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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,

Acting in accordance with the ordinary legislative procedure,

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 (‘waste hierarchy’), this Regulation should contribute to the transition to a circular economy.

(3)European Parliament and Council Directive 94/62/EC 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 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 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, 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.

(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 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 and (EC) No 1272/2008 of the European Parliament and of the Council should be reinforced as the cornerstones for regulating chemicals in the Union and that they should be complemented by coherent approaches to assess and manage chemicals in existing sectorial 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.

(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 and 2009/292/EC, 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 and with Regulation (EU) 2019/6 of the European Parliament and of the Council, 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, contact-sensitive plastic packaging for in vitro diagnostics medical devices covered by Regulation (EU) 2017/746 of the European Parliament and of the Council, 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 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. 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 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 in vitro 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 of 22 March 1989, the United Nations Convention on the Law of the Sea of 10 December 1982, 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, 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, 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, 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. 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 for wine, Regulation (EU) 2019/787 of the European Parliament and of the Council for spirit drinks or Regulation (EU) 2023/2411 of the European Parliament and of the Council 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. 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 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 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 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 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. 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.

(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 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, 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 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.

(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 and Regulation (EU) 2024/1157 of the European Parliament and of the Council 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 and Commission Implementing Decision (EU) 2018/896.

(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, 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 and 2014/25/EU 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, 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. 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.

(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, 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,

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