability): description of the packaging:

5.   

The object of the declaration referred to point 4 is in conformity with the relevant Union harmonisation legislation: … (reference to the other Union acts applied).

6.   

References to the relevant harmonised standards or the common specifications used or references to the other technical specifications in relation to which conformity is declared:

7.   

Where applicable, the notified body … (name, address, number) … performed … (description of intervention) … and issued the certificate(s): … (details, including the date of the certificate(s), and, where appropriate, information on the duration and conditions of validity).

8.   

Additional information:

Signed for and on behalf of:

(place and date of issue):

(name, function) (signature):

(

*1

)

  (identification number of the declaration)

ANNEX IX

Information for registration and reporting to the register referred to in Article 44

Part A

Information to be submitted upon registration

1.

The information to be submitted by the producer or its authorised representative for extended producer responsibility shall include:

(a) name and brand names (if available) under which the producer makes its packaging, including packaging of packaged products, available on the territory of the Member State and address of the producer, including postal code and place, street and number, country, telephone, if any, web address and e-mail address, indicating a single contact point;

(b) where a producer has authorised an authorised representative with carrying out the extended producer responsibility obligations on its behalf, in addition to the information referred in point (a): name and address including postal code and place, street and number, country, telephone and e-mail address of the authorised representative;

(c) national identification code of the producer, including its trade register number or equivalent official registration number and the European or national tax identification number;

(d) a declaration on how the producer meets its responsibilities under Article 45, including a certificate issued by the producer responsibility organisation where Article 46(1) applies.

2.

Where a producer responsibility organisation is entrusted with carrying out the extended producer responsibility obligations, the information to be provided by the producer shall include the name and contact details, including postal code and place, street and number, country, telephone, web address and e-mail address and the national identification code of the producer responsibility organisation, including the trade register number or an equivalent official registration number and the European or national tax identification number of the producer responsibility organisation, the represented producer’s mandate, and a statement by the producer or, where applicable, producer’s authorised representative for the extended producer responsibility or the producer responsibility organisation stating that the information provided is true.

3.

Where a producer responsibility organisation that has been entrusted with carrying out the extended producer responsibility obligations by the producer as referred to in Article 46(1), carries out the obligation to register set out in Article 44, it shall, in addition to the information required under point 1 of this Part, provide:

(a) the names and contact details, including postal codes and places, streets and numbers, countries, telephones, web addresses and e-mail addresses of the producers represented;

(b) the mandate of each represented producer, where applicable;

(c) where the producer responsibility organisation represents more than one producer, a separate indication of how each one of the represented producers meets the responsibilities set out in Article 45.

Part B

Information to be submitted for reporting

1.

Information to be submitted for reporting in accordance with Article 44(7):

(a) national identification code of the producer;

(b) reporting period;

(c) quantities by weight of packaging categories as set out in Table 1 of Annex II that the producer makes available on the territory of the Member State for the first time or that the producer unpacks without being an end user;

(d) arrangements to ensure the producer responsibility regarding the packaging made available for the first time on the territory of the Member State or from which packaged products are unpacked by a producer who is not an end user.

2.

Information to be submitted for reporting in accordance with Article 44(8):

(a) national identification code of the producer;

(b) reporting period;

(c) information on packaging types set out in Table 1 of this point;

(d) arrangements to ensure the producer responsibility regarding the packaging made available for the first time on the territory of the Member State or from which packaged products are unpacked by a producer who is not an end user.

Table 1

3.

Information to be submitted for reporting in accordance with Article 44(10):

(a) quantities, by weight, per category of packaging waste, as defined in Table 2 of Annex II, collected in the Member State and sent for sorting;

(b) quantities, by weight, per category of packaging waste recycled, recovered and disposed of within the Member State or shipped within Union or in a third country as set out in Table 3 of Annex XII;

(c) quantities, by weight, of separately collected single-use plastic beverage bottles with a capacity of up to three litres and single-use metal beverage containers with a capacity of up to three litres, as set out in Table 5 of Annex XII.

ANNEX X

Minimum requirements for deposit and return systems

For the purpose of this Annex, the following definition applies:

‘system operator’ means any natural or legal person who is entrusted with a responsibility to establish or operate a deposit and return system in a Member State.

Minimum general requirements for deposit and return systems

Member States shall ensure that the deposit and return systems established on their territories meet the following minimum requirements:

(a) a single system operator is established or licenced or, in the case there is more than one system operator, Member State shall adopt measures to ensure coordination between the different system operators;

(b) the governance and related operational rules of the system allow for equal access and fair conditions of all economic operators wishing to become part of the system, provided they make available on the market packaging that belongs to a packaging type or category included in the system;

(c) control procedures and reporting systems are set up allowing the system operator to obtain data on the collection of packaging covered by the deposit and return system;

(d) a minimum deposit level is established, which is sufficient to achieve the required collection rates;

(e) minimum requirements on the financial capacity of the system operator are established allowing the system operator to perform its functions;

(f) the system operator is a non-profit and independent legal entity;

