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

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the European Commission,

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

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

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

Whereas:

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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