(g) the system operator performs exclusively roles arising from the rules of this Regulation, and any additional roles related to the coordination and operation of the deposit and return system as established by the Member States;

(h) the system operator coordinates the functioning of the deposit and return system;

(i) the system operator keeps in writing:

(i) a statute establishing the internal organisation of the system;

(ii) evidence of the funding system of the system;

(iii) a statement proving the compliance of the system with the requirements laid down in this Regulation, as well as any additional requirements established in the Member State in which it operates;

(j) a sufficient amount of the annual turnover of the system operator is used for public awareness campaigns on the management of packaging waste;

(k) system operators provide any information requested by the competent authorities of a Member State in which the system operates, for the purposes of monitoring compliance with the requirements in this Annex;

(l) Member States shall ensure that final distributors are obligated to accept the deposit bearing packaging of the packaging material and format that they distribute and to provide end users with redeemed deposits when the deposit bearing packaging is returned, unless end users have equally accessible means to redeem the deposit after the use of the deposit bearing packaging, through one of the collection channels that, for food packaging, ensure food grade recycling and that are authorised for that purpose by the national authorities.

This obligation does not apply where the sale surface area does not make possible for end users to return deposit bearing packaging. However, final distributors will always have to accept the return of the empty packaging of products they sell;

(m) the end user is able to return the deposit bearing packaging without the need to purchase any goods; deposit shall be redeemed to the end user;

(n) all deposit bearing packaging that is to be collected by a deposit and return system is clearly labelled, so that the end users can easily identify the need to return such packaging;

(o) fees are transparent.

In addition to the minimum requirements, Member States may set additional requirements, as appropriate, in order to ensure the fulfilment of the objectives of this Regulation, in particular to increase the purity of the collected packaging waste, reduce litter or promote other circular economy objectives.

Member States with regions with high transboundary business shall ensure that the deposit and return systems allows for collection of packaging from other Member States’ deposit and return systems at designated collection points and shall endeavour to enable the possibility of return of a deposit that was charged to the end user when purchasing the packaging.

ANNEX XI

Implementation plan to be submitted pursuant to Article 52(2), point (d)

The implementation plan to be submitted pursuant to Article 52(2), point (d), shall contain the following:

(a) assessment of the past, current and projected rates of recycling, landfilling and other treatment of packaging waste and the streams of which it is composed;

(b) assessment of the implementation of waste management plans and waste prevention programmes in place pursuant to Articles 28 and 29 of Directive 2008/98/EC;

(c) reasons for which the Member State considers that it might not be able to attain the relevant target laid down in Article 52(1), point (b) or (d), within the deadline set therein and an assessment of the time extension necessary to meet that target;

(d) measures necessary to attain the targets set out in Article 52(1), point (b) or (d), of this Regulation that are applicable to the Member State during the time extension, including appropriate economic instruments and other measures to provide incentives for the application of the waste hierarchy as set out in Article 4 of Directive 2008/98/EC;

(e) a timetable for the implementation of the measures identified in point (d), determination of the body competent for their implementation and an assessment of their individual contribution to attaining the targets applicable in the event of a time extension;

(f) information on funding for waste management in line with the polluter pays principle;

(g) measures to improve data quality, as appropriate, with a view to better planning and monitoring performance in waste management.

ANNEX XII

Data to be included by Member States in their databases on packaging and packaging waste (in accordance with Tables 1 to 4)

1.   

For sales, grouped and transport packaging:

(a) quantities, for each packaging categories of packaging generated within the Member State (tonnage produced, imported and stored, less tonnage exported) (Table 1);

(b) quantities of reusable packaging (Table 2).

2.   

For sales, grouped and transport packaging waste:

(a) for each packaging category (Table 3):

(i) quantities of packaging made available on the territory of the Member State for the first time or of packaging from which products were unpacked by a producer who is not an end user;

(ii) quantities of generated packaging waste;

(iii) quantities of packaging disposed of, recovered, and recycled;

(b) the annual consumption of very lightweight plastic carrier bags, lightweight plastic carrier bags and thick plastic carrier bags per capita, separately for each category, as laid down in Article 56(1), point (b), (Table 4);

(c) separate collection rate of the packaging formats covered by the deposit return systems, as laid down in Article 50(1), (Table 5).

Table 1

Quantity of packaging (sales, grouped and transport) generated on the territory of the Member State

Table 2

Quantity of total reusable packaging (sales, grouped and transport) made available on the territory of the Member State for the first time

Table 3

Quantity per packaging category, as defined in Table 2 of Annex II, of: packaging made available on the territory of the Member State for the first time; packaging from which products were unpacked by a producer who is not an end user; generated packaging waste; and packaging waste disposed of, recovered and recycled on the territory of the Member State and exported

Table 4

Quantity of very lightweight plastic carrier bags, lightweight plastic carrier bags, thick plastic carrier bags, and very thick plastic carrier bags per capita, consumed on the territory of the Member State

Table 5

Separate collection rate of packaging formats covered under the deposit return systems, as laid down in Article 50(1)

ANNEX XIII

Correlation table